Contained Use of Genetically Modified Microorganisms Regulations, 2008 (L.N. 127 of 2008)

B 1939 A.L. 127 ta’ l-2008 ATT DWAR IL-{ARSIEN TA’ L-AMBJENT (KAP. 435) Regolamenti ta’ l-2008 dwar l-U]u Kontenut ta’ Mikro-Organi]mi :enetikament Modifikati BIS-SA{{A tas-setg[at mog[tija bl-artikoli 9, 10(2) u 11 ta’ l Att dwar il-{arsien ta’ l-Ambjent, hawnhekk i]jed ’il quddiem imsejja[ “l-Att”, il-Prim Ministru g[amel dawn ir-regolamenti li ;ejjin>– 1. It-titolu ta’ dawn ir-regolamenti hu Regolamenti ta’ l-2008 dwar l-U]u Kontenut ta’ Mikro-Organi]mi Modifikati :enetikament. 2. (1) L-g[an ta’ dawn ir-regolamenti hu li jkunu stabbiliti mi]uri g[all-u]u kontenut ta’ mikro-organi]mi modifikati ;enetikament bl-iskop li tkun protetta s-sa[[a umana u l-ambjent. (2) Dawn ir-regolamenti jipprovdu d-disposizzjonijiet neçessarji g[all-implimentazzjoni tad-Direttiva 90#219#KE tal-Kunsill Ewropew tat-23 ta’ April 1990, f’Malta, rigward l-u]u kontenut ta’ mikro-organi]mi modifikati ;enetikament u g[andhom jinqraw u jiftiehmu b[ala [a;a wa[da ma’ dik id-Direttiva. (3) Dawn ir-regolamenti g[andhom jinqraw u jiftehmu [a;a wa[da mar-Regolamenti ta’ l-2003 dwar il-Protezzjoni tal-{addiema minn Riskji relatati ma’ l-Espo]izzjoni g[al A;enti Bijolo;içi fuq il Post tax-Xog[ol, li g[andhom x’jaqsmu ma’ kwistjonijiet rigward is sa[[a u s-sigurtà fuq il-post tax-xog[ol. DEFINIZZJONIJIET U E}ENZJONIJIET> PARTI I 3. F’dawn ir-regolamenti kemm-il darba r-rabta tal-kliem ma tkunx te[tie; xort’ o[ra> “l-Awtorità Kompetenti” tfisser l-Awtorità ta’ Malta dwar l Ambjent u l-Ippjanar kif stipulat bl-avvi] intitolat Nomina ta’ l Awtorità ta’ Malta dwar l-Ambjent u l-Ippjanar b[ala l-awtorità kompetenti, u tali korp jew persuna li l-Ministru responsabbli g[all ambjent jista’ b’ordni fil-Gazzetta jinnomina u korpi jew persuni Titolu. G[anijiet. A. L. 228 ta’ l-2003. Tipi. Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,238, 29 ta’ April, 2008 Taqsima B –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– B 1940 differenti jistg[u ji;u nnominati b[ala l-awtorità kompetenti g[al dispo]izzjonijiet differenti u skopijiet differenti ta’ dawn ir regolamenti< “inçident” tfisser kull inçident li jinvolvi [elsien sinifikanti u mhux intenzjonat ta’ GMM fil-kors ta’ l-u]u tag[hom kontenut li jista’ jkun ta’ perikolu immedjat jew ritardat g[as-sa[[a umana jew l-ambjent< “mikro-organi]mu” tfisser entità mikrobijolo;ika, kemm çellulari kemm mhux çellulari, kapaçi li tirreplika jew li tittrasferixxi materjal ;enetiku, inklu] kull virus, viroid, çellula tal-pjanti u ta’ l-annimali fil-kultura< “mikro-organi]mu modifikat ;enetikament” jew “GMM” tfisser mikro-organi]mu li fih il-materjal ;enetiku ;ie mibdul b’tali mod li ma jkunx naturali permezz ta’ ta[lit u, jew rikombinazzjoni naturali> Fil-kuntest ta’ din it-tifsira> (a) modifikazzjoni ;enetika isse[[ ta’ l-inqas meta jintu]aw it-tekniki msemmija fi Skeda I, Parti A< (b) tekniki msemmija fi Skeda I, Parti B, ma ji;ux ikkunsidrati li jirri]ultaw f’modifikazzjoni ;enetika< “il-Ministru” tfisser il-Ministru responsabbli g[all-ambjent< “notifika” tfisser meta l-informazzjoni me[tie;a ti;i ippre]entata mill-Awtorità Kompetenti< “utent” tfisser persuna naturali jew legali li tkun responsabbli g[all-u]u kontenut ta’ GMM< “u]u kontentut” tfisser kull attività li fiha mikro-organi]mi ji;u modifikati ;enetikament jew li fiha dawk il-GMM ji;u kultivati, ma[]una, trasportati, meqruda, isir minnhom jew ji;u u]ati b’kull mod ie[or, u li dwar dawk il-mi]uri ta’ konteniment speçifiçi dawn ji;u w]ati biex jillimitaw il-kuntatt ma’, u sabiex ji;i provdut livell g[oli ta’ sigurtà g[al, popolazzjoni in ;enerali u g[all-ambjent. B 1941 ASSESSJAR> PARTI II 4. (1) Sabiex ji;i ]gurat li l-u]u kontenut ta’ GMM ma jkunx jipproduçi effetti kuntrarji fuq is-sa[[a umana u l-ambjent, l-utent g[andu jwettaq assessjar ta’ kull u]u kontenut rigward ir-riskji g[as sa[[a umana u l-ambjent li u]u kontenut b[al dan jista’ jikkaw]a, billi ju]a b[ala minimu l-elementi ta’ assessjar u l-proçedura stabbilità fi Skeda III, sezzjonijiet A u B. (2) L-assessjar imsemmi f’subregolament (1) g[andu jirri]ulta fil-klassifikazzjoni finali ta’ l-u]u kontenut f’erba’ klassijiet billi ti;i applikata l-proçedura stabbilita fi Skeda III, li g[andha tirri]ulta fl-assenjar ta’ livelli kontenuti skond is-subregolamenti (6) u (7)> Klassi 1> attivitajiet ta’ ebda riskju jew ta’ riskju negli;ibbli, li dwarhom ikun adatt il-livell 1 ta’ konteniment. Klassi 2> attivitajiet ta’ riskju baxx, li dwarhom ikun adatt il-livell 2 ta’ konteniment. Klassi 3> attivitajiet ta’ riskju moderat, li dwarhom ikun adatt il-livell 3 ta’ konteniment. Klassi 4> attivitajiet ta’ riskju g[oli, li dwarhom ikun adatt il-livell 4 ta’ konteniment. (3) Meta jkun hemm xi dubju dwar liema klassi tkun adatta g[all-u]u kontenut propost, g[andhom ji;u applikati l-aktar mi]uri stretti, kemm-il darba prova suffiçjenti, bi qbil ma’ l-Awtorità Kompetenti, ma tkunx ti;;ustifika l-applikazzjoni ta’ mi]uri inqas strin;enti. (4) L-assessjar imsemmi fis-subregolament (1) ta’ dan ir regolament g[andu b’mod speçjali jie[u in konsiderazzjoni il-kwistjoni tar-rimi ta’ skart u effluwenti. Meta jkun adatt, g[andhom ji;u implimentati il-mi]uri ta’ sigurtà me[tie;a sabiex tkun protetta s-sa[[a umana u l-ambjent. (5) L-utent g[andu j]omm record ta’ l-assessjar imsemmi fis-subregolament (1) ta’ dan ir-regolament u dak ir-record g[andu jkun disponibbli f’forma skond ma tkun trid l-Awtorità Kompetenti b[ala parti min-notifika skond ir-regolamenti 6, 8 u 9 jew meta ji;i hekk mitlub. (6) L-utent g[andu japplika, [lief meta l-paragrafu 2 ta’ Skeda IV jippermetti li jkunu applikati mi]uri o[ra, il-prinçipji ;enerali Assessjar. B 1942 u l-konteniment adatt u mi]uri protettivi o[ra stipulati fi Skeda IV li jikkorrispondu g[all-klassi ta’ u]u kontenut, sabiex l-espo]izzjoni g[al kull GMM f’xi post tax-xog[ol u l-ambjent tin]amm fl-inqas livell ra;onevolment prattikabbli, u b’hekk ji;i ]gurat livell g[oli ta’ sigurtà. (7) L-assessjar msemmi fis-subregolament (1) ta’ dan ir regolament u l-konteniment u l-mi]uri protettivi l-o[ra applikati g[andhom ji;u riveduti perjodikament, u minnufih jekk> (a) il-mi]uri ta’ konteniment applikati ma jibqg[ux aktar adegwati jew il-klassi assenjata lil dak l-u]u kontenut ma tkunx aktar korretta, jew (b) ikun hemm suspett li l-assessjar m’g[adux aktar valutat b’mod adattat fil-kuntest ta’ g[arfien xjentifiku u tekniku ;did. 5. (1) Ming[ajr pre;udizzju g[ar-regolament 4 (1), dawn ir regolamenti m’g[andhomx ikunu japplikaw> (a) meta modifikazzjoni ;enetika tirri]ulta mill-u]u ta’ tekniki jew metodi msemmija fi Skeda II, Parti A, jew (b) g[al kull u]u kontenut li jinvolvi biss tipi ta’ GMM li jkunu konformi mal-kriterji elenkati fi Skeda II, Parti B li jistabbilixxu s-sigurtà tag[hom g[as-sa[[a umana u l-ambjent. Dawn it-tipi ta’ GMM jinsabu elenkati fi Skeda II, Parti C. (2) Ir-regolament 4 (2), 4(5), 4(6), 4 (7) u regolamenti 6 sa 11 m’g[andhomx japplikaw g[at-trasport ta’ GMM bit-triq, bil-ba[ar jew bl-ajru. (3) Dawn ir-regolamenti m’g[andhomx japplikaw g[all [a]na, kultivar, trasport, qerda, rimi jew u]u ta’ GMM li jkunu tpo;;ew fis-suq skond ir-Regolamenti ta’ l-2002 dwar Tluq Deliberat ta’ Organi]mi Modifikati :enetikament fl-Ambjent, jew konformement ma’ le;islazzjoni relevanti o[ra, li tipprovdi g[all-assessjar ta’ l-impatt ta’ l-ambjent speçifiku, simili g[al dak stabbilit fir-regolamenti msemmija, sakemm l-u]u kontenut ikun skond il-kundizzjonijiet, jekk tkun il-ka], g[all-kunsens g[at-tqeg[id fis-suq. PERMESSI U PENALI> PARTI III> 6. Meta xi post ikun ser jintu]a g[all-ewwel darba g[al xi u]u kontenut, qabel ma jibda tali u]u, l-utent g[andu jippre]enta notifika lill-Awtorità Kompetenti, li jkun fiha ta’ l-inqas l-informazzjoni msemmija fi Skeda V, Parti A. E]enzjonijiet. A.L. 170 ta’ l-2002. Post u]at g[all ewwel darba. B 1943 7. (1) Meta xi u]u kontenut ta’ Klassi 1 ikun ser isiru g[all ewwel darba jew sussegwentement f’post notifikat skond ir-regolament 6, notifika li jkun fiha l-informazzjoni msemmija fi Skeda V, Parti B (minbarra s-sommarju ta’ l-assessjar msemmi f’regolament 4 (1)), g[andha ti;i ppre]entata lill-Awtorità Kompetenti. L-u]u kontenut fi Klassi 1 jista’ jkompli jsir minnufih wara li ssir in-notifika. (2) L-utenti ta’ GMM f’U]u Kontenut ta’ Klassi 1 ikunu me[tie;a li j]ommu record ta’ kull assessjar kif imsemmi fis subregolament 4 (5), li g[andu jkun disponibbli g[all-Awtorità Kompetenti meta ji;i hekk mitlub. 8. (1) Meta xi u]u kontenut ta’ Klassi 2 ikun ser isiru g[all ewwel darba jew sussegwentement f’post notifikat skond ir-regolament 6, g[andha tigi ppre]entata notifika li jkun fiha l-informazzjoni msemmija fi Skeda V, Parti B, g[andha ti;i ippre]entata lill-Awtorità Kompetenti. (2) Jekk il-post kien so;;ett g[al notifika preçedenti biex jitwettaq xi u]u kontenut ta’ Klassi 2 jew ta’ klassi og[la u kull kunsens assoçjat me[tie; ikun ;ie sodisfatti, l-u]u kontenut ta’ Klassi 2 jista’ jkompli jsir minnufih wara li ssir in-notifika l-;dida> I]da l-applikant jista’ wkoll, madankollu huwa stess jitlob deçi]joni dwar awtorizzazzjoni formali ming[and l-Awtorità Kompetenti. Id-deçi]joni g[andha ssir fi ]mien mhux izjed minn 45 jum min-notifika. (3) Jekk il-post ma kienx so;;ett g[al notifika preçedenti biex jitwettaq xi u]u kontenut ta’ Klassi 2 jew ta’ xi klassi og[la, l-u]u kontenut ta’ Klassi 2 jista’, fin-nuqqas ta’ xi indikazzjoni kuntrarja mill Awtorità Kompetenti, ikompli wara 45 jum minn meta ti;i ppre]entata n-notifika msemmija fis-subregolament (1), jew qabel bi qbil ma’ l Awtorità Kompetenti. 9. (1) Dwar l-ewwel u]u kontenut ta’ Klassi 3 u Klassi 4 u dawk li sussegwentement ikunu se jitwettqu f’post notifikat skond ir regolament 6, notifika li jkun fiha l-informazzjoni msemmija fi Skeda V, Parti C, g[andha ti;i ppre]entata lill-Awtorità Kompetenti. (2) U]u kontenut ta’ Klassi 3 jew ta’ klassi og[la ma jistax ikompli qabel ma jkun hemm il-kunsens bil-quddiem mill-Awtorità Kompetenti li g[andha tikkomunika d-Deçi]joni tag[ha bil-miktub> (a) mhux aktar tard minn 45 jum minn meta ti;i ppre]entata n-notifika l-;dida, fil-ka] ta’ postijiet li kienu so;;etti g[al notifika U]u Kontenut ta’ Klassi 1. U]u Kontenut ta’ Klassi 2. U]u Kontenut ta’ Klassi 3 u Klassi 4. B 1944 preçedenti biex jitwettaq xi u]u kontenut ta’ Klassi 3 jew ta’ klassi og[la u meta xi [tie;a ta’ kunsens assoçjat tkun ;iet sodisfatta, g[all-istess klassi jew g[al klassi og[la mill-u]u kontenut li bih ikun hemm [sieb li jitkompla< (b) mhux aktar tard minn 90 jum minn meta tkun ;iet ippre]entata n-notifika, fil-ka]ijiet l-o[ra. 10. (1) Il-persuna li tippre]enta notifika jew li titlob permess g[al attivitajiet imsemmija fir-regolamenti 6, 7, 8 u 9, hawn aktar ’l isfel imsejja[ l-applikant, g[andu jippre]enta t-talba tieg[u bil-miktub lill-Awtorità Kompetenti qabel ma jwettaq dik l-attività. (2) Sabiex l-Awtorità Kompetenti tkun tista’ tassessja notifika jew talba g[al permess b’mod adegwat, g[andu jkun hemm mehmu] ma’ l-applikazzjoni d-dokumenti rilevanti u kull informazzjoni me[tie;a kif speçifikat u me[tie; mill-Awtorità Kompetenti. L-applikant g[andu jindika b’mod çar jekk l-applikazzjoni tippre;udikax xi ka] ta’ infurzar, kaw]a jew kaw]i o[ra li jkunu jinsabu sub-judice. (3) L-Awtorità Kompetenti g[andha te]amina l-konformità tan-notifiki mal-[ti;iet ta’ dawn ir-regolamenti, l-e]attezza u l kompletezza ta’ l-informazzjoni mog[tija, il-korrettezza ta’ l-assessjar msemmi f’regolament 4 (1) u l-klassi ta’ kull u]u kontenut kif ukoll, fejn ikun adatt, kemm ikun sar kif imissu l-konteniment u mi]uri protettivi o[ra, l-immani;;ar ta’ skart, u mi]uri ta’ rispons f’ka] ta’ emer;enza. (4) Jekk ikun me[tie;, l-Awtorità Kompetenti tista’> (a) titlob lill-utent jipprovdi aktar informazzjoni jew jimmodifika l-kundizzjonijiet ta’ l-u]u kontenut propost jew li jemenda l-klassi assenjata lil xi u]u kontenut> I]da f’dan il-ka] l-Awtorità Kompetenti tista’ te[tie; li l-u]u kontenut, jekk ikun propost, ma jibdiex, jew, jekk ikun qed isir, ji;i sospi] jew terminat, sakemm l-Awtorità Kompetenti ma tag[tix l-approvazzjoni tag[ha abba]i ta’ aktar informazzjoni li tinkiseb jew tal-kondizzjonijiet modifikati ta’ l-u]u kontenut< (b) tillimita ]-]mien sa meta jkun permess li jsir l-u]u kontenut jew li dan ikun so;;ett g[all-çerti kondizzjonijiet speçifiçi. (5) G[all-fini tal-kalkolu tal-perjodi msemmija fir regolamenti 8 u 9, kull perjodu ta’ ]mien, li matulu, l-Awtorità Kompetenti> Notifiki lill Awtorità Kompetenti. B 1945 (a) tkun qieg[da tistenna xi informazzjoni ulterjuri li hija tista’ tkun ntalbet g[alih ming[and in-notifikant skond is subregolament 4(a), jew (b) tkun qeg[da twettaq inkjesta jew konsultazzjoni pubblika skond ir-regolament 15, m’g[andux jittie[ed in konsiderazzjoni. (6) Meta l-Awtorità Kompetenti to[ro; permess, hija tista’ timponi dawk il-kondizzjonijiet li tista’ tqis adatti u idonei. (7) Meta l-Awtorità Kompetenti tirrifjuta dak il-permess, hija g[andha tinforma lill-applikant bir-ra;unijiet g[al dak ir-rifjut. (8) Il-perjodu ta’ validità ta’ dak il-permess g[andu wkoll ikun stabbilit fid-diskrezzjoni ta’ l-Awtorità Kompetenti. (9) L-applikant g[andu jipprovdi kopja ta’ kull ri]ultat pubblikat u ta’ kull pubblikazzjoni o[ra, li jkunu rilevanti g[al dan il permess, lill-Awtorità Kompetenti fi ]mien tlett xhur mid-data ta’ pubblikazzjoni. (10) L-Awtorità Kompetenti m’g[andhiex to[ro; jew i;;edded permess jekk l-applikant involut ma jkunx issodisfa jew onora dawk il-kondizzjonijiet jew l-obligazzjonijiet li jori;inaw minn xi permess ie[or ma[ru; mill-Awtorità Kompetenti ta[t dawn ir regolamenti u, jew kull regolamenti o[ra li jkollhom x’jaqsmu mag[hom. 11. (1) (a) Jekk informazzjoni ;dida ssir sussegwentement disponibbli g[all-Awtorità Kompetenti li jista’ jkollha konsegwenzi sinifikanti g[ar-riskji li jin[olqu bl-u]u kontenut, l-Awtorità Kompetenti tista’ te[tie; lill-utent jimmodifika l-kondizzjonijiet ta’, jew li jissospendi jew iwaqqaf, l-u]u kontenut. (b) Meta utent isir jaf b’informazzjoni ;dida jew jimmodifika l-u]u kontenut b’mod li jista’ jkollu konsegwenzi sinifikanti g[ar-riskji li jin[olqu b’dan, l-utent g[andu jwaqqaf l-u]u kontenut u, mill-aktar fis possibbli, jinforma lill-Awtorità Kompetenti. (2) Qabel ma jer;a’ jibda u]u kontenut li jkun twaqqaf skond is-subregolament (1), l-utent g[andu – (a) jirrevedi l-assessjar mwettaq skond ir-regolament 4, u l-klassi u l-livell ta’ konteniment applikati skond is-subregolament 4(2), ta’ dak ir-regolament< u Informazzjoni ;dida dwar riskji ta’ u]u kontenut. B 1946 (b) jippre]enta notifika emendata lill-Awtorità Kompetenti. (3) G[all-fini tas-subregolament (2) id-dispo]izzjonijiet li jkollhom x’jaqsmu mal-pre]entata ta’ notifika minn utent skond ir regolamenti 6, 8 jew 9, u g[all-ipproçessar u deçi]joni dwar notifika b[al dik mill-Awtorità Kompetenti skond ir-regolament 10, g[andhom ikunu japplikaw, skond kif ikun adatt, g[al notifika emendata b[al li kieku din kienet notifika skond ir-regolamenti 6, 8 jew 9. 12. (1) Persuna tista’ tinsab [atja ta’ reat ta[t dawn ir regolamenti jekk> (a) hija tonqos milli tikkonforma ru[ha ma’ xi dispo]izzjoni ta’ dawn ir-regolamenti jew tonqos milli tikkonforma mal kondizzjonijiet tal-permess jew ma’ xi ordni o[ra mog[tija le;ittimament skond xi dispo]izzjoni ta’ dawn ir-regolamenti< jew (b) hija tikser xi restrizzjoni, projbizzjoni jew rekwi]it impost minn jew ta[t dawn ir-regolamenti< jew (ç) hija ta;ixxi f’kontravenzjoni ta’ xi dispo]izzjoni ta’ dawn ir-regolamenti< jew (d) hija tag[mel xi dikjarazzjoni jew tippre]enta informazzjoni jew dokumenti, li dik il-persuna tkun taf li huma falz g[all-fini li takkwista l-approvazzjoni jew it-tkomplija tal permess skond ir-regolamenti 6, 8, 9 jew 11 2(b)< jew (e) hija tikkonfoffa jew tipprova tikkonfoffa, tg[in jew tipprova tg[in, t[ajjar jew tipprova t[ajjar, tag[ti parir jew tipprova tag[ti parir, tqabbad jew tipprova tqabbad, lil xi persuna o[ra sabiex din tikser id-dispo]izzjonijiet ta’ dawn ir-regolamenti jew jekk hija tonqos milli tikkonforma ru[ha ma’ dawk id-dispo]izzjonijiet, inklu]a kull ordni mog[tija le;ittimament skond xi dispo]izzjoni ta’ dawn ir-regolamenti, jew biex tikser xi restrizzjoni, projbizzjoni jew rekwi]it imposti minn jew ta[t ir-regolamenti msemmija jew b[ala ri]ultat ta’dan. (2) Kull persuna li tag[mel jew tipprova tag[mel xi reat kontra dawn ir-regolamenti g[andha, meta tinstab [atja, te[el il-penali li ;ejjin> (a) meta tinsab [atja g[all-ewwel darba ta’ reat ta[t Klassi 1, multa ta’ mhux inqas minn [ames mitt euro, i]da mhux i]jed minn elf euro< meta tinsab [atja g[at-tieni darba jew aktar g[al reat ta[t Klassi 1, multa ta’ mhux inqas minn elf euro, i]da mhux Reati. Penali. B 1947 i]jed minn elfejn u [ames mitt euro jew g[al pri;unerija g[al ]mien mhux i]jed minn sentejn jew g[al dik il-multa u pri;unerija flimkien< (b) meta tinsab [atja g[all-ewwel darba ta’ reat ta[t Klassi 2, multa ta’ mhux inqas minn elf euro, i]da mhux aktar minn elfejn euro< meta tinsab [atja g[at-tieni darba jew aktar g[al reat ta[t Klassi 2, multa ta’ mhux inqas elfejn euro, i]da mhux i]jed minn tlett elef u [ames mitt euro jew g[al pri;unerija g[al ]mien mhux i]jed minn sentejn jew g[al dik il-multa u pri;unerija flimkien< (ç) meta tinstab [atja g[all-ewwel darba ta’ reat ta[t Klassi 3, multa ta’ mhux inqas minn elfejn u [ames mitt euro, i]da mhux i]jed minn sitt elef euro< meta tinsab [atja g[at-tieni darba jew aktar g[al reat ta[t Klassi 3, multa ta’ mhux inqas minn erbat elef u [ames mitt euro, i]da mhux i]jed minn [amsa u g[oxrin elf euro jew g[al pri;unerija g[al ]mien ta’ mhux i]jed minn sentejn jew g[al dik il-multa u pri;unerija flimkien< (d) meta tinsab [atja g[all-ewwel darba ta’ reat ta[t Klassi 4, multa ta’ mhux inqas minn tnax-il elf euro, i]da mhux i]jed minn [amsa u g[oxrin elf euro< meta tinsab [atja g[at-tieni darba jew aktar g[al reat ta[t Klassi 4, multa ta’ mhux inqas [amsa u g[oxrin elf euro, i]da mhux aktar minn [amsa u tletin elf euro jew g[al pri;unerija g[al ]mien ta’ mhux i]jed minn sentejn jew g[al dik il-multa u pri;unerija flimkien> I]da l-Qorti g[andha tordna lil persuna li tinsab [atja li tkun g[amlet reat kontra dawn ir-regolamenti, t[allas l-ispejje] li l Awtorità Kompetenti tkun g[amlet b’ri]ultat ta’ dak ir-reat, inklu]a kull azzjoni li ssir b[ala rimedju g[al danni ka;unati b’dak ir-reat, ir-revoka tal-permess ma[ru; mill-Awtorità Kompetenti u l konfiska tal-corpus delicti, inklu]i wkoll l-ispejje] kollha m;arrba g[a]-]amma u t-trasport ta’ dak il-corpus delicti. (3) Il-Qorti g[andha tordna lill-[ati biex ine[[i il-kaw]i tar reat u li jre;;a lura kull [a;a li tkun saret ming[ajr permess fi ]mien li jkun suffiçjenti g[al dan il-g[an skond ma’ ji;i stabbilit mill-Qorti< u, jekk il-[ati jonqos milli jikkonforma ru[u ma ordni b[al dik fi]-]mien stipulat, g[andu je[el multa ta’ mhux inqas minn sittin euro u mhux i]jed minn [ames mitt euro, skond mal-Qorti tista’ tistabbilixxi, g[al kull ;urnata li n-nuqqas ikompli wara li jiskadi t-terminu msemmi. (4) Id-dispo]izzjonijiet ta’ l-artikoli 23 u 30 tal-Kodiçi Kriminali g[andhom, mutatis mutandis, ikunu japplikaw g[all proçedimenti dwar reati kontra dawn ir-regolamenti, b’dan illi l Applikabilità tal Kodiçi Kriminali. Kap. 9. B 1948 iskwalifika milli persuna jkollha jew tikseb liçenza jew permess mill Awtorità Kompetenti m’g[andha f’ebda ka] tkun ta’ inqas minn sena. (5) Minkejja d-dispo]izzjonijiet ta’ l-artikolu 370 tal-Kodiçi Kriminali, proçedimenti g[al reat kontra dawn ir-regolamenti g[andhom isiru quddiem il-Qorti tal-Ma;istrati (Malta) jew il-Qorti tal-Ma;istrati (G[awdex), skond kif ikun il-ka], u g[andhom jkunu skond id dispo]izzjonijiet tal-Kodiçi Kriminali li jirregolaw il-proçedura quddiem dawk il-qrati b[ala qrati ta’ ;udikatura kriminali. (6) Minkejja d-dispo]izzjonijiet tal-Kodiçi Kriminali, l Avukat :enerali g[andu dejjem ikollu dritt ta’ appell quddiem il-Qorti ta’ l-Appell Kriminali minn kull sentenza mog[tija mill-Qorti tal Ma;istrati (Malta) jew mill-Qorti tal-Ma;istrati (G[awdex) dwar proçedimenti g[al xi reat kontra dawn ir-regolamenti. 13. L-Awtorità Kompetenti tista’ torganizza spezzjonijiet u mi]uri o[ra ta’ kontroll sabiex ti]gura li l-utent ikun jikkonforma ru[u ma’ dawn ir-regolamenti. KONSULTAZZJONI PUBBLIKA U KUNFIDENZJALITÀ> PARTI IV 14. (1) Meta l-kxif ta’ data li jkollha x’taqsam ma’ dawn ir regolamenti tkun taffetwa lil xi wa[da jew aktar minn dawn li ;ejjin> (a) il-kunfidenzjalità tal-proçedimenti ta’ awtoritajiet pubbliçi, ir-relazzjonijiet internazzjonali u d-difi]a nazzjonali, (b) is-sigurtà pubblika, (ç) fatti li huma, jew li kienu, sub-judice, jew ta[t inkjesta (inklu] inkjesti dixxiplinari), jew li jiffurmaw is-su;;ett g[al proçedimenti ta’ investigazzjoni preliminari, (d) kunfidenzjalità kummerçjali u industrijali, inklu]a l proprjetà intellettwali, (e) il-kunfidenzjalità ta’ data personali u, jew inkartamenti< (f) materjal fornut minn terzi ming[ajr ma dik il-parti tkun ta[t obbligu legali li tag[mel dan, (g) materjal, li l-kxif tieg[u x’aktarx li jista’ jwassal g[al dannu fl-ambjent li dak il-materjal ikollu kuntatt mieg[u, in notifikant jista’ jindika l-informazzjoni fin-notifiki ippre]entati Spezzjonijiet u Mi]uri ta’ Kontroll. Kxif ta’ Data Kunfidenzjali. B 1949 f’konformità ma’ dawn ir-regolamenti li g[andhom ji;u trattati b’mod kunfidenzjali> I]da f’dawn il-ka]ijiet g[andha ting[ata ;ustifikazzjoni li tista’ ti;i verifikata. (2) L-Awtorità Kompetenti g[andha tiddeçiedi, wara konsultazzjoni man-notifikant, liema informazzjoni g[andha tin]amm b[ala wa[da kunfidenzjali u g[andha tinforma lin-notifikant bid deçi]joni tag[ha. (3) F’ebda ka] m’g[andha l-informazzjoni li ;ejja, tin]amm kunfidenzjali meta din tkun ;iet ippre]entata skond ir-regolamenti 6, 8 jew 9> (a) il-karatteristiçi ;enerali tal-GMM, l-isem u l-indirizz tan notifikant, u l-lok ta’ l-u]u, (b) il-klassi ta’ l-u]u kontenut u l-mi]uri ta’ konteniment, (ç) l-evalwazzjoni ta’ effetti prevedibbli, b’mod partikolari dawk l-effetti li jag[mlu l-[sara lis-sa[[a umana u l-ambjent. (4) L-Awtorità Kompetenti m’g[anda xxandar ebda informazzjoni lil terzi li tkun ;iet deçi]a li tibqa’ kunfidenzjali skond is-subregolament (2) u li tkun ;iet notifikata jew b’xi mod ie[or provduta b’mod konformi ma’ dawn ir-regolamenti, u g[andha tipprote;i d drittijiet ta’ proprjetà intellettwali li jkollhom x’jaqsmu mad-data li tkun ;iet mog[tija. (5) Jekk, g[al xi ra;uni li tkun, in-notifikant jirtira n-notifika tieg[u, l-Awtorità Kompetenti g[andha tirrispetta l-kunfidenzjalità ta’ l-informazzjoni mog[tija. 15. Ming[ajr pre;udizzju g[ar-regolament 14, l-Awtorità Kompetenti tista’ tikkonsulta lill-pubbliku dwar xi aspetti ta’ l-u]u kontenut propost meta hija tqis li dan ikun adatt. IN?IDENTI U PJANIJIET TA’ EMER:ENZA> PARTI V 16. (1) L-Awtorità Kompetenti g[andha ti]gura li qabel ma jibda u]u kontenut> (a) jitfassal pjan ta’ emer;enza g[al kull u]u kontenut f’dawk il-ka]ijiet meta l-mi]uri ta’ konteniment jistg[u jfallu u jwasslu g[al perikolu serju, kemm jekk immedjat kemm jekk Konsultazzjoni pubblika. Pjanijiet ta’ Emer;enza. B 1950 ritardat, g[al bnedmin barra mill-post u, jew g[all-ambjent, [lief meta dak il-pjan ta’ emer;enza jkun di;à ;ie mfassal ta[t le;islazzjoni rilevanti o[ra< (b) informazzjoni fuq pjanijiet ta’ emer;enza, g[al dawk inklu]i l-mi]uri ta’ sigurtà rilevanti li g[andhom ji;u applikati, g[andha ting[ata b’mod adatt, u ming[ajr ma din ikollha g[alfejn tintalab, ming[and korpi u awtoritajiet li jistg[u jkunu affettwati bl inçident. Din l-informazzjoni g[andha ti;i a;;ornata f’intervalli adatti. Din g[andha tkun ukoll disponnibli g[all-pubbliku. (2) Fl-istess [in, l-Awtorità Kompetenti g[andha tara li informazzjoni b[al dik li tkun tqassmet liç-çittadini tag[ha g[andha tkun disponibbli g[al Stati Membri o[ra involuti. 17. (1) F’ka] ta’ inçident, l-utent ikun minnufih me[tie; jinforma lill-Awtorità Kompetenti u li jipprovdilha din l-informazzjoni li ;ejja> (a) iç-çirkustanzi ta’ l-inçident, (b) l-identità u l-kwantitajiet ta’ kull GMM involut, (ç) kull informazzjoni me[tie;a biex ji;u valutati l-effetti ta’ l-inçident fuq is-sa[[a tal-popolazzjoni in ;enerali u ta’ l-ambjent, (d) il-mi]uri li jkunu ttie[du. (2) L-utent g[andu jinforma lill-Awtorità Kompetenti msemmija fir-Regolament ta’ l-2003 dwar il-Protezzjoni tal-{addiema minn Riskji relatati ma’ l-Espo]izzjoni g[al-A;enti Bijolo;içi fuq il-Post tax-Xog[ol, b’xi inçident b[al dak. (3) Meta ting[ata informazzjoni b’konformità mas subregolament (1), l-Awtorità Kompetenti, flimkien ma’ l-Awtorità Kompetenti msemmija fis-subregolament (2), tkun me[tie;a> (a) ti]gura li jittie[du l-mi]uri kollha me[tie;a, u minnufih tinforma lil Stati Membri o[ra li jistg[u jkunu affettwati bl-inçident, (b) ti;bor, meta dan ikun possibbli, l-informazzjoni me[tie;a g[al anali]i s[i[ ta’ l-inçident u, meta jkun adatt, tag[mel Okkorrenza ta’ Inçidenti. B 1951 ir-rakkomandazzjonijiet tag[ha sabiex ji;u evitati inçidenti simili fil-futur u biex tillimita l-effetti tag[hom. (4) F’ka] ta’ inçident, l-Awtorità Kompetenti flimkien ma’ l-Awtorità Kompetenti msemmija fis-subregolament (2), tista’ titlob lill utent biex i[allas jew jikkontribwixxi g[al xi jew kull spejje] li jori;inaw minn dan l-inçident. 18. L-Awtorità Kompetenti g[andha tikkonsulta lil Stati Membri o[ra, li x’aktarx li ji;u affettwati f’ka] ta’ inçident, fuq l implimentazzjoni proposta tal-pjanijiet ta’ emer;enza. DRITTIJIET> PARTI VI 19. (1) G[andu jit[allas dritt lill-Awtorità Kompetenti g[al> (a) notifika dwar post li jkun ser jintu]a g[all-ewwel darba mog[tija lill-Awtorità Kompetenti ta[t ir-regolament 6, skond id drittijiet applikabbli mni]]la f’Parti A ta’ Skeda VI, skond liema minnhom ikun japplika< (b) notifika dwar u]u kontenut individwali, mog[tija lill Awtorità Kompetenti ta[t ir-regolamenti 7, 8 u 9 skond id-drittijiet applikabbli mni]]la f’Parti B ta’ Skeda VI, skond liema minnhom ikun japplika< (ç) notifika emendata dwar u]u kontenut, mog[tija lill Awtorità Kompetenti ta[t ir-regolament 11 skond id-drittijiet applikabbli mni]]la f’Parti ? ta’ Skeda VI, skond liema minnhom ikun japplika< (2) L-Awtorità Kompetenti tista’ tag[mel, jew tirran;a li jsiru, dawk l-investigazzjonijiet addizzjonali li tqis me[tie;a, b[ala parti mill-e]ami jew monitor;; tag[ha ta’ notifika ta’ u]u kontenut sabiex hija tkun tista’ tivvaluta sew in-notifika u tista’ titlob lill-utent i[allas jew jikkontribwixxi g[al xi spejje] ta’ kull investigazzjoni b[al dik. (3) L-Awtorità Kompetenti tista’ tirkupra l-ammont ta’ kull [las lilha dovut minn xi [tie;a ta[t ir-regolament 17 (4). Komunikazzjoni ma’ Stati Membri o[ra. Dritt g[al notifika dwar post li ser ikun u]at g[all-ewwel darba. Dritt g[al notifika g[al u]u kontenut individwali. Dritt g[al notifika emendata ta’ u]u kontenut. Investigazzjonijiet. Rkupru ta’ spejje] jew [lasijiet. B 1952 DISPO}IZZJONIJIET O{RA> PARTI VII 20. L-Iskedi I sa IV li jinsabu ma’ dawn ir-regolamenti qeg[din ji;u pubblikati bil-lingwa Ingli]a mat-test Ingli] ta’ dawn ir-regolamenti. 21. Ir-Regolamenti ta’ l-2002 dwar l-U]u Kontenut ta’ Mikro Organi]mi Modifikati :enetikament, qeg[din b’dawn ji;u m[assra. I[assar A.L. 169 ta’ l-2002. L-iskeda I sa IV jinsabu pubblikati bil-lingwa Ingliza biss. B 1953 SCHEDULE I PART A Techniques of genetic modification referred to in Regulation 3 are, inter alia: 1. Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation. 2. Techniques involving the direct introduction into a micro-organism of heritable material prepared outside the micro-organism including micro-injection, macro-injection and micro-encapsulation. 3. Cell fusion or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally. PART B Techniques referred to in Regulation 3 which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs made by techniques/methods other than techniques/methods excluded by Schedule II, PART A: (1) in vitro fertilisation; (2) natural processes such as: conjugation, transduction, transformation; (3) polyploidy induction. B 1954 SCHEDULE II PART A Techniques or methods of genetic modification yielding micro-organisms to be excluded from the Regulation on the condition that they do not involve the use of recombinant nucleic acid molecules or GMMs other than those produced by one or more of the techniques/methods listed below 1. Mutagenesis. 2. Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes. 3. Cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions. 4. Self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants. Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms. PART B Criteria establishing the safety of GMMs for human health and the environment This Schedule describes in general terms the criteria to be met when establishing the safety of types of GMMs for human health and the environment. 1. GENERAL CRITERIA 2.1. Strain verification/authentication Identity of the strain must be precisely established. Modification must be known and verified. 2.2. Documented and established evidence of safety Documented evidence of the safety of the organism must be provided. B 1955 2.3. Genetic stability Where any instability could adversely affect safety, evidence of stability is required. 2. SPECIFIC CRITERIA 3.1. Non-pathogenic The GMM should not be capable of causing disease or harm to a healthy human, plant or animal. Since pathogenicity includes both toxigenicity and allergenicity, the GMM should therefore be: 3.1.1. Non-toxigenic The GMM should not produce increased toxigenicity as a result of the genetic modification nor be noted for its toxigenic properties. 3.1.2. Non-allergenic The GMM should not produce increased allergenicity as a result of the genetic modification nor be a noted allergen, having, for example, allergenicity comparable in particular with that of the micro-organisms identified in Legal Notice 228 of 2003 on the protection of workers from risks related to exposure to biological agents at work. 3.2. No harmful adventitious agents The GMM should not harbour known harmful adventitious agents such as other micro-organisms, active or latent, existing alongside or inside the GMM that could cause harm to human health and the environment. 3.3. Transfer of genetic material The modified genetic material must not give rise to harm if transferred nor should it be self-transmissible or transferable at a frequency greater than other genes of the recipient or parental micro-organism. 3.4. Safety for the environment in the event of a significant and unintended release GMMs must not produce adverse effects on the environment, immediate or delayed, should any incident involving a significant and unintended release occur. B 1956 PART C Types of GMMs which meet the criteria listed in Part B can be referred to Schedule III of the Protection of Workers from Risks related to Exposure to Biological Agents at Work Regulations, 2003 (Legal Notice 228 of 2003). B 1957 SCHEDULE III PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN REGULATION 4 (1) This Schedule describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Regulation 4 (1). It may be supplemented, as regards in particular section B, by guidance notes which may be issued by the Competent Authority . A. ELEMENTS OF ASSESSMENT 1. The following should be considered as potentially harmful effects: disease to humans including allergenic or toxic effects, disease to animals or plants, deleterious effects due to the impossibility of treating a disease or providing an effective prophylaxis, deleterious effects due to establishment or dissemination in the environment, deleterious effects due to the natural transfer of inserted genetic material to other organisms. 2. The assessment referred to in Regulation 4 (1) should be based on the following: (a) the identification of any potentially harmful effects, in particular those associated with: (i) the recipient micro-organism; (ii) the genetic material inserted (originating from the donor organism); (iii) the vector; (iv) the donor micro-organism (as long as the donor micro-organism is used during the operation); (v) the resulting GMM; (b) the characteristics of the activity; (c) the severity of the potentially harmful effects; (d) the likelihood of the potentially harmful effects being realised. B. PROCEDURE 3. The first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, any harmful properties associated with the vector or inserted material, including any alteration in the recipient's existing properties. B 1958 4. In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Regulation 4: (i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants (1) ; (ii) the nature of the vector and the insert is such that they do not endow the GMM with a phenotype likely to cause disease to humans, animals or plants (1) , or likely to cause deleterious effects in the environment; (iii) the GMM is unlikely to cause disease to humans, animals or plants (1) and is unlikely to have deleterious effects on the environment. 5. In order to obtain the necessary information to implement this process the user may firstly take into account relevant Community legislation (in particular Council Directive 90/679/EEC). International or national classification schemes (e.g. WHO, NIH, etc.) and their revisions due to new scientific knowledge and technical progress may also be considered. These schemes concern natural micro-organisms and as such are usually based on the ability of micro-organisms to cause disease to humans, animals or plants and on the severity and transmissibility of the disease likely to be caused. Directive 90/679/EEC classifies micro-organisms, as biological agents, into four classes of risk on the basis of potential effects on a healthy human adult. These classes of risk can be used as guidance to the categorisation of the contained use activities in the four classes of risk referred to in Regulation 4 (2). The user may also take into consideration classification schemes referring to plant and animal pathogens (which are usually established on a national basis). The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures. 6. The hazard identification process carried out in accordance with paragraphs 3 to 5, should lead to the identification of the level of risk associated with the GMM. 7. Selection of the containment and other protective measures should then be made on the basis of the level or risk associated with the GMMs together with consideration of: (i) the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro-organisms used in the contained use activity); (ii) the characteristics of the activity (e.g. its scale; nature); (iii) any non-standard operations (e.g. the inoculation of animals with GMMs; equipment likely to generate aerosols). 1 This would only apply to animals and plants in the environment likely to be exposed B 1959 Consideration of items (i) to (iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the GMM as identified under paragraph 6. 8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Regulation 4 (2). 9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Regulation 4 (2). B 1960 SCHEDULE IV CONTAINMENT AND OTHER PROTECTIVE MEASURES General principles 1. These tables present the normal minimum requirements and measures necessary for each level of containment. Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene, shall apply: (i) to keep workplace and environmental exposure to any GMM to the lowest practicable level; (ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary; (iii) to test adequately and maintain control measures and equipment; (iv) to test, when necessary, for the presence of viable process organisms outside the primary physical containment; (v) to provide appropriate training of personnel; (vi) to establish biological safety committees or subcommittees, if required; (vii) to formulate and implement local codes of practice for the safety of personnel, as required; (viii) where appropriate to display biohazard signs; (ix) to provide washing and decontamination facilities for personnel; (x) to keep adequate records; (xi) to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area; (xii) to prohibit mouth pipetting; (xiii) to provide written standard operating procedures where appropriate to ensure safety; (xiv) to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs; (xv) to provide safe storage for contaminated laboratory equipment and materials, when appropriate. 2. The titles of the tables are indicative: Table I A presents minimum requirements for laboratory activities. Table I B presents additions to and modifications of Table I A for glasshouse/growth room activities involving GMMs. B 1961 Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs. Table II presents minimum requirements for activities other than laboratory activities. In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level. In some cases users may, with the agreement of the Competent Authority, not apply a specification under a particular containment level or combine specifications from two different levels. In these tables "optional" means that the user may apply these measures on a case-by case basis, subject to the assessment referred to in Regulation 4 (1). B 1962 Table I A Containment and other protective measures for laboratory activities Containment levels Specifications 1 2 3 4 1 Laboratory suite: isolation (1) Not required Not required Required Required 2 Laboratory: sealable for fumigation Not required Not required Required Required Equipment 3 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required (bench) Required (bench) Required (bench, floor) Required (bench, floor, ceiling, walls) 4 Entry to lab via airlock (2) Not required Not required Optional Required 5 Negative pressure relative to the pressure of the immediate environment Not required Not required Required except for (1) Required 6 Extract and input air from the laboratory should be HEPA-filtered Not required Not required Required (HEPA) (4) – extract air except for (3) Required (HEPA) (5) – input and extract air 7 Microbiological safety post Not required Optional Required Required 8 Autoclave On site In the Building En suite (6) In Lab = double ended System of work 9 Restricted access Not required Required Required Required 10 Biohazard sign on the door Not required Required Required Required 11 Specific measures to control aerosol dissemination Not required Required minimise Required prevent Required prevent 12 Shower Not required Not required Optional Required 14 Protective clothing Suitable protective clothing Suitable protective clothing and (optional) footwear Suitable protective clothing Complete change of clothing and footwear before entry and exit 15 Gloves Not required Optional Required Required 18 Efficient vector control (e.g. for rodents and insects) Optional Required Required Required B 1963 Containment levels Specifications 1 2 3 4 Waste 19 Inactivation of GMMs in effluent from hand washing sinks or drains and showers and similar effluents Not required Not required Optional Required 20 Inactivation of GMMs in contaminated material and waste Optional Required Required Required Other measures 21 Laboratory to contain its own equipment Not required Not required Optional Required 23 An observation window or alternative is to be present so that occupants can be seen Optional Optional Optional Required 1 Isolation = the laboratory is separated from other areas in the same building or is in a separated building. 2 Airlock = entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. 3 Activities where transmission does nor occur via airborne route. 4 HEPA = High efficiency particulate air. 5 Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air. 6 With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing an equivalent level of protection. B 1964 Table I B Containment and other protective measures for glasshouses and growth-rooms The terms "glasshouse" and "growth-room" refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment. All provisions of Table I A shall apply with the following additions/modifications: Containment levels Specifications 1 2 3 4 Buildings 1 Greenhouse: permanent structure (1) Not required Required Required Required Equipment 3 Entry via a separated room with two interlocking doors Not required Optional Optional Required 4 Control of contaminated run-off water Optional Minimise (2) run-off Prevent run-off Prevent run-off System of work 6 Measures to control undesired species such as insects, rodents, arthropods Required Required Required Required 7 Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of genetically modified micro-organisms Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination 1 The glasshouse shall consist of a permanent structure with a continuous water proofed covering, located on a site graded to prevent entry of surface-water run-off having self-closing lockable doors. 2 Where transmission can occur through the ground. B 1965 Table I C Containment and other protective measures for activities in animal units All provisions of Table I A shall apply with the following additions/modifications: Containment levels Specifications 1 2 3 4 Facilities 1 Isolation of animal unit (1) Optional Required Required Required 2 Animal facilities (2) separated by lockable doors Optional Required Required Required 3 Animal facilities designed to facilitate decontamination (waterproof and easily washable material (cages, etc.)) Optional Optional Required Required 4 Floor and/or walls easily washable Optional Required (floor) Required (floor and walls) Required (floor and walls) 5 Animals kept in appropriate containment facilities such as cages, pens or tanks Optional Optional Optional Optional 6 Filters on isolators or isolated room (3) Not required Optional Required Required 1 Animal unit: a building, or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves. food storage areas, etc. 2 Animal facility: a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures. 3 Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. B 1966 Table II Containment and other protective measures for other activities Containment levels Specifications 1 2 3 4 General 1 Viable micro-organisms should be contained in a system which separates the process from the environment (closed system) Optional Required Required Required 2 Control of exhaust gases from the closed system Not required Required, prevent dissemination Required, prevent dissemination Required, prevent dissemination 3 Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system Optional Required, prevent dissemination Required, prevent dissemination Required, prevent dissemination 4 Inactivation of bulk culture fluids before removal from the closed system Optional Required, by validated means Required, by validated means Required, by validated means 5 Seals should be designed so as to minimise or prevent release Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination 6 The controlled area should be designed to contain spillage of the entire contents of the closed system Optional Optional Required Required 7 The controlled area should be sealable to permit fumigation Not required Optional Optional Required Equipment 8 Entry via airlock Not required Not required Optional Required 9 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required (bench if any) Required (bench if any) Required (bench if any, floor) Required (bench, floor, ceiling, walls) 10 Specific measures to adequately ventilate the controlled area in order to minimise air contamination Optional Optional Optional Required 11 The controlled area should be maintained at an air pressure negative to the immediate surroundings Not required Not required Optional Required 12 Extract and input air from the controlled area should be HEPA filtered Not required Not required Required (extract air, optional for input air) Required (input and extract air) System of work 13 Closed systems should be located within a controlled area Not required Optional Required Required 14 Access should be restricted to nominated personnel only Not required Required Required Required 15 Biohazard signs should be posted Not required Required Required Required 17 Personnel should shower before leaving the controlled area Not required Not required Optional Required B 1967 Containment levels Specifications 1 2 3 4 18 Personnel should wear protective clothing Required (work clothing) Required (work clothing) Required Complete change before exit and entry Waste 22 Inactivation of GMMs in effluent from handwashing sinks and showers or similar effluents Not required Not required Optional Required 23 Inactivation of GM Ms in contaminated material and waste including those in process eft1uent before final discharge Optional Required, by validated means Required, by validated means Required, by validated means I B 1968 SCHEDULE V PART A Information required for the notification referred to in Regulation 6: name of user(s) including those responsible for supervision and safety, information on the training and qualifications of the persons responsible for supervision and safety, details of any biological committees or subcommittees, address and general description of the premises, a description of the nature of the work which will be undertaken, the class of the contained uses, only for class 1 contained uses, a summary of the assessment referred to in Regulation 4 (1) and information on waste management. PART B Information required for the notification referred to in Regulation 8: the date of submission of the notification referred to in Regulation 6, the name of the persons responsible for supervision and safety and information on the training and qualification, the recipient, donor and/or parental micro-organism(s) used and, where applicable, the host-vector system(s) used, the source(s) and the intended function(s) of the genetic material(s) involved in the modification(s), identity and characteristics of the GMM, the purpose of the contained use including the expected results, approximate culture volumes to be used, description of the containment and other protective measures to be applied, including information about waste management including the wastes to be generated, their treatment, final form and destination, a summary of the assessment referred to in Regulation 4 (1), the information necessary for the Competent Authority to evaluate any emergency response plans if required under Regulation 16. PART C Information required for the notification referred to in Regulation 9: (a) - the date of submission of the notification referred to in Regulation 6, B 1969 the name of the persons responsible for supervision and safety and information on the training and qualification; (b) - the recipient or parental micro-organism(s) to be used, the host-vector system(s) to be used (where applicable), the source(s) and intended functions(s) of the genetic material(s) involved in the modification(s), identity and characteristics of the GMM, the culture volumes to be used; (c) - description of the containment and other protective measures to be applied, including information about waste management including the type and form of wastes to be generated, their treatment, final form and destination, the purpose of the contained use including the expected results, description of the parts of the installation; (d) information about accident prevention and emergency response plans, if any: any specific hazards arising from the location of the installation, the preventive measures applied such as safety equipment, alarm systems and containment methods, procedures and plans for verifying the continuing effectiveness of the containment measures, a description of information provided to workers, the information necessary for the Competent Authority to evaluate any emergency response plans if required under Regulation 16; (e) a copy of the assessment referred to in Regulation 4 (1). B 1970 SCHEDULE VI Fees Part A: First time use of facility Class 1 – € 500 Class 2 – € 1,200 Class 3 – € 4,700 Class 4 – € 15,000 Part B: Individual contained use activities Class 1 – € 30 Class 2 – € 800 Class 3 – € 4,500 Class 4 – € 10,000 Part C: Amended Notification Class 1 – € 30 Class 2 – € 500 Class 3 – € 1,500 Class 4 – € 7,000 B 1971 L.N. 127 of 2008 ENVIRONMENT PROTECTION ACT (CAP. 435) Contained Use of Genetically Modified Micro-organisms Regulations, 2008 BY virtue of the powers conferred by articles 9, 10(2) and 11 of the Environment Protection Act, hereinafter referred to as “the Act”, the Prime Minister has made the following regulations> 1. The title of these regulations is the Contained Use of Genetically Modified Micro-organisms Regulations, 2008. 2. (1) The objective of these regulations is to lay down measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment. (2) These regulations provide the provisions required for the implementation in Malta of the European Council Directive 90#219#EEC of the 23rd of April 1990 on the contained use of genetically modified micro-organisms and shall be read and construed as one with such legal instrument. (3) These regulations are to be read and construed with the Protection of Workers from Risks related to Exposure to Biological Agents at Work Regulations, 2003, in relation to issues in connection with occupational health and safety. PART I> DEFINITIONS AND EXEMPTIONS 3. In these regulations, unless the context otherwise requires> “accident” means any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment< “the Competent Authority” means the Malta Environment and Planning Authority as prescribed by the notice entitled Nomination of the Malta Environment and Planning Authority as the competent authority, and such other body or person as the Minister responsible for the environment may by order in the Gazette prescribe and different bodies or persons may be designated as the competent Citation. Objectives. L.N. 228 of 2003. Interpretation. B 1972 authority for different provisions and different purposes of these regulations< “contained use” means any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment< “genetically modified micro-organism” or “GMM” means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and, or natural recombination. Within the terms of this definition> (a) genetic modification occurs at least through the use of the techniques listed in Schedule I, Part A< (b) the techniques listed in Schedule I, Part B, are not considered to result in genetic modification< “micro-organism” means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture< “the Minister” means the Minister responsible for the environment< “notification” means the presentation of the requisite information to the Competent Authority< “user” means any natural or legal person responsible for the contained use of GMMs. PART II> ASSESSMENT 4. (1) In order to ensure that the contained use of GMMs does not produce adverse effects on human health and the environment the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that these contained uses may incur, using as a minimum the elements of assessment and the procedure set out in Schedule III, sections A and B. Assessment. B 1973 (2) The assessment referred to in sub-regulation (1) shall result in the final classification of the contained uses in four classes applying the procedure set out in Schedule III, which will result in the assignment of containment levels in accordance with sub-regulations (6) and (7)> Class 1> activities of no or negligible risk, for which level 1 containment is appropriate. Class 2> activities of low risk, for which level 2 containment is appropriate. Class 3> activities of moderate risk, for which level 3 containment is appropriate. Class 4> activities of high risk, for which level 4 containment is appropriate. (3) Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless sufficient evidence, in agreement with the Competent Authority, justifies the application of less stringent measures. (4) The assessment referred to in sub-regulation (1) hereof shall especially take into account the question of disposal of waste and effluents. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment. (5) A record of the assessment referred to in sub-regulation (1) hereof shall be kept by the user and made available in an appropriate form to the Competent Authority as part of the notification pursuant to regulations 6, 8 and 9 or on request. (6) The user shall apply, except to the extent that paragraph 2 of Schedule IV allows other measures to be applied, the general principles and the appropriate containment and other protective measures set out in Schedule IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured. (7) The assessment referred to in sub-regulation (1) hereof and the containment and other protective measures applied shall be reviewed periodically, and forthwith if> B 1974 (a) the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct, or (b) there is reason to suspect that the assessment is no longer appropriately judged in the light of new scientific or technical knowledge. 5. (1) Without prejudice to regulation 4 (1), these regulations shall not apply> (a) where genetic modification is obtained through the use of the techniques or methods listed in Schedule II, Part A, or (b) for contained uses involving only types of GMMs meeting the criteria listed in Schedule II, Part B which establish their safety to human health and the environment. These types of GMMs are listed in Schedule II, Part C. (2) regulation 4(2), 4(5), 4(6), 4(7) and regulations 6 to 11 shall not apply to the transport of GMMs by road, sea or air. (3) These regulations shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with the Deliberate Release into the Environment of Genetically Modified Organisms Regulations, 2002 or pursuant to other relevant legislation, which provides for a specific environmental risk assessment similar to that laid down in the said regulations, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market. PART III> PERMITTING AND PENALTIES 6. When premises are to be used for the first time for contained uses, the user shall be required to submit to the Competent Authority, before commencing such use, a notification containing at least the information listed in Schedule V, Part A. 7. (1) For the first time or subsequent Class 1 contained uses to be carried out in premises notified in accordance with regulation 6, a notification containing the information listed in Schedule V, Part B (excluding the summary of assessment referred to in regulation 4 (1)), shall be submitted to the Competent Authority. The Class 1 contained use may proceed immediately following notification. (2) Users of GMMs in Class 1 Contained Use shall be required to keep a record of each assessment referred to in sub-regulation Exemptions. L.N. 170 of 2002. Premises used for the first time. Contained Use of Class 1. B 1975 4 (5), which shall be made available to the Competent Authority on request. 8. (1) For the first and subsequent class 2 contained uses to be carried out in premises notified in accordance with regulation 6, a notification containing the information listed in Schedule V, Part B shall be submitted to the Competent Authority. (2) If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification> Provided that the applicant can, however, himself request a decision on a formal authorisation from the Competent Authority. The decision must be made within a maximum of 45 days from the notification. (3) If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the Competent Authority, proceed 45 days after submission of the notification referred to in sub-regulation (1), or earlier with the agreement of the Competent Authority. 9. (1) For the first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with regulation 6, a notification containing the information listed in Schedule V, Part C shall be submitted to the Competent Authority. (2) A class 3 or higher class of contained use may not proceed without the prior consent of the Competent Authority which shall communicate its Decision in writing> (a) at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed< (b) at the latest 90 days after submission of the notification, in other cases. Contained Use of Class 2. Contained Use of Class 3 and Class 4. B 1976 10. (1) The person submitting a notification or requesting a permit for activities referred to in regulations 6, 7, 8 and 9, hereinafter referred to as the applicant, shall submit his request in writing to the Competent Authority prior to carrying out such activities. (2) In order to enable the Competent Authority to adequately assess a notification or a request for permission, the application shall be accompanied by the relevant documents and any other requisite information as specified and required by the Competent Authority. The applicant shall clearly indicate whether the application would prejudice any enforcement case, court case or other causes currently sub-judice. (3) The Competent Authority shall examine the conformity of the notifications with the requirements of these regulations, the accuracy and completeness of the information given, the correctness of the assessment referred to in regulation 4 (1) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures. (4) If necessary, the Competent Authority may> (a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to any contained use> Provided that in this case the Competent Authority may require that the contained use, if proposed, does not begin, or, if in progress, is suspended or terminated, until the Competent Authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use< (b) limit the time for which the contained use should be permitted or subject it to certain specific conditions. (5) For the purpose of calculating the periods referred to in regulations 8 and 9, any period of time during which the Competent Authority> (a) is awaiting any further information which it may have requested from the notifier in accordance with sub-regulation 4(a), or (b) is carrying out a public inquiry or consultation in accordance with regulation 15, shall not be taken into account. Notifications to the Competent Authority. B 1977 (6) Whenever the Competent Authority issues a permit, it may impose such conditions as it may deem fit and appropriate. (7) Whenever the Competent Authority refuses such permit, it shall inform the applicant of the reasons for such refusal. (8) The period of validity of such permit shall also be established at the discretion of the Competent Authority. (9) The applicant shall provide a copy of any published results and other publications relevant to this permit to the Competent Authority within three months from the date of publication. (10) The Competent Authority shall not issue or renew any permit if the applicant in question has not fulfilled or honoured any of the conditions or obligations arising from any other permit issued by the Competent Authority under these regulations and, or the related regulations. 11. (1) (a) If new information subsequently becomes available to the Competent Authority which could have significant consequences for the risks posed by the contained use, the Competent Authority may require the user to modify the conditions of, or suspend or terminate, the contained use. (b) Where a user becomes aware of new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the user shall discontinue the contained use and, as soon as practicable, inform the Competent Authority. (2) Prior to resuming a contained use discontinued in accordance with sub-regulation (1), the user shall – (a) review the assessment carried out in accordance with regulation 4, and the class and level of containment applied in accordance with sub-regulation 4(2) thereof< and (b) submit an amended notification to the Competent Authority. (3) For the purposes of sub-regulation (2) the provisions in relation to the submission of a notification by a user in accordance with regulations 6, 8 or 9, and to the processing and determination of such a notification by the Competent Authority in accordance with regulation New information on risks of contained use. B 1978 10, shall apply, as appropriate, to an amended notification as if it were a notification under regulations 6, 8 or 9. 12. (1) Any person shall be guilty of an offence under these regulations if> (a) he fails to comply with any provision of these regulations or fails to comply with permit conditions or with any order lawfully given in terms of any provision of these regulations< or (b) he contravenes any restriction, prohibition or requirement imposed by or under these regulations< or (c) he acts in contravention of any of the provisions of these regulations< or (d) he makes a statement or presents information or documentation, which such person knows to be false for the purpose of obtaining the approval or continuation of a permit in line with regulations 6, 8, 9 or 11 2(b)< or (e) he conspires or attempts to conspire, aids or attempts to aid, abets or attempts to abet, counsel or attempt to counsel, procures or attempt to procure any other person to contravene the provisions of these regulations or to fail to comply with any such provisions, including any order lawfully given in terms of any of the provision of these regulations, or to contravene any restriction, prohibition or requirement imposed by or under the said regulations or by virtue thereof. (2) Any person who commits, or attempts to commit an offence against these regulations shall, on conviction, be liable to the following range of penalties> (a) on first conviction for an offence under Class 1 a fine (multa) of not less than five hundred euro but not exceeding one thousand euro< on a second or subsequent convictions for an offence under Class 1, a fine (multa) of not less than one thousand euro, but not exceeding two thousand five hundred euro or to imprisonment for a term not exceeding two years or to both such fine and imprisonment< (b) on first conviction for an offence under Class 2 a fine (multa) of not less than one thousand euro but not exceeding two thousand euro< on a second or subsequent convictions for an offence under Class 2, a fine (multa) of not less than two thousand euro, Offences. Penalties. B 1979 but not exceeding three thousand five hundred euro or to imprisonment for a term not exceeding two years or to both such fine and imprisonment< (c) on first conviction for an offence under Class 3 a fine (multa) of not less than two thousand five hundred euro but not exceeding six thousand euro< on a second or subsequent convictions for an offence under Class 3, a fine (multa) of not less than four thousand five hundred euro, but not exceeding twenty-five thousand euro or to imprisonment for a term not exceeding two years or to both such fine and imprisonment< (d) on first conviction for an offence under Class 4 a fine (multa) of not less than twelve thousand euro but not exceeding twenty-five thousand euro< on a second or subsequent convictions for an offence under Class 4, a fine (multa) of not less than twenty five thousand euro, but not exceeding thirty-five thousand euro or to imprisonment for a term not exceeding two years or to both such fine and imprisonment> Provided that the Court shall order any person who has been found guilty of committing an offence against these regulations to pay for the expenses incurred by the Competent Authority as a result of the said offence, including any remedying action for any damage caused by the said offence, the revocation of the permit issued by the Competent Authority and the confiscation of the corpus delicti, including any expenses incurred for the keeping and transport of the said corpus delicti. (3) The Court shall order the offender to remove the causes of the offence and to undo anything which was done without a permit within a time sufficient for the purpose to be fixed by the Court< and, if the offender fails to comply with any such order within the time so fixed, he shall be liable to a fine (multa) of not less than sixty euro and not more than five hundred euro, as the Court may fix, for every day that the default continues after the expiration of the said time. (4) The provisions of articles 23 and 30 of the Criminal Code shall apply, mutatis mutandis, to proceedings in respect of offences against these regulations, so however that the disqualification from holding or obtaining a licence or permit from the Competent Authority shall in no case be for less than one year. (5) Notwithstanding the provisions of Article 370 of the Criminal Code, proceedings for an offence against these regulations shall be held before the Court of Magistrates (Malta) or the Court of Applicability of the Criminal Code. Cap. 9. B 1980 Magistrates (Gozo), as the case may be, and shall be in accordance with the provisions of the Criminal Code regulating the procedure before the said courts as courts of criminal judicature. (6) Notwithstanding the provisions of the Criminal Code, the Attorney General shall always have a right of appeal to the Court of Criminal Appeal from any judgement given by the Court of Magistrates (Malta) or the Court of Magistrates (Gozo) in respect of proceedings for any offence against these regulations. 13. The Competent Authority may organise inspections and other control measures to ensure user compliance with these regulations. PART IV> PUBLIC CONSULTATION AND CONFIDENTIALITY 14. (1) Where disclosure of data related to these regulations, affects one or more of the following> (a) the confidentiality of the proceedings of public authorities, international relations and national defence, (b) public security, (c) matters which are, or have been, sub-judice, or under enquiry (including disciplinary enquiries), or which are the subject of preliminary investigation proceedings, (d) commercial and industrial confidentiality, including intellectual property, (e) the confidentiality of personal data and#or files, (f) material supplied by a third party without that party being under a legal obligation to do so, (g) material, the disclosure of which would make it more likely that the environment to which such material is related would be damaged, the notifier may indicate the information in the notifications submitted pursuant to these regulations that should be treated as confidential> Provided that a verifiable justification must be given in such cases. Inspections and Control Measures. Disclosure of Confidential Data. B 1981 (2) The Competent Authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision. (3) In no case may the following information, when submitted according to regulations 6, 8 or 9, be kept confidential> (a) the general characteristics of the GMMs, name and address of the notifier, and location of use, (b) class of contained use and measures of containment, (c) the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment. (4) The Competent Authority shall not divulge to third parties any information decided to be confidential according to sub regulation (2) and notified or otherwise provided pursuant to these regulations, and shall protect intellectual property rights relating to the data received. (5) If, for whatever reasons, the notifier withdraws the notification, the Competent Authority must respect the confidentiality of the information supplied. 15. Without prejudice to regulation 14, the Competent Authority may hold public consultations on aspects of the proposed contained use where it considers to be appropriate. PART V> ACCIDENTS AND EMERGENCY PLANS 16. (1) The Competent Authority shall ensure that before a contained use commences> (a) an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and, or to the environment, except where such an emergency plan has been drawn up under other relevant legislation< (b) information on such emergency plans, including the relevant safetymeasures to be applied, is supplied in an appropriate Public consultation. Emergency Plans. B 1982 manner, and without them having to request it, to bodies and authorities liable to be affected by the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available. (2) The Competent Authority shall at the same time make available to other Member States concerned, the same information as that which is disseminated to their nationals. 17. (1) In the event of an accident, the user shall be required to inform immediately the Competent Authority and provide the following information> (a) the circumstances of the accident, (b) the identity and quantities of the GMMs concerned, (c) any information necessary to assess the effects of the accident on the health of the general population and the environment, (d) the measures taken. (2) The user shall also inform the Competent Authority cited in the Protection of Workers from Risks related to Exposure to Biological Agents at Work Regulations, 2003, of such accident. (3) Where information is given pursuant to sub-regulation (1), the Competent Authority, in collaboration with the Competent Authority cited in sub-regulation (2), shall be required to> (a) ensure that any measures necessary are taken, and immediately alert other Member States which could be affected by the accident, (b) collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof. Occurrences of Accidents. B 1983 (4) In the event of an accident, the Competent Authority in collaboration with the Competent Authority cited in sub-regulation (2), may require the user to defray or contribute towards any or all of the costs incurred by it arising from such accident. 18. The Competent Authority shall consult with other Member States, likely to be affected in the event of an accident, on the proposed implementation of emergency plans. PART VI> FEES 19. (1) A fee shall be paid to the Competent Authority in respect of> (a) a notification of a first time use of a premises given to the Competent Authority under regulation 6, in accordance with the applicable fees indicated in Part A of Schedule VI, whichever is appropriate< (b) a notification of an individual contained use given to the Competent Authority under regulations 7, 8 and 9, in accordance with the applicable fees indicated in Part B of Schedule VI, whichever is appropriate< (c) An amended notification of a contained use given to the Competent Authority under regulation 11, in accordance with the applicable fees indicated in Part C of Schedule VI, whichever is appropriate< (2) The Competent Authority may carry out, or arrange to have carried out, such additional investigations as it considers necessary, as part of its examination or monitoring of a notification of a contained use to enable it properly to assess the notification and may require the user to defray or contribute towards the cost of any such investigations. (3) The Competent Authority may recover the amount of any payment due to it arising from a requirement under regulation 17 (4). Fee for notification of first time use of a premises. Communication with other Member States. Fee for notification of any individual contained use. Fee for an amended notification of a contained use. Agency investigations. Recovery of costs or charges. B 1984 PART VII> OTHER PROVISIONS 20. The Schedules I to IV to these regulations are being published in the English language with the English text of these regulations. 21. The Contained use of genetically modified micro-organisms Regulations, 2002, is hereby repealed. Schedules I to IV published in English only. Repeal of L.N. 169 of 2002. B 1985 SCHEDULE I PART A Techniques of genetic modification referred to in Regulation 3 are, inter alia: 1. Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation. 2. Techniques involving the direct introduction into a micro-organism of heritable material prepared outside the micro-organism including micro-injection, macro-injection and micro-encapsulation. 3. Cell fusion or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally. PART B Techniques referred to in Regulation 3 which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs made by techniques/methods other than techniques/methods excluded by Schedule II, PART A: (1) in vitro fertilisation; (2) natural processes such as: conjugation, transduction, transformation; (3) polyploidy induction. B 1986 SCHEDULE II PART A Techniques or methods of genetic modification yielding micro-organisms to be excluded from the Regulation on the condition that they do not involve the use of recombinant nucleic acid molecules or GMMs other than those produced by one or more of the techniques/methods listed below 1. Mutagenesis. 2. Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes. 3. Cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions. 4. Self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants. Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms. PART B Criteria establishing the safety of GMMs for human health and the environment This Schedule describes in general terms the criteria to be met when establishing the safety of types of GMMs for human health and the environment. 1. GENERAL CRITERIA 2.1. Strain verification/authentication Identity of the strain must be precisely established. Modification must be known and verified. 2.2. Documented and established evidence of safety Documented evidence of the safety of the organism must be provided. B 1987 2.3. Genetic stability Where any instability could adversely affect safety, evidence of stability is required. 2. SPECIFIC CRITERIA 3.1. Non-pathogenic The GMM should not be capable of causing disease or harm to a healthy human, plant or animal. Since pathogenicity includes both toxigenicity and allergenicity, the GMM should therefore be: 3.1.1. Non-toxigenic The GMM should not produce increased toxigenicity as a result of the genetic modification nor be noted for its toxigenic properties. 3.1.2. Non-allergenic The GMM should not produce increased allergenicity as a result of the genetic modification nor be a noted allergen, having, for example, allergenicity comparable in particular with that of the micro-organisms identified in Legal Notice 228 of 2003 on the protection of workers from risks related to exposure to biological agents at work. 3.2. No harmful adventitious agents The GMM should not harbour known harmful adventitious agents such as other micro-organisms, active or latent, existing alongside or inside the GMM that could cause harm to human health and the environment. 3.3. Transfer of genetic material The modified genetic material must not give rise to harm if transferred nor should it be self-transmissible or transferable at a frequency greater than other genes of the recipient or parental micro-organism. 3.4. Safety for the environment in the event of a significant and unintended release GMMs must not produce adverse effects on the environment, immediate or delayed, should any incident involving a significant and unintended release occur. B 1988 PART C Types of GMMs which meet the criteria listed in Part B can be referred to Schedule III of the Protection of Workers from Risks related to Exposure to Biological Agents at Work Regulations, 2003 (Legal Notice 228 of 2003). B 1989 SCHEDULE III PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN REGULATION 4 (1) This Schedule describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Regulation 4 (1). It may be supplemented, as regards in particular section B, by guidance notes which may be issued by the Competent Authority . A. ELEMENTS OF ASSESSMENT 1. The following should be considered as potentially harmful effects: disease to humans including allergenic or toxic effects, disease to animals or plants, deleterious effects due to the impossibility of treating a disease or providing an effective prophylaxis, deleterious effects due to establishment or dissemination in the environment, deleterious effects due to the natural transfer of inserted genetic material to other organisms. 2. The assessment referred to in Regulation 4 (1) should be based on the following: (a) the identification of any potentially harmful effects, in particular those associated with: (i) the recipient micro-organism; (ii) the genetic material inserted (originating from the donor organism); (iii) the vector; (iv) the donor micro-organism (as long as the donor micro-organism is used during the operation); (v) the resulting GMM; (b) the characteristics of the activity; (c) the severity of the potentially harmful effects; (d) the likelihood of the potentially harmful effects being realised. B. PROCEDURE 3. The first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, any harmful properties associated with the vector or inserted material, including any alteration in the recipient's existing properties. B 1990 4. In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Regulation 4: (i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants (1) ; (ii) the nature of the vector and the insert is such that they do not endow the GMM with a phenotype likely to cause disease to humans, animals or plants (1) , or likely to cause deleterious effects in the environment; (iii) the GMM is unlikely to cause disease to humans, animals or plants (1) and is unlikely to have deleterious effects on the environment. 5. In order to obtain the necessary information to implement this process the user may firstly take into account relevant Community legislation (in particular Council Directive 90/679/EEC). International or national classification schemes (e.g. WHO, NIH, etc.) and their revisions due to new scientific knowledge and technical progress may also be considered. These schemes concern natural micro-organisms and as such are usually based on the ability of micro-organisms to cause disease to humans, animals or plants and on the severity and transmissibility of the disease likely to be caused. Directive 90/679/EEC classifies micro-organisms, as biological agents, into four classes of risk on the basis of potential effects on a healthy human adult. These classes of risk can be used as guidance to the categorisation of the contained use activities in the four classes of risk referred to in Regulation 4 (2). The user may also take into consideration classification schemes referring to plant and animal pathogens (which are usually established on a national basis). The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures. 6. The hazard identification process carried out in accordance with paragraphs 3 to 5, should lead to the identification of the level of risk associated with the GMM. 7. Selection of the containment and other protective measures should then be made on the basis of the level or risk associated with the GMMs together with consideration of: (i) the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro-organisms used in the contained use activity); (ii) the characteristics of the activity (e.g. its scale; nature); (iii) any non-standard operations (e.g. the inoculation of animals with GMMs; equipment likely to generate aerosols). 1 This would only apply to animals and plants in the environment likely to be exposed B 1991 Consideration of items (i) to (iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the GMM as identified under paragraph 6. 8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Regulation 4 (2). 9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Regulation 4 (2). B 1992 SCHEDULE IV CONTAINMENT AND OTHER PROTECTIVE MEASURES General principles 1. These tables present the normal minimum requirements and measures necessary for each level of containment. Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene, shall apply: (i) to keep workplace and environmental exposure to any GMM to the lowest practicable level; (ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary; (iii) to test adequately and maintain control measures and equipment; (iv) to test, when necessary, for the presence of viable process organisms outside the primary physical containment; (v) to provide appropriate training of personnel; (vi) to establish biological safety committees or subcommittees, if required; (vii) to formulate and implement local codes of practice for the safety of personnel, as required; (viii) where appropriate to display biohazard signs; (ix) to provide washing and decontamination facilities for personnel; (x) to keep adequate records; (xi) to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area; (xii) to prohibit mouth pipetting; (xiii) to provide written standard operating procedures where appropriate to ensure safety; (xiv) to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs; (xv) to provide safe storage for contaminated laboratory equipment and materials, when appropriate. 2. The titles of the tables are indicative: Table I A presents minimum requirements for laboratory activities. Table I B presents additions to and modifications of Table I A for glasshouse/growth room activities involving GMMs. B 1993 Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs. Table II presents minimum requirements for activities other than laboratory activities. In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level. In some cases users may, with the agreement of the Competent Authority, not apply a specification under a particular containment level or combine specifications from two different levels. In these tables "optional" means that the user may apply these measures on a case-by case basis, subject to the assessment referred to in Regulation 4 (1). B 1994 Table I A Containment and other protective measures for laboratory activities Containment levels Specifications 1 2 3 4 1 Laboratory suite: isolation (1) Not required Not required Required Required 2 Laboratory: sealable for fumigation Not required Not required Required Required Equipment 3 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required (bench) Required (bench) Required (bench, floor) Required (bench, floor, ceiling, walls) 4 Entry to lab via airlock (2) Not required Not required Optional Required 5 Negative pressure relative to the pressure of the immediate environment Not required Not required Required except for (1) Required 6 Extract and input air from the laboratory should be HEPA-filtered Not required Not required Required (HEPA) (4) – extract air except for (3) Required (HEPA) (5) – input and extract air 7 Microbiological safety post Not required Optional Required Required 8 Autoclave On site In the Building En suite (6) In Lab = double ended System of work 9 Restricted access Not required Required Required Required 10 Biohazard sign on the door Not required Required Required Required 11 Specific measures to control aerosol dissemination Not required Required minimise Required prevent Required prevent 12 Shower Not required Not required Optional Required 14 Protective clothing Suitable protective clothing Suitable protective clothing and (optional) footwear Suitable protective clothing Complete change of clothing and footwear before entry and exit 15 Gloves Not required Optional Required Required 18 Efficient vector control (e.g. for rodents and insects) Optional Required Required Required B 1995 Containment levels Specifications 1 2 3 4 Waste 19 Inactivation of GMMs in effluent from hand washing sinks or drains and showers and similar effluents Not required Not required Optional Required 20 Inactivation of GMMs in contaminated material and waste Optional Required Required Required Other measures 21 Laboratory to contain its own equipment Not required Not required Optional Required 23 An observation window or alternative is to be present so that occupants can be seen Optional Optional Optional Required 1 Isolation = the laboratory is separated from other areas in the same building or is in a separated building. 2 Airlock = entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. 3 Activities where transmission does nor occur via airborne route. 4 HEPA = High efficiency particulate air. 5 Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air. 6 With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing an equivalent level of protection. B 1996 Table I B Containment and other protective measures for glasshouses and growth-rooms The terms "glasshouse" and "growth-room" refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment. All provisions of Table I A shall apply with the following additions/modifications: Containment levels Specifications 1 2 3 4 Buildings 1 Greenhouse: permanent structure (1) Not required Required Required Required Equipment 3 Entry via a separated room with two interlocking doors Not required Optional Optional Required 4 Control of contaminated run-off water Optional Minimise (2) run-off Prevent run-off Prevent run-off System of work 6 Measures to control undesired species such as insects, rodents, arthropods Required Required Required Required 7 Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of genetically modified micro-organisms Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination 1 The glasshouse shall consist of a permanent structure with a continuous water proofed covering, located on a site graded to prevent entry of surface-water run-off having self-closing lockable doors. 2 Where transmission can occur through the ground. B 1997 Table I C Containment and other protective measures for activities in animal units All provisions of Table I A shall apply with the following additions/modifications: Containment levels Specifications 1 2 3 4 Facilities 1 Isolation of animal unit (1) Optional Required Required Required 2 Animal facilities (2) separated by lockable doors Optional Required Required Required 3 Animal facilities designed to facilitate decontamination (waterproof and easily washable material (cages, etc.)) Optional Optional Required Required 4 Floor and/or walls easily washable Optional Required (floor) Required (floor and walls) Required (floor and walls) 5 Animals kept in appropriate containment facilities such as cages, pens or tanks Optional Optional Optional Optional 6 Filters on isolators or isolated room (3) Not required Optional Required Required 1 Animal unit: a building, or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves. food storage areas, etc. 2 Animal facility: a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures. 3 Isolators: transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. B 1998 Table II Containment and other protective measures for other activities Containment levels Specifications 1 2 3 4 General 1 Viable micro-organisms should be contained in a system which separates the process from the environment (closed system) Optional Required Required Required 2 Control of exhaust gases from the closed system Not required Required, prevent dissemination Required, prevent dissemination Required, prevent dissemination 3 Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system Optional Required, prevent dissemination Required, prevent dissemination Required, prevent dissemination 4 Inactivation of bulk culture fluids before removal from the closed system Optional Required, by validated means Required, by validated means Required, by validated means 5 Seals should be designed so as to minimise or prevent release Minimise dissemination Minimise dissemination Prevent dissemination Prevent dissemination 6 The controlled area should be designed to contain spillage of the entire contents of the closed system Optional Optional Required Required 7 The controlled area should be sealable to permit fumigation Not required Optional Optional Required Equipment 8 Entry via airlock Not required Not required Optional Required 9 Surfaces resistant to water, acids, alkalis, solvents, disinfectants, decontamination agents and easy to clean Required (bench if any) Required (bench if any) Required (bench if any, floor) Required (bench, floor, ceiling, walls) 10 Specific measures to adequately ventilate the controlled area in order to minimise air contamination Optional Optional Optional Required 11 The controlled area should be maintained at an air pressure negative to the immediate surroundings Not required Not required Optional Required 12 Extract and input air from the controlled area should be HEPA filtered Not required Not required Required (extract air, optional for input air) Required (input and extract air) System of work 13 Closed systems should be located within a controlled area Not required Optional Required Required 14 Access should be restricted to nominated personnel only Not required Required Required Required 15 Biohazard signs should be posted Not required Required Required Required 17 Personnel should shower before leaving the controlled area Not required Not required Optional Required B 1999 Containment levels Specifications 1 2 3 4 18 Personnel should wear protective clothing Required (work clothing) Required (work clothing) Required Complete change before exit and entry Waste 22 Inactivation of GMMs in effluent from handwashing sinks and showers or similar effluents Not required Not required Optional Required 23 Inactivation of GM Ms in contaminated material and waste including those in process eft1uent before final discharge Optional Required, by validated means Required, by validated means Required, by validated means I B 2000 SCHEDULE V PART A Information required for the notification referred to in Regulation 6: name of user(s) including those responsible for supervision and safety, information on the training and qualifications of the persons responsible for supervision and safety, details of any biological committees or subcommittees, address and general description of the premises, a description of the nature of the work which will be undertaken, the class of the contained uses, only for class 1 contained uses, a summary of the assessment referred to in Regulation 4 (1) and information on waste management. PART B Information required for the notification referred to in Regulation 8: the date of submission of the notification referred to in Regulation 6, the name of the persons responsible for supervision and safety and information on the training and qualification, the recipient, donor and/or parental micro-organism(s) used and, where applicable, the host-vector system(s) used, the source(s) and the intended function(s) of the genetic material(s) involved in the modification(s), identity and characteristics of the GMM, the purpose of the contained use including the expected results, approximate culture volumes to be used, description of the containment and other protective measures to be applied, including information about waste management including the wastes to be generated, their treatment, final form and destination, a summary of the assessment referred to in Regulation 4 (1), the information necessary for the Competent Authority to evaluate any emergency response plans if required under Regulation 16. PART C Information required for the notification referred to in Regulation 9: (a) - the date of submission of the notification referred to in Regulation 6, B 2001 the name of the persons responsible for supervision and safety and information on the training and qualification; (b) - the recipient or parental micro-organism(s) to be used, the host-vector system(s) to be used (where applicable), the source(s) and intended functions(s) of the genetic material(s) involved in the modification(s), identity and characteristics of the GMM, the culture volumes to be used; (c) - description of the containment and other protective measures to be applied, including information about waste management including the type and form of wastes to be generated, their treatment, final form and destination, the purpose of the contained use including the expected results, description of the parts of the installation; (d) information about accident prevention and emergency response plans, if any: any specific hazards arising from the location of the installation, the preventive measures applied such as safety equipment, alarm systems and containment methods, procedures and plans for verifying the continuing effectiveness of the containment measures, a description of information provided to workers, the information necessary for the Competent Authority to evaluate any emergency response plans if required under Regulation 16; (e) a copy of the assessment referred to in Regulation 4 (1). B 2002 Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press Prezz#Price €2.98 (Lm1.28) SCHEDULE VI Fees Part A: First time use of facility Class 1 – € 500 Class 2 – € 1,200 Class 3 – € 4,700 Class 4 – € 15,000 Part B: Individual contained use activities Class 1 – € 30 Class 2 – € 800 Class 3 – € 4,500 Class 4 – € 10,000 Part C: Amended Notification Class 1 – € 30 Class 2 – € 500 Class 3 – € 1,500 Class 4 – € 7,000