Gene Technology (Further Amendment) Regulations 2007

Gene Technology (Further Amendment) Regulations 2007 S.R. No. 147/2007 TABLE OF PROVISIONS Regulation Page 1 Objective 1 2 Authorising provision 1 3 Commencement 1 4 Principal Regulations 2 5 Definition 2 6 Dealings exempt from licensing 2 7 Time limit for deciding application 2 8 Prescribed authorities 3 9 New regulation 9A 3 9A Risks posed by dealings proposed to be authorised by licence 3 10 New regulation 11A inserted in Division 1 of Part 3 4 11A Time limit for deciding variation application 4 11 Regulation 13 substituted 5 13 Requirements in relation to undertaking notifiable low risk dealings 5 12 New regulation 13A inserted in Division 2 of Part 3 6 13A Requirements in relation to notifying Regulator of notifiable low risk dealings 6 13 Part 5 substituted 8 PART 5—ETHICS AND COMMUNITY COMMITTEE 8 31 Ethics and Community Committee—conditions of appointment 8 32 Ethics and Community Committee—Committee procedures 9 33 Ethics and Community Committee—operation of subcommittees 9 14 Schedule 2—Dealings exempt from licensing 9 15 Schedule 3—Notifiable low risk dealings in relation to a GMO 10 i -- 1 of 16 -- Regulation Page 16 New Part 1 of Schedule 3 inserted 12 PART 1—NOTIFIABLE LOW RISK DEALINGS SUITABLE FOR PHYSICAL CONTAINMENT LEVEL 1 12 1.1 Kinds of dealings 12 ═══════════════ ENDNOTES 14 ii -- 2 of 16 -- STATUTORY RULES 2007 S.R. No. 147/2007 Gene Technology Act 2001 Gene Technology (Further Amendment) Regulations 2007 The Governor in Council makes the following Regulations: Dated: 18 December 2007 Responsible Minister: DANIEL ANDREWS Minister for Health MELISSA VAN ROSSUM Acting Clerk of the Executive Council 1 Objective The objective of these Regulations is to amend the Gene Technology Regulations 2001. 2 Authorising provision These Regulations are made under section 193 of the Gene Technology Act 2001. 3 Commencement (1) These Regulations, other than regulations 5, 7(2) and 13, come into operation on the day they are made. (2) Regulations 5, 7(2) and 13 come into operation on 1 January 2008. 1 -- 3 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 4 4 Principal Regulations In these Regulations, the Gene Technology Regulations 20011 are called the Principal Regulations. 5 Definition In regulation 3 of the Principal Regulations for the definition of expert adviser substitute— "expert adviser means— (a) in Part 4, an expert adviser appointed under section 102(1) of the Commonwealth Act; and (b) in Part 5, an expert adviser appointed under section 112(1) of the Commonwealth Act;". 6 Dealings exempt from licensing Regulation 6(1)(c) of the Principal Regulations is revoked. 7 Time limit for deciding application (1) For regulation 8(1)(b) of the Principal Regulations substitute— "(b) in relation to an application to which Division 4 of Part 5 of the Act applies— (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment— 150 days after the day the application is received by the Regulator; and 2 -- 4 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 8 (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and (iii) in any other case—255 days after the day the application is received by the Regulator.". (2) In regulations 8(2)(e) and 8(3) of the Principal Regulations for "Gene Technology Ethics Committee" (wherever occurring) substitute "Ethics and Community Committee". (3) After regulation 8(3) of the Principal Regulations insert— "(4) In subregulation (1)— limited and controlled release application means an application for a licence to which section 50A of the Act applies.". 8 Prescribed authorities Regulation 9(c) of the Principal Regulations is revoked. 9 New regulation 9A After regulation 9 of the Principal Regulations insert— "9A Risks posed by dealings proposed to be authorised by licence For the purpose of section 51(1)(a) of the Act, the Regulator must have regard to the following matters— 3 -- 5 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 10 (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO; (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism; (c) provisions for limiting the dissemination or persistence of the GMO or its genetic material in the environment; (d) the potential for spread or persistence of the GMO or its genetic material in the environment; (e) the extent or scale of the proposed dealings; (f) any likely impacts of the proposed dealings on the health and safety of people.". 10 New regulation 11A inserted in Division 1 of Part 3 After regulation 11 of the Principal Regulations insert— "11A Time limit for deciding variation application For the purposes of section 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for variation of the licence is received by the Regulator.". 4 -- 6 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 11 11 Regulation 13 substituted For regulation 13 of the Principal Regulations substitute— "13 Requirements in relation to undertaking notifiable low risk dealings (1) A person may undertake a notifiable low risk dealing only if— (a) a person or an accredited organisation has requested an Institutional Biosafety Committee to assess whether the proposed dealing is a notifiable low risk dealing; and (b) the Committee has assessed the proposed dealing to be a notifiable low risk dealing; and (c) the person who proposes to undertake the proposed dealing and the project supervisor for the proposed dealing have been notified that the Committee— (i) has assessed the proposed dealing to be a notifiable low risk dealing; and (ii) considers that the personnel to be involved in the proposed dealing have appropriate training and experience. (2) A notifiable low risk dealing must comply with the following requirements— (a) the dealing must be conducted— (i) for a kind of dealing mentioned in Part 1 of Schedule 3, in a facility that is certified by the Regulator to at least physical containment 5 -- 7 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 12 level 1 and is of appropriate design for the kind of dealing being undertaken; or (ii) for a kind of dealing mentioned in Part 2 of Schedule 3, in a facility that is certified by the Regulator to at least physical containment level 2 and is of appropriate design for the kind of dealing being undertaken; or (iii) in another facility in accordance with any technical and procedural guidelines relating to containment of GMOs, as in force from time to time under section 27(d) of the Act, that the Regulator has determined in writing are appropriate for conducting the dealing; (b) to the extent that the dealing involves transporting a GMO, the transporting must be conducted in accordance with applicable technical and procedural guidelines, as in force from time to time under section 27(d) of the Act.". 12 New regulation 13A inserted in Division 2 of Part 3 After regulation 13 of the Principal Regulations insert— "13A Requirements in relation to notifying Regulator of notifiable low risk dealings (1) An Institutional Biosafety Committee that has assessed a proposed dealing to be a notifiable low risk dealing must— (a) make a record of the proposed dealing in a form approved by the Regulator; and 6 -- 8 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 12 (b) if the Regulator, by written notice given to the Committee, requests a copy of the record, give a copy of the record to the Regulator by the end of the period mentioned in the notice; and (c) give a copy of the record to— (i) the person or accredited organisation that requested the Committee to assess the proposed dealing; and (ii) the project supervisor for the proposed dealing. (2) The person or accredited organisation must— (a) for the financial year in which the Committee assessed the proposed dealing, include a copy of the Committee's record— (i) for an accredited organisation—in the annual report given to the Regulator for the financial year; or (ii) in any other case—in a report given to the Regulator, in the form approved by the Regulator, by the person for the financial year; and (b) retain a copy of the Committee's record for 3 years after the date that the person or accredited organisation ceased to be involved with the conduct of the dealing. 7 -- 9 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 13 (3) The Regulator may, by written notice, require— (a) the Committee; or (b) the person or accredited organisation; or (c) any other person involved with the conduct of the proposed dealing— to give the Regulator any further information about the dealing that the Regulator requires in order to be satisfied that the dealing is a notifiable low risk dealing. (4) A Committee, person or accredited organisation receiving a notice under subregulation (3) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.". 13 Part 5 substituted For Parts 5 and 6 of the Principal Regulations substitute— "PART 5—ETHICS AND COMMUNITY COMMITTEE 31 Ethics and Community Committee— conditions of appointment Note Regulation 31 of the Commonwealth Regulations provides that Division 1 of Part 4 of the Commonwealth Regulations applies to the conditions of appointment of members of the Ethics and Community Committee. 8 -- 10 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 14 32 Ethics and Community Committee— Committee procedures Note Regulation 32 of the Commonwealth Regulations provides that Division 2 of Part 4 of the Commonwealth Regulations applies to the procedures of members of the Ethics and Community Committee. 33 Ethics and Community Committee— operation of subcommittees Note Regulation 33 of the Commonwealth Regulations provides that regulations 24, 25, 26 and 28 of the Commonwealth Regulations apply to a subcommittee established under subsection 111(1) of the Commonwealth Act. __________________". 14 Schedule 2—Dealings exempt from licensing In Schedule 2 to the Principal Regulations— (a) in Part 1— (i) omit item 1; and (ii) in item 4(1) for "subitems (2) and (3)" substitute "subitem (2)"; and (iii) in item 4(2)(e)(ii) for "virions." substitute "virions; and"; and (iv) after item 4(2)(e) insert— "(f) must not confer an oncogenic modification."; and (v) omit item 4(3); and (b) in Part 2—in item 4, column 3 for "(other than a retroviral vector that is able to transduce human cells)" substitute "unable to transduce human cells". 9 -- 11 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 15 15 Schedule 3—Notifiable low risk dealings in relation to a GMO (1) In the Note at the beginning of Part 1 of Schedule 3 to the Principal Regulations for "Part 2" substitute "Part 3". (2) In clause 1.1 of Part 1 of Schedule 3 to the Principal Regulations, for "The following kinds of dealings are notifiable low risk dealings" substitute "The following kinds of notifiable low risk dealings may be conducted in physical containment level 2 facilities". (3) In clause 1.1(e)(ii) of Part 1 of Schedule 3 to the Principal Regulations for "fungi; or" substitute "fungi;". (4) Clause 1.1(e)(iii) of Part 1 of Schedule 3 to the Principal Regulations is revoked. (5) For clause 1.1(i) of Part 1 of Schedule 3 to the Principal Regulations substitute— "(i) a dealing involving the introduction of a replication defective viral vector able to transduce human cells into a host mentioned in Part 2 of Schedule 2 if— (i) the donor nucleic acid is incapable of correcting a defect in the vector leading to production of replication competent virions; and (ii) either— (A) the vector is a retroviral vector; or (B) the donor nucleic acid confers an oncogenic modification.". (6) In Part 1 of Schedule 3 to the Principal Regulations, for "1.1 Kinds of dealings" substitute "2.1 Kinds of dealings". 10 -- 12 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 15 (7) In the Notes at the beginning of Part 2 of Schedule 3 to the Principal Regulations for "Part 1" substitute "Parts 1 and 2". (8) In clause 2.1(a) of Part 2 of Schedule 3 to the Principal Regulations for "paragraph 1.1(h) of Part 1" substitute "clause 2.1(h) of Part 2". (9) In clause 2.1(c) of Part 2 of Schedule 3 to the Principal Regulations for "paragraph 1.1(h) of Part 1" substitute "clause 2.1(h) of Part 2". (10) In clause 2.1(d) of Part 2 of Schedule 3 to the Principal Regulations for "paragraph 1.1(i) of Part 1" substitute "clause 1.1(c) of Part 1 or clause 2.1(i) of Part 2". (11) In clause 2.1(e)(iii) of Part 2 of Schedule 3 to the Principal Regulations for "paragraph 1.1(g) of Part 1" substitute "clause 2.1(g) of Part 2". (12) In clause 2.1(f)(i) of Part 2 of Schedule 3 to the Principal Regulations for "paragraph 1.1(g) of Part 1" substitute "clause 2.1(g) of Part 2". (13) In clause 2.1(i) of Part 2 of Schedule 3 to the Principal Regulations omit "able to transduce human cells". (14) In clause 2.1(k) of Part 2 of Schedule 3 to the Principal Regulations for "paragraph 1.1(f) of Part 1" substitute "clause 2.1(f) of Part 2". (15) In Part 2 of Schedule 3 to the Principal Regulations, for "2.1 Kinds of dealings" substitute "3.1 Kinds of dealings". (16) For the heading to Part 1 of Schedule 3 to the Principal Regulations substitute "PART 2— NOTIFIABLE LOW RISK DEALINGS SUITABLE FOR PHYSICAL CONTAINMENT LEVEL 2". 11 -- 13 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 15 (17) For the heading to Part 2 of Schedule 3 to the Principal Regulations substitute "PART 3— DEALINGS THAT ARE NOT NOTIFIABLE LOW RISK DEALINGS". 16 New Part 1 of Schedule 3 inserted Before Part 2 (as renumbered by regulation 15(16)) of Schedule 3 to the Principal Regulations insert— "PART 1—NOTIFIABLE LOW RISK DEALINGS SUITABLE FOR PHYSICAL CONTAINMENT LEVEL 1 Note Because of regulation 12(1) a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3 of this Schedule. 1.1 Kinds of dealings The following kinds of notifiable low risk dealings may be conducted in physical containment level 1 facilities— (a) a dealing involving a genetically modified laboratory mouse or a genetically modified laboratory rat, unless— (i) an advantage is conferred on the animal by the genetic modification; or (ii) because of the genetic modification, the animal is capable of secreting or producing an infectious agent; (b) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid confers an oncogenic modification; 12 -- 14 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 r. 15 (c) a dealing involving a defective viral vector able to transduce human cells in a host mentioned in item 4 of Part 2 of Schedule 2 (animal or human cell culture), unless— (i) the vector is a retroviral vector; or (ii) the donor nucleic acid confers an oncogenic modification.". ═══════════════ 13 -- 15 of 16 -- S.R. No. 147/2007 Gene Technology (Further Amendment) Regulations 2007 Endnotes ENDNOTES 1 Reg. 4: S.R. No. 153/2001 as amended by S.R. No. 50/2007. 14 -- 16 of 16 --