Victorian Consolidated Regulations

GENE TECHNOLOGY REGULATIONS 2001

S.R. No. 153/2001
Version incorporating amendments as at 1 January 2008

TABLE OF PROVISIONS

           Regulation Page

   PART 1-PRELIMINARY

   1.      Objective
   1A.     Authorising provision
   2.      Commencement
   3.      Definitions
   3A.     Numbering
   3B.     Notes

   PART 2-INTERPRETATION AND GENERAL OPERATION

   4.      Techniques not constituting gene technology
   5.      Organisms that are not genetically modified organisms

   PART 3-DEALINGS WITH GMOs

           Division 1-Licensing system

   6.      Dealings exempt from licensing
   7.      Application for licence-prescribed fee
   8.      Time limit for deciding an application
   9.      Prescribed authorities
   9A.     Risks posed by dealings proposed to be authorised by licence
   10.     Risk assessment-matters to be taken into account
   11.     Prescribed conditions of licence
   11A.    Time limit for deciding variation application

           Division 2-Notifiable low risk dealings

   12.     Notifiable low risk dealings
   13.     Requirements in relation to undertaking notifiable low risk dealings
   13A.    Requirements in relation to notifying Regulator of notifiable
           low risk dealings

           Division 3-Certification and accreditation

   14.     Regulator to decide certification application within 90 days
   15.     Application for certification-failure to provide section 85 information
   16.     Regulator to decide accreditation application within 90 days
   17.     Application for accreditation-failure to provide section 93 information

   PART 4-GENE TECHNOLOGY TECHNICAL ADVISORY COMMITTEE

           Division 1-Conditions of appointment

   18.     GTTAC members and advisers-term of appointment
   19.     GTTAC members and advisers-resignation
   20.     GTTAC members-disclosure of interests
   21.     GTTAC members and advisers-termination of appointment
   22.     GTTAC members-leave of absence
   23.     Expert advisers-disclosure of interests

           Division 2-Committee procedures

   24.     Committee procedures generally
   25.     Committee meetings
   26.     Presiding member
   27.     Quorum
   28.     Voting
   29.     Records and Reports

           Division 3-Subcommittees

   30.     Operation of subcommittees

   PART 5-ETHICS AND COMMUNITY COMMITTEE

   31.     Ethics and Community Committee-conditions of
           appointment
   32.     Ethics and Community Committee-Committee procedures
   33.     Ethics and Community Committee-operation of
           subcommittees

   PART 6-Revoked

           34-36. Revoked

   PART 7-MISCELLANEOUS

   37.     Reviewable State decisions
   38.     Review of decisions
   39.     Record of GMO and GM Product Dealings
   40.     Inspector identity card

   PART 8-TRANSITIONAL

   41.     Existing facilities-certification
   42.     Existing organisations-accreditation
   43.     Notifiable low risk dealings
           __________________
           SCHEDULE 1-Techniques not Constituting Gene Technology
           SCHEDULE 1A-Organisms that are not Genetically Modified Organisms
           SCHEDULE 2-Dealings Exempt from Licensing

   PART 1-EXEMPT DEALINGS

   PART 2-HOST/VECTOR SYSTEMS FOR EXEMPT DEALINGS

   PART 3-DEFINITIONS
           SCHEDULE 3-Notifiable Low Risk Dealings in Relation to
   a GMO

   PART 1-NOTIFIABLE LOW RISK DEALINGS SUITABLE
   FOR PHYSICAL CONTAINMENT LEVEL 1.
   1.1. Kinds of dealings

   PART 2-NOTIFIABLE LOW RISK DEALINGS SUITABLE
   FOR PHYSICAL CONTAINMENT LEVEL 2.
   2.1. Kinds of dealings

   PART 3-DEALINGS THAT ARE NOT NOTIFIABLE LOW
   RISK DEALINGS
   3.1. Kinds of dealings
           SCHEDULE 4-Revoked
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           ENDNOTES
           1. General Information
           2. Table of Amendments
           3. Explanatory Details