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Gene Technology (Licence Charges) Bill 2000 [and] Gene Technology (Consequential Amendments) Bill 2000
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Bills Digest Nos. 9-10 2000-01
Gene Technology (Licence Charges) Bill 2000
Gene Technology (Consequential Amendments) Bill 2000
ISSN 1328-8091
CD Copyright Commonwealth ofAustralia 2000
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Published by the Department of the Parliamentary Library, 2000
INFORMATION AND RESEARCH SERVICES
Bills Digest No.9 2000-01
Gene Technology (Licence Charges) Bill 2000
Katrine Del Villar and Angus Martyn Law and Bills Digest Group 15 August 2000
Contents
Purpose . . . . . . . . ⢠. ⢠. . . . ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠. ⢠1
Background _................â¢.â¢.â¢... _.. _â¢...â¢.â¢...... _â¢.... 1
Main Provisions _ 1
Gene Technology (licence Charges) Bill 2000
Date Introduced: 22 June 2000
House: House of Representatives
Portfolio: Health and Aged Care
Commencement: Immediately after the commencement of the Gene Technology Act 2000.
Purpose
The purpose of the Bill is to enable annual licence charges to be levied on licences authorising certain dealings with genetically modified organisms (GMO licences) issued under the Gene Technology Bill 2000.
Background
This Bill, together with the Gene Technology Bill 2000 and the Gene Technology (Consequential Amendments) Bill 2000, fanTIs part of a package of Bills which establish the Gene Technology Regulator and introduce the federal component of a national scheme for regulating certain dealings with genetically modified organisms. This Bill imposes
licence charges, which are a fonn of taxation. A separate Bill is required to satisfy section 55 of the Constitution, which in part provides:
'Laws imposing taxation shall deal only with the imposition of taxation. and any provision therein dealing with any other mailer shall be of no effect.'
For further background the reader is referred. to the Digest (Bills Digest No. II. 2000-0I) for the Gene Technology Bill 2000.
Main Provisions
Clause 4 provides that the holder of a GMO licence is liable to pay an annual licence charge each financial year that the GMO licence is current. The amount of the licence charge will be set by regulations (subclause 4(2» made by the Governor-General (clause 5).
Warning:
This DigesllO'
This Digest does not haw! on.l'ojJicilJ11l'galstatus. OtherSlJurrl.'S shouldbe roflSullffl to dnerminl' thl' subSl'qUl.'nt lJfficjlJl stlJfWi lJ!tM Bill.
INFORMATION AND RESEARCH SERVICES
Bills Digest
No. 10 20()()-{)1
Gene Technology (Consequential Amendments) Bill 2000
Katrine Del Villar and Angus Martyn Law and Bills Digest Group 15 August 2000
Contents
Purpose ..........â¢.â¢.................â¢...............................
Background .............â¢...
Main Provisions 2
Agricultural and Veterinary Chemicals 2
Food . . ... 3
Industrial Chemicals 4
Therapeutic Goods....................................â¢................ 4
Miscellaneous .....................................â¢.â¢.....â¢.......... 5
Concluding Comments ......................â¢.â¢.......................... 5
Endnotes ................................â¢.â¢.....â¢.â¢.................. 6
Gene Technology (Consequential Amendments) Bill 2000
Date Introduced: 22 June 2000
House: House of Representatives
Portfolio: Health and Aged Care
Commencement: On the same day as the Gene Technology Bill 2000 commences which will be by Proclamation, or at the latest 6 months after Royal Assent.
Purpose
The purpose of the Bill is to amend a number of Commonwealth regulatory schemes to require other regulatory bodies to consider advice from the Gene Technology Regulator when making decisions to approve cenain dealings with genetically modified products.
Background
This Bill, together with the Gene Technology Bill 2000 and the Gene Technology (Licence Charges) Bill 2000, fanns part of a package of Bills which establish the Gene Technology Regulator (the Regulator) and introduce the federal component of a national scheme for regulating certain dealings with genetically modified organisms (GMOs). For
further background the reader is referred to the Digest (Bills Digest No. 11,2000-01) for the Gene Technotogy Bit! 2000.
The Gene Technology Bill 2000 establishes a comprehensive regime for the regulation of dealings with GMOs. This Bill amends four existing schemes to regulate the approval of products derived from or produced from GMOs (GM products). The Bill thus provides an additional layer, or second generation ofregulation.
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2 Gene Technology (ConsequentialAmendments) Bill 2000
Main Provisions
The Bill applies to therapeutic goods, agricultural. veterinary and industrial chemicals and food derived from or produced from GMOs. These may be, for example, bread made using genetically modified wheat, medicines or chemicals made using genetically modified ingredients. The Bill also applies to foods which are themselves GMOs, such as the sale of raw genetically modified tomatoes.
The Bill amends the current Commonwealth regulatory schemes to require the relevant regulatory agency to request advice from the Regulator, and to consider that advice when making decisions in relation to products which are GM products or contain GM products. The regulatory agencies must also notify the Regulator of decisions made in relation to
GM products, so that these decisions can be included on the Record of GMO and GM Product Dealings. I
The regulatory agencies dq not have to follow the Regulator's advice, although they must have regard to it. If a regulatory agency approves a licence or registration or other dealing with GM product, in contravention of the Regulator's advice, there is no provision requiring this fact to be made public. The Record of GMO and GM Product Dealings contains infonnation relating to the person authorised, and any conditions specified in the
licence or authority, but does not contain copies of documents such as the Regulator's written advice or any risk management plans.
In the following discussion, all references to items are to Schedule I of the Bill.
Agricultural and Veterinary Chemicals
The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the National Registration Authority (NRA), which administers the scheme for the approval and registration of agricultural and veterinary chemicals set out in the Agricultural and Veterinary Chemicals Code Act 1994. Under Part 2 of the Agricultural and Veterinary
Chemicals Code Act 1994, the NRA is responsible for the approval of active constituents for proposed or existing chemical products, the registration of chemical products, and the approval of labels for containers for chemical products.
The NRA already has a discretionary power to consult with industry bodies, Commonwealth and State governments, scientific experts, consumer and environmental groupS.2 Item 3 inserts proposed section 8A into the Agricultural and Veterinary Chemicals (Administration) Act 1992, which would require the NRA to consult the
Regulator if an active constituent or a chemical product is or contains a GM product. The NRA must give written notice to the Regulator that an application has been made involving a GM product, and seek the advice of the Regulator, in relation to decisions concerning the:
⢠approval, variation or reconsideration ofan approval ofan active constituent,
Warllillg:
This Digesl "'as preparmfordebole. II reflects Ihe legislation Q5 i'l/Toducedanddoes nQ/ canvass subsl'quent aml'ndml'nlS,
This Digesl does nOI haV!' anyofficial legal status. O/hl'rso..,....es should~ consulli'd10 dl'terminl' the subsequent ~tTu:ialstatus ~rthe Bill.
Gene Technology(ConsequelllialAmendmenlS)Bill 2000 3
⢠registration, variation or reconsideration of the registration ofa chemical product,
⢠approval, variation or reconsideration of an approval ofa chemical product's container label, or
⢠issue of a permit to allow a person to do something with an active constituent or a chemical product that would otherwise be prohibited.
The Regulator must provide the advice requested, in writing, within a specified time period, and the NRA must take that advice into account in determining the application. The NRA is not obliged to follow any advice given by the Regulator, but must inform the Regulator of the NRA's final decision.
Items 4, S, 6 and 7 insert cross-references to proposed section SA into the Agricultural and Veterinary Chemicals Code Act 1994. These simply ensure that the NRA must seek advice from the Regulator before making the decisions referred to above in relation to a chemical product or active constituent which contains a GM product.
Food
The Australia New Zealand Food Authority (ANZFA) is established by the Australia New Zealand Food Authority Act 1991. A ZFA has responsibility for developing food standards and codes of practice relating to food.
ANZFA is subject to direction from the Commonwealth Minister for Health and Aged Care in relation to the performance of its functions,) but is otherwise not required to follow the advice of any government agencies. However, in developing draft food regulatory measures, ANZFA must invite submissions from relevant government agencies,
and consider those submissions in refining the measures.4 Additionally, a number of provisions of the Australia New ZealandFoodAuthority Act 1991 require ANZFA to give notice to 'each appropriate government agency' of certain decisions made by ANZFA in the development or variation of draft food regulatory measures,s draft codes of practice,6
and draft food standards. 7
Item 12 inserts proposed section ItA into the Australia New ZealandFoodAuthority Act 1991, which provides that ANZFA need only give notice to the Regulator if the food regulatory measure relates to food which is or contains a GMO or a GM product. This has the sensible effect that the Regulator will only be an 'appropriate government agency' in relation to food containing GMOs or GM products, not food with no GM content.
The practical effect of the changes to the Australia New Zealand FoodAuthority Act 1991 appears to be that food containing GM products will undergo the nonnal approval processes followed by ANZFA, including obtaining comments from the Regulator as well as other agencies. Food that is a GMO (such as sale of raw GM tomatoes) will be subject
to the licensing regime prescribed in the Gene Technology Bill 2000, as well as to
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4 Gene Technology (Consequential Amendments)Bill 2000
ANZFA'$ usual consultation and approval process. The manufacture of food containing GMOs may also be subject to licensing under the Gene Technology Bill 2000 in addition to approval by ANZFAS
Industrial Chemicals
The Industrial Chemicals (Notification and Assessment) Act 1989 instituted a national system of notification and assessment of industrial chemicals. New industrial chemicals must not be introduced without a permit, which is issued by the Director of Chemicals Notification and Assessment (the Director) after an assessment process. The assessment
and permit approval process currently does not require any consultation with other I . 9
re evant government agencies.
Item 16 inserts proposed sections lOA, JOB and JOC into the Industrial Chemicals (Notification andAssessment) Act 1989. Proposed section lOA would require the Director to consult the Regulator in relation to the assessment of and application for a pennit for any industrial chemical that is or contains a OM product. As with agricultural and veterinary chemicals, the Director must give written notice to the Regulator that an
application has been made involving a GM product, and seek the advice of the Regulator. The Regulator must provide written advice within a specified time period, and the Director must take that advice into account in making the ultimate decision on the application, and infonn the Regulator of the decision. However, the Director is not obliged to follow any
advice given by the Regulator.
The Director also has the ability to seek advice from the Regulator about an entire class of industrial chemicals containing a certain class of OM products (proposed section JOB of the Industrial Chemicals (Notification and Assessment) Act 1989). If an advice from the Regulator about a class of OM products is in force, the Director does not need to seek advice from the Regulator in relation to applications for assessments and pennits for
industrial chemicals containing those OM products (proposed subsection JOA(5». However, the Director still has to take the class advice into account in making individual decisions, and must notify the Regulator of each individual decision made (proposed section IOC).
Therapeutic Goods
The Therapeutic Goods Act 1989 establishes a national system of controls on the availability of therapeutic goods (prescription, non-prescription and alternative medicines and products, as well as therapeutic devices) within Australia. Under the scheme, all therapeutic goods supplied within Australia must either be registered or listed on the Australian Register of Therapeutic Goods, unless they are exempt or the subject of a special approval from the Secretary to the Department of Health and Aged Care. The
Secretary, through the Therapeutic Goods Administration, has responsibility for the
Warning:
This Digest ...as prepared/ordebate. /I reflects the legislation as introducedand dQfs not canl'ClSS subsequ"mamendments.
This Digesl daes n()/ ha\oe anyvifidallegalSlaIWi. Olher~o..,r~~ should~ consulted 10 delermin~ ihe subsequent qlficial SialWi qflhf.' Bill.
Gene Technology (Consequential Amendments) Bill 2000 5
registration and listing of approved therapeutic goods. Currently, there is no requirement in the legislation to consult externally prior to making decisions on registration and listing.
Item 19 inserts proposed sections 30C, 30D and 30E into the Therapeutic Goods Act 1989. Proposed seclion 30C would require the Secretary to consult the Regulator in relation to applications for registration or listing of any therapeutic good which is or contains a OM product. Consonant with the proposed amendments to the schemes for
agricultural and veterinary chemicals and industrial chemicals, the Secretary must give written notice to the Regulator that an application has been made involving a OM product. and seek the advice of the Regulator. The Regulator then provides written advice within the specified time period. The Secretary must take that advice into account in making the decision whether to register or list the therapeutic good, and must infonn the Regulator of the decision. However. the Secretary is not obliged to follow any advice given by the Regulator.
There is also a process for the Secretary to seek advice from the Regulator about an entire class of therapeutic goOds containing a certain class of GM products (proposed seclion 30D of the Therapeutic Goods Act 1989). which duplicates the amendments to the industrial chemicals scheme. Ifan advice from the Regulator about a class ofGM products
is in force, the Secretary does not need to request advice from the Regulator in relation to applications for registration or listing of therapeutic goods containing those GM products (proposed subsection 30C(S». However, the Secretary still has to take the class advice into account in making individual decisions, and notify the Regulator of each individual decision made (proposed section 30E).
Miscellaneous
hem 13 amends the Freedom ofInformation Act 1982 to exempt confidential commercial infonnation (as defined in proposed section 187 of the Gene Technology Bill 2(00) from disclosure.
Items 1, 2. 8, 9, 10, 11, 14, IS, 17 and 18 insert definitions of "Gene Technology Regulator". "GMOn and "GM product" which cross-refer to the definitions contained in the Gene Technology Bill 2000.
Concluding Comments
The Bill does not alter the substance of the existing Commonwealth regulatory schemes in relation to food. therapeutic goods, agricultural, veterinary and industrial chemicals. The Bill merely adds an additional element to the existing structure of regulation. requiring advice from the Regulator to be sought and considered in relation to certain applications
for products containing GMOs. The Regulator's advice on GM products used in all four
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6 Gene Technology(ConsequentialAmendments)Bill 2000
areas is intended to provide some measure of consistency of treatment of GM products, and thus achieve the "harmonisation of risk assessments relating to GMOs and GM products" which is one of the functions of the Regu!ator. IO
Although provision is made for the Regulator to provide advice about a class of GM products in relation to both therapeutic goods and industrial chemicals, no such provision for class advice is made in relation to agricultural and veterinary chemicals. I I The reason for this omission is not immediately apparent.
Endnotes
See subsection 138(5) of the Gene Technology Bill 2000, Explanatory Memorandum to the Gene Technology (Consequential Amendments) Bill 2000, p. I.
2 Section 8 of the Agriculturalalld Veterinary Chemicals (Administration)Act 1992.
3 Section II ofthe Australia New ZealandFood AuthorityAct 1991.
4 Sections 16, 17,22 and 24 of the Australia New Zealand FoodAuthorityAct 1991.
5 Sections 16, 17, 17A, 20B, 22 and 24 of the Australia New ZealandFood AuthorityAct 1991.
6 Sections 17B and 25A of the Australia New ZealandFood Authority Act 1991.
7 Sections 27 and 28B of the Australia NewZealandFoodAuthority Act 1991.
8 Use ofa GMO to make a GM product is a 'dealing' with a GMO, and hence it is an offence to manufacture the GM product unless the manufacture is either licensed, exempt, listed on the GMO Register or a notifiable low-risk dealing.
9 Part 3 of the 1ndustrial Chemicals (Notification alld Assessment)Act 1989.
10 Proposed section 27(i) of the Gene Technology Bill 2000.
II No provision is made in relation to food, as the regulatory system for food appears not to operate on a class system, but focuses on individual measures and standards for particular products.
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This Digesll<"(IsprefKJredfordeOOle. tl rtfleeu Ihe tegi.JlI1/ion as in/reducedanddoes not canvasssubsequemI1mendmenu.
This Digesl does not have(Ulyoflicial tegal !laIUS. Olhersources shouldbe toruli/led 10 delermine Ihe SUbsequefll q{ficiat SlalUS q(lhe Bill.
