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Gene Technology (Consequential Amendments) Bill 2000

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2000

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GENE TECHNOLOGY (CONSEQUENTIAL AMENDMENTS) BILL 2000

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Minister for Health and Aged Care,

the Hon. Michael Wooldridge, MP)



GENE TECHNOLOGY (CONSEQUENTIAL
AMENDMENTS) BILL 2000

 

 

OUTLINE

 

This Bill represents one component of a national scheme to be established to protect the public health and safety of people and to protect the environment, by identifying risks posed by, or as a result of, gene technology and managing those risks through regulating certain dealings with genetically modified organisms (GMOs).

 

At present there are a range of regulators who provide regulatory oversight in relation to genetically modified products (GM products).  GM products are things derived or produced from a live or viable GMO.  For example, the Therapeutic Goods Administration regulates therapeutic goods including genetically modified therapeutics and the Australia New Zealand Food Authority coordinates the regulation, by States and Territories, of food including genetically modified food. 

 

As such the Gene Technology Bill 2000 provides for the direct regulation of all live or viable GMOs (acknowledging the greater potential risks that may arise in relation to live organisms that may be able to propagate) and regulation of GM products where they are not regulated by any existing regulators.  Where GM products are regulated by existing regulators they will continue to be so regulated.

 

This Bill ensures, however, that existing regulators of GM products have access to comprehensive advice on genetic safety from the Gene Technology Regulator and that the Gene Technology Regulator holds a comprehensive database of all GMOs or GM products approved in Australia.

 

The Bill requires that existing regulators of GM products (operating under existing schemes for the regulation of food, therapeutic goods, agricultural and veterinary chemicals and industrial chemicals) must:

·          seek advice from the Gene Technology Regulator in relation to any application for approval of a GM product;

·          take such advice into account in decision making under relevant legislation; and

·          notify the Gene Technology Regulator of all decisions made in relation to GM products to enable those decisions to be entered on a central, publicly available database of all GMOs and GM products, held by the Gene Technology Regulator.

 

For this purpose, the Bill:

(a)     amends the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals (Code) Act 1994 ;

(b)    amends the Australia New Zealand Food Authority Act 1991;

(c)     amends the Industrial Chemicals (Notification and Assessment) Act 1989 ; and

(d)    amends the Therapeutic Goods Act 1989.

 

The Bill also amends Schedule 3 of the Freedom of Information Act 1982 to clarify that information that is declared to be confidential commercial information under the Gene Technology Act 2000 is also protected under the Freedom of Information Act 1982.

 

 

FINANCIAL IMPACT STATEMENT

 

In the 1999 Budget, the Federal Government committed $7.6 million over 2 years for the

development of gene technology legislation and establishment of the Gene Technology Regulator.  Once the Gene Technology Regulator is established, it is intended that the costs incurred by the Gene Technology Regulator as a result of fulfilling his/her functions under the legislation be 100% cost recovered from the users of the regulatory regime (for example, those seeking licensing under the Gene Technology Bill 2000).   The fees and charges levied, in order to recover the costs of the regulatory system, will be prescribed in regulations made under the Gene Technology Bill 2000 and the Gene Technology (Licence Charges) Bill 2000 .  Regulations will be made following an independent analysis of the costs associated with the legislative scheme, extensive consultation with stakeholders and the preparation of a Regulation Impact Statement detailing the costs, benefits and impacts of the proposed charges.

 

It is not anticipated that this Bill will result in any significant costs to government in addition to those incurred as the result of the operation of the Gene Technology Bill 2000.

 

 

REGULATION IMPACT STATEMENT

 

1.         Background

 

Recognising the important role of existing regulators, the Gene Technology Bill 2000 has been drafted to ensure: the protection of public health and safety and the environment through the effective identification and management of any risks posed by GMOs; minimum duplication and overlap between the Gene Technology Regulator and existing regulators; and the harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies.

 

The Gene Technology Bill 2000 provides for the direct regulation of all live or viable GMOs and regulation of GM products where they are not regulated by an existing regulator.  Where GM products are regulated by existing regulators they will continue to be regulated by those regulators, with advice from the GTR.

 

This Regulation Impact Statement (RIS) assesses the impact of a range of options, including the option presented in the Gene Technology (Consequential Amendments) Bill 2000, for minimising duplication between existing agencies and ensuring that existing regulators of GM products have access to advice on genetic safety, to assist their consideration of approvals for GM products.

 

2.         Problem

 

The package of legislation for the regulation of GMOs (including the Gene Technology Bill 2000, the Gene Technology (Licence Charges) Bill 2000 and the Gene Technology (Consequential Amendments) Bill 2000 ) addresses the problems associated with the shortcomings in the current administrative arrangements for the protection of health and safety of people and the environment from any risks posed by live, viable GMOs and GM products.

 

As part of a package of legislation, this legislation specifically addresses the following problems:

·          At present, there is no formal process for existing regulators of GM products to seek, and take into account, advice on genetic safety aspects of GM products.  The existing Regulators currently use GMAC as a source of advice but under the new system GMAC will no longer exist. 

·          In the absence of a capacity for advice to be sought from the Gene Technology Regulator and taken into account by the existing regulators the following problems would emerge:

Ø   There would be no consistency in the way that matters of genetic safety are considered by existing regulators in relation to GM products;

Ø   There would be little reassurance to the community that matters of genetic safety have been adequately addressed during the assessment process for GM products; 

Ø   There would be no central repository of information about those GMOs and GM products that have been approved for use/sale in Australia which would:

-                       make it difficult for Australia to fulfil potential future reporting obligations under the Biosafety Protocol; and

-           reduce the information available to consumers of GMOs and GM products, making it more difficult for consumers to make informed decisions in the market place.

 

In summary, while informal arrangements with existing regulators could continue under the new system, current problems would also continue including lack of consistency, inadequate reassurance to the public that issues of genetic safety are adequately addressed by existing regulators and the absence of a comprehensive central database. 

 

3.         Objectives

 

The objectives of government action in this area are:

·          to minimise duplication of effort and resources between existing regulators (and clarify the interface between the Gene Technology Regulator and other existing regulators);

·          to ensure that a comprehensive assessment of any risks posed by, or as a result of, gene technology is undertaken by all regulators of GMOs and GM products; and

·          to enable the public and other stakeholders to access a comprehensive database of all GMOs and GM products in Australia.

 

In summary the objectives are about having an assessment system for GMOs and GM products that is comprehensive and efficient and provides an outcome that is transparent.

 

4.         Options and impact analysis

 

Option 1 - Amendments to the legislation of existing Regulators of GM products

 

This would involve amendments being made to the legislation of existing regulators to ensure that existing regulators of GMOs and GM products (including the regulators of  food, therapeutic goods, agricultural and veterinary chemicals and industrial chemicals) must:

·          seek advice from the GTR in relation to any application for approval of a GM product;

·          take such advice into account in decision making; and

·          notify the GTR of all decisions made in relation to GM products to enable those decisions to be entered on a central, publicly available database of all GMOs and GM products, held by the GTR (the Record of GMOs and GM Products is established in the Gene Technology Bill 2000 ).

 

Legislation requiring amendment to effect the changes detailed above would include:

a)       the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals (Code) Act 1994 ;

b)       the Australia and New Zealand Food Authority Act 1991 ;

c)       the Industrial Chemicals (notification and Assessment) Act 1989 ; and

d)      the Therapeutic Goods Act 1989 .

 

This option would give a formal legislative basis for the interaction between the existing regulators and the Gene technology Regulator in terms of requesting and providing information, making decisions and establishing publicly available information systems.

 

The option would require amendments to the above-mentioned primary legislation and the implementation of formal channels of communication between the regulators and the Gene Technology Regulator.

 

Option 2 - Informal sharing of information between existing regulators of GMOs and GM products

 

Option 2 would maintain the key features of the current GMAC system.  That is, the existing regulators (Australia New Zealand Food Authority, the Therapeutic Goods Administration, the National Registration Authority and the National Industrial Chemicals Notification and Assessment Scheme) could informally seek the advice of the Gene Technology Regulator in relation to risks posed by GM products.

 

This would be an ad hoc arrangement, whereby the Gene Technology Regulator’s advice would be requested only if the relevant agency considered it necessary to seek such input from the Gene Technology Regulator to assist its decision-making process.  There would be no formal requirement that the information must be sought nor could a regulator be compelled to seek such information or establish appropriate networks.

 

Agencies would seek the Gene Technology Regulator’s advice and consider that advice under existing legislation.  Administrative processes would be likely to evolve differently in accordance with the individual needs of the ‘principal’ regulator and the capacity of the Gene Technology Regulator to provide the advice requested (the amount and type of  advice provided would be uncertain in this environment).

 

Impact group identification

 

The following groups are relevant to the proposal:

  • Governments;
  • Industry;
  • Consumers; and
  • Community.


Assessment of Impacts of Option 1



Affected Group

Advantages

Disadvantages

Government

·          The requirements are clear on the face of the legislation

·          No need to establish centres of expertise on genetic safety in each agency, thus avoiding costs of duplication and realising economies of scale

·          Ready access to expert advice on genetic safety

·          Capacity for the establishment of a consolidated database in relation to GMOs and GM products within Australia

·          Processes for meeting the  legal requirements will need to be developed - ie for requesting advice and taking such advice into account

·          Potential increase in information technology and human resource infrastructure requirements to ensure smooth exchange of information consistent with the legislative requirements.

 

Industry

·          Requirement that the Gene Technology Regulator provide advice within the timeframes of the ‘primary’ regulator ensures that product development processes are not affected

 

Consumers

·          Consumers of products produced using gene technology can be confident that risks have been comprehensively assessed by the ‘primary’ regulator in close co-operation with the Gene Technology Regulator.  All live, viable GMOs would also be directly regulated by the Gene Technology Regulator

·          Capacity to gain information in relation to GMOs and GM products in Australia via the consolidated database

 

Community

·          Can be confident that, as new technologies emerge, any regulatory gaps are effectively ‘filled’ and that risks associated with GM products are comprehensively assessed. 

·          Capacity to gain information in relation to GMOs and GM products in Australia via the consolidated database

 

 

Assessment of Impacts of Option 2

 

Affected Group

Advantages

Disadvantages

Government

·          Lower costs associated with setting up administrative processes for exchange of information and advice.  

·          No amendments to primary legislation of the existing regulators necessary.

 

·          May lead to duplication as some agencies may choose to establish their own units to assess genetic risks rather than utilise the Gene Technology Regulator’s services.

·          May cause inconsistency and uncertainty in both assessments and processes for considering genetic safety.

Industry

·          Assessment of GM products by existing regulators remains unchanged.

 

 

·          Less transparent system may produce consumer uncertainties about particular products and a possible reluctance to purchase such products

·          Potential for inconsistent decision-making between the different regulatory systems in relation to genetic safety

Consumers

 

·          May lead to consumer uncertainties and an unwillingness to purchase certain products - where there is no guarantee that the Gene Technology Regulator has been consulted and his/her advice taken into account

Community

 

·          May be seen as ‘trivialising’ the risks posed by GM products

·          May lead to suspicions as to whether a full and proper assessment of any risks posed to human health and safety and the environment as a result of gene technology has been carried out for a particular GM product

 



 

5.         Consultation

 

Extensive consultations have been undertaken during the development of the Gene Technology Bill 2000.   This has provided an opportunity to raise with various stakeholders the policy intent behind the proposed Gene Technology (Consequential Amendments) Bill 2000 .  Consultations took the following forms:

 

1.                   Targeted consultations held with industry, environmental, consumer and other groups;

2.                   Public consultations held in all capital cities and in three regional centres;

3.                   Public submissions (on the form of the legislation) called for;

4.                   Intensive consultations with the existing regulators, relevant Commonwealth agencies and States and Territories.

 

During consultations, stakeholders emphasised the need for:

·          Comprehensive regulation of all GMOs and GM products;

·          Capacity for existing regulators to access the advice of the GTR;

·          Consistency in decision-making concerning genetic safety;   and

·          A comprehensive database of all GMOs and GM products.

 

6.         Conclusion and Preferred Option

 

The Bill reflects a preference for Option 1.  The advantages of this option are that it:

·          minimises duplication of effort and resources between existing regulators to a greater extent than Option 2;

·          ensures that an assessment of any risks posed by, or as a result of, gene technology is undertaken by all regulators of GMOs and GM products;

·          imposes no foreseeable additional costs on industry; and

·          provides for the collection of comprehensive information about GMOs and GM products approved in Australia, for inclusion on a centralised database.

 

7.         Implementation and Review

 

The changes proposed in this Bill will become part of the existing legislative schemes for foods, therapeutics, industrial chemicals and agricultural and veterinary chemicals. As such, the effectiveness of the arrangements will be subject to periodic review under the existing systems.  However, it is proposed that the effects of the Bill would also be reviewed at the end of the first five-year period when the gene technology scheme is comprehensively reviewed by governments in accordance with the Inter-governmental Agreement on Gene Technology as referenced in the Gene Technology Bill 2000 .

 

8.         Competition Principles Agreement Statement

 

There is arguably some potential to limit competition because the proposed consequential amendments require the regulators to seek advice from the GTR in relation to the genetic safety of GM products.  However, this is extremely unlikely to have any impact on competition since there is no bar on the regulators seeking advice from numerous other relevant bodies and taking that advice into account in decision-making.  The proposed amendments simply recognise that the GTR will be the central repository of expertise in this area.

 

The recommended option does not restrict competition by adding costs or delays to the assessment of GMOs and GM products which compete in markets with non-GM products over and above costs and delays inherent in current arrangements.



 

 

NOTES ON CLAUSES





PART 1 - PRELIMINARY

 

Clause 1 - Short title

 

This is a formal provision that specifies the short title of the Act as the Gene Technology (Consequential Amendments) Act 2000.

 

Clause 2 - Commencement

 

This clause provides that the Act will commence immediately upon the commencement of clause 55 of the Gene Technology Act 2000 .  Clause 55 of the Gene Technology Act 2000 requires the Gene Technology Regulator to make a decision on any licence application received and assessed by him or her.

 

Clause 3 -  Schedule(s)

 

This clause provides that every Act specified in the Schedule to this Bill is either amended or repealed as set out in that Schedule, and any other item included in the Schedule is to have effect according to its terms.

 

SCHEDULE 1  - CONSEQUENTIAL AMENDMENTS

 

Agricultural and Veterinary Chemicals (Administration) Act 1992

 

Items 1 and 2 insert in section 4 the definitions of “Gene Technology Regulator” and “GM product”.  These terms have the same meaning as in the Gene Technology Act 2000 .

 

Item 3 inserts a new clause, clause 8A, which requires the National Registration Authority (NRA) to consult the Gene Technology Regulator for the purposes of making a range of decisions under the Agricultural and Veterinary Chemical (Administration) Act 1992 .  This clause requires the NRA to consult the Gene Technology Regulator when deciding whether to grant an application, make a variation or reconsider any of the following:

(a)     approval of an active constituent that is, or contains, a GM product;

(b)    registration of a chemical product that is, or contains, a GM product; and

(c)     approval of a label for containers for a chemical product that is, or contains, a GM product.

 

The NRA must also consult the Gene Technology Regulator before deciding whether to issue a permit in respect of an active constituent or chemical product where either the active constituent or the chemical product is, or contains, a GM product.

 

Sub-clause 3 of the new clause 8A describes the formal process for the NRA to consult with the Gene Technology Regulator.  It provides that the NRA must give written notice to the Gene Technology Regulator stating that the application has been made, a reconsideration is to be undertaken or the permit is being considered and requesting the Gene Technology Regulator to provide advice about the application, reconsideration or issue of a permit.

 

Sub-clauses 8A(4) and (5) provide that the Gene Technology Regulator may give written advice in response to a request for advice from the NRA and that the advice must be given in the time period specified by the NRA.

 

Sub-clause 8A(6) provides that if the Gene Technology Regulator provides advice to the NRA on an application, reconsideration or permit, the NRA must take the advice into account in making the decision on the application, reconsideration or issue to which the notice relates.  The NRA must inform the Gene Technology Regulator of the decision.  This will then enable the Gene Technology Regulator to enter information relating to the decision on the Record of GMOs and GM products established under the Gene Technology Bill 2000.

 

Agricultural and Veterinary Chemicals (Code) Act 1994

 

Item 4 inserts a new paragraph after paragraph 14(3)(c), to cross reference the changes to the Agricultural and Veterinary Chemicals (Administration) Act 1992 detailed at Item 3.

 

Item 5 inserts a new paragraph after paragraph 29(1)(c), to cross reference the changes to the Agricultural and Veterinary Chemicals (Administration) Act 1992 detailed at Item 3.

 

Item 6 inserts a new paragraph after paragraph 34(1)(d), to cross reference the changes to the Agricultural and Veterinary Chemicals (Administration) Act 1992 detailed at Item 3.

 

Item 7 inserts a new paragraph after paragraph 114(1), to cross reference the changes to the Agricultural and Veterinary Chemicals (Administration Act) 1992 detailed at Item 3.

 

Australia New Zealand Food Authority Act 1991

 

Item 8 inserts a new paragraph after paragraph (b) of the definition of appropriate government agency in subsection 3(1). The new paragraph includes the Gene Technology Regulator in the list of appropriate government agencies.

 

The effect of this change (in combination with the changes referred to at Item 11) is that the Australia New Zealand Food Authority (the Authority) must, after accepting an application for the development and variation of food regulatory measures in relation to GMOs or GM products, give written notice to the Gene Technology Regulator inviting written advice from the Gene Technology Regulator on the application.  The Authority must then have regard to such advice in making an assessment of the application. 

 

The Authority must advise the Gene Technology Regulator of the nature of the recommendations made to the Australia New Zealand Food Standards Council (the Council).  The final decision of the Council is publicly notified in the Government Gazette.  The decision, as it relates to GMOs or GM products, would then be entered on the Gene Technology Regulator’s Record of GMOs and GM products (established under the Gene Technology Act 2000 ).

 

Items 9, 10 and 11 insert three further definitions in subsection 3(1).  The terms “Gene Technology Regulator”, “GMO” and “GM product” are defined as having the same meaning as in the Gene Technology Act 2000.   

 

Item 12 inserts a new clause (clause 11A - Notices to be given to the Gene Technology Regulator) after section 11.  Clause 11A provides that the Authority is only required to give notice to the Gene Technology Regulator in relation to an existing or proposed food regulatory measure if the measure relates to food that is or contains a GMO or GM product. 

 

Freedom of Information Act 1982

 

Item 13 inserts in Schedule 3 of the Freedom of Information Act 1982 (the FOI Act), references to subsections 187(1) and 187(2) of the Gene Technology Act 2000.

 

The effect of this amendment is to clarify that information that the Gene Technology Regulator declares to be confidential commercial information under the Gene Technology Act 2000 is protected as such under the FOI Act.  Including a reference to the relevant provisions of the Gene Technology Act 2000 in Schedule 3 of the FOI Act clarifies that these provisions are provisions to which section 38 of the FOI Act applies.  Section 38 of the FOI Act provides an exemption for certain documents to which secrecy provisions apply.

 

It is also proposed that an equivalent provision will be included in corresponding State laws to ensure national consistency regarding the treatment of confidential commercial information.

 

Industrial Chemicals (Notification and Assessment) Act 1989

 

Items 14 and 15 insert two new definitions in section 5.  The terms “Gene Technology Regulator” and “GM product” are defined as having the same meaning as in the Gene Technology Act 2000.   

 

Item 16 inserts three new clause (clauses 10A, 10B and 10C) after section 10.

 

The new clause 10A (Consultation with Gene Technology Regulator) requires the Director of Chemicals Notification and Assessment to give written notice to the Gene Technology Regulator requesting the Gene Technology Regulator to provide advice in relation to an application for assessment of an industrial chemical that is, or contains, a GM product or an application for a permit in relation to an industrial chemical that is, or contains, a GM product.

 

Sub-clauses 10A(3) and (4) provide that the Gene Technology Regulator may give written advice in response to a request for advice from the Director about the assessment or application and that the advice must be given in the time period specified by the Director in the written notice provided to the Gene Technology Regulator requesting the advice.

 

Sub-clause 10A(5) provides that if an advice is in force from the Gene Technology Regulator under clause 10B in relation to a class of GM products, the Director is not required to seek the advice of the Gene Technology Regulator on a case by case basis provided that the application or assessment falls within the class of GM products in relation to which the Gene Technology Regulator issued an advice under clause 10B.

 

The new clause 10B (Director may seek advice about classes of GM products) provides that the Director may request advice from the Gene Technology Regulator regarding a class of GM products that are also industrial chemicals.  The Gene Technology Regulator may provide advice in relation to such a request and the advice remains in force until it is withdrawn by the Gene Technology Regulator by written notice given to the Director.

 

The effect of this provision is that if the same genetic modification or GM product occurs within a range of industrial chemicals, the Director does not need to seek advice from the Gene Technology Regulator in relation to every application but may seek advice from the Gene Technology Regulator about the class of GM products and then apply such advice to each assessment or application undertaken by the Director.

 

The new clause 10C (Director to take advice into account) provides that if the Gene Technology Regulator provides advice to the Director (either in response to an individual application or assessment under clause 10A or in response to a request for advice about a class of GM products under clause 10B), the Director must take that advice into account in undertaking an assessment or in making a decision on the application for a permit. 

 

This clause also provides that the Director must inform the Gene Technology Regulator of the assessment or the decision on the application.  This will then enable the Gene Technology Regulator to enter information relating to the assessment or the decision on the Record of GMOs and GM products established under the Gene Technology Bill 2000.

 

Therapeutic Goods Act 1989

 

Items 17 and 18 insert two new definitions in subsection 3(1).  The terms “Gene Technology Regulator” and “GM product” are defined as having the same meaning as in the Gene Technology Act 2000.

 

Item 19 inserts three new clauses (clauses 30C, 30D and 30E) after section 30.

 

The new clause 30C (Consultation with Gene Technology Regulator) requires the Secretary to give written notice to the Gene Technology Regulator requesting the Gene Technology Regulator to provide advice in relation to an application for listing or registration of a therapeutic good under section 23 of the Therapeutic Goods Act 1989 if the therapeutic good is, or contains, a GM product.

 

Sub-clauses 30C(3) and (4) provide that the Gene Technology Regulator may give written advice in response to a request for advice from the Secretary and that advice must be given in the time period specified by the Secretary in the written notice provided to the Gene Technology Regulator requesting the advice.

 

Sub-clause 30C(5) provides that if an advice is in force from the Gene Technology Regulator under clause 30D in relation to a class of therapeutic goods that are also GM products, the Secretary is not required to seek the advice of the GTR on a case by case basis provided that the application for listing or registration falls within the class of GM products in relation to which the Gene Technology Regulator issued an advice under clause 30D.

 

The new clause 30D (Secretary may seek advice about classes of GM products) provides that the Secretary may request advice from the Gene Technology Regulator regarding a class of GM products that are also therapeutic goods. The Gene Technology Regulator may provide advice in relation to such a request and the advice remains in force until it is withdrawn by the Gene Technology Regulator by written notice given to the Secretary.

 

The effect of this provision is that if the same genetic modification or GM product occurs within a class of therapeutic goods, the Secretary does not need to seek advice from the Gene Technology Regulator in relation to every application but may seek advice from the Gene Technology Regulator about the class of GM products that are also therapeutic goods and then apply such advice to each assessment of an application for registration or listing undertaken by the Secretary.

 

The new clause 30E (Secretary to take advice into account) provides that if the Gene Technology Regulator provides advice to the Secretary (either in response to an individual application for registration or listing under clause 30C or in response to a request for advice about a class of GM products under clause 30D), the Secretary must take that advice into account in undertaking an assessment of an application for registration or listing of the therapeutic good. 

 

The clause also provides that the Secretary must inform the Gene Technology Regulator of the decision on the application for registration or listing.  This will then enable the Gene Technology Regulator to enter information relating to the listed or registered therapeutic good on the Record of GMOs and GM products established under the Gene Technology Bill 2000.