Bills Digest No. 10  2000-01 Gene Technology (Consequential Amendments) Bill 2000


Numerical Index | Alphabetical Index

WARNING:
This Digest was prepared for debate. It reflects the legislation as introduced and does not canvass subsequent amendments. This Digest does not have any official legal status. Other sources should be consulted to determine the subsequent official status of the Bill.

CONTENTS

Passage History
Purpose
Background
Main Provisions
Endnotes
Contact Officer & Copyright Details

Passage History

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 certain dealings with genetically modified products.

Background

This Bill, together with the Gene Technology Bill 2000 and the Gene Technology (Licence Charges) Bill 2000, forms 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 for the Gene Technology Bill 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 of regulation.

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.(1)

The regulatory agencies do 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 information 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 1 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 of an approval of an active constituent,
  • registration, variation or reconsideration of the registration of a chemical product,
  • approval, variation or reconsideration of an approval of a 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, 5, 6 and 7 insert cross-references to proposed section 8A 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. ANZFA 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,(3) 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 Zealand Food Authority 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,(5) draft codes of practice,(6) and draft food standards.(7)

Item 12 inserts proposed section 11A into the Australia New Zealand Food Authority 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 Food Authority Act 1991 appears to be that food containing GM products will undergo the normal 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 ANZFA's 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 ANZFA.(8)

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 relevant government agencies.(9)

Item 16 inserts proposed sections 10A, 10B and 10C into the Industrial Chemicals (Notification and Assessment) Act 1989. Proposed section 10A would require the Director to consult the Regulator in relation to the assessment of and application for a permit for any industrial chemical that is or contains a GM 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 inform 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 GM products (proposed section 10B of the Industrial Chemicals (Notification and Assessment) Act 1989). If an advice from the Regulator about a class of GM products is in force, the Director does not need to seek advice from the Regulator in relation to applications for assessments and permits for industrial chemicals containing those GM products (proposed subsection 10A(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 10C).

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 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 section 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 GM 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 GM 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 inform 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 section 30D of the Therapeutic Goods Act 1989), which duplicates the amendments to the industrial chemicals scheme. If an advice from the Regulator about a class of GM 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(5)). 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

Item 13 amends the Freedom of Information Act 1982 to exempt confidential commercial information (as defined in proposed section 187 of the Gene Technology Bill 2000) from disclosure.

Items 1, 2, 8, 9, 10, 11, 14, 15, 17 and 18 insert definitions of "Gene Technology Regulator", "GMO" 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 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 Regulator.(10)

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.(11) The reason for this omission is not immediately apparent.

Endnotes

  1. See subsection 138(5) of the Gene Technology Bill 2000, Explanatory Memorandum to the Gene Technology (Consequential Amendments) Bill 2000, p. 1.
  2. Section 8 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.
  3. Section 11 of the Australia New Zealand Food Authority Act 1991.
  4. Sections 16, 17, 22 and 24 of the Australia New Zealand Food Authority Act 1991.
  5. Sections 16, 17, 17A, 20B, 22 and 24 of the Australia New Zealand Food Authority Act 1991.
  6. Sections 17B and 25A of the Australia New Zealand Food Authority Act 1991.
  7. Sections 27 and 28B of the Australia New Zealand Food Authority Act 1991.
  8. Use of a 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 Industrial Chemicals (Notification and Assessment) Act 1989.
  10. Proposed section 27(i) of the Gene Technology Bill 2000.
  11. 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.

Contact Officer and Copyright Details

Katrine Del Villar and Angus Martyn
15 August 2000
Bills Digest Service
Information and Research Services

This paper has been prepared for general distribution to Senators and Members of the Australian Parliament. While great care is taken to ensure that the paper is accurate and balanced, the paper is written using information publicly available at the time of production. The views expressed are those of the author and should not be attributed to the Information and Research Services (IRS). Advice on legislation or legal policy issues contained in this paper is provided for use in parliamentary debate and for related parliamentary purposes. This paper is not professional legal opinion. Readers are reminded that the paper is not an official parliamentary or Australian government document.

IRS staff are available to discuss the paper's contents with Senators and Members
and their staff but not with members of the public.

ISSN 1328-8091
© Commonwealth of Australia 2000

Except to the extent of the uses permitted under the Copyright Act 1968, no part of this publication may be reproduced or transmitted in any form or by any means, including information storage and retrieval systems, without the prior written consent of the Parliamentary Library, other than by Members of the Australian Parliament in the course of their official duties.

Published by the Department of the Parliamentary Library, 2000.

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