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Part 3—Categorisation and assessment of industrial chemicals

Part 3 Categorisation and assessment of industrial chemicals

Division 1 Simplified outline of this Part

23   Simplified outline of this Part

This Part sets out the categories of introduction and the requirements that must be met for each category.

Penalties apply if a person introduces an industrial chemical without meeting the requirements of one of these categories.

There are 6 categories: listed introductions, exempted introductions, reported introductions, assessed introductions, commercial evaluation introductions and exceptional circumstances introductions.

This Part sets out how to apply to the Executive Director for an assessment certificate or commercial evaluation authorisation and how exceptional circumstances authorisations are issued.

It also sets out how changes may be made to certificates and authorisations.

Division 2 Introduction categories

24   Introductions must be authorised

             (1)  A person contravenes this subsection if:

                     (a)  the person introduces an industrial chemical; and

                     (b)  the introduction is not authorised by any of the following:

                              (i)  section 25 (which deals with listed introductions);

                             (ii)  section 26 (which deals with exempted introductions);

                            (iii)  section 27 (which deals with reported introductions);

                            (iv)  section 28 (which deals with assessed introductions);

                             (v)  section 29 (which deals with commercial evaluation introductions);

                            (vi)  section 30 (which deals with exceptional circumstances introductions).

Note:          The introduction of an industrial chemical may also be subject to prohibitions or conditions based on Australia’s obligations under international agreements or arrangements: see Division 3 of Part 9.

Fault-based offence

             (2)  A person commits an offence if the person contravenes subsection (1).

Penalty:  500 penalty units.

Strict liability offence

             (3)  A person commits an offence of strict liability if the person contravenes subsection (1).

Penalty:  60 penalty units.

Civil penalty provision

             (4)  A person is liable to a civil penalty if the person contravenes subsection (1).

Civil penalty:          500 penalty units.

25   Listed introductions

                   An introduction of an industrial chemical by a person is authorised by this section if:

                     (a)  the industrial chemical is listed on the Inventory; and

                     (b)  the introduction is in accordance with the terms of the Inventory listing.

Note:          Part 5 deals with the Inventory and the process for getting an industrial chemical listed on the Inventory.

26   Exempted introductions

             (1)  An introduction of an industrial chemical by a person is authorised by this section if the introduction is an exempted introduction in accordance with rules made for the purposes of subsection (2).

             (2)  The rules may prescribe the following:

                     (a)  circumstances in which an introduction of an industrial chemical is an exempted introduction ;

                     (b)  circumstances in which an introduction of an industrial chemical is not an exempted introduction .

Note:          An exempted introduction is an industrial chemical introduction that poses a very low risk to human health and the environment.

             (3)  Without limiting subsection (2), the rules may prescribe different circumstances for different industrial chemicals, or classes of industrial chemicals, and may prescribe circumstances relating to any of the following:

                     (a)  the hazards of the industrial chemical to human health;

                     (b)  the hazards of the industrial chemical to the environment;

                     (c)  the exposure of humans to the industrial chemical from the introduction and use of the industrial chemical;

                     (d)  the exposure of the environment to the industrial chemical from the introduction and use of the industrial chemical.

27   Reported introductions

             (1)  An introduction of an industrial chemical by a person is authorised by this section if:

                     (a)  the introduction is a reported introduction in accordance with rules made for the purposes of subsection (2); and

                     (b)  a pre-introduction report for the industrial chemical has been given to the Executive Director in accordance with section 97; and

                     (c)  the introduction is in accordance with the terms of the pre-introduction report.

Note:          For information and reporting obligations, including pre-introduction reports: see Part 6.

             (2)  The rules may prescribe the following:

                     (a)  circumstances in which an introduction of an industrial chemical is a reported introduction ;

                     (b)  circumstances in which an introduction of an industrial chemical is not a reported introduction .

Note:          A reported introduction is an industrial chemical introduction that poses a low risk to human health or the environment.

             (3)  Without limiting subsection (2), the rules may prescribe different circumstances for different industrial chemicals, or classes of industrial chemicals, and may prescribe circumstances relating to any of the following:

                     (a)  the hazards of the industrial chemical to human health;

                     (b)  the hazards of the industrial chemical to the environment;

                     (c)  the exposure of humans to the industrial chemical from the introduction and use of the industrial chemical;

                     (d)  the exposure of the environment to the industrial chemical from the introduction and use of the industrial chemical;

                     (e)  whether the introduction of the industrial chemical has been the subject of an assessment (however described) by an international body.

28   Assessed introductions

                   An introduction of an industrial chemical by a person is authorised by this section if:

                     (a)  the person is the holder of an assessment certificate, or is covered by an assessment certificate, for the industrial chemical; and

                     (b)  the introduction is in accordance with the terms of the assessment certificate.

Note 1:       An assessed introduction is generally an industrial chemical introduction that poses a medium to high risk to human health or the environment. If an introduction of an industrial chemical does not fall within the definition of an exempted or reported introduction and is not listed on the Inventory, it is generally an assessed introduction.

Note 2:       A person can choose to apply for an assessment certificate for an introduction that would otherwise be authorised under another section in this Division: see Division 3.

29   Commercial evaluation introductions

                   An introduction of an industrial chemical by a person is authorised by this section if:

                     (a)  the person is the holder of a commercial evaluation authorisation for the industrial chemical; and

                     (b)  the introduction is in accordance with the terms of the commercial evaluation authorisation.

30   Exceptional circumstances introductions

                   An introduction of an industrial chemical by a person is authorised by this section if:

                     (a)  the person is the holder of an exceptional circumstances authorisation for the industrial chemical; and

                     (b)  the introduction is in accordance with the terms of the exceptional circumstances authorisation.

Division 3 Assessment certificates

Subdivision A Obtaining a certificate

31   Applying for a certificate

             (1)  A person may apply to the Executive Director for an assessment certificate for the introduction of an industrial chemical.

Note 1:       For general requirements relating to applications: see section 167.

Note 2:       An application for the proper name or end use for an industrial chemical to be treated as confidential business information may be made at the time of applying for an assessment certificate: see section 105.

             (2)  A joint application under subsection (1) may be made by 2 or more persons.

             (3)  An application under subsection (1) cannot be made for an industrial chemical that is listed on the Inventory.

Note:          If an introduction of an industrial chemical is not within the terms of the Inventory listing for the industrial chemical, the introduction may otherwise be authorised as an exempted or reported introduction, or an application may be made to vary the terms of the Inventory listing: see sections 26, 27 and 88.

32   Executive Director must consider application

             (1)  The Executive Director must consider the application in accordance with this Subdivision.

             (2)  A decision on the application must be made under subsection 37(1) within the following period (the consideration period ) after the day the application is made:

                     (a)  unless paragraph (b) or (c) applies—70 working days;

                     (b)  unless paragraph (c) applies—if the rules prescribe a number of working days for that type of application, that number of working days;

                     (c)  if the Executive Director and each applicant agree to a number of working days—that number of working days.

Note:          For circumstances affecting the calculation of the consideration period: see section 169.

             (3)  In considering the application, the Executive Director must have regard to the following:

                     (a)  any risks to human health or the environment associated with the proposed introduction or use of the industrial chemical;

                     (b)  whether any conditions of a kind mentioned in subsection 38(2) are necessary to manage any such risks;

                     (c)  any further information provided in accordance with section 33 or subsection 167(4);

                     (d)  any advice given by a prescribed body in accordance with section 34;

                     (e)  any advice given by the Gene Technology Regulator in accordance with section 35;

                      (f)  any submissions made by an applicant in accordance with section 36.

33   Executive Director may request further information

             (1)  The Executive Director may, by written notice given to an applicant, request further information to be provided for the purposes of considering the application.

             (2)  The information must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

             (3)  If the requested information is not provided within the period mentioned in subsection (2), the Executive Director may take the application to be withdrawn.

34   Consultation with prescribed bodies

             (1)  The Executive Director must, by written notice, seek the advice of a body prescribed by the rules for the purposes of this subsection if the Executive Director is considering doing either of the following:

                     (a)  not issuing an assessment certificate under paragraph 37(1)(b) on the basis that the Executive Director is not satisfied that the risks to human health or the environment can be managed;

                     (b)  including conditions of a kind mentioned in subsection 38(2) on the assessment certificate on the basis that the conditions are necessary to manage risks to human health or the environment.

             (2)  In considering an application, the Executive Director may, by written notice, seek the advice of a body prescribed by the rules for the purposes of this subsection.

             (3)  The body may provide a response to the Executive Director.

             (4)  The response must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

35   Consultation with Gene Technology Regulator

             (1)  The Executive Director must, by written notice, seek the advice of the Gene Technology Regulator if the application relates to an industrial chemical that is a GM product or contains a GM product.

             (2)  The Gene Technology Regulator may provide a response to the Executive Director.

             (3)  The response must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

36   Submissions on draft assessment statement

             (1)  The Executive Director must, by written notice, provide each applicant with a draft assessment statement.

             (2)  An applicant may make a written submission to the Executive Director about the draft statement.

             (3)  A submission must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

37   Issue of certificate and assessment statement

             (1)  After considering the application, the Executive Director must decide to:

                     (a)  issue an assessment certificate; or

                     (b)  not issue an assessment certificate.

             (2)  The Executive Director must be satisfied that any risks to human health or the environment can be managed before deciding to issue an assessment certificate.

             (3)  The Executive Director must not issue the assessment certificate if the Executive Director is not satisfied that any risks to human health or the environment can be managed.

             (4)  To avoid doubt, the Executive Director must not issue the assessment certificate if the Executive Director is satisfied that the chemical is not an industrial chemical.

             (5)  The Executive Director must give written notice of the decision and the assessment statement to each applicant.

             (6)  If the decision is to issue an assessment certificate, the Executive Director must also give the assessment certificate to each applicant.

             (7)  The Executive Director must publish the assessment statement on the AICIS website.

38   Content of certificate

             (1)  An assessment certificate must be in writing and include the following (the terms of the assessment certificate):

                     (a)  the proper name for the industrial chemical;

                     (b)  the defined scope of assessment;

                     (c)  any conditions relating to the introduction or use of the industrial chemical;

                     (d)  any specific requirements to provide information to the Executive Director in relation to the introduction;

                     (e)  any other information prescribed by the rules for the purposes of this paragraph.

             (2)  For the purposes of paragraph (1)(c) the conditions must be any of the following kinds:

                     (a)  a condition on the volume of industrial chemical permitted to be introduced;

                     (b)  a condition on where the industrial chemical is permitted to be introduced or used;

                     (c)  a condition on the period for which the industrial chemical is permitted to be introduced.

39   When certificate is in force

                   An assessment certificate for an industrial chemical is in force for the period beginning the day notice of the issue of the certificate is given under subsection 37(5) and ending on the earliest of the following:

                     (a)  the day the certificate is taken to be cancelled under subsection 42(7);

                     (b)  the day notice of the cancellation of the assessment certificate is given under subsection 51(3) or 52(6);

                     (c)  if a condition of a kind mentioned in paragraph 38(2)(c) is included on the certificate—the day after the last day that the industrial chemical is permitted to be introduced in accordance with that condition;

                     (d)  the day the Executive Director lists the industrial chemical on the Inventory in relation to the certificate under subsection 82(1) or 83(2);

                     (e)  the day the Executive Director varies the listing for the industrial chemical in relation to the certificate under subsection 87(2).

Subdivision B Changes to certificate holders or persons covered by a certificate

40   Applying to change persons covered

Adding persons

             (1)  A holder of an assessment certificate may apply to the Executive Director for a person to be covered by the certificate.

Note:          For general requirements relating to applications: see section 167.

             (2)  The Executive Director must grant the application if satisfied that:

                     (a)  the application complies with section 167; and

                     (b)  the following consent to the application:

                              (i)  each holder of the certificate;

                             (ii)  the person to be covered by the certificate.

             (3)  The Executive Director must give written notice of the decision to the following:

                     (a)  each holder of the certificate;

                     (b)  the person to be covered by the certificate.

Removing persons

             (4)  A person covered by an assessment certificate may apply to the Executive Director to be removed as a person covered by the certificate.

Note:          For general requirements relating to applications: see section 167.

             (5)  The Executive Director must grant the application if satisfied that the application complies with section 167.

             (6)  The Executive Director must give written notice of the decision to the following:

                     (a)  the applicant;

                     (b)  each holder of the certificate.

41   Applying to change certificate holders

Adding persons

             (1)  A person may apply to the Executive Director to be added as a holder of the certificate.

Note:          For general requirements relating to applications: see section 167.

             (2)  The Executive Director must grant the application if satisfied that:

                     (a)  the application complies with section 167; and

                     (b)  the following consent to the application:

                              (i)  the applicant;

                             (ii)  each holder of the certificate.

             (3)  The Executive Director must give written notice of the decision to the following:

                     (a)  the applicant;

                     (b)  each holder of the certificate.

Removing persons

             (4)  A holder of an assessment certificate for which there are joint certificate holders may apply to the Executive Director to remove the person as a holder of the certificate.

Note:          For general requirements relating to applications: see section 167.

             (5)  The Executive Director must grant the application if satisfied that the application complies with section 167.

             (6)  The Executive Director must give written notice of the decision to the following:

                     (a)  the applicant;

                     (b)  each holder of the certificate.

42   Changing certificate holders on Executive Director’s initiative

             (1)  The Executive Director may remove a person as a holder of an assessment certificate, or remove a person as a person covered by the certificate, if the Executive Director is satisfied that:

                     (a)  the person is not complying with the terms of the assessment certificate; or

                     (b)  the person has made a statement, or given a document or information, to the Executive Director in connection with the assessment certificate that was false or misleading in a material particular.

             (2)  Before removing the person, the Executive Director must give written notice of the proposed removal, and the reasons for the removal, to the person.

             (3)  The person may make a written submission to the Executive Director about the proposed removal.

             (4)  A submission must be made within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

             (5)  After considering any submissions made during that period the Executive Director must decide to:

                     (a)  remove the person from the assessment certificate; or

                     (b)  not remove the person from the assessment certificate.

             (6)  The Executive Director must give written notice of the decision to the following:

                     (a)  the person;

                     (b)  each holder of the certificate.

             (7)  If after removing the person there are no holders of the certificate, the certificate is taken to be cancelled on the day the notice is given under subsection (6).

Subdivision C Varying the terms of an assessment certificate

43   Applying for a variation of the terms of an assessment certificate

             (1)  The holder of an assessment certificate may apply to the Executive Director to vary a term of the assessment certificate.

Note 1:       For general requirements relating to applications: see section 167.

Note 2:       If the variation relates to the end use for an industrial chemical, an application for this end use to be treated as confidential business information may be made at the time of applying for the variation: see section 105.

             (2)  If there is more than one holder of the assessment certificate, the holders of the certificate must make a joint application.

44   Executive Director must consider application

             (1)  The Executive Director must consider the application in accordance with this Subdivision.

             (2)  A decision on the application must be made under subsection 49(1) within the following period (the consideration period ) after the day the application is made:

                     (a)  unless paragraph (b) or (c) applies—70 working days;

                     (b)  unless paragraph (c) applies—if the rules prescribe a number of working days for that type of application, that number of working days;

                     (c)  if the Executive Director and each applicant agree to a number of working days—that number of working days.

Note:          For circumstances affecting the calculation of the consideration period: see section 169.

             (3)  In considering the application, the Executive Director must have regard to the following:

                     (a)  any risks to human health or the environment associated with the proposed introduction and use of the industrial chemical;

                     (b)  any further information provided in accordance with section 45 or subsection 167(4);

                     (c)  any advice given by a prescribed body in accordance with section 46;

                     (d)  any advice given by the Gene Technology Regulator in accordance with section 47;

                     (e)  any submissions made by an applicant in accordance with section 48.

45   Executive Director may request further information

             (1)  The Executive Director may, by written notice given to an applicant, request further information to be provided for the purposes of considering the application.

             (2)  The information must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

             (3)  If the requested information is not provided within the period mentioned in subsection (2), the Executive Director may take the application to be withdrawn.

46   Consultation with prescribed bodies

             (1)  The Executive Director must, by written notice, seek the advice of a body prescribed by the rules for the purposes of this subsection if the Executive Director is considering doing any of the following:

                     (a)  including, removing or varying a condition of a kind mentioned in subsection 38(2) on the basis that the inclusion, removal or variation is necessary to manage risks to human health or the environment;

                     (b)  not varying a term of the assessment certificate under paragraph 49(1)(b) on the basis that the Executive Director is not satisfied that the risks to human health or the environment can be managed.

             (2)  In considering an application, the Executive Director may, by written notice, seek the advice of a body prescribed by the rules for the purposes of this subsection.

             (3)  The body may provide a response to the Executive Director.

             (4)  The response must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

47   Consultation with Gene Technology Regulator

             (1)  The Executive Director must, by written notice, seek the advice of the Gene Technology Regulator if the application relates to an industrial chemical that is a GM product or contains a GM product.

             (2)  The Gene Technology Regulator may provide a response to the Executive Director.

             (3)  The response must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

48   Submissions on draft assessment statement

             (1)  If the Executive Director proposes to make a variation to a term of the assessment certificate, the Executive Director must, by written notice, give the draft assessment statement to each applicant.

             (2)  An applicant may make a written submission to the Executive Director about the draft statement.

             (3)  A submission must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

49   Issue of varied assessment certificate and assessment statement

             (1)  After considering the application, the Executive Director must decide to:

                     (a)  vary the term of the assessment certificate; or

                     (b)  not vary the term of the assessment certificate.

             (2)  The Executive Director must be satisfied that any risks to human health or the environment can be managed before deciding to vary the term of the assessment certificate.

             (3)  The Executive Director must not vary the term of the assessment certificate if the Executive Director is not satisfied that any risks to human health or the environment associated with the variation can be managed.

             (4)  The Executive Director must give written notice of the decision and the assessment statement to each applicant.

             (5)  If the decision is to vary the assessment certificate, the Executive Director must also give the varied assessment certificate to each applicant.

             (6)  The Executive Director must publish the assessment statement on the AICIS website.

             (7)  To avoid doubt, a single notice or assessment statement given under this section may cover more than one term of an assessment certificate.

50  Variations on Executive Director’s initiative

             (1)  The Executive Director may vary a term of an assessment certificate for the introduction of an industrial chemical if:

                     (a)  the Executive Director has completed an evaluation under Part 4 relating to the introduction of the industrial chemical; and

                     (b)  the Executive Director has concluded as part of that evaluation that the terms of the assessment certificate may require variation to manage the risks to human health or the environment from the introduction and use of the industrial chemical; and

                     (c)  the Executive Director has published the evaluation statement for the evaluation.

             (2)  The Executive Director must give written notice of the proposed variation, and the reasons for the variation, to each holder of the assessment certificate.

             (3)  The holder of the assessment certificate may make a written submission to the Executive Director about the proposed variation.

             (4)  A submission must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

             (5)  After considering any submissions made during that period the Executive Director must decide to:

                     (a)  vary the term of the assessment certificate; or

                     (b)  not vary the term of the assessment certificate.

             (6)  The Executive Director must give written notice of the decision and the assessment statement to each holder of the certificate.

             (7)  If the decision is to vary the assessment certificate, the Executive Director must also give the varied assessment certificate to each applicant.

             (8)  The Executive Director must publish the assessment statement on the AICIS website.

             (9)  To avoid doubt, a single notice or assessment statement given under this section may cover more than one term of an assessment certificate.

Subdivision D Cancelling an assessment certificate

51   Applying to cancel a certificate

             (1)  The holder of an assessment certificate may apply to the Executive Director to cancel the certificate.

Note:          For general requirements relating to applications: see section 167.

             (2)  The Executive Director must grant the application if the Executive Director is satisfied that:

                     (a)  the application complies with section 167; and

                     (b)  each holder of the certificate consents to the application.

             (3)  The Executive Director must give written notice of the decision to the following:

                     (a)  the applicant;

                     (b)  each holder of the certificate.

52   Cancelling on Executive Director’s initiative

             (1)  The Executive Director may cancel an assessment certificate for an industrial chemical if:

                     (a)  the Executive Director has completed an evaluation under Part 4 relating to the introduction of the industrial chemical; and

                     (b)  the Executive Director has concluded as part of that evaluation that the Executive Director is not satisfied that the risks to human health or the environment from the introduction and use of the industrial chemical can be managed; and

                     (c)  the Executive Director has published the evaluation statement for the evaluation.

             (2)  The Executive Director must give written notice of the proposed cancellation, and the reasons for the cancellation, to each holder of the certificate.

             (3)  The holder of the assessment certificate may make a written submission to the Executive Director about the proposed cancellation.

             (4)  A submission must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

             (5)  After considering any submissions made during that period the Executive Director must decide to:

                     (a)  cancel the assessment certificate; or

                     (b)  not cancel the assessment certificate.

             (6)  The Executive Director must give written notice of the decision and the assessment statement to each holder of the assessment certificate.

             (7)  The Executive Director must publish the assessment statement on the AICIS website.

Division 4 Commercial evaluation authorisations

Subdivision A Obtaining an authorisation

53   Applying for an authorisation

             (1)  A person may apply to the Executive Director for a commercial evaluation authorisation for the introduction of an industrial chemical if:

                     (a)  the introduction is for the purpose of ascertaining the industrial chemical’s potential for commercial application; and

                     (b)  the introduction or use of the industrial chemical will not involve any of the following:

                              (i)  making the industrial chemical available to the general public in circumstances prescribed by the rules for the purposes of this subparagraph;

                             (ii)  release of the industrial chemical into the environment without prior treatment;

                            (iii)  uncontrolled use in any workplace;

                            (iv)  introduction of a volume of the industrial chemical that exceeds the volume prescribed by the rules for the purposes of this subparagraph; and

                     (c)  the person does not hold, or has not previously held, an authorisation under this section for the industrial chemical and the end use for the industrial chemical; and

                     (d)  the person has not made another application under this section for the industrial chemical and end use that is yet to be decided or withdrawn.

Note 1:       For general requirements relating to applications: see section 167.

Note 2:       An application for the proper name or end use for the industrial chemical to be treated as confidential business information may be made at the time of applying for an authorisation: see section 105.

             (2)  A joint application under subsection (1) may be made by 2 or more persons.

54   Executive Director must consider application

             (1)  The Executive Director must consider the application in accordance with this Subdivision.

             (2)  A decision on the application must be made under subsection 58(1) within the following period (the consideration period ) after the day the application is made:

                     (a)  unless paragraph (b) or (c) applies—20 working days;

                     (b)  unless paragraph (c) applies—if the rules prescribe a number of working days for that type of application, that number of working days;

                     (c)  if the Executive Director and each applicant agree to a number of working days—that number of working days.

Note:          For circumstances affecting the calculation of the consideration period: see section 169.

             (3)  In considering the application, the Executive Director must have regard to the following:

                     (a)  whether the volume of the industrial chemical proposed to be introduced has been justified by the applicant for effective commercial evaluation of the industrial chemical;

                     (b)  whether the time period to be covered by the authorisation has been justified by the applicant for effective commercial evaluation of the industrial chemical;

                     (c)  whether any conditions relating to the introduction or use of the industrial chemical are necessary to manage any risks, or potential risks, to human health or the environment associated with the proposed introduction and use of the industrial chemical;

                     (d)  whether the requirements mentioned in paragraphs 53(1)(a) and (b) will be met;

                     (e)  any further information provided in accordance with section 55 or subsection 167(4);

                      (f)  any advice given by a prescribed body in accordance with section 56;

                     (g)  any advice given by the Gene Technology Regulator in accordance with section 57.

55   Executive Director may request further information

             (1)  The Executive Director may, by written notice given to an applicant, request further information to be provided for the purposes of considering the application.

             (2)  The information must be given within the period specified in the notice, which must not be less than 10 working days after the day the notice is given.

             (3)  If the requested information is not provided within the period mentioned in subsection (2), the Executive Director may take the application to be withdrawn.

56   Consultation with prescribed bodies

             (1)  In considering an application, the Executive Director may, by written notice, seek the advice of a body prescribed by the rules for the purposes of this subsection.

             (2)  The body may provide a response to the Executive Director.

             (3)  The response must be given within the period specified in the notice, which must not be less than 10 working days after the day the notice is given.

57   Consultation with Gene Technology Regulator

             (1)  The Executive Director must, by written notice, seek the advice of the Gene Technology Regulator if the application relates to an industrial chemical that is a GM product or contains a GM product.

             (2)  The Gene Technology Regulator may provide a response to the Executive Director.

             (3)  The response must be given within the period specified in the notice, which must not be less than 10 working days after the day the notice is given.

58   Issue of authorisation

             (1)  After considering the application, the Executive Director must decide to:

                     (a)  issue a commercial evaluation authorisation; or

                     (b)  not issue a commercial evaluation authorisation.

             (2)  The Executive Director must not issue the authorisation if the Executive Director is not satisfied that any risks to human health or the environment can be managed.

             (3)  To avoid doubt, the Executive Director must not issue the commercial evaluation authorisation if the Executive Director is satisfied that the chemical is not an industrial chemical.

             (4)  The Executive Director must give written notice of the decision to each applicant.

             (5)  If the decision is to issue a commercial evaluation authorisation the Executive Director must also give the authorisation to each applicant.

59   Content of authorisation

             (1)  A commercial evaluation authorisation must be in writing and include the following (the terms of the authorisation):

                     (a)  the proper name for the industrial chemical;

                     (b)  the period for which the authorisation is in force (which must not be more than 4 years);

                     (c)  the end use for the industrial chemical;

                     (d)  that any introduction of an industrial chemical under the authorisation must be for the purposes of commercial evaluation;

                     (e)  any conditions relating to the introduction or use of the industrial chemical that are necessary to manage risks to human health or the environment from the introduction or use of the industrial chemical;

                      (f)  any specific requirements to provide information to the Executive Director in relation to the introduction;

                     (g)  any other information prescribed by the rules for the purposes of this paragraph.

             (2)  The Executive Director must publish the following on the AICIS website in relation to a commercial evaluation authorisation for an industrial chemical:

                     (a)  the proper name for the industrial chemical;

                     (b)  that a commercial evaluation authorisation is in force for the industrial chemical;

                     (c)  the end use for the industrial chemical;

                     (d)  the period for which the authorisation is in force.

Note:          If an application to treat the proper name or end use for the industrial chemical as confidential business information has been approved, the Executive Director must publish an AACN or generalised end use instead of the proper name or end use if prescribed circumstances apply: see section 109.

Subdivision B Changing authorisation holders

60   Applying to change authorisation holders

Adding persons

             (1)  A person may apply to the Executive Director to be added as a holder of a commercial evaluation authorisation.

Note:          For general requirements relating to applications: see section 167.

             (2)  The Executive Director must grant the application if satisfied that:

                     (a)  the application complies with section 167; and

                     (b)  the following consent to the application:

                              (i)  the applicant;

                             (ii)  each holder of the authorisation.

             (3)  The Executive Director must give written notice of the decision to the following:

                     (a)  the applicant;

                     (b)  each holder of the authorisation.

Removing persons

             (4)  A holder of a commercial evaluation authorisation for which there are joint authorisation holders may apply to the Executive Director to remove the person as a holder of the authorisation.

Note 1:       If the person is the only holder of the authorisation, the person may apply to cancel the authorisation: see section 65.

Note 2:       For general requirements relating to applications: see section 167.

             (5)  The Executive Director must grant the application if satisfied the application complies with section 167.

             (6)  The Executive Director must give written notice of the decision to the following:

                     (a)  the applicant;

                     (b)  each holder of the authorisation.

61   Changing authorisation holders on Executive Director’s initiative

             (1)  The Executive Director may remove a person as a holder of a commercial evaluation authorisation if the Executive Director is satisfied that:

                     (a)  the person is not complying with the terms of the authorisation; or

                     (b)  the person has made a statement, or given a document or information, to the Executive Director in connection with the authorisation that was false or misleading in a material particular.

             (2)  Before removing the person, the Executive Director must give written notice of the proposed removal, and the reasons for the removal, to the person.

             (3)  The person may make a written submission to the Executive Director about the proposed removal.

             (4)  A submission must be made within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

             (5)  After considering any submissions made during that period, the Executive Director must decide to:

                     (a)  remove the person as a holder of the authorisation; or

                     (b)  not remove the person as a holder of the authorisation.

             (6)  The Executive Director must give written notice of the decision to the following:

                     (a)  the person;

                     (b)  each holder of the authorisation.

             (7)  If, after removing the person, there are no holders of the authorisation, the Executive Director may take the authorisation to be cancelled.

Subdivision C Varying the terms of an authorisation

62   Applying for a variation of the terms of an authorisation

             (1)  The holder of a commercial evaluation authorisation may apply to the Executive Director to vary a term of the authorisation.

Note:          For general requirements relating to applications: see section 167.

             (2)  If there is more than one holder of the authorisation, the holders of the authorisation must make a joint application.

63   Issue of varied authorisation

             (1)  The Executive Director must consider the application in accordance with this Subdivision.

             (2)  A decision on the application must be made under subsection (4) within the following period (the consideration period ) after the day the application is made:

                     (a)  unless paragraph (b) or (c) applies—20 working days;

                     (b)  unless paragraph (c) applies—if the rules prescribe a number of working days for that type of application, that number of working days;

                     (c)  if the Executive Director and each applicant agree to a number of working days—that number of working days.

Note:          For circumstances affecting the calculation of the consideration period: see section 169.

             (3)  In considering the application, the Executive Director must have regard to the following:

                     (a)  any risks, or potential risks, to human health or the environment associated with the proposed variation;

                     (b)  any further information provided in accordance with subsection 167(4).

             (4)  After considering the application, the Executive Director must decide to:

                     (a)  vary the term of the authorisation; or

                     (b)  not vary the term of the authorisation.

             (5)  The Executive Director must not issue the authorisation if the Executive Director is not satisfied that any risks to human health or the environment can be managed.

             (6)  The Executive Director must give written notice of the decision to each holder of the authorisation.

             (7)  To avoid doubt, a single notice under subsection (6) may cover more than one term of the authorisation.

64   Variations on Executive Director’s initiative

             (1)  The Executive Director may vary a term of a commercial evaluation authorisation.

             (2)  Before making the variation, the Executive Director must give written notice of the proposed variation, and the reasons for the variation, to each holder of the authorisation.

             (3)  The holder of the authorisation may make a written submission to the Executive Director about the proposed variation.

             (4)  A submission must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

             (5)  After considering any submissions made during that period, the Executive Director must decide to:

                     (a)  vary the term of the authorisation; or

                     (b)  not vary the term of the authorisation.

             (6)  The Executive Director must give written notice of the decision to each holder of the authorisation.

             (7)  If the decision is to vary the term of the authorisation, the Executive Director must also give the varied authorisation to each holder of the authorisation.

             (8)  To avoid doubt, a single notice under subsection (6) may cover more than one term of the authorisation.

Subdivision D Cancelling an authorisation

65   Applying to cancel an authorisation

             (1)  The holder of a commercial evaluation authorisation may apply to the Executive Director to cancel the authorisation.

Note:          For general requirements relating to applications: see section 167.

             (2)  The Executive Director must grant the application if the Executive Director is satisfied that:

                     (a)  the application complies with section 167; and

                     (b)  each holder of the authorisation consents to the application.

             (3)  The Executive Director must give written notice of the decision to each authorisation holder.

66   Cancelling on Executive Director’s initiative

             (1)  The Executive Director may cancel a commercial evaluation authorisation for the introduction of an industrial chemical if the Executive Director is not satisfied that the risks to human health or the environment from the introduction and use of the industrial chemical can be managed.

             (2)  The Executive Director must give written notice of the proposed cancellation, and the reasons for the cancellation, to each holder of the authorisation.

             (3)  The holder of the authorisation may make a written submission to the Executive Director about the proposed cancellation.

             (4)  A submission must be given within the period specified in the notice, which must not be less than 20 working days after the day the notice is given.

             (5)  After considering any submissions made during that period, the Executive Director must decide to:

                     (a)  cancel the commercial evaluation authorisation; or

                     (b)  not cancel the commercial evaluation authorisation.

             (6)  The Executive Director must give written notice of the decision to each holder of the authorisation.

Division 5 Exceptional circumstances authorisations

67   Exceptional circumstances authorisations

             (1)  The Minister may issue an exceptional circumstances authorisation for the introduction of an industrial chemical.

             (2)  Before deciding to issue the authorisation, the Minister must:

                     (a)  consult with the Executive Director; and

                     (b)  be satisfied that the introduction of the industrial chemical is in the public interest to address significant risks to human health or the environment.

             (3)  The authorisation must be in writing and include the following (the terms of the authorisation):

                     (a)  the proper name for the industrial chemical;

                     (b)  the period for which the authorisation is in force;

                     (c)  the scope of the authorisation;

                     (d)  any condition relating to the introduction or use of the industrial chemical that the Minister is satisfied is necessary to manage any risks to human health or the environment from the introduction or use of the industrial chemical;

                     (e)  any specific requirements to provide information to the Executive Director in relation to the authorisation;

                      (f)  any other information prescribed by the rules for the purposes of this paragraph.

             (4)  The Minister must determine each holder of the authorisation and give each such person written notice of the authorisation and the authorisation.

             (5)  The Executive Director must publish the following on the AICIS website in relation to an exceptional circumstances authorisation for an industrial chemical:

                     (a)  the commonly known name for the industrial chemical;

                     (b)  that an exceptional circumstances authorisation is in force for the industrial chemical;

                     (c)  the reasons why an exceptional circumstances authorisation is necessary;

                     (d)  the period for which the authorisation is in force.