Commonwealth Consolidated Acts Commonwealth Consolidated Acts
Agricultural and Veterinary Chemicals Code Act 1994
1 Subsection 3(1) of the Code set out in the Schedule (definition of approval )
Repeal the definition, substitute:
"approval" means approval under Part 2 of:
(a) an active constituent for a proposed or existing chemical product; or
(b) a label for containers for a chemical product;
and, in relation to an active constituent, other than in Division 2 of Part 2 and Part 3, includes re - approval.
2 Subsection 3(1) of the Code set out in the Schedule
Insert:
"re-approval" means re - approval of an active constituent under Division 3A of Part 2.
3 Subsection 3(1) of the Code set out in the Schedule (definition of registration )
Repeal the definition, substitute:
"registration" means registration under Part 2 of a chemical product and, other than in Division 2 of Part 2 and Part 3, includes re - registration.
4 Subsection 3(1) of the Code set out in the Schedule
Insert:
"re-registration" means re - registration of a chemical product under Division 3A of Part 2.
5 After Division 3 of Part 2 of the Code set out in the Schedule
Insert:
Division 3A -- Re - approving and re - registering
(1) This Division provides for re - approval and re - registration of active constituents and chemical products.
(2) Section 29D provides for holders of approvals and registrations to make applications, and sets out the time for making applications. Applications must meet the application requirements specified in section 8A.
(3) The APVMA must complete a preliminary assessment of an application. If the application passes preliminary assessment, the APVMA must notify the applicant (section 29E).
(4) Section 29F sets out the circumstances in which the APVMA must re - approve or re - register an active constituent or chemical product.
(5) The APVMA may vary relevant particulars or conditions to allow re - approval or re - registration (section 29G).
(6) If the APVMA does not re - approve or re - register an active constituent or chemical product, it must reconsider the existing approval or registration under Division 4 (section 29H).
(7) Sections 29J and 29K set out how re - approval and re - registration take place.
(1) The holder of the approval of an active constituent or the registration of a chemical product may apply for re - approval or re - registration of the constituent or product.
(2) The application must:
(a) meet the application requirements; and
(b) be made:
(i) for re - approval--not earlier than 6 calendar months, and not later than 3 calendar months, before the date entered in the Record as the date the approval ends; or
(ii) for re - registration--not earlier than 6 calendar months, and not later than 3 calendar months, before the date entered in the Register as the date after which the registration cannot be renewed under Division 6; or
(iii) within such further period as the APVMA allows under subsection ( 3).
Note: For meets the application requirements , see section 8A.
(3) In circumstances prescribed by the regulations and upon payment of the prescribed fee (if any), the APVMA may accept a late application if the application is made on or before:
(a) for re - approval--the day the approval ends; or
(b) for re - registration--the day after which the registration cannot be renewed under Division 6.
(4) Subsection ( 1) has effect subject to any condition imposed on the approval or registration under subsection 23(2).
Note: Subsection 23(2) provides for an approval or registration to last for not more than one year.
(1) The APVMA must complete a preliminary assessment of the application within 2 months after it is lodged.
(2) If it appears from the preliminary assessment that the application meets the application requirements, the APVMA must, within 14 days, give written notice to the applicant:
(a) stating that the application has passed preliminary assessment and that it will be determined under section 29F; and
(b) setting out any matters prescribed by the regulations.
(3) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
(4) The APVMA may alter the application, after it has passed preliminary assessment, with the written consent of the applicant.
29F Re - approval or re - registration
(1) If the application is for re - approval of an active constituent, the APVMA must re - approve the constituent unless it appears to the APVMA that there are reasonable grounds to believe that the constituent does not meet the safety criteria.
Note: For notice of re - approval, see section 8F.
(2) If the application is for re - registration of a chemical product , the APVMA must re - register the product unless it appears to the APVMA that there are reasonable grounds to believe that the product does not do one or more of the following:
(a) meet the safety criteria;
(b) meet the trade criteria;
(c) meet the efficacy criteria.
Note: For notice of re - registration, see section 8F.
(3 ) For the purposes of subsections ( 1) and (2) , the APVMA must have regard to any submission given in response to a notice in relation to the constituent or product under section 47B (advance notice of end of approval or registration).
29G Varying relevant particulars and conditions to allow re - approval or re - registration
(1) To allow the re - approval or re - registration, the APVMA may:
(a) vary the relevant particulars or conditions of the approval or registration; or
(b) for a chemical product--vary the relevant particulars or conditions of the approval of any label for the product.
Note: The APVMA may only vary relevant particulars or conditions that it has imposed . See section 6B.
(2) If the variation would affect any instructions for the use of the active constituent or chemical product, or any instructions on a label, the APVMA must not make the variation until it has consulted each co - ordinator designated for a jurisdiction and taken into account any recommendations made by the co - ordinators.
(3) If the APVMA decides to vary the relevant particulars or conditions, it must record in the Record, Register or r elevant APVMA file, as required , the relevant particulars or conditions as varied and the date on which the variation is made.
( 4 ) If the relevant particulars or conditions of the registration of a listed chemical product are varied in such a way that the product and every label for the product comply with the established standard for the product, the APVMA must remove from the Register the date after which the registration of the product cannot be renewed under Division 6.
29H Reconsideration if APVMA does not re - approve or re - register
(1) If the APVMA does not re - approve or re - register the active constituent or chemical product it must:
(a) reconsider the existing approval or registration under Division 4; and
(b) give written notice of the reconsideration to the holder within 14 days.
(2) The notice must:
(a) set out the reasons for the reconsideration; and
(b) state that:
(i) for an approval--the approval will not end until the reconsideration has been concluded; or
(ii) for a registration--the date after which the registration cannot be renewed under Division 6 will be the day on which the reconsideration is concluded; and
(c) state that, if the approval or registration is affirmed on reconsideration, the active constituent or chemical product will be re - approved or re - registered.
(3) The notice may be included with the notice in relation to the reconsideration given under subsection 32(1).
29J How re - approval takes place
(1) Re - approval of an active constituent takes place when the APVMA records the following in the Record:
(a) a statement that the constituent has been re - approved and the date of the re - approval;
(b) the date the approval (as re - approved) ends.
(2) The date the approval ends must:
(a) be worked out in accordance with the method prescribed by the regulations; and
(b ) be the last day of a calendar month at least 7 years but not more than 15 years after the re - approval takes place.
(3) Despite subsection ( 2), the APVMA may re - approve the active constituent for a period of less than 7 years to provide for the approval to end at the same time as another approval of the active constituent.
(4) Paragraph ( 2)(b) does not apply if the approval is subject to the condition that it remains in force only for a stated period of not more than 1 year (see subsection 23(2)).
29K How re - registration takes place
(1) Re - registration of a chemical product takes place when the APVMA records the following in the Register:
(a) a statement that the product has been re - registered and the date of the re - registration;
(b) the date the registration (as re - registered) ends, which must be the last day of a calendar month not more than 12 months after the re - registration takes place;
(c) unless the product and each label for the product comply with the established standard for the product--the date (the last renewal date ) after which the registration cannot be renewed under Division 6.
(2) The last renewal date must:
(a) be worked out in accordance with the method prescribed by the regulations; and
(b) be the last day of a calendar month at least 7 years but not more than 15 years after the re - registration takes place.
(3) However, the last renewal date may be less than 7 years after the re - registration takes place to provide for the last renewal date to be the same as the last renewal date for another chemical product that contains one or more of the same active constituents.
(4) Paragraph ( 2)(b) does not apply if the registration is subject to the condition that it remains in force only for a stated period of not more than 1 year (see subsection 23(2)).
6 Division 6 of Part 2 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
Division 6 -- Duration of approvals and registrations and renewal of registrations
7 Section 47 of the Code set out in the Schedule
Repeal the section, substitute:
(1) This Division deals with the duration of approvals and registrations, and with renewing registrations.
(2) Section 47 sets out the periods for which approvals and registrations are in force.
(3) Section 47A provides for the APVMA to vary the duration of the approval of an active constituent or the registration of a chemical product containing an active constituent if 2 or more foreign regulators have prohibited the use of the active constituent on safety grounds.
(4) The APVMA must publish at least 12 months' advance notice of:
(a) the end of an approval; and
(b) the date after which a registration cannot be renewed (section 47B).
The APVMA may give less than 12 months' notice if it varied the date under section 47A.
(5) The APVMA must publish notice of the end of an approval or registration as soon as practicable after the approval or registration has ended (section 47C).
(6) If the APVMA publishes notice of the end of the approval or registration of a constituent or a product under section 47C, then:
(a) certain persons are taken to have a permit to possess, have custody of or use of the constituent or product for a limited period (section 47D); and
(b) persons may only supply the constituent or product in accordance with instructions contained in the notice (section 47E).
(7) Section 48 provides for applications for renewal of a registration.
(8) The APVMA must renew the registration if the application requirements are met (section 49).
(9) Renewal takes place by entry in the Register (section 50).
(10) The approval of a label for a container for a chemical product is automatically renewed when the registration of the product is renewed (section 51).
Subdivision B -- Period of approval or registration
47 Period of approval or registration
(1) The approval of an active constituent ends on the later of the following days:
(a) the day entered in the Record as the date the approval ends;
(b) if an application is made for re - approval of the active constituent but is not determined by the day entered in the Record--the day on which the application is determined.
(2) The registration of a chemical product ends on the later of the following days:
(a) the day entered in the Register as the date the registration ends;
(b) if an application is made for renewal of the registration but is not determined by the day entered in the Register--the day on which the application is determined.
(3) The registration of a chemical product also ends if the approval of an active constituent for the product ends.
(4) The approval of a label for containers for a chemical product ends when the registration of the product ends.
(5) If:
(a) the registration of a chemical product ends; but
(b) a person is taken under section 47D to have been issued with a permit to possess, have custody of or use the product;
the approval of a label for containers for the product continues in force until the permit ceases to have effect.
(6) To avoid doubt, this section does not limit any power under this Code to cancel or suspend an approval or registration.
47A Varying duration--decisions of foreign regulators
(1) This section applies if:
(a) regulators of agricultural or veterinary chemicals of 2 or more foreign countries, being regulators who are prescribed by the regulations, have decided, within a 7 year period, to prohibit all uses of:
(i) the same active constituent; or
(ii) one or more chemical products containing the same active constituent; and
(b) the uses were prohibited because the active constituent:
(i) was an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; or
(ii) was likely to have an effect that is harmful to human beings; or
(iii) was likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and
(c) the active constituent is:
(i) approved under this Code, but not approved or re - approved after the first of those decisions; or
(ii) contained in a chemical product th at is registered under this Code, but not registered or re - registered after the first of those decisions; and
(d) the approval or registration is not being reconsidered under Division 4.
(2) The APVMA must vary the following as necessary to meet the requirement in subsection ( 3) :
(a) the date (the end date ) entered in the Record or Register as the day the approval or registration ends;
(b) for a chemical product for which there is a date entered in the Register as the date after which the registration of the product cannot be renewed under Division 6 -- t hat date (the last renewal date ) .
(3) The end date and last renewal date (if applicable) must be the last day of a calendar month in the period that begins 6 months and ends 18 months after the second of those decisions was made.
(4) Neither the end date nor the last renewal date may be varied again under this section.
(5 ) If the end date or last renewal date is varied, t he holder must be given written notice of the date as varied at least 6 months before it occurs.
(6 ) This section does not apply to extend:
(a) the duration of the approval or registration; or
(b) the period before the day after which the registration cannot be renewed.
Subdivision C -- Notifying end of approvals and registrations
47B Advance notice of end of approval or registration
(1) The APVMA must publish in the Gazette at least 12 months' notice of the following:
(a) the end of the approval of an active constituent;
(b) the date after which the registration of a chemical product cannot be renewed under this Division.
(2) The notice must:
(a) invite submissions about whether or not:
(i) the constituent should be re - approved; or
(ii) the product should be re - registered; and
(b) specify the time by which the submissions must be given to the APVMA, which must be no later than 6 months before the existing approval or registration ends.
(3) The APVMA must give the holder at least 12 months' notice of:
(a) the end of the approval of an active constituent; and
(b) the date after which the registration of a chemical product cannot be renewed under this Division.
(4) The notice must:
(a) set out the relevant particulars and conditions of the approval or registration; and
(b) state:
(i) the date the approval ends; or
(ii) the date after which the registration cannot be renewed under this Division; and
(c) include any information prescribed by the regulations.
(5) The APVMA may give less than 12 months' notice if, under section 47A, the APVMA varied:
(a) the date the approval or registration ends; or
(b) the date after which the registration cannot be renewed under this Division.
47C Notice of end of approval or registration
(1) The APVMA must publish in the Gazette , and in any other manner that it thinks appropriate, notice of the following:
(a) the end of the approval of an active constituent;
(b) the end of the registration of a chemical product.
(2) The notice must:
(a) be published as soon as practicable after the approval or registration ends; and
(b) state that the approval or registration has ended; and
(c) set out the date on which the approval or registration ended; and
(d) contain instructions for possessing, having custody of or using the constituent or product; and
(e) contain a warning of the consequences if a person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to supply the constituent or product or to possess or have custody of the constituent or product with the intention of supplying it; and
(f) contain any other warnings or explanations in relation to the constituent or product that the APVMA thinks desirable; and
(g) contain any other information that the APVMA thinks appropriate.
(3) Subsection ( 1) does not apply if the APVMA thinks that, in the circumstances, it is unnecessary to publish the notice.
(4) If a notice is published under this section, the APVMA must:
(a) as soon as practicable cause a copy of the notice to be given to the holder; and
(b) cause a copy of the notice to be given to any other person who, in the opinion of the APVMA, should be given notice of the ending of the approval or registration and of the instructions, warnings and explanations contained in the notice.
47D Permit taken to have been issued
(1) If, after the publication of a notice under section 47C, a person possesses, has custody of or uses the constituent or product in accordance with the instructions contained in the notice, the person is taken to have been issued with a permit to possess, have custody of or use the constituent or product in accordance with those instructions until:
(a) 1 year after the day on which the approval or registration ended; or
(b) the APVMA, by notice published in the Gazette , declares that this subsection ceases to apply in respect of the constituent or product;
whichever first occurs.
(2) A permit that is taken to have been issued to a person under subsection ( 1) does not authorise the person to manufacture or import the constituent or product.
47E Possession or custody with intention of supply
(1) This section applies if, after the publication of a notice under section 47C, a person has possession or custody of the constituent or product with the intention of supplying it.
(2) The person must not possess, have custody of or otherwise deal with the constituent or product except in accordance with the instructions contained in the notice.
(3) Subsection ( 2) does not apply to a possession, custody or dealing if the constituent or product was approved or registered when the possession, custody or dealing took place because of its having been approved or registered or having become reserved after its previous approval or registration ended.
(4) A person commits an offence if the person contravenes subsection ( 2).
Penalty: 300 penalty units.
Note: A defendant bears an evidential burden in relation to the matter in subsection ( 3). See subsection 13.3(3) of the Criminal Code .
(5) For the purposes of subsection ( 4), strict liability applies to the physical element of circumstance in subsection ( 1), that the publishing of the notice was under section 47C.
Note: For strict liability, see section 6.1 of the Criminal Code .
(6) Subsection ( 2) is a civil penalty provision.
Note 1: Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions.
Note 2: For the evidential burden in civil penalty proceedings in relation to the matter in subsection ( 3), see section 145CD.
Subdivision D -- Renewing registrations
8 Section 48 of the Code set out in the Schedule (heading)
Repeal the heading, substitute:
9 Subsection 48(1) of the Code set out in the Schedule
Omit "interested person", substitute "holder".
10 Subsection 48(2) of the Code set out in the Schedule
Repeal the subsection, substitute:
(2) The application (the renewal application ) must be made:
(a) subject to subsection ( 3), not later than one month, or a shorter period that the APVMA permits, before the registration ends; and
(b) before the day entered in the Register as the day after which the registration cannot be renewed under this Division.
11 At the end of section 48 of the Code set out in the Schedule
Add:
(4) If an application (the re - registration application ):
(a) has been made for re - registration of the chemical product; but
(b) has not been determined before the day by which the renewal application must be made;
the day entered in the Register as the day after which the registration cannot be renewed under this Division is taken to be the day on which the re - registration application is determined.
(5) The APVMA may alter the renewal application with the written consent of the holder.
(6) Subsection ( 1) has effect subject to any condition imposed on the registration under subsection 23(2).
Note: Subsection 23(2) provides for an approval or registration to last for not more than one year.
12 Sections 49 and 50 of the Code set out in the Schedule
Repeal the sections, substitute:
(1) If the APVMA is satisfied that the renewal application meets the application requirements, the APVMA must renew the registration:
(a) if the application was made in accordance with subsection 48(2)--before the day entered in the Register as the day the registration ends; or
(b) if the application was made in accordance with subsection 48(3)--within 1 month after the application was made.
Note: For notice of renewal, see section 8F.
(2) Otherwise, the APVMA must refuse the application.
Note: For notice of refusal, see section 8G.
Renewal of the registration of a chemical product takes place when the APVMA enters in the Register a statement that the registration has been renewed and the date on which the registration (as renewed) ends, which must be the last day of a calendar month not more than 12 months after the renewal takes place.