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Food Standards Australia New Zealand Amendment Bill 2010

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2010

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

 

 

 

 

FOOD STANDARDS AUSTRALIA NEW ZEALAND AMENDMENT BILL 2010

 

 

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Parliamentary Secretary for Health and Ageing,

the Honourable Catherine King)





FOOD STANDARDS AUSTRALIA NEW ZEALAND AMENDMENT BILL 2010

 

OUTLINE

 

The primary purpose of this Bill is to implement a reform agreed to by the Council of Australian Governments (COAG) on 3 July 2008, that calls for the recognition , for domestically grown produce, by Food Standards Australia New Zealand (hereafter referred to as the Authority), of the Australian Pesticides and Veterinary Medicines Authority's (APVMA) residue risk assessment and the promulgation of the resulting maximum residue limits (MRLs) in the Australia New Zealand Food Standards Code (the Food Code).  The implementation of this reform requires the amendment of the Food Standards Australia New Zealand Act 1991 (the Act), and consequential amendments to the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994

The COAG-agreed reform is designed to streamline current regulatory processes which create circumstances whereby a primary producer may legally use a particular chemical product on their crops and livestock in compliance with the relevant APVMA product registration or permit, but may not legally be able to sell the treated produce (plant and animal products) because there is no corresponding MRL in the Food Code.  If a relevant MRL is not specified in the Food Code, residues of the particular chemical are not permitted in food.

The amendments will eliminate duplication and improve the efficiency of the regulatory process by allowing the APVMA to vary the MRL Standard in the Food Code.  Public health and safety will be ensured by a requirement that the Authority conduct a dietary risk assessment (or review and prepare comments on an assessment conducted by another party), and provide this to the APVMA for consideration in their decision making

The Authority will also retain the capacity to vary the MRL Standard, for example in a case where an application for an MRL Standard relating to imported food is received.  Similarly the Ministerial Council will retain its oversight of the Food Standards Code as a whole and will continue to have the capacity to request a review of any food standard established in the Food Code, including the MRL standard.

The Bill also amends the annual reporting requirements for the Authority and corrects some minor inconsistencies, mainly stemming from the relatively complex amendments made to the Act in 2007.  The Bill also corrects an inconsistency in the Act that limits the Authority’s capacity to cost-recover for its activities.

The Bill has been subject to consultation within the Commonwealth Government, including the Department of Agriculture Fisheries and Forestry, the Authority and the APVMA, and also State and Territory Governments and the Government of New Zealand.   

Financial Impact Statement

Implementation of Reform was agreed by COAG without the provision of additional funding.  Therefore the reform will have to be funded through existing resources.  The amendments will result in a transfer of some functions from the Authority to the APVMA.  Funding associated with these functions will be transferred as appropriate.

FOOD STANDARDS AUSTRALIA NEW ZEALAND AMENDMENT BILL 2010

 

NOTES ON CLAUSES

 

Clause 1 - Short title

This clause provides that the Bill may be cited as the Food Standards Australia New Zealand Amendment Act 2010 .

 

Clause 2 - Commencement

Subclause 2(1) provides that each provision of this Act specified in column 1 (list of provisions) of the table commences, or is taken to have commenced, in accordance with column 2 (commencement details). 

 

Commencement information table

Clause 1 of the table provides that sections 1 to 3 will commence on the day the Bill receives Royal Assent.

                                                                                                 

Clause 2 of the table provides that Schedule 1 will commence on Proclamation, or no longer than 6 months after Royal Assent.  This provision is included to provide some certainty for stakeholders on the start date of the new mechanism for establishing MRLs in the Food Standards Code, and to ensure that the implementation arrangements between the Authority and the APVMA are aligned.

 

Subclause 2(2) provides that Column 3 of the table can contain additional information that is not part of the Act.

 

Clause 3 - Schedule (s)

This clause provides that all Acts amended by the Bill are amended as set out in the relevant schedule of the Bill that contains the amendment. 

 



SCHEDULE 1 - AMENDMENTS

PART 1 - MAIN AMENDMENTS

 

Agricultural and Veterinary Chemicals (Administration) Act 1992

 

Item 1

This item allows the APVMA to exercise any functions and powers that may be conferred upon it by Division 2A of Part 3 of the Food Standards Australia New Zealand Act 1991 .  This will enable the APVMA to vary the MRL Standard of the Code.

 

Agricultural and Veterinary Chemicals Code Act 1994

 

Item 2

The existing subsection 13A(1) of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) requires that the APVMA notify the Authority when it receives an application for the registration of a chemical product, which, if used, would be likely to result in chemical residues occurring in food at a level not already permitted under the MRL Standard. 

 

This item repeals the existing subsection 13A(1) of the Agvet Code and replaces it with a provision that is similar, but broader.  The new provision will require the APVMA to notify the Authority of:

·                      any applications received under sections 10 or 27 of the Agvet Code, which relate to:

-           approval of an active constituent for a proposed or existing chemical product;

-           registration of a chemical product;

-           approval of a label for containers for a chemical product; or

-           variation of the relevant particulars or the conditions of an approval or registration of a chemical product;

·                      any variations of the relevant particulars or conditions of the registration of a chemical product or the approval of a label for containers of a chemical product resulting from a reconsideration by APVMA under subsections 34(5) or 34(3) of the Agvet Code;

·                      any applications received under section 110 of the Agvet Code for a permit for an active constituent or a chemical product (which may include permits for minor use, research or emergency use);

in relation to which it is likely that, if the application is granted or variation effected, a variation would be required to the MRL Standard to allow the sale of foods lawfully treated with the product. 

 

The amendment is intended to ensure that the provision covers all applications or variations that may give rise to an amended MRL Standard. 

 

The existing subsection 13A(2) provides that confidential commercial information will not be divulged in the notification.

 

Item 3

Existing subsection 13A(2) of the Agvet Code sets out the requirements of the notice that must be given to the Authority in accordance with subsection 13A(1) of the Agvet Code.  This item replaces the words “The notice” with the words “A notice under this section” to remove any ambiguity in the current wording of the clause.

 

Item 4

This item repeals paragraph 13A(2)(c) of the Agvet Code, relating to the timing of the notice, and substitutes a new paragraph that reflects the broader provisions of subsection 13A(1). It requires APVMA to notify the Authority, in the case of:

1.       applications for registrations, or variations to registrations, for chemical products (sections 10 or 27 of the Agvet Code), as soon as practicable after the application is acknowledged;

2.       variations to registrations resulting from APVMA reconsiderations (subsections 34(5) or 34A(3) of the Agvet Code), as soon as practicable after the variation is made; and

3.       applications for a permit (section 110 of the Agvet Code), as soon as practicable after the application is made.

The reference to an application for registration being ‘acknowledged’ (subparagraph 13A(2)(c)(i)) will rely on the definition of 'acknowledge' in section 3 of the Agvet Code.

 

Item 5

This item inserts a new paragraph into subsection 14(5) of the Agvet Code, which requires the APVMA to consider any dietary exposure assessment prepared by the Authority, or comments provided by the Authority on an assessment conducted by another person or body, in satisfying itself that the use of the constituent or product in accordance with the instructions for its use will not constitute an undue hazard to public health and safety or the environment, as set out in paragraph 14(3)(e) of the Agvet Code.  Amendments made by item 14 to the FSANZ Act will provide for the Authority to prepare or comment on dietary exposure assessments.

 

Item 6

This item provides that the amendments made by items 2 to 4 apply in relation to applications made on or after the commencement of those items.  

 

 

Food Standards Australia New Zealand Act 1991

 

Item 7

This item adds a note at the end of section 54 that states:

 

Division 2A deals with variations by the APVMA of the Maximum Residue Limits Standard.

 

This note draws the reader’s attention to the new Division 2A established by item 14 of this Bill.

 

Items 8, 9, 10, 11, 12 and 15

These items are consequential amendments that remove from various provisions of the Act references to subdivision H of Division 2 of Part 3, which is repealed by item 13.

 

Item 13

Item 13 repeals subdivision H of Division 2 of Part 3 of the current Act which imposes requirements on the Authority in relation to the process for varying the MRL Standard in cases where APVMA has given notice under s 13A of the Agvet Code. These provisions will be superseded by the amendments which authorise the APVMA itself to vary the MRL Standard.  Repeal of these provisions will not affect the ability of the Authority to vary the MRL Standard. 

 

Item 14

Item 14 inserts into Part 3 of the Act a new Division 2A that establishes a mechanism whereby the APVMA may vary the MRL Standard in the Food Code.  Division 2A contains new sections 80 through 83.

 

Section 80 provides that Division 2A will apply only where the APVMA notifies the Authority under section 13A of the Agvet Code of an application (refer to items 2, 3 and 4 above). 

 

Section 81 provides that the Authority is required to give public notice as soon as practicable after receiving notification from the APVMA under section 13A of the Agvet Code.  The public notice given by the Authority must include the particulars contained in the APVMA notice as well as any other matter that the Authority considers appropriate.  The purpose of the public notice is to inform persons or bodies with an interest in the food regulatory system that the MRL Standard may change. 

 

Section 81 requires the Authority to give the public notice as soon as practicable after being notified by the APVMA under section 13A of the Agvet Code.  In the event of a person applying under s 110 of the Agvet Code for a permit to deal with an agricultural and veterinary emergency, s 81 would not require the APVMA to delay giving the permit. Although the Authority is required to give the public notice as soon as practicable, in emergency situations this could be after the APVMA has issued the permit.

 

Section 82 authorises the APVMA to vary the MRL Standard to cover the chemical product referred to in its notice under section 13A of the Agvet Code.  It also sets out the procedure that is to be followed. 

 

Subsection 82(2) provides that a variation to the MRL Standard by the APVMA is a legislative instrument under the Legislative Instruments Act 2003 (LIA), but is not subject to the disallowance or sunsetting provisions of the LIA.  This is consistent with the current provisions of the FSANZ Act, under which all variations of standards in the Food Code (including variations of the MRL Standard by the Authority) are legislative instruments but are not subject to disallowance or sunsetting.  The disallowance provisions in the LIA do not apply to legislative instruments made for the purposes of an intergovernmental body or scheme involving the Commonwealth and one or more States (s 44 of the LIA).  The FSANZ scheme involves the Commonwealth, the States and Territories, and New Zealand.

 

Section 17 of the LIA requires that before making a legislative instrument, the rule-maker must be satisfied that appropriate consultation has been undertaken.  It is expected that this consultation requirement will normally be met through the consultation which the APVMA undertakes as part of its assessment processes when considering the registration, or permit for use, of a chemical product under the AgVet Code.

 

Subsection 82(3) provides that before making a variation to the MRL Standard, the APVMA must notify the Authority of a proposed variation. The amended section 13A of the Agvet Code contains a similar requirement; it is intended that one notification would satisfy the requirements of both Acts .  Under section 13A of the Agvet Code, the notification must contain the particulars of the product and its active constituents, other than commercial confidential information, and any other matters the APVMA thinks are appropriate. It is likely this would include details of the commodity to be treated, and the likely level of the active constituent to be included in the MRL Standard.

 

Subsection 82(4) provides that, for any proposed variation of the MRL Standard, the Authority must prepare a dietary exposure assessment, or review and provide comments on an assessment prepared by another person or body.  The dietary exposure assessment can only be prepared by another person or body with the Authority’s agreement. The Authority must provide the assessment and, if relevant, the comments on the assessment, to the APVMA and the Australia and New Zealand Food Regulation Ministerial Council.  In the event of a permit application to the APVMA to deal with an emergency situation, it is expected that the Authority will comply with this section in a manner commensurate with the urgency of the application.

 

Subsection 82(5) provides that before making a variation to the MRL standard, the APVMA must consider any assessment and, if applicable, any comments on the assessment prepared under subsection 82(4).

 

Subsections 82(6) to 82(8) set out that the APVMA must give a copy of any variation to the MRL standard to the Authority, that the APVMA must publish a Gazette notice of the variation, and that the variation to the MRL standard takes effect on the day the Gazette notice is published. Where necessary, Australia’s obligations under the World Trade Organization Agreement on Sanitary and Phytosanitary Measures will need to be fulfilled before the Gazette notice can be published.

 

Section 83 clarifies that the Authority will retain the power to vary the MRL standard, (under Part 4 of the FSANZ Act), despite the new provisions that allow the APVMA, in the course of approving registrations or permits for chemical products, to vary the MRL Standard.  For example, the Authority will continue to process applications to set MRLs that relate to imported food.

 

Items 16, 17, 18 and 19

These items amend the annual reporting requirements (with respect to MRLs) contained in section 152 of the Act, so that they refer to the new MRL setting procedure established by this Bill.

 

Item 20

This item provides that these amendments will apply to the assessment of relevant applications that are made after the commencement of the Food Standards Australia New Zealand Amendment Act 2010.  All proposals raised (as per the current MRL setting process) prior to the commencement of these amendments will be dealt with under the current legislative requirements, including for the Authority’s annual reporting requirements.

 



PART 2 - Other Amendments

 

Food Standards Australia New Zealand Act 1991

 

Item 21

This item amends paragraph 66(1)(a) so that the current reference to ‘the obligation on a person’ is amended to ‘the obligation on any person’.  This provides consistency in the wording between this and paragraph 66(1)(b) and also with similar provisions in subsections 36(a) and 36(b).

 

Item 22

This item repeals subsection 146(6) and introduces new provisions that broaden the Authority’s capacity to charge for its activities. As currently drafted subsection 146(6) limits the fixing of charges to work that the Authority undertakes in relation to an application to develop or vary a food standard. The amended provisions will bring section 146 into line with other sections of the Act, for example, subsection 13(o) which states that a function of the Authority is “to make the Authority’s knowledge, expertise, equipment, facilities and intellectual property available to other persons on a commercial basis”.

 

Item 23

This Item (in conjunction with item 39) divides section 152 into two subsections.  All of the prescribed the Authority’s annual reporting requirements are contained in subsection 152(1).

 

Items 24, 26, 28, 31, 34, 35 and 37

These items amend references in section 152 that relate to the relevant year of the Authority’s annual report.  The amendments are such that the reporting requirements will consistently refer to ‘the current year’ rather than ‘that year’ or ‘financial year’, as is currently the case.

 

Item 25

This item inserts six additional requirements the Authority is required to report on:

·          the number of applications made under section 22;

·          the number of applications accepted under subsection 26(1);

·          the number of applications rejected under subsection 26(1), and reasons for the rejections;

·          the number of applications withdrawn under subsection 24(1);

·          the number of applications accepted under subsection 26(1) that the Authority had not begun to assess under section 29; and

·          the number of applications accepted under subsection 26(1) during a previous financial year that the Authority had not begun to assess under section 29 before the end of the current year.

 

Item 27

This item inserts two additional requirements the Authority is required to report on:

·          the number of applications accepted under subsection 26(1) during a previous financial year that the Authority had begun to assess under section 29 before the end of the current year, but that the Authority had not disposed of before the end of the current year; and

·          for an application covered by the paragraph above, the period that has elapsed since the application was accepted under subsection 26(1).

 

Item 29

This item inserts an additional requirement for the Authority to report on the number of applications declared under section 95 to be urgent applications during the current year.

 

Item 30

This item amends subsection 152(l) so that it will no longer refer to “proposals made by the Authority”, but to “proposals prepared by the Authority”.

 

Item 32

This item inserts two additional requirements for the Authority to report on:

·          the number of proposals prepared under section 55 during the current year that the Authority had not begun to assess under section 59 during that year; and

·          the number of proposals prepared under section 55 during a previous financial year that the Authority had not begun to assess under section 59 before the end of the current year.

 

Item 33

This item amends subsection 152(n) to remove the words “so made”, such that it is clear that all proposals disposed of in the current year are to be included in the annual report.

 

Item 36

This item inserts four additional requirements for the Authority to report on:

·          the number of proposals prepared under section 55 during a previous financial year that the Authority had begun to assess under section 59 before the end of the current year, but that the Authority had not disposed of before the end of the current year; and

·          for a proposal (covered by the requirement above), the period that has elapsed since the proposal was prepared under section 55; and

·          the number of proposals declared under section 95 to be urgent proposals during the current year; and

·          the number of occasions during the current year when the 12 month period referred to in subsection 101(1) ended with no decision having been made under that subsection, and the reasons for no decision having been made.

 

Item 38

This item inserts a second subsection which allows the Authority members to include any other matter in the annual report that they consider relevant.

 

Item 39

This item provides that these amendments will apply in relation to financial years ending on or after the commencement of those items.