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2008-2009-2010
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
FOOD STANDARDS AUSTRALIA NEW ZEALAND AMENDMENT BILL 2010
REPLACEMENT EXPLANATORY MEMORANDUM
(Circulated by the authority of the Parliamentary Secretary for Health,
the Hon. Mark Butler MP)
THIS MEMORANDUM REPLACES THE EXPLANATORY MEMORANDUM
PRESENTED TO THE HOUSE OF REPRESENTATIVES
ON 13 MAY 2010
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.
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