Bills Digest no. 167 2009–10
Food Standards Australia New Zealand Amendment Bill
2010
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage history
Purpose
Background
Financial implications
Main provisions
Contact officer & copyright details
Passage history
Food Standards Australia New Zealand
Amendment Bill 2010
Date introduced: 13 May 2010
House: House
of Representatives
Portfolio: Health and Ageing
Commencement: Schedule 1 on a date to be fixed by Proclamation but
no later than six months after the date of Royal Assent; all
remaining provisions on the day of Royal Assent.
Links: The
links to the Bill, its Explanatory Memorandum and second
reading speech can be found on the Bills page, which is at http://www.aph.gov.au/bills/.
When Bills have been passed they can be found at ComLaw, which is
at http://www.comlaw.gov.au/.
The primary purpose of the Food
Standards Australia New Zealand Amendment Bill 2010 (the Bill) is
to ensure that the residue risk assessments made by the Australian
Pesticides and Veterinary Medicines Authority (APVMA) are
recognised by Food Standards Australia New Zealand (FSANZ) for the
purposes of the Australia New Zealand Food Standards Code (the Food
Standards Code).
On 12 October 2005 the then Prime
Minister, Mr Howard, announced the appointment of a taskforce to
identify practical options for alleviating the compliance burden on
business from Government regulation.[1] The final report of the taskforce
contained 178 recommendations.[2] In particular, recommendation 4.58 proposed
that the Council of Australian Governments (COAG) establish a
high-level taskforce to oversee an independent public review of
chemicals and plastics regulation.[3]
In delivering the final government response to that report, the
former Treasurer, Mr Costello, stated that ‘COAG members are
actively working to address overlaps and inconsistencies in a
number of regulatory ‘hotspots’, including ...
chemicals and plastics’.[4]
The Productivity Commission was tasked with undertaking a study
of chemicals and plastics regulation to inform COAG, and in
particular to:
Investigate and document the current system of
regulation of chemicals and plastics in Australia, including the
interrelationships between the Australian, State and Territory
government agencies, and local government layers of regulation, and
the effect of these relationships on economic, public health and
safety, occupational health and safety, and environmental outcomes.
In examining these relationships, issues such as duplication and
inconsistency both within and across jurisdictions should be
identified.[5]
Australia and New Zealand have a joint system for regulating
food safety. This system is underpinned by an
intergovernmental agreement—the Food Regulation
Agreement—between the Commonwealth, state and territory
governments (and a treaty with New Zealand).[6] The Australia and New Zealand Food
Regulation Ministerial Council (the Ministerial Council) is
responsible for setting policy, and amending or rejecting food
standards.[7] The
standards are developed by FSANZ, a trans-Tasman standard-setting
body.[8]
Within Australia, the states and territories administer and
enforce the standards for all foods offered for sale. The
Australian Quarantine and Inspection Service inspects and samples
imported foods at the border to ensure they comply with the
standards.[9]
Chemicals and plastics are subject to three areas of food
regulation. These involve limits on the extent to which foods may
contain:
- residues from agricultural and veterinary (agvet)
chemicals
- food additives and processing aids
- contaminants, including residues from plastics used in
packaging.[10]
The use of agvet chemical products can pose potentially
significant risks to human health and the environment. In addition,
the use of agvet chemical products on exported primary produce can
affect Australia’s international trade. In recognition of
their hazardous properties, direct environmental and human exposure
paths, and direct trade impacts, agvet chemical use is regulated
via a dedicated regime.[11]
The National Registration Scheme for agvet chemicals regulates
the introduction and use of all agvet chemicals and
products.[12]
This includes:
- the assessment and registration of agvet chemicals and
products
- development of conditions of use and product quality
monitoring, and
- control-of-use of agvet products after retail sale.[13]
Under the National Registration Scheme, the APVMA is a statutory
authority which undertakes the assessment and registration of agvet
chemical products. Its functions include:
- assess the suitability for sale in Australia of chemical
products, active constituents for proposed or existing chemical
products, and labels for containers for chemical products
- provide information to governments about approved active
constituents, registered products, and approved labels
- evaluate the effects of the use of chemicals in states and
territories
- facilitate the introduction of uniform national standards on
controlling the use of chemicals.[14]
When maximum residue limits are being determined, the APVMA
considers the most extensive permitted use of the product taking
into account such factors as:
- how rapidly the chemical may be processed by either plant
and/or animal tissues
- how rapidly the chemical may be degraded by soil and other
environmental processes
- how frequently and at what intervals the chemical is used,
taking into account the potential for bio-accumulation
- how close to harvesting of plants, collection of milk and eggs
and/or slaughtering of livestock the chemical is used (including
withholding periods)
- the acceptable dietary exposure to low levels of chemicals in
food, and
- the effects of processing (e.g. flour from wheat; wine and
dried fruit from grapes; sugar from sugar cane).[15]
When the APVMA sets a maximum residue limit in food, it
recommends that FSANZ incorporate this maximum residue limit into
the Food Standards Code.[16]
Both the APVMA and FSANZ prescribe limits on agvet chemical
residues in food—termed maximum residue limits—and do
so in separate regulations:
- APVMA prescribes maximum residue limits that reflect
‘good agricultural practice’ so breaches of agvet
control-of-use requirements can be detected
- FSANZ prescribes maximum residue limits so that crops and
animals treated with chemicals can be verified as being safe for
human consumption.[17]
The APVMA consults with a wide range of groups through a number
of consultative and liaison committees. In addition to these
consultative structures, the APVMA routinely conducts consultations
with its stakeholders, seeks their input on issues, decisions and
scientific assessment outcomes relating to registration activities
and the review of existing chemicals, as well as on proposals to
reform requirements or procedures. By comparison, FSANZ
assessments are developed through public consultation, and provide
an opportunity for importers to have input into the setting of
residue standards.[18]
According to the Productivity Commission:
There is potential for two different maximum
residue limits to be prescribed for the same chemical in the same
food by the two agencies. In such cases, primary producers in most
jurisdictions would have to comply with the most stringent maximum
residue limit.[19]
There is some co-ordination between the two agencies. The usual
procedure is that the APVMA first prescribes a maximum residue
limit as part of its conditions of approval for an agvet product,
and then submits an application to FSANZ to include the maximum
residue limit in the Australia New Zealand Food Standards
Code.[20]
FSANZ has never rejected a maximum residue limit application
from the APVMA. This can be attributed to the fact that the APVMA
assesses the human-health impacts of a maximum residue limit before
approving it, and does so using dietary models and reference health
standards from FSANZ. For this reason, FSANZ does not usually
undertake its own dietary exposure assessment when considering a
maximum residue limit submitted by the APVMA.[21]
Inconsistencies do arise, however, because there is a time lag
between when the APVMA prescribes a maximum residue limit and when
FSANZ mirrors it in food standards. This has led to situations
where farmers complying with agvet control-of-use requirements set
by the APVMA cannot sell their produce because FSANZ has yet to
duplicate a relevant maximum residue limit in food
standards.[22]
The time lag arises, in part, because of the administrative
arrangements for approval of food standards:
- First, if FSANZ concludes that a proposed maximum residue limit
would be an appropriate food standard, their decision has to be
submitted to the FSANZ Board for approval.
- Secondly if the Board agrees, the decision then has to be
submitted to the Australia and the Ministerial Council for its
consideration
- Thirdly the Ministerial Council has 60 days to request a review
of FSANZ’s decision before it is incorporated into the Food
Standards Code.
The Productivity Commission concluded that the existing
governance arrangements are not consistent with best-practice.
In its draft report, the Productivity Commission
recommended that maximum residue levels, as set by the APVMA, be
automatically incorporated into the Food Standards Code.[23]
This Bill is a response to that recommendation.
The Bill has been referred to the Senate Community Affairs
Committee (the Committee) for inquiry and report by 15 June
2010.[24]
The reasons stated for referral of the Bill are that it involves
domestically grown produce, residue risk assessment and
chemicals/pesticides on crops, public health and safety
considerations, and State and Territory relations.
There were few submissions to the Committee and all supported
the proposed amendments.
According to the Explanatory Memorandum implementation of this
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 FSANZ to the APVMA. Funding associated
with these functions will be transferred as appropriate.[25]\
Item 1 of Schedule 1 to the Bill amends the
Agricultural and Veterinary Chemicals (Administration) Act
1992 which establishes the APVMA to insert proposed
subsection 7(1C). The proposed subsection will
confer functions and powers on the APVMA under the Foods
Standards Australia New Zealand Act 1991 (FSANZ Act).[26]
Schedule 1 to the Agricultural and Veterinary Chemicals Code
Act 1994 (the Code Act) contains the Agricultural and
Veterinary Chemicals Code (the Code). Existing section 10 of the
Code provides that a person may apply to APVMA:
- for approval of an active constituent for a proposed or
existing chemical product
- for registration of a chemical product, or
- for approval of a label for containers for a chemical
product.
Similarly, existing section 27 provides that an
‘interested person’ in
relation to any of the above, may apply to the APVMA for a
variation of either the particulars of the approval or
registration, or a variation of the conditions of the approval or
registration.[27]
The proposed amendments to section 13A set out three
circumstances in which the APVMA must notify FSANZ:
- where an application under section 10 or section 27 is made to
the APVMA, and it is likely that, if the application were granted,
a Maximum Residue Limits Standard would have to be varied:
proposed subsection 13A(1)[28]
- where a reconsideration of an approval or registration would be
likely to lead to a variation of a Maximum Residue Limits Standard:
proposed subsection 13A(1A), and
- where an application for a permit under section 110 is made to
the APVMA, and it is likely that, if the permit were granted a
Maximum Residue Limits Standard would have to be varied:
proposed subsection 13A(1B).
Items 3 and 4 of the Bill amend subsection
13A(2) to specify that the APVMA must notify FSANZ ‘as soon
as practicable’ after an application or a variation is
made.[29]
Existing subsection 14(1) of the Code provides that the APVMA
must grant an application under section 10 if it is satisfied about
a range of matters which are listed in existing subsection 14(3) of
the Code. Existing subsection 14(5) prescribes those matters
that the APVMA must have regard to, in order to be so
satisfied. Item 5 of the Bill inserts
proposed paragraph 14(5)(ea) so that the APVMA
must also consider comments about dietary exposure assessment, or
any dietary exposure assessment prepared, by FSANZ.[30]
Item 13 of the Bill repeals existing
Subdivision H of Division 2 of Part 3 of the Food Standards
Australia New Zealand Act 1991 (FSANZ Act). That
subdivision currently sets out the rules for a variation of the
Maximum Residue Limits Standard. Items
8–12 and items 15–18 are
amendments which are a consequence of the repeal of Subdivision
H.
In its place, item 14 of the Bill inserts
proposed Division 2A into the FSANZ Act.
According to proposed section 80 the Division
applies if the APVMA notifies FSANZ of an application or variation
in relation to a chemical product.[31] As soon as practicable after it
has received the notice, FSANZ must do the following:
- give public notice of the receipt of the notice from the APVMA
setting out the particulars of the application or variation, and
any other matter that it thinks appropriate: proposed
section 81, and
- prepare a dietary exposure assessment of the proposed
variation—and give a copy to the APVMA and to the Ministerial
Council: proposed subsection 82(4).
Proposed subsection 82(1) empowers the APVMA to
vary the Maximum Residue Limits Standard to include or change a
permitted maximum residue limit to cover a chemical product.
Although the variation is a legislative instrument, it is not
subject to the disallowance procedures or to the requirement in the
Legislative Instruments Act 2003 for sunsetting:
proposed subsection 82(2).
The APVMA must not make a variation to a maximum residue limits
standard without first considering the dietary exposure assessment
which has been prepared and given by FSZANZ: proposed
subsection 82(5).[32]
Once the APVMA has decided to vary a maximum residue limits
standard it must give a copy of the variation to FSANZ and publish
a copy of the variation in the Gazette: proposed
subsections 82(6) and (7). Under proposed
subsection 82(8), the variation of the maximum residue
limit takes effect in the Food Code on the date that it is
published in the Gazette.
Proposed section 83 confirms that Division 2A
will not limit FSANZ’s power to vary the Maximum Residue
Limits Standard. For example, ‘FSANZ will continue to
process applications to set maximum residue limits that relate to
imported food’.[33]
Section 146 of the FSANZ Act authorises charges to be paid to
FSANZ for services and facilities that it provides
to a body or person. Those charges are fixed by
regulation. Existing subsection 146(6) provides that a charge
may only be fixed if it relates to an application to develop or
vary a standard and either:
- the development or variation of the standard would confer an
exclusive, capturable commercial benefit on the applicant, or
- the applicant has elected to have the consideration of the
application expedited.
Item 22 repeals and replaces subsection 146(6)
to provide that a charge may be fixed in relation to an application
to develop or vary a standard only if the development or variation
of the standard would confer an exclusive, capturable
commercial benefit on the applicant; or the applicant has elected
to have the consideration of the application expedited.
Although the rewording is only subtly different from the
existing wording, the amendment means that FSANZ may charge third
parties for a greater range of services or activities—not
just for certain applications to develop or vary a food standard,
as is currently the case.
Items 25–38 amend section 152 which sets
out those matters which FSANZ must include in its annual
report. In particular, item 36 inserts
proposed paragraphs 152(pa)–(pd) so that
numbers of proposals for development or variation of food
regulatory matters are included.
Members, Senators and Parliamentary staff can obtain further
information from the Parliamentary Library on (02) 6277 2434.
Paula Pyburne
11 June 2010
Bills Digest Service
Parliamentary Library
Back to top