Chapter 1
Referral of inquiry
1.1
The Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014 (the bill) was introduced in the House of
Representatives on 19 March 2014. On 20 March 2014, the Senate referred
the provisions of the bill to
the Senate Rural and Regional Affairs and Transport Legislation Committee (the
committee) for inquiry and report by 16 June 2014.
1.2
The Selection of Bills Committee noted the reasons for referral and
principal issues for
consideration were to 'Investigate thoroughly the impact of this
legislation on the health and safety of human beings, animals and the
environment as a priority of the regulatory system.'[1]
Purpose of the bill
1.3
A key objective of the bill is to wind back the re-registration process
for agricultural chemicals and veterinary medicines (together referred to as 'agvet
chemicals').
1.4
In particular, the purpose of this bill is to:
-
amend the Agricultural and Veterinary Chemicals Code Act 1994
to:
-
prevent the expiry of active constituent approvals and prevent
the application of dates after which a registration cannot be renewed;
-
remove the requirement for applications to be made to re-approve
active constituents or re-register chemical products;
-
enable the Australian Pesticides and Veterinary Medicines
Authority (APVMA) to require information to be provided about substances
supplied as a chemical product;
-
simplify how variations to approvals and registrations are
processed by APVMA; and
-
enable APVMA to charge a fee when it provides copies of documents
in its possession; and
-
amend the Agricultural and Veterinary Chemicals Code Act 1994,
Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994,
Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 and
the Food Standards Australia New Zealand Act 1991 to make consequential
amendments.[2]
Conduct of the inquiry
1.5
The committee wrote to
a number of stakeholder groups seeking submissions on the provisions of the bill. Twenty
two submissions were received. Given the non-controversial nature of the
bill, the committee agreed not to hold a public hearing in relation to this
inquiry.
Background
The regulatory environment
1.6
Agricultural chemicals and veterinary medicines are regulated through a
cooperative National Registration Scheme (NRS) for Agricultural and Veterinary
Chemicals. The NRS was first agreed to by the Australian Agriculture Council
(subsequently the Standing Council on Primary Industries) in 1991 and is
described in a ministerial level intergovernmental agreement that was signed in
September 1995.[3]
1.7
The NRS is a partnership between the Commonwealth and the states and
territories, with a shared division of responsibilities. Assessment and
registration of agvet chemicals, as well as the control of supply activities up
to the point of retail sale are undertaken on behalf of the states by the
Australian Pesticides and Veterinary Medicines Authority (APVMA), a
Commonwealth authority. Control of the use of agvet chemicals after sale is the
responsibility of the states and territories.[4]
1.8
In 2006 an audit by the Australian National Audit Office (ANAO) examined
the APVMA's arrangements for planning and overseeing the delivery of its
regulatory functions and for administering its cost recovery framework.[5] The ANAO noted:
Since the ANAO’s previous audit in 1997–98, and particularly in recent
years, the APVMA has
introduced various initiatives to improve
the effectiveness of its operations.
However, key programs to monitor the
quality of pesticides and veterinary
medicines, such as the
Manufacturers’ Licensing Scheme and the Chemical Review Program, could be better administered. Greater emphasis
needs to be given
to compliance programs and to
completing chemical reviews in
order for the APVMA
to provide assurance that manufacturers of
pesticides and veterinary medicines are meeting the required standards, and that
products approved for sale
in Australia are safe and effective. The APVMA is also not meeting
its obligation to finalise all Applications
within statutory timeframes. This increases
the cost of regulation, for
both the APVMA and
applicants, and impacts on
users’ access to pesticides
and veterinary medicines.[6]
1.9
In 2006, the Council for Australian Governments (COAG) identified
the need for regulatory reform in relation to chemicals and established a
Ministerial Taskforce, to 'develop
a streamlined and harmonised national system of chemicals and plastics
regulation'.[7]
COAG also referred the matter to the Productivity Commission for advice. In
2008, the Commission published a report, Chemicals and Plastics Regulation,
which found that:
...the current institutional and regulatory arrangements are broadly effective in
managing the risks to health and safety, but are less effective in managing
risks to the environment and national security. Efficiency could be
enhanced by: national uniformity in some regulatory areas; reducing costs and
delays in obtaining regulatory approvals; and attaining economies of scale in
regulatory administration.[8]
1.10
In 2009, COAG announced that a Memorandum of Understanding for Chemicals
and Plastics Regulatory Reform had been agreed to, and established the Standing
Committee on Chemicals to co-ordinate, monitor and advise governments on the
implementation of reforms identified by the Productivity Commission.[9]
In mid-2013 ministers confirmed their commitment to a new NRS agreement.[10]
1.11
The APVMA's operations are described in the Explanatory Memorandum as
follows:
The APVMA is responsible for
administering and managing the parts of the NRS that oversee registration,
quality assurance and compliance of agvet chemicals up to and including the
point of retail sale.
Australia currently has around
11 700 separate agvet chemical products registered (approximately 8 350
agricultural and 3 350 veterinary), each of which contains one or more of
around 2 230 approved active constituents, of which around 782 are unique.[11]
Recent changes – the Amendment Act
1.12
The Agricultural and Veterinary Chemicals Legislation Amendment Bill
2013 (the amendment bill) was passed by Parliament in June 2013. The amendment bill
made changes to: approvals, registrations, permits and licences, re-approval
and re-registration, enforcement, data protection, and levy collection.[12]
The amendment bill also included other amendments to remove redundant
provisions and amend outdated provisions.[13]
1.13
Prior passing of the amendment bill, there was no mandatory requirement
for agvet chemicals, once approved or registered, to be reviewed. Some of the
amendments in the amendment bill provided for such a scheme as follows:
The Act [as it became] reformed the approval, registration
and reconsideration (review) of agvet chemicals to improve the effectiveness of
the regulatory system and reduce inefficiency at
the APVMA, while making processes more predictable, clearer and less unwieldy
for industry. The reforms were intended to improve community’s confidence that
chemicals approved for use in Australia are safe.
The reforms of the Amendment Act (including provisions for
re-approval of active constituents and re-registration of chemical products, or
re-registration) commence on 1 July 2014.[14]
1.14
The amendment bill was examined by four Parliamentary committees,
including the Senate Standing Committee for the Scrutiny of Bills and the
Parliamentary Joint Committee on Human Rights. The Senate Rural and Regional
Affairs and Transport Legislation Committee tabled its report on 27 February
2013, recommending that the amendment bill be passed.[15]
The Coalition Senators' Dissenting Report indicated that Coalition Senators did
not support its passage on account of the mandatory requirement for re-registration
of agricultural and veterinary chemicals, which was described as 'expensive and
developed without a compelling cost/benefit analysis'.[16]
The bill
1.15
The Agricultural and Veterinary Chemicals Legislation Amendment
(Removing Re-approval and Re-registration) Bill 2014 (the bill) amends:
-
the Agricultural and Veterinary Chemicals Code Act 1994
(Code Act);
-
the Agricultural and Veterinary Chemicals Legislation
Amendment Act 2013 (Amendment Act);
-
the Agricultural and Veterinary Chemical Products (Collection
of Levy) Act 1994 (Collection Act); and
-
the Food Standards Australia New Zealand Act 1991 (FSANZ
Act).[17]
1.16
The explanatory memorandum indicates that the bill implements an
election commitment to remove the requirement to re-register agvet chemicals:
The Bill implements the Australian Government’s 2013 election
commitment to remove the requirement for agricultural chemicals and veterinary
medicines...re-registration by removing end dates for approvals and last renewal
dates for registrations so that approvals will no longer end after a particular
period and registrations may be renewed perpetually, and removing redundant
provisions that allow applications to re-approve and re-register active
constituents and chemical products.[18]
The government considers that,
prior to the Agricultural and Veterinary Chemicals Legislation Amendment Act
2013, existing chemical review mechanisms provided sufficient basis for the
examination of newly discovered risks about the safety, efficacy or trade
impact of a chemical. New mechanisms (the re-registration scheme) duplicating
the existing system and impose additional costs on industry are not required. [19]
1.17
Schedule 1 of the Bill would amend the Agvet Code to prevent the expiry
of active constituent approvals and prevent the application of dates after
which a registration cannot be renewed. Active constituent approvals are to
continue in force so long as they are not cancelled. Registrations would
continue in force so long as they are not cancelled, subject to renewal of the
registration. The bill would also remove provision for applications to be made
to re-approve active constituents or re-register chemical products.[20]
1.18
While the bill would remove re-registration, other provisions strengthened
by the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013
would be retained. The existing comprehensive powers held by APVMA ensure that any
newly identified risks about the safety, efficacy or trade impact of a chemical
are examined, would be retained. The APVMA would also retain powers to recall
unsafe chemical products or suspend or cancel the registration of a chemical
product if they no longer meet criteria for registration.[21]
The bill would also introduce reforms that aim to:
-
reduce red tape by providing for less frequent registration
renewals;
-
improve the APVMA’s ability to secure information about the
safety of chemicals supplied in the market;
-
introduce further simple reforms to the regulation of agvet
chemicals to reduce red tape and improve efficiency;
-
oblige the APVMA to provide access to information about approvals
and registrations in its files to persons eligible to receive it; and
-
address some minor implementation issues identified in existing
reform legislation.[22]
Consultation
1.19
A consultation paper and an exposure draft of the bill were released,
with submissions sought between 18 December 2013 and 7 March 2014. The Explanatory
Memorandum notes that 42 submissions were received and meetings were held with
stakeholders over January and February 2014. The bill was revised to address
some issues raised during the consultation.[23]
Acknowledgements
1.20
The committee thanks those organisations and individuals who made
submissions.
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