Referral of the inquiry
On 16 October 2018, the Senate moved that the following matters be
referred to the Rural and Regional Affairs and Transport References Committee (the
Committee) for inquiry and report by 1 February 2019:
The independence of regulatory
decisions made by the Australian Pesticides and Veterinary Medicines Authority
(APVMA), with particular reference to:
- the responsiveness and effectiveness of the APVMA's process for
reviewing and reassessing the safety of agricultural chemicals in Australia,
including glyphosate, and how this compares with equivalent international
the funding arrangements of the APVMA, comparisons with equivalent
agricultural chemical regulators internationally and any impact these arrangements
have on independent evidence‑based decision making;
the roles and responsibilities of relevant departments and agencies of
Commonwealth, state and territory governments in relation to the regulation of
pesticides and veterinary chemicals;
the need to ensure Australia's farmers have timely access to safe,
environmentally sustainable and productivity enhancing products;
the impact of the APVMA's relocation on its capability to undertake
chemical reviews in a timely manner; and
any other related matters.
Conduct of the inquiry
Information about the inquiry was made available on the Committee's
webpage. The Committee wrote to government departments, industry stakeholder
groups, community groups and individuals to invite submissions. The Committee received
110 public submissions. A list of organisations and individuals that made
public submissions, together with additional information authorised for
publication, is at Appendix 1.
The Committee also received a large number of form letter submissions.
Approximately 110 such submissions raised concerns about pesticides and their
impact on bees. Approximately 237 raised concerns about the safety of chemicals
in general, the safety of glyphosate more specifically, and the need to ban the
use of neonicotinoid‑based pesticides. The Committee also received
approximately 200 emailed form letters, addressed to the inquiry, but which
contained no content.
The Committee held public hearings on 20 November 2018 and 7 December
2018 in Canberra.
A list of witnesses who appeared at the hearings is at Appendix 2.
Submissions and Hansard transcripts of evidence may be accessed through the Committee's
The Committee thanks all the organisations and individuals who made
submissions to the inquiry and appeared before the Committee to give evidence.
Note on references
References to Hansard are to the proof transcript. Page numbers may vary
between the proof and the official (final) Hansard transcript.
Structure and scope of the report
The report is divided into five chapters. Chapter 1 states the inquiry's
terms of reference and provides an overview of the use of pesticides and
veterinary medicines in Australia. It concludes by describing the role of the
Chapter 2 discusses previous reviews of the APVMA's performance, the
decision to relocate the APVMA to Armidale and its consequences, and how the
APVMA's performance compares globally.
Chapter 3 sets out a brief history of government charging for services
and the charging practices of other regulatory agencies in Australia and
internationally. It examines the APVMA's funding model and perceptions of the
authority's independence. The chapter discusses the impact of the charging
framework on the registration of chemicals in Australia, and the use of international
data for assessment.
Chapter 4 details the APVMA's processes for chemical reconsideration and
the reconsideration practices of regulators internationally. It examines the
process for reconsideration as it applied to glyphosate, and discusses the APVMA's
chemical risk approach. It also explores the issue of innovation in the
development of products and practices for Australian pests and Australian
Chapter 5 broadly examines some of the community concerns raised in evidence
about decisions made by the regulator. It discusses social licence; perceptions
of a conflict in the mandate of the APVMA; the comprehensiveness of the
regulator's assessments; the public availability of data; and the regulator's responsiveness
to community concerns. The chapter also examines options to formalise contact
between industry and the APVMA, and international models for community
Chapter 6 provides the Committee's views and recommendations.
Issues not addressed by the report
The Committee received several submissions that raised concerns with the
lack of uniformity in the way states and territories manage their control‑of‑use
responsibilities for agricultural and veterinary (agvet) chemicals,
particularly off‑label use.
This matter was raised by the Productivity Commission in 2016 when it
recommended that the Australian, state and territory governments implement a
national control‑of‑use regime (including harmonisation of off‑label
use provisions) for agvet chemicals by the end of 2018.
The Australian Government responded to this report in January 2019. It
stated that harmonised models for training and licensing of fee-for-service
operators and users of restricted chemical products and schedule seven poisons,
and record keeping for agricultural chemicals were finalised in 2017–18. It
further noted that full national implementation is required by 2022.
The Government also noted that it had been working with state and
territory governments to implement a Council of Australian Governments (COAG)
2010 direction to harmonise agricultural and veterinary chemical regulation. It
further explained that while it has continued to work with state and territory
governments, a proposal for harmonising agricultural off-label use is expected
to be considered by the Agriculture Ministers' Forum (AGMIN) this year.
Given that these matters are subject to ongoing discussions at AGMIN at
the direction of COAG, the Committee did not investigate them. The Committee
did, however, receive a volume of evidence that highlighted significant
impediments caused by the lack of a nationally consistent regime. For these
reasons, a number of submitters encouraged reform in this area.
Use of pesticides and veterinary medicines in Australia
Australia's agricultural industry is worth an estimated $60 billion
annually and an effective and trusted pesticides and veterinary medicines regulator
is central to its integrity and ongoing viability.
Each year, over $3 billion is spent on agvet chemicals in Australia.
According to the Department of Agriculture and Water Resources (DAWR), agvet
...brought long‑term benefits to Australian agriculture
by supporting increased productivity, better quality produce, and agricultural
industries that are more competitive.
It was put to the Committee that agvet chemicals are an integral
component of sustainable production systems, providing primary producers with
the means to manage pests and maintain biosecurity whilst contributing to the
productivity and viability of Australia's agricultural industries.
More than 11,480 pesticide and veterinary medicine products, managed by
over 900 registrants, are currently registered in Australia. These range from
products to treat crop and garden diseases and pests, to medicines to treat
agricultural and companion animals.
The APVMA receives around 5,000 applications annually for various assessments.
Role of the Australian Pesticides and Veterinary Medicines Authority
The Minister for Agriculture and Water Resources has overall policy
responsibility for agvet chemicals. DAWR manages the legislation that relates
to agvet chemicals, including the legislation under which the National
Registration Scheme for Agricultural and Veterinary Chemicals (NRS) operates.
The Department's responsibilities include amending current legislation or introducing
new bills in circumstances where Australian, state and territory governments
have agreed there is a need.
The APVMA sits within the DAWR portfolio as an independent statutory
authority. In its submission to the inquiry, the APVMA stated its 'primary
purpose is to protect the health and safety of people, animals and the
environment' by ensuring chemical products are safe. It noted that:
In many cases, the products we regulate are intrinsically
hazardous. Pesticides, herbicides, fungicides and parasiticides protect the
environment, animals and agricultural crops from pests and diseases. We
regulate agvet chemical products using a structured process combining scientific
methodology, legislation and risk assessment to ensure products are safe to use
and do not adversely impact trade.
The APVMA is established under the Agricultural and Veterinary
Chemicals (Administration) Act 1992 (Administration Act) to administer the NRS
in partnership with state and territory governments, and the scheme's
In Australia, agvet chemicals are regulated under a cooperative
statutory scheme. The APVMA is the independent statutory authority responsible
for assessing, registering, and regulating agvet chemicals in Australia. The
APVMA's regulatory responsibilities extend from registration and manufacturing
through to the point of sale. The APVMA must evaluate and register all agvet
chemicals prior to their legal sale, supply or use in Australia. It is the
responsibility of state and territory governments to regulate and monitor how
chemicals are used after they are sold.
The APVMA administers the Agricultural and Veterinary Chemicals Code
Act 1994 (Agvet Code Act), and related supporting legislation and
The APVMA regulates agvet chemicals by:
approving active constituents and registering agvet chemical
reconsidering active constituents and agvet chemical products
when new scientific information emerges that suggests a change in the risks to
human health, the environment, animal or crop safety, or trade;
administering a permit scheme for the legal use of chemicals in
ways contrary to the label instructions, or for the limited use of unregistered
chemicals (permits are subject to the same safety, efficacy and trade criteria
as active constituents and chemical products);
licensing the manufacture of chemical products (currently
restricted to veterinary chemical products);
conducting compliance and enforcement activities associated with
the sale, supply, import, export, manufacture, labelling, packaging, storage
and advertising of agvet products and active constituents; and
enforcing compliance with the Agvet Code (as set out in the
Schedule to the Agvet Code Act) in partnership with law enforcement, the judiciary,
and Australian, state and territory government agencies.
The APVMA can call upon other specialist government agencies and
researchers to conduct aspects of evaluation, approval, registration, reconsideration
and permit issuances. Specialist expertise can be sought from:
the Department of the Environment and Energy—for the environmental
impact of agvet chemicals;
the Department of Health—for human health, including the Poisons
Scheduling Committee, Food Standards Australia New Zealand (FSANZ), and the Office
of the Gene Technology Regulator (OGTR); and
state and territory departments with responsibility for
agriculture or primary industries—for the quality, efficacy and safety of agvet
Under the APVMA's compliance and monitoring powers, the authority also undertakes
post market surveillance and testing with regard to the continued safety and
effectiveness of registered products.
A number of submissions highlighted the importance of the APVMA's role
in the protection of Australian agriculture, forestry, horticulture and
aquaculture. Submitters noted that the APVMA responds to biosecurity threats,
protects farm workers and the community, and supports Australian trade. The
APVMA's role in supporting trade was considered to be of particular importance
given that more than two thirds of agricultural commodities produced on farms
are exported each year. Submitters also commented that the authority was
recognised globally as a world‑leading independent, science‑based
regulator with a proven track record of scientific and evidence‑based
Submitters emphasised the point that the APVMA must retain the necessary
scientific and administrative resources to perform its important role efficiently.
The point was also made that the authority must retain the trust of the
community in the decisions it makes.
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