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Agricultural and Veterinary Chemicals (Administration) Act - Chemicals - Reports - 1993-94


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Annual Report 1993-1994

National Registration Authority ^ A GR IC U LT U RA L & V E T E R I N A R Y C H E M IC A L S

© Commonwealth of Australia 1994 ISSN 1322-9745

This work is copyright. Apart from any use permitted under the Copyright Act 1968, no part may be reproduced by any process without written permission from the Australian Government Publishing Service. Requests and inquiries concerning reproduction and rights should be addressed to the Manager, Commonwealth Information Services, Australian Government Publishing Service, GPO Box 84, Canberra ACT 2601.

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Typesetting and cover design: City Graphics Printed by Microdata, Canberra

<5 > National Registration Authority

~CR A G R IC U L T U R A L & V E T E R I N A R Y C H E M I C A L S

First Floor, Industry H ouse, National Circuit, Barton ACT

PO Box E240, Q ueen Victoria Terrace, ACT 2 6 0 0

Tel: (06) 2 7 2 5 1 5 8 Fax: (06) 2 7 2 4 7 5 3

14 October 1994

Senator the Hon. Bob Collins Minister for Primary Industries and Energy Parliament House CANBERRA ACT 2600

Dear Minister

On behalf of the National Registration Authority for Agricultural and Veterinary Chemicals, I have much pleasure in submitting the Annual Report and Financial Statements for the year ending 30 June 1994

in accordance with the provisions of the Agricultural anil Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Act 1988. I am also providing a copy of this Report to the relevant State and Territory Ministers.

Subsection 34C(2) of the Acts Interpretation Act 1901 has the effect of requiring this Report to be furnished on or by 31 December. Subsection 34C(3) of the same Act requires the Minister to table the Report in each

House of the Parliament within 15 sitting days from the day on which the Report was received.

Yours sincerely

BEN SELINGER Chair

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Contents

Guide to the 1993-94 Annual Report vi Financial Statements 39

Chairman's Report vii Appendixes 53

Chapter 1: Corporate overview 1 Appendix A Legislation 55

The National Registration Authority 3 Appendix B Staffing overview 58

Mission 3 Appendix C Freedom

of Information 59

Structure 3

How the NRA was established 3 Appendix D Clearance for registration: statistics 1993-94 63

Minister 4 Appendix E Social justice and equity 64

Board of Directors 4 Appendix F External scrutiny 66

The NRA at work 6 Appendix G Information

technology purchasing 67

Highlights of the year 9

Chapter 2: Program reports 11 Index of reporting requirements 68 Glossary 69

Program Structure 13

Main Index 70

Program 1 Executive 14

Subprogram 1.1 Special Projects 15 List of tables Table 1: Violations in supply, labelling and advertising

agricultural and veterinary chemicals 27

Table 2: Senior officer performance

Program 2 Chemicals Registration

Subprogram 2.1 Agricultural (ihemicals Registration

19

19

Subprogram 2.2 Veterinary Chemicals Registration 21

pay by group 31

Table 3: Staffing and EEO profile as at 30 June 1994 58

List of figures

Fig 1: NRA organisational structure as at 30 June 1994 2

Subprogram 2.3 Chemicals Review 23

Program 3 Compliance 26

Program 4 Corporate services 29 Fig 2: Summary of the registration process for agricultural and

Subprogram 4.1 Business Administration 29

veterinary chemicals 7

Fig 3: NRA Program structure 13

Subprogram 4.2 Corporate Affairs 36 Fig 4: Operating costs 33

Guide to the 1993-94 Annual Report

The National Registration Authority for Agricultural and Veterinary Chemicals’ Annual Report 1993-94 is the Authority’s account to the Minister for

Primary Industries and Energy of performance during its first full year of operation.

The Report presents an overview from the Chairman, Professor Ben Selinger and a corporate overview describing the establishment of the NRA, its mission, structure and its work.

Program reports discuss progress made and outcomes achieved during the reporting period. The performance indicators that were in place at 30 June

1994 are consistent with a more detailed set of performance indicators that were developed during the period for the NRA’s first corporate and operational plans.

Financial statements for the year are followed by appendixes containing information on legislation, staffing, Freedom of Information, clearance statistics, social justice and equity, external scrutiny and information technology purchasing.

A compliance index refers to pages in the Report where the mandator)' requirements for annual reporting have been met. A subject index is also provided to aid access to the Report.

Comments on this Report Comments and inquiries relating to this Annual Report may be directed to: Mr Phil Goodsell

Corporate Secretary Telephone: (06) 271 6352 Facsimile: (06) 272 4753 The NRA’s offices are situated at Level 1, Industry House, corner of National Circuit and Brisbane Avenue, Barton A.C.T. The postal address is

PO Box E240 Queen Victoria Terrace ACT 2600. Telephone: (06) 272 5158 • Facsimile: (06) 272 4753

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Chairman’s overview

The first year of life of any organism is critical, and an organisation like the NRA is no exception. We have metamorphosed from a branch of the Australian Public Service into a

statutory authority required to operate in a commercial manner. This transition has not been easy. ( )ur activities in 1993-94 have focused on creating this new enterprise. This has meant setting our strategic

direction based on a hard look at our operations and a comprehensive evaluation of likely developments and pressures in agricultural and veterinary

chemical use. The NRA’s Corporate and Annual Operating Plans, developed during the reporting period, identify issues crucial

to the success of the NRA and define goals for the various functional areas. The result will be an efficient and cost-effective national registration and

regulatory system for agricultural and veterinary chemicals. The NRA intends to establish confidence amongst

Australians that the chemicals approved for sale on the Australian market are safe and and effective. In conjunction with the States and Territories, we will endeavour to ensure that they are in

practice used safely and effectively. The establishment of the NRA’s Board of Directors has brought together people with broad skills and

div erse views. The Board has set effective policy frameworks and provided sound guidance and support to management and staff. The Board is

part-time and its members are very busy. I am particularly grateful for the efforts and energy they have devoted to our operation.

Professor Ben Selinger

I am particularly indebted to Directors, Douglas McGuffog and Peter Bailey for placing the NRA on a solid financial footing so as to m eet our

obligations both to the Government and industry as a cost effective and efficient regulatory authority. In the first year of operation, the NRA’s

expenditure was well within the Budget allocation. We are now well placed to move into an interim cost recovery phase from 1 July 1995. Effective

accrual accounting practices and other financial policies will ensure that we move smoothly from Budget funding to full cost recovery.

Directors Garry G oucher and Hermann Mani are taking a lead role in piloting the NRA towards a quality assurance program, ensuring that our

processes, procedures, guidelines and training meet IS09002 standards and are consistent with international best practice.

Directors Don Burke, Renata Musolino and Dr Barbara Wilson have suggested innovative w'ays o f ensuring that the NRA meets its obligations in

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establishing open and transparent processes. The NRA is moving quickly to address its priorities.

We have improved the relationships with our stakeholders and clients and the other government agencies with whom we work.

We are re-examining the status of ‘the label’ on a product as a legal document and we are working to ensure that labels become easier to understand, particularly for people from non- English-speaking backgrounds.

Another priority addresses the chemicals that are still in large-scale use but were registered some time ago, to ensure that they meet current quality, health, safety and environmental standards. This will become our Existing Chemicals Review Program.

Of increasing concern are the chemicals used for minor crops (like aquaculture and horticulture) for which there are less data. Our aim is to support the needs of emerging industries in a practical way. For this purpose, we are developing a Minor Use Program.

The requirement to approve active ingredients used in formulated products is to ensure that if sources of these change, the quality is not compromised. A revised Technical Grade Active

Constituent Program trill be introduced next year. A public reporting system for the adverse effects of products in use is needed. In response to this need, we are now considering a Suspected Adverse Product Experience program.

As the NRA moves from Government funding to full cost recovery, the industry which is now

paying, is naturally apprehensive about supporting what some see as non-core business activities. Industry lobbyists, as well as those from environmental and

consumer groups, have so far failed to get the Government to provide for community benefit funding for some of

these activities and place them outside of the cost recovery process. The Directors with industrial backgrounds, particularly Hermann Mani and Douglas McGuffog, have communicated to industry the Board’s view that there is a need for a certain level of review and compliance activity but there are limits to the amount of public good activity that can be funded by industry.

The NRA is well up with international practice in chemicals assessment and will be increasing its use of the best of overseas data and assessment information. We are

increasing our cooperation with New Zealand and sharing the experiences of a range of programs. However, we must never forget that major problems reside in the use of the chemicals rather than in the inadequacy of the data on which the chemicals were registered. Australia’s investment in local toxicology testing is likely to remain inadequate and more paper assessment by the NRA is unlikely to provide a significantly increased benefit. Instead, we must make fuller use of overseas

assessments and focus resources to ensure that chemicals are used properly in the field. This must be done in close partnership with the States and Territories.

Our liaison committees with industry and the State regulators will be joined next year by a community7 liaison

committee. Its initial task will be to advise on future membership and an effective communications process. The Agricultural and Veterinary

Chemicals Gazette, Public Release Summaries on about-to-be considered products, and a regular newsletter arc alreadv starting to improve the way we communicate with industry, interest

groups, the States and the general public. The XRA’s ‘requirements document’ is notv being rewritten from the point of view of the applicant

needing to supply information rather than the bureaucrat wanting it. The NRA inherited two difficult issues in 1993-94 — the use of organochlorine termiticides and the

introduction of a genetically engineered animal growth hormone, Porcine Somatotrophin (PST). From September to December

1993, the NRA undertook a major review of organochlorine insecticides involving an open public inquiry. As a

result of extensive public and industry consultation, the NRA recommended that organochlorines be withdrawn

from the market. The registration of PST was an important step that again, involved extensive public consultation.

Information about the product was made av ailable through the NRA’s first Public Release Summary and comment was invited. Based on rigorous

assessment of the scientific, technical and ethical evidence, and input from the industry and the public, PST was approved for registration. Australia is the

first country in the world to register PST. On the question of communication, I must say that the establishment of a

national database for agricultural and veterinary chemicals (NCRIS) from the disparate State systems has been a triumph that only those familiar with

the intricacies of computer systems can really appreciate. The NRA intends to move onto the information

superhighway with a vengeance, allowing us to project our products and deliberations onto the world network. In spite of all this change and

development activity, dealing with the core business of the NRA has not suffered. Indeed, the timeframes for evaluation of applications have

improved and waiting lists have generally reduced. The product managers have had to balance the needs of the core business with these

parallel processes and have succeeded admirably under difficult circumstances. Organisational support staff have had to deal with structures that seem to have

been changing for years. Their tolerance and success is appreciated. The support of Federal Parliament in the gestation of the NRA through

the Senate Report and in its birth through legislation has been most constructive. The encouragement and commitment of the responsible

Ministers, initially the Hon. Simon Crean, MP and more recently Senator the Hon. Bob Collins, has been most helpful. We now look forward to similar

support from those States still to pass complementary legislation so that the NRA will have its full range of powers under the National Registration System

by 1 January 1995.

Ben Selinger FTS Chair

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Chapter 1 Corporate overview

National Registration Authority 30 June 1994

Board of Directors Chair Professor Ben Selinger

Deputy Chair Dr Barbara Wilson Board members Mr Peter Bailey Mr Don Burke Mr Garry Goucher

Mr Hermann Mani Mr Douglas McGuffog Ms Renata Musolino

Chief Executive Officer Mr Leo Devin

National Registration Manager Mr Gregory Hooper

Business Administration Section Mr Barry Sandison Manager

Agricultural Registration Section Dr Ron Eichner Manager

Corporate Affairs Section Mr Phil Goodsell Manager

Veterinary Registration Section Dr Trevor Doust Manager

Special Projects Section Dr John Owusu Manager

Compliance Section Mr Stephen McDonald Manager

Existing Chemicals Review Section Ms Jeanine Crovvther Manager

Fig 1:

NRA organisational structure as at 30 June 1994

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The National Registration Authority

Mission The mission of the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) is:

i to establish an efficient

and cost-effective national registration regime fo r agricultural and veterinary chemical^ that will protect the

health and safety o f people and the environment, and enhance the domestic and export market potential o f Australia’s

agricultural and livestock . industries. J

Structure The NRA is a small statutory authority, employing 60 people as at 30 June 1994. It is managed by a Chief

Executive Officer who is responsible to the Board of Directors. A National Registration Manager directs the operations of the Agricultural and

Veterinary Registration Sections and the Existing Chemicals Review Section. The Business Administration, Corporate Affairs and Special Projects

Sections report to the Chief Executive Officer. (Fig 1)

How the NRA was established The formal regulation of agricultural and veterinary chemicals is currently a

responsibility of the States and Territories.

Since the early 1960s, the Commonwealth, under the aegis of the then Australian Agricultural Council, has coordinated a national approach to

the assessment and clearance of selected classes of agricultural and veterinary chemical products. At the Special Premiers’

Conference, held in October 1990, registration of agricultural and veterinary' chemicals was identified as an area where regulation should be

reviewed. In July 1991, the Commonwealth, State and Territory Ministers responsible for agricultural issues

decided to establish a National Registration Scheme. Under the arrangements agreed to, the Commonwealth would be responsible

for the registration of agricultural and veterinary chemicals up to the point of retail sale, with the States and

Territories responsible for control of use. For efficiency reasons, it was agreed that the monitoring of products in the marketplace — to ensure that

they are registered and labelled in accordance with the conditions of registration — would be undertaken by the States and Territories on behalf of

the Commonwealth. Recognising that legislation to give effect to this decision would take time, Commonwealth, State and Territory

Ministers entered into an interim formal agreement that provided for the Commonwealth to progressively take

over all registration functions except the issuing of formal registration certificates.

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In August 1992, the Commonwealth announced that it would establish a National Registration Authority for Agricultural and Veterinary Chemicals

(NRA) to undertake all registration activities, with associated policy issues being the responsibility of the Department of Primary Industries and Energy.

Legislation to establish the NRA received Royal Assent on 24 December 1992 and came into effect on 15 June 1993.

The NRA was provided with the powers and functions of the Australian Agricultural and Veterinary Chemicals Council which it replaced. The NRA will receive its full powers, and the

National Registration Scheme will commence, on a date to be agreed when the Commonwealth passes a package of bills for agricultural and veterinary chemicals, and the States and Territories pass complementary legislation. The commencement date is likely to be 1 January 1995.

Minister The NRA exists within the Primary Industries and Energy Portfolio. Senator the Hon. Bob Collins was appointed Minister for Primary Industries and Energy on 22 December

1993, replacing the Hon. Simon Cl ean, MP.

Board of Directors The NRA’s focus and strategic direction are determined by a Board of Directors, as provided for under the Agricultural

and Veterinary Chemicals (Administration) Act 1992.

The Board comprises one part-time Chair and seven part-time Directors. The Chairman of the Board is Ben Selinger, Professor of Chemistry at the Australian National University.

Directors have been selected for their experience in the regulation of agricultural and veterinary chemicals at the State Government level; the agricultural and veterinary chemicals industry; the rural sector; the trade union movement, and consumer

interests. The Minister appointed the inaugural Board members for a term of three years from 15 June 1993. Two Board appointments changed during the year. Mr Barry Buffier resigned on 31 August 1993 and Mr Ian Champion on 10 September 1993, being replaced on 8 December 1993 by Mr Peter Bailey and Mr Hermann Mani respectively.

The Board held six meetings during the year: 21 July 1993 (Canberra)

6-7 September 1993 (Canberra) 22-23 November 1993 (Sydney) 1-2 February 1994 (Wagga Wagga) 14-15 March 1994 (Canberra)

17-18 May 1994 (Canberra)

Membership of the NRA Board is shown on page 5.

Chair Directors

Professor Ben Selinger Department of Chemistry Australian National University Canberra, ACT

Deputy Chair

Dr Barbara Wilson Group General Manager (Agriculture) Department of Primary

Industries Adelaide, SA

Mr Peter Bailey General Manager Resource Protection and Standards

Department of Agriculture Melbourne, VIC

Mr Don Burke Managing Director CTC Productions Pty Ltd Kenthurst, NSW

Mr Garry Goucher Director of Policy National Farmers’ Federation Canberra, ACT

Mr Hermann Mani Managing Director Ciba Australia Ltd Pendle Hill, NSW

Mr Douglas McGuifog Managing Director McGuffog and Co, Pty Ltd Brisbane, QLD

Ms Renata Musolino OH&S Coordinator Australian Council of Trade- Unions

Melbourne, VIC

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The NRA at work The NRA assesses the agricultural and veterinary chemicals proposed by companies for supply and use in Australia. It puts the product data

through a rigorous evaluation process to ensure that they meet appropriate standards of quality, safety and efficacy and have no adverse impact on trade or the environment.

Only after this rigorous assessment process, will an agricultural or veterinary chemical be cleared for registration and entry' onto the Australian market. Changes to existing

products, including their labelling, must also be approved and where necessary, new information submitted to support the changes requested. The registration process is similar to those operating in other countries and there is a regular exchange of information at an international level.

The assessment process takes full account of the nature of the product, the amount of data for review and the extent of consultation required between the NRA, manufacturers, advisory agencies and the States or Territories. Assessments against these criteria may take several months to complete in the case of new products, whereas assessments of variations to products already on the market may be completed more quickly.

Registration of agricultural and veterinary chemicals Assessment carried out by the NRA’s scientific and veterinary' personnel involves scrutiny of extensive data associated with the product. Residues studies on crops and animals are

assessed in order to establish a Maximum Residue Limit (MRL) and withholding period (WHP). The recommendations for using the product are checked to see that they are consistent with data provided and labelling is examined to ensure it is accurate and meets Commonwealth and State legislative requirements.

During the evaluation process, the NRA liaises with the applicant on any technical issues or areas of concern. For specialist advice during the assessment process, the NRA obtains input from three Commonwealth agencies — the Chemicals Safety Unit of the Department of Human Services and Health (CSU), the Commonwealth Environment Protection Agency

(CEPA) and Worksafe Australia. The CSU evaluates toxicology data submitted by applicants to assess any health risk which may be posed to the community.

CEPA’s role is to evaluate data on the likely environmental implications and recommend measures to avoid or minimise adverse environmental effects of agricultural and veterinary chemicals.

Worksafe Australia conducts occupational health and safety' assessments to ensure that any risks arising out of potential worker exposure to agricultural and veterinary chemical products are minimised.

At some stages of the assessment process, there may be consultation with the States and Territories, other Commonwealth agencies and a range of expert panels or committees that provide advice to the NRA. This process ensures that appropriate knowledge

and experience are incorporated into the assessment process. Prior to the clearing of products containing new active ingredients,

Public Release Summaries are published to notify the community that the product is under assessment; to offer further information, and to invite comment which is taken into account before final decisions are made.

When the assessment is complete, the product will be either cleared for registration, or rejected. In many cases, the NRA proposes amendments to the

product label as a requirement of clearance. Until Commonwealth and State/Territory legislation comes into

operation (early 1995), the formal registration of agricultural and veterinary chemical products is a responsibility of the States and

Territories.

Fig 2: A summary of the registration process for

agricultural and veterinary chemicals

Compliance and surveillance After registration, products are subject to ongoing scrutiny under compliance and surveillance arrangements

undertaken on behalf of the NRA by

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the States and Territories. Surveillance involves inspections of premises that store or supply agricultural and veterinary chemicals to check that products and labels are registered; that the container is approved; that correct information is on the product label and associated literature; that it is stored correctly, and when necessary, that it carries a visible

expiry date, batch number and date of manufacture. Compliance involves testing of product formulations to ensure that they meet approved standards.

Specialist Programs Although the assessment of agricultural and veterinary7 chemicals is the NRA’s core business, a number of other

programs are being developed for implementation in 1994-95. An Existing Chemicals Review Program will be developed to re-assess chemicals that were registered several years ago, to ensure that they meet

contemporary quality, health, safety and environmental standards. A Minor Use Program will look at chemicals used on minor crops such as horticulture and aquaculture and to encourage the development of efficacy and residue data.

During the year, the NRA commenced the development of a program that will enable the public to report any adverse effects of agricultural and veterinary chemical products. This program — the Suspected Adverse Product Experience program — will commence in late

1994. A Technical Grade Active

Constituent Program will look at the quality of the active ingredients used in product formulations to ensure that, if manufacturing sources of these change, the quality will not be compromised.

Consultation The NRA places a high priority on communication with various stakeholders involved in the National Registration Scheme. It operates or participates in a number of consultative forums on issues relating to agricultural and veterinary chemicals and products. These consultative mechanisms make an important contribution to the development of key programs and priorities.

At Commonwealth level, the Interagency Coordination Committee provides a forum for the NRA, the Chemicals Safety Unit, the Commonwealth Environmental Protection Agency and Worksafe Australia to focus on priorities and

resource allocation issues. At Commonwealth/State level, the Registration Liaison Committee provides a mechanism for the coordination of the respective functions and responsibilities of the Commonwealth and States/Territories. At this committee, the States and Territories also report on the operation and effectiveness of the Compliance Program.

The Agricultural Chemicals Consultative Committee provides a forum on registration issues for the NRA, the Commonwealth agencies and

the agricultural chemicals industry. The agricultural chemicals industry relies on participation by Avcare Ltd (the

Highlights of the year

National Association for Crop Protection and Animal Health) the Aerosol Association of Australia Inc, the Swimming Pool and Spa Association of

Australia and other bodies associated with agricultural chemicals registration. The Veterinary Chemicals Consultative Committee provides a consultative forum for the NRA, the

Commonwealth agencies and the veterinary medicines industry. Representation includes Avcare Ltd, the Veterinary Manufacturers and

Distributors Association, the Australian Veterinary Association and other bodies associated with veterinary chemicals registration.

The Industry Liaison Committee is the broadly based industry committee that meets to discuss fees for the cost recovery program and other policy

issues. During the year, work commenced on the establishment of a Community Consultative Committee, consistent with the NRA’s desire to seek

community advice on registration and public information issues.

Commitment The NRA is committed to the continuous improvement of the systems

used to register agricultural and veterinary chemicals and to the harmonisation of regulatory processes with key agencies in the field.

• · · The NRA conducted a major review and public inquiry into organochlorine insecticides from September to December 1993, at the request of the Agricultural and Resource Management Council of Australia and New Zealand

(ARMCANZ). As a result of an open public inquiry' and extensive consultation with the industry, and Commonwealth, State and Territory

governments, the NRA recommended that all organochlorines be phased out of the Australian market by June 1995. ARMCANZ accepted the NRA's

recommendation but agreed that the phase-out in the Northern Territory'be delayed until 1987.

• · · Following a period of public consultation, the NRA completed its assessment of Porcine Somatotropin (PST), a naturally occuring protein that can be genetically engineered for use in

pork production. PST was approved for registration in October 1993 and the product can now be supplied to the

Australian market.

• · · The NRA made significant progress towards developing its stated commitment to a more open, and transparent decision-making process

for regulating agricultural and veterinary chemicals in Australia. A t example has been the high level of public consultation undertaken in each

stage of the development of an Existing Chemicals Review Program (ECRP). The ECRP will allow all interested parties such as the public, industry, the

States and specialist agencies the opportunity' to nominate products and chemicals for review'.

Highlights of the year (continued)

• · · New publications were introduced to inform clients and stakeholders about NRA issues. Public Release Summaries were introduced to notify the public about chemical products under assessment, offer more information and invite comments for consideration in the decision-making process. A newsletter, NRA News was introduced to share information with stakeholders, and a specialised

Agricultural and Veterinary Chemicals Gazette was established to carry notifications of new products cleared for registration and changes to the clearance conditions of existing

registered products.

• · · The NRA held a seminar, ‘Working with the NRA’ to enhance the working relationships between applicants and the Authority.

• · · Significant progress was made in developing a national compliance and surveillance plan involving the NRA in partnership with all States and Territories. When fully implemented, it will provide an improved national picture of the quality of agricultural and veterinary chemicals, their labelling and associated advertising.

• · · Substantial progress was made towards consolidating and updating the NRA’s product registrant databases in preparation for the commencement of the National Registration Scheme in January 1995.

• · · Interim cost recovery legislation was introduced, allowing the NRA to ensure that the Government-set target of 83 per cent industrv funding in

1994— 95 is achieved.

• · · The num ber of assessments completed for agricultural and veterinary chemicals improved significantly during the year as a result

of improved processes and work practices.

• · · The NRA’s first Corporate Plan was developed, setting out the vision and objectives for the peiiod 1994— 95 to 1996-97. The first Annual

Operational Plan was also finalised, setting out the specific activities that will be undertaken in 1994— 95.

• · · Accrual accounting was successfully introduced.

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Chapter 2 Program reports

Program reports

Program structure The XRA operates within four program areas: • Executive Program

• ( hemicals Registration Program • Compliance Program • Corporate Services Program

Executive Program The Executive Program provides for the overall management of the NRA. It undertakes strategic planning and

development; plans and initiates corporate activities; manages the allocation of resources; develops and oversees the NRA’s human resources

management strategy and ensures that corporate systems and processes are in place to enable staff to do their jobs

well and to ensure accountability. It also provides for appropriate quality control procedures to underpin continuous improvement.

The Executive Program coordinates the NRA’s three operational programs:

Chemicals Registration Program The Chemicals Registration Program represents the core business of the NRA, It works to ensure that the

process of evaluating agricultural and veterinary chemicals and clearance for registration is rigorous and professional, as well as accountable and

transparent. It also undertakes the reassessment of existing products through the Chemicals Review Program.

Compliance Program The Compliance Program addresses the concerns of clients and stakeholders and ensures that

agricultural and veterinary chemical Fig 3: NRA products available to consumers are Program formulated and labelled in accordance structure with conditions of registration.

Corporate Services Program The Corporate Services Program provides efficient and cost-effective administrative and management

support services to clients, stakeholders and other functional units within the Authority itself. The program comprises two functional areas: Business

Administration and Corporate Affairs.

Program 1 Executive

Objective ‘to ensure the NRA fulfils its mission by jnoviding, within policies established by the Board, effective strategic leadership

and overall management. ’

Description The Executive Program provides strategic leadership and overall management of the NRA within policies determined by the Board. The Program focuses on the efficiency, effectiveness and integrity of the NRA’s operations; the development of the NRA’s people and external relationships; and on the NRA’s ability to meet current and future challenges in carrying out its mission.

The Chief Executive Officer, who is accountable to the Board for the performance of the NRA, undertakes this Program with the assistance of senior managers and the Special Projects Section.

Goals • Develop and manage a world-class agricultural and veterinary chemical registration system which includes

open, transparent, rigorous and accountable decision-making processes • Promote international awareness of

the integrity of Australia’s agricultural and veterinary chemicals registration system • Ensure that Australia meets its

international obligations through contributing effectively to international policy-setting and decision-making on agricultural and veterinary chemical standards and practices

• Provide for effective communication with external stakeholders • Develop the NRA’s people and

provide a safe and fulfilling work environment

Activities and performance The Chairman’s Report and the ‘Highlights of the Year’ in the preceding sections of the Report, and the detailed reports that follow this section, identify a range of activities and outcomes achieved in this first year of operation of the NRA. In addition to those mentioned elsewhere, there are a number of items worthy of note.

This initial rear has been a time of developing the organisational infrastructure to support the new registration and regulatory system expected to come into operation in January 1995, while at the same time

coping with the demands of operating the existing system An important step in the life of the NRA was the development, through extensive involvement of the staff and

the Board, of a Statement of Purpose. This statement includes a set of aspirations and values as to how the NRA’s mission should be pursued and fulfilled.

New planning and budgetary systems have been put in place leading to the preparation of the 1994-95 to 1996-97 Corporate Plan and the 1994-95 Annual Operational Plan. These systems trill be progressively strengthened and improved to service

the NRA well in future years. The impending move to recovery of costs from industry in 1994-95 also made

necessary the development of new procedures and systems in preparation for that event. In relation to the new National

Registration Scheme, considerable effort has been expended in working with the relevant areas of the Department of Primary Industries and

Energy in ensuring that the interests of the NRA are reflected in the new legislation. As well, much work has been done in developing effective working relationships with the other

Commonwealth agencies involved in the Scheme and also in defining and developing relationships with the States and Territories.

SUBPROGRAM 1.1

Special Projects • · ·

Objective ‘to investigate developments and approaches which could improve the effectiveness and technical efficiency of

the framework for the registration of agricultural and veterinary chemical products. '

Description The Special Projects Subprogram undertakes policy research and advises the other functional areas of the NRA,

particularly the Executive, on technical and non-technical issues relating to the regulation of agricultural and veterinary chemicals.

It also monitors and analyses domestic and international policy trends and issues through contact with other Commonwealth and State

government agencies, industry, international regulatory authorities, other NRA stakeholders and through appropriate representation in domestic

and international forums. This Subprogram is carried out by the Special Projects Section.

Goals • Initiate development of the Suspected Adverse Product Experience Program

• Initiate development of a program to license manufacturers of veterinary chemical products • Commence development of policies

and suategies for international collaboration • Develop strategies for the regulation of chemicals used in aquaculture

• Develop strategies that will minimise chemical residues at injection sites • Represent the NRA at international forums

• Redesign the NRA’s Requirements Manual to make it more user- friendly

Performance indicators • Substantial progress in the development of the Suspected Adverse Product Experience

scheme • Development of an implementation plan for the licensing of

manufacturers of chemical products • Positive progress towards collaboration with international regulatory agencies • Develop a framework for the

regulation of chemicals used in aquaculture • Prepare a report recommending measures to minimise chemical

residues at injection sites • The NRA’s interests adequately represented at international forums and its policy positions communicated • Draft revised Requirements Manual

to be prepared byjuly 1994

Activities and performance Suspected Adverse Product Experience Program The Suspected Adverse Product Experience (SAFE) program was developed during the reporting period to provide members of the public, farmers, animal owners, veterinarians and others with a comprehensive national reporting system and database for recording suspected adverse experiences involving registered

agricultural and veterinary chemical products. A ‘adverse product experience’ is any unexpected effect involving target or non-target plants and animals, human beings or the environment, that may be associated with an agricultural or veterinary product.

Manufacturers of agricultural and veterinary chemical products are obliged under current and proposed legislation to report all suspected adverse

experiences with their products to the NRA. The SAFE program vdll collect information on adverse experiences reported by professional users of agricultural and veterinary chemical products, such as veterinarians, and from the general public.

During the year, the NRA completed an implementation plan and draft reporting procedures in consultation with major stakeholders. The program will be implemented in

late 1994.

Licensing of manufacturers of chemical products Under the National Registration legislation, the NRA will be required to license the manufacturers of agricultural and veterinary chemical products.

The first step will be to license the manufacturers of veterinary chemical products, based on the concept of Good Manufacturing Practice (GMP). Licensing of agricultural chemical product manufacturers will be introduced at a later stage.

At year’s end a draft report outlining the essential elements of the licensing scheme had been completed.

International collaboration Collaboration with New Zealand

The NRA Board has agreed to explore opportunities for working cooperatively with New Zealand on the regulation of agricultural and veterinary chemicals,

and where possible, to minimise duplication of effort and draw upon the overall expertise within the two countries.

The Board has identified labelling of aerosols, adverse drug experience reporting, licensing of manufacturers of agricultural and veterinary chemical products, data requirements for

registration and the review of existing chemicals as areas with potential for closer cooperation and harmonisation. To establish a firm basis for

cooperation between Australia and New Zealand, three meetings have been held between NRA staff and their New Zealand counterparts.

Considerable progress has been made in the areas of aerosol labelling, adverse drug experience reporting and licensing of manufacturers.

Other International Collaboration Negotiations are continuing with the USA, UK, Canada and other countries to achieve collaboration on the

evaluation of veterinary drugs.

Codex Committee on Residues of Veterinary Drugs in Food

The NRA is represented on the Australian delegation to the Codex Committee on Residues of Veterinary Drugs in Food (CCR\T)F) and

continues to provide briefings on, and contribute to the development o f Australia’s position on these and other

Codex issues. At the CCRVDF meeting in June 1994 for example, Australia was successful in having Porcine Somatotropin (PST), Cypermethrin and Alphacypermethrin nominated for evaluation at the July 1996 meeting of

the CCRVDF.

Aquaculture Progress in this area has been limited because there are few identifiable national or State aquaculture organisations. NRA contact with the

industry has so far focused on Tasmanian salmon growers. The NRA is developing better links with the industry through the Aquaculture Cooperative Research

Centre (a new research organisation dedicated to solving some of the technical issues facing the industry) and the Animal Health Committee on Fish

Diseases. A meeting with both the chemical and aquaculture industries is planned for early 1995 to determine priorities

and consider the most effective way of registering products. Meanwhile, the NRA is reviewing the Codex Code of Good Practice for Aquaculture for its possible adoption by the industry.

Based on risk analysis, the NRA has classified chemical products used in aquaculture into five categories and developed a framework to regulate

their use. The categories are: • products exempt from registration requirements; • products required to be registered

but which do not require the establishment of Maximum Residue Limits (MRLs);

• products required to be registered with MRLs; • prohibited products, and • products with insufficient data for

decision-making. These categories will be used as a basis for developing appropriate

procedures for controlling the use of chemicals in aquaculture.

Implications of residues at injection sites Residue studies, both in Australia and overseas, have indicated that some injectable antimicrobial products persist at the injection site longer than

the approved withholding period. Although these residues are unlikely to cause any human health problems, their presence does have implications for overseas trade.

A working party has been established to investigate this issue and a report, drafted during the year, is expected to be available in August

1994.

Requirements manual The task of redesigning the Requirements Manual to make it more user-friendly has proved more complex

than originally anticipated and the original deadline ofjuly 1994 will not be met.

o

Program 2 Chemicals registration

Objective ‘to ensure that the evaluation and registration process [or agricultural and ve term ms chemicals is rigorous and professional, as well as accountable, often

mul transparent. ’

Description Before agricultural and veterinary chemical products can be sold or used in Australia, they must be assessed and cleared for registration by the NRA.

I he Chemicals Registration Program provides for the rigorous evaluation of submissions from companies intending to market new or modified agricultural or veterinary chemical products.

In January 1994, Public Release Summaries were introduced for products containing new active ingredients. Through advertisements in the major metropolitan newspapers in each State and Territory, the NRA now informs the community about products under evaluation and their proposed use, offers an information package and invites comment. Each submission from a member of the public receives a reply and the submissions are taken into account before a decision is made on the clearance of the product for registration.

Arrangements for reassessing products under the Existing Chemicals Rev iew Program are now being developed.

At 30 June 1994, the Chemicals Registration Program consisted of three Subprograms: Agricultural Chemicals Registration, Veterinary Chemicals

Registration and the Existing Chemicals Review Program.

SUBPROGRAM 2.1

Agricultural Chemicals Registration • · ·

Objective ‘to serve as the national focal point for the assessment and registration of new and existing agricultural chemical products, and ensure that the processes for evaluating the safety, efficacy and

quality of products are rigorous and earned out within agreed timeframes. ’

Description The Agricultural Chemicals Registration Subprogram conducts and coordinates detailed evaluations of new

chemicals and changes to existing chemical products ensuring the safety, efficacy and quality of these products. It also provides technical and policy

advice on chemicals registration issues to industry, the Government and the public. The Agricultural Chemicals Registration Section has responsibility

for this Subprogram.

Goals • Conduct assessment of submissions within agreed timeframes • Develop and foster liaison with

clients and stakeholders • Increase the capabilities of staff through team building, personal and professional development,

improving processes and quality assurance • Contribute to the development and implementation of new guidelines,

databases and legislation

• Integrate the operations of the two Sections involved in the assessment of agricultural chemical products

Performance indicators • Number of product submissions completed • Number of submissions evaluated

within agreed timeframes • Feedback from clients and stakeholders • Improving the content of and use of

the Agricultural Issues database and the National Chemical Registration Information System (NCRIS) • Provision of timely advice • Enhanced capacity and capability' of the Section’s officers.

Activities and performance The Agricultural Registration Section and the Image Product Section were amalgamated in October 1993 to form

the Agricultural Registration Section, in a move to streamline activities, reduce duplication and maintain consistency' in assessing products for registration.

From 1 July 1993 until 30 June 1994, the Section received 797 submissions for evaluation. These submissions included:

— new chemical entities (including approvals for commercial trials of some of these new chemicals); — new products; — major extensions of use for

existing registered products; and — minor technical and administrative changes to existing registered products. A record 635 submissions were processed to completion, and about 90

per cent of submissions received front

November 1993 were processed within the required timeframes. This contrasts with performance during the first part of the year, when about 30 per cent of submissions were processed within the agreed time frames. The improvement in throughput can be attributed to improved processes and work practices that w'ere introduced when the Agricultural Chemicals Registration Section was created.

Improvement in the mechanics of registration, combined with a contribution to and implementation of new' databases, has achieved an increased capacity and capability.

The Section continued to liaise with agencies in Australia and overseas during the year as part of its continuing work in improving the registration

process. A num ber of key guideline documents w'ere developed to an advanced stage, including:

• Agricultural Chemical Products Labelling Code • Registration Requirements for Biopesticides • The National Permits System

During the year, the Section also took on a range of new functions: including file creation; receipting monies for application fees; entering new applications into the NCRIS database; providing the above functions for the TGAC program; and participating as a member of the National Drugs and Poisons Committee.

Consultation with clients and stakeholders was a high priority'. Meetings were held with representatives of agricultural and related chemical

industries, grower organisations, and a range of State and Commonwealth government groups to seek their views on the services provided and the technical and scientific issues associated with the registration process.

Feedback from various clients and stakeholders has. in general, been very favourable. Individuals have provided comment both orally and in writing

and this is contributing to an environment where officers within the Section, through recognition and feedback, are achieving professional

satisfaction in their work.

Veterinary Chemicals Registration s e e

Objective ‘to serve as the national focal point Jor the assessment and registration of new and existing veterinary chemical products, and ensure that the processes for evaluating the safety, efficacy and

quality of products are rigorous and carried out within legislative timeframes. ’

Description The Veterinary Chemicals Registration Subprogram is carried out by the Veterinary Chemicals Registration Section.

The Section conducts and coordinates detailed evaluations of new and existing chemical products ensuring the safety', efficacy and quality

of those products. It also issues import and export certificates and provides technical and policy advice on veterinary registration issues to

industry, government and the public.

Goals • Maintain the num ber of submissions awaiting evaluation below 70 • Conduct assessment of submissions

within agreed timeframes • Develop subprogram infrastructure and write efficacy and target animal guidelines

• Develop and foster liaison with clients and stakeholders • Increase the capabilities of staff through team building and

personal and professional development

S U B P R O G R A M 2 .2

• Develop veterinary chemical and policy databases

Performance indicators • Maintenance of the num ber of submissions awaiting evaluation below 70

• Completion of product submission within the agreed timeframes • Positive feedback from clients and stakeholders • Completion of efficacy and target

animal guidelines by due date • Number of import and export certificates issued • Improvement of submissions quality

before evaluation

Activities and performance Between 1 July 1993 and 30 June 1994, the Section received 608 new product and existing product submissions. At 1 July 1993, the Section

had 602 products under evaluation. In the period 1 July 1993 to 30 June 1994, 370 product submissions were cleared and 141 were rejected, withdrawn or deactivated. The Section completed 76 per cent of clearances within the agreed timeframes.

The Section issued 36 certificates of import under the Customs (Prohibited Imports) Regulation 5H Item 3A — (anabolic, androgenic and growth hormone substances), and 94 certificates of export (free sale certificates). All import and export certificates were issued within the agreed timeframes.

In April 1994, the Veterinary Section also took over file creation, receipting of application fees and database entry from the Business

Administration Section. Considerable restructuring of processing functions have resulted in improved procedures and quality assurance of file handling.

Introduction of a coarse prescreen now enables deficiencies in product submissions to be identified at an earlv stage. This has contributed to an improvement in the qualitv of product applications and has improved

processing times. To assist clients, the Section revised the Code of Labelling Practice for Veterinary Chemical Products in consultation with the State regulatory authorities and industry. A ‘Questions and Answers' booklet was prepared to enhance the information package given to prospective applicants.

Efficacy and target animals safety guidelines hat e been completed on the following topics to assist applicants conducting clinical research trials: • Companion Animals

Ectoparasiticides • Therapeutic Pet Food Diets • Enzymes • Direct Fed Microbials • Ovine Lousicides • Sheep Blowfly • Melaleuca Oil products

The Section has also investigated the potential to deregulate the requirement for certain categories of stockfoods and stockfoods additives to be registered by the NRA. Certain conditions regarding inclusion levels, impurities and labelling trill still applv.

Categories that may not require NRA registration following implementation of the Agricultural and Veterinary Chemicals Code Act 1994 are:

• Stockfoods • Stockfood ingredients • Vitam in/m ineral/am ino acids in stockfoods at normal nutritional

levels

• Medicated stockfoods • Medicated premixes • Non-medicated blocks and licks • ( Colour intensifiers for avian birds.

Feedback from the agricultural and veterinary chemical industry was generally complimentary regarding both technical and policy advice and

processing times. Work on the Veterinary Chemical and Policy i databases commenced and, at year’s end. was progressing well to meet the

October 1994 completion date.

Chemicals Review • · ·

Objective ‘to assess the quality of active ingredients used in agricultural chemical products; to review existing agricultural and veterinary

chemical products to ens ure their safety and effectiveness in their intended use; and to develop a minor use program so that chemical products are availablefor

use in crof> and animal species to facilitate emerging agricultural enterprises. ’

Description The Chemicals Review Subprogram is responsible for the development, implementation and management of

two key initiatives of the National Registration Scheme: the Existing Chemicals Review Program (ECRP) and the Minor Use Program (MUP).

It operates an Ad Hoc Review Program which assesses whether any chemical product identified as not meeting contemporary standards of safety and use should be withdrawn

from sale. The Subprogram also undertakes evaluation and assessment of the active constituents of chemical products under the Technical Grade Active Constituent (TGAC) program.

The Subprogram is carried out by the Chemicals Review Section.

Goals • Make substantial progress towards developing the ECRP and MUP Programs • Review chemicals identified under

the Ad Hoc Review Program • Approve quality TGACs for use in registered agricultural products

S U B P RO GR AM 2 .3

Performance indicators • Acceptance by the NRA Board of the ECRP outline, completion of the initial phases of the Program’s

development and the obtaining of public comment on the Program • Completion and acceptance of a program outline and

implementation schedule for the MUP • Progress towards completing the re­ assessment and re-evaluation of

chemicals nominated for ad hoc review and progress in withdrawing designated chemicals • Completion of assessments of older

TGAC submissions lodged before the commencement of the National Registration Scheme • Significant progress towards

establishing a new TGAC program for agricultural products consistent with the requirements of the National Registration Scheme legislation

Activities and performance Existing Chemicals Review Program (ECRP) The ECRP is being established to reassess previously registered chemicals for continued use in the light of current standards.

During the year, a framework for the Program was developed in conjunction with relevant Commonwealth agencies. Consultation with community groups and industry on the Program’s framework was also undertaken.

The NRA Board accepted an outline of the Program at its meeting in November 1993.

Three brochures were distributed nationally to obtain industry and community input to the proposed review process and selection criteria.

Notices seeking comment on the Program were inserted in metropolitan daily newspapers and the rural press. As a result of the large interest in the Program generated by the notices, the deadline for written comment was extended to August 1994.

Further public consultation meetings are planned for next year to facilitate additional discttssion on the details of the Program.

Minor Use Program (MUP) The Minor Use Program was developed during the year to address situations where the cost of providing data to support product registration is not economicallyjustifiable in relation to the value of chemical sales. This applies to the registration of chemical products associated with small and specialised industries such as exotic fruits, nuts, and alpaca and emu production. The Program will encourage the generation of data necessary to obtain approvals to use the desired chemicals in small or emerging industries of this type.

An outline and implementation schedule for the Minor Use Program was completed by 30 June 1994 following consultation with industry. Further development of the scope of the Program and the composition of a coordinating committee to provide technical advice and to determine funding priorities was agreed to by the

NRA Board.

Ad Hoc Review Program The initial locus of the Ad I loc Review Program is to establish an NRA protocol for reconsideration and

withdrawal < > 1 clearances a n d /o r registration of agricultural and veterinary chemicals. The protocol was i under development at year’s end.

In February 1994, the Board agreed to revoke clearances for mercury (except in sugar cane), promecarb and fenaminosulf.

Technical Grade Active Constituent Program (TGAC) The TGAC ’ ■ Program is aimed at ensuring that only active ingredients of acceptable quality arc incorporated into

registered agricultural products. During the year, the focus was on improving and upgrading operational systems for evaluating TGAGs. A new database was established containing tt]> I to-date information on the status of I applications and approvals.

A preliminary plan for a new TGAC Program to operate under the new National Registration legislation was being prepared at year’s end and a register of approved TGAGs sources was

being finalised.

Program 3 Compliance

Objective ‘to respond to issues of concern to clients and stakeholders and ensure that agricultural and veterinary chemical products in the market place are formulated and labelled in accordance

with the registered conditions. ’

Description Compliance refers to the enforcement of regulations and registration

standards of agricultural and veterinary chemicals. It is directed at quality of product, accurate labelling, correct advertising, storage and packaging.

The Compliance Program ensures that agricultural and veterinary chemicals meet the standards required by the NRA by providing regulatory, technical and financial support to the States and Territories and by negotiating and liaising with the chemical industry to develop innovative solutions to non-compliance.

The Compliance Section, formed in early 1994, is responsible for the development, implementation and coordination of the Program.

Goals • To finalise the development of the National Compliance Program • To provide national reporting of

compliance activities funded by the NRA and undertaken by the States and Territories • To proride national coordination of compliance activities • To assist in the development of the Agricultural and Veterinary Chemicals Regulations

Performance indicators • Draft agreement for provision of compliance sendees and funding prepared for consideration by State

and Territory departments • Increased uniformity in reporting of activities • Draft inspector’s procedures

prepared for discussion • Effective coordination of State/Territory activities

Activities and performance Development of the National Compliance Program

A draft State/Territory — NRA Agreement for Compliance and the draft Inspector’s Procedural Manual were developed during the year and submitted

to the Registration Liaison Committee (RLC) in May 1994. This represents a significant step in the development of the National Compliance Program.

Compliance agreement The draft Compliance Agreement covers the provision of surveillance, formulation monitoring and analytical services as well as the funding and

reporting arrangements associated with these activities. The draft Agreement was submitted to State and Territory departments in June 1994 for their consideration. A model operational plan will be developed for further consideration by the RLC in late 1994.

Procedural manual for inspectors During the year, a procedural manual was developed for inspectors who undertake surveillance and testing

Table 1: Violations in supply, labelling and advertising of agricultural

and veterinary chemicals

N o te : S e v e ra l v io la tio n s

m a y b e d e a lt w ith

t h r o u g h o n e a c tio n ,

s u c h as a w a r n in g le tte r,

activities on behalf of the NRA. The project required extensive consultation to determine the correct legal and scientific methods for undertaking sampling of products and correcting

non-compliance. The manual, to be published in 1994— 95, will ensure that authorised officers employed by the States and Territories approach

enforcement and compliance on behalf of the NRA in a fair and uniform way.

Training During the reporting year, the Section provided initial training on the operation of the Compliance Program and the interim reporting scheme to staff of the States/Territories. The

training introduced procedures that ! encourage a uniform national approach to compliance activities.

Reporting of State and Territory compliance activities The NRA provided funding for individual State and Territory

compliance programs during the year. The funding was provided specifically to support the current surveillance activities of the States and Territories,

assist government laboratories in developing testing methods, and in achieving accreditation with the National Association of Testing

Analysts. The surveillance programs resulted in 1083 violations being detected nationally during 3348 inspections of premises storing or supplying agricultural and veterinary chemicals.

Premises inspected included those of manufacturers, wholesalers, retail plant nurseries, retail pet suppliers, swimming pool accessory suppliers and

ship chandlers. The violations detected fell into categories detailed in Table 1.

In addition to the surveillance activities, some States undertook sampling and testing programs to determine the quality of products in

the marketplace against approved standards. Fifty-three products were tested and 22 failed to meet one or more of the registration standards.

Uniformity in reporting The compliance activities to be reported and a uniform format for reporting were agreed between the NRA and the

States and Territories during the year. When introduced in July 1994, this reporting scheme will provide detailed

information about violations and allow the NRA to report information back to the States and Territories and initiate appropriate action.

National activities Diazinon The Compliance Section responded to a request from the Registration liaison Committee to undertake a marketplace survey of liquid diazinon products. The request arose from concerns that dog

and cattle deaths had occurred after using diazinon formulations suspected of containing toxic breakdown products.

The Section designed, implemented and coordinated a program in which State and Territory staff took samples in the marketplace and the NSW Agriculture Laboratory at Rydalmere,

NSW analysed 159 samples from 57 products. Test results showed that liquid diazinon products required the addition of stabilisers to prevent the breakdown of the diazinon into toxic products.

Water initiates the breakdown of diazinon. A report, prepared in January 1994 contained recommendations for adding stabilisers and providing

warnings about water contamination. Labels of diazinon products used on companion animals notv warn against allotting water to enter the container.

Provision of advice State and Territory activities included the surveillance of premises to detect products that do not comply with State and Territory requirements as well as undertaking the testing of some products. The Section responded to

185 State and Territory inquiries regarding the clearance status of products. The Section has referred or directly dealt with 24 complaints from

the industry. These complaints ranged from the importation of unapproved Technical Grade Active Constituents (TGACs) to the sale of unregistered products, and advertising that did not comply with legislation.

Program 4 Corporate services

Objective Ίο pnndde efficient, cost-effective and client-focused management and administrative sendees to the functional

areas of the \ R \ , its clients and stakeholders. '

Description The Program comprises two Subprograms that support the operations of the NRA and assist it in

meeting its statutory requirements. These are Business Administration and Corporate Affairs.

SUBPROGRAM 4. 1

Business Administration • · · Objective

Ίο provide efficenl and effective human resources, financial and information technologs; sendees to the staff of the NRA. ’

Description The Business Administration Section provides human resource, finance and information technology services, advice

and support to all functional areas of the NRA. Under the guidance of the Executive Program, the Section is responsible for: • Human resources, planning,

management of recruitment, remuneration, staff training, Equal Employment Opportunity, Occupational Health and Safety and

industrial democracy; • Financial management, planning, processing and reporting of

expenditure and revenue, including managing funding arrangements for the three Commonwealth agencies (the Commonwealth Environment Protection Agency, Worksafe Australia and the

Department of Human Services and Health’s Chemicals Safety Unit) that undertake some of the NRA’s specialist assessment services. • Information technology

development, maintenance and support of the Authority’s IAN and corporate information systems including purchase of software,

hardware and consumables.

Performance indicators Human resources • Establish an in-house Human Resources Unit • Establish formal policies and

procedures relating to terms and conditions of employment • Ensure compliance with legislative requirements including the

establishment of Equal Employment, Occupational Health and Safety, Industrial Democracy and Human Resources policies

Financial management • Establish an accrual accounting system for the NRA • Establish an audit and finance

committee • Develop cost recovery arrangements • Clearance of the 1992-93 Financial Statements by the Australian

National Audit Office (ANAO)

Information technology • Transfer and establish the IT platform in the NRA’s new premises with minimal disruption to services

• Develop and implement the Application Tracking System • Improve the national database of registered agricultural and veterinary

chemical products (NCRIS)

Activities and performance In consultation with staff, a review of activities was undertaken in late 1993 to identify a number of possible approaches to the provision of corporate support services. The NRA subsequently adopted new processes which will: introduce higher level advice to senior managers and the

Board; allow- for transfer of full personnel and payroll activities from the Department of Primary Industries and Energy; and, eliminate duplication of functions.

Human resource management Recruitment and selection The NRA established a Human Resource Unit and, in April 1994, appointed a Human Resources Manager.

Recruitment of professional officers for the registration sections of the organisation was a priority throughout the year. The recruitment of temporary employees was another major activity which enabled the NRA to create more

flexibility in the working environment during the organisation’s transition and to enable specific activities to be developed and implemented, without the requirement to commit permanent resources.

As part of establishing the NRA, a number of officers were outposted from the Department of Human Services and Health and will become part of the NRA’s permanent establishment in 1994-95.

Human Resource Development (HRD) Consultants were engaged to develop the following programs: • Human Resource Management

Plan

• Equal Employment Opportunity Program • Salary- Structure review, and • Merit Based pay

Development of these Programs was well underway at year’s end and they will be finalised during 1994-95.

All of these Programs have been developed according to requirements under Section 74(2) of the Agricultural and Veterinary Chemicals (Administration)

Act 1992.

Training and development

At the XRA. training and development is considered fundamental to building a fully functional, professional organisation.

Throughout the year, staff attended a range of training and development activities which largely concentrated on individual skills development. Administrative funds totalling S72.233 were expended on training. This is

equivalent to 3.13 per cent of the NRA's salary budget.

Performance pay In accordance with the APS Section 134C Agreement, performance pay

became available to staff at the Senior Officer level as part of the inaugural performance appraisal cycle. The table below details the numbers of eligible staff and the aggregate amounts of

performance pay made.

Equal Employment Opportunity The XRA has adopted the EEO policy of the Department of Primary

Industries and Energy until its own policy is finalised.

The draft EEO policy is currently being prepared and will be implemented during 1994— 95, following consultation with staff. The NRA is committed to EEO

as an integral part of management and ensures that all decisions relating to employment are based on merit.

The NRA fosters a work environment that enables employees to work in an atmosphere free from discrimination. The NRA’s EEO

performance is monitored through reviews, and staffing and employment practices are updated as required.

While corporate responsibility for the effective management of EEO lies with the Human Resource Manager, all staff are responsible for supporting and

promoting the principles and practices of EEO in the workplace. The NRA’s EEO statistics are at Appendix B.

Occupational Health and Safety (OH&S)

The NRA is committed to developing and maintaining a healthy and safe working environment. In order to address the

requirements of the Occupational Health and Safety (Commonwealth Employment) Act 1991, the following statements are provided:

Number of eligible staff Aggregate amount paid

Senior Officer Grade A and equivalent 4 16 000

Senior Officer Grade B and equivalent 4 16 000

Senior Officer Grade C and equivalent 9 13 500

Table 2: Senior Officer performance

pay by group

o

r

Health and safety policy: The NRA is currently developing an occupational health and safety policy in accordance with the requirements of the Act. The policy will focus on actions being taken to ensure the NRA meets its obligations to provide healthy and safe working conditions for its employees.

In the interim, where applicable, the NRA has applied principles consistent with OH&S policies in place within the Department of Primary Industries and

Energy.

Occupational Health and Safety Agreement: At 30 June 1994, a draft agreement was being prepared for distribution to staff and the unions for

their comment. The NRA's OH&S agreement will be finalised once full consultation has taken place with staff and their unions.

Statistics on reportable incidents: During 1993-94, one employee retired on the grounds of invalidity. Four reports of injury were received covering stress, Occupational Overuse Syndrome and back strain.

New reporting regulations will take effect with the introduction of the NRA’s Occupational Health and Safety agreement.

Numbers of investigations: No OH&-S investigations were conducted within the NRA during the year.

Employee Assistance Program.

The NRA has an agreement with an independent contractor to provide counselling services for staff. This body offers counselling for personal and professional matters. A number of staff have used this service over the year for issues such as financial management, stress management, personal matters and rehabilitation.

Industrial democracy At the NRA, staff are consulted on all major work-related issues. During the year, staff took part in working groups

on accommodation, work place bargaining and merit based pay. Fortnightly staff meetings continue to provide an opportunity to discuss issues and propose new ideas. A suggestions box is also used to put forward items for discussion.

Formal consultation between the Chief Executive Officer and union representatives occurs on a regular basis.

Financial management The Finance Unit operated on an accrual accounting basis in 1993-94, incorporating the introduction of a computerised accounting system.

The NRA’s financial results for 1993-94 are set out in the Financial Statements on page 39. The 1992-93 Financial Statements were audited by the Australian National Audit Office. An Audit and Finance

Committee was established in September 1993 to oversee the NRA’s financial reporting processes. Preliminary administrative arrangements were in place at

Chemicals Evaluation: 2%

Compliance: 19%

Salaries: 46%

Depreciation: 2%

Consultants: 4%

POE: 9%

Administrative expenses: 11%

ΓΤ Services: 6%

Training: 1%

Salaries — $3 072 000 Administrative expenses — $705 000 Training — $94 000 IT Services — $399 000

POE — $614 000

Consultants — $229 000 Depreciation — $128 000 Compliance — $1 267 000 Chemicals Evaluation — $133 000

30 June 1994, to implement the Government’s decision to introduce an interim cost recovery program for the registration of agricultural and

veterinary chemicals.

Revenue The NRA was fully funded by Commonwealth Parliamentary appropriation, totalling $7,222,000, for

1993-94. A further $166,341 was received in general revenue including 580,000 from the Canberra Institute of Technology to compensate for an

earlier than expected move from premises in the Hotel Kurrajong, and interest of $51,854. The sum of SI ,497,000 was generated by the NRA through

application fees for new chemical Fig 4: products and paid into the Operating costs

Consolidated Revenue Fund. Legislation enabling the recovery of costs from industry was passed through the Commonwealth Parliament, receiving Royal Assent on 21 June 1994, and will

take effect in the new financial year.

Expenditure Operating costs for the period were $6,640,777. For more information, refer to Financial Statements at page 39.

Accommodation Following negiotiations with the Canberra Institute of Technology, the

NRA relocated its offices from temporary accommodation in the

Hotel Kurrajong to occupy the greater part of the first floor in the nearby Industry House. A five-year lease agreement will be settled in 1994— 95.

Insurance

Early in the year, the NRA purchased compr ehensive insurance cover including professional indemnity, directors’ and officers’ liability and an asset replacement policy. To ensure that this cover was appropriate, a tender process was used to select a private sector insurance broker to review the NRA’s insurances. The recommendations of the review will be incorporated into the existing cover.

There was one minor insurance claim settled during the year, for accidental damage to computer equipment.

Market surveys and advertising

During the year, the NRA spent $66,706 on non-campaign print media advertising. This covered recruitment advertising and public notices to inform the community about agricultural and veterinary products under assessment

by the NRA. No payments were made to advertising agencies, market research or polling organisations.

Direct mail services were restricted to handling charges for packaging of a newsletter, brochures and letters, at a total cost of $649.

Consultants The NRA continues to rely, as far as possible, upon its own resources to undertake its functions. Where resources were not available in-house to undertake specialist projects and it was

more cost effective to do so, the NRA engaged consultants via a tender and contract process. Total expenditure on consultants for the reporting year was $229,261.

During 1993-94, the major consultants contracted to the NRA were:-Arthur Andersen Accounting services and operational

review KPMG Corporate and operational plans Ernst and Young Review of resources (final payment only) Richard Oliver Pty Ltd Insurance review Jackson Wells Communications

Communication facilitation Walter Beilin Mission and vision statements development Price Waterhouse

Information technology review The ASK Group Development of an Automated Tracking System (ATS)

For more information about consultancies, please contact: The Accountant Telephone: (06) 272 3158

Information technology Information technolog)7 services were successfully transferred from the Hotel Kurrajong to the NRA’s new location in

Industry House in October 1993. The NRA’s current environment uses several Local Area Networks (LANs) connected to IBM compatible PC’s installed with the MS-DOS Operating System and a Microsoft

Windows Graphical User Interface. The primary LAN provides gateway access to a Facilities Managed UNIX host sy stem run for the NRA by the

Information Technology Sendees Bureau of the Department of Primary Industries and Energy. This host supports the NRA’s

National Chemicals Registration and Information System (NCRIS). It also supports the product Application Tracking System (ATS) used by the

registration sections of the NRA. The outsourced bureau services include the integrated Voice Data platform on which all NRA networking depends.

Communications gateway sendees were introduced to the IAN and these features will be used in 1994— 95 to support AARNET and other services,

including access to the National library and a range of international information sources.

Development of the National Chemicals Registration System Lists of registered agricultural and

veterinary chemical products held in the States and Territories were merged | during the year to create the National ! Chemicals Registration Information

System (NCRIS). [tine 1994 saw the early launch of the new product Application Tracking , Sy stem, linked to the NCRIS database.

This system monitors the progress of product applications through the | NRA’s assessment program. At year’s end, NCRIS had been

.1 further developed to take on a range of files m anagement functions. A major project was undertaken to incorporate extensive data on

registered agricultural and veterinaiy chemical products, including details of active constituent chemicals, uses,

packsizes and poison schedules. The extensive development of NCRIS, rvhich yvas substantially completed by 30 June, enables the secure and confidential storage of data and the ability to retrieve accurate and

up-to-date information. In October 1994, NCRIS will be linked to the accrual accounting system.

SUBPROGRAM 4.2

Corporate Affairs s e e

Objective ‘to Josler and enhance the NRA’s effectiveness and its corporate reputation by providing excellence in servicing its corporate needs and in ensuring that the NRA meets its corporate responsibilities. ’

Description This Subprogram, undertaken by the Corporate Services Section, ensures that the NRA’s corporate responsibilities are met; its statutory powers are implemented fairly and consistently; and that it conveys a

positive public image of the NRA as a responsible regulator. The Section provides secretariat services to the Board and its committees and promotes effective communication with Directors, committee members, NRA staff, key agencies and other stakeholders. It also coordinates the NRA’s corporate planning and reporting functions and responds to legal issues including interpretation of

relevant legislation and Freedom of Information inquiries.

Goals • Coordinate corporate business and services to the NRA Board and its committees • Prepare NRA business plans and

reports

• Provide sound and timely information and legal advice and develop an awareness of the new legislative environment • Under the guidance of the

Executive, establish a forum for the

NRA to consult with community groups • Establish and produce an NRA newsletter and the Agricultural and

Veterinary Chemicals Gazette

Performance indicators • Delivery of effective corporate services to the NRA Board and committees including high quality

business papers, efficient arrangements for meetings, accurate and timely reporting of outcomes • Completion of Corporate and

Operational Plans for submission to the Minister for approval • Provision of sound and timely legal advice • Holding the inaugural meeting of

the NRA’s Community Consultative Committee • Publication of a NRA Newsletter and an Agricultural and Veterinary

Chemicals Gazette in accordance with publication schedules and ongoing feedback from clients

Activities and performance Secretariat services The Section delivered a comprehensive range of corporate and secretariat services to the NRA Board, which met on six occasions in 1993-94.

During the year, Secretariat support was also given to the Registration Liaison Committee (three meetings); the Interagency Coordination Committee (six meetings); the Veterinary Chemicals Consultative

Committee (two meetings) and the Agricultural Chemicals Consultative Committee (one meeting).

The establishment of an NRA Community Consultative Committee (C.CC) was raised during consultations with consumer and environmental groups on the proposed National

Registration legislation.

At its fourth meeting, in November 1993, the Board agreed to establish a joint community liaison sub-committee with the Agricultural and Veterinary

Chemicals Policv Committee — a committee of the Agricultural and Resources Management Council of Australia and New Zealand.

There was a delay in determining the membership of the joint consultative committee and the inaugural meeting of the NRA’s

Community Consultative Committee could not be achieved within the reporting year. The committee will now meet early in 1994— 95.

Corporate planning During the reporting period, the NRA developed its first Corporate Plan covering the period 1994— 95 to

1996-97, and a draft Operational Plan for 1994— 95. Preparation of the plans followed an evaluation of the NRA’s operations since its establishment, an analysis of likely

developments in the agricultural and veterinary chemicals industry, and an assessment of the strategic directions the NRA should take.

The Corporate Plan and draft Annual Operational Plan were prepared for submission to the Minister for Primary Industries and Energy for his approval.

Legal services The NRA has responsibility for administering a range of legislation dealing with the Commonwealth’s agricultural and veterinary chemical

regulatory responsibilities. Specific legal advice was provided or obtained on a variety of matters affecting the operation of the assessment and

clearance process for agricultural and veterinary' chemicals. The NRA’s obligations under administrative and

corporations law were also discharged. A program to increase staff understanding and appreciation of the new National Registration legislation

provisions was agreed to by the Board. During the year, the NRA provided advice on the drafting and promulgation of the package of

National Registration legislation w'hich, when enacted, will provide the NRA with its full range of powers over registration and compliance. A

comprehensive guide to NRA legislation is at Appendix A.

Communications During 1993-94, the NRA established a monthly newsletter, NRA News, which is now distributed to all stakeholders. It carries information about the work of

the NRA and includes comment on a range of Australian and international agricultural and veterinary chemical issues.

In )une 1994, the NRA introduced a specialised Agricultural and Veterinary Chemicals Gazelle. The Gazette carries notifications of new products that have been cleared for registration and advice

on changes to the clearance conditions of existing registered products.

Financial Statements

AUSTRALIAN NATIONAL AUDIT OFFICE

Centenary House 19 National Crt Barton ACT 2600

Independent Audit Report [To the Minister for Primary Industries and Energy

Scope I have audited the financial statements of die National Registration Authority for Agricultural and Veterinary Chemicals for the year ended 30 June 1994. The statements comprise:

[· Statement of Financial Position • Operating Statement • Statement of Cash Flows • Notes to and forming part of the Financial Statements, and • Statement bv Directors

The Directors of the Authority are responsible for the preparation and presentation of the financial statements and the information contained therein. I have conducted an independent audit of the financial statements in order to express an opinion on them to the Minister for Primary' Industries and Energy.

The audit has been conducted in accordance with Australian National Audit Office Auditing Standards, which incorporate the Australian Auditing Standards, to proricle reasonable assurance as to whether the financial statements are free of material misstatement. Audit procedures included examination, on a test basis, of evidence

suppolling the amounts and other disclosures in the financial statements, and the evaluation of accounting policies and significant accounting estimates. These procedures have been undertaken to form an opinion of whether, in all material respects, the financial statements arc presented fairly and in accordance with Australian

accounting concepts and standards and statutory7 requirements so as to present a view which is consistent with my understanding of the Authority’s financial position, the results of its operation and its cash flows.

The audit opinion expressed in this report has been formed on the above basis.

Audit Opinion In accordance with sub-section 63H (2) of the Audit Act 1901, I now report that the statements are in agr eement with the accounts and records of the Authority, and in my opinion:

(i) the statements are based on proper accounts and records (ii) the statements show7 fairly in accordance with Statements of Accounting Concepts and applicable Accounting Standards the financial transactions and cash flows for the year ended 30 June 1994 and the state of affairs of the Authority' as at 30 June 1994

(ii) the receipt, expenditure and investment of moneys, and the acquisition and disposal of assets, by the Authority during the period have been in accordance with the Agricultural and Veterinary Chemicals (Administration) Act 1992, and (iv) the statements are in accordance with tire Guidelines for Financial Statements of Public

Authorities and Commercial Activities.

D.S. Lennie Executive Director Australian National Audit Office Canberra

27 September .1994 GPO Box 7 0 7 Canberra Australian Capital Territory 2 6 0 1 Telephone (06) 2 0 3 7 3 0 0 Facsimile (06) 2 0 3 7 7 7 7

National Registration Authority for Agricultural and Veterinary Chemicals

Statement by the Board of Directors

In accordance with a resolution of the Board of the National Registration Authority for Agricultural and Veterinary Chemicals, we state that:

1. In the opinion of the Directors:

(a) the operating statement shows fairly the operating result of the Authority from 1 July 1993 to 30 June 1994;

(b) the statement of financial position shows fairly the financial position of the Authority as at 30 June 1994; and,

(c) the statement of cashflows shows fairly the Authority’s cash flow from 1 July 1993 to 30June 1994.

2. The Board members are not aware of any circumstances that have arisen since the end of the financial year that would have affected the determination of an amount or item in the accounts for the year ended 30 June 1994.

3. The financial statements of the Authority have been prepared in accordance with the Guidelines for Financial Statements of Public Authorities and Commercial Activities which require compliance with Statements of Accounting Concepts and Australian Accounting Standards.

On behalf of the Board, this 28th day of September, 1994

Ben Selinger Douglas McGuffog

Chairman Director

Operating Statement for the year ended 30 June 1994

National Registration Authority for Agricultural and Veterinary Chemicals

Note 1994 1993

$ $

COST OF SERVICES

Operating Expenses Communications 110,794 3,688

Compliance Expenses 1,266,878 —

Computer Supplies & Services 398,788 150

Consultants 229,261 17,690

Depreciation 127,505 4,499

Efficacy 133,000 —

Office Supplies & Services 172,719 1,971

Property Operating Costs 614,510 226

Publications 96,381 —

Staffing Costs 3,166,197 101,734

Sundry 132,558 1,321

Travel 192,186 1,266

Total Operating Expenses 6,640,777 132,545

Operating Revenues from independent sources Interest Received 51,854 —

Other Revenue 3(b) 34,487 2,632

Total Operating Revenues from independent sources 86,341 2,632

Net Cost of Services 6,554,436 129,913

REVENUE FROM GOVERNMENT Parliamentary Appropriations Received 7,222,000 200,000

Supplementary Funding 80,000 —

Total Revenue from Government 7,302,000 200,000

Operating Result 2 747,564 70,087

Accumulated operating results at beginning of financial year 70,087 —

Accumulated operating results at end of financial year $817,651 $ 70,087

The accompanying notes form an integral part of the financial statements. Ο

National Registration Authority for Agricultural and Veterinary Chemicals

Statement of Financial Position as at 30 June 1994

Note 1994

$

1991 1

CURRENT ASSETS Cash 4 966,544 237,41-

Receivables 5 26.798 46.75(

Other 6 52,646 71.19;

Total Current Assets $1,045,988 $ 355,361

NON-CURRENT ASSETS Property, Plant and Equipment 7 297,612 240,571:

Total Non-Current Assets $297,612 $ 240,572

Total Assets $1,343,600 $ 595,932

CURRENT LIABILITIES Creditors 8 145,105 207,945

Provisions 9 196,891 399,169

Total Current Liabilities $341,996 $607,114

NON-CURRENT LIABILITIES Provisions 9 306,901 41,679

Total Non-Current Liabilities $ 306,901 $ 41,679

Total Liabilities $ 648,897 $ 648,793

NET ASSETS $ 694,703 $(52,861)

EQUITY Capital (122,948) (122,948)

Accumulated operating results 817,651 70,087

TOTAL EQUITY $ 694,703 $ (52,861)

o The accompanying notes fonn an integral pail of the financial statements.

National Registration Authority for Agricultural and Veterinary Chemicals

Statement of Cash Flows for the year ended 30 June 1994

Note 1994 1993

$ $

CASH FLOWS FROM OPERATING ACTIVITIES

Inflows: Parliamentary Appropriations 7,222,000 200,000

Supplementary Funding 80,000 —

Interest Received 46,252 —

Other Receipts 81,237 51,100

7,429,489 251,100

Outflows: Staffing Costs 3,166,790

Payments to Suppliers and Creditors 3,368,251

6,535,041 13,685

Net cash provided by operating activities 10 894,448 237,415

CASH FLOWS FROM INVESTING ACTIVITIES

Payments, for property, plant & equipment 165,319 —

Net increase in cash held 729,129 237,415

Cash at beginning of period 237,415 —

Cash at end of period 966,544 237,415

The accompanying notes form an integral part of the financial statements. o

National Registration Authority for Agricultural and Veterinary Chemicals

Notes to and forming part of the Financial Statements for the year ended 30 June 1994

1. STATEMENT OF SIGNIFICANT ACCOUNTING POLICIES

1.1 Basis of Accounting

The financial statements have been made out in accordance with the Guidelines for Financial Statements of Public Authorities and Commercial Activities issued by die Department of Finance in January 1994. The financial statements confonn with

Statements of Accounting Standards and Concepts issued by the Institute of Chartered Accountants in Australia and the Australian Society of Certified Practising Accountants. The Authority fully employs accrual accounting principles.

The accounts have been prepared in accordance with the historical cost convention, except for certain assets which are at valuation. Unless odierwise indicated, all amounts are expressed in Australian currency.

1.2 Prior Year

For comparative purposes, the Authority commenced operations on 15 June 1993.

1.3 Property, Plant and Equipment

Transfer of Assets Property', plant and equipment was transferred from the Department of Primary Industries and Energy to the Authority on its establishment on 15June 1993. They were valued at the cost of acquisition at that date.

Subsequent Acquisition of Assets All acquisitions of assets are accounted for at cost. Cost is detennined as die fair value of the assets at date of acquisition plus costs incidental to the acquisition. Assets costing $2,000 or greater are capitalised, whereas items under $2,000 are

expensed under the relevant expense category in the year of acquisition.

Depreciation Depreciation is provided on a straight line basis on all property, plant and equipment, at rates calculated to allocate die cost or valuation of those assets over their estimated useful lives.

1.4 Leases

Leases of noncurrent assets, where substantially all the tisk and benefits of ownership remain with the lessor, are classified as operating leases. Operating lease payments are charged as expenses in the period in which they are incurred.

National Registration Authority For Agricultural and Veterinary Chemicals

Notes to and forming part of the Financial Statements for the year ended 30 June 1994

1.5 Employee Entitlements

Provision is made for employees’ long service leave and recreational leave entitlements.

Long Service I .eave Long service leave is provided for those employees with 5 years or more service.

Employees become entitied to long service leave following 10 years service.

Annual Leave Annual leave is provided for those employees who have an entidement at balance date.

1.6 Insurance

The Authority has taken out commercial insurance to cover a wide range of risks to the Authority's property and public liability. The Authority’s workers compensation insurance is provided through Comcare.

1.7 Taxation

The Authority is exempt from income tax by virtue of Section 67 of its enabling legislation. Consequently no provision has been made for income tax.

However it is subject to fringe benefits tax and sales tax.

1.8 Segment Reporting

Industry Segment The Audvority’s activities relate to one industry segment being agricultural and veterinary chemicals.

Geographical Segment The Authority operates in Australia and is therefore one geographical area for reporting purposes.

1.9 Cash For the putposes of the statement of cash flows, cash includes cash on hand, cash at bank, and the Authority’s Salaries Trust Account which are readily available for use in the day-to-day operations. The Authority’s cash at the end of the financial vear is shown within the Statement of Cash Flows.

Notes to and forming part of the Financial Statements for the year ended 30 June 1994

National Registration Authority for Agricultural and Veterinary Chemicals

1994 1993

$ $

2. OPERATING RESULT Operating result of $747,564 (1993 - $70,087) has been determined:

(a) after crediting Parliamentary Appropriation 7,222,000 200,000

Supplementary Funding 80.000 —

Interest received or due and receivable 51,854 —

Resources provided free of charge — 2,632

(b) after charging Salaries and wages, including the salary of the officer referred to in Note 3(a) 2,943,091 77,534

Depreciation 127,505 4,499

Amounts set aside to provisions for employee benefits 62,944 5,344

3. (a) RESOURCES PROVIDED BY THE DEPARTMENT OF PRIMARY INDUSTRIES AND ENERGY The salary payments for 1993 include the salary of one officer allocated by DPIE to provide executive support to the Authority. — 2,632

(b) OTHER REVENUE Resources of DPIE officer — 2632

Reimbursement of Administration Expenses 28,415 —

Gains on Sales of Assets 3,005

Information Seminars Revenue 2,500 —

Sundry Revenue 567 —

$34,487 $ 2,632

CASH Cash at Bank 930,849 57,415

Cash on Hand 2,408 —

Salaries Trust Account 33,287 180.000

$966,544 $237,415

RECEIVABLES — CURRENT Trade Debtors 20,935 —

Other Debtors 5,863 46,750

$ 26,798 $ 46,750

OTHER ASSETS — CURRENT Prepaid expenses $ 52,646 $71,195

Notes to and forming part of the Financial Statements for the year ended 30 June 1994

National Registration Authority for Agricultural and Veterinary Chemicals

1994 1993

$ $

PROPERTY, PLANT AND EQUIPMENT Computer Equipment — at cost 306,030 189,009

Accumulated Depreciation (112,748) (4,025)

193,282 184,984

Office Equipment — at cost 92,418 56,062

Accumulated Depreciation (17,489) (474)

74,929 55,588

Furniture & Fittings — at cost 31,168 —

Accumulated Depreciation (1,767) —

29,401 —

Total Property, Plant and Equipment, net $297,612 $240,572

CREDITORS Trade Creditors 3,475 7,064

Other Creditors 2,886 —

Moneys held on behalf of the Commonwealth Government — 51,100

Accrued Expenses 138.744 149,781

$145,105 $207,945

PROVISIONS Employee Entitlements Current Liability Provision — Long Service Leave 34,100 179,003

Provision — Annual Leave 162,791 220.166

$196,891 $399,169

Non-Current Liability Provision — Long Service Leave $306,901 $ 41,679

Notes to and forming part of the Financial Statements for the year ended 30 June 1994

National Registration Authority for Agricultural and Veterinary Chemicals

1994 $

10. RECONCILIATION OF OPERATING RESULT WITH CASH FLOWS FROM OPERATIONS Operating result before abnormal and extraordinary items 747,564

Depreciation 127,505

Changes in assets and liabilities (Increase) decrease in debtors and accrued revenue 19,952 (Increase) decrease in prepaid expenses 18,549

(Decrease) increase in creditors and accrued expenses. (82,066) (Decrease) increase in provisions: 62,944

Net cash from operating activities $894,448

11. CONTINGENCIES The Authority is not aware of any contingencies requiring disclosure at balance date.

12. COMMITMENTS Purchasing Commitments Payable within 12 months 64,487

Finance Lease Commitment Payable — within 12 months 10,000

after 1 year, but within 2 years 5,000

Operating Lease Commitment Payable — within 12 months 17,016

after 1 year, but within 2 years 17,016

after 2 years, but within 5 years 13,204

later than 5 years —

1993 $

70,087 4,499

157,485 5,344

$237,415

240,508

$126,723 $240,508

National Registration Authority for Agricultural and Veterinary Chemicals

Notes to and forming part of the Financial Statements for the year ended 30 June 1994

13. REMUNERATION OF BOARD MEMBERS During the year amounts received or due and receivable by the Board of the Authority totalled $99,777 (1993 $3,487). No member of the Board has received, or become entitied to receive, a material benefit by way of contract made by the

Authority with a member of the Board or with an organisation in which he or she is a member, takes part in the management of its affairs or has a substantial interest. Board members of the Authority are as follows: Professor Ben Selinger

Doctor Barbara Wilson Mr Douglas McGuffog Ms Renata Musolino Mr Don Burke Mr Peter Bailey

Mr Hermann Mani Mr Garry Goucher Mr Barry Buffier Mr Ian Ghampion

Chairman Deputy Chairman Appointed 15.6.93 Appointed 15.6.93

Appointed 15.6.93 Appointed 15.6.93 Appointed 15.6.93 Appointed 8.12.93

Appointed 8.12.93 Appointed 15.6.93 Resigned 31.8.93 Resigned 10.9.93

In addition, the Authority paid the Australian National University to enable the university to employ a part-time lecturer and release the Chairman to assist with the promoting of the Authority during its establishment period. The Chairman continued to receive remuneration from the University during this period.

14. REMUNERATION OF EXECUTIVES There was one executive of the Authority who received, or became entitied to receive, remuneration during the financial year above $100,000. The executive received remuneration of $118,024 and performance pay of $10,000.

15. SUPERANNUATION COMMITMENTS The Authority contributes to both the Commonwealth Superannuation Scheme and the Public Sector Superannuation Scheme administered by die Australian Retirement Benefits Office for employee benefits relating to superannuation.

Respective contribution rates are 12.4% (PSS) and 20% (CSS) of salary, in addition to the 2% to 5% contribution under the Superannuation (Productivity) Act.

In compliance with the Superannuation Guarantee (Administration) Act 1992, the Authority also contributes 5% of salary to AGEST on behalf of all temporary employees. During the year the Authority made contributions totalling $51,109 (1993 $12,408).

16. AUDITOR’S REMUNERATION The financial statements include an amount payable for audit services in auditing the financial statements, amounting to $18,000 (1993 — Nil).

17. POST BALANCE DATE EVENTS Since the end of the financial year the Authority has entered into a contract for $201,888, being for fitout of its premises.

Appendixes

Appendix A Legislation

Legislative background In Juh 1991, the Commonwealth, States and Territories agreed to establish the National Registration Scheme for agricultural and veterinary chemicals.

Currently, the Commonwealth is responsible for the scientific evaluation of agricultural and veterinary chemicals and clearing for registration those

products that meet acceptable , standards. The States and Territories are responsible for registration, and control of use of these chemicals.

Under the new Scheme, to be fully | operational in early 1995, the Commonwealth will be responsible for registration and control of agricultural

and veterinary chemicals up to the point of retail sale. The States and Territories will have responsibility for control-of-use activities, such as licensing of pest control operators and aerial spraying.

In assuming its responsibilities under the Scheme, the Commonwealth established the N’RA on 15 June 1993, following implementation of the Agricultural and Veterinary Chemicals

(Administration) Act 1992. At the same time, the existing legislative structure, the Agricultural and Veterinary Chemicals Act 19HH, was amended to transfer the powers and functions of the outgoing Australian Agricultural and Veterinary Chemicals

Council to the NRA. The operation of the 1988 Act was extended by the Primary Industries and Energy legislation Amendment Act 1994 until 30 June 1996.

To give effect to the National Registration Scheme, a package of legislation was passed by Parliament on 1 March 1994. The package consists of

seven Commonwealth Bills, three of which deal with the registration activities and fovtr that relate to registration fees and charges. The

legislation contains the detailed operational provisions for registering chemical products and prorides the NRA with its full range of powers.

The National Registration Scheme trill be in place when a majority of the States and Territories, to include New South Wales, have enacted complementary legislation to effect the

operational legislation in each State. This is expected to take place early in 1995.

Legislation A gricultural a n d V eterinary C hem icals A ct 1 9 8 8 [No. 91 of 1988] This Act, which commenced on 1 July

1989, establishes procedures for a uniform system of evaluating agricultural and veterinary chemical products to ascertain their suitability for use in Australia. When it is satisfied that the chemical product will not result in any unacceptable risk to people, the environment or Australia’s agricultural export trade, and that the product is effective for its permitted uses and accurately described, the regulatory authority may issue the product with a clearance enabling it to be registered

in the States and Territories for particular uses.

Agricultural an d V eterinary C hem icals A m en d m en t A c t 1 9 9 2 [No. 263 of 1992] This Act also came into effect on

15 June 1993 and amends the 1988 Act by transferring the powers and functions

of the NRA’s predecessor — the Australian Agricultural and Veterinary Chemicals Council — to the NRA.

Agricultural and Veterinary C hem icals (Adm inistration) A ct 1992 [No. 262 of 1992] This Act, which came into effect on

15June 1993, establishes the NRA to undertake the Commonwealth’s responsibilities under the National Registration Scheme for Agricultural and Veterinary Chemicals.

Prim ary Industries an d Energy L egislation A m en dm ent A ct 1 9 9 3 [No. 94 of 1993] This Act, which commenced on

16 December 1993, amends the 1988 Act and the 1992 Administration Act to enhance the NRA’s capacity to involve the public in determining approvals for agricultural and veterinary chemicals.

Prim ary In dustries an d Energy L egislation A m en dm ent A c t 1 9 9 4 [No. 94 of 1994] This Act, by an amendment to the 1988 Act commencing on 30 June 1994, extends the operation of the 1988 Act until 30 June 1996.

The National Registration legislation comprises the following seven Acts: — the Agricultural and Veterinary Chemicals Act 1994 [No. 36 of 1994]

— the Agricultural and Veterinary Chemicals Code Act 1994 [No. 47 of 1994] — the Agricultural and Veterinary

Chemicals (Consequential Amendments) Act 1994 [No. 37 of 1994] — the Agricultural and Veterinary

Chemical Products (Collection of I/ay) Act 1994 [No. 41 of 1994] — the Agricultural and Veterinary Chemical Products Levy Imposition

(Customs) Act 1994 [No. 39 of 1994] — the Agricultural and Veterinary Chemical Products I jay Imposition (Excise) Act 1994 [No. 38 of 1994] — the Agricultural and Veterinary

Chemical Products levy Imposition (General) Act 1994 [No. 40 of 1994]. This legislative package, expected to be operational in January 1995, will implement the National Registration Scheme and proride the NRA with its full range of powers including the detailed operational provisions for the evaluation and registration of agricultural and veterinary chemical

products, the controls over the importation, manufacture and export of chemical products, and the compliance and enforcement provisions.

The 1988 Act trill be repealed with the residual provisions relating to the functions of the NRA being incorporated in the 1992 Administration Act.

The last four Acts in the package contain the cost recovery mechanisms — in particular, the imposition, assessment and collection of a levy on sales of chemical products.

The Interim Cost Recovery legislation. comprises the following six Acts: — the Agricultural and Veterinary Chemical Products (Collection of Interim

Levy) Act 1994 [No. 71 of 1994] — the Agricultural and Veterinary Chemical Products Interim ljay Imposition (Customs) Act 1994

[No. 73 of 1994] — the Agricultural ami Veterinary Chemical Products Interim levy Imposition (Excise) Art 1994

[No. Tool 1994] — the Agricultural and Veterinary ('.hemicnl Products Interim l/iiy Imposition (General) Act 1994

| No. 74 of 1994] — the Agricultural and Veterinary (.hemteal Products (Collection ojI jury) Amendment Art 1994 [No. 72 of 1994] — the Agricultural and Veterinary

Chemical (Administration) Amendment Act 1994 [No. 76 of 1994].

This legislative package, which mostly commenced on 1 July 1994, gives effect to interim cost-recovery arrangements for the operation of the

National Registration Scheme pending the commencement of the National Registration legislation. The package provides for the imposition, assessment and collection o f an interim levy on the sale of agricultural and veterinary chemical products.

Regulations The Agricultural and Veterinary Chemicals Regulations (Statutory Rules 1989, No. 165), which came into effect on 1 Julv 1989, declared certain chemical products not to be either an agricultural or a veterinary chemical

product and set the fees payable for making applications for clearance of chemical products. The Agricultural and Veterinary

Chemicals Regulations (Amendment) (Statutory Rules 1992, No. 172), which commenced on 1 July 1992, amended the Agricultural and Veterinary

Chemicals Regulations by deleting the

schedules which had declared certain chemical products not to be either an agricultural or a veterinary chemical product.

The Agricultural and Veterinary Chemicals Regulations (Amendment) (Statutory Rules 1994, No. 216), which took effect from July 1 1994, amended the Agricultural and Veterinary ( Chemicals Regulations by providing for a new structure of fees payable when

applying for clearance of an agricultural or a veterinary chemical product. The Agricultural and Veterinary

Chemicals (Collection of Interim Levy) Regulations (Statutory Rules 1994, No. 215), which also commenced on 1 July 1994, prescribed the State laws

under which an agricultural or veterinary chemical product is registered under the Agricultural and Veterinary Chemical Products (Collection of

Interim levy) Act 1994 and set the rate of levy for the relevant calendar year.

Appendix B Staffing overview

Table 3: Staffing and EEO profile as at 30 June 1994

The NRA places a strong emphasis on its employees and realises the importance of a workplace which is

committed to employee development, consultation and well-being. In order to achieve this, the NRA has adopted an approach that will build on the high level of abilities that employees have so that these abilities can be nurtured and developed to achieve an organisation that is responsive and fully accountable.

Section 45(2) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 provides for the NRA to determine terms and conditions of employment for employees and consultants.

The Board of the NRA has determined that until such time as the NRA determines its own terms and conditions of employment, conditions wall be those of the Public Service Act

1922. Staff recruited to the NRA since its establishment have been employed on equivalent terms and conditions. A significant number of NRA staff were outposted to the Authority from

the Department of Primary Industries and Energy on its establishment in June 1993. The NRA is currently in the process of developing new terms and conditions of employment for its staff and it is expected that these will be

introduced in 1994-95.

N o te s

1. T a b le r e f e r s to p e r m a n e n t s ta f f in s u b s ta n tiv e p o s itio n s . T e m p o r a r ie s a n d c o n t r a c to r s a r e n o t in c lu d e d .

2. C la ss ific a tio n s in c lu d e s lik e c la s sific a tio n s .

3 . A T S I, N E S B , a n d D isability a r e d i e d e f i n iti o n s c o n t a in e d w ith in th e P u b lic S e rv ic e C o m m is s io n

d o c u m e n t e n t i t l e d Έ Ε Ο P r o g r a m G u id e l in e s 1 a n d 2 U p d a t e d ’.

A T S I= A b o r ig in a l o r T o r r e s S tr a i t I s la n d e r; N E S B = n o n -E n g lis h -s p e a k in g b a c k g ro u n d ;

D is a b ility ^ p e r s o n w ith a disability'.

4 . E E O in f o r m a ti o n is d e riv e d f r o m v o lu n ta r y r e s p o n s e s to a s ta f f survey.

5 . T h e R e s id u e E v a lu a tio n S e c tio n o f t h e D e p a r t m e n t o f H u m a n S e n d e e s a n d H e a l th w as o u tp o s te d

to t h e N R A in M a rc h 1994. A s t h e S e c tio n w as n o t p a r t o f d i e N R A ’s e s ta b lis h m e n t, d ie s ta ff d o

n o t a p p e a r in t h e c h a r t a b o v e .

I I Appendix C Freedom of Information

Section 8 of' the FOI Act requires each agency to publish detailed information on the wax it is organised, its powers, decisions made and arrangements for

public involvement in its work. This statement, together with the information contained in this Report is intended to meet the requirements of

the Irmhim of Information Art I 982.

Organisation and Structure The NRA operates nationally under the direction of a Board of Directors. Further details about the Board are at page 4 and an organisation chart is at

page 2. The XRA's offices are situated in Canberra; the address details can be found on page \ i.

Public Access Requests for access to documents under the I rmlom of Information Art 19X2, must be made bv writing to:

The Corporate Secretary National Registration Authority PO Box E240, Queen Victoria Terrace, ACT 2600. The power to grant or refuse access to NRA documents, including internal reviexv powers, is held by the Chief Executive Officer. Initial inquiries may be made by telephoning (06) 271 6302.

The following documents are freely axailable from the NRA on request: • Interim Requirements for the Registration of Agricultural and

Veterinary Chemicals Products, [une 1993 • Code of Practice for Labelling Agricultural Chemical Products,

first edition, October 1989

Interim Code of Practice for labelling Veterinary Chemical Products, May 1994 Code of Practice for labelling Home Garden and Domestic Pest Control Products, first edition, November 1992 National Registration Authority for Agricultural and Veterinary

( Chemicals — Inquiry into the Use of the Organochlorine Insecticides for Termite Control, 20January 1994 Guidelines for Registration of

Biological Products Guidelines for Stock Food and Stock Food Additives Requirements for Importation of Veterinary Chemicals and

Biologicals into Australia Answers to common questions from industry related to veterinary chemicals products, November 1993 Questions and Answers on Agricultural Chemical Products,

November 1993 Regulatory Control of Agricultural and Veterinary Chemicals — Questions and Ansxvers

Let’s Talk Pesticides pamphlets: — Answers to some common questions on agricultural and veterinary chemicals

— Evaluation and registration; Public Release Summaries — Porcine Somatotropin. October 1993 — Chlorsulon in the product

Ivomec-Plus Injection for Cattle, March 1994 — Metosulam in the product Eclipse Herbicide, April 1994 — Imidacloprid in the product

Confidor Insecticide, May 1994

Ministerial powers In accordance with section 10 of the enabling legislation, the Agricultural and Veterinary Chemicals (Administration) Ad

1992, the Commonwealth Minister responsible for administering the agricultural and veterinary chemicals legislation may give written directions to the NRA relating to the functions or powers which have been conferred on it under applicable State or Commonwealth laws. The NRA must comply with any such direction. During

1993-94, the Minister gave no such direction.

NRA functions and powers The NRA is responsible for regulating agricultural and veterinary chemical products proposed by companies for supply and use in Australia.

The Authority has functions and powers that are conferred upon it by the Agricultural and Veterinary Chemicals (Administration) Act 1992, the Agricultural and Veterinary Chemicals Act

1988, and by a law of a State.

The NRA’s functions are to: • grant or withdraw clearances for the registration of chemical products for use in States and Territories for

specified purposes under specified conditions; • determine the conditions to which such clearances are subject or to

vary such conditions; • obtain advice from other bodies concerning the granting or withdrawing of such clearances or

determination or variation of such conditions; • evaluate the effects of the use of chemical products in States and

Territories; • develop, in consultation with the National Health and Medical

Research Council and the National Occupational Health and Safety Commission, codes of practice, standards and guidelines for, and to recommend precautions to be taken in, use of chemical products in States and Territories; • collect, interpret, disseminate and

publish information relating to chemical products and their use; • encourage and facilitate the application and use of results of

. evaluation and testing of chemical products; • exchange information with the Authority’s overseas counterparts

relating to chemical products and their use; • report or advise the Minister, when requested by the Minister, or on its

own initiative, on any matter or issue relating to agricultural and veterinary chemicals or arising in the course of the performance of its functions; • consult with persons and

organisations concerned with chemical products and their use; • encourage and facilitate the introduction of uniform national

procedures for the control of the use of agricultural and veterinary chemical products; and • coordinate a program funded by

the NRA that is designed to ensure compliance with the laws of the States and the Territories relating to the formulation and labelling of agricultural and veterinary chemical products.

I lie NRA has power to do all that is necessan or convenient to be done in connection with the performance of its functions, which may include:

• entering into contracts; • acquiring, holding and disposing of real and personal property; • occupying, using and controlling

am land or building owned or held under lease bv the Commonwealth, a State or a Territory and made available for the purposes of the

\RA:

• appointing agents and attorneys, and acting as an agent for other persons; and • doing anything incidental to any of

its powers.

Categories of documents held by the NRA Documents and publications • 1 )ata packages provided by

registration applicants for evaluation of chemical products • Public Release Summaries • N RA brochures, newsletters and

booklets on relevant issues • Interim Requirements for the Registration of Agricultural and Veterinary Chemical Products

Files and records • Files are maintained on specific chemicals as well as on a broad range of topics relating to the

XRA's operations and functions. • The NRA also maintains agreements, protocols, criteria and guidelines on the operation of the

clearance and registration process and the development of technical data.

• Technical information in the form of individual product applications is retained by the NRA.

Decisions Meeting papers, briefs, minutes and resolutions of decisions for the NRA’s Board of Management and the various NRA committees are maintained.

Computer databases The NRA. maintains databases to store, manipulate and record product applications, to ‘track’ submissions,

product registration details, financial records, mailing lists and other information.

Card indexes and lists Some information, such as staff details, industry and stakeholders’ contact details, is stored on card indexes and

lists. Some of these documents contain confidential commercial information and may not be divulged except in accordance with the provisions of section 20 of the Agricultural and

Veterinary Chemicals Act 1988 (as amended).

Public consultation Special consideration is also given to the NRA’s consultative mechanisms with the agricultural and veterinary

chemicals industry and other relevant specialised industry sectors and community groups. The N R \ has a general policy of making itself

accessible to industry associations and community organisations and regularly invites interested parties to meet with the Board or its committees. The NRA

consults on a regular basis with a wide range of groups and organisations with relevant interests and maintains close

contact with rural and sendee industries, researchers and other government agencies with an interest in agricultural and veterinary chemicals.

Appendix D Clearance for registration statistics 1993-94

Applications under Sections 12 and 13 of the Agricultural an d V eterinary C hem icals A c t 19 8 8 .

On .SOJune 1993, a total of 1414 applications were under consideration by the NRA. These consisted of: agricultural applications 636

veterinary applications 602

technical grade active constituents 176

I ethnical grade active consititucnts (TGACs) are the commercial grade of the active constituents that come from a manufacturer before they have been formulated into an end-use product.

From 1 July 1993 until 30 June 1994 a total of 1476 applications were received for evaluation. These consisted of:

agricultural applications 797 veterinary applications 608

TC .AGs applications 70

Also during the year, 1276 approvals were made consisting of: agricultural applications 635 veterinary applications 370

approval ofTGACs 65

certificates of import (veterinary) 36

certificates of free sale/ manufacture (agriculture) 41 certificates of free sale/ manufacture (veterinary) 94

A certificate of free sale (or manufacture) is given to foreign governments to facilitate the export of agricultural and veterinary chemical

products.

There were 209 applications withdrawn by the applicant or rejected during the year, consisting of: agricultural applications 61

veterinary applications 141

TGACs applications 7

On 30 June 1994, a total of 1610 applications were under consideration bv the NRA. These consisted of: agricultural applications 737

veterinary applications 699

TGACs applications 174

Reconsideration of Clearance under Section 17 The NRA reconsidered the use of several chemicals during 1993— 94.

In November 1993, the Board made a decision to revoke registration certificates for Sulphonamides (except for Sulphadimidine,Trimethoprim and

provisionally, Sulfaquinoxaline). In February 1994, the Board made a decision to revoke certificates for Fenaminosulf, Prontecarb and Mercury

(all uses except sugar cane).

Appendix E Social justice and equity

In determining whether to clear a product for registration in the States or Territories, the NRA seeks the advice of external bodies. The key agencies providing specialist advice are: • the Chemicals Safety Unit (CSU) of

the Department of Human Senices and Health; • the Chemical Section of the Commonwealth Environment

Protection Agency (CEPA); and • the Agricultural and Veterinary Chemicals Section within Worksafe Australia.

The NRA places a high priority on establishing strong and effective working relationships with these agencies. The NRA also places a high

priority on communication with the various stakeholders involved in the National Registration Scheme. The NRA operates or participates in a number of consultative mechanisms dealing with issues relating to agricultural and veterinary chemicals.

At Commonwealth/State level, the Registration Liaison Committee provides a mechanism for the coordination of the respective functions and responsibilities of the Commonwealth and the States and Territories. This Committee also provides a focus for reporting by the States and Territories on the operation and effectiveness of the Compliance Program.

The Agricultural Chemicals Consultative Committee provides a consultative forum for the NRA, the Commonwealth agencies and the veterinary medicines industry.

Representation includes Avcare Ltd, the Veterinary Manufacturers and Distributors Association, the Aerosol

Association of Australia Inc, the Swimming Pool and Spa Association of Australia and other bodies associated with agricultural chemicals registration.

Similarly, the Veterinary Chemicals Consultative Committee provides a consultative forum for the NRA, the Commonwealth agencies and the veterinary medicines industry.

Representation includes Avcare Ltd, the Veterinary Manufacturers’ and Distributors’ Association, and the Australian Veterinary Association and

other bodies associated with veterinary chemicals registration. .The Industry Liaison Committee is the broadly based industry committee which meets to discuss fees for the cost recover)' program and other policy issues.

Given the importance of the agricultural and veterinary chemicals issues (for example, chemical residues) to Australia’s rural export industries such as beef, wool and grains, the NRA Board plans to meet annually with the Agricultural and Veterinary Chemicals

Committee of the National Farmers’ Federation. Communication with the community is a high priority for the NRA. One of the NRA’s major goals for

1994— 95 is the establishment of a Community Consultative Committee which will seek community advice on registration issues and facilitate the dissemination of accurate and timely advice on agricultural and veterinary chemicals matters.

As part of a general policy of making itself accessible, community organisations and other interested parties are regularly invited to meet with the Board or other NRA committees.

^ -

In its decision on the National Registration Scheme, the Government foreshadowed that the Scheme would provide greater opportunities for the

public to participate in the decision­ making of the NRA, and that under the Scheme more information would be made available to the public.

The NRA is now issuing a Public Release Summary (PRS) in respect of anv new chemical product with a new active ingredient. The PRS summarises

the outcome of the various assessments and the conditions the NRA proposes for the use of the product and invites comment which is considered before a

final decision is taken. The NRA is now notifVing all clearances granted in a special gazette — the Agricultural and Yeterinan Chemicals Gazelle.

Participation by EEC target groups in the work of the NRA is encouraged. The Deputy Chair of the NRA and one other Director are women. The NRA

has invited the Country Womens’ Association of Australia to nominate a member to the NRA’s Community Consultative Committee. The NRA is

also reviewing issues involved in the use of agricultural and veterinary chemicals by persons of a non-English-speaking background.

Appendix F External scrutiny

Client comments The NRA has established a number of consultative forums with its main stakeholders, where they are free to make any comments or complaints. These forums are described at page 64.

In addition, the NRA appoints a specific product manager to be responsible for each product applications submitted by clients for assessment and clearance. The product manager has the authority to address problems of complaints raised by applicants.

The National Registration legislation will, when it is proclaimed in early 1995, provide a means of receiving and responding to any complaints regarding NRA decisions in relation to the registration of a product.

Applications to the AAT The Agricultural and Veterinary Chemicals Act 1988 (as amended) provides that an applicant may apply to the Administrative Appeals Tribunal (AAT)

for a review of a decision by the NRA to grant or refuse the issue of a clearance certificate for new products or for variations to existing products. No applications regarding decisions made by the NRA were made to the AAT in

1993-94.

Inquiries by Parliamentary Committees The NRA gave evidence to the public hearing held by the Senate Standing Committee on Rural and Regional Affairs on 14 February 1994. On

3 February 1994, the Senate had referred the package of seven Bills relating to agricultural and veterinary

chemicals (the National Registration Scheme — see Appendix A) to the Standing Committee for consideration and report.

The Senate Standing Committee recommended to the Senate that the package of Bills be agreed to without amendment. The Committee further recommended that the agricultural and veterinary chemicals legislation be reviewed after 18 to 20 months of operation, addressing issues such as:

• public access to information; • cost recovery, including communin' service obligations; • third parn- appeals; and • control of use after sale.

Auditor-General’s report In accordance with sub-section 63H(2) of the Audit Act 1901, the Auditor- General reported that the audited

financial statements were in agreement with the accounts and records of the NRA.

The report covered the period from the NRA’s establishment on 15 June 1993 to 30 June 1993.

Ombudsman’s Reports The NRA was not subject to any inquiries by the Ombudsman in 1993-94.

Privacy The NRA adhered to the Information Privacy Principles as set out in the Privacy Act 1988, and was not subject to any report or determination by the Privacy Commissioner relating to its operations.

,Ί

Appendix G Information technology (ΓΓ) purchasing

Tin- NRA's IT purchasing hits been based on cost-effective implementation of open systems solutions. Most IT purchases have been made front

Common L sc Contracts with no purchase warranting the issue of a Request for Tender or the establishment of an acquisitions council.

In 1994-95, the NRA will commence development of an Information Management System, incorporating an Information

Technology Strategic Plan. The NRA's close interaction with our facilities management provider (Department of Primary Industries and

Cnergy) ensures that the IT platform remains compliant with the Government Open Systems Interconnection Profile (GOSIP).

Index of reporting requirements

Letter of transmission iii

Aids to access Table of contents V

Aphabetical index 70

Glossary' 69

Guide to the 1993-94 Annual Report

Information contact officer vi Chairman’s overview vii

Corporate overview 1

Organisation chart 2

Social justice and equity 64

EEO appointments 58

EEO Plan 30, 31

Internal and external scrutiny 66 Client comments 28, 66

Program performance reports 11 Program structure 13

Staffing overview 30, 58

Performance pay 31

Training 31

Consultants 34

Financial statements 39

Industiial Democracy 32

Occupational Health and Safety 31,32 Freedom of Information 59

Market surveys and Advertising 34

Glossary

AT Administrative Allairs NRA National Registration

Tribunal Authority for Agricultural and

ANA() Australian National Audit Veterinary Chemicals

OfTice NRS National Registration Scheme

AQIS Australian Agricultural OH&S Occupational Health and Quarantine Service Safety-

ATS Application Tracking System PRS Public Release Summary AT SI Aboriginal and Torres Strait PST Porcine Somatotropin Islanders RI.C Registration Liaison

CEPA ( lornmonwealth Environment Committee

Protection Agency SAFE Suspected Adverse Product

C.(:(: Community Consultative Experience

Committee TGAC Technical Grade Active

CCRYDF Codex Committee on Constituent

Residues of Veterinary Drugs in Food WHP Withholding Period CRIS Chemical Registration

Information System

CSV Chemical Safety Unit — Department of Health DIME Department o f Primary Industries and Energy E( :r p Existing Chemical Review

Program

EEC) Equal Employment Opportunity FOI Freedom of Information (,MAC Genetic Manipulation

Advisory Committee c;m p Good Manufacturing Practice

GOSIP Government Open System Interconnection Profile IT Information Technology IAN Local Area Network MRI. Maximum Residue Level

MUP Minor Use Program N'CRIS National Chemical Registration Information System

XESB Non-English-Speaking Background

Index

Accommodation, office, 33 accounting policies, 46 Agricultural and Veterinary Chemicals Policy Committee (AVCPC), 37 Agricultural Chemicals Consultative

Committee (ACCC), 9, 36, 64 Agricultural Chemicals Registration Subprogram, 19 annual report requirements,

compliance with, 68 applications to AAT, 66 aquaculture, 17 assets and liabilities of the NRA, 44 Ad Hoc Review Program, 25 Audit and Finance Committee, 32

audit opinion, 41 Auditor General’s report, 66 Australian Agricultural Council, 3 Australian Quarantine Inspection

Service, 7 Australian Veterinary Association, 9 Avcare Ltd (National Association for Crop Protection and Animal

Health), 9 Board of Directors, 4, 5 Budget funding, see parliamentary appropriation, 43 Business Administration, 29 Cashflows, 45 Chairman’s overview, vii Chemicals Registration Program, 19 Chemicals Review Subprogram, 23 chemical residues, at injection sites, 18 Chemicals Safety Unit, 7, 8 clearance statistics, 63 clients’ comments, 66 Code of Good Practice for

Aquaculture, 17 Code of Labelling Practice for Veterinary Chemical Products, 22 Codex Committee on Residues of

Veterinary Drugs in Food, 17

Community Consultative Committee (CCC), 9, 37 Commonwealth agencies, participating in NRS, 6, 7 Commonwealth Environment

Protection Authorin', 6, 7 Compliance Program, 26 compliance, inspections, 27 consultancy sendees, to NRA, 34 contact addresses

freedom of information, vi, 59 Corporate Affairs Subprogram, 36 Corporate and Annual Operating

Plans, 37 corporate communication, 37 corporate overview, 1 cost recovery, 32, 33 Corporate Sendees Program, 29 Department of Human Sendees and

Health, 6, 7 Department of Primary Industides and Energy, 4 diazinon, 28 documents, categories held, 61 equal employment opportunity, 31 establishment of the NRA, 3 Executive officers, 2, 58 Executive Program, 14 Existing Chemicals Review Program, 24 expenditure, 33 external scrutiny, 66 Financial management, 32 financial statements, 39 freedom of information statement, 59 functions and powers of the NRA, 60 Government Open Systems

Interconnect Profile (GOSIP), 67 Genetic Manipulation Advisory Committee (GMAC), 7 Human resources management, 30 Human Resource Development, 30 Industrial democracy, 32 information technology, 34

insurance review, 34 Inspectors' Procedural Manual, compliance, 26 Interagency Coordination Committee

(ICC), 8 international c ollaboration, 6. 17 Labelling. 6, 7. 17, 27 leases, 34, 4fi legal services, 37 Local Area Network (IAN), 34 legislation, .35 Licensing of Manufacturers of

Chemical Products, IB market surveys and advertising, 34 merit based pax . 30 mission statement, 3

Minister responsible, 4 Minor l se Program (MVP), 8, 24 Maximum Residue Limit (MRI ), 6, 7 National Registration Manager, 2, 3

National Registration Scheme, 3, 4 NRA Newsletter, 37 non-Knglish speaking background staff, 58

Occupational Health and Safety, 31 operating expenses, 43 operating result, 48 organisation chart, 2

Parliamentary appropriation, 43 performance appraisal and pax , 31 powers of the NRA, 60 Privacx. 66

program structure, 13 Public Release Summaries, 7, 19 purchasing, information technology, 67 Recruitment and selection of staff, 30 Registration Liaison Committee

(RI.C), 8 registration process, 6, 7 Registration Requirements for Biopesticides, 20

regulations, 57 remuneration of Board members, 51

remuneration of Executives, 51 Requirements manual, 18 resources, provided by DPIE, 48 revenue, 33

Salary structure review, 30 Special Projects Subprogram, 15 social justice and equity, 64 staff development and training, 31 staffing overview, 58 staff recruitment and selection, 30 staffing statistics, 58 stockfood and stockfood additives, 22

Suspected Adverse Product Experience Program, 16 Taxation, 47 Technical Grade Active Constituent

Program, 25 training, compliance inspectors, 27 travel, 43 Veterinary Chemicals Registration

Subprogram, 21 Veterinary ( Chemicals Consultative Committee (VCCC),9 Veterinary Manufacturers and

Distributors Association (VMDA), 9 Withholding Period (VVHP), 6, 7

Notes

Notes