HEALTH MONITORING PROGRAM
AGRICULTURAL AND VETERINARY CHEMICALS
Donald K Anton
Environmental Defender’s Office Ltd
Level 9, 89 York Street
Sydney NSW 2000
tel: +61 2 9262 6989 -- fax: +61 2 9262 6998
email: email@example.com -- internet: www.edo.org.au
TABLE OF CONTENTS
1. Introduction and policy context 1
2. The consultant’s brief 2
3. Commonwealth regulation of agriculture and veterinary chemicals 3
3.1 Introduction 3
3.2 The National Registration Scheme 4
3.3 Monitoring for veterinary chemical products 5
3.4 AgVet chemicals residue regulation 5
3.4.1 Maximum residue limits 5
3.4.2 National Residue Survey 6
3.4.3 Australian Total Diet Survey 6
3.4.4 Industry residue monitoring schemes 7
3.5 Occupational health and safety regulation of AgVet chemicals 7
3.5.1 National standards and Codes of Practice 7
3.5.2 National Code of Practice for the Control of
Workplace Hazardous Substances 8
3.5.3 Material Data Safety Sheets 8
3.5.4 Industrial chemicals notification and assessment 10
3.6 Consumer protection laws related to AgVet chemicals 12
3.7 AgVet chemical research and development programs 13
3.8 National strategies related to AgVet chemicals 13
3.8.1 National Strategy for the Management of
Agricultural and Veterinary Chemicals 14
3.8.2 Review of Data Protection Arrangements under
the Agricultural and Veterinary Chemicals Code Act 1994 14
3.8.3 Collection, Storage and Destruction Scheme for
Unwanted Farm and Household Pesticides 14
3.8.4 Draft Final Organochlorine Pesticide Waste Management Plan 15
3.8.5 National Strategy for the Management of Chemicals
Used at Work 15
3.8.6 National Strategy for Ecologically Sustainable Development 15
3.8.7 National Environmental Health Strategy 16
3.9 Australian participation in international activities related to
AgVet chemicals 16
3.9.1 Codex Alimentarius Commission 16
3.9.2 Intergovernmental Forum on Chemical Safety 17
3.9.3 International Programme on Chemical Safety 17
3.9.4 Inter-Organisation Programme for the Sound Management
of Chemicals 18
3.9.5 Code of Conduct on the Distribution and Use of Pesticides 18
3.9.6 Convention concerning Safety in the use of Chemicals at Work 18
3.9.7 Code of Practice on Safety in the use of Chemicals at Work 19
3.9.8 Draft Convention on the Prior Informed Consent Procedure
for Certain Hazardous Chemicals and Pesticides in International Trade 19
3.9.9 OECD activities 19
3.9.10 Negotiation toward a Convention on
Persistent Organic Pollutants 20
3.9.11 Trans-Tasman Harmonisation Scheme 20
4. State regulation of AgVet chemicals (with particular reference to NSW 21
4.1 Brief overview of State and Territory regulation of AgVet chemicals 21
4.2 The regulation of AgVet chemicals in NSW 21
4.2.1 Pesticide control 21
4.2.2 Registration, permits and orders for pesticides 21
4.2.3 Restricted pesticides 22
4.2.4 Stock medicines 22
4.2.5 Registration, permits and orders for stock medicines 22
4.2.6 Powers of the Director-General of Agriculture 23
4.2.7 Control of crop dusting and aerial spraying 23
4.2.8 Special controls for environmentally hazardous chemicals 23
4.2.9 Declared chemical wastes and chemical control orders 23
4.2.10 Chemical residues 24
4.2.11 Prohibited Residues 24
4.2.12 Stock chemical residues 24
5. Commonwealth functions, powers and responsibilities with respect to
the regulation of AgVet chemicals beyond the point of product registration 25
5.1 Functions, powers and duties of the National Registration Authority 25
5.1.1 Enabling legislation 25
5.1.2 NRA plans and charters 26
5.2 Functions, powers and duties of the
National Occupational Health and Safety Commission 27
5.2.1 Enabling legislation 27
5.2.2 Operational plan 28
5.3 Functions, powers and duties of the
Department of Health and Aged Care 29
5.3.1 National Health and Medical Research Council 31
5.3.2 Australian Institute of Health and Welfare 34
5.3.3 Public Health Division 34
6. Legislative Options for an AgVet Chemical Health Monitoring Program 35
6.1 Introduction 35
6.2 Existing legal authority 35
6.2.1 Extending existing limited monitoring programs 35
6.2.2 Extending AgVet chemical review programs 36
6.2.3 Reliance on existing powers of Commonwealth statutory
authorities and the Department of Health 38
6.2.4 Support indicated in national strategies related to
AgVet chemicals 40
6.3 The appropriate legal framework for a national
health monitoring program 41
6.3.1 Self-regulation by industry 41
6.3.2 Federal preemption of the field 42
6.3.3 Federal and State cooperative arrangements 44
6.4 Objects of a cooperative health monitoring program 44
6.5 National reporting scheme for adverse incidents 46
6.6 Uniform use reporting requirements under a cooperative arrangement 46
6.6.1 Community right to know and use reporting 46
6.6.2 Full reporting of agricultural use 47
6.6.3 Full reporting by AgVet chemical manufacturers, importers
and retailers 47
6.6.4 Uses for the data under full use reporting 48
6.7 Licence requirements under a cooperative arrangement 49
6.7.1 Public participation in new licencing requirements 49
6.7.2 Review of licences 50
6.7.3 Chemical application warning notices and buffer zones 51
6.7.4 Chemical use reduction plans 51
6.7.5 Mandatory training programs 51
6.7.6 Chemical impact assessment program 51
6.8 Public access to use reporting data and licencing details 52
7. Further Work 54
1. Introduction and policy context
Managing the potential risks to human health and the environment that are associated with agricultural and veterinary chemicals (AgVet chemicals) is a major challenge facing governments today. The Agriculture and Resource Management Council of Australia and New Zealand (ARMCANZ) wrote earlier this year in Management of Agricultural and Veterinary Chemicals: A National Strategy (AgVet Strategy): “Concern about the adverse effects of using agricultural and veterinary chemicals continues to increase worldwide. People want to know that their food and clothing does not contain chemical residues that might harm them. Moreover, there is an increasing demand for information about how and what types of chemicals are being used, and assurance that they pose no danger to health, livestock or the environment”.
Meeting the challenge posed by AgVet chemicals, however, is near impossible because of a dearth of knowledge and data relating to human exposure to AgVet chemicals in Australia. Governments have never provided resources to record quick poisoning exposures, and have been reluctant to even admit that slow poisoning exists. Indeed, in 1988 the Commonwealth government abandoned a centralised data recording system for cases of acute poisoning. Accordingly, little, if any, data exists about the exposure risks of consumers, rural communities, or of major users of AgVet chemicals.
An essential component of an effective AgVet chemical management regime to minimise adverse impacts on health and the environment is a public system for gathering and easily accessing data on health and environmental complaints resulting from exposure and use, as well as data on AgVet chemical use (including composition of the chemical used, quantity used, locations used, and method of use).
Gathering data of this nature is critical in order to meet the key objectives of risk reduction in the use of chemicals, minimisation of risks to human health, and minimisation of risks to the environment, all of which are emphasised in the AgVet Strategy. Generating this data would assist regulators in developing priorities for better management of agricultural and veterinary chemicals. It would help satisfy the strong community demand for accessible information about chemical use and Australia’s chemical load. It would promote chemical use reduction and cleaner production of agricultural products.
As this report makes clear, there is existing legal authority for the establishment of a national Health Monitoring Program (HMP) to record the frequency and nature of health complaints, as well as collect data on the use of and exposure to AgVet chemicals. Unfortunately, to date, neither the Commonwealth nor State and Territory governments have employed this authority to institute such a program to help protect public health and safety. In light of recent national developments, however, such as the National Pollutant Inventory and the Adverse Experience Reporting Program for veterinary chemical products, it would appear that the time is past due for the implementation of a national HMP for agricultural and veterinary chemicals.
2. The consultant’s brief
The Community Consultative Committee (CCC) of the National Registration Authority for Agricultural & Veterinary Chemicals (NRA) has retained the Environmental Defender’s Office Ltd (EDO) as a consultant for assistance in the development of a proposal to establish a health monitoring program (HMP) for agricultural chemicals.
The consultant’s brief which emerged after a number of discussions with the CCC consists of five parts. More specifically, this report:
Ø provides an overview of the Commonwealth legislative and administrative framework for agricultural chemical use and management in Australia;
Ø provides a brief description of the primary state agricultural chemical legislation, with a more detailed description of the legislative and administrative arrangements in New South Wales with respect to control of use, public health, occupational health and safety, and environmental protection;
Ø reviews (as appropriate) the Commonwealth Constitution, enabling legislation, charters, and operational plans for the NRA, Commonwealth Department of Health and Family Services, and the National Occupational Health and Safety Commission in order to determine Commonwealth responsibility to monitor the health impacts of agricultural chemicals beyond the point of product registration;
Ø provides option/s for developing an HMP within a legislative framework. One option included in the discussion is a nationally coordinated HMP with the states having responsibilities for collecting and reporting into a national scheme. Consideration is also given to how the regulation of access to chemical use data would impact on a HMP; and
Ø identifies where further work is needed.
It is understood that an optimal HMP would attempt to collect data from health professionals, industry and government studies, reporting on use, international collaboration and experience, and anecdotal information.
3. Commonwealth regulation of agricultural and veterinary chemicals
In investigation legal options for a national HMP, it is necessary at the outset to examine the existing Commonwealth legal framework for regulating AgVet chemicals. This examination will assist in identifying both deficiencies in the law, as well as current legal mechanisms that might aid in the establishment of an HMP.
The responsibility for the regulation and management of AgVet chemicals in Australia is spread across a number of different government bodies at the Commonwealth, State and Territory levels. The responsibility for the regulation of AgVet chemicals in Australia is also subject to a number of different laws and regulations within each jurisdiction. The division in responsibility between Commonwealth and State jurisdiction is largely due to the Australian Constitution and historical development of Constitutional law doctrine.
Because responsibility for managing AgVet chemicals is split between the Commonwealth and the States, ARMCANZ has been established as the main political vehicle for coordinating those responsibilities. ARMCANZ is essentially an annual meeting of Ministers. It does, however, have an active subcommittee structure under the Standing Committee on Agriculture and Resource Management (SCARM), which is made up of head of government departments. Primary duties relating to AgVet chemical issues rests with the Agricultural and Veterinary Chemicals Policy Committee (AVCPC).
At the federal level, AgVet laws and regulations can be broken down into six principal program areas. These include:
Ø The National Registration Scheme established under the Agricultural and Veterinary Chemicals Act 1994 (Cth); the Agricultural and Veterinary Chemicals Code Act 1994 (Cth); the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cth); together with the complimentary AgVet laws of each of the States and Territories. A nascent program for monitoring veterinary chemicals has been established under these laws.
Ø An AgVet chemical residue program that includes a Residue Monitoring Survey established under the National Residue Survey Administration Act 1992 (Cth) and the National Residue Survey Levy Regulations (Cth); as well as the establishment of maximum residue limits set by the Australia New Zealand Food Standards Council (a council of Health Ministers) under the National Food Authority Act 1991 (Cth) and the Food Standards Code (Cth).
Ø A regulatory and research program covering workplace hazardous substances established under the National Occupational Health and Safety Commission Act 1985 (Cth); Industrial Chemicals (Notification and Assessment) Act 1989 (Cth); the National Health Regulations (Cth); and Guidelines for Health Surveillance for organophosphate pesticides.
Ø A research and development program carried out by the Environment Australia, the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and the Bureau of Resource Sciences (BRS), as well as joint government/industry and academic bodies.
Ø A related and growing regime of National Strategies is in the process of development which addresses, among other things, the issues surrounding sound management of AgVet chemicals.
Ø A program focussed on participation in international efforts and activities designed to address the regulation and management of AgVet chemicals.
Each of these program areas are addressed in the remainder of this section.
3.2 The National Registration Scheme
The national registration scheme for AgVet chemicals became operational in 1995 and is designed as a single assessment and regulation system. Its primary function is to assess and evaluate the suitability the use of active constituents of AgVet chemicals and to regulate the manufacture and supply of these chemicals. The scheme is administered by the NRA. The NRA is responsible for the regulation of the manufacture, distribution and supply of AgVet chemicals up to the point of retail sale. After that point, the control-of-use becomes the responsibility of the States and Territories.
The Agricultural and Veterinary Chemicals Code Act 1994 (Cth)(the Code Act) contains the detailed operational provisions for registering chemical products and provides the NRA with its powers. The Code is a schedule to the Code Act and applies only in the Australian Capital Territory. The Code obtains its legal force in the States and the Northern Territory by complimentary legislation passed in each of those jurisdictions. This legal structure is largely necessitated by the Australian Constitution and gives the Code national coverage.
The National Registration Scheme applies to agricultural and veterinary chemical products, both of which are precisely defined in the Code Act. It is an offence to sell an agricultural or veterinary chemical product in Australia unless it has been assessed and registered by the NRA. It is also an offence under the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cth) to import an unregistered chemical product into Australia. The NRA may grant approvals and registrations subject to conditions. Failure to comply with the NRA’s conditions is an offence and the NRA may suspend or cancel the registration or approval.
The NRA must keep a Record of approved active constituents and a Register of agricultural and veterinary chemical products available to be inspected by the public. Both the Record and Register are to contain a part for confidential commercial information that is not generally available for public inspection.
The National Registration Scheme includes an Existing Chemicals Review Program (ERCP) that reviews older chemicals in use in order to ensure they meet contemporary standards of safety, taking into account any new information and scientific data that has emerged since their initial registration. However, because the use or health effects of these chemicals are not monitored, the ERCP is much less efficient than it would be with a HMP.
The National Registration scheme also entails a Special Review Program to allow the NRA to immediately review chemicals if urgent concerns about chemicals arise that may necessitate alteration of conditions of registration or cause them to be withdrawn. Reviews are undertaken by the NRA’s Chemical Review Section.
The NRA may issue recall notices for chemical products in appropriate circumstances. Recall notices require people who have, or have had, stocks of chemical products in their possession to stop supplying the products and to take action as directed by the NRA.
The NRA may issue permits allowing people to carry out activities that would otherwise be prohibited under the scheme. A person can apply to the NRA for a permit, or the NRA may give a permit on its own initiative. The NRA must keep a record of permits and the record must be available for public inspection. A person must have a licence under the AgVet Code Act to manufacture chemical products. The NRA generally issues licences subject to conditions. The NRA may publish a list of licence holders and their details.
The NRA is responsible for approving labels and containers that must be used for each AgVet chemical, as well as the purposes for which each AgVet chemical can be use. In practice, the authorised purposes for which a registered pesticide can be used are those set out on the registered label(s). Penalties for failure to follow label instructions include fines up to a maximum of $40,000 for a company and $20,000 for an individual.
3.3 Monitoring program for veterinary chemical products
Under s 161 of the Code Act, the NRA has established an Adverse Experience Reporting Program (AERP) to hear and investigate reports of any “adverse experiences” that might be the result of using veterinary chemical products. AERP is highly dependent upon reporting by veterinarians, although any person is entitled to make reports. An adverse experience is an unexpected effect involving animals, humans, or the environment, that appears associated with the use of a veterinary chemical product in accordance with label directions. The AERP, however, does not extend to agricultural chemicals. A discussion with the NRA about the AERP, indicated that the program is funded primarily by the AgVet chemical industry.
3.4 Commonwealth AgVet chemicals residue regulation
Australia has a number of different residue monitoring programs designed to help ensure that agricultural produce meets national and international standards.
3.4.1 Maximum residue limits (MRLs)
Under the AgVet Chemicals (Administration) Act 1992, the NRA must publish each year approved standards for residues of chemical products in “protected commodities”. A protected commodity is any substance or thing used or capable of being used as food or drink (or as an ingredient in food or drink) by humans, any agricultural commodity, animal feed, or other prescribed substance or thing.
The NRA recommends MRLs to the Australia New Zealand Food Authority (ANZFA), which has the responsibility for assessing the dietary exposure resulting from the use of AgVet chemicals. If it is determined that the use of a particular chemical is acceptable in terms of risk to public health, ANZFA makes recommendations to the Australia New Zealand Food Standards Council (ANZFSC) (a council of Health Ministers) for the establishment of a new MRL. If approved by ANZFSC, the MRL is incorporated into the national Food Standards Code, which in turn, is incorporated into State and Territory food legislation.
Existing MRLs can be reconsidered if there is a change in use of a chemical or if new data becomes available. There is, however, no monitoring system in place to ensure that new data comes to light. The NRA will consider requests for reconsideration of an MRL from any person or organisation with a bona fide interest in the chemical.
3.4.2 National Residue Survey
The National Residue Survey (NRS) was established by the National Residue Survey Administration Act 1992 (Cth). It is administered by the Bureau of Resource Sciences (BRS) of the Department of Primary Industries and Energy. It is a cooperative arrangement between the government and participating industries and fully funded by such industries.
The NRS monitors chemical residues in Australian raw food commodities. According to promotional literature, the NRS monitors AgVet chemicals used in the production of meats, grains, honey, fruit, vegetables, nuts and seafood. Since 1996, it has been compulsory for meat from all species slaughtered for export or domestic use to be tested under the NRS, under the Australian Standard for the Hygienic Production of Meat for Human Consumption.
NRS programs include both domestic and export market segments. The BRS description of its NRS management states that “NRS activities are driven primarily by the needs of participating industries to maintain access to key markets and establish a bank of objective and scientifically valid data to underpin quality assurance programs and assist in resolving residue-related trade incidents”. It appears that data gathered by the NRS also contributes to the establishment of scientifically-based standards for residues in food only as an incidental matter.
The NRS, in collaboration with the Residue Management Group (RMG), an industry based initiative, has implemented five “targeted testing programs” in addition to the broad NRS. These targeted testing programs include: the National Organochlorine Residue Management Program, the National Antibacterial Residue Minimisation Program, the Hormonal Growth Promotants Audit Program, the Chlorfluazuron Program, and the Endosulfan Management Program. All these targeted programs have been concerned with cattle and appear to be driven, as the NRS is generally, by the need to maintain access to key export markets.
3.4.3 Australian Total Diet Survey
In addition to its role in setting MRLs, ANZFA is responsible for overseeing the Australian Total Diet Survey (ATDS). The Survey seeks to estimate the total dietary burden of pesticides and contaminants. It biennially examines the levels of pesticides and contaminants in food purchased from retail outlets in all capital cities. The food is tested in a “table ready” state, instead of before preparation. ANZFA utilises the results from the ATDS when developing recommendations for standards of food produced and processed for consumption by the Australian public. These standards are published in the Food Standards Code and are ordinarily adopted by respective State and Territory health and agriculture legislation.
3.4.4 Industry residue monitoring schemes
A number of commodity-focused organisations conduct their own residue surveys outside of what is required by law. These surveys are designed primarily with the aim of quality assurance. Industry commodity surveys are run by the Australian Wheat Board, the Australian Wine and Brandy Corporation, the International Wool Secretariat, and the Australian Wool Residue Management Council.
3.5 Occupational health and safety regulation of AgVet chemicals
Under the Australian Constitution, the States and Territories have traditionally been viewed as having primary responsibility for making laws about workplace health and safety and for enforcing those laws. Each State and Territory has a principle Occupational Health and Safety (OSH) Act which sets out requirements for ensuring that workplaces are safe and healthy. Under State and Territory law, employers must generally ensure the health, safety and welfare of their employees by: (i) providing and maintaining a safe workplace, facilities, plan and systems of work; (ii) ensuring the safe use, handling, storage and transport of plant or substances; and (iii) ensuring proper information, instruction, training and supervision are provided.
3.5.1 National Standards and Codes of Practice
Nevertheless, the Commonwealth Government does play a significant role in protecting worker health and safety under cooperative arrangements with the States and Territories. The National Occupational Health and Safety Commission (NOHSC), for example, provides a forum for the Commonwealth, State and Territory Governments, Employer Organisations and Trade Unions to develop national approaches to OHS matters. Under the National Occupational Health and Safety Commission Act 1985 (Cth), the Commission has the power to declare National OHS Standards and Codes of Practice. These are developed as the basis for nationally consistent OHS Regulations and Codes of Practice. Importantly, however, they are not legally enforceable unless State and Territory Governments adopt them as regulations or codes of practice under their principal OHS Acts.
Regulation 12(1) of the National Model Regulations for the Control of Workplace Hazardous Substances, requires employers to take action to prevent exposure of persons in the workplace to hazardous substances at work, or if that is not practicable, to ensure that exposure is adequately controlled so as to minimise risks to health. A number of Exposure Standards have been declared by NOHSC under s 38(1) of the National Occupational Health and Safety Commission Act (1985) for a limited number of AgVet chemicals, including: Chlordane, Captan, Amitrole, Aldrin, Glutaraldehyde, DDT, Ethylenimine, and various arsenites and arsenates.
NOHSC has declared Adopted National Exposure Standards for Atmospheric Contaminants in the Occupational Environment and developed a Guidance Note on the Interpretation of Exposure Standards for Atmospheric Contaminants in the Occupational Environment (3rd ed, 1995), both of which are relevant to the discussion here because the definition of “hazardous substance” is found in the NOHSC List of Designated Hazardous Substances and includes a number of AgVet Chemicals.
3.5.2 National Code of Practice for the Control of Workplace Hazardous Substances
NOHSC had declared a National Code of Practice for the Control of Workplace Hazardous Substances. The definition of “hazardous substance” is found in the NOHSC List of Designated Hazardous Substances and includes a number of AgVet Chemicals. Under the Code of Practice there are a number of obligations imposed on manufacturers, importers, suppliers and employers. Importantly for the purposes of this Report, the Code of Practice imposes health surveillance and monitoring duties upon employers.
Health Surveillance. Health surveillance is required for employees who have been identified in the workplace assessment as having, among other things, a significant risk to health from exposure to a hazardous substance. A key purpose of the surveillance is to ensure that workers are not exposed to unsafe or unacceptable levels of hazardous substances. A registered medical practitioner is responsible for the supervision of health surveillance, either by directly carrying out the health surveillance program or by supervising a program carried out by a suitably qualified person such as an occupational health nurse.
Monitoring exposure. Under the Code of Practice an employer is also responsible for monitoring the exposure of employees to hazardous substances. Monitoring involves the use of valid and suitable techniques to derive a quantitative estimate of the exposure of employees to hazardous substances. For airborne contaminants, monitoring involves the periodic and/or continuous sampling of workplace atmospheres to derive a quantitative measure of exposure to hazardous substances
through inhalation. For this sort of monitoring to be of value in risk assessment, there must be a relevant exposure standard against which to compare the results obtained.
3.5.3 Material Safety Data Sheets
Manufacturers and suppliers of hazardous substances are required by law to provide Material Safety Data Sheets (MSDS) for all hazardous substances manufactured or imported into Australia. An MSDS is aimed at those handling and using the hazardous substance and, accordingly, the information it contains should be stated in plain language and be understandable to the lay person. The MSDS for a substance describes its identity (product name, physical description and properties, uses and composition), relevant health hazard information, precautions for use and safe handling information. Manufacturers and importers must also provide a copy of each MSDS for the Australian National Material Safety Data Sheet Repository, maintained by Worksafe Australia.
Duties of Suppliers. Under the National Code of Practice for the Control of Workplace Hazardous Substances suppliers have a duty to supply information using the MSDS. A current MSDS must be provided on or before the first occasion that a hazardous substance is supplied, to each person who purchases the hazardous substance from the supplier. When the MSDS has been revised, a copy of the revised MSDS must be sent out to each purchaser of the substance. Suppliers must also provide MSDS on request to purchasers and to prospective purchasers.
Additionally, suppliers are responsible for providing, on request, any further information that they may have regarding the safe use of hazardous substances they supply. This information shall include summary reports produced under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth), where available, and any other relevant information, for example, conditions for safe use.
Suppliers also have the duty to ensure the correct labelling of hazardous substances which they supply to others. Minimum standards on the labelling of workplace hazardous substances are given the National Code of Practice for the Labelling of Workplace Substances. However, when products are labelled in accordance with the Agricultural and Veterinary Chemicals Act 1988 (Cth), they are regarded as being appropriately labelled.
Duties of Employers. Under the labelling Code of Practice, employers must ensure that all employees and employee representative have ready access to MSDS. Employers should encourage employees to read MSDS for those hazardous substances which they may be exposed to in their work. An employer also has the responsibility for maintaining a readily accessible and up-to-date information Register that includes a list of all hazardous substances used or produced at the workplace and the MSDS for all hazardous substances as required by the national model regulations. The completion of simple and obvious assessments should also be noted in the register.
An MSDS obtained from a supplier must not be altered by an employer, except where the MSDS is provided from overseas and is not available in one of the acceptable formats described in the National Code of Practice for the Preparation of Material Safety Data Sheets. If an employer wishes to add additional information to the supplier`s MSDS, it should be appended to the MSDS. However, it must be clearly marked to indicate that the appended information is not part of the original MSDS. Specific workplace information may be added in this manner and is not considered to be an alteration to the MSDS.
Commercially confidential information. In limited cases under the National Code of Practice for the Preparation of Material Safety Data Sheets, nondisclosure in an MSDS of genuine commercially confidential information about ingredient identity may be permitted.
Full disclosure by manufacturers and importers is always required for a “Type I ingredient” on an MSDS. A Type I ingredient includes the chemical name of any ingredient which:
Ø in accordance with NOHSC`s Approved Criteria for Classifying Hazardous Substances is carcinogenic, mutagenic, teratogenic, a skin or respiratory sensitiser, very corrosive, corrosive, toxic or very toxic, a harmful substance which can cause irreversible effects after acute exposure, or a harmful substance which can cause serious damage to health after repeated or prolonged exposure; or
Ø has an exposure standard listed in the NOHSC`s Adopted National Exposure Standards for Atmospheric Contaminants in the Occupational Environment, and is present in a quantity which exceeds the lowest relevant concentration cutoff level specified for the hazard classification in the NOHSC`s Approved Criteria for Classifying Hazardous Substances.
A claim of commercial confidentiality cannot be made in relation to any ingredient which meets these criteria and generic names are not permitted for any of the above Type I ingredients.
For Type II ingredients, manufacturers or importers may use a generic name on an MSDS, in place of the chemical name of an ingredient, if:
Ø the ingredient is a harmful substance but does not meet the criteria of Type I ingredients, but
Ø is present in a quantity which exceeds the lowest relevant concentration cutoff level specified for the hazard classification in the Approved Criteria for Classifying Hazardous Substance.
The manufacturer or importer shall notify Worksafe Australia where a generic name is used in place of the chemical name for a commercially confidential Type II ingredient. The generic name used should describe the functionality of the ingredient which contributes to the hazard.
If an ingredient is not a Type I or a Type II ingredient, then the chemical name need not be included by the manufacturer or importer in the MSDS. Instead, a generic name for the ingredient, as precise as is reasonably possible, should be used. Notification to Worksafe Australia is not required if a generic name is used in place of the chemical name for these ingredients. When use of a generic name provides inadequate commercial protection, and the ingredient is not a hazardous substance, the general term `other ingredients determined not to be hazardous` may be used, except where a Type III ingredient has known synergistic effects.
Where the chemical identity of an ingredient has not been disclosed on the MSDS, it is necessary to include on the MSDS the name and contact details where further information on the confidential information can be provided. Even if commercially confidential information is involved, the manufacturer or importer has an obligation under the National Model Regulations for the Control of Workplace Hazardous Substances to disclose the chemical identity of an ingredient in specific emergency and nonemergency situations.
Finally, if formulation confidentiality is involved and the exact amount of the ingredient in the formulation cannot be specified, then the proportion ranges of each ingredient contained in the product should be indicated so as to provide as much information as possible about the potential hazards of a formulation. The following proportion changes are recommended:
>60% , 30 60% , 10 <30% , <10%
3.5.4 Industrial Chemicals Notification and Assessment
Brief mentioned should be made of the distinction in treatment of AgVet chemicals and industrial chemicals under the law, in terms of registration, notification and assessment requirements.
The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) was established under the Industrial Chemicals (Notification and Assessment) Act 1989 (Cth), to aid in the protection of people at work, the public and the environment from the harmful effects of industrial chemicals. NICNAS is intended to complement other existing schemes for the regulation chemicals, including agricultural and veterinary chemicals.
NICNAS commenced operation on 17 July 1990. It is part of Worksafe Australia (WSA), and is the responsibility of the Minister for Industrial Relations. It is administered by the Director Chemicals Notification and Assessment, who is a statutory office holder under the Act. NICNAS originally operated on a 50% cost recovery basis and moved to 100% cost recovery in 199798.
Before NICNAS, industrial chemicals could be introduced into Australia without an assessment of their health and environmental effects. NICNAS seeks to ensure that new industrial chemicals entering Australia are assessed for their health and environmental effects before the chemical is used or released to the environment. NICNAS also evaluates those chemicals which have been in use for a longer time (existing chemicals) on a priority basis in response to concerns about the health and environmental effects of these chemicals. There is, however, no active health monitoring program under NICNAS. The results of NICNAS assessments are made available to those companies which introduce chemicals, people in the workplace and regulatory agencies. NICNAS reports are also publicly available.
The Act requires new industrial chemicals to be notified and assessed prior to their introduction by import or manufacture. A secondary notification system is also in place to ensure the original assessment remains valid as new information becomes available, or new uses or methods of production are identified. Selected chemicals in use prior to the commencement of NICNAS or otherwise not required to be notified, may be declared priority existing chemicals (PEC) by the Minister for Industrial Relations and assessed under the PEC program.
Australian Inventory of Chemical Substances. The legal device which distinguishes new from existing chemicals is known as the Australian Inventory of Chemical Substances (AICS). The AICS is a listing of all industrial chemicals in use in Australia between 1 January 1977 and 28 February 1990, and consists of a public and a confidential section. Any chemical not included in the AICS is regarded as a new chemical unless it is outside the scope of the Act or otherwise exempt from notification. New chemicals must be notified and assessed before being manufactured or imported into Australia. The AICS is primarily a list of chemical identity data. It does not contain toxicity data, information on the chemical`s use or a list of manufacturers.
Notification of new chemicals. Persons intending to introduce a new industrial chemical into Australia by way of manufacture or import are ordinarily required to notify this intention to the Director and apply for an assessment certificate. An application for an assessment certificate must be accompanied by a dossier of prescribed information to enable an assessment of the potential health and environmental effects of that chemical.
WSA undertakes the primary toxicological evaluation and occupational health and safety assessment. The Department of Health and Aged Care (DHFS) assesses the potential public health effects and the Environmental Protection Agency (EPA) assesses the potential environmental hazard. WSA prepares a consolidated assessment report, combining its assessment with those of the DHFS and EPA. Assessments must be completed within 90 days of receipt of a satisfactory notification dossier.
Notification of existing chemicals. The priority existing chemical (PEC) provisions were introduced because there are over 38000 existing industrial chemicals in use, most of which have not been tested. Chemicals which do not have to be notified as new chemicals, either because they are listed on the AICS or because they are exempt from notification, may be selected as priority existing chemicals (PEC) and assessed under the PEC program. The public may nominate chemicals to be included in the selection process. Nominated chemicals are then screened and ranked against predetermined selection criteria.
The Director can request manufacturers and importers of existing chemicals to supply relevant information within defined periods. This enables a decision to be taken on whether they should be declared PEC`s. After a chemical is declared a PEC, the manufacturers and/or importers must supply specified information which is used to perform an assessment of the potential hazards. The information to be provided varies and is determined on a casebycasebasis. Notice of these requirements is published in the Chemical Gazette.
Dissemination of information and assessments. An assessment report is prepared for each new and existing chemical assessed by NICNAS. The assessment report comprises a technical assessment of the potential hazard, taking into account both human and environmental exposure to the chemical, and the chemical`s toxicity. On the basis of the assessment, recommendations are made on controls and precautions that need to be taken when manufacturing, using, storing and disposing of the chemical. A full public report is also produced.
At the request of the notifier, and having regard to the public interest, the Director may determine that certain items of information should be exempt from publication in the full public report. A defined set of basic information, including prescribed data relating to the health effects and environmental effects, cannot be exempt. A summary of the full public report is published in the Chemical Gazette.
The Chemical Gazette. The Chemical Gazette is a monthly publication issued on the first Tuesday of every month. Summary assessment reports are published in the Chemical Gazette on all chemicals assessed by NICNAS. Information published in the summary reports include: (i) physical and chemical data about the chemical; (ii) health and environmental effects of the chemical; (iii) the precautions and restrictions to be observed in the manufacture, handling, (iv) storage, use and disposal of the chemical; and (v) recommendations arising from the assessment of the chemical by NICNAS.
The Chemical Gazette also includes other information about NICNAS such as notices and declarations which must be made under the Act, including: (i) listings of new additions to the AICS; (ii) approvals of foreign schemes; (iii) PEC declarations; (iv) amendments to the Schedule which specifies the data that are required to be submitted by the notifier in the notification statement; and (v) notices requiring persons exporting a chemical to give information about movements out of Australia.
3.6 Commonwealth consumer protection laws related to AgVet chemicals
The Trade Practices Act 1974 (Cth) indirectly regulates the use of and information about AgVet chemicals in the context of private legal action. Under the Pts V and VA of the Trade Practices Act, consumers of agricultural and veterinary chemicals, as well as consumers of food or other products which these chemicals are used to produce, are entitled to goods reasonably fit for the purpose for which they are purchased, goods of a merchantable quality, good that meet the conditions of warranties, and goods that correspond to their description.
The law of torts and contract may also provide indirect consumer protection in the use of or exposure to AgVet chemicals. Significant obstacles will have to be overcome, but actions for breach of warranty, negligence, deceit, may provide means of redress for wrongs committed in connection with AgVet chemicals.
3.7 Commonwealth AgVet Chemical Research and Development Programs
3.7.1 Environment Protection Group (Chemicals and the Environment Branch) of Environment Australia
The assessment of environmental hazards arising from agricultural and veterinary chemicals is a responsibility of the Chemicals and the Environment Branch (CEB) which makes recommendations to the NRA on these issues.
The Branch contributes to international activities aimed at the environmentally sound management of hazardous wastes and hazardous chemicals. At domestic level, the Branch administers the Hazardous Waste Act covering the export and import of hazardous waste and contributes to the national strategy aimed at managing unwanted farm and household chemicals.
The Risk Assessment and Policy Section (RAPS) establishes the hazard of a product to the environment by using the information provided by the company and the information available from other sources, such as literature searches and overseas assessment reports. RAPS then assesses the environmental hazard of the chemical considering exposure and toxicity data.
The hazard assessment is a comparison of the results from the evaluation of the exposure, which takes into account the method and frequency of application, as well as the substance`s persistence and mobility in the environment, and the toxic effects. Depending on the degree of environmental hazard, actions to minimise this hazard may be considered, such as specific restraints or label instructions and warnings.
3.7.2 Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Research into agriculture and natural resources is carried out in many divisions of CSIRO. It produces a range of scientific information and general information related to AgVet chemicals. CSIRO conducts research for the development of new agricultural products important to integrated pest management, including pest and weed resistant crops. As well, CSIRO has been involved in research into technologies for environmental monitoring and impact assessments, as well as strategic research into pest and diseases of plants and animals.
3.7.3 Bureau of Resource Sciences (BRS)
BRS is an independent science body within the Department of Primary Industries and Energy. It provides frequent scientific and technical information about resource assessment issues that affect agricultural and other industries. The Bureau is also responsible for the National Residue Survey.
3.8 National strategies related to AgVet chemicals
A number of national initiatives and strategies include elements of AgVet chemicals within their frameworks. In order to appreciate the total scope of Commonwealth involvement in AgVet chemical management, it is important to be aware of these related programs.
3.8.1 National Strategy for the Management of Agricultural and Veterinary Chemicals
In June 1998, ARMCANZ endorsed a document entitled Management of Agricultural and Veterinary Chemicals: A National Strategy. The prominent objectives of the proposed Strategy it to minimise risks posed by AgVet chemicals to human health and the environment, as well as improving the assessment of chemicals. The proposed strategy recognises that the management of AgVet chemicals is continuously evolving and that today there is increased public demand for more knowledge about risks of unwanted impacts on human health, as well as on agricultural and natural resource sustainability.
More specifically in terms of this Report, the proposed Strategy emphasises that much of the concern about the health and environmental risks of AgVet chemicals “stems from that lack of reliable information on the extent of their use and the health and environmental impacts”. The proposed Strategy goes on to highlight that in Australia, “the need to collect meaningful information on chemical use is being more widely expressed and acknowledged. These developments are expected to continue, and reflect a community desire to minimise the risks associated with AgVet chemicals”.
Specific strategic action recommended by the proposed Strategy include: (i) developing and implementing mechanisms for collecting and disseminating accurate data on the use of AgVet chemicals in order to help identify and manage potential risks; (ii) developing coordinated and systematic approaches to post-registration monitoring and assessment of the direct and indirect effects of chemicals on human health; and (iii) further developing a coordinated reporting and investigation program for adverse health incidents.
3.8.2 Review of Data Protection Arrangements under the Agricultural and Veterinary Chemicals Code Act 1994
In October 1998, the Commonwealth Data Protection Working Party release an Issues Paper on the Review of Data Protection Arrangements under the Agricultural and Veterinary Chemicals Code Act 1994 (Cth). The Review seeks to address issues related to whether increased protection of “testing data” generated in the AgVet chemical registration process is warranted. As discussed below, while enhanced protection may be warranted in narrowly defined circumstances, it should not be at public expense, either in terms of financial outlay or public health and environmental safety.
3.8.3 Collection, Storage and Destruction Scheme for Unwanted Farm and Household Pesticides
In June 1997, the Joint Standing Committee of Australian and New Zealand Environment and Conservation Council (ANZECC) and ARMCANZ released a Discussion Paper on the Collection and Destruction of Unwanted Farm and Household Chemicals. The Committee stressed that there are clear environmental, public and occupational health, and international trade reasons why Australia should safely manage and destroy its unwanted stocks of organochlorine pesticides (OCPs) and other unwanted farm and household chemicals. In supporting this conclusion, however, the Committee was not able to rely on any coordinated results from a national health monitoring program. Instead, it was only able to point out that monitoring of land and aquatic environments, and of human tissue and breastmilk have, from time to time, revealed levels of OCPs above acceptable standards.
Indeed, the Discussion Paper makes clear that a one-off national Australian collection scheme was initiated in 1987, not because Australian health or agricultural authorities discovered a threat to public health and safety through systematic monitoring and testing. Rather, this scheme was instituted only after the US Government detected OCP residues in Australian beef. Commonwealth, State and Territory governments were keen to retain the good image of Australia`s agricultural industries and started collecting these unwanted and dangerous chemicals, in addition to restricting or prohibiting the use of most OCPs, particularly DDT. The important point here, however, is that a national Australian health monitoring program would have more likely disclosed this health threat much more quickly.
In 1998, whether in response to the Discussion Paper or not, AVCARE, the Veterinary Manufacturers and Distributors Association, The National Farmers’ Federation, and the Australian Local Government Association, entered into a Head of Agreement on an Industry Waste Reduction Scheme. The objective of this voluntary Scheme is to reduce the number of crop protection and animal health product container from entering the distribution stream and increase the use of recycling of such containers.
3.8.4 Draft Final Organochlorine Pesticide Waste Management Plan
ANZECC has also commissioned the preparation of a management plan for organochlorine pesticides (OCPs). Their intention is to see that public health and the environment are protected by the safe management and eventual destruction of unwanted quantities of OCPs that are held by farmers and householders in all parts of the country. Reductions in threats to Australian exports of agricultural produce through accidental contamination by OCPs and the potential impact on our reputation as a supplier of clean products is also an important consideration. ANZECC released a final consultation paper in May 1997.
3.8.5 National Strategy for the Management of Chemicals Used at Work
The National Strategy for the Management of Chemicals Used at Work was published by NOHSC in 1989. It aims to reduce chemicalrelated occupational injury and disease in Australia and facilitate cooperation on a national level. The extent of chemicalrelated injury and disease in Australia is difficult to define. Statistics currently collected do not adequately describe either chemical exposures or chemically related diseases and injuries. However, it is assumed that exposure to chemicals is probably widespread. The legislative arrangements through which chemicals are presently managed are numerous and fragmented at Commonwealth, State and Territory level. The strategy builds on existing activities and identifies gaps which may be filled through activities by the National Commission itself and by other organisations. The strategy has four essential elements: assessment of hazards of chemicals and the causes of chemical related injury and disease; information and education; workplace exposure control; and requirements of the emergency services.
3.8.6 National Strategy for Ecologically Sustainable Development (ESD)
In 1992, following the “Earth Summit”, Australia adopted the National ESD Strategy. Chapter 1 of the Strategy address agricultural issues, including AgVet chemicals. It broadly focuses on the goal of facilitating “the ecologically sustainable development of agricultural industries so that they contribute to longterm productivity and to Australia`s economic wellbeing, and protect the biological and physical resource base on which agricultural industries depend, and improve human health and safety”.
In order to achieve this goal, the Strategy states that a key objective is: “to improve effective and safe management of agricultural and veterinary chemicals while improving levels of, and access to information on these chemicals.” Moreover, in order to meet this objective, the Strategy commits government to: (i) implement the national scheme for the evaluation and registration of agricultural chemicals; (ii) at the Commonwealth level, ensure that coverage of the National Residues Survey and Australian Market Basket Survey meet necessary information requirements and that this information is widely disseminated; (iii) assess the merits of setting indicative national targets for the use of selected agricultural and veterinary chemicals; and (iv) at the Commonwealth level, examine the possibility of commencing surveys to monitor agricultural chemical residues in wildlife and the wider environment.
3.8.7 National Environmental Health Strategy
A National Environmental Health Strategy is being developed by the National Environmental Health Forum. As part of this process, a discussion paper entitled Environmental Health in Australia: Towards a National Strategy was released by the Environmental Health Unit of the Department of Health and Aged Care for public consultation in September 1998.
The Discussion Paper indicates that the Strategy is intended to cover all issues associated with environmental hazards that threaten human health, including contaminated water and food, chemical exposures, polluted air and soil, and vector-borne diseases. It recognises the National Environment Protection Council (NEPC) in the management of environmental health policy in Australia, as such it is envisioned that the Strategy will be implemented through the national framework of intergovernmental cooperation found in the arrangements for National Environment Protection Measures (NEPMs).
The Discussion Paper recognises the need for better management tools in protecting and improving environmental health. It emphasises the need to assess the changes of environmental health risks over time so that policy makers and regulators have necessary information to make the best possible risk management decisions. In order to achieve this goal, the Discussion paper explicitly points out the need for “ongoing surveillance of environmental hazards” and recommends the establishment of “a national environmental health surveillance system”, together with an “information clearinghouse”.
3.9 Australian participation in international activities related to AgVet chemicals
3.9.1 Codex Alimentarius Commission
The Codex Alimentarius Commission was established in 1962 in order to assist in the development and implementation of the joint Food Standards Programme administered by the United Nations Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO). Australia participates as a member of the Commission.
The work of the Commission focus on five main areas: (i) protecting the health of the consumers and ensuring fair practices in the food trade; (ii) promoting coordination of all food standards work undertaken by international governmental and nongovernmental organizations; (iii) determining priorities and initiating and guiding the preparation of draft standards through and with the aid of appropriate organizations; (iv) finalizing standards elaborated and, after acceptance by governments, publishing them in a Codex Alimentarius either as regional or worldwide standards; and (v) amending published standards, after appropriate survey in the light of developments.
3.9.2 Intergovernmental Forum on Chemical Safety
The Intergovernmental Forum on Chemical Safety (IFCS), was created by a Resolution of the International Conference on Chemical Safety held in Stockholm in April 1994. Australia is currently a member of the IFCS Standing Committee.
IFCS seeks to provide a mechanism for cooperation among governments and promotes chemical risk assessment and the environmentally sound management of chemicals. IFCS is a noninstitutional arrangement whereby representatives of governments meet together with intergovernmental and non-governmental organizations with the aim to integrate and consolidate national and international efforts to promote chemical safety. Intergovernmental and nongovernmental organizations participate without the right to vote.
IFCS currently has six priorities for action which include: (i) expanding and accelerating international assessment of chemical risks; (ii) harmonization of classification and labelling of chemicals; (iii) information exchange on toxic chemicals and chemical risks; (iv) establishment of risk reduction programmes; (v) strengthening of national capabilities and capacities for management of chemicals; and (vi) prevention of illegal international traffic in toxic and dangerous products.
In connection with the first priority area -- assessment of chemical risks -- IFCS has highlighted that industry should be encouraged to generate and supply data required for risk assessment to the greatest possible extent and human exposure data, and good quality health effects data, should also be generated. IFCS has also formed an Ad Hoc Working Group of Persistent Organic Pollutants (POPs) to assist the United Nations Environment Programme in the negotiations of a legally binding instrument regulating POPs.
3.9.3 The International Programme on Chemical Safety
The International Programme on Chemical Safety (IPCS) was established in 1980, and is a joint programme of three Cooperating Intergovernmental Organizations, the International Labour Organisation (ILO), the United Nations Environment Programme (UNEP), and the World Health Organisation (WHO). Australia participates in all three of these intergovernmental organisations.
The two main roles of IPCS are: (i) to establish the scientific basis for safe use of chemicals, and (ii) to strengthen national capabilities and capacities for chemical safety.
IPCS areas of activity include: (i) evaluation of chemical risks to human health and the environment; (ii) development of methodologies for Evaluation of Hazards and Risks; (iii) prevention and management of toxic exposures and chemical emergencies; and (iv) development of the human resources required in the above areas.
3.9.4 Inter-Organisation Programme for the Sound Management of Chemicals
The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC) was established in 1995 to serve as a mechanism for coordinating efforts of intergovernmental organizations in the assessment and management of chemicals. The IOMC is designed to be a cooperative undertaking among intergovernmental organizations that, within the framework of their own respective constitutional mandates, work together as partners to promote international work in the environmentally sound management of chemicals. The Participating Organizations are FAO, ILO, UNEP, WHO, United Nations Industrial Development Organisation (UNIDO), United Nations Institute for Training and Research (UNITAR), and the Organisation for Economic Cooperation and Development (OECD). Australia participates in all of these organisations.
3.9.5 Code of Conduct on the Distribution and Use of Pesticides
The International Code of Conduct on the Distribution and Use of Pesticides was developed to address a number of difficulties associated with the use of pesticides in developing countries where adequate regulatory infrastructures are frequently lacking. The Code was adopted by United Nations Food and Agricultural Organisation (FAO) member countries in 1985 to incorporate the principle of Prior Informed Consent.
The twelve articles of the Code are supported by a set of detailed technical Guidelines which provide guidance on their implementation. Importantly, a number of these Guidelines address "post registration" activities related to AgVet Chemicals, including: PostRegistration Surveillance and Other Activities in the Field of Pesticides (1988); Pesticide Storage and Stock Control Manual (1995); Good Practice for Ground and Aerial Application of Pesticides (1988); Personal Protection When Working with Pesticides in Tropical Climates (1990); and Guidelines on the Prevention of Accumulation of Obsolete Pesticide Stocks (1995). Other Guidelines include: The Registration and Control of Pesticides (1985), Legislation on the Control of Pesticides (1989), and Initial Introduction and Subsequent Development of a Simple National Pesticide Registration and Control Scheme (1991).
3.9.6 ILO Convention concerning Safety in the use of Chemicals at Work (No. 170)
While Australia has not ratified this Convention, it is a member of the International Labour Organisation. The Convention is an important legal mechanism which protects workers from the harmful effects of chemicals by:
Ø ensuring that all chemicals are evaluated to determine their hazards;
Ø providing employers with a mechanism to obtain from suppliers information about the chemicals used at work so they can implement effective programmes to protect workers from chemical hazards;
Ø providing workers with information about the chemicals in their workplaces, and about appropriate preventive measures so that they can effectively participate in protective programs; and
Ø establishing principles for such programmes to ensure that chemicals are used safely.
3.9.7 ILO Safety in the Use of Chemicals at Work - Code of Practice
The ILO Code of Practice contains recommendations designed to ensure the efficient flow of chemical information from manufacturers or importers to users of chemicals. The Code is also intended to allow employers to formulate measures to project workers, the public and the environment. The subjects covered by the Code include classification systems, labelling and marking, chemical safety data sheets, design and installation, control measures, work systems, personal protection, information and training, medical surveillance, emergency procedures, monitoring and reporting, and confidentiality.
3.9.8 Draft Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (PIC Convention)
On 16 March 1998, 95 countries, including Australia, unanimously agreed on a legally binding Convention on international trade and hazardous chemicals and pesticides. The Convention addresses the problems raised by the fact that chemicals and pesticides banned or severely restricted in industrialised countries may still by exported to the developing world. The Convention requires that harmful pesticides and chemicals that have been banned or severely restricted in at least two countries must not be exported unless explicitly agreed by the importing country. The treaty, however, is not a worldwide ban on these chemicals. The Convention currently covers 22 pesticides and five industrial chemicals that have been banned or severely restricted in a number of countries. More hazardous chemicals can be added to the PIC list if they have the potential to damage human health and the environment under their normal conditions of use. The Convention will replace the present voluntary PIC procedure under the Code of Conduct on the Distribution and Use of Pesticides.
3.9.9 OECD Activities
As a member of the OECD, Australia has had involvement in a number of OECD activities related to AgVet chemicals, including the Chemical Accidents Programme and the Pesticide Risk Reduction Project.
Chemical Accidents Programme. The Programme works in three areas: (i) development of guidance on preventing, preparing for, and responding to chemical accidents; (ii) facilitation of information sharing among both OECD and nonmember countries; and (iii) analysis of issues of particular interest to Member countries.
The Programme has produced a number of guidance documents, including Guiding Principles for Chemical Accident Prevention, Preparedness and Response (1992), and subsequently Anticipating and Responding to Health Effects of Chemical Accidents. These documents recommend the establishment of early warning alert systems to warn those potentially affected by an accident or that there is an imminent threat of an accident. Health and medical aspects are also covered, as well as access to data related to chemical composition and toxicology.
Pesticide Risk Reduction Project. This Project is intended to support Member countries` pesticide risk reduction efforts by collecting information on successful approaches to risk reduction. The project is being carried out jointly with the FAO, in recognition that pesticide risks concern both developed and developing countries. In 1996, the Project recommended that work be done on increasing safety by minimising the risk associated with pesticide application and handling.
3.9.10 Negotiations toward a Convention on Persistent Organic Pollutants (POPs Convention)
Over 100 governments met in June 1998, for the first round of talks on an international agreement to minimize emissions and releases of persistent organic pollutants (POPs) into the environment. The Convention is intended to address the growing body of scientific evidence that indicates exposure to very low doses of certain POPs – which are among the most toxic substances ever created – can lead to cancer, damage to the central and peripheral nervous systems, diseases of the immune system, reproductive disorders, and interference with normal infant and child development. Another concern behind the treaty negotiations is the growing accumulation of unwanted and obsolete stockpiles of pesticides and toxic chemicals. The negotiations are focusing on a list of 12 POPs: aldrin, chlordane, DDT, dieldrin, dioxins, endrin, furans, heptachlor, hexachlorobenzene, mirex, PCBs, and toxaphene. Scientific criteria will be developed for identifying other POPs that may be added to the list later. The negotiations are expected to conclude by the year 2000. Australia attended the first round of talks and intends to be present a further negotiations.
3.3.11 Trans-Tasman Harmonisation Scheme
In 1996 Australia and New Zealand created the Joint Implementation Committee for Trans-Tasman Harmonisation of Registration of Agricultural and Veterinary Chemicals under the bi-lateral Closer Economic Relations Trade Agreement. This committee has been working on the operational harmonisation of AgVet chemical registration between Australia and New Zealand.
4. State regulation of AgVet Chemicals (with particular emphasis on NSW)
Given that Constitutionally, States have traditionally been viewed as possessing authority for the regulation of AgVet chemicals past the point of sale, it is important to have a basic understanding about the legal framework in place in the States the currently control the use of pesticides in the post-registration context. This understanding highlights the deficiencies in existing law in terms of post-registration monitoring of the health effects of AgVet chemical use.
4.1 Brief Overview of State and Territory Regulation of AgVet Chemicals
The administration of legal regulations governing the use -- as opposed to registration -- of agricultural chemicals rests generally and historically with the agriculture and/or health departments of most State and Territory governments.
In Victoria, for example, the Agricultural and Veterinary Chemicals (Control of Use) Act 1992, enacts offences for the use of unregistered AgVet chemicals and prohibits a chemical from being used in a way other than for the purposes listed on its label. The Act, like most State Acts, imposes restrictions and prohibitions on manufacture, sale and use of AgVet chemicals. It also enacts controls on the aerial spraying of these chemicals, including licencing and security requirements.
The question of chemical residues in food substances as a by-product of chemical spraying has also attracted the attention of State regulators, and moves have been made to ban the sale of products with unacceptable concentrations. In Western Australia, for example, the Agricultural Produce (Chemical Residues) Act 1983 aims to establish maximum residue limits, and to ensure that produce containing unacceptable levels is not used in the manufacture of foodstuffs. Produce suspected of containing residues in excess of maximum prescribed limits can be “quarantined”. Additionally, land where excess chemical residues are likely to occur in any produce harvested from that land may be taken out of production for grazing or crop growing purposes.
Besides these rather limited control-of-use requirements, there does not appear to be any State or Territory that provides for a health monitoring program in connection with the use of and exposure to AgVet chemicals. Indeed, in no State is there a provision for the public’s right to know about the use of or potential exposures to AgVet chemicals.
4.2 The Regulation of AgVet Chemicals in NSW
4.2.1 Pesticide control
The Pesticides Act 1978 (NSW) mainly controls the use of pesticides by consumers. It had broader control over pesticides, but the AgVet Acts have suspended many of its provisions in particular, registration of pesticides is now dealt with under the AgVet Acts. The Pesticides Act is administered by the Environment Protection Authority, which has a Pesticides Registrar. The Pesticides Act defines “pesticides” to include agricultural chemical products and veterinary chemical products that are used for the external control of ectoparasites of animals.
4.2.2 Registration, permits and orders for pesticides
Registration. As discussed above, the NRA is responsible for registering: (i) all pesticides that
can be used in NSW; (ii) the containers and labels that must be used for each pesticide; and (iii) the purposes for which each pesticide can be used. Registration of a pesticide and approval of a label under the AgVet Code is taken to be registration for the purposes of the NSW Pesticides Act.
Permits. It is possible to get permission from the EPA’s Pesticides Registrar, in addition to the NRA to use an unregistered pesticide. The Registrar can issue a permit if satisfied that there are reasonable grounds for the pesticide not being registered.
Orders. The Pesticides Registrar can also make orders, with the consent of the Minister for the Environment, to allow activities which would otherwise be offences under the Pesticides Act. The Registrar may make orders to allow specified pesticides to be used in circumstances where the quantities involved do not make it economically worthwhile for the manufacturer or supplier to apply for registration.
4.2.3 Restricted Pesticides
Some pesticides are categorised as “restricted pesticides” by the Pesticides Act. Restricted pesticides may only be used in accordance with a certificate of competency by the Registrar, and any conditions on the certificate.
4.2.4 Stock medicines
Stock medicine is defined as a veterinary chemical product within the meaning of the AgVet Code, excluding a chemical product used for the external control of ectoparasites of stock. In other words, stock medicines are all veterinary chemical products other than pesticides.
The NRA is responsible for assessment, registration and controls over supply of stock medicines. The NSW Department of Agriculture retains residual control under the Stock Medicines Act 1989 (NSW) over the use of stock medicines once purchased. The basic division of functions between the NRA and the Department of Agriculture occurs at the point of sale.
4.2.5 Registration, permits and orders for stock medicines
The NRA is responsible for registration of stock medicines for use in New South Wales. Registration of a stock medicine or approval of a label under the AgVet Code is taken to be registration of the medicine or label for the purposes of the Stock Medicines Act.
It is an offence under the Stock Medicines Act to: (i) sell, possess or use unregistered stock medicines; (ii) use registered stock medicines for an unauthorised purpose; or (iii) fail to inform a buyer of stock that it has been treated with a medicine for which there is a withholding period, of the treatment given and the date of expiry of the withholding period.
In practice, the authorised purposes for which a registered stock medicine can be used are those set out on the registered label(s) or in instructions sold with the container. Veterinary surgeons are exempt from a number of these offences in carrying out their work. You have a defence to possessing or using an unregistered stock medicine if it was supplied by a veterinary surgeon. If you used an unregistered stock medicine, it is a defence to establish that you didn’t know it was unregistered and had no reasonable grounds for suspecting that the stock medicine was unregistered.
4.2.6 Powers of the Director-General of Agriculture
The Director-General of Agriculture may issue a permit to use an unregistered stock medicine. The Director-General can make orders with the consent of the Minister for Agriculture, allowing activities that would otherwise be offences under the Act.
In practice the Director-General often grants permits and orders in circumstances where the quantities of stock medicine involved are too small to make it economically worthwhile for the manufacturer or supplier to apply for registration.
The Director-General may also make orders that: (i) prohibit or regulate the supply and use of a particular stock medicine; (ii) require a supplier to recover a stock medicine; or (iii) require landholders to mark stock treated with the stock medicine.
4.2.7 Control of crop dusting and aerial spraying
Under the Pesticides Act, both pilots and aircraft must have pesticide licences to conduct aerial spraying of pesticide and fertilizers. The Pesticides Act contains controls and reporting requirements relating to the application of pesticides and fertilisers from aircraft.
Pilots must not spray pesticides from aircraft within 150 metres (horizontally) from the boundary of any dwelling, school premises, factory premises or public place without the consent of the owner or occupier. Pilots who spray within the 150 metre buffer zone are guilty of an offence. There is no requirement for a 150 metre buffer zone if ground rigs rather than aircraft are used to apply the pesticide.
The Department of Urban Affairs and Planning recommends that Local Councils incorporate a 150 metre buffer between development and land where agricultural management may involve aerial spraying of pesticides. It also recommends that Draft Local Environmental Plans rezone land to take the 150 metre rule into account.
4.2.8 Special controls for environmentally hazardous chemicals
The Environmentally Hazardous Chemicals Act 1985 (NSW) is administered by the Environment Protection Authority (EPA) and provides for stringent controls over organochlorine pesticides no longer in use, for example: chlordane, DDT, dieldrin, lindane and heptachlor. New pesticides are normally assessed and registered by the NRA under the National Registration Scheme. However, the EPA can assess existing pesticides and make Chemical Control Orders (CCOs) to further restrict the handling and use of those pesticides.
4.2.9 Declared chemical wastes and chemical control orders
The EPA may declare a substance to be chemical waste if satisfied that: (i) the substance is, or is likely to be stored in accumulating deposits; (ii) the substance is, or is likely to be, dumped or abandoned; or (iii) the substance is “otherwise dealt with as chemical waste”. The EPA will usually consider whether the waste is hazardous or toxic in some fashion before declaring it to be chemical waste. General pesticide wastes and used pesticide containers have been declared as chemical wastes.
The EPA can make Chemical Control Orders over declared chemical wastes. Chemical Control Orders can: (i) prohibit activities; (ii) impose conditions on activities; and (iii) require licensing of activities, in relation to a declared chemical waste. Activities regulated may include storage, processing, transportation and/or disposal of the chemical waste. The EPA must keep a register of all declared chemical wastes and CCOs.
The EPA has also issued Scheduled Chemical Wastes Chemical Control Order 1994 in relation to specified waste.
4.2.10 Chemical residues
The NSW Environment Minister and the EPA have power under the Pesticides Act to control pesticide residues in foodstuffs that are situated at the farm, in storage or being transported. An EPA inspector may issue a notice that states how a specified foodstuff must be dealt with, if the inspector believes that a foodstuff contains a prohibited residue. The Minister may order destruction of a foodstuff that is subject to an inspector’s notice.
4.2.11 Prohibited Residues
A residue is prohibited if it is in excess of the maximum residue limits set by the Commonwealth Department of Health and Aged Care. Maximum allowable concentrations of residues in various substances are set out in the Pesticides Regulation 1995.
4.2.12 Stock (Chemical Residues) Act 1975 (NSW)
The Stock (Chemical Residues) Act is concerned with the effect on stock of chemicals. The Minister may by order in the Gazette declare that stock containing more than a specified level of a particular residue in their body tissues or certain secretions are “chemically affected”. The Minister may also declare in the Gazette that stock which have been treated with or exposed to a stock medicine or other specified substance are chemically affected. NSW Agriculture inspectors are able to enter land and take specimens from any head of stock or carcass in order to ascertain whether particular stock are chemically affected.
The Minister or a specified officer may issue a detention notice that prevents indefinitely the movement of chemically affected stock. Inspectors may order temporary detentions of residue affected stock. If the Minister is of the opinion that stock is likely to become chemically affected by grazing on particular land the Minister can by notice in the Gazette restrict the use of that land. The Minister may also order the destruction or disposal of residue affected stock if there is no reasonable possibility that such stock would ever cease to be chemically affected.
5. Commonwealth functions, powers and responsibilities with respect to the regulation of agricultural chemicals beyond the point of product registration
A paramount part of this Report is to determine whether Constitutional and legislative authority currently exists to establish a national health monitoring program for AgVet chemicals. Accordingly, this section examines the functions, powers and responsibilities of the most relevant statutory authorities operating in the field at a national level.
5.1 Functions, powers and duties of the NRA in connection with AgVet Chemicals
As mentioned above, the NRA derives its powers from two principal statutory sources: the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cth)(Administration Act) and the Agricultural and Veterinary Chemicals Code Act 1994 (Cth)(Code Act). It also has whatever powers are conferred on it by the AgVet Regulations as well as any functions and powers conferred on it by the laws of any State.
5.1.1 Enabling legislation
It is plain the under the above-mentioned statutes and regulations, that the NRA possesses significant power to establish and implement a health monitoring program. Under s 7 of the Administration Act the NRA core functions and powers include the following:
Ø to assess the suitability for sale in Australia of active constituents for proposed or existing chemical products, chemical products and labels for containers for chemical products;
Ø to provide information to the Governments and authorities of the Commonwealth, the States and the participating Territories about approved active constituents for proposed or existing chemical products, registered chemical products and approved labels for such products and to cooperate with those Governments and authorities on matters relating to the management and control of chemical products;
Ø to evaluate the effects of the use of chemical products in the States and participating Territories;
Ø to cooperate with Governments and authorities of the Commonwealth, the States and the participating Territories for the purpose of facilitating a consistent approach to the assessment and control of chemicals;
Ø in cooperation with Governments and authorities of the Commonwealth, the States and the participating Territories, to develop codes of practice, standards and guidelines for, and to recommend precautions to be taken in connection with, the manufacture, export, import, sale, handling, possession, storage, disposal and use of chemical products in the States and participating Territories;
Ø to collect, interpret, disseminate and publish information relating to chemical products and their use;
Ø to encourage and facilitate the application and use of results of evaluation and testing of chemical products;
Ø to exchange information relating to chemical products and their use with overseas and international bodies having functions similar to the NRA`s functions;
Ø to encourage and facilitate the introduction of uniform national procedures for control of the use of chemical products;
Ø to fund, and cooperate in, a program designed to ensure that active constituents for proposed or existing chemical products, chemical products, and labels for containers for chemical products, comply with the AgVet Codes and the AgVet Regulations.
The NRA also has the power to do all things necessary or convenient to be done in connection with the performance of its functions, including the power to do anything incidental to any of its powers or functions.
In the performance of its functions and the exercise of its powers, the NRA is to have regard to the Commonwealth Government`s policy in relation to the principle of ecologically sustainable development and, in particular, to the need to use, conserve and enhance the community`s resources so that ecological processes, on which life depends, are maintained, and the total quality of life, now and in the future, can be increased.
Under s 161 of the Code Act, the NRA also has the responsibility to receive any new relevant information relating to an approved active constituent for a proposed or existing chemical product or in relation to a registered chemical product. Indeed, any interested person or permit holder that becomes aware of such information has a duty to provide the information to the NRA and failure to do so is an offence. Information is considered to be relevant if, among other things, it shows that the use of a chemical product or its constituents may be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues. Information is also relevant if it shows the use of a chemical product or its constituents may be likely to have an effect that is harmful to human beings or likely to have an unintended effect that is harmful to animals, plants or the environment.
The NRA (as well as the Commonwealth Department of Human Services and Health, and the National Occupational Health and Safety Commission) also has the power under s 159 of the Code Act and s cl 65 of the Code Regulations to require an interested person to provide further information for the purposes of reconsidering the approval of an active constituent, the registration of a chemical product or the approval of a label for containers; or in deciding whether to suspend of cancel a permit in respect of an active constituent for a proposed or existing chemical product or in respect of a chemical product.
5.1.2 NRA plans and charters
In reviewing the NRA’s current Corporate Plan, Operational Plan, and Service Charter, it also is clear that a national health monitoring program easily fits withing its goals, directions and targets. For example, one of the nine strategic directions contained in NRA’s Corporate Plan emphasises that
it is committed to “ensur[ing] existing chemicals meet contemporary standards, consistent with statutory obligations, by rigorous and timely review, and appropriate regulatory activity”.
The current NRA Operational Plan contains a key goal of “facilitat[ing] compliance with the Act through product review, quality assurance and enforcement programs. Additionally the NRA Service Charter indicates that it is dedicated to managing “quality assurance programs that monitor ongoing safety and performance of registered products”. The development of a AgVet chemical health monitoring also accords with the results of a recent NRA survey conducted through NRA News. Over half of the respondents indicated that more information on “adverse reporting experience” about AgVet chemicals would be welcome.
5.2 Functions, powers, and duties of the National Occupational Health and Safety Commission (NOHSC) in connection with AgVet Chemicals
The purpose of the NOHSC is to lead and coordinate national efforts to prevent or reduce the incidence and severity of occupational injury and disease by providing health and safe working environments. Naturally, these include working environments that in anyway involve potential harm caused by AgVet chemicals.
5.2.1 Enabling legislation
The National Commission’s objectives, functions and power are set out in the National Occupational Health and Safety Commission Act 1985 (Cth). NOHSC’s objectives include the: (i) development of community awareness and facilitation of public debate on occupational health and safety (OHS); (ii) provision of a national forum to develop policies and strategies on OHS; and (iii) achievement of a national focus for OHS matters.
Key functions to be exercised by NOHSC are:
Ø to formulate policies and strategies relating to occupational health and safety matters;
Ø to declare national standards and codes of practice;
Ø to collect, interpret and disseminate information relating to occupational health and safety matters;
Ø to direct the conduct of inquiries in respect of occupational health and safety matters;
Ø to publish reports, periodicals and papers relating to occupational health and safety matters;
Ø to consult and cooperate with other persons, organizations and governments on occupational health and safety matters;
Ø to carry out, arrange for, or assist testing of matters and things relevant to occupational health and safety matters;
Ø by arrangement with particular employers, to carry out, arrange for, or assist in the evaluation of occupational hazards in places of work;
Ø to carry out, arrange for, or assist research on occupational health and safety matters;
Ø to encourage and facilitate the application or utilization of the results of that research or testing; and
Ø to do anything incidental to or conducive to the performance of any of the preceding functions.
Importantly, under s 38 of the Commission Act, NOHSC has the power to declare national standards and codes of practice relating to occupational health and safety matters. Under s 39, the NOHSC may also direct that an inquiry be conducted in respect of any occupational health and safety matter.
Under s 29 of the Commission Act, the National Institute of Occupational Health and Safety is established. The Institute is charged with a positive duty to carry out work relating to: research, statistics, testing, training, and other matters (whether or not related to research, statistics, testing or training), as NOHSC determines.
5.2.2 The NOHSC Operational Plan
The NOHSC has a strong commitment to the prevention of worker injury. The NOHSC, in it Operational Plan, states:
Prevention of occupational fatalities, injuries and diseases saves unnecessary human suffering and loss. In addition, the role that prevention plays in business success is being increasingly recognised. The capacity of prevention to deliver productivity improvements to workplaces provides a platform for the National Occupational Health and Safety Commission’s efforts to improve prevention performance.
One of the four major NOHSC program areas is “measuring prevention outcomes in the jurisdictions”. In 1997 Labour Ministers’ Council (LMC), which advises NOHSC on future directions and approves, rejects or modifies recommendations made by NOHSC on national OHS standards, took a more active role in decisions about national prevention efforts. Of course, one important method of prevention is an adequate health monitoring system.
5.3 Functions, powers and duties of the Department of Health and Aged Care in connection with AgVet Chemicals
The Department of Health and Aged Care derives its power, as an executive agency, directly from Chapter II, s 64 of the Australian Constitution. However, the Constitution gives very little guidance as to actual powers, functions and responsibilities of the “departments of State of the Commonwealth” that may be established under s 64. While there are broad Constitutional limitations on what departments can do (for example an executive department could not usurp judicial or legislative power of which it is not possessed), there is very little, if anything, the Constitution that indicates what departments may or must do.
While the Constitution provides little assistance in determining precise powers, functions, and responsibilities of the Department, a look across Commonwealth legislation discloses that the Department or Secretary of the Department are conferred with specific responsibilities in a number of Commonwealth Acts. However, nothing in any of those Acts appears to be relevant to a health monitoring program.
The Department does have a Corporate Plan 1997-98, however, that bears generally on the functions, powers and duties of the Department. The Corporate Plan relates that the Department:
Ø provides expert policy advice and analysis to the Government;
Ø implements Government policy in a way that addresses both individual and population needs, focuses on outcomes and supports the key role of families in providing care and support;
Ø communicates information about health and family services and Government policy reforms;
Ø promotes planning by governments, focused on outcomes for individuals and communities;
Ø promotes investment in prevention and early intervention and incentives for effective, best practice service delivery;
Ø works in partnership with the States and Territories to set objectives, priorities, strategic directions and benchmarks, provide funding, define performance standards, monitor and report on performance against agreed outcomes for the whole health and family services system; and
Ø works in partnership with our stakeholders to ensure the delivery of high quality, costeffective services.
In addition, to these primary functions, there also exists two independent statutory authorities and within the Department, as well as the Division of Public Health, all of which are involved in activities similar to those that would be required of a health monitoring program.
5.3.1 National Health and Medical Research Council (NHMRC)
Enabling Legislation. The NHMRC was first constituted in 1936. The current legislative arrangements are found in the National Health and Medical Research Council Act 1992 (Cth)(NHMRC Act). The Council is a statutory authority within the portfolio of the Commonwealth Minister for Health and Aged Care.
The objects of the Act relate that it is designed to establish a national body to pursue activities:
Ø to raise the standard of individual and public health throughout Australia; and
Ø to foster the development of consistent health standards between the various States and Territories; and
Ø to foster medical research and training and public health research and training throughout Australia; and
Ø to foster consideration of ethical issues relating to health.
Under s 7 of the Act, the functions of NHMRC are:
Ø to inquire into, issue guidelines on, and advise the community on, matters relating to: (i) the improvement of health, (ii) the prevention, diagnosis and treatment of disease, (iii) the provision of health care, (iv) public health research and medical research, and (v) ethical issues relating to health.
Ø to advise, and make recommendations to, the Commonwealth, the States and Territories on any of the five matters referred to above.
Ø to make recommendations to the Commonwealth on expenditure: (i) on public health research and training, and (ii) on medical research and training.
Under s 7, the NHRMC also has the power to exercise any functions incidental to any of the foregoing.
Under s 35 of the NHMRC Act, the appointment of a Medical Research Committee is required. The functions of the Research Committee are:
Ø To advise and make recommendations to the NHMRC on the application of the Fund (the Medical Research Endowment Fund).
Ø To monitor the use of assistance provided from the Fund.
Ø To advise the Council on matters relating to medical research, including the quality and scope f such research in Australia.
Ø Such other functions as the Minister from time to time determines, which currently include: (i) monitoring the outputs and outcomes of research provided from the Fund, and (ii) working with the Strategic Research Development Committee, to absorb successful research initiatives into the mainstream health research effort.
Under s 39 of the Act, the NHMRC has also established the Health Advisory Committee and Strategic Research Development Committee.
The Office of NHMRC provided the terms of reference for the Health Advisory Committee. According to the terms of reference the Committee is:
Ø To inquire into and advise on all matters of health including: (i) health promotion, (ii) illness and injury prevention, (iii) health service delivery, including methods of diagnosis and treatment, (iv) health technology assessment, (v) clinical practice, (vi) the impact or the social and physical environment, (vii) the role of disciplines other than medicine, (viii) the health needs of groups such as Aboriginal and Torres Strait Islanders, women, immigrants, older people, children and adolescents.
Ø To advise Council on administrative and legislative procedures that could be introduced to implement recommendations about health.
Ø To develop standards, guidelines and strategies.
Ø To consult with government, health care professionals and the community.
Ø To prepare reports based on research evidence, submissions and other documents.
Ø To advise Council on ways of informing the community on health matters.
The Strategic Research Development Committee, according to the NHMRC publication The inside guide to the National Health and Medical Research Council for the 19971999 triennium (Sept. 1997), is responsible for:
Ø defining a research and research training agenda based on identified gaps in knowledge and skills;
Ø enhancing the national research capacity, skills and institutional capability to respond in a focused and timely fashion to emerging health research needs;
Ø developing the national capacity to identify, target, generate and link researchbased knowledge which is applicable to programs policies and interventions;
Ø fostering the ability to evaluate the application of researchbased knowledge to programs, policies and interventions in medicine and public health.
The Strategic Research Development Committee’s terms of reference recite that the committee has the following responsibilities:
Ø In areas of underdeveloped health research, to develop and build programs of targeted research which may include: (i) contracted or commissioned research, (ii) investigator initiated research, (iii) training or the provision of scholarships, or (iv) a combination of the above.
Ø To develop, research, evaluate and disseminate information on the concept and practice of targeted research in health.
Ø To seek and integrate advice from the Council, the Australian Health Ministers` Advisory Council, State, Territory and federal Departments of Health, the Australian Research Council, the Australian Institute of Health and Welfare and any other relevant body on current and likely future priorities for targeted research in the context of the international research scene and gaps in the current research effort and emerging issues.
Ø To advise Council and its concordat partners in respect of strategies for translating identified research questions into proposals for targeted research.
Ø To report to Council on the process and outcomes of reviews of all strategic research development initiatives.
Ø To provide a resource to Council and its partners for commissioning research or assessing targeted proposals in specific areas of strategic research development.
Ø To liaise with the Research Committee (Public Health and Medical) in planning and monitoring national research training needs and outcomes.
Strategic Plan. The NHMRC Strategic plan 19972000 identifies the following objectives:
Ø To ensure that Australia maintains and further develops its research effort across all areas of health.
Ø To develop further a strategic research capability so that areas identified to be of importance to health care in Australia where the research effort is currently underdeveloped and emerging health problems can be targeted for special research endeavour.
Ø To ensure that advice is developed which is relevant, timely and informed by evidence and that it reaches its proposed target audiences.
Ø To continue to provide high quality ethical advice with respect to health research and health care.
Ø To enhance the transfer of research and discovery into improvement in quality of care and health outcomes.
In the Strategic Plan, NHMRC has declared that it “will work with others for the health of all Australians, by promoting informed debate on ethics and policy, providing knowledge based advice, fostering a high quality and internationally recognised research base and applying research rigour to health issues”.
In the Strategic Plan, NHMRC dedicates itself to:
Ø asserting the primacy of NHMRC`s goal of improving health throughout Australia;
Ø reaffirming its commitment to excellence and accountability pursued through a strong, innovative and independent NHMRC;
Ø exploiting NHMRC`s unique brief to promote the development and application of knowledge within the health system;
Ø providing mechanisms to strengthen its contributions to high quality health research in the service of the Australian community and to evidence based health care and health promotion;
Ø recognising that public consultation on all issues is vital.
5.3.2 Australian Institute of Health and Welfare (AIHW)
The Australian Institute of Health and Welfare is an independent health and welfare statistics and information agency in the Department of Health and Aged Care. AIHW advises on, plans and coordinates national health statistics developments. To draw together the information the Institute works with health agencies of the Commonwealth and the States and Territories, and with the Australian Bureau of Statistics, under the National Health Information Agreement, and with other bodies outside that Agreement.
Enabling legislation. The AIHW was established under the Australian Institute of Health and Welfare Act 1987 (Cth). AIHW is responsible for both health and welfare functions conferred by the Act. Under s 5 of the Act, the Institute`s healthrelated functions are:
Ø to collect, with the agreement of the Australian Bureau of Statistics and, if necessary, with the Bureau`s assistance, healthrelated information and statistics, whether by itself or in association with other bodies or persons;
Ø to produce healthrelated information and statistics, whether by itself or in association with other bodies or persons;
Ø to coordinate the collection and production of healthrelated information and statistics by other bodies or persons;
Ø to provide assistance, including financial assistance, for the collection and production of healthrelated information and statistics by other bodies or persons;
Ø to conduct and promote research into the health of the people of Australia and their health services;
Ø to publish methodological and substantive reports on work carried out by or in association with the Institute under this subsection;
Ø to make recommendations to the Minister on the prevention and treatment of diseases and the improvement and promotion of the health and health awareness of the people of Australia; and
Ø to do anything incidental to any of the foregoing.
Under s 6 of the Act, the Institute also has to power to, among other things, (i) release data to other bodies or persons, (ii) publish the results of any of its work; and (iii) to do anything incidental to any of its powers.
Plans and Reports. The AIHW Corporate Plan 1996-1999 states that the mission of the Institute is to inform community discussion and decision making through national leadership in the development and provision of authoritative and timely information and analysis on the health and welfare of Australians.
According to the Corporate Plan, the major goal and purpose of the AIHW is to be the leading agency in Australia in coordinating, developing, collecting, and analysing data, and disseminating accurate, consistent and timely information and statistics, on the health of Australians and their health and welfare services. AIHW seeks to be the national authority on information about health and health and welfare, and to be recognised as such by all levels of government and the wider community.
The AIHW Annual Report 1996-97 indicates that the Institute is presently carrying out a program of surveillance of injuries nation-wide. The discussion of the surveillance program indicates a many similarities to the health monitoring program being proposed by the Community Consultative Committee. The Annual Report states:
The National Injury Surveillance Unit undertakes public health surveillance of injury at the national level to support injury prevention and control. It engages in all aspects of surveillance, and places special emphasis on analysis and dissemination of information, and on developing injury surveillance methods. It also provides a national contact point for liaison and information sharing on injury control, produces information resources, and encourages training and research. . . .
Efforts were continued and extended to improve existing data sources and to develop new ones, including planning and commencement, at the end of the year, of a project to investigate the practicability of obtaining quantitative national estimates of injury visits to emergency departments.
The set of data items and classifications for injury surveillance published as the National Data Standards for Injury Surveillance, Version 2.0, was revised in consultation with injury surveillance and prevention personnel throughout Australia. Mechanisms to improve communication between the injury surveillance sector and health information processes were developed.
At the invitation of the Department of Health and Family Services, a project for the development of an injury surveillance system based on a national probability sample of emergency department cases was designed.
The AIHW Annual Report goes on to say that the Institute has been given the lead role for information infrastructure development under the National Public Health Partnership. A National
Public Health Information Working Group, under the chairmanship of the Institute Director, has canvassed the scope of national public health information. The Working Group also plans to take a strategic approach to identifying key public health information issues, determine gaps in the information base and ensure consistent definitions and classifications for national use.
Following Meeting the National Needs for Public Health Information, a review of the statistical information needs of the Public Health Division of the Department of Health and Aged Care by the Institute`s Principal Research Fellow, the Institute signed a Memorandum of Understanding (MOU) with the Department to provide statistical and health information services. Unfortunately, it has not been possible to obtain a copy of the MOU.
The Annual Report also indicates that the Australian Health Ministers` Advisory Council has granted the Institute a sum of $63,000 for developing a framework to monitor the health of young Australians. A working group, consisting of distinguished child and youth health professionals, is being established to develop the framework. This framework will form the basis of biennial reports on the health of children and young adults, under the MOU signed with the Public Health Division of the Department, beginning in 1998.
The Annual Report also describes a number of Disease Registers maintained by AIHW, including the National Cancer Statistics Clearing House and the National Death Index and mortality surveillance. AIHW also became involved in cardiovascular disease monitoring. To overcome the deficiency of national data on medical and surgical care for cardiovascular disease, the Institute has examined the potential to enhance the angioplasty and surgery databases established by the National Heart Foundation, to create a national cardiovascular procedures database. It has also commenced compilation of a national register of cardiovascular disease monitoring activity.
5.3.3 Public Health Division
In addition to the NHMRC, the Department of Health and Aged Care also has a Public Health Division (PHD). The PHD is a major part of the Department and is responsible for national leadership in important public health matters that is responsive to current and emerging threats, and which effectively promotes and protects the public health.
The current Business Plan for PHD states that the role of the Public Health Division in the Commonwealth Department of Health and Aged Care is to forge and maintain Public Health partnerships which enable:
Ø agreement on national priorities for public health action linked (inter alia) to National Health Priority Areas;
Ø effective planning, implementation and coordination of national and international strategies and interventions;
Ø monitoring, evaluating and reporting on outcomes;
Ø strengthening and monitoring national public health infrastructure, such as research, information, continuous improvement programs, workforce, surveillance and legislation; and a stronger profile for public health in Australian society.
PHD has established a “Public Health Development and Programs”, which has as its objective a strong national public health capacity and effective national leadership. It includes activities aimed at understanding and controlling the determinants of disease, promoting good health, and reducing public exposure to risks encountered as part of lifestyle or in the environment. These activities are, in the main, the responsibility of the National Centre for Disease Control and the Public Health Promotion and Protection Branch in the Public Health Division.
The business plan also mentions of the development of a Rural Public Health Strategy. A number of calls to PHD revealed that the Health Ministers’ Council has taken control of the Strategy and that, at least in earlier draft, a health monitoring program for agricultural and veterinary chemicals was included for consideration.
6. Legislative Options for an AgVet Chemical Health Monitoring Program
In an ideal world, the preferable legislative option for establishing a national HMP would be the enactment of a specific law designed for that purpose. Such a law would set the parameters of the HMP, establish administrative responsibilities, detail reporting requirements, provide for access to information, and outline other key elements. Both temporal and political considerations make the likelihood of achievement of this option difficult. Nevertheless, it is an option that is worth pursuing in the long-term.
In the short to medium-term, however, existing legal arrangements would allow the establishment of a less well defined HMP under the auspices of the Commonwealth, either with or without the cooperation of the States and Territories. Of course, an effective HMP will have to rely on information collected at a State and local level to a very large degree. Accordingly, while this report reviews the option of an exclusive Commonwealth HMP, it recommends that the best HMP currently available will include a cooperative arrangement between the Commonwealth and the States.
6.2 Existing legal authority
At the outset, in reviewing legislative options for a national HMP it is important to consider the possibilities presented by the status quo. Despite that fact that neither the Commonwealth nor any State has an existing health monitoring program, the review of the current legal framework above indicates that legal authority already exists for the establishment of an HMP.
Three avenues exist by which existing legal framework might be extended to establish a national health monitoring program. First, the current limited monitoring programs administered by the National Registration Authority (NRA) and the National Occupational Health and Safety Commission (NOHSC) which address or include AgVet chemicals, provide a legal basis for adding a health monitoring component similar to that envisioned by the Community Consultative Committee (CCC). Second, a number of post-registration chemical review programs could and should be expanded to include a health monitoring program. Indeed, these review programs are currently deficient because they do not include a formal mechanism for collecting data on health effects. Third, a number of Commonwealth statutory authorities currently possess the explicit authority, by virtue of enabling legislation, to establish an effective national HMP.
Each of these options are addressed in turn below. Additionally, various commitments made by government supporting the establishment of health monitoring and access to information are highlighted.
6.2.1 Extending existing limited monitoring programs
Adverse Experience Reporting Program. The most compelling case for the legal authority to establish of a national HMP can, perhaps, be found in s 161 of the Code Act. As discussed above, under that provision the NRA has established an Adverse Experience Reporting Program to hear and investigate problems associated with the use of veterinary chemicals. Section 161, however, is not limited to veterinary chemicals. Its focus is on all chemical products, including both agricultural and veterinary chemicals.
Moreover, the provisions of s 161 are broad enough to include the type of HMP, envisioned by the Community Consultative Committee. Nothing in s 161, besides relevance, limits the type of information that the NRA is responsible for receiving relating to chemical products. Accordingly, it would appear that s 161 permits the establishment of an HMP that would allow data to be collected from individuals, health professionals, industry and government studies, and international experience.
There is, however, at least one drawback in attempting to use this framework for establishing a HMP. As indicated above, a discussion with the NRA about the program revealed that it is primarily funded by the AgVet chemical industry. In such a circumstance the potential for “agency capture” is always present. Moreover, it is doubtful whether agency being funded by the industry it is intended to regulate is an appropriate regulator.
Surveillance and monitoring under the NOHSC Code of Practice. Under the National Code of Practice for the Control of Workplace Hazardous Substances, a more limited opportunity for using the existing legal framework for an HMP is present. The Code itself sets the limits the breadth of regime of health surveillance and monitoring it establishes. Firstly, it is limited to “hazardous substances”, which is a much smaller subset of AgVet chemicals. Secondly, it pertains only to duties imposed on employers for surveillance and monitoring. Finally, the Code is limited by NOHSC ability to declare codes of practice relating to health and safety matters, and not more broadly.
Nevertheless, the existing Code provides a mechanism for incorporating the formal monitoring of AgVet chemicals in the occupational health and safety context. Under the Code, health surveillance and monitoring should take the following factors into consideration:
Ø the nature and extent, including duration, of exposure;
Ø the changes attributable to exposure which may occur in exposed workers and the likelihood that a disease or adverse health effect may occur, which must both be related to the nature and degree of exposure;
Ø the frequency at which any changes may be expected to occur;
Ø an assessment of available epidemiological information on human exposure and toxicological data;
Ø the sensitivity, specificity and reliability of the detection and measurement of these changes;
Ø the remedial action which is available to reverse or arrest these changes; and
Ø the resources and levels of competence required to perform the necessary detection and/or measurement procedures.
6.2.2 Extending Commonwealth AgVet chemical review programs
As this Report has made clear, there are a number of Commonwealth legislative and/or administrative programs that do indeed address public health issues related to AgVet chemicals after they are registered. The glaring problem, however, with all these programs is that they are formally incomplete because they do not incorporate a HMP to ensure the adequacy of information for decision-making.
Existing Chemicals Review Program and Special Review Program. These review programs run by the NRA highlight that public health concerns about AgVet chemicals that come to light after registration will allow the amendment of conditions of registration or, indeed, the withdrawal of such chemicals. However, the way in which these concerns become manifest is presently a matter of luck. There is no systematic mechanism in place to collect information about possible health problems associated with the use of or exposure to registered AgVet chemicals.
Yet, the NRA has the power under s 7 of the Administration Act to both collect information relating to chemical products and their use, as well as to evaluate the effects of the use of chemical products. Accordingly, it would appear that there is legal authority to enhance both of these review programs by including the necessary missing component -- a HMP.
Material Safety Data Sheets. Under the National Code of Practice for the Preparation of Material Safety Data Sheets manufacturers and importers have a duty to review and, if necessary, reissue a MSDS in the following circumstances:
Ø whenever there is a change in formulation which: (i) affects the hazardous properties of the substance, (ii) alters the form or appearance of the substance, or (iii) alters the mode of application of the substance;
Ø whenever there is a change to the substance which alters its health and/or safety hazard or risk;
Ø whenever new health and/or safety information on the substance becomes available; or
Ø to reflect new regulations and standards.
In all cases however, the review and, if necessary, reissue of an MSDS shall be no longer than five years after the last date of issue. However, like the Existing Chemicals Review Program and Special Review Program, there is no systematic mechanism in place to collect information about possible health problems associated with the use of or exposure to registered AgVet chemicals.
Yet, like the NRA, the National Occupational Health and Safety Commission, currently has the power to collect information relating to occupational health and safety matters. Of course, there can be little doubt that this information could include information generated by a HMP. Accordingly, it would appear that there is legal authority to enhance the review of MSDS by establish a specific mechanism for collecting information generated by a HMP.
Maximum residue limits. Current law provides that existing MRLs can be reconsidered if new data become available which shed light the health effects of a residue. However, like the provision for reviews in connection with the Existing Chemicals Review Program, the Special Review Program and Material Safety Data Sheets, no health monitoring system is in place to ensure that new data comes to light.
One of the functions of the Australia New Zealand Food Authority (ANZFA), which has the responsibility for assessing the dietary exposure resulting from the use of AgVet chemicals, is to review standards, including MRLs, contained in the Food Standards Code. Nothing indicates the manner or form in which the review must take place. Accordingly, it would appear that the ANZFA could institute a HMP in order to assist in making its reviews effective.
6.2.3 Reliance on existing power of Commonwealth statutory authorities and Department of Health
As discussed above in Section 5, a number of Commonwealth statutory authorities appear to have broad legislative power that would allow them to establish a HMP. In particular, the National Registration Authority (NRA), the National Occupational Health and Safety Commission (NOHSC), National Health and Medical Research Council (NHMRC), the Australian Institute of Health and Welfare (AIHW), and more generally the Public Health Division of the Department of Health and Aged Care (PHD), all appear to be possessed of sufficient authority to institute a HMP. The most pertinent legal authority is set out below.
NRA. Among other things, the NRA has specific power under s 7 of the Administration Act to collect any information relating to chemical products, including the sort of information and data that would be obtained by the proposed HMP. It also has the responsibility to evaluate the effects, including the health effects, of the use of chemical products. Clearly, based on these powers alone it would appear that the NRA could institute a national HMP.
Moreover, the NRA is committed in its Corporate Plan to ensuring that chemicals meet contemporary standards and its Service Charter indicates it is dedicated to quality assurance programs that monitor ongoing safety and performance of registered products. It is plain that a HMP is one necessary way to meet these goals.
NOHSC. In the more limited context of occupational health and safety (OHS), NOHSC is empowered under the Commission Act to collect and disseminate any information relating to OHS matters. Besides the limited context in which this power of NOHSC operates, it is nonetheless similar to the power of the NRA, and would appear to include the power to collect information that would necessarily include information of the sort envisioned to be gathered by a national HMP.
Department of Health and Aged Care. As noted above, the Department derives its powers directly from s 61 of the Constitution as an Commonwealth department of State. The power set out in s 61 provide little, if any, detail about precise functions, powers, and duties conferred and imposed on government Departments. There can be little doubt, however, that those powers are very wide. In Barton v Commonwealth (1974) 131 CLR 477, the High Court held that s 61:
enables the Crown to undertake all executive action which is appropriate to the position of the Commonwealth under the Constitution and to the spheres of responsibility vested in it by the Constitution.
Some idea about the scope of these powers can be gleaned from Victoria v Commonwealth (the AAP case)(1975) 134 CLR 338 and Davis v Commonwealth (1988) 166 CLR 79. In the AAP case, the High Court divided on the question of whether s 61 of the Constitution authorised the executive government to oversee the coordination of community-based welfare services throughout Australia. There was, however, significant support for the proposition that “the executive power of the Commonwealth . . . exercisable by the Governor-General” extended beyond those powers which are expressly conferred on the Governor-General, as the titular Chief-Executive of Australia, by the Constitution or legislation and includes those functions, powers and privileges that can be described as inherent in a national government.
This approach was endorsed by a majority of the High Court in the Davis case, in order to support its conclusion that the commemoration of the bicentenary of European entry into Australia was “pre-eminently the business and the concern of the Commonwealth as the national government and as such falls fairly and squarely within the federal executive power”. In reaching this conclusion, Brennan J, emphasised that s 61 confers on the Executive branch of government “power to engage in enterprises and activities peculiarly adapted to the government of a nation and which cannot otherwise be carried on for the benefit of the nation”. For the majority of the Court this means that executive power of the Commonwealth is not exclusively restricted to matters within the heads of legislative power, but have considerable elasticity.
Based on the foregoing, a reasonable argument can be made that the Department of Health has ample authority to establish a national health monitoring program. A national HMP is an enterprise in which there is a need for national action and in which the States cannot engage effectively by themselves. Indeed, intervention to monitor and protect human health and safety is best accomplished at the national level. After all as the National Environment Protection Council Act 1994 makes clear, every Australian, no matter where he or she lives, is entitled to equal protection from the dangers and risks associated with agricultural chemicals and their residues. Moreover, uniform national regulation in this area would decrease the likelihood of economic and social dislocation resulting from competitive disadvantages between geographical regions. One clear way in which to help ensure that the environmental health of all Australians receives equivalent protection is through the establishment of a national HMP.
This conclusion is supported by the activities already carried out by the Public Health Division (PHD) of the Department. PHD’s business plan states that part of its role is to strengthen national public health infrastructure, including information and surveillance systems and activities. It is clear that a national HMP falls within this role and would support that part of PHD’s mission directed at reducing public exposure to risks encountered in the environment. Indeed, it appears that a national HMP was being explicitly contemplated in the development of the PHD’s Rural Public Health Strategy.
The conclusion that the Department of Health has the power to establish a national HMP is also supported by the express powers conferred upon two independent statutory authorities within the Department: the Australian Institute of Health and Welfare (AIHW) and the National Health and Medical Research Council (NHMRC).
AIHW. Under s 5 of the Australian Institute of Health and Welfare Act 1987, AIHW is responsible for collecting health-related information and statistics, whether by itself or in association with other bodies or persons. It is also charged with the duty to produce health-related information and statistics and provide assistance, including financial assistance, for the collection and production of health related statistics by other bodies or persons. In connection with these functions, AIHW has the power to anything necessary or incidental to their exercise.
It is clear that these powers are broad enough to include the development and implementation of a national HMP. Indeed, the AIHW has already engaged in monitoring and surveillance activities under these powers through its National Injury Surveillance Unit. The AIHW 1996-97 Annual Report indicates that the Unit engaged in all aspects of public health surveillance of injury at the national level to support injury prevention, and placed special emphasis on dissemination of information.
Additionally the AIHW has placed a special emphasis on monitoring the health of young Australians. This monitoring program, however, is currently incomplete because it does not appear to include specific monitoring of the health effects of AgVet chemicals. This component of monitoring is essential because as Kate Short has emphasised in her book Quick Poison, Slow Poison: Pesticide Risk in the Lucky Country, children’s chemical risk is greater than adults because their immune systems are still developing and their bodies retain more chemicals.
NHMRC. It is less certain under the present legal arrangements how a HMP could be established under existing authority of the NHMRC. However, the NHMRC does have broad powers under which it is arguable that the power exists. In particular, under s 7 of the NHMRC Act, the Council has the power to inquire into matters relating to the improvement of health and the prevention and diagnosis of disease, as well as to exercise any function incidental to these powers. A reasonable argument can be mounted to the effect that the combination of these powers support NHMRC authority to institute a HMP. The collection of data for a HMP involves an examination of matters relating to the improvement of health and the prevention and diagnosis of disease. At the very least an HMP should be seen as part of a function incidental to these powers because it would support them.
6.2.4 Support indicated in National Strategy related to AgVet Chemicals
A number of national strategies canvassed above in Section 3 also bear upon the a national HMP. For instance, the Discussion Paper on the Collection, Storage and Destruction Scheme for Unwanted Farm and Household Pesticide explicitly recognised that it was relying on incomplete health monitoring data in identifying the problem it is designed to address. This is because, at least in part, there is no national HMP in place to effectively collect data. The same is true of the National Strategy for the Management of Chemicals Used at Work, which recognises that data currently collected does not adequately describe either chemical exposures or chemically related diseases and injuries.
Perhaps more importantly than these deficiencies, however, is that a number of strategies that have been developed and endorsed by governments evince a strong commitment on the part of the Commonwealth government to the underlying idea a national HMP.
AgVet Strategy. A key objective of the AgVet Strategy is to minimise risks posed by AgVet chemicals to human health and the environment. The Strategy highlights that these risks stem from the lack of reliable information on the extent of chemical use and their health and environmental impacts. Importantly, the Strategy emphasises “the need to collect meaningful information on chemical use” and recommends “developing coordinated and systematic approaches to post-registration monitoring and assessment of the direct and indirect effects of chemicals on human health”.
National Ecologically Sustainable Development Strategy. The Strategy contains a prime objective of improving “effective and safe management of agricultural and veterinary chemicals while improving levels of, and access to information on these chemicals”. It is certain that the development of a HMP such as is being proposed by the Community Consultative Committee would help ensure that this objective is met.
National Environmental Health Strategy. This Discussion Paper recognises the need for better management tools in protecting and improving environmental health. It emphasises the need to assess the changes of environmental health risks over time so that policy makers and regulators have necessary information to make the best possible risk management decisions. In order to achieve this goal, the Discussion paper explicitly points out the need for “ongoing surveillance of environmental hazards” and recommends the establishment of “a national environmental health surveillance system”, together with an “information clearinghouse”. Again, it is certain that the development of a HMP such as is being proposed by the Community Consultative Committee would help ensure that this objective is met.
6.3 The appropriate legal framework for a national health monitoring program
Based on the foregoing, it seems clear that there already exists the legal power to create a national health monitoring program. However, it is also necessary to consider what sort of legal framework within which it should exist. This section examines three principal arrangements that might be employed to implement a HMP: (i) self-regulation, (ii) federal preemption of the field, and (iii) a cooperative federal arrangement. The sections concludes that given the historical, legal and political context in which a national HMP would be placed, a cooperative federal arrangement would be best suited to coordinating the implementation of the HMP.
6.3.1 Self-regulation by industry
A steady drumbeat of criticism has placed public health and environmental regulation under siege, compelling affected government agencies to reexamine their methods of controlling agricultural and industrial practices. The primary target of these efforts is the so-called “command and control” framework that is the basis for most existing rules. Command and control rules impose detailed, legally enforceable standards, conditions and affirmative requirements on agricultural and industry operators.
The most prominent alternative to command and control is what has been termed “self-regulation” by legal scholars to connote alternative compliance plans conceived of by regulated entities. Government may specify broad performance standards but, it is argued, in the name of market efficiency, should leave the design of the means used to achieve those standards up to the discretion of the regulated entity.
In the context of this Report, the criticism of traditional regulation is misplaced. Such criticism ignores vitally important considerations involving effective protection of human health and the environment because of a myopic focus on economic inefficiency. Any monitoring or regulatory system that involves protection of public health and the environment must function despite a number of practical realities for which excessive preoccupation with theoretical efficiency fails to account. These realities include pervasive uncertainty, high decision-making costs, and manipulative strategic behaviour resulting from conflicting private and public interests.
Under these realistic constraints, the indisputable fact that “command and control” standards may be less that 100% efficient does not prove that any other approach would necessarily perform better. The critical issue is not which regulatory system aspires to ideal “efficiency”, but which is most likely to prove effective. It is here that a more, not less stringent, legislative framework for the monitoring and regulation of agricultural chemicals has the overriding advantage implementing health-based standards that can effectively protect human health and the environment from threats posed by agricultural chemicals and their residues.
Moreover, in terms of market efficiency, it is clear that legislative regulation has a number of additional salutary advantages. These advantages include: (i) decreased information collection and evaluation costs, (ii) cost savings due to greater consistency and predictability of results, (iii) benefits flowing from greater accessibility of decisions to public scrutiny and participation, (iv) savings due to reduced opportunities for avoidance behaviour by government agencies in response to political pressures, (v) savings due to reduced opportunities for obstructive behaviour by regulated parties, and (vi) establishment of a regulatory level playing field for all market participants.
Accordingly, this Report recommends against self-regulation in the context of a national health monitoring program.
6.3.2 Federal Preemption of the Field
One legislative option to establish and implement a national HMP might be for the Commonwealth to assume complete control. This might be accomplished either under new, specifically designed HMP legislation, or under the authority under existing arrangements outlined above in Section 6.2.
If the Department of Health were to employ its existing Commonwealth executive power under s 61 of the Constitution, it is doubtful whether any new grant of legislative power would be required to create a national HMP. Its also probable that such an exercise of power would be constitutionally valid for the reasons explained above in connection with the nature of executive power under s 61 of the Constitution.
If however, the existing functions conferred upon the independent statutory authorities discussed above in Section 6.2.3 were employed to establish a HMP, or if new, specifically designed HMP legislation was enacted, they would have to fall within the heads of Commonwealth legislative power.
Traditionally the authority for regulation of AgVet chemicals has been viewed as constitutionally vested in the States as an incident of the power to control land use and natural resources, as well as the power to protect worker and public health and safety. It is, however, possible to argue that under contemporary constitutional law that the Commonwealth has the power to pass HMP legislation to clarify any of the existing possibilities for implementing a HMP under current law, or to enact new legislation designed to implement a new HMP regime.
A number of powers under the Australian Constitution might be relied on to enact and implement a HMP (ie the trade and commerce power, corporations power, taxation power), but since these powers are significantly limited by the nature of activities and entities that may be regulated, reliance on these particular powers would only partially suffice to establish a HMP and as such it would be formally incomplete and most likely ineffective.
However, it is possible to argue that the Commonwealth has the legislative authority to establish a comprehensive national HMP under the external affairs power. Section 51(xxix) of the Australian Constitution authorises the Commonwealth parliament to legislate with respect to “External affairs”. Over the past 3 decades, this power has been interpreted and applied by the High Court to expand the reach of Commonwealth legislative power, in line with the growth of the international agenda. As one well know commentator has observed, the external affairs power provides the bases for shifting the distribution of legislative power within Australia from the States to the Commonwealth, to match Australia’s increasing commitments with the world order.
The High Court has recognised that the external affairs power can be utilised by the Commonwealth in four different circumstances, including to legislate on matters physically external to Australia and on matters of “international concern”.
Matters physically external to Australia
In Polyukhovich v Commonwealth (1991) 172 CLR 501, five member of the High Court clearly endorsed the proposition that s 51(xxix) will support federal legislation dealing with persons,
activities or things outside Australia. Accordingly, any health monitoring done outside of Australia by AgVet chemical manufactures, suppliers or users, could be required to be provided under federal law as a condition of doing business in Australia. The Commonwealth power over quarantine might also support such a requirement.
Matters of international concern
In Commonwealth v Tasmania (the Dams case)(1983) 158 CLR 1, it was made clear that Commonwealth legislation is permissible under s 51(xxix) of the Constitution if it touches a “matter of international concern to Australia”. In other words, federal legislation is valid, even in the absence of a treaty or customary obligation between Australia and other states, if it shown to deal with an issue of “international concern shown by other nation-states”. Of course, proving that a matter is of international concern is not an easy task.
The evidence by which it might be proved, however, is illustrated by the judgement of Stephen J in Koowarta v Bjelke-Peterson (1982) 153 CLR 168. In concluding that the prohibition of racial discrimination was a matter of international concern, Stephen J referred to aspects of the Charter of the United Nations, pronouncements of the Declaration of Human Rights, resolutions of the UN General Assembly, opinions of the International Court of Justice and eminent jurists, the European Convention on Human Rights, and the Convention on the Elimination of all Forms of Racial Discrimination. In concluding that the matter was of international concern, Stephen J stressed that the sustained and widespread international activity, established that the topic had become for Australia a part of external affairs, and thus subject to Commonwealth legislation.
In connection with a national HMP for Australia, it is possible to argue that the extensive activity of the international community, including Australia, in connection with the management of AgVet chemicals demonstrates that it is clear matter of international concern. This concern, moreover, is also directed to significant monitoring activities related to chemicals. For example, the work of the Codex Alimentarius Commission, in which Australia participates, involves not only protecting the health of consumer through food standards, but also amending standards “after appropriate survey in the light of developments”. The Intergovernmental Forum on Chemical Safety, which includes Australia as a member of the Standing Committee, promotes chemical risk assessment and the environmentally sound management of chemicals. In connection with this priority area, the Forum has highlighted the need to generate human exposure and health effects data.
The need for monitoring chemical exposure and their health effects has also been recognised by a host of other international organisations that Australia participates in including: the Food and Agricultural Organisation, the International Labour Organisation, the World Health Organisation, the United Nations Environment Program, the United Nations Industrial Development Organisation, and the United Nations Institute for Training and Research. Accordingly, a convincing argument can be made that the Commonwealth has the Constitutional legislative power to create and implement a national HMP.
6.3.3 Federal and State Cooperative Arrangement
At the end of the day, the crucial question is what the best legislative option is for an effective nation HMP. In making this estimation, it is important to appreciate political realities and the historical context in which an HMP will be located. Over the past two decades there has been a trend towards cooperative legislative arrangements between the Commonwealth, States and Territories to maximise national consistency in approach to regulation. Several of these cooperative arrangements apply to matters of public health and environmental protection. These matters include legislation covering food safety, radiation, national environment protection measures, and worker health and safety.
While cooperative arrangements for environmental regulation have not had a large degree of success in the past, a cooperative approach to a national HMP is probably the most politically acceptable legal framework suggested in this Report. It is also probably the most effective way to marshal resources for the proposed regime and ensure the widest possible participation in the collection of data.
By adopting a cooperative approach, governments of Australia could establish a national reporting regime for adverse incidents and exposure reporting, as well as a uniform mandatory reporting scheme connected to the use of AgVet chemicals.
6.4 Objects of a cooperative health monitoring program
In establishing a national HMP, it is imperative to ensure that the legal framework that is adopted set forth its objectives and includes, at a minimum, a commitment to the principles of ecologically sustainable development (ESD). ESD requires the effective integration of long term environmental and economic considerations into decision-making processes, in order to promote the objective of environmental protection. A national legal framework ought to spell out that ESD shall be achieved through the implementation of, amongst other things, the following principles and programs:
Ø The precautionary principle -- namely, that if there are threats of serious or irreversible environmental damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation.
Ø Inter - generational equity - namely that the present generation should ensure that the health, diversity and productivity of the environment is maintained or enhanced for the benefit of future generations. The principle of inter-generational equity requires that intra-generational equity also be observed.
Ø Conservation of biological diversity and ecological integrity as a fundamental and primary consideration.
Ø Improved valuation and pricing of environmental resources, including but not limited to:
(i) the inclusion of environmental factors in the valuation of assets and services - namely the pricing of goods and services to be based upon a full life cycle assessment of the costs of providing those goods and services, including assessment of the cost of natural and environmental resources utilised or degraded, and the costs of the ultimate disposal of any waste which may be generated;
(ii) implementation of the polluter pays principle - namely producers of pollution and waste to bear the cost of avoidance, abatement, recycling, remediation or containment;
(iii) the pursuit of environmental goals by establishing incentive structures, including market mechanisms which enable those best placed to maximise benefits and/or minimise costs to develop their own solutions and responses to environmental problems.
Ø Recognition that the environmental impacts of actions and policies occur at local, regional and global levels.
Ø Community participation - namely that decision making processes and the formulation of policies, programs and management plans necessarily involve the participation of members of the community, through:
(i) transparency of administrative process and the provision of access to complete information to the fullest extent possible;
(ii) public notification of decision making processes and the formulation of policies, programs and management plans; and
(iii) full consultation and consideration of community input.
Additionally, the EDO encourages the adoption of farther ranging purposes to be included in an Objects Clause. The Objects of the Act should also provide for the:
Ø Promotion of AgVet chemical use reduction and exposure prevention;
Ø Expansion and acceleration of the assessment of AgVet chemical risks;
Ø Fostering of an integrated pest management approach to AgVet chemical regulation; and
Ø Establishment of a mandatory AgVet chemical use reporting system.
6.5 National reporting regime for adverse incidents
The crux of a national HMP involves the collection and investigation of reports of adverse experiences linked to the use of or exposure to AgVet chemicals. In establishing a cooperative legal framework for the collection of this data, it is vital to include existing Commonwealth, State and Territory sources and repositories of such information. Of course, specific purpose mechanisms should also be created at the State and Territory level to coordinate the local collection of information and pass on such information to a national coordinating body. The national body would also be responsible for collecting and disseminating information collected under mandatory use reporting requirements outlined in section 6.6 below.
Applicants and registrants of chemical products should continue to be required under s161 of the AgVet Code to report to the NRA, including any information received that shows that the use of, or any other dealing with, a constituent or chemical product may be a hazard to the safety of people. However, the legal framework for the reporting scheme should be expanded to include reporting by medical professionals, employers, and any concerned individual. Training on reporting for medical professionals and employers should also be included in the national HMP.
6.6 Uniform use reporting programs under Cooperative Arrangements
6.6.1 Community Right to Know and Use Reporting
An essential component of effective AgVet chemical regulation is provisions that give the community the right to know about chemical activities (production, storage, transportation and application) taking place around them. Community right to know laws shift the focus from a reactive, crisis-by-crisis approach to public health chemical issues toward citizen and governmental monitoring of existing and potential chemical hazards which helps prevent crises in the first place. It is a truism that public concern about chemical risks to health and the environment only becomes manifest when the public becomes aware of AgVet chemical problems.
In order for AgVet chemical monitoring regime to be truly transparent, there needs to be a publicly accessible chemical use reporting system established. It is only with this information that the community can begin to feel safe. Only then can informed regulatory decisions at the strategic level be made.
A crucial first step in developing comprehensive community right to know legislation, is the establishment of an effective method of collecting information that the community has the right to know about. Naturally, reporting requirements should be as broad as possible to ensure the likelihood of the discovery of any potential AgVet chemical risks that may become manifest. Reporting requirements should be developed in connection with the “agricultural use” and “manufacturing, import and retail” of AgVet chemicals.
6.6.2 Full Reporting of Agricultural Use
In connection with “agricultural use”, both individual AgVet chemical users and commercial pest control operators (PCOs) -- those engaged in the business of pest control for hire, such as ground and aerial applicators, structural operators, and professional gardeners -- should be required to file, at the very least, a quarterly reports on AgVet chemical use with a state environmental or health authority. The legal definition of “agricultural use”should be wide enough to include AgVet chemical applications to farms, parks, golf courses, cemeteries, rangeland, pastures, and along roadside and railroad rights-of-way. In addition, all post-harvest AgVet chemical treatments of agricultural commodities, along with all AgVet chemical treatments in poultry and fish production, should be required to be reported.
In order to enhance AgVet chemical risk assessment -- including cumulative impacts -- associated with agricultural uses, operator and site identification numbers should be assigned. Prior to the use of AgVet chemicals, every PCO should be required to obtain an operator identification number from a State environment or health authority in order to track the quantity of regulated AgVet chemicals being applied each month. Likewise, individual users of amounts of regulated AgVet chemicals over certain thresholds, will need to obtain a site identification number for each location and crop/commodity where pest control work will be performed.
Under the full use reporting regulations, regulated individual AgVet chemical users be required to report monthly the AgVet chemicals they use to the environment or health authority. PCOs should be required to report the use of AgVet chemicals to the environment or health authority within seven days of completion of the application. The following information should be required to be reported for each significant agriculture application of a AgVet chemicals:
Ø precise location -- including section, range, base, and meridian field location -- where application was performed;
Ø operator/applicator identification number;
Ø operator/applicator name and address;
Ø site identification number;
Ø commodity/crop/site treated;
Ø acres or units planted;
Ø acres or units treated;
Ø date and time of application;
Ø application method (air, ground, other);
Ø National Registration Authority AgVet chemical registration number of the product applied;
Ø AgVet chemical product name and manufacturer’s/importer’s/retailer’s name and address;
Ø total amount of product applied;
Ø person who prepared the report.
6.6.3 Full Reporting by Manufacturers, Importers, Retailers and Growers
In addition to mandatory reporting for agricultural uses, manufacturers, importers and retailers of AgVet chemicals, and growers and retailers of foodstuffs treated with AgVet chemicals, should also be required to report. Manufacturers, importers and retailers of AgVet chemicals should be required to report on the nature, quantity, and destination of chemical products being released into the stream of commerce. Growers and retailers of products treated with AgVet chemical should be required to monitor and report on products containing excessive levels of chemicals. The community has a right to know about the nature and prevalence of chemical exposure because of the adverse effects of these products on human health, wildlife and the environment. Such information will assist in regulatory AgVet chemical risk assessment determinations. Reporting on AgVet chemical distribution by manufacturers, importers and retailers is critical to efforts to protect public health.
In addition to information on adverse health effects presently required, the reporting requirement for manufacturers, importers, retailers and growers should include the mandatory provision, similar to that recently announced under U.S. environmental law, of information to the EPA on:
Ø AgVet chemicals found in food above approved levels;
Ø AgVet chemicals detected in surface, ground and drinking water above safety standards;
Ø newly identified types of ingredients which may be of toxicological or environmental concern;
Ø specific details about incidents causing adverse effects; and
Ø occurrence of products no longer effective because of resistance developed by the pests.
6.6.4 Uses for the Data under Full Use Reporting
The development of AgVet chemical use reporting responds to concerns of many individuals and groups, including government officials, scientists, farmers, legislators, and public interest groups. The community is entitled to know what and how much AgVet chemical use is going on around them in order to make informed choices. Additionally, farm workers are entitled to more information to determine exposure and potential risk to those who handle AgVet chemicals or who work in treated fields. The current system for estimating exposure to AgVet chemical residues does not provide sufficient data on which to make realistic risk assessments; this results in underestimates, as well as overestimates, of risk. There are several key areas in which data generated by full use reporting will prove to be beneficial.
Public Health - The introduction of a AgVet chemical use reporting system will provide complete AgVet chemical use data for evaluating possible human illness clusters in the future. Moreover, more complete food labelling requirements can be developed for food processors, produce packers, and retailers based on a complete history of AgVet chemical use on crops.
Risk Assessment - Without information on actual AgVet chemical use, regulatory bodies must assume -- as they should -- that all planted crop acreage is treated with many AgVet chemicals, even though most crops are treated with just a few chemicals. If the assumptions used by regulatory agencies are incorrect, regulators could make judgements that are overly conservative by several orders of magnitude. There is a significant cost to society in overestimates of risk. The use report data, on the other hand, provides actual use data so that regulatory bodies can better assess risk and make more realistic risk management and licencing decisions.
Worker Health and Safety - Under the reporting regulations, PCOs should be required to give farmers a written notice after every AgVet chemical application that includes the date and time the application was completed, and the reentry and preharvest intervals (respectively, the intervals between the time a AgVet chemical is applied and when workers may enter the field, and the time of application and when a commodity can be harvested). This notice gives the farmer accurate information to help keep workers from entering fields prematurely, and also lets the farmer know the earliest date a commodity can be harvested.
Environmental Protection -- The following are just two examples of how AgVet chemical use reporting can help promote the protection of the environment.
ENDANGERED SPECIES - Sitespecific AgVet chemical use report data required under the proposal in this submission, can be combined with data on locations of endangered species. The resulting database will assist resolve potential AgVet chemical use conflicts with endangered species. It will also allow for the examination of patterns of AgVet chemical use near habitats to determine the necessary use limitations to be contained in licences. With locationspecific data on AgVet chemical use, it will be easier to evaluate the possible impact of AgVet chemicals on endangered species so that restrictions can be targeted where they are needed to protect fish and wildlife.
WATER CONTAMINATION - Sitespecific records will help track AgVet chemical use in areas susceptible to ground water contamination. Importantly, it will help regulatory authorities to track nonpoint source pollution and its cumulative impacts. These records will also provide data to help researchers determine why certain soil types are more prone to ground water contamination. By using AgVet chemical use data, determinations can be made whether or not a contaminated well is directly related to agricultural practices. The reporting data can also be use to assist in pinpointing specific unsustainable agricultural practices, that will allow more precise alternative use recommendations to be made to assure protection of surface water.
Pest Management - The development of a AgVet chemical use reporting database, will present a complete picture about what AgVet chemicals are used (insecticides, fungicides, herbicides, etc.) on different crops. Reducedrisk pest management alternatives can then be developed considering the different regions of the state and commodities grown in these regions.
6.7 Licence requirements for significant pesticide activities
In order to effectively protect public health and meet the objective of pesticide use reduction and pesticide exposure prevent, a new uniform licencing requirement needs to be established in all States and Territories under a cooperative arrangement for manufacturers, importers, retailers, transporters, individual pesticide users, and PCOs involved with significant amounts of pesticides annually. The State and Territory environmental or health departments should be charged with licencing responsibility.
Where the use of pesticides is of a significant level, a licence should be required for an individual user or PCO. The should be so regardless of whether the application is aerial or by ground rigs. The licence should be subject to periodic review and the licence holder should be required to periodically prepare AgVet chemical use reduction plans.
6.7.1 Public Participation in New Licencing Requirements
A licencing requirement for significant pesticide activities would open up environmental decision-making regarding pesticides to the public, instead of keeping the process closed and the public in the dark as the current process does. This is in stark contrast to the general tenor of environmental law across Australia. The framework of planning and development laws in most States and Territories emphasises community participation in recognition of the fact that it improves the quality of environmental decision making. It is unacceptable to deny the community that participation when it comes to the licencing process involving AgVet chemicals.
As a nation Australia has committed itself to the principles contained in the Rio Declaration 1992
which include a clear recognition of the public role in achieving the objectives of those principles. The Rio Declaration - Principle 10 - states that :
“Environmental issues are best handled with the participation of all concerned citizens, at the relevant level ......States shall facilitate and encourage public awareness and participation by making information widely available. Effective access to judicial and administrative proceedings, including redress and remedy, shall be provided.”
State governments have also made a commitment to the principles of ecologically sustainable development in the 1992 National Strategy for Ecologically Sustainable Development. Public participation is integral to achieving the objectives of this strategy (see in particular Parts 12, 13 and 16).
It is clear that the national framework for an HMP should provide for public participation in connection with the proposed new licencing requirements. The State or Territory regulatory authority should be required to publish a notice of all applications for licences and approvals received, including applications for renewal and variance. The public should then be provided an opportunity to comment on the application. Further, the regulatory authority should be required to take account of any public comment in deciding whether or not to issue a licence or approval. As a consequence, in order for the public to know what regard has been had for any comments submitted, the regulatory authority will need to give reasons for a decision to grant or deny an application.
Finally, there should be rights of appeal for objectors, as well as applicants dissatisfied with a licencing decision relating to registered pesticides, together with pesticides that are not registered but which are likely to have a significant effect on the environment. This would accord with similar rights provided for under section 98 of the NSW Environmental Planning and Assessment Act (EPA Act) for designated development. At a broader level, the Act should also provide for third party enforcement rights for breaches of the Act similar to those contained in section 123 of the EPA Act.
6.7.2 Review of Licences
Licences should be issued for a maximum of three years. Variation of licences should be permitted. However, where an application for a licence variation is made, the State or Territory regulatory authority should be required to notify the public of such application, provide the public with an adequate opportunity to comment, and take those comments into consideration into consideration in making its decision. Further, the regulatory authority should be required to give reasons for its decision on the application for the variance and those reasons should be available to the public.
The national legal framework should provide for a review of licences to be conducted by the regulatory authority within the three year period of a licence or where a situation arises or an event occurs that may result in a threat to human health or environmental damage, or has resulted in environmental damage. The decision to hold a review should be discretionary on the part of the EPA but reasons for not holding a review should be made publicly available. The results of a review should also be made public.
6.7.3 Pesticide Application Warning Notices and Application Buffer Zones
It is essential, as part of a national HMP, that the community receive adequate notification prior to the application of significant quantities of AgVet chemicals by either air or surface application. It would be the duty of the person intending to use the chemicals to notify, in writing, neighbouring properties. The notice would be require to be given at least 48 hours prior to pesticide application.
Of course, rural and urban notification would be different. In an urban setting, it is probably sufficient that adjacent properties should be notified of AgVet chemical applications. After all, in urban areas neighbours may include hospitals, child care centres, nursing homes, and other sensitive individuals.
In the case of proposed application in rural areas, written notification should be required for a properties within 1 kilometre of an intended spray area. Moreover, for properties located within 500 metres of a spray area, not only should notification be required, but also written consent for the application. The current 150 metre application buffer zone is inadequate.
6.7.4 Chemical use reduction plans
AgVet chemical use reduction is another crucial aspect of a complete national health monitoring program. Use reduction focuses on preventing the use of harmful (or potentially harmful) chemicals before they are released into the environment. As a matter of ecologically sustainable development, chemical use reduction and prevention ought to be the preferred method of pest management. A reductive focus that concentrates on changes in harmful and expensive production processes is good for both the environment and the economy.
Once an adequate licencing system is in place for users of AgVet chemicals, specific reduction plans should be required of all licence holders. All AgVet chemical licences proposed in this Report should require the holder of a licence to develop a chemical use reduction program and comply with the program. It is only in this way that the attention of chemical users will be sufficiently focused on integrated pest management and decreasing reliance on chemcials. Additionally, the legislation should require the agricultural industry, as a whole, to develop an industry wide plan for chemical use reduction.
6.7.5 Mandatory Training Programs
In order to ensure not only the greater care in the use of registered chemicals, but more importantly, to ensure the broadest dissemination of information about health issues as possible, it is necessary to establish a mandatory training program for the users of pesticides. Mandatory training should be made compulsory under the Act in a course accredited in accordance with the Act and must include at a minimum, training in integrated pest management and safe pesticide usage.
6.7.6 Chemical impact assessment program
Finally, the establishment of an adequately funded Chemical Impact Assessment Program (CIAP) as a component of a health monitoring program would greatly strengthen the overall effectiveness of an HMP. The mission of a CIAP would be to help promote informed regulatory decisions concerning registered chemicals. The CIAP would pursue its mission through state activities that:
Ø Develop and analyse information on current pesticide use and pest control practices within NSW;
Ø Determine impacts of pesticide regulations on agricultural productivity;
Ø Gather alternative information on pesticides that have been identified as having potential problems ; and
Ø Address integrated pest management and pest control issues related to human health and the environment.
6.8 Public Access to Use Reporting Data and Licencing Details
A national public register for the AgVet chemical reporting could be established under a national HMP. The register should contain details about the following information: (i) the complete licence application, including the AgVet chemicals, crop, area of application, etc., involved in the application, (ii) each determination made in respect of a licence application, (iii) the name and address of each licence holder, (iv) the terms and conditions of each licence, (v) details of any variations of conditions of a licence, (vi) details of any transfer of a licence, (vii) details of any suspension, revocation or surrender of a licence, and (viii) such other information proscribed by the regulations. This information should be made available in hard copy and electronic form over the Internet.
Additionally, an annual summary of AgVet chemical use report data should be prepared, indexed by chemical and by commodity, and containing individual use report data. Of course, this data should be made publicly available in printed and electronic form. In addition, public requests for specific data only, such as all reports for one PCO, crop, commodity, chemical, etc., or in any combination of data fields should be permitted. Detailed, individual use report data will provide an accurate and complete picture of AgVet chemical use for indepth analytical purposes. The printed reports and the full database on electronic media should be made available to interested parties, including representatives of the agricultural industry, environmental groups, marketing and research companies, libraries, and members of the public.
It is clear that the public should have a nearly absolute right to know about the chemicals (including constituent elements) to which they have the potential to be exposed and which are in their environment. Of course, this need not include the precise formulation, the precise concentration of constituent elements, the method by which or at what temperature the constituent elements were combined, etc. It is necessary, however, to ensure that a national HMP be able to record WHAT, HOW MUCH and WHERE AgVet chemicals are being used in order to protect public health, the environment, and the community’s right to know.
This conclusion is supported by the recently concluded Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters. While Australia is not a party the convention, it nevertheless reflects a growing commitment by the international community to ensuring that mandatory systems are established so that there is an adequate free flow of information to public authorities about proposed and existing activities which may significantly affect the environment or public health.
All of this is not to say that if revealing both chemical and submitter identity could disclose confidential/trade secret information that could be used unfairly that confidentiality is not a concern. However, keeping the information out of the public’s hands is an inappropriate response. Instead, a regulatory structure ought to be put in place that would protect that information by making others who obtain and use such information for commercial gain, pay for the information.
If secrecy about the basic issues of WHAT, HOW MUCH and WHERE are going to be allowed, it is clear that it must be narrowly limited. Moreover, in order to keep information out of public hands, those claiming confidentiality ought to bear the burden of proof and the decision of any regulatory authority needs to be appealable to the courts. In order to establish confidentiality the five following common sense standards ought to be used, so that a proponent of keeping information confidential would need to prove:
Ø the person claiming confidentiality has not already disclosed the information;
Ø another law does not require disclosure of the information;
Ø failure to disclose would not create a significant public health/environmental risk;
Ø disclosure would cause substantial harm to the person claiming confidentiality; and
Ø the chemical identity is not readily discoverable through reverse engineering.
If confidentiality is to be allowed, then in the event of an exposure to a confidential chemical causing a medical emergency, the manufacturer must have a duty to immediately disclose the information that has been claimed confidential to a treating physician. Also the any employer must be able to request the information in a nonemergency situation in connection with an occupational health and safety medical program it runs in order to provide medical treatment or assess the hazards of the chemicals to which workers are exposed. In both cases the person receiving the information has a duty to keep it confidential.
7. Further Work
Given the parameters of the Consultant’s brief, there are a number of issues that present themselves for further work. It would be useful for this work to be carried out to complement the matters canvassed in this report. This Report recommends that the further attention be directed to the following issues:
Ø The financial costs associated with establishing and implementing a national health monitoring program needs to be determined. This report has made no attempt to estimate costs associated with an HMP.
Ø The most appropriate source of funding for a national health monitoring program needs to be investigated further. In Section 6.1.1, this report notes the danger of “agency capture” in connection with an industry funded program. It also questions the appropriateness of a regulator accepting such funding from an industry it is intended to regulate. However, further work should be carried out in this areas in order to see the effects of such funding arrangements on the Adverse Experience Reporting Program for veterinary chemicals.
Ø More research is needed to determine existing sources of data and potential sources of data in the States and Territories to feed into a national health monitoring program. Additionally, more study is necessary in order to flesh out an coordinated administrative structure for a monitoring program that includes local, State and Commonwealth components.
Once a national health monitoring program is established, considerable thought should be given to the subsequent addition program component that includes mandatory screening tests for health effects of high-volume AgVet chemicals in use. Research indicates that even the most basic toxicity testing results cannot be found in the public record for nearly 75% of the top-volume chemicals in commercial use today. A similar percentage exists for AgVet chemicals