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Department of Agriculture and Water ResourcesChemical Labelling Duplication Review5 August 2016

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.

Member of Deloitte Touche

This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not rely on, disclose or refer to it in any document. We accept no duty of care or liability to you or any third party for any loss suffered in connection with the use of this document.This is a draft document. As it is a work in progress it may be incomplete, contain preliminary conclusions and may change. You must not


Tim KarlovDirectorAgvet Chemical RegulationSustainable Agriculture, Fisheries and Forestry DivisionDepartment of Agriculture and Water ResourcesGPO Box 858Canberra ACT 2601

5 August 2016

Dear Tim

Thank you for providing Deloitte Touche Tohmatsu (Deloitte) with the opportunity to assist the Department of Agriculture and Water Resources with the review of the impacts of work health and safety legislation on agricultural chemicals and veterinary medicines labelling (agvet chemical labelling).

This final review report has been prepared for the Department of Agriculture and Water Resources and focuses on the duplication of effort and unnecessary costs associated with agvet chemical product compliance with both work health and safety legislation and agvet chemical legislation.

We wish to take this opportunity to thank the stakeholders, managers and staff who participated in this engagement for their assistance and the professional manner in which they responded to our inquiries.

Yours sincerely

Tony MorrisNational WHS Partner Sustainability Services, Risk AdvisoryDeloitte Touche Tohmatsu

Liability limited by a scheme approved under Professional Standards Legislation.

Member of Deloitte Touche Tohmatsu Limited

Deloitte Touche TohmatsuABN 74 490 121 060

Grosvenor Place225 George StreetSydney NSW 2000PO Box N250 Grosvenor PlaceSydney NSW 1220 Australia

Tel: +61 2 9322 7000Fax: +61 9322 7001www.deloitte.com.au



Contents

Glossary of common abbreviations 5

1 Important note 6

2 Executive summary 7

2.1 Background to the chemical labelling duplication regulation review 7

2.2 The review process 7

2.3 Context and clarification 8

2.4 Summary of findings and recommendations 8

3 Regulatory Review 11

3.1 Establishment of the APVMA and SWA 11

3.2 Scope of the regulatory review 11

3.3 The objectives of the agvet chemical and WHS legislation 11

3.4 Understanding the difference between a hazard and a risk 12

3.5 Background to the WHS regulatory regime 13

3.6 Purpose, scope and application of the GHS 15

3.7 Background to the agvet chemical regulatory system 17

3.8 Identifying areas of potential duplication complying with both sets

of legislation 22

4 Options 26

4.1 Option 1 – Additional GHS labelling added to existing agvet

WHS labelling 26

4.2 Option 2 – Remove the APVMA WHS labelling requirements for

hazardous workplace chemicals and rely on the GHS 26

4.3 Option 3 – Full exemption for Agvet chemical labelling from

WHS workplace chemical labelling requirements 27

4.4 Option 4 – Aligning the FAISD Handbook with GHS and

WHS requirements 27

5 Stakeholder engagement 28

5.1 Targeted Stakeholder Engagement 28

5.2 Important note on engagement of stakeholders 28

5.3 The Commonwealth Government Agencies 29

5.4 WHS Regulators 32

5.5 Agvet Industry 33

5.6 Worker’s Representative 34

5.7 Government Health 35

Deloitte: Chemical Labelling Duplication Review



5.8 Public Stakeholder Engagement 35

6 Analysis, costs and benefits 37

6.1 General analysis commentary 37

6.2 Approach for the costs and benefits analysis 42

6.3 Specifying the assessment criteria 43

7 Recommendations 51

Appendix A: Regulation 80E 53

Appendix B: Legislative Review 55




Glossary of common abbreviations

Inherent Limitations

The Services provided are advisory in nature and have not been conducted in accordance with the standards issued by the Australian Auditing and Assurance Standards Board and consequently no opinions or conclusions under these standards are expressed.

The Review was carried out in accordance with regulation 80E of the Agricultural and Veterinary Chemical Code Regulations 1995 and therefore did not constitute a review engagement in accordance with Australian Auditing Standards

Because of the inherent limitations of any internal control structure, it is possible that errors or irregularities may occur and not be detected. The matters raised in this report are only those which came to our attention during the course of performing our procedures and are not necessarily a comprehensive statement of all the weaknesses that exist or improvements that might be made.

Our work is performed on a sample basis; we cannot, in practice, examine every activity and procedure, nor can we be a substitute for management’s responsibility to maintain adequate controls over all levels of operations and their responsibility to prevent and detect irregularities, including fraud.

Any projection of the evaluation of the control procedures to future periods is subject to the risk that the systems may become inadequate because of changes in conditions, or that the degree of compliance with them may deteriorate.

Recommendations and suggestions for improvement should be assessed by management for their full commercial impact and public value before they are implemented.

We believe that the statements made in this report are accurate, but no warranty of completeness, accuracy, or reliability is given in relation to the statements and representations made by, and the information and documentation provided by Department of Agriculture and Water Resources personnel and stakeholders. We have not attempted to verify these sources independently unless otherwise noted within the report.

Limitation of Use

This report is intended for the information and use of Department of Agriculture and Water Resources in accordance with your Deed of Standing Offer, Schedule 9, Order for Services, Reference 127074, Purchase Order 22951 of 23 December 2015. No other person or entity is entitled to rely, in any manner, or for any purpose, on this report. We do not accept or assume responsibility to anyone other than Department of Agriculture and Water Resources for our work, for this report, or for any reliance, which may be placed on this report by any party other than Department of Agriculture and Water Resources.




Regulatory Review

Glossary of common abbreviations

Whilst not an exhaustive list, below are some common abbreviations used in this report.

ADG Code Australian Code for the Transport of Dangerous Goods by Road or Rail

Agvet Agricultural and veterinary

Agvet Code Agricultural and Veterinary Chemicals Code; the schedule to the Agricultural and Veterinary Chemicals Code Act, 1994 (Cth)

Agvet Labelling Codes Agricultural Labelling Code and Veterinary Labelling Code

APVMA Australian Pesticides and Veterinary Medicines Authority

Agvet Code Regulations Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth)

GHS Globally Harmonised System for the Classification and Labelling of Chemicals

PCBU Person who conducts a business or undertaking

SDS Safety Data Sheets

SUSMP Standard for the Uniform Scheduling of Medicines and Poisons

SWA Safe Work Australia

The Department Department of Agriculture and Water Resources

WHS Work health and safety (in some state jurisdictions of Australia WHS can also be referred to as OHS or OSH)




Regulatory Review

1 Important note

We advise readers of this report to read it in full and in the order in which the content is presented. This will provide the context required for what is a complex subject matter with many stakeholders (both government and private) and legislation across federal, state and territory jurisdictions.

Reading only one or several chapters of the report (or out of sequence) will not provide the reader with adequate context or the full picture and may lead to misunderstanding and misinterpretation of other commentary.




Regulatory Review

2 Executive summary

2.1 Background to the chemical labelling duplication regulation review

Deloitte Touche Tohmatsu (Deloitte) was appointed by the Department of Agriculture and Water Resources (the Department) to conduct a review of any duplication of effort and unnecessary costs, in relation to agricultural and veterinary (agvet) chemical products, that arises from complying with both work health and safety (WHS) legislation and agvet chemical legislation. The review is required by regulation 80E of the Agricultural and Veterinary Chemical Code Regulations 1995 (Agvet Code Regulations) which includes the terms of reference for this review. A full extract of regulation 80E is contained in Appendix A of this report.

The requirement for this review arose following the introduction of the harmonised WHS laws in January 2012, which, amongst other legislative changes, required all workplace hazardous chemicals (from 1 January 2017) to be labelled in accordance with the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS). Prior to this change in the WHS laws in 2012, a full exemption for agvet chemical labelling from WHS (and therefore GHS) chemical labelling requirements applied on the basis the agvet chemical legislation and label information satisfied the WHS information requirements (National Occupational Health and Safety Commission, 1994).

This review has:

Identified some duplication of effort and associated costs arising from the need to comply with both sets of legislation

Identified and analysed options for streamlining the regulation of WHS in relation to chemical products, and addressing any identified duplication. This included analysis of the costs, benefits and consequences of options for the safe use of agvet chemical products

Made recommendations relating to matters within the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) functions and powers, for preferred options to address any identified duplication and improve the regulation of WHS in relation to agvet products.

The purpose of this review was to gather views on:

The role and scope of agvet chemical and WHS legislation

Complexities arising from the intersection of agvet chemical legislation and WHS legislation

The obligations under WHS legislation for hazardous agvet chemical products

The key issues and concerns expressed of agvet chemical stakeholders.

2.2 The review process

Phase 1 – Regulatory review This phase consisted of a desktop review of the relevant legislation. It sought to identify any duplication of effort arising from the need for registered agvet chemicals products to comply with labelling requirements under both WHS and agvet chemical legislation. The review consisted of relevant Acts, Regulations, codes of practice and the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS). This process identified preliminary options, which were explored in later phases.

Phase 2 – Targeted stakeholder interviewsFollowing consultation with the Department of Agriculture and Water Resources, interviews with stakeholders representing the agvet chemical industry, agvet chemical users, WHS regulatory agencies and agvet chemical regulatory agencies took place in March and April 2016. Twenty-two (22) stakeholder interviews were conducted with the purpose of understanding the issues and refining preliminary options, including identifying other viable options to address potential duplication (and on the basis any other viable options identified were within the scope of the review terms).




Regulatory Review

A wide-range of views were identified about the potential for duplication and the costs and benefits of complying with both agvet chemical and WHS legislation. Stakeholders’ responses also reflected differing understanding and views on the relative importance of the issue. Chapter 5 of this report provides further detail on the stakeholder interviews.

Phase 3 – Open public consultation May 2016This phase involved inviting public submissions from any interested person or organisation about matters relevant to the review. Public submissions were open for 4 weeks and closed on 31 May 2016. Chapter 5.8 contains a summary of the public stakeholder engagement.

Phase 4 – Report preparation and recommendationsDeloitte analysed all the information obtained during the review and prepared this report, which includes the following chapters:

Chapter 3 contains a regulatory review in relation to agvet chemical products with respect to the WHS legislation and agvet chemical legislation.

Chapter 4 introduces options considered and discussed as part of the review to identify duplication of effort and associated costs arising from the need to comply with both sets of legislation

Chapter 5 provides details of targeted stakeholder and public stakeholder engagement

Chapter 6 provides general analysis commentary and an analysis of the costs and benefits of each option

Chapter 7 provides recommendations consistent with the terms of reference for this review.

Appendices referenced in the review appear at the end of this report following the recommendations.

2.3 Context and clarification

The review did not seek to re-examine (nor make recommendations with respect to) the policy basis for WHS legislation as it applies to agvet chemicals. Any changes to WHS legislation, including as it relates to agvet chemicals, rests outside the authority of agriculture portfolios at Commonwealth, state and territory levels.

This review focusses only on the implementation of GHS labelling requirements as it relates to agvet chemicals. It is important to bear in mind the GHS requirements apply to all hazardous chemicals, of which agvet chemicals are a (relatively small) sub-component, comprising approximately 1%.

Consistent with the review’s terms of reference, and to provide a foundation for effective consultation with stakeholders, four options for agvet chemical labelling were agreed between Deloitte and the Department of Agriculture and Water Resources. The four options are outlined in Chapter 4 of the review. During this review, stakeholders were encouraged to raise any additional viable options within scope of the terms for consideration, however no further options were raised.

2.4 Summary of findings and recommendations

Deloitte found that while work health and safety (WHS) legislation creates a need for some further (or additional) health and safety information to be placed on some agvet chemical product labels, it introduces only a small amount of duplication.

The potential for duplication was significantly reduced during the course of this study, following the publication of a Safe Work Australia (SWA) policy on the matter.

The review found that both the agvet chemical and WHS legislative regimes exist, inter alia, for the health and safety of people at work and the community. Both consider, and seek to provide for the health and safety of workers throughout the supply chain. While in this respect, they are duplicative in terms of policy intent, a detailed analysis of the two legislative regimes demonstrated differences in objectives, implementation and enforcement. Those differences are outlined in more detail in Chapter 3, the regulatory review.




Regulatory Review

For the classification and labelling of hazardous workplace chemicals, the WHS regulatory system adopts the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), which applies a hazard-based approach and supports workplace-specific risk assessments.

In contrast, the agvet chemical regulatory system applies a risk-based approach, which identifies and considers the intrinsic hazards of chemical products and assesses and provides instructions on how to manage the risks they pose to users and others who may handle the product including during processing, storage, transport and disposal. If the risks associated with a product or use cannot be appropriately managed, that is, exposure to a hazard cannot be effectively mitigated and therefore an unacceptable risk level remains, that product or use will not be registered by the APVMA.

The distinction between hazard and risk, the WHS and agvet approaches and their resultant effect on the labelling of agvet chemical products is important context to understand and therefore explained in the regulatory review at Chapter 3.

The APVMA’s assessments consider both chronic (long-term) and acute (short-term) effects, physicochemical effects (such as flammability or corrosiveness) and the potential for exposure to a product or its residues during handling (including transport, storage and processing), use and after application, including disposal of product and containers. Specific consideration of exposure is given to workers likely to have long-term interaction with agvet products, such as spray contractors. Based on the risk assessment, risk management measures are placed on a product to reduce any identified human health risks to an acceptable level. These measures include engineering controls, safety directions, use restraints, scheduling recommendations and requirements for the use of personal protective equipment.

Stakeholder views on the inclusion of additional GHS-based label statements were generally aligned among stakeholder groups. Agvet chemical industry and user stakeholders were generally opposed to the introduction of GHS for agvet chemical products; these stakeholders raised concerns over regulatory burden and the cost of implementation, a perception of little to no benefit for users arising from the additional WHS statements and the potential for the statements to confuse users. WHS regulators, policy makers and worker representatives were supportive of additional hazard and precautionary statement GHS information on agvet chemical product labelling; these stakeholders argued in favour of workers right to information about workplace hazards and precautionary statements, equity among industries, and the requirement for the information to support workplace risk assessment obligations under WHS laws. Some WHS stakeholders appeared to have misconceptions about the protections provided by the risk-based agvet regulatory system, while agvet chemical stakeholders appeared to focus on the effects of the GHS statements for their own users rather than others in the supply chain.

It became clear during the review that sufficient data was not available to conduct a robust cost-benefit analysis of the various options available to streamline the regulation of work health and safety in relation to chemical products. Accordingly, we analysed a number of relevant criteria which considered the health and safety impacts, costs of GHS implementation and the net impact of increased label information.




Regulatory Review

The Deloitte review acknowledged the agvet chemical industry has and maintains many existing health and safety controls designed to manage the risk of persons working in the agvet chemical industry (including those involved in the handling of the chemicals, namely transportation, storage, processing, use or disposal). Labels on agvet chemical products providing (amongst other content) health and safety information are but only one control, amongst many, designed to promote the health and safety of people who handle the products.

Following the analysis arising from Chapters 3, 5 and 6 of this report, Deloitte considers there is likely to be a small on-going health benefit from the provision of additional GHS information on agvet chemical labels. We believe the persons most likely to benefit from additional GHS labelling information are not agvet chemical end-users (since they can rely on the APVMA approved risk-based label for its use) but rather, those workers in the supply chain who are familiar with handling all types of chemical products containing the GHS information on labels. We also believe GHS information will benefit some of those who consider illegal off-label use of the agvet chemical products. Some illegal off-label users may not read information or health and safety instructions on a label or may already be aware of the risks but deliberately ignore them; these people will not benefit from additional GHS label information. However, if GHS label information were added, it is possible that some illegal off-label users may stop and consider any hazards or warnings on the label relating to potential health and safety risks they may be about to expose themselves or others to, and so consider changing their behaviour.

The review required Deloitte to estimate how much the additional GHS information may cost industry. It became clear during the review that insufficient data was available to conduct a robust cost-benefit analysis. However, using the available information, Deloitte estimated the one-off cost to industry of GHS to be around $15 - $15.8 million. The estimate includes manufacturing costs (including redesign artwork and printing of labels) and time costs to implement the GHS changes. The estimate excludes potential costs associated with any stock recalls, re-labelling existing stock and those associated with organisations who may engage consultants. However, it over-estimates the number of labels that will need ‘replacing’ (since an unknown proportion of labels will not need to be changed). Deloitte’s estimate is less than those provided by industry during the review, which ranged between $20 million for farm products and $75 million; however, it is consistent with calculations from a separate Regulatory Impact Statement conducted by Access Economics in 2010, calculated as $13.7 million in today’s terms.

Deloitte queried why veterinary medicines, and in particular those whose use involves a qualified veterinary professional, are treated differently to therapeutic goods which are exempt from GHS label requirements. Deloitte also noted that it would be advantageous for SWA and WHS regulators to communicate with and support industry in relation to the GHS labelling requirements; that it would be valuable to schedule a post-implementation review of the introduction of the GHS label statements, and that it would be useful for SWA and WHS regulators to clarify the labelling requirements outlined in the WHS Regulation for stock held in workplaces which was supplied pre 1 January 2017.

Deloitte made four (4) recommendations (outlined in Chapter 7 of this report) relating to matters within the APVMA’s functions and powers in accordance with regulation 80E of the Agvet Code Regulations for the conduct of this review. These are as follows:

1. The APVMA continues to work with SWA to assist industry determine which GHS hazard and precautionary statements (required for each hazardous chemical classification) are equivalent to, or substantially the same, as APVMA approved agvet chemical labelling statements to minimise duplication.

2. Where appropriate, the APVMA take GHS labelling into account in consideration of any future changes to agvet chemical labelling requirements.

3. The APVMA applies any discretion it has to permit manufacturers of veterinary chemical products the choice of being able to “re-stick” any new labelling on agvet chemical products at the point of supply, without the need for current stock in trade to be returned to the manufacturer (or GMP facility) for relabelling in accordance with Good Manufacturing Practice.

4. Where requested by SWA and in the interests of WHS in relation to the use and handling of agvet chemical products, the APVMA, the Department of Agriculture and Water Resources and Department of Employment continue to support SWA and its members’ communications and information flow regarding the labelling changes to manufacturers, importers, suppliers and agvet industry users and handlers.




Regulatory Review

3 Regulatory Review

The two regulatory regimes subject of our review are the agvet chemical and WHS regulatory regimes.

3.1 Establishment of the APVMA and SWA

The Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cth) established the Australian Pesticides and Veterinary Medicines Authority (“APVMA”) as the national regulator of agricultural and veterinary chemicals (“agvet chemicals”) up to the point of retail sale. The APVMA is a major stakeholder in this review and its functions and powers include, amongst other things, regulating the information that must be included on the label of an agvet chemical product (Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cth)).

Separate and distinct from the APVMA, Safe Work Australia (SWA) was established in 2009 following a commitment from all states, territories and the Commonwealth to adopt uniform occupational health and safety (OHS) laws comprised of a model Act, supported by model Regulations and Codes of Practice complemented by a nationally consistent approach to compliance and enforcement. SWA is the national body responsible for developing uniform OHS laws (now referred to as the model WHS legislation). SWA is a tripartite body comprising 15 members, including representatives of the Commonwealth, all states and territories and two members each from relevant industry associations and trade unions. As the primary lead in the development of WHS policy in Australia, including the legislative changes relating to the GHS/WHS labelling of agvet chemicals, SWA is a major stakeholder in this review.

3.2 Scope of the regulatory review

As some agvet chemicals defined by the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (sections 4 – 5) (“Agvet Code”) may not meet the WHS Regulations’ definition of a hazardous substance, this review and analysis is restricted to those substances, mixtures and articles that are classified as:

An agvet chemical by the Agvet Code; and

A hazardous workplace chemical under the WHS Regulations.

In circumstances where an agvet chemical also meets the definition of a hazardous workplace chemical, the agvet chemical manufacturer or importer and the supplier is subject to prescribed labelling requirements under both the agvet and WHS legislative regimes.

3.3 The objectives of the agvet chemical and WHS legislation

The footnotes in this report include relevant references to legislation and demonstrate the amount and detail of legislation relevant to this review in the agvet and WHS legislative landscapes. However, there are two primary pieces of legislation fundamental to this review; the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth), referred to below as the Agvet Code and the Work Health & Safety Act 2011 (Cth), referred to below as the WHS Act.

On its face, it could be perceived the two regulatory regimes (agvet and WHS) have some duplication with respect to their objects and purpose, in that both exist, inter alia, for the health and safety of people at work and the community. However, whilst crossover exists, a detailed analysis of the two legislative regimes demonstrates differences in their objectives, implementation and enforcement.




Regulatory Review

The Agvet Code’s object (Agricultural and Veterinary Chemicals Code – Schedule, Section 4, Part I, Division 1) is to make provision for and in relation to the evaluation, approval, and control of the supply, of active constituents for proposed or existing agvet chemical products and the evaluation, approval, and control of the manufacture and supply of agvet chemical products. In summary, the Agvet Code is to be implemented in a manner that:

Recognises health and safety of people, animals and the environment is the first priority of the system; and

Reflects established best-practice principles for the assessment and management of risk, based on science; and

Balances regulatory effort and any burden imposed by the system of regulation on holders of approvals, registrations, permits and licences, the domestic industry for manufacturing and formulating chemical products and users of chemical products with the risk of the use of the products and constituents to the health and safety of people, animals and the environment; and

Recognises that the use of chemical products that pose unmanageable risks to health and safety of people, animals and the environment is not appropriate in Australia; and

Promotes community confidence, is open and accountable, and gives opportunity for public involvement and participation; and

Secures compliance with the (Agvet) Code through appropriate, proportionate, consistent and effective compliance and enforcement measures.

The object of the WHS Act at section 3 (Work Health & Safety Act 2011 (Cth)) is to provide for a balanced and nationally consistent framework to secure the health and safety of workers (and non-workers) at workplaces by:

Protecting workers and other persons against harm to their health, safety and welfare through the elimination or minimisation of risks arising from work; and

Providing for fair and effective workplace representation, consultation, co-operation and issue resolution in relation to WHS; and

Encouraging unions and employer organisations to take a constructive role in promoting improvements in WHS practices, and assisting persons conducting businesses or undertakings and workers to achieve a healthier and safer working environment; and

Promoting the provision of advice, information, education and training in relation to WHS; and

Securing compliance with the Act through effective and appropriate compliance and enforcement measures; and

Ensuring appropriate scrutiny and review of action taken by persons exercising powers and performing functions under the Act; and

Providing a framework for continuous improvement and progressively higher standards of WHS; and

Maintaining and strengthening the national harmonisation of laws relating to WHS and to facilitate a consistent national approach to WHS.

In furthering the above objectives, the WHS Act states regard must be had to the principle that workers and other persons should be given the highest level of protection against harm to their health, safety and welfare from hazards and risks arising from work as is reasonably practicable

3.4 Understanding the difference between a hazard and a risk

Prior to reading this regulatory review further, it is important to understand the distinction between a hazard and risk in the context of health and safety and this review. This is relevant given the GHS system uses a hazard-based approach, whereas the agvet chemical system uses a risk-based approach for the purpose of the information appearing on labels for chemicals.

A ‘hazard’ is something that has the potential to cause harm. A ‘risk’ is the possibility that some level of harm might arise from exposure to a hazard. In simple terms, a hazard will not pose a risk to someone or something (such as the environment) without exposure.




Regulatory Review

Each hazard classification begins with an assessment of the hazards posed by any given chemical. The degree of its capacity to harm depends on its intrinsic properties, i.e. its capacity to interfere with normal biological processes, and its capacity to burn, explode, corrode, etc. The concept of risk or the likelihood of harm occurring, and subsequently communication of that information, is introduced when exposure is considered in conjunction with the potential hazards. The simple formula for risk is:

Hazard x exposure = risk

Reducing the hazard or exposure will minimise the risk or likelihood of harm.

3.5 Background to the WHS regulatory regime

On 1 January 2012 the model OHS laws, now named ‘model work health and safety (WHS) laws’ (Work Health and Safety Act) commenced in the Commonwealth, New South Wales, Queensland, the Northern Territory and the Australian Capital Territory. The model WHS laws commenced in Tasmania and in South Australia on 1 January 2013. Western Australia and Victoria are yet to implement the model WHS framework, however in both those jurisdictions work health and safety is governed by a system of laws, regulations, and compliance similar to the model WHS laws.

Each jurisdiction is responsible for enforcing its own WHS laws and they have their own WHS regulators to monitor and enforce compliance. The model WHS legislation implemented in most jurisdictions and the WHS/OHS legislation in Victoria and Western Australia, applies to workers in all

industries in Australia and to all areas of employment, including workers in the agvet sector. The model WHS laws are underpinned by a primary duty of care to ensure the health and safety of all persons (including workers and others) at a workplace, so far as is reasonably practicable.

The model WHS Regulations at regulations 32 to 35, place duties on a person who conducts a business or undertaking (PCBU) to identify reasonably foreseeable hazards that could give rise to a risk to health and safety and to manage risks arising from those hazards.

While Australian WHS laws do not include industry specific regulations for the agvet industry, the risks and hazards associated with agvet work is covered by regulations dealing with hazards and risks, which includes (but is not limited to) hazardous chemicals.

Relevant to hazardous chemicals, the WHS legislation includes labelling requirements for materials defined as substances, mixtures or articles that, with a number of exceptions, satisfy the GHS criteria as hazardous. From 1 January 2017, the Commonwealth and all Australian states and territories (but for Victoria, Western Australia and the Australian Capital Territory) will require workplace hazardous chemicals to be labelled in accordance with the GHS. Note Victoria and Western Australian legislation adopt GHS classification and labelling as acceptable and compliant for the purposes of their respective state WHS laws. The A.C.T. legislature will similarly have discretion to adopt GHS.

WHS labelling requirement for agvet chemicalsThe WHS Regulations place duties upon manufacturers, importers, suppliers and a person conducting a business or undertaking to ensure hazardous chemicals (including agvet chemicals) are correctly classified and labelled (Work Health and Safety Regulations 2011 (Cth), regulation 335(1), regulation 338, and regulation 341). To be “correctly labelled”, the hazardous chemical must be labelled in accordance with the GHS and Part 3 of Schedule 9 of the WHS Regulations (Work Health and Safety Regulations regulation 335(2)).

Manufactures, importers, suppliers and persons conducting a business or undertaking were provided a five (5) year transition period (from 1 January 2012) for this requirement of the WHS Regulation to commence on 1 January 2017.

The purpose of the transition period was to allow manufacturers, importers and suppliers time to classify their chemicals according to the GHS, develop new labels, and for those newly classified and labelled chemicals to flow through the supply chain to end users.

For the purpose of the WHS Regulations, a hazardous chemical means a substance, mixture or article that satisfies the criteria for a hazard class in the GHS but does not include a substance, mixture or article that satisfies the criteria solely for one of the following hazard classes (Safe Work Australia, 2015):

a) acute toxicity – oral – category 5;




Regulatory Review

b) acute toxicity – dermal – category 5;

c) acute toxicity – inhalation – category 5;

d) skin corrosion/irritation – category 3;

e) serious eye damage/eye irritation – category 2B;

f) aspiration hazard– category 2;

g) flammable gas – category 2;

h) acute hazard to the aquatic environment– category 1,2 or 3;

i) chronic hazard to the aquatic environment– category 1,2,3 or 4;

j) hazardous to the ozone layer

In addition to the WHS Regulations, a Code of Practice for the ‘Labelling of Workplace Hazardous Chemicals’ September 2015 from SWA applies to substances, mixtures and articles used, handled or stored at the workplace and which are defined as hazardous chemicals under the WHS Regulations.

The Code is an approved code of practice under section 274 of the WHS Act. It is a guide to achieving the standards of health, safety and welfare required under the WHS Act and the WHS Regulations and applies to any organisation or person who has a duty of care in the circumstances described in the code.

Codes of practice are admissible in court proceedings under the WHS Act and Regulations. Courts may regard a code of practice as evidence of what is known about a hazard, risk or control and may rely on the code in determining what is reasonably practicable in the circumstances to which the code relates.

Where appropriate in this review, relevant content from the Code has been referenced. A full copy of the 102 pages of this Code can be accessed on the Safe Work Australia website.

Partial exemption granted by WHS from some GHS labelling for agvet chemicalsFor those workplace hazardous chemicals classified as agvet chemicals by the Agvet Code, the WHS Regulations grant an agvet chemical specific ‘partial exemption’ (Safe Work Australia, 2016) declaring that an agvet chemical is correctly labelled if:

(a) The chemical is labelled in accordance with the requirements of the Australian Pesticides and Veterinary Medicines Authority; and

(b) the label is in English and includes the following:

a. Any hazard statement consistent with the correct classification of the chemical;

b. Any precautionary statement consistent with the correct classification of the chemical.

This partial exemption means a number of GHS labelling requirements applying to other workplace hazardous chemicals do not apply to agvet chemicals. Agvet chemicals, for example, do not need to include a GHS pictogram or GHS ‘signal words’. This partial exemption means that a hazardous chemical that carries an approved APVMA agvet chemical label can meet the WHS Regulations’ hazardous chemical labelling requirements:

1. If the hazard and precautionary statements consistent with the correct classification of the hazardous chemical by the GHS are already included in the APVMA approved sections of the label; or

2. If the hazard and precautionary statements are not already included in the APVMA approved sections of the label, by including the statements consistent with the correct classification of the hazardous chemical by the GHS, in a distinct panel or clearly delineated text box or a separate label.

General exemptions granted by WHS from GHS labellingSome hazardous chemicals (including agvet chemicals) are granted general exemptions for some of the hazardous labelling requirements under the GHS including:

1. Consumer products: where a hazardous chemical (including an agvet chemical) is labelled in accordance with the Standard for the Uniform Scheduling of Medicines and Poisons


http://www.safeworkaustralia.gov.au/sites/SWA/about/Publications/Documents/643/COP_Labelling_of_Workplace_Hazardous_Chemicals.pdf



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(SUSMP), has its original label and is packaged in the same quantity as a consumer product and is likely to be used in the same manner and frequency in the workplace as in a home or domestic setting.

In its information sheet on this topic, SWA gives the examples of:

A one litre container of glyphosate weed killer at 100 g/litre active ingredient when sold through retail outlets for home and garden use and is advertised as “Home and Garden Weed Killer”. This product would not have to comply with the WHS labelling requirements

A 20-litre drum of glyphosate weed killer at 450 g/litre active ingredient requiring dilution of one litre in 100 litres sold through specialist horticultural or rural supply stores would be considered as intended for workplace use and would require labelling in accordance with GHS requirements.

2. Small containers: The label for small containers need only include as much WHS Regulation hazard and precautionary information as is reasonably practicable. At a minimum, they must include a hazard statement (or hazard pictogram) for the most significant hazard that is not already communicated by the agvet chemical label (Work Health and Safety Regulations – Schedule 9 Part 3 (4) (2)). If all of the hazards are already communicated on the agvet chemical label, no GHS information is required. Agvet chemicals are not required to have GHS pictograms on the label.

3.6 Purpose, scope and application of the GHS

An understanding of the GHS system, adopted by the WHS legislature, is critical to this review.

Established in 1999, the United Nations Economic and Social Council’s Sub-Committee of Experts on the Globally Harmonised System of Classification and Labelling of Chemicals (UNSCEGHS), being the body responsible for maintaining the GHS and promoting its implementation, has provided the purpose, scope and application of the GHS in its 3rd and 4th Edition publications. Relevant excerpts of that publication have been summarised and reproduced below to provide understanding and context.

UNSCEGHS outlines that, owing to the potential for adverse effects to people or the environment, a number of countries or organisations around the world have developed laws or regulations requiring information to be prepared and provided to those using chemicals, through labelling or safety data sheets (SDS). Given the large number of chemicals available and their varied uses, individual regulation is simply not possible for any entity. Provision of information gives those using chemicals the identities and hazards of the chemicals, and allows the appropriate protective measures to be implemented in the local use settings.

Whilst the laws or regulations existing around the world (prior to the GHS) were similar in many respects, their differences were significant enough to result in different labels or SDS for the same chemical in different countries. Through variations in definitions of hazards, a chemical may be considered flammable in one country, but not another, or it may be considered to cause cancer in one country, but not another. Decisions on when or how to communicate hazards on a label or SDS varied around the world and organisations seeking to trade internationally required experts to follow changes in the laws and regulations to prepare different labels and SDS. Owing to the complexity of developing and maintaining such a system for classifying and labelling chemicals, some countries had no system at all.

Given the reality of the extensive global trade in chemicals, and the need to develop national programs to ensure their safe use, transport and disposal, it was recognised an internationally harmonised approach to classification and labelling would provide the foundation for such programs. In UNSCEGHS’ Plan of Implementation adopted in Johannesburg on 4 September 2002, the World Summit on Sustainable Development encouraged countries to implement the GHS as soon as possible with a view to having the system fully operational by 2008.

The scope of the GHS included the following elements:

a) Harmonised criteria for classifying substances and mixtures according to their health, environmental and physical hazards; and

b) Harmonised hazard communication elements, including requirements for labelling and SDS




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The Coordinating Group for the Harmonisation of Chemical Classification Systems (CG/HCCS) indicated that they carefully considered many issues regarding the possible application of the GHS. Concerns were raised whether certain sectors or products should be exempted or whether (or not) the system ought to be applied to all stages of the life cycle of a chemical. Following those considerations, three parameters were identified as critical to application of the GHS system in a country or region, namely:

1. The GHS covers all hazardous chemicals. The mode of application of the hazard communication elements of the GHS (e.g. labels, SDS) may vary by product category or stage in the life cycle. Target audiences for the GHS include consumers, workers, transport workers and emergency responders.

2. The mandate for development of a GHS does not include establishment of uniform test methods of promotion of further testing to address adverse health outcomes.

3. In addition to animal data and valid in vitro testing, human experience, epidemiological data, and clinical testing provide important information that should be considered in application of the GHS.

Further relevant commentary provided in the publication regarding the parameters above, and worth mentioning in our review include:

In relation to parameter 1 above:

Since all chemicals in commerce are made in a workplace (including consumer products) handled during shipment and transport by workers, and often used by workers, there are no complete exemptions from the scope of the GHS for any particular type of chemical or product.

At other stages of the life cycle for these same chemicals, the GHS may not be applied at all. For example, at the point of intentional human intake or ingestion, or intentional application to animals, products such as human or veterinary pharmaceuticals are generally not subject to hazard labelling. Such requirements would not normally be applied to these products as a result of the GHS. It should be noted that the risks to subjects associated with the medical use of human or veterinary pharmaceuticals are generally addressed in package inserts and are not part of the GHS harmonised process.

In relation to parameter 3 above:

GHS is not intended to harmonise risk assessment procedures or risk management decisions (such as establishment of a permissible exposure limit for employee exposure), which generally require some risk assessment in addition to hazard classification.

The goal of the GHS is to identify the intrinsic hazards found in substances and mixtures and to convey information about these hazards. The criteria for hazard classification are harmonised. Hazard statements, symbols and signal words have been standardised and harmonised and now form an integrated hazard communication system. The GHS will allow the hazard communication elements of the existing systems to converge.

Competent authorities (e.g. relevant government agencies) will decide how to apply the various elements of the GHS based on the needs of the competent authority and the target audience. In particular, whilst the GHS expects all hazardous chemical systems use the GHS classification criteria based on hazard, GHS also envisaged these competent authorities may authorise chemical labelling systems providing information based on the likelihood of harm (risk-based labelling such as the agvet chemical risk based system). In this case, the competent authority would establish procedures for determining the potential exposure and risk for the use of the product (United Nations, 2009).

Safety data sheetsThe two modes of application of the hazard communication elements for GHS are labels and safety data sheets (SDS).

A SDS, previously called a Material Safety Data Sheet (MSDS), is a document that provides information on the properties of hazardous chemicals and how they affect health and safety in the workplace. An SDS includes information on the identity of the chemical, health and physicochemical hazards, safe handling and storage procedures, emergency procedures and disposal considerations.

WHS regulators expect (as part of a business or undertaking’s safe system of work) that the SDS is referenced when assessing health and safety risks of each hazardous chemical. The WHS Regulations require the manufacturer or importer of a hazardous chemical to prepare an SDS for the chemical. A




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supplier of hazardous chemicals must provide the manufacturer or supplier’ current SDS on the first supply to a workplace and upon request thereafter.

The hazard and precautionary statements available on the label of a chemical product is also available on the SDS.

Safe Work Australia’s Code of Practice for the Preparation of Safety Data Sheets for Hazardous Chemicals provides detailed guidance on how to prepare a SDS for workplace chemicals.

3.7 Background to the agvet chemical regulatory system

The APVMA manages potential risks posed by agvet chemicals by, among other things, imposing conditions on approvals or registrations, and through requiring certain information to be contained on chemical product labels. Access to certain agvet chemical products is restricted if the Agvet Code Regulations declare them to be restricted chemical products.

The APVMA’s legislative framework provides for consistency, efficiency and transparency of agvet chemical approvals, registrations and reconsiderations, and helps the APVMA to align its regulatory effort with risk.

Section 1A of the Agvet Code sets out the purpose and framework for regulatory decision making for agvet chemicals. This section of the Agvet Code states the code is to be implemented by the APVMA in a manner which maintains a balance between regulatory effort, the regulatory burden imposed on those affected, and the risk associated with chemical’s use.

The APVMA states “in administering the code, (they) aim to ensure regulatory compliance in keeping with what is reasonably necessary to manage risks to the health and safety of human beings, animals and the environment.”

The statutory criteria the APVMA address in making regulatory decisions include criteria for safety, efficacy, trade and labelling. For the purpose of this review, safety and labelling are the relevant criteria considered in this report.

In respect of the safety criteria, subsection 5A(1) of the Agvet Code relevantly states the following:

A chemical product meets the safety criteria if use of the product, in accordance with any instructions approved or to be approved by the APVMA or contained in an established standard:

Is not, or would not be, an undue hazard to the safety of people exposed to the product during its handling or people using anything containing its residues

Is not, or would not be, likely to have an effect that is harmful to human beings

Is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

Relevant to the criteria above, subsection 3 of the Agvet Code defines “handling” as including transportation, storage, processing, use or disposal of the chemical product.

The APVMA must have regard to the following for the purposes of being satisfied as to whether a chemical product meets the safety criteria (safety related matters highlighted for ease of reference):

1. The toxicity of the product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings

2. The relevant poison classification of the product as determined under the existing health arrangements

3. How the product is formulated4. The composition and form of the constituents of the product

5. Any conditions to which its registration is, or would be, subject

6. Any relevant particulars that are, or would be, entered in the Register for the product

7. Whether the product conforms, or would conform, to any standard made for the product

8. Any matters prescribed by the Agvet Code Regulations, including:

For all chemical products, the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product

For a product manufactured in Australia, whether each step in the manufacture of the product complies, or will comply, with the Manufacturing Principles and the Australian GMP Code (this




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does not apply if the product is an exempt product, a listed chemical product, or a reserved chemical product)

For a product manufactured outside Australia, whether each step in the manufacture of the product complies, or will comply, with a standard that the APVMA has determined is comparable to manufacturing principles and the Australian GMP Code (this does not apply if the product is an exempt product, a listed chemical product, or a reserved chemical product)

For a molluscicide in the form of a bait, where the active constituent is either metaldehyde or methiocarb:

o whether the product contains sufficient pigment or dye to colour the bait a distinctive colour (green for metaldehyde and blue for methiocarb)

o whether the product contains, in the bait, any bone meal or other product of animal origin

For an agricultural chemical product to be applied to seeds to be supplied and stored before planting or sowing, whether the product contains sufficient pigment or dye to colour the seed to enable it to be readily distinguished from untreated seed to which the chemical product has not been applied.

The APVMA may consider one or more of the following for the purposes of being satisfied as to whether a chemical product meets the safety criteria:

1. The acceptable daily intake of each constituent contained in the product

2. Any dietary exposure assessment prepared under subsection 82(4) of the Food Standards Australia New Zealand Act 1991 as a result of any proposed variation notified under subsection 82(3) of that Act in relation to the product, and any comments on the assessment given to us under subsection 82(4) of that Act

3. Whether any trials or laboratory experiments have been carried out to determine the residues of the product, and if so, the results of those trials or experiments, and whether those results show that the residues of the product will not be greater than limits that we have approved or will approve

4. The stability of the product

5. The specifications for containers for the product

6. Other matters as the APVMA thinks relevant.

The APVMA’s assessments consider both chronic (long-term) and acute (short-term) effects, physicochemical effects (such as flammability or corrosiveness) and the potential for exposure to a product or its residues during handling (including transport, storage and processing), use and after application.

Specific consideration of exposure is given to workers likely to have long-term interaction with agvet products, such as spray contractors. Based on the risk assessment, risk management measures are placed on a product to reduce any identified human health risks to an acceptable level, in addition to environmental and animal health risks. These measures include engineering controls, safety directions, use restraints, scheduling recommendations and requirements to use personal protective equipment. If the risks associated with a product or use cannot be appropriately managed, that is, exposure to a hazard (including acute, chronic or physicochemical) is not effectively mitigated and therefore an unacceptable risk level remains, that product or use will not be registered by the APVMA.

The following link to the APVMA web site outlines the recommendation and guidelines for submitting data, in addition to the toxicological data, to enable the characterisation of the human health, environmental and animal health risks associated with the use of agvet chemical products, as part of the application for registration or extension of use and for permit applications. http://apvma.gov.au/node/1027.

The APVMA assesses toxicology data and/or scientific argument provided by the applicant on the potential environmental, human and animal health hazards arising from proposed use of the chemical product. This information is important in establishing relevant health recommendations for the safe use of the chemical product, including:

Acceptable daily intakes

Acute reference doses


http://apvma.gov.au/node/1027



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Poison scheduling (the SUSMP)

First aid instructions

Safety directions

Warning statements

Re-entry/re-handling statements

Other limitations on use (for example, restraints, restrictions).

In conducting the WHS assessment module, the APVMA reviews data to determine:

The human health hazards of the product

Potential exposure during handling or use of the product by professional and/or household users

Potential post-application exposure, such as during re-entry to treated crops or areas or re-handling of treated commodities such as seed, grain or treated timber products

Chemical accredited trainingAs outlined earlier, the APVMA is the national regulator of agvet chemicals up to the point of retail sale. Post sale, state and territory regulators are responsible for the use of agvet chemicals. As a further means of health and safety control in the agvet industry, most states and territories require users to have current training accreditation to use agvet chemicals. The legislation for chemical accreditation varies for each state and territory of Australia. The table below provides a brief, non-exhaustive summary of some of those training requirements. For further detail regarding chemical accreditation, refer to the relevant state and territory legislation or the website for ChemCert, an industry based non-profit organisation established in 1999 as a peak accreditation body to work with all industry sectors throughout Australia for the training and industry accreditation for users of agvet chemicals.

State Chemical accreditation requirements

Northern Territory and Victoria Accredited chemical training is required to use agvet products that are Schedule 7 poisons and other restricted chemical products.

New South Wales Any person who uses pesticides at work must receive accredited chemical training and be re-accredited every 5 years. Pesticides include herbicides, insecticides, fungicides, bactericides, baits, lures and rodenticides (rat poison).

South Australia Any person who purchases or uses Schedule 7 poisons must hold a current chemical accreditation, renewable every 5 years.

All commercial users of a specific group of herbicides must hold a current statement of attainment for chemical training.

Queensland, Tasmania, Western Australia and Northern Territory

Commercial operators spraying certain agvet chemicals are required to be licensed and hold accredited chemical training

3.7.2 Labelling requirements for the agvet chemical regulatory systemThe applicant for registration of an agvet chemical has a duty to comply with the labelling requirements of the Agvet Code. To comply with the labelling criteria of section 5D of the Agvet Code the label of an agvet chemical must include the following information:

(a) The circumstances in which the product should be used

(b) How the product should be used

(c) The times when the product should be used

(d) The frequency of the use of the product

(e) The withholding period after the use of the product

(f) The re-entry period after the use of the product

(g) The disposal of the product when it is no longer required

(h) The disposal of containers of the product


http://www.chemcert.com.au/state-legislation



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(i) The safe handling of the product and first aid in the event of an accident caused by the handling of the product

(j) Any matters prescribed by the regulations.

The matters ‘prescribed by the regulations’ (s 5D(1)(j)) are outlined in the Agvet Code Regulations (r 8AE(1)(a)-(e)) ‘labelling criteria’ and require the following information (primarily for the purposes of the safety criteria) on an agvet chemical label:

(a) The duration of any treatment using the [agvet chemical] (for a veterinary chemical product)

(b) The prevention of undue prejudice to trade or commerce between Australia and places outside of Australia;

(c) The appropriate signal words (if any) required by the current Poisons Standard;

(d) For a chemical product that is a date-controlled chemical product—the storage of containers for the product;

(e) Any other matter determined by the APVMA CEO under sub-regulation (2).

The Agvet Code (s 12(a)) also requires a label for an agvet chemical to include other prescribed particulars detailed in the Agvet Code Regulations (r 17(1)), namely:

(a) The appropriate signal words required by the current Poisons Standard;

(b) The name of the chemical product that is to appear on a label for containers of the chemical product;

(c) The name of each active constituent of the product;

(d) The proportion of each active constituent of the product;

(e) The name of each constituent for the product that is:

a. Not an active constituent; and

b. Classified as a poison in the current Poisons Standard;

(f) The proportion of each constituent referred to in paragraph (e);

(g) The net contents of the product;

(h) Particulars determined by the APVMA CEO under sub regulation (2).

Section 18D of the Agvet Code Regulations also requires the agvet label contain the following information:

(a) The agvet chemical’s ‘distinguishing number’ and ‘the instructions and any particulars that are to be contained on the label’ (s 21(c) (iii) and (iv))

(b) The batch number of the chemical product;

(c) The expiry date of the chemical product (if applicable);

(d) The date of manufacture of the chemical product (if applicable);

(e) The name and address of the person primarily responsible for marketing the product.

Section 18E of the Agvet Code Regulations requires an agvet label comply with the requirements of:

(a) If a labelling standard has been made by the APVMA—the labelling standard; or

(b) If a labelling standard has not been made by the APVMA—either:

a. If the product is a veterinary chemical product—the Veterinary Labelling Code b. If the product is an agricultural chemical product—the Agricultural Labelling Code

Both the Veterinary Labelling Code and the Agricultural Labelling Code referred to above (“Agvet Labelling Codes”) [draw] together the [labelling] requirements of the Agvet Code and Agvet Code Regulations’ by outlining the ‘standard labelling requirements’ that must be followed for agvet chemicals.

While a number of ‘variations’ to these standard requirements are detailed for specific agvet chemical classes, the label for an agvet chemical must include the standard labelling requirements detailed in the respective Agvet Code Regulations, regulation 18E (b) Veterinary or Agricultural Labelling Code and, if applicable, include the variations prescribed in the relevant Agvet Code Regulations, regulation 18E (a) labelling code.




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The labelling codes also reference certain non-APVMA statutory and non-statutory instruments and documents (refer to Appendix B, Table 1) with which an agvet chemical label must comply and other instruments for which compliance is considered non-mandatory best practice. These non-APVMA statutory and non-statutory instruments include:

The Poisons Standard February 2016 consisting of the Standard for the Uniform Scheduling of Medicines and Poisons (“the SUSMP”) – refer to footnote 26

The Australian Code for the Transport of Dangerous Goods by Road or Rail (“the ADG Code”)

The Therapeutic Goods Administration (TGA) Approved Terminology for Medicines (“the TGA ATM”)

Australian Standard AS 1719-1994 Recommended Common Names for Pesticides (“AS1719-1994”)

The National Measurement Act and Regulations (the “NMI requirements”)

The First Aid Instruction and Safety Directions Handbook (“the FAISD Handbook”)

The Competition and Consumer Act 2010 (Cth) (“the CCA”)

The Commerce (Trade Descriptions) Act 2010 (Cth) (“the CTDA”)

The Agvet Labelling Codes’ requirements are summarised in Appendix B, Table 1. The table also references non-APVMA instruments and documents as each relates to the Agvet Labelling Codes’ requirements.

Section 25 of the Agvet Labelling Codes state (amongst other things) if the chemical product is classified as a hazardous chemical under the WHS Regulations, there are likely to be (additional) labelling requirements for labelling in the WHS Regulations. This section of both Codes outline the mechanism for including this other labelling information by directing that relevant and required label information be shown in a ‘distinct panel or clearly delineated box’ and must not be incorporated amongst the APVMA required safety directions or other instructions.

Both of the labelling codes:

Make it clear that section 25 information does not constitute ‘relevant particulars’ and is ‘not… assessed or approved as part of the APVMA approval process’.

State that ‘inquiries ought to be made to Safe Work Australia or state or territory workplace health and safety agencies for this information’.

The APVMA has published a guide for ‘Understanding Pesticide Chemical Labels’ which explain what the different sections of the label mean.

3.7.3 Relationship of the Agvet Code to other lawsSection 2 of the Agvet Code excludes the operation of any other laws of the States or participating Territories that are inconsistent with the Agvet Code. However, a law is not taken to be inconsistent if it can operate concurrently with the Agvet Code (s 2 (1) & (2)).

Consistent with the commentary above, Section 25 of the Agvet Labelling Codes recognise other legislation (such as the transport of dangerous goods and WHS legislation) may require the agvet chemical labelling to include other (non-APVMA approved) statements or information on the labelling of agvet chemical products.

3.7.4 Australian Code for the Transport of Dangerous Goods by Road or Rail (ADG Code)Dangerous goods are substances, mixtures or articles that, because of their physical, chemical (physicochemical) or acute toxicity properties, present an immediate hazard to people, property or the environment. Types of substances classified as dangerous goods include explosives, flammable liquids and gases, corrosives, chemically reactive or acutely (highly) toxic substances. Many dangerous goods are also classified as hazardous substances.

The ADG Code contains a list of substances classified as dangerous goods and it sets out the requirements for transporting dangerous goods by road and rail in Australia. The ADG Code assists Australia’s transport and logistics industry to operate safely when carrying dangerous goods and the introduction to the Code states, “…It is important that all members of the supply chain understand and


http://www.ntc.gov.au/Media/Reports/(7E6FD0E5-2D6A-4747-BE48-C0DDDF676A3A).pdf

http://archive.apvma.gov.au/use_safely/docs/understanding_labels_booklet.pdf

https://www.saiglobal.com/PDFTemp/Previews/OSH/As/as1000/1700/1719.PDF

http://www.tga.gov.au/publication/tga-approved-terminology-medicines


https://www.legislation.gov.au/Details/F2016L01505

https://www.legislation.gov.au/Details/F2016L01505



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work to the requirements of the Code, including the consignor, packer, truck driver and dangerous goods transport companies, along with dangerous goods professionals and trainers”.

The primary focus of the ADG Code is on the safe transportation of dangerous goods by road and rail. It does not contain any provisions relating to usage, storage or security of the goods.

Labelling provisions in the ADG Code include precautions (via markings and symbols) to be taken in transporting, handling or storing a package (e.g. a skull and crossbones symbol and the word toxic or a symbol representing a fire and the words flammable liquid, as relevant) must be displayed on a package.

The ADG Code should be read in conjunction with the specific dangerous goods transport legislation that has been enacted in the relevant state or territory. Agvet chemical labels must comply with the ADG Code.

3.7.5 The Poisons Standard (Scheduling)Scheduling refers to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), which contains classification of poisons into Schedules as recommendations. The SUSMP is also referred to as the Poisons Standard.

The scheduling classification sets the level of control on the availability of poisons. Labelling and packaging requirements may also be a consequence of scheduling, but are the subject of Commonwealth registration schemes such as the agvet chemical registration system. The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling such as the agvet chemical regulatory system.

Poison substances are classified into one of ten schedules in the SUMSP. The higher numbers signify an increasing level of professional healthcare intervention combined with increasingly stricter container and labelling requirements. Appendix B, Table 6 contains a summary of Schedules (1 to 10) and indicates which schedules apply to the agvet industry. Appendix B, Table 7 contains a summary of conditions for availability and use of Schedule 7 poisons.

In addition to scheduling classification, the SUSMP is presented with a view to promoting uniform signal headings on labels for poisons, labelling and packaging requirement for poisons including cautionary statements and additional controls on the availability and use of poisons in Australia. The agvet chemical regulatory system and its labelling requirements integrate with the SUSMP and the Agvet Code Regulations require (amongst other things) that agvet chemical labels contain the appropriate signal words required in the current Poisons Standard as well as cautionary words or phrases and storage or disposal statements.

3.8 Identifying areas of potential duplication complying with both sets of legislation

WHS and agvet labelling requirements for hazard and precaution statementsUnder both the WHS and agvet chemical regulatory systems, hazards and precautions of chemical products are required to be listed on the label of the product.

As outlined in Appendix B, Table 3 the Agvet Labelling Codes require agvet chemical labels to comply with other instruments when including hazard and precautionary information on an agvet chemical label, the most important being:

The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP); and

The First Aid Instruction and Safety Directions Handbook (FAISD Handbook)

Each of the documents (the SUSMP and FAISD Handbook) detail statements that are incorporated in prescribed sections of an agvet chemical label relevant to the hazards presented by each and the precautions necessary for safe handling.

The WHS Regulation, on the other hand, requires that agvet chemical labels include both hazard and precautionary statements ‘consistent with the correct classification of the chemical’ under the GHS (WHS Regulations 2011, r 335, part 3 Schedule 9). This WHS regulatory requirement is further referenced in the Safe Work Australia Code of Practice for ‘Labelling of Workplace Hazardous Chemicals’ (March, 2015) at paragraph 3.9.





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The WHS and GHS hazard-based approachAs the GHS system applies a hazard-based approach to the classification and labelling of hazardous workplace chemicals, this means a label of a hazardous workplace chemical, including an agvet chemical, must communicate the intrinsic hazards (in addition to any precautionary statements) of the product based on its GHS classification.

The GHS system was never intended to be a risk-based approach. Rather, its intention was to create a global foundational system to identify the intrinsic hazards found in substances and mixtures and to convey hazard information. GHS then envisaged other competent authorities (such as the AVPMA and WHS regulators) would decide how to apply the various elements of the GHS based on the needs of the authority and the target audience.

The APVMA risk-based approachIn applying its risk-based approach when assessing the hazards presented by an agvet chemical and prior to its approval, the APVMA engages experts to assess relevant data from clinical studies as well as the toxicity and WHS information associated with the proposed product. An evidence-based approach is used which considers data from studies (including toxicology studies) relevant to the chemistry for each product.

The assessments consider both chronic (long-term) and acute (short-term) health effects, physicochemical effects (such as flammability or corrosiveness) and the potential for exposure to a product or its residues during handling (including transport or storage), use and after application. Specific consideration of exposure is given to workers likely to be frequent, long-term users or handlers of the product.

Based on the risk assessment, risk management measures are placed on a product to reduce any identified human health risks (and other risks) to an acceptable level. These measures include engineering controls, safety directions, use restraints and scheduling recommendations. If the risks associated with a product or use cannot be appropriately managed, that is, exposure to a hazard (including acute, chronic or physicochemical) is not effectively mitigated and therefore an unacceptable risk level remains, that product or use will not be registered by the APVMA.

The outcome of this approach means the APVMA considers the risk of harm to health and safety (including animal, human and the environment) that could occur from potential exposure to the intrinsic hazards. This consideration of the agvet chemical includes the effective implementation of product specific APVMA approved controls necessary to prevent, eliminate or reduce exposure to an acceptable level.

Matter of difference between the APVMA and WHS agvet labellingThe contrast between the APVMA risk-based approach and the GHS hazard-based approach may lead to a position whereby, in certain circumstances, the precautionary information requirements of the agvet and GHS systems to be communicated on a label may differ.

This can occur where the potential hazard exposure, following a risk assessment and in context of effective control implementation, is deemed by the APVMA to be of such a low risk as not to warrant a precaution. In other words, the APVMA may effectively ‘risk assess’ a potential hazard’s precautionary information from the label information, notwithstanding the existence of an intrinsic hazard. Whereas the existence of any intrinsic hazard, irrespective of its volume, in an agvet chemical will require the hazard statement and precautionary statement to appear on the label for the purposes of the GHS and therefore meet the requirements of the WHS legislation.

There may be circumstances where the APVMA’s risk-based approach may deem a particular agvet chemical’s label need not include a precaution for an intrinsic hazard contained in the product due to the low risk presented by the product’s use or handling. In this circumstance, the relevant intrinsic hazard and corresponding precautionary statement (as classified by GHS) will need to be included on the agvet chemical’s label and separated from the other agvet chemical label content by placing the GHS content in a clear text box. This will be additional information required rather than duplication.

Potential duplication between agvet labelling and GHS labelling requirements Determining the hazard and precaution information for communication on an agvet chemical and applying both agvet chemical labelling and GHS chemical labelling requirements, may lead to the




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identification some label information or statements, which are equivalent or substantially similar in content.

Safe Work Australia (SWA) has identified this potential duplication and has published an information sheet for agvet manufacturers and importers. This sheet indicates, inter alia, when the agvet chemical’s first aid, safety, storage and / or disposal label information includes hazard and precautionary statements that are ‘equivalent or substantially the same’ to those required by the WHS Regulations, these statements do not need to be repeated elsewhere on the packaging label.

In its ‘Information sheet for manufacturers and importers of agricultural and veterinary (agvet) chemicals’ SWA has provided a small table (reproduced below) of examples of the APVMA statements it considers is equivalent to GHS statements and where already present on an agvet label, obviate the need for the GHS statement to be duplicated. We note the information sheet does not refer to or provide guidance on hazard and precautionary statements that are ‘substantially the same’.

GHS Statement Equivalent APVMA statement

May cause an allergic skin reaction Repeated exposure may cause allergic disorders

Toxic if inhaled Product and spray are poisonous if inhaled

Wash hands thoroughly after handling Wash hands after use

Take off contaminated clothing and wash before use

After each day’s use, wash gloves, goggles and contaminated clothing

The information sheet has been approved for publication by all Safe Work Australia Members comprising representation from all Australian WHS jurisdictions. The Members approval is demonstrative of the WHS regulators intent to adopt the policy in the information sheet.

While Western Australia and Victoria have not adopted the approved model WHS legislation (and the Australian Capital Territory did not adopt the ‘hazardous chemicals’ chapter of the harmonised WHS Regulation), we note the following:

In Victoria, the Occupational Health and Safety Regulations state that a manufacturer or importing supplier of a hazardous substance need not comply with the hazardous substance labelling requirements of the Victorian Regulations if the container is labelled in accordance with “equivalent legislation” (i.e. the harmonised WHS regime and GHS) (Occupational Health and Safety Regulations 2007 (Vic) r 4.1.9 & r 4.1.10)

In Western Australia, the Western Australian government, in response to the ‘Labelling of Agvet Chemicals under WHS legislation’ Discussion Paper stated in answer to a question regarding Western Australia’s approach to the GHS that ‘Safe Work Australia is providing guidance on the implementation of the GHS in Australia….WA will have reference to SWA guidance material’

The Australian Capital Territory (A.C.T.), unlike other harmonised jurisdictions did not adopt Chapter 7 for ‘hazardous chemicals’ of the Model Work Health and Safety Regulations as part of its Work Health and Safety Regulation 2011. The A.C.T. continues to regulate chemical products as dangerous substances under the A.C.T. Dangerous Substances Act 2004 and its subordinate law, including the A.C.T. Dangerous Substances (General) Regulation 2004. The A.C.T. Dangerous Substances (General) Regulation 2004 references the requirements of the Australian Code for the Transport of Dangerous Goods by Road and Rail (the ADG Code). The APVMA’s Agvet Labelling Codes require adherence to the ADG Code in the relevant state or territory when labelling any agvet chemical products.

Further hazard and precautionary statements equivalent or substantially the sameWhilst SWA provides four examples of agvet chemical label statements in its information sheets that are equivalent to GHS statements (and therefore need not be repeated on a separate GHS label for WHS purposes) there are many other APVMA approved labelling statements that may be reasonably considered as equivalent or substantially the same as the GHS hazard and precautionary statements.

On this basis, Deloitte prepared two draft tables, which we provided to SWA for their consideration and review, namely:

One which compared GHS hazard statements to the APVMA mandatory statements outlined in the FAISD Handbook; and


http://www.agriculture.gov.au/SiteCollectionDocuments/about/foi/2015-16/foi-2015-16-13/documents-22-27.pdf

http://www.agriculture.gov.au/SiteCollectionDocuments/about/foi/2015-16/foi-2015-16-13/documents-22-27.pdf

http://www.safeworkaustralia.gov.au/sites/swa/about/ourmembers/pages/members

http://www.safeworkaustralia.gov.au/sites/SWA/about/Publications/Documents/954/manufacturers-importers-agvet-chemicals-information-sheet.docx

http://www.safeworkaustralia.gov.au/sites/SWA/about/Publications/Documents/954/manufacturers-importers-agvet-chemicals-information-sheet.docx



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A second table, which compared GHS precautionary statements to statements outlined in the FAISD Handbook.

The purpose of these tables is to identify which APVMA approved agvet labelling statements may be equivalent or substantially the same as GHS hazard and precautionary statements and therefore, need not appear on the agvet chemical label a second time.

SWA made comparison with the tables it was developing in-house, and responded to our draft tables indicating which agvet chemical label statements it considered equivalent to GHS statements and which could be made public for the purposes of this report. SWA advised some of the statements may be equivalent in certain circumstances, but not in others, and therefore not all statements have been reproduced. Having said that, a significant number of statements were considered by SWA as equivalent and this will provide substantial guidance to agvet chemical manufacturers or importers and suppliers when considering what additional labelling content will be required.

Tables 4 and 5 in Appendix B of this report contain the Deloitte tables which SWA have considered the GHS statements are equivalent to the existing agvet labels and therefore do not need to be repeated on the agvet chemical labelling.




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4 Options

Following consultation with the Department and in order to commence this review and provide a foundation for our discussions with stakeholders, four options for agvet chemical labelling were agreed for the purpose of initial discussion and consultation. During this review, stakeholders were encouraged to raise any additional viable options for consideration, however none were brought forward.

The four options referenced for the purpose of initial discussion and consultation, were:

4.1 Option 1 – Additional GHS labelling added to existing agvet WHS labelling

This option represents the legislation as it is at the time of this review and the ‘status quo’ based on commentary throughout this report. It applies to labelling of hazardous workplace agvet chemicals supplied after 1 January 2017 in WHS national harmonised jurisdictions (that is, those State and Territory jurisdictions that adopted the model WHS legislation). With this option, the existing APVMA approved labelling information does not need to change. Neither does APVMA need to approve the inclusion of the GHS content required by the WHS legislation on the product label. Manufacturers or importers and suppliers will need to amend the labels to include any relevant WHS content not already included under agvet requirements.

Where statements are not already on the agvet chemical label, WHS Regulators have provided two options for manufacturers or importers and suppliers of agvet chemicals to place the two elements required under WHS on the labelling. These elements are hazard and precautionary statements based on the GHS. SWA have advised this WHS information required for the GHS system, should be separated from the other agvet label elements by either:

1. Placing it on the same label as the agvet label elements but in a separate clear text box (refer example below provided by SWA); or

2. Placing it on a separate label to the agvet label elements on the same container.

4.2 Option 2 – Remove the APVMA WHS labelling requirements for hazardous workplace chemicals and rely on the GHS

This option would remove the WHS components of APVMA assessment of hazardous workplace agvet chemical products (and consequently from the relevant particulars of the approved label). WHS information would rely completely on the GHS classification and labelling requirements as required by the WHS legislation.

The non-WHS assessments and agvet label content would remain untouched. In relation to this option, the review team notes that:

The APVMA would need to continue to undertake health and safety assessments for those consumer goods that are not intended primarily for workplace use;

The remaining APVMA risk assessments and label content (regarding environment, animal health etc.) may still “crossover” with components of the WHS hazard assessment; and

The APVMA could not remove its WHS assessment requirements without requesting a legislative change.




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4.3 Option 3 – Full exemption for Agvet chemical labelling from WHS workplace chemical labelling requirements

This option would re-instate the previous full exemption for agvet chemical labelling from WHS chemical labelling requirements on the basis the current agvet chemical label information satisfied the WHS information requirements.

Our review has considered the non-financial costs and benefits of this option. As this option involves maintaining the previous arrangements, there is no “financial cost” involved, and as such – the financial benefits of this option will be considered in terms of “avoided cost” i.e. the costs of avoiding the changes that option 1 (commencing on 1 January, 2017) will bring.

While the review’s terms of reference (as set out in the Agvet Code Regulations) provide for this option to be analysed, they exclude making recommendations about it on the basis that any changes to WHS legislation, including changes relating to agvet chemicals, rests outside of the agriculture portfolio’s authority. Delivery of this option is within the power of the state, territory and Commonwealth WHS regulators.

SWA Members have considered similar options in recent years and have not supported this approach.

4.4 Option 4 – Aligning the FAISD Handbook with GHS and WHS requirements

This option concerns the alignment of the First Aid Instruction and Safety Directions (FAISD) Handbook with GHS terminology.

In determining the safety instructions to be included on the approved label for an agvet chemical product, the APVMA has reference to the FAISD Handbook. The FAISD Handbook is consolidated advice provided to the APVMA by the Office of Chemical Safety in the Australian Government Department of Health. The statements in the FAISD Handbook reflect the Australian-specific circumstances and are phrased to reflect Australian language structure. The statements from the FAISD Handbook were developed independently of the GHS terminology.

Aligning the language of equivalent statements in the FAISD Handbook with those of the GHS would ensure the statements required by WHS exist within the APVMA approved content and there would be no need for the two separate GHS statements in a separate box on the labelling, since they would already be in the agvet chemical label’s information.

Whilst this is a potential option and was open for discussion, there are several fundamental issues, which impact on the practicality of this option, in particular:

The current agvet chemical labelling will still need to change in circumstances where the current FAISD Handbook statements do not align with the GHS statements.

On the basis the GHS system is hazard-based and the agvet system is risk-based, the APVMA approved labels will likely not cover all of the required GHS intrinsic hazard and precautionary statements

This option would require the APVMA to engage, consult and work with the Health agencies to agree and execute this approach.

Unless agreed otherwise by all relevant stakeholders, any such alignment may only apply to new labelling content and may not be retrospective. We do note however, that the APVMA has discretion to reconsider approval of a label without notice in certain circumstances and therefore may arguably have this statutory discretion itself (Agricultural and Veterinary Chemicals Code Act 1994 s34AF).




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5 Stakeholder engagement

5.1 Targeted Stakeholder Engagement

Following consultation with the Department, interviews with stakeholders representing the agvet industry, agvet users, WHS regulatory agencies and agvet regulatory agencies took place in March and April 2016. Contact was made with thirty-three (33) stakeholders inviting them to participate in the interview process. Their numbers included the following groups.

Stakeholder Number of stakeholdersCommonwealth Government Agencies 5

WHS Regulators 9

Agvet Industry 17

Worker’s Representative 1

Government health 1

Twenty-two (22) stakeholders accepted and the interviews were conducted with the purpose of understanding the issues, refining preliminary options and identifying other viable options to address any potential duplication. The following interviews took place face to face with stakeholders:

The Australian Pesticides and Veterinary Medicines Authority (APVMA) Safe Work Australia (SWA)

CropLife Australia Limited Animals Medicines Australia

National Farmers’ Federation (NFF) Plastics and Chemical Industries Association

The following interviews took place over the phone: Australian Government Department of Employment Agvet Chemicals Task Group (ACTG)

Office of Industrial Relations (QLD) SafeWork SA

WorkSafe, Department of Commerce (WA) Sheep Meat Council of Australia

Cattle Council of Australia Australian Pork Limited

Voice of Horticulture AusVeg

NSW Farmers Australian Chamber of Commerce and Industry

Elanco Animal Health Australian Manufacturing Workers’ Union

ACCORD Australasia Philstic Labels

Prior to each interview, the organisation’s representative(s) were provided with a background and purpose of the review, four options the review team identified (refer to Chapter 4 above, ‘Options’) and a list of themes of information being sought. Refer to Appendix C for a copy of this briefing material.

5.2 Important note on engagement of stakeholders

The views of a majority of the stakeholders (whilst knowledgeable as regards their own operations and undertakings) revealed some misunderstanding, misinterpretation, inaccurate beliefs and in some cases a lack of awareness of the detailed subject matter concerning the regulation of WHS relating to




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agvet chemical products. Given the complexity of the subject matter involved, amount of relevant legislation and Commonwealth, State and Territory governmental bodies involved, this was not surprising.

As a result, the stakeholder summaries provided below should not be all accepted as factual statements of truth. It was not the Deloitte review team’s role to correct stakeholders during the interview, but rather understand their position, beliefs and perception relevant to the matters. One of the goals of this review and our report is to describe the understanding of various stakeholders and their perceptions as it relates to these matters.

Additionally, we have not sought to correct the views of stakeholders in this Chapter of our report. Instead, from the contemporaneous notes we took during interviews, whilst not quoting various representatives, we have sought to summarise their views as they put them to us, for the benefit of the reader’s understanding.

Please note however, our commentary in Chapter 6 (analysis, costs and benefits) of this report addresses major misconceptions and uninformed perceptions, which may arise in some of the stakeholder comments below.

5.3 The Commonwealth Government Agencies

Safe Work Australia (SWA) Safe Work Australia was established by the Safe Work Australia Act 2008, with primary responsibility to lead the development of policy to improve WHS and workers’ compensation arrangements across Australia. SWA began operating as an independent Australian Government statutory agency on 1 November 2009. It is jointly funded by the Commonwealth, State and Territory governments through an Intergovernmental Agreement.

As a national policy body, SWA does not regulate WHS laws. The Commonwealth (Comcare), States and Territories retain responsibility for regulating and enforcing WHS laws in their jurisdiction.

As the primary lead in the development of WHS policy in Australia, including the legislative changes relating to the GHS/WHS labelling of agvet chemicals, SWA is a major stakeholder in this review.

The label is the most immediate and accessible source of information for hazardous chemicals. SWA’s position is that hazard and precautionary statements on the label will provide workers handling agvet chemicals, who may not have read the safety data sheet (SDS), with the same kind of information about the hazards of the chemicals as workers in other sectors. This information is also important for the health and safety of workers who are not end users but may become exposed to the chemical through inadvertent contact (e.g. during the storage, transport, packing or disposal of the products).

SWA expressed the following additional views:

The person who conducts the business or undertaking (PCBU) and its officers (not the APVMA) have the ultimate duty under WHS legislation to assess and control risks of chemicals in the specific circumstances that they will be used in the workplace. The APVMA risk assessment process may not accurately anticipate all these circumstances and cannot replace the obligation on the PCBU to conduct their own risk assessment in the context of the PCBU’s operations and particular work environment

Manufacturers, suppliers and industry stakeholders have had 5 years notice to get ready for this change in the law

The requirement to relabel as of 1 January 2017 relates to the date of supply. In other words, if an end user has possession of an agvet product supplied prior to 1 January 2017, the new label will not need to be affixed

In relation to the industry’s request that the 1 January 2017 relate to the date of manufacture rather than the date of supply, SWA notes that some chemicals do not have the date of manufacture on the product and therefore compliance and enforcement would be difficult

Any duplication on the label is not useful and SWA has therefore provided a Policy Statement and Information Sheets for manufacturers, importers and businesses using, handling or storing agvet chemicals. The information sheets clarify that where statements which are equivalent or substantially the same already appear on the agvet chemical label following the APVMA risk assessment, the manufacturer/supplier does not need to repeat the statement in the GHS/WHS




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section of the label. SWA suggests a reasonable person test would apply i.e. whether the statements convey the same meaning and if so, they need not be repeated

There are intrinsic hazards in a chemical, which will not be listed on a current agvet label (via a hazard statement) and therefore will not have a corresponding precautionary statement, such as “may cause cancer”. Other examples were provided by SWA. The hazard and precautionary statements will not be inconsistent or cause confusion, but rather, will provide additional information, which has not been provided to date for some agvet chemical products.

As well as supporting option 1 (the change in legislation coming into effect on 1 January 2017), SWA indicated support for option 2 on the basis it would provide Australia with a “level playing field” for all chemical products.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) The APVMA is an Australian government statutory authority established in 1993 to centralise the registration of all agricultural and veterinary chemical products into the Australian marketplace. As the lead national regulator of agricultural and veterinary chemicals up to the point of retail sale, the APVMA’s function and powers include, amongst other things, regulating the information that must be included on the label of an agvet chemical. As a result, they are a major stakeholder in this review.

The APVMA expressed the following views:

APVMA recognises the work by SWA to clarify its position concerning duplication and information sheets provided on their web site. This guidance provides assistance to the agvet chemical industry and takes a pragmatic approach about what should occur when there is potential duplication

The approach for information for the GHS/WHS requirements being separately boxed/included on labels makes it clear that the GHS/WHS information is separate to the risk assessment label information

It is not the role of the APVMA, as the independent regulator, to comment on government policy directions regarding concurrent operation of hazard and risk based labelling for agvet chemical products. The APVMA is not aware of any specific concerns regarding worker safety arising from the current risk based assessment and labelling approach undertaken by the APVMA for agvet chemical regulation

There are operational concerns associated with option 2 in that it will create a fragmented system for agvet chemical products. In particular, the APVMA risk based assessment and labelling approach would still need to continue for those products regulated by the APVMA, which do not fall within the scope of the GHS requirements. APVMA risk assessments that result in risk based labelling take account of domestic consumers as well as the workplace and therefore the APVMA will still be required to conduct the same risk assessment process for health and safety if option 2 were to be adopted. The system (under option 2) will therefore become very fragmented

The basis for consideration of GHS labelling was originally targeted at industrial chemicals and frameworks where risk based assessment processes are not well established as they are for pesticides and veterinary products

Whilst risk assessments for industrial chemical use ought to be conducted by the end user, for the agvet industry, the APVMA have a good idea how the product will be used and the possibilities about what can go wrong is narrowed. Therefore, the APVMA are in the best position to conduct the risk assessment

The legislative framework under which the APVMA operates addresses the risks associated with the proposed use of an agvet chemical with the state and territory responsibility under the National Registration Scheme for agvet chemicals considering control of use issues, including off label use.

The risk assessments of use of product by the APVMA are not designed to cater for unforeseen “off label use” i.e. the APVMA cannot conduct a risk assessment where a user does not use the product in accordance with its intended and labelled use

In the APVMA’s experience, where the intrinsic hazards associated with agvet chemical products cannot be mitigated through proposed use, applicants do not generally apply for registration of




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the product in Australia and accordingly, these products are not registered for use in Australia in the agvet industry

APVMA directions regarding storage of agvet chemicals are related to ensuring the stability of the product through to the point of use to ensure safety and efficacy of the chemical product when used for its intended purpose

The APVMA’s assessment takes into account the transport and storage of products to their destination to ensure containers are adequate to provide for safety and efficacy of the product, and are based on the assumption the product arrives at the end users safely

While the GHS system provides intrinsic hazard information for workers, it will not prevent a potentially dangerous chemical getting to market. The APVMA’s risk assessment and registration system is designed to ensure risks associated with proposed use of agvet chemical products are mitigated to avoid dangerous chemicals getting to market where the associated risks cannot be mitigated

The APVMA has a systematic process for reconsideration of chemicals to reassess the safe, continued use of agvet chemicals where new information becomes available following registration. This system is based on comprehensive scientific assessments and information on the process, and outcomes of reviews are published on the APVMA website. These reviews can result in labels being amended to provide revised instructions for safe use of the relevant agvet chemical products

Whilst the APVMA understands the agvet chemical industry supports option 3, with respect to option 1 commencing on 1 January 2017, the APVMA will continue to consult and work with the agvet chemical industry, the Department, SWA and where required WHS regulators to minimise any duplication for industry as a result of risk based agvet chemical regulation operating concurrently with the GHS/WHS system, which will focus on the intrinsic hazards.

It is worthy to note the wide acceptance by agvet industry stakeholders that the risk assessment process adopted by the APVMA and the resultant agvet chemical labelling provides the agvet industry and end users with readily available and useful health and safety information and controls and is a proactive means for the industry to manage health and safety risks when using agvet chemicals.




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Other Government commentary Other Commonwealth Government stakeholders expressed the following:

Whatever the recommendations may be, the outcomes require clear communication and guidance to all stakeholders.

The SWA information sheets are clear and concise and they were developed in consultation with the relevant stakeholders. There was criticism that these information sheets ought to have been published earlier and provided to the agvet industry associations and their members.

The Department of Employment also considers GHS labelling complements APVMA-approved label elements. It considers that the format and content of the GHS labelling elements may prompt careful reading of the entire label, particularly for vulnerable workers, in cases of off-label use or where a workplace’s approach to WHS is lax.

5.4 WHS Regulators

Deloitte approached all WHS regulators in Australia requesting their input to participate in a phone interview. The following three regulators agreed to participate:

WorkSafe, Department of Commerce (WA); a non-harmonised WHS jurisdiction

Office of Industrial Relations (Qld); a harmonised WHS jurisdiction

SafeWork SA; a harmonised jurisdiction.

Views expressed from one or more of the WHS state regulators included the following:

All three WHS regulators supported SWA’s policy position and the adoption of option 1, including Western Australia (currently a non-harmonised jurisdiction)

As a WHS regulator, if chemical labels are not adequate from 1 January 2017 the regulator has the power to issue an improvement notice rather than immediately seek to prosecute for a breach

There is a perception that the APVMA risk assessments exclude long term health effects and carcinogenic impact

One regulator made a point that, if industrial chemicals are required to have the GHS information on a chemical label, then why not the agvet industry.

As the labels currently stand, there is no equity of information for workers. The current labels are only designed for end-users in the agvet industry and not for other workers and non-workers who may be exposed to the products

Every worker should have the right to that information i.e. the intrinsic hazards making up a chemical product and the relevant precautionary statements

One regulator stated they would not be holding the end-users liable for the labelling but rather, will enforce the obligations consistent with the WHS laws on the manufacturers and suppliers. Another regulator said they expect manufacturers and suppliers to comply from 1 January 2017, however they intend to provide a 12 month transition period for end users

The APVMA take a “purist approach”, assuming that people will follow the chemicals’ recommended use and labelling instructions. Our experience is, that’s not real life and some persons will use the product in a way not intended by the APVMA

Do not believe there is a potential for confusion with the option 1 changes. Suggest that if there is any doubt regarding potential duplication, there is always the option to review. If those who suggest it could be confusing, then it could be argued that the Safety Data Sheet (SDS) is confusing and inconsistent with the labelling and we (the WHS Regulator) don’t hear that argument

Will be focussed on educating the industry on what the changes mean to them when the change comes into effect. One regulator stated the core issue is more training and education of people who come into contact with agvet chemicals so they understand the purpose and use of the additional GHS information which will be provided on the label




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One of the regulators never understood the previous exemption which had been granted to the agvet industry and suggests that a label which lists hazards for its use should not be confusing nor should the additional information conflict with the existing agvet chemical labelling

5.5 Agvet Industry

Several industry bodies representing the Agvet chemical industry were interviewed during the review. All of them argued against option 1 and the impending GHS labelling changes coming into effect on 1 January 2017. Views expressed by one or more of the agvet chemical industry bodies included the following:

The GHS/WHS changes are a “mindless regulatory initiative”

Believed option 1 will not improve health and safety for the agvet industry

An exemption is given to the Therapeutic Goods Administration (TGA) so why not the Agvet industry?

The additional GHS/WHS information sought to be included on the label is available in the safety data sheet for each product (SDS)

The United States of America is exempt from GHS for the agvet industry, why not Australia?

Support GHS where there is “no base system” (i.e. no regulatory system for the regulation and use of hazardous chemicals) but in Australia we have the APVMA and a great risk based system

The policy makers at SWA in their information sheets suggest the relevant trigger for the new labelling requirements coming in on 1 January 2017 is the “date of supply”, however the regulators have in their Regulations that the obligation exists at the end user as of 1 January 2017 (reference Clauses 335, 341 and Schedule 9 Parts 3 and 10 of the harmonised WHS Acts)

One industry body said it calculated the cost of the GHS labelling changes required by the WHS legislation as costing the agriculture industry $57M, on the basis it calculated the cost of affixing additional labelling to be just below $5,000 per label.

Preference was for option 3 to apply i.e. an exemption be provided to the agvet industry not to have to comply with GHS labelling requirements

SWA have improved their clarity with the information sheets they have provided, however they are not the regulators and they don’t enforce the WHS laws

The relevant date (for when GHS labelling information is required to be displayed on the agvet chemicals) should be the date of manufacture and not the date of supply as SWA has proposed in their guidance information

There should be another three-year transition for enforcement

The use of safety data sheets rather than a focus on labelling should be encouraged. The label is merely an alert and by design, and doesn’t contain all relevant information

This has been a “long fought” (by the agvet industry) and argued issue in the industry

The options need to allow for exemptions, a transition period and ensure there is a review process

Communication and education regarding the changes to labelling will be critical

The reason why the APVMA does not require chronic health hazards such as carcinogenicity to be included on the labels is because, following the risk assessment by the APVMA, carcinogenicity may not be considered a realistic hazard/risk

There needs to be further dialogue between government agencies and industry

Labelling is only one control. Training and information including safety data sheets are other controls, which are as equally important as the label.

The views of representatives in the agvet chemical industry were mixed. Many were cautious about the impending introduction of GHS on the labelling, whilst a number accepted the importance of labelling information generally on health and safety. Individual representative views included:




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See little value adding the intrinsic hazard and precautionary statements for GHS to the labels

Some studies have suggested providing too much information/instructions on safety reduces safety outcomes and/or de-sensitises users

Believes there is a possibility for duplication with option 1

Understand the need for alignment with global standards (i.e. GHS) but cannot see much if any benefit in changing the labels

Accepted the best safety information/control was the label and is most often the first point of call for a worker

Agreed there could be better labelling for the purposes of transporting the products

The majority of costs are time costs incurred by agvet firms in establishing their regulatory requirements and which labels require redesign and re-printing, with a smaller design fee outsourced to labelling manufacturers of between $50-100 per label pack size.

Education and training is the key. Farmers will go to the resellers for more information, so it’s important to ensure the right person is provided with information to enable them to inform others who will likely come to them for advice

One representative believed the whole idea of labelling is outdated and we should be looking at alternatives, for example; a comprehensive searchable database via iPhone application that contains all relevant health and safety information and the information should be presented in the simplest possible way

Accepted most users will go to a label to obtain information rather than a safety data sheet.

The change (option 1) will be additional effort for the industry with no justification for a satisfactory award

The major risk on farms is mechanical and not chemical

Some smaller farms are “more relaxed” and we (the farming industry) need to ensure health and safety controls are in place for the safe use of chemicals at those smaller workplaces.

5.6 Worker’s Representative

A representative from the AMWU was interviewed and provided the following views:

This matter has been reviewed and discussed for approximately 10 years and cannot understand why it has required another review

Workers and the community have a “right to know” all potential hazards with any chemical. They feel this is best communicated through the GHS system which is an internationally agreed labelling and classification system

Supports option 1 but with the inclusion of relevant pictograms on the basis that many workers are from non-English speaking backgrounds who may be at risk and pictures can assist greatly in that regard

The current agvet chemical labelling system does not address longer term health and safety risks

Additional information and precautionary statements can only increase the chances of improved health and safety outcomes.

The perception is that the APVMA work for their agvet industry and their risk assessment are completed for the agvet industry in order to register a product for use. It therefore assumes that the product is only used in the way it was intended

The SWA policy and information sheet guidance is clear and useful.

5.7 Government Health

SA Health provided their views during the stakeholder process. Whilst separate to the WHS regulators, SA Health’s stakeholder interest concerns the South Australian’s controlled substances legislation (Controlled Substances Act 1984 (SA), Controlled Substances (Poisons) Regulations 2011 (SA) and Controlled Substances (Pesticide) Regulations 2003 (SA)). The purpose of these Acts is public health protection, which includes controls over handling of agvet products that contain scheduled poisons (i.e.




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those scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons or SUMP). Their views included:

Option 1 will require a significant public awareness information campaign. Having hazard-based information on a risk-based labelling may cause confusion. The public (as opposed to persons who conduct a business or undertaking) need to be educated

A hazard based system for industrial chemicals is fine, whereas agvet chemical uses are restricted at law and can run a risk-based approach

There will be a flow on of costs being borne by farmers who will be required to update their training without receiving any perceived benefit for this investment, other than compliance with the law

The TGA has been given an exemption from GHS labelling, why not the agvet industry?

The lines between the workplace and domestic use are blurred and SWA needs to improve their guidance in this area

Note there are offences for organisations and people who “contravene mandatory label instructions” which have a maximum fine of $35,000

The SWA information sheet regarding criteria for the volume of product and type of retail setting is not clear-cut. It is ambiguous and may result in inadvertent non-compliance by a manufacturer or supplier or incur excessive costs if requiring different labelling depending on which retail premises it may be sold from

Argued, because not all jurisdictions are harmonised for the purposes of WHS legislation (in particular Victoria and Western Australian are non-harmonised jurisdictions) the labelling requirements are likely to be inconsistent across the nation

5.8 Public Stakeholder Engagement

In addition to the targeted stakeholder interviews, Deloitte also invited public submissions from interested persons or organisations about matters relevant to the review. The public was provided with background information, the purpose of the review, four options the review team identified (refer to Section 5 above, ‘Options’) and a list of themes of information being sought.

Submissions were invited through the Department of Agriculture and Water Resources’ website and submissions were sent directly to Deloitte at [email protected] from 1 May 2016 to 31 May 2016. Refer to Appendix D for a copy of this invitation.

Twenty-two public submissions were received and considered by Deloitte.

To assist the reader, high-level extracts of each submission can be found in Appendix E of this report. Original submissions are in Appendix F and include:

1. Accord Australasia

2. The Australia Forest Products Association (AFPA)

3. AgForce Grains

4. Animal Medicines Australia

5. Australian Manufacturing Workers’ Union (AMWU)

6. Australian Oilseeds Federation

7. Australian Veterinary Association

8. Australian Chamber of Commerce and Industry

9. Australian Paint Manufacturers Federation(APMF)

10. AUSVEG

11. Cotton Australia

12. CropLife Australia

13. Grain Producers Australia

14. Grain Growers Limited

15. Growcom


mailto:[email protected]



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16. National Farmers’ Federation

17. Plastics and Chemical Industries Association

18. Pastoralists and Graziers Association of WA (PGA)

19. Summerfruit Australia Ltd

20. The Veterinary Manufacturers and Distributors Association Ltd (VMDA)

21. Western Australian Farmers Federation (Inc)

22. WorkSafe Victoria

Two late public submissions were received after the submission close date and were not included in the summary at Appendix E, however both submissions can be found in Appendix G. Deloitte noted the views expressed in the two late submissions were also expressed by other public submissions.




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6 Analysis, costs and benefits

6.1 General analysis commentary

Whilst it would not be practical or useful for us to address each and every view raised by stakeholders in this review, we have commented below on matters we believe are substantive and which go towards the objective and purpose of this WHS duplication review required by regulation 80E of the Agvet Code Regulations. We believe this commentary will be advantageous to outline prior to considering the costs and benefits.

Whilst we may reference areas of the legislative review at Chapter 3 of this report in our commentary below, we do not seek to cover the same content and therefore the reader should familiarise themselves with that Chapter to ensure our commentary provides them with context.

On another matter, whilst the scope of this review did not seek to re-examine the policy basis for the WHS legislation applying to agvet chemicals (and therefore no recommendations relating to policy matters were made in Chapter 7), where we identified matters we believe are fundamental to the improvement of health and safety in relation to agvet chemical products, we made comments in this section for consideration of the relevant policy makers.

Fundamental rationale for the introduction of GHS statements (the why?)We understand the fundamental reasons put forward by SWA and the WHS regulators regarding the need for GHS statements to apply to agvet chemical labelling, is it will provide:

a. Global consistency with GHS and alignment to international standards

b. A more consistent approach with the laws in respect of workplace chemicals

c. Workers (and non-workers alike) not directly associated with the agvet industry but who may nevertheless be inadvertently exposed to an agvet chemical product with critical information regarding the intrinsic hazards and precautionary statements they may not otherwise have immediate access to via the current agvet chemical label

d. Consistency with the object of the WHS Act 2011, and in particular, to the requirement that regard must be had to the principle that workers and other persons should be given the highest level of protection against harm to their health, safety and welfare from hazards and risks arising from work as is reasonably practicable.

With the exception of persons who may consider illegal off-label use of an agvet chemical, we do not see the inclusion of the GHS statements to agvet chemical labelling as providing much, if any, improvement of information on health and safety to persons working in the agvet industry.

However, there are persons (workers and non-workers alike) not employed in the agvet industry but who may be involved in, or present during an agvet chemicals’ handling (including storage, transport, processing or disposal). We acknowledge, the APVMA’s risk assessment considers these persons during its risk assessment for labelling requirements (and in the context, other regulations apply including but not limited to the Australian Code for the Transport of Dangerous Goods by Road or Rail and Scheduling controls). However, the APVMA equally accepts, consistent with its legislative remit, that its scientific risk assessment process is more focussed on the known end user.

Whilst we acknowledge the agvet chemical labelling requirements include information regarding the safe handling of the product and first aid in the event of an accident caused by the handling of the product, the fundamental argument that a person has the right to know information regarding the intrinsic hazards of a chemical product and its associated precautionary statement remains. The GHS statements will provide this in circumstances where the label does not already contain the equivalent information. Whether these additional statements may improve the health and safety of people at work is a debatable topic, with arguments on both sides.

However, what cannot be debated is the fact that GHS information will not be inconsistent with the existing agvet chemical labelling content and is additional safety information available if the person




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involved in its handling or use cares to read it, and the information is provided for the person’s health and safety.

We also note agvet chemicals constitute a small proportion of hazardous chemicals overall and those involved in the handling of other hazardous chemicals will be familiar with the GHS statements on labels.

Representation of stakeholders Given the primary rationale of the policy maker (SWA) and WHS regulators for GHS statements to be added to agvet chemical labelling is that workers not employed directly in the agvet industry have the right to have access to critical information such as intrinsic hazards and precautionary statements. In addition, given the fact the vast majority of stakeholders interviewed for this review were end-users or industry organisations representing end-users of agvet chemicals, it could be argued the views of workers who don’t work in the agvet industry were not equally represented in this review. However, Deloitte believe SWA, the regulators and worker’s representative interviewed have adequately represented and argued for the interests of these workers and non-workers who may be inadvertently exposed to an agvet chemical.

GHS system reliance on competent authorities Whilst we have already identified and raised differences between the GHS hazard-based and the APVMA’s risk-based assessment system, there is another distinction we feel is worthwhile highlighting; the GHS system does not itself prevent products from accessing the market. The system left this to competent authorities to determine how to apply the various elements of the GHS.

The model WHS Regulation (which implements GHS in Australia) contains provisions which prohibit and restrict the use or exposure of certain carcinogens or hazardous chemicals (Model WHS Regulation r380 to 382 and Schedule 10). It also requires exposure standards for substances and mixtures are not exceeded (Model WHS Regulation r49)

The APVMA’s risk assessment and registration system is designed to ensure risks associated with the proposed use of agvet chemical products are mitigated to avoid dangerous agvet chemicals from accessing the market where the risks cannot be mitigated. The APVMA also has a systematic process for reconsideration of agvet chemicals to reassess the safe continued use of the products where new information may become available following the registration process. The APVMA review may result in a label being amended to provide revised instructions for safe use of the agvet chemical product.

WHS and Agvet legislation not inconsistentIn commenting on the legislative review, the WHS and agvet legislation are not inconsistent, and therefore can, and do operate concurrently. There is some potential duplication with respect to their implementation (e.g. referencing precautionary statements on agvet chemical labelling) as outlined in this report, however there can be (and to some extent already is) adequate discretion, consultation and guidance provided by agencies such as SWA (e.g. in their Information Sheets for manufacturers and importers of agvet chemicals) to effectively manage this.

Could either legislation seek to cover the field for regulating WHS in the agvet industry? Whilst inconsistent with the current legislation, thereby requiring a change in law, the review team notes it would be possible (although not necessarily advantageous) for either one of the legislative regimes (the agvet or WHS) to attempt to cover the field for work health and safety with respect to agvet chemical products.




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Using option 3 as an example where a full exemption for agvet chemical labelling from WHS workplace chemical labelling requirements would apply, the agvet chemical legislators could attempt to cover the field. However, unless the agvet legislators and in turn, the APVMA include the GHS intrinsic hazards and associated precautionary statements on the labelling requirements for the agvet chemical products, the benefits proposed by WHS policy makers and regulators enacting this legislative change for agvet chemical labelling will be lost.

Equally, consistent with option 2 involving the removal of the WHS labelling requirements from the APVMA approved label for hazardous workplace chemicals, it is possible for the WHS legislation to attempt to cover the field. In this instance, consistent with industrial chemicals, WHS information would rely completely on the GHS classification and labelling requirements of the WHS legislation. If the legislators were to agree for this to occur, then the agvet industry would be relying on a hazard-based system for work health and safety, and will be required to conduct its own risk assessment at the end-user point. In other words, the valuable outcomes of the risk assessment process conducted by the APVMA on behalf of the agvet industry and the associated health and safety controls and information would be lost. It is also worthy to note that the GHS system does not apply to the full product range regulated by the APVMA (e.g. consumer goods, small packaging) and accordingly, under option 2, the APVMA’s role to continue to assess those chemical products would continue and thereby create a divided and most likely inefficient system.

Commentary on some views expressed by some of the WHS state regulatorsSome of the views expressed by some of the WHS regulators (responsible to enforce the WHS laws in their state or territory) disclosed they were not fully aware of the APVMA’s role, or all of its powers and functions as the national regulator of agvet chemicals.

For instance, one regulator believed the current agvet chemical labelling was designed only with end-users in the agvet industry in mind and not for other non-agvet workers or other persons who may be at the workplace. This perception or view is not correct as the APVMA’s labelling criteria and risk assessment process includes the “safe handling of the product and first aid in the event of an accident caused by the handling of the product”. The term handling is defined in the agvet legislation to include transportation, storage, processing, use or disposal. As a result, the labelling requirements cover instructions and make them available to people handling and using the chemical through the supply chain.

A regulator’s view expressed there was a perception the APVMA’s risk assessments excluded long-term health effects and carcinogenicity. This is also incorrect. Consistent with the APVMA’s published guidelines carcinogenicity is a relevant consideration whenever biologically significant residues of the compound or its metabolites occur, or when human exposure to the compound results from the normal use pattern of the compound. If a chemical is found to be carcinogenic, the APVMA will consider whether there is human exposure (e.g. for a fumigant there may not be any), whether there is any ‘safe’ level of exposure and whether any exposure above that safe level can be mitigated. Where it cannot be mitigated, the APVMA cannot be satisfied of the safety criteria and as such will not register the product for that use. The APVMA advised Deloitte it has refused registration of specific chemicals on the grounds of carcinogenicity risk.

One regulator asked the rhetorical question: if industrial chemicals are required to have the GHS information on the label, why not the agvet industry? What appears on its face to be a simple question can only be adequately answered by a deep understanding of the risk-based approach adopted by the APVMA as opposed to the hazard-based foundational approach of the GHS system. At its commencement, the risk assessment process will consider the composition and form of the constituents of the product (including intrinsic hazards). Since the use of agvet chemicals is known (which is not the case with most other industrial chemicals) the value of a scientific risk assessment for health and safety concerning the use of the agvet chemical provides useful information for the end-user with respect to health and safety controls for its safe use and first aid instructions in the event of an incident.




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Accreditation and training in the agvet industryWe acknowledge agvet industry bodies offer accreditation and training support for the safe storage, handling, transport and sale of agvet chemicals. Whilst not mandatory, these programs train and accredit staff and businesses in handling and providing responsible advice in the safe and effective use of agvet chemicals. Agsafe, as a provider of these accreditation and training programs advises, “…the aim of the program is to ensure that there is responsibility and compliance with government regulations and industry standards throughout the supply chain.”

Health and safety controls in the agvet industry other than labelling informationThe agvet chemical industry has and maintains many existing health and safety controls designed to manage the risk of persons working in the agvet chemical industry, including those involved in the handling of the chemicals, namely transportation, storage, processing, use or disposal of the chemicals. Labels on agvet chemical products providing (amongst other content) health and safety information are but only one control, amongst many, designed to promote the health and safety of people who handle the products. These include, but are not necessarily limited to:

The APVMA conditions on approvals or registration process

Accreditation and training as outlined above

Other GHS information provided in safety data sheets (SDS)

Scheduling controls in relation to chemical access, label information, packaging, supply, training and use

Application of the ADG Code for the safe transportation of dangerous goods by road or rail

Controls on use required by state and territory governments, including compulsory training and accreditation requirements in many instances.

Commentary on some views expressed by representatives in the agvet industryA number of agvet industry stakeholders interviewed were of the mistaken belief a policy decision is required between keeping the APVMA risk-based approach for agvet chemical labelling or scrapping the risk-based approach and use the GHS hazard-based approach. In other words, they believed the two approaches could not (or would not be able) to co-exist.

By contrast, the GHS labelling requirements due to take effect on 1 January 2017, are for the APVMA’s risk-based approach and labelling to remain with the two additional GHS statements to be added to the label in a clear text box. Moreover, consistent with our legislative commentary above, the two laws (agvet and WHS) are not inconsistent in their objectives and are able to co-exist and promote health and safety together.

Generally, many agvet industry stakeholders interviewed appeared self-industry focussed when asked questions regarding the changes. That is, the answers of a significant proportion of those interviewed appeared to consider the introduction of the GHS statements on labelling in the context of the agvet industry and its effect on their operations only. Many did not appear open to consider the rationale of the labelling improvement arguments raised by the likes of SWA, WHS regulators and worker representatives. In circumstances where the change proposed may appear to have little or no perceived benefit to the person being interviewed or their industry, this focus is understandable.

Some representatives from the agvet industry did consider that there may be an advantage to having the GHS information added to the labels for those persons who may not be working in the agvet industry and in circumstances where the current labelling does not provide that information.

We note the GHS system relies on the two modes of application for hazard communication, namely labels and SDSs, and also acknowledge the GHS envisaged that risk based labelling was acceptable where deemed appropriate by a competent authority.

A valid argument raised by agvet industry stakeholders is the health and safety risk in the event of an incident involving an agvet chemical spill. In particular, that a person should access the safety data sheet (SDS) rather than attempt to read a label proximate to the spill area. This argument is valid and accepted.




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However, a counter argument also exists that other proactive (non-incident) opportunities and moments for workers in the supply chain to read the label, including when conducting a risk assessment on the contents of the product in the context of their working environment by referencing the most immediate and accessible source of information. This is likely to be the label in many instances.

Work health and safety; a focus on risk On numerous occasions during stakeholder interviews, arguments were raised by representatives in the agvet industry suggesting there have been “no incidents on record involving inadequate chemical labelling in the agvet industry”. Firstly, whilst lack of information on any label may contribute to a risk to health and safety, it would be difficult for any person to establish a causal link between a purported lack of information on a chemical label and any particular incident. It is therefore unlikely, in our opinion, that an incident would be recorded as being attributable to a lack of information on a label.

Whether the claim of there being no recorded incidents owing to inadequate labelling on agvet chemicals is right or wrong, the point raised (on a number of occasions) in our opinion is irrelevant when considered in the context of managing future health and safety risk.

It is over simplifying matters to suggest that because there may have been no recorded incidents, the current information provided on all agvet chemical labels meets all health and safety needs. Neither does it mean there is no health and safety risk in the future and that the provision of additional GHS information on the labelling will not reduce that risk.

Unlike the GHS hazard-based foundational system it has adopted for chemicals, the WHS legislation is founded on foreseeable risk, and persons who conduct a business or undertaking must proactively manage health and safety risks using safe systems of work. Having immediate access to the label as the source of the quickest and immediate source of information, which will contain additional GHS statements not previously available on the agvet chemical labelling, may provide assistance to some.

Commentary on general matters for improvement of health and safety in the agvet industry Whilst the scope of our review did not include an analysis or re-examination of the policy basis for WHS legislation applying to agvet chemicals, there are some matters we feel are relevant to raise for consideration of the appropriate policy makers. They are:

6.1.1.1 The veterinary industry

Whilst the GHS system was designed to cover all hazardous chemicals, it also recognised the hazard communication elements (labels, safety data sheets) may vary by product category or stage in the life cycle.

In particular, examples were identified by the United Nations Economic and Social Council’s Sub-Committee of Experts on the GHS, where the GHS may not be applied. The Sub-Committee gives the example of the point of intentional human intake or ingestion, or intentional application to animals that products such as human or veterinary pharmaceuticals are generally not subject to hazard labelling under existing systems. Such requirements would not normally be applied to these products as a result of the GHS. Consistent with this GHS commentary, the model WHS Regulations state that GHS does not apply to veterinary chemical products within the meaning of the Agvet Code at the point of intentional administration to animals (WHS Regulations 2011, regulation 328(6)(d)).

The Sub-Committee then goes on to note that the risks to subjects associated with the medical use of human or veterinary pharmaceuticals are generally addressed in package inserts and are not part of this harmonisation process.

The national WHS policy maker has exempted therapeutic goods from GHS workplace labelling when in a form and package intended for intake or administration to a patient or consumer, or intended for use for therapeutic purposes. We note that therapeutic goods which are in ‘bulk’ for manufacturing, packaging, or compounding purposes are not included in the exemption and must be labelled in accordance with the GHS requirements.

Given the analogous use (and controls on use and supply) of therapeutic goods to the veterinary industry and in particular where its use involves a qualified and trained veterinary professional as the primary risk mitigation factor, Deloitte is uncertain why the veterinary industry is treated differently to therapeutic goods with regards to the exemption from GHS.




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6.1.1.2 SWA and WHS regulators to lead communication and education to industry

We believe it would be advantageous for SWA as the policy maker and the WHS regulators as the enforcers to proactively lead the communication, information flow and education regarding the GHS labelling changes to manufacturers, importers, suppliers and agvet industry users and handlers. Wherever possible, we believe SWA and the WHS regulators should seek the assistance and support of the APVMA and agvet industry bodies and suppliers to assist communications and the education.

6.1.1.3 Review effectiveness of the GHS statements on agvet labelling

As a concept of sound regulatory review, a scheduled review of the introduction of GHS statements on agvet chemical labelling may be advantageous.

6.1.1.4 SWA and WHS regulators clarify Clause 355 and 341 of the WHS Regulation

We believe SWA and the WHS regulators ought to work together to clarify consistent guidance and enforcement intent of clauses 355 and 341 of the WHS Regulations. In particular, that an end-user of a chemical product in the agvet industry from 1 January 2017 will or will not be held liable for an offence regarding an agvet chemical label for an agvet chemical in their possession which was supplied pre 1 January 2017 and which does not have the required GHS labelling requirements.

We note that SWA has provided policy guidance in its information sheet that the commencement date of 1 January 2017 relates to the product’s “supply date”. In other words, a chemical supplied pre 1 January 2017 will not attract liability for the end-user. SWA Members have approved publication of this information sheet and policy.

6.2 Approach for the costs and benefits analysis

It was originally envisaged that a cost-benefit analysis (CBA) be undertaken in order to definitively quantify the costs and benefits of GHS harmonisation and provide a methodologically robust benefit-cost ratio, as a common metric on which to assess the merits of a particular government intervention. However, following consultations with key stakeholders, it became clear that sufficiently robust data was not going to be available, on both the cost and the benefits side of the equation to allow for a meaningful and robust cost-benefit analysis to be undertaken. For example:

Costs are driven largely by time costs. Quantifying this robustly would require information from a representative sample of liable entities on the estimated time, energy and staffing numbers required to comply with the changes, which was not available to us. While we have prepared a rough estimate of the industry wide cost below, this is a ‘back of the envelope’ calculation and is not considered adequately robust for inclusion in a cost-benefit framework; it is based on self-reported time estimates from a limited sample of businesses.

Typically, the benefits in a CBA are expressed in monetary terms providing estimates of impacts relative to a baseline scenario (often simply a ‘do nothing’ scenario). Often these take the form of reduced costs. However, the benefits-side of this analysis are inherently difficult to quantify and monetise. This is particularly the case for the health and safety information-provision benefits of adopting GHS labelling on agvet products.

Accordingly, we analysed a number of criteria which considered the health and safety impacts, costs of GHS implementation and the net impact of increased label information. We have provided commentary on the key assessment criteria to enable the reader to form their own judgment based on the information presented.

Given the use of this approach, rather than a CBA, consulting with a broad range of stakeholders was critical to ensure the views formed based on those consultations are as balanced and informed as possible.

Stakeholders representing government, industry, regulators, end users (as well as a public consultation period) were consulted and provided with an opportunity to provide their thoughts, opinions and views. Stakeholders agreeing to interviews were provided with documentation outlining the purpose of the review and the type of information being sought.

The types of questions put to stakeholders included (but were not limited to):

What is the total process involved in supply chain for the design of labels?

What are the types of costs associated with each element of the supply chain?




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What is the marginal cost of producing a label – i.e. what is the cost per label?

What is the difference in cost between a label containing two items and a label containing 200 items?

What are the (financial and non-financial) costs and benefits of each option?

Are you aware of any deaths or injuries arising from the use of Agvet chemical labels in accordance with label instructions? Or from Agvet chemicals not used in accordance with label instructions?

6.3 Specifying the assessment criteria

The criteria were primarily developed and informed by the stakeholder consultation exercise. Having consulted with stakeholders, conducted extensive desktop research and analysis, and reviewed the various submissions made in response to the public call for submissions, it was decided to concentrate the analysis on three key criteria:

The option’s impact on overall costs to stakeholders, including manufacturers or importers, suppliers and end users;

The option’s impact on health and safety outcomes; and

The option’s impact on the potential complexity and confusion of agvet labelling, with flow-on impacts for users’ time as well as health and safety outcomes.

We did not seek to repeat any qualitative commentary provided above in this Chapter and those comments should be read with the further descriptions below Chapters 6.3.1 to 6.3.3 of the cost and benefits criteria.

The cost of GHS implementationNotwithstanding the difficulties described above in quantifying the costs and benefits, it is nevertheless important for this review to reach a rough estimate of how much the GHS implementation may cost industry. As such, a separate illustrative calculation has been developed by Deloitte, and is presented below along with a summary of industry’s estimates from the stakeholder consultations.

6.3.1.1 Obtaining a ‘back of the envelope’ cost estimate

In order to obtain as robust an estimate as possible, we have calculated a ‘back of the envelope’ figure from two completely separate sources.

Our cost estimate based on stakeholder feedback is $15 – 15.8 million.

Our cost estimate using the Regulatory Impact Statement for ‘proposed revisions to the national OHS framework for the control of workplace hazardous substances and dangerous goods’, dated 21 January 2010, is $13.7 million.

Although these are ‘rough estimates’ calculated using the methodologies described below, it is noteworthy they are from two completely different sources using two separate methodologies which yield a similar result, with only $1.3 to 2.1 million difference between them. This gives a degree of confidence that the ‘true’ cost lies somewhere around these two figures.

6.3.1.2 Estimate based on stakeholder feedback

We understand there are approximately 12,000 agvet chemical products, of which approximately 8,700 are liable for labelling changes under the GHS. We were further advised the cost of redesigning artwork is around $60 per label design. Assuming 8,700 new label designs, that amounts to $522,000.

As noted in section 4.1, liable entities have a choice between placing GHS information in a separate text box on existing labels or printing a separate label containing the GHS information. Based on online quotes from three Australian label manufacturers, we make the following observations:

The cost of printing a label does not tend to differ depending on the amount of information to be printed (i.e. the marginal cost of information is zero).

On a per label basis, we have assumed 50 cents per new label as a conservative (over) estimate, based on the average quote online.

The total number of labels to be printed (i.e. the number of products multiplied by the number of units sold of each product) is unknown, but obviously an estimate is required for the total printing costs. Two different estimates were made:


http://www.safeworkaustralia.gov.au/sites/swa/about/publications/pages/risproposedrevisionstonationalohsframework



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First, we started with the National Farmers’ Federation’s estimate of $20 million for overall manufacturing costs for the farming sector. Factoring this figure up by a third to account for non-farm chemicals (i.e. $20 million to $30 million) and dividing by an assumed manufacturing cost of $60 per label, implies an estimate of 500,000 labels needing to be printed (i.e. 30 million divided by $60 per label). Assuming all liable products opted to print new labels rather than redesign existing labels, this gives an estimated overall printing cost of around $250,000 (i.e. 500,000 labels multiplied by 50 cents per label).

Second, using a factored up 2010 RIS estimate of approximately 1.5 million labels in total gives an estimated printing cost of $750,000.

Virtually all stakeholders commented that time costs would have the most significant impact in implementing the GHS changes and yet they are the most difficult to estimate.

One stakeholder with around 15% of the market and 30 individual products advised they had incurred (or will incur) time costs of approximately $50,000 in preparing for the GHS implementation. Extrapolating that figure to an assumed 8,700 liable products overall gives us a rough estimate of $14.5 million in time costs

In summary, our estimated overall cost of GHS implementation consists of three separate components:

$14.5 million in time costs;

$522,000 in design costs; and

Printing costs of between $0 (assuming all labels were re-designed rather than reproduced) and $750,000 (using the 2010 RIS estimates and assuming all labels were re-produced rather than re-designed).

The total estimated cost is thus $15 - $15.8 million depending on the extent to which liable labels are re-designed versus re-produced.

6.3.1.3 Estimate based on 2010 Regulatory Impact Statement (2010 RIS)

The 2010 RIS estimated that the costs of ‘label variation’ would be around $1200 per label, which in today’s terms equates to $1,462 (assuming 2.5% growth a year between 2007-08 and 2015-16). Applying that figure to an estimated 8,700 liable products gives an overall ‘label variation’ cost of $12.7 million.

The RIS (at page 71) further estimates the total one off costs for GHS implementation across all hazardous chemicals would be $79 million, or $96 million in today’s terms. Assuming agvet chemicals account for approximately 1% of this cost (refer to Chapter 2.3 of this report) this means an additional $1 million (approximately) attributable to agvet.

Overall, using Access Economics’ 2010 estimates (extrapolated to today’s terms) gives a total cost of $13.7 million.

6.3.1.4 Key points to consider in relation to cost estimates

There are a couple points to make in relation to both estimates above:

The calculations do not assume any form of stock write off nor re-labelling of existing stock. This is largely because manufacturers, importers and suppliers had been provided with a five (5) year transition period so stock write-off would not be an issue. However, we have been informed some manufacturers, importers and suppliers in the chemical industry generally (not just some in the agvet industry) have not taken advantage of this transition period. (We note that the policy statement and information sheets produced by Safe Work Australia to assist duty holders understanding and complying with the GHS requirements were released in February 2016.

There remains an option of “re-sticking” the new label over the existing label. Whilst ”re-sticking” labels may be viable for agriculture chemical products, for veterinary chemical products it is subject to an assessment by the APVMA to consider the use of its discretion to permit “re-sticking” of labels without the need for that stock to be returned to the manufacturer or Good Manufacturing Practice facility. In all, whilst we acknowledge some stock write-off is a possibility, we do not consider it to be very large and have not included this in the estimates above.

Our estimates also assume the new GHS information will be printed on labels. While we acknowledge some labels are imprinted directly on tin or metal, we understand that the number of products with this approach is minimal. Furthermore, the possibility of using a standard label


http://www.safeworkaustralia.gov.au/sites/swa/about/publications/pages/labelling-agvet-chemicals



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instead makes the printing onto tin something of a business decision rather than an economic cost.

On the other hand, as demonstrated in our Tables 4 and 5 at Appendix B (as reviewed by SWA) a number of hazard and precautionary statements for GHS will be equivalent to the existing APVMA approved labelling content (based on the FAISD Handbook). Where that is the case, there does not need to be any additional GHS information and no change to the labelling for the relevant statement(s) since it will be taken the existing APVMA approved label contains the equivalent information. In other words, a number of the 8,700 labels potentially liable for GHS adoption will not need to change because existing APVMA approved agvet chemical labelling is equivalent to the corresponding GHS statement(s) and we understand that many registered products are not actually available on the market (and so will not require label re-design). We are not in a position to know how many of the 8,700 agvet chemical products the “equivalent statements” may apply nor how many will not need new labels as they will not reach market in future and therefore this has not been factored into our calculations. Detailed guidance on which agvet and GHS statements are “equivalent or substantially the same” have not been released at the time of this report. We were informed by SWA that a comprehensive list of GHS and APVMA label statements considered equivalent or substantially the same is being developed by SWA for publication.

We were also advised some organisations in the agvet industry have opted to hire regulatory consultants seeking advice on their liabilities for the implementation of GHS labelling requirements. While we acknowledge some organisations may do this and consider it a positive sign they are actively preparing for the change, seeking such advice is not mandatory and will not be something all organisations in the agvet industry will do. We note there is public guidance available from Safe Work Australia referenced in this report (via the Information Sheets) and the industry can leverage off peak agvet industry bodies who we expect will be in a position to advise their members. Considering these matters and whilst we acknowledge there will be some organisations who still wish to seek their own external advice, it is a discretionary spend and we have not included this in our estimates.

6.3.1.5 Industry cost estimatesA wide range of cost estimates were provided by industry bodies during the stakeholder consultations and the subsequent public submission period. These estimates range between $11 million for the veterinary sector to $75 million. A summary of estimates is provided below. In general, Deloitte was provided with minimal information pertaining to how these estimates were compiled.




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Cost estimate Industry body proposing the estimate

Notes on methodology (where provided)

$11 million (veterinary only)

Animal Medicines Australia Estimate based on an average cost of $5,000 per product. This implies 2,200 liable veterinary products, which is consistent with earlier advice that veterinary products account for approximately one third of the agvet industry.Assuming the $5,000 per product figure is applicable across the broader agvet industry, and assuming 8,700 liable products overall, this implies a total industry figure of $43.5 million

$57.9 million(Agriculture only)

CropLife Australia Compiled based on advice from individual members, assuming a cost of $4,773 per label. It was impossible for us to know how individual members made their calculations, nor to assess the accuracy or otherwise of this assessment.Figure also noted (though not referenced) in submissions by AgForce and Grain Producers Australia

$20 million(Farming only)

National Farmers’ Federation

It is unclear how this figure was derived, however the submission notes the estimated $20 million cost will apply ‘to the manufacturing industry’ that will be passed directly on to the farm gate.We therefore assume this $20 million refers only to the direct printing and artwork costs and relates to farming only.Cotton Australia acknowledges the NFF figure in its submission

$65 million(Agriculture only)

Pastoralists & Graziers Association of Western Australia

Multiplies the CropLife figures of 6,500 products, two pack sizes and $5,000 cost per label.In our view, many of the costs included in that $5,000 estimate (design, artwork, regulatory costs) are not attributable to individual pack sizes. While a product may have two pack sizes and two labels, the design, artwork and regulatory costs would be incurred once, not twice.

$75 million Veterinary Manufacturers and Distributors Association

It is unclear how this figure was calculated.

Source: public submissions, 2016.

Deloitte was not provided enough information to assess the veracity of these estimates above. We do however make the following comments:

The estimation of time costs is troublesome for a number of reasons. First, unless a business hired extra staff specifically for the purpose of GHS, then the ‘time cost’ is an opportunity cost (the proportion of time spent on GHS harmonisation could have been time spent on other tasks) rather than a financial cost. While this does not make it any less valid, it does make the measurement troublesome and easy to overestimate (in the absence of regular timesheets it is impossible to know precisely how much time workers allocate solely to GHS).

Our ‘back of the envelope calculations’ noted above suggests that the true industry-wide figure is likely to be in the order of $15 – 15.8 million, which is around two to three times lower than most of the submissions made above. Given this, further detail on the methodologies employed in arriving at these estimates would have been warranted to allow for independent evaluation.

A number of industry stakeholders commented that a requirement to relabel all existing stock come 1 January 2017 (which we note follows a 5-year transition period) would impose a significant burden on the industry. Products will either have to be sent back to the manufacturer




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or importer for re-labelling, or new labels will need to be created for existing stock and distributed to suppliers for “re-sticking” (at an unknown cost). Our estimates assume that stock will not have to be returned to the manufacturers for relabelling, based on the 5-year transition period and the fact that the re-sticking process for the new labels on existing stock can occur at the point of supply/sale. In other words, our estimate assumes the extent of stock ‘wastage’ would be minimal. However if, as appears a requirement under the current Good Manufacturing Practice (GMP) for veterinary chemical products, the goods are required to be returned to the manufacturer (or other licenced labelling facility) for relabelling purposes, the process of removing the stock from storage or sales shelves for return to the manufacturer for relabelling would materially increase manufacturing costs and therefore our estimate costs of GHS implementation. Please note recommendation 3 in Chapter 7 relates to this point in an attempt to avoid stock having to be returned to the manufacturer.

Further to the above point, whilst the GMP does not apply to the agriculture chemical industry (and therefore unlike veterinary products are not required to return products to the manufacturer for relabelling) some manufacturers may, in their discretion, decide to return stock for relabelling rather than relying on the supplier to re-sticker for reasons such as reputation and consistency of relabelling.

It is apparent none of the entities who estimated costs in the table above took into account those labels where there will be no changes to existing APVMA approved labelling for agvet chemicals. That is, where the hazard and precautionary statements for GHS will be equivalent to (or substantially the same as) the existing APVMA approved labelling content, based on the FAISD Handbook. Deloitte took a conservative approach for our estimate to this reduction in costs on the basis we are not in a position to know how many of the 8,700 agvet chemical products the “equivalent statements” may apply or how many products will not reach market in future and therefore do not require label re-design and therefore this reduction was not factored into our calculations.

It is asserted by some stakeholders that costs will inevitably be passed through to the farm gate (i.e. the end user). This may not necessarily be the case however, particularly where competition exists throughout the supply chain. In other words, competitive tensions at both the point of manufacture and the point of retail may limit the capacity for cost pass through.

Health and safety impacts Without repeating the analysis and commentary above under this Chapter, arguments for the implementation of GHS labelling requirements often involved an underlying assumption that it will lead to improved worker health and safety outcomes.

Accordingly, to determine the potential magnitude of this impact, stakeholders were asked about the health and safety impacts under existing labels, and their views on what the potential benefits of the inclusion of GHS hazard and precautionary statements might be. However, as clearly emerged from stakeholder consultations, the impact of GHS labelling on health safety outcomes is very difficult to capture.

Additionally, our analysis takes into account that the information provided on labels of agvet chemicals is but only one of many health and safety controls designed to minimise risks to health and safety. The agvet chemical industry has and maintains many existing health and safety controls (outlined earlier in this chapter) designed to manage and minimise the risk of persons working in the agvet chemical industry (including those involved in the handling of the chemicals, namely transportation, storage, processing, use or disposal). State and territory governments also impose controls on supply and use, including requirements for training and certification in many cases.

An Australian farming study, funded by the Rural Industries Research and Development Corporation on the ‘Effectiveness of Risk Control Measures to Reduce Occupational Exposure to Pesticides’ (February 2009), as one of its recommendations, supported the adoption of the GHS labelling system to “improve health and safety information” for farmers on labelling.

One of the arguments against the implementation of the GHS requirements generally pointed out the actual number of incidents directly linked to agvet chemical usage (or mis-use) and or agvet chemical labelling is nil or negligible.


http://pass.org.au/wp-content/uploads/2008/03/2009-PPE_Project_-RIRDC-Farmsafe-Aust-Final_Report_Final.pdf



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Although rare, chemical related incidents or injuries do occur:

Data from the APVMA Adverse Experiences Annual Report for 2013 show 135 reports relating to adverse experiences from registered veterinary medicines and agricultural chemicals involving effects on human health, of which 21 were classified as “probable or possible, 99 as off-label (used contrary to label instructions) and 15 as unlikely or unknown”

Health and safety risks increase when known safety controls (such as those appearing on the labelling of the hazardous chemical products) are not followed. Two Australian farming studies, both funded by the Rural Industries Research and Development Corporation in 2007 and 2009, found between 10% and 65% of farmers were routinely not using the recommended personal protective equipment (including mask/respirator, gloves and overalls) in accordance with the labelling instructions when using pesticides (hazardous chemicals) on their farm (RIRDIC, 2007; RIRDC, 2009).

In terms of instructions for the protection of worker health and safety during the handling of agvet chemicals, the APVMA must be satisfied of the adequacy of instructions, advice and warnings that will appear on the label such that the product:

Would not be an undue hazard to the safety of people exposed to it during its handling (transportation, storage, processing, use or disposal); and

Would not be likely to have an effect that is harmful to human beings.

The APVMA receives reporting on worker injuries related to chemical misuse or disregarding the label, and is not aware of any recent cases of worker injury resulting from inadequate labelling. If the APVMA were made aware of worker injuries related to inadequate labelling it advises it would likely reconsider the label to ensure that it provided adequate instructions.

However as noted above, of 135 reported ‘adverse experiences’ relating to agvet chemicals, 99 related to off label usage, which, but for permitted off-label use (i.e. with a permit) is not included within the APVMA’s remit. Unauthorised (non-permitted) off-label use is illegal and may constitute an offence. It is impossible to determine, for every container of chemicals, how much was used ‘on label’ versus ‘off label’. Anecdotally though, in the agvet industry, as with the pharmaceutical industry, ‘off-label use’, albeit illegal, can and does occur and should not be ignored.

A broader economic argument could also be made that permitted off-label usage can often support valuable innovations and changes. Put simply, off label usage (where permitted) is not necessarily a bad thing, and this is why users of agvet chemicals can apply to the APVMA for a specific ‘off label permit’ if they can demonstrate value in their proposed usage.

It would be unreasonable to expect the APVMA to conduct its thorough and robust risk assessment for unforeseen off label usage, not to mention inefficient and nigh impossible. In addition, one would be naïve to think illegal off-label use will never occur in the agvet industry. It is proper and valid to argue an assumption that persons engaging in illegal off-label use are not likely to read information or instructions on a label, or are aware of the risks and deliberately ignore appropriate safety measures and so will not benefit from additional GHS label information. However, it can equally be argued that some persons who would otherwise ignore label safety instructions may stop to give consideration of any GHS hazards and warnings if these were included on the label, before embarking on a higher-risk off-label use of the chemical.

We note, however, that, given the training requirements and controls on supply, which apply to more dangerous chemicals, and the broad coverage of industry quality assurance schemes, that in many cases, decisions to ignore label instructions may be deliberate and by persons informed of the risks.

Irrespective of the illegality of using the chemical against its intended labelling instructions, it could be argued this minority group should be made aware (or reminded) of the intrinsic hazards and associated precautionary statements, as the risk assessment and associated health and safety precautions and controls on the agvet chemical label would not have envisaged or considered the off-label use.

Following the analysis arising from Chapters 3, 5 and 6 of this report, Deloitte considers there is likely to be a small on-going health benefit by the provision of additional GHS information on agvet chemical labels.

We suggest the benefit would be small on the basis of existing health and safety controls in the agvet chemical industry and that the persons likely to benefit from additional GHS statements are not the general agvet chemical end-users, but persons not employed in the agvet industry yet are involved in


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its handling who are familiar with GHS labelling on chemical products as well as off-label users in the agvet industry. Assuming there is some health benefit (however small), it will be ongoing and compounding, rather than a one off.

To be clear, it cannot be said with certainty that implementing the GHS statements on agvet chemical labelling will prevent health and safety incidents. Equally, it cannot be said with certainty that it will not prevent a health and safety incident. What we can be certain of (and is relevant to the small benefit described above) is that information regarding the intrinsic hazard and associated precautionary statements, which may not appear on existing agvet chemical labelling, will appear on labelling under the GHS system and will be available to any person who may decide to read that information. This GHS information will not be inconsistent with existing agvet chemical labelling, but will be in addition to it.

Net impact of increased information on the hazard Many or most of the impacts of increased information will be picked up through its flow-on effects to potential improved health and safety outcomes. However, there are two potentially additional and separate impacts of increased information, being the net effect of:

Providing persons considering ‘off-label’ use of the agvet chemical and other persons involved in the safe handling of the product (the latter whom the APVMA consider when assessing adequate instructions on a label) with access to GHS statements regarding intrinsic hazards and precautionary statements, which may not be made available on the current agvet chemical labelling. This additional GHS information could possibly help these persons make more informed health and safety decisions and assessments; and

The creation of additional content leading to a potential for increased complexity, which may cause confusion.

6.3.1.6 The intrinsic value of increased information

One of the key principles of the International Labour Organization (ILO) Convention 170 is that workers have a right to information about the chemicals they use at work. We note much of the GHS information is already made available, but is in each product’s safety data sheet rather than on the more visible and immediately accessible labels.

Although we acknowledge there is indeed some intrinsic value of increased information, it is our view that this impact will be relatively small.

The APVMA’s scope when conducting risk assessments is comprehensive and while it considers ‘defined’ usage and handling of chemical products, there is no evidence that the APVMA has ignored particular aspects of the supply chain that have resulted in negative health and safety outcomes. It is worth pointing out that the GHS information will itself not explicitly consider what a product is used for. That said, increased information on intrinsic hazards of certain products will itself likely have some intrinsic value (albeit small).

6.3.1.7 Potential for confusion from excess information

Increased information on labels was suggested to us in stakeholder consultations as a potential source of confusion, which may lead to negative health and safety outcomes. Notably, GHS research and documentation acknowledges this potential and balances that against the “users right to know” information regarding intrinsic hazards (United Nations, 2009).

With the size of some agvet chemical labels (for example up to 30 pages in length) it was suggested the safety data sheet (SDS) may be more easily referenced in some instances. Whilst this point is valid, we note that an option for the manufacturer or supplier of the agvet chemicals is to place the GHS statements on a separate label to the agvet label elements. It has also been suggested that splitting the WHS information between different sections of the label may confuse users who conduct workplace risk assessments based on the label structure (e.g. if the user bases their risk assessment on the GHS content only without identifying additional hazards in label particulars approved under agvet chemical legislation which will appear on a separate section of the label).

As the WHS amendments for GHS require only two elements be added to the labelling requirements, namely hazard and precautionary statements, this limits the potential for duplication and any potential for material increases in complexity and confusion. Where the APVMA approved label has statements


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equivalent or substantially the same as the GHS statements, the GHS statements do not need to be repeated. In addition, it is not suggested the GHS statements will be inconsistent with the current agvet chemical labelling but will provide further information for any person reading the labelling content.




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7 RecommendationsConsistent with the terms of reference for this work health and safety duplication review and regulation 80E of the Agvet Code Regulations, our recommendations below relate to matters within the APVMA’s functions and powers for preferred options to:

address any identified duplication; and

improve the regulation of WHS in relation to chemical products.

The Deloitte review team recommends:

1. The APVMA continues to work with SWA to assist industry determine which GHS hazard and precautionary statements (required for each hazardous chemical classification) are equivalent to, or substantially the same, as APVMA approved agvet chemical labelling statements to minimise duplication.

2. Where appropriate, the APVMA take GHS labelling into account in consideration of any future changes to agvet chemical labelling requirements.

3. The APVMA applies any discretion it has to permit manufacturers of veterinary chemical products the choice of being able to “re-stick” any new labelling on agvet chemical products at the point of supply without the need for current stock in trade to be returned to the manufacturer (or GMP facility) for relabelling in accordance with Good Manufacturing Practice.

4. Where requested by SWA and in the interests of WHS in relation to the use and handling of agvet chemical products, the APVMA, the Department of Agriculture and Water Resources and Department of Employment continue to support SWA and its members’ communications and information flow regarding the labelling changes to manufacturers, importers, suppliers and agvet industry users and handlers.




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References

Agricultural and Veterinary Chemicals (Administration) Act 1992 (Commonwealth)

Agricultural and Veterinary Chemicals Code Act 1994 (Commonwealth)

National Code of Practice for the Labelling of Workplace Substances, March 1994, National Occupational Health and Safety Commission

Rural Industries Research and Development Corporation, 2009, Effectiveness of risk control measures to reduce occupational exposure to pesticides, Canberra, Australia.

Rural Industries Research and Development Corporation, 2002, Organophosphate pesticide exposure in agricultural workers, Canberra, Australia

Safe Work Australia, GHS Hazardous Chemical Information List, 2015

Safe Work Australia, Information sheet for manufacturers and importers of agricultural and veterinary (Agvet) chemicals dated 19 February 2016

United Nations 2009, Globally Harmonized System of Classification and Labelling of Chemicals (GHS): Third edition, Geneva and New York.

Work Health & Safety Act 2011 (Commonwealth)

Work Health and Safety Regulations 2011 (Commonwealth)

5.




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Appendix A: Regulation 80E

Regulation 80E, Agricultural and Veterinary Chemicals Code Regulations 1995

80E Work health and safety duplication review

(1) A review (a work health and safety duplication review) must be conducted in relation to any duplication of effort, and unnecessary costs, caused by the need to comply, in relation to chemical products, with both of the following kinds of legislation:

(a) work health and safety legislation;(b) agricultural and veterinary chemical legislation.

Terms of reference

(2) The terms of reference for the work health and safety duplication review must include terms that require the following:

(a) the identification of any duplication of effort arising from the need to comply with both work health and safety legislation and agricultural and veterinary chemical legislation;

(b) the identification and analysis of options for streamlining the regulation of work health and safety in relation to chemical products, and addressing any identified duplication, including an analysis of:

(i) the costs and benefits of options; and(ii) the consequences of options for the safe use of chemical products;

(c) the making of recommendations, relating to matters within the APVMA’s functions and powers, for preferred options to:

(i) address any identified duplication; and(ii) improve the regulation of work health and safety in relation to chemical products.

Persons conducting review

(3) The review is to be conducted by the Department, with input from other relevant government agencies.

Use of external expertise

(4) The Department may draw on external expertise where necessary for the review.

Submissions to review

(5) The Department must request submissions in relation to the review from members of the public.

(6) Submissions received in relation to the review must be:

(a) considered by the Department; and(b) made public, unless the person making the submission has requested that the

submission, or a part of the submission, be kept confidential.

Time for completion of review

(7) The Department must complete the review, and give a written report of the review to the Minister, no later than 30 September 2016.

Review report and response

(8) The Minister must ensure that the report of the review is published on the Department’s website within 6 weeks of receiving the report.




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(9) The Minister must ensure that the Minister’s response to the report of the review is published on the Department’s website within 3 months of receiving the report.

(10) In this regulation:

agricultural and veterinary chemicals legislation means the following:

(a) the Code [that is, the Agricultural and Veterinary Chemicals Code];(b) these Regulations;(c) the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 and

regulations made under that Act;(d) the Agricultural and Veterinary Chemicals (Administration) Act 1992 and regulations

made under that Act.

work health and safety legislation means legislation that user industries must comply with that is enacted as required by the Intergovernmental Agreement for Regulatory and Operational Reform in Occupational Health and Safety made by the Council of Australian Governments on 3 July 2008.

6.




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Appendix B: Legislative Review




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The Agvet Labelling Codes’ requirements are summarised in Appendix B “Legislative Review” table 1. The table also references non-APVMA instruments and documents as each relates to the Agvet Labelling Codes’ requirements.

Table 1: The Agvet Labelling Codes’ requirements

Code Section

Agricultural Labelling Code Veterinary Labelling Code

1 Signal heading –SUSMP and, if relevant, the ADG Code must be followed (mandatory)

Signal heading SUMP and, if relevant, the ADG Code must be followed (mandatory)

2 Product name Product name

3 Constituent statements –the active constituent statement to conform to AS1719-1994 (best practice)

Constituent statements – where relevant, the active constituent statement must follow SUSMP (mandatory). Where SUSMP does not apply, active constituent to be named as per the TGA ATM (best practice)

4 Mode of action indicator Statement of claims for use

5 Statement of claims for use Net contents statement – NMI requirements to be followed

6 Restricted chemical product statements Directions for use

7 Net contents statement

NMI requirements to be followed

Restraints




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8 Name and address of person primarily responsible for marketing the product

CCA must be followed (mandatory) and CTDA to be adhered to (best practice)

Contraindications

9 Directions for use Precautions

10 Not to be used statement Side effects

11 Other limitations and prohibitions Dosage and administration

12 Withholding period statements General directions

13 Trade advice statements Withholding period statements

14 General instructions Trade advice

15 Resistance warnings Safety directions - FAISD must be followed (mandatory)

16 Compatibility statements First aid instructions FAISD must be followed (mandatory)

17 Precaution statements Additional user safety information

18 Protection statements Environmental protection statements

19 Storage and disposal statements - if a Schedule 7 substance, SUSMP must be followed (mandatory)

Disposal statements




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20 Safety directions – FAISD must be followed (mandatory)

Storage statements

21 First aid instructions - FAISD must be followed (mandatory)

Name and address of person primarily responsible for marketing the product CCA must be followed (mandatory) and CTDA to be adhered to (best practice)

22 Batch number APVMA label approval number

23 Date of manufacture and/or expiry date of product Expiry date and date of manufacture of the product

24 APVMA label approval number Batch number

25 Dangerous goods and worker safety legislative requirements – ADG Code to be followed (best practice)

Other label information – ADG Code and WHS regulations to be followed when required by each instrument / regime (mandatory)




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Table 2: APVMA Label reference to Hazard / Hazards Hazard / Hazards

Code Section

Agricultural Labelling Code Code Section

Veterinary Labelling Code

1 Signal heading

(1) requirement that a statement of the principal hazard may be included for Schedule 5 poisons only

(2) that the statement ‘fire and explosion hazard’ may be used for dry chlorinating compounds of more than 10% available chlorine that are also classified as Class 5.1 oxidising substances by the ADCG

1 Signal heading

requirement that a statement of the principal hazard may be included for Schedule 5 poisons only

18 Protection statements

A label must include statements necessary to minimise hazards to crops, native and other non-target plants, livestock (including bees), wildlife, fish, crustaceans and the environment

15 Safety directions

Where safety directions are required to address ‘human hazards’ these must be included on the label

- - 19 Disposal statements

Where hazards to the environment and humans exist, a statement providing advice on the appropriate method to dispose of unused chemicals and used containers must be included

Table 3: APVMA reference to Precaution / Precautions




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Precaution / precautions

Code Section

Agricultural Labelling Code Code Section

Veterinary Labelling Code

17 Precaution statements

the label must include any precaution statements necessary to minimise health risks to humans or animals

6 Directions for use

Requirement that directions for safe and effective use must include a heading entitled precautions

20 Safety directions statements

A label must include safety directions that relate to safety in handling, use and storage of the product from the (FAISD) handbook: handbook of first aid instructions, safety directions, warning statements and general safety precautions for agricultural and veterinary chemicals

9 Precautions

Where precaution statements are necessary to minimise health risks to target animals these must be used under the Section 9 label heading of ‘precautions’. The word precaution is used throughout this section, however it relates only to the health risks to the target animals and not to human health risks

- - 15 Safety directions statements

A label must include safety directions that relate to safety in handling, mixing and using the product from the (FAISD) handbook: handbook of first aid instructions, safety directions, warning statements and general safety precautions for agricultural and veterinary chemicals

- - 16 First aid instructions

The label must include first aid instructions from the (FAISD) handbook: handbook of first aid instructions, safety directions, warning statements and general safety precautions for agricultural and veterinary chemicals




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Table 4 below compares the GHS hazard statements required for each hazardous chemical classification to all of the APVMA mandatory statements outlined in the FAISD Handbook. Note the GHS hazard statements are for each hazard of the product, whereas the FAISD Handbook statement is related to the risks assessed by the APVMA.

Column 1 identifies the GHS hazard statement code (e.g. H240)

Column 2 details the GHS hazards class (i.e. ‘Acute toxicity’) and the required hazard statement for agvet chemicals of this classification;

Column 3 identifies the APVMA / FAISD statement reference relevant to the GHS hazard statement (where there is no equivalent APVMA / FAISD warning statement for a GHS hazard statement no FAISD reference is recorded)

Column 4 outlines the APVMA / FAISD statement that could be reasonably construed as equivalent or substantially similar to the relevant GHS hazard statement listed in the table; and

Column 5 records an assessment of whether the APVMA / FAISD statement could be reasonably considered ‘equivalent or substantially the same’ as the GHS hazard statement listed in the table

Table 4: Comparison of GHS hazard statements and APVMA (FAISD) statements

Hazard statements

GHS Table A3.1.1

GHS Hazard Class (1) and (2) required Hazard Statement(s)

FAISD Code # FAISD HANDBOOK (4th Ed) Warning Statements

Considered equivalent / substantially the same by SWA

1 2 3 4 5

H240 (1) Self – reactive substances and mixtures; and Organic peroxides(2) Heating may cause an explosion

22 May cause fire or explosion Yes

H241 (1) Self – reactive substances and mixtures; and Organic peroxides(2) Heating may cause a fire or explosion


H242 (1) Self – reactive substances and mixtures; and Organic peroxides(2) Heating may cause a fire


H270 (1) Oxidizing gases(2) May cause or intensify fire; oxidizer

22 May cause fire or explosion -Yes

H271 1) Oxidizing liquids; Oxidizing solids(2) May cause fire or explosion; strong oxidizer


H290 (1) Corrosive to metals (2) May be corrosive to metals

02, 03, 04 Corrosive,Corrosive liquidStrongly alkaline

Yes

H300 (1) Acute toxicity, oral(2) Fatal if swallowed

128, 133 CAN KILL IF SWALLOWED Yes

H301 (1) Acute toxicity, oral (2) Toxic if swallowed

130, 133 POISONOUS IF SWALLOWED Yes

H302 (1) Acute toxicity, oral (2) Harmful if swallowed

129, 133 HARMFUL IF SWALLOWED Yes




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Hazard statements

GHS Table A3.1.1




1 2 3 4 5

H303 (1) Acute toxicity, oral (2) May be harmful if swallowed

129, 133 HARMFUL IF SWALLOWED Yes

H304 (1) Aspiration hazard (2) May be fatal if swallowed and enters airway

128, 133, 132

CAN KILL IF SWALLOWED OR INHALED

Yes

H305 (1) Aspiration hazard(2) May be harmful if swallowed and enters airway

129, 133, 132 HARMFUL IF SWALLOWED OR INHALED

Yes

H310 (1) Acute toxicity, dermal (2) Fatal in contact with skin

128, 131 CAN KILL IF ABSORBED BY SKIN CONTACT

Yes

H311 (1) Acute toxicity, dermal (2) Toxic in contact with skin

129,131

HARMFUL IF ABSORBED BY SKIN CONTACT

Yes

H312 (1) Acute toxicity, dermal (2) Harmful in contact with skin

129, 131 HARMFUL IF ABSORBED BY SKIN CONTACT

Yes

H313 (1) Acute toxicity, dermal (2) May be harmful in contact with skin

129, 131 HARMFUL IF ABSORBED BY SKIN CONTACT

Yes

H314 (1) Skin corrosion / irritation (2) Causes severe skin burns and eye damage

39 Attacks skin and eyes Yes

H315 (1) Skin corrosion / irritation (2) Causes skin irritation

161, 164 WILL IRRITATE THE SKIN Yes

H316 (1) Skin corrosion / irritation (2) Causes mild skin irritation

161, 164 WILL IRRITATE THE SKIN Yes

H317 (1) Sensitisation, skin (2) May cause an allergic skin reaction

34 May cause allergy Yes

H318 (1) Serious eye damage / eye irritation(2) Causes serious eye damage

207, 162 WILL DAMAGE THE EYES Yes

H319 (1) Serious eye damage / eye irritation(2) Causes serious eye irritation

161, 162 WILL IRRIATE THE EYES Yes

H320 (1) Serious eye damage / eye irritation(2) Causes eye irritation

161, 162 WILL IRRIATE THE EYES Yes

H330 (1) Acute toxicity, inhalation(2) Fatal if inhaled

128, 132 CAN KILL IF INHALED Yes

H331 (1) Acute toxicity, inhalation (2) Toxic if inhaled

129, 132 HARMFUL IF INHALED Yes

H332 (1) Acute toxicity, inhalation (2) Harmful if inhaled





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Hazard statements

GHS Table A3.1.1




1 2 3 4 5

H333 (1) Acute toxicity, inhalation (2) May be harmful if inhaled


H334 (1) Sensitization, respiratory (2) May cause allergy or asthma symptoms or breathing difficulties if inhaled

31 Breathing vapour or spray mist is harmful and may cause an asthma-like reaction

Yes

H335 (1) Specific target organ toxicity, singly exposure; Respiratory tract irritation (2) May cause respiratory irritation

30 Irritant to skin, eyes, mucous membranes and upper respiratory tract

Yes

H336 (1) Specific target organ toxicity, singly exposure; Narcotic effects (2) May cause drowsiness or dizziness

- No equivalent / substantially similar statements in the FAISD. In the unlikely event that an APVMA Agvet Chemical meets the GHS definition for this hazardous chemical this statement will need to be included at section 25.

-

H340 (1) Germ cell mutagenicity (2) May cause genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

26 WARNING-May cause birth defects

Yes

H341 (1) Germ cell mutagenicity (2) Suspected of causing genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

26 WARNING-May cause birth defects

Yes

H350 (1) Carcinogenicity (2) May cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

06 May cause cancer Yes

H351 (1) Carcinogenicity (2) Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

06 May cause cancer Yes




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Hazard statements

GHS Table A3.1.1




1 2 3 4 5

H360 (1) Reproductive toxicity (2) May damage fertility or the unborn child (state specific effect if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

38 WARNING-Contains (name of substance) which causes defects in laboratory animals. Women of childbearing age should avoid contact with (name of substance)

No

H361 (1) Reproductive toxicity (2) Suspected of damaging fertility or the unborn child (state specific effect if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

38 Caution: Accidental self-injection may affect fertility in both men and women and pregnancy. Not to be used by women of childbearing age. Care should be taken to avoid accidental self-injection and needle stick injury when administering this product. In the event of accidental self-injection, seek medical advice immediately

Yes (but only for self-injection exposure route)

H372 (1) Specific target organ toxicity, repeated exposure (2) Causes damage to organs (or state all organs affected if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard

190 REPEATED EXPOSURE MAY HAVE A CUMULATIVE POISONING EFFECT

No

H373 (1) Specific target organ toxicity, repeated exposure (2) May cause damage to organs (or state all organs affected if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard

190 REPEATED EXPOSURE MAY HAVE A CUMULATIVE POISONING EFFECT

No

H300 + H310

1) Acute toxicity, oral and acute toxicity dermal (2) Fatal if swallowed or in contact with skin

128,133,131

CAN KILL IF SWALLOWED OR ABSORBED BY SKIN CONTACT

Yes

H300 + H330

(1) Acute toxicity, oral and acute toxicity inhalation (2) Fatal if swallowed or inhaled

128,133,132

CAN KILL IF SWALLOWED OR INHALED

Yes

H310 + H330

(1) Acute toxicity, dermal and acute toxicity, inhalation (2) Fatal in contact with skin or if inhaled

128,131,132

CAN KILL IF ABSORBED BY SKIN CONTACT OR INHALED

Yes




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Hazard statements

GHS Table A3.1.1




1 2 3 4 5

H300 + H310 + H330

(1) Acute toxicity, oral, acute toxicity, dermal and acute toxicity, inhalation (2) Fatal if swallowed, in contact with skin or if inhaled

128,133,131,132

CAN KILL IF SWALLOWED OR ABSORBED BY SKIN CONTACT OR INHALED (also 13 ‘May be fatal if inhaled, swallowed or absorbed through skin’)

Yes

H301 + H311

(1) Acute toxicity, oral and acute toxicity, dermal (2) Toxic if swallowed or in contact with skin

130,133,131

POISONOUS IF SWALLOWED OR IF ABSORBED BY SKIN CONTACT

Yes

H301 + H331

(1) Acute toxicity, oral and acute toxicity, inhalation (2) Toxic if swallowed or inhaled

130,133,132

POISONOUS IF SWALLOWED OR INHALED

Yes

H311 + H 331

(1) Acute toxicity, dermal and acute toxicity, inhalation (2) Toxic in contact with skin or if inhaled

130,131,132

POISONOUS IF ABSORBED BY SKIN CONTACT OR INHALED

Yes

H301 + H311 + H331

(1) Acute toxicity, oral and acute toxicity, dermal and acute toxicity, inhalation (2) Toxic if swallowed, in contact with skin or if inhaled

130,133,132,132

POISONOUS IF SWALLOWED, ABSORBED BY SKIN CONTACT OR IF INHALED

Yes

H302 + H312

(1) Acute toxicity, oral and acute toxicity dermal (2) Harmful if swallowed or in contact with skin

129,133,131

HARMFUL IF SWALLOWED OR IF ABSORBED BY SKIN CONTACT

Yes

H302 + H332

(1) Acute toxicity, oral and acute toxicity inhalation (2) Harmful if swallowed or inhaled

129,133,132

HARMFUL IF SWALLOWED OR INHALED

Yes

H312 + H332

(1) Acute toxicity, dermal and acute toxicity, inhalation (2) Harmful in contact with skin or if inhaled

129,131,132

HARMFUL IF ABSORBED BY SKIN CONTACT OR INHALED

Yes

H302 + H312 + H332

(1) Acute toxicity, oral and acute toxicity, dermal and acute toxicity, inhalation (2) Harmful if swallowed, in contact with skin or if inhaled

129,133,132,132

HARMFUL IF SWALLOWED, ABSORBED BY SKIN CONTACT OR IF INHALED

Yes

H303 + H313

(1) Acute toxicity, oral and acute toxicity, dermal (2) May be harmful if swallowed or in contact with skin

129,133,131

HARMFUL IF SWALLOWED OR IF ABSORBED BY SKIN CONTACT

Yes




Regulatory Review

Hazard statements

GHS Table A3.1.1




1 2 3 4 5

H303 + H333

(1) Acute toxicity, oral and acute toxicity, inhalation (2) May be harmful if swallowed or if inhaled

129,133,132

HARMFUL IF SWALLOWED OR INHALED

Yes

H313 + H333

(1) Acute toxicity, dermal and acute toxicity, inhalation (2) May be harmful in contact with skin or if inhaled

129,131,132

HARMFUL IF ABSORBED BY SKIN CONTACT OR INHALED

Yes

H303 + H313 + H333

(1) Acute toxicity, oral, acute toxicity, dermal and acute toxicity, inhalation (2) May be harmful if swallowed, in contact with skin or if inhaled

129,133,132,132

HARMFUL IF SWALLOWED, ABSORBED BY SKIN CONTACT OR IF INHALED

Yes

H315 + H320

(1) Skin corrosion / irritation and serious eye damage / eye irritation (2) Causes skin and eye irritation

160,162,164

WILL IRRITATE THE EYES AND SKIN

Yes




Regulatory Review

Table 5 below compares the GHS precautionary statements required for each hazardous chemical classification to statements as outlined in the FAISD Handbook. Importantly, there are likely to be a number of precautionary statements required by the GHS that have no equivalent to agvet chemicals because certain GHS hazard classifications (such as ‘unstable explosive’) are not relevant to agvet chemicals. For the sake of completeness these GHS precautionary statements were nevertheless included in the draft tables we provide SWA for their review.

Column 1 identifies the GHS precautionary statement code (i.e. P201)

Column 2 details the GHS precautionary statement text and the GHS hazard classes to which it applies

Column 3 identifies the FAISD statement reference relevant to the GHS precautionary statement required on an Agvet label (where there is no equivalent FAISD statement for a GHS precautionary statement no FAISD reference is recorded)

Column 4 outlines the FAISD statement that could be reasonably construed as equivalent or substantially similar to the identified GHS precautionary statement listed in the table; and

Column 5 records an assessment of whether (in the author’s view) the FAISD statement could be reasonably considered ‘equivalent or substantially the same’ as the GHS hazard statement listed in the table

Table 5: Comparison of GHS precautionary statements and APVMA (FAISD) statements

Precautionary statements

GHSSection

GHS Precautionary statements vs hazard statements

Handbook Section

FAISD HANDBOOK (4th Ed.)General safety precautions


1 2 3 4 5

P201 Obtain special instructions before use(H200, H340 – H341, H350 – H351, H360 - H362)

- No equivalent / substantially similar statements in the FAISD. The Agvet labelling Codes require a substantially similar statement in the ‘Signal Heading’ section of the APVMA approved label (‘READ SAFETY DIRECTIONS BEFORE OPENING OR USING’)

Yes

P202 Do not handle until all safety precautions have been read and understood(H200, H230 – H231, H340 – H341, H350 – H351, H360 – H361)

- As above Yes

P210 Keep away from heat/sparks/open flames/hot surfaces. No smoking.(H201 - H205, H220 - H229, H240 - H242, H250, H271 - H272)

123 Keep away from heat, sparks, and naked flames

No.However, would be considered equivalent if FAISD statement 111 ‘No smoking’ was also on the label.




Regulatory Review


GHSSection


Handbook Section



1 2 3 4 5

P211 Do not spray on an open flame or other ignition source(H222 - H223, H229)

123 Keep away from heat, sparks, and naked flames

Yes

P220 Keep / store away from clothing / …./ combustible materials.(H240 - H242, H270 - H272)

126,113

Avoid contact with clothing. Do not allow to come into contact with combustible materials such as paper, fabric, sawdust or kerosene

Yes

P221 Take any precautions to avoid mixing with combustibles/…(H271 - H272)

113 Do not allow to come into contact with combustible materials such as paper, fabric, sawdust or kerosene

Yes

P223 Do not allow contact with water(H260 - H261)

412 KEEP AWAY FROM WATER AND LIQUIDS

Yes

P231 Handle under inert gas.(H260 - H261)

- As above -

P235 . Keep cool.(H224 – H227, H240 - H242, H251 - H252)

115 Store under cover in a dry, clean, cool, well ventilated place away from sunlight

Yes

P240 Ground / bond container and receiving equipment(H201 – H205, H224 – H226, H228)

- No equivalent / substantially similar statements in the FAISD. If an APVMA Agvet Chemical has GHS identified hazardous attributes this statement will need to be included at section 25

-

P251 Do not pierce or burn, even after use(H222 - H223, H229)

- No equivalent / substantially similar statements in the FAISD. The Veterinary labelling Code at 19.1.1.2 states that ‘aerosols should be completely emptied before disposal. Place empty can in household rubbish. Do not puncture or incinerate’.

Yes – for veterinary chemicals

P260 Do not breathe dust / fume / gas / mist / vapour / spray(H314, H330, H362, H370 - H373)

108 Avoid breathing dust (or) vapour (or) spray mist

Yes

P261 Avoid breathing dust / fume / gas / mist / vapours / spray(H331 - H332, H334 - H336, H317)

108 Avoid breathing dust (or) vapour (or) spray mist

Yes

P262 Do not get in eyes, on skin, or on clothing(H310)

101,104,126

Avoid contact with eye. Avoid contact with skin. Avoid contact with clothing

Yes

P263 Avoid contact during pregnancy / while nursing(H362)

36 Do not use if pregnant Partial. (For pregnancy only. No mention of breastfeeding / nursing in the FAISD)




Regulatory Review


GHSSection


Handbook Section



1 2 3 4 5

P264 Wash… thoroughly after handling(H300 - H302, H310, H314 - H315, H319 - H320, H362, H370 - H372)

107 Wash hands thoroughly after use Yes

P273 Avoid release to the environment(H400 - H402, H410 – H413)

- As above -

P280 Wear protective gloves/protective clothing/eye protection/face protection’ (where the type of protection is at the discretion of the manufacturer(H200 - H205, H224 – H228, H240 - H242, H250 - H252, H260 - H261, H271 - H272, H310 - H312, H314 - H315, H317 - H319, , H340 – H341, H350 – H351, H360 – H361)

290,296,103

WEAR FACE SHIELD

P282 Wear cold insulating gloves / face shield / eye protection(H281)

103 No. Not considered equivalent. The GHS statement relates only to the use of gases under pressure, while the FAISD statement is general. The appropriate equivalent to 103 is P280

P283 Wear fire / flames resistant / retardant clothing(H271)

290 WEAR PROTECTIVE CLOTHING (NOMIATE SPECIFIC MATERIAL) FASTENED TO THE NECK AND WRIST

Yes

P284 In case of inadequate ventilation wear respiratory protection(H330, H334)

290,301

WEAR FULL FACE RESPIRATOR

Yes

Response statements




Regulatory Review


GHSSection


Handbook Section



1 2 3 4 5

P310 If swallowed: Immediately call a poison centre / doctor / …(H300, H301, H310, H330, H314, H318, H304 – H305)

A If poisoning occurs, contact a doctor or Poisons Information Centre

Yes

P311 Call a poison centre / doctor… Manufacturer / supplier or the competent authority to specify the appropriate source of emergency medical advice(H331, H334, H370 - H371)

A If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126, New Zealand 0800 764 766. (‘i’ ‘If poisoning occurs get to a doctor or hospital quickly)

Yes

P312 If swallowed: Call a poison centre / doctor / … / if you feel unwell(H302 - H303, H311 - H313, H332 - H333, H335 – H336)

A If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126, New Zealand 0800 764 766.

Yes

P314 Get medical advice / attention if you feel unwell(H372 - H373)

I If poisoning occurs get a doctor or hospital quickly

Yes

P315 Get immediate medical advice / attention(H281)

I If poisoning occurs get a doctor or hospital quickly

Yes

P334 If on skin: Immerse in cool water / wrap in wet bandages(H250, H260 - H261)

If skin contact occurs, remove contaminated clothing and wash skin thoroughly

No. The GHS statement is a response for burns.The FAISD statement is not specific enough to be equivalent. The combination of P352, 353 and 360 equivalent to the FAISD statement

P335 Brush off loose particles from skin. Immerse in cool water / wrap in wet bandages(H250, H260 - H261)

If skin contact occurs, remove contaminated clothing and wash skin thoroughly

No. The GHS statement is a response for burns.The FAISD statement is not specific enough to be equivalent. The combination of P352, 353 and 360 are equivalent to the FAISD statement.

P338 If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing(H314, H318 - H320)

S If in eyes, hold eyes open, flood with water for at least 15 minutes and see a doctor

Yes




Regulatory Review


GHSSection


Handbook Section



1 2 3 4 5

P340 If inhaled: Remove person to fresh air and keep comfortable for breathing(H314, H330 - H332, H334 - H336)

g Remove from contaminated area. Apply artificial respiration if not breathing

Yes

P342 If experiencing respiratory symptoms: Call a poison centre / doctor / … Manufacturer / supplier or the competent authority to specify the appropriate source of emergency medical advice(H334)

a If poisoning occurs, contact a doctor or Poisons Information Centre

Yes

P351 If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing(H314, H318 - H320)

s If in eyes, hold eyes open, flood with water for at least 15 minutes and see a doctor

Yes

P352 If on skin: Wash with plenty of water / … (Manufacturer / supplier or the competent authority may specify a cleansing agent if appropriate, or may recommend an alternative agent in exceptional cases if water is clearly inappropriate(H310 - H312, H315, H317)

f If skin contact occurs, remove contaminated clothing and wash skin thoroughly (‘t’ may be also be appropriate for H310 – H312 associated with hydrofluoric acid)

Yes

P353 If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water / shower.(H314, H224 – H226)

f If skin contact occurs, remove contaminated clothing and wash skin thoroughly

Yes

P360 If on clothing: Rinse immediately contaminated clothing and skin with plenty of water before removing clothes(H271)

-f If skin contact occurs, remove contaminated clothing and wash skin thoroughly

Yes

P361 If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water / shower.(H310 - H311, H314, H224 – H226)

f If skin contact occurs, remove contaminated clothing and wash skin thoroughly

Yes




Regulatory Review


GHSSection


Handbook Section



1 2 3 4 5

P362 Take off contaminated clothing and wash it before reuse.(H312, H315, H317)

360,212

AFTER EACH DAYS USE, WASH CLOTHING

Yes

P363 Wash contaminated clothing before reuse(H314)

360,212

AFTER EACH DAYS USE, WASH CLOTHING

Yes

P364 Take off immediately all contaminated clothing and wash it before reuse(H310 - H312, H315, H317)

332,330360,212

REMOVE CLOTHING IMMEDIATELY IF CLOTHING BECOMES CONTAMINATED. AFTER EACH DAYS USE, WASH CLOTHING

Yes

Storage statements

P401 Store… (in accordance with local / regional / national / international regulations (to be specified))(H200 - H205)

-115 Store under cover in a dry, clean, cool, well ventilated place away from sunlight

Yes

P402 Store in a dry place. Store in a closed container(H260 - H261)

- A substantially similar statement is used as an example at section 19.1.4 of the Agvet Labelling Code.

Yes

P403 Store in well – ventilated place(H220 - H221, H224 – H227, H240 - H242, H330 - H331, H335 – H336, H270, H280 - H281)

115- Store under cover in a dry, clean, cool, well ventilated place away from sunlightA substantially similar statement is used as an example at section 19.1.4 of the Agvet Labelling Code.

Yes

P404 Store in a dry place. Store in a closed container(H260 - H261)

-115 Store under cover in a dry, clean, cool, well ventilated place away from sunlightA substantially similar statement is used as an example at section 19.1.4 of the Agvet Labelling Code.

Yes

P405 Store locked up(H300 - H301, H304 – H305, H310 - H311, H314, H330 - H331, H335 – H336, H340 – H341, H350 – H351, H360 – H361, H370 - H371)

- A substantially similar statement is directed for use the Agvet labelling code for Schedule 7 poisons at section 19.1.1 and at 1.2.4.1 for products containing an aqueous solution of paraquat 1

Yes – for the products mentioned

P410 Protect from sunlight. (H222 - H223, H229, H240 - H242, H251 - H252, H280)

-115 Store under cover in a dry, clean, cool, well ventilated place away from sunlight

Yes




Regulatory Review

Table 6 below contains a summary of Schedules 1 to 10 from the Standard for the Uniform Scheduling of Medicines and Poisons (SUMSP), also referred to as the Poisons Standard.

Table 6: Schedule summary of the SUMSP

Schedule # General description of the Schedules

Applies to agriculture and/or vet

Schedule 1 Not currently in use NA

Schedule 2.

Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.

Vet

Schedule 3.

Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.

NA

Schedule 4.

Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.

Vet

Schedule 5.

Caution – Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.

Both

Schedule 6.

Poison – Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.

Both

Schedule 7.

Dangerous Poison – Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply. (see Table 7 below)

Both

Schedule 8.

Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.

Both

Schedules9 & 10 Prohibited substances

NA




Regulatory Review

Table 7 below contains a summary of conditions for availability and use of Schedule 7 poisons.The following controls are recommended for poisons only when included in Schedule 7. These conditions for availability and use may be implemented through poisons controls or other State or Territory legislation. Note: not all controls will apply to all Schedule 7 poisons.

Table 7: Conditions for availability and use of Schedule 7 poisons

1. Not to be available except to authorised or licensed persons.

2. Not to be used in printing inks.

3. Not to be used except by or in accordance with the directions of accredited government vermin control officers.

4. Not to be used in industries which handle, process or store foods, animal feeds or packaging materials.


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