Veterinary Manual of Requirements and Guidelines - Vet MORAG

APVMA logo

Part 6 - Occupational Health and Safety

1.   INTRODUCTION

This chapter provides information on requirements and guidelines for submitting occupational health and safety (OHS) data for applications for registration of veterinary chemical products and applications for permits.

OHS data are evaluated by the Office of Chemical Safety (OCS) within the Department of Health and Ageing. The OHS data provide essential information on:

  • the human health hazards of the product
  • potential worker exposure during manufacture and/or use of the product
  • any subsequent exposure which may occur, for example during re-handling of treated animals.

The impact on the health and safety of Australian workers who may be exposed to a product or its residues under working conditions, is assessed using risk assessment methodology which takes into account the hazard and the potential for worker exposure consistent with the following approach:

  • Hazard evaluation — based on the physico-chemical properties and toxicological profile of the product. The data requirements relating to physico-chemistry and toxicology are discussed in detail in Part 2 (Chemistry and Manufacture) and Part 3 (Toxicology) of this volume of MORAG.
  • Exposure assessment — based on measured and/or extrapolated exposure data. As the methodologies and technologies associated with toxicological evaluation and worker exposure estimation continue to develop and gain international acceptance, OHS data requirements may change to reflect those advances.

It should be noted that additional regulatory information, including recommendations made by other governments and internationally-recognised organisations, may also be considered during the assessment process.

1.1.   National Occupational Health and Safety Commission (NOHSC)

In February 2005, the functions of the National Occupational Health and Safety Commission (NOHSC) were transferred to the Department of Employment and Workplace Relations. A new body was formed, known as the Australian Safety and Compensation Council (ASCC). This comprises representatives from each State and Territory government, the Australian Government, and employer and employee representatives.

While maintaining a national approach to workplace safety and workers’ compensation, the role of ASCC is to coordinate research and provide policy to the Workplace Relations Ministers’ Council composed of the Federal Workplace Relations Minister and respective State and Territory counterparts. This administrative change has been reflected where possible throughout the following text. However, references to NOHSC are retained in certain circumstances for maintaining accuracy or continuity, for example in the title of publications.

2.   TYPES OF APPLICATIONS

The OHS data elements required for an application depend upon the nature of the application. The nature of the application determines which Part 6 (OHS) data module will be required; each module requires a number of OHS data elements.

2.1.   Modular categories

There are two modules in Part 6 for veterinary applications and each module is relevant to different types of applications. The modules which are associated with each type of application may be seen in Volume 3: Module levels for modular categories.

The data elements for modules 6.2 and 6.3 relate to data requirements for a particular type of application and are related to the degree of OHS risk posed by the application. The modules are more fully explained in Volume 3: Module levels for modular categories and also in the individual category chapters in Volume 2: Category requirements and guidelines.

Reduced assessment (module 6.2) of OHS and limited assessment (module 6.3) of OHS comprise a sub-set of the data elements contained in comprehensive assessment (module 6.1). Comprehensive assessment is required for some agricultural applications but is not required for veterinary applications.

Volume 3: Module levels for modular categories and the individual category chapters in Volume 2: Category requirements and guidelines provide information and guidance on the OHS data requirements for each type of application.

If an applicant does not believe a particular data element is necessary, the applicant must maintain the data heading, but may provide valid scientific argument as to why the data element should not be included. For some applications, studies included under the heading ‘Related Studies’ would not be required because of the active constituent, or the target animal species for which the product is intended. For other products, specific product guidelines may be available, which provide guidance on which of the data elements listed in Table 1 are required for that type of product.

2.2.   Fixed categories

Veterinary applications which are evaluated under one of the fixed categories do not require submission of OHS data.

3.   DATA REQUIREMENTS AND GUIDELINES

3.1.   General requirements

In general, OHS data packages must be submitted according to the procedures outlined in Volume 1: Application procedures.

If an applicant does not believe a particular data element is necessary, the applicant must maintain the data heading, but may provide valid scientific argument as to why the data element should not be included. For some applications, studies included under the heading ‘Related Studies’ would not be required because of the active constituent, or the target animal species for which the product is intended. For other products, specific product guidelines may be available, which provide guidance on which of the data elements listed in Table 1 are required for that type of product.

For example, some formulated products are supplied ready for use and do not require mixing or loading. Therefore, the following statement would be acceptable under the ‘Mixing and loading’ heading:

‘The requirement for information is not relevant because the product is supplied in a ready-to-use form and does not need mixing or loading’.

A template for submission of Part 6 data for reduced assessment (module 6.2) of OHS data is provided at 4. TEMPLATE FOR SUBMISSION OF PART 6 OHS DATA . This template may also be used for limited assessment (module 6.3) by deleting the headings of data elements which are not required by the module.

3.2.   Data elements

The data elements required for applications which require a reduced assessment (module 6.2) of OHS or limited assessment (module 6.3) of OHS data, are shown in Table 1.

If an applicant believes that the requirement for a data element is irrelevant, a brief explanation to justify the absence of the required information must be provided under heading of the data element.

Table 1:  Data elements for a comprehensive Part 6 (OHS) submission

Data element

Contents

Data summary

Hazard

Occupational exposure

Risk management and workplace information

Risk assessment

CONTENTS

A table of contents is essential.

DATA SUMMARY

The application must include an overall summary of the OHS information provided in relation to the product as well as a rationale for any conclusions made. The summary should contain:

  • a brief description of the product (including hazard classification and packaging)
  • a brief description of the use pattern of the product
  • an outline of the potential for occupational exposure (eg during manufacture, formulation, re-packing, mixing, loading, application, re-handling or wherever appropriate)
  • workplace information (including label safety directions, control measures etc)

Tables may be used as a means of summarising the information. If studies are cited, they should be cross-referenced in the main body of the application.

In most cases the summary need not exceed two to three pages.

HAZARD

The applicant must consider the life cycle of the product. For example, if it is intended that the product will be manufactured or formulated in Australia, there will be potential for local workers to become exposed to the active constituent and/or the finished product.

In Australia, workplace OHS legislation is the responsibility of the various States and Territories and is generally based on the National Model Regulations developed by the National Occupational Health and Safety Council (NOHSC – now Australian Safety and Compensation Council [ASCC]). Under OHS legislation, it is the responsibility of the employer to ensure the overall safety of the work environment.

It is assumed there is compliance with all relevant State and Territory OHS regulations for products produced in Australia. Nevertheless, applicants must submit data linked to activities involving potential worker exposure to the active constituent or product in order to provide a comprehensive view of the OHS risk.

Physical and chemical properties

Data requirements for a product manufactured or formulated in Australia (see data guidelines below for details)

  1. Active constituent
  1. Product
  1. Individual constituents

Data guidelines

IUPAC name, CAS number, purity, colour and physical appearance, odour, vapour pressure, volatility

In some instances the data may be descriptive (eg colour, appearance, odour) whereas quantitative data are required for other properties (eg vapour pressure, volatility).

Hazardous properties

These include properties recognised under the NOHSC/ASCC Approved Criteria for Classifying Hazardous Substances (NOHSC/ASCC, 2004) such as corrosive, carcinogenic, mutagenic, irritant. Also included are physico-chemical properties recognised under the ADG Code such as explosive, flammable, oxidiser.

ADG Code

This is the Australian Code for the Transport of Dangerous Goods by Roads and Rail which sets out technical requirements and guidelines for the transport of dangerous goods by road and rail. It is implemented by State and Territory legislation.

For current information on the ADG Code, applicants are advised to visit the Australian Government Department of Transport and Regional Services website at A link to an external sitehttp://www.dotars.gov.au.

Packaging information

This should include container volume or weight, container construction material, neck size of the container if its contents are a liquid.

Formulation type

This should be consistent with types listed in the Handbook of First Aid Instructions and Safety Directions for Agricultural and Veterinary Chemicals (FAISD Handbook) published by the Therapeutic Goods Administration (TGA) at http://www.health.gov.au/internet/main/publishing.nsf/content/ocs-faisd-handbook.htm

Dry particulate formulations

Dusts, powders and granulates may be a risk to workers as a potential source of respirable particles. Therefore the following information should be provided:

  • the particle size distribution (or nominal size range) for solid products intended for either direct application or for dispersion in water
  • the dust or fines content of particulate products in order to determine the percentage of respirable particles for classification purposes
  • estimates for attrition and friability for granular products to determine whether the capacity for dust generation meets the criteria for classification as a hazardous substance:
    • note that attrition is the process of surface wear on granules resulting from friction or impact
    • friability is the tendency for granules to crumble. In both instances, a hazard may exist through the generation of respirable particles.

Hazard classification

Hazard classification of workplace chemicals is required under State and Territory legislation. Applicants should check the NOHSC/ASCC Hazardous Substances Information System in the first instance to determine whether the chemical has been previously classified as hazardous. The database is at A link to an external sitehttp://www.nohsc.gov.au/applications/hsis/ and replaces the NOHSC/ASCC List of Designated Hazardous Substances.

If the chemical has not been classified, it should be classified by referring to the Approved Criteria for Classifying Hazardous Substances (NOHSC/ASCC, 2004 or the latest edition).

Exposure standard

This refers to a value established by NOHSC/ASCC for the airborne concentration of an individual chemical causing no discomfort or impairment to workers’ health.

Applicants should check the NOHSC/ASCC Hazardous Substances Information System to determine whether there is an Australian exposure standard for a particular chemical. Where no NOHSC/ASCC exposure standard has been established for Australia, a value set by an overseas regulatory authority may be submitted.

The NOHSC/ASCC publication Guidance Note on the Interpretation of Exposure Standards for Atmospheric Contaminants in the Occupational Environment provides additional advice.

Note: Where any of the above information has been supplied elsewhere in the application it need not be  repeated. The applicant may simply cross-reference its location in the application.

Data requirements for finished product imported into Australia (see data guidelines above for details)

  1. Product
  1. Individual constituents
Toxicology

A full description of the relevant toxicological data requirements is provided in data Part 3 (Toxicology). If these data have been supplied elsewhere in the application the applicant need only make a cross-reference to their location.

These data should include information on potential human health effects and biological indices relevant to the product use in the workplace.

Additional guidelines on toxicological data are in the next section, Occupational exposure.

OCCUPATIONAL EXPOSURE

The submission must contain information relevant to all potential sources of occupational exposure to the active constituent and the product. This information makes it possible to assess worker exposure, a crucial step in assessing OHS risk.

Exposure-related data may be derived from various sources such as measured worker exposure studies or from extrapolations based on surrogate data or suitable data models.

In general, data obtained from studies conducted under field conditions are preferred. However, calculations based on modelling or surrogate data may show that potential exposure levels associated with a particular use pattern are sufficiently low not to warrant measured exposure studies. Where the calculations reveal a cause for concern, it may be necessary to conduct measured studies to confirm or eliminate these concerns.

With respect to extrapolated worker exposure, suitable databases and models continue to be developed and improved. For example, the United Kingdom’s Predictive Operator Exposure Model (POEM) and the North American Pesticide Handlers’ Exposure Database (PHED) have been used routinely in the past. Where applicants submit data derived from such sources, full disclosure of the source is required. Measured worker exposure data may be drawn from published and unpublished studies available to the applicant. The exposure studies should contain individual worker data. Data to this level of detail are frequently absent from published reports.

Any consideration of potential worker exposure must take account of the following scenarios.

Mixing and loading

Many products require preparation prior to application or end-use. In most cases this step simply involves dilution of the concentrated product with water. However, the risk of exposure for the worker carrying out this exercise is often significant.

Data requirements – veterinary products (see data guidelines below for details)

Data guidelines

The data requirements cover an extremely broad range of veterinary products for which mixing and loading may be necessary prior to end-use, eg ectoparasiticides.

The applicant should address any issues relevant to the use pattern described on the label and other activities that may result in exposure to the chemical. Note that whilst these data may address most situations for the purposes of exposure assessment, there may be unusual circumstances where additional information is required for an effective assessment. Where this is the case, the applicant should submit the relevant information.

Equipment/system

Applicants should propose any measures believed necessary to control exposure. Mixing and loading systems may be closed or open.

Closed systems make use of engineering control measures to minimise release of the product during the mixing/loading operation. An example is the use of specifically designed product containers that fit directly to enclosed mixing tanks. Systems such as this effectively eliminate the potential for exposure which exists with open systems eg through splashing.

Container volume

This refers to the product container and need not be submitted again if provided earlier.

Average number of mixing/loading operations per day

This should be based on the typical use pattern of the product (based on the number of animals to be treated per day).

Duration of treatment season

This may require further detail, such as operations per season, if a simple statement of the period of time does not adequately describe the situation.

Volume of product used per day

This should be consistent with the information entered above based on the proposed use pattern (depending on the number of animals treated per day). For ectoparasiticide dipping/jetting, size of dipping tanks or jetting volumes should be provided.

Proposed personal protective equipment

This should be selected to minimise or eliminate exposure to the chemical in question.

Product application

Veterinary chemicals may be applied using many different methods and techniques, all of which have the potential to cause worker exposure. The provision of data relevant to the specific use pattern on the label makes it possible to assess potential exposure.

Data requirements – veterinary products (see data guidelines below for details)

Data guidelines

The applicant should address any issues relevant to the use pattern described on the label and other activities that may result in exposure to the chemical. Note that, whilst the following data requirements may address most situations for the purposes of exposure assessment, there may be unusual circumstances where additional information is required for an effective assessment. Where this is the case, the applicant should submit the relevant information.

Animal/use situation

Animals to be treated and the application stage (eg: timing of treatment, animal age, to prevent an infection, before/after shearing).

Application method/equipment

There are numerous veterinary product types that use various application methods and equipment. The common application methods include injections, tablets, implants, oral drenches, pour-on applications, dipping/jetting and drenching. Diagrams and/or photographs should be provided for product-specific application equipment (this is not necessary for common veterinary applications).

Application rate

The maximum and minimum product application rates should be provided to estimate the maximum possible product use by workers.

Total time for application per day

This should be based on a typical or representative use situation, considering the differences in farm sizes and contract workers.

Proposed personal protective equipment

This should be selected to minimise or eliminate exposure to the chemical in question.

Details should be provided of the required glove type, taking into account the formulation characteristics, relevant breakthrough time of the glove material, and practical issues for the user (such as availability and feasibility of wearing the glove during use of the product).

Respirator or any other equipment details should be provided taking into account practical issues for the user.
Re-handling

Worker exposure to veterinary chemical residues or their degradation products may be possible after a treatment has been completed, depending on the treatment method eg re-handling treated animals immediately after a pour-on application for vaccination, ear tagging, pregnancy testing or artificial insemination. Applicants should check whether there are specific re-handling requirements as an outcome of an APVMA review (eg the review of sheep ectoparasiticide products).

Data requirements (where relevant)

Data guidelines

Re-handling activities

Any expected re-handling activities after a pour-on, dipping or jetting applications, such as vaccination, ear tagging, pregnancy testing or artificial insemination.

Task-specific worker exposure studies

These should be submitted if available. Studies are of use only if they are based on the specific re-handling tasks in question (eg shearing after a sheep ectoparasiticide application).

Proposed withholding period

This should be provided by the applicant if it has been previously established by another authority.

Proposed personal protective equipment

This should be selected to minimise or eliminate exposure to the chemical in question.

Proposed restricted re-handling period

The applicant may propose a restricted re-handling period in order to minimise or eliminate exposure to the chemical in question.

Dermal absorption

Dermal absorption studies on the active constituent or the formulation must be submitted if available (for details, see Toxicokinetics and metabolism in Part 3 – Toxicology).

RISK MANAGEMENT AND WORKPLACE INFORMATION

Measures to control occupational exposure before and during end use and re-handling

Applicants are encouraged to submit risk management strategies and propose workplace information. Where indicated by the risk assessment, measures may be needed to control occupational exposure to the substance before, during and/or after end-use. The assessment process determines whether any proposed measures are required in order to reduce exposure.

Wherever possible, using available risk assessment methods, the level of protection afforded by controls (including use of personal protective equipment) should be estimated quantitatively. In order to support use of a product, these measures must sufficiently reduce exposure to a level that provides an acceptable margin between exposure and the relevant toxicological end-points.

Applicants are encouraged to consider various measures to minimise exposure in accordance with the hierarchy of control measures in the NOHSC/ASCC National Code of Practice for the Control of Workplace Hazardous Substances (NOHSC/ASCC, 1994). User comfort should also be taken into account.

Product label

New active constituents

Where the isolated active constituent will be handled by Australian workers, a copy of the label required under Commonwealth and State/Territory Hazardous Substances Regulations must be provided.

If a copy of the printed label is not available at the time of submission, final text may be provided as an alternative.

Existing active constituents

A copy of the label need not be submitted.

New products

The label for new products is included in Part 1 (Application Overview) of the submission and need not be resubmitted in the OHS submission.

Material safety data sheet (MSDS)

An MSDS must be included for:

  • new active constituents that are classified as hazardous according to the NOHSC/ASCC criteria and will be handled by Australian workers
  • products classified as hazardous according to the NOHSC/ASCC criteria.

The MSDS for active constituent and product must be written in accordance with the NOHSC/ASCC National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC/ASCC, 2003).

The health effects information contained in the MSDS for a new active constituent must be consistent with the information on the label. For instance, appropriate safety phrases and risk phrases are selected from appendices in the NOHSC/ASCC National Code of Practice for the Labelling of Workplace Substances (NOHSC/ASCC, 1994).

Although the health effects information in the MSDS for a product must also be consistent with the information on the label, the label in this instance contains first aid instructions and safety directions assigned from the TGA’s Handbook of First Aid Instructions and Safety Directions (FAISD Handbook).

Training requirements

In certain circumstances specific training in the use of a product may be required for OHS reasons. For example, the product may require the use of dedicated application equipment, or the product may be very toxic.

Information must be provided on any special training or accreditation required by the relevant authority in the use of the product.

Occupational exposure monitoring

Occupational exposure monitoring may be required in order to confirm that exposure is controlled. This may be by means of atmospheric monitoring and/or health surveillance.

Atmospheric monitoring

This is not commonly required during end-use of products. However, for some products, atmospheric monitoring will be required. Also, monitoring may be indicated during manufacturing or formulation.

For new active constituents, applicants must indicate whether atmospheric monitoring is necessary, either during manufacture and formulation, or end-use. If it is necessary, an exposure limit, justification for the limit and the proposed monitoring method must be proposed. Where internal company exposure guidelines are set, justification must be provided for the guideline and details of the monitoring method.

Health surveillance

Australian Government and State/Territory law establishes health surveillance requirements. For information on substances nationally recommended for health surveillance, refer to a current NOHSC/ASCC Schedule and Guidelines for Health Surveillance (NOHSC/ASCC, 1995).

For new active constituents, applicants must indicate whether health surveillance is necessary for either manufacture/formulation or end use. If necessary, a biological index, justification for the index and the proposed monitoring method must be provided.

Where an internal company health surveillance system is in place specifically for the active constituent, justification for the system and details of the monitoring method must be provided.

Contraindications

Any health or other circumstances that are peculiar to the product and would contraindicate use in certain circumstances must be listed.

RISK ASSESSMENT

Margin of exposure (MOE) between exposure and the toxicological end-point

Calculation of an acceptable margin between relevant toxicological end-points and predicted repeated exposure is required to support registration of the product. This is often called the margin of safety (MOS) or margin of exposure (MOE) and accounts for a range of uncertainties in the assessment of OHS risk. The acceptable margin varies depending on a range of factors, including:

  • the quality of the data on which the predicted margin is based
  • the nature and severity of the toxic effects
  • the dose-response relationship
  • the type of data (eg animal or human toxicology data, external exposure or biological monitoring data).

As a general rule, a MOE greater than 100 is required when using animal toxicology data and a MOE greater than 10 is required when using human toxicology data.

Further requirements where the MOE is inadequate

Where the applicant’s preliminary risk assessment (eg using surrogate data or an exposure model) indicates an unacceptable MOE, further data and refinement of the risk assessment are required. Refinements may include:

  • percutaneous absorption studies (in vitro rat and human and, in vivo rat studies for the neat formulation and diluted solution if applicable)
  • a worker exposure study using the product submitted for registration
  • calculations based on additional risk management strategies.

Worker exposure studies must be conducted in accordance with current best practice. The OECD’s Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application provides guidance on worker exposure studies and general guidance on minimum requirements for studies.

This OECD guidance is not as prescriptive as the United States Environment Protection Agency (USEPA) Occupational and Residential Exposure Test Guidelines and requires study authors to design the details of studies to suit the particular work situation to be assessed.

Australian studies involving workers must comply with National Health and Medical Research Council (NHMRC) guidelines including, National Statement on Ethical Conduct in Research Involving Humans (NHMRC, 1999) and Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans (NHMRC, 2002).
Risk assessment proposed by the applicant (acute and repeat dose)

Applicants are encouraged but not required to propose a risk assessment, by comparing relevant toxicological end points and exposure information (either measured or extrapolated).

Previous publicly available assessment reports provide examples of the OHS risk assessment process. These will be most relevant if they are on a similar product type and are recent (as methods are improved over time). References that provide some advice on risk assessment include:

  • International Programme on Chemical Safety (IPCS). Environmental Health Criteria 222, Biomarkers in Risk Assessment: Validity and Validation.

  • IPCS. Environmental Health Criteria 214, Human Exposure Assessment.

  • IPCS. Environmental Health Criteria 210, Principles for the Assessment of Risks to Human Health from Exposure to Chemicals.

  • IPCS. Environmental Health Criteria 170, Assessing Human Health Risks of Chemicals: Derivation of Guidance Values for Health-Based Exposure Limits.

  • IPCS. Environmental Health Criteria 155, Biomarkers and Risk Assessment: Concepts and Principles.

  • IPCS. Environmental Health Criteria 6, Principles for Evaluating the Toxicity of Chemicals (Part 1).

4.   TEMPLATE FOR SUBMISSION OF PART 6 OHS DATA

TABLE OF CONTENTS

 

OVERALL SUMMARY

 

HAZARD

Physical and chemical properties:

  • active constituent

 

  • product

 

  • individual constituents

 

Toxicology

 

OCCUPATIONAL EXPOSURE

Mixing and loading

 

Product application

 

Re-handling

 

Dermal absorption

 

RISK MANAGEMENT AND WORKPLACE INFORMATION

Measures to control occupational exposure:

  • before and during end-use

 

  • re-handling treated animals

 

Product label

 

Material safety data sheet (MSDS)

 

Training requirements (if applicable only)

 

Occupational exposure monitoring (if applicable only):

  • atmospheric monitoring

 

  • health surveillance

 

Contraindications

 

RISK ASSESSMENT

Repeat dose risks - Margin of exposure (MOE)

 

Further requirements where the MOE is inadequate

 

Risk assessment proposed by the applicant (acute and repeat dose)

 

5.   GLOSSARY

ADG

The Australian Code for the Transport of Dangerous Goods by Roads and Rail.

Biological index

The index provides a warning level of biological response to a substance or agent, or warning levels of the substance or agent or its metabolite(s), in the tissues, fluids or exhaled air of an exposed worker.

Contraindication

A condition or a specific situation that renders a particular type of treatment undesirable or unacceptable.

Exposure standard

An airborne concentration of a particular substance in a person’s breathing zone, as established by the NOHSC/ASCC Exposure Standards for Atmospheric Contaminants in the Occupational Environment. If no Australian standard is available, a standard set by an overseas regulatory authority may suffice.

First aid instructions

Instructions derived from the TGA’s FAISD Handbook.

Standard first aid statements in the FAISD Handbook only apply to agricultural and veterinary chemicals registered by the APVMA, when present in concentrations at which they would be scheduled as poisons.

The standard first aid statements should be addressed to exposed individuals, bystanders, first aid officers and ambulance officers.

Health surveillance

The monitoring of individuals for the purpose of identifying changes in health status due to occupational exposure to a hazardous substance. Refer to the NOHSC/ASCC Guidelines for Health Surveillance.

Manufacturer

Any person involved in any stage of the manufacturing process, such as toll manufacturers and sub-contractors involved in packaging and labelling, sterilising and testing, up to and including release for supply.

Material safety data sheet (MSDS)

Data sheets produced by manufacturers or importers of a substance which describe the properties and uses of the substance, ie its identity, chemical and physical properties, health hazard information, precautions for use and safe handling information.

The data sheets also provide the information needed to allow the safe handling of hazardous substances used in an occupational setting.

See the NOHSC/ASCC National Code of Practice for the Preparation of Material Safety Data Sheets.

Margin of exposure (MOE)

The margin between the relevant toxicological end-point and predicted/measured exposure (also called margin of safety, or MOS).

Non-active constituent

Any ingredient other than an active constituent which is part of a formulated product. Non-active constituents are added at the time of manufacture for various reasons, eg to improve formulation characteristics such as stability, solubility and spreadability.

Re-handling period

A time period that elapses before an individual handles a treated animal/product, or a time period that defines when individuals may handle a treated product.

Risk

The likelihood that a substance will cause harm in the circumstances of its use.

Risk assessment

An evaluation of scientific information on the hazardous properties of substances and the extent of human exposure to those substances. The estimate of risk is based on the anticipated level of exposure and the hazard posed by the substance in question. The existence of response variability means that the hazard is not uniform for everyone.

Risk phrases

Phrases that describe the hazards associated with the normal, or reasonably foreseeable, handling or use of a substance. Risk phrases are assigned from appendixes in the NOHSC/ASCC National Code of Practice for the Labelling of Workplace Substances. Risk information should include effects of overexposure or any likely chronic effects following multiple low-level exposure.

Safety directions

Phrases that give directions for the safe handling and storage of a veterinary chemical, and use of personal protective equipment. Safety directions are derived from the Handbook of First Aid Instructions and Safety Directions for Agricultural and Veterinary Chemicals (FAISD Handbook). Under poisons and pesticides legislation, many veterinary chemical products are required to be labelled with safety directions to ensure their safe handling. The FAISD Handbook contains guidelines for regulatory authorities and for manufacturers on drafting suitable safety directions, including general warnings, specific precautions and protective equipment relating to the safety of the user, which are necessary in the preparation and use of the veterinary chemical, and following its use.

Safety phrases

Phrases that provide information on workplace substances relating to safe storage, handling and personal protection. Safety phrases are assigned from appendixes in the NOHSC/ASCC National Code of Practice for the Labelling of Workplace Substances.

Toxicological end-point

Any toxicity test result or monitoring data that indicates a toxic effect of exposure. An example of a toxicological end-point is the LD50, which is the dose of a substance that produces death in 50 per cent of a population of experimental organisms.

6.   REFERENCES

REVISION HISTORY

Revision Date Description of Revision
1 July 2005

First edition

  • first MORAG edition—unchanged from the original Vet Requirements Series.
1 October 2005

Second edition

  • no changes.
1 April 2006

Third edition

  • complete revision of the content.
1 April 2007

Fourth edition

  • minor text edits.