Ag Volume 3
Part 6 Occupational health & safety
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Ag Volume 3
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Part 6 Occupational health & safety
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Part 6 – Occupational health and safety (OHS) |
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Table of Contents |
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1. INTRODUCTIONThis chapter sets out the requirements and guidelines for submitting occupational health and safety (OHS) data as part of applications for registration of agricultural chemical products and applications for a permit. 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 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:
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, eg in the title of publications. 2. TYPES OF APPLICATIONSThe 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 categoriesThere are three modules in Part 6. Each module is relevant to different types of application. The modules relevant to each type of application are in Volume 3, ‘Module levels for modular categories’. The data elements for Modules 6.1, 6.2 and 6.3 relate 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. Comprehensive assessment (Module 6.1) requires submission of a full OHS data package, containing all of the data elements listed in the column titled ‘Data required’ in Volume 3, ‘Module levels for modular categories’, according to the type of product or application in the column titled ‘Type of application’. Reduced assessment (Module 6.2) and limited assessment (Module 6.3) comprise a sub-set of the data elements contained in comprehensive assessment (Module 6.1). 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 crops 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 categoriesApplications which are evaluated under a fixed category (eg Category 4) may require submission of OHS data. The level of data corresponds to Module 6.1, 6.2 or 6.3 depending on the application category, and is provided in the relevant category chapter in Volume 2: Category requirements and guidelines.
3. DATA REQUIREMENTS AND GUIDELINES3.1. General requirementsOHS data packages must be submitted according to the procedures outlined in Volume 1: Application procedures. A template for submission of Part 6 data for comprehensive assessment (Module 6.1) of OHS data is provided at: 4. This template may also be used for reduced assessment (Module 6.2) and limited assessment (Module 6.3) by deleting the headings of data elements which are not required by the module. Comprehensive assessment (Module 6.1) requires submission of a full OHS data package, containing all of the data elements listed in the column titled ‘Data required’ in Volume 3: Module levels for modular categories, according to the type of product or application in the column titled ‘Type of application. Reduced assessment (Module 6.2) and limited assessment (Module 6.3) comprise a sub-set of the data elements contained in comprehensive assessment (Module 6.1). 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 crops 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’. 3.2. Data elementsThe data elements required for a comprehensive assessment (Module 6.1) 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
CONTENTSA table of contents is essential. DATA SUMMARYThe 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:
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. HAZARDThe 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 NOHSC. 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
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). 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. 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
This should include container volume or weight, container construction material, neck size of the container if its contents are a liquid. 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 Dusts, powders and granulates may be a risk to workers as a potential source of respirable particles. Therefore the following information should be provided:
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 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). 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.
ToxicologyA 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 EXPOSUREThe 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 loadingMany 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 guidelines The data requirements cover an extremely broad range of agricultural products for which mixing and loading are necessary prior to end use, eg broadacre crop sprays and urban pest control. 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. 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. This refers to the product container and need not be submitted again if provided earlier. This refers to the volume of the mixing tank. Average number of mixing/loading operations per day This should be based on the typical use pattern of the product. A number of examples may be provided if necessary. 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 described on the label. Proposed personal protective equipment This should be selected to minimise or eliminate exposure to the chemical in question. Product applicationAgricultural 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 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. Crop refers to the type of crop for treatment (eg cotton, bananas, stone fruit). Use situation means a description of the area or location under treatment. In many cases this will be self-evident (eg broadacre, horticulture, orchard). However where the target crop is to be treated in an enclosed space such as a greenhouse, the use situation is highly significant in terms of potential worker exposure. There are numerous application methods and types of equipment used for agricultural purposes. Where the product is to be applied by spraying, the method should be indicated eg aerial, vehicle-mounted, hand-held, misting, fogging. In the case of vehicle-mounted sprayers, it is important to indicate whether the vehicle is fitted with an enclosed cab; if so, the cab should be described (eg air-conditioned, filtered). Hand-held sprayers should be identified as either knapsack or vehicle-mounted. The method of droplet production should also be described, eg hydraulic nozzle, rotary disc atomiser, air blast, and should include dimensions where relevant. Diagrams and/or photographs should be provided for product-specific application equipment (this is not necessary for common agricultural spray equipment). Application rate and spray volume The maximum and minimum product application rate (L/ha) should be provided to estimate the maximum possible active constituent concentration in the spray. Concentration of active constituent in the spray mix This should be provided in g/L or as a percentage at all proposed application rates or as a range. Total time for application per day This should be based on a typical or representative use situation, considering the differences in farm sizes for various crops. This should be provided in ha/day and may vary with the application equipment to be used. 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-entry and re-handlingWorker exposure to agricultural chemical residues or their degradation products is possible after a treatment has been completed. For example, re-entry to a treated crop to inspect for efficacy of the pesticide application or for general crop management activities such as irrigation, scouting and pruning may result in contact with the chemical or its degradation product if it is still present at a sufficient level. Occupational activities such as unloading fumigation chambers and processing treated seeds are further examples where exposure through re-entry or re-handling may occur.
Data guidelines Task specific worker exposure studies These should be submitted if available. Studies are of use only if they are based on the specific re-entry or re-handling tasks in question. When exposure studies are not available, crop transfer coefficient values related to specific re-entry activities should be provided if available. Dislodgeable foliar residue studies These studies are used in calculating the levels of chemical present following treatment of agricultural crops and estimating worker exposure. These are of use where soils are fumigated. The data allow the levels of fumigant to be calculated following fumigation and estimating worker exposure. 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 entry or re-handling period The applicant may propose a restricted entry or re-handling period in order to minimise or eliminate exposure to the chemical in question. Dermal absorptionDermal absorption studies on the active constituent or the formulation must be submitted if available. RISK MANAGEMENT AND WORKPLACE INFORMATIONMeasures to control occupational exposure before and during end use and re-entry or re-handlingApplicants 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 labelNew active constituents Where the isolated active constituent will be handled by Australian workers, a copy of the label required under Australian Government 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:
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 Training requirementsIn 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 monitoringOccupational 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. This is not commonly required during end use of products, eg during spray applications to crops. However, for some product types such as highly toxic fumigants, 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 necessary, an exposure limit, justification for the limit and the proposed monitoring method must be provided. Where internal company exposure guidelines are set, justification must be provided for the guideline and details of the monitoring method. 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. Tank mixingThe applicant must comment on any tank mixes that may impact on the risk assessment, eg tank mixing of cholinesterase inhibitors or known synergists, based on available data such as the published literature. Protective equipment requirements for tank mixed products must address the risk associated with the most hazardous component of the mixture in the first instance. However, the protective equipment selected must be suitable for use with all components. For example, the composition of some gloves may not provide satisfactory protection from all ingredients in some tank mixes. Applicants must comment on this issue in the submission. ContraindicationsAny health or other circumstances that are peculiar to the product and would contraindicate use in certain circumstances must be listed. RISK ASSESSMENTMargin of exposure (MOE) between exposure and the toxicological end-pointCalculation 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:
Further requirements where the MOE is inadequateWhere the applicant’s preliminary risk assessment (eg using surrogate data or an exposure model) indicates an MOE, further data and refinement of the risk assessment are required. Refinements may include:
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:
4. TEMPLATE FOR SUBMISSION OF PART 6 OHS DATACONTENTS
DATA SUMMARY
HAZARD
Toxicology
OCCUPATIONAL EXPOSURE
Product application
Re-entry and re-handling
Dermal absorption
RISK MANAGEMENT AND WORKPLACE INFORMATION
Product label
Material safety data sheet (MSDS)
Training requirements
Occupational exposure monitoring:
Tank mixing
Contraindications
RISK ASSESSMENT
Further requirements where the MOE is inadequate
Risk assessment proposed by the applicant (acute and repeat dose)
5. GLOSSARYADG 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-entry period A time period that elapses before an individual re-enters a treated area, or a time period that defines when individuals may re-enter a treated area. 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 an agricultural chemical, and use of personal protective equipment. Safety directions are derived from the 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. Transfer coefficient value The area of treated foliage that a worker contacts when performing a specific re-entry activity in a given time period (cm2/h). 6. REFERENCES
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Revision history
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