Operators are persons who are involved in activities relating to the application of a pesticide, such as mixing/loading the product into the application equipment, operation of the sprayer, and emptying or cleaning the sprayer and containers after use. Operators may be either professionals (e.g. farmers, contract applicators, commercial pest control operators or government staff involved in vector control) or amateur users (e.g. home garden users). So far, the Toolkit includes risk assessment for professional users.

Operators in agriculture will generally mostly be exposed to pesticides through contact with spray cloud (via dermal or inhalation routes) or indirectly through contact with pesticide deposits (dermal). Operator exposure likely to occur under the proposed conditions of use should not have an adverse effect on persons using the pesticide.

Operator risk assessment should in principle be conducted for all pesticides and all proposed uses, unless it can be convincingly shown that operator exposure will be negligible. Such a risk assessment should take into account the dose, application method and frequency, climatic conditions, and personal protective equipment, among others.

The following assessment methods are available:

Operators are persons who are involved in activities relating to the application of a pesticide, such as mixing/loading the product into the application equipment, operation of the sprayer, and emptying or cleaning the sprayer and containers after use. Operators may be either professionals (e.g. farmers, contract applicators, commercial pest control operators or government staff involved in vector control) or amateur users (e.g. home garden users). So far, the Toolkit includes risk assessment for professional users.

Operators in public health will generally mostly be exposed to pesticides through contact with spray cloud (via dermal or inhalation routes). Operator exposure likely to occur under the proposed conditions of use should not have an adverse effect on persons using the pesticide.

Operator risk assessment should in principle be conducted for all pesticides and all proposed uses, unless it can be convincingly shown that operator exposure will be negligible. Such a risk assessment should take into account the dose, application method and frequency, climatic conditions, and personal protective equipment, among others.

The following assessment methods are available:

Workers are persons who, as part of their job, enter an area that has been treated previously with a pesticide (e.g. for pruning, cutting, picking, harvesting, pest inspection) or who handle a crop that has been treated with a pesticide (e.g. sorting, bundling, packing).
 
Workers in agriculture will often be exposed to pesticides through contact with foliage and fruits. Crop maintenance and harvesting activities include frequent contacts with the crop, and dermal exposure is therefore generally considered to be the most important exposure route.
 
Inhalation exposure may be to vapour and/or airborne aerosols (including dust). Of particular relevance are indoor treatments (e.g. in greenhouses), where inhalation can be a relevant route of exposure for workers after re-entry. After outdoor applications of pesticides, vapour and aerosols tend to dissipate more rapidly, leading to lower inhalation potential than from indoor treatments. Worker inhalation estimates after outdoor applications are therefore only necessary in exceptional cases (e.g. for very volatile substances).
 
Oral exposure may occur secondarily to dermal exposure, by transfer of hand to mouth. However, workers exposure by this route is generally assumed to be negligible in comparison with that via skin and inhalation.
 
Worker risk assessment should in principle be conducted for all pesticides and all proposed uses where workers may be re-entering a crop after pesticide application, or will handle treated crops. Such risk assessment should take into account the dose, application method and frequency, climatic conditions, and personal protective equipment, among others.
 
The following assessment methods are available:

If a Maximum Residue Limit (MRL) has already been adopted for the pesticide active ingredient and the commodity or commodity group, the residue evaluation can focus on dietary risk assessment. The regulatory authority may have established the MRL based on local residue trial data, or it may have adopted the international Codex MRL.
 
The assessments that can be done in this situation are shown in the flow chart below.

If a Maximum Residue Limit (MRL) has not yet been adopted for the pesticide active ingredient and the commodity or commodity group, a comprehensive residue evaluation generally has to be carried out.
 
In a comprehensive residue evaluation, for a given pesticide and commodity (-group), the registrar generally follows the following steps:

    Establish residue definition(s) of the pesticide, both for dietary risk assessment and for MRL compliance monitoring.
    Estimate residue levels of the pesticide in the relevant commodity(ies) on the basis of Good Agricultural Practice (GAP).
    Assess dietary risks of the expected residues, both following long-term and short-term exposure.
    Define maximum residue limits (MRLs) of the pesticide for the relevant commodity(ies), which can be used to monitor and enforce the GAPs authorized by the registration.

Each of these steps can be assessed locally, or an existing evaluation from another regulatory body may be accepted by the registrar. The latter is referred to as “bridging” from an existing evaluation. Whether a complete residue assessment is done locally, or is bridged (partly or entirely), depends on national policy, available resources and the similarity between the national situation and the already evaluated one.
 
The various paths that can be chosen when conducting a residue evaluation are shown in the flow chart below.

The use of a pesticide may affect non-target arthropods living above-ground, such bees and other pollinators, natural enemies of crops pests, or other arthropods. This, in turn, may have an adverse impact on agricultural production (e.g. by reducing pollination or natural regulation of pests), or other economic activities such as honey, beeswax or silk production. It may indirectly disturb populations of animals that feed on arthropods (e.g. birds, reptiles, mammals). Pesticides may also affect biodiversity, since arthropods form an important part of animal biodiversity.
Methods for hazard and risk assessment of a pesticide for above-ground terrestrial arthropods are described in this section. Arthropods living in the soil are covered in a different section. Aquatic arthropods are discussed as part of aquatic risk assessment.

note: a group of non-target arthropods should be selected from the 4th selection box above to show the assessment methods for that group.

In many countries, the hazard classification of a pesticide product must be mentioned on the pesticide label. This to facilitate the communication of hazards to the user of the product and minimize its risks.

In some countries, national hazard classification systems apply and examples of these have been listed in the Hazard Classification module of the Toolkit.

Two international hazard classification systems are often applied on pesticide labels: the WHO Recommended Classification of Pesticides by Hazard and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

More information about the WHO classification can be found on the relevant WHO web page.

FAO and WHO currently recommend the GHS for hazard classification of pesticide products, because it is more comprehensive than the WHO classification, covering physical, health and environmental hazards.

A general introduction to the GHS can be found as a Special Topic in the Toolkit.

Here, more information is provided about the way in which hazards can be classified under the GHS, and how to assess GHS classifications when they have been proposed by the applicant.

• Classification of Physical Hazards
• Classification of Health Hazards
• Classification of Environmental Hazards

The Registration Authority can use different approaches to classify the product or verify a proposed classification. Which of these approaches can be applied, depends on the pesticide product to be classified and on the human resources available at the Registration Authority.

The following assessment methods are available:

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Relevant documents

• FAO/WHO Guidelines on good labelling practice for pesticides
• Assessment summary table – Evaluation of the pesticide label

Principle

Generally, the applicant will need to provide the draft label for the pesticide product submitted for registration.

The registration authority then verifies:

1. whether the draft label meets the requirements as defined in national legislation;
2. whether the labelling elements of the GHS are properly included, in case the GHS is applied for pesticide labelling in the country;
3. whether the recommendations of the FAO/WHO Guidelines on good labelling practice for pesticides are followed, as far as relevant.

The pesticide label is the principal, and sometimes the only, communication between the manufacturer or supplier and the user of the product. The label is the main source of information on the identity and directions for use of a pesticide, i.e. for what purpose and when and how it may be used. It may also state who is allowed to use the pesticide.

In addition, the label informs the user about the hazards of the pesticide and the risks of using it, which should help the user to assess the actual risk of handling and applying the product under specific local conditions. The label is thus an important tool to protect human health and the environment.

The appeal to the user to "read the label" will be successful only if the essential messages on the label are as simple and direct as possible. If a label is too complex, too technical or badly laid out, the product may not be used correctly, and the user and non-target organisms may be exposed to unnecessary risks. Clear directions and warnings that can be readily understood by all potential users are therefore essential.

The pesticide registration authority needs to assess if the draft label provides such essential information correctly and effectively. It will subsequently authorize the final version of the label.

Data required

The applicant should provide:

• The draft label for the pesticide product submitted for registration: for initial review
• The definitive label for the pesticide product: generally after (a provisional) approval for registration has been granted

Procedure

The label evaluation process to be followed is summarized in the flow chart below.

Step 1.  Review the content, structure, wording and style of the draft label.

The Assessment Summary Table – Evaluation of the pesticide label {INSERTLINK to the Table} can be used to facilitate this review. The Registration Authority can amend this table to reflect the national pesticide labelling requirements.

Step 2.  Check whether the GHS classification is applied correctly (if relevant)

If the country has adopted the Globally Harmonized System of classification and labelling of chemicals (GHS), specific attention should be given to the correct classification of the product and inclusion of the right label elements of the GHS (also see “Classification” in the Assessment Methods module of the Toolkit

Step 3.  Inform the applicant about corrections or amendments (if required)

If required, inform the applicant about corrections or amendments that need to be made on the label. After resubmission of the draft label, verify whether these corrections have been correctly incorporated.

Step 4.  Obtain and check the definitive label

Generally after (provisional) approval of the registration of the product, the definitive label needs to be provided by the applicant. The definitive label needs to be re-checked to ensure that its contents and material quality meet the requirements of the regulator (verify in particular the final sections of Part B of the Assessment Summary Table).

Introduction

The Safety Data Sheet (SDS) should provide comprehensive information about a substance or mixture (i.e. pesticide active ingredient or formulation) for use in the workplace. Both employers and workers use it as a source of information about hazards, including environmental hazards, and to obtain advice on safety precautions. The information acts as a reference source for the management of hazardous chemicals in the workplace.

The SDS for pesticide products can be used by registration authorities to verify whether any components of the formulation (e.g. safeners, synergists and co-formulants) are classified as hazardous, even if that information is lacking or incomplete in the registration dossier.

An SDS contains information on the potential health effects of exposure and how to work safely with the substance or mixture. It also contains hazard information derived from physicochemical properties or environmental effects, on the use, storage, handling, and emergency response measures related to that substance or mixture.

All or part of the SDS can be used to inform workers, employers, health and safety professionals, emergency personnel, relevant government agencies, as well as members of the community.

The SDS is product related and, usually, is not able to provide specific information that is relevant for any given workplace where the product may finally be used, although where products have specialized end uses the SDS information may be more workplace-specific. The information therefore enables the employer to:

1. implement worker protection measures (such as use of Personal Protection Equipment), including training, which is specific to the individual workplace; and
2. consider any measures which may be necessary to protect the environment.

According to the GHS, an SDS should be produced for all substances and mixtures which meet the harmonized criteria for physical, health or environmental hazards under the GHS. Furthermore, an SDS needs to be prepared for all mixtures which contain ingredients that meet the criteria for carcinogenic, toxic to reproduction or specific target organ toxicity in concentrations exceeding the cut-off limits for SDS specified by the criteria for mixtures. The registration authority may also require SDS’s for mixtures not meeting the criteria for classification as hazardous, but which contain hazardous ingredients in certain concentrations (see 1.5.3.1 in the GHS document).

For pesticide products, this means that an SDS should be elaborated for:

1. All pesticide active ingredients and pesticide formulations which trigger any hazard classification under the GHS (either physical, health or environmental) 

or

2. All pesticide formulations which contain an active ingredient that triggers a hazard classification for carcinogenicity, toxicity to reproduction or specific target organ toxicity (STOT), and is present in the formulation at a concentration exceeding the cutoff limits listed in Table 1.5.1. of the GHS. This also applies if the pesticide formulation itself is not classified as hazardous.

or

3. If the regulatory authority requires so, for any pesticide formulation containing active ingredients that trigger a hazard classification according to the GHS, and exceed the cutoff limits listed in Table 1.5.1. of the GHS.

The SDS should provide a clear description of the data used to identify the hazards. The minimum information in Table 1.5.2 of the GHS document (minimum information for an SDS) should be included in the SDS under the relevant headings. If specific information is not applicable or not available under a particular subheading, the SDS should clearly state this. Additional information may be required by competent authorities.

An SDS should include information according to the following mandatory 16 headings:

1. Identification of the substance/mixture and of the company/undertaking
2. Hazard identification 
3. Composition/information of ingredients
4. First aid measures
5. Fire-fighting measures
6. Accidental release measures
7. Handling and storage
8. Exposure controls / personal protection
9. Physical and chemical properties
10. Stability and reactivity
11. Toxicological information
12. Ecological information
13. Disposal considerations
14. Transport information 
15. Regulatory information
16. Other information

Procedure for review of the SDS for pesticide products

Step 1

Check that SDS are available for all substances in the product that require an SDS to be prepared. An SDS should also be made available for the product (mixture).

Step 2

The information in the SDS should be presented according to the 16 headings above.

Check if  all hazardous ingredients in a mixture, which are hazardous to health or the environment within the meaning of the GHS and are present above their cut-off levels, are included in section 3 of the SDS. For these substances, check that the chemical identity,  the identification number and concentration or concentration ranges are given. If the SDS is for only one substance, check if the chemical identity and identification number is given.

Check that the data (physical and chemical properties, health and environment) derived from the pesticide registration dossier and /or other data sources, are in line with the data in SDS.

Step 3

Check whether the classification(s) in the SDS of the product is identical to the classification obtained.

Step 4

Additional/final check of information in SDS and label.

Compare the label information in section 2 of the SDS and on the label.

• Is the information consistent?
• Is the information in the SDS easy to read and understand? Is it relevant and reliable?
• Is the risk information on the label submitted by the company correct according to your findings and GHS?