Practice of Risk Assessment

I. Integrated GSSMaker / For GPS/JIPS

1. The Flow of Process from Risk Assessment to the GSS Creation

The diagram below outlines the flow of process, from risk assessment to creation of a GSS, using various functions of BIGDr.

1.1 The basic flow of process under the JIPS from risk assessment to GSS creation

Step 1: Select substances for risk assessment

  1. Make an inventory of the chemicals your company sells into the market or transports off the production site.
  2. Establish whether any chemicals are exempt from the risk assessment.

    Exemptions: chemicals for which no GPS-specific Risk Assessments has to be conducted as already covered by other regulatory programs

    • Chemicals that are Active Pharmaceutical Ingredients (APIs)
    • Chemicals not used as industrial chemicals and therefore already covered under specific regulations (e.g. agricultural active ingredients, biocides, cosmetics or food & feed applications)
    • Chemicals used for military purposes (e.g. explosives)
    • Non-isolated, non-transported intermediates
    • Isolated on-site used intermediates under strictly controlled conditions
    • R&D chemicals
    • Waste and/or recycling of products

Step 2: Gather information

[Types of information to gather]
  • Standard Parameters: Basic information of chemicals, such as the name and structural formula, physiochemical properties, etc.

    Standard Parameters

    • Basic information of chemicals:CAS Number(S), Name, Structural Formula, Composition of the chemicals, etc.
    • Physical-Chemical Properties:Molecular Weight, Vapour Pressure, Water Solubility, Partition Co-efficient: n-Octanol/Water, etc.
    • Environmental Fate:biodegradability, decomposition rate constant, Bioaccumulation, etc.
  • Hazard Information: Intrinsic information for each substance based on pre-defined health and environment end points.

    Hazard Information

    • Human Health:Acute toxicity (skin/oral/inhalation), Eye/Skin irritation and corrosivity (when gathering new information non-animals methods are recommended), Sensitization (when gathering new information non-animals methods are recommended), Mutagenicity/Carcinogenicity, Repeated dose (skin/oral/inhalation), Reproductive or Developmental toxicity (skin/oral/inhalation), etc.
    • Environment:Acute toxicity, Chronic toxicity
  • Exposure Information: Unique to each application/use and each company. Based on exposure categories and dependent on use.

    Exposure Information

    A detailed commentary on PROC, PC, AC, ERAC can be found in "ICCA Guidance on Chemical Risk Assessment".

    • Worker: Process Category (PROC), Mode of operation, Physical State, Term (Short, long, etc.), Dispersive/Vaper Pressure under working temperature, Ventilation, Protective equipment/Rate of collection, Mixture,chemical protective glove/Rate of protection, etc.
    • Comsumer: Chemical Product Category (PC), Article Categories (AC), Body weight og articles in the make, Skin transition coefficient, etc.
    • Environment: Environmental Release Categories (ERC). Emission data (air/water./soil) such as PRTR, etc.
[Things to consider in the process of gathering information]
  • How to obtain the information: Refer to the Seminar Materials (in Japanese) under the Links page of BIGDr. You can effectively gather hazard information by utilizing the BIGDr's Chemical Hazard Database and the hazard information sources on the Links page.
  • Evaluate the quality of the Information: Refer to the order of priority of information sources indicated in the hazard information sources of the Links page of BIGDr. Using the information sources rated as Priority 1 is preferable.
  • Data Gaps: If you find gaps in the information gathered, consider the possibility of data estimation in Step 4.

Step 3: Allocate substances into risk assessment priorities

  • Allocate substances into Priorities according to the process below.
  • Determine the order of the substances for risk assessment based on their allocated Priorities.

化学品に固有のハザードがあるか

[Does Chemical have intrinsic hazard?]
  • A chemical substance is considered to have intrinsic hazard in case any gathered hazard information falls under a certain GHS category when compared with the GHS classification criteria
  • On the other hand, a chemical substance is considered to have no intrinsic hazard in case all the hazard information obtained falls outside of the GHS Classification criteria.
  • GHS classification criteria can be found in "Purple Book" (UNECE).
Perform risk assessment of each substance in the order of Priorities allocated in Step 3.

Step 4: Develop a Base Set of Information required for risk assessments (Identify and fill the information gaps)

  1. When priority-relevant information (Base Set) is missing from the information already gathered in Step 2, complete the Base Set by estimating the missing data or generating new data in a test.
  2. For more information on which estimation method can be applied for which endpoint, refer to page 70 of the JIPS Guidance on Chemical Risk Assessment, 2nd Edition in the Links page of BIGDr.
  3. However, a data gap is not necessarily a data need. (Refer to page 50 of the JIPS Guidance on Chemical Risk Assessment, 2nd Edition)

Information to be gathered based on the Priority allocation

  • The following tables show the information that should be gathered based on the Priority allocation of a chemical. The first table (top) displays the human health effects while the second table (bottom) displays the environmental effects (ecotoxicity).

Step 5: Characterize Hazard

  1. In general, follow the formulas below. The QSARs can also be used.
    [For Human Health] DNEL = NOAEL / AF
    [For Environment] PNEC = LC50 / AF (environment)
    [NOAEL: No-observed-adverse-effect level, LC50: 50% Lethal Concentration, AF: Assessment Factors]

Step 6: Assess Exposure

  1. Assess exposure to workers, consumers, and the environment.
  2. Use the preferred tool, the ECETOC TRA Tool, for assessment.
  3. Use the Tier 2 tools (e.g. RiskOfDerm, ART, ConsExpo) when more detailed assessment is required.

Step 7: Conduct Risk Characterization

  1. In general, risks are determined by the RCRs (Risk Characterization Ratios)
    [For Human Health] RCR = EXPOSURE / DNEL
    [For Environment] RCR = PEC / PNEC
    ↓
    RCR ≥ 1: Risk is high. Detailed assessment and risk reduction measures are required.
    RCR < 1: Risk is controlled. No further action is required.
Return to [Step 6: Assess Exposure]
Repeat the steps until there is no more concern for risks (RCR < 1) by refining the exposure scenarios.

Step 8: Document Risk Assessment Process and Publish Relevant Outcomes

Create a GPS/JIPS safety summary (GPS Safety Summary: GSS) in accordance with the generic template and register it on the ICCA website.

Repeat the processes for the next substance [Step 4: Develop a Base Set of information required for risk assessment]

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1.2 The Flow of Process from Risk Assessment to a GSS Creation using BIGDr

1.2.1 For substances whose information are available in the GSSMaker

Step 1: Select substance for risk assessment

  • Confirm that the information of the respective chemical is available in the chemical DB of GSSMaker.

Step 2: Gather information

[Types of information to gather]
  • Standard Parameters:Not necessary
  • Hazard Information:Not necessary
  • Exposure Information:Unique to each application/use and each company. Based on exposure categories and dependent on use.

Step 3: Allocate Substances into Risk Assessment Priorities → Not necessary

(Priority allocation of substances is not necessary when selecting substances from the chemical DB of GSSMaker, which contains only about 20 substances.)

Step 4: Develop a Base Set of Information required for risk assessment → Not necessary

(The Base Set of information is already stored in the chemical DB of GSSMaker.)

Step 5: Characterize Hazard → Not necessary

(Hazard characterization has already been conducted for the substances in the chemical DB of GSSMaker)

Step 6: Assess Exposure

  • Assess exposure with GSSMaker using the information gathered in Step 2.

Step 7: Conduct Risk Characterization

  • Determine risks based on the RCRs (Risk Characterization Ratios) calculated by GSSMaker.
    [For Human Health] RCR = EXPOSURE / DNEL
    [For Environment] RCR = PEC / PNEC ↓
    RCR ≥ 1: Risk is high. Detailed assessment and risk reduction measures are required.
    RCR < 1: Risk is controlled. No further action is required.
Return to [Step 7: Conduct Risk Characterization]
Repeat the steps until there is no more concern for risks (RCR < 1) by refining the exposure scenarios.

Step 8: Document Risk Assessment Process and Publish Relevant Outcomes

  • Create a GPS/JIPS Safety Summary (GSS), using the GSS creation function of GSSMaker. Edit the contents as necessary and complete a GSS.
  • Register the GSS on the ICCA website. (Refer to the Links page of BIGDr.)

Repeat the processes for the next substance [Step 4: Develop a Base Set of information required for risk assessment]

1.2.2 For substances whose information are not available in GSSMaker

(Includes when using the substance information that a user has gathered, instead of the information stored in GSSMaker.)

Step 1: Select substances for risk assessment

  • Confirm that the information of the respective chemicals is not available in the chemical DB of GSSMaker.

Step 2: Gather information

[Types of information to gather]
  • Standard Parameters: Basic information of chemicals, such as the name and structural formula, the physiochemical properties, etc.
  • Hazard Information: Intrinsic information for each substance based on pre-defined health and environment end points.
  • Exposure Information: Unique to each application/use and each company. Based on exposure categories and dependent on use.

Step 3: Allocate Substances into Risk Assessment Priorities

  • When there are a large number of chemicals, determine the risk assessment priorities by following the priority allocation process.
  • When there are relatively few chemicals, conduct the risk assessment in any order.

Step 4: Develop a Base Set of information required for risk assessment

  • For more information on which estimation method can be applied for which endpoint, refer to page 70 of the JIPS Guidance on Chemical Risk Assessment, 2nd Edition in the Links page of BIGDr.
  • However, a data gap is not necessarily a data need. (Refer to page 50 of the JIPS Guidance on Chemical Risk Assessment, 2nd Edition)

Step 5: Hazard Characterization

  • Calculate the DNEL and PNEC using data gathered in Steps 2 and 4.

Step 6: Exposure Assessment

  • Assess exposure with GSSMaker using the information gathered in Step 2.

Step 7: Conduct Risk Characterization

  • Determine risks from the RCRs (Risk Characterization Ratios) calculated by GSSMaker.
    ↓
    RCR ≥ 1: Risk is high. Detailed assessment and risk reduction measures are required.
    RCR < 1: Risk is controlled. No further action is required.
Return to [Step 7: Conduct Risk Characterization]
Repeat the steps until there is no more concern for risks (RCR < 1) by refining the exposure scenarios.

Step 8: Document Risk Assessment Process and Publish Relevant Outcomes

  • Create a GPS/JIPS Safety Summary (GSS), using the GSS creation function of GSSMaker. Edit the contents as necessary and complete a GSS.
  • Register the GSS on the ICCA website. (Refer to the Links page of BIGDr.)

Repeat the processes for the next substance [Step 4: Develop a Base Set of information required for risk assessment]

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2. Points to Check when RCR > 1 in TRA Calculation

GSSMaker is designed so that a GPS Safety Summary cannot be created when any TRA results in an RCR > 1. Therefore, points to check in case of an RCR > 1 are summarized to serve as a reference in reducing the RCRs below 1. In addition, three sets of checklists are prepared to correspond to the three types of mode (Tier I - Easy mode, Tier I - Normal mode, Tier II mode) available in GSSMaker.

Points shared across all the modes and exposure targets:
Are the hazard reference values appropriate?
  • Check that the values are reliable and the appropriate uncertainty factor is used.
  • Check that the values and units of the physiochemical properties correspond.
  • Check that the values are entered correctly.

(1) RCR > 1 in Tier I - Easy mode
Check the following points before advancing to the Tier I - Normal mode.
Exposure target Point to check Notes
Workers Is the correct ventilation quality selected? The ratio of the reduction in the amount of exposure varies drastically depending on which ventilation quality is selected
Are the breathing protections and protective gloves selected correctly? Amount of exposure is reduced greatly by selecting the breathing protections and safety gloves if they are worn.
Is the PROC selected correctly? Please be aware of the differences in the typical PROCs in Europe and in Japan.
Consumers Is the PC/AC Subcategory selected correctly? Not only the PC/AC Category but also the selection of Subcategory changes the amount of exposure. Please check that Subcategory is selected correctly.
Environment — —

(2) RCR > 1 in Tier I - Normal mode
Check the following points before advancing to Tier II mode. Italicized points are the same as in (1). Please skip ahead if these points have already been checked.
Exposure target Point to check
(Italicized points are repeated from above)		 Notes
Workers Is the correct ventilation quality selected? The ratio of the reduction in the amount of exposure varies drastically depending on which ventilation quality is selected
Are the breathing protections and protective gloves selected correctly? Amount of exposure is reduced greatly by selecting the breathing protections and safety gloves if they are worn.
Is the PROC selected correctly? Please be aware of the differences in the typical PROCs in Europe and in Japan.
Consumers Is the concentration of substance in mixture (0-1) entered correctly? ECETOC TRA's default concentration is set to 50%. However, this must be corrected, for example in the case of solvents, to the concentration on the wall after its application (2✕10-6 in the example used in the seminar).
Is the PC/AC Subcategory selected correctly? Not only the PC/AC Category but also the selection of Subcategory changes the amount of exposure. Please check that the Subcategory is selected correctly.
Environment Is the SPERC scenario selected correctly? Scenarios are defined in details for SPERC. Please check if there are any other applicable options. Particularly, check that the combination of the ERC, industry category, and scenario is appropriate.
Is the daily amount used at site [kg] entered correctly? Since a lager value is set as the default daily amount used at site for SPERC, amount of exposure becomes large if the correct value is not entered. Enter the amount used at your site.

(3) RCR > 1 in Tier II mode
Check the following points and double check the points described in (1) and (2) again.Please consult an expert if an RCR remains >1 even after confirming all the points below.
Italicized points are same as in (1) and (2). Please skip ahead if these points have already been checked.
Exposure target Point to check
(Italicized points are repeated from above)		 Notes
Workers Is the correct ventilation quality selected? The ratio of the reduction in the amount of exposure varies drastically depending on which ventilation quality is selected
Are the breathing protections and protective gloves selected correctly? Amount of exposure is reduced greatly by selecting the breathing protections and safety gloves if they are worn.
Is the PROC selected correctly? Please be aware of the differences in the typical PROCs in Europe and in Japan.
Consumers Is the concentration of substance in mixture (0-1) entered correctly? ECETOC TRA's default concentration is set to 50%. However, this must be corrected, for example, in the case of solvents, to the concentration on the wall after its application (2✕10-6 in the example used in the seminar).
Is the PC/AC Subcategory selected correctly? Not only the PC/AC Category but also the selection of Subcategory changes the amount of exposure. Please check that the Subcategory is selected correctly.
Environment Besides the amount of release, is the presence or absence of a treatment facility selected correctly? Presence of a treatment facility reduces the amount of exposure. Please check if the selection is correct.
Is the SPERC scenario selected correctly? Scenarios are defined in details for SPERC. Please check if there are any other applicable options. Particularly, check that the combination of the ERC, industry category, and scenario is appropriate.
Is the daily amount used at site [kg] entered correctly? Since a larger value is set as the default daily amount used at site for SPERC, amount of exposure becomes large if the correct value is not entered. Enter the amount used at your site.
Notes
  • The TRA allows its users to create their own consumer subcategories. GSSMaker does not support this function. Please use the TRA directly.
  • River flow [m3/d] and effluent discharge rate [m3/d] can be specified as the STP Parameters in Tier II mode of the TRA. GSSMaker does not support this function. Please use the TRA directly.

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3. How to derive the hazard assessment values from key study

  • The Ministry of the Environment: Preliminary Assessment of Environmental Risk
  • NITE/CERI etc.: Initial Risk Assessment Reports
  • OECD: SIDS

Please refer to the following document for how to derive the hazard assessment values from key studies.
https://www.jcia-bigdr.jp/jcia-bigdr/doc/document/key_study.pdf[Japanese]

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4. FAQ on using ECETOC TRA Tool

FAQ on using ECETOC TRA Tool

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II. How to select PROC (Process Category)

1. How to select PROC (Process Category)

PROC selection flowchart/checklist and the latest descriptor list are summarized in order to aid the appropriate selection of PROCs (process categories) when building worker exposure scenarios with the GSSMaker Worker Tool. The PROCs consist of 28 categories of typical activities and processes at workplaces for the objective of conducting worker exposure assessment under EU REACH. For example, PROC7 is defined as tasks involving industrial spraying, whereas PROC10 is defined as tasks involving roller application or brushing. The amounts of worker exposure can be estimated with the GSSMaker Worker Tool by selecting the appropriate PROCs and other conditions.
EU ECHA: Descriptor list for Process categories (see page 50)

flow chart / check list

The 3-step process to help select PROC is shown below: “flow chart of sampling/transfers”, “checklist of high exposure process” and “flow chart of general process”.

    First step: flow chart of sampling/transfers



    [flow chart of sampling]
    [flow chart of transfers]

    Second step: High exposure process

    [check list of High exposure process]
    PROC No. Question Check
    PROC5
    Are solid or liquid materials mixed and stirred in the batch process?

    [Description of ECHA guidance]
    • Covers mixing or blending of solid or liquid materials in the context of manufacturing or formulating sectors, as well as upon end use
    • Charging/discharging of the blending vessel and sampling are considered separate activities and are not included in this PROC.
    		  
    PROC6
    Are calendering operations performed?

    [Description of ECHA guidance]
    • Processing of large surfaces at elevated temperature
    • e.g., calendering of textile, rubber, or paper
    		  
    PROC7
    Are industrial spray operations performed?
    For example, operations such as surface coating, adhesion, surface treatment/cleaners, air care, and blast spraying are applicable.
    Criteria for determining if a spray operation is for “industrial use” determines not only if the operation is implemented at an industrial facility but also if the operation is performed under appropriate technical control. For details, see the following reference. If the operation is not applicable to industrial use, then confirm PROC11.

    [Description of ECHA guidance]
    • Air dispersive techniques, i.e., dispersion into air (=atomization) by, e.g., pressurized air, hydraulic pressure or centrifugation, applicable for liquids and powders. Spraying for surface coating, adhesives, polishes/cleaners, air care products, blasting.
    • The reference to ‘industrial’ means that workers involved have received specific task training, follow operating procedures and act under supervision. Where engineering controls are in place, they are also operated by trained personnel and regularly maintained according to procedures. It is not meant that the activity can only take place at industrial sites.
    		  
    PROC10
    Are roller or brushing operations performed?
    The point is to determine if potential exists for exposure due to splashing.

    [Description of ECHA guidance]
    • This includes application of paints, coatings, removers, adhesives or cleaning agents to surfaces with potential exposure arising from splashes.
    • This PROC can also be assigned to tasks such as cleaning of surfaces using long-handle tools.
    		  
    PROC11
    Are non-industrial spray operations performed?
    Criteria for determining if a spray operation is for “non-industrial use” are not to determine whether the operation is performed at a facility other than an industrial facility but to determine whether the operation is not performed under appropriate technical control.

    [Description of ECHA guidance]
    • Air dispersive techniques, i.e., dispersion into air (=atomization) by, e.g., pressurized air, hydraulic pressure or centrifugation, applicable for liquids and powders. Includes spraying of substances/mixtures for surface coating, adhesives, polishes/cleaners, air care products, blasting
    • The reference to ‘non-industrial’ is to differentiate where conditions mentioned in PROC7 cannot be met. It is not meant that the activity can only take place at non-industrial sites
    		  
    PROC12
    Are operations that use a foaming agent in the production of foaming products performed?
    Both continuous and batch processes are applicable.

    [Description of ECHA guidance]
    • Use of substances to facilitate the process of production of foams by forming gas bubbles in a liquid mixture.
    • It can be either a continuous or a batch process.
    		  
    PROC13
    Are molded product treatments through dipping or pouring performed?
    Operations such as dipping, rinsing, and washing (with a detergent) are applicable.

    [Description of ECHA guidance]
    • Treatment of articles by dipping, pouring, immersing, soaking, washing out or washing in substances.
    • Includes handling of treated objects (e.g., from/to treatment basin, after drying, plating).
    • The service life of the article after the treatment needs to be reported separately.
    		  
    PROC14
    Are the operations of tablet formation, compression, extrusion, pellet formation, and granulation performed?

    [Description of ECHA guidance]
    • This covers processing of mixtures and/or substances into a defined shape for further use
    		  
    PROC17
    Is lubricating oil injected under high-energy conditions in metal operation processes?
    Operations such as metal rolling and molding processes as well as metal excavation and grinding processes are applicable.

    [Description of ECHA guidance]
    • Covers metal working processes where the lubricants are exposed to high temperature and friction, e.g., metal rolling/forming processes, drilling and grinding, etc.
    • Transfers for refilling or discharging from/to reservoirs are not covered.
    		  
    PROC18
    Are operations that use ordinary grease agents or lubrication under high-kinetic-energy conditions performed?
    This description includes not only machine operations but also processes with manual operations.

    [Description of ECHA guidance]
    • Use of lubricant or greasing agents in high kinetic energy conditions, including manual application.
    • It does not refer to any filling operation.
    		  
    PROC19
    Are any types of manual operations that include contact with the hands performed?
    This description includes, for example, manual cement-mixing processes, mortar production processes, and processes that involve mixing hair dye and bleach.

    [Description of ECHA guidance]
    • Addresses tasks where exposure of hands and forearms can be expected; no dedicated tools or specific exposure controls other than PPE can be put in place.
    • Examples are manual mixing of cement and plasters in construction works or mixing of hair dyes and bleaches.
    		  

    Third step: General process

    [flow chart of general process]

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