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Guidelines for Risk Assessment on Chemicals

Notification No. 2, Guidelines for Risk Assessment, March 30, 2006

Up Date : 2007.06.12

  1. Purpose

    Pursuant to the provisions of Paragraph 2 of Article 28-2 of the Industrial Safety and Health Act, these Guidelines shall stipulate the basic concept and actions for assessment of risks associated with chemical substances, preparation products containing chemical substances or other materials that may cause hazards or health impairments to workers, so that measures necessary to prevent workers from being exposed to risks or hazards are appropriately and effectively implemented in each workplace based on the results of such assessment, and aim to promote voluntary safety and health activities by the employer.

    As part of the Guidelines for Risk Assessment (Notification No. 1, Guidelines for Risk Assessment, 2006), these Guidelines shall stipulate detailed matters related to chemical substances, etc. For the sake of convenience, these Guidelines also include matters that are stipulated in the general guidelines in an overlapped manner even if there are no detailed matters that should be specified in these Guidelines.

    These Guidelines shall also be designed to address risk assessment and associated measures as stipulated in the Guidelines on Occupational Safety and Health Management Systems (Ministry of Labour Notification No. 53, 1999).

  2. Scope

    These Guidelines shall be applicable to all hazards inherent in work performed by workers that may arise when producing, handling, storing or transporting chemical substances, pharmaceutical products containing chemical substances or other materials that may cause hazards or health impairments to workers (hereinafter referred to as “chemical substances, etc.”).

  3. Implementation Items

    The employer shall implement the following items as part of the risk assessment to be taken based on the results of such risk assessment (hereinafter referred to as “risk assessment and control measures”).

    1. The identification of hazards caused by chemical substances, etc.
    2. An estimation of the severity and the extent of possibility of occurrence of injuries or diseases that might be caused by hazards from chemical substances, etc., identified in item (1) (hereinafter referred to as “risks”)
    3. Setting priorities to reduce the risks estimated under item (2), and examining measures to reduce risks (hereinafter referred to as “risk reduction measures”)
    4. Implementing risk reduction measures in accordance with priorities set under item (3)
  4. Organizational Structure

    1. The employer shall implement risk assessment and control measures under the following organization.
      1. The employer shall have the person who supervises and manages an overall business undertaking (who assumes the highest position in a workplace), such as a general safety and health manager, supervise and manage the implementation of risk assessment and control measures, etc.
      2. The employer shall have a safety supervisor, a health supervisor, etc., in a workplace manage the implementation of risk assessment and control measures.
      3. The employer shall designate a person to take charge of the management of chemical substances, etc. (hereinafter referred to as a “chemical substance management officer”) from among those who have the ability to appropriately manage chemical substances, etc., and have such chemical substance management officer perform technical work related to risk assessment and control measures, under the management of the safety supervisor, health supervisor, etc.
      4. The employer shall have workers participate in related activities through opportunities such as a safety and health committee, a safety committee or a health committee.
      5. In implementing risk assessment and control measures, the employer shall strive to have a chemical substance management officer and other persons who have professional knowledge regarding chemical substances, etc., and machinery or facilities associated with chemical substances, etc., participate in such activities. As necessary, the employer shall seek participation in risk assessment by persons who are well versed in the characteristics of chemical facilities, experts such as a production engineer, and those who have expertise in chemical substances, etc.
    2. The employer shall provide education and training programs necessary to implement risk assessment and control measures to persons designated in item (1) above.
  5. Implementation Timing

    1. The employer shall implement risk assessment and control measures when work specified in “a” through “e” below is conducted.
      1. When a structure associated with chemical substances, etc., is installed, relocated, modified or dismantled
      2. When a facility associated with chemical substances, etc., is newly introduced or a change is made to a facility
      3. When raw materials that are chemical substances, etc., are newly adopted or changed
      4. When a working method or working procedures associated with chemical substances, etc., are newly adopted or changed
      5. Otherwise, when risks perceived in a workplace change or are likely to change, such as in the following cases:
        1. If an industrial accident caused by chemical substances, etc., occurred and problems were found in the contents of risk assessment and control measures conducted in the past
        2. When new expertise concerning risks or hazards from chemical substances, etc., is acquired
        3. Because of the elapse of a certain period after the most recent investigation, etc., when the quality of machinery, equipment, etc., associated with chemical substances, etc., has been degraded due to aging, when workers do not have adequate knowledge and/or experience relative to safety and health due to turnover or when new safety and health expertise is acquired
    2. The employer shall recognize that it is necessary to implement risk reduction measures before the start of work specified in “a” through “d” of item (1) above.
    3. It is also desirable for the employer to conduct risk assessment and control measures when plans relative to “a” through “d” of item (1) above are formulated.
  6. Determination of Risk Assessment and Control Measures

    Based on the following considerations, the employer shall determine what work is subject to risk assessment and control measures.

    1. All risks or hazards caused by chemical substances, etc., in a workplace shall be subject to risk assessment and control measures.(2) Of work specified in item (1) above, work that is expected to cause only minor injuries or diseases such as walking on a flat walkway can be excluded.
    2. Work in which the occurrence of injuries or diseases due to risks or hazards caused by chemical substances, etc., is reasonably foreseeable, such as work in which an industrial accident caused by chemical substances, etc., or an incident that caused hazards or health impairments from chemical substances, etc., occurred in the past, shall be subject to risk assessment and control measures.
  7. Collection of Information

    1. When implementing risk assessment and control measures, the employer shall gather the materials listed below and make use of the information contained in such materials. In gathering the materials, the actual situation of work sites shall be taken into consideration, and not only materials concerning routine work but also those related to non-routine work shall be gathered.
      1. Information concerning hazards caused by chemical substances, etc., and machinery, equipment, etc., associated with chemical substances, etc., such as material safety data sheets (MSDS) for chemical substances and specifications
      2. Work standards, operated procedures, etc., associated with chemical substances, etc.
      3. Information on the peripheral work environment such as the layout of machinery and equipment, etc., associated with chemical substances, etc.
      4. The results of working environment measurements, etc.
      5. Information on situations where multiple employers conduct work in one place, such as hazards caused by chemical substances, etc., arising from several kinds of operations performed in a single location
      6. Actual cases of occurrences of accidents and statistics on accidents, etc.
      7. Other materials and information relevant to implementing risk assessment and control measures
    2. When gathering information, the employer shall take note of the following matters.
      1. When the employer plans to acquire new chemical substances, etc., the employer shall obtain material safety data sheets (MSDS) for the relevant chemical substances, etc., from those who transfer or provide said chemical substances, etc.
      2. When the employer plans to introduce new machinery, equipment, etc. associated with chemical substances, etc., the employer shall require the manufacturer of such machinery, equipment, etc., to conduct risk assessment and control measures at the design and production stages of said facility and shall obtain the results of such risk assessment and control measures.
      3. When the employer plans to use or remodel machinery, equipment, etc., associated with chemical substances, etc., that is not owned by the employer, the employer shall obtain the results of risk assessment and control measures conducted by the person or company that owns management title over such facilities.
      4. When multiple employers conduct work in one location, each employer shall obtain the results of risk assessment and control measures conducted by the principal employer to prevent an industrial accident caused by chemical substances, etc., due to the performance of different types of work at one location.
      5. When multiple employers conduct work in one location where risks or hazards from chemical substances, etc., exist such as where workers may be exposed to chemical substances, etc., each employer shall obtain the results of risk assessment and control measures conducted by the principal employer regarding such relevant location.
  8. Identification of Hazards

    1. Based on work standards, etc., the employer shall examine work in detail on units necessary to identify risks or hazards from chemical substances, etc., and shall identify hazards inherent in each work unit in accordance with the classification of hazards that is specified in the “Globally Harmonized System of Classification and Labelling of Chemicals (GHS)” published by the United Nations (hereinafter referred to as “GHS”), etc.

      However, in chemical plants, etc., the employer may divide such a plant into several sections by using a method of division by a process, a method of division by layout, or other appropriate methods. Then, facilities in each section shall be made subject to risk assessment and control measures to identify hazards caused by chemical substances, etc.

    2. In identifying risks or hazards caused by chemical substances, etc., as specified in item (1), the employer shall take into consideration the additional effect of worker fatigue, etc., on risks or hazards.
  9. Estimation of Risks

    1. In order to determine priorities to reduce risks, the employer shall estimate risks using a method such as those described below, taking into consideration the severity and the extent of possibility of the occurrence of injuries or diseases that may be caused by hazards from chemical substances, etc.
      1. A method in which the severity of injuries or diseases and the extent of possibility of the occurrence of injuries or diseases are measured and plotted on vertical and horizontal axes, and risks are estimated by using a table in which risks are predetermined according to the severity and the degree of possibility
      2. A method in which the extent of possibility of the occurrence of injuries or diseases and the severity of such injuries or diseases are numerically expressed based on prescribed criteria, and such numerals are added or multiplied to estimate the degree of risk
      3. A method in which risks are estimated by separating the severity of injuries or diseases and the extent of possibility of the occurrence of injuries or diseases on a phased basis
    2. Notwithstanding the provisions in item (1), the employer may estimate risks with respect to diseases caused by chemical substances, etc., by using one of the following methods and by taking into consideration the degree of hazards of and the amount of exposure to the relevant chemical substances, etc. However, of the following two methods, the employer is encouraged to adopt the method indicated in “a.”
      1. A method in which a workerfs exposure concentration of the chemical substance, etc., that is subject to investigation is measured and the measurement result is compared to exposure limits of the relevant chemical substance (“occupational exposure limits” published by the Japan Society for Occupational Health). If the measured exposure concentration is below such exposure limits, the relevant risks may be treated as being within the permissible range
      2. A method in which the degree of hazards of the chemical substance, etc., which is subject to investigation and the level of a workerfs exposure to the relevant chemical substance, etc., are measured and plotted on vertical and horizontal axes, and risks are estimated by using a table in which risks are predetermined according to the degree of hazards and the level of exposure
    3. In estimating the extent of possibility of the occurrence of injuries or diseases as specified in item (1) and exposure concentration as specified in item (2), the employer shall be aware of and make use of the following matters.

      However, information indicated in “i” below shall be required only when such information is available.

      1. Properties of the relevant chemical substance, etc.
      2. Production or handling volume of the relevant chemical substance, etc.
      3. Details of work related to the production, etc., of the relevant chemical substance, etc.
      4. Working conditions for the production, etc., of the relevant chemical substance, etc., and the status of associated facilities
      5. Personnel assignments to work related to the production, etc., of the relevant chemical substance, etc.
      6. Working hours
      7. Installation of ventilation systems
      8. Utilization of protective devices
      9. With respect to the relevant chemical substance, etc., measurement results of concentration in the existing working environment or exposure concentration, or results of biological monitoring
    4. The employer shall estimate risks relative to chemical substances, etc., as specified in items (1) and (2) in accordance with the classification of risks or hazards specified in the GHS. During this estimation process, the employer shall consider the following matters.
      1. Reliability of functions or measures to prevent industrial accidents (hereinafter referred to as “safety and health functions, etc.”) such as the installation of safety devices, “off limits” measures and the installation of exhaust ventilation systems as well as the ability to maintain such functions or measures
      2. Possibility of undoing or ignoring safety and health functions, etc.
      3. Possibility of foreseeable intentional or accidental incorrect use or dangerous behavior, such as deviation from work procedures or errors in handling
      4. Even if the existence of a hazard is not proven, if there are reasonable grounds for suspecting a hazard, the employer shall strive to estimate risks by assuming the existence of a hazard based on such grounds
    5. In estimating risks as specified in item (1), the employer shall take note of the following matters.
      1. Accurately identifying those persons who may suffer estimated injuries or diseases and the details of such injuries or diseases
      2. Estimating the severity of the most serious injuries or diseases by assuming the worst possible case, rather than by using the severity of injuries or diseases that actually occurred in the past
      3. Because it is desirable to use common criteria to measure the severity of injuries or diseases regardless of their type, the employer shall principally use the number of days absent, etc., due to such injuries or diseases as the measurement criteria.
  10. Study and Implementation of Risk Reduction Measures

    1. The employer shall ensure that the measures required by applicable laws and ordinances are fully implemented. In addition, the employer shall study and implement measures for reducing risks in the order of priority given below.
      1. Cessation of the use of high-hazard chemical substances, etc., or replacement with lower-hazard materials
      2. Reduction of the extent of the possibility of the occurrence of injuries or the level of exposure such as by changing the operating conditions of chemical reaction processes and the form of chemical substances, etc., handled in a workplace
      3. Engineering measures such as the adoption of explosion-protected structures for machinery and equipment associated with chemical substances, etc., and double safety devices, and/or industrial hygiene engineering measures such as the enclosure of machinery and equipment associated with chemical substances, etc., and the installation of local exhaust systems, etc.
      4. Administrative measures such as the preparation of instruction manuals
      5. Use of personal protective equipment
    2. In studying measures as specified in item (1), the risk reduction measures to which a higher priority is given must be implemented in as many cases as possible, except for cases in which the burden incurred to reduce such a risk is substantially greater than the expected effect of preventing an industrial accident, leading to a significant imbalance between the cost and effect, and where the implementation of such measures is considered highly irrational.
    3. If a long time is required to implement appropriate risk reduction measures for risks that might lead to fatalities, residual disability or severe diseases, provisional measures shall immediately be taken.
  11. Recording

    The employer shall maintain a written record of the following activities.

    1. Investigated chemical substances, etc.
    2. Examined and identified work or process
    3. Identified hazards
    4. Estimated risks
    5. Priorities established for risk reduction measures
    6. Details of implemented risk reduction measures

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