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PD ISO/TS 12901 โ Nanotechnologies Occupational Risk Management for Engineered Nanomaterials Technical Specification Series
Nanotechnologies โ Occupational Risk Management Applied to Engineered Nanomaterials โ Technical Specification Series Overview
๐ฌ PD ISO/TS 12901 is a BSI Published Document series adopting ISO technical specifications on nanotechnologies, focused on occupational risk management for engineered nanomaterials (ENM). The series was prepared by BSI technical committee NTI/1 (Nanotechnologies) and carries ICS 07.030 (physics and chemistry) and 13.100 (occupational safety). Because of their small size, engineered nanomaterials have special physicochemical properties, so occupational exposure risk assessment differs significantly from conventional materials. The series provides systematic guidance from two levels โ principles and approaches, and the control banding approach โ for managing engineered nanomaterials in the workplace.
๐จ Nanoparticles can enter the body via inhalation and skin contact, and their health effects are still under study. Where full toxicological data are lacking, occupational risk management should apply the precautionary principle and avoid relaxing controls based solely on current data.
1. Series Structure and Scope ๐
This batch comprises two technical specifications forming a complete occupational risk management methodology for engineered nanomaterials:
| Part | Document | Subject | Main Content |
|---|---|---|---|
| Principles and approaches | PD ISO/TS 12901-1:2012 (ISO/TS 12901-1:2012) | Occupational risk management โ principles and approaches | Risk identification, hazard assessment, exposure assessment, risk characterisation, risk control and monitoring |
| Control banding | PD ISO/TS 12901-2:2014 (ISO/TS 12901-2:2014) | Occupational risk management โ use of the control banding approach | Control banding framework, information gathering and data recording, hazard banding, control band determination and application |
๐ก The two parts complement each other: Part 1 gives a complete, systematic risk management methodology; Part 2 offers a simplified banding tool that can be implemented quickly even when data are incomplete โ suited to SMEs and early R&D settings.
2. Hazard Identification and Assessment for ENM ๐
Part 1 systematically sets out the basic steps of occupational risk management for engineered nanomaterials:
- Risk identification: identify the presence, form and process stages of engineered nanomaterials in the workplace and the exposed population.
- Hazard assessment: collect information on toxicity, particle size, surface chemistry and solubility, and assess potential health hazards.
- Exposure assessment: evaluate airborne concentration, size distribution and routes of exposure (inhalation, dermal, ingestion).
- Risk characterisation and control: characterise risk from hazard and exposure information and apply engineering, management and personal protective controls.
โ ๏ธ Hazard assessment for engineered nanomaterials often faces data gaps: toxicity differs greatly between nanomaterials, and different surface modifications of the same material can change its hazard โ uncertainty and data sources should be clearly stated.
3. The Control Banding Approach ๐ฏ
Part 2 (2014) details the application of control banding to occupational risk management for engineered nanomaterials:
- Principle: combine hazard level with potential exposure level and map to different “control bands”, each recommending controls of an appropriate rigour.
- Information gathering and data recording: collect nanomaterial information, quantities, processes and site details, and keep records.
- Hazard banding: assign a hazard band based on hazard characteristics (toxicity, particle size, solubility).
- Control band determination and application: determine the control band with the exposure magnitude and select the corresponding engineering and management controls.
โ
The value of control banding is “starting risk management with minimal data”: even without quantitative exposure measurements and complete toxicological data, the banding approach can quickly deliver reasonable control suggestions and prioritise resources.
4. Control Bands and Recommended Measures ๐
| Control Band | Typical Scenario | Recommended Controls | Verification |
|---|---|---|---|
| Low band | Small quantities, low volatility, enclosed operations | Good ventilation, standard procedures, basic PPE (gloves, coveralls) | Periodic inspections and risk re-review |
| Medium band | Powder handling, possible dust generation | Local exhaust, wet methods, respiratory protection (e.g., N95-class) | Exposure monitoring and process improvement |
| High band | Aerosol-generating processes, large quantities | Enclosed systems, HEPA filtration, positive-pressure respirators, medical surveillance | Quantitative exposure measurement and audits |
๐จ Banding is not a one-off verdict: as processes change, quantities grow or new hazard information appears, the band and measures must be re-assessed and the risk management system dynamically maintained.
5. Engineering Practice Essentials ๐ ๏ธ
- ๐ Site assessment: run risk assessment across the production, use and disposal of nanomaterials, producing a risk register and control plan.
- ๐ง Engineering controls: give priority to local exhaust, containment and wet methods to reduce exposure.
- ๐ Monitoring and records: carry out exposure and health monitoring and keep nanomaterial safety data files.
- ๐ Training and emergency: train staff and run spill drills, with procedures for abnormal conditions.
6. Frequently Asked Questions โ
โ Q: Why do engineered nanomaterials need dedicated risk management?
A: Their small size gives high surface area and special surface activity, which may produce toxicological behaviour unlike the bulk form, and occupational exposure limits are underdeveloped โ dedicated methods are required.
A: Their small size gives high surface area and special surface activity, which may produce toxicological behaviour unlike the bulk form, and occupational exposure limits are underdeveloped โ dedicated methods are required.
โ Q: How does control banding differ from quantitative risk assessment?
A: Control banding is a qualitative/semi-quantitative simplified classification tool for fast decisions when data are scarce; quantitative assessment needs fuller data and suits high-risk or regulatory scenarios.
A: Control banding is a qualitative/semi-quantitative simplified classification tool for fast decisions when data are scarce; quantitative assessment needs fuller data and suits high-risk or regulatory scenarios.
โ Q: How should companies choose the level of controls?
A: Follow the hierarchy of elimination โ substitution โ engineering controls โ management controls โ PPE, favouring engineering measures with PPE as the last line of defence.
A: Follow the hierarchy of elimination โ substitution โ engineering controls โ management controls โ PPE, favouring engineering measures with PPE as the last line of defence.
๐ Q: Is the technical specification mandatory for companies?
A: It is a recommended guide; adoption depends on regulatory obligations and risk-assessment needs, but it should be followed for nanomaterial occupational safety to lower compliance and health risk.
A: It is a recommended guide; adoption depends on regulatory obligations and risk-assessment needs, but it should be followed for nanomaterial occupational safety to lower compliance and health risk.