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RISK MANAGEMENT

 

EFMA PRODUCT STEWARDSHIP FOR FERTILIZERS

Version 1.4 31-07-2008

4) RISK MANAGEMENT

INTRODUCTION

 


Risk Management involves developing a comprehensive understanding of a product's SHE risks and taking appropriate steps to prevent or reduce such risks. A management system should be put in place which identifies documents and evaluates as far as possible the actual and potential risks, mainly through hazard identification and exposure estimation, at each stage of the product life cycle. Proper prioritisation of such risks by informed judgment on their severity and consequences is important before taking management decisions on the appropriate actions to protect employees, contractors, users, the general public and the environment.


The purpose of risk management is to ensure that no chemical or process directly related to manufacturing, transport, use or disposal, presents any unacceptable risks to people or the environment, and that any risks that do exist are reduced to the lowest practical level. The process consists of to major parts:


- Risk Assessment
- Risk Reduction and Control

Risk Assessment

For the purposes of Product Stewardship, risk is a function of two factors. Firstly, the intrinsic properties of a product; i.e. how hazardous it is. Secondly, the likely extent to which people or the environment could be exposed to it, whether as part of normal operations or as a consequences of an incident. The diagram below simplifies Risk Characterisation.


 

Risk Reduction and Control

After evaluation of the actual and potential risks at each stage of the product life cycle one should develop and implement appropriate actions to control and minimise product risk. The following principles apply:

  • Design, develop or modify products to meet customer's need while striving to minimise SHE impacts
  • Evaluate risks resulting from the intended uses and the reasonably foreseeable uses of products and periodically update the evaluation
  • Establish and maintain information on SHE hazards reasonably foreseeable exposure form new and existing products.
  • Whenever technically and economically feasible develop and continuously improve processes for minimising waste, reducing emissions and for the reuse, recovery, recycling and disposal of products.
  • Develop and implement appropriate actions to control or minimise risks.

A not exclusive list of actions can be found below:

  • Reformulate with less Hazardous Components.
  • Safe storage
  • Safe disposal
  • Labeling
  • Training
  • Engineering controls
  • Emission controls
  • Incident monitoring
  • Haulier/Contractor/Operator Auditing
  • Distribution control
  • Protective equipment
  • Responsible advertising
  • Pre-emptive control
  • After Sales Support

 

 


LEGAL REQUIREMENTS

 

 


Legal requirements regarding risks in the product life chain are mainly focusing on the products as such.The Directives on Dangerous substances and Dangerous preparations where adopted in the 1960s to ensure protection of public health, in particular the health of workers handling dangerous substances (see chapter 3.1.5.1). The voluntary ICCA High production volume program goes beyond gathering of data and includes a preliminary risk assessment for high production volume chemicals. EFMA has finalised a joint research program with The Fertilizer Institute in the USA and testing data for 23 Fertilizers are available. EFMA will proceed fulfilling further requirements (i.e. Risk Assessment) of the ICCA program.
In addition the Commission is drafting an Directive on EU policy on Chemicals. All existing and new substances above 1 tonne should be registered in a central database and at higher tonnage special attention should be given to long-term and chronic effects. The REACH Directive is now in force (see chapter 3.1.5.)

Legal requirements regarding the production and storage are laid down in the IPPC Directive and the Seveso II Directive.

 

 

 


EFMA REQUIREMENTS

 

 

The aim of product stewardship is to identify and manage any risks that a product may present at any stage in its lifecycle. It may not be possible for a supplier to manage risks associated with the product such risks in all parts of the chain directly, but suppliers should recognise that they are part of a chain, that they should make all reasonable efforts both to manage those risks over which they have direct control and to work with others in the chain to help them manage risks within their control.

A change - in organisation, raw materials, manufacturing process, distribution, use, etc - can often affect product risk. All such changes should be specifically reviewed as part of the overall risk management activities (see chapter 3.1.3.4: management of change).

Another safeguard to manage risks is by specifying HSE requirements as part of the contracts, whether this is a contract for purchasing of raw materials (see chapter 3.1.1.2.) for maintenance work (see chapter 3.1.3.8.), contracting storage operators (chapters 3.1.4.3. and 3.1.7.2.) or selection of transport operators (see chapter 3.1.6.4.).

 





EFMA IMPLEMENTATION

 

 

EFMA's product stewardship program consists of 5 fundamental steps regarding assessment and managing of risks in the product life chain:

 

 


4.1. DETERMINE PRODUCT PROPERTIES

 


Obtain a thorough understanding of any potentially harmful properties which the product possesses. This applies not only to products which are formally classified as hazardous, but also to any other products with properties which could foreseeably cause harm.
The following guidance's contain further advice relevant to product assessment:

 

Determine product properties
4.1.1. Product creation, development and change minimising HSE impacts
4.1.2. Establish product specification, raw materials specification and specification for additives
4.1.3. Product safety (SDS etc.)
4.1.4. Classify and label products for supply
4.1.5 Develop and supply Safety Data Sheets and product safety literature
4.1.6. Conform with customers and regulatory requirements on product quality
4.1.7 Classify and label products for transport
4.1.8. Product application

 

 

 


 

4.2. IDENTIFY EXPOSURE AND ASSESS RISK

 

Determine the potential exposure of people and the environment to the product. Normal and abnormal circumstances should both be considered. Abnormal circumstances include spillages and accidents, for example. Identify specific risk scenarios based on the product properties and potential exposures. What occurs, or might happen, and what are the consequences to health and the environment?
The following guidance's contain further advice relevant to exposure assessment:

 

Identify exposure and assess risk
4.2.1. Establish Best Practices Production Standards (BAT)
4.2.2. Assess risks and establish emergency plans
4.2.3. Product safety (SDS etc.)
4.2.4. Bulk blending
4.2.5 Assess risks in storage and manage storage operators.
4.2.6. Packaging in transit and use
4.2.7 Develop and supply Safety data sheets and product safety literature.
4.2.8. Identify, characterise and evaluate risks form the intended use and foreseeable misuse of products
4.2.9. Operate customer partnership
4.2.10 Risk assessment for distribution activities
4.2.11 Transport operator assessment and selection (dangerous goods)
4.2.12 Assess risk in storage en route, and manage storage operators
4.2.13 Product application
4.2.14 Establish environmental fate of all components/impurities and of waste products.

 

 

 


 

 

4.3. PRIORITISE RISKS

 

Prioritise the risks for attention, reflecting the probability of the scenario occurring, its consequences, and the ability of the organisation to influence these factors. Focus on those risks where the company has the greatest ability to bring about improvements.

 

 

 



4.4 DESIGN AND IMPLEMENT CONTROLS

 

Control measures and action plans should be developed and implemented to manage the priority risks.

The following guidance's describe measures which can be used in managing risks:

 

Design and implement controls
4.4.1 Establish controls in raw material purchasing and product sourcing with regard to product safety .
4.4.2 Product creation, development and change minimising HSE impacts
4.4.3 Review changes to manufacturing processes for impact on product risk (management of change)
4.4.4. Assess risks and establish emergency plans
4.4.5 Establish Best Practices Safety management
4.4.6 Product Safety (SDS etc.)
4.4.7 Establish Best Practice for safe loading and filling
4.4.8 Establish source batch traceability for all product batches
4.4.9 Establish Best Practice Warehouse standards
4.4.10 Re-use and recycling of primary and secondary packaging
4.4.11 Develop and supply Safety Data Sheets and product safety literature
4.4.12 Provide information to, and work in partnership with distributors
4.4.13 Product safety complaints, product recall and incidents
4.4.14 Operate customer partnership
4.4.15 Conform with customers and regulatory requirements on product quality
4.4.16 Establish guidance for transport on raw materials
4.4.17 Develop information for transport (TREMCARDS), dangerous good notes and advice to drivers
4.4.18 Establish a Dangerous goods Safety adviser
4.4.19 Driver training
4.4.20 Product Emergency Response
4.4.21 Establish Safe loading for ships
4.4.22 Establish guidelines for transport
4.4.23 Re-use and recycling of primary and secondary packaging
4.4.24 Best Practice warehouse standards
4.4.25 Training in product handling and use
4.4.26 Establish codes of Best Practice
4.4.27 Waste minimisation and disposal
4.4.28 Customer waste
4.4.29 Establish guidance for non-conforming material

 

 

 


 

4.5.) MONITOR PROGRESS

 

'It is strongly recommended that the organisation periodically reviews progress in implementing action plans. Points to consider include:

Monitor progress
4.5.1. Develop specific performance measures for product stewardship

 

 

 

 


 

 

4.6.) REVIEWING

 

Reviewing
4.6.1. Self-assessment of product stewardship and audit
4.6.2. Management review of product stewardship

 

 

 


 

4.7 CORRECTIVE AND PREVENTIVE ACTIONS

 

Corrective and Preventive Actions
4.7.1. Action program
4.7.2. Management of actions

 

 


 

 

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