Risk management measures

A statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC and the risk management measures in this connection which have been applied to reduce the risk of infection... 

Article 3(37) of REACH defines exposure scenarios as the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment [...] . 

The risk asses sment may include an evaluation of what the risks mean in practice to those effected. This will depend heavily on how the risk is perceived. Risk perception involves peoples beliefs, attitudes, judgements and feelings, as well as the wider social or cultural values that people adopt towards hazards and their benefits. The way in which people perceive risk is vital in the process of assessing and managing risk. Risk perception will be a major determinant in whether a risk is deemed to be acceptable and whether the risk management measures imposed are seen to resolve the problem. 

Risk management measures can be separated into genuine risk management measures and ingenuine, auxiliary, risk management measures. While only the former should be considered seriously, the latter is reviewed briefly lest a responsible marketer or public policy official finds himself or herself leaning in ill-advised directions. 

As alluded to in the BSE illustration given earlier, genuine risk management measures can focus on systematic hazard removal based on the HACCP system or on some other alternative or more appropriate system. In some cases, this can involve the isolation of the cause of the problem. In other cases, it can involve the conservative elimination of all suspected contaminants. Concurrent with this is the importance of reporting these efforts in a proactive means and keeping consumers informed about decisions, processes, and progress. 

Companies will be required to provide information on the identity and properties of a compound (including physical, chemical, toxicological, and ecotoxicological properties), the intended uses, the estimated human and environmental exposure, risks for humans and the environment, and proposals for risk management measures. Information requirements will depend largely on production volumes, but might be adjusted based on the intrinsic properties and conditions of use of individual substances. 

The harmonised EU safety data sheet is designed to describe systematically the hazardous properties of chemicals and to inform users about suitable and effective risk management measures. For some years this safety data sheet also has to state what (eco)toxicological standard effects have not been verified for a specific substance. The EU instrument has now been in existence for thirteen years, while the corresponding DIN predecessor had already been introduced in the 1980s. Nevertheless, many safety data sheets still indicate extensive quality shortcomings. 

The attempt to carry out risk assessment on a scientific basis has resulted in the systematic separation of risk assessment and practical risk management. An undesirable effect of this strict separation is the fact that the present practice of risk assessment does not produce the information that is required for formulation of risk management measures in a goal-oriented way. 

The first action is to gather existing available test data on the substance, including the conduct of a literature search. Additionally, usage and exposure data and risk management measures should be obtained. From this, the need for further information can be determined. 

Studies are not needed if the substance is a known genotoxic carcinogen and/or a germ cell mutagen and appropriate risk management measures are implemented. Also, the studies are not needed if the substance has no evidence of toxicity, there is no systemic absorption (from toxicokinetic data) and there is no significant human exposure. 

All available and relevant information on substances on their own, in preparations and in articles should be collected to assist in identifying hazardous properties, and recommendations about risk management measures should systematically be conveyed through supply chains, as reasonably necessary, to prevent adverse effects on human health and the environment. In addition, communication of technical advice to support risk management should be encouraged in the supply chain, where appropriate."... 

Other possible risk management measures range from control of recipes and specifications, awareness of the reuse of intermediate products in production (rework), and, in the case of carry over through the production line, discarding the first amount of product. 

The communication requirements of REACH ensure that manufacturers, importers, and their customers (i.e., downstream users and distributors) have the information they need to use chemicals safely. Information relating to health, safety and environmental properties, and risks and risk management measures is required to be passed both up and down the supply chain. The primary tool for information is the familiar safety data sheet (SDS) for all dangerous substances. 

Then, chemicals control becomes further sophisticated, as risk management measures are introduced in the light of the precautionary principle. Risk reductions by private companies and risk communications among various stakeholders are considered essential. Measures such as Pollutant Release and Transfer Register (PRTR) and Material Safety Data Sheets (MSDS) have been introduced. This type of measures has become important in Northeast Asia since the late 1990s. 

The latter deadline is set nearly 20 years after the ministerial call for a new chemicals policy in the EU. Above 10 t, a Chemical Safety Report with data on a relatively large set of parameters, including data on intrinsic properties, exposure scenarios and risk management measures, is to be included in the registration (Article 14, Annex 1). For substances in quantities of 1-10 t, a technical dossier with more basic data (Article 10) is stated to be sufficient. Concerning so-called non-phase-in substances , i.e. basically those not being produced or marketed before REACH, the registration provisions entered into force on 1 June, 2008 (Article 141). 

The second form of evaluation involves substances that for one reason or another are considered or assumed to be problematic (Chapter 2). Both the ECHA and the Member State s Competent Authorities will continuously evaluate suspected substances, on the basis of a risk-oriented rolling action plan and criteria for prioritisation developed by the ECHA and member states (Article 44). If needed, further information can be requested from registrants (Article 46). If an evaluation indicates that further risk management measures are needed, it may result in the... 

On the other hand, a number of EPA-initiated voluntary agreements and programs have led to well-needed risk management measures in some important cases, for instance regarding fluorinated substances such as PFOA, detergents and certain brominated flame retardants (see further in EDF 2007a). 

In general, the scope and detail of a risk assessment determines the appropriateness of a given risk management measure (Section 2.3). Additional scientific study such as lifecycle assessment (LCA) can inform managers of the appropriateness of one regulatory measure compared with another in terms of the overall effects on health and the environment (Section 2.3). A socio-economic analysis of the effects of a regulatory measure can be carried out. Ultimately, the tolerability of a risk, which depends on perceived risks and benefits of a given risky chemical or activity, also influences the appropriateness of a risk reduction measure. 

---