Risk assessment information requirements

Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade14 This requires the provision of information from risk assessments to importing nations prior to the import of such chemicals. 

As discussed above, although MSDSs are invaluable resources, they suffo- some limitations as applied to risk assessment in the specific context of the laboratory. Appendix B introduces the concept of the Laboratory Chemical Safety Summary (LCSS), which is specifically tailored to the needs of the laboratory worker. As indicated in their name, LCSSs provide information on chemicals in the context of laboratory use. These documents are summaries and are not intended to be comprehensive or to fulfill the needs of all conceivable users of a chemical. In conjunction with the guidelines described in this chapte, the LCSS provides essential information required to assess the risks associated with the use of a particular chemical in the laboratory. 

Commercial suppliers are required by law to provide their chemicals in containers affixed with precautionary labels. Labels usually present concise and nontechnical summaries of the principal hazards associated with their contents. Note that precautionary labels should not replace MSDSs and LCSSs as the primary source of information for risk assessment in the laboratory. Howevo", labels can serve as valuable reminders of the key hazards associated... 

The notification dossier may also contain a risk assessment prepared by the notifier. The precise contents of a notification will depend on, e.g., the quantity of the substance to be placed on the market and, to an extent, on the properties and uses of the substance. The thresholds for notification and a summary of the information requirements are given in Table 14.12. 

The potential sources of hazards should be listed for risk assessment. SARA requires certain industries to provide information to the planning committee. Information about snuill as well as large industries is necessary to perinit the committee to evaluate tlie significant risks. Tlie information required by SARA (some of which was provided in Cliapter 2) includes ... 

Most human or environmental healtli hazards can be evaluated by dissecting tlie analysis into four parts liazard identification, dose-response assessment or hazard assessment, exposure assessment, and risk characterization. For some perceived healtli liazards, tlie risk assessment might stop with tlie first step, liazard identification, if no adverse effect is identified or if an agency elects to take regulatory action witliout furtlier analysis. Regarding liazard identification, a hazard is defined as a toxic agent or a set of conditions that luis the potential to cause adverse effects to hmnan health or tlie environment. Healtli hazard identification involves an evaluation of various forms of information in order to identify the different liaz.ards. Dose-response or toxicity assessment is required in an overall assessment responses/cffects can vary widely since all chemicals and contaminants vary in their capacity to cause adverse effects. This step frequently requires that assumptions be made to relate... 

FIGURE 7.1.2 Four parts of risk assessment and required information. Source Renwick, A.G. et al., Food Chem. Toxicol., 41, 1211, 2003. With permission.)... 

The degree of confidence in the final estimation of risk depends on variability, uncertainty, and assumptions identified in all previous steps. The nature of the information available for risk characterization and the associated uncertainties can vary widely, and no single approach is suitable for all hazard and exposure scenarios. In cases in which risk characterization is concluded before human exposure occurs, for example, with food additives that require prior approval, both hazard identification and hazard characterization are largely dependent on animal experiments. And exposure is a theoretical estimate based on predicted uses or residue levels. In contrast, in cases of prior human exposure, hazard identification and hazard characterization may be based on studies in humans and exposure assessment can be based on real-life, actual intake measurements. The influence of estimates and assumptions can be evaluated by using sensitivity and uncertainty analyses. - Risk assessment procedures differ in a range of possible options from relatively unso-... 

The concept of risk assessment requires a profound understanding of food dynamics and technological conditions that may impact the risk levels of certain hazardous compounds. It requires that scientific information and data are collected to underpin conclusions about risk levels. Risk assessment can be used to scientifically underpin the selection of hazards that must be covered by a quality or safety assurance system (e.g., HACCP) that will improve the reliability of the system. 

Most of the provisions of the Toxic Substances Control Act (TSCA) of 1976 (PL 94-469) rely in some way on risk assessment of chemicals. Under the reporting requirements of the statute, any manufacturer, processor, or distributor of a chemical for commercial purposes must inform the EPA immediately after discovering any information which "reasonably supports the conclusion" that a chemical substance or mixture "presents a substantial risk of injury to health or to the environment" unless the EPA Administrator has been adequately informed already. EPA is mandated to establish regulations for testing new or existing substances when it is determined that there is not enough health or environmental information, that testing is necessary to develop such information and that the chemical or mixture "may present an unreasonable risk of injury to health or the environment."... 

Council Directive 92/32/EEC (392), the Seventh Amendment of the Dangerous Substances Directive (DSD) (391), Council Directive 67/548/EEC, requires pre-marketing notification of new chemical substances. Notification ensures that sufficient information is available on the hazardous properties of new substances for labelling and risk assessment (see Section 14) which will ensure the necessary control measures are in place (67). 

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