Chemical Safety

First part of class concerning causation in the law: purpose of causation concerns assessing and demonstrating if a substance has caused a specific adverse effect to health or to the environment; difference between commission and omission of an action, as different types of facts associated with different criteria for causal assessment; difference between causation, namely the naturalistic production of an event, and negligence, as deviation from due standards of behavior, as separate legal assessments; counterfactual test aimed to assess whether an action has or has not produced an adverse event; structuring counterfactual analysis through necessary and necessary-and-sufficient actions and conditions, and their different significance in causal assessment; reconstruction of the remote antecedents of the final event and selection of the antecedents that constitute the legal cause of the event and have legal relevance; testing causation in omission: assessing whether the omitted action would have avoided the event; general causation: assessing the existence of a causal link between a fact or exposure and an event or disease; specific causation: testing general causation in the individual case by verifying whether alternative explanations of the event exist; universal laws and statistical association as alternative standards to assess general causation; identifying when multiple facts are synergic to an event; use of epidemiological data and statistical association to assess the probability that a substance may produce an effect; use of risk ratios and odds ratios to identify the substance most likely responsible for an effect; criminal and civil standards of proof: beyond any reasonable doubt and more likely than not; measurement of probability and requirement that the probability of effect attributable to the investigated substance exceeds the incidence of the same effect in the general population, in civil causation; identification of synergic substances through their statistical response.

Follows a list of the major topics dealt in the second part of class concerning damage prevention. Risk assessment as a European regulatory instrument: legal value and obligation to assess all occupational risks; transparency, disclosure and participation mechanisms involving workers' representatives and public authorities. Hazards and risks: definition of hazard and risk; inclusion of suspected hazards according to the precautionary principle; conversion of hazards into measurable risks through probability and severity metrics. Occupational Exposure Limits (OEL): role and legal meaning of occupational exposure limits; persistence of hazards even below occupational exposure limits. Risk prioritization and continuous improvement: prioritization of preventive actions according to measured risks; allocation of preventive resources and continuous improvement of occupational safety standards. Preventive measures: priority assigned by European occupational safety law to primary prevention through elimination of hazards at source; hierarchy of residual preventive measures. Best Available Technology principle: reduction of occupational exposure to as low a level as is technically possible. EU Directive on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances: identification of carcinogens, mutagens and reprotoxic substances according to IARC, CLP and ACGIH; specific requirements for risk assessment, including assessment of nature, degree and duration of exposure; hierarchy of preventive measures, including substitution and closed systems; air measurements and biological fluids monitoring as tools to verify effectiveness of preventive measures; long-term record keeping of exposed employees and records to the purpose of statistical analysis and medical control. EU Directive on the protection of the health and safety of workers from the risks related to dangerous chemicals: field of application and identification of dangerous chemicals; distinction between slight and non-slight risks and corresponding preventive obligations; hierarchy between general and specific preventive measures; role of Safety Data Sheets in chemical risk assessment; exposure measurements; conditions for their avoidance. Regulation No 1907/2006 (REACH): registration, evaluation, authorization and restriction of chemicals as instruments to generate the scientific information required for carcinogen and dangerous chemicals risk assessments previously examined; role of registration dossiers and Safety Data Sheets in supporting occupational and carcinogenic risk assessment. Regulation (EC) No 1272/2008 (CLP): European Union Regulation establishing harmonized criteria for classification, labelling and packaging of hazardous substances and mixtures; understanding hazard statements (e.g. H350: May cause cancer) and precautionary statements (e.g. P280: Wear protective gloves/protective clothing/eye protection) in order to obtain the information required for actual chemical and carcinogenic risk assessments drafting. EU Regulation on personal protective equipment: CE marking and harmonized technical standards; understanding EN standards as instruments to identify PPE protective properties and their suitability for the risks identified during chemical and carcinogenic risk assessment.