Safety regulations reporting requirements

Even before 9/11, the chemical industry was (and is) one of the nation s most regulated industries. It is subject to numerous environmental regulations as well as to the voluntary obligations imposed by the chemical industry s environmental, health, and safety improvement initiatives. Including federal/state OSHA statutes, fifteen major federal statutes, as well as numerous state laws, impose significant compliance and reporting requirements on the industry (see sidebar 3.3). 

In the past decade, there has been increased emphasis on drug safety, and more public visibility of safety problems. The volume of reports now exceeds 250000 spontaneous reports per year, and adverse events are highlighted in the medical press and also in the general media. The FDA has released extensive proposed new regulations for post-approval reporting that in part move to harmonise requirements with ICH recommendations for periodic safety update reports (PSURs)... 

Every laboratory should have an internal accident-reporting system. This includes provisions for investigating the cause of an injury as well as any potentially serious incident that does not result in injury. The primary aim of such investigations should be to make recommendations to improve safety, not to assign blame for an incident. Local legal regulations may require reporting procedures for accidents or injuries. 

Other standards, actions and programs, such as regulations on mercury exposures in the workplace, reporting requirements, fish consumption advisories and consumer safety measures. 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case. " The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

It is almost too obvious to state that companies should be aware of chemical substances that they manufacture or import, but in fact this is often not the case, and is where a compliance problem arises. The regulatory requirements are typically published by chemical name and Chemical Abstracts Service (CAS) Number, whereas in many companies trade names are more commonly used when tracking chemicals. The Material Safety Data Sheet (MSDS) system most often is the easiest place to determine whether a product or an isolated intermediate contains a component that is subject to regulation. With respect to imports, they should be cleared by a regulatory review prior to importation not only for general TSCA compliance, but also to ascertain whether or not there are any TSCA reporting requirements under TSCA... 

Safety audit reports are written document which the auditors compile in accordance with relevant laws and regulations in order to realize the implementation of a safety audit of the audited entity on the basis of production safety audit opinion. Safety audit report is the direct results of audit work. Safety auditors should work in accordance with the content, scope and requirements of safety audit. And the auditors should also process work papers by sorting and analysis, comprehensive, classification, analysis of audit evidence to identify problems and correct the audit opinion as well as conclusions What s more, those responsible should be asked to sign in safety audit reports. 

Vn.l. This appendix offers general advice on the demonstration of compliance with the requirements for packages containing fissile material set forth in paras 671 to 682 of the Regulations. Performance and documentation of a thorough criticality safety assessment provides the demonstration of compliance called for in these paragraphs. The documentation of the criticality safety assessment included in a Safety Assessment Report (SAR) is an essential part of the application for approval to the competent authority. This criticality safety assessment should be performed by the application of suitable quality assurance procedures at aU stages as prescribed in para. 813. 

Similar to the Final Safety Analysis Report in the U.S., a frmdamental feature of the British regulatory system is the requirement for each licensee to demonstrate the safety of its proposed operation in a document known as the safety case. The Nil also enforces safety and health regulations related to non-nuclear hazards at licensed sites. This role is perhaps comparable with those of the U.S. Environmental Protection Agency and state safety and health authorities. The relationship between the U.K. licensees and the safety authorities is generally less antagonistic than that found in the U.S. The majority of discrepancies found by Nil inspectors are addressed at the individual... 

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