Industrial chemical regulation 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). 

Of all governmental regulatory agencies worldwide, the EPA probably has the most widespread application of, and expertise in, QSAR. The use is underpinned by TSCA, which provides the framework for the regulation of new industrial chemicals by the EPA. Within TSCA, Section 5 of the Act specifies the premanufacture reporting requirements for new chemicals. Within TSCA the burden of proof is placed on the EPA to demonstrate risk and exposure for a new chemical. Since there is no requirement at the premanufacture notification (PMN) stage for the producer to provide... 

Guidance Note for Chlorine Installations on Technical Aspects of the Strfety Case Report Required by Control of Industrial Major Accident Hazard (CIMAH) Regulations, Appendix VI, ICI Chlor-Chemicals... 

At the same time, however, there is emerging evidence that PMN requirements have significantly inhibited innovation in the chemical industry. Section 5 has inevitably had some impact on innovation, and EPA regulations that add to the basic statutory requirements are likely to impose burdens on the chemical industry that are unnecessary. That is why CMA recommends that the Agency, at a minimum, limit those regulations to the clear requirements of the statute. Requirements such as supplemental reporting of PMN information, mandatory consumer contacts, advance substantiation of confidentiality claims, and the "invalidation" of incomplete PMNs, will only serve to increase the costs of a process that already imposes substantial burdens. Since EPA can adequately protect human health and the environment without these requirements, they should be eliminated. 

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.64 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. 

The PSI element of both the OSHA PSM Standard and the EPA RMP regulation can be improved by requiring the inclusion of all existing information on chemical reactivity. Examples of such information are chemical reactivity test data, such as DSC, thermogravimetric analysis (TGA), or accelerating rate calorimetry and relevant incident reports from the plant, the corporation, industry, and government. OSHA and EPA should require the facility to consult such resources as Bretherick s Handbook of Reactive Chemical Hazards,Sax s Dangerous Properties of Industrial Materials, and computerized tools (e g., CHETAH, The Chemical Reactivity Work Sheet). 

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