Risk assessment regulatory requirements

Clinical candidate selection - characterize candidates and assess risk (induding regulatory requirements prior to clinical trials) of identified molecules... 

Basic professional development courses offered by SCHC are MSDS and Label Preparation Workshops Science, Toxicology and Industrial Hygiene for Hazard Communication and Hazard Determination Risk Assessment. Regulatory courses include Canadian Mexican Hazard Communication Pesticide Consumer Product Labeling Component Disclosure Requirements European Union Hazard Communication Transportation Classification Labeling HMIS/NEPA Labeling and International Chemical Control Laws. 

To put this incident into perspective, consider that, in the United States over the seven-year period that encompassed 1984 (1981-1987), only 309 deaths were reported nationwide associated with chemiccd releases into all media combined. The Bhopal incident was unique both in the severity and the large number of people effected over a single release at one time. The Bhopal incident had a regulatory impact worldwide. In the United States, for example, it helped build support for a more stringent amendment to the Clean Air Act, first signed in 1970, that finally went into effect in 1990. This amendment listed 189 chemicals for which special standards and risk assessments were required by the end of that decade. These chemicals were selected by the U.S. EPA based on their relative toxicity and the volume of release. Methyl isocyanate was on that list. 

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... 

It is a regulatory requirement that analytical methods be developed to determine residues of concern in crops, feed, and food commodities as well as environmental samples (air, soil, and water). Methods for crops, feed, and food commodities are required for enforcement purposes but are also needed for a variety of other purposes, such as gathering monitoring data for risk assessment. For nearly any purpose, the methods must be robust, that is, when used by different analysts in several laboratories, they should provide reproducibly similar results. 

Studies may be designed for estimating exposures to a wide array of wildlife, including birds, mammals and amphibians. Many regulatory requirements involve birds, and less emphasis is currently placed on other species. As regulatory requirements evolve, ecological risk assessments will be required for more species. This may require alternative approaches for food item analysis to allow estimates of pesticide ingestion. 

Some organizations develop risk assessment systems that first determine the regulatory impact of each computer system by using the following questions. If there is no regulatory impact, no validation activities are required by the regulating agencies. However, those systems can be validated for business or other reasons. 

U.S. EPA s recommendations regarding stack emission tests, which may be performed at hazardous waste combustion facilities for the purpose of supporting MACT standards and multipathway, site-specific risk assessments, where such a risk assessment has been determined to be necessary by the permit authority, can be found in the U.S. EPA document on Risk Burn Guidance for Hazardous Waste Combustion Facilities.32 The applicability of the new standards has been demonstrated in the management of hazardous waste incinerators, whose performance was shown to clearly surpass the regulatory requirements in all tested areas.33... 

An obvious and all-important aspect of Section 8 is that it is a mechanism to facilitate the acquisition of information that EPA needs. Accordingly, the proper test of EPA s performance under Section 8 is not the amount of information that EPA acquires or the number of companies required to report, but the Agency s success in building a data-base for accomplishing its specific risk assessment, testing and chemical control responsibilities under Sections 4, 5, 6 and 7 of TSCA. In view of this purpose, it was of great concern that EPA has repeatedly failed to define carefully, and then articulate fully, the connection between a proposal under Section 8, and a specific regulatory objective under some other provision of TSCA. 

Jellinek, S. D. Paper presented at Fuji Techno Systems Seminar on the Impact of Regulatory Requirements on Chemical Substances, Tokyo, Japan, Oct. 30, 1980, cited in U.S. Office of Technology Assessment, "Assessment of Technologies for Determining Cancer Risks from the Environment " 1981, p. 148. 

Risk assessment studies can be performed using whatever process information is available (CCPS 1992a). Obviously, the more information and knowledge that is available, the more thorough and valuable the risk study can be. For facilities that must meet regulatory requirements for process hazard analyses, certain process safety information (PSI) is required to be compiled and up to date before starting the analysis. 

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