Hazard characterization defined

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... 

For the two aforementioned steps, hazard identification and hazard characterization, data adequacy is of high importance. The data adequacy is defined by the reliability and the relevance of the data for human risk assessment [3],... 

Non-carcinogenic risk is normally characterized in terms of a hazard index defined by the ratio of the estimated intake dose from exposure to the reference dose (RfD). Reference doses depend on the exposure route and may be used with its exposure data. The hazard index is calculated as... 

The time-dependent human health hazard characterization for lead is best summarized by chronological blocks of time and those adverse health effects that were considered of medical or scientific importance. Associated with the various levels of adverse health effect severity are body lead burdens or dose. The combination of these dose ranges, whether measured at the time or retroactively imputed as likely lead doses given current knowledge, defines the dose—response relationship, also called the dose—effect severity relationship. This topic as the third component of health risk assessment is addressed in Chapter 22. 

Risk characterization is defined as the integration of the data and analysis of the above three components to determine the likelihood that humans wiU. experience any of the various forms of toxicity associated with a substance. When the exposure data are not available, hypothetical risk is characterized by the integration of hazard identification and dose—response evaluation data. 

Explosion-proof enclosures are characterized by strong metal enclosures with special close-fitting access covers and breathers that contain an ignition to the inside of the enclosure. Field wiring in the hazardous environment is enclosed in a metal conduit of the mineral-insulated-cable type. All conduit and cable connections or cable terminations are threaded and explosion-proof. Conduit seals are put into the conduit or cable system at locations defined by the National Electric Code (Article 501) to prevent gas and vapor leakage and to prevent flames from passing from one part of the conduit system to the other. 

Self-reactivity can be defined as the potential for a material to decompose or undergo energetic changes. Some of the methods for characterizing selfreactivity hazards are listed in Table A.3. 

If the RFA or other information has indicated a release of hazardous constituents, then from the owner/operator s perspective, the Corrective Action process truly begins. The first step in the process, the RCRA Facility Investigation (RFI), is directed toward development of the engineering information about the site necessary to permit selection and evaluation of remedial alternatives. The main engineering thrust of the RFI is the characterization of site conditions by defining the nature and extent of the problem. 

The first major objective for the inherent safety review is the development of a good understanding of the hazards involved in the process. Early understanding of these hazards provides time for the development team to implement recommendations of the inherent safety effort. Hazards associated with flammability, pressure, and temperature are relatively easy to identify. Reactive chemistry hazards are not. They are frequently difficult to identify and understand in the lab and pilot plant. Special calorimetry equipment and expertise are often necessary to fully characterize the hazards of runaway reactions and decompositions. Similarly, industrial hygiene and toxicology expertise is desirable to help define and understand health hazards associated with the chemicals employed. 

Hazard identification is defined as tlie process of determining whetlier human exposure to an agent could cause an increase in the incidence of a health condition (cancer, birtli defect, etc.) or whetlier exposure to nonliumans, such as fish, birds, and otlier fonns of wildlife, could cause adverse effects. Hazard identification cliaracterizes tlie liazard in terms of tlie agent and dose of the agent. Since tliere are few hazardous chemicals or hazardous agents for wliich definitive exposure data in humans exists, tlie identification of health hazards is often characterized by the effects of health hazards on laboratory test animals or other test systems. ... 

Reactive hazards are briefly defined and characterized below. However, neither Section 2.0 nor this report in its entirety is intended to substitute for any of the more extensive guides and references on this topic or to eliminate the need for expert analysis in dealing with reactive hazards. 

Site characterization is defined as the process of collecting information from an investigation site in order to support the evaluation of a hazardous chemical-based incident... 

Pre-entry criteria define the conditions and circumstances under which site characterization activities will be initiated and the manner in which these activities will proceed. At each stage of the process (i.e., approach to the site, on-site characterization activities, sample collection, and exiting the site), specific criteria may be defined for proceeding to the next stage. The pre-entry criteria may also specify the general makeup of the site characterization team under various circumstances. For example, under low-hazard conditions chemical facility teams may perform site characterization, while specially trained responders might be called upon to assist in the case of potentially hazardous conditions at the site. The criteria developed for a particular chemical facility should be consistent with the role that the facility has assumed in performing site characterization activities. 

Next, it is important to characterize the dose-response relationship for the agent. Data from the initial hazard assessment, combined with exposure assessment information, are used to determine the most sensitive endpoint. Available data are used to define the dose at which there is no observed effect (NOAEL - no observed adverse effect level) and the shape of the dose-response curve (Figure 19.1). It may be necessary to perform additional studies to define the dose-response curve. 

The second objective of the hazard assessment concerns characterization of the identified hazards of a particular substance. Under REACH this means that the registrant must define so-called derived no-effect levels., abbreviated DNELs. With respect to human health, these values constitute exposure levels above which humans should not be exposed and below which risks for humans are considered controlled. The DNEL derivation is a complex process which comprises several conversion steps and the application of different assessment factors. In the case of reproductive toxicity, the registrant derives separate DNELs with respect to developmental toxicity on the one hand and to impairment of sexual function and fertility on the other hand. 

Since risk analysis plays an important role in public policy decision making, efforts have been made to devise a means by which to identify, control, and communicate the risks imposed by agricultural biotechnology. A paradigm of environmental risk assessment was first introduced in the United States by Peterson and Arntzen in 2004. In this risk assessment, a number of assumptions and uncertainties were considered and presented. These include (1) problem formulation, (2) hazard identihcation, (3) dose-response relationships, (4) exposure assessment, and (5) risk characterization. Risk assessment of plant-made pharmaceuticals must be reviewed on a case-by-case basis because the plants used to produce proteins each have different risks associated with them. Many plant-derived biopharmaceuticals will challenge our ability to define an environmental hazard (Howard and Donnelly, 2004). For example, the expression of a bovine-specihc antigen produced in a potato plant and used orally in veterinary medicine would have a dramatically different set of criteria for assessment of risk than, as another example, the expression of a neutralizing nonspecihc oral antibody developed in maize to suppress Campylobacter jejuni in chickens (Peterson and Arntzen, 2004 Kirk et al., 2005). 

Exposure Levels in Humans. Silver has been detected in the blood, tissues, urine, and feces of humans. The only biological monitoring studies located consisted of small numbers of worker populations in chemical manufacturing industries. Studies that better characterize important sources of general population exposure and define populations with potentially high exposure, such as those located near hazardous waste sites, would be helpful. More specific information concerning the chemical from of silver present at hazardous waste sites would also be useful. These data would assist in developing a more accurate estimate of the potential for silver exposure from hazardous waste sites contaminated with the metal. 

Briefly recalled, the WASTOXHAS approach consists in characterizing the ecotoxicological hazard potential of contaminant fluxes from waste leachate obtained under defined conditions with two different dynamic leaching procedures laboratory simulated leaching tests and field leaching tests. The approach developed below considered a specific scenario that simulates a waste deposit receiving rain or run-off water (Perrodin et al., 2002). 

CMC information It should contain sufficient detail to assure identification, quality, purity, and strength of the investigational drug. It should include stability data of duration appropriate to the length of the proposed study. FDA concerns to be addressed focus on products made with unknown or impure components, products with chemical structures known to be of likely high toxicity, products known to be chemically unstable, and products with an impurity profile indicative of a health hazard or insufficiently defined to assess potential health hazard, or poorly characterized master or working cell bank. 

This chapter will address the implications of the data presented in previous chapters for assessing the risks from environmental chemical exposures. WHO/IPCS has defined risk assessment as an empirically based paradigm that estimates the risk of adverse effects from exposure of an individual or population to a chemical, physical, or biological agent. As shown in Figure 21, it includes the components of hazard identification (Is there an adverse effect ), dose-response assessment (How severe is it ), exposure assessment (What is the level of exposure ), and risk characterization (What is the risk ) (NRC, 1983 IPCS, 2000). 

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