Hazard identification documentation

California Environmental Protection Agency Hazard Identification Documents on Reproductive and Developmental Toxicity... 

CFR1910.1200 41CFR101-42.202(a) through (c) 4.1.3 Identification and Documentation of Hazardous Materials - Actual or potential hazards associated with an excess hazardous material shall be documented with a Material Safety Data Sheet (MSDS) supplied by the manufacturer, distributor or importer. If an MSDS is not available, a Hazardous Materials Identification System (HMIS) record from the automated Department of Defense database is acceptable. If an MSDS or HMIS record is not available, a hazard identification document prepared by the owning DOE organization that meets the MSDS content requirements for hazardous chemicals set forth in the OSHA Hazard Communication Standard (29CFR1910.1200) shall be used. 

In order to understand the use and intent of the various immunotoxicology regulatory guidelines and guidance documents, the difference between two concepts familiar to toxicologists should be emphasized. Hazard, identification refers to a method which is essentially qualitative that is, it is designed to detect the ability of a test article to produce a certain (in the context of toxicology) adverse effect, without reference to exposure issues. Risk assessment, on the other hand, takes into consideration method, dose, and duration of exposure, condition(s) of the exposed population, and concurrent... 

The MORT technique has received domestic and international recognition, and has been applied to a wide range of projects from investigation of occupational incidents to hazards identification. It is supported by detailed documentation, and has been subjected to continued development efforts since it was originally introduced. Today there are several predefined trees available from public and proprietary sources that are based, at least in part, upon tbe MORT tool. 

The check list method is based on past experience. The process description, the operating mode, is screened using a list of possible failures or deviations from this particular operating mode. Thus, it is obvious that the quality and comprehensiveness of the check list directly govern its efficiency. Indeed, the experience of the authors confirms that the check list is essential. This method is well adapted to discontinuous processes as practised in the fine chemicals and pharmaceutical industries, where processes are often performed in multi-purpose plants. The basic document for the hazard identification is the process description, also called operating mode. Each step of the process is analysed with the check list. 

The hazard identification methods presented in Sections 1.5.1 to 1.5.6 above are all based on strongly systematic procedures. In the check list method, the systematic is provided by the check list itself. The comprehensiveness can be verified in the matrix (see Figures 1.4 and 1.5). With the FMEA, the systematic is provided by the division of the system into elements and the failure modes considered. In the HAZOP study, the systematic stems from the division of the plant into nodes and lines, then the systematic application of the keywords. With the decision table method, the systematic is inherent to the table. For the FTA and ETA, the systematic is given by the tree and the logical ports. Nevertheless, the work of the team must be traceable, even by persons who did not participate to the analysis. Thus, it is recommended to also document the hazards that were not considered as critical. 

Hazard Identification. The process of determining whether exposure to a particular substance at any dose can cause a response in a biological organism and, if so, the type(s) of response is called hazard identification. Hazard identification typically involves doses of a substance that are much higher than would actually be experienced in routine exposures of the public, including exposures resulting from waste disposal. Once the hazardous nature of a substance is determined, the results are documented and the hazard identification process need not be repeated for other applications. 

With respect to the hazard identification part of the risk assessments, the main uncertainties discussed in these documents relate to the human health relevance of the observed developmental neurotoxicity in rodents. These are uncertainties that have been highlighted in all three documents. Likewise, the predicted no effect concentration for contaminated sediments is considered uncertain in all three risk assessments. The predicted no-effect concentration (NOEC) for water is considered uncertain for Octa and Deca, and the predicted no-effect concentration for the terrestrial compartment is identified as uncertain for Octa. 

Before any assessment can be performed, die team must be supplied with required documentation and process details. As widi other hazard identification steps, die following materials are usually needed ... 

As described in a highly referenced document (NRC, 1983), important components of this process include hazard identification, assessment of exposure and dose-response relationships, and characterization of the risk. Uncertainty factors are built into the risk assessment process to account for variations in individual susceptibility, extrapolation of data from studies in laboratory animals to humans (i.e. interspecies variation in toxicokinetics), and extrapolation from high-dose to low-dose exposures. In the case of the association between exposure to chemicals and drugs and autoimmunity or autoimmune diseases, much of the information needed to evaluate risk in the context of the traditional United States National Research Council paradigm is not available. The following represents a discussion of issues in chemical-induced autoimmunity relevant to the use of existing data and data needs in risk assessment. 

The NRC document calls for hazard identification, dose-response assessment, exposure assessment, and risk characterization. In an effort to place descriptive experimental toxicity results in a clearer perspective and place more emphasis on evaluation, this outline deviates slightly from the NRC document and calls for hazard evaluation, hazard extrapolation, exposure assessment and risk characterization. In addition, a few comments on risk acceptability are given. Exposure assessments have been adequately discussed elsewhere in this symposium and will be discussed here only as they relate to hazard identification, evaluation, extrapolation and risk characterization. 

What criteria are used to select appropriate standards and requirements (e.g., Woik Smart Standards, Standards/Requirements Identification Documents, or others, as applicable) to address all chemical hazards What are the qualifications of individuals performing standards selection ... 

The Type A investigation of a sodium potassium (NaK) accident that occurred at the Y-12 plant on December 8, 1999, identified a lack of understanding of the hazard from NaK and its reactive byproducts as one of the root causes of the accident. The investigation found that personnel involved in planning the task, the safety documentation for the facility, the procedure for the task, and the procedures supporting hazard identification and analysis did not address the complete NaK hazard. The investigation also determined that detailed hazard identification data supported by accident analysis and appropriate control information was readily available. 

The Pantex Emergency Hazards Assessment (MNL-190881) includes quantitative hazards analyses of onsite chemicals lhat exceed either the TQ in 29 CFR 1910.119, or the TPQ in 40 CFR 355 Appendix A. This document includes hazard identification and characterization, development of accident scenarios, and consequence analysis using airborne dispersion modeling. 

An outline of the individual CRM activities including hazard identification, control option analysis, verification activities, etc. (note that the plan should focus on areas where there is an intention to vary the approach from what is documented in the SMS). 

Documentation of results for each part of the risk assessment (i.e., each duty/responsibility) could follow the standard spreadsheet format for any PHA or hazard identification (for more details, refer to CCPS Guidelines for Hazard Evaluation Procedures) ... 

HCF procedure development maintains consistency by follow/ing the TA-V Nuclear Facilities Conduct of Operations Manual (SNL 1998a) and the SNL ES H Manual (SNL 1998b). These documents describe procedure format and content, including Purpose, Scope, Ownership, Responsibilities, Definitions and Acronyms, Hazard Identification, Equipment and Materials, Format, Review and Approval Authority, and Document Control. Use of this format complies with DOE Order 5480.19, Conduct of Operations, Chapter 16 (DOE 1990). TA-V Standard Operating Procedures are written for tasks specifically identified in the Technical Safely Requirements (TSR) or as required by other directives or the SNL ES H manual to address special hazards. TA-V document types and hierarchy is described in TA-V Nuclear Facilities Conduct of Operations Manual (SNL 1998a) Chapter 16. 

This module is divided into two sections. First one is related to hazard analysis and uses HAZOP methodology. It gives the possibility to make hazard identification reports as well as storing external sources used in the analysis, e.g. P ID (piping installation diagrams), documentation, etc. 

The FSA approach is a standardized holistic approach, and consists of five steps (IMO 2002) 1) Hazard Identification, 2) Risk Assessment, 3) Estabhsh Safety Measures, 4) Cost-Benefit Assessment, and 5) Recommendation for decision making. It is mandated that in order to be consistently appUed by different parties, the process must be clearly documented and formally recorded in a uniform and systematic manner (IMO 2002). In general, the availability of suitable data for all steps in the analysis is vital. If not readily available, these may be estimated through models, expert judgment and simulations. 

The safety community provides expertise in hazard identification, analysis, and control techniques. TTie safety representative may serve as the primary advisor to the chairperson in articulating system safety goals, tasks, and responsibilities. The safety representative frequently has the job of writing or drafting documents generated by the SSWG. 

During the concept phase, hazard identification is initiated and documented by preparing a preliminary hazard list (PHL). 

Hazard identification is continued throughout the design stage and documented in the preliminary hazard analysis (PHA), subsystem hazard analysis (SSHA), and the system hazard analysis (SHA). Even though the primary purpose of these products is to analyze previously identified hazards and to determine the adequacy of controls, every effort should be made to continue to identify new hazards, especially those associated with interfaces and changes. 

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