Interpretation and Guidance

OSHA provides guidanee on interpretation, ineluding numerous examples, in its publieation HAZWOPER Interpretive Quips (IQs.) The IQs are poliey statements abstraeted from offieial OSHA letters of inter- 

Wlien determining the scope of HAZWOPER, exposure includes two elements the presence of a hazard and worker access to the hazard. 

For example, contaminated areas of a hazardous waste site potentially pose some level of health hazards. 

For exposure to occur, workers should have access to the hazard (e.g., they should work in or near contaminated areas). Under normal circumstances, those workers who are prevented from entering contaminated areas (by using access controls) are not exposed to contaminated material. In many cases these workers do not fall under the requirements, provided that they are not exposed to other safety hazards as a result of the operation. Conversely, workers in contaminated areas are covered because they have access to health hazards and could be potentially exposed [1]. 

Safety hazards are treated in the same manner. For example, workers who work in trenches in clean areas of the site would be covered by the OSHA Excavation and Trenching Standard, Subpart P, 29 CFR 1926. Workers who work in trenches in contaminated areas would fall under both Subpart P and HAZWOPER. Workers who do not work in trenches fall under HAZWOPER only when working in contaminated areas and would not be covered by either standard when working solely in clean areas, provided they are not exposed to safety hazards resulting from hazardous waste operations. 

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Robertson M, Chan TSS, APLAC interpretation and guidance on the estimation of uncertainty of measmement in testing, J. AOACInt. 2003 86(5) 1070-1076. 

FAQ from the FMCSA Are previous interpretations and guidance regarding hours-of-service still valid ... 

To acquire and consolidate regulatory experiences on botanical drugs, a dedicated BRT has been established in CDER. The BRT will provide scientific expertise on botanical issues to other reviewing staff to ensure consistent interpretation and implementation of the Botanical Guidance and related policies. In addition, the BRT has the following functions ... 

Many aspects of REACH are to be reviewed within a few years of REACH coming into force in June 2007- These include Annex I, which sets out the requirements for CSRs (to be reviewed within 12 months) Annex XIII (criteria for identification of PBT and vPvB substances) (within 18 months) the authorization of endocrine-disrupting substances (after 6 years) and the registration requirements for substances below 10 tonnes (after 12 years). These reviews, along with the fact that the implementation of REACH will depend on how its provisions are interpreted and the guidance documents that are produced, mean that it is very difficult to say what REACH will mean in practice for the production and use of synthetic chemicals and the protection of human health and the environment from their harmful effects. 

Various aspects of the hydrodynamics of gas-solid flnidization have been studied extensively with conclusions that afford guidance to the interpretation and extension of pilot plant data. Some of the leading results bearing on the sizing of vessels will be discussed here. Heat transfer performance is covered in Chapter 17. Example 6.16 applies to some of the cited data. 

Although the set of examples presented are unlikely to be directly related to the systems of immediate interest to the reader, it is hoped that the discussion will highlight the methodologies commonly applied, the various approaches that can be used to solve similar problems, as well as some of the difficulties encountered and the strategies used to surmount them. Above all, it is hoped that these case studies will provide both inspiration and guidance to readers in the design of their own experiments and in the interpretation of their results. 

This report presents a roadmap for approaching those challenges. It provides an overview of the state of the science, a profile of international applications, and guidance for the design of biomonitoring studies. It also presents a systematic approach to interpreting the public-health implica-... 

As one can see, the current laboratory operation standard is a loose compilation of several existing standards. As a result, each laboratory operates to a set of its own rules that have emerged over the years from the requirements of different accrediting entities. This variability makes the understanding of internal laboratory process difficult. More complications are introduced by a great variety of analytical methods and the possibilities for their interpretation. Specific guidance for laboratory analyses... 

In addition to the unique regulatory structure in the European Union and the specific guidelines referred to above, there are a few other comments and issues relating to the interpretation and application of the ICH guidance. 

This appendix describes experimental animal and in vitro studies that are used to assess developmental toxicity and male and female reproductive toxicity from exposures to pesticides, industrial chemicals, and food ingredients. The testing of pharmaceutical agents is not described in detail here, but can be found in FDA (1994). A summary of the study types, protocols, endpoints and limitations is presented in Table D-l. A description of the manifestations of each type of toxicity and guidance on the interpretation of results from the studies also are presented. 

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