Technical Guidance Notes

TRGS 900 (Technical guidance note for hazardous substances) (2000) Tungsten and tungsten compounds. Bundesarbeitsblatt 10 34—70. 

Environment Agency, Technical Guidance Note El Best Practical Environmental Option -Assessments for Integrated Pollution Control, The Stationery Office, London (1997)... 

The Environment Agency provides full details on the hazardous waste regime in Technical Guidance WMl Special Wastes A technical guidance note on their definition and classification. Further related documents can be obtained from the Environment Agency website. 

The ECPI approach has been adopted by the European Commission in their "Technical Guidance Document on the Risk Assessment of Notified New Substances" as the model for assessment of environmental exposure from additives in plastics. It is important to note, however, that due to the effect of ultraviolet degradation and microbial attack, a significant proportion of the emissions from flexible PVC consists of plasticizer degradation products. In these instances, therefore, the level of plasticizers appearing in the environment will be significantly less than indicated by the plasticizer loss data. 

This Committee published its own technical rules, many of which were later incorporated into British Standards. It continues to make an active contribution to standards, guidance notes, legislation and international policy on inspection. Some independent inspection bodies have no connection with insurance but many do, and these companies have the advantage of feedback from an analysis of insurance claims. 

For biocides, the Technical Guidance Document (EC 2003) as well as the Technical Notes for Guidance (TNsG) should be used as a basis for the risk assessment. Further details on these Guidance Documents are available at the ECB Web site (ECB 2006) under the heading Biocides. ... 

Technical Guidance Document Threshold Limit Values Technical Notes for Guidance... 

Several steps have been taken towards a more harmonised methodology within the more general area of risk assessment of chemicals. The EU has proposed a number of principles for assessment of risks to man and the environment in directive 93/67/EEC (EC 1993) as well in the Technical guidance documents in support of directive 96/67/EEC on risk assessment (EC 2003), to further common practices in risk assessment. A harmonisation of national exposure limits is to be expected, since the EU sets both binding and indicative OELs for each member state to consider in its national regulations. However as noted by Vincent (1998) a full international harmonisation of OELs is unlikely and may not even be the most... 

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... 

Department of Employment, Technical Data Notes (now being superseded by Guidance Notes), HMSO, London. (See Appendix 2)... 

Administrative definitions of the law may also be found in the form of approved codes of practice and guidance notes made under the HSW Act, 1974. Codes of practice are made or approved by the HSE. Both are regarded as authoritative guidance on acceptable or good practice. In other words they are akin to Unger s (1975) technical or instrumental rules. These administrative definitions are not static. Their whole rationale is that they should be modified in response to changing circumstances, for example, new information or technological advances. 

This book is intended to fill the gap between a technical manual and the many topic guidance notes such as those published by the Health and Safety Executive. Uniquely, the amount of space devoted to construction EH S management is the same as that given over to techniques and to the law. Experience shows that time spent on pre-construction activity and planning Is amply repaid during the construction phase of work, when safety Issues can be much more difficult to resolve. 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

CPMP/1CH/2887/99 Note for guidance on Organisation of Common technical document Draft consensus guideline (released for comment July 2000)... 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E8 Note for Guidance on General Considerations for Clinical Trials, CPMP/ICH/291/95. London European Agency for the Evaluation of Medicinal Products, 1997. 

Within this context three Technical Notes for Guidance (TNGs) were commissioned for preparation by May 14th 2000. Only one document is currently available, the Guidance on Data Requirements for Active Substances and Biocidal Products . This was finalised in December 1999 and is available on the ECB website. The two other TNGs (namely, the Criteria for Annex 1 Entry and the Common Principles for the Evaluation of Dossiers) appeared as draft documents in 1998. Revised versions of these documents have since been made available for comment. No indication has been given by the Commission when final versions of the documents will be published. 

This brings me to some reflections about the activities carried out at the Quantum Chemistry Group under the guidance of Per-Olov Lowdin to whom this work is dedicated. In a way the Technical Note, now included as an Appendix, is still unfinished because it does not have an abstract nor acknowledgments to the various members of the group with which I discussed the subject matter. 

The Technical Notes for Guidance on Human Exposure to Biocidal Products (EU, 2002a) provide indicative exposure values for a range of exposure scenarios (summarized in EU, 2002b). These have been derived from experiments and are suggested to be used in similar situations. Uncertainty is associated with the data selection procedure (i.e. the degree to which the selected data are representative for the situation that they are supposed to describe). ... 

EU (2002a) Technical notes for guidance Human exposure to biocidal products—Guidance on exposure estimation. Ispra, European Union, European Chemicals Bureau, Directorate-General Environment, June (B4-3040/2000/291079/MAR/E2 http //ecb.jrc.it/biocides/). 

ICH S3A. Note for Guidance on Toxicokinetics The Assessment of Systemic Exposure in Toxicity Studies. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 27 October 1994. 

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