User safety assessment communication

Every user of a chemical is asked to communicate his special application of the supplied substance to the dehverer in order to make this an identified use. Therefore the necessary information for this exposure scenario should be provided to the manufacturer or importer. For registered substances, the manufacturer or importer shall prepare a chemical safety assessment and amend his chemical safety report before the next delivery in a time frame of 1 month. 

Safety Authority will take responsibility in this area. How this will work out has to be seen in the near future. Nevertheless, the straightforwardness of the approach does not hide the relatively complex methods that are used or have to be used. The models applied in the determination of the PEC are far from simple they contain the current state-of-the-art of the scientific description of chemical, physical and microbiological processes in the environment. The methods will be kept update and communications with the research institutes and the users of the models will continue. The main aim is to keep having available a system of methods to carry out risk assessments for plant protection products. 

If a SNUR cross-references a subsection of 40 C.F.R. 721.72 then it will be a significant new use to manufacture, import, or process the SNUR substance unless the manufacturers, importers, processors, and users have a hazard communication program to warn about the risks that the substance poses. This group of significant new uses builds on a system of hazard communication established by the Occupational Health and Safety Administration (OSHA). OSHA has promulgated Hazard Communication Standards that require employers to assess hazards posed by the chemicals they make or import and provide hazard information on labels and in MSDSs. Employers and processors of chemicals that pose hazards must make the labels and MSDSs available in the work place and train their employees in safe handling procedures. 

As indicated in Chapter 1, pharmacovigilance is essentially a risk management process for medicines. The process starts with identification of a possible hazard, this is then evaluated and investigated and, if necessary, some action is then taken with a view to minimising risk. Implementation requires tools for communicating with users and the final step should be that an assessment of effectiveness is made. The process is iterative because new evidence may emerge or the measures taken may mm out to be insufficient. Rarely can a dmg safety issue be considered completely and permanently resolved. 

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