Proposed Safety Assessment Process

A hierarchical approach is recommended to assist in determining the appropriate level of assessment by considering (1) the harm (e.g., toxicity), and (2) the potential adverse effects of a new ingredient. This hierarchical approach will guide the level of assessments to be applied to the new ingredient by considering the following factors  

While each submission is unique and a reflection of the ingredient and its intended use, there is an opportunity to standardize the format and approach to the submission that would streamline its preparation and evaluation. The committee recommends amplifying the current approach without being prescriptive. It should be noted that some of the elements of the system proposed here are currently in place. The committee recognizes that some of its recommendations may require statutory changes. 

The committee proposes the following elements, described in detail below, for infant formula-related submissions to the regulatory agency  

RECOMMENDATION Elements of the safety assessments of infant formulas need to 

The introduction of a new ingredient submission should include the regulatory background to the submission and a summary of the submission. 

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The entire safety assessment process that supports new product research and development is a multistage effort in which none of the individual steps is overwhelmingly complex, but for which the integration of the whole process involves fitting together a large and complex pattern of pieces. This paper proposes an approach in which integration of in vitro test systems calls for a modification of... 

Toxicologists must rely on results obtained from an alternative method if it is to serve as a replacement for an in vivo toxicity test. Two measures of alternative method performance must be known in order to define reliability from a test user s point of view. First, a toxicologist must know it is possible to consistently reproduce the data obtained from the alternative method over long periods of time. A test that does not provide the same results on the same test substance repeatedly would not be useful in the safety assessment process. Second, it must be possible to consistently predict in vivo toxicity endpoints at a known level of accuracy and precision. These measures of reliability are objective endpoints that can be measured experimentally. The part of the validation process that provides the data needed to confirm the reliability of an alternative method as proposed by its developers is the validation study. 

The proposed methodology also covers the developing of conceptual scheme, criterions, requirements and elements of A SW verification and validation assessment process technology for safety-related systems, as well as recommendations for its utilizations in practical applications. The presented results are obtained during the generalization of practical experience of expert analyzing of real NPP I C A SW, in particular ASUT-IOOOM system for Zaporozhey NPP. 

In the present paper, the use of BNs is tested. The goal of the work is to define how the analysts should interact with the BN in order to translate their assessments into a BN input and to convert the BN output into suitable information for Probabilistic Safety Assessment (PSA). In this respect, two interfaces for the input assessment process and a framework for the output conversion are proposed. 

We suggest a semi-quantitative approach where the initial part of the risk assessment process is carried out in a workshop by the use of expert elicitation. The information gathered in the workshop is then refined by the risk analysts. The alternative safety measures are categorised by cost-effectiveness to provide support for decision-making. In the proposed method evaluation of cost-effectiveness is based on calculated expected values as in a traditional cost-effectiveness analysis (e.g. expected cost per ejqiected nmnber of lives saved), as well as uncertainties. 

A number of standards require a system to be accompanied by a safety case, and a SoS should be no different. The safety case communicates an argument, supported by evidenee, that a system is acceptably safe in a given operational context. The safety ease eaptures the underlying reasoning and evidence that support claims made about the safety of a system. We believe that the hazard assessment process we have proposed is compatible with the creation of a safety case. We also believe that it will be possible to produce a manageable SoS safety case which takes ae-count of SoS specific issues and which conforms to relevant standards. 

Assess the adequacy of these mitigation measures and, if necessary, propose additional ones, process should be recorded in a Change Safety Analysis Report, and the System Hazard Log should be updated in line with the Change Safety Analysis Report. ... 

The LOLER strategy is based on the requirement within the Management of Health and Safety at Work Regulations 1999 for a risk assessment to identify the nature and level of risks associated with a proposed lifting operation. The factors to be considered in the LOLER assessment process are the ... 

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