Final report of the Color Additive Scientific Review Panel

The Color Additives Scientific Review Panel considered whether there was information sufficient to perform a carcinogenic risk assessment on the colors D&C Red No. 19 (R-19), D&C Red No. 37 (R-37), D&C Orange No. 17 (O-17), D&C Red No. 9 (R-9), D&C Red No. 8 (R-8) and FD&C Red No. 3 (R-3) and to evaluate the assessments sent to FDA as part of the petitions for use of the colors for drug and external uses by the Cosmetic, Toiletry and Fragrance Association (CTFA). There is a lack of human data concerning the colors for making a human health assessment, so the assessments are based upon the extrapolation of animal data. The risk assessments are determined for exposure to single chemicals. Excluded from consideration are possible effects from exposure to multiple chemicals, such as co-carcinogenesis, promotion, synergism, antagonism, etc. In the light of recent efforts in establishing a consensus in risk assessment, the Panel has determined that the CTFA assessments for R-10, O-17, and R-9 are consistent with present acceptable usages, although it questions some of the assumptions used in the assessments. The Panel identified a number of general assumptions made, and discusses their validity, their impact on total uncertainty, and the potential options to address the gaps in understanding that necessitate the assumption. The Panel also derived revised risk estimates using more "reasonable" assumptions than "worst-case" situations, for 90th percentile and average exposure. For those assumptions that are easily quantifiable, the Panel's estimates are less than an order of magnitude lower than the CTFA risk estimates, indicating that the underestimates and overestimates of the CTFA risk estimates tend to balance each other. The impact of most of the assumptions is not quantifiable. The assessment for R-3 is complicated by the fact that there is no good skin penetrance study for this color. It was assumed that the penetrance is similar to that of another water-soluble xanthene color, R-19. It is expected that the absorption of the color is not likely to exceed that of the smaller molecule, R-19. Therefore, the risk estimates are similar to the CTFA estimates, but with different reasoning. The estimates for R-8 and R-37 are different from the others in that there is a lack of any exposure or toxicological information on these colors.(ABSTRACT TRUNCATED AT 400 WORDS)     

Integrating strategic issues into strategic management

The notion of a ‘strategic issues’ is rather pervasive in the field of planning in both conceptual [5, 19] and practical contexts. For instance, sometime ago the Wall Street Journal [41] reported that at least 50 large firms have created positions of ‘issues management director’; a dramatic increase in the number of such positions. ‘True’ strategic issues have a readily apparent importance to any organization; yet the process of identifying such issues and of integrating them into strategic planning and management is not well developed. Most treatments of strategic issues deal only with specific segments of the overall process through which relevant issues may be initially identified and finally translated into appropriate strategy [e.g. 5, 17]. This paper demonstrates that it is practical to develop a comprehensive process of ‘strategic issue management’ (SIM) that will facilitate the systematic identification, assessment and analysis of such issues. Such a process can ensure that issue-related factors are fully integrated into the formulation and implementation of strategy and plans. As such, SIM is a process whereby strategic issues may become an integral element of strategic management.     

Making planning more effective

The authors have been carrying out a comparative study of strategic planning in a set of ten, diverse organizations from both public and private sectors. The research focused on two issues: (1) what constitutes effective planning? and (2) what is the impact of participation on that effectiveness. This paper describes those elements of the results of the research which have greatest relevance to practising planners and managers.     

U.K. competition policy evaluated

This paper surveys the application of U.K. monopoly policy and examines its general impact on industrial structure and market processes. It considers the effects of the Competition Act 1980 in relation to U.K. monopoly control and concludes that unless further measures are introduced, competitive pressures are likely to be weakened over the longer term.     

Marketing: The key to organizational effectiveness

The aim of this paper is to make clear the difference between the marketing concept and marketing strategy. It advocates that not only should the former be used by all structures of business organizations, but that it is necessary to do so. It is the marketing strategy chosen by the firm that is dependent upon the organizational structure and not the concept.     

An overview of the Salmonella enteritidis risk assessment for shell eggs and egg products.

This article summarizes a quantitative microbial risk assessment designed to characterize the public health impact of consumption of shell eggs and egg products contaminated with Salmonella Enteritidis (SE). This risk assessment's objectives were to: (1) establish the baseline risk of foodborne illness from SE, (2) identify and evaluate potential risk mitigation strategies, and (3) identify data gaps related to future research efforts. The risk assessment model has five modules. The Egg Production module estimates the number of eggs produced that are SE-contaminated. Shell Egg Processing, Egg Products Processing, and Preparation & Consumption modules estimate the increase or decrease in the numbers of SE organisms in eggs or egg products as they pass through storage, transportation, processing, and preparation. A Public Health Outcomes module then calculates the incidence of illnesses and four clinical outcomes, as well as the cases of reactive arthritis associated with SE infection following consumption. The baseline model estimates an average production of 2.3 million SE-contaminated shell eggs/year of the estimated 69 billion produced annually and predicts an average of 661,633, human illnesses per year from consumption of these eggs. The model estimates approximately 94% of these cases recover without medical care, 5% visit a physician, an additional 0.5% are hospitalized, and 0.05% result in death. The contribution of SE from commercially pasteurized egg products was estimated to be negligible. Five mitigation scenarios were selected for comparison of their individual and combined effects on the number of human illnesses. Results suggest that mitigation in only one segment of the farm-to-table continuum will be less effective than several applied in different segments. Key data gaps and areas for future research include the epidemiology of SE on farms, the bacteriology of SE in eggs, human behavior in food handling and preparation, and human responses to SE exposure.     

Psychiatric hospitalization and process description: what will nursing add?

1. Inpatient treatment programs operating in the managed care environment must clearly articulate their treatment outcomes and the processes of care that are connected to these outcomes. 2. The work of inpatient psychiatric nurses can be organized and articulated through the therapeutic processes of the Four S Model: Safety, Structure, Support, and Symptom Management. 3. Nurses are vital contributors to the inpatient treatment process, but will be marginalized if they are unable to articulate how their interventions contribute to the positive treatment outcomes.     

Suicide ideation among US college students. Associations with other injury risk behaviors

Suicide, the endpoint of a continuum that begins with suicide ideation, is the third leading cause of death among the US college-aged population. The first and second leading causes of death among this age group, unintentional injury and homicide, may also be linked to suicide ideation. We used data from the National College Health Risk Behavior Survey to examine the association between suicide ideation and injury-related behaviors among 18- to 24-year-old college students. Students who reported suicide ideation were significantly more likely than students who did not report considering suicide to carry a weapon, engage in a physical fight, boat or swim after drinking alcohol, ride with a driver who had been drinking alcohol, drive after drinking alcohol, and rarely or never used seat belts. Given this clustering of injury-related risk behaviors, college prevention programs should aim to reduce risks for injuries comprehensively, rather than addressing each risk behavior separately.