Additives assessment

A thorough assessment also will identify problem areas, strengths and supports clients may have to help them reach treatment goals, and what kinds of treatment strategies may be the best match for them. In addition, assessment throughout treatment is truly the only way that you have to document progress toward treatment goals. 

TSCHANZ C, BUTCHKO H H, STARGEL W W and KOTSONIS F N (Eds), The Clinical Evaluation of a Food Additive - Assessment of Aspartame, Boca Raton, CRC Press, 1996. 

For systemic effects, ECETOC (2003) recommended a default assessment factor of 6 for extrapolation from subacute (28 days) to chronic exposure, and a factor of 2 from subchronic (90 days) to chronic exposure. For local effects, no additional assessment factor is needed for duration of exposure extrapolation for substances with a local effect below the threshold of cytotoxicity. 

WHO/IPCS (1994, 1996, 1999) did not consider an extrapolation factor for duration of exposure specifically, but the uncertainty related to this element is included in a broader defined additional factor addressing the adequacy of the overall database (Section 5.9). The US-EPA (1993) has adopted the 10-fold factor to account for the uncertainty involved in extrapolating from less than chronic NOAELs to chronic NOAELs. This default value has later on been reconfirmed (US-EPA 2002) when only a subchronic duration smdy is available to develop a chronic reference value no chronic reference value is derived if neither a subchronic nor a chronic smdy is available. For systemic effects, ECETOC (2001) recommended a default assessment factor of 6 for extrapolation from subacute (28 days) to chronic exposure, and a factor of 2 from subchronic (90 days) to chronic exposure. For local effects, no additional assessment factor is needed for duration of exposure extrapolation for substances with a local effect below the threshold of cytotoxicity. KEMl (2003) suggested that extrapolation from subchronic to chronic exposure should be based on the distribution of NOAEL ratios reported by Vermeire et al. (2001) with an assessment factor of 16 covering 95% of the substances compared and for extrapolation from subacute to chronic exposure, with an assessment factor of 39 covering 95% of the substances. 

The nature of an effect includes the adversity of the toxicity expressed as the level of and the basis for NOAEL and LOAEL values (Section 4.2.2), and the severity of the specific endpoint or key event (Section 4.2.3), for example judging skin irritation less severe than teratogenicity. An additional assessment factor for severe and/or irreversible effects has been proposed by various groups. This section gives an overview of such proposals and evaluations. Then, the key issues are summarized and our recommendations are presented. 

An additional assessment factor, of up to 10, has been apphed in some cases where the NOAEL has been derived for a critical effect, which is considered as a severe and irreversible effect, such as teratogenicity or non-genotoxic carcinogenicity, especially if associated with a shallow dose-response relationship. The principal rationale for an additional factor for nature of toxicity has been to provide a greater margin between the exposure of any particularly susceptible humans and the dose-response curve for such toxicity in experimental animals. 

An additional assessment factor is applied in case of potential remaining uncertainties which are related to the quality of the... 

An important complication that is specific to human developmental toxicity studies is the necessity to control for confounding factors that influence human development, such as parental intelligence, quality of home environment, nutritional factors and socioeconomic status (Bellinger et al., 1992 Bellinger, 1995). These may influence the outcomes from the newborn period to adulthood. In addition, assessment methods must take into consideration the time (days, months or years) that may intervene between exposure/insult and the expression of toxicity at a much later age. 

APVMA (2004). The reconsideration of approvals of the active constituent atrazine, registrations of products containing atrazine, and their associated labels. Second Draft Final Review Report including additional assessments. October. 

In Superfund s Section 105 requirement for a Revised NCP, Congress mandated a scheme for responding to releases of hazardous materials. For old dump sites response starts with a survey and prioritization of sites based on risk assessment. After prioritization the focus turns to selection of cost-effective remedies which will adequately protect the public health and welfare and the environment. In revising the NCP, EPA is engaged in a pioneering effort to develop a practical and effective site assessment model. After prioritization additional assessment will often... 

Medium exposure occasional white, blue, or black smoke visible in the workplace soot deposits visible a few complaints of irritancy or other ill effects CO2 levels near 800 ppm and/or CO levels approaching 10 ppm or NO2 levels approaching the exposure limit controls may not be adequate additional assessment for other contaminants or additional controls will likely be required... 

It may be more reasonable to consider the percent of the commodity suj ly that is heated instead of the percent of the crop that is treated. By doing so, we can account separately for the amount of domestically produced commodity that is treated, as well as the amount of commodity imported into the country that is treated. Using percent of the commodity supply that is heated should allow EU dietary exposure assessments to avoid the practice of assuming that 100% of a commodity is heated. If evidence indicates that the entire food supply in a particular area is heated, additional assessments may be conducted with that assumption. 

In addition, assessment of the patient s contact lens cleaning regimen is also important. Cleaning regimen, once a critical component to lens care, has been eliminated with daily disposable lens replacement and has evolved with frequent lens replacement. Daily cleaning is essential, and when applicable, disinfection with a hydrogen peroxide system may still be an important consideration.The use of enzymatic cleaning has diminished because disposable lenses have replaced the need for it, but it may be a consideration in select cases. 

Additionally, assessments of the stability of glaucoma rely on the quality of the baseline data. 

Optimizing assays for HTS performance involves several steps including reducing the number of required reagent additions assessing QC and availability of the reagents determining... 

Life-cycle assessment (LCA) is an additional assessment approach for making environmental decisions. LCA can be defined as an inventory of all the steps in the development, manufacture, use, and disposal of a product or a commodity with a determination of the environmental consequences (Todd and Curan 1999). The purpose of an LCA is to provide information to a decision maker so that choices can be made in the design of a manufacturing process to minimize environmental impacts or risks. 

Other refinements could be provided by implementing the target-organ toxicity dose approach, which attempts to estimate the plausible critical effect and IOC that would have been calculated had the particular mixture been tested (Mumtaz et al. 1994, 1997). This approach is complicated, and would be suggested only when additional assessment is needed, perhaps to resolve differences between expected and actual health effects outcomes, or where critical effects are different across constituents or fractions that make up the mixture. ... 

Eco-efficiency assessment focuses in principle on the entire life cycle, but then concentrates on specific events in a life cycle where the alternatives under consideration differ. Eco-efficiency analysis includes the cost data as well as the straight life cycle data. Eigure 5.3 shows that life cycle assessment is based on the environmental profile, which can be obtained, for example, from data provided by the plants and which includes the path from the cradle to the work-gate. On extending this approach to the entire life cycle, a life cycle assessment is obtained. Adding to these additional assessment criteria again, followed by an economic assessment, then leads to an eco-efficiency analysis (Figure 5.4). 

Both methods involve heating the lubricant to temperatures in excess of 200°C with a high volume of air being passed through the sample for extended periods of time. Despite the different approaches both methods assess the effect on the lubricant in much the same way by measuring increases in viscosity, total acid number, TAN, and insolubles content. Method 9 additionally assesses volatility loss and formation of a solidus , essentially the point at which the sample no longer flows. FTM 5308 adds the dimension of assessing the effect of the oxidised lubricant on metal test pieces, namely ... 

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