Tolerability, definition

An important functionality in assembly modeling is the definition of geometric and functional tolerances that are supported by the respective CAD module (Figure 5). Thereby, the geometrical and functional tolerance definitions are carried out based on assembly specifications and international standards. Special analysis functions are utilized for the control of complex assemblies and products. 

Tolerance definitions according to ISO, DIN, ANSI, and other standards. 

Requirements definition - Where designers require tighter tolerances than normal, they must find out how this can be achieved, which secondary processes/process... 

The more dense, more mature peas sink and are drawn off near the bottom of the separator, while the less dense, less mature peas float and are carried off at the top. During the process the peas absorb salt, and unless it is removed by thorough washing enough may be retained to make the product objectionable to the taste. In a packing specification it is necessary to state the amount of salt that will be tolerated. Available methods for the determination of salt are not applicable to production-line control. One which is sufficiently simple and rapid for this purpose is definitely needed. 

A. Hausberger I think a sulfur-tolerant catalyst would definitely be an advantage in that the requirement for critical control of the sulfur removal system would be eliminated. If you can allow some sulfur to pass on through the methanator into the product gas, the amount of reagent or regeneration cost of the sulfur removal system would be reduced. As to what level of sulfur could be tolerated, that is a hard question to answer since I don t think that there is a sulfur-tolerant catalyst. 

In general, for smokers with cardiac disease, the benefits of nicotine replacement therapy outweigh the potential risks. In a safety and efficacy study that included veterans with cardiac disease, smoking concurrently with the nicotine patch was not associated with an increase in adverse events (Joseph et al. 1996). Although bupropion SR is generally well tolerated by smokers, it has not been adequately studied in persons with cardiac disease, and definitive conclusions regarding its safety in this patient population cannot currently be made (Society for Research on Nicotine and Tobacco 2003). 

By definition, the determinative procedure must be able to quantify the concentration of the marker residue. For compounds with a tolerance, it is critical that the analysis be able to determine accurately if the concentration of the marker residue is above or below the tolerance in the target tissue. The CVM guidelines for determinative procedures call for an average recovery >80% with a coefficient of variation (CV) of <10% for marker residue tolerances of lOOpgkg or greater and an average recovery of >60% with a CV of <20% for marker residues with a tolerance below 100 ppb. 

In summary, the proposal of an appropriate definition of the residue is not a process which follows simple and unambiguous rules in each case. The differences between residue definitions of some European MRLs and US tolerances illustrate the importance of harmonization. However, the great effort sometimes necessary to reach a suitable and accepted residue definition, which considers the needs of risk assessors (toxicologists) and the feasibility aspects of residue analysts, is clearly a vital prerequisite for any method development and validation. 

The RAC and processed commodities to be collected for each crop are listed in OPPTS 860.1000. Close attention should be paid to the definition and description of many of the commodities listed in the footnotes to Table 1. Reviewing a summary of the actual commercial processing practices for the crop may be helpful. Once the processing procedures and the agronomic practices to be simulated in the field residue trial are understood, a field study can be designed that will truly represent commercial production and processing practices. This will ensure that the study will yield useful, reliable, and accurate data to be used in the tolerance setting process. 

Sulfonylurea herbicides are generally applied to crops as an early post-emergent herbicide. Crops that are tolerant to these herbicides quickly metabolize them to innocuous compounds. At maturity, residues of the parent compound in food and feed commodities are nondetectable. Metabolites are not considered to be of concern, and their levels are usually nondetectable also. For this reason, the residue definition only includes the parent compound. Tolerances [or maximum residue limits (MRLs)] are based on the LOQ of the method submitted for enforcement purposes and usually range from 0.01 to 0.05 mg kg (ppm) for food items and up to O.lmgkg" for feed items. There is no practical need for residue methods for animal tissues or animal-derived products such as milk, meat, and eggs. Sulfonylurea herbicides are not found in animal feed items, as mentioned above. Furthermore, sulfonylurea herbicides intentionally dosed to rats and goats are mostly excreted in the urine and feces, and the traces that are absorbed are rapidly metabolized to nontoxic compounds. For this reason, no descriptions of methods for animal-derived matrices are given here. 

Experiments with aldicarb sulfone in ground beef involved simple extraction with acetonitrile during tissue homogenization and resulted in a definite immunoassay response at the tolerance level of 10 qg kg A moderate, but rather consistent, matrix effect was observed. A more severe matrix effect was observed in bovine milk, blood, and urine. For the liquid matrices, sample dilution was not a satisfactory strategy, because the assay variability increased at lower concentrations, negating any benefit of reducing the matrix effect. This work clearly demonsttated that matrix effects are... 

Oxime carbamates are generally applied either directly to the tilled soil or sprayed on crops. One of the advantages of oxime carbamates is their short persistence on plants. They are readily degraded into their metabolites shortly after application. However, some of these metabolites have insecticidal properties even more potent than those of the parent compound. For example, the oxidative product of aldicarb is aldicarb sulfoxide, which is observed to be 10-20 times more active as a cholinesterase inhibitor than aldicarb. Other oxime carbamates (e.g., methomyl) have degradates which show no insecticidal activity, have low to negligible ecotoxicity and mammalian toxicity relative to the parent, and are normally nondetectable in crops. Therefore, the residue definition may include the parent oxime carbamate (e.g., methomyl) or parent and metabolites (e.g., aldicarb and its sulfoxide and sulfone metabolites). The tolerance or maximum residue limit (MRL) of pesticides on any food commodity is based on the highest residue concentration detected on mature crops at harvest or the LOQ of the method submitted for enforcement purposes if no detectable residues are found. For example, the tolerances of methomyl in US food commodities range from 0.1 to 6 mg kg for food items and up to 40 mg kg for feed items. ... 

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