Reporting threshold

Poly(vinyl chloride) is Hsted on the TSCA inventory and the Canadian Domestic Substances List (DSL) as ethene, chloro-, homopolymer [9002-86-2]. Because polymers do not appear on the European Community Commercial Chemical Substances listing or EINECS, poly(vinyl chloride) is listed through its monomer, vinyl chloride [75-01-4]. In the United States, poly(vinyl chloride) is an EPA hazardous air pollutant under the Clean Air Act Section 112 (40 CER 61) and is covered under the New Jersey Community Right-to-Know Survey N.J. Environmental Hazardous Substances (EHS) List as "chloroethylene, polymer" with a reporting threshold of 225 kg (500 lb). 

Application of the de minimis limitation to process streams must also be reviewed. Mixtures containing toxic chemicals can be added to a process or generated within a process. In both cases (assuming reporting thresholds are exceeded) a facility is required to consider and report releases from the process up to the point where the concentration of the chemical falls below the de minimis level. For example, a 10% solution of a listed chemical is mixed Into a formulated cleaning solution, resulting in a final concentration of less than 1%. Releases such as air emissions, from the mixing vessel must be counted, but releases from the finished formulation are not counted because the de minimis exemption applies... 

A covered facility must report all releases of a listed chemical if it meets a reporting threshold for that chemical. However, if the facility is composed of several distinct establishments, EPA allows these establishments to submit separate reports for the chemical as long as all releases of the chemical from the entire facility are accounted for. Indicate in Section 3.2 whether your report is for the entire covered facility as a whole or for part of a covered facility. Check box a. if the chemical information applies to the entire covered facility. Check box b. if the chemical information applies only to part of a covered facility. 

Zero" reporting threshold means any quantity present on site must be reported. 

Reportable Threshold Quantity Ptannlng Quantity Notes (pounds) (pounds)... 

Commenting ona January 5,1999 proposal, environmental groups in early April called again on EPA to lower its proposed Toxic Release Inventory (TRI) reporting threshold to zero for certain chemicals. The chemicals include mercury, dioxins, and lead. Currently facilities are only required to report chemical releases if they manufacture or process at least 25,000 pounds or otherwise use 10,000 pounds annually of a fisted TRI chemical. The environmental advocates argued that any releases of chemicals considered to be persistent, bioaccumulative and toxic should be reported as a threat to public health. This abstract includes all the information contained in the original article. 

The outcome of planning should include the generation of a method definition requirement document (MDRD) in which all stake holders agree, prior to method development, on the critical attributes of the method. Considerations such as what impurities/degradation products should be monitored, requisite reporting thresholds, the need for an MS-compatible method, if identical methods for DP and DS are required, etc., should be clearly decided and agreed upon by all stakeholders. 

In addition, depending on the situation, other responses such as reporting threshold recovery, etc. may also be considered. The injection of the selectivity batch solution is used to test the suitability of the system. 

Further discussion of method validation can be found in Chapter 7. However, it should be noted from Table 11 that it is frequently desirable to perform validation experiments beyond ICH requirements. While ICH addresses specificity, accuracy, precision, detection limit, quantitation limit, linearity, and range, we have found it useful to additionally examine stability of solutions, reporting threshold, robustness (as detailed above), filtration, relative response factors (RRF), system suitability tests, and where applicable method comparison tests. 

Filtered and unfiltered samples are compared for the API and the impurities. Additionally, there should be no new impurities higher than the reporting threshold detected. 

The reporting threshold is a limit above which (>) an impurity needs to be reported. The reporting threshold is determined as described by the... 

ICH guidelines, and is generally 0.05% for DS and 0.10% for DP methods. Any impurity above this level should be reported. Especially for stability indicating methods, it may be valuable to apply a lower level as the reporting threshold to allow for a better trending process for degradation products at levels below 0.05% and 0.10% for DS and DP methods, respectively. 

Unspecified impurities are those that are typically found at levels below the reporting threshold. These are typically reported by the summation of all the impurity peaks. 

Enantiomeric determinations are typically done according to a normalized peak area (area%) calculation procedure. A reporting threshold solution containing the lowest level to be... 

Depending on the type of calculation procedure, a set of SST-parameters is selected including system precision, reporting threshold, and system drift checks. If normalized peak area reporting is applied, the evaluation of the system precision is obviously not necessary. Frequently applied parameters and tentative limits comparable to HPLC methods are compiled in the Table 2. ... 

Several method performance indicators are tracked, monitored, and recorded, including the date of analysis, identification of equipment, identification of the analyst, number and type of samples analyzed, the system precision, the critical resolution or tailing factor, the recovery at the reporting threshold level, the recovery of a second reference weighing, the recovery for the control references (repeated reference injections for evaluation of system drift), the separation quality, blank issues, out of spec issues, carry over issues, and other nonconformances. The quantitative indicators are additionally visualized by plotting on control charts (Figure 23). 

Reporting Threshold A limit above (>) which an impurity should be reported. (The limit of quantification should be less or equal to the reporting threshold.)... 

Maximum daily dose (g/day) Reporting threshold (%) Identification threshold Qualification threshold... 

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