Example applications, exempt

Step 2 allows you to identify uses of the chemical or chemical category that were included In Step 1 but that are exempt under section 313. Do not include In Step 2 exempt forms of the chemical not included in the calculations in Step 1. For example. If you did not report the freon contained in the building s air conditioners in Step 1, you would not include the amount as exempt in Step 2. Step 2 is intended for use when one form or use of the chemical is exempt while others forms require reporting. Note the type of exemption for future reference. Also identify, if applicable, the fraction or percentage of the chemical present that Is exempt. Add the amounts in each activity to obtain a subtotal for exempted amounts of the chemical or chemical categories at the facility. 

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... 

If a restricted waste does not meet its applicable treatment standard, it is prohibited from land disposal. Although most wastes become eligible for disposal by meeting the treatment standards, in some instances this may not be possible. For example, there may not be enough treatment capacity to treat a waste, or the concentration level may not be achievable. To address these situations, U.S. EPA established procedures that allow wastes to be disposed of under special circumstances. The following exemptions, variances, and extensions allow wastes to be disposed of without meeting their respective treatment standards or to be treated to a different standard1,2 ... 

In developing this clarification, the CG/HCCS carefully considered many different issues with regard to the possible application of the GHS. There were concerns raised about whether certain sectors or products should be exempted, for example, or about whether or not the system would be applied at all stages of the life cycle of a chemical. Three parameters were agreed in this discussion, and are critical to application of the system in a country or region. These are described below ... 

The mechanism of regulatory control is dependent upon whether the clinical trial is conducted under the auspices of a company, or independently, for example, by a medical or dented practitioner and whether it is to be conducted within or outside the terms (e.g., indication, dosage) of an MA. Most commonly the clinical trial will be sponsored by a company, and be designed to investigate a new aspect of efficacy or Scifety in the absence of or outside the terms of an MA in this case the company sponsor must, by application to the MCA, obtain a Clinical Trial Exemption (CTX), or rarely by choice, a Cliniced Trial Certificate (CTC). However,... 

In the US, an IND (Investigational New Drug) application has to be filed with the FDA. For other countries, a notification has to be submitted to the respective regulatory authorities. For example, Clinical Trial Exemption (CTX) applications are required for the UK, Clinical Trial Notification (CTN) and CTX for Australia, and a Clinical Trial Certificate (CTC) for Singapore and the European Agency for the Evaluation of Medicinal Products (EMEA). A more extensive discussion concerning regulatory authorities and the processes and procedures of applications is presented in Chapters 7 and 8. The relevant authority will review the application. A positive response from the authority is required before the trial can commence. 

Other factors used to determine if a polymer meets the RRR criteria are similar to those used in the determination as to whether a substance qualifies for the polymer exemption in the US, but subtle differences exist. Eor example, in the US, if one of the reactants used at greater than two weight percent to manufacture a polymer is not on the TSCA Inventory or covered by an applicable Section 5 exemption, this fact alone will disqualify the polymer from meeting the polymer exemption criteria. In Canada, such a situation would not disqualify a polymer from being considered to be RRR, although the reactant s presence on the DSL does affect which Schedule of data must be submitted. 

The EPA defers to the FDA in this determination. pp follows the FDA s examples of when the FDA begins regulating a product this occurs when an application for exemption for an investigational use of a new drug, animal drug, or device is submitted. ... 

The binding boxes have a different function for TMEs, LVEs, and LoREX applications because those exemptions require the filer to abide by the limitations in the applications. For example, a LVE filer can be bound to a production limit lower than ten thousand kilograms per year by listing a lower quantity and checking the binding box. ... 

The law of occupation belongs to ius in hello, and is thus apparently insulated from ius ad bellum. For example, when a proposal arose to exempt forces acting under UN authority from the law of occupation on the ground that they would be acting against an aggressor state, the discriminatory application of the law of occupation on the basis of ius ad bellum considerations was rejected. However, the division between ius ad bellum and ius in hello is not entirely impermeable. As discussed in the next section, ius ad bellum serves as a normative standard by which to examine the legality of an occupation. 

Office workers who encounter hazardous chemicals only in isolated instances are not covered by the rule. OSHA considers most office products (i.e., pens, pencils, adhesive tape) to be exempt under the provisions of the rule, either as articles or as consumer products. For example, OSHA has previously stated that intermittent or occasional use of a copying machine does not result in coverage under the rule. However, if an employee handles the chemicals to service the machine, or operates it for long periods of time, then the program would be applicable. 

In special cases (e.g. new technology which is not in line with the applicable regulations), it is possible to get a special authorization for a certain vehicle type. An example is the Volkswagen XLl equipped with CMS instead of rearview mirrors and already produced in a small series (see [23]). In the following sections, an analysis of exemptions for new technologies (like e.g. CMS) will be presented. As such exemption procedures are country-specific, two examples are given by focusing on the European- and on the US-market. 

Paragraph (b) of the standard, scope and application, includes exemptions for various chanicals or workplace situations. After compiling the complete list of chemicals, you should review paragraph (b) to determine if any of the items can be eliminated from the list because they are exanpted materials. For example, food, drugs, and cosmetics brought into the workplace for employee consumption are exempt. Therefore, rubbing alcohol in the first-aid kit would not be covered. 

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