Essential use exemption

As a result of the Montreal Protocol, almost imperceptibly, aerosol deodorants, furniture polishes, and hair sprays were reformulated with altemative, often inflammable propellants, and CFCs were phased out as refrigerants. Such replacement propellants were not suitable for use in pMDIs for reasons of flammability and toxicity, and the Montreal Protocol recognized that some temporary exemption from the protocol may be necessary to allow identification of altemative propellants. It provided for this eventuality by means of an essential-use exemption clause. Essentiality exists when ... 

Recognizing the fact that pMDIs were the most widely used form of inhaled therapy and available in all markets for all types of inhaled respiratory medicine, it was felt that their use did justify an essential use exemption from the Montreal Protocol. Dry-powder devices were recognized as an alternative for many, but they were not available in all countries for all medicines and were not always suitable for the young and those with low inspiratory flow rates also, they may not be suitable in certain humid climates. In some markets their extra cost would also deprive many of necessary treatment. 

January 1, 2013. That Act requires EPA to report to Congress within one year of the date of the Act on mercuric chloride, mercurous chloride or calomel, mercuric oxide, and other mercury compounds, if any, that are currently used in significant quantities in products or processes. The Act also allows petitions for an essential use exemption from the ban for a specified use at an identified foreign facility for up to three years and up to ten metric tons of elemental mercury, if EPA makes required findings. EPA has announced that it intends to file a notice of proposed rule making in early 2011 to establish the standards and procedures regarding essential use exemptions. ... 

Essential Use Exemption. (A) Any person residing in the United States may petition the Administrator for an exemption from the prohibition in... 

Regulatory Status. Regulated in the United States as a dietary supplement. Capsicum (red pepper, cayenne pepper) and paprika are GRAS as natural seasonings and flavorings ( 182.10). Their essential oils, solvent-free oleoresins and natural extractives are also GRAS ( 182.20) paprika and paprika oleo-resin are also approved as color additives for food use exempt from certification ( 73.340 and 73.345). Capsaicin-containing topical products are approved in over-the-counter... 

ODS solvents are required to be replaced with non-depleting chemicals. Controlling these substances is not an alternative. ODS solvents are listed in Table 18.1.2. Substitute solvents deemed acceptable have been identified for some of these ODS solvents under EPA s Significant New Alternatives Policy (SNAP), but other health concerns have limited their use. Some exemptions to the use of phase out ODS exist for essential uses as long as they are consistent with the Montreal Protocol (to date, none has been authorized by EPA). ... 

Ephedra is subject to the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994. The act essentially protects dietary supplements like ephedra. That is, while U.S. federal agencies can regulate prescription drug and food additives, DSHEA exempts herbal products and supplements from federal regulation. The law states that the United States Food and Drug Administration (FDA) cannot regulate dietary supplements unless, or until, they are proven to be unsafe and pose a risk to users. The United States Drug Enforcement Administration (DEA) monitors ephedrine because it can be used to make methamphetamine. 

Given the qualitative definitions of the three waste classes, the boundaries of the waste classes would be quantified based on explicit descriptions of how the definitions are related to risk. The boundaries would be expressed in terms of limits on amounts (concentrations) of individual hazardous substances, with specified rules for how to classify waste that contains mixtures of hazardous substances, such as the sum-of-fractions rule for mixtures of substances that induce stochastic effects. Specifically, waste would be classified as exempt if the risk that arises from disposal in a municipal/industrial landfill for nonhazardous waste does not exceed negligible (de minimis) levels. Use of a negligible risk to quantify limits on concentrations of hazardous substances in exempt waste is appropriate because the waste would be managed in all respects as if it were nonhazardous. Nonexempt waste would be classified as low-hazard if the risk that arises from disposal in a dedicated near-surface facility for hazardous wastes does not exceed acceptable (barely tolerable) levels. An essential condition of the definitions of exempt and low-hazard waste is that an acceptable (barely tolerable) risk must be substantially greater than a negligible risk. Waste would be classified as high-hazard if it would pose an unacceptable (de manifestis) risk when placed in a dedicated near-surface facility for hazardous wastes. 

Use of the risk index in classifying waste is illustrated in Figure 6.2. Classification of waste essentially is a two-step process. The first step involves a determination of whether a waste can be classified as exempt, based on an assumed negligible risk and an exposure scenario for inadvertent intruders appropriate to disposal of waste in a municipal/industrial landfill for nonhazardous waste. If the waste is not exempt, the second step involves a determination of whether a waste can be classified as low-hazard, based on an assumed acceptable (barely tolerable) risk and an exposure scenario for inadvertent intruders appropriate to disposal in a dedicated nearsurface facility for hazardous wastes. 

A medicine is essentially a substance or article which is manufactured, imported, sold or supplied wholly or principally for a therapeutic purpose (qv). The term can include an ingredient used in the preparation of any therapeutic product. Except in the case of certain specified exemptions, the consent of the Minister of Health is required before a new medicine can be distributed in New Zealand. 

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