Regulatory Definitions

Application and Use of the Regulatory Definition of Significant Noncompliance for Industrial Users, September 9, 1991 (Memorandum) ERIC W986 NTIS PB95-201786. 

The final steps in the hazardous waste identification process determine whether a waste poses a sufficient chemical or physical hazard to merit regulation. These steps in the hazardous waste identification process involve evaluating the waste in light of the regulatory definition of hazardous waste. The remainder of this chapter explains the definition, characteristics, and properties of hazardous wastes. 

Acidic wastes with a pH of <2.0 and alkaline wastes with a pH of >12.5 are defined as hazardous (40 CFR Part 261). To meet the regulatory definition of nonhazardous, acidic wastes must be neutralized to a pH of >2.0 by reducing the hydrogen ion concentration, and alkaline wastes must be neutralized to a pH of <12.5 by increasing the hydrogen ion concentration. 

Water with a salinity of less than 10,000 mg/L is considered to be a potential underground source of drinking water. By regulatory definition, deep-well injection of hazardous waste can occur only in very saline waters or brines. Actual salinities of waters in currently used deep-well injection zones vary greatly.70 Normally, the term brine is used to refer to the natural waters in deep-well injection zones. As noted above, however, this term is not technically correct if TDS levels are less than 35,000 mg/L. 

By definition, a nutraceutical (derived from the term nutritional pharmaceutical ) is a foodstuff (fortified food or dietary supplement) that is held to provide health or medical benefits in addition to its basic nutritional value [1], Nutraceuticals derived from botanicals deliver a concentrated form of presumed bioactive agents from plants that are not generally part of the food supply. The term nutraceutical has no regulatory definition. Similarly, functional foods, as defined by the International Life Sciences Institute (ILSI), are foods that by virtue of physiologically active food components, provide health benefits beyond basic nutrition [2], For the purposes of this review, these two terms will be differentiated by the form in which they are consumed. Nutraceuticals refers to dietary supplements most often found in pill or capsule form functional foods are ingested as part of a normal food pattern. Both are intended to provide beneficial effects beyond their nutritional value, and contribute to an improved state of health and/or reduction of risk of disease. 

The use of microcapsules in food is generally that of an additive. By regulatory definition, a food additive is any substance which becomes added to food either intentionally or unintentionally other than food itself. This includes both compounds added directly and those that are added indirectly such as migrating from packaging materials. We will limit our discussion here to direct, intentional additives. This means, for example, that the Vitamin C in orange juice is not an additive but the Vitamin C added to orange juice is. 

Do not attempt to compare fluid types as defined here with the reservoir descriptions as defined by the state regulatory agencies which have jurisdiction over the petroleum industry. The legal and regulatory definitions of oil, crude oil, gas, natural gas, condensate, etc., usually do not bear any relationship to the engineering definitions given here. In fact, the regulatory definitions are often contradictory. 

Early Descriptions of Radioactive Waste Categories. The following sections discuss the earliest categories of radioactive waste that were developed prior to the current legal and regulatory definitions of waste classes. These categories applied only to waste that arises from operations of the nuclear fuel cycle. 

Statutory and Regulatory Definitions. The first regulatory definition of high-level waste was developed by AEC in 1970 and is contained in 10 CFR Part 50, Appendix F (AEC, 1970). Specifically ... 

Statutory and Regulatory Definitions. The earliest statutory definitions of transuranic waste were contained in AEA (1954), the National Security and Military Applications of Nuclear Energy Authorization Act (NSMA, 1980), and the Low-Level Radioactive Waste Policy Act (LLRWPA, 1980). All of these laws defined transuranic waste in terms of concentrations of long-lived, alpha-emitting... 

In 1985, EPA developed a regulatory definition of transuranic waste in 40 CFR Part 191 (EPA, 1985) that incorporated the increase in the lower limit on concentrations of long-lived, alpha-emitting transuranium radionuclides. This definition was retained when 40 CFR Part 191 was repromulgated in 1993 (EPA, 1993a). EPA s definition is the same as the current statutory definition described below. 

Statutory and Regulatory Definitions. Current statutory definitions of low-level waste are contained in NWPA (1982) and the Low-Level Radioactive Waste Policy Amendments Act (LLRWPAA, 1986). In the Nuclear Waste Policy Act, low-level waste is defined as radioactive waste that ... 

EPA has not yet developed a regulatory definition of low-level waste. Such a definition presumably would be developed in the course of establishing general environmental standards for land disposal of low-level waste. 

Another type of an action level is a regulatory definition of hazardous waste that allows identifying hazardous materials and determining the waste disposal alternatives. The Resource Conservation and Recovery Act (RCRA), which is the law for disposal of solid and hazardous wastes, regulates hazardous waste in its Subtitle C. The RCRA, promulgated in 1976 and amended in 1984, today primarily focuses on regulating the operation of hazardous waste sites and on land disposal activities. 

All chemical substances are impure — there is no such thing as 100% purity. However, many substances are pure enough for use. Why is the word substance used here Apart from its regulatory definition, it is to distinguish practical from theoretical. The substance is the sample available to the experimenter. A compound is seen here as a theoretical concept, a material having molecules of only the intended substance within it. Various classes of substance can be distinguished, which would be treated differently both in respect of validation and estimation itself ... 

Does not require pre-market approval by the FDA because it meets the regulatory definition of human cells, tissue, and cellular and tissue-based products, or HCT/Ps. 

Should the U.S. regulatory definition of an asbestos fiber (length 5 m with aspect ratio 3 1), establishedfor purposes of quantifying exposure levels, be changed ... 

All research personnel must search for clues about safety events from many sources, such as information in clinical records at the study sites information in data collection forms (e.g. CRFs, diary cards, quality-of-life forms, psychiatric rating scales, etc.), occurrence of missed and/or unscheduled visits, dropouts and withdrawals use of any concomitant medications/devices and abnormal laboratory data. AEs may also occur simply as a result of study procedures and study participation. Information about definitions of AEs and requirements for reporting AEs must be clearly stated in the protocol and explained to the site staff, who must also be educated in the correct procedure and immediate requirement for reporting any AE suspected to be serious or unexpected as per the regulatory definitions. 

The waste management hierarchy introduces a myriad of terms that require definitions due to subtle differences between them. To precisely define these terms is an arduous task that becomes even more complex when regulatory definitions are added to an originally operational or technical definition. Table 1 provides generally accepted definitions for some of the most commonly encountered terms in the literature of this field. 

Regulatory Definition of Hazardous, Radioactive, and Mixed Waste. Existing federal regulations give specific regulatory definitions for all waste types. Wastes that are of most Interest to environmental restoration and waste management are hazardous waste, radioactive waste, and mixed waste. 

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