Radioactive materials exemptions

This rule varies from state to state. Some materials are exempt from Nuclear Regulatory Commission or State licensing requirements. Most institutions already have an institutional license which would specify the safety officer. It would be well for the clinical chemistry laboratory to check with this individual before beginning to use radioactive materials. If there is no license, many manufacturers of isotope materials will assist the laboratory in obtaining the proper license. 

A harmonized pan-European notification system, i.e., covering the entire EU, was introduced for new substances as part of the 6th Amendment to the 67-Directive (EEC 1967), which was adopted in September 1979 (Directive 79/831/EEC - EEC 1979) and came into force in all Member States on 18 September 1981. Over 6800 notifications in total, representing more than 4300 substances, have been submitted since 1981. Inherent of legislation are principles for notification, including criteria for exemption. Exemption categories include consumer products pertaining to pharmaceuticals, cosmetics, and foodstuffs. The Directive is not applicable to pesticides, radioactive materials, wastes, and substances used in scientific research (ECB 2006). 

Exempt Radioactive Wastes. The radioactive waste classification system in the United States does not include a general class of exempt waste (see Table 1.1). Rather, many products and materials that contain small amounts of radionuclides (e.g., specified consumer products, liquid scintillation counters containing 3H and 14C) have been exempted from requirements for use or disposal as radioactive material on a case-by-case basis. The various exemption levels are intended to correspond to low doses to the public, especially compared with dose limits in radiation protection standards for the public or doses due to natural background radiation. However, the exemption levels are not based on a particular dose, and potential doses to the public resulting from use or disposal of the exempt products and materials vary widely. 

The classification system lacks a set of principles for determining when a waste contains sufficiently small amounts of radionuclides that it can be exempted from regulatory control as radioactive material. The lack of a general class of exempt waste increases in importance as the resources required for management and disposal of radioactive waste increase compared with the resources required for management and disposal of these materials as nonradioactive waste, and it may foreclose possible beneficial uses of slightly contaminated materials. 

This Section describes the concepts used in exempting waste that contains radioactive material and discusses efforts in the United States to establish exemption levels for radioactive waste. 

Established Exemption Levels. NRC s radiation protection standards in 10 CFR Part 20 (NRC, 1991) include limits on concentrations or annual releases of radionuclides for unrestricted discharge into sanitary sewer systems, except any excreta from individuals undergoing medical treatment with radioactive material are exempt from the limits. These regulations also include an exemption for land disposal of liquid scintillation materials and animal carcasses that contain 2 kBq g 1 (0.05 pCi g-1) or less of 3H or 14C, although the exempted scintillation materials must be managed in accordance with RCRA requirements due to the presence of toluene. 

Current NRC regulations for source material in 10 CFR Part 40 (AEC, 1961) and byproduct material in 10 CFR Part 30 (AEC, 1965a) specify conditions for exemption of many products or materials that contain small amounts of radioactive material (see also Schneider et al, 2001). These exemptions apply to commercial or specialized industrial uses of radioactive materials, as well as their disposal, and they include many common consumer products e.g., timepieces, smoke detectors, thorium gas mantles). These exemptions were established based on judgments by AEC and NRC that the benefits of exempt uses far outweighed the risks to public health. 

NRC regulations described above represent a case-by-case approach to establishing exemption levels for radioactive material. Although the various exemption levels are expected to correspond to low doses from use and disposal of materials compared, for example, with dose limits in radiation protection standards for the public... 

NCRP has developed a recommendation on a negligible individual dose that could be used to establish exemption levels for radioactive waste for such purposes as disposal and recycle/reuse, but this recommendation has not been adopted by regulatory authorities. Indeed, NRC is prohibited by law from implementing a proposed generic policy on exemption of radioactive materials that was consistent with the NCRP recommendation. 

IAEA has been developing recommendations on classification of radioactive waste and principles for exempting radioactive waste from regulatory requirements for radioactive material for more than 30 y. This Section briefly reviews these developments. 

Exempt waste would be defined as waste that contains such low concentrations of radionuclides that it could be exempted from regulatory control as radioactive material because the radiological hazards associated with disposal of the waste would be negligible. The basis for defining exempt radioactive waste recommended by IAEA is a limit on annual dose to individuals from waste disposal of 10 xSv (see Section 4.1.3.2). 

Recommendations on Exemption Principles. IAEA has developed recommendations on general principles for exemption of radioactive material from regulatory control (IAEA, 1988). Any practice or source could be exempted from regulatory control if (1) the annual dose to individuals would be less than 10 xSv and (2) the annual collective dose from an unregulated practice would be less... 

Finally, recommendations on principles that could be used to exempt radioactive waste from regulatory control as radioactive material have been developed both in the United States (NCRP,... 

Issues of dual regulation also arise in management and disposal of waste that contains NAEM and waste classified as hazardous under RCRA. This type of waste is subject to dual regulation essentially because the definition of hazardous waste developed by EPA under RCRA (EPA, 1980b) does not include NARM waste (Section 4.2.1.2). Waste that contains NARM can be regulated under RCRA only if it is specifically included in the definition of hazardous waste, even though the exemption of radioactive materials defined in AEA from regulation under RCRA does not apply to NARM. 

Contents Indude legal and regulatory framework, alternative modes for transportation, employee training, relationship between shippers and carriers, safety in shipping, exemptions from transportation requirements, enforcement proceedings, risk management, radioactive materials, and waste transport... 

The TCCL applies to all chemical substances except those regulated by other legislation ie, radioactive materials, pharmaceuticals, cosmetics, agrochemicals and fertilisers and additives for food and animal feed. However, naturally occurring substances and articles are excluded from the provisions of the TCCL. Also, substances manufactured or imported at <100 kg a or solely for testing and research are exempt fiiom notification. 

Therefore, these radioactive materials are exempt from TSCA. 

Radioactive Material, name of radionuclides, description of physical and chemical form, activity, label category, transport index, Fissile exempt, package identification markings, and/or appropriate warnings Class 7 materials... 

There are a number of other classes described in paragraphs 30.15-20 of 10 CFR, in which the persons purchasing certain items containing radioactive materials are exempt fiom having a license, although the original manufacturer must have had a specific hcense to allow production of the unit. Among these are self-luminous devices and gas and aerosol detectors. 

Not all uses of radioisotopes require securing a license. There are many commercial products, such as watch dials and other self-luminous applications, and some types of smoke detectors that contain very small quantities of radioactive materials which the owner obviously does not require a license to possess. However, those who take advantage of exemptions must use no more than the exempt quantities listed in Schedule B, 10 CFR Section 30.71. In Table 5.4, the units are in microcuries. To convert to becquerels, multiply the number given in microcuries by 37,000. 

Clearance is a regulatory mechanism similar to exemption and relates to the removal of radioactive material or radioactive objects within authorized practices from any further control by the regulatory body. It relieves operators that wish to release substances, material or objects from further regulatory requirements subject to compliance with clearance levels approved by the regulatory body. Both exemption and clearance are essentially generic authorizations. 

The principles of exemption and their application to the transport of radioactive material are dealt with in para. 401. 

The concept of low dispersible radioactive material applies only to qualification for exemption from the requirements for Type C packages in the air transport mode. 

In previous editions of the Regulations, a single exemption value of 70 Bq/g was used to define radioactive material for transport purposes. Following publication of the BSS [1], it was recognized that this value had no radiological basis. The radiological protection criteria defined in the BSS were therefore used to establish radionuclide specific exemption values for transport purposes (see para. 401.3). 

The exemption values were derived by using a variety of exposure scenarios and pathways that did not explicitly address the transport of radioactive material. Additional calculations were performed for transport specific scenarios [7]. These transport specific exemption values were then compared with the values in the Basic Safety Standards. It was concluded that the relatively small differences between both sets did not jnstify the incorporation into the Regulations of a set of exemption values different from that in the Basic Safety Standards, given that the use of different exemption values in various practices may give rise to problems at interfaces and may cause legal and procedural complications. 

The activity concentration exemption values are to be applied to the radioactive material within a packaging or in or on a conveyance. 

FRANCOIS, R, et al., The application of exemption values to the transport of radioactive materials , IRPA 9 (Proc. 9th IRPA Int. Congr. Vienna, 1996), Vol. 4, IRPA, Vienna (1996) 674. 

It is possible that radionuclides may be identified and shipped as environmentally hazardous substances by this process, even if the radionuclides are not present in sufficient quantity to be defined as radioactive material in accordance with the definition of 49 CFR 173.4(B. It is a serious error to assume that radionuclides not meeting the definition of radioactive material are exempt from the hazardous materials regulations. 

This is determined by comparison with a table of values for each isotope in 49 CFR 173.436, or by comparison with values derived in accordance with the formulas in 49 CFR 173.433. Material is exempt from radioactive material designation (Class 7) if it fails either of the two criteria. 

SCOs are not regulated for shipment if contamination is below the definition of contamination in 49 CFR 173.403. SCOs are also exempt from classification as radioactive material if the total activity on the surface can be demonstrated to be less than the activity limit for an exempt consignment (see 49 CFR 173.401(b)(5) as of 2014, and DOT interpretations 05-0145 dated July 1,2005, and 08-0012 dated May 7,2008 available on the PHMSA website, http //www.phmsa.dot.gov/hazmat/regs/interps). 

Recall from the discussion of radioactive material in this chapter that uranium and thorium ores, and other naturally radioactive ores that are not intended for processing to remove the radionuclides are exempt from the HMR. This is an example of how physically identical material, equal in isotopes and activity, can be regulated differently for shipment based on its administrative status, previous use, or intended use. When planning for compliant shipping, the history and planned use of the material can be as important as fhe isotopic analysis. 

The main purpose of this Act is to ensure effective control over radioactive wastes. Under the Act those who keep or use radioactive materials on premises used for the purposes of an undertaking (trade, business, profession etc.) are required to register with Her Majesty s Inspectorate of Pollution of the Department of the Environment, Welsh Office, Her Majesty s Industrial Pollution Inspectorate for Scotland of the Scottish Development Department or the Department of the Environment for Northern Ireland, according to the region, or to be exempted from registration. Conditions may be attached to registrations and exemptions, and these are made with regard to the amount and character of the radioactive waste likely to arise. 

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