Title 40—Protection of Environment--Volume 1
PART 191—ENVIRONMENTAL RADIATION PROTECTION STANDARDS FOR MANAGEMENT AND DISPOSAL OF SPENT NUCLEAR FUEL, HIGH-LEVEL AND TRANSURANIC RADIOACTIVE WASTES
§ 191.01   Applicability.
This subpart applies to:
(a) Radiation doses received by members of the public as a result of the management (except for transportation) and storage of spent nuclear fuel or high-level or transuranic radioactive wastes at any facility regulated by the Nuclear Regulatory Commission or by Agreement States, to the extent that such management and storage operations are not subject to the provisions of part 190 of title 40; and
(b) Radiation doses received by members of the public as a result of the management and storage of spent nuclear fuel or high-level or transuranic wastes at any disposal facility that is operated by the Department of Energy and that is not regulated by the Commission or by Agreement States.
§ 191.02   Definitions.
Unless otherwise indicated in this subpart, all terms shall have the same meaning as in Subpart A of Part 190.
(a) Agency means the Environmental Protection Agency.
(b) Administrator means the Administrator of the Environmental Protection Agency.
(c) Commission means the Nuclear Regulatory Commission.
(d) Department means the Department of Energy.
(e) NWPA means the Nuclear Waste Policy Act of 1982 (Pub. L. 97-425).
(f) Agreement State means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended (68 Stat. 919).
(g) Spent nuclear fuel means fuel that has been withdrawn from a nuclear reactor following irradiation, the constituent elements of which have not been separated by reprocessing.
(h) High-level radioactive waste, as used in this part, means high-level radioactive waste as defined in the Nuclear Waste Policy Act of 1982 (Pub. L. 97-425).
(i) Transuranic radioactive waste, as used in this part, means waste containing more than 100 nanocuries of alpha-emitting transuranic isotopes, with half-lives greater than twenty years, per gram of waste, except for: (1) High-level radioactive wastes; (2) wastes that the Department has determined, with the concurrence of the Administrator, do not need the degree of isolation required by this part; or (3) wastes that the Commission has approved for disposal on a case-by-case basis in accordance with 10 CFR Part 61.
(j) Radioactive waste, as used in this part, means the high-level and transuranic radioactive waste covered by this part.
(k) Storage means retention of spent nuclear fuel or radioactive wastes with the intent and capability to readily retrieve such fuel or waste for subsequent use, processing, or disposal.
(l) Disposal means permanent isolation of spent nuclear fuel or radioactive waste from the accessible environment with no intent of recovery, whether or not such isolation permits the recovery of such fuel or waste. For example, disposal of waste in a mined geologic repository occurs when all of the shafts to the repository are backfilled and sealed.
(m) Management means any activity, operation, or process (except for transportation) conducted to prepare spent nuclear fuel or radioactive waste for storage or disposal, or the activities associated with placing such fuel or waste in a disposal system.
(n) Site means an area contained within the boundary of a location under the effective control of persons possessing or using spent nuclear fuel or radioactive waste that are involved in any activity, operation, or process covered by this subpart.
(o) General environment means the total terrestrial, atmospheric, and aquatic environments outside sites within which any activity, operation, or process associated with the management and storage of spent nuclear fuel or radioactive waste is conducted.
(p) Member of the public means any individual except during the time when that individual is a worker engaged in any activity, operation, or process that is covered by the Atomic Energy Act of 1954, as amended.
(q) Critical organ means the most exposed human organ or tissue exclusive of the integumentary system (skin) and the cornea.
§ 191.03   Standards.
(a) Management and storage of spent nuclear fuel or high-level or transuranic radioactive wastes at all facilities regulated by the Commission or by Agreement States shall be conducted in such a manner as to provide reasonable assurance that the combined annual dose equivalent to any member of the public in the general environment resulting from: (1) Discharges of radioactive material and direct radiation from such management and storage and (2) all operations covered by Part 190; shall not exceed 25 millirems to the whole body, 75 millirems to the thyroid, and 25 millirems to any other critical organ.
(b) Management and storage of spent nuclear fuel or high-level or transuranic radioactive wastes at all facilities for the disposal of such fuel or waste that are operated by the Department and that are not regulated by the Commission or Agreement States shall be conducted in such a manner as to provide reasonable assurance that the combined annual dose equivalent to any member of the public in the general environment resulting from discharges of radioactive material and direct radiation from such management and storage shall not exceed 25 millirems to the whole body and 75 millirems to any critical organ.
§ 191.04   Alternative standards.
(a) The Administrator may issue alternative standards from those standards established in § 191.03(b) for waste management and storage activities at facilities that are not regulated by the Commission or Agreement States if, upon review of an application for such alternative standards:
(1) The Administrator determines that such alternative standards will prevent any member of the public from receiving a continuous exposure of more than 100 millirems per year dose equivalent and an infrequent exposure of more than 500 millirems dose equivalent in a year from all sources, excluding natural background and medical procedures; and
(2) The Administrator promptly makes a matter of public record the degree to which continued operation of the facility is expected to result in levels in excess of the standards specified in § 191.03(b).
(b) An application for alternative standards shall be submitted as soon as possible after the Department determines that continued operation of a facility will exceed the levels specified in § 191.03(b) and shall include all information necessary for the Administrator to make the determinations called for in § 191.04(a).
(c) Requests for alternative standards shall be submitted to the Administrator, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
§ 191.05   Effective date.
The standards in this subpart shall be effective on November 18, 1985.
§ 191.11   Applicability.
(a) This subpart applies to:
(1) Radioactive materials released into the accessible environment as a result of the disposal of spent nuclear fuel or high-level or transuranic radioactive wastes;
(2) Radiation doses received by members of the public as a result of such disposal; and
(3) Radioactive contamination of certain sources of ground water in the vicinity of disposal systems for such fuel or wastes.
(b) This subpart does not apply to:
(1) Disposal directly into the oceans or ocean sediments;
(2) Wastes disposed of before November 18, 1985; and
(3) The characterization, licensing, construction, operation, or closure of any site required to be characterized under section 113(a) of Public Law 97-425, 96 Stat. 2201.
§ 191.12   Definitions.
Unless otherwise indicated in this subpart, all terms shall have the same meaning as in subpart A of this part.
Accessible environment means: (1) The atmosphere; (2) land surfaces; (3) surface waters; (4) oceans; and (5) all of the lithosphere that is beyond the controlled area.
Active institutional control means: (1) Controlling access to a disposal site by any means other than passive institutional controls; (2) performing maintenance operations or remedial actions at a site, (3) controlling or cleaning up releases from a site, or (4) monitoring parameters related to disposal system performance.
Annual committed effective dose means the committed effective dose resulting from one-year intake of radionuclides released plus the annual effective dose caused by direct radiation from facilities or activities subject to subparts B and C of this part.
Aquifer means an underground geological formation, group of formations, or part of a formation that is capable of yielding a significant amount of water to a well or spring.
Barrier means any material or structure that prevents or substantially delays movement of water or radionuclides toward the accessible environment. For example, a barrier may be a geologic structure, a canister, a waste form with physical and chemical characteristics that significantly decrease the mobility of radionuclides, or a material placed over and around waste, provided that the material or structure substantially delays movement of water or radionuclides.
Controlled area means: (1) A surface location, to be identified by passive institutional controls, that encompasses no more than 100 square kilometers and extends horizontally no more than five kilometers in any direction from the outer boundary of the original location of the radioactive wastes in a disposal system; and (2) the subsurface underlying such a surface location.
Disposal system means any combination of engineered and natural barriers that isolate spent nuclear fuel or radioactive waste after disposal.
Dose equivalent means the product of absorbed dose and appropriate factors to account for differences in biological effectiveness due to the quality of radiation and its spatial distribution in the body; the unit of dose equivalent is the “rem” (“sievert” in SI units).
Effective dose means the sum over specified tissues of the products of the dose equivalent received following an exposure of, or an intake of radionuclides into, specified tissues of the body, multiplied by appropriate weighting factors. This allows the various tissue-specific health risks to be summed into an overall health risk. The method used to calculate effective dose is described in appendix B of this part.
Ground water means water below the land surface in a zone of saturation.
Heavy metal means all uranium, plutonium, or thorium placed into a nuclear reactor.
Implementing agency means:
(1) The Commission for facilities licensed by the Commission;
(2) The Agency for those implementation responsibilities for the Waste Isolation Pilot Plant, under this part, given to the Agency by the Waste Isolation Pilot Plant Land Withdrawal Act (Pub. L. 102-579, 106 Stat. 4777) which, for the purposes of this part, are:
(i) Determinations by the Agency that the Waste Isolation Pilot Plant is in compliance with subpart A of this part;
(ii) Issuance of criteria for the certifications of compliance with subparts B and C of this part of the Waste Isolation Pilot Plant's compliance with subparts B and C of this part;
(iii) Certifications of compliance with subparts B and C of this part of the Waste Isolation Pilot Plant's compliance with subparts B and C of this part;
(iv) If the initial certification is made, periodic recertification of the Waste Isolation Pilot Plant's continued compliance with subparts B and C of this part;
(v) Review and comment on performance assessment reports of the Waste Isolation Pilot Plant; and
(vi) Concurrence by the Agency with the Department's determination under § 191.02(i) that certain wastes do not need the degree of isolation required by subparts B and C of this part; and
(3) The Department of Energy for any other disposal facility and all other implementation responsibilities for the Waste Isolation Pilot Plant, under this part, not given to the Agency.
International System of Units is the version of the metric system which has been established by the International Bureau of Weights and Measures and is administered in the United States by the National Institute of Standards and Technology. The abbreviation for this system is “SI.”
Lithosphere means the solid part of the Earth below the surface, including any ground water contained within it.
Passive institutional control means: (1) Permanent markers placed at a disposal site, (2) public records and archives, (3) government ownership and regulations regarding land or resource use, and (4) other methods of preserving knowledge about the location, design, and contents of a disposal system.
Performance assessment means an analysis that: (1) Identifies the processes and events that might affect the disposal system; (2) examines the effects of these processes and events on the performance of the disposal system; and (3) estimates the cumulative releases of radionuclides, considering the associated uncertainties, caused by all significant processes and events. These estimates shall be incorporated into an overall probability distribution of cumulative release to the extent practicable.
Radioactive material means matter composed of or containing radionuclides, with radiological half-lives greater than 20 years, subject to the Atomic Energy Act of 1954, as amended.
SI unit means a unit of measure in the International System of Units.
Sievert is the SI unit of effective dose and is equal to 100 rem or one joule per kilogram. The abbreviation is “Sv.”
Undisturbed performance means the predicted behavior of a disposal system, including consideration of the uncertainties in predicted behavior, if the disposal system is not disrupted by human intrusion or the occurrence of unlikely natural events.
Waste, as used in this subpart, means any spent nuclear fuel or radioactive waste isolated in a disposal system.
Waste form means the materials comprising the radioactive components of waste and any encapsulating or stabilizing matrix.
§ 191.13   Containment requirements.
(a) Disposal systems for spent nuclear fuel or high-level or transuranic radioactive wastes shall be designed to provide a reasonable expectation, based upon performance assessments, that the cumulative releases of radionuclides to the accessible environment for 10,000 years after disposal from all significant processes and events that may affect the disposal system shall:
(1) Have a likelihood of less than one chance in 10 of exceeding the quantities calculated according to Table 1 (appendix A); and
(2) Have a likelihood of less than one chance in 1,000 of exceeding ten times the quantities calculated according to Table 1 (appendix A).
(b) Performance assessments need not provide complete assurance that the requirements of § 191.13(a) will be met. Because of the long time period involved and the nature of the events and processes of interest, there will inevitably be substantial uncertainties in projecting disposal system performance. Proof of the future performance of a disposal system is not to be had in the ordinary sense of the word in situations that deal with much shorter time frames. Instead, what is required is a reasonable expectation, on the basis of the record before the implementing agency, that compliance with § 191.13 (a) will be achieved.
§ 191.14   Assurance requirements.
To provide the confidence needed for long-term compliance with the requirements of § 191.13, disposal of spent nuclear fuel or high-level or transuranic wastes shall be conducted in accordance with the following provisions, except that these provisions do not apply to facilities regulated by the Commission (see 10 CFR Part 60 for comparable provisions applicable to facilities regulated by the Commission):
(a) Active institutional controls over disposal sites should be maintained for as long a period of time as is practicable after disposal; however, performance assessments that assess isolation of the wastes from the accessible environment shall not consider any contributions from active institutional controls for more than 100 years after disposal.
(b) Disposal systems shall be monitored after disposal to detect substantial and detrimental deviations from expected performance. This monitoring shall be done with techniques that do not jeopardize the isolation of the wastes and shall be conducted until there are no significant concerns to be addressed by further monitoring.
(c) Disposal sites shall be designated by the most permanent markers, records, and other passive institutional controls practicable to indicate the dangers of the wastes and their location.
(d) Disposal systems shall use different types of barriers to isolate the wastes from the accessible environment. Both engineered and natural barriers shall be included.
(e) Places where there has been mining for resources, or where there is a reasonable expectation of exploration for scarce or easily accessible resources, or where there is a significant concentration of any material that is not widely available from other sources, should be avoided in selecting disposal sites. Resources to be considered shall include minerals, petroleum or natural gas, valuable geologic formations, and ground waters that are either irreplaceable because there is no reasonable alternative source of drinking water available for substantial populations or that are vital to the preservation of unique and sensitive ecosystems. Such places shall not be used for disposal of the wastes covered by this part unless the favorable characteristics of such places compensate for their greater likelihood of being disturbed in the future.
(f) Disposal systems shall be selected so that removal of most of the wastes is not precluded for a reasonable period of time after disposal.
§ 191.15   Individual protection requirements.
(a) Disposal systems for waste and any associated radioactive material shall be designed to provide a reasonable expectation that, for 10,000 years after disposal, undisturbed performance of the disposal system shall not cause the annual committed effective dose, received through all potential pathways from the disposal system, to any member of the public in the accessible environment, to exceed 15 millirems (150 microsieverts).
(b) Annual committed effective doses shall be calculated in accordance with appendix B of this part.
(c) Compliance assessments need not provide complete assurance that the requirements of paragraph (a) of this section will be met. Because of the long time period involved and the nature of the processes and events of interest, there will inevitably be substantial uncertainties in projecting disposal system performance. Proof of the future performance of a disposal system is not to be had in the ordinary sense of the word in situations that deal with much shorter time frames. Instead, what is required is a reasonable expectation, on the basis of the record before the implementing agency, that compliance with paragraph (a) of this section will be achieved.
(d) Compliance with the provisions in this section does not negate the necessity to comply with any other applicable Federal regulations or requirements.
(e) The standards in this section shall be effective on January 19, 1994.
§ 191.16   Alternative provisions for disposal.
The Administrator may, by rule, substitute for any of the provisions of subpart B alternative provisions chosen after:
(a) The alternative provisions have been proposed for public comment in the Federal Register together with information describing the costs, risks, and benefits of disposal in accordance with the alternative provisions and the reasons why compliance with the existing provisions of Subpart B appears inappropriate;
(b) A public comment period of at least 90 days has been completed, during which an opportunity for public hearings in affected areas of the country has been provided; and
(c) The public comments received have been fully considered in developing the final version of such alternative provisions.
§ 191.17   Effective date.
The standards in this subpart shall be effective on November 18, 1985.
§ 191.21   Applicability.
(a) This subpart applies to:
(1) Radiation doses received by members of the public as a result of activities subject to subpart B of this part; and
(2) Radioactive contamination of underground sources of drinking water in the accessible environment as a result of such activities.
(b) This subpart does not apply to:
(1) Disposal directly into the oceans or ocean sediments;
(2) Wastes disposed of before the effective date of this subpart; and
(3) The characterization, licensing, construction, operation, or closure of any site required to be characterized under section 113(a) of Public Law 97-425, 96 Stat. 2201.
§ 191.22   Definitions.
Unless otherwise indicated in this subpart, all terms have the same meaning as in subparts A and B of this part.
Public water system means a system for the provision to the public of piped water for human consumption, if such system has at least fifteen service connections or regularly serves at least twenty-five individuals. Such term includes:
(1) Any collection, treatment, storage, and distribution facilities under control of the operator of such system and used primarily in connection with such system; and
(2) Any collection or pretreatment storage facilities not under such control which are used primarily in connection with such system.
Total dissolved solids means the total dissolved (filterable) solids in water as determined by use of the method specified in 40 CFR part 136.
Underground source of drinking water means an aquifer or its portion which:
(1) Supplies any public water system; or
(2) Contains a sufficient quantity of ground water to supply a public water system; and
(i) Currently supplies drinking water for human consumption; or
(ii) Contains fewer than 10,000 milligrams of total dissolved solids per liter.
§ 191.23   General provisions.
(a) Determination of compliance with this subpart shall be based upon underground sources of drinking water which have been identified on the date the implementing agency determines compliance with subpart C of this part.
(b) [Reserved]
§ 191.24   Disposal standards.
(a) Disposal systems.
(1) General. Disposal systems for waste and any associated radioactive material shall be designed to provide a reasonable expectation that 10,000 years of undisturbed performance after disposal shall not cause the levels of radioactivity in any underground source of drinking water, in the accessible environment, to exceed the limits specified in 40 CFR part 141 as they exist on January 19, 1994.
(2) Disposal systems above or within a formation which within one-quarter ( 1/4 ) mile contains an underground source of drinking water. [Reserved]
(b) Compliance assessments need not provide complete assurance that the requirements of paragraph (a) of this section will be met. Because of the long time period involved and the nature of the processes and events of interest, there will inevitably be substantial uncertainties in projecting disposal system performance. Proof of the future performance of a disposal system is not to be had in the ordinary sense of the word in situations that deal with much shorter time frames. Instead, what is required is a reasonable expectation, on the basis of the record before the implementing agency, that compliance with paragraph (a) of this section will be achieved.
§ 191.25   Compliance with other Federal regulations.
Compliance with the provisions in this subpart does not negate the necessity to comply with any other applicable Federal regulations or requirements.
§ 191.26   Alternative provisions.
The Administrator may, by rule, substitute for any of the provisions of this subpart alternative provisions chosen after:
(a) The alternative provisions have been proposed for public comment in the Federal Register together with information describing the costs, risks, and benefits of disposal in accordance with the alternative provisions and the reasons why compliance with the existing provisions of this subpart appears inappropriate;
(b) A public comment period of at least 90 days has been completed, during which an opportunity for public hearings in affected areas of the country has been provided; and
(c) The public comments received have been fully considered in developing the final version of such alternative provisions.
§ 191.27   Effective date.
The standards in this subpart shall be effective on January 19, 1994.