Atomic Energy Act of 1954, as amended; Reorganization Plan No. 3, of 1970.
The provisions of this part apply to radiation doses received by members of the public in the general environment and to radioactive materials introduced into the general environment as the result of operations which are part of a nuclear fuel cycle.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
Operations covered by this subpart shall be conducted in such a manner as to provide reasonable assurance that:
(a) The annual dose equivalent does not exceed 25 millirems to the whole body, 75 millirems to the thyroid, and 25 millirems to any other organ of any member of the public as the result of exposures to planned discharges of radioactive materials, radon and its daughters excepted, to the general environment from uranium fuel cycle operations and to radiation from these operations.
(b) The total quantity of radioactive materials entering the general environment from the entire uranium fuel cycle, per gigawatt-year of electrical energy produced by the fuel cycle, contains less than 50,000 curies of krypton-85, 5 millicuries of iodine-129, and 0.5 millicuries combined of plutonium-239 and other alpha-emitting transuranic radionuclides with half-lives greater than one year.
The standards specified in § 190.10 may be exceeded if:
(a) The regulatory agency has granted a variance based upon its determination that a temporary and unusual operating condition exists and continued operation is in the public interest, and
(b) Information is promptly made a matter of public record delineating the nature of unusual operating conditions, the degree to which this operation is expected to result in levels in excess of the standards, the basis of the variance, and the schedule for achieving conformance with the standards.
(a) The standards in § 190.10(a) shall be effective December 1, 1979, except that for doses arising from operations associated with the milling of uranium ore the effective date shall be December 1, 1980.
(b) The standards in § 190.10(b) shall be effective December 1, 1979, except that the standards for krypton-85 and iodine-129 shall be effective January 1, 1983, for any such radioactive materials generated by the fission process after these dates.
The Atomic Energy Act of 1954, as amended, 42 U.S.C. 2011-2296; Reorganization Plan No. 3 of 1970, 5 U.S.C. app. 1; the Nuclear Waste Policy Act of 1982, as amended, 42 U.S.C. 10101-10270; and the Waste Isolation Pilot Plant Land Withdrawal Act, Pub. L. 102-579, 106 Stat. 4777.
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.
Unless otherwise indicated in this subpart, all terms shall have the same meaning as in Subpart A of Part 190.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(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 manage-ment 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.
(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.
The standards in this subpart shall be effective on November 18, 1985.
(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.
Unless otherwise indicated in this subpart, all terms shall have the same meaning as in subpart A of this part.
(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
(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.
(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
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 eco-systems. Such places shall not be used for disposal of the wastes covered by this part unless the favorable char-acter-is-tics of such places com-pen-sate for their greater likelihood of being dis-turbed 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.
(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.
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
(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.
The standards in this subpart shall be effective on November 18, 1985.
(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.
Unless otherwise indicated in this subpart, all terms have the same meaning as in subparts A and B of this part.
(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.
(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.
(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]
(a) Disposal systems.
(1)
(2)
(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.
Compliance with the provisions in this subpart does not negate the necessity to comply with any other applicable Federal regulations or requirements.
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
(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.
The standards in this subpart shall be effective on January 19, 1994.
(a) An amount of spent nuclear fuel containing 1,000 metric tons of heavy metal (MTHM) exposed to a burnup between 25,000 megawatt-days per metric ton of heavy metal (MWd/MTHM) and 40,000 MWd/MTHM;
(b) The high-level radioactive wastes generated from reprocessing each 1,000 MTHM exposed to a burnup between 25,000 MWd/MTHM and 40,000 MWd/MTHM;
(c) Each 100,000,000 curies of gamma or beta-emitting radionuclides with half-lives greater than 20 years but less than 100 years (for use as discussed in Note 5 or with materials that are identified by the Commission as high-level radioactive waste in accordance with part B of the definition of high-level waste in the NWPA);
(d) Each 1,000,000 curies of other radionuclides (i.e., gamma or beta-emitters with half-lives greater than 100 years or any alpha-emitters with half-lives greater than 20 years) (for use as discussed in Note 5 or with materials that are identified by the Commission as high-level radioactive waste in accordance with part B of the definition of high-level waste in the NWPA); or
(e) An amount of transuranic (TRU) wastes containing one million curies of alpha-emitting transuranic radionuclides with half-lives greater than 20 years.
(a) If a particular disposal system contained the high-level wastes from 50,000 MTHM, the Release Limits for that system would be the quantities in Table 1 multiplied by 50 (50,000 MTHM divided by 1,000 MTHM).
(b) If a particular disposal system contained three million curies of alpha-emitting transuranic wastes, the Release Limits for that system would be the quantities in Table 1 multiplied by three (three million curies divided by one million curies).
(c) If a particular disposal system contained both the high-level wastes from 50,000 MTHM
For example, if a particular disposal system contained only high-level wastes with an average burnup of 3,000 MWd/MTHM, the unit of waste for that disposal system would be:
If that disposal system contained the high-level wastes from 60,000 MTHM (with an average burnup of 3,000 MWd/MTHM), then the Release Limits for that system would be the quantities in Table 1 multiplied by ten:
For example, if radionuclides A, B, and C are projected to be released in amounts Q
The calculation of the committed effective dose (CED) begins with the determination of the equivalent dose, H
The next step is the calculation of the effective dose, E. The probability of occurrence of a stochastic effect in a tissue or organ is assumed to be proportional to the equivalent dose in the tissue or organ. The constant of proportionality differs for the various tissues of the body, but in assessing health detriment the total risk is required. This is taken into account using the tissue weighting factors, w
For internal irradiation from incorporated radionuclides, the total absorbed dose will be spread out in time, being gradually delivered as the radionuclide decays. The time distribution of the absorbed dose rate will vary with the radionuclide, its form, the mode of intake and the tissue within which it is incorporated. To take account of this distribution the quantity committed equivalent dose, HΤ(τ) where is the integration time in years following an intake over any particular year, is used and is the integral over time of the equivalent dose rate in a particular tissue or organ that will be received by an individual following an intake of radioactive material into the body. The time period, τ, is taken as 50 years as an average time of exposure following intake:
If the committed equivalent doses to the individual tissues or organs resulting from an annual intake are multiplied by the appropriate weighting factors, w
[
The Agency believes that the implementing agencies must determine compliance with §§ 191.13, 191.15, and 191.16 of subpart B by evaluating long-term predictions of disposal system performance. Determining compliance with § 191.13 will also involve predicting the likelihood of events and processes that may disturb the disposal system. In making these various predictions, it will be appropriate for the implementing agencies to make use of rather complex computational models, analytical theories, and prevalent expert judgment relevant to the numerical predictions. Substantial uncertainties are likely to be encountered in making these predictions. In fact, sole reliance on these numerical predictions to determine compliance may not be appropriate; the implementing agencies may choose to supplement such predictions with qualitative judgments as well. Because the procedures for determining compliance with subpart B have not been formulated and tested yet, this appendix to the rule indicates the Agency's assumptions regarding certain issues that may arise when implementing §§ 191.13, 191.15, and 191.16. Most of this guidance applies to any type of disposal system for the wastes covered by this rule. However, several sections apply only to disposal in mined geologic repositories and would be inappropriate for other types of disposal systems.
Sec. 275 of the Atomic Energy Act of 1954, 42 U.S.C. 2022, as added by the Uranium Mill Tailings Radiation Control Act of 1978, Pub. L. 95-604, as amended.
This subpart applies to the control of residual radioactive material at designated processing or depository sites under section 108 of the Uranium Mill Tailings Radiation Control Act of 1978 (henceforth designated “the Act”), and to restoration of such sites following any use of subsurface minerals under section 104(h) of the Act.
(a)
(1) Waste (which the Secretary determines to be radioactive) in the form of tailings resulting from the processing of ores for the extraction of uranium and other valuable constituents of the ores; and
(2) Other wastes (which the Secretary determines to be radioactive) at a processing site which relate to such processing, including any residual stock of unprocessed ores or low-grade materials.
(b)
(c)
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(1) Any site, including the mill, designated by the Secretary under Section 102(a)(1) of the Act; and
(2) Any other real property or improvement thereon which is in the vicinity of such site, and is determined by the Secretary, in consultation with the Commission, to be contaminated with residual radioactive materials derived from such site.
(m)
(n)
(o)
(p)
(q)
(r)
(1)(i) Which supplies any public water system as defined in § 141.2 of this chapter; or
(ii) Which contains a sufficient quantity of groundwater to supply a public water system; and
(A) Currently supplies drinking water for human consumption; or
(B) Contains fewer than 10,000 mg/l total dissolved solids; and
(2) Which is not an exempted aquifer as defined in § 144.7 of this chapter.
Control of residual radioactive materials and their listed constituents shall be designed
(a) Be effective for up to one thousand years, to the extent reasonably achievable, and, in any case, for at least 200 years, and,
(b) Provide reasonable assurance that releases of radon-222 from residual radioactive material to the atmosphere will not:
(1) Exceed an average
(2) Increase the annual average concentration of radon-222 in air at or above any location outside the disposal site by more than one-half picocurie per liter.
(c) Provide reasonable assurance of conformance with the following groundwater protection provisions:
(1) The Secretary shall, on a site-specific basis, determine which of the constituents listed in Appendix I to Part 192 are present in or reasonably derived from residual radioactive materials and shall establish a monitoring program adequate to determine background levels of each such constituent in groundwater at each disposal site.
(2) The Secretary shall comply with conditions specified in a plan for remedial action which includes engineering specifications for a system of disposal designed to ensure that constituents identified under paragraph (c)(1) of this section entering the groundwater from a depository site (or a processing site, if residual radioactive materials are retained on the site) will not exceed the concentration limits established under paragraph (c)(3) of this section (or the supplemental standards established under § 192.22) in the uppermost aquifer underlying the site beyond the point of compliance established under paragraph (c)(4) of this section.
(3) Concentration limits:
(i) Concentration limits shall be determined in the groundwater for listed constituents identified under paragraph (c)(1) of this section. The concentration of a listed constituent in groundwater must not exceed:
(A) The background level of that constituent in the groundwater; or
(B) For any of the constituents listed in Table 1 to subpart A, the respective value given in that Table if the background level of the constituent is below the value given in the Table; or
(C) An alternate concentration limit established pursuant to paragraph (c)(3)(ii) of this section.
(ii)(A) The Secretary may apply an alternate concentration limit if, after considering remedial or corrective actions to achieve the levels specified in paragraphs (c)(3)(i)(A) and (B) of this section, he has determined that the constituent will not pose a substantial present or potential hazard to human health and the environment as long as the alternate concentration limit is not exceeded, and the Commission has concurred.
(B) In considering the present or potential hazard to human health and the
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(4) Point of compliance: The point of compliance is the location at which the groundwater concentration limits of paragraph (c)(3) of this section apply. The point of compliance is the intersection of a vertical plane with the uppermost aquifer underlying the site, located at the hydraulically downgradient limit of the disposal area plus the area taken up by any liner, dike, or other barrier designed to contain the residual radioactive material.
(d) Each site on which disposal occurs shall be designed and stabilized in a manner that minimizes the need for future maintenance.
A groundwater monitoring plan shall be implemented, to be carried out over a period of time commencing upon completion of remedial actions taken to comply with the standards in § 192.02, and of a duration which is adequate to demonstrate that future performance of the system of disposal can reasonably be expected to be in accordance with the design requirements of § 192.02(c). This plan and the length of the monitoring period shall be modified to incorporate any corrective actions required under § 192.04 or § 192.12(c).
If the groundwater concentration limits established for disposal sites under provisions of § 192.02(c) are found or projected to be exceeded, a corrective action program shall be placed into operation as soon as is practicable, and in no event later than eighteen (18) months after a finding of exceedance. This corrective action program will restore the performance of the system of disposal to the original concentration limits established under
(a) Conform with the groundwater provisions of § 192.02(c)(3), and
(b) Clean up groundwater in conformance with subpart B, modified as appropriate to apply to the disposal site.
This subpart applies to land and buildings that are part of any processing site designated by the Secretary of Energy under section 102 of the Act. section 101 of the Act, states, in part, that “processing site” means—
(a) Any site, including the mill, containing residual radioactive materials at which all or substantially all of the uranium was produced for sale to any Federal agency prior to January 1, 1971, under a contract with any Federal agency, except in the case of a site at or near Slick Rock, Colorado, unless—
(1) Such site was owned or controlled as of Januray 1, 1978, or is thereafter owned or controlled, by any Federal agency, or
(2) A license (issued by the (Nuclear Regulatory) Commission or its predecessor agency under the Atomic Energy Act of 1954 or by a State as permitted under section 274 of such Act) for the production at site of any uranium or thorium product derived from ores is in effect on January 1, 1978, or is issued or renewed after such date; and
(b) Any other real property or improvement thereon which—
(1) Is in the vicinity of such site, and
(2) Is determined by the Secretary, in consultation with the Commission, to be contaminated with residual radioactive materials derived from such site.
(a) Unless otherwise indicated in this subpart, all terms shall have the same meaning as defined in subpart A.
(b)
(c)
(d)
(e)
Remedial actions shall be conducted so as to provide reasonable assurance that,
(a) The concentration of radium-226 in land averaged over any area of 100 square meters shall not exceed the background level by more than—
(1) 5 pCi/g, averaged over the first 15 cm of soil below the surface, and
(2) 15 pCi/g, averaged over 15 cm thick layers of soil more than 15 cm below the surface.
(b) In any occupied or habitable building—
(1) The objective of remedial action shall be, and reasonable effort shall be made to achieve, an annual average (or equivalent) radon decay product concentration (including background) not to exceed 0.02 WL. In any case, the radon decay product concentration (including background) shall not exceed 0.03 WL, and
(2) The level of gamma radiation shall not exceed the background level by more than 20 microroentgens per hour.
(c) The Secretary shall comply with conditions specified in a plan for remedial action which provides that contamination of groundwater by listed constituents from residual radioactive material at any designated processing site (§ 192.01(1)) shall be brought into compliance as promptly as is reasonably achievable with the provisions of § 192.02(c)(3) or any supplemental standards established under § 192.22. For the purposes of this subpart:
(1) A monitoring program shall be carried out that is adequate to define backgroundwater quality and the areal extent and magnitude of groundwater contamination by listed constituents from residual radioactive materials (§ 192.02(c)(1)) and to monitor compliance with this subpart. The Secretary shall determine which of the constituents listed in Appendix I to part 192 are present in or could reasonably be derived from residual radioactive material at the site, and concentration limits shall be established in accordance with § 192.02(c)(3).
(2) (i) If the Secretary determines that sole reliance on active remedial procedures is not appropriate and that cleanup of the groundwater can be more reasonably accomplished in full or in part through natural flushing, then the period for remedial procedures may be extended. Such an extended period may extend to a term not to exceed 100 years if:
(A) The concentration limits established under this subpart are projected to be satisfied at the end of this extended period,
(B) Institutional control, having a high degree of permanence and which will effectively protect public health and the environment and satisfy beneficial uses of groundwater during the extended period and which is enforceable by the administrative or judicial branches of government entities, is instituted and maintained, as part of the remedial action, at the processing site and wherever contamination by listed constituents from residual radioactive materials is found in groundwater, or is projected to be found, and
(C) The groundwater is not currently and is not now projected to become a source for a public water system subject to provisions of the Safe Drinking Water Act during the extended period.
(ii) Remedial actions on groundwater conducted under this subpart may occur before or after actions under Section 104(f)(2) of the Act are initiated.
(3) Compliance with this subpart shall be demonstrated through the monitoring program established under paragraph (c)(1) of this section at those locations not beneath a disposal site
Section 108 of the Act requires the Secretary of Energy to select and perform remedial actions with the concurrence of the Nuclear Regulatory Commission and the full participation of any State that pays part of the cost, and in consultation, as appropriate, with affected Indian Tribes and the Secretary of the Interior. These parties, in their respective roles under section 108, are referred to hereafter as “the implementing agencies.” The implementing agencies shall establish methods and procedures to provide “reasonable assurance” that the provisions of Subparts A and B are satisfied. This should be done as appropriate through use of analytic models and site-specific analyses, in the case of Subpart A, and for Subpart B through measurements performed within the accuracy of currently available types of field and laboratory instruments in conjunction with reasonable survey and sampling procedures. These methods and procedures may be varied to suit conditions at specific sites. In particular:
(a)(1) The purpose of Subpart A is to provide for long-term stabilization and isolation in order to inhibit misuse and spreading of residual radioactive materials, control releases of radon to air, and protect water. Subpart A may be implemented through analysis of the physical properties of the site and the control system and projection of the effects of natural processes over time. Events and processes that could significantly affect the average radon release rate from the entire disposal site should be considered. Phenomena that are localized or temporary, such as local cracking or burrowing of rodents, need to be taken into account only if their cumulative effect would be significant in determining compliance with the standard. Computational models, theories, and prevalent expert judgment may be used to decide that a control system design will satisfy the standard. The numerical range provided in the standard for the longevity of the effectiveness of the control of residual radioactive materials allows for consideration of the various factors affecting the longevity of control and stabilization methods and their costs. These factors have different levels of predictability and may vary for the different sites.
(2) Protection of water should be considered on a case-specific basis, drawing on hydrological and geochemical surveys and all other relevant data. The hydrologic and geologic assessment to be conducted at each site should include a monitoring program sufficient to establish background groundwater quality through one or more upgradient or other appropriately located wells. The groundwater monitoring list in Appendix IX of part 264 of this chapter (plus the additional constituents in Table A of this paragraph) may be used for screening purposes in place of Appendix I of part 192 in the monitoring program. New depository sites for tailings that contain water at greater than the level of “specific retention” should use aliner or equivalent. In considering design objectives for groundwater protection, the implementing agencies should give priority to concentration levels in the order listed under § 192.02(c)(3)(i). When considering the potential for health risks caused by human exposure to known or suspected carcinogens, alternate concentration limits pursuant to paragraph 192.02(c)(3)(ii) should be established at concentration levels which represent an excess lifetime risk, at a point of exposure, to an average individual no greater than between 10
(3) The plan for remedial action, concurred in by the Commission, will specify how applicable requirements of subpart A are to be satisfied. The plan
(4) The groundwater monitoring list in Appendix IX of part 264 of this chapter (plus the additional constituents in Table A in paragraph (a)(2) of this section) may be used for screening purposes in place of Appendix I of part 192 in monitoring programs. The monitoring plan required under § 192.03 should be designed to include verification of site-specific assumptions used to project the performance of the disposal system. Prevention of contamination of groundwater may be assessed by indirect methods, such as measuring the migration of moisture in the various components of the cover, the tailings, and the area between the tailings and the nearest aquifer, as well as by direct monitoring of groundwater. In the case of vicinity properties (§ 192.01(l)(2)), such assessments may not be necessary, as determined by the Secretary, with the concurrence of the Commission, considering such factors as local geology and the amount of contamination present. Temporary excursions from applicable limits of groundwater concentrations that are attributable to a disposal operation itself shall not constitute a basis for considering corrective action under § 192.04 during the disposal period, unless the disposal operation is suspended prior to completion for other than seasonal reasons.
(b)(1) Compliance with § 192.12(a) and (b) of subpart B, to the extent practical, should be demonstrated through radiation surveys. Such surveys may, if appropriate, be restricted to locations likely to contain residual radioactive materials. These surveys should be designed to provide for compliance averaged over limited areas rather than point-by-point compliance with the standards. In most cases, measurement of gamma radiation exposure rates above and below the land surface can be used to show compliance with § 192.12(a). Protocols for making such measurements should be based on realistic radium distributions near the surface rather than extremes rarely encountered.
(2) In § 192.12(a), “background level” refers to the native radium concentration in soil. Since this may not be determinable in the presence of contamination by residual radioactive materials, a surrogate “background level” may be established by simple direct or indirect (e.g., gamma radiation) measurements performed nearby but outside of the contaminated location.
(3) Compliance with § 192.12(b) may be demonstrated by methods that the Department of Energy has approved for use under Pub. L. 92-314 (10 CFR part 712), or by other methods that the implementing agencies determine are adequate. Residual radioactive materials should be removed from buildings exceeding 0.03 WL so that future replacement buildings will not pose a hazard [unless removal is not practical—see § 192.21(c)]. However, seal-ants, filtration, and ventilation devices may provide reasonable as-sur-ance of reductions from 0.03 WL to below 0.02 WL. In unusual cases, indoor radiation may exceed the levels specified in § 192.12(b) due to sources other than residual radioactive materials. Re-medial actions are not required in order to comply with the standard when there is reasonable assurance that residual radioactive materials are not the cause of such an excess.
(4) The plan(s) for remedial action will specify how applicable requirements of subpart B would be satisfied. The plan should include the schedule and steps necessary to complete the cleanup of groundwater at the site. It should document the extent of contamination due to releases prior to final disposal, including the identification and location of listed constituents and the rate and direction of movement of contaminated groundwater, based upon the monitoring carried out under § 192.12(c)(1). In addition, the assessment should consider future plume movement, including an evaluation of such processes as attenuation and dilution and future contamination from beneath a disposal site. Monitoring for assessment and compliance purposes should be sufficient to establish the extent and magnitude of contamination, with reasonable assurance, through use of a carefully chosen minimal number of sampling locations. The location and number of monitoring wells, the frequency and duration of monitoring, and the selection of indicator analytes for long-term groundwater monitoring, and, more generally, the design and operation of the monitoring system, will depend on the potential for risk to receptors and upon other factors, including characteristics of the subsurface environment, such as velocity of groundwater flow, contaminant retardation, time of groundwater or contaminant transit to receptors, results of statistical evaluations of data trends, and modeling of the dynamics of the groundwater system. All of these factors should be incorporated into the design of a site-specific monitoring program that will achieve the purpose of the regulations in this subpart in the most cost-effective manner. In the case of vicinity properties (§ 192.01(l)(2)), such assessments will usually not be necessary. The Secretary, with the concurrence of the Commission, may consider such factors as local geology and amount of contamination present in determining criteria to decide when such assessments are needed. In cases where § 192.12(c)(2) is invoked, the plan should include a monitoring program sufficient to verify projections of plume movement and attenuation periodically during the extended cleanup period. Finally, the plan should specify details of the method to be used for cleanup of groundwater.
Unless otherwise indicated in this subpart, all terms shall have the same meaning as defined in Title I of the Act or in subparts A and B. The implementing agencies may (and in the case of paragraph (h) of this section shall) apply standards under § 192.22 in lieu of the standards of subparts A or B if they determine that any of the following circumstances exists:
(a) Remedial actions required to satisfy subpart A or B would pose a clear and present risk of injury to workers or to members of the public, notwithstanding reasonable measures to avoid or reduce risk.
(b) Remedial actions to satisfy the cleanup standards for land, § 192.12(a), and groundwater, § 192.12(c), or the acquisition of minimum materials required for control to satisfy §§ 192.02(b) and (c), would, notwithstanding reasonable measures to limit damage, directly produce health and environmental harm that is clearly excessive compared to the health and environmental benefits, now or in the future. A clear excess of health and environmental harm is harm that is long-term, manifest, and grossly disproportionate to health and environmental benefits that may reasonably be anticipated.
(c) The estimated cost of remedial action to satisfy § 192.12(a) at a “vicinity” site (described under section 101(6)(B) of the Act) is unreasonably high relative to the long-term benefits, and the residual radioactive materials do not pose a clear present or future hazard. The likelihood that buildings will be erected or that people will spend long periods of time at such a vicinity site should be considered in evaluating this hazard. Remedial action will generally not be necessary where residual radioactive materials have been placed semi-permanently in a location where site-specific factors limit their hazard and from which they are costly or difficult to remove, or
(d) The cost of a remedial action for cleanup of a building under § 192.12(b) is clearly unreasonably high relative to the benefits. Factors that should be included in this judgment are the anticipated period of occupancy, the incremental radiation level that would be affected by the remedial action, the residual useful lifetime of the building, the potential for future construction at the site, and the applicability of less costly remedial methods than removal of residual radioactive materials.
(e) There is no known remedial action.
(f) The restoration of groundwater quality at any designated processing site under § 192.12(c) is technically impracticable from an engineering perspective.
(g) The groundwater meets the criteria of § 192.11(e).
(h) Radionuclides other than radium-226 and its decay products are present in sufficient quantity and concentration to constitute a significant radiation hazard from residual radioactive materials.
Federal agencies implementing subparts A and B may in lieu thereof proceed pursuant to this section with respect to generic or individual situations meeting the eligibility requirements of § 192.21.
(a) When one or more of the criteria of § 192.21(a) through (g) applies, the Secretary shall select and perform that alternative remedial action that comes as close to meeting the otherwise applicable standard under § 192.02(c)(3) as is reasonably achievable.
(b) When § 192.21(h) applies, remedial actions shall reduce other residual radioactivity to levels that are as low as is reasonably achievable and conform to the standards of subparts A and B to the maximum extent practicable.
(c) The implementing agencies may make general determinations concerning remedial actions under this section that will apply to all locations with specified characteristics, or they may make a determination for a specific location. When remedial actions are proposed under this section for a specific location, the Department of Energy shall inform any private owners and occupants of the affected location and solicit their comments. The Department of Energy shall provide any such comments to the other implementing agencies. The Department of Energy shall also periodically inform the Environmental Protection Agency of both general and individual determinations under the provisions of this section.
(d) When § 192.21(b), (f), or (g) apply, implementing agencies shall apply any remedial actions for the restoration of contamination of groundwater by residual radioactive materials that is required to assure, at a minimum, protection of human health and the environment. In addition, when § 192.21(g) applies, supplemental standards shall ensure that current and reasonably projected uses of the affected groundwater are preserved.
Subparts A, B, and C shall be effective March 7, 1983.
This subpart applies to the management of uranium byproduct materials under section 84 of the Atomic Energy Act of 1954 (henceforth designated “the
References in this subpart to other parts of the Code of Federal Regulations are to those parts as codified on January 1, 1983.
(a) Unless otherwise indicated in this subpart, all terms shall have the same meaning as in Title II of the Uranium Mill Tailings Rediation Control Act of 1978, subparts A and B of this part, or parts 190, 260, 261, and 264 of this chapter. For the purposes of this subpart, the terms “waste,” “hazardous waste,” and related terms, as used in parts 260, 261, and 264 of this chapter shall apply to byproduct material.
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(a)
(2) Uranium byproduct materials shall be managed so as to conform to the ground water protection standard in § 264.92 of this chapter, except that for the purposes of this subpart:
(i) To the list of hazardous constituents referenced in § 264.93 of this chapter are added the chemical elements molybdenum and uranium,
(ii) To the concentration limits provided in Table 1 of § 264.94 of this chapter are added the radioactivity limits in Table A of this subpart,
(iii) Detection monitoring programs required under § 264.98 to establish the standards required under § 264.92 shall be completed within one (1) year of promulgation,
(iv) The regulatory agency may establish alternate concentration limits (to be satisfied at the point of compliance specified under § 264.95) under the criteria of § 264.94(b), provided that, after considering practicable corrective actions, these limits are as low as reasonably achievable, and that, in any case, the standards of § 264.94(a) are satisfied at all points at a greater distance than 500 meters from the edge of the disposal area and/or outside the site boundary, and
(v) The functions and responsibilities designated in Part 264 of this chapter as those of the “Regional Administrator” with respect to “facility permits” shall be carried out by the regulatory agency, except that exemptions of hazardous constituents under § 264.93 (b) and (c) of this chapter and alter-nate concentration limits established -under § 264.94 (b) and (c) of this chapter -(except as otherwise provided in -§ 192.32(a)(2)(iv)) shall not be effective until EPA has concurred therein.
(3)(i) Uranium mill tailings piles or impoundments that are nonoperational and subject to a license by the Nuclear Regulatory Commission or an Agreement State shall limit releases of radon-222 by emplacing a permanent radon barrier. This permanent radon barrier shall be constructed as expeditiously as practicable considering technological feasibility (including factors beyond the control of the licensee) after the pile or impoundment ceases to be operational. Such control shall be carried out in accordance with a written tailings closure plan (radon) to be incorporated by the Nuclear Regulatory Commission or Agreement State into individual site licenses.
(ii) The Nuclear Regulatory Commission or Agreement State may approve a licensee's request to extend the time for performance of milestones if, after providing an opportunity for public participation, the Nuclear Regulatory Commission or Agreement State finds that compliance with the 20 pCi/m
(iii) The Nuclear Regulatory Commission or Agreement State may extend the final compliance date for emplacement of the permanent radon barrier, or relevant milestone, based upon cost if the new date is established after a finding by the Nuclear Regulatory Commission or Agreement State, after providing an opportunity for public participation, that the licensee is making good faith efforts to emplace a permanent radon barrier; the delay is consistent with the definition of “available technology” in § 192.31(m); and the delay will not result in radon releases that are determined to result in significant incremental risk to the public health.
(iv) The Nuclear Regulatory Commission or Agreement State may, in response to a request from a licensee, authorize by license or license amendment a portion of the site to remain accessible during the closure process to accept uranium byproduct material as defined in section 11(e)(2) of the Atomic Energy Act, 42 U.S.C. 2014(e)(2), or to accept materials similar to the physical, chemical and radiological characteristics of the in situ uranium mill tailings and associated wastes, from other sources. No such authorization may be used as a means for delaying or otherwise impeding emplacement of the permanent radon barrier over the remainder of the pile or impoundment in a manner that will achieve compliance with the 20 pCi/m
(v) The Nuclear Regulatory Commission or Agreement State may, in response to a request from a licensee, authorize by license or license amendment a portion of a pile or impoundment to remain accessible after emplacement of a permanent radon barrier to accept uranium byproduct material as defined in section 11(e)(2) of the Atomic Energy Act, 42 U.S.C. 2014(e)(2), if compliance with the 20 pCi/m
(4)(i) Upon emplacement of the permanent radon barrier pursuant to 40 CFR 192.32(a)(3), the licensee shall conduct appropriate monitoring and analysis of the radon-222 releases to demonstrate that the design of the permanent radon barrier is effective in limiting releases of radon-222 to a level
(ii) When phased emplacement of the permanent radon barrier is included in the applicable tailings closure plan (radon), then radon flux monitoring required under § 192.32(a)(4)(i) shall be conducted, however the licensee shall be allowed to conduct such monitoring for each portion of the pile or impoundment on which the radon barrier has been emplaced by conducting flux monitoring on the closed portion.
(5) Uranium byproduct materials shall be managed so as to conform to the provisions of:
(i) Part 190 of this chapter, “Environmental Radiation Protection Standards for Nuclear Power Operations” and
(ii) Part 440 of this chapter, “Ore Mining and Dressing Point Source Category: Effluent Limitations Guidelines and New Source Performance Standards, Subpart C, Uranium, Radium, and Vanadium Ores Subcategory.”
(6) The regulatory agency, in conformity with Federal Radiation Protection Guidance (FR, May 18, 1960, pgs. 4402-4403), shall make every effort to maintain radiation doses from radon emissions from surface impoundments of uranium byproduct materials as far below the Federal Radiation Protection Guides as is practicable at each licensed site.
(b)
(1) Disposal areas shall each comply with the closure performance standard in § 264.111 of this chapter with respect to nonradiological hazards and shall be designed
(i) Be effective for one thousand years, to the extent reasonably achievable, and, in any case, for at least 200 years, and,
(ii) Limit releases of radon-222 from uranium byproduct materials to the atmosphere so as to not exceed an average
(2) The requirements of § 192.32(b)(1) shall not apply to any portion of a licensed and/or disposal site which contains a concentration of radium-226 in land, averaged over areas of 100 square meters, which, as a result of uranium byproduct material, does not exceed the background level by more than:
(i) 5 picocuries per gram (pCi/g), averaged over the first 15 centimeters (cm) below the surface, and
(ii) 15 pCi/g, averaged over 15 cm thick layers more than 15 cm below the surface.
If the ground water standards established under provisions of § 192.32(a)(2) are exceeded at any licensed site, a corrective action program as specified in § 264.100 of this chapter shall be put into operation as soon as is practicable, and in no event later than eighteen (18) months after a finding of exceedance.
Subpart D shall be effective December 6, 1983.
This subpart applies to the management of thorium byproduct materials under section 84 of the Atomic Energy Act of 1954, as amended, during and following processing of thorium ores, and to restoration of disposal sites following any use of such sites under section 83(b)(1)(B) of the Act.
Except as otherwise noted in § 192.41(e), the provisions of subpart D of this part, including §§ 192.31, 192.32, and 192.33, shall apply to thorium byproduct material and:
(a) Provisions applicable to the element uranium shall also apply to the element thorium;
(b) Provisions applicable to radon-222 shall also apply to radon-220; and
(c) Provisions applicable to radium-226 shall also apply to radium-228.
(d) Operations covered under § 192.32(a) shall be conducted in such a manner as to provide reasonable assurance that the annual dose equivalent does not exceed 25 millirems to the whole body, 75 millirems to the thyroid, and 25 millirems to any other organ of any member of the public as a result of exposures to the planned discharge of radioactive materials, radon-220 and its daughters excepted, to the general environment.
(e) The provisions of § 192.32(a) (3) and (4) do not apply to the management of thorium byproduct material.
The regulatory agency may, with the concurrence of EPA, substitute for any provisions of § 192.41 of this subpart alternative provisions it deems more practical that will provide at least an equivalent level of protection for human health and the environment.
Subpart E shall be effective December 6, 1983.
Pub. L. 102-579, 106 Stat. 4777, as amended by Pub. L. 104-201,110 Stat. 2422; Reorganization Plan No. 3 of 1970, 35 FR 15623, Oct. 6, 1970, 5 U.S.C. app. 1; Atomic Energy Act of 1954, as amended, 42 U.S.C. 2011-2296 and 10101-10270.
This part specifies criteria for the certification or any re-certification, or subsequent actions relating to the terms or conditions of certification of the Department of Energy's Waste Isolation Pilot Plant's compliance with the disposal regulations found at part 191 of this chapter and pursuant to section 8(d)(1) and section 8(f), respectively, of the WIPP LWA. The compliance certification application submitted pursuant to section 8(d)(1) of the WIPP LWA and any compliance re-certification application submitted pursuant to section 8(f) of the WIPP LWA shall comply with the requirements of this part.
Unless otherwise indicated in this part, all terms have the same meaning as in part 191 of this chapter.
(a) Compliance application(s) shall be:
(1) Addressed to the Administrator; and
(2) Signed by the Secretary.
(b) Communications and reports concerning the criteria in this part shall be:
(1) Addressed to the Administrator or the Administrator's authorized representative; and
(2) Signed by the Secretary or the Secretary's authorized representative.
(a) Any certification of compliance issued pursuant to section 8(d)(1) of the WIPP LWA may include such conditions as the Administrator finds necessary to support such certification.
(b) Whether stated therein or not, the following conditions shall apply in any such certification:
(1) The certification shall be subject to modification, suspension or revocation by the Administrator. Any suspension of the certification shall be done at the discretion of the Administrator. Any modification or revocation of the certification shall be done by rule pursuant to 5 U.S.C. 553. If the Administrator revokes the certification, the Department shall retrieve, as soon as practicable and to the extent practicable, any waste emplaced in the disposal system.
(2) Any time after the Administrator issues a certification, the Administrator or the Administrator's authorized representative may submit a written request to the Department for information to enable the Administrator to determine whether the certification should be modified, suspended or revoked. Unless otherwise specified by the Administrator or the Administrator's authorized representative, the Department shall submit such information to the Administrator or the Administrator's authorized representative
(3) Any time after the Administrator issues a certification, the Department shall report any planned or unplanned changes in activities or conditions pertaining to the disposal system that differ significantly from the most recent compliance application.
(i) The Department shall inform the Administrator, in writing, prior to making such a planned change in activity or disposal system condition.
(ii) In the event of an unplanned change in activity or condition, the Department shall immediately cease emplacement of waste in the disposal system if the Department determines that one or more of the following conditions is true:
(A) The containment requirements established pursuant to § 191.13 of this chapter have been or are expected to be exceeded;
(B) Releases from already-emplaced waste lead to committed effective doses that are or are expected to be in excess of those established pursuant to § 191.15 of this chapter. For purposes of this paragraph (b)(3)(ii)(B), emissions from operations covered pursuant to part 191, subpart A of this chapter are not included; or
(C) Releases have caused or are expected to cause concentrations of radionuclides or estimated doses due to radionuclides in underground sources of drinking water in the accessible environment to exceed the limits established pursuant to part 191, subpart C of this chapter.
(iii) If the Department determines that a condition described in paragraph (b)(3)(ii) of this section has occurred or is expected to occur, the Department shall notify the Administrator, in writing, within 24 hours of the determination. Such notification shall, to the extent practicable, include the following information:
(A) Identification of the location and environmental media of the release or the expected release;
(B) Identification of the type and quantity of waste (in activity in curies of each radionuclide) released or expected to be released;
(C) Time and date of the release or the estimated time of the expected release;
(D) Assessment of the hazard posed by the release or the expected release; and
(E) Additional information requested by the Administrator or the Administrator's authorized representative.
(iv) The Department may resume emplacement of waste in the disposal system upon written notification that the suspension has been lifted by the Administrator.
(v) If the Department discovers a condition or activity that differs significantly from what is indicated in the most recent compliance application, but does not involve conditions or activities listed in paragraph (b)(3)(ii) of this section, then the difference shall be reported, in writing, to the Administrator within 10 calendar days of its discovery.
(vi) Following receipt of notification, the Administrator will notify the Secretary in writing whether any condition or activity reported pursuant to paragraph (b)(3) this section:
(A) Does not comply with the terms of the certification; and, if it does not comply,
(B) Whether the compliance certification must be modified, suspended or revoked. The Administrator or the Administrator's authorized representative may request additional information before determining whether modification, suspension or revocation of the compliance certification is required.
(4) Not later than six months after the Administrator issues a certification, and at least annually thereafter, the Department shall report to the Administrator, in writing, any changes in conditions or activities pertaining to the disposal system that were not required to be reported by paragraph (b)(3) of this section and that differ from information contained in the most recent compliance application.
(a) The following publications are incorporated into this part by reference:
(1) U.S. Nuclear Regulatory Commission, NUREG-1297 “Peer Review for
(2) American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance (NQA) Standard, NQA-1-1989 edition, “Quality Assurance Program Requirements for Nuclear Facilities;” IBR approved for § 194.22.
(3) ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition “Quality Assurance Requirements for Nuclear Facility Applications;” IBR approved for § 194.22 and § 194.23.
(4) ASME NQA-3-1989 edition, “Quality Assurance Program Requirements for the Collection of Scientific and Technical Information for Site Characterization of High-Level Nuclear Waste Repositories” (excluding section 2.1 (b) and (c)); IBR approved for § 194.22.
(b) The publications listed in paragraph (a) of this section were approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be inspected or obtained from the Air Docket, Docket No. A-92-56, room M1500 (LE131), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, or copies may be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(1) For ASME standards, contact American Society of Mechanical Engineers, 22 Law Drive, P.O. Box 2900, Fairfield, NJ 07007-2900, phone 1-800-843-2763.
(2) For Nuclear Regulatory Commission documents, contact Division of Information Support Services, Distribution Service, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or contact National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161, phone 703-487-4650.
The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute for any of the provisions of this part alternative provisions, or minor alternative provisions, in accordance with the following procedures:
(a) Alternative provisions may be substituted after:
(1) Alternative provisions have been proposed for public comment in the
(2) A public comment period of at least 120 days has been completed and public hearings have been held in New Mexico;
(3) The public comments received have been fully considered; and
(4) A notice of final rulemaking is published in the
(b) Minor alternative provisions may be substituted after:
(1) The minor alternative provisions have been proposed for public comment in the
(2) A public comment period of at least 30 days has been completed for the minor alternative provisions and the public comments received have been fully considered;
(3) A notice of final rulemaking is published in the
The criteria in this part shall be effective on April 9, 1996. The incorporation by reference of certain publications listed in the criteria is approved by the Director of the Federal Register as of April 9, 1996.
(a)
(1) Upon submission by the Department of a site-specific quality assurance program plan the Agency will evaluate the plan to determine whether it establishes the applicable Nuclear Quality Assurance (NQA) requirements of § 194.22(a)(1) for the items and activities of §§ 194.22(a)(2)(i), 194.24(c)(3) and 194.24(c)(5). The program plan and other documentation submitted by the Department will be placed in the dockets described in § 194.67.
(2) The Agency will conduct a quality assurance audit or an inspection of a Department quality assurance audit at the relevant site for the purpose of verifying proper execution of the site-specific quality assurance program plan. The Agency will publish a notice in the
(3) The Agency's written decision regarding compliance with the requisite quality assurance requirements at a waste generator site will be conveyed in a letter from the Administrator's authorized representative to the Department. No such compliance determination shall be granted until after the end of the public comment period described in paragraph (a)(2) of this section. A copy of the Agency's compliance determination letter will be placed in the public dockets in accordance with § 194.67. The results of any inspections or audits conducted by the Agency to evaluate the quality assurance programs described in paragraph (a)(1) of this section will also be placed in the dockets described in § 194.67.
(4) Subsequent to any positive determination of compliance as described in paragraph (a)(3) of this section, the Agency intends to conduct inspections, in accordance with §§ 194.21 and 194.22(e), to confirm the continued compliance of the programs approved under paragraphs (a)(2) and (a)(3) of this section. The results of such inspections will be made available to the public through the Agency's public dockets, as described in § 194.67.
(b)
(1) DOE will implement waste characterization programs and processes in accordance with § 194.24(c)(4) to confirm that the total amount of each waste component that will be emplaced in the disposal system will not exceed the upper limiting value or fall below the lower limiting value described in the introductory text of § 194.24(c). Waste characterization processes will include the collection and use of acceptable knowledge; destructive and/or nondestructive techniques for identifying and measuring waste components; and the validation, control, and transmittal to the WIPP Waste Information System database of waste characterization data, in accordance with § 194.24(c)(4).
(2) The Agency will verify the compliance of waste characterization programs and processes identified in paragraph (b)(1) of this section at sites without EPA approval prior to October 14, 2004, using the following process:
(i) DOE will notify EPA by letter that a transuranic waste site is prepared to ship waste to the WIPP and has established adequate waste characterization processes and programs. DOE also will provide the relevant waste characterization program plans and documentation. EPA may request additional information from DOE.
(ii) EPA will conduct a baseline compliance inspection at the site to verify that adequate waste characterization program plans and technical procedures have been established, and that those plans and procedures are effectively implemented. The inspection will include a demonstration or test by the site of the waste characterization processes identified in paragraph (b)(1) of this section. If an inspection does not lead to approval, we will send an
(iii) The Agency will announce in the
(iv) Our written decision regarding compliance with the requirements for waste characterization programs and processes described in paragraph (b)(1) of this section will be conveyed in a letter from the Administrator's authorized representative to DOE. EPA will not issue a compliance decision until after the end of the public comment period described in paragraph (b)(2)(iii) of this section. EPA's compliance decision will respond to significant and timely-received comments. A copy of our compliance decision will be placed in the public docket described in § 194.67. DOE will comply with any requirements identified in the compliance decision and the accompanying inspection report.
(3) Subsequent to any positive determination of compliance as described in paragraph (b)(2)(iv) of this section, the Agency intends to conduct inspections, in accordance with § 194.24(h), to confirm the continued compliance of approved waste characterization programs and processes at transuranic waste sites. EPA will make the results of these inspections available to the public in the dockets described in § 194.67.
(4) Subsequent to any positive determination of compliance as described in paragraph (b)(2)(iv) of this section, the Department must report changes or expansions to the approved waste characterization program at a site in accordance with the tier designations established in the Baseline Compliance Decision.
(i) For changes or expansions to the waste characterization program designated as “Tier 1,” the Department shall provide written notification to the Agency. The Department shall not ship for disposal at WIPP any waste that has been characterized using the new or revised processes, equipment, or waste streams until EPA has provided written approval of such new or revised systems.
(ii) For changes or expansions to the waste characterization program designated as “Tier 2,” the Department shall provide written notification to the Agency. Waste characterized using the new or revised processes, equipment, or waste streams may be disposed at WIPP without written EPA approval.
(iii) EPA may conduct inspections in accordance with § 194.24(h) to evaluate the implementation of Tier 1 and Tier 2 changes or expansions to the waste characterization program at a site.
(iv) Waste characterization program changes or expansions that are not identified as either “Tier 1” or “Tier 2” will not require written notification by the Department to the Agency before implementation or before shipping waste for disposal at WIPP.
(5) Subsequent to any positive determination of compliance as described in paragraph (b)(2)(iii) of this section, EPA may revise the tier designations for approving changes or expansions to the waste characterization program at a site using the following process:
(i) The Agency shall announce the proposed tier changes in a letter to the Department. The letter will describe the Agency's reasons for the proposed change in tier designation(s). The letter and any supporting inspection report(s) or other documentation will be placed in the dockets described in § 194.67.
(ii) If the revised designation entails more stringent notification and approval requirements (
(iii) If the revised designated entails less stringent notification and approval requirements, (
(6) A waste generator site that EPA approved for characterizing and disposing transuranic waste at the WIPP under this section prior to October 14, 2004, may continue characterizing and disposing such waste at the WIPP under paragraph (c) of this section until EPA has conducted a baseline compliance inspection and provided a Baseline Compliance Decision under paragraph (b)(2) of this section.
(i) Until EPA provides a Baseline Compliance Decision for such a site, EPA may approve additional transuranic waste streams for disposal at WIPP under the provisions of paragraph (c) of this section. Prior to the effective date of EPA's Baseline Compliance Decision for such a site, EPA will continue to conduct inspections of the site in accordance with § 194.24(c).
(ii) EPA shall conduct a baseline compliance inspection and issue a Baseline Compliance Decision for such previously approved sites in accordance with the provisions of paragraph (b) of this section, except that the site shall not be required to provide written notification of readiness as described in paragraph (b)(2)(i) of this section.
(c)
(1) For each waste stream or group of waste streams at a site, the Department must:
(i) Provide information on how process knowledge will be used for waste characterization of the waste stream(s) proposed for disposal at the WIPP; and
(ii) Implement a system of controls at the site, in accordance with § 194.24(c)(4), to confirm that the total amount of each waste component that will be emplaced in the disposal system will not exceed the upper limiting value or fall below the lower limiting value described in the introductory text of § 194.24(c). The implementation of such a system of controls shall include a demonstration that the site has procedures in place for adding data to the WIPP Waste Information System (“WWIS”), and that such information can be transmitted from that site to the WWIS database; and a demonstration that measurement techniques and control methods can be implemented in accordance with § 194.24(c)(4) for the waste stream(s) proposed for disposal at the WIPP.
(2) The Agency will conduct an audit or an inspection of a Department audit for the purpose of evaluating the use of process knowledge and the implementation of a system of controls for each waste stream or group of waste streams at a waste generator site. The Agency will announce a scheduled inspection or audit by the Agency with a notice in the
(3) The Agency's written decision regarding compliance with the requirements for waste characterization programs described in paragraph (b)(1) of this section for one or more waste
(4) Subsequent to any positive determination of compliance as described in paragraph (b)(3) of this section, the Agency intends to conduct inspections, in accordance with §§ 194.21 and 194.24(h), to confirm the continued compliance of the programs approved under paragraphs (b)(2) and (b)(3) of this section. The results of such inspections will be made available to the public through the Agency's public dockets, as described in § 194.67.
Information provided to the Administrator in support of any compliance application shall be complete and accurate. The Administrator's evaluation for certification pursuant to section 8(d)(1)(B) of the WIPP LWA and evaluation for recertification pursuant to section 8(f)(2) of the WIPP LWA shall not begin until the Administrator has notified the Secretary, in writing, that a complete application in accordance with this part has been received.
Unless otherwise specified by the Administrator or the Administrator's authorized representative, 5 copies of any compliance application(s), any accompanying materials, and any amendments thereto shall be submitted in a printed form to the Administrator's authorized representative. These paper copies are intended for the official docket in Washington, DC, as well as the four informational dockets in Albuquerque and Santa Fe, New Mexico. In addition, DOE shall submit 10 copies of the complete application in alternative format (
Information may be included by reference into compliance applications(s), provided that the references are clear specific and that unless, otherwise specified by the Administrator or the Administrator's authorized representative, 5 copies of reference information are submitted to the Administrator's authorized representative. These paper copies are intended for the official docket in Washington, DC, as well as the four informational dockets in Albuquerque and Santa Fe, New Mexico. Reference materials that are widely available in standard text books or reference books need not to be submitted. Whenever possible, DOE shall submit 10 copies of reference materials in alternative format (
Any compliance application shall include:
(a) A current description of the natural and engineered features that may affect the performance of the disposal system. The description of the disposal system shall include, at a minimum, the following information:
(1) The location of the disposal system and the controlled area;
(2) A description of the geology, geophysics, hydrogeology, hydrology, and geochemistry of the disposal system and its vicinity and how these conditions are expected to change and interact over the regulatory time frame.
(i) Existing fluids and fluid hydraulic potential, including brine pockets, in and near the disposal system; and
(ii) Existing higher permeability anhydrite interbeds located at or near the horizon of the waste.
(3) The presence and characteristics of potential pathways for transport of waste from the disposal system to the accessible environment including, but not limited to: Existing boreholes, solution features, breccia pipes, and other potentially permeable features, such as interbeds.
(4) The projected geophysical, hydrogeologic and geochemical conditions of the disposal system due to the presence of waste including, but not limited to, the effects of production of heat or gases from the waste.
(b) A description of the design of the disposal system including:
(1) Information on materials of construction including, but not limited to: Geologic media, structural materials, engineered barriers, general arrangement, and approximate dimensions; and
(2) Computer codes and standards that have been applied to the design and construction of the disposal system.
(c) Results of assessments conducted pursuant to this part.
(d) A description of input parameters associated with assessments conducted pursuant to this part and the basis for selecting those input parameters.
(e) Documentation of measures taken to meet the assurance requirements of this part.
(f) A description of waste acceptance criteria and actions taken to assure adherence to such criteria.
(g) A description of background radiation in air, soil and water in the vicinity of the disposal system and the procedures employed to determine such radiation.
(h) One or more topographic map(s) of the vicinity of the disposal system. The contour interval shall be sufficient to show clearly the pattern of surface water flow in the vicinity of the disposal system. The map(s) shall include standard map notations and symbols, and, in addition, shall show boundaries of the controlled area and the location of any active, inactive, and abandoned injection and withdrawal wells in the controlled area and in the vicinity of the disposal system.
(i) A description of past and current climatologic and meteorologic conditions in the vicinity of the disposal system and how these conditions are expected to change over the regulatory time frame.
(j) The information required elsewhere in this part or any additional information, analyses, tests, or records determined by the Administrator or the Administrator's authorized representative to be necessary for determining compliance with this part.
(a) In submitting documentation of continued compliance pursuant to section 8(f) of the WIPP LWA, the previous compliance application shall be updated to provide sufficient information for the Administrator to determine whether or not the WIPP continues to be in compliance with the disposal regulations. Updated documentation shall include:
(1) All additional geologic, geophysical, geochemical, hydrologic, and meteorologic information;
(2) All additional monitoring data, analyses and results;
(3) All additional analyses and results of laboratory experiments conducted by the Department or its contractors as part of the WIPP program;
(4) An identification of any activities or assumptions that deviate from the most recent compliance application;
(5) A description of all waste emplaced in the disposal system since the most recent compliance certification or re-certification application. Such description shall consist of a description of the waste characteristics and waste components identified in §§ 194.24(b)(1) and 194.24(b)(2);
(6) Any significant information not previously included in a compliance certification or re-certification application related to whether the disposal system continues to be in compliance with the disposal regulations; and
(7) Any additional information requested by the Administrator or the
(b) To the extent that information required for a re-certification of compliance remains valid and has been submitted in previous certification or re-certification application(s), such information need not be duplicated in subsequent applications; such information may be summarized and referenced.
(a) The Administrator or the Administrator's authorized representative(s) shall, at any time:
(1) Be afforded unfettered and unannounced access to inspect any area of the WIPP, and any locations performing activities that provide information relevant to compliance application(s), to which the Department has rights of access. Such access shall be equivalent to access afforded Department employees upon presentation of credentials and other required documents.
(2) Be allowed to obtain samples, including split samples, and to monitor and measure aspects of the disposal system and the waste proposed for disposal in the disposal system.
(b) Records (including data and other information in any form) kept by the Department pertaining to the WIPP shall be made available to the Administrator or the Administrator's authorized representative upon request. If requested records are not immediately available, they shall be delivered within 30 calendar days of the request.
(c) The Department shall, upon request by the Administrator or the Administrator's authorized representative, provide permanent, private office space that is accessible to the disposal system. The office space shall be for the exclusive use of the Administrator or the Administrator's authorized representative(s).
(d) The Administrator or the Administrator's authorized representative(s) shall comply with applicable access control measures for security, radiological protection, and personal safety when conducting activities pursuant to this section.
(a)(1) As soon as practicable after April 9, 1996, the Department shall adhere to a quality assurance program that implements the requirements of ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition, and ASME NQA-3-1989 edition (excluding Section 2.1 (b) and (c), and Section 17.1). (Incorporation by reference as specified in § 194.5.)
(2) Any compliance application shall include information which demonstrates that the quality assurance program required pursuant to paragraph (a)(1) of this section has been established and executed for:
(i) Waste characterization activities and assumptions;
(ii) Environmental monitoring, monitoring of the performance of the disposal system, and sampling and analysis activities;
(iii) Field measurements of geologic factors, ground water, meteorologic, and topographic characteristics;
(iv) Computations, computer codes, models and methods used to demonstrate compliance with the disposal regulations in accordance with the provisions of this part;
(v) Procedures for implementation of expert judgment elicitation used to support applications for certification or re-certification of compliance;
(vi) Design of the disposal system and actions taken to ensure compliance with design specifications;
(vii) The collection of data and information used to support compliance application(s); and
(viii) Other systems, structures, components, and activities important to the containment of waste in the disposal system.
(b) Any compliance application shall include information which demonstrates that data and information collected prior to the implementation of the quality assurance program required pursuant to paragraph (a)(1) of this section have been qualified in accordance with an alternate methodology, approved by the Administrator or the Administrator's authorized representative, that employs one or more
(c) Any compliance application shall provide, to the extent practicable, information which describes how all data used to support the compliance application have been assessed for their quality characteristics, including:
(1) Data accuracy, i.e., the degree to which data agree with an accepted reference or true value;
(2) Data precision, i.e., a measure of the mutual agreement between comparable data gathered or developed under similar conditions expressed in terms of a standard deviation;
(3) Data representativeness, i.e., the degree to which data accurately and precisely represent a characteristic of a population, a parameter, variations at a sampling point, or environmental conditions;
(4) Data completeness, i.e., a measure of the amount of valid data obtained compared to the amount that was expected; and
(5) Data comparability, i.e., a measure of the confidence with which one data set can be compared to another.
(d) Any compliance application shall provide information which demonstrates how all data are qualified for use in the demonstration of compliance.
(e) The Administrator will verify appropriate execution of quality assurance programs through inspections, record reviews and record keeping requirements, which may include, but may not be limited to, surveillance, audits and management systems reviews.
(a) Any compliance application shall include:
(1) A description of the conceptual models and scenario construction used to support any compliance application.
(2) A description of plausible, alternative conceptual model(s) seriously considered but not used to support such application, and an explanation of the reason(s) why such model(s) was not deemed to accurately portray performance of the disposal system.
(3) Documentation that:
(i) Conceptual models and scenarios reasonably represent possible future states of the disposal system;
(ii) Mathematical models incorporate equations and boundary conditions which reasonably represent the mathematical formulation of the conceptual models;
(iii) Numerical models provide numerical schemes which enable the mathematical models to obtain stable solutions;
(iv) Computer models accurately implement the numerical models; i.e., computer codes are free of coding errors and produce stable solutions;
(v) Conceptual models have undergone peer review according to § 194.27.
(b) Computer codes used to support any compliance application shall be documented in a manner that complies with the requirements of ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition. (Incorporation by reference as specified in § 194.5.)
(c) Documentation of all models and computer codes included as part of any compliance application performance assessment calculation shall be provided. Such documentation shall include, but shall not be limited to:
(1) Descriptions of the theoretical backgrounds of each model and the method of analysis or assessment;
(2) General descriptions of the models; discussions of the limits of applicability of each model; detailed instructions for executing the computer codes, including hardware and software requirements, input and output formats with explanations of each input and output variable and parameter (e.g., parameter name and units); listings of input and output files from a sample computer run; and reports on code verification, benchmarking, validation, and quality assurance procedures;
(3) Detailed descriptions of the structure of computer codes and complete listings of the source codes;
(4) Detailed descriptions of data collection procedures, sources of data, data reduction and analysis, and code input parameter development;
(5) Any necessary licenses; and
(6) An explanation of the manner in which models and computer codes incorporate the effects of parameter correlation.
(d) The Administrator or the Administrator's authorized representative may verify the results of computer simulations used to support any compliance application by performing independent simulations. Data files, source codes, executable versions of computer software for each model, other material or information needed to permit the Administrator or the Administrator's authorized representative to perform independent simulations, and access to necessary hardware to perform such simulations, shall be provided within 30 calendar days of a request by the Administrator or the Administrator's authorized representative.
(a) Any compliance application shall describe the chemical, radiological and physical composition of all existing waste proposed for disposal in the disposal system. To the extent practicable, any compliance application shall also describe the chemical, radiological and physical composition of to-be-generated waste proposed for disposal in the disposal system. These descriptions shall include a list of waste components and their approximate quantities in the waste. This list may be derived from process knowledge, current non-destructive examination/assay, or other information and methods.
(b) The Department shall submit in the compliance certification application the results of an analysis which substantiates:
(1) That all waste characteristics influencing containment of waste in the disposal system have been identified and assessed for their impact on disposal system performance. The characteristics to be analyzed shall include, but shall not be limited to: Solubility; formation of colloidal suspensions containing radionuclides; production of gas from the waste; shear strength; compactability; and other waste-related inputs into the computer models that are used in the performance assessment.
(2) That all waste components influencing the waste characteristics identified in paragraph (b)(1) of this section have been identified and assessed for their impact on disposal system performance. The components to be analyzed shall include, but shall not be limited to: metals; cellulosics; chelating agents; water and other liquids; and activity in curies of each isotope of the radionuclides present.
(3) Any decision to exclude consideration of any waste characteristic or waste component because such characteristic or component is not expected to significantly influence the containment of the waste in the disposal system.
(c) For each waste component identified and assessed pursuant to paragraph (b) of this section, the Department shall specify the limiting value (expressed as an upper or lower limit of mass, volume, curies, concentration, etc.), and the associated uncertainty (i.e., margin of error) for each limiting value, of the total inventory of such waste proposed for disposal in the disposal system. Any compliance application shall:
(1) Demonstrate that, for the total inventory of waste proposed for disposal in the disposal system, WIPP complies with the numeric requirements of § 194.34 and § 194.55 for the upper or lower limits (including the associated uncertainties), as appropriate, for each waste component identified in paragraph (b)(2) of this section, and for the plausible combinations of upper and lower limits of such waste components that would result in the greatest estimated release.
(2) Identify and describe the method(s) used to quantify the limits of waste components identified in paragraph (b)(2) of this section.
(3) Provide information that demonstrates that the use of acceptable knowledge to quantify components in waste for disposal conforms with the
(4) Provide information which demonstrates that a system of controls has been and will continue to be implemented to confirm that the total amount of each waste component that will be emplaced in the disposal system will not exceed the upper limiting value or fall below the lower limiting value described in the introductory text of paragraph (c) of this section. The system of controls shall include, but shall not be limited to: Measurement; sampling; chain of custody records; record keeping systems; waste loading schemes used; and other documentation.
(5) Identify and describe such controls delineated in paragraph (c)(4) of this section and confirm that they are applied in accordance with the quality assurance requirements found in § 194.22.
(d) The Department shall include a waste loading scheme in any compliance application, or else performance assessments conducted pursuant to § 194.32 and compliance assessments conducted pursuant to § 194.54 shall assume random placement of waste in the disposal system.
(e) Waste may be emplaced in the disposal system only if the emplaced components of such waste will not cause:
(1) The total quantity of waste in the disposal system to exceed the upper limiting value, including the associated uncertainty, described in the introductory text to paragraph (c) of this section; or
(2) The total quantity of waste that will have been emplaced in the disposal system, prior to closure, to fall below the lower limiting value, including the associated uncertainty, described in the introductory text to paragraph (c) of this section.
(f) Waste emplacement shall conform to the assumed waste loading conditions, if any, used in performance assessments conducted pursuant to § 194.32 and compliance assessments conducted pursuant to § 194.54.
(g) The Department shall demonstrate in any compliance application that the total inventory of waste emplaced in the disposal system complies with the limitations on transuranic waste disposal described in the WIPP LWA.
(h) The Administrator will use inspections and records reviews, such as audits, to verify compliance with this section.
(a) Unless otherwise specified in this part or in the disposal regulations, performance assessments and compliance assessments conducted pursuant the provisions of this part to demonstrate compliance with § 191.13, § 191.15 and part 191, subpart C shall assume that characteristics of the future remain what they are at the time the compliance application is prepared, provided that such characteristics are not related to hydrogeologic, geologic or climatic conditions.
(b) In considering future states pursuant to this section, the Department shall document in any compliance application, to the extent practicable, effects of potential future hydrogeologic, geologic and climatic conditions on the disposal system over the regulatory time frame. Such documentation shall be part of the activities undertaken pursuant to § 194.14, Content of compliance certification application; § 194.32, Scope of performance assessments; and § 194.54, Scope of compliance assessments.
(1) In considering the effects of hydrogeologic conditions on the disposal system, the Department shall document in any compliance application, to the extent practicable, the effects of potential changes to hydrogeologic conditions.
(2) In considering the effects of geologic conditions on the disposal system, the Department shall document in any compliance application, to the extent practicable, the effects of potential changes to geologic conditions, including, but not limited to: Dissolution; near surface geomorphic features and processes; and related subsidence in the geologic units of the disposal system.
(3) In considering the effects of climatic conditions on the disposal system, the Department shall document in
(a) Expert judgment, by an individual expert or panel of experts, may be used to support any compliance application, provided that expert judgment does not substitute for information that could reasonably be obtained through data collection or experimentation.
(b) Any compliance application shall:
(1) Identify any expert judgments used to support the application and shall identify experts (by name and employer) involved in any expert judgment elicitation processes used to support the application.
(2) Describe the process of eliciting expert judgment, and document the results of expert judgment elicitation processes and the reasoning behind those results. Documentation of interviews used to elicit judgments from experts, the questions or issues presented for elicitation of expert judgment, background information provided to experts, and deliberations and formal interactions among experts shall be provided. The opinions of all experts involved in each elicitation process shall be provided whether the opinions are used to support compliance applications or not.
(3) Provide documentation that the following restrictions and guidelines have been applied to any selection of individuals used to elicit expert judgments:
(i) Individuals who are members of the team of investigators requesting the judgment or the team of investigators who will use the judgment were not selected; and
(ii) Individuals who maintain, at any organizational level, a supervisory role or who are supervised by those who will utilize the judgment were not selected.
(4) Provide information which demonstrates that:
(i) The expertise of any individual involved in expert judgment elicitation comports with the level of knowledge required by the questions or issues presented to that individual; and
(ii) The expertise of any expert panel, as a whole, involved in expert judgment elicitation comports with the level and variety of knowledge required by the questions or issues presented to that panel.
(5) Explain the relationship among the information and issues presented to experts prior to the elicitation process, the elicited judgment of any expert panel or individual, and the purpose for which the expert judgment is being used in compliance applications(s).
(6) Provide documentation that the initial purpose for which expert judgment was intended, as presented to the expert panel, is consistent with the purpose for which this judgment was used in compliance application(s).
(7) Provide documentation that the following restrictions and guidelines have been applied in eliciting expert judgment:
(i) At least five individuals shall be used in any expert elicitation process, unless there is a lack or unavailability of experts and a documented rationale is provided that explains why fewer than five individuals were selected.
(ii) At least two-thirds of the experts involved in an elicitation shall consist of individuals who are not employed directly by the Department or by the Department's contractors, unless the Department can demonstrate and document that there is a lack or unavailability of qualified independent experts. If so demonstrated, at least one-third of the experts involved in an elicitation shall consist of individuals who are not employed directly by the Department or by the Department's contractors.
(c) The public shall be afforded a reasonable opportunity to present its scientific and technical views to expert panels as input to any expert elicitation process.
(a) Any compliance application shall include documentation of peer review that has been conducted, in a manner required by this section, for:
(1) Conceptual models selected and developed by the Department;
(2) Waste characterization analyses as required in § 194.24(b); and
(3) Engineered barrier evaluation as required in § 194.44.
(b) Peer review processes required in paragraph (a) of this section, and conducted subsequent to the promulgation of this part, shall be conducted in a manner that is compatible with NUREG-1297, “Peer Review for High-Level Nuclear Waste Repositories,” published February 1988. (Incorporation by reference as specified in § 194.5.)
(c) Any compliance application shall:
(1) Include information that demonstrates that peer review processes required in paragraph (a) of this section, and conducted prior to the implementation of the promulgation of this part, were conducted in accordance with an alternate process substantially equivalent in effect to NUREG-1297 and approved by the Administrator or the Administrator's authorized representative; and
(2) Document any peer review processes conducted in addition to those required pursuant to paragraph (a) of this section. Such documentation shall include formal requests, from the Department to outside review groups or individuals, to review or comment on any information used to support compliance applications, and the responses from such groups or individuals.
The release limits shall be calculated according to part 191, appendix A of this chapter, using the total activity, in curies, that will exist in the disposal system at the time of disposal.
(a) Performance assessments shall consider natural processes and events, mining, deep drilling, and shallow drilling that may affect the disposal system during the regulatory time frame.
(b) Assessments of mining effects may be limited to changes in the hydraulic conductivity of the hydrogeologic units of the disposal system from excavation mining for natural resources. Mining shall be assumed to occur with a one in 100 probability in each century of the regulatory time frame. Performance assessments shall assume that mineral deposits of those resources, similar in quality and type to those resources currently extracted from the Delaware Basin, will be completely removed from the controlled area during the century in which such mining is randomly calculated to occur. Complete removal of such mineral resources shall be assumed to occur only once during the regulatory time frame.
(c) Performance assessments shall include an analysis of the effects on the disposal system of any activities that occur in the vicinity of the disposal system prior to disposal and are expected to occur in the vicinity of the disposal system soon after disposal. Such activities shall include, but shall not be limited to, existing boreholes and the development of any existing leases that can be reasonably expected to be developed in the near future, including boreholes and leases that may be used for fluid injection activities.
(d) Performance assessments need not consider processes and events that have less than one chance in 10,000 of occurring over 10,000 years.
(e) Any compliance application(s) shall include information which:
(1) Identifies all potential processes, events or sequences and combinations of processes and events that may occur during the regulatory time frame and may affect the disposal system;
(2) Identifies the processes, events or sequences and combinations of processes and events included in performance assessments; and
(3) Documents why any processes, events or sequences and combinations of processes and events identified pursuant to paragraph (e)(1) of this section were not included in performance assessment results provided in any compliance application.
(a) Performance assessments shall examine deep drilling and shallow drilling that may potentially affect the disposal system during the regulatory time frame.
(b) The following assumptions and process shall be used in assessing the likelihood and consequences of drilling
(1) Inadvertent and intermittent intrusion by drilling for resources (other than those resources provided by the waste in the disposal system or engineered barriers designed to isolate such waste) is the most severe human intrusion scenario.
(2) In performance assessments, drilling events shall be assumed to occur in the Delaware Basin at random intervals in time and space during the regulatory time frame.
(3) The frequency of deep drilling shall be calculated in the following manner:
(i) Identify deep drilling that has occurred for each resource in the Delaware Basin over the past 100 years prior to the time at which a compliance application is prepared.
(ii) The total rate of deep drilling shall be the sum of the rates of deep drilling for each resource.
(4) The frequency of shallow drilling shall be calculated in the following manner:
(i) Identify shallow drilling that has occurred for each resource in the Delaware Basin over the past 100 years prior to the time at which a compliance application is prepared.
(ii) The total rate of shallow drilling shall be the sum of the rates of shallow drilling for each resource.
(iii) In considering the historical rate of all shallow drilling, the Department may, if justified, consider only the historical rate of shallow drilling for resources of similar type and quality to those in the controlled area.
(c) Performance assessments shall document that in analyzing the consequences of drilling events, the Department assumed that:
(1) Future drilling practices and technology will remain consistent with practices in the Delaware Basin at the time a compliance application is prepared. Such future drilling practices shall include, but shall not be limited to: The types and amounts of drilling fluids; borehole depths, diameters, and seals; and the fraction of such boreholes that are sealed by humans; and
(2) Natural processes will degrade or otherwise affect the capability of boreholes to transmit fluids over the regulatory time frame.
(d) With respect to future drilling events, performance assessments need not analyze the effects of techniques used for resource recovery subsequent to the drilling of the borehole.
(a) The results of performance assessments shall be assembled into “complementary, cumulative distribution functions” (CCDFs) that represent the probability of exceeding various levels of cumulative release caused by all significant processes and events.
(b) Probability distributions for uncertain disposal system parameter values used in performance assessments shall be developed and documented in any compliance application.
(c) Computational techniques, which draw random samples from across the entire range of the probability distributions developed pursuant to paragraph (b) of this section, shall be used in generating CCDFs and shall be documented in any compliance application.
(d) The number of CCDFs generated shall be large enough such that, at cumulative releases of 1 and 10, the maximum CCDF generated exceeds the 99th percentile of the population of CCDFs with at least a 0.95 probability. Values of cumulative release shall be calculated according to Note 6 of Table 1, appendix A of part 191 of this chapter.
(e) Any compliance application shall display the full range of CCDFs generated.
(f) Any compliance application shall provide information which demonstrates that there is at least a 95 percent level of statistical confidence that the mean of the population of CCDFs meets the containment requirements of § 191.13 of this chapter.
(a) Any compliance application shall include detailed descriptions of proposed active institutional controls, the controls' location, and the period of
(b) Performance assessments shall not consider any contributions from active institutional controls for more than 100 years after disposal.
(a) The Department shall conduct an analysis of the effects of disposal system parameters on the containment of waste in the disposal system and shall include the results of such analysis in any compliance application. The results of the analysis shall be used in developing plans for pre-closure and post-closure monitoring required pursuant to paragraphs (c) and (d) of this section. The disposal system parameters analyzed shall include, at a minimum:
(1) Properties of backfilled material, including porosity, permeability, and degree of compaction and reconsolidation;
(2) Stresses and extent of deformation of the surrounding roof, walls, and floor of the waste disposal room;
(3) Initiation or displacement of major brittle deformation features in the roof or surrounding rock;
(4) Ground water flow and other effects of human intrusion in the vicinity of the disposal system;
(5) Brine quantity, flux, composition, and spatial distribution;
(6) Gas quantity and composition; and
(7) Temperature distribution.
(b) For all disposal system parameters analyzed pursuant to paragraph (a) of this section, any compliance application shall document and substantiate the decision not to monitor a particular disposal system parameter because that parameter is considered to be insignificant to the containment of waste in the disposal system or to the verification of predictions about the future performance of the disposal system.
(c) Pre-closure monitoring. To the extent practicable, pre-closure monitoring shall be conducted of significant disposal system parameter(s) as identified by the analysis conducted pursuant to paragraph (a) of this section. A disposal system parameter shall be considered significant if it affects the system's ability to contain waste or the ability to verify predictions about the future performance of the disposal system. Such monitoring shall begin as soon as practicable; however, in no case shall waste be emplaced in the disposal system prior to the implementation of pre-closure monitoring. Pre-closure monitoring shall end at the time at which the shafts of the disposal system are backfilled and sealed.
(d) Post-closure monitoring. The disposal system shall, to the extent practicable, be monitored as soon as practicable after the shafts of the disposal system are backfilled and sealed to detect substantial and detrimental deviations from expected performance and shall end when the Department can demonstrate to the satisfaction of the Administrator that there are no significant concerns to be addressed by further monitoring. Post-closure monitoring shall be complementary to monitoring required pursuant to applicable federal hazardous waste regulations at parts 264, 265, 268, and 270 of this chapter and shall be conducted with techniques that do not jeopardize the containment of waste in the disposal system.
(e) Any compliance application shall include detailed pre-closure and post-closure monitoring plans for monitoring the performance of the disposal system. At a minimum, such plans shall:
(1) Identify the parameters that will be monitored and how baseline values will be determined;
(2) Indicate how each parameter will be used to evaluate any deviations from the expected performance of the disposal system; and
(3) Discuss the length of time over which each parameter will be monitored to detect deviations from expected performance.
(a) Any compliance application shall include detailed descriptions of the
(1) Identification of the controlled area by markers that have been designed and will be fabricated and emplaced to be as permanent as practicable;
(2) Placement of records in the archives and land record systems of local, State, and Federal governments, and international archives, that would likely be consulted by individuals in search of unexploited resources. Such records shall identify:
(i) The location of the controlled area and the disposal system;
(ii) The design of the disposal system;
(iii) The nature and hazard of the waste;
(iv) Geologic, geochemical, hydrologic, and other site data pertinent to the containment of waste in the disposal system, or the location of such information; and
(v) The results of tests, experiments, and other analyses relating to backfill of excavated areas, shaft sealing, waste interaction with the disposal system, and other tests, experiments, or analyses pertinent to the containment of waste in the disposal system, or the location of such information.
(3) Other passive institutional controls practicable to indicate the dangers of the waste and its location.
(b) Any compliance application shall include the period of time passive institutional controls are expected to endure and be understood.
(c) The Administrator may allow the Department to assume passive institutional control credit, in the form of reduced likelihood of human intrusion, if the Department demonstrates in the compliance application that such credit is justified because the passive institutional controls are expected to endure and be understood by potential intruders for the time period approved by the Administrator. Such credit, or a smaller credit as determined by the Administrator, cannot be used for more than several hundred years and may decrease over time. In no case, however, shall passive institutional controls be assumed to eliminate the likelihood of human intrusion entirely.
(a) Disposal systems shall incorporate engineered barrier(s) designed to prevent or substantially delay the movement of water or radionuclides toward the accessible environment.
(b) In selecting any engineered barrier(s) for the disposal system, the Department shall evaluate the benefit and detriment of engineered barrier alternatives, including but not limited to: Cementation, shredding, supercompaction, incineration, vitrification, improved waste canisters, grout and bentonite backfill, melting of metals, alternative configurations of waste placements in the disposal system, and alternative disposal system dimensions. The results of this evaluation shall be included in any compliance application and shall be used to justify the selection and rejection of each engineered barrier evaluated.
(c)(1) In conducting the evaluation of engineered barrier alternatives, the following shall be considered, to the extent practicable:
(i) The ability of the engineered barrier to prevent or substantially delay the movement of water or waste toward the accessible environment;
(ii) The impact on worker exposure to radiation both during and after incorporation of engineered barriers;
(iii) The increased ease or difficulty of removing the waste from the disposal system;
(iv) The increased or reduced risk of transporting the waste to the disposal system;
(v) The increased or reduced uncertainty in compliance assessment;
(vi) Public comments requesting specific engineered barriers;
(vii) The increased or reduced total system costs;
(viii) The impact, if any, on other waste disposal programs from the incorporation of engineered barriers (e.g., the extent to which the incorporation of engineered barriers affects the volume of waste);
(ix) The effects on mitigating the consequences of human intrusion.
(2) If, after consideration of one or more of the factors in paragraph (c)(1)
(d) In considering the ability of engineered barriers to prevent or substantially delay the movement of water or radionuclides toward the accessible environment, the benefit and detriment of engineered barriers for existing waste already packaged, existing waste not yet packaged, existing waste in need of re-packaging, and to-be-generated waste shall be considered separately and described.
(e) The evaluation described in paragraphs (b), (c) and (d) of this section shall consider engineered barriers alone and in combination.
Any compliance application shall include information that demonstrates that the favorable characteristics of the disposal system compensate for the presence of resources in the vicinity of the disposal system and the likelihood of the disposal system being disturbed as a result of the presence of those resources. If performance assessments predict that the disposal system meets the containment requirements of § 191.13 of this chapter, then the Agency will assume that the requirements of this section and § 191.14(e) of this chapter have been fulfilled.
Any compliance application shall include documentation which demonstrates that removal of waste from the disposal system is feasible for a reasonable period of time after disposal. Such documentation shall include an analysis of the technological feasibility of mining the sealed disposal system, given technology levels at the time a compliance application is prepared.
Compliance assessments that analyze compliance with § 191.15 of this chapter shall assume that an individual resides at the single geographic point on the surface of the accessible environment where that individual would be expected to receive the highest dose from radionuclide releases from the disposal system.
In compliance assessments that analyze compliance with § 191.15 of this chapter, all potential exposure pathways from the disposal system to individuals shall be considered. Compliance assessments with part 191, subpart C and § 191.15 of this chapter shall assume that individuals consume 2 liters per day of drinking water from any underground source of drinking water in the accessible environment.
In compliance assessments that analyze compliance with part 191, subpart C of this chapter, all underground sources of drinking water in the accessible environment that are expected to be affected by the disposal system over the regulatory time frame shall be considered. In determining whether underground sources of drinking water are expected to be affected by the disposal system, underground interconnections among bodies of surface water, ground water, and underground sources of drinking water shall be considered.
(a) Any compliance application shall contain compliance assessments required pursuant to this part. Compliance assessments shall include information which:
(1) Identifies potential processes, events, or sequences of processes and events that may occur over the regulatory time frame;
(2) Identifies the processes, events, or sequences of processes and events included in compliance assessment results provided in any compliance application; and
(3) Documents why any processes, events, or sequences of processes and events identified pursuant to paragraph (a)(1) of this section were not included in compliance assessment results provided in any compliance application.
(b) Compliance assessments of undisturbed performance shall include the effects on the disposal system of:
(1) Existing boreholes in the vicinity of the disposal system, with attention to the pathways they provide for migration of radionuclides from the site; and
(2) Any activities that occur in the vicinity of the disposal system prior to or soon after disposal. Such activities shall include, but shall not be limited to: Existing boreholes and the development of any existing leases that can be reasonably expected to be developed in the near future, including boreholes and leases that may be used for fluid injection activities.
(a) Compliance assessments shall consider and document uncertainty in the performance of the disposal system.
(b) Probability distributions for uncertain disposal system parameter values used in compliance assessments shall be developed and documented in any compliance application.
(c) Computational techniques which draw random samples from across the entire range of values of each probability distribution developed pursuant to paragraph (b) of this section shall be used to generate a range of:
(1) Estimated committed effective doses received from all pathways pursuant to § 194.51 and § 194.52;
(2) Estimated radionuclide concentrations in USDWs pursuant to § 194.53; and
(3) Estimated dose equivalent received from USDWs pursuant to § 194.52 and § 194.53.
(d) The number of estimates generated pursuant to paragraph (c) of this section shall be large enough such that the maximum estimates of doses and concentrations generated exceed the 99th percentile of the population of estimates with at least a 0.95 probability.
(e) Any compliance application shall display:
(1) The full range of estimated radiation doses; and
(2) The full range of estimated radionuclide concentrations.
(f) Any compliance application shall document that there is at least a 95 percent level of statistical confidence that the mean and the median of the range of estimated radiation doses and the range of estimated radionuclide concentrations meet the requirements of § 191.15 and part 191, subpart C of this chapter, respectively.
(a) Upon receipt of a compliance application submitted pursuant to section 8(d)(1) of the WIPP LWA and § 194.11, the Agency will publish in the
(b) A copy of the compliance application will be made available for inspection in Agency dockets established pursuant to § 194.67.
(c) The notice will provide a public comment period of 120 days.
(d) A public hearing concerning the notice will be held if a written request is received by the Administrator or the Administrator's authorized representative within 30 calendar days of the date of publication pursuant to paragraph (a) of this section.
(e) Any comments received on the notice will be made available for inspection in the dockets established pursuant to § 194.67.
(f) Any comments received on the notice will be provided to the Department and the Department may submit to the Agency written responses to the comments.
(a) The Administrator will publish a Notice of Proposed Rulemaking in the
(b) The notice will provide a public comment period of at least 120 days.
(c) The notice will announce public hearings in New Mexico.
(d) Any comments received on the notice will be made available for inspection in the dockets established pursuant to § 194.67.
(a) The Administrator will publish a Final Rule in the
(b) A document summarizing significant comments and issues arising from comments received on the Notice of Proposed Rulemaking, as well as the Administrator's response to such significant comments and issues, will be prepared and will be made available for inspection in the dockets established pursuant to § 194.67.
(a) Upon receipt of documentation of continued compliance with the disposal regulations pursuant to section 8(f) of the WIPP LWA and § 194.11, the Administrator will publish a notice in the
(b) Copies of documentation of continued compliance received by the Administrator will be made available for inspection in the dockets established pursuant to § 194.67.
(c) The notice will provide a public comment period of at least 30 days after publication pursuant to paragraph (a) of this section.
(d) Any comments received on such notice will be made available for public inspection in the dockets established pursuant to § 194.67.
(e) Upon completion of review of the documentation of continued compliance with the disposal regulations, the Administrator will publish a notice in the
(a) If the Administrator determines that any changes in activities or conditions pertaining to the disposal system depart significantly from the most recent compliance application, the Agency will publish a Notice of Proposed Rulemaking in the
(b) Any comments received on the notice will be made available for inspection in the dockets established pursuant to § 194.67.
(a) The Administrator will publish a Final Rule in the
(b) A document summarizing significant comments and issues arising from comments received on the Notice of Proposed Rulemaking as well as the Administrator's response to such significant comments and issues will be prepared and will be made available for inspection in the dockets established pursuant to § 194.67.
The Agency will establish and maintain dockets in the State of New Mexico and Washington, DC. The dockets will consist of all relevant, significant information received from outside parties and all significant information
In accordance with the provisions of the WIPP Compliance Criteria of this part, the Agency finds that the Waste Isolation Pilot Plant (“WIPP”) will comply with the radioactive waste disposal regulations at part 191, subparts B and C, of this chapter. Therefore, pursuant to Section 8(d)(2) of the WIPP Land Withdrawal Act (“WIPP LWA”), as amended, the Administrator certifies that the WIPP facility will comply with the disposal regulations. In accordance with the Agency's authority under § 194.4(a), the certification of compliance is subject to the following conditions:
(a) Not later than the final recertification application submitted prior to closure of the disposal system, the Department shall provide, to the Administrator or the Administrator's authorized representative:
(1) a schedule for implementing passive institutional controls that has been revised to show that markers will be fabricated and emplaced, and other measures will be implemented, as soon as possible following closure of the WIPP. Such schedule should describe how testing of any aspect of the conceptual design will be completed prior to or soon after closure, and what changes to the design of passive institutional controls may be expected to result from such testing.
(2) documentation showing that the granite pieces for the proposed monuments and information rooms described in Docket A-93-02, Item II-G-1, and supplementary information may be: quarried (cut and removed from the ground) without cracking due to tensile stresses from handling or isostatic rebound; engraved on the scale required by the design; transported to the site, given the weight and dimensions of the granite pieces and the capacity of existing rail cars and rail lines; loaded, unloaded, and erected without cracking based on the capacity of available equipment; and successfully joined.
(3) documentation showing that archives and record centers will accept the documents identified and will maintain them in the manner identified in Docket A-93-02, Item II-G-1.
(4) documentation showing that proposed recipients of WIPP information other than archives and record centers will accept the information and make use of it in the manner indicated by the Department in Docket A-93-02, Item II-G-1 and supplementary information.
(b) Upon receipt of the information required under paragraph (a) of this condition, the Agency will place such documentation in the public dockets identified in § 194.67. The Agency will determine if a modification to the compliance certification in effect is necessary. Any such modification will be conducted in accordance with the requirements at §§ 194.65 and 194.66.
15 U.S.C. 2665.
(a)
(b)
Definitions in 15 U.S.C. 2602 and 2662 apply to this part unless otherwise specified in this section. In addition, the following definitions apply:
(a)
(1)
(ii) Each organization seeking listing for primary measurement services that submits an initial application after the effective date of this section shall pay an annual fee of $390 per device. This fee will be prorated quarterly, based on the acceptance date of an organization's application.
(iii) Organizations that have or are seeking a listing for secondary measurement services for their primary devices will not be required to pay the additional $50 fee applicable to secondary organizations.
(2)
(ii) Each organization seeking listing for secondary measurement services that submits an initial application after the effective date of this section shall pay an annual fee of $50 for each business location listed. This fee will be prorated quarterly, based on the acceptance date of an organization's application.
(iii) Primary organizations that have or are seeking secondary listings for methods other than those for which they are listed as a primary, are subject to the fees.
(3)
(ii) Each individual who submits an initial application after the effective date of this section shall pay an annual fee of $105. This fee will be prorated quarterly, based on the acceptance date of an individual's application.
(iii) Individuals who have or are seeking listing status as an RMP primary or secondary organization are subject to the applicable fees under paragraphs (a)(1) and (2) of this section.
(4)
(B) Each individual who is not a listed participant in the RCP program on the effective date of this section and submits an initial application after the effective date of this section shall pay an annual fee of $210. This fee will be prorated quarterly, based on the acceptance date of an individual's application.
(ii) An organization or individual who is not a listed participant in EPA's radon proficiency programs on the effective date of this section and/or whose proficiency program application has not yet been accepted by EPA becomes subject to the fees described above once its application has been accepted by EPA. Fees for such organizations or individuals will be prorated quarterly, based on the acceptance date of the application. To remain listed, each participant in the RMP or RCP programs, whether individual or
(b)
(c)
(2) If the appropriate fee or a revised payment invoice for an individual or organization participating in the RMP or RCP program has not been received by EPA on or before the payment due date, EPA will send, by certified mail, notice that the individual or organization will be delisted from the proficiency program unless he/she pays the fee within 30 days of this second certified notification. If payment still has not been received by EPA after 30 days of the second certified notification, the organization's or individual's listing shall be removed from the proficiency program.
(3) New or initial applicants to the RMP or RCP programs will be assessed a fee at the time of their initial application. EPA will send a payment invoice to the new applicant upon acceptance of the initial application. The applicant will be given at least 30 days from the date on the payment invoice to remit payment. The fee assessed will be prorated quarterly, based on the acceptance date of the application. If the appropriate fee has not been received by EPA by the payment due date, the application will be placed in an inactive file with no further action taken by EPA.
(d)
(e)
(2) EPA will use a three-step process to adjust the fees annually. First, EPA will estimate the costs of providing each of the proficiency programs for the upcoming year. EPA will account for future additional fixed costs (e.g.,
EPA will not process an application or continue a participant's listing in the National Radon Measurement Proficiency program, individual proficiency component of the RMP program, or the National Radon Contractor Proficiency program until the appropriate remittance provided in § 195.20(a) has been received by EPA. Failure by a currently EPA-listed organization or individual to remit the required fees in a timely manner will result in the loss of that organization's or individual's listing status as specified in § 195.20(c).
Sec. 801, Pub. L. 102-486, 106 Stat. 2921, 42 U.S.C. 10141 n.
This subpart covers the storage of radioactive material by DOE in the Yucca Mountain repository and on the Yucca Mountain site.
(1) The highly radioactive material resulting from the reprocessing of spent nuclear fuel, including liquid waste produced directly in reprocessing and any solid material derived from such liquid waste that contains fission products in sufficient concentrations; and
(2) Other highly radioactive material that the Commission, consistent with existing law, determines by rule requires permanent isolation.
(1) The site recommended by the Secretary of DOE to the President under section 112(b)(1)(B) of the Nuclear Waste Policy Act of 1982 (42 U.S.C. 10132(b)(1)(B)) on May 27, 1986; or
(2) The area under the control of DOE for the use of Yucca Mountain activities at the time of licensing, if the site designated under the Nuclear Waste Policy Act is amended by Congress prior to the time of licensing.
The NRC implements this subpart A. The DOE must demonstrate to NRC that normal operations at the Yucca Mountain site will and do occur in compliance with this subpart before NRC may grant or continue a license for DOE to receive and possess radioactive material within the Yucca Mountain site.
The DOE must ensure that no member of the public in the general environment receives more than an annual committed effective dose equivalent of 150 microsieverts (15 millirems) from the combination of:
(a) Management and storage (as defined in 40 CFR 191.2) of radioactive material that:
(1) Is subject to 40 CFR 191.3(a); and
(2) Occurs outside of the Yucca Mountain repository but within the Yucca Mountain site; and
(b) Storage (as defined in § 197.2) of radioactive material inside the Yucca Mountain repository.
The standards in this part take effect on July 13, 2001.
This subpart covers the disposal of radioactive material in the Yucca Mountain repository by DOE.
All definitions in subpart A of this part and the following:
(1) The atmosphere (including the atmosphere above the surface area of the controlled area);
(2) Land surfaces;
(3) Surface waters;
(4) Oceans; and
(5) The lithosphere.
(1) The surface area, identified by passive institutional controls, that encompasses no more than 300 square kilometers. It must not extend farther:
(a) South than 36°40′13.6661″ north latitude, in the predominant direction of ground water flow; and
(b) Than five kilometers from the repository footprint in any other direction; and
(2) The subsurface underlying the surface area.
(1) Markers, as permanent as practicable, placed on the Earth's surface;
(2) Public records and archives;
(3) Government ownership and regulations regarding land or resource use; and
(4) Other reasonable methods of preserving knowledge about the location, design, and contents of the Yucca Mountain disposal system.
(1) Identifies the features, events, processes, (except human intrusion), and sequences of events and processes (except human intrusion) that might affect the Yucca Mountain disposal system and their probabilities of occurring;
(2) Examines the effects of those features, events, processes, and sequences of events and processes upon the performance of the Yucca Mountain disposal system; and
(3) Estimates the annual committed effective dose equivalent incurred by the reasonably maximally exposed individual, including the associated uncertainties, as a result of releases caused by all significant features, events, processes, and sequences of
The NRC implements this subpart B. The DOE must demonstrate to NRC that there is a reasonable expectation of compliance with this subpart before NRC may issue a license.
(a) The NRC will determine compliance, based upon the arithmetic mean of the projected doses from DOE's performance assessments for the period within 1 million years after disposal, with:
(1) Sections 197.20(a)(1) and 197.20(a)(2) of this subpart; and
(2) Sections 197.25(b)(1), 197.25(b)(2), and 197.30 of this subpart, if performance assessment is used to demonstrate compliance with either or both of these sections.
(b) [Reserved]
Reasonable expectation means that NRC is satisfied that compliance will be achieved based upon the full record before it. Characteristics of reasonable expectation include that it:
(a) Requires less than absolute proof because absolute proof is impossible to attain for disposal due to the uncertainty of projecting long-term performance;
(b) Accounts for the inherently greater uncertainties in making long-term projections of the performance of the Yucca Mountain disposal system;
(c) Does not exclude important parameters from assessments and analyses simply because they are difficult to precisely quantify to a high degree of confidence; and
(d) Focuses performance assessments and analyses upon the full range of defensible and reasonable parameter distributions rather than only upon extreme physical situations and parameter values.
The DOE should not project changes in society, the biosphere (other than climate), human biology, or increases or decreases of human knowledge or technology. In all analyses done to demonstrate compliance with this part, DOE must assume that all of those factors remain constant as they are at the time of license application submission to NRC. However, DOE must vary factors related to the geology, hydrology, and climate based upon cautious, but reasonable assumptions of the changes in these factors that could affect the Yucca Mountain disposal system during the period of geologic stability, consistent with the requirements for performance assessments specified at § 197.36.
(a) The DOE must demonstrate, using performance assessment, that there is a reasonable expectation that the reasonably maximally exposed individual receives no more than the following annual committed effective dose equivalent from releases from the undisturbed Yucca Mountain disposal system:
(1) 150 microsieverts (15 millirems) for 10,000 years following disposal; and
(2) 1 millisievert (100 millirems) after 10,000 years, but within the period of geologic stability.
(b) The DOE's performance assessment must include all potential pathways of radionuclide transport and exposure.
The reasonably maximally exposed individual is a hypothetical person who meets the following criteria:
(a) Lives in the accessible environment above the highest concentration of radionuclides in the plume of contamination;
(b) Has a diet and living style representative of the people who now reside in the Town of Amargosa Valley, Nevada. The DOE must use projections based upon surveys of the people residing in the Town of Amargosa Valley, Nevada, to determine their current diets and living styles and use the mean values of these factors in the assessments conducted for §§ 197.20 and 197.25; and
(c) Drinks 2 liters of water per day from wells drilled into the ground water at the location specified in paragraph (a) of this section.
(a) The DOE must determine the earliest time after disposal that the waste package would degrade sufficiently that a human intrusion (see § 197.26) could occur without recognition by the drillers.
(b) The DOE must demonstrate that there is a reasonable expectation that the reasonably maximally exposed individual will receive an annual committed effective dose equivalent, as a result of the human intrusion, of no more than:
(1) 150 microsieverts (15 millirems) for 10,000 years following disposal; and
(2) 1 millisievert (100 millirems) after 10,000 years, but within the period of geologic stability.
(c) The analysis must include all potential environmental pathways of radionuclide transport and exposure.
For the purposes of the analysis of human intrusion, DOE must make the following assumptions:
(a) There is a single human intrusion as a result of exploratory drilling for ground water;
(b) The intruders drill a borehole directly through a degraded waste package into the uppermost aquifer underlying the Yucca Mountain repository;
(c) The drillers use the common techniques and practices that are currently employed in exploratory drilling for
(d) Careful sealing of the borehole does not occur, instead natural degradation processes gradually modify the borehole;
(e) Only releases of radionuclides that occur as a result of the intrusion and that are transported through the resulting borehole to the saturated zone are projected; and
(f) No releases are included which are caused by unlikely natural processes and events.
The DOE must demonstrate that there is a reasonable expectation that, for 10,000 years of undisturbed performance after disposal, releases of radionuclides from waste in the Yucca Mountain disposal system into the accessible environment will not cause the level of radioactivity in the representative volume of ground water to exceed the limits in the following Table 1:
(a) It is the volume of ground water that would be withdrawn annually from an aquifer containing less than 10,000 milligrams of total dissolved solids per liter of water to supply a given water demand. The DOE must project the concentration of radionuclides released from the Yucca Mountain disposal system that will be in the representative volume. The DOE must then use the projected concentrations to demonstrate a reasonable expectation to NRC that the Yucca Mountain disposal system complies with § 197.30. The DOE must make the following assumptions concerning the representative volume:
(1) It includes the highest concentration level in the plume of contamination in the accessible environment;
(2) Its position and dimensions in the aquifer are determined using average hydrologic characteristics which have cautious, but reasonable, values representative of the aquifers along the radionuclide migration path from the Yucca Mountain repository to the accessible environment as determined by site characterization; and
(3) It contains 3,000 acre-feet of water (about 3,714,450,000 liters or 977,486,000 gallons).
(b) The DOE must use one of two alternative methods for determining the dimensions of the representative volume. The DOE must propose its chosen method, and any underlying assumptions, to NRC for approval.
(1) The DOE may calculate the dimensions as a well-capture zone. If DOE uses this approach, it must assume that the:
(i) Water supply well(s) has (have) characteristics consistent with public water supply wells in the Town of Amargosa Valley, Nevada, for example, well-bore size and length of the screened intervals;
(ii) Screened interval(s) include(s) the highest concentration in the plume of contamination in the accessible environment; and
(iii) Pumping rates and the placement of the well(s) must be set to produce an annual withdrawal equal to the representative volume and to tap the highest concentration within the plume of contamination.
(2) The DOE may calculate the dimensions as a slice of the plume. If DOE uses this approach, it must:
(i) Propose to NRC, for its approval, where the location of the edge of the plume of contamination occurs. For example, the place where the concentration of radionuclides reaches 0.1% of the level of the highest concentration in the accessible environment;
(ii) Assume that the slice of the plume is perpendicular to the prevalent direction of flow of the aquifer; and
(iii) Assume that the volume of ground water contained within the slice of the plume equals the representative volume.
(a) Yes, there are limits on what DOE must consider in the performance assessments.
(1) The DOE's performance assessments conducted to show compliance with §§ 197.20(a)(1), 197.25(b)(1), and 197.30 shall not include consideration of very unlikely features, events, or processes, i.e., those that are estimated to have less than one chance in 100,000,000 per year of occurring. Features, events, and processes with a higher chance of occurring shall be considered for use in performance assessments conducted to show compliance with §§ 197.20(a)(1), 197.25(b)(1), and 197.30, except as stipulated in paragraph (b) of this section. In addition, unless otherwise specified in these standards or NRC regulations, DOE's performance assessments need not evaluate the impacts resulting from features, events, and processes or sequences of events and processes with a higher chance of occurring if the results of the performance assessments would not be changed significantly in the initial 10,000-year period after disposal.
(2) The same features, events, and processes identified in paragraph (a)(1) of this section shall be used in performance assessments conducted to show compliance with §§ 197.20(a)(2) and 197.25(b)(2), with additional considerations as stipulated in paragraph (c) of this section.
(b) For performance assessments conducted to show compliance with §§ 197.25(b) and 197.30, DOE's performance assessments shall exclude unlikely features, events, or processes, or sequences of events and processes. The DOE should use the specific probability of the unlikely features, events, and processes as specified by NRC.
(c) For performance assessments conducted to show compliance with §§ 197.20(a)(2) and 197.25(b)(2), DOE's performance assessments shall project the continued effects of the features, events, and processes included in paragraph (a) of this section beyond the 10,000-year post-disposal period through the period of geologic stability. The DOE must evaluate all of the features, events, or processes included in paragraph (a) of this section, and also:
(1) The DOE must assess the effects of seismic and igneous scenarios, subject to the probability limits in paragraph (a) of this section for very unlikely features, events, and processes. Performance assessments conducted to show compliance with § 197.25(b)(2) are also subject to the probability limits for unlikely features, events, and processes as specified by NRC.
(i) The seismic analysis may be limited to the effects caused by damage to the drifts in the repository, failure of the waste packages, and changes in the elevation of the water table under Yucca Mountain. NRC may determine the magnitude of the water table rise and its significance on the results of the performance assessment, or NRC may require DOE to demonstrate the magnitude of the water table rise and its significance in the license application. If NRC determines that the increased elevation of the water table does not significantly affect the results of the performance assessment, NRC may choose to not require its consideration in the performance assessment.
(ii) The igneous analysis may be limited to the effects of a volcanic event directly intersecting the repository. The igneous event may be limited to that causing damage to the waste packages directly, causing releases of radionuclides to the biosphere, atmosphere, or ground water.
(2) The DOE must assess the effects of climate change. The climate change analysis may be limited to the effects
(3) The DOE must assess the effects of general corrosion on engineered barriers. The DOE may use a constant representative corrosion rate throughout the period of geologic stability or a distribution of corrosion rates correlated to other repository parameters.
Yes. We can amend this rule by conducting another notice-and-comment rulemaking. Such a rulemaking must include a public comment period. Also, we may hold one or more public hearings, if we receive a written request to do so.
Yes. The individual protection and ground water protection standards are severable.
Unless otherwise directed by NRC, DOE shall use the radiation weighting factors and tissue weighting factors in this Appendix to calculate the internal component of the annual committed effective dose equivalent for compliance with §§ 197.20 and 197.25 of this part. NRC may allow DOE to use updated factors issued after the effective date of this regulation. Any such factors shall have been issued by consensus scientific organizations and incorporated by EPA into Federal radiation guidance in order to be considered generally accepted and eligible for this use. Further, they must be compatible with the effective dose equivalent dose calculation methodology established in ICRP 26 and 30, and continued in ICRP 60 and 72, and incorporated in this appendix.
The calculation of the committed effective dose equivalent (CEDE) begins with the determination of the equivalent dose, H
The next step is the calculation of the
For internal irradiation from incorporated radionuclides, the total absorbed dose will be spread out in time, being gradually delivered as the radionuclide decays. The time distribution of the absorbed dose rate will vary with the radionuclide, its form, the mode of intake and the tissue within which it is incorporated. To take account of this distribution the quantity
If the annual committed equivalent doses to the individual tissues or organs resulting from an annual intake are multiplied by the appropriate weighting factors, w