[Title 40 CFR F]
[Code of Federal Regulations (annual edition) - July 1, 1996 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)]
[Subchapter F - RADIATION PROTECTION PROGRAMS]
[From the U.S. Government Publishing Office]




  40
  PROTECTION OF ENVIRONMENT
  12
  1996-07-01
  1996-07-01
  false
  RADIATION PROTECTION PROGRAMS
  F
  SUBCHAPTER F
  
    PROTECTION OF ENVIRONMENT
    ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
  


               SUBCHAPTER F--RADIATION PROTECTION PROGRAMS


PART 190--ENVIRONMENTAL RADIATION PROTECTION STANDARDS FOR NUCLEAR POWER OPERATIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
190.01  Applicability.
190.02  Definitions.

      Subpart B--Environmental Standards for the Uranium Fuel Cycle

190.10  Standards for normal operations.
190.11  Variances for unusual operations.
190.12  Effective date.

    Authority: Atomic Energy Act of 1954, as amended; Reorganization 
Plan No. 3, of 1970.

    Source: 42 FR 2860, Jan. 13, 1977, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 190.01   Applicability.

    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.



Sec. 190.02   Definitions.

    (a) Nuclear fuel cycle means the operations defined to be associated 
with the production of electrical power for public use by any fuel cycle 
through utilization of nuclear energy.
    (b) Uranium fuel cycle means the operations of milling of uranium 
ore, chemical conversion of uranium, isotopic enrichment of uranium, 
fabrication of uranium fuel, generation of electricity by a light-water-
cooled nuclear power plant using uranium fuel, and reprocessing of spent 
uranium fuel, to the extent that these directly support the production 
of electrical power for public use utilizing nuclear energy, but 
excludes mining operations, operations at waste disposal sites, 
transportation of any radioactive material in support of these 
operations, and the reuse of recovered non-uranium special nuclear and 
by-product materials from the cycle.
    (c) General environment means the total terrestrial, atmospheric and 
aquatic environments outside sites upon which any operation which is 
part of a nuclear fuel cycle is conducted.
    (d) Site means the area contained within the boundary of a location 
under the control of persons possessing or using radioactive material on 
which is conducted one or more operations covered by this part.
    (e) Radiation means any or all of the following: Alpha, beta, gamma, 
or X-rays; neutrons; and high-energy electrons, protons, or other atomic 
particles; but not sound or radio waves, nor visible, infrared, or 
ultraviolet light.
    (f) Radioactive material means any material which spontaneously 
emits radiation.
    (g) Curie (Ci) means that quantity of radioactive material producing 
37 billion nuclear transformations per second. (One millicurie 
(mCi)=0.001 Ci.)
    (h) Dose equivalent means the product of absorbed dose and 
appropriate factors to account for differences in biological 
effectiveness due to the quality of radiation and its spatial 
distribution in the body. The unit of dose equivalent is the ``rem.'' 
(One millirem (mrem)= 0.001 rem.)
    (i) Organ means any human organ exclusive of the dermis, the 
epidermis, or the cornea.
    (j) Gigawatt-year refers to the quantity of electrical energy 
produced at the busbar of a generating station. A gigawatt is equal to 
one billion watts. A gigawatt-year is equivalent to the amount of energy 
output represented by an average electric power level of one gigawatt 
sustained for one year.
    (k) Member of the public means any individual that can receive a 
radiation dose in the general environment, whether he may or may not 
also be exposed to radiation in an occupation associated with a nuclear 
fuel cycle. However, an individual is not considered a member of the 
public during any

[[Page 6]]

period in which he is engaged in carrying out any operation which is 
part of a nuclear fuel cycle.
    (l) Regulatory agency means the government agency responsible for 
issuing regulations governing the use of sources of radiation or 
radioactive materials or emissions therefrom and carrying out inspection 
and enforcement activities to assure compliance with such regulations.



      Subpart B--Environmental Standards for the Uranium Fuel Cycle



Sec. 190.10   Standards for normal operations.

    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.



Sec. 190.11   Variances for unusual operations.

    The standards specified in Sec. 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.



Sec. 190.12   Effective date.

    (a) The standards in Sec. 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 Sec. 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.



PART 191--ENVIRONMENTAL RADIATION PROTECTION STANDARDS FOR MANAGEMENT AND DISPOSAL OF SPENT NUCLEAR FUEL, HIGH-LEVEL AND TRANSURANIC RADIOACTIVE WASTES--Table of Contents




      Subpart A--Environmental Standards for Management and Storage

Sec.
191.01  Applicability.
191.02  Definitions.
191.03  Standards.
191.04  Alternative standards.
191.05  Effective date.

             Subpart B--Environmental Standards for Disposal

191.11  Applicability.
191.12  Definitions.
191.13  Containment requirements.
191.14  Assurance requirements.
191.15  Individual protection requirements.
191.16  Alternative provisions for disposal.
191.17  Effective date.

     Subpart C--Environmental Standards for Ground-Water Protection

191.21  Applicability.
191.22  Definitions.
191.23  General provisions.
191.24  Disposal standards.
191.25  Compliance with other Federal regulations.
191.26  Alternative provisions.
191.27  Effective date.
Appendix A to Part 191--Table for Subpart B
Appendix B to Part 191--Calculation of Annual Committed Effective Dose
Appendix C to Part 191--Guidance for Implementation of Subpart B


[[Page 7]]


    Authority: 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.

    Source: 50 FR 38084, Sept. 19, 1985, unless otherwise noted.



      Subpart A--Environmental Standards for Management and Storage



Sec. 191.01  Applicability.

    This subpart applies to:
    (a) Radiation doses received by members of the public as a result of 
the management (except for transportation) and storage of spent nuclear 
fuel or high-level or transuranic radioactive wastes at any facility 
regulated by the Nuclear Regulatory Commission or by Agreement States, 
to the extent that such management and storage operations are not 
subject to the provisions of part 190 of title 40; and
    (b) Radiation doses received by members of the public as a result of 
the management and storage of spent nuclear fuel or high-level or 
transuranic wastes at any disposal facility that is operated by the 
Department of Energy and that is not regulated by the Commission or by 
Agreement States.



Sec. 191.02  Definitions.

    Unless otherwise indicated in this subpart, all terms shall have the 
same meaning as in Subpart A of Part 190.
    (a) Agency means the Environmental Protection Agency.
    (b) Administrator means the Administrator of the Environmental 
Protection Agency.
    (c) Commission means the Nuclear Regulatory Commission.
    (d) Department means the Department of Energy.
    (e) NWPA means the Nuclear Waste Policy Act of 1982 (Pub. L. 97-
425).
    (f) Agreement State means any State with which the Commission or the 
Atomic Energy Commission has entered into an effective agreement under 
subsection 274b of the Atomic Energy Act of 1954, as amended (68 Stat. 
919).
    (g) Spent nuclear fuel means fuel that has been withdrawn from a 
nuclear reactor following irradiation, the constituent elements of which 
have not been separated by reprocessing.
    (h) High-level radioactive waste, as used in this part, means high-
level radioactive waste as defined in the Nuclear Waste Policy Act of 
1982 (Pub. L. 97-425).
    (i) Transuranic radioactive waste, as used in this part, means waste 
containing more than 100 nanocuries of alpha-emitting transuranic 
isotopes, with half-lives greater than twenty years, per gram of waste, 
except for: (1) High-level radioactive wastes; (2) wastes that the 
Department has determined, with the concurrence of the Administrator, do 
not need the degree of isolation required by this part; or (3) wastes 
that the Commission has approved for disposal on a case-by-case basis in 
accordance with 10 CFR Part 61.
    (j) Radioactive waste, as used in this part, means the high-level 
and transuranic radioactive waste covered by this part.
    (k) Storage means retention of spent nuclear fuel or radioactive 
wastes with the intent and capability to readily retrieve such fuel or 
waste for subsequent use, processing, or disposal.
    (l) Disposal means permanent isolation of spent nuclear fuel or 
radioactive waste from the accessible environment with no intent of 
recovery, whether or not such isolation permits the recovery of such 
fuel or waste. For example, disposal of waste in a mined geologic 
repository occurs when all of the shafts to the repository are 
backfilled and sealed.
    (m) Management means any activity, operation, or process (except for 
transportation) conducted to prepare spent nuclear fuel or radioactive 
waste for storage or disposal, or the activities associated with placing 
such fuel or waste in a disposal system.
    (n) Site means an area contained within the boundary of a location 
under the effective control of persons possessing or using spent nuclear 
fuel or radioactive waste that are involved in any activity, operation, 
or process covered by this subpart.
    (o) General environment means the total terrestrial, atmospheric, 
and

[[Page 8]]

aquatic environments outside sites within which any activity, operation, 
or process associated with the management and storage of spent nuclear 
fuel or radioactive waste is conducted.
    (p) Member of the public means any individual except during the time 
when that individual is a worker engaged in any activity, operation, or 
process that is covered by the Atomic Energy Act of 1954, as amended.
    (q) Critical organ means the most exposed human organ or tissue 
exclusive of the integumentary system (skin) and the cornea.



Sec. 191.03  Standards.

    (a) Management and storage of spent nuclear fuel or high-level or 
transuranic radioactive wastes at all facilities regulated by the 
Commission or by Agreement States shall be conducted in such a manner as 
to provide reasonable assurance that the combined annual dose equivalent 
to any member of the public in the general environment resulting from: 
(1) Discharges of radioactive material and direct radiation from such 
management and storage and (2) all operations covered by Part 190; shall 
not exceed 25 millirems to the whole body, 75 millirems to the thyroid, 
and 25 millirems to any other critical organ.

    (b) Management and storage of spent nuclear fuel or high-level or 
transuranic radioactive wastes at all facilities for the disposal of 
such fuel or waste that are operated by the Department and that are not 
regulated by the Commission or Agreement States shall be conducted in 
such a manner as to provide reasonable assurance that the combined 
annual dose equivalent to any member of the public in the general 
environment resulting from discharges of radioactive material and direct 
radiation from such management and storage shall not exceed 25 millirems 
to the whole body and 75 millirems to any critical organ.



Sec. 191.04  Alternative standards.

    (a) The Administrator may issue alternative standards from those 
standards established in Sec. 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 Sec. 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 
Sec. 191.03(b) and shall include all information necessary for the 
Administrator to make the determinations called for in Sec. 191.04(a).
    (c) Requests for alternative standards shall be submitted to the 
Administrator, U.S. Environmental Protection Agency, 401 M Street, SW., 
Washington, DC 20460.



Sec. 191.05  Effective date.

    The standards in this subpart shall be effective on November 18, 
1985.



             Subpart B--Environmental Standards for Disposal



Sec. 191.11  Applicability.

    (a) This subpart applies to:
    (1) Radioactive materials released into the accessible environment 
as a result of the disposal of spent nuclear fuel or high-level or 
transuranic radioactive wastes;
    (2) Radiation doses received by members of the public as a result of 
such disposal; and
    (3) Radioactive contamination of certain sources of ground water in 
the vicinity of disposal systems for such fuel or wastes.
    (b) This subpart does not apply to:
    (1) Disposal directly into the oceans or ocean sediments;

[[Page 9]]

    (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.

[50 FR 38084, Sept. 19, 1985, as amended at 58 FR 66414, Dec. 20, 1993]



Sec. 191.12  Definitions.

    Unless otherwise indicated in this subpart, all terms shall have the 
same meaning as in subpart A of this part.
    Accessible environment means: (1) The atmosphere; (2) land surfaces; 
(3) surface waters; (4) oceans; and (5) all of the lithosphere that is 
beyond the controlled area.
    Active institutional control means: (1) Controlling access to a 
disposal site by any means other than passive institutional controls; 
(2) performing maintenance operations or remedial actions at a site, (3) 
controlling or cleaning up releases from a site, or (4) monitoring 
parameters related to disposal system performance.
    Annual committed effective dose means the committed effective dose 
resulting from one-year intake of radionuclides released plus the annual 
effective dose caused by direct radiation from facilities or activities 
subject to subparts B and C of this part.
    Aquifer means an underground geological formation, group of 
formations, or part of a formation that is capable of yielding a 
significant amount of water to a well or spring.
    Barrier means any material or structure that prevents or 
substantially delays movement of water or radionuclides toward the 
accessible environment. For example, a barrier may be a geologic 
structure, a canister, a waste form with physical and chemical 
characteristics that significantly decrease the mobility of 
radionuclides, or a material placed over and around waste, provided that 
the material or structure substantially delays movement of water or 
radionuclides.
    Controlled area means: (1) A surface location, to be identified by 
passive institutional controls, that encompasses no more than 100 square 
kilometers and extends horizontally no more than five kilometers in any 
direction from the outer boundary of the original location of the 
radioactive wastes in a disposal system; and (2) the subsurface 
underlying such a surface location.
    Disposal system means any combination of engineered and natural 
barriers that isolate spent nuclear fuel or radioactive waste after 
disposal.
    Dose equivalent means the product of absorbed dose and appropriate 
factors to account for differences in biological effectiveness due to 
the quality of radiation and its spatial distribution in the body; the 
unit of dose equivalent is the ``rem'' (``sievert'' in SI units).
    Effective dose means the sum over specified tissues of the products 
of the dose equivalent received following an exposure of, or an intake 
of radionuclides into, specified tissues of the body, multiplied by 
appropriate weighting factors. This allows the various tissue-specific 
health risks to be summed into an overall health risk. The method used 
to calculate effective dose is described in appendix B of this part.
    Ground water means water below the land surface in a zone of 
saturation.
    Heavy metal means all uranium, plutonium, or thorium placed into a 
nuclear reactor.
    Implementing agency means:
    (1) The Commission for facilities licensed by the Commission;
    (2) The Agency for those implementation responsibilities for the 
Waste Isolation Pilot Plant, under this part, given to the Agency by the 
Waste Isolation Pilot Plant Land Withdrawal Act (Pub. L. 102-579, 106 
Stat. 4777) which, for the purposes of this part, are:
    (i) Determinations by the Agency that the Waste Isolation Pilot 
Plant is in compliance with subpart A of this part;
    (ii) Issuance of criteria for the certifications of compliance with 
subparts B and C of this part of the Waste Isolation Pilot Plant's 
compliance with subparts B and C of this part;
    (iii) Certifications of compliance with subparts B and C of this 
part of the Waste Isolation Pilot Plant's compliance with subparts B and 
C of this part;
    (iv) If the initial certification is made, periodic recertification 
of the

[[Page 10]]

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 Sec. 191.02(i) that certain wastes do not need the degree of 
isolation required by subparts B and C of this part; and
    (3) The Department of Energy for any other disposal facility and all 
other implementation responsibilities for the Waste Isolation Pilot 
Plant, under this part, not given to the Agency.
    International System of Units is the version of the metric system 
which has been established by the International Bureau of Weights and 
Measures and is administered in the United States by the National 
Institute of Standards and Technology. The abbreviation for this system 
is ``SI.''
    Lithosphere means the solid part of the Earth below the surface, 
including any ground water contained within it.
    Passive institutional control means: (1) Permanent markers placed at 
a disposal site, (2) public records and archives, (3) government 
ownership and regulations regarding land or resource use, and (4) other 
methods of preserving knowledge about the location, design, and contents 
of a disposal system.
    Performance assessment means an analysis that: (1) Identifies the 
processes and events that might affect the disposal system; (2) examines 
the effects of these processes and events on the performance of the 
disposal system; and (3) estimates the cumulative releases of 
radionuclides, considering the associated uncertainties, caused by all 
significant processes and events. These estimates shall be incorporated 
into an overall probability distribution of cumulative release to the 
extent practicable.
    Radioactive material means matter composed of or containing 
radionuclides, with radiological half-lives greater than 20 years, 
subject to the Atomic Energy Act of 1954, as amended.
    SI unit means a unit of measure in the International System of 
Units.
    Sievert is the SI unit of effective dose and is equal to 100 rem or 
one joule per kilogram. The abbreviation is ``Sv.''
    Undisturbed performance means the predicted behavior of a disposal 
system, including consideration of the uncertainties in predicted 
behavior, if the disposal system is not disrupted by human intrusion or 
the occurrence of unlikely natural events.
    Waste, as used in this subpart, means any spent nuclear fuel or 
radioactive waste isolated in a disposal system.
    Waste form means the materials comprising the radioactive components 
of waste and any encapsulating or stabilizing matrix.

[50 FR 38084, Sept. 19, 1985, as amended at 58 FR 66414, Dec. 20, 1993]



Sec. 191.13  Containment requirements.

    (a) Disposal systems for spent nuclear fuel or high-level or 
transuranic radioactive wastes shall be designed to provide a reasonable 
expectation, based upon performance assessments, that the cumulative 
releases of radionuclides to the accessible environment for 10,000 years 
after disposal from all significant processes and events that may affect 
the disposal system shall:
    (1) Have a likelihood of less than one chance in 10 of exceeding the 
quantities calculated according to Table 1 (appendix A); and
    (2) Have a likelihood of less than one chance in 1,000 of exceeding 
ten times the quantities calculated according to Table 1 (appendix A).
    (b) Performance assessments need not provide complete assurance that 
the requirements of Sec. 191.13(a) will be met. Because of the long time 
period involved and the nature of the events and processes of interest, 
there will inevitably be substantial uncertainties in projecting 
disposal system performance. Proof of the future performance of a 
disposal system is not to be had in the ordinary sense of the word in 
situations that deal with much shorter time frames. Instead, what is 
required is a reasonable expectation, on the basis of the record before 
the implementing agency, that compliance with Sec. 191.13 (a) will be 
achieved.


[[Page 11]]





Sec. 191.14  Assurance requirements.

    To provide the confidence needed for long-term compliance with the 
requirements of Sec. 191.13, disposal of spent nuclear fuel or high-
level or transuranic wastes shall be conducted in accordance with the 
following provisions, except that these provisions do not apply to 
facilities regulated by the Commission (see 10 CFR Part 60 for 
comparable provisions applicable to facilities regulated by the 
Commission):
    (a) Active institutional controls over disposal sites should be 
maintained for as long a period of time as is practicable after 
disposal; however, performance assessments that assess isolation of the 
wastes from the accessible environment shall not consider any 
contributions from active institutional controls for more than 100 years 
after disposal.

    (b) Disposal systems shall be monitored after disposal to detect 
substantial and detrimental deviations from expected performance. This 
monitoring shall be done with techniques that do not jeopardize the 
isolation of the wastes and shall be conducted until there are no 
significant concerns to be addressed by further monitoring.
    (c) Disposal sites shall be designated by the most permanent 
markers, records, and other passive institutional controls practicable 
to indicate the dangers of the wastes and their location.
    (d) Disposal systems shall use different types of barriers to 
isolate the wastes from the accessible environment. Both engineered and 
natural barriers shall be included.
    (e) Places where there has been mining for resources, or where there 
is a reasonable expectation of exploration for scarce or easily 
accessible resources, or where there is a significant concentration of 
any material that is not widely available from other sources, should be 
avoided in selecting disposal sites. Resources to be considered shall 
include minerals, petroleum or natural gas, valuable geologic 
formations, and ground waters that are either irreplaceable because 
there is no reasonable alternative source of drinking water available 
for substantial populations or that are vital to the preservation of 
unique and sensitive ecosystems. Such places shall not be used for 
disposal of the wastes covered by this part unless the favorable 
characteristics of such places compensate for their greater likelihood 
of being disturbed in the future.
    (f) Disposal systems shall be selected so that removal of most of 
the wastes is not precluded for a reasonable period of time after 
disposal.



Sec. 191.15  Individual protection requirements.

    (a) Disposal systems for waste and any associated radioactive 
material shall be designed to provide a reasonable expectation that, for 
10,000 years after disposal, undisturbed performance of the disposal 
system shall not cause the annual committed effective dose, received 
through all potential pathways from the disposal system, to any member 
of the public in the accessible environment, to exceed 15 millirems (150 
microsieverts).
    (b) Annual committed effective doses shall be calculated in 
accordance with appendix B of this part.
    (c) Compliance assessments need not provide complete assurance that 
the requirements of paragraph (a) of this section will be met. Because 
of the long time period involved and the nature of the processes and 
events of interest, there will inevitably be substantial uncertainties 
in projecting disposal system performance. Proof of the future 
performance of a disposal system is not to be had in the ordinary sense 
of the word in situations that deal with much shorter time frames. 
Instead, what is required is a reasonable expectation, on the basis of 
the record before the implementing agency, that compliance with 
paragraph (a) of this section will be achieved.
    (d) Compliance with the provisions in this section does not negate 
the necessity to comply with any other applicable Federal regulations or 
requirements.
    (e) The standards in this section shall be effective on January 19, 
1994.

[58 FR 66414, Dec. 20, 1993]

[[Page 12]]



Sec. 191.16  Alternative provisions for disposal.

    The Administrator may, by rule, substitute for any of the provisions 
of subpart B alternative provisions chosen after:
    (a) The alternative provisions have been proposed for public comment 
in the Federal Register together with information describing the costs, 
risks, and benefits of disposal in accordance with the alternative 
provisions and the reasons why compliance with the existing provisions 
of Subpart B appears inappropriate;
    (b) A public comment period of at least 90 days has been completed, 
during which an opportunity for public hearings in affected areas of the 
country has been provided; and
    (c) The public comments received have been fully considered in 
developing the final version of such alternative provisions.

[50 FR 38084, Sept. 19, 1985. Redesignated at 58 FR 66414, Dec. 20, 
1993]



Sec. 191.17  Effective date.

    The standards in this subpart shall be effective on November 18, 
1985.

[50 FR 38084, Sept. 19, 1985; 50 FR 40003, Oct. 1, 1985. Redesignated at 
58 FR 66414, Dec. 20, 1993]



     Subpart C--Environmental Standards for Ground-Water Protection

    Source: 58 FR 66415, Dec. 20, 1993, unless otherwise noted.



Sec. 191.21  Applicability.

    (a) This subpart applies to:
    (1) Radiation doses received by members of the public as a result of 
activities subject to subpart B of this part; and
    (2) Radioactive contamination of underground sources of drinking 
water in the accessible environment as a result of such activities.
    (b) This subpart does not apply to:
    (1) Disposal directly into the oceans or ocean sediments;
    (2) Wastes disposed of before the effective date of this subpart; 
and
    (3) The characterization, licensing, construction, operation, or 
closure of any site required to be characterized under section 113(a) of 
Public Law 97-425, 96 Stat. 2201.



Sec. 191.22  Definitions.

    Unless otherwise indicated in this subpart, all terms have the same 
meaning as in subparts A and B of this part.
    Public water system means a system for the provision to the public 
of piped water for human consumption, if such system has at least 
fifteen service connections or regularly serves at least twenty-five 
individuals. Such term includes:
    (1) Any collection, treatment, storage, and distribution facilities 
under control of the operator of such system and used primarily in 
connection with such system; and
    (2) Any collection or pretreatment storage facilities not under such 
control which are used primarily in connection with such system.
    Total dissolved solids means the total dissolved (filterable) solids 
in water as determined by use of the method specified in 40 CFR part 
136.
    Underground source of drinking water means an aquifer or its portion 
which:
    (1) Supplies any public water system; or
    (2) Contains a sufficient quantity of ground water to supply a 
public water system; and
    (i) Currently supplies drinking water for human consumption; or
    (ii) Contains fewer than 10,000 milligrams of total dissolved solids 
per liter.



Sec. 191.23  General provisions.

    (a) Determination of compliance with this subpart shall be based 
upon underground sources of drinking water which have been identified on 
the date the implementing agency determines compliance with subpart C of 
this part.
    (b) [Reserved]



Sec. 191.24  Disposal standards.

    (a) Disposal systems.
    (1) General. Disposal systems for waste and any associated 
radioactive material shall be designed to provide a reasonable 
expectation that 10,000 years of undisturbed performance after

[[Page 13]]

disposal shall not cause the levels of radioactivity in any underground 
source of drinking water, in the accessible environment, to exceed the 
limits specified in 40 CFR part 141 as they exist on January 19, 1994.
    (2) Disposal systems above or within a formation which within one-
quarter (\1/4\) mile contains an underground source of drinking water. 
[Reserved]
    (b) Compliance assessments need not provide complete assurance that 
the requirements of paragraph (a) of this section will be met. Because 
of the long time period involved and the nature of the processes and 
events of interest, there will inevitably be substantial uncertainties 
in projecting disposal system performance. Proof of the future 
performance of a disposal system is not to be had in the ordinary sense 
of the word in situations that deal with much shorter time frames. 
Instead, what is required is a reasonable expectation, on the basis of 
the record before the implementing agency, that compliance with 
paragraph (a) of this section will be achieved.



Sec. 191.25  Compliance with other Federal regulations.

    Compliance with the provisions in this subpart does not negate the 
necessity to comply with any other applicable Federal regulations or 
requirements.



Sec. 191.26  Alternative provisions.

    The Administrator may, by rule, substitute for any of the provisions 
of this subpart alternative provisions chosen after:
    (a) The alternative provisions have been proposed for public comment 
in the Federal Register together with information describing the costs, 
risks, and benefits of disposal in accordance with the alternative 
provisions and the reasons why compliance with the existing provisions 
of this subpart appears inappropriate;
    (b) A public comment period of at least 90 days has been completed, 
during which an opportunity for public hearings in affected areas of the 
country has been provided; and
    (c) The public comments received have been fully considered in 
developing the final version of such alternative provisions.



Sec. 191.27  Effective date.

    The standards in this subpart shall be effective on January 19, 
1994.

               Appendix A to Part 191--Table for Subpart B

          Table 1--Release Limits for Containment Requirements          
   [Cumulative releases to the accessible environment for 10,000 years  
                             after disposal]                            
------------------------------------------------------------------------
                                                                Release 
                                                               limit per
                                                                 1,000  
                                                                MTHM or 
                                                                 other  
                         Radionuclide                           unit of 
                                                                 waste  
                                                                  (see  
                                                                 notes) 
                                                                (curies)
------------------------------------------------------------------------
Americium-241 or -243........................................        100
Carbon-14....................................................        100
Cesium-135 or -137...........................................      1,000
Iodine-129...................................................        100
Neptunium-237................................................        100
Plutonium-238, -239, -240, or -242...........................        100
Radium-226...................................................        100
Strontium-90.................................................      1,000
Technetium-99................................................     10,000
Thorium-230 or -232..........................................         10
Tin-126......................................................      1,000
Uranium-233, -234, -235, -236, or -238.......................        100
Any other alpha-emitting radionuclide with a half-life                  
 greater than 20 years.......................................        100
Any other radionuclide with a half-life greater than 20 years           
 that does not emit alpha particles..........................      1,000
------------------------------------------------------------------------

                         Application of Table 1

    Note 1: Units of Waste. The Release Limits in Table 1 apply to the 
amount of wastes in any one of the following:
    (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

[[Page 14]]

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.

    Note 2: Release Limits for Specific Disposal Systems. To develop 
Release Limits for a particular disposal system, the quantities in Table 
1 shall be adjusted for the amount of waste included in the disposal 
system compared to the various units of waste defined in Note 1. For 
example:
    (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 and 5 million curies of alpha-emitting 
transuranic wastes, the Release Limits for that system would be the 
quantities in Table 1 multiplied by 55:

                                                                        
               50,000 MTHM                     5,000,000 curies TRU     
------------------------------------------ + ----------------------- =55
                1,000 MTHM                     1,000,000 curies TRU     
                                                                        

    Note 3: Adjustments for Reactor Fuels with Different Burnup. For 
disposal systems containing reactor fuels (or the high-level wastes from 
reactor fuels) exposed to an average burnup of less than 25,000 MWd/MTHM 
or greater than 40,000 MWd/MTHM, the units of waste defined in (a) and 
(b) of Note 1 shall be adjusted. The unit shall be multiplied by the 
ratio of 30,000 MWd/MTHM divided by the fuel's actual average burnup, 
except that a value of 5,000 MWd/MTHM may be used when the average fuel 
burnup is below 5,000 MWd/MTHM and a value of 100,000 MWd/MTHM shall be 
used when the average fuel burnup is above 100,000 MWd/MTHM. This 
adjusted unit of waste shall then be used in determining the Release 
Limits for the disposal system.
    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:

                                                                        
                                 (30,000)                               
      1,000 MTHM  x       ---------------------       = 6,000 MTHM      
                                 (5,000)                                
                                                                        

    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:

                                                                        
                                  60,000 MTHM                           
                              -------------------  =10                  
                                   6,000 MTHM                           
                                                                        

which is the same as:

                                                                        
     60,000 MTHM                        (5,000 MWd/MTHM)                
----------------------     x    -------------------------------    =10  
      1,000 MTHM                       (30,000 MWd/MTHM)                
                                                                        

    Note 4: Treatment of Fractionated High-Level Wastes. In some cases, 
a high-level waste stream from reprocessing spent nuclear fuel may have 
been (or will be) separated into two or more high-level waste components 
destined for different disposal systems. In such cases, the implementing 
agency may allocate the Release Limit multiplier (based upon the 
original MTHM and the average fuel burnup of the high-level waste 
stream) among the various disposal systems as it chooses, provided that 
the total Release Limit multiplier used for that waste stream at all of 
its disposal systems may not exceed the Release Limit multiplier that 
would be used if the entire waste stream were disposed of in one 
disposal system.
    Note 5: Treatment of Wastes with Poorly Known Burnups or Original 
MTHM. In some cases, the records associated with particular high-level 
waste streams may not be adequate to accurately determine the original 
metric tons of heavy metal in the reactor fuel that created the waste, 
or to determine the average burnup that the fuel was exposed to. If the 
uncertainties are such that the original amount of heavy metal or the 
average fuel burnup for particular high-level waste streams cannot be 
quantified, the units of waste derived from (a) and (b) of Note 1 shall 
no longer be used. Instead, the units of waste defined in (c) and (d) of 
Note 1 shall be used for such high-level waste streams. If the 
uncertainties in such information allow a range of values to be 
associated with the original amount of heavy metal or the average fuel 
burnup, then the calculations described in previous Notes will be 
conducted using the values that result in the smallest Release Limits, 
except that the Release Limits need not be smaller than those that would 
be calculated using the units of waste defined in (c) and (d) of Note 1.
    Note 6: Uses of Release Limits to Determine Compliance with 
Sec. 191.13 Once release limits for a particular disposal system have 
been determined in accordance with Notes 1 through 5, these release 
limits shall be used to determine compliance with the requirements of 
Sec. 191.13 as follows. In cases where a mixture of radionuclides is 
projected to be released to the accessible environment, the

[[Page 15]]

limiting values shall be determined as follows: For each radionuclide in 
the mixture, determine the ratio between the cumulative release quantity 
projected over 10,000 years and the limit for that radionuclide as 
determined from Table 1 and Notes 1 through 5. The sum of such ratios 
for all the radionuclides in the mixture may not exceed one with regard 
to Sec. 191.13(a)(1) and may not exceed ten with regard to 
Sec. 191.13(a)(2).
    For example, if radionuclides A, B, and C are projected to be 
released in amounts Qa, Qb, and Qc, and if the applicable 
Release Limits are RLa, RLb, and RLc, then the cumulative 
releases over 10,000 years shall be limited so that the following 
relationship exists:

                                                                                                                
                                              Qa       Qb       Qc                                              
                                            -----  + -----  + -----       1                                     
                                             RLa      RLb      RLc                                              
                                                                                                                


[50 FR 38084, Sept. 19, 1985, as amended at 58 FR 66415, Dec. 20, 1993]

 Appendix B to Part 191--Calculation of Annual Committed Effective Dose

                           I. Equivalent Dose

    The calculation of the committed effective dose (CED) begins with 
the determination of the equivalent dose, HT, to a tissue or organ, 
T, listed in Table B.2 below by using the equation:
[GRAPHIC] [TIFF OMITTED] TR20DE93.009

where DT,R is the absorbed dose in rads (one gray, an SI unit, 
equals 100 rads) averaged over the tissue or organ, T, due to radiation 
type, R, and wR is the radiation weighting factor which is given in 
Table B.1 below. The unit of equivalent dose is the rem (sievert, in SI 
units).

             Table B.1.--Radiation Weighting Factors, wR\1\             
------------------------------------------------------------------------
                                                                    wR  
               Radiation type and energy range \2\                 value
------------------------------------------------------------------------
Photons, all energies...........................................       1
Electrons and muons, all energies...............................       1
Neutrons, energy < 10 keV.......................................       5
          10 keV to 100 keV.....................................      10
          >100 keV to 2 MeV.....................................      20
          >2 MeV to 20 MeV......................................      10
          >20 MeV...............................................       5
Protons, other than recoil protons,   >2 MeV....................       5
Alpha particles, fission fragments, heavy nuclei................     20 
------------------------------------------------------------------------
\1\ All values relate to the radiation incident on the body or, for     
  internal sources, emitted from the source.                            
\2\ See paragraph A14 in ICRP Publication 60 for the choice of values   
  for other radiation types and energies not in the table.              

                           II. Effective Dose

    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, 
wT in Table B.2, which represent the proportion of the stochastic 
risk resulting from irradiation of the tissue or organ to the total risk 
when the whole body is irradiated uniformly and HT is the 
equivalent dose in the tissue or organ, T, in the equation:
[GRAPHIC] [TIFF OMITTED] TR20DE93.010


               Table B.2--Tissue Weighting Factors, wT \1\              
------------------------------------------------------------------------
                     Tissue or organ                         wT value   
------------------------------------------------------------------------
Gonads..................................................            0.25
Breast..................................................            0.15
Red bone marrow.........................................            0.12
Lung....................................................            0.12
Thyroid.................................................            0.03
Bone surfaces...........................................            0.03
Remainder...............................................       \2\ 0.30 
------------------------------------------------------------------------
\1\ The values are considered to be appropriate for protection for      
  individuals of both sexes and all ages.                               
\2\ For purposes of calculation, the remainder is comprised of the five 
  tissues or organs not specifically listed in Table B.2 that receive   
  the highest dose equivalents; a weighting factor of 0.06 is applied to
  each of them, including the various sections of the gastrointestinal  
  tract which are treated as separate organs. This covers all tissues   
  and organs except the hands and forearms, the feet and ankles, the    
  skin and the lens of the eye. The excepted tissues and organs should  
  be excluded from the computation of HE.                               

          III. Annual Committed Tissue or Organ Equivalent Dose

     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, HT() 
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, , is taken as 50 years as an average time of 
exposure following intake:

[[Page 16]]

[GRAPHIC] [TIFF OMITTED] TR20DE93.011


for a single intake of activity at time t0 where HT(t) is the 
relevant equivalent-dose rate in a tissue or organ at time t. For the 
purposes of this part, the previously mentioned single intake may be 
considered to be an annual intake.

                   IV. Annual Committed Effective Dose

    If the committed equivalent doses to the individual tissues or 
organs resulting from an annual intake are multiplied by the appropriate 
weighting factors, wT, and then summed, the result will be the 
annual committed effective dose, E():
[GRAPHIC] [TIFF OMITTED] TR20DE93.012


[58 FR 66415, Dec. 20, 1993]

    Appendix C to Part 191--Guidance for Implementation of Subpart B

    [Note: The supplemental information in this appendix is not an 
integral part of 40 CFR part 191. Therefore, the implementing agencies 
are not bound to follow this guidance. However, it is included because 
it describes the Agency's assumptions regarding the implementation of 
subpart B. This appendix will appear in the Code of Federal 
Regulations.]

    The Agency believes that the implementing agencies must determine 
compliance with Secs. 191.13, 191.15, and 191.16 of subpart B by 
evaluating long-term predictions of disposal system performance. 
Determining compliance with Sec. 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 Secs. 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.
    Consideration of Total Disposal System. When predicting disposal 
system performance, the Agency assumes that reasonable projections of 
the protection expected from all of the engineered and natural barriers 
of a disposal system will be considered. Portions of the disposal system 
should not be disregarded, even if projected performance is uncertain, 
except for portions of the system that make negligible contributions to 
the overall isolation provided by the disposal system.
    Scope of Performance Assessments. Section 191.13 requires the 
implementing agencies to evaluate compliance through performance 
assessments as defined in Sec. 191.12(q). The Agency assumes that such 
performance assessments need not consider categories of events or 
processes that are estimated to have less than one chance in 10,000 of 
occurring over 10,000 years. Furthermore, the performance assessments 
need not evaluate in detail the releases from all events and processes 
estimated to have a greater likelihood of occurrence. Some of these 
events and processes may be omitted from the performance assessments if 
there is a reasonable expectation that the remaining probability 
distribution of cumulative releases would not be significantly changed 
by such omissions.
    Compliance with Sec. 191.13. The Agency assumes that, whenever 
practicable, the implementing agency will assemble all of the results of 
the performance assessments to determine compliance with Sec. 191.13 
into a ``complementary cumulative distribution function'' that indicates 
the probability of exceeding various levels of cumulative release. When 
the uncertainties in parameters are considered in a performance 
assessment, the effects of the uncertainties considered can be 
incorporated into a single such distribution function for each disposal 
system considered. The Agency assumes that a disposal system can be 
considered to be in compliance with Sec. 191.13 if this single 
distribution function meets the requirements of Sec. 191.13(a).
    Compliance with Secs. 191.15 and 191.16. When the uncertainties in 
undisturbed performance of a disposal system are considered, the 
implementing agencies need not require that a very large percentage of 
the range of estimated radiation exposures or radionuclide 
concentrations fall below limits established

[[Page 17]]

in Secs. 191.15 and 191.16, respectively. The Agency assumes that 
compliance can be determined based upon ``best estimate'' predictions 
(e.g., the mean or the median of the appropriate distribution, whichever 
is higher).
    Institutional Controls. To comply with Sec. 191.14(a), the 
implementing agency will assume that none of the active institutional 
controls prevent or reduce radionuclide releases for more than 100 years 
after disposal. However, the Federal Government is committed to 
retaining ownership of all disposal sites for spent nuclear fuel and 
high-level and transuranic radioactive wastes and will establish 
appropriate markers and records, consistent with Sec. 191.14(c). The 
Agency assumes that, as long as such passive institutional controls 
endure and are understood, they: (1) Can be effective in deterring 
systematic or persistent exploitation of these disposal sites; and (2) 
can reduce the likelihood of inadvertent, intermittent human intrusion 
to a degree to be determined by the implementing agency. However, the 
Agency believes that passive institutional controls can never be assumed 
to eliminate the chance of inadvertent and intermittent human intrusion 
into these disposal sites.
    Consideration of Inadvertent Human Intrusion into Geologic 
Repositories. The most speculative potential disruptions of a mined 
geologic repository are those associated with inadvertent human 
intrusion. Some types of intrusion would have virtually no effect on a 
repository's containment of waste. On the other hand, it is possible to 
conceive of intrusions (involving widespread societal loss of knowledge 
regarding radioactive wastes) that could result in major disruptions 
that no reasonable repository selection or design precautions could 
alleviate. The Agency believes that the most productive consideration of 
inadvertent intrusion concerns those realistic possibilities that may be 
usefully mitigated by repository design, site selection, or use of 
passive controls (although passive institutional controls should not be 
assumed to completely rule out the possibility of intrusion). Therefore, 
inadvertent and intermittent intrusion by exploratory drilling for 
resources (other than any provided by the disposal system itself) can be 
the most severe intrusion scenario assumed by the implementing agencies. 
Furthermore, the implementing agencies can assume that passive 
institutional controls or the intruders' own exploratory procedures are 
adequate for the intruders to soon detect, or be warned of, the 
incompatibility of the area with their activities.
    Frequency and Severity of Inadvertent Human Intrusion into Geologic 
Repositories. The implementing agencies should consider the effects of 
each particular disposal system's site, design, and passive 
institutional controls in judging the likelihood and consequences of 
such inadvertent exploratory drilling. However, the Agency assumes that 
the likelihood of such inadvertent and intermittent drilling need not be 
taken to be greater than 30 boreholes per square kilometer of repository 
area per 10,000 years for geologic repositories in proximity to 
sedimentary rock formations, or more than 3 boreholes per square 
kilometer per 10,000 years for repositories in other geologic 
formations. Furthermore, the Agency assumes that the consequences of 
such inadvertent drilling need not be assumed to be more severe than: 
(1) Direct release to the land surface of all the ground water in the 
repository horizon that would promptly flow through the newly created 
borehole to the surface due to natural lithostatic pressure--or (if 
pumping would be required to raise water to the surface) release of 200 
cubic meters of ground water pumped to the surface if that much water is 
readily available to be pumped; and (2) creation of a ground water flow 
path with a permeability typical of a borehole filled by the soil or 
gravel that would normally settle into an open hole over time--not the 
permeability of a carefully sealed borehole.

[50 FR 38084, Sept. 19, 1985. Redesignated and amended at 58 FR 66415, 
Dec. 20, 1993]



PART 192--HEALTH AND ENVIRONMENTAL PROTECTION STANDARDS FOR URANIUM AND THORIUM MILL TAILINGS--Table of Contents




 Subpart A--Standards for the Control of Residual Radioactive Materials 
                 from Inactive Uranium Processing Sites

Sec.
192.00  Applicability.
192.01  Definitions.
192.02  Standards.
192.03  Monitoring.
192.04  Corrective Action.
Table 1 to Subpart A--Maximum Concentration of Constituents for 
          Groundwater Protection

Subpart B--Standards for Cleanup of Land and Buildings Contaminated with 
  Residual Radioactive Materials from Inactive Uranium Processing Sites

192.10  Applicability.
192.11  Definitions.
192.12  Standards.

                        Subpart C--Implementation

192.20  Guidance for implementation.
192.21  Criteria for applying supplemental standards.
192.22  Supplemental standards.

[[Page 18]]

192.23  Effective date.

   Subpart D--Standards for Management of Uranium Byproduct Materials 
   Pursuant to Section 84 of the Atomic Energy Act of 1954, as Amended

192.30  Applicability.
192.31  Definitions and cross-references.
192.32  Standards.
192.33  Corrective action programs.
192.34  Effective date.

Table A to Subpart D

   Subpart E--Standards for Management of Thorium Byproduct Materials 
   Pursuant to Section 84 of the Atomic Energy Act of 1954, as Amended

192.40  Applicability.
192.41  Provisions.
192.42  Substitute provisions.
192.43  Effective date.

  Appendix I to Part 192--Listed Constituents

    Authority: 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.

    Source: 48 FR 602, Jan. 5, 1983, unless otherwise noted.



 Subpart A--Standards for the Control of Residual Radioactive Materials 
                 from Inactive Uranium Processing Sites



Sec. 192.00  Applicability.

    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.



Sec. 192.01  Definitions.

    (a) Residual radioactive material means:
    (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) Remedial action means any action performed under section 108 of 
the Act.
    (c) Control means any remedial action intended to stabilize, inhibit 
future misuse of, or reduce emissions or effluents from residual 
radioactive materials.
    (d) Disposal site means the region within the smallest perimeter of 
residual radioactive material (excluding cover materials) following 
completion of control activities.
    (e) Depository site means a site (other than a processing site) 
selected under Section 104(b) or 105(b) of the Act.
    (f) Curie (Ci) means the amount of radioactive material that 
produces 37 billion nuclear transformation per second. One picocurie 
(pCi) = 10 -12Ci.
    (g) Act means the Uranium Mill Tailings Radiation Control Act of 
1978, as amended.
    (h) Administrator means the Administrator of the Environmental 
Protection Agency.
    (i) Secretary means the Secretary of Energy.
    (j) Commission means the Nuclear Regulatory Commission.
    (k) Indian tribe means any tribe, band, clan, group, pueblo, or 
community of Indians recognized as eligible for services provided by the 
Secretary of the Interior to Indians.
    (l) Processing site means:
    (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) Tailings means the remaining portion of a metal-bearing ore 
after some or all of such metal, such as uranium, has been extracted.
    (n) Disposal period means the period of time beginning March 7, 1983 
and ending with the completion of all subpart A requirements specified 
under a plan for remedial action except those specified in Sec. 192.03 
and Sec. 192.04.

[[Page 19]]

    (o) Plan for remedial action means a written plan (or plans) for 
disposal and cleanup of residual radioactive materials associated with a 
processing site that incorporates the results of site characterization 
studies, environmental assessments or impact statements, and engineering 
assessments so as to satisfy the requirements of subparts A and B of 
this part. The plan(s) shall be developed in accordance with the 
provisions of Section 108(a) of the Act with the concurrence of the 
Commission and in consultation, as appropriate, with the Indian Tribe 
and the Secretary of Interior.
    (p) Post-disposal period means the period of time beginning 
immediately after the disposal period and ending at termination of the 
monitoring period established under Sec. 192.03.
    (q) Groundwater means water below the ground surface in a zone of 
saturation.
    (r) Underground source of drinking water means an aquifer or its 
portion:
    (1)(i) Which supplies any public water system as defined in 
Sec. 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 Sec. 144.7 of 
this chapter.

[48 FR 602, Jan. 5, 1983, as amended at 60 FR 2865, Jan. 11, 1995]



Sec. 192.02  Standards.

    Control of residual radioactive materials and their listed 
constituents shall be designed \1\ to:
---------------------------------------------------------------------------

    \1\ Because the standard applies to design, monitoring after 
disposal is not required to demonstrate compliance with respect to 
Sec. 192.02(a) and (b).
---------------------------------------------------------------------------

    (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\ release rate of 20 picocuries per square 
meter per second, or
---------------------------------------------------------------------------

    \2\ This average shall apply over the entire surface of the disposal 
site and over at least a one-year period. Radon will come from both 
residual radioactive materials and from materials covering them. Radon 
emissions from the covering materials should be estimated as part of 
developing a remedial action plan for each site. The standard, however, 
applies only to emissions from residual radioactive materials to the 
atmosphere.
---------------------------------------------------------------------------

    (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 Sec. 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

[[Page 20]]

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 environment of alternate concentration limits, the following 
factors shall be considered:
    (1) Potential adverse effects on groundwater quality, considering:
    (i) The physical and chemical characteristics of constituents in the 
residual radioactive material at the site, including their potential for 
migration;
    (ii) The hydrogeological characteristics of the site and surrounding 
land;
    (iii) The quantity of groundwater and the direction of groundwater 
flow;
    (iv) The proximity and withdrawal rates of groundwater users;
    (v) The current and future uses of groundwater in the region 
surrounding the site;
    (vi) The existing quality of groundwater, including other sources of 
contamination and their cumulative impact on the groundwater quality;
    (vii) The potential for health risks caused by human exposure to 
constituents;
    (viii) The potential damage to wildlife, crops, vegetation, and 
physical structures caused by exposure to constituents;
    (ix) The persistence and permanence of the potential adverse 
effects;
    (x) The presence of underground sources of drinking water and 
exempted aquifers identified under Sec. 144.7 of this chapter; and
    (2) Potential adverse effects on hydraulically-connected surface-
water quality, considering:
    (i) The volume and physical and chemical characteristics of the 
residual radioactive material at the site;
    (ii) The hydrogeological characteristics of the site and surrounding 
land;
    (iii) The quantity and quality of groundwater, and the direction of 
groundwater flow;
    (iv) The patterns of rainfall in the region;
    (v) The proximity of the site to surface waters;
    (vi) The current and future uses of surface waters in the region 
surrounding the site and any water quality standards established for 
those surface waters;
    (vii) The existing quality of surface water, including other sources 
of contamination and their cumulative impact on surface water quality;
    (viii) The potential for health risks caused by human exposure to 
constituents;
    (ix) The potential damage to wildlife, crops, vegetation, and 
physical structures caused by exposure to constituents; and
    (x) The persistence and permanence of the potential adverse effects.
    (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.

[60 FR 2865, Jan. 11, 1995]



Sec. 192.03  Monitoring.

    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 Sec. 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

[[Page 21]]

Sec. 192.02(c). This plan and the length of the monitoring period shall 
be modified to incorporate any corrective actions required under 
Sec. 192.04 or Sec. 192.12(c).

[60 FR 2866, Jan. 11, 1995]



Sec. 192.04  Corrective Action.

    If the groundwater concentration limits established for disposal 
sites under provisions of Sec. 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 Sec. 192.02(c)(3), to the extent 
reasonably achievable, and, in any case, as a minimum shall:
    (a) Conform with the groundwater provisions of Sec. 192.02(c)(3), 
and
    (b) Clean up groundwater in conformance with subpart B, modified as 
appropriate to apply to the disposal site.

[60 FR 2866, Jan. 11, 1995]

    Table 1 to Subpart A.--Maximum Concentration of Constituents for    
                         Groundwater Protection                         
------------------------------------------------------------------------
      Constituent concentration \1\                   Maximum           
------------------------------------------------------------------------
Arsenic.................................  0.05                          
Barium..................................  1.0                           
Cadmium.................................  0.01                          
Chromium................................  0.05                          
Lead....................................  0.05                          
Mercury.................................  0.002                         
Selenium................................  0.01                          
Silver..................................  0.05                          
Nitrate (as N)..........................  10.                           
Molybdenum..............................  0.1                           
Combined radium-226 and radium-228......  5 pCi/liter                   
Combined uranium-234 and uranium-238 \2\  30 pCi/liter                  
Gross alpha-particle activity (excluding  15 pCi/liter                  
 radon and uranium).                                                    
Endrin (1,2,3,4,10,10-hexachloro-6,7-     0.0002                        
 exposy-1,4,4a,5,6,7,8,8a-octahydro-1,4-                                
 endo,endo-5,8-dimethanonaphthalene).                                   
Lindane (1,2,3,4,5,6-                     0.004                         
 hexachlorocyclohexane, gamma insomer).                                 
Methoxychlor (1,1,1-trichloro-2,2'-bis(p- 0.1                           
 methoxyphenylethane)).                                                 
Toxaphene (C10H10Cl6, technical           0.005                         
 chlorinated camphene, 67-69 percent                                    
 chlorine).                                                             
2,4-D (2,4-dichlorophenoxyacetic acid)..  0.1                           
2,4,5-TP Silvex (2,4,5-                   0.01                          
 trichlorophenoxypropionic acid).                                       
------------------------------------------------------------------------
\1\ Milligrams per liter, unless stated otherwise.                      
\2\ Where secular equilibrium obtains, this criterion will be satisfied 
  by a concentration of 0.044 milligrams per liter (0.044 mg/l). For    
  conditions of other than secular equilibrium, a corresponding value   
  may be derived and applied, based on the measured site-specific ratio 
  of the two isotopes of uranium.                                       


[60 FR 2866, Jan. 11, 1995]



Subpart B--Standards for Cleanup of Land and Buildings Contaminated with 
  Residual Radioactive Materials from Inactive Uranium Processing Sites



Sec. 192.10  Applicability.

    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.

[[Page 22]]



Sec. 192.11  Definitions.

    (a) Unless otherwise indicated in this subpart, all terms shall have 
the same meaning as defined in subpart A.
    (b) Land means any surface or subsurface land that is not part of a 
disposal site and is not covered by an occupiable building.
    (c) Working Level (WL) means any combination of short-lived radon 
decay products in one liter of air that will result in the ultimate 
emission of alpha particles with a total energy of 130 billion electron 
volts.
    (d) Soil means all unconsolidated materials normally found on or 
near the surface of the earth including, but not limited to, silts, 
clays, sands, gravel, and small rocks.
    (e) Limited use groundwater means groundwater that is not a current 
or potential source of drinking water because (1) the concentration of 
total dissolved solids is in excess of 10,000 mg/l, or (2) widespread, 
ambient contamination not due to activities involving residual 
radioactive materials from a designated processing site exists that 
cannot be cleaned up using treatment methods reasonably employed in 
public water systems, or (3) the quantity of water reasonably available 
for sustained continuous use is less than 150 gallons per day. The 
parameters for determining the quantity of water reasonably available 
shall be determined by the Secretary with the concurrence of the 
Commission.

[48 FR 602, Jan. 5, 1983, as amended at 60 FR 2866, Jan. 11, 1995]



Sec. 192.12  Standards.

    Remedial actions shall be conducted so as to provide reasonable 
assurance that, as a result of residual radioactive materials from any 
designated processing site:
    (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 (Sec. 192.01(1)) shall be brought into compliance as 
promptly as is reasonably achievable with the provisions of 
Sec. 192.02(c)(3) or any supplemental standards established under 
Sec. 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 (Sec. 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 
Sec. 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

[[Page 23]]

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 and its cover where 
groundwater contains listed constituents from residual radioactive 
material.

[48 FR 602, Jan. 5, 1983, as amended at 60 FR 2867, Jan. 11, 1995]



                        Subpart C--Implementation



Sec. 192.20  Guidance for implementation.

    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

[[Page 24]]

order listed under Sec. 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 10-4 and 10-6.

      Table A to Sec.  192.20(a)(2)--Additional Listed Constituents     
Nitrate (as N)                                                          
Molybdenum                                                              
Combined radium-226 and radium-228                                      
Combined uranium-234 and uranium-238                                    
Gross alpha-particle activity (excluding radon and uranium)             
------------------------------------------------------------------------

    (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 should include the schedule and steps necessary to 
complete disposal operations at the site. It should include an estimate 
of the inventory of wastes to be disposed of in the pile and their 
listed constituents and address any need to eliminate free liquids; 
stabilization of the wastes to a bearing capacity sufficient to support 
the final cover; and the design and engineering specifications for a 
cover to manage the migration of liquids through the stabilized pile, 
function without maintenance, promote drainage and minimize erosion or 
abrasion of the cover, and accommodate settling and subsidence so that 
cover integrity is maintained. Evaluation of proposed designs to conform 
to subpart A should be based on realistic technical judgments and 
include use of available empirical information. The consideration of 
possible failure modes and related corrective actions should be limited 
to reasonable failure assumptions, with a demonstration that the 
disposal design is generally amenable to a range of corrective actions.
    (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 Sec. 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 
(Sec. 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 Sec. 192.04 during the disposal period, unless the disposal 
operation is suspended prior to completion for other than seasonal 
reasons.
    (b)(1) Compliance with Sec. 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 Sec. 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 Sec. 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.

[[Page 25]]

    (3) Compliance with Sec. 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 
Sec. 192.21(c)]. However, sealants, filtration, and ventilation devices 
may provide reasonable assurance of reductions from 0.03 WL to below 
0.02 WL. In unusual cases, indoor radiation may exceed the levels 
specified in Sec. 192.12(b) due to sources other than residual 
radioactive materials. Remedial 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 
Sec. 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 
(Sec. 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 Sec. 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.

[48 FR 602, Jan. 5, 1983, as amended at 60 FR 2867, Jan. 11, 1995]



Sec. 192.21  Criteria for applying supplemental standards.

    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 Sec. 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, 
Sec. 192.12(a), and groundwater, Sec. 192.12(c), or the acquisition of 
minimum materials required for control to satisfy Secs. 192.02(b) and 
(c), would, notwithstanding reasonable measures to limit damage, 
directly produce health and environmental harm that is clearly excessive

[[Page 26]]

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 Sec. 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 where only minor 
quantities of residual radioactive materials are involved. Examples are 
residual radioactive materials under hard surface public roads and 
sidewalks, around public sewer lines, or in fence post foundations. 
Supplemental standards should not be applied at such sites, however, if 
individuals are likely to be exposed for long periods of time to 
radiation from such materials at levels above those that would prevail 
under Sec. 192.12(a).
    (d) The cost of a remedial action for cleanup of a building under 
Sec. 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 Sec. 192.12(c) is technically impracticable from 
an engineering perspective.
    (g) The groundwater meets the criteria of Sec. 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.

[48 FR 602, Jan. 5, 1983, as amended at 60 FR 2868, Jan. 11, 1995]



Sec. 192.22  Supplemental standards.

    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 Sec. 192.21.
    (a) When one or more of the criteria of Sec. 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 Sec. 192.02(c)(3) as is reasonably achievable.
    (b) When Sec. 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 Sec. 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 Sec. 192.21(g) applies, supplemental standards shall 
ensure that current and reasonably

[[Page 27]]

projected uses of the affected groundwater are preserved.

[48 FR 602, Jan. 5, 1983, as amended at 60 FR 2868, Jan. 11, 1995]



Sec. 192.23  Effective date.

    Subparts A, B, and C shall be effective March 7, 1983.



   Subpart D--Standards for Management of Uranium Byproduct Materials 
   Pursuant to Section 84 of the Atomic Energy Act of 1954, as Amended

    Source: 48 FR 45946, Oct. 7, 1983, unless otherwise noted.



Sec. 192.30  Applicability.

    This subpart applies to the management of uranium byproduct 
materials under section 84 of the Atomic Energy Act of 1954 (henceforth 
designated ``the Act''), as amended, during and following processing of 
uranium ores, and to restoration of disposal sites following any use of 
such sites under section 83(b)(1)(B) of the Act.



Sec. 192.31  Definitions and cross-references.

    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) Uranium byproduct material means the tailings or wastes produced 
by the extraction or concentration of uranium from any ore processed 
primarily for its source material content. Ore bodies depleted by 
uranium solution extraction operations and which remain underground do 
not constitute ``byproduct material'' for the purpose of this subpart.
    (c) Control means any action to stabilize, inhibit future misuse of, 
or reduce emissions or effluents from uranium byproduct materials.
    (d) Licensed site means the area contained within the boundary of a 
location under the control of persons generating or storing uranium 
byproduct materials under a license issued pursuant to section 84 of the 
Act. For purposes of this subpart, ``licensed site'' is equivalent to 
``regulated unit'' in subpart F of part 264 of this chapter.
    (e) Disposal site means a site selected pursuant to section 83 of 
the Act.
    (f) Disposal area means the region within the perimeter of an 
impoundment or pile containing uranium by product materials to which the 
post-closure requirements of Sec. 192.32(b)(1) of this subpart apply.
    (g) Regulatory agency means the U.S. Nuclear Regulatory Commission.
    (h) Closure period means the period of time beginning with the 
cessation, with respect to a waste impoundment, of uranium ore 
processing operations and ending with completion of requirements 
specified under a closure plan.
    (i) Closure plan means the plan required under Sec. 264.112 of this 
chapter.
    (j) Existing portion means that land surface area of an existing 
surface impoundment on which significant quantities of uranium byproduct 
materials have been placed prior to promulgation of this standard.
    (k) As expeditiously as practicable considering technological 
feasibility means as quickly as possible considering: the physical 
characteristics of the tailings and the site; the limits of available 
technology; the need for consistency with mandatory requirements of 
other regulatory programs; and factors beyond the control of the 
licensee. The phrase permits consideration of the cost of compliance 
only to the extent specifically provided for by use of the term 
``available technology.''
    (l) Permanent Radon Barrier means the final radon barrier 
constructed to achieve compliance with, including attainment of, the 
limit on releases of radon-222 in Sec. 192.32(b)(1)(ii).
    (m) Available technology means technologies and methods for 
emplacing a permanent radon barrier on uranium mill tailings piles or 
impoundments.

[[Page 28]]

This term shall not be construed to include extraordinary measures or 
techniques that would impose costs that are grossly excessive as 
measured by practice within the industry or one that is reasonably 
analogous, (such as, by way of illustration only, unreasonable overtime, 
staffing or transportation requirements, etc., considering normal 
practice in the industry; laser fusion, of soils, etc.), provided there 
is reasonable progress toward emplacement of a permanent radon barrier. 
To determine grossly excessive costs, the relevant baseline against 
which cost increases shall be compared is the cost estimate for tailings 
impoundment closure contained in the licensee's tailings closure plan, 
but costs beyond such estimates shall not automatically be considered 
grossly excessive.
    (n) Tailings Closure Plan (Radon) means the Nuclear Regulatory 
Commission or Agreement State approved plan detailing activities to 
accomplish timely emplacement of a permanent radon barrier. A tailings 
closure plan shall include a schedule for key radon closure milestone 
activities such as wind blown tailings retrieval and placement on the 
pile, interim stabilization (including dewatering or the removal of 
freestanding liquids and recontouring), and emplacement of a permanent 
radon barrier constructed to achieve compliance with the 20 pCi/  
m2-s flux standard as expeditiously as practicable considering 
technological feasibility (including factors beyond the control of the 
licensee).
    (o) Factors beyond the control of the licensee means factors 
proximately causing delay in meeting the schedule in the applicable 
license for timely emplacement of the permanent radon barrier 
notwithstanding the good faith efforts of the licensee to achieve 
compliance. These factors may include, but are not limited to, physical 
conditions at the site; inclement weather or climatic conditions; an act 
of God; an act of war; a judicial or administrative order or decision, 
or change to the statutory, regulatory, or other legal requirements 
applicable to the licensee's facility that would preclude or delay the 
performance of activities required for compliance; labor disturbances; 
any modifications, cessation or delay ordered by state, Federal or local 
agencies; delays beyond the time reasonably required in obtaining 
necessary governmental permits, licenses, approvals or consent for 
activities described in the tailings closure plan (radon) proposed by 
the licensee that result from agency failure to take final action after 
the licensee has made a good faith, timely effort to submit legally 
sufficient applications, responses to requests (including relevant data 
requested by the agencies), or other information, including approval of 
the tailings closure plan by NRC or the affected Agreement State; and an 
act or omission of any third party over whom the licensee has no 
control.
    (p) Operational means that a uranium mill tailings pile or 
impoundment is being used for the continued placement of uranium 
byproduct material or is in standby status for such placement. A 
tailings pile or impoundment is operational from the day that uranium 
byproduct material is first placed in the pile or impoundment until the 
day final closure begins.
    (q) Milestone means an enforceable date by which action, or the 
occurrence of an event, is required for purposes of achieving compliance 
with the 20 pCi/m\2\-s flux standard.

[48 FR 45946, Oct. 7, 1983, as amended at 58 FR 60355, Nov. 15, 1993]



Sec. 192.32  Standards.

    (a) Standards for application during processing operations and prior 
to the end of the closure period. (1) Surface impoundments (except for 
an existing portion) subject to this subpart must be designed, 
constructed, and installed in such manner as to conform to the 
requirements of Sec. 264.221 of this chapter, except that at sites where 
the annual precipitation falling on the impoundment and any drainage 
area contributing surface runoff to the impoundment is less than the 
annual evaporation from the impoundment, the requirements of 
Sec. 264.228(a)(2) (iii)(E) referenced in Sec. 264.221 do not apply.
    (2) Uranium byproduct materials shall be managed so as to conform to 
the ground water protection standard in Sec. 264.92 of this chapter, 
except that for the purposes of this subpart:

[[Page 29]]

    (i) To the list of hazardous constituents referenced in Sec. 264.93 
of this chapter are added the chemical elements molybdenum and uranium,
    (ii) To the concentration limits provided in Table 1 of Sec. 264.94 
of this chapter are added the radioactivity limits in Table A of this 
subpart,
    (iii) Detection monitoring programs required under Sec. 264.98 to 
establish the standards required under Sec. 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 
Sec. 264.95) under the criteria of Sec. 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 
Sec. 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 Sec. 264.93 (b) 
and (c) of this chapter and alternate concentration limits established 
under Sec. 264.94 (b) and (c) of this chapter (except as otherwise 
provided in Sec. 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\2\-s flux standard has been demonstrated 
using a method approved by the NRC, in the manner required in 
192.32(a)(4)(i). Only under these circumstances and during the period of 
the extension must compliance with the 20 pCi/m\2\-s flux standard be 
demonstrated each year.
    (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 Sec. 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\2\-s flux standard, averaged 
over the entire pile or impoundment.

[[Page 30]]

    (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\2\-s flux standard of 
Sec. 192.32(b)(1)(ii) is demonstrated by the licensee's monitoring 
conducted in a manner consistent with Sec. 192.32(a)(4)(i). Such 
authorization may be provided only if the Nuclear Regulatory Commission 
or Agreement State makes a finding, constituting final agency action and 
after providing an opportunity for public participation, that the site 
will continue to achieve the 20 pCi/m2-s flux standard when averaged 
over the entire impoundment.
    (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 not exceeding 20 pCi/m\2\-s as required by 40 CFR 
192.32(b)(1)(ii). This monitoring shall be conducted using the 
procedures described in 40 CFR part 61, Appendix B, Method 115, or any 
other measurement method proposed by a licensee that the Nuclear 
Regulatory Commission or Agreement State approves as being at least as 
effective as EPA Method 115 in demonstrating the effectiveness of the 
permanent radon barrier in achieving compliance with the 20 pCi/m\2\-s 
flux standard.
    (ii) When phased emplacement of the permanent radon barrier is 
included in the applicable tailings closure plan (radon), then radon 
flux monitoring required under Sec. 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) Standards for application after the closure period. At the end 
of the closure period:
    (1) Disposal areas shall each comply with the closure performance 
standard in Sec. 264.111 of this chapter with respect to nonradiological 
hazards and shall be designed1 to provide reasonable assurance of 
control of radiological hazards to
---------------------------------------------------------------------------

    \1\ The standard applies to design with a monitoring requirement as 
specified in Sec. 192.32(a)(4).
---------------------------------------------------------------------------

    (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 average2 release rate of 20 
picocuries per square meter per second (pCi/m2s).
---------------------------------------------------------------------------

    \2\ This average shall apply to the entire surface of each disposal 
area over periods of at least one year, but short compared to 100 years. 
Radon will come from both uranium byproduct materials and from covering 
materials. Radon emissions from covering materials should be estimated 
as part of developing a closure plan for each site. The standard, 
however, applies only to emissions from uranium byproduct materials to 
the atmosphere.
---------------------------------------------------------------------------

    (2) The requirements of Sec. 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

[[Page 31]]

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.

[48 FR 45946, Oct. 7, 1983, as amended at 58 FR 60355-60356, Nov. 15, 
1993]



Sec. 192.33  Corrective action programs.

    If the ground water standards established under provisions of 
Sec. 192.32(a)(2) are exceeded at any licensed site, a corrective action 
program as specified in Sec. 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.



Sec. 192.34  Effective date.

    Subpart D shall be effective December 6, 1983.

                          Table A to Subpart D                          
------------------------------------------------------------------------
                                                               pCi/liter
------------------------------------------------------------------------
Combined radium-226 and radium-228...........................          5
Gross alpha-particle activity (excluding radon and uranium)..         15
------------------------------------------------------------------------



   Subpart E--Standards for Management of Thorium Byproduct Materials 
   Pursuant to Section 84 of the Atomic Energy Act of 1954, as Amended

    Source: 48 FR 45947, Oct. 7, 1983, unless otherwise noted.



Sec. 192.40  Applicability.

    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.



Sec. 192.41  Provisions.

    Except as otherwise noted in Sec. 192.41(e), the provisions of 
subpart D of this part, including Secs. 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 Sec. 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 Sec. 192.32(a) (3) and (4) do not apply to the 
management of thorium byproduct material.

[48 FR 45946, Oct. 7, 1983, as amended at 58 FR 60356, Nov. 15, 1993]



Sec. 192.42  Substitute provisions.

    The regulatory agency may, with the concurrence of EPA, substitute 
for any provisions of Sec. 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.



Sec. 192.43  Effective date.

    Subpart E shall be effective December 6, 1983.

               Appendix I to Part 192--Listed Constituents

Acetonitrile
Acetophenone (Ethanone, 1-phenyl)
2-Acetylaminofluorene (Acetamide, N-9H-fluoren-2-yl-)
Acetyl chloride
1-Acetyl-2-thiourea (Acetamide, N-(aminothioxymethyl)-)
Acrolein (2-Propenal)
Acrylamide (2-Propenamide)
Acrylonitrile (2-Propenenitrile)
Aflatoxins
Aldicarb (Propenal, 2-methyl-2-(methylthio)-,O-
[(methylamino)carbonyl]oxime
Aldrin (1,4:5,8-Dimethanonaphthalene, 1,2,3,4,10,10-hexachloro-
1,4,4a,5,8,8a-
hexahydro(1,4,4a,5,8,8
)-)
Allyl alcohol (2-Propen-1-ol)
Allyl chloride (1-Propane,3-chloro)
Aluminum phosphide
4-Aminobiphenyl ([1,1'-Biphenyl]-4-amine)

[[Page 32]]

5-(Aminomethyl)-3-isoxazolol (3(2H)-Isoxazolone,5-(aminomethyl)-)
4-Aminopyridine (4-Pyridineamine)
Amitrole (lH-1,2,4-Triazol-3-amine)
Ammonium vanadate (Vanadic acid, ammonium salt)
Aniline (Benzenamine)
Antimony and compounds, N.O.S.\1\
---------------------------------------------------------------------------

    \1\ The abbreviation N.O.S. (not otherwise specified) signifies 
those members of the general class not specifically listed by name in 
this appendix.
---------------------------------------------------------------------------

Aramite (Sulfurous acid, 2-chloroethyl 2-[4-(1,1-dimethylethyl)phenoxy]-
1-methylethyl ester)
Arsenic and compounds, N.O.S.
Arsenic acid (Arsenic acid H3AsO4)
Arsenic pentoxide (Arsenic oxide As2O5)
Auramine (Benzamine, 4,4'-carbonimidoylbis[N,N-dimethyl-])
Azaserine (L-Serine, diazoacetate (ester))
Barium and compounds, N.O.S.
Barium cyanide
Benz[c]acridine (3,4-Benzacridine)
Benz[a]anthracene (1,2-Benzanthracene)
Benzal chloride (Benzene, dichloromethyl-)
Benzene (Cyclohexatriene)
Benzenearsonic acid (Arsenic acid, phenyl-)
Benzidine ([1,1'-Biphenyl]-4,4'-diamine)
Benzo[b]fluoranthene (Benz[e]acephananthrylene)
Benzo[j]fluoranthene
Benzo[k]fluoranthene
Benzo[a]pyrene
p-Benzoquinone (2,5-Cyclohexadiene-1,4-dione)
Benzotrichloride (Benzene, (trichloro-
  methyl)-)
Benzyl chloride (Benzene, (chloromethyl)-)
Beryllium and compounds, N.O.S.
Bromoacetone (2-Propanone, 1-bromo-)
Bromoform (Methane, tribromo-)
4-Bromophenyl phenyl ether (Benzene, l-bromo-4-phenoxy-)
Brucine (Strychnidin-10-one, 2,3-dimeth-
  oxy-)
Butyl benzyl phthalate (1,2-Benzenedicarbozylic acid, butyl phenylmethyl 
ester)
Cacodylic acid (Arsinic acid, dimethyl)
Cadmium and compounds, N.O.S.
Calcium chromate (Chromic acid H2CrO4, calcium salt)
Calcium cyanide (Ca(CN)2)
Carbon disulfide
Carbon oxyfluoride (Carbonic difluoride)
Carbon tetrachloride (Methane, tetrachloro-)
Chloral (Acetaldehyde, trichloro-)
Chlorambucil (Benzenebutanoic acid, 4-[bis(2-chloroethyl)amino]-)
Chlordane (4,7-Methano-1H-indene,1,2,4,5,6,7,8,8-octachloro-
2,3,3a,4,7,7a-hexahydro-)
Chlorinated benzenes, N.O.S.
Chlorinated ethane, N.O.S.
Chlorinated fluorocarbons, N.O.S.
Chlorinated naphthalene, N.O.S.
Chlorinated phenol, N.O.S.
Chlornaphazin (Naphthalenamine, N,N'-bis(2-chlorethyl)-)
Chloroacetaldehyde (Acetaldehyde, chloro-)
Chloroalkyl ethers, N.O.S.
p-Chloroaniline (Benzenamine, 4-chloro-)
Chlorobenzene (Benzene, chloro-)
Chlorobenzilate (Benzeneacetic acid, 4-chloro--(4-
chlorophenyl)--hydroxy-, ethyl ester)
p-Chloro-m-cresol (Phenol, 4-chloro-3-methyl)
2-Chloroethyl vinyl ether (Ethene, (2-chloroethoxy)-)
Chloroform (Methane, trichloro-)
Chloromethyl methyl ether (Methane, chloromethoxy-)
-Chloronapthalene (Naphthalene, 2-chloro-)
o-Chlorophenol (Phenol, 2-chloro-)
1-(o-Chlorophenyl)thiourea (Thiourea, (2-chlorophenyl-))
3-Chloropropionitrile (Propanenitrile, 3-chloro-)
Chromium and compounds, N.O.S.
Chrysene
Citrus red No. 2 (2-Naphthalenol, 1-[(2,5-dimethoxyphenyl)azo]-)
Coal tar creosote
Copper cyanide (CuCN)
Creosote
Cresol (Chresylic acid) (Phenol, methyl-)
Crotonaldehyde (2-Butenal)
Cyanides (soluble salts and complexes), N.O.S.
Cyanogen (Ethanedinitrile)
Cyanogen bromide ((CN)Br)
Cyanogen chloride ((CN)Cl)
Cycasin (beta-D-Glucopyranoside, (methyl-ONN-azoxy)methyl)
2-Cyclohexyl-4,6-dinitrophenol (Phenol, 2-cyclohexyl-4,6-dinitro-)
Cyclophosphamide (2H-1,3,2-Oxazaphosphorin-2-amine,N,N-bis(2-
chloroethyl)
tetrahydro-,2-oxide)
2,4-D and salts and esters (Acetic acid, (2,4-dichlorophenoxy)-)
Daunomycin (5,12-Naphthacenedione,8-acetyl-10-[(3-amino-2,3,6-trideoxy-
-Llyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-
trihydroxy-1-methoxy-,(8S-cis))
DDD (Benzene, 1,1'-(2,2-dichloroethylidene)bis[4-chloro-)
DDE (Benzene, 1,1-(dichloroethylidene)bis[4-chloro-)
DDT (Benzene, 1,1'-(2,2,2-trichloroethlyidene)bis[4-chloro-)
Diallate (Carbomothioic acid, bis(1-methylethyl)-,S-(2,3-dichloro-2-
propenyl) ester)
Dibenz[a,h]acridine
Dibenz[a,j]acridine
Dibenz[a,h]anthracene
7H-Dibenzo[c,g]carbazole

[[Page 33]]

Dibenzo[a,e]pyrene (Naphtho[1,2,4,5-def)crysene)
Dibenzo[a,h]pyrene (Dibenzo[b,def]crysene)
Dibenzo[a,i]pyrene (Benzo[rst]pentaphene)
1,2-Dibromo-3-chloropropane (Propane, 1,2-dibromo-3-chloro-)
Dibutylphthalate (1,2-Benzenedicarboxylic acid, dibutyl ester)
o-Dichlorobenzene (Benzene, 1,2-dichloro-)
m-Dichlorobenzene (Benzene, 1,3-dichloro-)
p-Dichlorobenzene (Benzene, 1,4-dichloro-)
Dichlorobenzene, N.O.S. (Benzene; dichloro-, N.O.S.)
3,3'-Dichlorobenzidine ([1,1'-Biphenyl]-4,4'-diamine, 3,3'-dichloro-)
1,4-Dichloro-2-butene (2-Butene, 1,4-dichloro-)
Dichlorodifluoromethane (Methane, dichlorodifluoro-)
Dichloroethylene, N.O.S.
1,1-Dichloroethylene (Ethene, 1,1-dichloro-)
1,2-Dichloroethylene (Ethene, 1,2-dichloro-,(E)-)
Dichloroethyl ether (Ethane, 1,1'-oxybis[2-chloro-)
Dichloroisopropyl ether (Propane, 2,2'-oxybis[2-chloro-)
Dichloromethoxy ethane (Ethane, 1,1'-[methylenebis(oxy)bis[2-chloro-)
Dichloromethyl ether (Methane, oxybis[chloro-)
2,4-Dichlorophenol (Phenol, 2,4-dichloro-)
2,6-Dichlorophenol (Phenol, 2,6-dichloro-)
Dichlorophenylarsine (Arsinous dichloride, phenyl-)
Dichloropropane, N.O.S. (Propane,
  dichloro-,)
Dichloropropanol, N.O.S. (Propanol, dichloro-,)
Dichloropropene; N.O.S. (1-Propane, dichloro-,)
1,3-Dichloropropene (1-Propene, 1,3-dichloro-)
Dieldrin (2,7:3,6-Dimethanonaphth[2,3-b]oxirene,3,4,5,6,9,9-hexachloro-
1a,2,2a,3,6,6a,7,7a,octahydro-
,(1a,2,2a,3,6,6a,7
,7a)-)
1,2:3,4-Diepoxybutane (2,2'-Bioxirane)
Diethylarsine (Arsine, diethyl-)
1,4 Diethylene oxide (1,4-Dioxane)
Diethylhexyl phthalate (1,2-Benzenedicarboxlyic acid, bis(2-ethylhexl) 
ester)
N,N-Diethylhydrazine (Hydrazine, 1,2-diethyl)
O,O-Diethyl S-methyl dithiophosphate (Phosphorodithioic acid, O,O-
diethyl S-methyl ester)
Diethyl-p-nitrophenyl phosphate (Phosphoric acid, diethyl 4-nitrophenyl 
ester)
Diethyl phthalate (1,2-Benzenedicarboxylic acid, diethyl ester)
O,O-Diethyl O-pyrazinyl phosphorothioate (Phosphorothioic acid, O,O-
diethyl O-pyrazinyl ester)
Diethylstilbesterol (Phenol, 4,4'-(1,2-diethyl-1,2-ethenediyl)bis-,(E)-)
Dihydrosafrole (1,3-Benxodioxole, 5-propyl-)
Diisopropylfluorophosphate (DFP) (Phosphorofluoridic acid, bis(1-methyl 
ethyl) ester)
Dimethoate (Phosphorodithioic acid, O,O-dimethyl S-[2-(methylamino) 2-
oxoethyl] ester)
3,3'-Dimethoxybenzidine ([1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-)
p-Dimethylaminoazobenzene (Benzenamine, N,N-dimethyl-4-(phenylazo)-)
7,12-Dimethylbenz[a]anthracene (Benz[a]anthracene, 7,12-dimethyl-)
3,3'-Dimethylbenzidine ([1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethyl-)
Dimethylcarbamoyl chloride (carbamic chloride, dimethyl-)
1,1-Dimethylhydrazine (Hydrazine, 1,1-dimethyl-)
1,2-Dimethylhydrazine (Hydrazine, 1,2-dimethyl-)
,-Dimethylphenethylamine (Benzeneethanamine, 
,-dimethyl-)
2,4-Dimethylphenol (Phenol, 2,4-dimethyl-)
Dimethylphthalate (1,2-Benzenedicarboxylic acid, dimethyl ester)
Dimethyl sulfate (Sulfuric acid, dimethyl ester)
Dinitrobenzene, N.O.S. (Benzene, dinitro-)
4,6-Dinitro-o-cresol and salts (Phenol, 2-methyl-4,6-dinitro-)
2,4-Dinitrophenol (Phenol, 2,4-dinitro-)
2,4-Dinitrotoluene (Benzene, 1-methyl-2,4-dinitro-)
2,6-Dinitrotoluene (Benzene, 2-methyl-1,3-dinitro-)
Dinoseb (Phenol, 2-(1-methylpropyl)-4,6-dinitro-)
Di-n-octyl phthalate (1,2-Benzenedicarboxylic acid, dioctyl ester)
1,4-Dioxane (1,4-Diethyleneoxide)
Diphenylamine (Benzenamine, N-phenyl-)
1,2-Diphenylhydrazine (Hydrazine, 1,2-diphenyl-)
Di-n-propylnitrosamine (1-Propanamine,N-nitroso-N-propyl-)
Disulfoton (Phosphorodithioic acid, O,O-diethyl S-[2-(ethylthio)ethyl] 
ester)
Dithiobiuret (Thioimidodicarbonic diamide [(H2N)C(S)]2NH)
Endosulfan (6,9,Methano-2,4,3-benzodioxathiepin,6,7,8,9,10,10-
hexachloro-1,5,5a,6,9,9ahexahydro,3-oxide)
Endothall (7-Oxabicyclo[2.2.1]heptane-2,3-dicarboxylic acid)
Endrin and metabolites (2,7:3,6-Dimethanonaphth[2,3-
b]oxirene,3,4,5,6,9,9-hexachloro1a,2,2a,3,6,6a,7,7a-octa-
hydro,(1a,2,2a,3,6,6a
,7,7a)-)
Epichlorohydrin (Oxirane, (chloromethyl)-)
Epinephrine (1,2-Benzenediol,4-[1-hydroxy-2-(methylamino)ethyl]-,(R)-,)
Ethyl carbamate (urethane) (Carbamic acid, ethyl ester)
Ethyl cyanide (propanenitrile)
Ethylenebisdithiocarbamic acid, salts and esters (Carbamodithioic acid, 
1,2-Ethanediylbis-)

[[Page 34]]

Ethylene dibromide (1,2-Dibromoethane)
Ethylene dichloride (1,2-Dichloroethane)
Ethylene glycol monoethyl ether (Ethanol, 2-ethoxy-)
Ethyleneimine (Aziridine)
Ethylene oxide (Oxirane)
Ethylenethiourea (2-Imidazolidinethione)
Ethylidene dichloride (Ethane, 1,1-
  Dichloro-)
Ethyl methacrylate (2-Propenoic acid, 2-methyl-, ethyl ester)
Ethylmethane sulfonate (Methanesulfonic acid, ethyl ester)
Famphur (Phosphorothioic acid, O-[4-[(dimethylamino)sulphonyl]phenyl] 
O,O-dimethyl ester)
Fluoranthene
Fluorine
Fluoroacetamide (Acetamide, 2-fluoro-)
Fluoroacetic acid, sodium salt (Acetic acid, fluoro-, sodium salt)
Formaldehyde (Methylene oxide)
Formic acid (Methanoic acid)
Glycidylaldehyde (Oxiranecarboxyaldehyde)
Halomethane, N.O.S.
Heptachlor (4,7-Methano-1H-indene, 1,4,5,6,7,8,8-heptachloro-3a,4,7,7a-
tetrahydro-)
Heptachlor epoxide (, , and  isomers) (2,5-
Methano-2H-indeno[1,2-b]-oxirene, 2,3,4,5,6,7,7-heptachloro-
1a,1b,5,5a,6,6a-hexa-hydro-
,(1a,1b,2,5,5a,6,6a
)-)
Hexachlorobenzene (Benzene, hexachloro-)
Hexachlorobutadiene (1,3-Butadiene, 1,1,2,3,4,4-hexachloro-)
Hexachlorocyclopentadiene (1,3-Cyclopentadiene, 1,2,3,4,5,5-hexachloro-)
Hexachlorodibenzofurans
Heptachlorodibenzo-p-dioxins
Hexachloroethane (Ethane, hexachloro-)
Hexachlorophene (phenol, 2,2'-Methylenebis[3,4,6-trichloro-)
Hexachloropropene (1-Propene, 1,1,2,3,3,3-hexachloro-)
Hexaethyl tetraphosphate (Tetraphosphoric acid, hexaethyl ester)
Hydrazine
Hydrocyanic acid
Hydrofluoric acid
Hydrogen sulfide (H2S)
Indeno(1,2,3-cd)pyrene
Isobutyl alcohol (1-Propanol, 2-methyl-)
Isodrin (1,4,5,8-Dimethanonaphthalene, 1,2,3,4,10,10-hexachloro-
1,4,4a,5,8,8a-hexahydro, 
(1,4,4a,5,8,8a)-)
Isosafrole (1,3-Benzodioxole, 5-(1-propenyl)-)
Kepone (1,3,4-Metheno-2H-cyclobuta[cd]pentalen-2-one, 
1,1a,3,3a,4,5,5,5a,5b,6-decachlorooctahydro-)
Lasiocarpine (2-Butenoic acid, 2-methyl-,7-[[2,3-dihydroxy-2-(1-
methoxyethyl)-3-methyl-1-oxobutoxy]methyl]-2,3,5,7a-tetrahydro-1H-
pyrrolizin-l-yl ester)
Lead and compounds, N.O.S.
Lead acetate (Acetic acid, lead(2+) salt)
Lead phosphate (Phosphoric acid, lead(2+) salt(2:3))
Lead subacetate (Lead, bis(acetato-O)tetrahydroxytri-)
Lindane (Clohexane, 1,2,3,4,5,6-hexachloro-, 
(1,2,3,4,5,6)-)
Maleic anhydride (2,5-Furandione)
Maleic hydrazide (3,6-Pyridazinedione, 1,2-dihydro-)
Malononitrile (Propanedinitrile)
Melphalan (L-Phenylalanine, 4-[bis(2-chloroethyl)aminol]-)
Mercury and compounds, N.O.S.
Mercury fulminate (Fulminic acid, mercury(2+) salt)
Methacrylonitrile (2-Propenenitrile, 2-methyl-)
Methapyrilene (1,2-Ethanediamine, N,N-dimethyl-N'-2-pyridinyl-N'-(2-
thienylmethyl)-)
Metholmyl (Ethamidothioic acid, N-[[(methylamino)carbonyl]oxy]thio-, 
methyl ester)
Methoxychlor (Benzene, 1,1'-(2,2,2-trichloroethylidene)bis[4-methoxy-)
Methyl bromide (Methane, bromo-)
Methyl chloride (Methane, chloro-)
Methyl chlorocarbonate (Carbonchloridic acid, methyl ester)
Methyl chloroform (Ethane, 1,1,1-trichloro-)
3-Methylcholanthrene (Benz[j]aceanthrylene, 1,2-dihydro-3-methyl-)
4,4'-Methylenebis(2-chloroaniline) (Benzenamine, 4,4'-methylenebis(2-
  chloro-)
Methylene bromide (Methane, dibromo-)
Methylene chloride (Methane, dichloro-)
Methyl ethyl ketone (MEK) (2-Butanone)
Methyl ethyl ketone peroxide (2-Butanone, peroxide)
Methyl hydrazine (Hydrazine, methyl-)
Methyl iodide (Methane, iodo-)
Methyl isocyanate (Methane, isocyanato-)
2-Methyllactonitrile (Propanenitrile, 2-hydroxy-2-methyl-)
Methyl methacrylate (2-Propenoic acid, 2-methyl-, methyl ester)
Methyl methanesulfonate (Methanesulfonic acid, methyl ester)
Methyl parathion (Phosphorothioic acid, O,O-dimethyl O-(4-nitrophenyl) 
ester)
Methylthiouracil (4(1H)Pyrimidinone, 2,3-dihydro-6-methyl-2-thioxo-)
Mitomycin C (Azirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione,6-amino-8-
[[(aminocarbonyl) oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-
methy-, [1aS-(1a,8,8a,8b)]-)
MNNG (Guanidine, N-methyl-N'-nitro-N-nitroso-)
Mustard gas (Ethane, 1,1'-thiobis[2-chloro-)
Naphthalene
1,4-Naphthoquinone (1,4-Naphthalenedione)
-Naphthalenamine (1-Naphthylamine)
-Naphthalenamine (2-Naphthylamine)
-Naphthylthiourea (Thiourea, 1-naphthalenyl-)
Nickel and compounds, N.O.S.
Nickel carbonyl (Ni(CO)4 (T-4)-)

[[Page 35]]

Nickel cyanide (Ni(CN)2)
Nicotine and salts (Pyridine, 3-(1-methyl-2-pyrrolidinyl)-, (S)-)
Nitric oxide (Nitrogen oxide NO)
p-Nitroaniline (Benzenamine, 4-nitro-)
Nitrobenzene (Benzene, nitro-)
Nitrogen dioxide (Nitrogen oxide NO2)
Nitrogen mustard, and hydrochloride salt (Ethanamine, 2-chloro-N-(2-
chloroethyl)-N-methyl-)
Nitrogen mustard N-oxide and hydrochloride salt (Ethanamine, 2chloro-N-
(2-chloroethyl)N-methyl-, N-oxide)
Nitroglycerin (1,2,3-Propanetriol, trinitrate)
p-Nitrophenol (Phenol, 4-nitro-)
2-Nitropropane (Propane, 2-nitro-)
Nitrosamines, N.O.S.
N-Nitrosodi-n-butylamine (l-Butanamine, N-butyl-N-nitroso-)
N-Nitrosodiethanolamine (Ethanol, 2,2'-(nitrosoimino)bis-)
N-Nitrosodiethylamine (Ethanamine, N-ethyl-N-nitroso-1)
N-Nitrosodimethylamine (Methanamine, N-methyl-N-nitroso-)
N-Nitroso-N-ethylurea (Urea, N-ethyl-N-nitroso-)
N-Nitrosomethylethylamine (Ethanamine, N-methyl-N-nitroso-)
N-Nitroso-N-methylurea (Urea, N-methyl-N-nitroso-)
N-Nitroso-N-methylurethane (Carbamic acid, methylnitroso-, ethyl ester)
N-Nitrosomethylvinylamine (Vinylamine, N-methyl-N-nitroso-)
N-Nitrosomorpholine (Morpholine,
 4-nitroso-)
N-Nitrosonornicotine (Pyridine, 3-(1-nitroso-2-pyrrolidinyl)-, (S)-)
N-Nitrosopiperidine (Piperidine, 1-nitroso-)
Nitrosopyrrolidine (Pyrrolidine, 1-nitroso-)
N-Nitrososarcosine (Glycine, N-methyl-N-nitroso-)
5-Nitro-o-toluidine (Benzenamine, 2-methyl-5-nitro-)
Octamethylpyrophosphoramide (Diphosphoramide, octamethyl-)
Osmium tetroxide (Osmium oxide OsO4, (T-4)-)
Paraldehyde (1,3,5-Trioxane, 2,4,6-tri
methyl-)
Parathion (Phosphorothioic acid, O,O-diethyl O-(4-nitrophenyl) ester)
Pentachlorobenzene (Benzene, pentachloro-)
Pentachlorodibenzo-p-dioxins
Pentachlorodibenzofurans
Pentachloroethane (Ethane, pentachloro-)
Pentachloronitrobenzene (PCNB) (Benzene, pentachloronitro-)
Pentachlorophenol (Phenol, pentachloro-)
Phenacetin (Acetamide, N-(4-ethoxyphenyl)-)
Phenol
Phenylenediamine (Benzenediamine)
Phenylmercury acetate (Mercury, (acetato-O)phenyl-)
Phenylthiourea (Thiourea, phenyl-)
Phosgene (Carbonic dichloride)
Phosphine
Phorate (Phosphorodithioic acid, O,O-diethyl S-[(ethylthiomethyl] ester)
Phthalic acid esters, N.O.S.
Phthalic anhydride (1,3-isobenzofurandione)
2-Picoline (Pyridine, 2-methyl-)
Polychlorinated biphenyls, N.O.S.
Potassium cyanide (K(CN))
Potassium silver cyanide (Argentate(l-), bis(cyano-C)-, potassium)
Pronamide (Benzamide, 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)-)
1,3-Propane sultone (1,2-Oxathiolane, 2,2-dioxide)
n-Propylamine (1-Propanamine)
Propargyl alcohol (2-Propyn-1-ol)
Propylene dichloride (Propane, 1,2-
dichloro-)
1,2-Propylenimine (Aziridine, 2-methyl-)
Propylthiouracil (4(1H)-Pyrimidinone, 2,3-dihydro-6-propyl-2-thioxo-)
Pyridine
Reserpinen (Yohimban-16-carboxylic acid, 11,17-dimethoxy-18-[(3,4,5-
trimethoxybenzoyl)oxy]-smethyl ester, (3,16 
,17,18,20)-)
Resorcinol (1,3-Benzenediol)
Saccharin and salts (1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide)
Safrole (1,3-Benzodioxole, 5-(2-propenyl)-)
Selenium and compounds, N.O.S.
Selenium dioxide (Selenious acid)
Selenium sulfide (SeS2)
Selenourea
Silver and compounds, N.O.S.
Silver cyanide (Silver cyanide Ag(CN))
Silvex (Propanoic acid, 2-(2,4,5-trichlorophen
oxy)-)
Sodium cyanide (Sodium cyanide Na(CN))
Streptozotocin (D-Glucose, 2-deoxy-2-
[[methylnitrosoamino)carbonyl]amino]-)
Strychnine and salts (Strychnidin-10-one)
TCDD (Dibenzo[b,e][1,4]dioxin, 2,3,7,8-tetrachloro-)
1,2,4,5-Tetrachlorobenzene (Benzene, 1,2,4,5-tetrachloro-)
Tetrachlorodibenzo-p-dioxins
Tetrachlorodibenxofurans
Tetrachloroethane, N.O.S. (Ethane, tetrachloro-, N.O.S.)
1,1,1,2-Tetrachloroethane (Ethane, 1,1,1,2-tetrachloro-)
1,1,2,2-Tetrachloroethane (Ethane, 1,1,2,2-tetrachloro-)
Tetrachloroethylene (Ethene, tetrachloro-)
2,3,4,6-Tetrachlorophenol (Phenol, 2,3,4,6-tetrachloro-)
Tetraethyldithiopyrophosphate (Thiodiphosphoric acid, tetraethyl ester)
Tetraethyl lead (Plumbane, tetraethyl-)
Tetraethyl pyrophosphate (Diphosphoric acid, tetraethyl ester)
Tetranitromethane (Methane, tetranitro-)
Thallium and compounds, N.O.S.
Thallic oxide (Thallium oxide Tl2O3)
Thallium (I) acetate (Acetic acid, thallium (1+) salt)

[[Page 36]]

Thallium (I) carbonate (Carbonic acid, dithallium (1+) salt)
Thallium (I) chloride (Thallium chloride TlCl)
Thallium (I) nitrate (Nitric acid, thallium (1+) salt)
Thallium selenite (Selenius acid, dithallium (1+) salt)
Thallium (I) sulfate (Sulfuric acid, thallium (1+) salt)
Thioacetamide (Ethanethioamide)
3,Thiofanox (2-Butanone, 3,3-dimethyl-1-(methylthio)-, O-
[(methylamino)carbonyl] oxime)
Thiomethanol (Methanethiol)
Thiophenol (Benzenethiol)
Thiosemicarbazide (Hydrazinecarbothioamide)
Thiourea
Thiram (Thioperoxydicarbonic diamide [(H2N)C(S)]2S2, 
tetramethyl-)
Toluene (Benzene, methyl-)
Toluenediamine (Benzenediamine, ar-methyl-)
Toluene-2,4-diamine (1,3-Benzenediamine, 4-methyl-)
Toluene-2,6-diamine (1,3-Benzenediamine, 2-methyl-)
Toluene-3,4-diamine (1,2-Benzenediamine, 4-methyl-)
Toluene diisocyanate (Benzene, 1,3-diisocyanatomethyl-)
o-Toluidine (Benzenamine, 2-methyl-)
o-Toluidine hydrochloride (Benzenamine, 2-methyl-, hydrochloride)
p-Toluidine (Benzenamine, 4-methyl-)
Toxaphene
1,2,4-Trichlorobenzene (Benzene, 1,2,4-trichloro-)
1,1,2-Trichloroethane (Ethane, 1,1,2-trichloro-)
Trichloroethylene (Ethene,trichloro-)
Trichloromethanethiol (Methanethiol, trichloro-)
Trichloromonofluoromethane (Methane, trichlorofluoro-)
2,4,5-Trichlorophenol (Phenol, 2,4,5-trichloro-)
2,4,6-Trichlorophenol (Phenol, 2,4,6-trichloro-)
2,4,5-T (Acetic acid, 2,4,5- trichloro-
  phenoxy-)
Trichloropropane, N.O.S.
1,2,3-Trichloropropane (Propane, 1,2,3-trichloro-)
O,O,O-Triethyl phosphorothioate (Phosphorothioic acid, O,O,O-triethyl 
ester)
Trinitrobenzene (Benzene, 1,3,5-trinitro-)
Tris(1-aziridinyl)phosphine sulfide (Aziridine, 
1,1',1''phosphinothioylidynetris-))
Tris(2,3-dibromopropyl) phosphate (1-Propanol, 2,3-dibromo-, phosphate 
(3:1))
Trypan blue (2,7-Naphthalendisulfonic acid, 3,3'-[(3,3'-dimethyl[1,1'-
biphenyl]-4,4'-diyl)bis(azo)]bis(5-amino-4-hydroxy-, tetrasodium salt)
Uracil mustard (2,4-(1H,3H)-Pyrimidinedione, 5-[bis(2-
chloroethyl)amino]-)
Vanadium pentoxide (Vanadium oxide V2O5)
Vinyl chloride (Ethene, chloro-)
Wayfarin (2H-1-Benzopyran-2-one, 4-hydroxy-3-(3-oxo-1-phenlybutyl)-)
Zinc cyanide (Zn(CN)2)
Zinc phosphide (Zn3P2)

[60 FR 2868, Jan. 11, 1995]



PART 194--CRITERIA FOR THE CERTIFICATION AND RE-CERTIFICATION OF THE WASTE ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL REGULATIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
194.1  Purpose, scope, and applicability.
194.2  Definitions.
194.3  Communications.
194.4  Conditions of compliance certification.
194.5  Publications incorporated by reference.
194.6  Alternative provisions.
194.7  Effective date.

  Subpart B--Compliance Certification and Re-certification Applications

194.11  Completeness and accuracy of compliance applications.
194.12  Submission of compliance applications.
194.13  Submission of reference materials.
194.14  Content of compliance certification application.
194.15  Content of compliance re-certification application(s).

        Subpart C--Compliance Certification and Re-certification

                          General Requirements

194.21  Inspections.
194.22  Quality assurance.
194.23  Models and computer codes.
194.24  Waste characterization.
194.25  Future state assumptions.
194.26  Expert judgment.
194.27  Peer review.

                        Containment Requirements

194.31  Application of release limits.
194.32  Scope of performance assessments.
194.33  Consideration of drilling events in performance assessments.
194.34  Results of performance assessments.

[[Page 37]]

                         Assurance Requirements

194.41  Active institutional controls.
194.42  Monitoring.
194.43  Passive institutional controls.
194.44  Engineered barriers.
194.45  Consideration of the presence of resources.
194.46  Removal of waste.

           Individual and Ground-water Protection Requirements

194.51  Consideration of protected individual.
194.52  Consideration of exposure pathways.
194.53  Consideration of underground sources of drinking water.
194.54  Scope of compliance assessments.
194.55  Results of compliance assessments.

                     Subpart D--Public Participation

194.61  Advance notice of proposed rulemaking for certification.
194.62  Notice of proposed rulemaking for certification.
194.63  Final rule for certification.
194.64  Documentation of continued compliance.
194.65  Notice of proposed rulemaking for modification or revocation.
194.66  Final rule for modification or revocation.
194.67  Dockets.

    Authority: The Waste Isolation Pilot Plant Land Withdrawal Act of 
1992, Pub.L. 102-579, 106 Stat. 4777; 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; Nuclear Waste Policy Act of 1982, as amended, 42 U.S.C. 
10101-10270.

    Source: 61 FR 5235, Feb. 9, 1996, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 194.1  Purpose, scope, and applicability.

    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.



Sec. 194.2  Definitions.

    Unless otherwise indicated in this part, all terms have the same 
meaning as in part 191 of this chapter.
    Certification means any action taken by the Administrator pursuant 
to section 8(d)(1) of the WIPP LWA.
    Compliance application(s) means the compliance certification 
application submitted to the Administrator pursuant to section 8(d)(1) 
of the WIPP LWA or any compliance re-certification applications 
submitted to the Administrator pursuant to section 8(f) of the WIPP LWA.
    Compliance assessment(s) means the analysis conducted to determine 
compliance with Sec. 191.15, and part 191, subpart C of this chapter.
    Delaware Basin means those surface and subsurface features which lie 
inside the boundary formed to the north, east and west of the disposal 
system by the innermost edge of the Capitan Reef, and formed, to the 
south, by a straight line drawn from the southeastern point of the Davis 
Mountains to the most southwestern point of the Glass Mountains.
    Deep drilling means those drilling events in the Delaware Basin that 
reach or exceed a depth of 2,150 feet below the surface relative to 
where such drilling occurred.
    Department means the United States Department of Energy.
    Disposal regulations means part 191, subparts B and C of this 
chapter.
    Management systems review means the qualitative assessment of a data 
collection operation or organization(s) to establish whether the 
prevailing quality management structure, policies, practices, and 
procedures are adequate to ensure that the type and quality of data 
needed are obtained.
    Modification means action(s) taken by the Administrator that alters 
the terms or conditions of certification pursuant to section 8(d)(1) of 
the WIPP LWA. Modification of any certification shall comply with this 
part and part 191 of this chapter.
    Population of CCDFs means all possible complementary, cumulative 
distribution functions (CCDFs) that can

[[Page 38]]

be generated from all disposal system parameter values used in 
performance assessments.
    Population of estimates means all possible estimates of radiation 
doses and radionuclide concentrations that can be generated from all 
disposal system parameter values used in compliance assessments.
    Quality assurance means those planned and systematic actions 
necessary to provide adequate confidence that the disposal system will 
comply with the disposal regulations set forth in part 191 of this 
chapter. Quality assurance includes quality control, which comprises 
those actions related to the physical characteristics of a material, 
structure, component, or system that provide a means to control the 
quality of the material, structure, component, or system to 
predetermined requirements.
    Re-certification means any action taken by the Administrator 
pursuant to section 8(f) of the WIPP LWA.
    Regulatory time frame means the time period beginning at disposal 
and ending 10,000 years after disposal.
    Revocation means any action taken by the Administrator to terminate 
the certification pursuant to section 8(d)(1) of the WIPP LWA.
    Secretary means the Secretary of Energy.
    Shallow drilling means those drilling events in the Delaware Basin 
that do not reach a depth of 2,150 feet below the surface relative to 
where such drilling occurred.
    Suspension means any action taken by the Administrator to withdraw, 
for a limited period of time, the certification pursuant to section 
8(d)(1) of the WIPP LWA.
    Waste means the radioactive waste, radioactive material and 
coincidental material subject to the requirements of part 191 of this 
chapter.
    Waste characteristic means a property of the waste that has an 
impact on the containment of waste in the disposal system.
    Waste component means an ingredient of the total inventory of the 
waste that influences a waste characteristic.
    WIPP means the Waste Isolation Pilot Plant, as authorized pursuant 
to section 213 of the Department of Energy National Security and 
Military

[[Page 39]]

Applications of Nuclear Energy Authorization Act of 1980 (Pub.L. 96-164; 
93 Stat. 1259, 1265).
    WIPP LWA means the Waste Isolation Pilot Plant Land Withdrawal Act 
of 1992 (Pub.L. 102-579, 106 Stat. 4777).



Sec. 194.3  Communications.

    (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.



Sec. 194.4  Conditions of compliance certification.

    (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 within 30 calendar days of receipt of the 
request.
    (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 Sec. 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 Sec. 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;

[[Page 40]]

    (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.



Sec. 194.5  Publications incorporated by reference.

    (a) The following publications are incorporated into this part by 
reference:
    (1) U.S. Nuclear Regulatory Commission, NUREG-1297 ``Peer Review for 
High-Level Nuclear Waste Repositories,'' published February 1988; 
incorporation by reference (IBR) approved for Secs. 194.22, 194.23 and 
194.27.
    (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 
Sec. 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 Sec. 194.22 and Sec. 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 Sec. 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, 401 M Street, 
SW, Washington, DC 20460, or copies may be inspected at the Office of 
the Federal Register, 800 N. Capitol Street NW, 7th floor, Suite 700, 
Washington, DC, or copies may be obtained from the following addresses:
    (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.



Sec. 194.6  Alternative provisions.

    The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute 
for any of the provisions of this part alternative provisions chosen 
after:
    (a) The alternative provisions have been proposed for public comment 
in

[[Page 41]]

the Federal Register together with information describing how the 
alternative provisions comport with the disposal regulations, the 
reasons why the existing provisions of this part appear inappropriate, 
and the costs, risks and benefits of compliance in accordance with the 
alternative provisions;
    (b) A public comment period of at least 120 days has been completed 
and public hearings have been held in New Mexico;
    (c) The public comments received have been fully considered; and
    (d) A notice of final rulemaking is published in the Federal 
Register.



Sec. 194.7  Effective date.

    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.



  Subpart B--Compliance Certification and Re-certification Applications



Sec. 194.11  Completeness and accuracy of compliance applications.

    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.



Sec. 194.12  Submission of compliance applications.

    Unless otherwise specified by the Administrator or the 
Administrator's authorized representative, 30 copies of any compliance 
application, any accompanying materials, and any amendments thereto 
shall be submitted in a printed form to the Administrator.



Sec. 194.13  Submission of reference materials.

    Information may be included by reference into compliance 
application(s), provided that the references are clear and specific and 
that, unless otherwise specified by the Administrator or the 
Administrator's authorized representative, 10 copies of the referenced 
information are submitted to the Administrator. Referenced materials 
which are widely available in standard textbooks or reference books need 
not be submitted.



Sec. 194.14  Content of compliance certification application.

    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. Such description shall include, at a minimum:
    (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

[[Page 42]]

    (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.



Sec. 194.15  Content of compliance re-certification application(s).

    (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 
Secs. 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 
Administrator's authorized representative.
    (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.



        Subpart C--Compliance Certification and Re-certification

                          General Requirements



Sec. 194.21  Inspections.

    (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

[[Page 43]]

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.



Sec. 194.22  Quality assurance.

    (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 Sec. 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 of 
the following methods: Peer review, 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 Sec. 194.5); corroborating data; confirmatory testing; or a 
quality assurance program that is equivalent in effect to 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 
Sec. 194.5.)
    (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;

[[Page 44]]

    (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.



Sec. 194.23  Models and computer codes.

    (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 
Sec. 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 Sec. 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

[[Page 45]]

within 30 calendar days of a request by the Administrator or the 
Administrator's authorized representative.



Sec. 194.24  Waste characterization.

    (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 Sec. 194.34 and Sec. 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 which demonstrates that the use of process 
knowledge to quantify components in waste for disposal conforms with the 
quality assurance requirements found in Sec. 194.22.
    (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 Sec. 194.22.

[[Page 46]]

    (d) The Department shall include a waste loading scheme in any 
compliance application, or else performance assessments conducted 
pursuant to Sec. 194.32 and compliance assessments conducted pursuant to 
Sec. 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 Sec. 194.32 and compliance assessments conducted pursuant to 
Sec. 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.



Sec. 194.25  Future state assumptions.

    (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 Sec. 191.13, Sec. 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 Sec. 194.14, Content of compliance certification 
application; Sec. 194.32, Scope of performance assessments; and 
Sec. 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 any compliance 
application, to the extent practicable, the effects of potential changes 
to future climate cycles of increased precipitation (as compared to 
present conditions).



Sec. 194.26  Expert judgment.

    (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

[[Page 47]]

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.



Sec. 194.27  Peer review.

    (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 Sec. 194.24(b); 
and
    (3) Engineered barrier evaluation as required in Sec. 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 Sec. 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

[[Page 48]]

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.

                        Containment Requirements



Sec. 194.31  Application of release limits.

    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.



Sec. 194.32  Scope of performance assessments.

    (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.



Sec. 194.33  Consideration of drilling events in performance assessments.

    (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 events, and the results of 
such process shall be documented in any compliance application:
    (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.

[[Page 49]]

    (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.



Sec. 194.34  Results of performance assessments.

    (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 Sec. 191.13 of this chapter.

                         Assurance Requirements



Sec. 194.41  Active institutional controls.

    (a) Any compliance application shall include detailed descriptions 
of proposed active institutional controls, the controls' location, and 
the period of time the controls are proposed to remain active. 
Assumptions pertaining to active institutional controls and their 
effectiveness in terms of preventing or reducing radionuclide releases 
shall be supported by such descriptions.
    (b) Performance assessments shall not consider any contributions 
from active institutional controls for more than 100 years after 
disposal.



Sec. 194.42  Monitoring.

    (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

[[Page 50]]

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.



Sec. 194.43  Passive institutional controls.

    (a) Any compliance application shall include detailed descriptions 
of the measures that will be employed to preserve knowledge about the 
location, design, and contents of the disposal system. Such measures 
shall include:
    (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

[[Page 51]]

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.



Sec. 194.44  Engineered barriers.

    (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) of this section, the Department concludes that an 
engineered barrier considered within the scope of the evaluation should 
be rejected without evaluating the remaining factors in paragraph (c)(1) 
of this section, then any compliance application shall provide a 
justification for this rejection explaining why the evaluation of the 
remaining factors would not alter the conclusion.
    (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.

[[Page 52]]



Sec. 194.45  Consideration of the presence of resources.

    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 
Sec. 191.13 of this chapter, then the Agency will assume that the 
requirements of this section and Sec. 191.14(e) of this chapter have 
been fulfilled.



Sec. 194.46  Removal of waste.

    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.

           Individual and Ground-water Protection Requirements



Sec. 194.51  Consideration of protected individual.

    Compliance assessments that analyze compliance with Sec. 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.



Sec. 194.52  Consideration of exposure pathways.

    In compliance assessments that analyze compliance with Sec. 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 Sec. 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.



Sec. 194.53  Consideration of underground sources of drinking water.

    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.



Sec. 194.54  Scope of compliance assessments.

    (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.

[[Page 53]]



Sec. 194.55  Results of compliance assessments.

    (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 Sec. 194.51 and Sec. 194.52;
    (2) Estimated radionuclide concentrations in USDWs pursuant to 
Sec. 194.53; and
    (3) Estimated dose equivalent received from USDWs pursuant to 
Sec. 194.52 and Sec. 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 
Sec. 191.15 and part 191, subpart C of this chapter, respectively.



                     Subpart D--Public Participation



Sec. 194.61  Advance notice of proposed rulemaking for certification.

    (a) Upon receipt of a compliance application submitted pursuant to 
section 8(d)(1) of the WIPP LWA and Sec. 194.11, the Agency will publish 
in the Federal Register an Advance Notice of Proposed Rulemaking 
announcing that a compliance application has been received, soliciting 
comment on such application, and announcing the Agency's intent to 
conduct a rulemaking to certify whether the WIPP facility will comply 
with the disposal regulations.
    (b) A copy of the compliance application will be made available for 
inspection in Agency dockets established pursuant to Sec. 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 Sec. 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.



Sec. 194.62  Notice of proposed rulemaking for certification.

    (a) The Administrator will publish a Notice of Proposed Rulemaking 
in the Federal Register announcing the Administrator's proposed 
decision, pursuant to section 8(d)(1) of the WIPP LWA, whether to issue 
a certification that the WIPP facility will comply with the disposal 
regulations and soliciting comment on the proposal.
    (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 Sec. 194.67.



Sec. 194.63  Final rule for certification.

    (a) The Administrator will publish a Final Rule in the Federal 
Register announcing the Administrator's decision, pursuant to section 
8(d)(1) of the WIPP LWA, whether to issue a certification that the WIPP 
facility will comply with the disposal regulations.
    (b) A document summarizing significant comments and issues arising 
from

[[Page 54]]

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 Sec. 194.67.



Sec. 194.64  Documentation of continued compliance.

    (a) Upon receipt of documentation of continued compliance with the 
disposal regulations pursuant to section 8(f) of the WIPP LWA and 
Sec. 194.11, the Administrator will publish a notice in the Federal 
Register announcing that such documentation has been received, 
soliciting comment on such documentation, and announcing the 
Administrator's intent to determine whether or not the WIPP facility 
continues to be in compliance with the disposal regulations.
    (b) Copies of documentation of continued compliance received by the 
Administrator will be made available for inspection in the dockets 
established pursuant to Sec. 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 Sec. 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 Federal Register announcing the Administrator's decision 
whether or not to re-certify the WIPP facility.



Sec. 194.65  Notice of proposed rulemaking for modification or revocation.

    (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 Federal Register announcing the 
Administrator's proposed decision on modification or revocation, and 
soliciting comment on the proposal.
    (b) Any comments received on the notice will be made available for 
inspection in the dockets established pursuant to Sec. 194.67.



Sec. 194.66  Final rule for modification or revocation.

    (a) The Administrator will publish a Final Rule in the Federal 
Register announcing the Administrator's decision on modification or 
revocation.
    (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 Sec. 194.67.



Sec. 194.67  Dockets.

    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 considered by the Administrator in certifying 
whether the WIPP facility will comply with the disposal regulations, in 
certifying whether or not the WIPP facility continues to be in 
compliance with the disposal regulations, and in determining whether 
compliance certification should be modified, suspended or revoked.



PART 195--RADON PROFICIENCY PROGRAMS--Table of Contents




                      Subpart A--General Provisions

Sec.
Sec. 195.1  Purpose and applicability.
Sec. 195.2  Definitions.

                             Subpart B--Fees

Sec. 195.20  Fee payments.
Sec. 195.30  Failure to remit fee.

    Authority: 15 U.S.C. 2665.

    Source: 59 FR 13175, Mar. 18, 1994, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 195.1  Purpose and applicability.

    (a) Purpose. The purpose of this part is to establish and collect 
the fees from

[[Page 55]]

applicants and participants required by section 305 of the Toxic 
Substances Control Act, U.S.C. 2665 to defray the cost to EPA for 
operating the following programs: The National Radon Measurement 
Proficiency (RMP) Program, the individual proficiency component of the 
RMP Program, and the National Radon Contractor Proficiency (RCP) 
Program.
    (b) Applicability. This part applies to all applicants and 
participants in the following EPA programs: The National Radon 
Measurement Proficiency Program, the individual proficiency component of 
the RMP Program, and the National Radon Contractor Proficiency Program.



Sec. 195.2  Definitions.

    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:
    Acceptance date means the date on which EPA enters the application 
into the data system.
    Accepted application refers to an application that has been entered 
into the data system.
    Applicant means an individual or organization that submits an 
application to the RMP program, including the individual proficiency 
component of the RMP program, or the RCP program. An applicant to the 
RMP program must submit a separate application for each location from 
which it provides radon measurement services. After the application is 
accepted by EPA, the applicant becomes a ``participant'' in the 
proficiency programs.
    Application means the documents submitted to EPA by applicants to 
the RMP and RCP programs which request participation in a program.
    Device/measurement device means a unit, component, or system 
designed to measure radon gas or radon decay products.
    EPA means the U.S. Environmental Protection Agency.
    Individual proficiency/RMP exam means the exam which evaluates 
individuals who provide radon measurement services in a residential 
environment.
    Listed participant in an individual or organization who has met all 
the requirements for listing in the RMP and RCP programs.
    Measurement method is a means of measuring radon gas or radon decay 
products encompassing similar measurement devices, sampling techniques, 
or analysis procedures.
    Organization is any individual, sole proprietorship, partnership, 
business, company, corporation, college or university, government agency 
(includes Federal, State and local government entities), laboratory, or 
institution.
    Participant is an individual or organization engaged in radon 
measurement and/or mitigation activities or in offering radon 
measurement and/or mitigation services to consumers and others, whose 
proficiency program application EPA has accepted.
    Primary measurement services (primary) refers to radon measurement 
services using a specific device which services include the capability 
to read and/or analyze the results generated from the device.
    Radon Contractor Proficiency (RCP) program refers to EPA's program 
to evaluate radon mitigation contractors and the contractor's ability to 
communicate information to the public.
    Radon Measurement Proficiency (RMP) program refers to EPA's program 
to evaluate organizations and individuals offering measurement services 
to consumers. It provides a means for organizations to demonstrate their 
proficiency in measuring radon and its decay products in indoor air.
    Radon mitigation contractor means a contractor who provides radon 
mitigation services to the public.
    Secondary radon measurement services (secondary) refers to radon 
measurement services that do not include the reading or the ability to 
analyze the results of the measurement devices used. These services may 
include placement and retrieval of devices, reporting results, and/or 
consultation with consumers.



                             Subpart B--Fees



Sec. 195.20  Fee payments.

    (a) Fee Amounts. Applicants to and participants in the RMP and RCP 
programs shall pay fees according to the following fee schedule:

[[Page 56]]

    (1) Organizations Listed for or Seeking Listing for Primary 
Measurement Services in the RMP Program. (i) In order to remain a listed 
participant, each organization that is listed for primary measurement 
services in the RMP program on the effective date of this section shall 
pay an annual fee of $390 for each device.
    (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) Organizations Listed for or Seeking Listing for Secondary 
Measurement Services in the RMP Program. (i) In order to remain a listed 
participant, each organization that is listed for secondary measurement 
services in the RMP program on the effective date of this section shall 
pay an annual fee of $50 for each business location listed.
    (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) Individual Proficiency Component of the RMP Program. (i) In 
order to remain a listed participant, each individual listed in the RMP 
individual proficiency program on the effective date of this section 
shall pay an annual fee of $105.
    (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) RCP Program. (i)(A) In order to remain a listed participant, 
each individual listed in the RCP program on the effective date of this 
section shall pay an annual fee of $210.
    (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 organization, shall submit the 
appropriate annual fee to EPA each year.
    (b) Exemptions. State and local governments are exempted from these 
fees under section 305(e)(2) of TSCA, 15 U.S.C. 2665.
    (c) Determination of Fees. (1) Participants listed in the RMP and 
RCP programs on the effective date of this section will be sent, by EPA, 
a payment invoice with its fee calculation at least 30 days before the 
payment is due. Fees will be assessed based on the current information 
in EPA's proficiency data bases. Participants who intend to pay the 
invoiced fee amount must send their payment to EPA following the 
procedures in the invoice. Organizations or individuals who wish to 
notify EPA of any errors or corrections they wish to make to their 
listing status must do so by following the instructions on the payment 
invoice. Corrected payment invoices for both the RMP Program and the RCP 
Program shall be sent to: Radon Proficiency

[[Page 57]]

Programs User Fees, c/o Sanford Cohen and Associates, Inc. (SC&A), 1418 
I-85 Parkway, Montgomery, Alabama, 36106. EPA will review the 
corrections noted on the payment invoice, adjust the payment invoice 
amount (as appropriate) and issue a new invoice. Participants must pay 
the amount in the corrected payment invoice within 30 days of the date 
listed on the corrected invoice.
    (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) Payment Procedures. Each remittance to EPA under this section 
shall be in United States currency and shall be paid by certified check, 
personal or business check, or money order made payable to the order of 
the ``U.S. ENVIRONMENTAL PROTECTION AGENCY'' and sent to: U.S. EPA, 
Washington Financial Management Center, Radon Proficiency Program User 
Fees (IRAA), P.O. Box 952491, St. Louis, Missouri, 63195-2491. The fee 
payment shall include the original copy of the EPA payment invoice. 
Collection of fees will begin in the calendar year beginning January 1, 
1995. Specific guidance on how and when fees must be paid can be found 
in How to Pay Your Radon Proficiency Programs User Fees, U.S. EPA/Office 
of Radiation and Indoor Air. Copies of this document can be obtained by 
contacting the RIS at (334) 272-2797 or by FAX at (334) 260-9051.
    (e) Adjustment of Fees. (1) EPA shall collect 100 percent of its 
operating costs associated with its radon proficiency programs by 
calendar year 1998. As necessary, EPA shall adjust the fees established 
by this subpart each year over the next four years to collect the 
following percentages of program costs:

------------------------------------------------------------------------
    Year 1         Year 2         Year 3         Year 4        Year 5   
------------------------------------------------------------------------
30%..........       47.5%            65%          82.5%           100%  
------------------------------------------------------------------------

Actual fees for each fiscal year will be calculated based on program 
costs and participation rates. New fee schedules will be published in 
the Federal Register as a technical amendment final rule to this part to 
become effective 30 days or more after publication.
    (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., updating examinations) and increases/decreases in 
variable costs due to inflation and other factors. In order to calculate 
increases/decreases in costs due to inflation, EPA may use one of the 
three following indices: the Federal General Schedule (GS) pay scale, 
the Consumer Price Index (CPI), and/or a component of the CPI, such as 
services. Second, EPA will estimate the number of participants for each 
program. At a minimum, these participation rates will be based on past 
and current program participation rates. Third, EPA shall calculate the 
per capita costs that individuals and organizations should pay to enable 
it to recover its fixed and variable costs each year for each program. 
EPA shall also consider potential industry impacts as it adjusts to 
levels to ultimately achieve full cost recovery over the period of five 
years.

[60 FR 41816, Aug. 14, 1995]

[[Page 58]]



Sec. 195.30  Failure to remit fee.

    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 Sec. 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 Sec. 195.20(c).