Display Related Directives to this directive.

IMPLEMENTATION
GUIDE
for use with DOE M 435.1-1

Chapter II

High-Level Waste Requirements

(This page intentionally left blank.) II. A. Definition of High-Level Waste.

High-level waste is the highly radioactive waste material resulting from the
reprocessing of spent nuclear fuel, including liquid waste produced directly in
reprocessing and any solid material derived from such liquid waste that contains
fission products in sufficient concentrations; and other highly radioactive material
that is determined, consistent with existing law, to require permanent isolation.

Objective:

The objective of this requirement is to provide the criteria for determining which DOE
radioactive wastes are to be managed as high-level waste, and therefore, in accordance with DOE
M 435.1-1, Chapter II, High-Level Waste Requirements, and Chapter I, General Requirements
and Responsibilities.

Discussion:

As required in DOE M 435.1-1, Section I.1.C., Radioactive Waste Management, all radioactive
wastes subject to DOE O 435.1 shall be managed as either high-level waste, transuranic waste,
low-level waste, or mixed low-level waste. To assist in determining whether a particular waste
stream is high-level waste, another waste type, or not addressed by DOE O 435.1 and DOE M
435.1-1, see the guidance that accompanies the requirement at Section I.1.C. For those waste
streams that meet the definition of high-level waste cited above, the requirements of Chapter II of
DOE M 435.1-1 shall be met.

This definition is consistent with the definition provided in the Nuclear Waste Policy Act of 1982
(NWPA), as amended. It is slightly modified from the Nuclear Waste Policy Act of 1982, as
amended, definition and, as discussed below, allows DOE to make a determination of what is
high-level waste based on existing law.

The identification of high-level waste is considered relatively straightforward since it is primarily
linked to the source from which it was derived, i.e., it is the highly radioactive material resulting
from the reprocessing of spent nuclear fuel. However, the definition does imply a concentration
limit by including solid material derived from liquid waste that contains fission products in
sufficient concentrations. Background and knowledge of both the Nuclear Waste Policy Act of
1982, as amended, definition and the Nuclear Regulatory Commission definition, at 10 CFR Part
60, is needed to ensure that waste that is to be managed as high-level waste has been properly
characterized to be high-level waste. High-level waste must be managed in accordance with
Chapter II of DOE M 435.1-1.

Background. The following discussion is provided in terms of the Nuclear Waste Policy Act of
1982, as amended, definition but is fully applicable to the definition at Section II.A of DOE M
435.1-1. The Nuclear Waste Policy Act of 1982, as amended, provides for the disposal of high-
level radioactive waste and establishes a program of research, development, and demonstration
regarding the disposal of high-level radioactive waste. In the Nuclear Waste Policy Act of 1982,
as amended, the term high-level radioactive waste is defined as:

"(a) the highly radioactive material resulting from the reprocessing of spent nuclear fuel,
including liquid waste produced directly in reprocessing and any solid material derived
from such liquid waste that contains fission products in sufficient concentrations; and (b)
other highly radioactive material that the Commission, consistent with existing law,
determines by rule requires permanent isolation."

Thus the Nuclear Waste Policy Act of 1982, as amended definition for high-level waste provides
for the inclusion of both source-based material and concentration-based material as high-level
waste.

Note that the Nuclear Waste Policy Act of 1982, as amended, does not mandate that materials
regarded as high-level waste pursuant to this definition be disposed of in a geologic repository.
Indeed, the Nuclear Waste Policy Act of 1982, as amended, directs the Secretary of Energy to
continue and accelerate a program of research, development, and investigation of alternative
means and technologies for the permanent disposal of high-level waste. DOE has not been
specifically authorized by Congress to construct or operate facilities for disposal by alternative
means, and it is not clear whether additional authorization might be needed in order to dispose of
high-level waste by means other than emplacement in a deep geologic repository (52 FR 5994).

Also note that the Nuclear Waste Policy Act of 1982, as amended, definition and the definition
for high-level waste in DOE's predecessor directive for radioactive waste management, DOE
5820.2A, are fundamentally the same. However, there is one exception. The Nuclear Waste
Policy Act of 1982, as amended, provides for an additional mechanism for determining a waste is
high-level waste. This mechanism is to allow the Nuclear Regulatory Commission (NRC) to
determine, by rule, that a waste requires permanent isolation. The wording in Section II.A is
slightly different than the Nuclear Waste Policy Act of 1982, as amended, to allow DOE to make
a determination based upon existing law in Sections 202(3) and 202(4) of the Energy
Reorganization Act of 1974.

The NRC has posited that, "radioactive wastes that have historically been referred to as high-
level waste, i.e., reprocessing wastes, are initially both intensely radioactive and long-lived" (52
FR 5994). However, these wastes contain a wide variety of radionuclides with some (e.g., Sr-90,
Cs-137) having a relatively short half-life yet representing a large fraction of the radioactivity for
the first few centuries after the wastes are produced. These nuclides produce significant amounts
of heat and radiation, both of which are of concern when managing such wastes. Other
radionuclides, including C-14, Tc-99, I-129 and transuranic nuclides, have very long half-lives
and thus constitute the longer-term hazard of the wastes. Some of these nuclides pose a hazard
for sufficiently long periods of time that the term permanent isolation is used in the Nuclear
Waste Policy Act of 1982, as amended, to describe the type of disposal required to isolate them
from the environment. Permanent isolation does not, however, equate to repository disposal, and
can be conceivably attained by other means which comply with the requirements of 40 CFR Part
191. The Nuclear Regulatory Commission "considers that these two characteristics, intense
radioactivity for a few centuries followed by a long-term hazard requiring permanent isolation,
are key features which can be used to distinguish high-level wastes from other waste categories"
(52 FR 5994).

The Nuclear Waste Policy Act of 1982, as amended, identifies two sources of high-level waste.
First, the Nuclear Waste Policy Act of 1982, as amended, definition of high-level waste refers to
wastes produced by reprocessing spent nuclear fuel, which is essentially identical to the NRC's
definition at 10 CFR Part 60 [(1) Irradiated reactor fuel, (2) liquid wastes resulting from the
operation of the first cycle solvent extraction system, or equivalent, and the concentrated wastes
from subsequent extraction cycles, or equivalent, in a facility for reprocessing irradiated reactor
fuel, and (3) solids into which such liquid wastes have been converted]. However, there is one
difference. The Nuclear Waste Policy Act of 1982, as amended, wording would classify
solidified reprocessing waste as high-level waste only if such waste "contains fission products in
sufficient concentrations." This phrase implies that liquid reprocessing waste may be partitioned
or otherwise treated so that some of the solidified products will contain substantially reduced
concentrations of radionuclides and thus not be high-level waste, i.e., incidental waste. Second,
the Nuclear Waste Policy Act of 1982, as amended, authorizes the NRC to classify "other highly
radioactive material" (other than reprocessing wastes) as high-level waste if that material
"requires permanent isolation." Both of these elements of the Nuclear Waste Policy Act of 1982,
as amended, definition are discussed further below by providing summaries of the Nuclear
Regulatory Commission's attempt to revise the 10 CFR Part 60 definition of high-level waste.

In February 1987, the NRC published an Advanced Notice of Proposed Rulemaking, (52 FR
5992) announcing its intent to revise the definition of the term high-level radioactive waste that
appears in 10 CFR Part 60, "Disposal of High-Level Radioactive Wastes in Geologic
Repositories." In the Advanced Notice of Proposed Rulemaking, the Commission reviewed the
previous statutory and regulatory uses of the term, the NRC's current regulations related to waste
classification and disposal, and the pertinent provision of the Nuclear Waste Policy Act of 1982,
as amended, with the purpose of considering a change to its own rules to conform to the Nuclear
Waste Policy Act of 1982, as amended, definition. In particular, the NRC proposed to define
high-level waste in a manner that would apply the term high-level radioactive waste to materials
in amounts and concentrations exceeding numerical values that would be stated explicitly in the
form of a table. Thus, high-level waste would be characterized by the kind of hazard that could
only be guarded against by disposal in a geologic repository or equivalent facility. Those wastes
that could be disposed of safely in a facility less secure than a repository would continue to be
classified as low-level radioactive waste rather than as high-level waste.

At issue was whether the Commission should specify numerically the concentrations of fission
products which it considered sufficient to distinguish high-level waste from non-high-level waste
or, define high-level waste so as to add the Nuclear Waste Policy Act of 1982, as amended,
(clause (a)) wastes with those which have traditionally been regarded as high-level waste (52 FR
5994), i.e. by the waste's source. In addition, the Commission raised the issue as to whether to
consider a material highly radioactive if it contains concentrations of short-lived radionuclides in
excess of the Class C limits of Table 2 of 10 CFR Part 61. The Commission stated that such
concentrations are sufficient to produce significant radiation levels and to generate substantial
amounts of heat and should be considered highly radioactive. Finally, the phrase permanent
isolation was discussed and was believed to be much less subjective than is the term highly
radioactive. The Commission suggested that the term clearly implies the degree of isolation
afforded by a deep geologic repository, and a waste "requires permanent isolation" if it cannot be
safely disposed of in a facility that is less secure than a repository. Furthermore, the Advanced
Notice of Proposed Rulemaking (52 FR 5995) states that the Commission could determine which
wastes require permanent isolation by evaluating the disposal capabilities of alternative, less
secure, disposal facilities. The Commission noted that such less secure facilities might make use
of intermediate depth burial or various engineering measures, such as intruder barriers, to
accommodate wastes with radionuclide concentrations unsuitable for disposal by shallow land
burial. The Commission suggested that any such wastes which cannot be safely disposed of in
such facilities could be deemed to require permanent isolation and, if also highly radioactive,
could be classified as high-level wastes (52 FR 5995).

In May 1988 (53 FR 17709-17711), the NRC published its Proposed Rule at 10 CFR Part 61,
"Licensing Requirements for Land Disposal of Radioactive Waste," and stated that the proposed
amendments to this Rule obviated "the need for altering existing classifications of radioactive
wastes as high-level or low-level." In short, the NRC received nearly 100 comments on its
February 1987 Advanced Notice of Proposed Rulemaking and almost all agreed with the
Commission on one point: the use of the term high-level radioactive waste as used in the clause
(b) of the Nuclear Waste Policy Act of 1982, as amended definition, serves to identify those
wastes which require the degree of isolation afforded by a deep geologic repository. However,
comments differed widely regarding the specific wastes perceived to require that degree of
isolation. Some comments advocated classification of all radioactive wastes, other than the most
innocuous, as high-level waste while other comments preferred to reclassify, as low-level waste,
large quantities of defense reprocessing waste long regarded as high-level waste. Conspicuously
absent from the comments was any consensus regarding the means to be used by the
Commission to distinguish high-level waste from non-high-level waste. For example, the
concept of a numerical definition of high-level waste was criticized as an invitation to dilute or
fractionate wastes solely to alter their classification. From this discussion the Commission
determined it would be best to proceed quite differently from its objective suggestion as set forth
in the Advanced Notice of Proposed Rulemaking; i.e., the NRC abandoned their attempt to
provide a risk-based definition for high-level waste. Instead, the Commission continued to
embrace the definition at 10 CFR Part 60. In summary, the Commission stated that the
preferable construction of the statute was to conform to the traditional definition, i.e., to define
high-level waste by its source, not by its concentrations of fission products, and thus equate
Nuclear Waste Policy Act of 1982, as amended, wastes with those wastes which have
traditionally been regarded as high-level waste under Appendix F of 10 CFR Part 50 and the
Energy Reorganization Act of 1974 (ERA). The NRC stated that "NWPA (clause (a)) wastes
have little significance for purposes of the NWPA since the Federal Government was already
responsible for the disposal of all reprocessing waste at the time the statute was passed." Thus
"materials that are high-level waste for purposes of licensing-jurisdiction provisions of the ERA
will also be regarded as high-level waste under the NWPA. This would include the primary
reprocessing waste streams at DOE facilities, though not the incidental wastes produced in
reprocessing" (53 FR 17709).

Discussion. The above background information is intended to provide some background for the
following discussion on determining what waste streams are, and are not, high-level waste. First,
it is noted that the term reprocessing is not defined statutorily. However, reprocessing is
considered by the Department to be those actions necessary to separate fissile elements (U-235,
Pu-239, U-233, and Pu-241) and/or transuranium elements (e.g., Np, Pu, Am, Cm, Bk) from
other materials (e.g., fission products, activated metals, cladding) contained in spent nuclear fuel
for the purposes of recovering desired materials. Second, as discussed above, the concentration
of fission products is not the primary consideration when making determinations using clause (a)
of the Nuclear Waste Policy Act of 1982, as amended. The source of the waste is the primary
parameter for making high-level waste determinations, not the activity or concentration of fission
products. However, inclusion of solid wastes derived from the waste of spent nuclear fuel
reprocessing activities is also a consideration if the concentration of fission products is sufficient.
Third, it is recognized that the NRC's definition of high-level waste at 10 CFR 60.2, (which is
consistent with the definition of high-level radioactive waste in 10 CFR Part 50, Appendix F),
limits high-level waste to wastes that are the result of spent nuclear fuel reprocessing, beginning
with the separation/first cycle solvent extraction step, or equivalent. Specifically it states high-
level radioactive waste is:

"(1) irradiated reactor fuel, (2) liquid wastes resulting from the operation of the first cycle
solvent extraction system, or equivalent, and the concentrated wastes from subsequent
extraction cycles, or equivalent, in a facility for reprocessing irradiated reactor fuel, and
(3) solids into which such liquid wastes have been converted." (10 CFR 60.2)

With regard to part (1) of this definition, it is noted that requirements for DOE-managed spent
nuclear fuel, as of the time of the preparation of this guidance, have not been added to DOE O
435.1. Further, the hazards analysis performed to identify requirements for high-level waste did
not address the functions associated with management of spent nuclear fuel. Thus the
requirements contained in DOE M 435.1-1 do not apply to this DOE-managed spent nuclear fuel.

DOE M 435.1-1 supports the implementation of part (2) of the 10 CFR Part 60 definition to
mean that high-level wastes are wastes that are generated as a product of reprocessing of spent
nuclear fuel downstream of, and including, the first step in a separations process, and the
consistent waste streams from subsequent extraction cycles or steps. Separation processes
include aqueous separation processes, e.g., the Redox and the Purex processes, and nonaqueous
processes, e.g., pyrometallurgical and pyrochemical processes. Wastes that are produced
upstream of these separations processes, from such processes as chemical or mechanical
decladding, fuel dissolution, cladding separations, conditioning, or accountability measuring, are
not high-level waste. Such wastes are considered processing wastes and should be managed in
accordance with the appropriate Chapters of DOE M 435.1-1, as either transuranic, mixed low-
level, or low-level waste. In addition, these wastes may be commingled with materials-in-
process that require further processing to separate desired materials from wastes. The following
example is offered to clarify this interpretation.

Example: The spent nuclear fuel reprocessing operation at Site Z has been shut down for
some time. In the haste of shutting down the operation a number of material streams and
waste streams were left in the facility and are now being reviewed for disposition. The
following table describes some of the streams, designation of the stream as high-level
waste, or non-high-level waste, and the basis for the designation:

Stream
Designation
Basis

Fuel cladding hulls
(leached, partially leached,
and unleached)
Non-high-level
waste
Hulls are generated upstream of (before) the
first step of a separations process. They
should be characterized to determine proper
classification (e.g., LLW, MLLW, or TRU).

PUREX process first-cycle
raffinate stream, Pu
purification raffinate
stream
High-level waste
Both waste streams are generated by the
first step, or subsequent steps, of a
separations/decontamination process.

Contaminated
equipment/components:
a) Fuel Shear

b) Fuel Dissolver

c) First cycle solvent
extraction column

a) Non-high-
level waste

b) Non-high-
level waste

c) High-level
waste unless
WIR Evaluation
Process criteria
are met.

a) Waste contained/trapped in a fuel shear
was generated upstream of first step of
separations process. Fuel shear should be
characterized to determine proper
classification (e.g., LLW, MLLW or TRU).

b) Same as a).

c) Waste contained/trapped in column was
generated during first step of separations
process. May be managed as non-high-level
waste if column meets the Waste Incidental
to Reprocessing Evaluation Process criteria.

Electrometallurgical
treatment products:
a) Metal waste form
(includes uranium,
fission products, noble
metals)

b) Ceramic waste form
(includes fission
products, some actinides)

a) High-level
waste

b) High-level
waste

a) & b) Both waste streams are
generated by the first step, or subsequent
step, of a separation/decontamination
process.

As stated above, the Department recognizes that the Nuclear Waste Policy Act of 1982, as
amended, grants the NRC the authority, through the rulemaking process, to designate other
highly radioactive materials as high-level waste under existing law. For DOE, such existing law
would primarily be sections 202(3) and (4) of the Energy Reorganization Act of 1974.

Components and Equipment Contaminated with High-Level Waste. As discussed in detail in the
guidance to Section II.B, Waste Incidental to Reprocessing, components and equipment
contaminated with high-level waste are not considered high-level waste by the application of the
high-level waste definition in Section II.A, or the Nuclear Waste Policy Act of 1982, as
amended, definition, provided they meet the conditions of either the Waste Incidental to
Reprocessing Citation or Evaluation Process. In defining high-level waste both definitions use
the term "highly radioactive material" which is interpreted to mean waste material that is a result
of reprocessing spent nuclear fuel and any liquid waste or solid material derived from such
liquid. There is no precedence nor basis for including high-level waste-contaminated
components and/or equipment within the definition. In fact, the identification of items excluded
from high-level waste by the Atomic Energy Commission and subsequently by the Nuclear
Regulatory Commission, includes not only radioactive (fuel) hulls and other irradiated and
contaminated fuel structural hardware but also "ion exchange beds, sludges, and contaminated
laboratory items, clothing, tools, and equipment" (52 FR 5993). Thus, inclusion of these items
as candidates for the incidental waste process supports the DOE M 435.1-1 position that such
contaminated items may not be high-level waste. If they are not, they are subject to management
and disposal as another waste type, provided adequate protection is provided by their disposal as
another waste type (e.g., low-level waste or transuranic waste).

Spent Nuclear Fuel. Spent nuclear fuel is defined in the Nuclear Waste Policy Act of 1982, as
amended, as "fuel that has been withdrawn from a nuclear reactor following irradiation, the
constituent elements of which have not been separated by reprocessing." Because this definition
was developed with commercially-generated spent nuclear fuel in mind, it fails to differentiate
between defense-related spent nuclear fuel (drivers) and target elements (materials irradiated to
produce defense nuclear materials). For the purposes of managing high-level waste under DOE
M 435.1-1, spent nuclear fuel includes spent driver elements and/or irradiated target elements
that contain transuranium elements. Excluded from spent nuclear fuel are target elements, that
after irradiation, contain no transuranium elements (e.g., those for the production of tritium)
since such spent target elements contain neither fissile material nor long-life transuranic isotopes
that require permanent isolation. Historically, such spent targets (reprocessed and
unreprocessed) have been assayed, treated, and disposed of as low-level waste (Final
Environmental Impact Statement, DOE/EIS-0271, Construction and Operation of a Tritium
Extraction Facility at the Savannah River Site, DOE 1999). DOE M 435.1-1 supports the
continuation of this practice.

In April 1992, the Secretary of Energy approved a recommendation to phase out reprocessing of
spent nuclear fuel at DOE's Savannah River Site and Idaho National Engineering Laboratory for
the purpose of recovering highly enriched uranium for the weapons program (Secretary of
Energy Decision Memo, dated April 28, 1992). In a similar action in December 1994 the
Secretary of Energy approved a recommendation to prohibit the use of plutonium-239 and highly
enriched uranium separated and/or stabilized during facility phaseout, shutdown, and cleanout
activities for nuclear explosive purposes (Memorandum for the Secretary, approved December
20, 1994). From these actions it is evident that DOE no longer plans to reprocess spent nuclear
fuel for the purposes of recovering fissile materials and significant quantities of additional high-
level waste will not be generated in the future from these operations. However, it is recognized
there may be limited reprocessing at some of the high-level waste sites for spent nuclear fuel that
is considered "at risk materials." Similarly, for cost effective reasons as well as others, most
DOE high-level waste sites continually add radioactive liquid wastes (e.g., cooling, water,
decontamination solutions) that may, or may not be, high-level waste to their high-level waste
storage systems. This practice effectively increases the volume of high-level waste to be
managed, however, the net amount is usually minor due to the evaporation capabilities at the
sites. Such co-mingling of high-level waste with other waste types should be performed
considering the waste minimization objectives of DOE M 435.1-1, Section I.1.E.(20), Waste
Minimization and Pollution Prevention.

Disposition of Surplus Weapons-Usable Plutonium. The Department has the authority to
emplace surplus weapons-usable plutonium in immobilized high-level waste canisters and
dispose of this waste form in the geologic repository constructed under the Nuclear Waste Policy
Act of 1982, as amended, (NRC letter, C.J. Paperiello to L.H. Barrett, January 25, 1999). Thus
this composite waste form (plutonium can in a high-level waste canister) is considered high-level
waste and should be managed as such. Although the hazards analysis and requirements analysis
prepared to support the development of the high-level waste chapter of DOE M 435.1-1 did not
consider the inclusion of this waste form, its addition is not expected to change the requirements
contained in the chapter.

Non-Routine High-Level Waste. There is acknowledgment of a sub-category of high-level
waste, "non-routine high-level waste," that includes secondary radioactive solid wastes that meet
the source-based portion of the definition for high-level waste, but may not meet the current
immobilized high-level waste specification for a standard waste form, as defined by the
DOE/EM-0093, Waste Acceptance Product Specifications for Vitrified High-Level Waste Forms
(EM-WAPS). The current EM-WAPS document was written to allow acceptance of a standard
waste form, borosilicate glass canistered waste, but does recognize the production of
"nonconforming canistered high-level waste forms" from the high-level waste form producers.
Examples are expected to include immobilized waste that is suspected of being contaminated by
foreign materials and glass samples that were generated during production. Such waste forms
may be nonconforming and thus, may require review/acceptance by the DOE Office of Civilian
Radioactive Waste Management. If accepted, they will be a nonstandard waste form. Such
Office of Civilian Radioactive Waste Management acceptance is expected to include satisfying
the requirements in the EM-WAPS and approval of a treatment and disposition plan.

Example: At Site X, non-conforming high-level waste has been generated as a result of
high-level waste storage, pretreatment, and treatment activities. This waste includes:

glass chipped from high-level waste glass melters,
glass deposited on equipment
spilled high-level waste glass that was not captured in a canister,
glass samples/shards.

The Site is currently managing these wastes as nonconforming high-level wastes since
there are issues regarding contamination by foreign materials and the need to place these
wastes in canisters. However, each canister is expected to meet the EM-WAPS
specifications and be accepted by the Office of Civilian Radioactive Waste Management
as non-standard canistered waste forms. If any do not meet the EM-WAPS specifications,
they will be managed as non-conforming and the Office of Civilian Radioactive Waste
Management acceptance, as nonstandard waste form, will be necessary by way of an
Office of Civilian Radioactive Waste Management-approved action plan. The
requirement for an action plan is included in the EM-WAPS, specifications 4, Quality
Assurance.

The high-level waste scraps identified in the above example are considered non-routine high-
level waste forms. Currently both the Defense Waste Processing Facility at Savannah River and
West Valley Demonstration Project vitrification processes have produced small amounts of this
material and are storing it until a path forward can be determined.

Waste Incidental to Reprocessing. Those waste streams that meet the requirements of the waste
incidental to reprocessing processes, either by citation or by evaluation, are also excluded from
the scope of high-level waste. DOE M 435.1-1, Section II.B describes the process for making
such determinations and the accompanying guidance on this section provides further details on
this subject.

Interfaces Between the Office of Environmental Management and Office of Civilian Radioactive
Waste Management. The guidance for high-level waste disposal (DOE G 435.1-1, Section II.S)
provides information on the responsibilities and interfaces between the Offices of Environmental
Management and Civilian Radioactive Waste Management.

Supplemental References:

1. Nuclear Waste Policy Act of 1982, as amended, Public Law 97-425, Section 2.(12),
January 7, 1983.

2. Energy Reorganization Act of 1974, as amended, Public Law 93-438, Section 202 (3) and
(4).

3. AEC, 1969. "Siting of Commercial Fuel Reprocessing Plants and Related Waste
Management Facilities; Statement of Proposed Policy, 10 CFR Part 50, 'Licensing of
Production and Utilization Facilities'," Federal Register, Vol. 34, No. 8712, Atomic
Energy Commission, Washington, D.C., June 3, 1969.

4. AEC, 1970. "Siting of Commercial Fuel Reprocessing Plants and Related Waste
Management Facilities, 10 CFR Part 50, 'Licensing of Production and Utilization
Facilities'," Federal Register, Vol. 35, No. 17530-17533, Atomic Energy Commission,
Washington, D.C., November 14, 1970.

5. NRC, 1987. "Advanced Notice of Proposed Rulemaking; 10 CFR Part 60, 'Definition of
High-Level Radioactive Waste,'" Federal Register, Vol. 52, No. 5992, U.S. Nuclear
Regulatory Commission, Washington, DC, February 27, 1987.

6. NRC, 1988. "Proposed Rule; 10 CFR Part 61, Disposal of Radioactive Wastes, U.S.
Nuclear Regulatory Commission, Washington, D.C., Federal Register, Vol. 53, No.
17709, May 18, 1988.

7. Claytor, 1992. R.A. Claytor, Assistant Secretary for Defense Programs, to The Secretary
of Energy, memorandum, A Decision on Phaseout of Reprocessing at the Savannah River
Site (SRS) and the Idaho National Engineering Laboratory (INEL), U.S. Department of
Energy, April 28, 1992.

8. Reis and Grumbly, 1994. V.H. Reis & T.P. Grumbly, Assistant Secretary for Defense
Programs and Assistance Secretary for Environmental Management, memorandum,
Action: Commitment to Prohibit the Use of Plutonium-239 and Highly Enriched Uranium
Separated and/or Stabilized During Facility Phaseout, Shutdown, and Cleanout Activities
for Nuclear Explosive Purposes, U.S. Department of Energy, December 20, 1994.

9. Atomic Energy Act of 1954, as amended, Public Law 83-703, Title II, Section 11, (dd),
August 30, 1954.

10. NRC. Disposal of High-Level Radioactive Wastes in Geologic Repositories, 10 CFR Part
60, U.S. Nuclear Regulatory Commission, Washington, D.C.

11. Barrett, 1998. L.H. Barrett to C.J. Paperiello, letter, [no title], U.S. Department of
Energy, Washington, D.C., December 10, 1998.

12. Paperiello, 1999. C.J. Paperiello to L.H. Barrett, letter, U.S. Department of Energy Plans
for Disposal of Surplus Weapons Plutonium, U.S. Nuclear Regulatory Commission,
Washington, D.C., January 25, 1999.

13. EPA. Environmental Radiation Protection Standards for Management and Disposal of
Spent Nuclear Fuel, High-Level Waste and Transuranic Radioactive Wastes, 40 CFR
Part 191, U.S. Environmental Protection Agency, Washington, D.C.

14. DOE, 1996. Waste Acceptance Product Specifications for Vitrified High-Level Waste
Forms (EM-WAPS), Revision 2, DOE/EM-0093, U.S. Department of Energy,
Washington, D.C., December 16, 1996.

15. DOE, 1999. Construction and Operation of a Tritium Extraction Facility at the
Savannah River Site, Final Environmental Impact Statement, DOE/EIS-0271, U.S.
Department of Energy, Savannah River Operations Office, March 1999.

16. ERDA, 1977. Waste Management Operations, Savannah River Plant, Aiken, South
Carolina, Final Environmental Impact Statement, ERDA-1537, Energy Research and
Development Administration, Washington, D.C., September 1977. II. B. Waste Incidental to Reprocessing.

Waste resulting from reprocessing spent nuclear fuel that is determined to be
incidental to reprocessing is not high-level waste, and shall be managed under
DOE's regulatory authority in accordance with the requirements for transuranic
waste or low-level waste, as appropriate. When determining whether spent nuclear
fuel reprocessing plant wastes shall be managed as another waste type or as
high-level waste, either the citation or evaluation processes described below shall be
used:

(1) Citation. Waste incidental to reprocessing by citation includes spent nuclear
fuel reprocessing plant wastes that meet the description included in the
Notice of Proposed Rulemaking (34 FR 8712) for proposed Appendix D, 10
CFR Part 50, Paragraphs 6 and 7. These radioactive wastes are the result of
reprocessing plant operations, such as, but not limited to: contaminated job
wastes including laboratory items such as clothing, tools, and equipment.

(2) Evaluation. Determinations that any waste is incidental to reprocessing by
the evaluation process shall be developed under good record-keeping
practices, with an adequate quality assurance process, and shall be
documented to support the determinations. Such wastes may include, but
are not limited to, spent nuclear fuel reprocessing plant wastes that:

(a) Will be managed as low-level waste and meet the following criteria:

1. Have been processed, or will be processed, to remove key
radionuclides to the maximum extent that is technically and
economically practical; and

2. Will be managed to meet safety requirements comparable to
the performance objectives set out in 10 CFR Part 61, Subpart
C, Performance Objectives; and

3. Are to be managed, pursuant to DOE's authority under the
Atomic Energy Act of 1954, as amended, and in accordance
with the provisions of Chapter IV of this Manual, provided the
waste will be incorporated in a solid physical form at a
concentration that does not exceed the applicable
concentration limits for Class C low-level waste as set out in 10
CFR 61.55, Waste Classification; or will meet alternative
requirements for waste classification and characterization as
DOE may authorize.

(b) Will be managed as transuranic waste and meet the following criteria:

1. Have been processed, or will be processed, to remove key
radionuclides to the maximum extent that is technically and
economically practical; and

2. Will be incorporated in a solid physical form and meet
alternative requirements for waste classification and
characteristics, as DOE may authorize; and

3. Are managed pursuant to DOE's authority under the Atomic
Energy Act of 1954, as amended, in accordance with the
provisions of Chapter III of this Manual, as appropriate.

Objective:

The objective of this requirement is to ensure the implementation of a consistent and defensible
process to make waste incidental to reprocessing determinations across the DOE complex.
Implementation of the process will ensure DOE manages these waste streams within its
regulatory authority for disposal.

Discussion:

Certain waste streams produced during the generation of high-level waste may be determined to
be non-high-level waste through the waste incidental to reprocessing determination process. The
processes for making such determinations are included as requirements in DOE M 435.1-1,
Section II.B, and are described below. In conjunction with Section II.B is a requirement in
Section I.2.F.(18), Waste Incidental to Reprocessing, which delineates the responsibilities of the
Field Element Manager and the DOE Office of Environmental Management for making and
reviewing such waste incidental to reprocessing determinations. The information and analysis
necessary to support these determinations is included.

Background. In the Statement of Proposed Policy (34 FR 8712) for Appendix D, 10 CFR Part
50, "Policy Relating to the Siting of Fuel Reprocessing Plants and Related Waste Management
Facilities," the Atomic Energy Commission (AEC) noted that the term high-level waste, as used
in the proposed Appendix D, did not include all wastes originating from (spent nuclear fuel)
reprocessing plant operations (Paragraphs 6 and 7). Such wastes, later referred to as incidental
wastes by the Nuclear Regulatory Commission (NRC) (52 FR 5993), included waste streams
such as ion exchange beds, sludges, and contaminated laboratory items, clothing, tools, and
equipment. Additionally, this category included radioactive hulls and other irradiated and
contaminated fuel structural hardware. Although this language (Paragraphs 6 and 7) concerning
incidental waste was deleted from the final Policy under Appendix F, pending additional study
(35 FR 17530-17533), the principle of incidental wastes has been continually supported by both
the Department of Energy and the NRC , as well as their predecessors, even before the Proposed
Rulemaking.

In its Advance Notice of Proposed Rulemaking for the Definition of High-Level Radioactive
Waste at 10 CFR Part 60 (52 FR 5992-6001), the NRC introduced the term incidental wastes
and stated that high-level waste does not include such waste streams. Additionally, the
Commission stated (footnote 1, 52 FR 5993) that "incidental wastes generated in further
treatment of HLW (e.g., decontaminated salt with residual activities on the order of 1,500 nCi/g
Cs-137, 30 nCi/g Sr-90, 2 nCi/g Pu, as described in the Department of Energy's FEIS on long-
term management of defense HLW at the Savannah River Plant, DOE/EIS-0023, 1979) would
also, under the same reasoning, be outside the proposed Appendix D definition," if they met
certain chemical concentrations. Additionally, in the NRC's Proposed Rule for 10 CFR Part 61,
for shallow-land disposal of radioactive waste, the Commission stated that the preferable
construction of the statute "...is to conform to the traditional definition (for high-level waste).
Under this approach, materials that are HLW for purposes of the licensing-jurisdiction provisions
of the Energy Reorganization Act of 1974 will also be regarded as high-level waste under the
Nuclear Waste Policy Act of 1982, as amended. This would include the primary reprocessing
waste streams at DOE facilities, though not the incidental wastes produced in reprocessing" (53
FR 17709).

More recently, in response to a petition regarding disposal of waste at the Hanford site, the NRC
(States of Washington & Oregon: Denial of Petition for Rulemaking, 58 FR 12342-12347)
commented that:

"Assuming implementation of DOE's plans as described above, the Commission
concludes that any radioactive material from the double shell tanks that is deposited in
the grout facility would not be high-level radioactive waste subject to NRC's licensing
jurisdiction. The responsibility for safely managing those wastes rest with the
Department of Energy. The basis for the Commission's conclusion is that the
reprocessing wastes disposed of in the grout facility would be 'incidental' wastes because
of DOE's assurance that they:

(1) have been processed (or will be further processed) to remove key radionuclides to
the maximum extent that is technically and economically practical;

(2) will be incorporated in a solid physical form at a concentration that does not
exceed the applicable concentration limits for Class C LLW as set out in 10 CFR
Part 61; and

(3) are to be managed, pursuant to the Atomic Energy Act of 1954, as amended, so
that safety requirements comparable to the performance objectives set out in 10
CFR Part 61 are satisfied." (58 FR 12345)

A similar characterization was made for the West Valley Demonstration Project in the Technical
Evaluation Report prepared by the NRC Office of Nuclear Material Safety and Safeguards, dated
November 1988, which concluded there is reasonable assurance that the cement solidification of
the decontaminated supernatant (incidental waste) will meet the waste form stability
requirements of 10 CFR Part 61 (NRC Technical Evaluation, 11/88). This is an implicit
recognition by the NRC that the separated low-activity fraction of high-level waste need not be
managed and disposed as high-level waste.

The question of whether the NRC or DOE has the authority to make incidental waste
determinations (using the evaluation process) was raised by NRC Commissioner Curtiss in
December 1992 (SECY-92-391), as a precursor to the Commission's action on the 1993 Denial
of Petition for Rulemaking. In response, the NRC staff (memo for Commissioner Curtiss from J.
M. Taylor, 1/14/93) stated that DOE has the responsibility to make an initial determination, and
if DOE concludes that the action is not subject to NRC jurisdiction, then DOE can undertake the
activity without involving the NRC in any manner. However, if DOE concludes that NRC
jurisdiction is unclear (i.e., the waste may be high-level waste and therefore potentially subject to
NRC licensing), then DOE has two options: (1) consult with the NRC and then make a decision
based on the results of the consultation; or (2) proceed without communication with the NRC.
The staff response then cites the proposed letter from Bernero (USNRC) to DOE (transmitted
March 2, 1993) that the NRC would call upon DOE to provide relevant technical information
that would enable the NRC to make its own determination, should that be appropriate.
(Although this decision applied to the Hanford case only, DOE's interpretation, based on
discussions with NRC staff, is that it can be applied more broadly through DOE M 435.1-1.)
These two memoranda are interpreted to mean that the NRC expects the DOE to consult with
them for those waste streams that the DOE has some question of whether the waste stream is
high-level waste. In addition, as discussed in the guidance to Section I.2.F.(18), the NRC has
licensing authority over DOE facilities "authorized for the express purpose of subsequent long-
term storage of high-level radioactive waste generated by DOE and its predecessor agencies"
(Sullivan, 1998).

Determination Processes. Consistent with these concepts, Section II.B of DOE M 435.1-1 offers
two distinct processes by which DOE can determine whether reprocessing wastes can be
managed as low-level or transuranic waste under DOE's Atomic Energy Act authorities: (1) by
citation, and (2) by evaluation.

The citation process refers to those reprocessing waste items of the type that were discussed in
the Statement of Proposed Policy for Appendix D, 10 CFR Part 50, as not being high-level
waste. Although the exclusion of such items from the high-level waste definition was dropped
from the final rule (Appendix F), the concept of incidental waste has been supported by DOE and
the NRC. If a positive determination is made, the waste may require further characterization
and/or acceptable (process) knowledge to determine its final waste classification and disposition,
i.e., low-level or transuranic waste.

The evaluation process refers to those reprocessing wastes that have met, or will meet, the
evaluation criteria cited above or other consistent protective criteria approved by the Department.
Satisfying these criteria ensures the waste to be regulated and managed for disposal by the DOE
according to the requirement for low-level or transuranic wastes, as appropriate.

Finally, if the requirements of neither of these processes can be met, the reprocessing waste is to
be managed as high-level waste and its disposal must be in accordance with 10 CFR Part 60 and
40 CFR Part 191.

The distinction between the two processes is important because it is clear from background
events that citation process waste streams were so identified because of the ease of determining
up front that they do not pose the long-term hazards associated with high-level waste. Evaluation
process wastes, on the other hand, generally require a case-by-case evaluation and determination.
Consistent with this understanding, the responsibility for citation interpretations rests solely with
the DOE Field Element Manager, although consultation with the Office of Environmental
Management is encouraged. However, the Office of Environmental Management consultation is
required for waste that has been determined to be incidental through the evaluation process. In
addition, it is recommended that consultation with the NRC staff be considered for evaluation
process determinations, although this is not required. Roles and responsibilities are further
explained in the guidance to Section I.2.F.(18) of the General Requirements to DOE M 435.1-1.

Several meetings were held between staff personnel from the NRC and DOE to discuss the
acceptability of this dual determination approach. NRC staff agreed with this approach, but
recommended that sufficient guidance be developed for the implementation of both processes.
This guidance document is provided, in part, to meet the NRC staff recommendation. The NRC
staff also confirmed that it supports the position that DOE has authority to make incidental waste
determinations that involve waste streams that are incidental by use of the citation process. For
waste streams that are considered to be incidental by the evaluation process, and may be subject
to NRC licensing if contained in a facility authorized by Congress for the express purpose of
long-term storage, the staff suggested that communications with the NRC be maintained. This
suggestion is consistent with the staff position discussed above and the letter from R. Bernero,
USNRC, to J. Lytle, DOE-EM, dated March 2, 1993 and is provided in DOE M 435.1-1 by
recommending consultation with the NRC staff on evaluation determinations. Such
communication needs to: a) document the results of the analyses supporting DOE's conclusions;
b) be adequate for review; c) be developed with good record-keeping; and d) be conducted under
an adequate quality assurance process. Guidance for DOE M 435.1-1, Section I.2.F.(18),Waste
Incidental to Reprocessing, provides additional information on these elements and the roles and
responsibilities of the Field Element Manager, the DOE Headquarters , and the NRC.

The NRC staff also indicated that if they are requested to consult on such reviews that they
would prefer to review evaluation process waste stream candidates on a macro basis, in lieu of
reviewing individual waste streams or waste items. This is interpreted to mean that the NRC
staff would prefer to review an analysis for a group of high-level waste streams that have similar
characteristics or will require similar processing to meet the evaluation criteria, in lieu of
individual waste streams or waste items. Such grouping of waste streams is expected to make
the most efficient use of the NRC staff's resources and to avoid its involvement in each
evaluation process determination for each candidate waste stream or item within the DOE
complex. The Office of Environmental Management also prefers to see such grouping be
submitted for consultation and coordination. Further discussion on this subject is provided
below under the evaluation process.

DOE M 435.1-1 is not intended to create, or support the creation, of a new waste type titled
incidental waste. Waste incidental to reprocessing refers to a process for identifying waste
streams that would otherwise be considered high-level waste due to their sources of generation or
concentration, but can be managed in accordance with the DOE requirements for transuranic or
low-level waste, if the requirements for waste incidental to reprocessing are met.

Additionally, it is not the Department's intent to use the waste incidental to reprocessing process
to circumvent high-level waste disposal standards by not disposing of high-level waste in the
NRC-licensed geologic repository. The goal of the waste incidental to reprocessing
determination process is to safely manage and dispose of a limited number of reprocessing waste
streams that do not warrant geologic repository disposal because of their lack of long-term
threats to the environment and man. Moreover, meeting the evaluation process requirements are
difficult and resource intensive and therefore, the DOE high-level waste sites are encouraged to
manage high-level waste in a manner that will permit treatment and disposal in a geologic
repository. Therefore, non-standard high-level wastes, discussed in the guidance for Section
II.A, may be one of the primary waste streams targeted for application of the waste incidental to
reprocessing determination process.

To assist in making waste incidental to reprocessing determinations, Figure 1, "Decision Tree for
Waste Incidental to Reprocessing Determinations," has been included in this guidance. This
figure is a simple decision tree that provides some examples of reprocessing wastes and
reprocessing waste streams that are interpreted to be included within each determination process,
however, these examples are not considered all inclusive. It is expected that interpretations and
determinations by the DOE sites, in conjunction with DOE Headquarters, may revise this list.
Updates to this guidance will reflect such determinations and interpretations.

Application of the citation and evaluation processes is for two primary purposes: to support the
determination to manage specific waste streams as non-high-level waste, i.e., as low-level or
transuranic wastes; and to support closure activities of deactivated high-level waste
facilities/sites. Table 1, "Citation and Evaluation Process Results," is provided to illustrate the
six (positive) possible results that can result from applying the citation and evaluation process
requirements to a waste stream. A negative result to applying both the citation and evaluation
processes is possible with the result being that the waste stream is managed as high-level waste.
The check symbols under the columns Low-Level Waste, Transuranic Waste, and Facility/Site
Closure denote the Section II.B requirements that must be met in order for the waste stream to be
managed as indicated by the column heading.

Table 1. Citation and Evaluation Process Results (NA = not applicable)

Requirement(s)
Section
Low-Level
Waste
Transuranic
Waste
Facility/Site
Closure

II.B.(1)
Citation Process

II.B.(2)(a)(1), (2), & (3)
Evaluation Process

II.B.(2)(b)(1), (2), & (3)
Evaluation Process
NA

Following is a discussion on each of the determination processes, citation and evaluation.
Included, where appropriate, is additional guidance/discussion on the analysis and documentation
necessary for reprocessing waste streams to be managed as low-level waste or transuranic waste.
Additional information on deactivated high-level waste facility/closure process is provided by
the guidance to DOE M 435.1-1, Section II.U, Site Closure.

Citation Process. The citation process refers to those reprocessing waste items of the type that
were discussed in the Statement of Proposed Policy for Appendix D, 10 CFR Part 50, as not
being high-level waste (34 FR 8712). Figure 1 includes examples of wastes that have been
interpreted to be included within the citation process. Included are:

contaminated job wastes, a general category of wastes that are generated during
high-level waste transfer, pretreatment, treatment, storage and disposal activities.
Included is protective clothing, personal protective equipment (PPEs), work tools,
ventilation filter media, and other job-related materials necessary to complete
high-level waste management activities;
sample media (e.g., sampling vials, crucibles, other hardware);
decontamination media and decontamination solutions (e.g., swabs, other decon
work-related materials); and
laboratory clothing, tools, and equipment.

Interpreted to be excluded from the citation process are the following:

ion exchange beds;
sludges;
fuel cladding hulls and fuel structural hardware;
process filter media; and
contaminated components and equipment.

This list excludes three items: ion exchange beds, sludges, and fuel cladding hulls that were
included in the Appendix D proposed language. The first two of these have been excluded from
the citation process examples because of the potential long-term hazards their disposal may pose.
However, they may be candidates for the evaluation process. The third example that has been
excluded is fuel cladding hulls and fuel structure hardware. As explained in the guidance for
Section II.A, wastes from processes preceding the first step in a separations process are not
considered high-level waste and therefore are not subject to the waste incidental to reprocessing
process. Fuel structural hardware and fuel cladding hulls are generated prior to the first cycle
solvent extraction process, or equivalent, and are therefore not considered high-level waste. Also
excluded from the examples of citation waste is high-level waste contaminated components and
equipment. As discussed in the guidance to Section II.A, review of available supporting
documentation has concluded that although contaminated components and equipment are not
high-level waste, they can, and often do, retain significant amounts of residual waste even after
extensive decontamination efforts. Therefore, it is considered inappropriate for such components
and equipment to qualify under the citation process. However, they are considered candidates
for the evaluation determination process described below.

The following examples of process filter media and ventilation filter media are provided to
clarify the use of the term in the citation process examples above:

Examples: (1) At Site X, the high-level waste pretreatment process uses a filtration
process to filter precipitated Cs-137 from the tank solution. Disposal of the failed
(process) filter media from this process as transuranic, low-level, or mixed low-level,
using the citation process, is considered inappropriate. However, the filter is a candidate
for disposal as low-level or transuranic waste using the evaluation process. (2) The
high-level waste storage tanks at this site include a HEPA filtration system. Disposal of
the HEPA filters from this system as low-level or transuranic waste, using the citation
process, is considered appropriate. (3) The same site has an effluent treatment facility
(ETF) that treats overheads (evaporator distillate) from a high-level waste evaporator.
Since these overheads are not considered to be high-level waste (there is no carryover of
high-level waste to the waste stream) disposition of these failed filters does not need to be
subjected to the waste incidental to reprocessing processes. They are managed as low-
level or transuranic waste, as appropriate.

As indicated in Table 1, meeting the requirement in Section II.B.(1) can result in the waste being
managed as low-level waste or transuranic waste. The responsibility of interpreting the
Appendix D proposed language and using the citation process is within the DOE's authority. As
delineated in DOE M 435.1-1, Section I.2.F.(18), the authority to implement the citation process
and make these interpretations rests with the DOE Program Office responsible for the
management of the waste. In the case of high-level waste this responsibility has been assigned to
the Field Element Manager at the DOE Field Office or Operations Office. Consultation and
coordination with the DOE Office of Environmental Management for the citation process is
encouraged to support consistent interpretations across the DOE complex, but is not required.

Evaluation Process. As shown in Figure 1, waste streams resulting from the reprocessing of
high-level waste that are not interpreted to be included within the citation process may be assessed
for compliance with the evaluation process requirements. Examples of wastes streams that are
anticipated to be candidates for the application of the evaluation process include:

residual radioactive tank wastes whose removal is not considered to be technically
and economically practical;
contaminated storage, pretreatment, and treatment equipment (e.g., tank
mixer/pumps, waste slurry processing tanks);
thermocouple trees;
vitrification melter components;
failed vitrification melters;
process filter media; and
other process equipment that contains some amounts of waste in the form of
slurry, salt or glass.

The examples provided above are anticipated to meet the three evaluation process criteria;
however, note that the list provided above is not all inclusive. Other reprocessing waste streams
may be candidates for the evaluation process. However, any wastes that are determined to meet
these criteria must be supported by the necessary information and analysis as described in the
guidance for DOE M 435.1-1, Section I.2.F.(18). While the DOE Office of Environmental
Management consultation and coordination is required by the requirement in Section I.2.F.(18),
consultation with the NRC staff related to compliance with the evaluation requirements is also
strongly encouraged. The NRC staff has participated in regulatory compliance reviews using
these criteria in the past and has a level of expertise that is expected to complement the DOE
Office of Environmental Management's review.

DOE maintains that contaminated equipment, components, etc., whose disposal can be
demonstrated to not jeopardize the health and safety of the public, workers, and the environment
can be managed as non-high-level waste. These waste streams could be managed as low-level
waste, transuranic waste, or residual waste, which is part of a deactivated high-level waste
closure action and meets the performance objectives of a low-level or transuranic waste disposal
facility, provided the waste fits the requirements of the citation or evaluation process as
delineated in Table 1. Guidance for each of the processes follows.

II. B.(2) Evaluation. Determinations that any waste is incidental to
reprocessing by the evaluation process shall be developed under good
record-keeping practices, with an adequate quality assurance process,
and shall be documented to support the determinations. Such wastes
may include, but are not limited to, spent nuclear fuel reprocessing
plant wastes that:

(a) Will be managed as low-level waste and meet the following
criteria:

1. Have been processed, or will be processed, to remove
key radionuclides to the maximum extent that is
technically and economically practical; and

Although key radioncuclides are not defined by the NRC in either the Denial of Petition for
Rulemaking or the letter from R. Bernero to J. Lytle, dated March 2, 1993, it is generally
understood that key radionuclides applies to those radionuclides that are controlled by
concentration limits in 10 CFR 61.55. Specifically these are: long-lived radionuclides, C-14, Ni-
59, Nb-94, Tc-99, I-129, Pu-241, Cm-242, and alpha emitting transuranic nuclides with half-
lives greater than five years and; short-lived radionuclides, H-3, Co-60, Ni-63, Sr-90, and Cs-
137. In addition, key radionuclides are those that are important to satisfying the performance
objectives of 10 CFR Part 61, Subpart C. Analysis to date at DOE sites indicates other isotopes
important to satisfying these performance objectives include Se-79, Sn-126, and Np-237.

Processing to remove the key radionuclides to the extent technically practical could be a
chemical treatment process or a physical removal process. The examination of such processes
should include a range of alternatives; from processes that have been demonstrated by plant-scale
experience to be practical to those that have been demonstrated to be impractical due to their
technological immaturity, uncertainty, or risk. Selection of the chosen "technically practical
process" must be evaluated to a sufficient degree through a formal, documented assessment of
such factors as technical risk, incompatible physical or chemical requirements with the waste,
and potential impacts to the public, the worker and the environment.

The economically practical part of this requirement is determined by the development of total
life-cycle costs for an alternative, or unit costs, e.g., cost per curie removed. Some subjectivity
will be present in determining whether these costs are economically practical; however in
general, the goal should be to determine a relationship between costs and removal of the key
radionuclides and identify the point in this relationship at which removal costs increase
significantly and thus become impractical. An economic assessment may not be considered
necessary if a technology option is not first considered to be technically practical.

Example 1: To satisfy this criterion, Site X identified the available separation
technologies for each of the main radionuclides of interest in the waste stream (Cs-137,
Sr-90, transuranics, Tc-99, Se-79, Sn-126, C-14, I-129, H-3, and uranium), and
individually, as well as collectively, evaluated each to determine the status of the
technology and radionuclide removal efficiencies. A number of technologies were
identified and evaluated, including some for which tests on actual waste had been
conducted. The separation processes that were determined to be technically practical,
due to their technical maturity and full-scale demonstrated applications, were then
examined for economic practicability based on unit removal costs and process life-cycle
costs. An initial evaluation determined that two separation technologies were deemed to
be technically and economically practical and were selected for implementation for the
removal of the key radionuclides identified. A report documenting the assessment of each
of the technologies for technical practicality and economic practicality was issued by the
site program manager. Since this was the first use of the Evaluation Process for this
waste stream, or a similar waste stream, the site employed the consultation services of
the NRC. Following their evaluation, the assessment, confirming that the requirement at
II.B.(2)(a)1. had been met, along with the analysis that supports the position that the
waste meets the other Evaluation requirements at II.B.(2)(a)2. and II.B.(2)(a)3., was
forwarded to the DOE Headquarters for coordination and consultation, as required by
Section I.2.F.(18).

Example 2: The Site X facility and waste are the same as above except the economic
evaluation determined that none of the separation technologies were deemed to be
economically practical for removal of one of the radionuclides from a waste stream, due
to excessively high unit costs ($/Ci removed) and life-cycle costs, when compared to
direct disposal of the radionuclide as low-level waste. A report documenting this and the
assessment of each of the technologies for technical practicality and economic
practicality was issued by the site program manager. The waste stream that contained
the radionuclide in question was analyzed for acceptance at a low-level waste disposal
facility and it was concluded that the final waste form, incorporating the radionuclide,
would meet the requirements at both II.B.(2)(a)2. (safety requirements comparable to the
performance objectives in 10 CFR Part 61, Subpart C), and II.B.(2)(a)3. (solid physical
form at a concentration that does not exceed the applicable limits for Class C, 10 CFR
61.55). Therefore, the waste stream was deemed acceptable for disposal as low-level
waste.

II. B.(2)(a) Will be managed as low-level waste and meet the following criteria:

2. Will be managed to meet safety requirements comparable to
the performance objectives set out in 10 CFR Part 61, Subpart
C, Performance Objectives; and

Low-level waste requirements. When the waste stream is to be managed in accordance with low-
level waste requirements, an assessment needs to be prepared that provides reasonable
expectation that low-level waste performance objectives will be met. This assessment is
consistent with the requirements for a performance assessment, as defined in DOE M 435.1-1,
Section IV.P.(2). The Chapter IV performance objectives (Section IV.P.(1)) are considered
comparable to those at 10 CFR Part 61, Subpart C. In some cases the requirement to prepare a
performance assessment may be met in part, or totally, by the waste acceptance and waste
certification programs established by Chapter IV of DOE M 435.1-1. As discussed in the
guidance for Section IV.G, Waste Acceptance, performance assessment data are used to establish
waste acceptance criteria. Additionally, a primary element of a performance assessment is
analysis that demonstrates compliance with the performance objectives in DOE M 435.1-1,
Section IV.P.(1). Therefore, if a waste form is certified as meeting a low-level waste disposal
facility's waste acceptance criteria the waste form may meet the performance objectives in
Section IV.P.(1) as well, provided performance assessment imposed limits, e.g., quantity of
material, are also met. Documentation providing sufficient data to support this conclusion is
submitted for coordination with the DOE Office of Environmental Management, as required by
the requirement in Section I.2.F.(18).

Example: Site Y has a number of contaminated mixer/pumps that have been removed
from a high-level waste storage tank and are considered waste. Following
decontamination activities, characterization data show that the mixer/pumps can meet
the waste acceptance criteria for an on-site low-level waste disposal facility.
Documentation supporting this conclusion, and consistent with the requirements in
Section IV.J, Waste Certification, is prepared. Additionally, documentation is prepared
that concludes that meeting the disposal site's waste acceptance criteria meets the
disposal facility's performance objectives which have been shown previously to be
comparable to those in the NRC's 10 CFR Part 61, Subpart C, Performance Objectives.
Therefore Site Y concludes that the requirement at II.B.(2)(a)2. has been met and a stand-
alone performance assessment for this waste stream is not necessary. The set of
documentation supporting this conclusion is submitted to the DOE Office of
Environmental Management for consultation and coordination as required by the
requirement in Section I.2.F.(18).

Often the location and design of a low-level waste disposal facility are not finalized at the time
such an assessment is needed. In such cases, a preliminary or interim performance assessment
should be prepared, and submitted to the Office of Environmental Management for coordination.
Preparation and approval of a preliminary, or interim, as well as a final performance assessment
to support the meeting of this requirement, need to meet the requirements at DOE M 435.1-1,
Section I.2.E.(1), Disposal.

Example: To meet requirement II.B.(2)(a)2., Site X prepared an interim performance
assessment, in accordance with the requirements of DOE M 435.1-1, Section IV.P.(2), for
a waste stream that meets the other two applicable evaluation process requirements. The
performance assessment was considered interim because it was prepared before the
selection of a disposal facility site and design were finalized and before the final low-
level waste form was selected. The site forwarded a copy of the interim performance
assessment and a draft authorization letter to the DOE Office of Environmental
Management for coordination. The DOE Office of Environmental Management's review
concluded that although the interim performance assessment was limited in information
it did indicate that the performance objectives would be met. This finding was
conditional on the review of subsequent performance assessments and other stipulations
described in a site authorization letter. Although only an interim performance
assessment, the review and concurrence requirements at DOE M 435.1-1 Section
I.2.E.(1) for a performance assessment were applied.

In the case of facility/site closure with the residual waste characterized as low-level waste, the
requirement to conduct a performance assessment to meet the criterion in Section II.B.(2)(a)2.
should be coordinated with similar requirements in Section II.U, Site Closure, to avoid redundant
analysis.

II. B.(2)(a) Will be managed as low-level waste and meet the following criteria:

10 CFR 61.55 Concentration Limits. To meet this criterion, DOE needs to demonstrate that the
final waste form will not exceed the limits for Class C waste, as defined in 10 CFR 61.55. These
calculations should compare, by major radionuclide, the expected concentration after the
proposed treatment process with the limits as provided at 10 CFR 61.55. .

Example: To meet this criterion, Site X calculated an estimated total vitrified waste
volume in conjunction with the projected radionuclide activities. From these
calculations, the vitrified waste form is expected to meet the limits for 10 CFR 61.55
Class C, or less. This information was provided to the DOE Office of Environmental
Management for coordination.

Dilution of a waste stream to meet the concentration limits established in 10 CFR 61.55 is not
permitted by the Department. While it is recognized that in the course of stabilizing a waste
stream some changes in waste concentration may occur, actions to dilute a waste stream to meet
the above concentration limits are prohibited. The NRC's Branch Technical Position on
Concentration Averaging, dated January 17, 1995 (NRC, 1995), that supports the regulation at 10
CFR 61.55(a)(8), may be useful in making determinations. The Branch Technical Position states
that, "the concentration of a radionuclide (in waste) may be averaged over the volume of the
waste, or weight of the waste if the units (on the values tabulated in the concentration tables) are
expressed as nanocuries per gram." This Branch Technical Position provides specific guidance
to waste generators on the interpretation of the requirements in 10 CFR 61.55 as it applies to a
variety of different types and forms of low-level waste.

Consistent with the discussion above for the requirement in Section II.B.(2)(a)2., certification
that a waste form meets a low-level waste disposal facility's waste acceptance criteria may in
part, or totally, meet this requirement since, in general, waste that meets the definition of low-
level waste, as defined in Section IV.A, meets the concentration limits for Class C low-level
waste, as set forth in 10 CFR 61.55. However, there are exceptions as discussed in the guidance
for IV.A. For example, a waste form with a concentration of Cm-244 exceeding 100 nCi per
gram meets the definition of low-level waste, per Chapter IV of DOE M 435.1-1 (Cm-244 is an
alpha-emitting transuranic nuclide with a half-life of 18.1 years and is therefore not relevant to
whether the waste is transuranic waste) however, it does not meet the concentration limits in
Table 1 of 10 CFR 61.55 (Cm-244 has a half-life greater than 5 years and the concentration limit
is 100 nCi per gram). Thus careful attention needs to be paid to ensure that the concentration
limits set forth in 10 CFR 61.55 are not exceeded.

Alternative Requirements. If the limits contained at 10 CFR 61.55 for Class C low-level waste
cannot be met, the DOE Field Element may request that the DOE Office of Environmental
Management review and accept other provisions for the classification of the waste on a specific
basis. This provision is similar to the requirement at 10 CFR 61.58, Alternative Requirements
for Waste Classification and Characteristics. Analysis submitted to the DOE Office of
Environmental Management must provide reasonable expectation that after evaluation of the
specific characteristics of the waste, disposal site, and method of disposal, compliance with the
low-level waste performance objectives can be achieved.

Example: Following consultation with the NRC, Site X requested the DOE Office of
Environmental Management to review and accept an alternative to the Class C limits of
10 CFR 61.55 for the closure of a number of former high-level waste storage tanks. The
provided analysis noted that the NRC method for deriving the Class C concentration
limits in 10 CFR Part 61 is based on direct contact with the disposed waste by an
inadvertent intruder scenario and that the overall standard for determining Class C
concentrations limits is an annual dose equivalent to an inadvertent intruder of 500
mrem from all pathways. In the documentation provided to the DOE Office of
Environmental Management the case was made that the intruder scenarios for the Class
C determination are inappropriate because the residual waste in the tank will be
immobilized and located at least 10 meters below the ground surface, and the tank system
will be filled with a stable medium. A site-specific intruder analysis for a hypothetical
closed tank system was provided to the DOE Office of Environmental Management for
their review. The analysis concluded that the postulated site intruder would receive a
dose well below the limit of 500 mrem per year and demonstrated that the tank closures
will comply with the performance objectives of 10 CFR Part 61.

II.B.(2)(b) Will be managed as transuranic waste and meet the following criteria:

1. Have been processed, or will be processed, to remove key
radionuclides to the maximum extent that is technically and
economically practical; and

This is the same requirement as II.B.(2)(a)1., and the process for meeting this requirement is the
same. Therefore, the guidance for Section II.B.(2)(a)1. applies to this requirement.

II.B.(2)(b) Will be managed as transuranic waste and meet the following criteria:

2. Will be incorporated in a solid physical form and meet
alternative requirements for waste classification and
characteristics, as DOE may authorize; and

As discussed in the guidance above for Section II.B.(2)(a)3., Alternative Requirements, if the
limits contained at 10 CFR 61.55 for Class C low-level waste cannot be met, the DOE Field
Element may request that the DOE Office of Environmental Management review and accept
other provisions for classification of the waste, on a specific basis. This provision is similar to
the requirements at 10 CFR 61.58, Alternative Requirements for Waste Classification and
Characteristics, which states:

"The Commission may, upon request or on its own initiative, authorize other provisions
for the classification and characteristics of waste on a specific basis, if, after evaluation,
of the specific characteristics of the waste, disposal site, and method of disposal, it finds
reasonable assurance of compliance with the performance objectives [P.O.] in Subpart C
of this part."

In those cases where application of the alternative waste classification criteria results in the waste
being characterized as transuranic waste, and disposal will be in a facility other than WIPP (e.g.,
onsite as part of a deactivated high-level waste closure activity or at another DOE transuranic
waste disposal site), characterization/classification provisions may be proposed by a Field
Element. In such cases, DOE Headquarters shall be consulted and an analysis submitted for
review that provides reasonable assurance that after evaluation of the: (1) specific characteristics
of the waste, (2) disposal site characteristics, and (3) method of disposal, compliance with
applicable performance objectives can be achieved.

II.B.(2)(b) Will be managed as transuranic waste and meet the following criteria:

3. Are managed pursuant to DOE's authority under the Atomic
Energy Act of 1954, as amended, in accordance with the
provisions of Chapter III of this Manual, as appropriate.

In those cases where the waste stream will be managed as transuranic waste and disposal will be
in a facility other than the Waste Isolation Pilot Plant (WIPP) (e.g., onsite or at another DOE
transuranic waste disposal site), the Department is currently responsible for determining
compliance with 40 CFR Part 191 and ensuring the transuranic waste is disposed of safely. As
explained in the guidance to Section III.P., Disposal, sites other than WIPP are regulated by the
implementing agency, in this case, DOE. As discussed in the General Requirements Chapter of
this DOE M 435.1-1, Section I.2.F.(15), Disposal, the Field Element Manager is responsible for
reviewing and submitting a performance assessment to DOE Headquarters. The DOE
Headquarters Deputy Assistant Secretary for Waste Management will establish a process similar
to that used for low-level waste disposal facilities for reviewing and approving performance
assessments. Additional details on the criteria for reviewing and approving 40 CFR Part 191
performance assessments is included in the guidance to Section III.P. Since performance
assessment is defined, and the requirements for compliance and what must be included in a
performance assessment for a transuranic waste disposal facility are discussed in 40 CFR Part
191, this section of the guidance and the transuranic waste chapter only contain reference to the
40 CFR Part 191 standards, with no additional minimum requirements for disposal.

As discussed in the guidance to Chapter III of DOE M 435.1-1, the Department plans to dispose
defense transuranic waste at WIPP. Therefore, evaluations of treatment and disposal options for
those streams must be taken into account.

As discussed above, the high-level waste sites are encouraged to group similar waste streams,
that are to be subjected to the evaluation process, to support the process of coordinating with the
DOE Office of Environmental Management and site review and approval. Such grouping is
expected to expedite the decision process and make the most efficient use of limited resources in
the DOE Office of Environmental Management. Following are two examples of grouping:

Example 1: At Site Y, the high-level waste treatment (vitrification) activities are nearing
completion and plans for dispositioning the equipment contaminated with reprocessing
wastes within the pretreatment and treatment processes are being formulated. Analysis
indicates that decontamination activities can be held to a minimum if a number of
contaminated pretreatment and treatment components (mixer/pumps, slurry transfer
lines, slurry tanks, melter, process filter media) can be disposed as transuranic waste by
way of the evaluation process. In lieu of submitting individual analysis for each of
contaminated components, Site Y consults with the DOE Office of Environmental
Management and the NRC staff on the methodology they propose for meeting the three
appropriate evaluation requirements. Following such consultation, Site Y approves a
methodology for meeting each of the three evaluation criteria for a group of these
components.

Example 2: At Site Z, closure analysis activities are underway for a number of high-level
waste tanks. In reviewing the processes for removing the final amounts of high-level
waste from the tanks, it is concluded that the evaluation process requirements can be met
even if some small quantities of residual waste are allowed to remain in the tanks. In lieu
preparing an analysis for each tank, the site submits a methodology for meeting each of
the evaluation requirements for a group of the tanks. The methodology is submitted to
the DOE Office of Environmental Management for coordination and acceptance of this
methodology for the group of tanks is gained from the site program office. The closure
activities proceed for the group of tanks.

Facility Closure. Application of the evaluation process for deactivated high-level waste
facility/site closures is to ensure that any residual waste or residual contaminated components are
disposed appropriately. As indicated in Table 1, the requirements in Section II.B.(2)(a) 1., 2.,
and 3., or the requirements in Section II.B.(2)(b) 1., 2., and 3., must be met in order to manage
the waste as non-high-level waste and allow the residual waste or residual contaminated
components to be managed as low-level waste, or transuranic waste, as part of a deactivated
high-level waste closure action. Closure actions for deactivated high-level waste facilities are
distinguished from disposal of wastes incidental to reprocessing by the fact that closure actions
normally involve facilities that are not total dismantled and remain in their operational location.
However, because the residual material is part of a closure activity and will remain following
closure, the disposal requirements in Section IV.P. and III.P. for low-level and transuranic
wastes, respectively, are the appropriate requirements to satisfy Sections II.B.(2)(a)2. and
II.B.(2)(b)3. The requirements for closure of these facilities and sites (groups of facilities) are in
Section II.U, Site Closure.

The Field Element Manager is responsible for ensuring that the requirements of the evaluation
process are met. DOE M 435.1-1, Section I.2.F.(18), Waste Incidental to Reprocessing, defines
the responsibilities and roles of the Field Element Manager, the Office of Environmental
Management, and the consultation role that NRC staff may take in implementing the evaluation
process. Refer to the guidance for this section for additional information.

Mixed Waste. DOE M 435.1-1, Section II.C., Management of Specific Wastes, imposes the
requirement that all high-level waste is to be considered mixed waste, unless demonstrated
otherwise. This requirement applies to waste incidental to reprocessing determined wastes as
well. Waste that is determined to be incidental to reprocessing by the application of the waste
incidental to reprocessing determination processes should be considered mixed, unless
demonstrated otherwise.

Compliance with this requirement is demonstrated by documented citation and evaluation
processes that are implemented in a defensible manner and ensure that the Department is not
exceeding its regulatory authority for the management of high-level waste.

Supplemental References:

1. AEC, 1969. "Proposed Rule Making Statement of Proposed Policy; Siting of
Commercial Fuel Reprocessing Plants and Related Waste Management Facilities, 10
CFR Part 50, 'Licensing of Production and Utilization Facilities,'" Federal Register, Vol.
34, No. 8712, Atomic Energy Commission, Washington, D.C., June 3, 1969.

2. AEC, 1970. "Siting of Commercial Fuel Reprocessing Plants and Related Waste
Management Facilities, 10 CFR Part 50, 'Licensing of Production and Utilization
Facilities,'" Federal Register, Vol 35, No. 17532, Atomic Energy Commission,
Washington, D.C., November 14, 1970.

3. Energy Reorganization Act of 1974, Public Law 93-438, Section 202 (3) and (4).

4. DOE, 1979. Final Environmental Impact Statement: Long-Term Management of Defense
High-Level Radioactive Wastes, DOE/EIS-0023, Savannah River Plant, November, 1979.

6. Curtiss, 1992. NRC Commissioner J.R. Curtiss to J.M.Taylor, Executive Director for
Operations, memorandum, SECY-92-391: Denial of PRM-60-4-Petition for Rulemaking
Regarding Classification of Radioactive Waste at Hanford, U.S. Nuclear Regulatory
Commission, Washington, D.C., December 29, 1992.

7. Taylor, 1993. J.M. Taylor, Executive Director for Operations to Commissioner Curtiss,
memorandum, Staff Response to Concerns Raised by Commissioner James R. Curtiss on
Denial of PRM-60-4-Petition for Rulemaking Regarding Classification of Radioactive
Waste at Hanford, January 14, 1993.

8. NRC, 1993. "Denial of Petition for Rulemaking, 10 CFR Part 60, 'States of Washington
and Oregon: Denial of Petition for Rulemaking'," Federal Register, Vol. 58, No. 12342,
U.S. Nuclear Regulatory Commission, Washington, D.C., March 4, 1993.

9. Bernero, 1993. R. Bernero, USNRC, to J. Lytle, DOE-EM, letter, Hanford Waste Tank
Management, U.S. Nuclear Regulatory Commission, Washington, D.C., March 2, 1993.

10. Paperiello, 1997. C. Paperiello, USNRC, to J. Kinser, DOE-RL, letter, Classification of
Hanford Low-Activity Tank Waste Fraction, U.S. Nuclear Regulatory Commission,
Washington, D.C., June 9, 1997.

11. DOE, 1998. Life-Cycle Asset Management, DOE O 430.1A, U.S. Department of Energy,
October 14, 1998.

12. DOE, 1997. Deactivation Implementation Guide, Draft DOE G 430.1-3, U.S.
Department of Energy, October 1, 1997.

13. DOE, 1997. Decommissioning Implementation Guide, Draft DOE G 430.1-4, U.S.
Department of Energy, October 1, 1997.

14. NRC, 1988. Cement Solidification of Decontaminated Supernatant Waste for West
Valley Project, Technical Evaluation, Office of Nuclear Material Safety and Safeguards,
November 1988.

15. EPA. Environmental Radiation Protection Standards for Management and Disposal of
Spent Nuclear Fuel, High-Level Waste and Transuranic Radioactive Wastes, 40 CFR
Part 191, U.S. Environmental Protection Agency, Washington, D.C.

16. NRC, 1995. Issuance of Final Branch Technical Position on Concentration Averaging
and Encapsulation, Revision in Part to Waste Classification Technical Position, U.S.
Nuclear Regulatory Commission, Washington, D.C., January 17, 1995.

17. Sullivan, 1998. M.A. Sullivan, DOE, to J.T. Greeves, USNRC, letter, Natural Resources
Defense Council Petition to Exercise Licensing Authority over Savannah River Site High-
Level Waste Tanks, U.S. Department of Energy, Washington, D.C., September 30, 1998.

18. NRC, 1993. "Confederated Tribes and Bands of the Yakima Indian Nation: Denial of
Petition to Require License Application," Federal Register, Vol. 58, No. 64783, U.S.
Nuclear Regulatory Commission, Washington, D.C., December 9, 1993.

19. NRDC Inc. v. Administrator, Energy Research and Development Administration, 606 F.
2d 126, (D.C. Cir. 1979), affirming in part, remanding in part, reversing in part, vacating
in part, 451 F. Supp. 1245 (D.D.C. 1978), denying motion in part, granting motion in
part, 5 NRC 550 (1977) (Commission Decision).

20. NRC, 1994. "F. Robert Cook: Denial of Petition to Require License Application from
DOE with Respect to High-Level Waste," Federal Register, Vol. 59, No. 10439, U.S.
Nuclear Regulatory Commission, Washington, D.C., March 4, 1994. II. C. Management of Specific Wastes.

The following provide for management of specific wastes as high-level waste in
accordance with the requirements in this Chapter:

(1) Mixed High-Level Waste. Unless demonstrated otherwise, all high-level
waste shall be considered mixed waste and is subject to the requirements of
both the Atomic Energy Act of 1954, as amended, the Resource Conservation
and Recovery Act, as amended, DOE O 435.1, Radioactive Waste Management,
and this Manual.

(2) TSCA-Regulated Waste. High-level waste containing polychlorinated
biphenyls, asbestos, or other such regulated toxic components shall be
managed in accordance with requirements derived from the Toxic Substances
Control Act, as amended and DOE O 435.1, Radioactive Waste Management,
and this Manual.

Objective:

The objective of this requirement is to ensure that all high-level waste is managed as mixed
waste, unless demonstrated otherwise, and thus meets the requirements of both the Atomic
Energy Act of 1954, as amended and the Resource Conservation and Recovery Act (RCRA), and
that high-level waste that contains TSCA-regulated toxic components be managed in accordance
with the requirements of the Toxic Substances Control Act (TSCA). The RCRA and TSCA (if
applicable) statutes are to be met in addition to the requirements of DOE O 435.1 and DOE M
435.1-1.

Discussion:

DOE M 435.1-1 contains requirements for managing the radioactive character of high-level
waste. Guidance for implementing those requirements is included elsewhere in this document.
In developing DOE M 435.1-1 requirements, a safety and hazards analysis and an evaluation of
the requirements necessary to control the identified hazards were performed. It was concluded
that sufficient external regulations, promulgated pursuant to RCRA and TSCA, exist for
controlling the non-radiological hazard.

RCRA Regulations. The reprocessing of Department of Energy spent nuclear fuel produces
high-level waste that usually exhibits characteristics that render the high-level waste subject to
the requirements of the Resource Conservation and Recovery Act, as well as the Atomic Energy
Act of 1954, as amended.

Considering high-level waste to be a mixed waste is consistent with Department of Energy past
practice. The previous Radioactive Waste Management Order, DOE 5820.2A (see page I - 1),
specified that high-level waste was to be considered mixed waste unless demonstrated to the
contrary.

The DOE Office of Civilian Radioactive Waste Management (OCRWM) has clearly stated that
only spent nuclear fuel and high-level waste that is not regulated as hazardous waste under
RCRA Subtitle C is planned to be disposed in the monitored geologic repository licensed by the
Nuclear Regulatory Commission (NRC) under the Nuclear Waste Policy Act of 1982, as
amended. Prior to acceptance for disposal, generators and custodians must determine and
document that the waste is not regulated as a hazardous waste and is not prohibited from land
disposal. Therefore, DOE must develop appropriate data to ensure State and/or EPA regulators
that the applicable requirements have been addressed.

The processes that produce high-level waste from spent fuel usually involve the use of hazardous
chemicals, so it is reasonable to assume that high-level waste is a mixed waste unless it is
demonstrated to be otherwise. The reprocessing of spent nuclear fuel usually includes
dissolution in acid followed by solvent extraction which is then often neutralized by addition of
sodium hydroxide. The solvent is usually stripped from the component being extracted from the
spent fuel. The solvent is recycled rather than disposed of as high-level waste. Furthermore, the
fuel matrix and cladding are typically a source of hazardous metals. Thus, high-level waste
typically exhibits the characteristics of corrosivity (pH < 2 or pH >12.5 (after neutralization)) and
toxicity (because of the presence of one or more toxic metals).

Wastes exhibiting hazardous characteristics (see 40 CFR Part 261, Subpart C) must be treated for
these characteristics prior to disposal. High-level wastes generated from the reprocessing of
spent nuclear fuel exhibiting the characteristics of corrosivity (D002) and toxicity for metals
(D004 D011 corresponding to arsenic, barium, cadmium, chromium, lead, mercury, scandium,
and silver) may be treated through vitrification in accordance with the Land Disposal Restriction
(LDR) treatment standards specified in 40 CFR 268.40. The Environmental Protection Agency
has determined that vitrification (HLVIT) is the best demonstrated available technology (BDAT)
for treating high-level wastes that exhibit these characteristics. However, if additional
characteristic waste codes become applicable to the high-level waste, e.g., D018: benzene, the
treated high-level waste may need to meet the Universal Treatment Standards (40 CFR 268.48)
for any underlying hazardous constituents (UHCs). A treatability variance (40 CFR 268.44)
and/or determination of equivalent treatment (40 CFR 268.42(b)) may be necessary to fully
comply with the LDR standards if a DOE site elects to use a technology other than vitrification,
the BDAT, of if it is impractical to comply with all the standards applicable to individual waste
codes.

High-level waste treated by vitrification but containing listed hazardous wastes (either from the
reprocessing activities or from subsequent commingling of listed hazardous waste in high-level
waste storage tanks) will remain subject to RCRA, unless a delisting request is also approved by
the Environmental Protection Agency. The Office of Environmental Management "Waste
Acceptance Product Specifications for Vitrified High-Level Waste Forms" requires that the
producer of the high-level waste perform the appropriate tests and procedures to determine
whether the waste is a hazardous waste (see Specification 1.5). That specification also requires
that high-level waste producers petition the Environmental Protection Agency to delist the waste
if any RCRA listed components are found in immobilized high-level waste. Currently, high-
level waste at some sites has been determined to contain listed wastes and high-level waste at
other sites has been determined not to contain listed wastes.

Example: In the previous example, the resulting high-level wastes were mixed with
various listed hazardous wastes for which a petition for delisting has not been approved.
Even after the high-level waste is treated by vitrification, it may not be disposed in the
Office of Civilian Radioactive Waste Management-managed monitored, geologic
repository because the high-level waste continues to be considered a mixed waste until
the Environmental Protection Agency approves a petition for delisting of the hazardous
waste components.

The RCRA requirements described above may be imposed by the Environmental Protection
Agency or by states that have been granted these RCRA authorities by the Environmental
Protection Agency. The authorized states are permitted to promulgate hazardous waste
requirements that are more stringent than the federal requirements, as well as specifying the
treatment permitting approach. Any state-level hazardous waste requirements will need to be
reviewed on a state-by-state basis.

In summary, the operations performed in reprocessing spent nuclear fuel often produce high-
level waste that exhibits hazardous characteristics. DOE practice is to assume that high-level
waste is a mixed waste unless demonstrated otherwise. This approach provides a conservative
basis for developing effective plans for high-level waste management including the capabilities
for dealing with hazardous components and characteristics.

PCB, Asbestos, and Other TSCA Wastes. High-level wastes contaminated with PCBs do not
meet the definition of mixed waste, however, the situation is similar to RCRA in that there are
external regulations promulgated under the authority of the Toxic Substances Control Act that
need to be complied with in addition to the requirements of DOE O 435.1 and the Manual.
Waste managers responsible for managing PCB-containing products should consult the EPA
requirements at 40 CFR Part 761. The regulations impose requirements for the destruction,
storage awaiting destruction, and disposal of PCBs. Like mixed wastes, there are currently no
provisions to accommodate PCBs (exceeding 50 ppm) at a geologic repository. Review of the
EPA handbook, "Vitrification Technologies for Treatment of Hazardous and Radioactive
Waste," (EPA/625/R-92-002) finds that the combination of the vitrification process and off-gas
removal are capable of eliminating 99.99%, or better, of the organic constituents, including
TSCA-regulated organics, in a waste stream. Therefore, vitrification, the BDAT for high-level
waste exhibiting RCRA characteristics of corrosivity and toxicity for metals, is expected to meet
the treatment requirements for PCBs and other TSCA-regulated toxic components, for those
high-level waste streams that are determined to contain these components. At the time of the
preparation of this guidance, no DOE high-level waste site had declared the presence of
TSCA-regulated toxic components in their high-level streams. Planning for management of
high-level wastes that include a component which is regulated under TSCA should be addressed
in the Complex-Wide High-Level Waste Management Program and the appropriate Site-Wide
Waste Management Programs (DOE M 435.1, Sections I.2.B.(1) and I.2.F.(1)).

The DOE M 435.1-1 requirements imposed on the radioactive component of RCRA or TSCA
waste should not create a duplication of management activities that can be satisfied by
compliance with a RCRA or TSCA requirement. Also, documentation required by RCRA or
TSCA regulations which provides the same or similar information as required by DOE M
435.1-1 should be used to satisfy the DOE M 435.1-1 requirement.

Supplemental References:

1. DOE, 1996. Waste Acceptance Product Specifications for Vitrified High-Level Waste
Forms (EM-WAPS), Revision 2, DOE/EM-0093, U.S. Department of Energy,
Washington, D.C., December 16, 1996.

2. EPA. Characteristics of Hazardous Wastes, 40 CFR Part 261, Subpart C, U.S.
Environmental Protection Agency, Washington, D.C.

3. EPA. Lists of Hazardous Wastes, 40 CFR Part 261, Subpart D, U.S. Environmental
Protection Agency, Washington, D.C.

4. EPA. Applicability of Treatment Standards, 40 CFR 268.40, U.S. Environmental
Protection Agency, Washington, D.C.

5. EPA. Treatment Standards Expressed as Specified Technologies, 40 CFR 268.42, U.S.
Environmental Protection Agency, Washington, D.C.

6. EPA. Universal Treatment Standards, 40 CFR 268.48, U.S. Environmental Protection
Agency, Washington, D.C.

7. EPA. Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in
Commerce, and Use Prohibitions, 40 CFR Part 761, U.S. Environmental Protection
Agency, Washington, DC. II. D. Complex-Wide High-Level Waste Management Program.

A complex-wide program and plan shall be developed as described under
Responsibilities, 2.B and 2.D, in Chapter I of this Manual.

Objective:

The objective of this requirement is to ensure that development, documentation, and
implementation of a complex-wide high-level waste management program. The complex-wide
program and plan establishes the framework within which individual site programs operate.

Discussion:

The Department's management of high-level waste occurs at four sites that generate, store and
treat waste, as well as at a to-be-determined disposal site which is to serve as the nation's central
repository for high-level waste and spent nuclear fuel. A complex-wide program and plan are
seen as necessary to establish the overall mission for the Department's management of high-level
waste and to provide a framework within which the individual site programs operate. The
Radioactive Waste Management Manual, DOE M 435.1-1, General Requirements (Section I.2.B)
assigns the Assistant Secretary for Environmental Management's the responsibility for
developing and maintaining complex-wide, waste-type programs. The Manual General
Requirements (Section I.2.D) also assigns the Deputy Assistant Secretary for Waste Management
the responsibility for developing and implementing complex-wide, waste-type program plans.
The complex-wide high-level waste management program and plan should be developed
following the guidance provided for General Requirements, Sections I.2.B and I.2.D.

Compliance with this requirement is demonstrated by the presence of a Complex-Wide High-
Level Waste Management Program which includes the appropriate interfaces, technical
information data inputs, and other elements described in Chapter I of this Manual.

Supplemental References:

1. Toxic Substances Control Act, as amended, October 11, 1976.

2. EPA, 1992. Vitrification Technologies for Treatment of Hazardous and Radioactive
Waste, EPA Handbook, EPA/625/R-92/002, U.S. Environmental Protection Agency,
Washington, D.C., May 1992.
II. E. Site-Wide High-Level Waste Management Program.

In addition to the items in Chapter I of this Manual, documentation of the Site-Wide
Radioactive Waste Management Program shall include a description of the
High-Level Waste Systems Engineering Management Program to support
decision-making related to nuclear safety, including high-level waste requirements
analysis, functional analysis and allocation, identification of alternatives, and
alternative selection and system control.

Objective:

The objective of this requirement is to establish a structured and documented approach to
evaluating alternatives as the preferred method for reaching informed decisions on any issue
potentially affecting safety of high-level waste management safety systems, structures,
components and processes. Such decisions include selecting the solutions for storage and
treatment of high-level waste, through the design and fabrication of the hardware and the
development of software required (if any) to process the waste.

Discussion:

In addition to the Site-Wide Radioactive Waste Management Program requirements in DOE M
435.1-1, Section I.2.F.(1), this additional requirement applies specifically to the management of
high-level waste. The following guidance addresses that additional requirement only. Guidance
on the implementation of the General Requirements can be found in DOE G 435.1-1, Section
I.2.F.(1).

A systems engineering management program consists of requirements analysis, functional
analysis/allocation, synthesis (developing alternatives), and systems analysis (evaluation of
alternatives) and control. These elements of the process should be used progressively throughout
the life cycle of the program to achieve objectives and to re-define requirements, designs and
solutions for problems that may arise during program execution. A systems engineering
management program should invoke a graded approach consistent with the importance to safety
systems, structures, and components. Each of these elements is explained in detail in the interim
standard for Systems Engineering (EIA/IS 632). This Interim Standard is also referenced in the
Implementation Guide to DOE O 420.1. A brief overview of the systems engineering elements
extracted from the standard is presented below:

(1) Requirements Analysis: An analysis of the needs, objectives, and requirements in the
context of the mission, operations, environment, and the mandatory characteristics of the
system should be performed to determine the functional and performance requirements
for each primary system function.

An example of a functional requirement is to separate the high-level waste into a low
activity stream and a high activity stream to minimize the waste required for disposal in
the high-level waste repository. An example of a performance requirement is the percent
of the total radionuclide source term that must be concentrated in the high activity stream
(e.g. 98%) in order to qualify the low activity waste for non-repository disposal. In other
words, the functional requirements tell what must be done and the performance
requirements tell how well the function must be performed.

(1.1) Functional requirements identified in the requirements analysis should be used as
the top-level functions for the functional analysis. Identification of requirements
should include the degree of certainty in their estimate, their degree of criticality
to mission success and their relationship to other requirements.

(1.2) Requirements should be validated to establish traceability, both upwards and
downwards, so that each lower level requirement can be demonstrated to be
derived from a higher level requirement.

(2) Functional Analysis/Allocation: A functional hierarchy should be defined and integrated
down to the lowest level needed to support synthesis of solutions for people, products,
and processes and management of risks. More than one logical set of functional and
performance requirements could be developed to meet the high-level waste mission
objectives.

(2.1) Functional requirements should be analyzed to determine the subsidiary functions
required to accomplish the parent requirement.

For example, if the parent function is to separate the waste streams, subsidiary
functions may be wash the sludge and perform ion exchange.

When time is critical to the performance or sequencing of a function, a time-line analysis
should be performed. Functional requirements need to be logically sequenced with input,
output and interface requirements clearly defined and traceable.

(2.2) Functional allocation should be performed to establish a performance requirement
for each functional requirement. If all lower level functions are performed to
meet their performance requirement, the performance requirement of the highest
level function should also be satisfied.

Continuing the examples above, if sludge washing and ion exchange are the only
two subsidiary functions contained under the parent function "separate the waste
streams," then their performance requirements together must produce a high
activity waste stream that contains 98% of the waste.

(2.3) Verification of functional and performance requirements should be accomplished
by traceability.

(3) Synthesis (develop alternative ways to meet the mission/objectives): Solutions for each
logical set of functional and performance requirements should be defined and designed.
This synthesis should be performed interactively with functional analysis/allocation to
define a complete set of potential solutions.

In the examples above, one logical solution may be to allocate the 98% concentration to
only 2 subsidiary functions, while an alternative solution would include three (or more)
subsidiary functions in order to remove additional radionuclide species.

(3.1) The output of the synthesis should describe the complete system, including
interfaces within the system and to external systems.

(3.2) Care should be exercised to verify that the process and product design
requirements, and their implementation, satisfies the overall system requirement.

(4) Systems Analysis and Control: Systems analyses, trade-off studies and other analytical
tools should be utilized to select preferred alternatives. Decisions should be documented,
together with supporting material. Implementation of the selected alternative should be
coupled with control mechanisms, such as risk management, configuration management,
data management, and performance-based progress measurements, to assess status,
identify potential problems and to formulate alternative solutions for timely management
consideration.

The systems engineering management program documentation should include an approved
Systems Engineering Management Plan (SEMP), Systems Engineering Master Schedule (SEMS)
and a Systems Engineering Detailed Schedule (SEDS). The content of the SEMP, SEMS, and
the SEDS are explained in EIA/IS-632.

Outputs of the application of the systems engineering process ( inputs to decision making) should
be documented in an integrated decision data base that organizes the data used and generated.
The documentation should provide the audit trail of the systems engineering process outputs,
decisions and results, as well as traceability of the process. Traceability as used here is slightly
different from traceability used in the functional and performance analysis. Here the mission,
objectives, the environment under which the mission must be executed and mandatory overall
system performance is also included. Should any of these parameters change during the course
of the project, this traceability will assist the decision manager to understand how the changes
may impact on the decisions previously made.

Compliance with this requirement is demonstrated by a systems engineering management
program based on EIA/IS-632, Systems Engineering, coupled with the identification of
accountable individuals and their authorities. The implementation guide to DOE O 420.1
references EIA/IS-632 as an acceptable standard for systems engineering.

Supplemental References:

1. EIA, 1994. Electronic Institutes Association, Systems Engineering, EIA/IS-632,
Washington, D.C., December 1994. (Standards Proposal No. 3537-A has been issued
which proposes to upgrade and revise EIA/IS-632. When the proposed upgrade and
revision is approved, the standard will be published as ANSI/EIA-632, and EIA-IS-632
will be CANCELED.)

2. DOE, 1995. Facility Safety, DOE O 420.1, U.S. Department of Energy, Washington,
D.C., October 13, 1995.

3. DOE, 1995. Implementation Guide for Nonreactor Nuclear Safety Design Criteria and
Explosive Safety Criteria, (Implementation guide for DOE 420.1), DOE G 420.1-1, U.S.
Department of Energy, Washington, D.C., September 1995.II. F. Radioactive Waste Management Basis.

High-level waste facilities, operations and activities shall have a radioactive waste
management basis consisting of physical and administrative controls to ensure the
protection of workers, the public, and the environment. The following specific
waste management controls shall be part of the radioactive waste management
basis:

(1) Generators. The waste certification program.

(2) Pretreatment and Treatment Facilities. The waste acceptance requirements
and the waste certification program.

(3) Storage Facilities. The waste acceptance requirements and the waste
certification program.

Objective:

The objective of this requirement is to ensure that the hazards associated with high-level waste
management facilities, operations, and activities have been identified, their potential impacts
analyzed, and appropriate controls documented, implemented and maintained for the protection
of workers, the public, and the environment.

Discussion:

As described in the guidance on Section I.2.F.(2), DOE M 435.1-1 requires the radioactive waste
management basis to provide for development and documentation of measures to ensure the safe
and efficient management of radioactive waste. The measures include processes, procedures,
equipment specifications, instrument specifications, and other items that are intended to reduce
the likelihood of, or the consequences from, a problem that could arise from managing high-level
waste. Requiring an approved radioactive waste management basis for the initiation of new, or
continuation of existing, radioactive waste management activities should prevent the operation of
facilities for which safe design, configuration, and operation have not been demonstrated. The
required elements of the radioactive waste management basis vary with the type of waste
management operation or facility and the types of hazards associated with the operation or
facility. The radioactive waste management basis documentation listed above for each of the
three types of high-level waste management facilities, operations, and activities included in the
scope of DOE O 435.1 are not complete lists of those items which should be included in a
radioactive waste management basis. Several processes, procedures, and documents that are
required by other directives and requirements describe radioactive waste management measures
that should be considered part of the radioactive waste management basis.
The guidance at Section I.2.F.(2) discusses this aspect of the radioactive waste management basis
in detail.

Example: At Site X a facility was designed and built for dry storage of vitrified high-level
waste encapsulated in welded stainless steel canisters. Prior to transferring any
high-level waste to the facility, the Field Element Manager reviewed and approved the
documentation that was prepared and collected for the purpose of establishing the
Radioactive Waste Management Basis. The documentation included two items required
by DOE M 435.1-1 the waste acceptance requirements and the waste certification
program. These two items are designed to ensure that the high-level waste transferred to
the facility is appropriate and that the high-level waste transferred from the facility meets
the waste acceptance requirements for the receiving facility. Additional documentation
that established the Radioactive Waste Management Basis was prepared in response to
requirements other than DOE M 435.1-1 and consisted of the facility-specific procedures
implementing the Site X radiological control program, health and safety plan, training
program, quality assurance program, and record-keeping plan.

Also, as discussed in the Section I.2.F.(2) guidance, if a high-level waste management facility
operates under an approved Authorization Basis, it may not need any additional controls to
demonstrate that it has a radioactive waste management basis. In this case, the Authorization
Basis documentation should be reviewed and evaluated to determine whether it sufficiently
covers the requirements needed for a radioactive waste management basis. The Field Element
Manager has the responsibility to ensure the high-level waste management facilities under his or
her authority have a radioactive waste management basis.

Example: The Liquid Radioactive Waste Handling Facilities at Site A (which include the
Tank Farms, the In-Tank Precipitation Process, and the Replacement High-Level Waste
Evaporator) are used for management of highly radioactive and hazardous materials.
They are Category 2 nuclear facilities which renders them subject to a wide range of
DOE nuclear safety requirements. A review of the Authorization Basis documentation
revealed that the Authorization Basis includes the following documents and the
associated programs:

Safety Analysis Reports (SARs)
Technical Justification for Continued Operation/Basis for Interim
Operation/Design Basis Accident Analysis Report
Operational Safety Requirements/Technical Safety Requirements
Technical Standards
SAR Update Request Packages
Other Documents Identified by DOE-SR and WSRC as Authorization
Basis Documents (Safety Evaluations, Exemptions, Unreviewed Safety
Questions Evaluation)
DOE Safety Evaluation Reports
Listing of Documents that are to be Configuration Managed but are not
Authorization Basis Documents

Included within these documents are what the site considers to be the complete set of
operational requirements relied upon by the site to ensure that the public, workers, and
the environment are protected from the hazards associated with the management of the
radioactive waste handled in the facilities. For example, the establishment of limits of
fissionable material and chemical constituents that can be transferred to the waste tanks
by the generators is included in the SARs. These limits are essentially equivalent to the
limits that must be set for the waste acceptance requirements in this chapter (see Section
II. J). A radioactive waste management basis statement is prepared that concludes the
radioactive waste management basis is covered in the Authorization Basis documents.

For a facility that generates high-level waste, the radioactive waste management basis is to
include the program for certifying that waste meets the waste acceptance requirements of the
facility(ies) to which the waste will be sent. The waste certification program should be reviewed
against the applicable requirements of DOE M 435.1-1 and approved in accordance with the
manual before becoming part of the radioactive waste management basis. As discussed in
guidance on Section I.2.F.(2), several other processes and procedures are also part of the
complete radioactive waste management basis at a generating facility.

Example: A spent nuclear fuel reprocessing canyon generates high-level waste. The
radioactive waste management basis includes the waste certification procedures, the
safety and health plan, the training program, and the waste transfer procedure in
addition to the Authorization Basis. These elements are documented in a facility-specific
radioactive waste management basis statement covering the canyon, its operations, and
its activities.

Facilities that store or treat high-level waste must have approved waste acceptance requirements
(Section II. J of DOE M 435.1-1) prior to the issuance of a radioactive waste management basis.
The waste acceptance requirements will usually suffice as the documentation of the radiological,
physical, and chemical limitations on waste that can be safely received at the facility, provided
they are developed correctly considering the hazards of the waste to be managed, and are kept up
to date. A facility that stores or treats waste is expected to have a waste certification program.
Waste from these facilities will have to be certified as meeting the waste acceptance
requirements of the facility to which it will be transported, and the facilities have the potential for
generating radioactive waste (e.g., secondary processing streams from treatment, monitoring and
sampling, radioactive release cleanup). Consequently, storage and treatment facilities should
also have an approved waste certification program as part of their radioactive waste management
basis.

Example: A storage facility that stores vitrified mixed high-level waste has approved
waste acceptance requirements and a waste certification process to verify that the waste
meets the Office of Environmental Management Waste Acceptance Product Specifications
for Vitrified High-Level Waste Forms (EM-WAPS). The radioactive waste management
basis statement references the waste certification process and the waste acceptance
requirement documentation, which in turn invokes the EM-WAPS. The basis statement
also cites the RCRA permit issued for storage of mixed high-level waste.

Requirements that apply to disposal of high-level waste have been developed by the Nuclear
Regulatory Commission and will be applied to the disposal facilities, operations, and activities of
the DOE Office of Civilian Radioactive Waste Management. Other facilities for high-level
waste management must be covered by an approved radioactive waste management basis. At the
end of the useful life of non-disposal facilities, most or all of the high-level waste will be
removed in preparation for closure. (In this discussion the word "all" is enclosed in quotes to
suggest removal of radioactive material to the extent that the facility can be released for
unlimited use.) If all of the high-level waste is removed, then the facility need no longer be
considered a radioactive waste facility and an approved radioactive waste management basis is
no longer needed. In other cases residual high-level waste will be in the facility being closed,
and the facility will be subject to an approved radioactive waste management basis. However, if
the residual waste in the facility is determined to be incidental to reprocessing, then the waste is
managed as low-level waste or transuranic waste, as appropriate. Under those conditions, either
(1) the facility would be subject to an approved radioactive waste management basis appropriate
for the category of the remaining radioactive waste as long as the waste remains in the facility or
(2) the activities and operations leading to release of the facility for unlimited use would be
performed under a radioactive waste management basis appropriate for the radioactive waste.

As part of the radioactive waste management basis, site personnel should implement a system or
process for tracking the waste inventory at a storage, pretreatment or treatment facility. Tracking
the waste inventory is a means of ensuring that radionuclide limits established in accordance with
a safety analysis will not be exceeded. In addition, a system or process for accurately tracking
waste received at a facility can facilitate providing information to the complex-wide waste
management data system (see guidance for Section I.2.D.(2)).

Compliance with these requirements is demonstrated by a documented radioactive waste
management basis statement signed by the Field Element manager or a designee (see I.1.A,
Delegation of Authority) for each high-level waste management facility, operation, or activity.
Using a graded approach, it may be possible to include multiple activities under a single
radioactive waste management basis, but it should be possible to objectively identify which
activities are covered. Further, the radioactive waste management basis statement should include
or reference the measures that are established on a facility-specific basis to address the unique
waste management requirements and circumstances for each facility, operation, and/or activity.

Supplemental References:

1. DOE, 1996. Waste Acceptance Product Specifications for Vitrified High-Level Waste
Forms (EM-WAPS), Revision 2, DOE/EM-0093, U.S. Department of Energy,
Washington, D.C., December 16, 1996.

2. NRC. Disposal of High-Level Radioactive Wastes in Geologic Repositories, 10 CFR Part
60, U.S. Nuclear Regulatory Commission, Washington, D.C.
II. G. Quality Assurance Program.

The following requirements are in addition to those in Chapter I of this Manual.

(1) Product Quality. The requirements of DOE/RW-0333P, Quality Assurance
Requirements and Description, shall apply to those high-level waste items and
activities important to waste acceptance/product quality.

(2) Audits and Assessments. The evaluation and assessment requirements of
DOE/RW-0333P, Quality Assurance Requirements and Description, and
associated implementing procedures shall be met for high-level waste
acceptance and product quality activities, in addition to the assessment
requirements of other DOE directives and requirements identified in
Chapter I of this Manual.

Objective:

The objective of this requirement is to ensure that those items and activities important to waste
acceptance/product quality are identified and controlled by a quality assurance program that
implements the requirements of the Office of Civilian Radioactive Waste Management's Quality
Assurance Program, as defined in DOE/RW-0333P, including the audit and assessment
requirements.

Discussion:

In addition to the quality assurance requirements contained in Section I. 1.E.(12), Quality
Assurance Program, of DOE M 435.1-1, General Requirements, the final high-level waste form
must meet the quality assurance requirements published by the Office of Civilian Radioactive
Waste Management . These quality assurance requirements are imposed on the waste form
Producers by Specification 4., "Quality Assurance Specification," of the Waste Acceptance
Produce Specifications for Vitrified High-Level Waste Forms, DOE/EM-0093 (EM-WAPS).
The OCRWM requirements are contained in the "Quality Assurance Requirements and
Description for the Civilian Radioactive Waste Management Program (QARD)," (DOE/RW-
0333P) which is the principal quality assurance document for the OCRWM Program.

The QARD establishes the minimum elements of the quality assurance program and identifies
the program commitments necessary for the development and implement