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> SECY-01-0127
REFER TO: M010907
September 7, 2001
IN RESPONSE, PLEASE
MEMORANDUM FOR: |
William D. Travers
Executive Director for Operations |
FROM: |
Annette L. Vietti-Cook, Secretary /RA/ |
SUBJECT: |
STAFF REQUIREMENTS - AFFIRMATION SESSION, 11: 00
A.M., FRIDAY, SEPTEMBER 7, 2001, COMMISSIONERS' CONFERENCE ROOM, ONE
WHITE FLINT NORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE) |
I.SECY-01-0127 - Draft Final Rule: 10 CFR Part 63, "Disposal
of High-level Radioactive Wastes in a Proposed Geologic Repository at
Yucca Mountain Nevada
The Commission(1) approved a final rule
which establishes licensing criteria for a proposed repository at Yucca
Mountain, Nevada. These criteria have been adapted consistent with final
environmental standards for Yucca Mountain as published by the U.S. Environmental
Protection Agency (EPA). The staff should address the comments and incorporate
the changes noted in the attachment and forward the final rule to the
Office of Management and Budget (OMB). After OMB clearance is obtained,
the final rule should be reviewed by the Rules Review and Directives Branch
in the Office of Administration and forwarded to the Office of the Secretary
for signature and publication in the Federal Register.
(EDO)(SECY Suspense: Submission to OMB - 9/28/01)
In applying TEDE and considering potential doses to members of the public
from the repository, the staff should provide for the use of organ specific
weighting factors (e.g., such as contained in Part 20 or Federal Guidance
Report 12) for calculating effective dose equivalent, as opposed to using
a single weighting factor of 1 with the deep-dose equivalent, when considering
external exposures (as allowed under 10 CFR § 20.1003). In the consideration
of actual external exposures to workers, the deep-dose equivalent should
continue to be used unless DOE should seek authority to apply effective
dose equivalent.
The differences in approach revealed by this issue and the recent confusion
surrounding the assessment of external dose by some licensees (SECY-01-0140)
demonstrate the need for staff to develop guidance that specifies when
it is appropriate to use effective dose equivalent rather than deep-dose
equivalent for assessing the dose from external sources of radioactivity.
(EDO)(SECY Suspense: 9/30/02)
In § 63.322, the staff uses the term "unlikely natural processes and
events," but provides no probability cutoffs for defining these events.
Following issuance of the final Part 63, staff should initiate an expedited
rulemaking to establish the annual probability of occurrence that is seen
to constitute an unlikely event or process. During the separate rulemaking
to define the term "unlikely", the staff should evaluate the pros and
cons of both a range of values as well as a specific value to define "unlikely".
(EDO)(SECY Suspense: 60 days after Part 63 is submitted to
OMB)
After promulgation of the Part 63 final rule, The staff should promptly
publish a Federal Register notice to close out action on the petition
for rulemaking originally submitted in 1985 by the States of Nevada and
Minnesota and inform the affected States of this action.
(EDO)(SECY Suspense: 120 days after Part 63 is submitted to
OMB)
Attachment: Comments and Changes to the Final Rule in SECY-01-0127
cc: Chairman Meserve
Commissioner Dicus
Commissioner McGaffigan
Commissioner Merrifield
EDO
OGC
CFO
OCAA
OCA
OIG
OPA
Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
PDR
Attachment
Comments and Changes to the Final Rule in SECY-01-0127
General Comments
- The final rule and Statement of Considerations (SOC) should be revised
to use "total effective dose equivalent" (TEDE) instead of "annual committed
effective dose equivalent" (annual CEDE) for radiological doses to individuals.
The SOC should be modified to explain that TEDE is essentially equivalent
to annual CEDE in its application to Yucca Mountain and the basis for
the Commission's decision to use TEDE. The term "dose limit" should
be continually referenced throughout the rule language and SOC, as appropriate,
in-lieu of referencing a specific dose methodology (i.e. TEDE). Although
much of the original language already addresses this issue, it should
be referenced consistently and continually throughout the document.
The staff should revise (including removal), as needed, dosimetry terminology
to be consistent with 10 CFR Part 20.
- The EPA standard defines the Reasonably Maximally Exposed Individual
(RMEI) as a rural-resident exposed through the same general pathways
as a subsistence farmer. 66 Fed. Reg. 32,092 (June 13, 2001). In describing
the RMEI in the SOC for Part 63, staff indicates that the RMEI is a
member of a farming community (SECY-01-0127, Attachment 2, at 84). Because
the terminology is different, some might perceive a conflict between
the EPA standards and Part 63. The staff should ensure that the appearance
of a conflict is avoided in preparing the final Federal Register
notice.
- The staff uses the term "soluble radionuclides" in the context of
the human intrusion scenario. See § 63.322. Without further clarification,
the term might invite debate as to what radionuclides should be considered
as soluble. The staff should provide clarification as to the intended
meaning of this term.
- EPA's standard has three separate components -- the individual protection
standard, the ground-water standard, and the human intrusion standard.
The EPA did not address or include the human intrusion standard as being
a severable component in its proposed or final standards. Therefore,
the Commission supports the staff's interpretation and the draft final
Part 63, which indicates that only the individual protection and ground-water
protection standards are severable. See § 63.343.
- The definition of high-level radioactive waste in § 63.202 is not
appropriate for inclusion in the NRC rule because it would suggest incorrectly
that the NRC intends to leave to another rulemaking the determination
of whether irradiated reactor fuel should be deemed HLW.(2)
The staff should adopt subpart (A) of the definition from the Nuclear
Waste Policy Act of 1982 (42 U.S.C. § 10101(12)), as amended, as item
(1) of the regulatory definition; add "irradiated reactor fuel" as item
(2) of the definition; and to retain subpart (B) of the statutory definition
as item (3) of the regulatory definition. The staff should decide the
appropriate place (i.e., either § 63.2 or § 63.202) for the
revised definition to appear.
- The term "ground water" is defined in one part of the regulations
to include the vadose zone (§ 63.2) and in another part to exclude that
zone (§ 63.302). This will create needless confusion in the implementation
of the rule. The staff should develop one definition that applies in
all cases, but maintains consistency with the EPA standard.
- Section 63.16(d) as currently written can be interpreted to mean that
the public will be given the opportunity to comment on NRC comments
prior to sending the comments to DOE. The intent is that all comments
which are sent to DOE will be placed in a public forum to allow the
public to comment on them after the NRC comments are sent to DOE. The
rule language should be modified to eliminate any ambiguity of when
the staff intends to allow public comment.
- The staff should consider revising, as appropriate, multiple definitions
of the same term (e.g., barriers, performance assessment) into a single
definition. The staff should develop single definitions that apply in
all cases, but maintain consistency with the EPA standard.
Specific Changes to the Final Rule
- On page 5, paragraph 1, line 3, delete 'somewhat'. Revise line 5 to
read ' ... in its final standards for the purpose
of protecting groundwater.'
- On page 11, revise line 1 from the top to read ' ... EPA standards
do not specify
specific a frequency
....' Revise line 4 from the top to read ' ... protection.
Although while we have provided ....'
- On page 14, paragraph 1, revise line 2 to read ' ... enclosed in about
[The staff should insert the correct number]
100 individual letters ....'
- On page 18, paragraph 1, line 5, delete 'time-'.
- On page 19, last paragraph, revise lines 2 and 3 to read ' ... Part
63 regulations do not in any way lessen DOE's
responsibility
, in any way, to safely
site, design, and operate the proposed repository
safely.'
- On page 21, paragraph 1, delete the 2nd sentence (In setting
these ... the region.)
- On page 39, revise line 8 from the top to read ' ... has revised the
rule at § 63.11 1(b)(1) and (2) ....'
- On page 47, paragraph 1, revise line 3 to read ' ... permanent closure.
Although
while the primary focus
....'
- On page 50, last paragraph, revise line 7 to read ' ... confirmation
activities. Although
while the
NRC recognizes ....'
- On page 52, paragraph 1, revise line 3 to read ' ... the rule
on
in this issue matter.'
- On page 54, paragraph 2, revise the last line to read ' ... are appropriate
and has
will retain
ed them in the ....'
- On page 56, last paragraph, revise line 2 to read ' ... single performance
measure for individual protection, the NRC ....'
Revise the last line to read ' ... is appropriate and
it is retained in the ....'
- On page 57, 1st full paragraph, revise line 8 to read '
... contained requirements to ensure that:
(1) uncertainties ....'
- On page 60, last paragraph, revise the next to last line to read '
... complicate the specification. The approach defined
in Part 63, which ....'
- On page 61, revise line 1 from the top to read ' ... uncertainty,
is
considered an appropriate approach.'
- On page 63, 1st full paragraph, revise line 8 to read '
... flexibility in deciding
on how best to ....'
- On page 64, paragraph 2, revise lines 4 and 5 to read ' ... the Statement
s
of Consideration s for Part 60 ....'
- On page 66, 1st full paragraph, revise line 3 to read '
... Commission has
will incorporate
d, a n individual dose limit ....' Revise
lines 5 and 6 to read ' ... long held that a n individual
dose limit of 0.25 mSv/year (25mrem/year) TEDE
is (1) a ....'
- On page 67, last paragraph, after the period in line 8, insert the
following footnote: "Although an individual might be exposed
to more than one source of radiation, it would be a very rare circumstance
for that individual to retain the lifestyle and other characteristics
of the RMEI for more than one source." Revise the last line to read
' ... result in exposures above the 100 mrem/year
public dose ....'
- On page 69, 1st full paragraph, revise the next to last
line to read ' ... the total release limit yields
less information
is less insightful in its application
....'
- On page 70, paragraph 2, revise line 1 to read '
Although
while a distribution of ....'
- On page 71, paragraph 1, revise line 1 to read '
Although
while the Commission ....'
- On page 71, last paragraph, revise line 11 to read ' ... the RMEI
assures that the vast majority
all other
members of the population ....'
- On page 72, paragraph 3, revise line 1 to read ' ... believes that,
although
while it is appropriate
....' Revise line 3 to read ' ... to achievement of
the long-term performance objective is not appropriate.'
- On page 72, paragraph 4, revise line 4 to read ' ... individual will
receive a dose in excess of the
greater
than his or her respective annual dose ....'
- On page 73, 1st full paragraph, revise line 6 to read 'Therefore,
although
while the Commission
....'
- On page 73, last paragraph, revise the last line to read ' ... Commission
has
will incorporate
d, a dose limit ....'
- On page 74, revise line 1 from the top to read ' ...
believes
that this limit is fully protective, and has , in fact,
long held that its proposed the slightly
higher dose ....' Revise lines 6 through 9 from the top to
read ' ... in the final rule because it is required
in order to be consistent with EPA's final standards,
and but not because the Commission
is persuaded that its earlier proposal is unsafe ,
inadequate, or not appropriate in any way. The Commission is confident
that the even greater margin of safety afforded by the
0.15 mSv/yr (15 mrem/yr) limit is also amply
....'
- On page 74, delete the 1st full paragraph (The Commission
believes that ... fully protected.)
- On page 75, 1st full paragraph, revise line 6 to read '
... TEDE to be
as the appropriate
dose ....'
- On page 75, 2nd full paragraph, revise line 4 to read '
... 10 CFR 72.104, 10 CFR 61.41
10 CFR
61.40, and ....'
- On page 77, revise line 1 from the top to read 'However,
to conform to
consistent with the EPA standards,
the Commission ....'
- On page 77, 1st full paragraph, revise the last 3 lines
to read ' ... part of the background radiation
and notes that
EPA specifically accounted for these sources potentially exposing the
RMEI in selecting the relevant dose limits for inclusion in its standards
for Yucca Mountain.'
- On page 79, last paragraph, revise lines 1 through 3 to read ' ...
agencies (including EPA) follow ICRP's current guidelines
that the overall annual dose to members of the public
agree
that the overall annual public dose limit from all sources
should not exceed 1 mSv (100 mrem),
in order to be which is protective of all individuals
and the environment. These guidelines also hold that
exposures from a single practice should be limited to a fraction of
this overall dose. The purpose of the ....'
- On page 80, delete the sentence in lines 3 through 6 from the top
(Consequently, the limit of ... was derived.)
- On page 80, paragraph 1, a reference should be provided for the statement
in the 1st sentence. Revise line 6 to read ' ... the ground
water. Although
while the contaminated
ground ....' Revise line 8 to read ' ... contaminants will
be have been diluted to much ....'
- On page 80, delete the last paragraph (The International Community
... are necessary.)
- On page 82, paragraph 1, revise line 10 to read ' ... There
also are
also a number of ....'
- On page 83, paragraph 2, revise line 4 to read ' ... Commission
also is
also aware ....'
- On page 86, revise line 8 from the top to read ' ... physical ones,
also have
also contributed ....'
- On page 88, last paragraph, revise line 1 to read '
Although
While the Commission ....'
- On page 89, revise line 6 from the top to read ' ...
Although
While there are slight ....'
- On page 91, paragraph 2, revise line 1 to read '
Although
While the Commission ....' Revise line
4 to read ' Although While there
are ....'
- On page 92, revise line 2 from the top to read ' ... of the RMEI
to be
is protective of ....'
- On page 92, 1st full paragraph, revise line 7 to read '
... present day conditions to be
as
the most ....'
- On page 95, paragraph 1, revise line 1 to read '
Although
While it is beyond ....' Delete the sentence
in lines 9 through 12 (The Commission encourages ... (www.nrc.gov/NMSS/DWM/usfic.html).)
Revise line 14 to read ' ... NAS committee also
was also ....'
- On page 96, revise line 2 from the top to read ' ...
Although
While NRC analyses ....' Revise line 8
from the top to read ' ... these processes in its
their performance ....'
- On page 98, revise line 7 from the top to read ' ... requirements
for the purpose of protecting groundwater.'
- On page 99, item number 2, revise lines 3 and 4 to read ' ... Part
60, or any other
s criteria,
could can provide truly ....'
- On page 100, paragraph 1, revise line 1 to read ' ... safety and to
ensure
assure compliance ....'
- On page 101, 1st full paragraph, revise the next to last
line to read ' ... and provides the
associated technical
....'
- On page 101, 2nd full paragraph, revise line 1 to read
' ... would have required and the final rule requires
DOE ....'
- On page 102, revise line 9 from the top to read ' ... assessment should
ensure
assure an evaluation
....'
- On page 102, revise line 3 from the bottom to read ' ... the barriers
should be
a presented ....'
- On page 104, 1st full paragraph, revise lines 7 and 8 to
read ' ... contaminants exists whether or not the
waste package is breached. Thus a geologic barrier can provide
is
present, and provides defense in depth irrespective
of releases , even when releases from the waste
package are not occurring.' Revise line 14 to read
' ... repository system that can increases confidence
....'
- On page 123, 1st full paragraph, revise line 4 to read
' ... from Appendix B have been
will
be incorporated ....'
- On page 125, paragraph 1, next to the last line, delete the comma
after '2001'.
- On page 134, last paragraph, revise line 3 to read ' ... requirements
have been
will be clarified
to ....'
- On page 136, revise to next to last line to read ' ... abreast of
DOE activities and interacting with other stakeholders
at the Yucca Mountain site.'
- On page 137, revise line 1 from the top to read ' ... interact
on various
with the principal DOE staff engaged in
site characterization ....'
- On page 137, last paragraph, revise line 3 to read ' ...
Although
While these activities primarily ....'
- On page 138, revise line 1 from the top to read ' ... because this
provision is consistent with
mimics
section ....'
- On page 139, last paragraph, revise line 1 to read ' ... All
of
the above is in ....'
- On page 141, paragraph 1, revise line 9 to read ' ... these levels
represent s, comparisons ....'
- On page 142, revise lines 2 and 3 from the top to read ' ...
the
from characteristics of ... group or RMEI. The Commission
is quite certain that t The NAS did
not ....' Revise line 5 from the top to read ' ... explain more clearly
the risks associated with the potential repository
at Yucca Mountain complex technical and regulatory issues.'
- On page 142, last paragraph, revise line 5 to read ' ...
it
we can improve its and
need to do betterin our public outreach ....'
- On page 143, 1st full paragraph, revise line 3 to read
' ... Yucca Mountain site .
itself. Lastly,
DOE maintains an ....' Revise line 9 to read ' ... program. For
those that are interested, t The State
of ....'
- On page 143, last paragraph, revise line 3 to read ' ... related to
the HLW program also are
also
distributed to DOE , the State, Affected Units of
Local Government, and other stakeholders.' Revise lines 3-5 to read
' Since Effective November 1,
1999, NRC has made is making
HLW program documents generated and received available on its Electronic
Public Reading Room located at http: //www.gov/reading-rm/adams.html
nrc/adams /index.html. Revise line 6 to read ' ...
currently be found at the two designated ....'
Revise line 7 to read ' ... reading rooms (in Nevada)
:
James R. Dickinson Library
Government Publications Department
University of Nevada at Las Vegas
4505 Maryland Parkway
Las Vegas, NV 89154 (702) 895-1572 and
Business and Government Information Center
University of Nevada Library
University of Nevada, Reno
Reno, NV 89557-0044 (702) 784-6500 ext. 257
- On page 144, delete the Response to Issue 8 (The NRC is developing
a regulatory ... its inspection, licensing, ....)
- On page 145, delete everything from the top of the page through the
1st paragraph (... and other activities on those areas ...
totally different proposal.)
- On page 145, paragraph 2, revise line 8 to read ' ... are in place
to ensure
assure an appropriate
....'
- On page 150, last full paragraph, revise line 1 to read ' ... potential
risk of radiological sabotage to the repository
to radiological sabotage during the ....'
- On page 153, paragraph 1, revise lines 2 and 3 to read ' ... consultants
have been engaged over the years in scientific
investigations and research
over the years necessary
to ....'
- On page 153, add the following to the last line: 'In addition,
this final rule amends 10 CFR 60.1 to clearly state that Part 63, not
Part 60, applies to licensing a disposal facility at Yucca Mountain,
Nevada.'
- On page 155, last paragraph, revise lines 8 through 10 to read ' ...
with the rule. At the appropriate time, t
The
YMRP is currently under development by the staff and
will be shared with interested stakeholders , as it is developed,
and will be published for public comment. After
the public comment period, the Commission
Based on the public comments received, the staff will determine
if additional revisions to the YMRP or regulations
....'
- On page 158, paragraph 1, revise line 5 to read ' ... they
already have
already been determined ....'
- On page 159, 1st full paragraph, revise line 9 to read
' ... rule to provide changes to
of
that ....' Revise line 11 to read ' ... September 14, 2001
(extension of comment period, 66 FR 27045; May 16, 2001).'
- On page 161, revise line 6 for the top to read ' ... 49 CFR
§§ 397.101, 397.103, and ....'
- On page 168, paragraph 1, delete the 1st sentence (The
NRC is not required ... comment period.)
- On page 176, in Section 63.111, the staff should describe the revisions
to §§63.111(b)1 and 2 -- see the response to issue 3 on page 37.
- On page 179, revise line 3 from the top to read ' ... assurance requirements
and
more clearly ....'
- On page 204, revise line 2 from the bottom to read ' ...
its
their performance assessment used to ....'
- On page 206, revise line 2 from the bottom to read ' ... specifies
how DOE will identify
determine
which features, ....'
- On page 251, revise line 4 from the bottom to read ' ... function
is to provide a reasonable ....'
- On page 253, revise line 7 from the bottom to read ' ... which
statistically all voids, large and small, are
ideally
filled with water ....'
- On page 270, revise item (a) to read ' ... complete as possible in
the light of the information
that ....'
- On page 277, revise item (4)(i) to read ' ... important to safety
or barriers important to waste ....'
- On page 281, item (1), revise line 3 to read ' ... under the program
required by
under Subpart ....'
- On page 286, item (e), revise line 2 to read ' ... or any part of
a proposal is ....'
- On page 291, last paragraph, revise line 6 to read ' ... performance
is
are not to be ....'
- On page 299, 1st full paragraph, revise lines 5 and 6 to
read ' ... annual, drinking water
, dose to the whole
body or any organ of no greater less
than 0.04 ....'
- On page 305, item (f), next to last line, correct the spelling of
'environment'.
- On page 305, revise the last line to read ' ... characterizing and
modeling the behavior of the barriers.'
- On page 311, revise line 7 from the top to read ' ... to
ensure
assure safe operation in its safety ....'
- On page 317, in the paragraph on "Test control", revise line
2 to read ' ... systems, and components important
to safety will perform ....'
- On page 327, item (a), insert a colon at the end of the line.
- On page 332, paragraph (d), revise line 1 to read ' ... assessments
and analyses
upon the full range ....'
- On page 332, paragraph (c) under Section 63.305, revise line 2 to
read ' ... reasonable assumptions consistent with
present knowledge of
the changes in these factors
that ....'
1. Section 201 of the Energy Reorganization Act,
42 U.S.C. Section 5841, provides that action of the Commission shall be
determined by a "majority vote of the members present." Chairman Meserve
and Commissioners McGaffigan and Merrifield were present in the Conference
Room. Commissioner Dicus participated in the meeting via speakerphone.
2. As currently drafted, high-level radioactive waste
is defined in § 63.202 to encompass highly radioactive material from reprocessing
and "[o]ther highly radioactive material that the Commission, consistent
with existing law, determines by rule requires permanent isolation."
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