United States Air and Radiation EPA 402-R-96-001
Environmental Protection (6602J) January 1996
Agency
Criteria for the Certification
and Re-Certification of the
Waste Isolation Pilot Plant's
Compliance with the 40 CFR
Part 191 Disposal Regulations
Response to Comments
Document for 40 CFR Part 194
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RESPONSE TO COMMENTS
40 CFR Part 194:
Criteria for the Certification and Re-Certification of the Waste
Isolation Pilot Plant's Compliance with the 40 CFR Part 191
Disposal Regulations
January 31, 1996
Office of Radiation and Indoor Air
U.S. Environmental Protection Agency
Washinton, D.C.
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INTRODUCTION
The Waste Isolation Pilot Plant (WIPP) is a deep geologic repository proposed for the disposal of
transuranic radioactive waste. The facility, operated by the Department of Energy (DOE), is
subject to compliance with 40 CFR part 191, Environmental Standards for the Management and
Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes (hereafter
"radioactive waste disposal regulations" or "disposal regulations") promulgated by the U.S.
Environmental Protection Agency (EPA). In 1992 Congress enacted the Waste Isolation Pilot
Plant Land Withdrawal Act (WIPP LWA), which called for EPA to issue final radioactive waste
disposal regulations, to issue criteria for determining whether the WIPP complies with the
radioactive waste disposal regulations and for certifying whether the WIPP facility in fact
complies with the disposal regulations. See generally WIPP LWA § 8, Pub. L. No. 102-579.
The radioactive waste disposal regulations establish general standards that apply to the disposal
of spent nuclear fuel, high-level or transuranic radioactive wastes. The regulations require
affected disposal systems to analyze their performance over 10,000 years and to predict releases
of waste relative to specific containment requirements, to assess potential radiation doses
received by individuals and through ground water, and to address assurance requirements
intended to provide the confidence needed for long-term compliance with the containment
requirements. Under section 8(d)(l) of the WPP LWA, DOE must submit to EPA, and the
Agency must approve, an application for certification of compliance before transuranic
radioactive waste maybe emplaced for disposal in the WIPP. If EPA certifies compliance, every
five years following initial receipt of transuranic waste, section 8(f) of the WIPP LWA requires
DOE to submit documentation for EPA to determine whether the WPP facility continues to be
in compliance with the disposal regulations. The compliance criteria, finalized in this
rulemaking, to be codified at 40 CFR part 194, explain the basis on which the Agency will
evaluate whether the DOE's WPP facility complies and, if so, continues to comply with the
disposal regulations of 40 CFR part 191. The WIPP LWA call for specific criteria, implementing
the general disposal regulations at the WIPP facility.
Radioactive Waste Disposal Regulations: 40 CFR part 191
The EPA has the responsibility of promulgating the Federal environmental standards for spent
nuclear fuel, high-level, and transuranic radioactive wastes. Standards for disposal were first
promulgated in 1985 and judicial review was sought. The U.S. Court of Appeals for the First
Circuit remanded 40 CFR part 191, subpart B to the Agency for further consideration. See
NRDC v. EPA. 824 F.2d 1258 (1st Cir. 1987). The court found that the rationale for the
individual protection requirements was insufficient and that the public was given inadequate
notice of the groundwater protection requirements. However, the remand encompassed all
aspects of Subpart B. Section 8 of the WIPP LWA reinstated the 1985 disposal standards,
Subpart B, except those portions that were the subject of the judicial remand. Section 8 of the
WIPP LWA also required the Agency to issue final disposal standards, to address the issues that
were the subject of the remand. The Agency published the proposed amendments to 40 CFR
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part 191 in the Federal Register on February 10, 1993 (58 FR 7924). The EPAheld public
hearings in New Mexico. See 58 FR 8028 (Feb. 11, 1993). The EPA extended the public
comment period, in response to commenters at the public hearings. See 58 Fed. Reg. 15,320
(March 22, 1993). Final amendments were published in the Federal Register on December 20,
1993 (58 FR 66397).
WIPP Compliance Criteria: 40 CFR part 194
As noted, the WIPP LWA requires EPA to promulgate "Compliance Criteria" to implement the
disposal regulations specifically for WIPP. See WIPP LWA § 8(c). Since the enactment of the
WIPP LWA, EPA has been developing the criteria that will implement the 40 CFR part 191
disposal standards at the WIPP. The EPA has endeavored to provide substantial opportunity for
public participation in the development of the compliance criteria. Some of the public outreach
efforts are summarized below. In addition, EPA maintains a toll-free WPP "hotline" to facilitate
communications with the public.
The Agency published an Advance Notice of Proposed Rulemaking (ANPR) in the Federal
Register on February 11, 1993 (58 FR 8029). The ANPR requested comment on seven specific
issues, and the responses received were considered in EPA's deliberations on the proposed
criteria. In January 1994, a preliminary draft of proposed criteria was sent to interested parties
for comment. Among the parties who submitted comments were DOE, New Mexico
Environmental Evaluation Group (EEG), the Nuclear Regulatory Commission (NRC), several
offices of the State of New Mexico including the Attorney General's office, and citizens groups
based in New Mexico. The comments informed the proposed compliance criteria.
The proposed WIPP compliance criteria were published in the Federal Register on January 30,
1995 (60 FR 5766). The EPA held a public meeting in February 1995 to discuss aspects of the
proposed rule. The EPA held a public comment period of 90 days. In addition, public hearings
were held in Carlsbad, Albuquerque, and Santa Fe, New Mexico in March 1995. See 60 FR
11060 (March 1, 1995) (notice of public hearings). In response to a written request that EPA
extend the initial comment period by at least 30 days, the comment period was re-opened for an
additional 45 days beginning in August 1995. See 60 FR 39131 (Aug. 1, 1995). On September
6-7, 1995, EPA held a public advisory committee meeting of the WIPP Review Committee
National Advisory Council for Environmental Policy and Technology (NACEPT) in
Albuquerque, New Mexico. See 60 FR 43470 (Aug. 21, 1995) (notice of meeting). The EPA
elicited NACEPT's advice on the proposed criteria for passive institutional controls, release
limits and peer review. Members of the public were invited to submit written statements to
NACEPT and EPA provided opportunity for oral public comment to the Committee during the
meeting.
The EPA was sued in two separate lawsuits for its failure to meet the WPP LWA October 30,
1994 statutory deadline for the final compliance criteria. See New Mexico v. EPA. No. 95-1273
(D.C. Cir. filed May 26, 1995) & Southwest Research and Information Center v. EPA. No. 95-
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1285 (B.C. Cir. filed June 1, 1995). These two petitions asserted that EPA had unreasonably
delayed issuance of the final compliance criteria and requested the B.C. Circuit to issue an order
requiring EPA to promulgate the final criteria by Becember 31, 1995.
The petitions, and subsequent requests for rehearing, were rejected by two separate panels of the
B.C. Circuit. See New Mexico. No. 95-1273 (B.C. Cir. July 19, 1995) (Judges Silberman,
Sentelle and Tatel) & Southwest Research and Information Center v. EPA. No. 95-1285 (B.C.
Cir. Aug. 14, 1995) (Judges Wald, Ginsburg and Randolph). The court's orders reasoned that
while EPA had not issued the final compliance criteria by the statutory deadline, the agency's
delay was not so egregious to warrant a writ of mandamus, particularly in view of EPA's plans to
reopen the public comment period (see 60 Fed. Reg. 39,131, Aug. 1, 1995) and issue final
compliance criteria by February 1996. In light of the court orders, EPA has undertaken
additional steps to expedite the rulemaking and ensure that it issues the final compliance criteria
by February 1996.
Approximately 125 sets of written comments were submitted to EPA's Air Bocket regarding the
proposed WIPP compliance criteria. In addition, the Agency received oral testimony on the
proposed rule from over two hundred speakers during public hearings. Comments received on
the proposal were categorized according to the following topics, which correspond generally to
sections of the proposed rule:
General comments and issues Performance assessments
Certification conditions and applications Human intrusion
Inspections Active institutional controls
Quality assurance Monitoring
Models and computer codes Passive institutional controls
Waste characterization Engineered barriers
Future state assumptions Consideration of presence of resources
Expert judgment Removal of waste
Peer review Individual and ground water protection
Application of release limits Public participation
While a section of this document is assigned to each topic, the document should be read
comprehensively. Some comments presented overlapping issues — for example, comments
regarding mining could be relevant to the discussion of Performance Assessments or Human
Intrusion, or some other section. Further, some comments contain several points and some
comments repeat points that are addressed elsewhere within a particular section or in a wholly
different section. While in some instances EPA has cross-referenced related responses, it has not
done so in every instance. Thus, the responses to comments set out in this document should not
be read in isolation. Rather, the entire document should be considered as a whole, for it
collectively reflects EPA's consideration of significant comments.
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This document addresses comments received on the proposed regulations by summarizing the
concerns expressed by commenters and presenting the Agency's response to the comments. All
comments received during the initial comment period, during the re-opened comment period, and
during the time between the two comment periods have been fully considered. The Agency has
addressed all significant comments, both written and oral. Responding to comments was
difficult in many cases because comments did not articulate specific concerns, did not suggest
concrete alternatives, or did not substantiate the position advocated.
In addition to the comments received during or between the two public comment periods, EPA
received written comments after the close of the re-opened public comment period. These
comments have been placed in the late comments section of the rulemaking docket (Air Docket
Number A-92-56, Category IV-G) and are similarly denoted herein. The EPA has endeavored to
give the late comments full consideration, although not required to do so.
Some comments misunderstand EPA's charge in the WIPP compliance criteria rulemaking. As
noted, section 8(a) of the WIPP LWA expressly reinstated the provisions of the general
radioactive waste regulations adopted in 1985 except the specific aspects that were the subject of
the remand in NRDC v. EPA 824 F.2d 1258 (1st Cir. 1987). See 58 FR at 66399. Section 8(b)
of the WIPP LWA called for EPA to issue, through rulemaking, provisions of the disposal
regulations to address those specific aspects that were remanded. The rules were issued on
December 20, 1993. See 58 FR 66398. Section 8(c) of the WIPP LWA calls for EPA, through a
subsequent rulemaking proceeding, to issue criteria for determining the WIPP facility's
compliance with the final disposal regulations and prescribed that this rulemaking occur by
specific deadlines. This is the subject matter of the current rulemaking. Section 8(d) of the
WIPP LWA calls for EPA, through rulemaking, to certify whether the WIPP facility in fact
complies with the disposal regulations, on the basis of the specific compliance criteria issued for
the WIPP.
Some public comments on the WIPP compliance criteria requested changes to the underlying
disposal regulations themselves. Some comments address the technical underpinnings upon
which the disposal regulations are premised. For example, one comment questioned the
probabilistic basis for the containment requirements contained in 40 CFR part 191, and another
comment questioned the dose-response calculus used in developing the individual protection
requirements. The disposal regulations were adopted in 1985 after extensive technical analysis
and notice-and-comment rulemaking. Those aspects of the disposal regulations that were not the
specific subject of the judicial remand in NRDC v. EPA were reinstated by Congress. The EPA,
in turn, conducted a specific rulemaking to address those provisions that were the subject of the
remand. The EPA declines at this juncture to re-open the disposal regulations, and none of the
comments provide a compelling basis for EPA to question this judgment. The EPA instead is
limiting this rulemaking, pursuant to section 8(c) of the WIPP LWA, to issuing criteria to
implement the disposal regulations at the WIPP facility.
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Many comments reflect a different conception or perhaps in some instances a misconception
about EPA's responsibility in this rulemaking proceeding. As noted, in this rulemaking EPA is
implementing general radioactive waste disposal regulations at the WIPP. The disposal
regulations confer broad discretion on the implementing agency because of the "cutting edge"
and "one-of-a-kind" judgments that must be made in regulating radioactive waste disposal
activities. This is the first time criteria have been written to implement 40 CFR part 191 at a
particular site.
The EPA received many comments recommending that EPA prescribe more detailed
requirements in the compliance criteria. For example, EPA received comments suggesting that
the compliance criteria dictate specific engineered barriers for the WIPP. At the same time,
DOE, its contractors and its scientific labs were highly critical that EPA's compliance criteria
contain too much specificity and unduly constrain DOE.
The EPA has acted well within its discretion in issuing the final compliance criteria for the
WIPP. In this rulemaking, EPA has insisted on rigorous analysis and detailed information to
ensure that EPA and the public can thoroughly evaluate whether the WIPP complies with the
disposal regulations and to ensure that the underlying data and technical support used by DOE is
of sound, reliable quality. At the same time, the compliance criteria attempt to avoid prescribing
specific design choices or technical decisions so that EPA does not have the unintended effect of
making the facility less safe and to allow the scientists and technical experts administering the
WIPP the ability to make reasoned judgments. In addition, EPA believes strongly that it is
DOE's responsibility to design the facility, and EPA's responsibility to evaluate the adequacy of
that design. The compliance criteria rulemaking will be followed by DOE submittal of a
compliance application and an EPA certification rulemaking to determine whether the WPP
facility complies with the disposal regulations. The certification rulemaking provides the forum
for EPA to strictly scrutinize the WPP facility in light of the final compliance criteria.
The EPA also received public comments raising issues outside the purview of EPA's authority in
this rulemaking. For example, EPA received comments recommending that EPA modify the
criteria to address concerns about transportation. The radioactive waste regulations being
implemented in this rulemaking address disposal requirements and deliberately do not address
transportation of radioactive waste. The WIPP LWA establishes separate requirements regarding
transportation, and other issues, that directly apply to DOE.
The EPA also received comments directed at a draft guidance document, called the Compliance
Application Guidance (CAG). The CAG does not establish compliance criteria but is intended to
summarize and interpret the criteria issued in the final rule to provide guidance for the elements
of a complete compliance application. The CAG is still being developed and is expected to be
issued some time after the final rule. This document does not address comments on the CAG
that are unrelated to the compliance criteria.
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Some commenters requested that comments submitted on previous parts of this rulemaking be
considered (for example, comments on the ANPR). The Agency has done so to the extent
possible, but has omitted from this document comments which were not relevant to the proposed
version of the rule. In the interest of clarity and economy, some comments are paraphrased and
some closely related comments are combined.
A staff-level review of the proposed rule was conducted by the Nuclear Regulatory Commission.
While EPA has addressed these comments, they do not represent the views of the
Commissioners, and EPA was informed that the Commissioners have declined to comment on
the compliance criteria.
Each set of comments submitted to EPA is identified by a numeric/alphabetic code indicating its
source. A list of the commenters and their identification is given in Appendix A. Copies of all
comments submitted to EPA regarding the proposed rule can be found in Air Docket Number
A-92-56 (Categories IV-D, IV-F, and IV-G). For more information on docket locations, refer to
the Federal Register notice for the proposed or final rule. A list of acronyms and the terms they
represent are in Appendix B.
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Section 1; GENERAL COMMENTS AND ISSUES
Issue A: The EPA should assume a strong, independent regulatory posture and not be
overly influenced by the Office of Management and Budget (OMB) and the Department of
Energy (DOE). (SGNM-B, NMAG-A, NMAG-B, NMAG-F, SRIC-A, CCNS-A,A-01, A-07,
A-17, A-23, A-25, A-26, A-27, A-29, A-30, A-32, A-33, A-36, A-39, A-40, A-41, A-42, A-43,
A-44, A-46, A-47, A-48, A-51, A-53, A-54, A-55, A-60, A-65, A-66, A-67, S-09, S-12, S-25,
S-27, S-28, S-36, S-40, S-41, S-51, S-52, S-55, S-56, S-57, S-58, S-64, S-65, IV-D-05, IV-D-08,
IV-D-09, IV-D-12, IV-D-26, IV-D-27 [same as IV-D-86], IV-D-28, IV-D-29, IV-D-89, IV-D-91,
IV-D-92, IV-D-96).
1. It is requested that the Agency publish its final regulation without OMB review. The
inclusion of OMB review would be contrary to the intent of Pub. L. 102-579 and the applicable
Executive Order, No. 12866. (NMAG-D)
2. EPA should not submit the final rule to review by the Office of Management and Budget
(OMB). OMB review provides an additional, inappropriate opportunity for DOE to comment on
the criteria. OMB review is prohibited by Executive Order 12866 since there is a statutory
deadline for this rule, which makes it not practicable to schedule OMB review. (SPJC-G)
3. Any rulemaking regarding certification of the WIPP should be exempt from review by the
Office of Management and Budget, or any other Federal agency. (SPJC-G)
Response to Issue 1 .A:
President Clinton issued Executive Order (E.O.) 12,866 on September 30, 1993. Executive
Order 12,866 provides for centralized review of regulations by the Office of Management and
Budget's Office of Information and Regulatory Affairs (OMB/OIRA) to coordinate agency
rulemaking within the executive branch of the United States government. See E.O. 12,866, § 6.
Section 6(b)(2)(B) of E.O. 12,866 generally provides for a 90 day review period by OMB.
However, section 6(a)(3)(D) of E.O. 12,866 recognizes situations when an agency maybe
obligated by law to act more quickly than the 90 day review period allows:
In emergency situations or when an agency is obligated by law to act more quickly
than normal review procedures allow, the agency shall notify [OMB] as soon as possible
and, to the extent practicable, comply with subsections (a)(3)(B) and (C) of [section 6].
For those regulatory actions that are governed by a statutory or court-imposed deadline,
the agency shall, to the extent practicable, schedule rulemaking proceedings so as to
permit sufficient time for [OMB] to conduct its review.
The EPA was sued in two separate lawsuits for its failure to meet the WPP LWA statutory
deadline for the final compliance criteria. See New Mexico v. EPA. No. 95-1273 (B.C. Cir. filed
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May 26, 1995) & Southwest Research and Information Center v. EPA. No. 95-1285 (D.C. Cir.
filed June 1, 1995). These two petitions asserted that EPA had unreasonably delayed issuance of
the final compliance criteria and requested the D.C. Circuit to issue an order requiring EPA to
promulgate the final criteria by December 31,1995 and prohibiting OMB review under E.O.
12,866.
The petitions, and subsequent requests for rehearing, were rejected by two separate panels of the
D.C. Circuit. See New Mexico. No. 95-1273 (D.C. Cir. July 19, 1995) (Judges Silberman,
Sentelle and Tatel) & Southwest Research and Information Center v. EPA. No. 95-1285 (D.C.
Cir. Aug. 14, 1995) (Judges Wald, Ginsburg and Randolph). The court's orders reasoned that
while EPA had not issued the final compliance criteria by the statutory deadline, the agency's
delay was not so egregious to warrant a writ of mandamus, particularly in view of EPA's plans to
reopen the public comment period (see 60 Fed. Reg. 39,131, Aug. 1, 1995) and issue final
compliance criteria by February 1996. While the court orders did not impose a deadline upon
EPA or bar OMB review, OMB review was curtailed to facilitate EPA's ability to issue the final
compliance criteria by February 1996.
The EPA considered the views of OMB and DOE during the inter-agency review provided under
E.O. 12,866. However, the Administrator of EPA, exercising her independent judgment,
determined the contents of the final compliance criteria, considering all public comments.
Congress under the WIPP LWA delegated to the Administrator of EPA exclusive authority to
issue the criteria. Further, EPA's final action is fully consistent with the rulemaking procedures
at 5 U.S.C. § 553 and related principles of administrative law. Among other things, all aspects of
the final compliance criteria are a logical outgrowth of the proposed criteria. Consistent with
E.O. 12,866 EPA has placed in the WIPP compliance criteria rulemaking docket: the draft
regulatory text provided at the outset of the OMB review process, information identifying the
substantive revisions between the draft submitted and the Administrator's final action, and
information identifying those revisions that were made during the OMB review process. The
EPA has also placed summaries of inter-agency meetings in the rulemaking docket.
The EPA will not determine whether the WIPP facility complies with the final disposal
regulations until DOE submits a complete and final application and EPA conducts a thorough
review of that application in a public rulemaking conducted pursuant to 5 U.S.C. § 553. DOE
plans to submit its final compliance application to EPA in the Fall of 1996. No decision has been
made about the conduct of the interagency review process for this rulemaking. In all
circumstances, the Administrator of EPA will exercise her expertise and independent judgment
in determining whether the WIPP facility complies with the radioactive waste disposal
regulations. Further, EPA is committed to a decision-making process that fully comports with
the law and affords ample opportunity for public scrutiny.
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Issue B: Compliance procedures must protect "whistleblowers." (CARD-B, A-60, S-17,
S-40, IV-D-92)
Response to Issue l.B:
The EPA is fulfilling a specific regulatory responsibility in issuing the compliance criteria for the
WIPP. Section 8(c) of the WIPP LWA directs the Administrator of EPA to issue "criteria for the
Administrator's certification of compliance with the final disposal regulations." The final
disposal regulations at 40 CFRpart 191, subparts B and C, establish specific standards that
radioactive waste disposal systems must meet. The disposal regulations for which EPA is
required to establish criteria do not include whistleblower provisions or other provisions related
to employer-employee management for the operators of waste disposal facilities.
Further, DOE employees are given whistleblower protection under other provisions of federal
law. The Whistleblower Protection Act (WPA) (see, e.g.. Pub. L. Nos. 101-12 & 103-424)
provides protection for Federal employees, former Federal employees, and applicants for Federal
employment against job loss and recriminations because of whistleblowing activities. Under the
WPA, it is a prohibited personnel practice for an agency to subject an employee to a personnel
action if the action is threatened, proposed, taken, or not taken because of the employees
whistleblowing activities. The WPA defines whistleblowing activities as any disclosure of
information, including any disclosure to the Office of Special Counsel or the Office of Inspector
General, that the employee reasonably believes is evidence of a violation of any law, rule, or
regulation, or gross mismanagement, a gross waste of funds, an abuse of authority, or a
substantial and specific danger to public health or safety. See 5 U.S.C. § 2302. The WPA
applies to all Federal employees, including employees of DOE. Thus, protection for
whistleblowers is directly provided under the WPA.
The final rule provides EPA authority to conduct inspections and audits to confirm reported
conditions, activities, or information in compliance applications.
Issue C: Transportation problems associated with the WIPP have not been adequately
addressed. (C-ll, A-04, A-05, A-17, A-19, A-22, A-24, A-28, A-35, A-37, A-39, A-50, A-51,
A-54, S-14, S-15, S-31, S-32, S-36, S-38, S-40, S-41, S-46, S-56, S-59, IV-D-96, IV-D-97).
Response to Issue l.C:
As noted in response to Issue 1 .B, in this rulemaking EPA is establishing criteria for determining
compliance with EPA's radioactive waste disposal regulations at 40 CFR part 191, subparts B
and C, in accordance with section 8(c) of the WIPP LWA. Section 16 of the WIPP LWA
contains specific provisions related to transportation of radioactive waste to the WIPP.
Section 16 of the WIPP LWA contains transportation requirements that directly apply to DOE.
By contrast, transportation of waste to disposal systems is beyond the scope of EPA's disposal
regulations being implemented at the WPP in this rulemaking.
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Issue D: The entire concept of WIPP is flawed. It should either be abandoned or delayed
indefinitely until uncertainties can be resolved. Other solutions are possible, especially
those that may become viable in the future. The Agency should obtain more information
before finalizing the compliance criteria. (CARD-A, EEG-B, NMAG-B, SRIC-A, SRIC-F, A-
04, A-05, A-06, A-09, A-17, A-18, A-19, A-20, A-21, A-22, A-23, A-25, A-26, A-28, A-29, A-
32, A-35, A-36, A-37, A-38, A-39, A-43, A-49, A-51, A-52, A-53, A-54, A-55, A-57, A-58, A-
60, A-63, A-64, A-69, A-70, S-08, S-17, S-21, S-23, S-26, S-28, S-30, S-31, S-33, S-34, S-35, S-
36, S-42, S-43, S-45, S^6, S-48, S-50, S-54, S-55, S-56, S-58, S-59, S-60, S-61, S-63, S-64, S-
65, S-66, IV-D-05, IV-D-07, IV-D-29, IV-D-44, IV-D-45, IV-D-95, IV-D-96, IV-D-97, IV-D-98,
IV-G-5)
Response to Issue l.D:
Congress authorized DOE to proceed with construction of the WIPP:
The Secretary of Energy shall proceed with the Waste Isolation Pilot Plant
construction project authorized to be carried out in the Delaware Basin of southeast New
Mexico (project 77-13-f) in accordance with the authorization for such project as
modified by this section. Notwithstanding any other provision of law, the Waste Isolation
Pilot Plant is authorized as a defense activity of the Department of Energy, administered
by the Assistant Secretary of Energy for Defense Programs, for the express purpose of
providing a research and development facility to demonstrate the safe disposal of
radioactive wastes resulting from the defense activities and programs of the United States
exempted from regulation by the Nuclear Regulatory Commission.
See section 213(a) of the Department of Energy National Security and Military Applications of
Nuclear Energy Authorization Act of 1980, Pub. L. No. 96-164.
Congress subsequently withdrew the WIPP site from the public domain and reserved the lands
for DOE's use for the following WPP activities:
Such lands are reserved for the use of the Secretary [of DOE] for the construction,
experimentation, operation, repair and maintenance, disposal, shutdown, monitoring,
decommissioning, and other authorized activities associated with the purposes of WIPP
as set forth in section 213 of the Department of Energy National Security and Military
Applications of Nuclear Energy Authorization Act of 1980 and [the WIPP LWA].
See section 3 of the WIPP LWA, Pub. L. No. 102-579 (citation omitted).
At the same time that Congress withdrew the WIPP site from the public domain, Congress
delegated to EPA certain regulatory responsibilities at the WPP. See, e.g.. sections 8 and 9 of
the WIPP LWA. As noted, EPA's responsibility in the present rulemaking is to establish criteria
for determining whether the WIPP facility will comply with EPA's general radioactive waste
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disposal regulations. Congress also delegated to EPA the authority to certify, in a subsequent
rulemaking, whether WPP in fact complies with the disposal regulations. This subsequent
certification rulemaking will be based upon the compliance criteria issued in this rulemaking and
a compliance certification application to be submitted by DOE. Thus, Congress delegated to
EPA the responsibility to determine whether WIPP will comply with disposal standards intended
to protect the public from radioactive releases for 10,000 years. Congress also mandated that
EPA fulfill these regulatory responsibilities within specific time frames. Section 8(c) of the
WIPP LWA calls for EPA to issue final compliance criteria "[n]ot later than 2 years after the date
of the enactment of this Act." Section 8(d) of the WIPP LWA calls for EPA to certify whether
the WIPP facility in fact complies with the disposal regulations "[w]ithin 1 year of receipt of
[DOE's compliance certification] application."
Congress did not delegate to EPA the authority to abandon or delay the WIPP because future
technologies might evolve and eliminate the need for the WIPP. Congress did not delegate to
EPA the authority to weigh the competing risks of leaving radioactive wastes stored above-
ground at disperse sites or disposing of wastes in an underground repository. These
considerations are outside the scope of this rulemaking.
The comment that EPA should obtain more information before finalizing the compliance criteria
is vague. The EPA believes it has a sound basis for the compliance criteria established in this
rulemaking. Invariably in complicated policy making there can always be "more information"
obtained to guide decision making. However, Congress did not give EPA open-ended discretion
in deciding how long to take in developing the compliance criteria. The EPA has endeavored to
develop criteria based on sound information while also attempting to proceed in a manner
consistent with the statutory deadlines.
Issue E: The proposed rule is costly, time-consuming, vague, and provides little increase in
safety. (DOE-D, NMAG-A, NMAG-G, SNL-A, SGNM-A, SGNM-C, C-06, C-10, C-ll, C-12,
C-13, C-16, C-17, C-18, C-19, C-20, C-22, C-23, C-25, C-26, C-27, C-29, A-16, A-18, A-20,
A-31, A-34, A-35, A-38 , A^4, A-53, S-20, S-47, S-51, S-62, IV-D-35, IV-D-51, IV-D-64 [same
as IV-D-78], IV-D-76, IV-D-111 [same as IV-D-118])
Issue F: The compliance criteria should be strengthened. (CCNS-A, S-13, S-14, S-15, S-21,
S-24, S-36, S-39, S-58, IV-D-97).
Issue G: The strategy of having DOE conduct studies in key areas and then recommending
an approach for EPA's approval is sound and should be continued. (IV-D-100)
1. The EPA must provide sufficient flexibility in its regulatory program to avoid unnecessary
impacts on the operation of the WIPP facility while issues and problems are being resolved.
(IV-D-111)
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Response to Issues l.E through l.G:
In developing the final compliance criteria EPA has considered comments explaining particular
areas where the proposed rule was believed to necessitate more specificity. In the final rule, the
Agency has modified several sections from the proposal to clarify requirements for compliance
application analysis and supporting documentation, including, for example, the criteria on waste
characterization and monitoring. These issues are addressed in other sections of this document
and in the preamble accompanying the final rule.
The comments criticizing the proposed rule as providing little increase in safety and needing
strengthening are not specific. The EPA takes its regulatory oversight role at the WIPP very
seriously. While EPA cannot speculate what safety would be provided at the WIPP in the
absence of the disposal regulations, the application of the disposal regulations protect against
harmful releases of radioactive waste occurring over the next 10,000 years. The EPA has
adopted specific compliance criteria for the WIPP that are fully consistent with EPA's radioactive
waste disposal regulations. The EPA's charge in this rulemaking is to develop compliance
criteria.
In this rulemaking, EPA has insisted on rigorous analysis and detailed information to ensure that
EPA and the public can thoroughly evaluate whether the WIPP complies with the disposal
regulations and to ensure that the underlying data and technical support used by DOE is of sound,
reliable quality. At the same time, EPA recognizes that EPA is the overseeing regulatory agency,
and not the applicant seeking certification. Thus, the compliance criteria attempt to avoid
prescribing specific design choices or technical decisions so that EPA does not have the
unintended effect of making the facility less safe and to allow the scientists and technical experts
administering the WIPP the ability to make reasoned judgments. The Agency believes strongly
that it is DOE's responsibility to design the WIPP disposal system, and EPA's responsibility to
evaluate the adequacy of that design. The compliance criteria rulemaking will be followed by
DOE submittal of a compliance application and an EPA certification rulemaking to determine
whether the WIPP facility complies with the disposal regulations. During the certification
rulemaking, DOE's application must demonstrate, explain and justify that the WIPP facility
complies with the disposal regulations. In the certification rulemaking proceeding, the issues
will be particularized and concrete because EPA will be making a compliance judgment based on
actual, detailed information.
Issue H: 40 CFR part 194 contradicts, amends, and exceeds 40 CFR part 191 and does not
support its implementation. (DOE-D, WEC-A [same as WEC-B and WEC-C], WEC-D,
EEG-A, EEG-B, NMAG-B, NMAG-F, NMAG-G, SNL-A, SNL-B, SNL-C, SGNM-A, CCNS-B
[same as CCNS-C], C-06, C-ll, C-13, C-14, C-15, C-17, C-18, C-22, C-28, C-29, A-ll, A-13,
A-31 A-45, A-56, IV-D-06, IV-D-35, IV-D-64)
1. The proposed 40 CFR part 194 has logical inconsistencies. Deviations from the fundamental
rationale and technical bases, or from guidance derived from the fundamental rationale and
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technical bases of 40 CFR part 191 should be eliminated. Any apparent or intended deviations
should be justified, and the Agency should demonstrate quantitatively that the fundamental
rationale, technical bases, and guidance of 40 CFR part 191 have not been abandoned. (SNL-D)
2. Guidance in the proposed standards which are inconsistent with the fundamental basis and
requirements of 40 CFR part 191 should be reconsidered. A new basis is needed to demonstrate
that the results are consistent with human health and environmental protection goals. (DOE-E)
3. 40 CFR part 194 exceeds the authority granted by the WIPP LWA and violates its provisions.
(DOE-A [same as DOE-B and DOE-C], DOE-D, WEC-A, WEC-D, SNL-C, SRIC-B, SRIC-C,
SGNM-B, C-13, C-14, C-15, C-17, C-23, A-l 1, A-45, A-56, IV-D-111)
Response to Issue 1 .H:
The purpose of the rule is to establish criteria that implement the 40 CFR part 191 disposal
regulations at the WIPP. The provisions of the final rule are consistent with the disposal
regulations; for example, §194.31 of the final rule describes how release limits should be
calculated at the WIPP, and §194.41 describes the requirements for DOE to implement and
document the assurance requirement for active institutional controls. The EPA has exercised
discretion in adopting WPP-specific criteria from the more general disposal regulations and in
addressing issues associated with EPA's role as the implementing regulatory agency for the
WIPP. The disposal regulations at 40 CFR part 191 are crafted generally. The EPA has
established requirements in the compliance criteria for the WIPP that are a necessary adjunct of
EPA's role as the implementing regulatory agency. For example, the criteria relating to
inspections and audits are entirely consistent with EPA's mandate to implement 40 CFR part 191
at the WIPP. The EPA has also elected in this rulemaking to bind itself to specific procedures in
carrying out its compliance certification rulemaking. More specific comments on the relation of
the compliance criteria to the 40 CFR part 191 disposal regulations are addressed in subsequent
sections of this document.
Issue I: The rule should recognize the controlled area as a component of the disposal
system.
1. The terms "disposal system" and "repository" should be clarified and made consistent with
Part 191. (DOE-D, SNL-A, SNL-C)
2. The phraseology "away for the disposal system" and "toward the accessible environment" (40
CFR 194) effectively eliminates the consideration of the controlled area as a key natural barrier
component of the disposal system. The Supplementary Information should be revised to
specifically recognize the role of controlled area as a major component of the disposal system
that is expected to become contaminated during the regulatory time frame. (SNL-A, SNL-B,
SNL-C)
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Response to Issue 1.1:
The comment correctly states that the term "disposal system" denotes the entire system of
engineered and natural barriers. The natural barriers would include those geologic formations
which lie within the controlled area. Thus, in the case of ground water, for example, the
movement of radionuclides into underground sources of drinking waster (USDW) within the
controlled area would not constitute endangerment of ground water. The disposal regulations of
40 CFR part 191 permit this in recognition of the fact that the natural barriers, which might
contain potable ground water, nonetheless form a part of the system which isolates the
radioactive waste from the accessible environment surrounding the WIPP. See, e.g.. NRDC v.
EPA. 824 F.2d 1258 (1st Cir. 1987). The disposal regulations define "accessible environment"
to include the all of the lithosphere that is beyond the controlled area. See 40 CFR 191.12. This
definition recognizes that the controlled area may act as a natural barrier and may be considered
part of the disposal system.
The word "repository" does not appear in the regulatory language of the proposed or final
40 CFR part 194. The regulatory language uses the term "disposal system" when discussing the
specific requirements. Occasionally, in the supplementary information which appears in the
Federal Register, the Agency may refer to the WIPP as the "repository." This usage does not
alter the requirement placed on releases to the accessible environment, or to individuals residing
in or USDW's located in the accessible environment.
Issue J: Determination proceedings shouldn't be confused with certification and shouldn't
be included in this rule. (DOE-D, WEC-D, NMAG-A, SNL-C, SRIC-B, SRIC-C, CCNS-B)
Response to Issue 1 J:
Section 8(c) of the WIPP LWA requires EPA to promulgate criteria for the Administrator's
certification whether the WIPP facility will comply with the final disposal regulations (at 40 CFR
part 191, subparts B and C). Section 8(f) of the WIPP LWA also requires EPA to periodically
"determine whether or not the WPP facility continues to be in compliance with the final disposal
regulations" (so-called "determination proceedings"). Section 8(f) of the WIPP LWA calls for
DOE to submit to EPA "documentation of continued compliance with the final disposal
regulations" no later than five years after the initial receipt of transuranic waste for disposal at
WIPP and every five years thereafter until the end of the decommissioning phase.
The final rules contain the criteria and procedures that EPA will use to certify whether the WIPP
facility complies with the disposal regulations and to subsequently determine whether the WIPP
facility continues to be in compliance with the disposal regulations. Because determining
whether the facility continues to be in compliance is a logical and direct outgrowth of any initial
compliance certification, EPA believes it is sensible and practical to establish the requirements
and procedures that will govern recertification proceedings in this rule. As reflected in the final
rules, EPA may not change the terms or conditions of a compliance certification through a
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recertification proceeding. Any subsequent modification or revocation to the compliance
certification would require reopening the compliance certification issued under section 8(d)(l) of
the WIPP LWA and therefore is subject to the rulemaking procedures at 5 U.S.C. § 553 and
judicial review. Provisions related to compliance re-certifications have been retained in the final
rule. See also Section 2 of this document.
Issue K: The state and Federal laws for dumping need to be respected. (S-14)
Response to Issue 1 .K:
As noted, section 8 of the WPP LWA requires EPA to establish in this rulemaking the criteria
that implement EPA's radioactive waste disposal regulations at the WIPP. This rulemaking does
not implement other requirements under Federal and State law.
Section 9 of the WIPP LWA requires DOE to comply with all applicable Federal laws pertaining
to public health and safety or the environment. Section 9 also provides for periodic, biennial
oversight by EPA or the State, as appropriate, to determine whether DOE is in compliance with
applicable laws, regulations and permit requirements. The DOE also has agreements with the
State related to compliance with state laws.
The Land Disposal Restrictions of the Resource Conservation and Recovery Act (RCRA) are
Federal requirements which apply to disposal of hazardous materials at the WIPP. These
requirements are being addressed in another EPA regulatory proceeding. Determination of
compliance with State laws on disposal of hazardous materials will be made by the State Agency
reviewing DOE's RCRA permit application.
Issue L: Since WIPP is a major federal project significantly affecting the environment,
DOE is required to complete an environmental impact statement (EIS) prior to making a
decision. The rule should require that the application include a Supplemental EIS and
record of decision (ROD) supporting the decisions implicit in the application, e.g., decisions
as to current and proposed facilities at WIPP and at waste generating sites, and covering
all generation, treatment, storage and disposal alternatives. (CARD-B, CCNS-B, NMAG-B,
SRIC-C)
1. In §194.14 a subsection should be added to include the requirement that "supplemental
environmental impact statement and record of decision reflecting the Department's decision to
proceed as shown in the application after consideration of all applicable alternatives."
(NMAG-D)
2. The regulatory compliance process already integrates NEPA-required activities such as the
SEIS. No provisions regarding the integration or sequencing of documents related to other
regulatory compliance programs are needed or considered appropriate for the compliance
certification criteria. (DOE-E)
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Response to Issue 1 .L:
Neither the WIPP LWA nor the EPA radioactive disposal regulations provide that EPA must
include in its compliance criteria a requirement that DOE perform a supplemental EIS or Record
of Decision (ROD). Whether DOE is required to perform a supplemental EIS or ROD
addressing the issues identified by the commenters is governed by the National Environmental
Policy Act and is independent of EPA's rulemaking. The EPA will refer these comments to DOE
for its consideration. Irrespective of any NEPA requirements, EPA's final compliance criteria
require DOE to fully and thoroughly document the underlying basis for its compliance
certification application.
Issue M: The rule should distinguish between remote-handled transuranic waste and
contact-handled transuranic waste. (CCNS-B, A-13)
Response to Issue l.M:
The WIPP LWA defined and set limits on the amount and concentration of remote-handled (RH)
waste that can be disposed in the WIPP. See sections 2(12) and 7 of the WIPP LWA. Section 7
of the WIPP LWA establishes radiation dose rate (rem) and radioactivity (curie) limits for RH-
waste allowed for emplacement at the WIPP. Transuranic waste that is not RH-waste is
designated as contact-handled (CH). See section 2(3) of the WIPP LWA. In the final rule, the
Agency has clarified that DOE must demonstrate that the waste inventory at the WIPP complies
with the limitations on transuranic waste disposal established in the WIPP LWA. See §194.24(g)
of the final rule; see also Section 6 of this document.
Issue N: In a proposed rulemaking, it is inappropriate for the EPA to imply inadequate
information exists about a feature of the WIPP, when the Agency has not yet promulgated
final implementation criteria and no application has been submitted. All such references
should be deleted. (SNL-C)
Response to Issue 1 .N:
The EPA agrees that it is inappropriate to pre-judge whether the WIPP facility will comply with
the radioactive waste disposal regulations. No statements made in 40 CFR part 194 represent a
decision on the ultimate suitability of the WPP as a disposal system for transuranic radioactive
waste. The Agency may make a binding decision only as part of the rulemaking for certification
of compliance, conducted under section 8(d)(l) of the WIPP LWA. The Agency reserves final
judgment on any matters relating to whether the WIPP facility will comply with the disposal
regulations until the Agency conducts the rulemaking for certification of compliance pursuant to
section 8(d)(l). However, the Agency does not believe it is inappropriate to engage in public
discourse about issues related to the WIPP.
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Issue O: The definition of "undisturbed performance" should be clarified.
1. The definition of undisturbed performance should be clarified as follows: "undisturbed
performance means the predicted behavior of a disposal system, including characterization of the
uncertainties in predicted behavior, if the disposal system is not disturbed by human intrusion,
human activities, or the occurrence of unlikely natural events." (SNL-C)
2. EPA may wish to provide guidance, without applying a strict numerical limit, on the processes
and events that are to be considered for evaluations of the "undisturbed performance" of the
repository. (NRC)
3. It is appropriate that EPA define "unlikely natural events" and develop a list of probabilities
for qualifying events specific for the WIPP. (SGNM-D)
Response to Issue l.O:
The term "undisturbed performance" is defined in §191.12 as follows: "the predicted behavior of
a disposal system, including consideration of the uncertainties in predicted behavior, if the
disposal system is not disrupted by human intrusion or the occurrence of unlikely natural events."
However, based on language used in the proposal, this definition could have been interpreted to
mean that "undisturbed performance" should include consideration of the "human activities"
described in proposed § 194.33. It was not the Agency's intent to include consideration of
"human activities" in analyses of "undisturbed performance." For clarity, the terms "human
intrusion" and "human activity" used in the proposal have been replaced in the final rule by
"deep drilling" and "shallow drilling," respectively. For more detail, see §194.33 of the final
rule, and Section 12 of this document.
The disposal regulations require that compliance with the containment requirements be based on
performance assessments of the cumulative releases of radionuclides from all "significant"
processes and events that may affect the disposal system. See 40 CFR § 191.13(a)). Thus, the
disposal regulations contemplate that some processes and events may be insignificant and
excluded from consideration. The final rule provides a screening probability criteria to determine
which processes and events are insignificant and may be excluded. The final rule provides that
"[performance assessments need not consider processes and events that have less than one
chance in 10,000 of occurring over 10,000 years." See §194.32(d). This screening criteria is
informed by the implementing guidance (Appendix C) which accompanied the disposal
regulations. While the compliance criteria allow the exclusion of insignificant processes and
events, the final compliance criteria mandate documentation explaining why any processes and
events were not included performance assessment results. See § 194.32(e)(3). See Section 11 of
this document for further discussion of this issue.
Unlikely natural events are those natural events which may be excluded from performance
assessments, if it is demonstrated that their probability of occurring is less than the screening
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threshold. Any natural processes and events which, according to this criteria, must be included
in performance assessment must be considered when analyzing the undisturbed performance of
the disposal system. As discussed above, undisturbed performance need not consider human
intrusion into the disposal system. For further discussion of this issue as it relates to the
Individual and Groundwater Requirements, see Section 19 of this document.
Issue P: Forthcoming guidance documents should not be used to direct or dictate
experimental or other information gathering programs. (DOE-D, SNL-C)
Response to Issue l.P:
The EPA plans to issue non-binding guidance on the elements of a "complete" compliance
application that may summarize and interpret the criteria established in 40 CFR part 194. The
guidance will not establish additional compliance criteria.
Issue Q: Although the recommendations may be presented to EPA after the official
comment period for proposed compliance criteria closes, and EPA is not required to apply
the National Academy of Sciences (NAS) findings to WIPP, staff recommends that EPA
consider the NAS findings when developing the final rule. (NRC, IV-G-6)
Response to Issue 1.0:
The comment refers to a National Academy of Sciences (NAS) review of the technical bases for
standards applicable to a potential high-level radioactive waste disposal site at Yucca Mountain,
Nevada. The report is titled "Technical Bases for Yucca Mountain Standards" and was issued in
August 1995. The comment preceded issuance of the NAS report. The comments were not
elaborated by the commenter after the report was issued. Thus, EPA has not received any
specific comments in this rulemaking regarding the NAS report on Yucca Mountain.
The EPA reviewed the report in light of the general comment and concluded that the NAS
recommendations do not militate revisions to the final WIPP compliance criteria. The 1992
Energy Policy Act excluded Yucca Mountain from EPA's general radioactive waste disposal
regulations at 40 CFR part 191 and called upon EPA to develop separate standards for Yucca
Mountain, to protect the public from radioactive materials at the Yucca Mountain site. The NAS
report responds to specific questions presented by Congress in section 801 of the 1992 Energy
Policy Act. Congress called for the NAS report to inform EPA's development of the separate
standards for Yucca Mountain. Thus, the NAS report concerns a different site and, further,
addresses development anew of standards for the proposed Yucca Mountain radioactive waste
disposal facility. By contrast, in the 1992 WIPP LWA Congress charged EPA in the present
rulemaking with implementing the 40 CFR part 191 radioactive waste disposal regulations at
WIPP. The NAS report addresses approaches and assumptions addressed in 40 CFR part 191
and, for the reasons explained in the introduction and elsewhere in this document, EPA declines
to revisit the policy and technical bases of 40 CFR part 191.
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Issue R: The EPA should adopt the use of guidance in the following area of the compliance
criteria: "Future state assumptions," "Expert judgment," "Consideration of human-
initiated processes and events." and "Consideration of protected individual." The EPA
should use the compliance criteria in these sections to establish a broad framework of
requirements, where supplementary guidance can provide an appropriate methodology for
demonstrating compliance. The EPA should adopt a more flexible approach in developing
performance measures appropriate for WIPP. (NRC, IV-D-94)
Response to Issue 1 .R:
As noted in the introduction and in response to Issue 1 .E, EPA has endeavored to balance
flexibility and prescriptiveness in the final rule. The EPA believes the criteria in the areas
identified by the commenter require documentation necessary to facilitate EPA and public review
of the WIPP compliance certification application.
Issue S: The EPA must reissue the Compliance Application Guidance (CAG) as part of the
rulemaking on the compliance criteria since this lies outside the rulemaking requirements
of the WIPP Land Withdrawal Act. (SRIC-C)
1. The CAG contains numerous provisions which can only be interpreted as mandatory.
(NMAG-C)
2. There is concern that the approach of issuing a separate CAG "as a supplement to the 40 CFR
part 194 compliance criteria" but apparently without going through the rigorous rule-making
process of 40 CFR part 194, may create confusion or be unlawful. (EEG-C, NMAG-B)
Issue T: The issuance of a separate guidance document is unnecessary. (DOE-D, SNL-C)
Response to Issues l.S and l.T:
The EPA intends to issue a non-binding guidance document, called the Compliance Application
Guidance (CAG), after the final compliance criteria are issued. The document would summarize
and interpret the final criteria to guide EPA's administrative determination about the
completeness of the compliance certification application. As noted, EPA has established a
screening for completeness as a predicate to EPA's compliance certification rulemaking.
The EPA has provided significant opportunity for public participation during the development of
the guidance. The EPA circulated a preliminary draft, dated March 21, 1995, to interested parties
for comment. In the Fall of 1995, a draft of the CAG was made available for public inspection,
and a 60-day public comment period was provided. See 60 FR 53921-53922 (Oct. 18, 1995). A
revised version of the guidance will reflect EPA's consideration of public comments and will be
made consistent with the final compliance criteria. The EPA has revised and clarified the final
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compliance criteria and guidance, in light of concerns that the draft guidance contains provisions
which could be interpreted as establishing additional compliance criteria.
Issue U: A clarification of the scope of the rule is needed.
1. The requirements for actions pursuant to an excessive release of waste should apply to all
stored materials, such as containers, engineered barriers et al. (IV-D-06)
2. Boundary conditions need to be established that can be met. (C-25)
Response to Issue 1 .U:
The WIPP LWA calls for EPA to implement the radioactive waste disposal standards (40 CFR
part 191, subparts B and C) at the WIPP in the present rulemaking. Thus, this rulemaking does
not address releases from stored containers not disposed at the WIPP. However, the final
compliance criteria do contain requirements that are a necessary adjunct of regulating disposal at
the facility such as characterization of the stored waste to be emplaced in the repository and pre-
closure monitoring to establish baseline conditions for assessing subsequent disposal system
performance. Potential releases during the management and storage phase that are not relevant to
the predicted long-term performance of the WIPP facility, are regulated under Subpart A of 40
CFR part 194. The EPA intends to issue guidance for the application of 40 CFR part 191,
subpart A, to the WIPP, addressing the management and storage of radioactive waste at the
WIPP prior to disposal. See also the response to Issue 2.K of this document.
Issue V: It is extremely important that uncertainties be reduced as much as possible.
(S-16, S-55)
Response to Issue 1 .V:
The Agency agrees with this statement, but also recognizes that not all information can be
obtained with absolute certainty. In several instances, provisions of the disposal regulations
expressly recognize that "there will inevitably be substantial uncertainties in projecting disposal
system performance." See, e.g.. §191.13(b). The EPA has attempted to mitigate uncertainty by
including General Requirements in 40 CFR part 194. These requirements are intended to ensure
that any compliance application is based on dependable and quality-assured data, that
assumptions have undergone appropriate peer review, and that EPA has inspection authority to
confirm disposal conditions and data [§§194.21-27]. The EPA's disposal regulations also
include assurance requirements [§191.14, §§194.41-46] in recognition of the many uncertainties
inherent in making long-term numerical predictions of performance.
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Issue W: There are several terms that warrant a formal definition.
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1. The "applicability" statement does not clearly cover proceedings other than the initial
certification proceeding and the subsequent determination proceedings. Clearly, there may be
other proceedings before the Agency wherein Part 194 will apply, and the applicability of these
rules should not be left in doubt. (NMAG-D, SRIC-G)
Response to Comment I.W.I:
The compliance criteria also contain provisions applicable to modification, suspension, or
revocation of any certification. The final rule has been clarified by stating that the criteria apply
as well to "subsequent actions relating to the terms or conditions of certification of the
Department of Energy's Waste Isolation Pilot Plant's compliance with the disposal
regulations .... [ see §194.1]."
2. The definition of "modification" should not have a reference to §8(f) of the WPP LWA; in
the definition of "revocation" and "suspension" the term "withdraw" should be replaced with
"terminate." (NMAG-D)
3. Definitions of suspension, modification, and revocation need to be clarified. (SRIC-G)
Response to Comments 1.W.2 and 1.W.3:
Comments to EPA have indicated concern that the re-certification process, conducted without
rulemaking, could be used to effect changes in the conditions incorporated in any certification.
The Agency believes that re-certification is a process intended to assess compliance and confirm
that the conditions of certification continue to be in effect. Thus, re-certification is a periodic
review, but not a process to be used to change a certification in effect. Any significant departures
from the conditions, activities, or evidence in the certification of compliance would necessitate a
modification to any underlying certification issued pursuant to section 8(d)(l) of the WIPP LWA
and therefore would be subject to the rulemaking procedures at 5 U.S.C. § 553 and judicial
review. The definitions of modification, suspension, and revocation in the final rule have been
revised to clarify that these actions apply to the certification under section 8(d)(l) of the WPP
LWA, if any, in effect at the WPP.
As suggested by the comment, the definition of "revocation" in the final rule has been revised to
mean "any action taken by the Administrator to terminate the certification under section 8(d)(l)
of the WPP LWA." The use of "terminate" is appropriate in this case because revocation is a
permanent action that necessitates retrieval of the waste.
Suspension of a certification, on the other hand, is not meant to be permanent. A suspension can
be issued at any time at the Administrator's discretion so as to promptly address any potential
threat to public health. In such an instance, the Agency would not intend to immediately
terminate any certification in effect, but rather would temporarily withdraw the certification
while the immediate threat was mitigated and any necessary remediation was planned or
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undertaken. The Agency could then determine whether modification or revocation was
necessary, actions that require rulemaking because they re-open the underlying certification.
Because suspension is an emergency action at the discretion of the Administrator and does not
constitute a permanent action regarding a certification, the term "withdraw" is used rather than
"terminate." See also the response to Issues 2.A, 2.B, and 2.D.
4. There is no technical basis for including definitions for exploratory and development well in
the rule. (EEG-D)
Response to Comment 1.W.4:
The EPA agrees that there is no need to include definitions to differentiate between exploratory
and developmental drill holes or wells. As discussed in the preamble to the final rule, and in
Section 12 of this document, the Agency believes that both types of wells must be used when
examining historical drill rates and establishing future drill rates for the purpose of performance
assessments.
5. Add definitions for Performance Assessment, Safe Distance, Controlled Area. (SGNM-D)
Response to Comment 1.W.5:
As noted in §194.2, all terms in the compliance criteria have the same meaning as in 40 CFR
part 191 unless otherwise noted in the criteria. The disposal regulations of 40 CFR part 191
include definitions of both controlled area and performance assessment. See §191.12.
Therefore, it is unnecessary to define them in the compliance criteria. The term safe distance is
not used in the final compliance criteria; a definition is not needed in the compliance criteria.
Issue X: The EPA should be more rigorous in its implementation of "reasonable
expectation" language. It cannot just set hypotheses and models, frame the conditional risk
analysis for the applicant, then claim without checking that the conditional means resulting
from this analysis necessarily support "reasonable expectation" of human safety.
(NMAG-E)
Response to Issue 1 .X:
The EPA has not specified models to be used in performance assessments of the disposal system.
The compliance criteria do specify some bounding assumptions, such as future state assumptions,
in order to deal with inherent uncertainty. The results of DOE's analyses will be thoroughly
reviewed by EPA through the compliance certification rulemaking process. The compliance
criteria impose extensive documentation and analyses requirements on the compliance
application so that EPA can scrutinize the underlying analysis. The Agency's evaluation will
include rigorous comparison with the disposal standards, including the statistical requirements
established for the results of performance assessments. In addition, the final criteria implement
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the assurance requirements and contain supplementary requirements in 40 CFR part 194, subpart
C, which ensure that any performance assessment and compliance application are based on
sound, reliable information. The level of protection of human health is established by the
disposal regulations of 40 CFR part 191. The compliance criteria are not intended to establish a
new or more stringent level of protection, but are meant to implement the level of public
protection embodied in the disposal regulations. The EPA believes that the final criteria are
sufficiently rigorous. For further discussion of the results of performance assessments, see
Section 11 of this document.
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Section 2: CERTIFICATION CONDITIONS AND COMPLIANCE APPLICATIONS:
SECTION 194.4 through SECTION 194.15
Issue A: The Agency cannot lawfully authorize changes in the terms of certification in a
"determination" proceeding pursuant to §8ff) of Pub. L. 102-579. (NMAG-D)
Issue B: Since the LWA dictates that determinations be done without rulemaking, any
conditions imposed under §194.04(a) would not have the benefit of due process to ensure
that they are reasonable. (WEC-D)
Response to Issues 2.A and 2.B:
At any point in time, there is only one certification in effect at the WIPP. The terms of
certification, if it is granted, are established at the time of initial certification pursuant to section
8(d)(l) of the WIPP LWA, based on the compliance application submitted at that time. The
terms of certification at the WIPP can be changed only through modification or revocation
rulemakings, as described in §§194.64-65 of the final rule, which represent a decision to re-open
the certification issued under section 8(d)(l). Re-certification (referred to as "determination in
the proposed rule) pursuant to section 8(f) is a process intended to confirm (and document) that
the conditions upon which certification is based continue to exist. Thus, re-certification is a
periodic review, but is not a process to be used to change a certification in effect. If review of
information submitted for re-certification, or provided at some other time, indicates that
information, activities or conditions depart significantly from those upon which certification has
been based, it will be necessary to modify or revoke the terms or conditions of certification or, in
the interim, to temporarily suspend the certification. Any such modification or revocation would
be re-opening the terms of the certification issued pursuant to section 8(d) and must therefore be
conducted by rulemaking, as described in §194.65 and §194.66, and subject to judicial review.
The definitions of modification, suspension, and revocation in the final rule clarify that these
actions apply to the certification, if any, in effect at the WIPP, and are not affected by the re-
certification review process.
The language in final §194.4(a) has been revised to clarify that conditions imposed by the
Administrator apply to the underlying certification at the WIPP. Like other terms of the
certification, such conditions may not be modified through the re-certification process. Any
changes in the terms or conditions of certification must be accomplished through rulemaking, as
described in §§194.64-65, and subject to judicial review. In the re-certification process DOE
must document that the WIPP facility continues to be in compliance and the information on
which certification is based continues to be valid, in order to obviate any need for modifying the
certification.
The Agency notes that although re-certifications of compliance are prohibited, under provisions
of the WIPP LWA, from undergoing a rulemaking process, EPA is committed to ensuring that
any re-certification is conducted in an open forum. To that end, the final rule requires that there
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will be a public notice and opportunity for public comment regarding any potential decision on
continued compliance, or re-certification [§194.64].
Issue C: Certification should include conditions with regard to: waste acceptance criteria;
waste characterization; reporting of concerns about operations, monitoring, and scientific
investigations; facility construction and maintenance; waste handling and related
operations: closure activities. This should be added to §194.04(a). (NMAG-D, NMAG-G)
1. Any certification or re-certification must include specific conditions regarding waste
acceptance criteria, waste characterization, volumes of waste allowed, facility construction and
maintenance, monitoring, waste handling and repository operations, and closure activities.
(SRIC-G)
Response to Issue 2.C:
Section 194.4 of the final rule defines general conditions, whether stated therein or not, which
apply to any certification, and also allows the Administrator to include any other conditions
deemed necessary to support a certification. According to the final rule, the Administrator may
also modify, suspend, or revoke a certification if information becomes available that shows
violations of the release limits or departs significantly from the information on which the
certification was based. The EPA believes that the areas mentioned in the comments are already
required, under various sections of the criteria [§194.4, §§194.21-27], to be addressed by
compliance applications. The Agency would specify additional conditions in the event that the
necessary confidence in the disposal system could be achieved by the implementation of
additional measures, or if EPA determines that the WIPP will comply with the disposal
regulations if certain terms of the application are changed. The compliance criteria provide the
flexibility to add conditions that would address such situations, and the public will have ample
opportunity to comment on the inclusion of any such conditions during the certification
rulemaking proceeding.
Issue D: The process regarding modification, suspension, or revocation of certification
should be clarified regarding the definition and basis for such actions and subsequent
restoration of certification. (DOE-D, WEC-D, CARD-B, NMAG-B, NMAG-F, NMAG-G,
SNL-A, SNL-B, SRIC-E, CCNS-B, A-l 1, A-16, A-41, A-45, IV-D-51, IV-D-76, IV-D-111)
Response to Issue 2.D:
The final rule authorizes EPA to modify, suspend, or revoke any certification. However, the
definitions of modification, suspension and revocation have been revised from the proposal to
clarify that these actions apply to the certification, if any, in effect at the WIPP, and are not
affected by the re-certification review process. (See response to Issues 2.A and 2.B, above, and
response to Comment 1.Y.2 for further discussion of the definitions.) Any modification or
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revocation of a certification must be done by formal rulemaking as specified in §§194.64-65 of
the final rule.
The EPA has established some criteria that will govern whether modification or certification is
required, but EPA declines to specify particular actions that may necessitate modification,
revocation or suspension. The EPA has not done so because the Agency believes it would be a
speculative and inexact undertaking in the absence of particular facts and circumstances. The
Agency believes that decisions about the appropriate actions should be based upon the nature and
gravity of a given scenario at the time it occurs. Any modification or revocation of a certification
will be done by formal rulemaking explaining the basis for the decision, must provide
opportunity for public comment on the decision, and will be subject to judicial review.
Suspension may be initiated at the Administrator's discretion, in order to promptly reverse or
mitigate a potential threat to public health. The Supplementary Information to the final rule
includes a discussion of the criteria and general circumstances which might necessitate action to
modify, suspend, or revoke a certification.
Issue E: The EPA should consider the requirements for modifications that currently exist
under other regulatory programs such as the Nuclear Regulatory Commission's (NRC's)
transportation certification process (found in 10 CFR Part 71) and the EPA's Resource
Conservation and Recovery Act (RCRA) program (found in 40 CFR Part 270.42). These
requirements are well understood, have been implemented and interpreted over several
years, and also provide a logical precedent. A modification of these rules to adapt them to
radioactive waste disposal would prove beneficial to the rulemaking. (DOE-E)
Response to Issue 2.E:
The compliance criteria requirements on modification of certification are consistent with the
examples cited in many ways, but also differ from them for important reasons. The
transportation certification requirements (10 CFR Part 71) of the Nuclear Regulatory
Commission (NRC) are subject to the regulations for modification and revocation of allNRC
licenses. These requirements are contained in 10 CFR Part 70. The conditions described in
§70.61 as those which would necessitate a modification or revocation are consistent with EPA's
requirements that DOE must report changes about the disposal system or other information in the
compliance application upon which a certification was based.
Section 270.42 of the Resource Conservation and Recovery Act (RCRA) describes Permit
modifications at the request of the permittee; it allows for different classes of RCRA-permit
modifications, which have more or less rigorous requirements for reporting, review, and approval
depending on the complexity of changes necessitating a modification [See §194.4.]. The classes
of modifications are standardized and have been in effect for some time. The EPA's compliance
criteria are similar to those of §270.42 in that they both require the facility operator to evaluate
the complexity or magnitude of changes to the facility, report changes to the regulating Agency,
and allow for public participation in the process. The criteria of 40 CFR part 194 are necessarily
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different from those of RCRA because the RCRA regulations — particularly the division of
modifications into different classes of complexity — can be based on extensive experience with
numerous permitted facilities and the types of changes likely to occur. There is no similar record
for transuranic (or even high-level) radioactive waste facilities. Because it is thus not possible to
anticipate the situations which might necessitate modification of a certification, EPA believes it
is not prudent to specify the circumstances that may or may not necessitate modification or
revocation. The Agency also notes that, in RCRA's modification regulations, more rigorous
review standards can be applied for changes that are especially complex, or for which "there is
significant public concern about the proposed modification [§270.42(b)(6)(ii)(C)(l)-(2)]."
Consistent with this approach, EPA believes that the level of public interest and concern
regarding the WIPP dictates that, for the WIPP, EPA should retain authority to request
information, require reporting of changes in the disposal system, and conduct modifications
through public rulemaking.
Issue F: Section 194.4 must specify that the EPA can deny certification. (SRIC-G)
Response to Issue 2.F:
The authority granted to EPA in the WIPP LWA allows the Agency to deny certification if
compliance cannot be demonstrated. Section 8(d) of the WIPP LWA calls for EPA to "certify,
by rule pursuant to section 553 of title 5, United States Code, whether the WIPP facility will
comply with the final disposal regulations." The final rule includes provisions for conducting
certification through rulemaking. The final rule does not in any way assume a particular outcome
to the certification process.
Issue G: The requirement to retrieve waste from the disposal system should be modified.
1. The requirement in the event of revocation that DOE "retrieve, to the extent practicable, any
waste emplaced in the disposal system (40 CFR 194)" should be modified to include both risk
and compliance with 40 CFR Part 191 Subparts B and C. (SNL-A)
2. Mandated removal or retrieval may be impractical and could pose occupational and public
health risks. Any retrieval decision should be based on a performance assessment and a
compliance assessment of waste already emplaced. (SNL-A)
3. A further condition of certification should be demonstration of retrieval capability. (CARD-B)
4. The requirement for retrieval should be removed. EPA should require a remedial plan that
includes retrieval as an alternative in the event no other solution is possible and the waste
emplaced poses a threat to human health and the environment. (IV-D-111)
5. To allow waste to remain at a site where certification has been revoked is unthinkable.
Section 194.04(b)(l) should remain. (NMAG-D)
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Response to Comments 2.G.I through 2.G.5:
Permission for disposal of transuranic waste at the WPP depends explicitly on a certification of
compliance under the WIPP LWA. See section 7(b) of the WIPP LWA. If certification is
revoked, then transuranic waste may not be disposed at the WIPP under the WIPP LWA. If, for
example, the WIPP has been unable to consistently demonstrate long-term performance in
accordance with the disposal regulations and is not reasonably expected to resume operation
consistent with the disposal regulations, the Agency believes it may become reasonable to require
retrieval of waste already emplaced in the WIPP. Therefore, EPA believes that a demonstration
of feasibility of retrieval should be made before emplacement of waste begins. The Agency has
declined to require a detailed plan because a plan written prior to emplacement is likely to be of
little use in dealing with the specifics of a retrieval operation that could occur decades later. Any
retrieval plan will have to be based on the situation and technologies that exist at the time of
retrieval, should it become necessary.
The Agency agrees that situations could arise where the risks of retrieving the waste exceed the
risks of leaving the waste in place and sealing the disposal system. Therefore, the final criteria
state that, in the event of a revocation, waste shall be retrieved to the extent practicable.
Practicability could be determined taking into account risks, a compliance assessment of the
waste already in place, and other factors. In making a decision of whether to revoke the
certification, EPA could determine that the waste emplaced up to that point in time does comply
with 40 CFRpart 191, but that additional waste would result in violation. In such a case, EPA
could modify the certification to allow the waste emplaced to remain, but not to allow any further
waste emplacement. Because it is not possible to predict the situations that might result in
revocation of certification, EPA believes it is inappropriate to be more specific on the conditions
that could make waste retrieval practicable. As noted, any revocation or modification decision
would be subject to public rulemaking. The requirement for retrieval has been retained in the
final rule. See also the response to Comment 20.G.6.
6. EPA and the State of New Mexico can invoke revocation and require implementation of
retrieval plan procedures. (SGNM-D)
Response to Comment 2.G.6:
The purpose of the rule is to specify requirements for implementing the 40 CFR part 191 disposal
regulations at the WIPP and to clarify compliance-related ambiguities which may exist. The
EPA is the sole implementing agency at the WIPP for the disposal regulations and 40 CFR
part 194. The State of New Mexico may have authority to require retrieval of waste under
separate agreements, or under regulations such as the RCRA operating permit, which is
implemented and enforced by the State. Such authority is separate from the compliance criteria
and is independently enforced. It is unnecessary and inappropriate to re-iterate any such
authority in the final criteria.
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Issue H: Requirements to provide additional information must be reasonable and not
overly detailed. EPA must have cause to ask for information and should require submittal
within "a reasonable time." rather than in 30 days. (DOE-D, WEC-D, SNL-D, IV-D-111)
Response to Issue 2.H:
The EPA has noted that it is not appropriate to specify at this juncture the particular actions that
may necessitate a modification, suspension or revocation, because it is impossible to foresee all
the situations which could precipitate such an action. For the same reason, the Agency believes it
is unwise to limit the circumstances under which the Administrator could request additional
information. Thus, EPA must retain broad authority to request information to learn about
planned or unplanned changes to the disposal system, a significant departure from expected
disposal system performance, a potential to exceed the release limits provided in §191.13, or any
other information relevant to assessing the need for modification, suspension or revocation.
While EPA intends to request information relevant to conditions of certification, such
determinations of relevance will be at the discretion of the Administrator. The Agency believes
that 30 days is a reasonable time for response by the DOE. Quick response time is important to
ensure that, if necessary, the potential consequences can be mitigated early. If a situation arises
where it is extremely difficult or impossible for DOE to obtain the requested information within
30 days, the Administrator has the flexibility to specify an alternative time frame for submittal of
the information. The 30-day requirement was retained in the final rule.
Issue I: Paragraph 194.04(b)(3) in reference to changes of conditions in disposal system
should be deleted. (WEC-D)
Response to Issue 2.1:
Section 194.4(b)(4) in the final rule (§194.4(b)(3) of the proposal) requires DOE to submit
reports to EPA documenting any changes in the disposal system that depart from the information
on which certification is based. The Agency strongly believes that any application for, or
certification of, compliance must be based on the most current information. If a certification of
compliance is issued for the WIPP, re-certification proceedings would take place only every five
years, too long an interval to wait for information to be updated. Even if an application has
demonstrated that the WIPP can comply with the disposal regulations, EPA is concerned that
operation of the facility could result in changes which, while minor in and of themselves,
collectively could have an impact on projected performance of the facility. The EPA does not
consider the requirement to submit information on modified facility conditions or activities to be
burdensome; the DOE should be documenting such changes in any case, and will be required
only to submit a report on changes to EPA, and not to redo performance assessment calculations.
Issue J: "Likely" should be defined and "in excess of what is permitted by the disposal
regulations" should be clarified. (NMAG-G)
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Response to Issue 2.J:
In the proposed compliance criteria, EPA included the requirement that DOE notify EPA "[i]f the
Department determines that a release of waste from the disposal system to the accessible
environment in excess of what is permitted under the disposal regulations has occurred or is
likely to occur . . . [60 FR 5784]." The comment requested clarification on terms used in the
proposed rule. This section of the rule is intended to address a known or imminent release from
the disposal system requiring immediate action; thus, it requires immediate notification of EPA,
and suspension of waste emplacement activities. In order to limit confusion over interpretation
of the term likely, the final rule states that waste emplacement must be suspended and EPA
notified if releases have occurred or are expected to occur. The EPA has retained use of a
qualitative descriptor because of the great difficulty in establishing a quantitative measure.
Situations which do not require immediate action, but which indicate the potential for
modifications or other action on a certification of compliance are addressed under
§194.04(b)(3)(v), which also requires notification of the Administrator.
In response to this comment, the final rule was also changed to clarify that "in excess of what is
permitted by the disposal regulations" means in excess of the radionuclide release limits
established according to §191.13; the committed effective doses established under §191.15; or
the concentrations of radionuclides and estimated doses due to radionuclides in underground
sources of drinking water, established under 40 CFRpart 191, Subpart C.
Issue K: Section 194.4(b)(6) should be eliminated in its entirety. Any releases from the
repository while the Department is still emplacing waste at the site are covered by 40 CFR
Part 191 Subpart A and should not be covered by 40 CFR Part 194. (EEG-A, EEG-C,
SNL-A, IV-D-111)
1. The Agency needs to define "release" in §194.04(b)(6) to include only unintentional spills or
releases to the environment. (WEC-D)
2. A provision regarding releases during operations should be incorporated. The DOE should be
required to provide plans to assure rapid response and remedy of the more likely consequences of
maximum hypothetical accidents. (NMAG-G, A-28, IV-D-06)
3. Compliance criteria should direct DOE to develop a contingency plan in the event that
monitoring devices indicate a leak to the accessible environment. (CCNS-B)
Response to Issue 2.K:
The Agency has not applied the compliance criteria addressing waste disposal to the management
of waste at the WIPP. The Agency intends issue guidance for compliance with 40 CFR part 191,
Subpart A, that would address accidents occurring in the management operational phase.
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Section 194.4(b)(3) of the final criteria [§194.4(b)(6) of the proposal] requires DOE to notify
EPA and suspend emplacement of waste if a release of waste has occurred or is expected to occur
which causes the containment, individual, or groundwater requirements to be exceeded.
Permission for emplacement of transuranic waste at the WPP depends explicitly on a
certification of compliance, pursuant to section 7(b) of the WPP LWA. If a certification is not
in effect, then emplacement of waste at the WPP is not allowed. Certification of compliance, in
turn, is based on a demonstration that (among other provisions) predicted releases from the
disposal system will not exceed the containment limits set forth in 40 CFR part 191.
If a release from the WIPP in excess of the disposal regulations has occurred or is expected, any
certification of compliance could be jeopardized. In such a situation, it is necessary and
reasonable that the Department stop emplacement of waste so the situation will not be worsened
and so DOE can take immediate mitigating action. In addition, DOE must notify EPA of details
of the release so that the Agency can determine if the release is related to factors involving the
long-term containment of waste. Absent this provision of the criteria, any such releases would
already have been required to be reported and evaluated during the re-certification process, since
re-certification will be used to confirm that the information and conditions upon which
certification is based continue the be valid.
If reported releases are determined to be related to the long-term containment of waste, action
may be taken to modify, suspend, or revoke a certification. While an investigation is ongoing, it
is reasonable that emplacement of waste should be suspended. If the release does not affect long-
term containment, it will be covered by Subpart A of 40 CFR part 191 and will not affect
certification. For these reasons, the requirements were retained in the final rule.
Issue L: Specify pre-application procedures, particularly with regard to draft applications.
(SGNM-A, NMAG-B, NMAG-F, SRIC-B, SRIC-C, SRIC-D, SRIC-F)
1. It is inappropriate for EPA to consider the DOE draft compliance certification application
before the Agency has issued final compliance criteria. The draft application prejudices the
compliance criteria rulemaking since it delineates DOE's views on the compliance criteria and
allows DOE comment opportunities not available to others. The draft application should not be
considered in formulating the rule. (SRIC-G)
Response to Issue 2.L:
The DOE submitted a draft compliance application (in two parts) to EPA's Office of Radiation
and Indoor Air (ORIA) during the spring and summer of 1995. The EPA does not believe that
the draft compliance certification application influenced the contents of the final compliance
criteria. However, in response to concerns voiced by the public, the Agency decided to re-open
the public comment period on the compliance criteria to provide an additional opportunity for
public comments in light of DOE's draft compliance certification application, a copy of which
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was placed in the public dockets. The comment period on the proposed criteria was therefore re-
opened for 45 days ending September 15, 1995. [See 60 FR 39191-39132.]
As EPA has reiterated previously, EPA will not and may not make a compliance certification
decision on the basis of the staffs review of a draft application. The comments provided by EPA
staff to DOE are of a technical nature and do not represent a final decision of compliance. Any
such compliance decisions are to be made by the Administrator of EPA only after EPA reviews a
complete and final compliance application submitted by the Secretary of Energy.
Moreover, until final compliance criteria are issued, no benchmark exists against which to judge
whether a draft application adequately demonstrate compliance. The EPA recognizes that the
Agency cannot, by law, approve any part of the draft application. The staffs review is not
intended to and plainly does not have any binding effect. Any decision about the sufficiency of a
compliance application will be made by the Administrator only after the final compliance criteria
are issued, a complete and final application is received from the Secretary of Energy and a public
rulemaking proceeding is conducted pursuant to 5 U.S.C. § 553.
Issue M: Post-certification procedures should be clarified with regard to reporting
requirements, violation assessment, mitigation, and reinstatement. (NMAG-B, NMAG-F,
NMAG-G,A-11,A-16)
1. The DOE and EPA must be accountable. The public should be able to rely on the government
for active, independent monitoring of WPP. (IV-D-96)
2. The EPA must remain in charge of compliance. (A-l, IV-D-73)
3. It is important that the EPA strictly and rigorously regulates the DOE and not simply rubber
stamp DOE decisions. (IV-D-28, IV-D-89)
Response to Issue 2.M:
If EPA certifies that the WIPP complies with the disposal regulations, ongoing confirmation will
be needed to ensure that the disposal conditions remain consistent with information contained in
the compliance application. The EPA intends to confirm disposal conditions in two ways — first,
by specifying several mechanisms to update the information in the application; and second, by
exercising its inspection authority to confirm information and field conditions. The conditions of
any certification require that DOE provide information on any planned or unplanned changes to
the disposal system that depart from the application [§194.4(b)(3)]. The final rule also requires
that DOE report annually any changes to the disposal system, and that a re-certification be
conducted every five years after initial certification, if one is granted, to confirm that the
conditions upon which any certification is based remain valid. In addition, EPA has retained in
the final rule the criteria which allow the Agency to modify, suspend, or revoke a certification
based on departures from information on which the certification was based [§194.4(b)(l)]. In
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response to concerns about EPA oversight of the WIPP after certification (if one is granted), EPA
revised the rule to allow for suspension of certification at the discretion of the Administrator
rather than through rulemaking. This will allow the Administrator to immediately withdraw the
effectiveness of a certification (for a limited period of time) and require DOE to temporarily
cease emplacing waste, if such actions are deemed necessary to promptly address any potential
threat to public health and to allow EPA time to evaluate whether a certification should be
modified or revoked. Finally, the final rule contains inspection criteria [§194.21] which provide
EPA with broad authority to conduct audits and inspections to assess the validity of information
used to support a compliance application, and to ensure that activities and records described in an
application are implemented as described. See responses to Comment 1.Y.2 and Issue 2.C for
more information on modification, suspension, and revocation.
Issue N: The definition of certification application is unacceptable and must be changed.
The Compliance Criteria must have different definitions for applications for certification
and for determinations. (SRIC-C)
Response to Issue 2.N:
The WIPP LWA requires EPA to promulgate criteria for the Administrator's certification of
compliance for WIPP with the final disposal regulations (40 CFR part 191). The WIPP LWA
also requires EPA to make periodic determinations of continued compliance (re-certifications,
referred to as "determinations" in the proposed rule). The comment did not suggest why it would
be appropriate to make a distinction between applications for initial certification and for re-
certification. The EPA recognizes that the determination of initial compliance and
determinations of continued compliance are conducted differently. The decision regarding initial
compliance is conducted by rule, and establishes the terms and conditions of certification of the
WIPP. Re-certification, which is not subject to rulemaking, is a periodic review process intended
to confirm (and document) that the conditions upon which certification is based continue to exist.
Since it is intended to identify any changes in information, re-certification documentation must
address the same issues considered in initial certification, regardless of the different processes
and purposes of certification and re-certification. That is, documentation of either initial or
continued compliance with the disposal regulations will be based on substantially similar
information requirements, documentation requirements and format. Because of this similarity,
and the desire for rulemaking to be as efficient as possible, the Agency believes that it is practical
to address requirements for both initial certification and continued compliance (re-certification),
and certification applications, in a single rule. The EPA has addressed specific instances where
certification and re-certification processes differ (see, e.g., §194.14, §194.64).
Issue O: Rule should clarify whether "phased" applications for certification are allowed.
1. Recognize DOE's ability to submit subsequent applications seeking authorization for future
operational changes. (DOE-D)
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2. The requirement should clarify that there is a single certification application and a single EPA
rulemaking to certify or not certify that the WIPP facility will comply with the disposal
regulations. (SRIC-C)
3. It is suggested that EPA recognize the concept of "phased disposal" and the ability of the DOE
to submit and seek subsequent approvals of different wastes, waste streams and operational
parameters after the initial certification through the process of submitting additional applications.
(IV-D-111)
4. "Phased disposal" is contrary to law and should not be authorized by regulation. The Agency
should reject the request to receive authorization for "phased disposal." (NMAG-D)
5. It would be illegal to modify the application to include wastes that were not contained in the
original application for disposal at WIPP. A separate rulemaking would need to be promulgated
to consider groups of waste in phases. (NMAG-D)
6. The DOE must not be allowed, under re-certification proceedings, to emplace wastes in the
WIPP that were previously prohibited. (SRIC-G)
7. The EPA must clarify that only a single certification proceeding is allowed. The DOE must
not be allowed to conduct "phased disposal." (SRIC-G)
Response to Issue 2.O:
The rule does not contain any procedures to deal with a phased approval process. As the General
Counsel of EPA stated in a letter to the General Accounting Office, "[this rule] would require
reproposal of additions or amendments to the compliance criteria proposal before EPA could act
on any partial application. . . . [Nov. 23, 1994]." EPA has not revised the rule to encompass
phased approval. At any point in time, there is only one certification in effect at the WIPP. The
terms of certification, if it is granted, are established at the time of initial certification, based on
the compliance application submitted at that time. The terms of certification at the WPP can be
changed only through modification or revocation rulemakings, as described in §§194.64-65. The
Agency believes that re-certification (referred to as "determination" in the proposed rule) is a
process intended to confirm (and document) that the conditions upon which certification is based
continue to exist. Thus, re-certification is a periodic review, but is not a process to be used to
change a certification in effect. If an initial certification is granted, and information subsequently
becomes available which differs significantly from the basis upon the certification was issued —
including changes relevant to long-term performance, or proposed disposal of waste not
described in the application — then EPA would undertake a modification, suspension, or
revocation to the certification. Any modification or revocation will be done by rulemaking in
accordance with section 8(d)(l) because EPA would be re-opening the initial certification. See
also the response to Issue 2.A.
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Issue P: Time period for certification decision needs to be clarified.
1. Acknowledge that decision on certification must be made within one year. (DOE-D, WEC-D)
2. It is reasonable to allow EPA the one-year period to act on a certification application after
DOE has submitted a complete application. (NMAG-D)
3. It is reasonable that the statutory review period on an application not begin until the
application is deemed complete. (SRIC-G)
Response to Comments 2.P.1 through 2.P.3:
Section 8(d)(l) of the WIPP LWA calls for EPA to certify whether the WIPP facility will comply
with the disposal regulations within one year of receipt of DOE's compliance application. The
concept of "completeness" is an administrative tool EPA is utilizing to screen a final compliance
application received from DOE that because of incompleteness does not even warrant further
EPA and public scrutiny. It would be highly unproductive for the public and EPA to devote
substantial resources reviewing an application that lacks basic elements and information required
by the compliance criteria. Inherent in the one year review period for a compliance application is
the supposition that the application is complete and therefore warrants regulatory scrutiny. Thus,
the one-year statutory review period commences when the Administrator determines that the
compliance application is complete. If EPA determines a final compliance application
"complete" then the compliance application will be subject to public notice-and-comment
rulemaking procedures pursuant to 5 U.S.C. § 553 and as elaborated in the final compliance
criteria.
4. Any changes made by DOE to a certification application should "re-start" the statutory review
period to allow sufficient opportunity for public comment and EPA review. (SRIC-G)
Response to Comment 2.P.4:
The blanket rule that the statutory review period re-start any time DOE submits new information
would be highly inefficient and discourage DOE from providing new information that, for
example, may help clarify or elucidate the compliance application. The EPA declines to adopt
this approach. Further, the rulemaking procedures required by Congress in the WIPP LWA place
procedural constraints on the consideration of new information to ensure that there is adequate
public notice and comment. As noted, EPA's review of a compliance application must be in
accordance with 5 U.S.C. § 553, the Administrative Procedure Act. Underlying principles of
administrative law require that the public be given "adequate notice" of agency action, and
govern the circumstances when new information received after the close of the public comment
period must be subject to additional public notice and comment.
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Issue O: Part 194 should clearly define completeness criteria, including extent of public
participation in determination, and incorporation of study results. (DOE-D, WEC-D,
EEG-C, NMAG-B, NMAG-F, NMAG-G, SRIC-C, SRIC-D, SRIC-E, CCNS-B, C-14, A-29,
A-35, A-38, A-41, S-17, S-21, S-28, S-29)
Response to Issue 2.0:
The final compliance criteria establish the required contents of a compliance application. For
example, §194.4 sets out specific information that a compliance application must include.
Various other provisions of the compliance criteria establish detailed documentation and
demonstration requirements for the compliance application. The EPA plans to summarize and
interpret these requirements in a guidance document intended to guide EPA's assessment
whether DOE's compliance application is "complete." The guidance document will not establish
binding compliance criteria and therefore is not being included in this rulemaking. See also
responses to Issue l.T and Issue 20. F.
Issue R: It is critical that the EPA remains aware that the certification process is a
regulatory-compliance driven process. The DOE should be required to submit only the
information necessary to determine compliance with the stated regulatory requirements.
(SNL-D)
Response to Issue 2.R:
The DOE is required to submit the information called for in the final compliance criteria, which
reflects information EPA has determined is necessary to determine whether the WIPP facility
will comply with the disposal regulations. Because EPA has the responsibility to evaluate a
compliance application and issue or deny a certification of compliance, the compliance criteria
provide that EPA may require additional information necessary to determine compliance [see.
e.g., §194.4, §191.14].
Issue S: The following may be added to §194.12, "access to geographical information
system/database to verify monitoring or experimental programs." (SGNM-D)
Response to Issue 2.S:
The compliance criteria allow sufficient access to information by EPA. Sections 194.12 and
194.13 of the final rule require that DOE submit copies of any accompanying materials and any
referenced information related to compliance applications. In addition, §194.23(d) allows the
Administrator to verify the results of computer simulations used to support any compliance
application. Materials needed to perform such verifications are to be provided by the
Department. The Agency also has discretion to request additional information in applications
under § 194.14(j). Further, the final rule provides inspection authority allowing EPA to conduct
inspections and audits to verify monitoring programs, or the accuracy of information.
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Issue T: A comprehensive table of references pertaining to the subject area should be
provided (§194.13). (SGNM-D)
Response to Issue 2.T:
Section 194.13 of the final rule requires that DOE include, with certification applications, copies
of any reference materials not generally available, in order to facilitate the Agency's review of
any application.
Issue U: It is a concern that the wording used in this section (§194.14(JV) and the
Supplementary Information would allow EPA to establish additional information
requirements other than those covered in the proposed rule at some later time. (IV-D-111)
Response to Issue 2.U:
Any compliance application must include, at a minimum, basic information about the WIPP site
and disposal system design, and must also address all the provisions of the compliance criteria;
these needs are embodied in § 194.14 of the final rule. In the face of uncertainty which remains
about many aspects of the WIPP, EPA believes it is appropriate to allow flexibility to require
additional information. Section 191.14(j) allows the Administrator to exercise discretion and
request such additional information. The EPA believes this provision is necessary and prudent,
and has retained it in the final rule.
Issue V: The requirements regarding the content of compliance applications is overly
detailed and too prescriptive.
1. Let the burden of deciding the scope and depth of information to be included in the
application rest with the applicant. The EPA should not pre-judge the importance of a particular
area of information on the basis of preliminary information. (EEG-A)
2. The proposed rule includes overly prescriptive detail in some areas. (TV-D-76)
Response to Issue 2.V:
Any compliance application must include, at a minimum, basic information about the WIPP site
and disposal system design, and must also address all the provisions of the compliance criteria;
these requirements are embodied in §194.14 of the final rule. The documentation required in the
compliance criteria is important to enable a rigorous, thorough assessment of whether the WIPP
facility will comply with the disposal regulations.
Issue W: Additional specific information should be included in the compliance application,
as described in Section 194.14.
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1. A "waste characterization program" should be added to the WAC and "including a record of
audits and surveillance and results of waste characterization studies." (SGNM-D)
2. Add the following to § 194.14, "a topographic map showing the surface projection for the
underground facility, the location of abandoned resource wells and WIPP wells, and location of
current and proposed oil/gas exploration wells." (SGNM-D)
3. Add a visual representation of the penetrated horizons within the 16 section boundary to
§194.14. (SGNM-D)
Response to Issue 2.W:
Many of the comments pertain to information which is already required to be submitted in an
application because it relates to provisions elsewhere (Subpart C) of the compliance criteria. For
example, the performance assessment provisions require an analysis of activities that occur in the
vicinity of the disposal system prior to disposal and are expected to occur in the vicinity soon
after disposal, including existing boreholes and the development of any existing leases that can
be reasonably expected to be developed in the near future. See § 194.32(c) and § 194.14. The
final rule requires the submittal of one or more topographic maps showing, among other things,
the location of any active, inactive, and abandoned injection and withdrawal wells in the
controlled area and in the vicinity of the disposal system (see §194.14(h)). As noted, any
compliance application must include, at a minimum, basic information about the WIPP site and
disposal system design, and must also address all the provisions of the compliance criteria; these
requirements are embodied in §194.14 of the final rule.
Regarding waste characterization, the final rule requires that DOE document its waste
characterization, and also implement a system of controls to confirm that waste is not emplaced
in the disposal system if it does not comply with the limits on waste components established
under § 194.24. As provided in the final rule, EPA intends to use inspections and records
reviews, such as audits, to verify compliance with the waste characterization requirements. For
further discussion of waste characterization, see Section 6 of this document.
Issue X: Change §194.15(a)(4) to state "new waste characterization information."
(SGNM-D)
Response to Issue 2.X:
Section 194.15(a)(5) of the final rule [§194.15(a)(4) in the proposal] requires DOE to submit
updated documentation on "[a] description of any waste emplaced in the disposal system since
the most recent certification or re-certification application. Such description shall consist of a
description of the waste characteristics and waste components identified in §194.24 . . . ." The
EPA does not believe that the language suggested in the comment would serve to further clarify
or elaborate on this requirement.
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Section 3: INSPECTIONS: SECTION 194.21
Issue A: The scope of the inspection requirements needs to be clarified.
1. This section is highly prescriptive and gives EPA inspection authority before an application
has been submitted. (DOE-D, SNL-B, SNL-C)
2. This section (§194.21) should be revised to state that inspections will not begin until DOE
submits its certification application and that the inspections will conform to all site requirements
such as safety, personnel procedures and related activities. (IV-D-111)
3. EPA's authority to conduct sampling, analysis, or monitoring should apply continuously.
(NMAG-B, IV-D-06)
Response to Comments 3.A.I through 3.A.3:
The Agency must exercise a robust inspection program to guarantee that information, data,
processes, and procedures documented by DOE in any compliance application are complete and
correct. The EPA maintains its position, as stated in the preamble to the proposed rule, that "its
inspection privileges [must] be broad enough to allow the Agency to inspect activities that may
provide information used to support compliance application(s) and are deemed by the
Administrator or the Administrator's authorized representative to be relevant to a compliance
certification or determination [60 FR 5770]." For example, the Agency must be able to inspect
and evaluate sources of data that are used in the performance assessment and data used in DOE's
Waste Acceptance Criteria. The final rule provides that EPA shall be afforded access at any time
to inspect any area of the WIPP, or any locations performing activities that provide information
relevant to compliance applications.
Currently, it is not the intent of the Agency to perform formal inspections before submittal of a
compliance application. However, in order to facilitate the evaluation of any application, the
Agency may begin an informal inspection process before submittal of the initial compliance
application. The preamble to the final rule clarifies that inspections will be used to verify the
adequacy of information included in compliance applications.
Section 194.21(d) of the final rule states that the Administrator's authorized representatives will
comply with applicable access control measures for security, radiological protection, and
personal safety when performing inspections.
4. EPA does not have the authority of unannounced and unfettered access to a particular location
that may have some remote connection to the WIPP facility. (WEC-D)
5. EPA's request to inspect operations directly affecting the WPP is reasonable. (WEC-D)
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6. The Agency's proposed authority to inspect the WPP site and locations which generate
compliance-related data should be retained. (NMAG-D, SRIC-G)
7. The requirement that shipments to WIPP must be inspected is redundant. (A-34, IV-D-11)
Response to Comments 3.A.4 through 3.A.7:
The rule does not grant EPA authority to inspect locations that have remote connections to the
WIPP facility, nor does it require that DOE or EPA perform inspections of all waste shipments to
the WIPP. The final rule does allow the Agency to inspect locations performing activities that
provide information relevant to compliance applications. In addition to allowing EPA access to
such sites, the final rule provides EPA with the right to monitor and measure aspects of the waste
proposed for disposal in the disposal system. Locations for inspections could include, in addition
to the WIPP disposal site, those sites at which waste characterization activities are conducted.
Inspections, including, random, unannounced inspections of WIPP-related activates and records,
will assist EPA in assuring the validity of information used to support compliance applications.
The EPA must have access to such information, regardless of whether it is located at the WIPP or
at generator or other sites. The provisions allowing EPA authority to inspect relevant sites has
been retained in the final rule.
8. The EPA must consider the entire environment, not just the borders of the WIPP site. (C-03)
Response to Comment 3.A.8:
The EPA is concerned about the entire accessible environment outside the controlled area. For
this reason, EPA's disposal regulations limit releases of radionuclides to the accessible
environment, which includes all those areas, land, water, and air outside the controlled area
containing the WIPP disposal system. In addition, 40 CFR part 191 limits radionuclide
concentrations in any ground water that may be affected by the WIPP, and limits radiation doses
to individuals on the surface of the earth. The Agency does not have the authority under the
disposal regulations to regulate releases from sites associated with (but located apart from) the
WIPP facility. Such releases may be regulated by State agencies or under the Resource
Conservation and Recovery Act (RCRA), but do not fall within the purview of this rulemaking.
However, EPA does believe it is important to understand what activities are being undertaken at
these sites if these processes provide or affect information upon which a compliance application
is based. Therefore, the final rule provides that EPA has the right to inspect any locations
performing activities relevant to compliance applications, to which the Department has rights of
access. This includes locations such as waste generator sites, which are outside the immediate
borders of the WIPP site.
9. The rule should require EPA to conduct inspections. (NMAG-B)
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Response to Comment 3.A.9:
The EPA is not required to bind itself to doing inspections. The EPA expects that it will conduct
numerous inspections to verify the accuracy and adequacy of information contained in
compliance applications. However, decisions on what and how to audit at facilities related to the
WIPP are within EPA's discretion as implementing agency for the disposal regulations at the
WIPP. It is important that this discretion be retained so that inspections can be conducted
commensurate with information needs. If a given site conducts few activities which provide
information relevant to compliance applications, or if the information affects parameters
unimportant to containment of waste in the WIPP, it would be illogical and not cost-effective for
EPA to be required to perform inspections at that location. The final rule does not require EPA
to conduct inspections.
Issue B: The nature of sampling and analysis for inspections needs to be clarified.
1. It is not clear how and for what purpose EPA will institute a parallel sampling and analysis
program at the WPP site. If EPA plans to conduct an independent sampling and analysis
program, it is strongly recommended that a pilot program be conducted prior to full
implementation to identify and quantify all of the "bugs" that are sure to arise. (IV-D-100)
Response to Comment 3.B.I:
The Agency is not proposing a parallel sampling program. The Agency will sample data it
believes are needed to verify information used to support any compliance application. The
Agency intends to develop and test any sampling plans before they are implemented to ensure
that procedures are readily understandable and useable. The final rule retains the criteria
allowing EPA to obtain samples and monitor aspects of the disposal system.
2. A feasibility requirement should be added to allow the Administrator to obtain samples, splits,
or monitor disposal system aspects (reference to 194.21(b)). (WEC-D)
Response to Comment 3.B.2:
As with any sampling or monitoring program, the Agency intends to evaluate the feasibility of
implementation and the value of the information to be obtained. As noted in §194.21(d) of the
final rule, EPA will comply with applicable access control measures for security, radiological
protection and personal safety as it implements inspection plans. However, the Agency believes
that, in order to make an objective decision regarding compliance, EPA must be allowed full
access to conduct inspections at sites providing information relevant to compliance applications.
The final rule does not limit EPA's authority as suggested by the comment.
Issue C: EPA needs to coordinate inspections with other organizations.
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1. EPA should provide notice of and coordinate DOE site inspections with the New Mexico
Environment Department. (SGNM-A)
2. EEG, State, NAS, and specified members of the public should have same rights as EPA.
Areas of disagreement between DOE and its reviews should be included in appendices of the
rule. (NMAG-G, CCNS-B)
3. EPA should provide comments or copies of its comments on inspections and/or the written
inspection reports under 194.21. (CCNS-A)
4. The State of New Mexico and other parties should be afforded access to the WIPP and related
facilities on reasonable notice. (SRIC-G)
5. The State, NAS, EEG, and other parties should have access to DOE records, similar to access
codified in NRC regulations. (NMAG-B)
Response to Issue 3.C:
Throughout its regulatory processes EPA has taken special steps to provide the public with
information pertaining to the WIPP. The Agency values public participation and input and
intends to place inspection reports or other relevant information in the docket for public
examination. At the same time, EPA will be performing many activities in implementing the
compliance criteria. Neither the WIPP LWA or 40 CFR part 191 require EPA to specify in the
WIPP compliance criteria that inspection reports be made publicly available. The EPA thinks it
more appropriate to address this and other similar implementation issues in policy statements and
in how the Agency elects to exercise its discretion in implementing the compliance criteria,
considering the circumstances that arise during the implementation phase. It is not possible or
reasonable to codify in the rule all commitments and procedures for information exchange
among EPA, DOE and the public.
Regarding rights to inspect DOE records and facilities, EPA notes that any outside party could
always request that EPA gather specific information, or audit specific aspects of a process. The
Agency would evaluate any such requests and could conduct inspections on that basis if
appropriate. Further, specified parties are entitled access to information pursuant to Section 17
of the WPP LWA, which reflects an explicit congressional judgment about access to
information. Section 17 directly established specific duties on DOE, independent of EPA's
compliance criteria. The EPA believes it is inappropriate to specify in this rule that specific
parties have exceptional access to information generated or recorded by DOE. It would also be
inappropriate to assign inspection rights to parties that have no regulatory authority at the WIPP
because of the particular importance in maintaining control of access to a site with radioactive
wastes and because Congress solely charged EPA with regulatory oversight. The EPA
recognizes that there may be benefits to coordinating inspections with other entities that have
regulatory authority over the WIPP (such as the State) and that might conduct inspections with
similar goals; the Agency will coordinate with such parties as appropriate.
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Issue D: EPA is exceeding its authority (references to 40 CFR part 191 and the AEA).
1. Part 191 does not set standards or requirements for site inspections, office space, or sampling.
(C-28)
2. Neither LWA nor Part 191 provide a regulatory basis for a "formalized" pre-certification
inspection process. (DOE-D, SNL-B)
Response to Comments 3.D.I and 3.D.2:
The WIPP LWA and 40 CFR part 191 establish EPA as the Agency with authority to implement
40 CFR part 191 for the WIPP. The General Requirements of Subpart C — including those for
inspections — ensure that an application for certification will be based on sound information and
that EPA has the right to confirm the accuracy of such information. The Agency must be
provided access to confirm the adequacy of information in a compliance application prior to
certification in order to make an objective decision regarding certification. Such requirements
are entirely consistent with EPA's mandate to implement 40 CFR part 191 at the WIPP. In fact,
effective and active oversight (including inspections and sampling) is a necessary adjunct of
EPA's responsibilities as implementing Agency. Therefore, providing for inspections to assure
quality, completeness, and adequacy is appropriate. See also the response to Issues 1 .H and 1.1.
3. This subsection should clearly state that it will be used as a criterion to evaluate whether a
reasonable expectation of compliance with 40 CFR 191.13, 191.15, and 191.24 exists. (DOE-D,
SNL-C)
Response to Comment 3.D.3:
A " reasonable expectation" of compliance with the disposal standards is established by the
entire body of evidence supplied in a compliance application. The general requirements of the
compliance criteria, including those for inspections, are intended to ensure that any compliance
application is based on dependable and verifiable information. As components of the final
compliance criteria, the inspection requirements are enforceable. Any application must
demonstrate that the requirements of §194.21 have been fulfilled specifically, and cannot meet
the requirements of this section by stating that other compensating factors establish a reasonable
expectation of compliance. The DOE must independently establish compliance with the final
rule, regardless of what actions EPA undertakes to establish or verify the adequacy of
information used in compliance applications. Therefore, EPA believes it is inappropriate to
include the suggested language in the final rule.
4. For non-mixed TRU waste, under the AEA exclusion in 40 CFR Part 261, the EPA would be
exceeding its authority as granted by the Atomic Energy Act of 1954. (IV-D-11)
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Response to Comment 3.D.4:
The WIPP LWA and 40 CFR part 191 specifically authorize EPA to regulate TRU waste,
including non-mixed TRU waste. Hazardous wastes are regulated by EPA as authorized by the
Resource Conservation and Recovery Act (RCRA). The RCRA regulations apply only to
materials categorized as solid waste. However, this does not include "special nuclear material,"
such as TRU wastes (See 40 CFR 261.4 and the Atomic Energy Act (AEA) of 1954, Section
1 l(a)). Thus, the comment correctly states that non-mixed TRU wastes cannot be regulated by
EPA under its RCRA authority. They may, however, be regulated by EPA under the authority of
the AEA, and thus under 40 CFR part 191. In addition, as noted above, EPA was specifically
authorized to implement the TRU waste disposal regulations at the WIPP. Therefore, EPA is not
exceeding its authority to regulate non-mixed TRU waste.
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Section 4: QUALITY ASSURANCE: SECTION 194.22
Issue A: The scope and nature of the quality assurance criteria need to be clarified.
1. The focus should be on quality control measures not on long term monitoring. (SNL-B,
IV-D-40)
2. Quality assurance standards should take priority over inspections both at WIPP and at the
generator and storage sites. (A-13)
Response to Comments 4.A.I and 4.A.2:
Quality assurance is an ongoing process intended to ensure that information contained in any
compliance application is reliable. Inspections serve a different purpose, allowing EPA to
confirm descriptions of field conditions and activities, as well as review documentation of
procedures. Monitoring serves a third purpose, to detect detrimental deviations from expected
performance of the disposal system. The EPA believes that quality assurance, inspections and
monitoring are all important requirements that must be met. The Agency will enforce all these
requirements to ensure that any application is based on reliable and verifiable information, and
EPA believes that it is inappropriate to prioritize these activities in the rule.
3. The definition of Quality Assurance should not include quality control because such a
definition confuses the two processes. The definition should be revised by separating Quality
Assurance and Quality Control. (SNL-C)
Response to Comment 4.A.3:
Section 194.22 of the final rule demonstrates that EPA intends to emphasize quality assurance
(which includes quality control) as it affects data, systems, structures, components and activities
important to containment of waste in the disposal system. The EPA believes that the definition
of quality assurance provided in the final rule [at § 194.2] is consistent with the use of this term in
the American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance (NQA)
standards, which are incorporated by reference in the final rule. In addition, the definition
provided in the rule emphasizes that EPA intends for quality assurance to be a planned and
systematic exercise which applies not only to experimental results, but also to the methods used
for conducting processes, activities and experiments which produce data or are important to
containment of waste in the disposal system. For these reasons, the definition in the final rule
retains the reference to quality control.
4. The QA requirements are not geared to the unique circumstances of the formal expert
judgment elicitation process, which produces information rather than data. (SNL-C)
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Response to Comment 4.A.4:
The EPA notes that it has addressed expert elicitation elsewhere in the rule at §194.26, which
imposes constraints on the use and conduct of expert judgment. In addition, the final rule
requires that the procedures for implementation the expert elicitation, if employed, shall be
shown to have been under conditions of quality control, as would any other process subject to the
requirements of a quality assurance program. In other words, while the product of expert
elicitation is different than data, EPA requires the process to be conducted in a quality-controlled
manner. The final rule clarifies that the criteria on quality assurance apply to the procedures for
implementation of expert judgment elicitation. See also the response to Comment 4.A.3.
Issue B: EPA needs to incorporate flexibility into its requirements.
1. DOE should be permitted to utilize a QA graded approach where appropriate. (DOE-D, WEC-
D)
2. Incorporate flexibility indicated in Supplementary Information into rule itself. (DOE-D)
Response to Issue 4.B:
The EPA believes that flexibility exists within the main requirements of the ASME Nuclear
Quality Assurance (NQA) series to address the graded approach issue. The ASME NQA-1
standard (Basic Requirements) states that the "program shall provide control over activities
affecting quality to an extent consistent with their importance [11.02.00:01p04]." The EPA will
evaluate DOE's use of this flexibility upon receipt of the certification application; however, EPA
has expressed concern to DOE that such flexibility be applied consistently and not be delegated
away from the overall program management level in such a way that it could be applied
arbitrarily. The EPA also believes that the citation of the ASME NQA standards incorporates all
supplementary requirements, and that no further citation is necessary. The final rule clarifies that
compliance applications shall provide, to the extent practicable, information that describes how
all data are qualified for their use in the demonstration of compliance [§ 194.22(d)]; this
statement allows flexibility in qualifying data which may not relate to critical parameters in
performance assessments.
Issue C: EPA should use specific standards for quality assurance (re: NQA series).
1. EPA must insist on the most stringent QA requirements for all aspects of WIPP. It is
encouraged that EPA use NRC QA requirements to modify some of the draft criteria. (SRIC-E)
2. The proposed rule cites NQA-1, NQA-2, and NQA-3; these standards have been updated
since the rule was published. Since NQA-1 is cited and invoked in all sections of NQA-3, NQA-
1 need not be cited. (IV-D-36)
3. Adopt requirements similar to NRC's 10 CFR Part 50, Appendix B. (NMAG-G)
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4. The selection of NQA-1, NQA-2, and NQA-3 are the appropriate QA programs for the WIPP.
(DOE-D, SNL-C)
5. Since NQA-3 was developed for high level waste disposal, it is questionable as to its
applicability. More appropriate would be "applicable portions for NQA-1, appropriately
supplemented." (IV-D-36)
Response to Comments 4.C.I through 4.C.5:
Neither the WIPP LWA nor the disposal regulations at 40 CFR part 191 expressly address the
issue of quality assurance; thus, they do not impose specific quality assurance requirements
which must be implemented in the compliance criteria. The EPA established the quality
assurance requirements in 40 CFR part 194 to ensure that compliance applications are based on
sound, quality-assured data and processes. It is not necessary to include the "most stringent"
standards available in order to meet this goal. The EPA anticipates that the certification
application will contain site characterization data, site evaluation data, facility design and
construction data, waste characterization data, and other information that is used in computer
models to demonstrate compliance for the WIPP, which is a nuclear facility. Given this, the
most appropriate standard is the American Society of Mechanical Engineers (ASME) Nuclear
Quality Assurance (NQA) series which is incorporated in the final rule. The EPA believes that
the quality assurance standards selected for inclusion in the final rule are reasonable and
appropriate because they represent a nationally accepted standard, developed under a consensus
process (including representatives of regulatory agencies), and designed to apply specifically to
nuclear facilities. Furthermore, the standards incorporated in the final rule address all major
processes and activities associated with the WIPP which EPA requires to be quality controlled.
Other standards were considered and rejected because they did not meet the goals for the quality
assurance program at the WIPP. For example, EPA's internal QAMS manual does not constitute
a nationally-accepted consensus standard. The American National Standards Institute
(ANSI) E4-1994 Standard is a consensus standard designed for national use. However, it was
developed to be applied broadly to environmental technologies and data; its application a nuclear
facility could be questionable in view of the stated scope of that standard.
The decision was made to select the 1989 and 1990 versions of the ASME NQA standards
because, taken together, they address all major processes and activities associated with the WIPP
which EPA requires to be quality controlled; they are sufficiently rigorous; and they include
adequate implementation guidance. In addition, the NQA versions cited were effective at the
approximate midpoint of the time period during which data for the WIPP was being collected;
their use imposes less of a retroactive penalty on DOE than other standards considered (including
more recent editions of NQA standards), allowing for consideration of reliable, quality "old data"
while still providing rigorous standards.
The EPA has examined the Nuclear Regulatory Commission's (NRC) quality assurance
requirements in its disposal regulations at 10 CFR part 50. The EPA agrees that the approach to
quality assurance embodied in NRC's requirements is reasonable and viable. Staff at NRC
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reviewed the QA requirements in the proposed rule, and concluded that they are substantially
similar to the NRC Appendix B approach. The final rule reflects a definition of QA that is
consistent with 10 CFR part 50, Appendix B, and incorporates standards by reference which are
consistent with the Appendix B criteria. However, EPA does not believe that it would be
appropriate to incorporate 10 CFR part 50 requirements in the final rule since NRC's
requirements were developed to apply specifically to licensees for nuclear power plants. The
ASME NQA standards, as a consensus industry standard, are designed to cover a broader range
of activities, including those expected to be conducted regarding the WIPP. Finally, EPA notes
that NRC's Appendix B requirements do not address QA of software or QA of technical data,
whereas these issues are addressed by the NQA standards, in Part 2.7 of NQA-2, and in NQA-3,
respectively. Therefore, EPA believes that the requirements of NQA-1 are substantially similar
to 10 CFR part 50, Appendix B; and that the ASME NQA standards taken as a whole address a
broader range of issues and are more comprehensive than NRC's requirements.
6. There are inconsistencies between the NQA standards and the EPA Quality Indicator
requirements found in 40 CFR 194.22. The applicability needs to be clarified and the QAMS
requirement should be deleted or include as an alternative. (IV-D-111)
7. Section 194.5 should read "reference ASME NQA-1 for design, inspection and test control
and EPA QAMS-005/80 for environmental and other monitoring data." (SGNM-D)
8. The adoption of NQA-1 is acceptable, but there are inconsistencies between NQA-1 and the
EPA's QAMS-005/80; the quality indicators are from QAMS-005/80, not NQA-1. (SNL-C)
9. Differences between NQA-1 and QAMS-005/80 should be addressed and rectified. (SNL-C)
10. This section is inconsistent with EPA's practices. (SNL-C)
Response to Comment 4.C.6 through 4.C.10:
The EPA believes that the appropriate quality assurance standards applicable to the WIPP are the
ASME NQA series, relevant parts of which have been incorporated by reference into the rule.
No other quality assurance standards are incorporated by reference into the rule. The document
referred to in several comments, EPA's Quality Assurance Management Staff (QAMS)
document number 005/80 (now obsolete), was Agency guidance applicable only to internal EPA
operations for all measurements and processes conducted by EPA. For that reason, it was not
included in the proposed rule, and has not been incorporated into the final rule. Because it is not
part of the rule, and does not apply to the WIPP, there is no need to resolve inconsistencies
between the QAMS and the NQA standards.
Several comments suggest that the list of quality indicators is inconsistent with the NQA
standards incorporated in the rule. This list of data quality indicators is based on EPA's
assessment of what is necessary to assure reliable data. The EPA believes the characteristics
cited are fully consistent with the intent and requirements of the NQA standards. The terms data
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validation and data verification have been removed from the list at §194.22(c) of the final rule to
avoid confusion. In their places, EPA has specified a list of data quality characteristics which
must be considered and documented in a compliance application. The final rule includes
definitions of these quality characteristics, in order to clarify the Agency's intent, and to lessen
confusion in interpreting these terms. The EPA believes that the data quality characteristics
included in the final rule are reasonable and sufficient to provide assurance that data has been
rigorously qualified for its use in any demonstration of compliance.
11. Delete the requirements in the proposed rule at 40 CFR 194.22(a)(l) that imposes Section II,
para. 3.3 and Section II, para. 17.1 and 17.2 from NQA-3. (DOE-E)
Response to Comment 4.C. 11:
The comment requested that the final rule exclude Section 17.1 of ASME NQA-3 ("Quality
Assurance Program Requirements for the Collection of Scientific and Technical Information for
Site Characterization of High-Level Nuclear Waste Repositories"). Section 17.1 of that standard
requires that geotechnical samples and other material samples be considered and treated as
quality assurance records. This classification would then subject such samples to several
burdensome requirements, such as a need for dual storage or fireproof storage. The EPA agrees
that the level of control associated with considering physical samples as quality assurance
records would be excessive. The Agency believes that the requirements in Section 13 of NQA-3
for handling, storage and shipping of samples are sufficiently rigorous and will ensure adequate
protection and control of such samples. Therefore, Section 17.1 of ASME NQA-3 is excluded
from incorporation by reference in the final rule, at sections §194.5 and §194.22.
Section 17.2 of NQA-3 applies to retrieval of reference records — documents and samples
referenced by final reports — from the quality assurance records system. As noted above, EPA
has excluded geotechnical samples from the definition of quality assurance records (by excluding
Section 17.1 of NQA-3 from incorporation by reference). Therefore, the Agency does not
believe that geotechnical samples are subject to the requirements of Section 17.2, since they are
not required to be treated as quality assurance records. The Agency does believe it is necessary
that documents referenced by final reports should be readily retrievable for review. The EPA
interprets the requirements of Section 17.2 to mean that documents must be retrievable from the
QA records system; samples should be retrievable from the applicable storage, in conformance
with the requirements of Section 13 of the ASME NQA-3 standard. For these reasons, Section
17.2 of NQA-3 has not been excluded from the QA requirements of the final rule.
The Agency does not believe it is necessary or appropriate to delete the quality assurance
requirements in Section 3.3 of NQA-3 which describe the application of peer review as part of a
quality assurance program. The scope of peer review requirements was narrowed in § 194.27 of
the final rule in response to concerns that such requirements were redundant with quality
assurance requirements in the rule. The EPA agreed that it would be unnecessary and
burdensome to require peer review of processes, data, or quality assurance procedures which had
already been qualified by other established means, such as those in a standard quality assurance
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program. However, as specified in the ASME NQA standards which have been incorporated by
reference into the final rule, EPA does believe that peer review can play a reasonable and
necessary part in quality assurance, where the soundness of information or procedures cannot be
assured otherwise. For these reasons, Section 3.3 of NQA-3 has not been excluded from the
quality assurance requirements of the final rule.
Issue D: The EPA is exceeding its authority from 40 CFR part 191 and the WIPP LWA.
1. EPA does not have the authority to require the implementation of certain QA programs; under
the WIPP LWA it is limited to developing criteria for certifying compliance with those disposal
regulations. (WEC-D, C-28)
2. This section should clearly state that it is intended as a criterion to evaluate whether a
reasonable expectation of compliance with 40 CFR 191.13, 40 CFR 191.15, and 40 CFR 191.24
exists. (SNL-B, SNL-C)
3. This subsection should clearly state that it will be used as a criterion to evaluate whether a
reasonable expectation of compliance with 40 CFR 191.13, 191.15, and 191.24 exists. (SNL-C)
4. The rule should simply state the documentation EPA would like the applicant to provide in
describing the DOE's engineering and operational approach. (WEC-A)
Response to Comments 4.D.1 through 4.D.4:
Several comments questioned EPA's authority to require conformance to specific quality
assurance requirements or the past precedent for doing so. Also, a number of comments stated
that EPA should clarify that its quality assurance requirements are to be used to evaluate whether
a reasonable expectation of compliance with 40 CFR part 191 has been provided in a
certification application. As to the issue of precedent, EPA has had no past precedent in the
certification of a nuclear waste disposal facility as required by the Land Withdrawal Act, and
notes that the Nuclear Regulatory Commission, which has such a precedent, has laid down
explicit quality assurance requirements at 10 CFR Part 60, and a standard at 10 CFR Part 50,
Appendix B. In its role as certifying Agency, EPA believes that confidence in the quality of data
and processes used by the applicant to demonstrate compliance with all of the 40 CFR part 191
requirements is of the utmost importance, in the eyes of both the regulator and the public. The
requirement for an adequately implemented quality assurance program conforming to an
nationally accepted quality assurance standards package is essential to obtain this confidence.
Indeed, with a compliance demonstration of a site as complex as the WIPP, it is all that more
important to ensure the quality assurance and quality control of all data and processes in the
evaluation of the application. See also the response to Comment 4.C.I, for further discussion of
the basis for selecting NQA standards. Any application must demonstrate that the requirements
of § 194.22 have been fulfilled specifically. For these reasons, the language regarding
"reasonable expectation of compliance" was not incorporated in the final rule.
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5. The completeness and quality of data used in the WIPP PA can be assured only if the Agency
requires DOE to supply data quality control information and makes provision for orderly review
both by the Agency and by the public of the data and the conclusions claimed to be drawn from
it. (NMAG-D)
Response to Comment 4.D.5:
Section 194.22 of the final rule requires that any compliance application submitted by DOE shall
include information which demonstrates that a quality assurance program conforming to the
requirements of paragraph 194.22(a) has been established and executed for specific activities and
data important to the containment of waste in the disposal system. Compliance applications
must also document that "old data" have been qualified in an appropriate manner. Finally,
applications must include information which describes how all data used to support the
compliance application have been assessed for quality characteristics. As noted, all such
information is required to be included in compliance applications, which will be examined by
EPA in determining whether the WIPP complies with the disposal regulations. Any application
will be placed in the dockets and will be available for public inspection and comment (see
§194.61 and §194.64 of the final rule). The EPA will verify appropriate execution of quality
assurance programs through inspections, record reviews and record keeping requirements, as
stated in §194.22 of the final rule. The Agency believes these requirements are reasonable to
assure the completeness and quality of data used in support of compliance applications.
Issue E: Clarification of data validation, data quality indicators, and data verification is
necessary.
1. The language in Section 194.22(c) should be modified so that the application of data quality
objectives is not retroactive. (DOE-D, SNL-C)
2. Reproducibility means that for every sample that is part of certification package, DOE must
demonstrate that the sample has been analyzed at more than one laboratory. (DOE-D)
3. Applicability of EPA data quality indicators needs to be clarified. (DOE-D)
4. Data verification will be impossible in many cases because there has not been a requirement
to collect duplicate data sets for many WIPP experiments. (DOE-D)
5. Data comparability and data verification are technically impossible to apply to existing ("old")
WIPP data. (SNL-C)
6. The requirement (§ 194.22(c)) to provide information establishing compliance with certain
quality indicators should be retained. (NMAG-D)
7. Delete the data qualification requirements in the proposed rule at 40 CFR 194.22(c). (DOE-E)
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Response to Comments 4.E.I through 4.E.7:
The EPA believes the data quality characteristics cited in the final rule are fully consistent with
the intent and requirements of the NQA standards. The final rule specifies a list of data quality
characteristics which must be considered and documented in a compliance application. The final
rule includes definitions of these quality characteristics, in order to clarify the Agency's intent,
and to lessen confusion in interpreting these terms. The EPA believes that the data quality
characteristics included in the final rule are reasonable and sufficient to provide assurance that
data has been qualified for its use in any demonstration of compliance.
Any application must provide, to the extent practicable, information which describes how all data
have been assessed for data characteristics, including data accuracy, precision,
representativeness, completeness, and comparability. The Agency is requiring the demonstration
of these data quality indicators in order to ensure that the type, quantity, and quality of data used
in WIPP decision-making processes will be appropriate for the use of the data in any
demonstration of compliance. Further, the EPA believes that these indicators will help the DOE
improve the effectiveness, efficiency, and defensibility of decisions made in a resource-effective
manner. To clarify the Agency's expectations, the final rule includes definitions of these terms
(accuracy, precision, etc.). The rigor of the analysis may differ according to the intended use of
the data, as indicated by § 194.22(d) and the NQA standards. The EPA recognizes that the
evaluation of some data quality characteristics is difficult to apply to "old data" or to apply over a
10,000-year regulatory time frame. Thus, EPA has stated in the final rule that such
documentation of these characteristics must be provided to the extent practicable, and has also
clarified that all data must be qualified with a rigor that is commensurate with the intended use of
the data in any compliance demonstration.
8. Data validation is not applicable to most WIPP data because of the 10,000-year period of
regulatory concern. (SNL-C)
9. "Validation" is difficult and cannot be done by observational data over two or three years.
Language should be added that allows validation "including extrapolation to the relevant time
period and circumstances." (NMAG-G)
10. The following should be added to §194.22(c)(l-8), "Quality indicators should include: (6)
Data Validation and (7) Data Verification." (SGNM-D)
Response to Comments 4.E.8 through 4.E.10:
The EPA notes that DOE must address the issue of data quality indicators directly as required in
the NQA standards incorporated in the rule (see Section 3 and Supplement 3SW1 of NQA-3).
The terms data validation and data verification have been removed from the list at § 194.22(c) of
the final rule to avoid confusion. In their places, EPA has specified a list of data quality
characteristics which must be considered and documented in a compliance application. The final
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rule includes definitions of these quality characteristics, in order to clarify the Agency's intent,
and to lessen confusion in interpreting these terms. The EPA believes that the data quality
characteristics included in the final rule are reasonable and sufficient to provide assurance that
data has been rigorously qualified for its use in any demonstration of compliance. Further, EPA
believes that the list of data quality characteristics is fully consistent with the intent and
requirements of the NQA standards incorporated in the final rule.
Regarding data validation in particular, EPA considers data validation a quality assurance
measure which is applied to all field or laboratory data as they are collected, for the purpose of
assessing overall quality of the data, screening outliers, etc. As discussed in several comments,
validation of the predictions of a model could be complicated by the 10,000-year time frame,
although EPA expects model and software validation to be conducted to the extent practicable
for the WIPP, consistent with the requirement of the NQA package cited at §194.22, and with the
criteria for models and codes at §194.23. For further discussion of the data quality indicators, see
response to Comment 4.E.I.
Issue F: There is a need to incorporate a flexible approach regarding QA of "old" data.
1. A flexible approach on QA for "old data" is the only reasonable route. The objective is to use
good data and not discard good data because of a technicality. (IV-D-51)
2. Flexibility in the approach regarding the QA of "old" data is appropriate and necessary.
(DOE-D, IV-D-76, IV-D-100)
3. Retrofitting old data to the new process will add time and money without additional safety.
(C-24)
4. The qualification of information collected prior to implementation of the quality assurance
program is an overly burdensome requirement. (WEC-D)
5. Subsection 194.22(b) should state that other alternative methods to be considered by the
Administrator include, but are not limited to, publications, confirmation by additional
experimentation, confirmation by the original investigator, and assurance by a peer review panel.
(SNL-C)
6. Endorse NQA-3 Supplement 3 SW-1, which addresses controls for qualification of data of
indeterminant quality. (DOE-D)
7. The requirements fail to state what criteria will be applied in assessing the qualifications of
data gathered before the institution of a quality assurance program. (NMAG-B)
8. Application of the proposed regulation to existing data that have already been developed is
technically not feasible, and should not be required. (SNL-C)
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9. All old data should be subjected to rigorous review process, including independent peer
review. (CARD-B, A-09)
10. The regulation does not show how requiring applicants to spend additional money to
reconfigure data that have already been computed and reported will enhance the safety of WIPP.
(A-34)
11. The draft criteria adequately address the topic of data obtained before quality assurance was
adopted, and use of expert judgment. (EEG-C)
12. A flexible approach for acceptance and inclusion of "old data" is justified. (SGNM-D)
13. Retain the flexible approach to data qualification, with specific reference to "flexibility" in
the text of 40 CFR part 194.22(b). Similarly, revise 40 CFR part 194.22(b) to state that only data
used to support a certification application is subject to qualification. (SNL-D)
14. The Agency should articulate criteria for its approval of quality assurance programs for "old
data." (NMAG-D)
15. There is a need for approved and documented procedures for the use of old data. Other
issues related to "old data" quality include independence of reviewers, necessary tests to be met
by data which are deemed qualified, QA requirements, etc. (NMAG-D)
16. Revise 40 CFR part 194.22(c) to eliminate any implication of retroactivity, and to add
applicability statements as previously recommended. (SNL-D)
17. Criteria need to be developed for an alternative method for a quality assurance program.
(NMAG-D)
Response to Issue 4.F:
The EPA believes that it is of utmost importance to have confidence in the quality of data which
are used in the WIPP compliance demonstration. The Agency is aware that such data have been
collected over a twenty-year period under a variety of quality assurance program approaches
which have been implemented to varying degrees. The EPA agrees that it is important to be
balanced in order to avoid establishing retroactive standards that would exclude existing data that
is reliable and of sound quality. In the interest of maintaining a balanced approach, the final rule
allows alternative methodologies to be used in qualifying old data, but also requires that
application of such methodologies must be approved by the Administrator.
Several comments requested that the final rule specify criteria or alternative methodologies for
qualifying data collected prior to the implementation of a quality assurance program meeting the
requirements of the NQA standards incorporated by reference in the final rule. In the interest of
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providing a balanced approach, while ensuring confidence in all data used in support of a
compliance application, EPA has identified four alternative approaches which may be acceptable
to qualify existing data. Since there is little previous experience in qualifying such data, the final
rule also requires approval by the Administrator for the use of alternative methodologies for
WIPP-related data. The four approaches which EPA may allow are:
• Establishing that data were collected under a quality assurance program which
was substantially equivalent in scope and implementation to that required to be
implemented by the final rule — namely, the ASME NQA standards which are
incorporated by reference. This is the most desirable approach since it directly
establishes confidence in the body of data to be qualified, based on the existence of an
implemented quality assurance program.
• Use of peer review, consistent with NUREG-1297, "Peer Review for High-Level
Nuclear Waste Repositories." Conformance to the guidelines established by
NUREG-1297 will ensure that the process is conducted using qualified and independent
peers, employs a formal process with clear objectives, and is adequately documented.
The purpose of the peer review would be to evaluate the overall adequacy of work which
generated the data under examination, and to establish whether the planning and
implementation of such work provide adequate confidence that the data are suitable for
their use in any compliance demonstration.
• Use of corroborating data. This would involve a formal comparison of the data to
be qualified with all other bodies of data from similar work which have been published in
scientific journals; and a systematic assessment of the confidence that can be afforded the
body of data to be qualified, due to agreement with similar work. Factors which need to
be addressed for this approach to be viable include consideration of all similar studies,
and a means for assessing the quality of published studies.
• Use of confirmatory testing. Data from studies of indeterminate quality could,
under some circumstance, be partially re-measured under adequate quality assurance. It
would be necessary to determine the confidence attained by re-measurement, by using a
statistically significant number of data points.
These four alternative approaches to data qualification are informed by guidance in
NUREG-1298, "Qualification of Existing Data for High-Level Nuclear Waste Repositories."
However, there is currently no implementation guidance available to use these approaches to
develop viable methodologies for data qualification. Hence, the final rule requires approval by
the Administrator of any alternative methodology employing one or more of these approaches.
The underlying important principle which emerges from quality assurance requirements in the
final rule is that all data used in the compliance demonstration need to be assessed to be adequate
to meet the quality needs of their intended use. Paragraph 194.22(b) of the final rule explicitly
applies to data and information collected prior to the implementation of a quality assurance
program that meets the requirements of the NQA standards cited. In response to public
comments, the final rule specifies four approaches that may be acceptable for use to qualify data
collected prior to implementation of a quality assurance program as noted. Application of these
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approaches to develop methodologies and apply them to WIPP-related data must be approved the
Administrator.
Issue G: The following should be added to §194.22(a)(2)(ip, "indefinite environmental
monitoring" and "continuous drilling fluid monitoring for radioactive elements for oil and
gas drilling within a projected distance from WIPP." (SGNM-D)
Response to Issue 4.G:
The final rule requires that the quality assurance program must be implemented for
"environmental monitoring, monitoring of the performance of the disposal system, and sampling
and analysis activities;" see §194.22(a)(2)(ii). Paragraph 194.22(a)(2)(viii) also requires
implementation of a quality assurance program for "[o]ther systems, structures, components, and
activities important to the containment of waste in the disposal system." Thus, drilling activities
by the Department, if they provide data used to support a demonstration of compliance, would be
subject to quality assurance requirements. It is not necessary to include such actions specifically
since they are covered by the provisions mentioned above. Drilling by parties other than the
Department would be subject to drilling regulations under the State of New Mexico and/or the
U.S. Department of the Interior (Bureau of Land Management), and would not be bound by the
QA requirements of this rule since their activities are not in support of a compliance
demonstration. Drilling regulations for resource exploration are separate from this rule, and are
enforced by regulatory agencies other than EPA. It would be unnecessary and inappropriate to
implement them in the compliance criteria.
Issue H: Quality Assurance Plans should also include "Data from Laboratory
Measurements." (SGNM-D)
Response to Issue 4.H:
The final rule requires that any quality assurance program be executed and implemented for
"[t]he collection of data and information used to support compliance application(s)
[§ 194.22(a)(2)(vii)]." Laboratory data and measurements relied upon or required in compliance
applications are included in this category, and thus are subject to the quality assurance
requirements of this section.
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Section 5: MODELS AND COMPUTER CODES: SECTION 194.23
Issue A: There are differences between the standards in 40 CFR part 191 and 40 CFR
part 194.
1. Part 191 does not set standards or requirements for independent or other computer modeling,
thus 194 is irrelevant. (C-28)
Response to Comment 5.A.I:
Performance assessments must provide a reasonable expectation that the WIPP will meet the
containment requirements of § 191.13. The basis of the demonstration of compliance with the
containment requirements is performance assessment, accomplished in part through the use of
computer modeling. Section 194.34 of the final rule establishes statistical requirements on the
results of performance assessments; those requirements speak to the issue of "reasonable
expectation." The EPA believes that a reasonable expectation of compliance is also based on
confidence that the information and methods used to conduct performance assessments are valid
and reliable. Thus, although there is no explicit requirement for computer models in the disposal
standards, the computer and model requirements are relevant and are within EPA's authority to
implement 40 CFR Part 191 at the WIPP.
2. If this subsection (194.23) is to be used in the Agency determination of reasonable expectation
compliance for 40 CFR part 191 sections 13, 15, and 21, then the subsection should so state.
(SNL-B, SNL-C)
Response to Comment 5.A.2:
Any application must demonstrate that the requirements of §194.23 have been fulfilled
specifically, and can not meet the requirements of this section by stating that other compensating
factors establish a reasonable expectation of compliance. Therefore, EPA believes it is
inappropriate to include the suggested language in the final rule.
3. The differences between the compliance demonstration requirements of 40 CFR 191.13,
191.15, and 191.24 are not reflected in the rule. (SNL-C)
Response to Comment 5.A.3:
The rule does separately address the compliance demonstration requirements of the containment,
individual, and ground water requirements. Statistical requirements regarding the results of
performance assessments (for the containment requirements) and compliance assessments (for
the individual and groundwater requirements) are articulated separately in the final rule at
§ 194.34 and § 194.55, respectively. Other provisions of the rule are not differentiated because
they apply to demonstrations of compliance for all the requirements. For example, data
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contained in compliance applications are subject to the quality assurance requirements of
§194.22 regardless of whether the data are used in performance assessment for containment
requirements of § 191.13, or for a compliance assessment pertaining to the individual protection
requirements of§191.15.
Issue B: There is a need for flexibility and criteria for the models and computer codes.
1. EPA should not be telling DOE what codes or theories it can or have to use for its analysis.
(IV-D-06)
Response to Comment 5.B.I:
The compliance criteria do not dictate to DOE what specific codes or theories it must use in its
analysis. The DOE may select the models and codes for performance assessments, but must
substantiate and justify the codes and theories that are used for EPA's review in the certification
rulemaking. Section 194.23 of the final rule establishes basic criteria which models and codes
must fulfill (e.g., that conceptual models and scenarios reasonably represent possible future states
of the disposal system, and that computer models accurately implement numerical models), and
specifies the minimum documentation of models needed to allow EPA to evaluate whether the
choice and implementation of models and codes in compliance applications is adequate.
2. EPA should provide assurances that a graded approach to documentation applies to WIPP
codes. (CARD-B)
Response to Comment 5.B.2:
It is expected that all codes used to model the performance of WIPP will have appropriate
documentation. Large, complex codes would be expected to have documentation that explains
the entire code, while smaller codes would require the same type of information, but the amount
of documentation would likely be less. That is, the level of quality assurance required is the
same for all codes, but the amount of documentation needed to fulfill quality assurance
requirements, as required in ASME NQA-2, Part 2.7 (incorporated by reference in the final rule),
is commensurate with the complexity and number of functions for which the code is used. In its
review of DOE's application for certification, EPA will examine documentation of codes. The
final rule does specify minimum information which must be included in compliance applications
for all codes; any compliance application must include detailed descriptions of the structure of
computer codes and complete listings of the source code, as well as a description of how
computer codes incorporate the effects of correlation of parameters. Such information is
reasonable and necessary to provide EPA adequate information to evaluate computer codes. The
Agency intends to conduct detailed reviews of the computer codes used in performance and
compliance assessments, since it is the results of computer codes themselves that will be
compared to the numerical requirements found at section 13 of 40 CFRpart 191.
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3. EPA must have requirements that account for possible lack of sufficient data support for
inferences, failure to account for all available data, and failure to account for all processes
believed to apply. (NMAG-B)
4. Conceptual models must be based on experimental data and mathematical expressions which
account for the relevant factors in the conceptual models. (NMAG-F)
Response to Comments 5.B.3 and 5.B.4:
Since the final rule requires that models (including information on natural processes expected to
occur at the WIPP) and data need to be documented and substantiated, EPA believes that the rule
addresses these concerns. Compliance applications must provide information on and
descriptions of models and computer codes which will permit the Agency to conduct a review of
the modeling approach, theoretical bases, and the methodology employed in developing the list
of processes and events used to support the compliance application. Section 194.23 specifies the
types of information which must be included in compliance applications for conceptual models,
mathematical models, numerical models, and computer codes. The EPA will review the
application to determine if it is complete and appropriately accounts for data and processes.
The Agency does recognize the importance of conceptual models, and their incorporated
assumptions, in accounting for processes expected to occur at the WIPP and for available site
characterization information. Examination of alternate conceptual models can help EPA evaluate
the soundness of the process by which the final conceptual models of disposal system behavior
were developed and also provide insight into the effect that changing certain assumptions might
have on the predicted behavior of the disposal system. Therefore, the final rule requires that
DOE describe plausible, alternative conceptual models seriously considered but not used to
support compliance applications, and an explanation of the reason(s) why such model(s) was not
deemed to accurately portray performance of the disposal system. In addition, compliance
applications must include documentation that conceptual models and scenarios reasonably
represent possible future states of the disposal system; such documentation would include a
discussion of the theoretical basis and the relationship of modeling assumptions to experimental
data which supports or contradicts such assumptions. Finally, conceptual models selected and
developed by DOE for use in compliance applications are subject to the peer review requirements
of the final rule [§194.27]. See also the response to Issue 5.1.
5. The EPA should avoid those situations where it independently models the design or
performance of the WPP where this modeling does not represent the manner in which DOE
proposes to operate the facility. (IV-D-100)
Response to Comment 5.B.5:
It is incumbent upon DOE to provide the models of the repository. The EPA does not intend to
conduct a separate performance assessment, but the Agency may use other models, as
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appropriate, to verify DOE's performance assessment. When the Agency uses other models to
verify DOE's models, the modeling will be suitable to the disposal system. The DOE will be
expected to provide the pertinent information in compliance application documentation so that
EPA can appropriately model the performance of the repository.
6. To determine which models are appropriate EPA must review DOE's plan to identify the
scenarios requiring consideration, and on that basis determine the conceptual models required.
(NMAG-F)
Response to Comment 5.B.6:
The final rule requires that DOE describe and justify the selection both of conceptual models and
of processes and events determined to be within the scope of performance assessment. [See
§ 194.23 and § 194.32.] The EPA will review the information provided in the application to
determine if all valid scenarios have been considered and if the models are appropriate. See also
the response to Comment 5.B.3.
7. EPA should not rely on a single set of conceptual models when evaluating compliance with
the numerical limits (i.e., containment requirements, individual protection requirements, and
ground water protection requirements) of Part 191, unless all plausible alternatives can be
definitely ruled out. It is recommended that EPA consider results from alternate conceptual
models when making its decision. It is also recommended that EPA not allow a range of
competing alternate conceptual models to be combined in performance assessment calculations.
(NRC)
Response to Comment 5.B.7:
The issue of conceptual models is important to the Agency. The EPA is requiring the applicant
to include information on plausible alternative conceptual models seriously considered but not
used to support compliance applications. The DOE must also explain the reasons why such
plausible models were not deemed to accurately portray performance of the disposal system. It is
EPA's intent, from this information on alternative models, to review the appropriateness of the
final model used. The compliance criteria do not require multiple conceptual models to be
compared directly based on their impact on performance assessment results; the Agency believes
that this approach might lead to selection of the least conservative model, rather than selection of
a realistic or accurate model. Rather, DOE must document in its compliance application that the
conceptual models implemented in PA reasonably represent possible future states of the disposal
system.
The EPA will not be restricted in its review of the WIPP modeling. Examining results from
alternative conceptual models is one possible evaluation method. Because the containment
requirements consider human intrusion while the individual and ground water protection
requirements do not, it will be necessary for DOE to use various conceptual models. This
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information should be apparent in the application. As noted above, the DOE must provide
documentation of the models so that the Agency can determine if they are selected and used
appropriately.
Issue C: The track record of DOE in dealing with a successful radioactive waste disposal
site should be factored into EPA's probabilistic models. (S-07)
Response to Issue 5.C:
The Agency will review the documentation provided in DOE's compliance application to
determine whether DOE is in compliance with the disposal regulations at 40 CFR part 191. The
Agency recognizes that uncertainty cannot be fully eliminated from performance assessment.
Therefore, performance assessments and compliance are required to account for uncertainty in
calculations, and EPA has required that compliance with numerical limits be demonstrated to
within specific statistical confidence limits. In addition, assurance requirements were included in
the disposal regulations to complement the numerical containment requirements and add
confidence in the long-term performance of the disposal system.
Issue D: Additional peer review of models and computer codes is unnecessary and
cumbersome. (DOE-D, SNL-C)
Response to Issue 5.D:
The Agency believes that in order for computer models to perform their function with acceptable
accuracy, they must be based upon appropriate conceptual, mathematical, and numerical models.
Peer review is an accepted method to achieve this goal, and is customary throughout industry for
computer codes and models. Section 194.27 of the final rule, Peer review, requires that
conceptual models selected and developed by the DOE for use in compliance applications must
be peer reviewed. Other levels of models and computer codes may undergo peer review, but peer
review is not required. While only conceptual models are required, a priori, to undergo peer
review, all levels of computer codes and models must be described and documented, pursuant to
the requirements of §194.23. The Agency believes peer review of conceptual models is
important because they embody the most basic models and assumptions upon which performance
assessments and compliance assessments are based. Models which already have undergone peer
review will not be required to do so again.
Issue E: EPA must adequately address climate change in all its predictive models and
assumptions. (A-43, A-48)
Response to Issue 5.E:
Climate change is required to be incorporated into the disposal system modeling. The issue of
climate change is specifically addressed under §194.25, Future states assumptions. The DOE
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must incorporate climate change into the appropriate models, and EPA will review the models to
ensure that it has been adequately incorporated. There are multiple ways in which climate
change can be incorporated into the modeling, and DOE must justify the approach ultimately
used in the application. At a minimum, DOE shall consider the effects of increased precipitation
(as compared to present conditions) on the disposal system [see §194.25].
Issue F: It would be difficult to verify model results and observed data.
1. It may not be feasible to provide information used to verify the results of the computer
simulation in 30 days; use a reasonable period of time. (WEC-D)
Response to Comment 5.F.1:
It is necessary to require DOE to promptly provide information for verifying computer
simulations in order for EPA to make a certification decision in a timely manner. If the computer
codes, data files, and hardware are documented properly, EPA believes that the 30-day request
time is adequate and reasonable.
2. Demonstrating agreement between model results and observed data is impossible given the
regulatory time frame. (SNL-C)
3. It is not possible to demonstrate agreement between data and model results because the
10,000-year period of performance is far beyond any reasonable data collection period. (DOE-D,
C-12)
4. EPA should require agreement between model results and measured and observed data.
(SGNM-A, IV-D-06)
5. While it can be helpful if there is information demonstrating agreement between modeled and
measured results, voluntary submission of such data should be encouraged but not required.
(IV-D-51)
6. The EPA should not limit its ability to assess the performance of the models and/or codes by
using an arbitrary approach; that is, whether models should be used to reproduce the data
faithfully or conservatively. (IV-D-100)
7. The rule as to models and codes should require DOE to discuss conceptual models considered
and rejected, to include covariance in its models, and to show a high degree of agreement
between models and measured data. (NMAG-D)
8. The Agency should retain the requirement that a high degree of agreement exist between the
model and measured data. (NMAG-D)
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Response to Comments 5.F.2 through 5.F.8:
The ability to verily model results depends on the process being modeled. For some short-term
processes for which data have been collected, such as with room closure and gas generation
models, it is possible to compare the models with measured data for an appropriate time period
represented by the data. In such instances, EPA expects that such information would be used
document whether conceptual models reasonably represent possible future states of the disposal
system; such justification is required by the final rule. The rule does not state, nor does EPA
expect, that agreement between model results and observed data can be demonstrated for 10,000
years. While it is impossible to demonstrate agreement between data and model results for long-
term processes over a 10,000-year time frame, the use of peer review of data and models,
computer code quality assurance procedures, benchmarking and other measures can contribute to
increased confidence that the disposal system will perform within expected limits. The use of
peer review and quality assurance are addressed in other sections of the rule. Section 194.23
requires that, at a minimum, compliance applications provide appropriate documentation of
models and codes supporting their selection and implementation.
Issue G: With current technology, computers should be able to account for the curie load
in a real-time sense. (S-53)
Response to Issue 5.G:
The EPA agrees that the decay of radionuclides is an integral part of the performance assessment
calculations that can be readily incorporated into models. In estimating potential releases from
the disposal system, the performance assessment codes will need to incorporate radionuclide
decay for each radionuclide and the subsequent activities to determine compliance with the
containment requirements and the individual and ground water protection requirements. In its
evaluation of DOE's codes, EPA will examine whether the decay has been appropriately
incorporated.
Issue H: The requirement for covariance is inappropriate.
1. Covariance is not an appropriate consideration for the rule. (DOE-D, SNL-C, A-45, IV-D-51)
2. It is not unreasonable to ask DOE to make covariance calculations. (SGNM-A, SGNM-B)
3. The subsection on covariance should be deleted because of its questionable technical basis.
(SNL-C)
4. It is suggested that EPA not impose a blanket requirement for a covariance study on DOE but
use the technique as a part of the regulatory process where valid results would be expected.
(IV-D-100)
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5. It is essential to deal with correlations among variable parameters. (NMAG-E)
6. DOE should be required to account for covariance in its computer models. (SRIC-G)
7. EPA should retain its requirements for the treatment of covariance. (NRC)
Response to Issue 5.H:
The intent of the rule is for the correlations of dependent sampled parameters (i.e., parameters
using distributions) to be considered in the computer codes and models. Thus not all input
parameters are subject to the covariance requirement; for input parameters which are not
sampled, or which can be demonstrated to be independent of other variables, DOE need not
account for correlation. The EPA believes that treating all variables as independent would be an
unrealistic assumption, and could introduce significant error in the results of compliance
assessments. The final rule requires that compliance applications include documentation of how
models and computer codes incorporate the effects of parameter correlation. In cases where
neglecting correlation between variables is not expected to significantly affect the results of
modeling, the final rule would not require models to include covariance, but the compliance
application would be required to explain the technical basis for the determination that results will
not be affected by the exclusion of correlation between parameters.
Issue I: The request for rejected models is excessive.
1. The request for listing of conceptual models is too open-ended. (DOE-D, SNL-C)
2. The DOE should not be required to defend what it did not do. Models not used should be
documented only to the extent that they reasonably represent the disposal system. (DOE-D,
SNL-B, SNL-C)
3. The EPA's request for rejected models is not related to health and safety. (A-45)
4. It would be counterproductive and a grave error to require DOE to identify and describe all
models considered. (IV-D-51)
5. The provisions to provide a complete listing and description of all models and codes
considered are inappropriate. (DOE-A, WEC-D)
6. It would seem prudent to focus on the adequacy of the codes and models used in the
performance assessment to show compliance rather than to dilute valuable resources on material
unrelated to compliance assessment codes. (IV-D-100)
7. The requirement for the applicant to show all conceptual models considered and how and why
a particular model was chosen is a very important and wise requirement. (EEG-C)
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8. The question of conceptual model uncertainty is so important and otherwise neglected that the
requirement should be retained. (NMAG-D)
9. DOE must be required to submit a complete listing of conceptual models considered but not
used in support of an application. (SRIC-G)
10. The proposed 40 CFR part 194.23(a)(2) creates an extra burden and unnecessary
documentation for the applicant to follow. (IV-D-65)
11. The requirement as stated appears to be unnecessary and any direct benefit to the
certification process is not clear. Since the disposal standards are performance standards and not
technical standards this approach should be deemed adequate and reasonable. (TV-D-111)
12. It is unreasonable and unnecessary for EPA to require that DOE defend information, such as
rejected conceptual models, that is not included in compliance applications. (DOE-A)
13. It is recommended that EPA should require that only a range ofplausible or credible
alternatives be explored and considered in detail by the applicant. (NRC)
Response to Comments 5.1.1 through 5.1.13:
Public comments have stated that the proposed rule was unreasonably burdensome in requiring a
listing and description of all conceptual models that were considered but not used to support
compliance applications. In the proposed rule, the Agency had required submission of this
complete listing of alternate conceptual models in order to evaluate the soundness of the process
by which the final conceptual models of disposal system behavior were developed and also to
provide insight into the effect that changing certain assumptions might have on the predicted
behavior of the disposal system. The Agency recognizes, however, that the development of
conceptual models may begin in the early stages of repository development, before a complete
site characterization has been achieved and in-depth experimental programs have been
performed. As a result, some conceptual models considered may have been preliminary in nature
and, in light of later information, be found not to provide accurate portrayals of disposal system
performance. Further, some conceptual models could have been reviewed initially but screened
out quickly because they contained assumptions that were clearly incompatible with conditions
known to exist at the WIPP. The Agency believes that a review of these preliminary conceptual
models will provide little insight into the technical adequacy of the final performance
assessments, the development of which will presumably be based on more thoroughly developed
and accurate conceptual models.
However, in the different case of plausible conceptual models — even those which may ultimately
be replaced — the Agency does believe that a review can provide beneficial insight into the
adequacy of the performance assessment that is contained in the compliance application. Models
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which are seriously considered but ultimately not used may contain different assumptions from
those contained in the final conceptual models used in performance assessments. For example,
there are multiple, plausible conceptual models for ground water flow in the Culebra Dolomite.
The Agency believes that by reviewing alternate conceptual models, the Agency can better
understand the effect of model choice on the results of long term predictions. The EPA believes
that it is especially important to examine the impact of different assumptions in conceptual
models regarding the processes and events that can have an effect on the disposal system. Hence,
the final rule requires that compliance applications include description of plausible, alternate
conceptual models seriously considered but not used to support the compliance application, and
requires that an explanation be provided of why these alternate conceptual models were deemed
not to accurately portray disposal system performance. The EPA does not expect that DOE
should provide the same level of documentation for rejected models as it does for models that are
used to support compliance applications. For the models not used, the application should list
(identify) these models and provide enough information so that the Agency can understand the
modeling approach, method of analysis and the assumptions underlying these analyses. The final
rule also requires that conceptual models selected and developed by DOE for use in compliance
applications must undergo peer review according to the requirements of § 194.27. For further
information, see also the response to Comments 5.B.3 and 5.B.4.
14. Additional modeling over and above the models which have already been created and those
which might be included with the application would be totally useless and would only propagate
uncertainty. (IV-D-111)
Response to Comment 5.1.14:
The EPA is not requiring modeling in addition to what is included in performance assessments
and compliance assessments. The Agency is requiring that DOE justify the selection of
conceptual models and include descriptions of plausible conceptual models seriously considered
but not selected for use. The Agency believes justification of the choice of conceptual models is
especially important because they embody the most basic models and assumptions upon which
performance assessments and compliance assessments are based. For the models not used, the
application should describe these models and provide enough information so that the Agency can
understand the modeling approach, method of analysis and the assumptions underlying these
analyses. The final rule does not, however, require that DOE perform additional modeling using
these alternate models. See also the response to Comment 5.B.7.
Issue J: EPA needs to determine the factors used to select appropriate computer models
and codes.
1. EPA should specify which models need to be included in application ("model" is a very broad
term). Also, a description of each model should be required (specifically for numerical,
computational, conceptual, and mathematical). Further, the consideration of alternative models
should be described and justification provided for the rejection of any models. (NMAG-G)
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2. The application should include detailed scientific and technical justification for each model
used directly or indirectly in support of the application. (NMAG-D)
Response to Comments 5.J.I and 5.J.2:
The compliance criteria do not specify the models to be used for performance or compliance
assessments. Rather, the application must describe the models that have been used. Plausible,
alternative conceptual models seriously considered but rejected must be discussed, although the
information necessary for rejected models is not as intensive as the requirements for the models
and codes actually used for compliance applications. The final compliance criteria require that
DOE document that conceptual models and scenarios reasonably represent possible future states
of the disposal system; that mathematical models incorporate equations and boundary conditions
which reasonably represent the mathematical formulation of the conceptual models; that
numerical models provide numerical schemes which enable the mathematical models to obtain
stable solutions, and that computer models accurately implement the numerical models
[§ 194.23(a)(3)]. In addition, computer codes must be documented in accordance with the
requirements of ASME NQA-2a-1990, Part 2.7, incorporated by reference, and the requirements
of § 194.23(c) of the final rule. The EPA believes that documentation in this manner should
provide the information needed by the Agency to evaluate the accuracy and adequacy of models
and codes used in compliance applications. See also the response to Comments 5.1.1
through 5.1.13.
3. EPA should not limit itself as to the factors it will use to assess the appropriateness of
computer codes and models. (IV-D-06)
Response to Comment 5.J.3:
The Agency has not limited itself on the factors used to assess whether computer codes and
models are used appropriately in compliance applications. The final rule does establish what
documentation is required for conceptual, mathematical, numerical, and computer models in a
compliance application. [See §194.23(a)(3) of the final rule, and the response to Comment 5.J.1
of this document.] The documentation requirements establish the minimum justification needed
for models and codes. For example, conceptual models and scenarios must reasonably represent
possible future states of the disposal system. The EPA is also requiring that detailed descriptions
be provided for all models and codes, including theoretical background, discussion of the limits
of applicability, and reports on quality assurance procedures applied. Such information will
allow EPA to evaluate many aspects of models and codes to determine if they have been selected
and applied appropriately. Finally, as specified in the final rule, EPA may verify the results of
computer simulations by performing independent simulations.
4. EPA should provide an explanation of how it will evaluate what constitutes a computer
model's reasonable representation of the WIPP facility. (WEC-D)
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Response to Comment 5.J.4:
A computer model's representation of the facility depends largely on the conceptual model which
forms the basis of the computer model. If a conceptual model is appropriate, then the measures
of a computer model's adequacy are objective and functional, if the appropriate quality assurance
has been performed on the code. That is, the computer model's adequacy depends primarily on
whether the implemented computer code is free of coding errors. The decision on whether a
conceptual model reasonably represents the disposal system can be difficult. Because such
decisions are complicated and can be subjective, EPA has placed additional requirements on
conceptual models. The DOE must submit information on rejected models, and the selection and
development of conceptual models by DOE is subject to peer review, pursuant to § 194.27 of the
final rule. See the response to Comment 5.1.1 of this document for further discussion of
conceptual models.
Issue K: Participants in the rulemaking must have access to all computer models and the
authority to request additional CCDFs.
1. The final rule must ensure that participants can require DOE to produce additional CCDFs
that use other data and assumptions provided by the person making such a request. (SRIC-E)
2. Participants in the certification rulemaking should be able to have access to all models,
computer codes, and information necessary to generate their own CCDFs, or range of CCDFs.
(SRIC-E, CCNS-B)
Response to Issue 5.K:
The final rule requires that DOE must provide EPA access to all materials or information
required to verify the results of computer simulations [§194.23(d)]. The rule requires that
numerous CCDFs be generated, and the Agency will have the capability to produce CCDFs as it
believes necessary during the review of the application. The EPA considered that some members
of the public could have an interest in performing additional simulations. However, given the
number and complexity of tools required to perform such simulations, EPA determined that it
would be an undue burden if DOE were required to make such material available to the public.
The Department is required to provide extensive documentation on the computer models and
codes used in any compliance application. This documentation includes computer codes and
detailed descriptions of the computer codes. In addition, compliance applications must include
detailed instructions for executing computer codes used in performance assessment calculations.
The Agency plans to place copies of any application and such supporting documents in the
docket for examination by the public. The EPA believes that such documentation will provide
adequate information to allow the public to comment on the adequacy of DOE's models.
Further, EPA notes that the public may comment to EPA during the certification rulemaking that
a particular simulation should be performed.
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Issue L: There is no "best" model, only "appropriate" and "inappropriate" ones. (DOE-D)
Response to Issue 5.L:
The Agency agrees with this comment. While having the "best" model is the ideal situation, this
is usually impossible, and models that satisfy the rule's requirements and satisfactorily model the
physical situation are acceptable. Any references to "best models" have been eliminated in the
final rule and preamble.
Issue M: The rule should list each parameter in the application for which a model is to be
provided. (NMAG-D)
Response to Issue 5.M:
The DOE must submit documentation on all conceptual, mathematical, numerical, and computer
models used in a compliance application. General descriptions of each model must be provided
in compliance applications, including detailed explanations of each input and output parameter.
Required documentation also includes detailed descriptions of data collection procedures,
sources of data, data reduction and analysis, and code input parameter development. Finally,
DOE must account for the effects of correlation between dependent parameters. The EPA
believes such documentation will adequately indicate what processes and parameters are
included in models.
Issue N: The following should be added to §194.23, "Models and codes used to support the
compliance application shall be fully and clearly documented in a manner compatible with
NUREG 0856 'Final Technical Position on Documentation of Computer Codes for High
Level Waste Management.'" (NMAG-D)
Response to Issue 5.N:
The EPA has considered such a requirement and determined that the intent, scope and
implementation of NUREG-0856 is substantially similar to the requirements of NQA-2a-1990
addenda, part 2.7 to NQA-2-1989 edition, in terms of documentation requirements (such as a
description of mathematical models and numerical methods). The specific documentation
requirements articulated in the final rule, combined with requirements incorporated by reference
in the NQA standards, address areas included in the NUREG. The NQA standards incorporated
by reference into the final rule are a nationally accepted standard, developed through a consensus
process (including participation by regulatory agencies), and designed to address the specific
needs of a nuclear facility. (See Section 4 of this document for further discussion of the selection
of quality assurance standards incorporated into the final rule.) The EPA believes that the
requirements of the ASME NQA standards taken as a whole address a broader range of issues
and are more comprehensive than NRC's requirements. The EPA does not believe that
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incorporation of the NUREG would provide additional information or assurance that models and
codes have been appropriately selected and implemented.
Issue O: A method is lacking for verification of computer modeling which analyzes risk
and probability of occurrence for natural hazards/events and anthropogenic processes and
hazards. (SGNM-D)
Response to Issue 5.O:
Any computer models used to conduct such analyses must be documented to the same degree as
all other models used in support of compliance applications. Several other sections of the rule
also contain requirements relevant to the features and processes considered in performance
assessments and compliance assessments. For example, paragraph §194.32(e)(3) of the final rule
requires the Department to justify why any processes and events were not included in
performance assessments. The preamble to the final rule clarifies EPA's approach to evaluating
the likelihood of processes and events. In addition, § 194.27 requires that peer review be
conducted of all conceptual models selected and developed by DOE for use in compliance
applications. The probability of occurrence of some events maybe subject to peer review under
this requirement, since the selection and evaluation of scenarios are central to the formulation of
conceptual models. Further, estimation of the probability of occurrence is subject to the quality
assurance and expert judgment requirements of the final rule, as applicable (see §194.22 and
§194.26). The EPA believes that the above criteria are adequate to ensure that DOE objectively
evaluates the probability of events.
Issue P: EPA should adopt a definition for "conceptual model" similar to that used by
Bonano, where the conceptual model describes the physical and/or chemical processes
taking place, the variables that relate to these processes, including boundary conditions
and the spatial and temporal scales of the assumed processes (Bonano, 1988) or similar to
that used by Tsang (Tsang, 1991), where a site specific conceptual model consists of three
main components: structure, processes, and boundary and initial conditions. (NRC)
Response to Issue 5.P:
The comment refers to multiple definitions for the use of conceptual models, suggesting that
alternative definitions of conceptual model are acceptable. While EPA has declined in the final
rule to define the term conceptual model, usage of the term in the final rule is compatible with
definitions described in the comment. Conceptual models provide a broad overview of the
disposal system, including processes which may occur during the regulatory time frame at the
WIPP, and may incorporate some simplifying assumptions regarding behavior of the system. In
the final rule, EPA has required that compliance applications document conceptual models, with
an emphasis on the justification of why selected models are appropriate for the disposal system.
Documentation of conceptual models of necessity should discuss site characteristics — including
the processes active on the site, the scale at which they operate and existing initial conditions
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(e.g., groundwater flow) — similiar to those discussed by Tsang. In addition, the data collected as
part of the site characterization effort should be used by DOE in establishing initial conditions for
the disposal system. Rather than specifically defining terms such as conceptual model or
mathematical model, EPA has instead chosen in the final rule to specify what information must
be provided on models used. The information required to be included in compliance applications
by §194.23 is intended to provide EPA with an understanding of the entire progression from
conceptual models to computer models and codes which are implemented in performance
assessments. Although EPA has not defined conceptual model as requested in the comment, the
final rule does require documentation of the factors described in the comment.
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Section 6: WASTE CHARACTERIZATION: SECTION 194.24
Issue A: An exact characterization of the wastes prior to disposal is necessary.
1. The DOE application must be based on detailed information about the specific waste being
disposed. (CARD-A, A-08, A-12, A-18, A-46, A-60, S-3)
2. An exact characterization of the waste must be developed. (SGNM-C, S-53)
3. DOE's application should disclose detailed information about the specific wastes to be
disposed. (S-37, IV-D-06, IV-D-13, IV-D-14, IV-D-15, IV-D-16, IV-D-17, IV-D-18, IV-D-19,
IV-D-20, IV-D-21, IV-D-22, IV-D-23, IV-D-24, IV-D-25, IV-D-30, IV-D-31, IV-D-32, IV-D-33,
IV-D-34, IV-D-35, IV-D-37, IV-D-38, IV-D-42, IV-D-46, IV-D-47, IV-D-48, IV-D-52, IV-D-53,
IV-D-54, IV-D-55, IV-D-56, IV-D-57, IV-D-58, IV-D-59, IV-D-60, IV-D-61, IV-D-62, IV-D-63,
IV-D-66, IV-D-67, IV-D-68, IV-D-69, IV-D-70, IV-D-71, IV-D-72, IV-D-74, IV-D-75, IV-D-79,
IV-D-80, IV-D-83, IV-D-87, IV-D-88, IV-D-99)
4. It must be specifically stated in the criteria that the DOE must provide detailed information
about the specific wastes to be disposed of at WIPP. (IV-D-43)
5. It's fundamental to compliance that DOE give a complete and accurate inventory of all waste
characteristics important to the facility's ability to contain radioactivity. (CARD-B, S-40)
6. The criteria for waste characterization must require specific information on the waste DOE
wants to dispose of in the WIPP. (S-l 1, S-14, S-37)
7. All the waste needs to specifically characterized as it exists now, not as it existed when it was
placed in the canisters. (S-12)
8. The final rule must require actual physical waste characterization. (SRIC-G)
Response to Comments 6.A.1 through 6.A.8:
The EPA revised the language from the proposed compliance criteria so that the final rule
clarifies the Agency's requirements on this issue. The rule requires DOE to describe the
chemical, radiological and physical composition of currently existing and, to the extent
practicable, of to-be-generated waste proposed for disposal in the disposal system. The
descriptions must include a list of waste components and their approximate quantities in the
waste. This list may be based upon process knowledge, current non-destructive
examination/assay, or other information or methods. Use of process knowledge to quantify
waste components in waste must conform with the quality assurance requirements found in
§194.22 of the final rule; collection of other data and information regarding waste
characterization are also subject to the quality assurance requirements of the final rule, pursuant
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to paragraph § 194.22(a)(2)(i). The EPA believes that it is essential for DOE to begin its
identification of waste characteristics and waste components which significantly influence the
containment of waste in the disposal system based on a comprehensive and detailed list which
includes the materials present in the waste from all generator sites. Once the significant
components are identified, the final rule requires that DOE limit, control and quantify these
components. Once limits have been established for waste components which significantly
influence containment of waste in the disposal system, DOE must implement a system of
controls to ensure that waste is emplaced in the disposal system only if the emplaced components
of such waste will not cause the limits on waste components to be violated (see §194.24(c)(4)
and § 194.24(e)). Furthermore, paragraph § 194.24(f) of the final rule requires that waste
emplacement in the disposal system must conform to the assumed loading conditions, if any,
used in performance assessments and in compliance assessments.
9. Contents of barrels containing waste must be identified before they are emplaced. (A-68, S-
17, S-21, S-40)
10. Waste characterization needs to be more intensely considered. (S-16, S-23, A-27, IV-D-07,
IV-D-26)
11. Adequate characterization of all waste coming to WIPP is essential to a determination of
compliance with the disposal regulations. (SRIC-A, SRIC-C, SRIC-E)
12. In reference to a "system of controls" to enforce the ranges applicable to waste
characteristics and categories, the Agency should require that the system be applied to existing
waste, and the results supplied. (NMAG-D)
13. All waste bound for WIPP must be characterized, not simply studied. (C-03, A-29, A-43,
A-48, IV-D-03)
14. Compliance criteria must insist that DOE not only include the results of its "study of the
effects of waste characteristics on the containment of the waste in the disposal system," but also
state what impacts the results of this study have on WIPP's ability to meet 40 CFR part 191
requirements. (SRIC-C, CCNS-B)
Response to Comments 6.A.9 through 6.A.14:
The waste characterization requirements have been revised from the proposal to clarify that DOE
must actually characterize waste proposed for disposal in the disposal system. The purpose of
the waste characterization analysis required pursuant to §194.24(b) of the final rule is to ensure
that all waste characteristics and waste components which influence containment of waste have
been systematically identified and evaluated; the evaluation is based on effects of components
and characteristics on the containment of waste in the disposal system (and therefore, on the
ability of the disposal system to demonstrate compliance with the disposal regulations). The
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required analysis thus identifies which waste components must be quantified during waste
characterization activities. Physical sampling or other methods of waste characterization (such as
use of process knowledge) must then be used to ensure that significant waste components are
controlled. Compliance applications must document why any waste characteristics and waste
components are not considered — that is, why they are not expected to significantly influence the
containment of waste in the disposal system. Once important components have been identified,
the Department must establish upper or lower limits, as appropriate, on such components.
Section 194.24 in the final rule clarifies that DOE is required to provide information which
shows that a system of controls is implemented which will assure that waste containers are
allowed to be emplaced in the disposal system only if their components fall within limits
established for the compliance demonstration. This system of controls is required to be applied
to all waste actually emplaced in the disposal system, regardless of whether such waste is
currently existing, or is yet to be generated. Thus, each container of waste (or group of
containers, depending on the important level of scale) to be shipped to the WIPP must be
characterized as to all waste parameters which are significant to compliance with the disposal
regulations. In addition, DOE is obligated by other regulatory requirements to characterize each
container of waste for components important to transportation and to compliance with the
Resource Conservation and Recovery Act.
Although EPA is not requiring that each drum of waste be characterized for every one of its
components quantitatively, the rule contains requirements for the identification and
characterization of all waste components which significantly influence containment of waste in
the disposal system. The rule requires that DOE describe the components of waste (both existing
and to-be-generated), based on reliable information. Both waste characterization sampling data
and the use of process knowledge for quantifying waste components are subject to the quality
assurance requirements of the final rule. The EPA is concerned that radiation exposures to
workers performing waste characterization should be limited as much as possible without
compromising the quality of waste characterization data; see response to Issue 6.L for further
discussion of this issue.
15. Future generated wastes should be fully characterized by an independent agency (not the
DOE). (A-48)
Response to Comment 6.A.15:
The EPA is requiring that DOE's compliance application provide assurance, through a
documented and implemented system of controls, that only those containers of waste (whether
generated in the past or the future) whose contents fall within the limits of waste characteristics
and components used to demonstrate compliance will be emplaced in the disposal system. This
means that all containers of waste, whether existing or to-be-generated, must meet the same
characterization requirements. As to the comment for independent characterization, EPA
believes that its independent oversight though inspections and audits of DOE waste
characterization will be sufficient. The EPA has revised the final rule language to clarify that
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future-generated waste must conform to the same characterization requirements as currently
stored waste.
Issue B: Waste characterization should occur at the current waste site.
1. It is essential that all waste be characterized that is to be transported and placed in the WPP.
(IV-D-12, IV-D-28, IV-D-92)
2. Characterization and the application should be done at each waste site so that actual physical
data is basis for application. (SRIC-C, A-08, S-03)
3. EPA should establish a regulatory requirement mandating facilities storing WPP destined
waste to submit the desired information, as part of this application for characterization and
disposal, rather than using the WIPP LWA as a mechanism to establish the right of access for
otherwise non-regulated activities. (IV-D-11)
Response to Comments 6.B.1 through 6.B.3:
Section 194.24 requires that the Department describe the chemical, physical and radiological
composition of the waste using currently available site data, including process knowledge. In
this sense, current characterization data is expected to be the basis of the application. However,
since the waste components for current and to-be-generated waste which are important to
compliance with the disposal standard have not been identified, EPA is requiring that they be
identified by a comprehensive process, that they be limited for purposes of estimating the
inventory, and that they be confirmed through actual waste characterization before waste is
emplaced at the WPP. The logistics of this characterization are left to the Department, as waste
generator and facility operator. This information must be provided as part of any compliance
application, and will therefore be subject to public review during a certification rulemaking. The
EPA will verify compliance with all characterization requirements through periodic audits and
inspections; this inspection authority extends to sites which generate waste proposed for disposal
at the WIPP.
It is DOE's responsibility to demonstrate compliance of the WPP. The EPA believes that a
single comprehensive DOE application, which must conform with waste characterization
requirements for all waste proposed for disposal from any generator site, is appropriate.
4. Perhaps a "chain-of-custody" and other administrative controls that would bar the introduction
of additional materials into a waste stream should be enacted, to ensure that the waste originally
destined for the WIPP is the waste actually disposed there. (IV-D-11)
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Response to Comment 6.B.4:
Paragraphs 194.24(c)(3)-(5) and §194.24(e) of the final rule address this concern. These
provisions require that waste maybe emplaced in the disposal system only if the components of
the waste fall within the limits under which compliance can be demonstrated. In addition, DOE
must establish and document controls to ensure that any waste approved for disposal meets the
limits. The EPA plans to verify compliance with these requirements through audits and
inspections [§194.24(f)]. The EPA clarified these requirements in the final rule.
Issue C: There is a need for the establishment of clearly defined criteria for waste
characterization.
1. The proposed rule includes extensive criteria for waste characterization, and does not specify
any particular method for characterizing the waste. It would be overly prescriptive and
inefficient to detail methods in the rule. (WEC-B)
2. The objectives of the rule (§194.24) need to define waste characterization processes and a
waste characterization plan. (NMAG-D)
Response to Comments 6.C.I and 6.C.2:
The final rule requires the Department to identify and describe the method(s) used to determine
and to limit important waste characteristics and components. Further, §194.24(c)(5) requires that
measurements and other controls used to characterize and limit waste components be conducted
in conformance with quality assurance requirements of § 194.22. This assures an appropriate
level of rigor to characterization without being overly prescriptive.
The Agency leaves the choice of characterization method(s) to the Department to allow
flexibility for selecting the method appropriate for the waste stream in question. Ultimately, as
part of its certification determination, the Agency will determine if the chosen methods are
adequate and provide the level of detail necessary to confirm the conditions under which
compliance is demonstrated through performance assessment.
3. EPA should clarify what it means by the statement "the DOE shall be required to substantiate
such characterization." (IV-D-11)
Response to Comment 6.C.3:
The final rule has been changed to amplify this point: "[Any compliance application shall]
[p]rovide information which demonstrates that the use of process knowledge to quantify
components in waste for disposal conforms with the quality assurance requirements found in
§194.22 [See §194.24(c)(3).]." The use of process knowledge for quantitative purposes must be
quality controlled in accordance with requirements of the ASME standards cited under §194.22,
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in order to substantiate that the data quality obtained by the use of process knowledge meets or
exceeds that required by the intended use of the data to confirm the waste conditions assumed in
the demonstration of compliance. If the Department chooses to use records of past processes to
meet pertinent waste characterization requirements, then the records need to be substantiated by
characterizing waste containers to verify the records of a particular waste stream. In addition, the
system of controls must be used to confirm that waste emplaced in the system does not violate
the limits established for waste components.
4. Guidance should be provided describing categorization methods which are acceptable and
which are not acceptable and the bases for acceptance or rejection of such methods. (IV-D-65)
Response to Comment 6.C.4:
Upon reassessment of the waste categorization requirement of the proposed rule, EPA has
determined that little is gained by the imposition of a requirement to group wastes into
categories, provided that all significant waste components are identified and controlled.
Therefore, in the final rule, EPA deleted the requirement to group wastes into categories. The
final rule does require identification of waste characteristics and waste components which
significantly influence containment of waste in the disposal system.
5. Application should list procedures and processes that will be followed for characterization,
characteristics of waste that will be allowed into WPP, and how it was concluded that WIPP can
contain such waste for 10,000 years. (CARD-B)
Response to Comment 6.C.5:
Section 194.24 requires that all necessary steps be taken to identify and limit significant waste
components. Compliance must be demonstrated by the performance assessment, based on the
inventory and the waste limits established in the compliance application, in accordance with
§194.24(c). Finally, controls are required to be in place to assure that no waste component limit
is exceeded. The final rule clarifies the steps that must be taken to appropriately characterize
waste for compliance with 40 CFR part 191 and the compliance criteria.
6. Applicant needs firm guidance regarding waste characterization requirements. (SGNM-A)
Response to Comment 6.C.6:
Section 194.24 requires the Department to take all necessary steps to derive and implement
essential waste characterization requirements important to compliance with the containment
requirements of 40 CFR part 191. The language in the final rule for §194.24 was modified from
the proposal to clarify EPA's expectations of waste characterization and spells out in reasonable
detail DOE's responsibilities.
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7. DOE has too much flexibility in the amount of characterization required of it. (A-41)
8. The compliance application should contain more specific provisions on the waste
characterization method and the waste in existence at the time of the application meets the
current Waste Acceptance Criteria. (NMAG-D)
Response to Comments 6.C.7 and 6.C.8:
Neither the WIPP LWA nor 191 prescribe specific waste characterization requirements to be
implemented by the compliance criteria, and EPA has broad discretion in establishing these
requirements. The EPA has specified requirements for DOE regarding the particular steps it
must follow to characterize waste proposed for disposal, and to verify that waste characterization
requirements are met for actual waste emplaced. The EPA is requiring DOE to set total
inventory (including all present and to-be-generated waste) limits on each waste component
identified as significant; to demonstrate compliance with the disposal regulations for this
inventory; and to demonstrate the existence of a system of controls to confirm that no limit is
exceeded in actual disposal operations, subject to inspection. The EPA has required that DOE
substantiate the identification of those characteristics and components which are important, and
that such an assessment provide substantiation for any decisions not to consider any waste
characteristic. This approach is believed to be neither too flexible nor too prescriptive.
9. EPA waste characterization requirements should be clearer and stronger. (A-41)
Response to Comment 6.C.9:
The comment did not suggest any specific requirements or revisions that EPA should implement.
It is important to understand that EPA has formulated its waste characterization requirements on
the basis of its assessment of current areas of uncertainty in DOE's transuranic waste
characterization program and current uncertainties in what waste parameters are or may be
significant to containment of waste in the disposal system and thus to the disposal regulations at
40 CFR part 191. From site visits it is evident to EPA that currently stored TRU waste contains a
wide diversity of materials, some of which may have the potential to cause waste-disposal system
interactions and therefore could affect the performance of the disposal system. Moreover, there
is considerable uncertainty in the large volume of waste to be generated in the future, and DOE
has been unable to provide EPA with any current plans for generating this waste, adding to this
uncertainty. Faced with this and other uncertainties, EPA is requiring the following: Rather than
adding prohibitive cost and worker radiation exposure by requiring full characterization by
physical sampling of all drums of waste (which would eliminate uncertainty but produce
substantial risk to human health), EPA is requiring DOE to identify, limit and confirm through
quantification, all waste components which can affect containment. The significant components
must be identified through an assessment of all waste components, characteristics of all currently
stored waste, and anticipated characteristics of waste to be generated in the future. The DOE
must substantiate all decisions to exclude waste characteristics which are deemed to be
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insignificant. The EPA is also requiring DOE to submit evidence which demonstrates that only
waste whose contents lie within limits used to demonstrate compliance are allowed to be
disposed of at the WIPP. In doing so, DOE must take into account the uncertainty of the
characterization method used, showing, that at the upper end of measurement uncertainty bands,
the waste still lies within the limits. In this way, EPA provides DOE the flexibility to address the
challenges of diverse waste characterization, but requires that all steps in this process which may
affect the demonstration of compliance are considered and addressed. The EPA believes this is
an appropriate balance between flexibility and prescriptiveness. The final rule clarifies the
requirements for appropriate waste characterization.
10. The rule should state that regular reports on compliance with waste characterization
requirements shall be made by DOE, that they shall operate, when submitted, to reopen the
certification rulemaking, and that the Agency must approve or disapprove the report. (NMAG-D)
Response to Comment 6.C.10:
The Department must implement and maintain documentation on a system of controls to track
the amount of waste entering the disposal system and to confirm that waste is emplaced in the
disposal system only if it conforms to the limits on components established in § 194.24(c). Waste
may not be emplaced at the WIPP unless it meets the description of waste proposed for disposal
at the facility. The EPA intends to confirm the adequacy of waste characterization activities,
both at the WIPP and at other applicable sites, through audits and inspections [§194.24(f)]. If it
is determined that conditions exist that differ significantly from those upon which a certification
of compliance is based, the Agency has the authority to suspend, modify, or revoke a
certification. Changes in waste characterization activities, like other changes to the disposal
system, maybe required to be reported under the requirements of §194.4, which also requires
submission of regular reports that document changes in activities. In addition, information on the
waste emplaced in the WIPP must be part of any certification application. The EPA does not
believe that requiring approval or dis-approval of such reports would enhance public safety to a
greater degree than the Agency's ability to modify, suspend or revoke certification, or not re-
certify.
Issue D: The future state of the waste needs to be addressed.
1. EPA needs to clarify whether there are different requirements for existing and to-be-generated
wastes. For example, in requiring detailed characterization, does that mean actual examination
of the waste? If so, it cannot be applied to future waste. Also, EPA needs to clarify how "any
other characteristics which could affect the transport of radionuclides" are to be identified.
Further, "statistically valid" is confusing. (NMAG-G)
2. The compliance criteria must address those "future" wastes much more completely than is
done in the draft criteria. (SRIC-E)
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Response to Comments 6.D.I and 6.D.2:
The final rule has been modified from the proposal in order to clarify the implementation of the
waste characterization requirements. The language questioned in comment 6.D.1 above has been
eliminated in the final rule. Instead, the final rule clarifies that DOE must identify, limit, and
control waste components which influence containment of waste in the disposal system, and thus
are directly relevant to the performance of the disposal system relative to the disposal regulations.
The results of DOE's analysis of waste characteristics and components, required under
§ 194.24(b), must be documented in any compliance application, as well as documentation that a
system of controls has been implemented at the WIPP to ensure that waste emplaced in the
disposal system conforms to the limits established for significant waste components. Thus, these
analyses and associated waste characterization activities will be subject to public scrutiny in the
compliance certification rulemaking.
In the interest of consistency, EPA is not requiring separate or different characterization of
existing or future generated waste. The EPA's approach is to require DOE to identify and limit
all components of the waste which influence containment of waste in the disposal system,
regardless of whether the wastes are currently existing or to-be-generated. In addition, EPA is
requiring DOE to implement a system of controls to assure that no limiting value is exceeded in
actual waste to be emplaced (again, irrespective of when the waste was generated). In this way,
EPA expects to be provided with assurance that important waste properties have been identified
and will be controlled adequately to remain within the boundaries used to in performance
assessments. The EPA modified the language from the proposed compliance criteria so the final
rule clarifies that DOE must account for the characteristics of future wastes planned for disposal
at the WPP when setting acceptance limits and conducting performance assessments to
demonstrate compliance. See also responses to Comments 6.A.9, 6.C.3, and 6.C.9.
3. Compliance criteria must state that all future waste will meet finalized WPP WAC and
undergo the same waste characterization analysis that is required for the current waste inventory.
(CCNS-B)
Response to Comment 6.D.3:
There is no difference in characterization requirements or controls between current and future
waste. The EPA has revised the language for the final rule to clarify that future-generated waste
must conform to the same characterization requirements as waste currently being stored. The
DOE's compliance application is required to demonstrate that containers of waste (whether
generated in the past or the future) will be emplaced in the WPP only if their contents fall within
the waste characteristic and component limits used to demonstrate compliance.
4. EPA should be more concerned with the final waste form to be disposed of in the WIPP, and
less concerned about the current characteristics and the storage operations at facilities storing
waste destined for the WIPP. (IV-D-11)
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Response to Comment 6.D.4:
The EPA is requiring the Department to describe all waste proposed for disposal, and to assess
and limit and control all significant waste characteristics and components of waste proposed for
disposal in WIPP. Thus, if waste form significantly influences the containment of waste in the
disposal system, it must be so limited and controlled. In such a case, the final waste form must
reflect the limits in the application, and DOE must demonstrate a system of controls to confirm
that this is the case.
5. Not only is activity level important the mobility of the radionuclides is also important. Some
radionuclides tend to attach more readily to clay or other negatively charged particle, while others
are more mobile, and have less of a tendency to attach to clays. Therefore, mobility of the
radionuclides in the environment should also be considered. (TV-D-11)
Response to Comment 6.D.5:
The final rule has been clarified to require the Department to assess the impact of all waste
characteristics influencing containment of wastes including the assessment of those waste
components which can affect solubility or formation of colloids. Compliance applications may
also include waste loading schemes (which may aggravate or mitigate the effects of factor such
as mobility of radionuclides); however, the final rule requires DOE to demonstrate that actual
waste emplacement at the WPP conforms to assumed waste loading conditions, if any, used in
performance assessments and compliance assessments. The DOE must comprehensively address
and control all significant factors which affect solubilization and mobilization of radionuclides
towards the accessible environment.
Issue E: The use of the range of values must be clarified.
1. The ranges for waste characteristics do not present criteria that can be assimilated. (DOE-A)
2. The waste characterization study does not explain how the study will give rise to values, range
of values, and maximum amounts of waste categories. The regulation should explain how such a
study will be designed. (NMAG-D)
Response to Comments 6.E.I and 6.E.2:
Some comments suggested that the limits on waste characteristics or components should be
expressed as a range and distribution of sensitive waste parameters, and that they may be difficult
to assimilate into waste acceptance criteria. The DOE is not precluded from fulfilling the
requirements of this section by expressing ranges and distributions of sensitive parameters.
However, the requirement is intended to result in a set of limiting values or ranges of values
which are to be applied at the inventory scale, room scale (if needed), and container scale to
define and limit the inventory proposed for disposal to that which can be shown to support
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compliance with the disposal regulations through performance assessment. This set of limits or
ranges of values could be called an "envelope" of important waste characteristics and
components.
Moreover, EPA is requiring DOE to implement a system of controls to limit the waste which is
actually emplaced in WIPP to that which lies within the envelope of limiting values. The DOE
must confirm that the actual waste inventory emplaced at WIPP conforms to the important
properties of the estimated inventory used to model the demonstration of compliance and
submitted with the certification application. The final rule language was modified from the
proposal to define waste characteristics and waste components, and to clarify the approach of
determining important waste characteristics and components, and establishing limits on them.
3. The range of values for each waste characteristic must not be lowered, but should be realistic
and conservative. (C-03)
Response to Comment 6.E.3:
In addition to those of § 194.23, the principal requirements that the total inventory planned for
disposal at the WIPP must meet are compliance with the requirements of § 194.34 and § 194.55
and compliance with the WPP LWA waste limits pursuant to § 194.24(g). The DOE must
confirm that waste emplaced in the disposal system conforms to the limiting values or range of
values established for each important waste characteristic or component. This has been clarified
in the final rule. This, coupled with the requirement for a system of controls which confirms that
the actual waste inventory emplaced at WIPP does not exceed any of the limits, assures that
compliance, if demonstrated, will be maintained. Compliance applications may establish broad
waste acceptance envelopes, but must demonstrate that the disposal system complies with the
disposal regulations under the stated assumptions. The requirements provide an incentive for
compliance applications to establish realistic limits on the components of waste proposed for
disposal, since such waste must be shown to conform to such limits before it can be emplaced in
the WIPP.
4. Will the range of values as discussed in the preamble be the means by which the DOE can
account for decay of radionuclides and the potential for the decay of organics? If so, a discussion
should be incorporated as one of the criteria. (IV-D-11)
Response to Comment 6.E.4:
The final rule requires that DOE conduct an analysis to identify waste characteristics and waste
components which influence containment of waste in the disposal system. The results of this
analysis must be used to establish limits on waste components, and DOE must implement and
document a system of controls to ensure that waste actually emplaced in the disposal system
conforms to the limits established for signficant components. The activity (in curies) of waste is
an example of a waste component for which limits must be established. The decay of
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radionuclides is not a waste characteristic or component, but rather would be accounted for in the
models used in performance assessment. Documentation of models and computer codes, as
required in §194.25 of the final rule, would include descriptions of the methods used to account
for decay of radionuclides. For further discussion of radionuclide decay, see Section 5 (Models
and Computer Codes) and Section 10 (Application of Release Limits) of this document. See also
the responses to Comments 6.E.I and 6.E.3.
Issue F: Characterizing wastes is not reasonable and the requirements are burdensome
and imprudent.
1. The requirement for action interferes with the systematic design approach and have not been
shown to be worthwhile. (DOE-D, WEC-A)
2. These requirements would increase the cost of waste characterization and potentially reduce
safety and increase the risk associated with the characterization activity. (WEC-A, SNL-C, C-13,
C-13, C-15, C-23, C-25)
3. The waste characterization processes delineated in the proposed rule are, in many ways, too
prescriptive. (DOE-A, IV-D-76)
4. Characterizing waste is unrealistic due to potential changes in waste generation. (C-25)
5. Waste need be characterized only to the extent needed to demonstrate compliance as modeled
by performance assessment. (DOE-D, SNL-A)
6. The approach taken by EPA is too-open ended and would result in a characterization effort
that would exceed that needed to demonstrate compliance with 40 CFR part 191. These
activities may require a degree of characterization that jeopardizes existing regulations that
protect occupational and public health and safety. (SNL-A, SNL-C)
7. Waste characterization should be limited to characterization sufficient to demonstrate
compliance with 40 CFR 191.13, 191.15, and 191.24, as modeled by performance assessment.
(SNL-C)
Response to Comments 6.F.I through 6.F.7:
The EPA's requirements were formulated to require DOE to identify and control, by
measurements or other means of quantification (such as use of process knowledge), those waste
characteristics which significantly influence the containment of radionuclides in the disposal
system. Flexibility has been afforded DOE to scope and provide the necessary information
through analysis and documentation (process knowledge, for example), provided that the results
are acceptably rigorous. The results of an analysis of waste characteristics and components will
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be used to establish criteria for waste acceptance, based on which characteristics and components
of waste are expected to significantly influence containment of waste in the disposal system.
The EPA agrees with the philosophy, in the interest of cost-effective expenditures and limiting
worker radiation exposures, of not prescribing detailed physical sampling requirements.
However, the transuranic waste currently stored at DOE facilities is highly heterogeneous and is
known to contain a wide variety of materials, chemicals, etc. which have potential to influence
the containment of radionuclides in the disposal system. Based upon DOE documentation to
date, it is not clear whether all waste characteristics and components which are significant to total
disposal system performance have been identified, or that adequate consideration has been given
in decisions to disregard other characteristics or components deemed less important. For this
reason, EPA has required that DOE substantiate the identification of those characteristics and
components which are significant (sometimes called sensitive parameters in the language of
performance assessment), and that such an assessment provide substantiation for any decisions
not to consider any waste characteristic or component. Further, EPA is requiring that all
significant waste components be limited (if necessary to demonstrate compliance), and quantified
before disposal to confirm that no limits are exceeded.
Waste characteristics affect the long-term behavior of the WIPP in a number of ways; solubility,
gas generation, shear strength, and other characteristics have been shown in previous
performance assessments to be critical parameters. There are a large number of waste
characteristics; some of these, such as activity of radionuclides in the waste, are important;
others, such as color of the waste are unimportant, to compliance. The EPA must ensure that the
information it receives in any compliance application provides sufficient detail on the waste
characteristics that affect containment. Without this assurance, DOE simply can not show a
reasonable expectation of compliance. The function of prescribing to DOE what waste
characterization is needed is completely within EPA's discretion in implementing the disposal
standards. The EPA believes that the approach in the final rule balances flexibility with
prescriptiveness to assure that waste characterization is rigorous and reliable for those waste
parameters important to containment of waste in the disposal system.
8. This subsection should clearly state that it will be used as a criterion to evaluate whether a
reasonable expectation of compliance with 40 CFR 191.13, 191.15, and 191.24 exists. (SNL-A,
SNL-C)
Response to Comment 6.F.8:
Meeting the requirements for waste characterization ensures that any compliance application is
based on dependable and verifiable information. The waste characterization requirement is
derived from the need to demonstrate a reasonable expectation of compliance with the disposal
regulations. Any application must demonstrate that the requirements of § 194.24 have been
fulfilled specifically, and cannot meet the requirements of this section by stating that other
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compensating factors establish a reasonable expectation of compliance. Therefore, EPA believes
it is inappropriate to include the suggested language in the final rule.
9. There is a question whether the cost of characterizing waste to such a great degree will offset
benefits gained. (A-13)
Response to Comment 6.F.9:
The Agency shares the concern for occupational exposure to the workers who are involved in
characterizing the waste, but believes it is also inappropriate to jeopardize future generations
from potential releases to the accessible environment because this generation failed to study and
characterize the waste that could significantly impact the total performance of the repository.
The Economic Impact Assessment indicates that the level of characterization required by the rule
does not appear to increase cost over the costs already anticipated for meeting other regulations.
The EPA has modified the language in the final rule from the proposed rule to clarify that waste
characterization should focus on those parameters that may significantly influence the
containment of waste in the disposal system. The Agency believes this strategy is both prudent
and cost-effective. See response to Comment 6.F.I for more information.
10. The requirements for action related to waste characterization have not been shown to be
worthwhile. (C-29)
Response to Comment 6.F.10:
The Agency is requiring the Department to identify and assess the impact of significant waste
characteristics and components on performance. Until this is done in an adequate fashion,
considerable uncertainty exists as to what waste characterization should take place. The final
rule also requires that DOE establish limits for significant waste components and implement a
system of controls to confirm that the characteristics of the inventory emplaced at the WIPP (if a
certification is granted) conform to estimates of the inventory used to demonstrate compliance.
The required actions increase confidence that the repository will contain the actual waste as
demonstrated by modeling. Moreover, this goal is to be obtained by performing the
characterization actions necessary to provide adequate assurance, making this approach highly
cost effective.
11. These requirements are premature and in the the final analysis are likely to be unnecessary.
(WEC-A)
Response to Comment 6.F. 11:
The disposal regulations require that DOE provide a reasonable expectation of meeting the
containment requirements of 40 CFR part 191. All processes which may affect the containment
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requirements need to be considered. In the case of the WIPP, certain waste/disposal system
interactions between the diverse types of waste materials in TRU waste and the conditions
associated with bedded salt need to be considered in order to assess whether the containment
requirements of the disposal regulations can be met. It is therefore necessary for EPA to require
waste characterization to the extent needed to identify waste characteristics significant to the
containment of waste and to require that these characteristics be quantified and controlled in the
overall inventory.
12. The DOE should not be required to study the performance effects of characteristics that will
not be represented in the WPP inventory. DOE only needs to confirm that the wastes comply
with applicable transportation criteria. (SNL-C)
Response to Comment 6.F.12:
The EPA is requiring the Department to identify, limit and control the waste characteristics that
significantly influence the containment of waste in the repository. The EPA does not require
characterization of the waste components that are not in the inventory. The transportation
regulations do not consider the long-term containment of disposed waste in a geologic repository.
Hence, compliance with the waste characterization requirements for transportation does not
assure that waste has been adequately characterized to show compliance with 40 CFR part 191.
13. The waste characteristics requirements are unnecessarily burdensome, and would have the
effect of excluding the more hazardous components of nuclear waste from WIPP. The effect of
such regulation is to subject people near the defense related facilities to potential hazards from
shallow ground water and air contamination, while delaying disposal of waste in salt that has
been recognized as providing the most substantial barriers to such contamination. (IV-D-40, IV-
D-64)
Response to Comment 6.F.13:
The requirements of § 194.24 do not specify any restrictions on transuranic waste which would
exclude the most hazardous components from disposal at WIPP unless the presence of such
components would prevent compliance with the disposal regulations at 40 CFR part 191 or are
otherwise inconsistent with the waste limits in the WIPP LWA. Even in such a case, DOE
would have the option to treat such waste instead of excluding it, provided that compliance could
be demonstrated and the WIPP LWA limits met. The WIPP Land Withdrawal Act imposes
limitations on waste which can be disposed of at the WIPP; for example, any waste which meets
the definition of High Level Waste may not be emplaced at the WIPP. The compliance criteria
cannot and do not negate such requirements of the WIPP LWA.
With regard to the near-term delays which may occur as a result of the need to meet waste
characterization provisions of § 194.24, EPA has taken care to afford DOE flexibility in
development and implementation of 40 CFR Part 191-based waste characterization requirements.
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However, the Agency feels that it is essential that the Department fully assess the potential for
waste/disposal system interactions which can affect the ability of the disposal system to contain
radionuclides for the 10,000 year regulatory period. Since the Department is required by RCRA
and the provisions of the Atomic Energy Act to manage currently stored transuranic waste in a
manner which is protective of human health and the environment, the Agency believes that any
additional time in this vital area, which is necessary to provide reasonable assurance of
compliance with the disposal regulations, will not result in increased risk.
14. The rule should be re-written as follows: DOE should identify the characteristics which are
important through performance assessments. When they have been identified, DOE should
develop waste characterization parameters which will ensure that the inventory will have the
required characteristics to support demonstrations of compliance. Existing waste must be shown
to meet the criteria through examination and statistical analysis. As to the future waste, DOE
must show that the waste characterization parameters will be satisfied or the waste will not go to
WIPP. (NMAG-G)
Response to Comment 6.F.I4:
The EPA appreciates the straightforward and concise manner in which this commenter has
formulated the waste characterization requirements, and has tried to clarify the entire content of
waste characterization in §194.24 of the final rule. There are a number of simplifications in the
commenter's approach which, if adopted literally, would have the effect of being overly
prescriptive. For example, the performance assessment (PA) is not the only methodology which
can or should be used to identify significant waste characteristics; logical screening and bounding
arguments, assessment through sidebar calculations, and use of ancillary models and codes (for
example, the actinide source term model) could be used as well as PA codes. Moreover, EPA
considers it important that DOE begin its assessment from a detailed list of waste components in
the waste, as opposed to a performance assessment model which already incorporates or excludes
a number of assumptions and conceptual models involving waste properties. The final rule
language generally conforms with the approach recommended in the comment.
15. It is recommended that the waste characterization requirements be made more general in
order to allow the DOE to develop a waste acceptance plan for compliance to the disposal
standards. The specifics of the waste parameter study should be left to the DOE instead of
codified in the rule. (DOE-E)
Response to Comment 6.F.15:
While EPA has specified the steps to be taken in order to establish important waste
characteristics and components, EPA has not dictated that limits be established for specific
characteristics or components. The final rule does include a list of waste characteristics and a list
of waste components which must be included in any studies to determine which characteristics
and components are significant to containment of waste. These lists have been derived from past
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performance assessments, which indicated that the parameters in question were critical to
containment of waste. Given this, EPA believes it is reasonable to require that the characteristics
be studied to determine if they are still considered important to containment. The Agency
believes this approach is not overly prescriptive.
16. It would be desirable to initiate a more aggressive program to prepare, characterize, and
certify transuranic waste containers for disposal at WIPP, but this idea, would be difficult to be
accepted by management without some assurance that WPP will open in FY '98 as planned.
(IV-D-111)
Response to Comment 6.F.16:
The purpose of waste characterization criteria is to ensure that all characteristics that are
significant to containment of waste are considered, and that DOE confirm that no waste is
emplaced in the system that falls outside the component limits under which compliance was
demonstrated (assuming compliance was demonstrated). The EPA's regulatory role at the WIPP
is not to ensure its operation by an given date, but rather to issue these compliance criteria and
then certify whether or not the WIPP complies with the disposal standards. A reasonable
expectation of compliance cannot be demonstrated if waste characterization is inadequate,
especially since predicted releases in performance assessments depend heavily on the
characteristics of waste. The requirements of the final rule provide an incentive for DOE to
aggresively pursue and accomplish rigorous waste characterization, since information resulting
from waste characterization efforts must be included in any compliance application.
Issue G: Worst case analysis may not be appropriate since it is difficult to know what the
worst case is, given the complexity of the system. Instead, EPA should call for a range and
distribution of sensitive parameters. (NMAG-G)
Response Issue 6.G:
The final rule requires that DOE establish limits (either upper or lower limits, as appropriate) on
all waste components determined to be significant to containment of waste. The DOE must then
demonstrate that, for the total inventory of waste proposed for disposal in the disposal system,
WIPP complies with the containment, individual, and ground-water requirements for the upper or
lower limits for each waste component, and for the plausible combination of upper and lower
limits that would result in the greatest estimated releases. Combinations of upper and lower
limits are not required to be considered if it can be shown that a given combination is not
plausible due to the nature of waste proposed for emplacement at the WIPP; any such exclusions
must be documented and justified in compliance applications. The EPA believes this approach is
reasonable because, once a waste "envelope" is established, it is possible that all the waste
emplaced in the WIPP could meet the limits for each component. This analysis is not considered
a "worst case" because the waste envelope establishes acceptance criteria which are real, rather
than hypothetical, limits. In addition, although compliance must meet the worst plausible
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combination of established limits on waste components, other aspects of the performance
assessment are still allowed to operated probabilistically, and are not held constant in "worst
case" scenarios.
Issue H: EPA is exceeding its authority. The proposed rule sets a new standard for waste
characterization.
1. The proposed rule sets a standard, and not a criterion to an existing standard. (IV-D-40)
2. If EPA deems that study on waste characterization is necessary to comply with 40 CFR
part 191 then such a requirement should be contained in that regulation. (WEC-D)
3. 40 CFR part 191 does not mention waste characterization, so Part 194 should not. (C-28)
4. Confirmation of the absence of waste characteristics is outside the scope of Subparts B and C
and should not be included with this regulation. (SNL-C)
5. EPA should examine the extent to which the proposed regulations require a substantial
increase in waste characterization from 40 CFR part 191. (C-13, C-15)
Response to Issue 6.H:
A specific waste characterization requirement is not in 40 CFR part 191. However, in order to
demonstrate compliance with the Containment requirements of 40 CFR part 191, it is essential to
evaluate how actual waste characteristics will impact the containment of radionuclides for the
long-term performance of the repository. In addition, the WIPP LWA established certain limits
on waste which may be emplaced in the WIPP, and waste characterization activities must be
undertaken to demonstrate that waste emplace in the WPP conforms to these limits.
The intent of the disposal regulations is that the implementing agency provide a reasonable
expectation of meeting the containment requirements of Part 191. All processes which may
affect the containment requirements need to be considered. In the case of the WIPP, certain
waste/disposal system interactions between the diverse types of waste materials in TRU waste
and the conditions associated with bedded salt need to be considered in order to assess whether
the containment requirements of 40 CFR part 191 can be met. It is therefore necessary for EPA
to require waste characterization to the extent needed to identify waste characteristics
significantly influencing the containment of waste and to require that these characteristics be
quantified and controlled in the overall inventory.
Issue I: EPA should impose a liquids prohibition on waste to be disposed of in the WIPP.
Of course, the ability to seek a waiver should also be incorporated into this prohibition.
Waivers could be performance based. (IV-D-11)
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Response to Issue 6.1:
Current transportation regulations, with which DOE must comply in order to transport waste to
the WIPP, impose a restriction on free liquids in the waste. The disposal regulations of 40 CFR
part 191 impose no explicit liquids restrictions for geologic disposal, but include containment
requirements. In the final compliance criteria, EPA is requiring DOE to assess the impact of all
waste components, and explicitly water and other liquids in the waste, on the disposal system
performance, and to limit all significant waste components to values for which compliance with
the containment requirements can be assured. 40 CFR Part 268, enforced separately from the
compliance criteria, imposes additional requirements connected with obtaining a "No Migration
Variance" which require an assessment of hazardous substances, including hazardous liquids.
The EPA will evaluate DOE's assessments for radioactive wastes in this area upon receipt of its
certification application for the WIPP. It is unknown at this time whether these assessments will
result in more stringent performance-based limits on free liquids in waste than those currently
required for transport, but if this is the case, then DOE must adhere to them.
Issue J: The waste characterization study should contain criteria and be submitted to EPA
before the compliance application is allowed to be submitted.
1. Any study of waste characteristics should be submitted at least one year prior to application
submission. (SRIC-C, SRIC-G)
2. The rule should contain specific characterization requirement that you find necessary to
support the performance assessment. The rule should require that existing waste be characterized
before the application is submitted. (NMAG-A)
3. The question of waste characterization is so complex that it is suggested that the Agency
require the study to be completed one year before the compliance certification application is
submitted. (NMAG-D)
4. DOE should complete its study of waste characterization needs before the compliance criteria
are made final, and the Agency should use the study to draft characterization requirements.
Existing waste should be characterized before the application is submitted. (NMAG-B)
Response to Issue 6.J:
Neither the WIPP LWA nor the disposal regulations being implemented call for EPA to require
DOE to complete an analysis of waste characterization before EPA may finalize compliance
criteria, or to characterize existing waste before a compliance application is submitted. Rather,
the waste characterization requirements are derived from the overall containment, ground-water
protection and dose-limiting requirements of 40 CFR part 191. The EPA believes that waste
characterization is a critical component of any compliance application, and has developed criteria
to ensure that extensive and dependable waste characterization is conducted in preparing a
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compliance application. As part of the final rule, DOE is required to characterize all existing
waste and all to-be-generated waste and to document this characterization as part of the
compliance application. The final rule also provides for verification of these properties through a
system of controls to ensure that waste is emplaced in the disposal system only if it will not cause
the established limits on waste components (pursuant to §194.24(c) of the final rule) to be
violated. The EPA believes this is a reasonable approach, that waste characterization form the
basis of the compliance application. The DOE is bound to adhere to the limits established, which
form the basis upon which compliance is demonstrated, if indeed compliance is demonstrated.
Any significant departure from the limits which form the basis of certification, if granted, would
require modification of the certification. The DOE must verify that the limits established in the
compliance application are met by any waste emplaced in the disposal system; because much of
the waste is still to-be-generated, the characterization assumptions must be specifically
confirmed. The EPA also has authority to inspect any waste characterization activities to
confirm that conditions or activities described in compliance applications remain valid.
The EPA is requiring the Department to set total inventory (including all present and future
waste) limits on each waste component identified as significant to containment of waste in the
disposal system, to demonstrate compliance with the disposal regulations for this inventory, and
to demonstrate the existence of a system of controls to confirm that no limit is exceeded in actual
disposal operations, subject to inspection. This places an upper bound on the many sources of
uncertainty which the comment has touched upon, rather than bounding only part of it.
The EPA's approach in §194.24 is to require that the Department take the essential steps to meet
all waste characterization requirements and controls necessary to assure that compliance with the
disposal regulations is demonstrated. The assumed properties of the waste used in the
compliance demonstration must be confirmed through quantification. The EPA will determine
during its review of the certification application whether the assessment, limitation and plans for
confirmatory quantification of significant waste components are adequate. In addition, EPA will
verify the adequacy of application materials, and the plans and performance of waste
characterization activities through inspections and audits.
With regard to requiring that existing waste be characterized before the application is submitted,
EPA believes that considerable delay and expense might be incurred with little gain by this
requirement. Since the majority of waste has not yet been generated, such a requirement would
do little to reduce the overall uncertainty in the inventory used to demonstrate compliance.
However, this uncertainty is addressed through EPA's requirement that DOE confirm waste
components before waste is emplaced. Moreover, requiring characterization before the
application submission does not assure that characterization is adequate. The EPA believes it is
more appropriate to evaluate waste characterization information (and any uncertainty regarding
characterization) within the context of the overall compliance determination. By evaluating the
overall approach to identification, limitation and confirmation of waste components which are
important to meeting the containment, individual and ground-water protection requirements of
40 CFR part 191, EPA can be assured that the waste characterization approach is adequate. For
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these reasons EPA has chosen not to require that existing waste be characterized before the
application, but instead chooses to require that a comprehensive waste characterization approach
be submitted as part of compliance applications.
Issue K: The utility of process knowledge must be clearly stated.
1 . EPA should place equal weight on "process knowledge." (IV-D-1 1)
2. Process knowledge is so rife with guesswork, assumptions, and relies so heavily on unreliable
documentation that it should be disallowed as a characterization procedure. (CARD-B)
3. DOE must be required to discuss clearly and precisely the uncertainties associated with
process knowledge in each case where it is used. (SGNM-C, A-35)
Response to Issue 6.K:
One comment states that EPA should give greater importance to the use of process knowledge
for characterization of waste, and several other comments state that process knowledge is
inherently unreliable and should not be allowed to be used. In the interest of reducing cost and
radiation worker exposure, EPA is willing to consider the use of process knowledge, but is
requiring DOE in the final rule to provide information which confirms that the use of process
knowledge conforms to the quality assurance requirements described under § 194.22. The EPA is
currently observing DOE's initiative to develop guidance for all of the waste generator sites on
the use of and substantiation of process knowledge, and will be observing DOE activities aimed
at verifying the documentation and other substantiation in the near future. By familiarizing itself
with the kinds of process knowledge to be used and the reliability of such knowledge, EPA can
share current concerns and be in a position at the time of the application to evaluate whether
DOE's use of process knowledge is substantiated sufficiently for its intended purpose in the
demonstration of compliance.
Issue L: More attention should be given to occupational exposure related to waste
characterization.
1. The tradeoff between accurate waste characterization and occupational exposure should be
explicitly recognized and ALARA specifically referenced. (DOE-D,
2. Visual examination of the waste entails great occupational risk and prohibitive cost. (SNL-C)
3. It should be recognized that the handling of radioactive wastes for the purposes of waste
characterization will subject people to doses of ionizing radiation. Such waste handling activities
constitute a hazard. This hazard must be evaluated in light of the information gained in
determining compliance with 40 CFR part 191. (IV-D-40)
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4. For purposes of personnel safety, EPA should accept process knowledge and non-invasive
evaluations as waste characterization methods in lieu of physical sampling and analysis.
(IV-D-111)
Response to Issue 6.L:
The EPA too is concerned about limiting worker radiation exposures. However, the transuranic
waste currently stored at DOE facilities is highly heterogeneous and is known to contain a wide
variety of materials, chemicals, etc. which have potential to influence the containment of
radionuclides in the disposal system. Based upon DOE documentation to date, it is not clear
whether all waste characteristics and components which are significant to total disposal system
performance have been identified, or that adequate consideration has been given in decisions to
disregard other characteristics or components deemed less important. For this reason, EPA has
required that DOE substantiate the identification of those characteristics and components which
are significant (sometimes called sensitive parameters in the language of performance
assessment), and that such an assessment provide substantiation for any decisions not to consider
any waste characteristic. Further, EPA is requiring that all significant waste components be
limited and quantified before disposal to confirm that no limits are exceeded.
The EPA believes that such an approach balances flexibility with prescription to assure that
waste characterization is rigorous and reliable for those waste parameters important to
containment of waste in the disposal system. The Agency shares the concern for occupational
exposure to the workers who are involved in characterizing the waste, but believes it is also
inappropriate to jeopardize future generations from potential releases to the accessible
environment because this generation failed to study and characterize the waste that could
significantly impact the total performance of the repository. The EPA's requirements were
formulated to require DOE to identify and control, by measurements or other means of
quantification (such as use of process knowledge), those waste characteristics which are
significant to the containment of radionuclides in the disposal system, as identified by study.
Flexibility has been afforded DOE to scope and provide the necessary information through study
and documentation (process knowledge, for example), provided that the results are acceptably
rigorous. The results of an analysis of waste characteristics and components will be used to
establish criteria for waste acceptance, based on which characteristics and components of waste
are expected to significantly influence containment of waste in the disposal system.
As to the ALARA principle, DOE is responsible for implementing radiation protection measures
with its work force, and is explicitly obligated through its Orders to address ALARA; this is not
an EPA regulatory function. The EPA has tried to afford sufficient flexibility to DOE to carry on
an effective ALARA program for its workers while also addressing the important issue of
protection of the public and the environment through demonstration of compliance with EPA
disposal regulations.
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Issue M: EPA should issue guidance on four alternatives to the use of visual examination:
1) non-destructive assay methods, 2) process knowledge, 3) statistical analyses, and
4) acceptable error bands or uncertainty ranges. (SNL-C)
Response to Issue 6.M:
At this juncture, EPA is not requiring the use of any specific characterization method and hence
does not intend to issue guidance on specific characterization methodologies. The EPA is
willing to consider the application of a variety of waste characterization methodologies, and is
expecting DOE to demonstrate that any such methodology is capable of producing data which are
adequately qualified to support their intended purpose (i.e., confirmation that waste
characteristics or components used in the performance assessment or otherwise deemed
significant do not exceed limiting values used to demonstrate compliance). Section 194.24 has
been clarified in the final rule to require that DOE submit information with its application to
confirm that the use of process knowledge and waste characterization measurements conforms
with the quality assurance requirements of § 194.22. In addition, paragraph 194.22(d) has been
added to the final rule requiring DOE to provide information which demonstrates how all data
(including waste characterization data) are qualified for their intended use.
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Section 7: FUTURE STATE ASSUMPTIONS: SECTION 194.25
Issue A: There is difficulty in predicting climatic conditions.
1. There is concern as to whether or not future hydrological factors have been sufficiently
considered. If the climate does warm, then the salt structures may destabilize. (C-25, A-55,
IV-D-73)
2. If reliable models of climate change cannot be created, the WIPP should not be opened.
(IV-D-91)
3. The issue of climate change is crucial since it is wetter than anticipated. (S-12)
4. There is no adequate means for predicting the performance of WPP under climatic conditions
of increasing moisture. (CARD-B)
5. The effects of climate change must be fully considered. (NMAG-D, SRIC-G)
Response to Issue 7.A:
The application for certification of compliance will have to show that climate change has been
adequately considered. There is evidence to indicate that past climate in the vicinity of the WPP
has been both wetter and drier than the present climate. Using the past as a guide we can assume
that the climate at WIPP will have future periods that are wetter and drier than they are today.
From paleontological information it is possible to make reasonable estimates of the magnitude of
climate change, even if the timing of the climate change events are not precise. The main effect
of climate change is precipitation and the subsequent recharge to aquifers in the vicinity of the
disposal system. The potential effects of more or less recharge, such as increased hydraulic
heads in the aquifers and possible dissolutioning, can and must be modeled. The final rule (at
§194.25) requires DOE to consider the effects of potential future climatic conditions on the
disposal system, and to document, to the extent practicable, the effects of potential changes to
future climate cycles of increased precipitation as compared to present conditions.
Issue B: EPA should limit consideration of climatic effects to those that may directly affect
disposal system performance (i.e.. ground water recharge). (DOE-D, SNL-C)
Response to Issue 7.B:
The EPA does not expect the Department to analyze effects of climatic conditions or events that
are not relevant to repository performance; performance assessments do not need to consider
natural processes and events that do not affect the disposal system during the regulatory time
frame (see §194.32(a)). However, the final rule does not explicitly limit the climatic conditions
which must be considered for the WIPP. The final rule does specifically require that DOE
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document the effects of potential changes to future climate cycles of increased precipitation as
compared to present conditions. Recharge to aquifers in the vicinity of the WPP is a potential
effect of increased precipitation, but is not the only effect that should be analyzed. Other
potential effects could include dissolution, or deterioration of shaft seals. The final rule does not
limit consideration of climatic changes to aquifer recharge, or to direct effects on the disposal
system. If natural processes such as climatic change are not included in performance
assessments, DOE must document why such a process, event, or sequence was not included,
pursuant to paragraph §194.32(e)(3) of the final rule. The EPA would expect such
documentation to include a technical rationale describing why the process is not expected to
affect the disposal system during the regulatory time frame.
Issue C: More investigation is needed into the karst formations at WIPP.
1. A large karst formation is moving toward WIPP and would likely intrude the WIPP site. The
possibility needs to be analyzed. (S-17, S-23)
2. The karst formation results in irregular water flows and thus it is difficult to measure how
quickly the water in the aquifer under the WIPP site flows into the Pecos River. (S-30)
3. The brine and karst features throughout the site are inappropriate. (C-03)
4. We do not understand why EPA and DOE are not more concerned about the very real dangers
that the karst represents. (CARD-A, A-60, S-40)
Response to Issue 7.C:
An analysis by EPA's Office of Solid Waste in 1990 indicated that in an undisturbed scenario,
brine pools would not be problematic to the performance of the WIPP [55 FR 47714]. In
addition, EPA examined karst formations at the site in response to a commenter who invited
EPA to the site to discuss this issue. Upon investigating the WIPP site, EPA found no evidence
of active karst features in the WPP Land Withdrawal Area. On the basis of this investigation
and further discussion, EPA concluded that karst is not now an issue at the WIPP, and is unlikely
to become one for many thousands of years, if ever [55 FR 47714].
Nevertheless, DOE must consider geologic features such as karst formations, when conducting
performance assessment. As geologic features exempted from the general future states
requirements (see §194.25(a)), the effects of brine pockets and karst formations maybe included
in performance and compliance assessments if they are found to affect the disposal system during
the regulatory time frame. The disposal regulations at 40 CFR Part 191 require that a
performance assessment be used in determining if a facility meets the containment requirements
(i.e., evaluation of the disturbed performance of the repository). The development of a
performance assessment for a facility requires an analysis of the following three elements: 1.)
identification of processes and events that might affect the disposal system; 2.) examination of
the effects of these processes and events; and 3.) estimation of the cumulative releases of
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radionuclides, considering the associated uncertainties, caused by all significant processes and
events. Similarly, the analysis required for the compliance assessment also considers potential
processes, events or sequences that may occur over the regulatory time frame for the undisturbed
performance of the repository. The final rule specifies that compliance applications must
consider, to the extent practicable, the effects of potential changes to geologic conditions,
including dissolution, near surface geomorphic features and processes, and related subsidence in
the geologic units of the disposal system (§194.25(b)(2)). Additionally, compliance applications
must consider natural processes that may affect the disposal system during the regulatory time
frame, and must document why any such processes are excluded from performance assessments
(§194.32). The Agency believes that performance and compliance assessments are the vehicles
to be used when considering the types of site specific concerns articulated in comments, and
believes that the requirements of the final rule regarding scope of performance assessments and
future state assumptions ensure that the effects of geologic features such as karst will be
adequately considered.
Issue D: The use of present conditions for future state assumptions needs to be
re-evaluated.
1. To reduce uncertainty in compliance assessment, EPA should specify certain "future states"
assumptions. DOE cannot assume any "future states" that would result in less protection of
human health and the environment than "current states." (SRIC-F)
Response to Comment 7.D.1:
The EPA agrees with the commenter's goal of reducing the uncertainty in modeling, and to that
end, EPA proposed to specify certain assumptions about the future to be used in long-term
modeling. For example, the final rule states that compliance assessment analyses should assume
that characteristics of the future remain the same as today (unless otherwise specified);
consideration of climate changes must include the effects of increased precipitation; and with
respect to human technology and behavior, present conditions should be used as default values.
As discussed in the preamble to the final rule, EPA has found no acceptable methodology to
predict the future state of society, science, languages or other characteristics of future mankind.
Therefore, to limit speculation and further uncertainty, the Agency has retained the proposed
approach towards future states. Present conditions at least have the advantage of providing
ascertainable and verifiable values. The EPA believes that this approach will minimize the
possibility of developing assumptions about the future that result in less protection to human
health and the environment than the current states will allow.
2. The assumption that future characteristics of the future remain what they are today is more
appropriately included in 40 CFR part 191. (WEC-D)
3. EPA should not specify future states assumptions to the modeler (DOE). (IV-D-06)
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Response to Comments 7.D.2 and 7.D.3:
The EPA believes that including the criteria for future states assumptions is completely within
the Agency's authority to implement 40 CFR part 194, subparts B and C, for the WIPP. The
general requirements of the compliance criteria, including those for future states assumptions,
support a reasonable expectation of compliance because they ensure that any compliance
application is based on dependable and verifiable information. Demonstrating compliance with
the disposal regulations involves the use of computer models, based on conceptual models,
which project, over an extended period of time, the transport of radionuclides from the disposal
system to the accessible environment, and resultant radiation doses to individuals and
radionuclide concentrations in ground water. Because of the long-term nature of these
evaluations, uncertainty of values may be very large for many parameters important to the
analysis. The Agency believes that the future states assumptions approach in the final rule will
enable compliance assessment to focus on more predictable and more significant features of
disposal system performance.
4. EPA should re-evaluate its proposal to employ present conditions as default values for future
states. (A-41)
5. EPA's deduction that it has no better approach on future state assumptions is troubling. (A-41)
6. It is arbitrary and nonconservative to assume that the future will resemble the present for
10,000 years. (NMAG-G, A-44)
7. The approach taken in dealing with Future States is balanced and appropriate and is the only
way this difficult issue can be addressed. (EEC-A, EEG-B, SNL-A, IV-D-76, IV-D-100)
8. Characteristics of the future should be assumed to remain what they are today, except those
related to geologic, hydrologic, or climatic conditions. This criterion should require that the
positive and negative aspects of the constant future state be assumed rigorously in the
performance assessment calculations. (EEG-C)
Response to Comments 7.D.4 through 7.D.8:
The Agency solicited comments specifically on its approach to future states assumptions with the
hope to gather ideas on this subject. After careful evaluation of comments received, the Agency
found that commenters did not provide any technically defensible or methodical new approaches
for the Agencys consideration. Given the state-of-the-art on this subject, the Agency believes
that it is reasonable to retain the proposed approach. The Agency continues to believe that there
is no reasonable way to predict what changes will take place in the future of mankind over the
10,000-year regulatory time frame. The use of present conditions at least has the advantage of
providing ascertainable and verifiable values. Any predictions of future conditions of mankind
and society would be speculative, and fixing such values for the purpose of performance
assessments would be arbitrary. The EPA does not believe that the future state assumptions in
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the final rule are necessarily non-conservative; DOE must fix all relevant values and rigorously
consider their impact — both positive and negative — in performance assessment calculations.
Where established scientific methods can make plausible predictions regarding future states (i.e.,
for geologic, hydro geologic, and climatic conditions), the final rule requires that DOE analyze
the potential evolution of these processes over the 10,000-year regulatory time frame.
9. One of the criteria EPA should use in evaluating WIPP is the amount of future nuclear waste
that will need to be disposed of at the WIPP. (IV-D-50)
Response to Comment 7.D.9:
The Agency considers to-be-generated waste that is proposed for disposal in the WIPP at
§ 194.24, Waste characterization. The Agency believes that characteristics of the wastes should
be determined, to the extent practicable, based on parameters that are both measurable and
verifiable. The amount of waste should be able to be estimated based on sampling and analysis,
process knowledge, or a combination; a documented and supportable estimate must be
established since the information will be used to determine the release limits under §191.13.
Estimates of to-be generated waste will have to be documented in order to be included in the
application. See Section 6 of this document for further discussion of waste characterization
requirements in the final rule.
10. Existing intrusions must become part of the undisturbed case: their presence must be
assumed in all calculations. (NMAG-B)
Response to Comment 7.D.10:
The Agency agrees with the comment. The consideration of undisturbed performance requires
an analysis of the predicted behavior of the disposal system, including consideration of the
uncertainties in the predictive behavior, if the disposal system is not disrupted by human
intrusion or the occurrence of unlikely natural events. Given the current activities in the
Delaware Basin, where the WIPP site is located, consideration of the existing intrusions should
be considered as part of the undisturbed case, consistent with the inclusion of all other conditions
of the site at the time the application is prepared. The EPA considers existing drill holes and
other artifacts of past intrusions to be part of the site description (the natural and present state of
the site) which underlies analysis of undisturbed scenarios. It is reasonable to assess the
undisturbed performance of WIPP to fully consider the realities of the site-specific conditions.
Section 194.32, Scope of performance assessments, has been revised in the final rule to explicitly
require that DOE document and analyze the effects on the disposal system of existing boreholes
and other activities.
11. It is not known at what rate Rustler Creep and the Nash Draw advance towards WIPP; these
characteristics must be studied and addressed. (C-03)
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Response to Comment 7.D. 11:
The Agency agrees with the comment. The movement of those formations towards the WIPP is
a natural geologic process that should be considered as part of the analysis of both performance
and compliance assessments. Section 194.54, Scope of compliance assessments, requires that
potential processes, events or sequences of processes and events that may affect the disposal
system during the regulatory time frame should be identified and considered. In a similar
fashion, §194.32, Scope of performance assessments, requires that both natural and human-
initiated processes and events that may affect the disposal system be considered. In addition, the
future state assumptions of the final rule (§194.25) require evaluation of changes in the long-term
geologic, hydrologic, or climatic conditions of the system and its vicinity. Therefore, the criteria
in 40 CFR part 194 require the evaluation of natural processes that may affect the performance of
the disposal system.
12. Significant geologic changes are not likely within the time frame of interest. (IV-D-51)
Response to Comment 7.D.12:
In the proposed rule, the Agency stated that the future state assumption of constant conditions
would not apply when dealing with the long-term geologic, hydrologic, or climatologic
conditions of the system and its vicinity. Future state assumptions, unless otherwise specified
(e.g., deep and shallow drilling in §194.33), apply to parameters or values that may vary or
change in significant and unforeseeable ways over the lengthy time frame that will be analyzed
for compliance.
Section 194.54, Scope of compliance assessments, requires that potential processes, events or
sequences of processes and events that may occur over the regulatory time frame should be
identified and considered. In a similar fashion, §194.32, Scope of performance assessments,
requires that both natural and human-initiated processes and events that may affect the disposal
system over the regulatory time frame be considered. In the course of performing such analysis
the Department needs to calculate the probability of the particular event or processes happening
during the regulatory time frame. If no significant geologic events would take place during the
regulatory time frame, then those processes or events may be excluded from performance
assessments; however, compliance applications must document and justify why such processes
were not considered in the analysis (i.e., why they were determined not to affect the disposal
system over the regulatory time frame).
13. Future states assumptions cannot be applied to institutional controls. (NMAG-D)
Response to Comment 7.D.13:
Future states assumptions do not apply to passive institutional controls. The final rule states that
conditions will be assumed to be the same as the present unless otherwise specified in the rule.
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The final rule also clarifies that such assumptions apply in performance assessments and in
compliance assessments; they are not to be applied to assurance requirements. The design of
passive institutional controls, both markers and records, must be designed so that they are as
permanent as possible, taking into account, to the extent possible, potential collapses in
institutional, societal, or linguistic structures. The final rule requires that DOE document the
period of time passive controls are expected to endure and be understood [§194.44]. Compliance
with the assurance requirement for passive controls will be evaluated based in part on the depth
of the analysis and the scope of potential societal changes which are accounted for in the design
of passive controls.
Issue E: The scope of the requirements needs to be clarified.
1. The wording in this section should be amended to state definitively that EPA intends for the
DOE to focus attention and resources on investigating the more predictable aspects of the
disposal system. (SNL-C)
Response to Comment 7.E.1:
The Agency agrees that spending resources on trying to assess parameters or values that may vary
or change in significant and unforeseeable ways over the lengthy regulatory time frame is not an
efficient way to allocate scarce resources and will not be of measurable value to the
demonstration of compliance. The Agency believes that the future state approach in the final rule
has the advantage of providing readily ascertainable and verifiable values. The EPA does not
believe it is necessary or appropriate to state in the rule the goal of the assumptions; EPA's
expectation for implementation of the future state assumptions is clearly stated.
2. This subsection should clearly state that it will be used as a criterion to evaluate whether a
reasonable expectation of compliance with 40 CFR 191.13, 191.15, and 191.24 exists. (SNL-B,
SNL-C)
Response to Comment 7.E.2:
The purpose of the future state assumptions is to avoid unverifiable and unbounded speculation
about possible future states of society, and to help focus compliance assessments on the more
predictable and more significant features of disposal system performance, instead of examining
exceedingly speculative developments over the 10,000-year regulatory time frame.
Demonstrating compliance with 40 CFR part 191 B and C involves the use of computer models
which project, over an extended period of time, the transport of radionuclides from the disposal
system to the accessible environment and resulting radiation doses to individual members of the
public. Given the long-term nature of these evaluations and the fact that many of the parameters
or values may change in significant and unforeseeable ways, the Agency decided to specify
certain assumptions about the future for use in long-term modeling. The Agency believes that
this approach has the advantage of providing readily ascertainable and verifiable values; and
allows the Department to focus its resources for data gathering in a more efficient way. The
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requirements for future state assumptions establish assumptions to be used in compliance
assessments and performance assessments; they are not used to analyze whether a reasonable
expectation of compliance has been achieved in the results. Any compliance application must
demonstrate that the requirements of § 194.25 must be specifically fulfilled.
3. It is recommended that EPA establish a clear framework for the treatment of indirect
anthropogenic effects (related to geologic, hydrologic or climatic conditions) on repository
performance. EPA should clearly state that these effects are not to be included in assessing the
"undisturbed performance" of the repository. (NRC)
Response to Comment 7.E.3
The EPA does not intend or expect that DOE will consider indirect anthropogenic effects on
repository performance, since this would be an exceedingly speculative undertaking. As stated
in the preamble to the final rule, the Agency believes that established scientific methods exist for
making plausible predictions regarding the future states of geologic, hydro geologic, and climatic
conditions. However, the Agency has not identified an acceptable methodology to make reliable
predictions about characteristics of future mankind. The final rule therefore specifies that such
characteristics should be assumed to remain as they are today (unless otherwise specified in the
rule). Analysis of geologic, hydrogeologic, and climatic conditions should include the evolution
of these natural processes over the regulatory time frame. Indirect anthropogenic effects — for
example, effects on living patterns due to increased precipitation — should not be included in
analysis of future states, since such assumptions pertain to the future state of society and
mankind.
4. It is unclear how the future state assumptions are to be used for the consideration of protected
individual. It is recommended that EPA develop a framework that integrates the treatment of
characteristics used in the compliance demonstrations, including those for the development of a
reference biosphere and an exposure scenario. This framework would be best developed as a
guidance document, which would provide the necessary flexibility to make the compliance
criteria implementable. (NRC)
Response to Comment 7.E.4:
The general requirements of the subpart C of the final rule apply both to performance
assessments (used to predict releases of radionuclides from the disposal system) and to
compliance assessments (used to predict radiation doses to individuals). Thus, compliance
assessments should assume (in conformance with §194.25 of the final rule, that the
characteristics of the future remain what they are today, provided that such characteristics are not
related to hydrogeologic, geologic, or climatic conditions. As stated in the disposal regulation at
40 CFR part 191, compliance assessments need not consider human intrusion or unlikely natural
events. The EPA believes that the requirements for future states assumptions in the final rule is
appropriately applied to the individual and groundwater requirements of the disposal regulations.
Establishment of a reference biosphere or exposure scenario would require unbounded
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speculation regarding future states of society; as previously discussed, EPA does not believe that
such speculation is productive. The final rule clarifies that, for the purposes of calculating
radiation doses to individuals, compliance assessments shall assume that the individual resides at
the single geographic point on the surface of the accessible environment where that individual
would be expected to receive the highest dose from radionuclide releases from the disposal
system (§194.51). For further discussion of future states assumptions, see response to
Comment 7.DA; for further information on the individual and groundwater requirements of the
final rule, see Section 19 of this document.
Issue F: The provisions should be changed so that they do not come into conflict with
existing regulations and so that their application is made clear. (NMAG-C)
Response to Issue 7.F:
The final rule states that characteristics of the future should be assumed to remain what they are
at the time a compliance application is prepared, except for geologic, hydrogeologic, and climatic
conditions, and unless otherwise specified in the compliance criteria or the disposal regulations.
The final rule also states that the future state assumptions of §194.25 apply to performance
assessments and compliance assessments conducted pursuant to the provisions of this part to
demonstrate compliance with §191.13, §191.13, and part 191, subpart C. The Agency believes
this clearly establishes how future states assumptions are to be applied and implemented. The
EPA is not aware of any other radioactive waste disposal regulations which apply to the WIPP,
and with which the final rule might conflict regarding future states assumptions. In addition,
EPA notes that the compliance criteria and disposal regulations are apart and separate from
RCRA or state regulations. The basis of compliance for these other rules differs significantly
from that of the disposal regulations since they apply to operational activities, have different
regulatory time frames, or are not based on performance assessments. Therefore, it is reasonable
and necessary that different assumptions and approaches be applied for each regulation.
Issue G: To the extent that the characteristics of future drilling, mining, or other land or
resource use are governed by regulation and oversight, the Agency cannot assume that
such regulation and oversight are effective more than 100 years into the future. (NMAG-C)
Response to Issue 7.G:
The final rule states that characteristics of the future should be assumed to remain what they are
at the time a compliance application is prepared, except for geologic, hydrogeologic, and climatic
conditions, and unless otherwise specified in the compliance criteria or the disposal regulations.
The final rule clarifies that the future state assumptions of §194.25 apply only to compliance
assessments and to performance assessments; they are not applicable to assurance requirements.
Moreover, elsewhere in the rule, at §194.41, EPA specifies that performance assessments may
not consider any contributions from active institutional controls for more than 100 years after
disposal. Such controls would include land access restrictions at the WIPP. In addition, the
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assumed frequency of drilling activities is established in §194.33, and is independent of any
analysis of whether drilling regulations will continue to exist in the future.
Issue H: This text of §195.25(a) should be changed to state, "Unless otherwise specified in
this part or in other disposal regulations, certifications or determinations of compliance
with the disposal regulations shall assume geologic, hydrologic, and climatic conditions
evolve with time, and all other systems remain as they are today." (IV-D-111 [same as
IV-D-118])
Response to Issue 7.H:
The final rule requires the same approach at that indicated in the comment. The EPA does not
believe that the specific wording suggested will provide clarification or information beyond the
language used in the final rule.
Issue I: The following should be added to §194.25, "The Department has the burden of
demonstrating the current state as to each point of fact asserted as the basis for a future
state assumption." (NMAG-D, SRIC-G)
Response to Issue 7.1:
As noted in § 194.11 of the final rule, information provided in support of any compliance
application shall be complete and accurate. Thus, assumptions about future states must be
supported with appropriate information, and information sources will be referenced.
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Section 8: EXPERT JUDGMENT: SECTION 194.26
Issue A: The necessary use of expert judgment is limited.
1. Section 194.26 establishes sufficient process and documentation requirements to be able to
evaluate the quality of the process. (SNL-C)
2. This section places unworkable restrictions on the selection of experts. (SNL-C, IV-D-06)
3. The proposed wording in the rule is too narrow in that it inappropriately limits necessary use
of judgment when data are not available. (SNL-B, DOE-D)
4. If expert elicitation is used, it should not remain unclear whether the result will be
objectionable for bias. (NMAG-D)
5. The final rule should provide for excluding certain persons from expert elicitation on the
grounds of presumed bias. (SRIC-G)
Response to Issue 8.A:
The Agency has placed certain requirements on the membership of expert panels to avoid the
creation of a panel that has a conflict of interest that might prejudice its judgment on scientific
matters related to the WIPP. In the proposed rule, a restriction was included that would require
an expert panel to consist at least two-thirds of persons not employed directly by the DOE or its
contractors. In the event that this requirement cannot be satisfied due to the unavailability of a
sufficient number of non-DOE experts and this circumstance can be documented, then only one-
half of the expert panel need to be non-DOE or DOE contractor.
The final rule modified the restriction placed on the number of expert panelists who must not be
employed directly or indirectly by DOE. The section still requires that two-thirds of the experts
be non-DOE or DOE contractor; however, in the event that a sufficient number of such experts
cannot be found, then only one-third of the experts must not be employed directly by the DOE or
its contractors. Previously, the requirement had stated that at lease one-half of the experts must
be non-DOE, regardless of availability. The Agency modified this requirement in recognition of
the DOE's pervasive work in the field of nuclear waste disposal. The Agency reasoned that it
would not be beneficial to reduce the technical qualifications of an expert panel in order that the
panel remain totally independent of the Department of Energy.
The restriction on the composition of expert panels applies specifically to those persons who
work for DOE, whether directly, by contract (such as the national laboratories) or, indirectly, by
research grants. However, those persons who are funded by DOE research grants but who are not
conducting a program of research related to WIPP, would not be subject to the exclusions applied
to DOE and DOE supported persons. Therefore, when assessing whether an expert panel's
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membership is in excess of the requirement that two-thirds not be employed by the DOE, directly
or indirectly, such individuals would not be counted.
The selection of the individual participants on the expert panel is also subject to certain
restrictions designed to minimize bias. The final rule prohibits the selection of participants who
will be requesting or using the elicited results of the expert judgment process. Additionally, the
final rule prohibits persons who supervise or are supervised by a member of the expert panel
from participating in the process as a panel member. The restrictions that apply to the
composition of the entire expert panel also will indirectly minimize the bias of the individual
participants, as noted above.
With respect to restricting the use of expert judgment in the place of experimental data, the
Department may substitute expert judgment for the gathering of measured data, provided that the
Department can justify that expert judgment does not substitute for information that could
reasonably be obtained through experimental data collection.
Issue B: EPA is appropriately and reasonably requesting the use of expert judgment.
1. The EPA is correct in allowing the use of expert judgment in those cases where it is not
possible to generate the necessary information through test or analysis. (IV-D-100)
2. The section on expert panels is interesting and well stated. (S-53)
3. The proposed arrangements for expert judgement are reasonable and adequate. The protection
against intimidated input is particularly important. (IV-D-51)
4. DOE should justify any decisions to treat critical variable distributions through expert opinion
rather than through experiments or measurement where feasible. (NMAG-E)
Response to Issue 8.B:
The Agency has developed the section of the final rule on expert judgment with the goal of
eliminating any bias that might improperly tilt the results of performance assessments,
compliance assessments and any other activity conducted as part of the compliance application.
Objective means of developing the compliance application are always preferred. However,
the Agency recognizes that, because there is ultimately a limit on DOE's resources, DOE must
weigh practical considerations that expert judgment does not substitute for information that could
reasonably be obtained through experimental data collection. While the Agency agrees that
actual measurements are preferable to the use of expert judgment, DOE may substitute expert
judgment for the gathering of measured data provided that the Department can justify this on the
basis of limitations of time and resources. Nonetheless, all distributions of uncertain variables
will be subject to random sampling across the full range of values during the numerical
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calculations of the performance and compliance assessments, unless an alternate, more
conservative method can be justified.
Issue C: Expert judgment is a poor alternative to scientific data. EPA should apply a
rigorous standard in determining where DOE use of expert judgment is appropriate and
warranted. (SGNM-D, CCNS-B)
Response to Issue 8.C:
The criteria for compliance, 40 CFR part 194 permit the use of expert judgment to produce data
as a substitute for laboratory and field measurements. The Agency agrees that actual
measurements are preferable to the use of expert judgment, but recognizes that practical
considerations must be weighed in assembling the application for certification. Accordingly, the
Department may substitute expert judgment for the gathering of measured data, provided that the
Department can justify this on the basis of limitations of time and resources.
The Agency has required that two-thirds of an expert panel shall consist of non-DOE or non-
DOE funded personnel. With this requirement, and the additional restrictions and documentation
requirements, the EPA believes that the likelihood of biased input will be greatly lessened.
Issue D: The definition of expert judgment needs to be clarified.
1. There is concern related to the restrictive definition of expert judgment present in the
proposed rule. (DOE-A)
2. There is no definition for "expert" or "expert judgment" in the proposed rule. A definition
should be added for these two terms. (SNL-C)
3. EPA's statement that expert judgment "be limited to those situations where data is not
reasonably attainable (60 FR 5773)" is too narrow and should be expanded. (SNL-C)
4. This [expert judgment] subsection should refer to "formally elicited expert judgment", rather
than "expert judgment." A formal approach has considerable advantages over an informal
approach. (DOE-D, SNL-C)
5. The expert judgment rule cannot be limited to formal elicitation. (NMAG-D)
Response Comments 8.D.1 through 8.D.5:
The Agency has not defined the term "expert judgment" explicitly. One should note, however,
that the requirements of this section apply to expert judgment used in cases in which data are not
reasonably obtainable through data collection or experimentation. The EPA is also requiring that
any compliance certification application clearly identify all instances in which such judgment is
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used along with the names and professional affiliations of all experts involved. The term "expert
judgment," as referred to in these statements, denotes any instances in which these methods are
used to generate data. The requirements in 40 CFR part 194 would apply to any such case in
which the collection of data is foregone in exchange for expert judgment.
The rule applies to expert judgment that is conducted by one individual or a panel of experts.
The Agency is requiring that all instances of expert judgment, including all those which
substitute for actual field and laboratory measurements, be conducted subject to the restrictions
and exclusions specified in 40 CFR part 194.
The Agency recognizes the commenter's concern that informal expert judgment might be used in
place of formal elicitation, for example, when determining the probability distributions of
uncertain parameters. However, section 34 of the final rule requires that the probability
distributions of all parameters be documented and described in the final application. Such
documentation and description must be adequate to support the numerical results of the
performance assessments and compliance assessments, and will be subject to the Agency's final
decision on the issuance of a certification.
6. It should not be assumed that restrictions on expert judgment only apply when estimates are to
be made for values which DOE has identified as model parameters. (NMAG-C)
7. The expert judgment provisions should remain which allow such judgments to be used only
when information could not be obtained through data collection or experimentation, and which
call for a structured process of elicitation. The rule should list which parameters are subject to
expert judgment. (NMAG-D)
8. Expert judgement should not be allowed to substitute for information that is reasonable
obtainable through data collection or experimentation. (SRIC-G)
Response to Comments 8.D.6 through 8.D.8:
The requirements on expert judgment apply equally to estimates of parameter values as to more
subjective judgments such as what might be the effect of passive institutional controls, or to any
other question that is the subject of an expert panel's deliberation. The final rule does place the
additional restriction on quantitative expert judgment, beyond those applied to non-quantitative
judgment, such that expert judgment may not be used in the place of reasonably obtainable data.
Nonetheless, all other requirements would still be in force for non-quantitative expert judgment.
With respect to listing which parameters DOE may derive by expert judgment, the Agency
believes that any decision on the specific treatment of parameters might quickly be over-turned
by the results of new experiment or studies. Hence, the Agency has declined to provide such an
instruction in the final rule. The Agency will look to the results of sensitivity and uncertainty
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analyses which are included in the compliance application in order to determine the relative
importance of the different parameters.
Issue E: Clarification is needed for the definition of expert judgment and professional
judgment.
1. There is no distinction between the use of professional judgment and the expert elicitation
process. (DOE-D)
2. EPA should distinguish between expert judgement applied to critical performance assessment
components and professional judgement applied throughout the scientific investigation. The
EPA must also distinguish between expert judgement and peer review. (WEC-D)
3. A distinction must be made between day-to-day use of professional judgment in scientific
decisions and a formal expert judgment elicitation process. (SNL-C)
4. It is recommended that EPA clearly and explicitly distinguish between "expert judgment" and
the formal process of "expert elicitation." It is also recommended that EPA specify, through
regulatory guidance, the types of information that must be acquired through formal expert
elicitation and those which may be obtained through less formal mass. (NRC)
Response to Issue 8.E:
The applicability of the section on expert judgment does not extend to an investigator's
judgment, unless that investigator's judgment provides a substitute for actual field or laboratory
measurements. Expert judgment and peer review are two separate activities, subject to the
exclusions and restrictions of different sections of the rule. Peer Review (§ 194.27) is applied to
completed studies and activities as a means of providing validation, while Expert Judgment
(§194.26) is conducted when such studies or activities cannot reasonably be performed.
Issue F: References to 40 CFR part 191 warrant clarification.
1. This subsection should be amended to state that authorization for the use of expert judgment
in implementing 40 CFR part 191 is granted by Appendix C of 40 CFR part 191. (SNL-C)
2. This subsection should clearly state that it will be used as a criterion to evaluate whether a
reasonable expectation of compliance with 40 CFR 191.13, 191.15, and 191.24 exists. (SNL-C)
Response to Issue 8.F:
The Agency has the authority to require a demonstration that the radioactive waste disposal
regulations found at 40 CFR part 191, subparts B and C, have been met, in the form of an
application for certification. See 106 Stat. 4777, Sec. 8(d). The final rule does allow expert
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judgment to be used to support analyses that are conducted to show the disposal system's
compliance with these disposal regulations.
The Agency does not believe that any one section of an application for certification should be
used as the basis for an assessment of "reasonable expectation." Instead, the entire record placed
before EPA will form the basis for this assessment. Any compliance application must comply
with the requirements of § 194.26 specifically.
Issue G: Guidance is needed for selecting the participants in the expert panels.
1. Specifying the number of experts for an elicitation is not an appropriate part of specifying
certification criteria. The requirement that a minimum of five individuals be used should be
made more flexible such that no minimum requirement is included. (SNL-B)
2. The restriction on including DOE employees and contractors in an elicitation should be lifted
and these individuals should be allowed to serve in an elicitation provided he or she is not
employed on any aspect of WIPP and that he/she demonstrates an absence of conflict of interest.
(DOE-D, SNL-C)
3. Suggests that 2/3 of experts should be non-DOE. EPA should clarify what relationships are
prohibited. (NMAG-G)
4. This subsection inappropriately requires specific panel composition and constraints on
membership. (DOE-D)
5. No group or individual should be provided an automatic right of presentation, irrespective of
experience and relevance. (C-28)
6. EPA should issue guidance to ensure that all expert panels have a uniform number of
members and to ensure that all expert panels be required to estimate probability in a single,
consistent and uniform manner. (SGNM-A)
7. The proposed regulation has the effect of eliminating professionals who have the greatest
experience in repository work from providing expert judgement. The Agency itself provides
independent judgement of the WPP, and the requirement on expert judgement needs to be
eliminated. (IV-D-40)
8. The manner in which the EPA suggests the experts is flawed and should be replaced with a
more reasonable basis that relies on the technical qualifications of the expert rather than their
employment history. (IV-D-100)
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9. It is suggested that the text be either deleted or changed to state, "Any individual employed by
the Department or one of the Department's contractors may serve as an expert." Prudent use of
experts would help to resolve conflict of interest issues. (IV-D-111)
10. Formal guidelines are needed for the selection of individuals used to render expert judgment.
(NMAG-D)
11. Concerning the specific issue of the selection of experts for purposed of expert judgment
elicitation, such persons should be required to meet a test of recognition by their peers in the
scientific community to demonstrate scientific competence in the field. (NMAG-E)
12. This section should also include a provision for elicitation of State representatives with
adequate credentials to expert panels. (SGNM-D)
Response to Issue 8.G:
The Agency has required that a minimum of five persons form an expert panel so that the elicited
results are representative of diverse viewpoint. The Agency believes that this will result in a
more informed and objective process. However, an expert elicitation that is subject to this
section could be conducted with fewer than five individuals in the event that there is a lack or
unavailability of potential experts, provided that a rationale is stated. Section 194.26 of the final
rule states this restriction:
At least five individuals shall be used in any expert elicitation process: Unless
there is a lack or unavailability of experts and a documented rational is provided
that explains why fewer than five individuals were selected.
The Agency agrees that any expert panel member should be free from conflict of interest.
Accordingly, the Agency has promulgated the requirement that two-thirds not be employed by
the DOE, directly or indirectly. The rule does not extend this restriction to those persons who
receive funding from the Department in those instances in which such funding is for activities
not related to the WIPP. Provided that the two-thirds requirement is met, expert panels may
include persons employed by the State of New Mexico or any other organization, provided that
their expertise can be demonstrated to be adequate for the elicitation that is to be conducted. The
final rule requires that compliance applications demonstrate this expertise, and the Agency's
judgment on the adequacy of this demonstration will be used in making the decision on the
issuance of a certification.
The Agency does not intend to sacrifice technical qualification for the sake of an expert panel's
independence from the DOE. The Agency recognizes the pervasiveness of the DOE's work in
the field of nuclear waste disposal. The final rule, 40 CFR part 194, requires that two-thirds of
the experts be non-DOE or DOE contractor; however, in the event that a sufficient number of
such experts cannot be found, then at least one-third of the experts must not be employed directly
by the DOE or its contractors. The Agency believes that this latter requirement does allow for
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the prudent selection of experts while providing a sufficient level of assurance that the outcome
of the elicitation will not be biased.
Issue H: Guidance is needed for the analysis of elicited values.
1. The supplementary information contains a misapprehension about expert judgment:
information elicited from experts cannot be "meaningfully averaged" without knowledgeable
weighting unless the elicited values are very close together. Portions of the supplementary
section that refer to this concept should be deleted. (SNL-C)
2. Eli citations from experts cannot be melded unless they are essentially in agreement to begin
with. In the event of divergent views, all must be reported and taken into consideration. (A-45)
3. The section does not define the processes to be used in eliciting expert judgements and
specifically overlooks the issue of combining judgments of multiple experts. (NMAG-B)
4. When DOE seeks expert opinion using incomplete data, arbitrary limits are set of particular
factors and inaccurate estimates to come up with information are used which may be of critical
importance in determining whether WPP will be safe. (S-l 1)
5. Supplemental Information is incorrect in discussion of "averaging" of elicited values.
(DOE-D)
6. Judgment should not be elicited collectively by panels; instead, individuals should be required
to independently express their views based on their expertise. The opinions should explain all
the decisions that lead up to them (by use of decision tree). (NMAG-G)
7. Panelists should be required to assign fractile probabilities values to high, low, and
intermediate levels of the variable in question; in other words, the exercise should focus on the
creation of a probability distribution function which may be incorporated into a PA. (NMAG-G)
8. It is imperative that all expert groups conform to identical restrictions in membership number
and utilize a single methodology for deriving quality probabilities. (SGNM-A)
9. The rule must be revised to specify methods to resolve differences among members of the
expert panel. (NMAG-D)
10. Concerning the aggregation of expert opinions of multiple experts, the process must include
methods to reduce the range of disagreement. To aggregate different opinions, it is preferable to
employ an interactive process. (NMAG-E)
11. It is important that there is currently no standard procedure for the aggregation of expert
opinions, and that this exercise will remain subjective in nature. The key to success is to focus
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on the probabilities of the models and assumptions as opposed to weighting the experts.
(NMAG-E)
12. There should be an interactive process wherein the experts discuss the data, explain their
models, discuss the probability of each of the models, assess such probabilities, and generate a
composite distribution. Criteria are needed to establish formal elicitation of expert judgment.
(NMAG-D)
13. Concerning elicitation of expert opinion on parameter values, the process must include the
elements of (a) clarity of question, (b) identification of desired central value-probably the mean-
and (c) the description of the thought process leading to the estimate. (NMAG-E)
14. Concerning elicitation of expert opinions as to distributions of variable parameters, the
process must include (a) construction of a probability distribution for a set of possible
hypotheses, (b) identification of the appropriate distribution model for an identified model
variable, and (c) given such model, identification of the distribution for the value of the variable.
(NMAG-E)
15. It is recommended that Sandia identify variables whose distributions are critical for the
results, to justify their decision to treat them through expert opinions, to better justify their
findings by describing exactly how they have encoded and aggregated expert opinions, or to redo
the encoding and aggregation of these judgments if it concluded that some of the variables have
not been properly treated. (NMAG-E)
Response to Issue 8.H:
The Agency has not required that any one specific process of expert judgment be used. The
Agency believes that a more productive application of expert judgment will take place if the
process of elicitation matches the needs of each individual instance. The method of combining
the elicited judgments of the individual experts is also initially left to the Department.
Documentation and a justification for the method employed must be included in the application
for certification and will be evaluated by the Agency when the final decision on whether to issue
a certification is made. Other requirements of the final rule might also apply to these results once
they have been incorporated into other parts of the compliance application, for example the
performance assessment.
Issue I: The following should be added to §194.26, "The results of any expert judgment
processes shall be peer-reviewed according to §194.27 of this part. The report of the
proceedings and findings of peer review processes shall be filed with the application.
(NMAG-D)
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Response to Issue 8.1:
To the extent that peer review is the professional judgment of a group of individuals, peer review
is in fact similar to an expert judgment. Typically, the knowledge gained from a peer review
derives its legitimacy from the familiarity that peer reviewers already have from performing
similar studies, analyses or experiments. Peer reviewers can then evaluate the adequacy of a
study or activity by comparison to these established norms or more generally, to scientific
principles. Expert judgment is not the equivalent of a laboratory experiment or study; it does not
objectively derive factual results by using conventional practices. Submitting the inherently
judgmental results of an expert elicitation to another group of experts, such as a peer review
group, would, effectively, be to repeat the elicitation. It is the Agency's view that this would not
add significant value to the results of the initial expert elicitation.
Issue J: Third parties must have an opportunity to present their views to expert panels.
1. The rule should require that groups and individuals with relevant expertise be afforded an
opportunity to present scientific and technical reviews to an expert elicitation panel. (TV-D-l 11)
2. DOE should not restrict third parties to present information to the expert panel. (NMAG-D)
3. Third parties should be allowed to provide information to any expert panel. (SRIC-G)
Response to Issue 8. J:
The final rule requires that DOE must solicit the views of the public, to be presented to the expert
panel members, and requires that DOE provide documentation which demonstrates that this has
occurred in the compliance application. The Agency believes that this requirement will insure
that the experts receive a broader spectrum of background information when such information is
presented to them at the start of the elicitation process.
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Section 9: PEER REVIEW: SECTION 194.27
Issue A: Compliance criteria must more clearly require independent peer review of all
documentation. (CCNS-B)
1. Peer review should be required for any part of the compliance demonstration that is not
subject to checking by a technical review. This may include experimental design, data collection
methodology, technical studies, scientific basis for scenario selection and construction, scientific
basis for conceptual models, use of experimental data in constructing conceptual models, and
conservatism of assumptions. (NMAG-D)
Response to Issue 9.A:
The Agency sought the advice of the WIPP Review Committee of the National Advisory
Council for Environmental Policy and Technology (NACEPT) in September, 1995 regarding
which activities should be required to be peer reviewed. During this meeting, members of the
public provided formal presentations and oral comments to the committee. See 60 Fed. Reg.
43470-43471 (Aug. 21, 1995). The Committee suggested that peer review of quality assurance
programs would be unnecessary, since, by requiring DOE to adhere to a program that meets
the requirements of three sets of ASME's standards, today's action would already be sufficient
to control the quality assurance process. The Agency agrees with both the Committee and with
similar public comment and has eliminated the requirement for peer review of quality
assurance programs and plans. The Committee also suggested that conceptual models should
be peer reviewed to help ensure that such models represent the physical reality of the disposal
system's long-term performance. The Agency agrees with this advice and therefore retains the
proposed rule's requirement that peer review be performed of conceptual models.
In the final rule, the Agency also requires peer review of conceptual models and of the
engineered barrier study and waste characterization analyses, the latter of which would include
studies by DOE of waste components and waste characteristics. Peer review of these two
activities is necessitated because of their central importance to the performance of the disposal
system. The Agency recognizes that peer review of all activities related to the WIPP is neither
practical nor sufficiently beneficial. In many instances, particularly with respect to data, the
Agency believes that formal peer review would be redundant with quality assurance programs
and has therefore deleted the proposed rule's requirement that data used to support models and
computer codes be peer reviewed.
In areas and activities for which peer review is not required, formal peer review can be partially
supplanted by the results of other reviews which are currently ongoing. In some cases, the
Agency does not believe that formal peer review could add significant value to those activities
which are already subject to the periodic reviews of such informal peer review groups as the
NAS WIPP Panel and the New Mexico Environmental Evaluation Group, for example. The
comments received from these reviews facilitate understanding the strengths and limitations of
the activities and analyses related to the WIPP. These groups routinely provide comments on,
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for example, models, experimental programs and scenarios. For these reasons, any compliance
application must include records of such informal peer reviews.
Issue B: It is DOE's responsibility to judge when peer review is required, and what should
be subject to review. (DOE-D, WEC-D)
1. It is not appropriate to assign responsibility to DOE to do peer review because critics of the
WIPP will view peer reviews conducted by DOE as biased. The EPA itself should conduct peer
review for the WIPP, similar to reviews conducted for other programs such as RCRA. (IV-G-3)
2. There are public perception problems associated with assigning DOE the responsibility for the
performance of peer reviews. (IV-G-3)
Response to Issue 9.B:
Although the responsibility for conducting peer review is DOE's, the selection of the experts
must follow the guidelines of NUREG-1297 with respect to the membership of the peer review
group. NUREG 1297 states that participants in a peer review group should have sufficient
freedom from funding considerations to ensure that the work is impartially reviewed, in addition
to having been uninvolved in the original work to be reviewed. Documentation of peer review
activities as required under section 194.27 must be part of the compliance applications.
Regardless of the recommendations or judgments made by the peer review groups, all decisions
on the adequacy of the compliance application will be EPA's and EPA's alone. In fact, by law, it
is EPA and EPA alone that conducts the rulemaking on certification. See 106 Stat. 4777, section
8(d) (Pub. L. 102-579). However, the Agency does intend to use review procedures internal to
the Agency, at its discretion, during the rulemaking on certification under section 8(d) and during
the periodic re-certification under section 8(f) of the WIPP Land Withdrawal Act.
Issue C: If this subsection is not deleted, then this subsection should clearly state that it
will be used as a criterion to evaluate whether a reasonable expectation of compliance with
40 CFR 191.13.191.15. and 191.24 exists. (SNL-A, SNL-C)
Response to Issue 9.C:
Several commenters have requested clarification on the relationship between compliance with
40 CFR Part 191 and the term "reasonable expectation." The term "reasonable expectation" is
used to express that absolute proof of compliance is not required since absolute proof of
compliance cannot be achieved for such long-term predictions. This term appears in the
containment requirements — section 13 of 40 CFR Part 191 — in which the Agency states that a
reasonable expectation of compliance is required to be considered by the Agency "on the basis of
the record before the implementing agency [EPA for the WIPP]." See 40 CFR 191.13.
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Issue D: This is the creation of a standard and not a criterion. (C-28)
Response to Issue 9.D:
The final rule does not contain additional standards for the protection of human health and the
environment. Rather, the final rule provides criteria for implementing 40 CFR Part 191 at the
WIPP facility. It is 40 CFR Part 191 that sets the quantitative and qualitative standards for
protection of public health and the environment that must be met by the WIPP. With respect to
the specific implementation of these standards in 40 CFR Part 194, Subparts A and B establish
the procedural requirements necessary to execute the Agency's activities mandated by
sections 8(d) and 8(f) of the WIPP Land Withdrawal Act. Subpart D provides for the public's
participation in those activities. Subpart C established the criteria which apply to the
performance assessments and compliance assessments used to demonstrate compliance with the
numerical requirements and also to the assurance requirements of the disposal regulations. This
section also contains seven general requirements which apply to all aspects of the compliance
application and to some of the activities conducted during its preparation. The section on peer
review in 40 CFR Part 194 is one of seven general requirements which apply to all portions of
the compliance application. Collectively, these seven general requirements establish the
adequacy of the calculations, studies, plans and analyses that support the compliance assessments
(required by 191.15 and subpart C) and performance assessments (required by 191.13) and to the
assurance requirements (191.14).
Issue E: The peer review process is inconsistent with NUREGs.
1. Some of the NUREGs contain secondary references—are they incorporated in the criteria also?
Perhaps EPA would be better off just incorporating the specific provisions it deemed necessary.
(NMAG-G)
2. The peer review process is inconsistent with NUREG-1297, which has its own scope.
(NMAG-B, NMAG-G)
3. The EPA should adopt the approach used by the U.S. Nuclear Regulatory Commission for
high-level nuclear waste repositories by providing guidance rather than requirements on peer
reviews, as the NRC has done in NUREG-1297. Peer reviews are not intended for routine
reviews of well established scientific and technical work. (IV-D-116)
4. Peer review is likely to be much-used, and the rule must call for true independence and
adherence to NUREG-1297, Peer Review for High-Level Waste Repositories. It will be
important for the peer reviewers to have a clear statement of the precise question to which they
are expected to address their judgment and to articulate their conclusion. (NMAG-D)
5. Any peer review documentation should follow the provisions of NUREG-1297. (SRIC-G)
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Response to Issue 9.E:
As stated in the preamble to the final rule, the Agency has incorporated NUREG-1297 by
reference in order to set criteria for the process used to conduct peer review. Those provisions of
NUREG-1297 which provide guidance on which activities should be peer reviewed do not
supersede or amend the requirements of the final rule, 40 CFR part 194. Any other discrepancies
in scope between the final rule and the NUREG are superseded by the explicit requirements of
the criteria.
Issue F: It is important to keep any standards and requirements for peer review.
1. The process for evaluating peer review should be open to the public and done by rule.
(NMAG-G)
2. It is important to keep in place any requirements that you have for peer review. (S-16, S-53)
3. Compliance criteria must meet the standards of peer review. (S-36)
4. The intent of peer review is to add value and credibility to activities and to minimize delays
that would be other wise costly after-the-fact. More value should be given to peer review
especially by organizations funded specifically for that purpose. (SGNM-D)
5. The final rule should require that peer review be done by DOE, prescribe the processes used,
and ensure that any peer review is fully documented. (SRIC-G)
Response to Issue 9.F:
The Agency agrees that peer review should be required. The Agency believes that the final rule's
requirements on peer review will add value to the compliance application. Regardless of the
extent to which peer review is used, the rulemaking on certification must be conducted by EPA.
See 106 Stat. 4777, section 8(d) (Pub. L. 102-579). All decisions on the adequacy of the
compliance application with respect to the disposal regulations will be EPA's and EPA's alone.
However, the Agency does intend to use review procedures internal to the Agency, at its
discretion, during the rulemaking on certification under section 8(d) and during the periodic re-
certification under section 8(f) of the WPP Land Withdrawal Act. The Agency's own review of
the compliance application for certification will be subject to rulemaking.
Section 27 of the final rule requires DOE to conduct peer review and specifies for which
activities peer review must be conducted. The final rule requires DOE to conduct peer review
of three specific elements of the WIPP program. In specific, the Agency has required peer
review of the selection and development of conceptual models, waste characterization
assessments and the study of engineered barriers. The requirement for peer review of
conceptual models will enrich DOE's process of selecting and developing conceptual models
with a broad spectrum of scientific viewpoints. Waste characterization is a field in which
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many new and precedent-setting techniques will be employed in areas in which no standardized
practice exists. Peer review of waste characterization analyses is indicated due to the
importance of a knowledge of the physical, chemical and radiological state of the waste in
predictions of the long term performance of the disposal system. This section, 194.27, also
requires peer review to be conducted of the study of engineered barriers so as to ensure that
the best possible information is provided to DOE on the selection of engineered barriers.
Compliance applications are required to include documentation of any peer review activities
that DOE may have conducted apart from those required by this rule, including those activities
which are similar to peer review, such as the reviews conducted by the WIPP Panel of the
National Academy of Sciences.
NUREG-1297 contains general guidance on how the process of peer review process is to be
conducted and documented. The final rule specifies that this guidance applies to the peer review
conducted by DOE for inclusion in a compliance application. The DOE must justify the specific
methods chosen to conduct peer review and provide documentation that peer review has been
adequately performed for the activities specified in section 27 of the final rule. These methods
and documentation, along with all other materials submitted in the compliance application, will
be subject to the Agency s review and approval as part of the rulemaking on certification and as
part of the reviews for re-certification.
Issue G: There is no necessity for peer review.
1. The peer review requirements would be costly, redundant, impose new requirements, are
unnecessary, and should not be required. (DOE-A, DOE-D, SNL-A, SNL-C, C-12, C-15, C-23,
A-13,A-31,IV-D-06)
2. The WIPP has always had oversight by the National Academy of Sciences. The program has
had adequate peer review, and there is no necessity for additional peer review. (IV-D-40)
3. It is recommended that the EPA delete the proposed universal requirement for peer review.
The proposal, as presently given, seems to add little or no value to DOE or to EPA. (F/-D-100)
4. Specific requirement of any type of peer review is inappropriate because of DOE's
responsibilities as the implementing agency, and because of the normal applicant/regulator roles.
The peer review requirements fail to recognize the implementation of the NQA-1 program under
§ 194.22 and the need for a graded approach towards technical reviews. It is recommended that
peer review references throughout the proposed 40 CFR part 194 and Supplementary Information
be deleted. Also, it is recommended that EPA's proposed strategy as discussed in the NACEPT
issue paper be abandoned. (SNL-D)
5. The EPA should delete the peer review requirements from the proposed rule. (DOE-E)
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6. It is recommended that the proposed use of peer review be deleted since, through the DOE
quality assurance program and the EPA participation in that program, the concerns will be/are
addressed. (IV-D-113)
Response to Issue 9.G:
The need for increased confidence in the disposal system and thus for peer review arises due to
the uncertainty inherent in the long-term projection of the behavior of the proposed disposal
system. The WPP in particular is the first system of this type, under consideration for disposal
of long-lived, highly radioactive wastes. As a result, the search for solutions to the technical
issues posed by geologic repositories has elicited considerable effort, but not complete agreement
among the scientists and engineers in the broader technical community. Peer review of certain
activities conducted at the WIPP can ensure that a more complete spectrum of knowledge and
experience will be utilized.
The EPA recognizes that some past examinations of DOE's WIPP activities could be considered
to be the equivalent of, although not identical to, peer review. The final rule requires that
documentation of these peer review activities be submitted as part of the compliance application.
The acceptability of these past reviews will be evaluated by EPA as part of its certification
decision; EPA's decisions on acceptability will take into account the similarity or compatibility
of past review with the guidelines established in NUREG-1297.
Issue H: Requiring DOE to institute a peer review process for documents and analyses
submitted to EPA seems to be asking the peer review group to perform a substantial part
of EPA's role. (IV-D-100)
1. The responsibility for the peer review of DOE's work belongs with the EPA. In the proposed
rule, the EPA seems to be requiring DOE to do the EPA's job. (TV-G-3)
Response to Issue 9.H:
The Agency does not intend for peer review of DOE's activities to supplant or replace the
Agency's review of compliance applications. Although the responsibility for conducting peer
review is DOE's, the selection of the participants must follow the guidelines of NUREG-1297
with respect to the membership of the peer review group. NUREG 1297 states that participants
in a peer review group should have sufficient freedom from funding considerations to ensure that
the work is impartially reviewed, in addition to having been uninvolved in the original work to
be reviewed. Documentation of peer review activities as required under section 194.27 must be
part of the compliance applications.
Regardless of the recommendations or judgments made by the peer review groups, all decisions
on the adequacy of the compliance application will be EPA's and EPA's alone. In fact, by law, it
is EPA and EPA alone that conducts the rulemaking on certification. See 106 Stat. 4777, section
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8(d) (Pub. L. 102-579). However, the Agency does intend to use review procedures internal to
the Agency, at its discretion, during the rulemaking on certification under section 8(d) and during
the periodic re-certification under section 8(f) of the WIPP Land Withdrawal Act.
Issue I: The use of peer review in the proposed rule is too broad and exceeds generally
accepted standards.
1. The scope of the peer review process proposed by EPA appears to presuppose that peer
review will be required to validate the entire WIPP program. The EPA needs to further evaluate
the costs associated with this level of peer review. (TV-D-111)
2. The scope of the proposed peer review program appears to exceed, by far any precedent
withing the nuclear or other regulated activities. Rather than mandating formal peer review for
"validation," the final rule should not specify uses of peer review. (TV-D-112)
3. The NAS would not be able to meet prerequisites for peer review. (DOE-D)
4. The "peer review" included in the proposed rule is much too broad in that it appears to require
peer review validation of the actions that have already been completed and subjected to review
by experts (peers) under the QA Program established by the DOE. This delay would result in
excessive costs and delay with minimal benefits. (IV-D-114)
5. The peer review requirement is redundant, excessive, and results in an inappropriate
stewardship of resources. The present technical reviews subjected to QA program controls are
sufficient oversight to provide adequate assurance of regulatory compliance. (IV-D-117)
6. It is believed that the DOE maintains the WPP program in accordance with ASME and DOE
QA requirements which are believed to be in compliance with NUREG-1297 Paragraph V. It
would appear that acceptance of DOE's Quality Assurance Program satisfy the basic need for
review of technical and programmatic judgments. There is no value in the proposed redundant
peer review system. (IV-D-122)
7. The EPA's position of having peer reviews conducted for QA programs and plans is
misguided, impractical, and unproductive. The requirement should be deleted from the Rule.
(IV-D-123)
8. Since EPA proposes in §194.27 that NUREG-1297 is the base document for use in
conducting peer reviews, it is significant that NUREG-1297 does not identify any
criteria/conditions where the need for QA programs or plans to undergo peer review is addressed.
For the EPA to propose to apply peer review to QA programs and plans would be a clear
misunderstanding of the original intent of the peer review process and how it should be applied.
(IV-D-123)
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9. Since the DOE has in place a quality assurance program consistent with the disposal standards
set forth in 40 CFR 191, and the applicable requirements of Appendix B of 10 CFR 50 and the
ASME nuclear standards, there appears to be no warranted necessity to require a peer review of
the entire WIPP quality assurance program. (IV-D-127)
10. The requirement to conduct peer review beyond that required by NQA seems duplicative and
is probably unnecessary. (IV-D-111)
11. Particularly in the area of qualification of old data, compliance criteria must require stringent
application of quality assurance standards. Peer review alone may not be appropriate in this area.
(CCNS-B)
Response to Issue 9.1:
The Agency sought the advice of the WIPP Review Committee of the National Advisory
Council for Environmental Policy and Technology (NACEPT) regarding which activities
should be required to be peer reviewed. The Committee suggested that peer review of quality
assurance programs would be unnecessary, since, by requiring DOE to adhere to a program
that meets the requirements of three sets of ASME's standards, today's action would already be
sufficient to control the quality assurance process. The Agency agrees with both the
Committee and with similar public comment and has eliminated the requirement for peer
review of quality assurance programs and plans.
The final rule provides for a separate treatment of the peer review that is performed as part of
quality assurance process versus peer review that is applied at a more general level. The
Agency does not believe it is useful or practical to require peer review of all aspects of a
compliance application. The final rule focuses peer review on critical activities associated with
the WIPP. In the context of quality assurance, peer review may be invoked in one of two
ways. First, existing data will be acceptable if it meets the requirements of a quality assurance
plan "equivalent in effect" to that which EPA requires of data generated after the QA programs
required by the final rule are in effect. Peer review can be part of such a quality assurance
plan. Alternatively, DOE may qualify existing data using a combinations of peer review,
corroborating data, or confirmatory testing, subject to the Administrator's approval.
The Agency recognizes that other review and oversight activities, in addition to peer review,
have occurred and will continue to occur during the WIPP's development, operation and
decommissioning. These activities may be similar but not identical to peer review with respect
to meeting the requirements of 40 CFR Part 194. Such review activities include the occasional
reviews performed by the National Academy of Sciences' WIPP Panel. All such reviews must
be documented in compliance applications.
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Section 10: APPLICATION OF RELEASE LIMITS: SECTION 194.31
Issue A: The 100-year time frame for calculating the release limits on the curie activity
warrants re-evaluation.
1. The assertions that DOE and Sandia have advocated calculating the release limits on the curie
activity 100 years after the shafts are sealed are wrong. (DOE-D, SNL-C)
2. Use of curie activity 100 years after disposal is certainly not too long. (A-41, IV-D-51)
3. The limit should be raised to 1,000 years. (C-03)
4. The establishment of a curie activity rate should be defined as the rate 100 years after
decommission. (C-14)
5. The wording implies that a release limit depends on the amount of an isotope in the WPP
depository. The proposed 100-year base for calculating release limits is a gross approximation
which is unnecessary. (IV-D-06)
6. The limit of 100 years is acceptable. (NMAG-B, C-14, A-41)
7. Section 194.31 would require that the expected curie activity remaining 100 years after
disposal be used as the basis for calculating applicable releases under Appendix A of 40 CFR
part!91.(IV-D-112)
8. The Agency should adopt as final its proposal to measure the radionuclide content of the
inventory 100 years after disposal. The 100-year date will bring the protection of 40 CFR
part 191 for TRU waste much closer to parity with the protections for spent fuel than would the
suggestion to use the initial inventory. (NMAG-D, SRIC-G)
9. The 100-year time period after disposal used in calculating applicable release limits is
reasonable. (SGNM-D)
Issue B: The waste unit should be based on the curie content at the time of assay.
1. The text for § 194.31 should be replaced to state, "The curie activity at the time the waste is
assayed prior to shipment to the WIPP shall be used in calculating applicable release limits under
Appendix A of 40 CFR part 191, Table 1." (IV-D-111)
2. The waste unit should be based on the curie content determined by the assay to be performed
prior to shipment to the WIPP. For newly generated waste, the waste-unit curie content assay
will be consistent with the derivation of 40 CFR part 191, which establishes zero time as the time
of the generation of the waste. For old waste, this measurement will incorporate the decay that
occurred during storage; the curie content at the time of generation will not be back-calculated.
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Assays of both old-waste and new-waste inventories can be adequately accounted for in the
performance assessment. (SNL-D)
3. It is recommended that the waste unit be based on the curie content determined at the time of
assay to be performed prior to shipment to the WIPP. (DOE-E)
4. Basing release limits on the curie activity at the "time of assay" would be inappropriate and
could be inaccurate. (SPJC-G)
Response to Issues 10.A and 10.B:
The proposed compliance criteria (in §194.31) included a pro vision that would have required that
the release limits for the WIPP be calculated based on the expected curie activity in the disposal
system 100 years after disposal (i.e., when the disposal system shafts are backfilled and sealed).
While some comments supported this position, others stated that the release limits should be
based on the curie content of the waste at some other point in time. This issue was addressed by
the WIPP Review Committee of the National Advisory Council for Environmental Policy and
Technology (NACEPT) at a public meeting in New Mexico in September, 1995. The NACEPT
committee reached two primary conclusions: 1) that the release limits should be based on longer-
lived radionuclides to reflect the long-term hazards presented by the waste; and 2) that statements
in the compliance criteria on release limits should be consistent with the basis for developing the
release limits in EPA's disposal regulations (40 CFR part 191). Consequently, EPA re-examined
the basis of the disposal regulations.
The Agency determined that development of the release limits in 40 CFR part 191 had already
incorporated the principle that long-term hazards, and thus long-lived radionuclides, should be
the focus of regulation. To that end, the release limits do not require consideration of alpha-
emitting radionuclides with half-lives less than 20 years. In addition, Appendix A of the disposal
regulations contains instructions for adjusting the release limits in Table 1 according to the
amount and type of waste in a disposal system. These conversion factors take into account the
differences in radioactive characteristics between spent nuclear fuel and transuranic waste. [See
40 CFR part 191, Appendix A, Note 1.] There is no indication that the disposal regulations (or
their implementing criteria) require an additional adjustment for transuranic waste. Thus, EPA
concluded that the release limits for the transuranic waste planned for emplacement at the WIPP
should be established consistent with the release limits for all types of waste regulated by the
disposal regulations.
In reviewing the basis for the release limits in 40 CFR part 191, EPA found no technical support
for setting the curie content (for any waste regulated under Part 191) at 100 years after disposal,
or at the time the waste is assayed. The disposal regulations call for calculation of "the
cumulative releases to the accessible environment for 10,000 years after disposal" [emphasis
added]. See 40 CFR 191.13(a). See also 40 CFR part 191, Appendix A, Table 1. The preamble
to the final disposal regulations also state that "[t]he release limits apply to radionuclides that are
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projected to move into the accessible environment during the first 10,000 years after disposal [50
FR 38071]." Note that the disposal regulations define disposal for a mined geologic repository
as that point when "all of the shafts to the repository are backfilled and sealed [§ 191.02(1)]." The
position that release limits should be set at the time of disposal, which is when the 10,000-year
regulatory time frame begins, is consistent with the disposal regulations. Calculation of
radioactive decay is readily accomplished with standard equations, and EPA does not believe it is
an undue burden on the DOE to account for decay of radionuclides between the time of assay and
time at which the disposal system is sealed. Based on these considerations, the Agency has
chosen in the final rule to determine release limits based on the total activity, in curies, of each
radionuclide in the transuranic waste predicted to be present at the time the WIPP is sealed.
Issue C: The requirements of Section 194.31 contradict 40 CFR part 191.
1. Selecting 100 years after disposal as point of time for setting release limits departs from
40 CFR Part 191 and should be a separate rulemaking. (DOE-D, WEC-D, A-41)
2. Proposed 100-year decay period is inconsistent with Agency's promulgation of an
"equivalence factor" for transuranic waste. (DOE-D)
3. The approach is inappropriate because the proposed requirement is more stringent than the
release limits in Appendix A to 40 CFR part 191. (SNL-C)
4. The requirement should be made consistent with Part 191 by fixing the curie content at the
time that the curie content of the waste container is determined for delivery to the WPP because
this is the only time that the curie content is assayed. (SNL-A, SNL-C)
5. The waste unit for TRU waste should be as consistent as possible with the derivation of
Table 1 in Appendix A to 40 CFR Part 191. (SNL-C)
6. The release limits in §191.13 (a) specifically apply to radionuclides with half-lives greater than
20 years, while the 100-year delay is intended to allow a "long enough period of time for most of
the radioactive material with short half-lives to decay to low levels (60 FR 5774)." (SNL-C)
7. The proposed time delay is inconsistent with the regulatory time frame established in 40 CFR
part 191. (SNL-C)
8. The proposed approach is inconsistent with the spent-fuel equivalency rationale developed to
allow derivation of a single set of release limits for geologic disposal of radioactive waste. EPA
based the waste unit derivation on a philosophy of equivalence between the various types of
waste regulated by 40 CFR part 191. (SNL-C)
9. The proposed approach directly contradicts 40 CFR part 191. (SNL-C)
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10. If EPA intends to increase the stringency of the release limits, then Table 1 of Appendix A
must be revised consistently through rulemaking for 40 CFR part 191. (SNL-C)
11. The part of the proposed rule appear to be a departure from the assumptions used for the
development of release limits in 40 CFR part 191. The curie content of the waste should be
specified at the time of assay. (IV-D-111)
12. The proposed approach of using 100 years to calculate applicable release limits is
inconsistent with the spent-fuel equivalency rationale established as the basis for the single set of
release limits. The waste unit determines the release limits for a specific repository. This is a
significant departure from the basis for derivation of the release limits for 40 CFR part 191, and
effectively imposes new release limits on the WIPP. (SNL-D)
Response to Issue 10.C:
The Agency has modified the final rule to ensure that implementation of release limits at the
WIPP is consistent with the technical basis and intent of the disposal regulations at 40 CFR
part 191. Upon reviewing the basis of the release limits in 40 CFR part 191, EPA concluded
that the conversion factors take into account the differences in radioactive characteristics
between spent nuclear fuel and transuranic waste. [See 40 CFR part 191, Appendix A, Note 1.]
There is no indication that the disposal regulations (or their implementing criteria) require an
additional adjustment for transuranic waste. Thus, EPA concluded that the release limits for the
transuranic waste planned for emplacement at the WIPP should be established consistent with the
release limits for all types of waste regulated by the disposal regulations.
In reviewing the basis for the release limits in 40 CFR part 191, EPA found no technical support
for setting the curie content (for any waste regulated under 40 CFR part 191) at 100 years after
disposal, or at the time the waste is assayed. The position that release limits should be set at the
time of disposal, which is when the 10,000-year regulatory time frame begins, is consistent with
the disposal regulations.
Calculation of radioactive decay is readily accomplished with standard equations, and EPA does
not believe it is an undue burden on the DOE to account for decay of radionuclides between the
time of assay and time at which the disposal system is sealed. The EPA expects that standard
methods of calculating the future activity of existing inventory will be applied by DOE. Such
methods would include the familiar Bateman equations, which account for both ingrowth
(increase in the quantity of a radionuclide from the decay of a heavier nucleus) and decay
(decrease due to decay of the nucleus of that same radionuclide). Based on these considerations,
the Agency has chosen in the final rule to determine release limits based on the total activity, in
curies, of each radionuclide in the transuranic waste predicted to be present at the time the WPP
is backfilled and sealed. See response to Issue 10.A for more information.
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Section 11; PERFORMANCE ASSESSMENTS: SECTIONS 194.32 AND 194.34
Issue A: Scenarios should be selected that represent the entire appropriate range of
processes and events.
1. Methods of conducting a Performance Assessment (PA) may be questioned including the
selection of scenarios for analysis, definition of computational scenarios, assignment of
probabilities to computational scenarios, development of conceptual models, transition of
conceptual models to computer models, selection of values, ranges of values, and sampling
methods for unknown values in conceptual models, and selection of CCDF expression for
comparison with release limits. (NMAG-B, NMAG-F)
2. It is appropriate that performance assessments need not consider processes, events, or
sequences of processes and events that have less than one chance in 10,000 of occurring over
10,000 years. (WEC-D, IV-D-06)
3. Performance Assessments must analyze scenarios which include post closure time periods
between 10,000 and 100,000 years. (SRIC-E, CCNS-B)
4. Performance assessment should include DOE's poor track record when figuring probabilities.
Risk assessment should include the low probability/high consequence scenarios. (CARD-B,
CCNS-B, S-21)
5. Mining should not be excluded from performance assessments. (A^l)
6. EPA regulations should specify scenario selection and require the DOE to prove that the site
can guard against for 10,000 years, the probability of intrusion by industry, the presence of
radiation through karst conditions, future sinkholes, and other results of climate changes, and the
possibility of compressed gas finding or causing fractures. (NMAG-G, S-40)
7. Scenario probability assignments based on "expert judgment" must be subjected to critical
review. (NMAG-F)
8. Performance assessments should evaluate the impact of natural and human-initiated processes
and events for a time period of 100,000 years. Such calculations would provide additional
confidence in the results of CCDFs. (SRIC-G)
9. It is recommended that EPA address the issue of general classes of processes and events being
subdivided. EPA should also be using a more qualitative treatment to address this issue. (NRC)
10. Criteria should require an explanation and justification of the selection of fixed and variable
parameters; the establishment of range, median, and probability distribution of variable
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parameters; and the sampling methods, including any probability judgments implied thereby.
(NMAG-B, NMAG-G)
11. The rule should require that the statements about ranges and uncertainty be supported by data
and explanation. (NMAG-C)
12. In the construction of scenarios, all relevant sequences of events and processes must be
considered, but the rule does not prescribe all possible sequences. (NMAG-D)
13. Low probability of occurrence, as defined in Appendix C to 40 CFR part 191, should be
retained as a screening criterion for processes, events, and scenarios. (SNL-D)
14. The time period of regulatory concern for the Containment Requirements should be retained
at 10,000 years, consistent with 40 CFR part 191. (SNL-D, DOE-E)
15. Consequence should be retained as a screening criterion for scenarios. (SNL-D)
16. Identifying scenarios as combinations of features, events, and processes is important, and
should be specified in the rule. The selection of, and justification for, the specific procedure used
in developing scenarios should be the responsibility of the DOE. (SNL-D)
17. The DOE recommends that low probability of occurrence and consequence, as defined in
Appendix C to Part 191 and used as one of the bases for the Standards in Appendix A, retained
as screening criteria for processes, events, and scenarios. (DOE-E)
18. DOE cannot appropriately use the Appendix C guidance of 40 CFR part 191 to reject certain
scenarios since the guidance is not required at the WIPP. DOE must justify excluding scenarios
based on low probability or insignificant consequence. (SRIC-G)
Response to Issue 11 .A:
The EPA intends to review all aspects of the analyses of performance and, in many sections of
40 CFR part 194, has required extensive justification for the different steps of the analysis. The
final rule requires that the application for certification must document and explain the treatment
of scenarios and variables in the analysis of disposal system performance. The Department of
Energy is required to justify those conceptual models that DOE selects and develops and explain
the progression of these models into mathematical, numerical and computer models.
Some comments stated that analyses of disposal system performance should model 100,000 years
of performance rather than the required 10,000 years. The EPA's requirement for an analysis to
extend 10,000 years was stated in 40 CFR part 191 and was the product of extensive analysis and
public review. In 40 CFR part 191, the Agency stated that "a disposal system capable of meeting
the proposed containment requirements for 10,000 years would continue to protect people and
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the environment well beyond 10,000 years [50 FR 38076]." Since the requirement of 10,000
years was established as part of the disposal regulations, 40 CFR part 191, the Agency's mandate
in implementing these standards at WIPP does not allow or necessitate a re-assessment of the
appropriateness of these disposal regulations.
Some commenters suggested that the EPA should specify which processes and events must be
considered by DOE in analyses of disposal system performance. The final rule's requirements on
the scope of performance assessments, including the processes and events that can affect the
disposal system, were based in part on the disposal regulations. The containment requirements
as provided in 40 CFR 191.13 apply at two sizes of cumulative release, calculated according to
Table 1 of Appendix A of 40 CFR Part 191: releases of "size 1" must be less likely than 1 in 10,
and releases of "size 10" must be less likely than 1 in 1,000. The Agency determined, for
example that, if a release of size 10 were only exceeded in 1 of 1,000 cases, the public health
would be adequately protected, including a margin of safety. By adding together the probability
of the combinations of individual processes and events which are predicted to cause these
releases, the precise probability of a size 10 release being exceeded may be determined. This
"cumulative probability," so called because it is the sum of many events' probabilities, may then
be compared to the 1 in 1,000 standard to test for compliance.
The disposal regulations at section 191.13 (a) require analysis of cumulative releases of all
"significant" processes and events. See also 40 CFR 191.12, definition of "performance
assessment." Thus, the disposal regulations recognize that some processes and events are so
small or unlikely that they should be excluded as insignificant. Appendix C of 40 CFR Part 191
provides guidance on this point, recommending that performance assessments not consider
categories of processes and events that are estimated to have less than 1 chance in 10,000 of
occurring over 10,000 years. Appendix C also provides that processes and events with a greater
likelihood of occurence may be omitted from performance assessments if there is a reasonable
expectation that the remaining probability distribution of cumulative releases would not be
significantly changed.
The Agency recognized that, at some sufficiently small level of probability, the likelihood of the
individual probabilities of processes' or events' occurring would be too small to add up to this 1
in 1,000 or to significantly affect the overall probability distribution and would therefore be too
unlikely an occurrence to pose a significant threat to public health. For the purposes of the
WIPP, the Agency has determined that, similar to the Appendix C guidance, this "threshold
probability" would be 1 in 10,000 over 10,000 years. Even with this threshold test, however, a
comprehensive spectrum of processes and events will nonetheless be included in the performance
assessments used to predict cumulative releases. Such geologic events as natural seismic
activity, magmatic activity would almost certainly be included performance assessments as their
probability of occurrence is almost certainly above the 1 in 10,000 threshold. However, certain
processes and events may safely be ruled out as being less than 1 in 10,000 likely to occur at the
WIPP over the 10,000 year regulatory time frame, such as glaciation and volcanic activity.
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It is further worth noting that this 1 in 10,000 threshold probability applies to categories of
processes and events. For the purposes of this screening requirement, processes and events
must be analyzed in the most general formulation possible; for example, the probability of
dissolution must be set equal to the probability of all types of dissolution occurring anywhere
in the Delaware Basin during the regulatory time frame. Performance assessments should,
however, conduct separate analyses of the different dissolution fronts which occur in the
Delaware Basin so as to account for the different hydrogeologic characteristics of each. To
ensure that the analysis to exclude a process and event is sufficiently rigorous and documented,
the final rule, at section 194.32(e) requires documentation showing why any processes and events
or sequences and combinations of processes and events that may occur in the regulatory time
frame and may affect the disposal system are not included in performance assessment results.
The Agency agrees with comments stating that, should the probability of such events be
established by expert judgment, then the judgment should be carefully reviewed. The Agency
has therefore included a section on the use of expert judgment at §194.27 of the final rule. In
addition, the final rule has specified that performance assessments "shall include an analysis of
the effects of the disposal system of any activities that occur in the vicinity of the disposal system
prior to and soon after disposal. Such activities shall include, but not be limited to: existing
boreholes and the development of existing leases that can be reasonably expected to be
developed in the near future, including boreholes and leases that may be used for fluid injection
[paragraph 194.32(b)]." Thus, applications must document existing bore holes near the site and
account for their potential impact over the 10,000-year regulatory time frame. Assumptions
about drilling over the regulatory time frame, however, are subject to the criteria of §194.33.
Regarding the issue of how to subdivide processes and events for probability analysis, EPA has
further explained the Agency's expectations on this issue for the final rule. The preamble to the
final rule states: "For the purposes of this screening requirement, processes and events must be
analyzed in the most general formulation possible; for example, the probability of dissolution
must be set equal to the sum of the probabilities of all types of dissolution occurring anywhere in
the Delaware Basin during the regulatory time frame. Performance assessments should,
however, conduct separate analyses of the different dissolution fronts which occur in the
Delaware Basin so as to account for the different hydrogeologic characteristics of each." See
also Section 12 of this document.
Issue B: The 95 % statistical confidence level does not appear to be well justified and
should be reconsidered.
1. The method for attaining statistical confidence in the mean presented in Supplemental
Information of the proposal is neither correct nor appropriate. "Sequences" are confused with
"combinations." (DOE-D, SNL-C)
2. EPA has wisely specified a confidence limit of 95 percent. However, the rule should define
when this is achieved. (SNL-A, SNL-C)
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3. Selection of a 95% level of statistical confidence for a reasonable expectation appears
arbitrary and in conflict with 40 CFR part 191. (DOE-D, WEC-D, IV-D-100)
4. The number of performance assessment runs required to satisfy this requirement would
exceed by three times the number of runs projected by the EPA. It is recommended that the EPA
reevaluate the confidence level requirements of this proposed rule. (SNL-A, IV-D-40)
5. The proposed approach set forth in § 194.34(b) is very difficult to implement. (SNL-C)
6. The Agency should start from the goal that the unconditional risk assessment have the aim of
proving compliance to the level of 90% certainty~"reasonable assurance"~and from there
establish the level of certainty called for in the conditional risk assessment. (NMAG-D)
7. The full uncertainty analysis of WIPP has not been done and would be extremely difficult. In
this situation, it is sensible to apply a test of reasonable expectations to the results of a
conditional risk analysis based on fixed hypotheses, provided that the hypotheses are globally
conservative, and the mean curves correspond to high fractiles of the CCDF families. (NMAG-E)
8. A reasonable way to judge compliance is to use the curve that represents the mean population
of CCDFs with a 95 percent level of statistical confidence. (SRIC-G)
9. The rationality of the mean as a relevant characteristic of a probability distribution does not
apply to collective decisions (such as governmental decisions), in which the administrator is
concerned not only with the probability distribution of the levels but also with the health and
safety of the most exposed members of the public. (NMAG-E)
Response to Issue ll.B:
The Agency declined to base compliance with the containment requirements on a percentile
value, such as the 95th percentile, as suggested in the comments. Instead, the Agency chose the
mean complementary cumulative distribution function (CCDF) as the value which must be in
compliance. In developing the proposed rule, the Agency considered basing compliance with the
containment requirements on a CCDF other than the mean CCDF. For example, the median
(50th percentile) CCDF and other percentile CCDF were considered as possible choices.
The mean CCDF was selected as the test for compliance because of several properties. First, the
mean is an indicator of "central tendency," a term which indicates that the location of the mean
is, in a statistical sense, at the center of the group of CCDFs. Second, the location of the mean is
strongly influenced by CCDFs which are "outliers" in the group of CCDFs. In effect, an
individual CCDF that is located far above or below the remaining CCDFs in a group exerts more
"leverage" on the location of the mean than would more centrally located CCDFs. This rule-of-
thumb becomes important in a situation in which there are several CCDFs located far above the
median, the latter being the "mid-point" CCDF to indicate that an equal number of CCDFs fall
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above as fall below the median. The specific location of the mean CCDF, however, will depend
on just how far above and how far below the median these CCDFs lie. If the CCDFs which fall
below the median lie fairly close in, then the CCDFs located far above will preferentially move
the mean towards higher values. It is worth noting that the median would be immune to this
"leveraging" or "over-balancing." In the case of WIPP, the groups of CCDFs generated in DOE's
preliminary performance assessments do, in fact, possess this lopsided quality in which CCDFs
that predict larger releases are not balanced by a similar number of CCDFs that predict small
releases.
The median CCDF was also considered during the development of the final rule. Like the mean,
the median has the advantage of being an indicator of the "central tendency" of a group of
CCDFs, since an equal number of CCDFs fall above as fall below the numerical value of the
median. As noted above, however, whereas the mean CCDF would be subject to the "leverage"
of extremely high or extremely low CCDFs, the median CCDF would be relatively stable.
Some comments have suggested that the Agency should determine compliance based upon a high
percentile value of the group of CCDFs that are generated, such as the 85th or 90th percentile.
The percentile value of a CCDF is an indicator of the relative numerical value of one CCDF in a
group with respect to all other CCDFs in that group. For example, the particular CCDF that
exceeds 90 percent of the group of CCDFs would be dubbed the "90th percentile." As
mentioned, the Agency considered the option of using a percentile valued CCDF to test
compliance with the numerical containment requirements of section 13 of 40 CFR part 191.
Higher percentiles, however, do not indicate the central tendency of a group of CCDFs and
would therefore less accurately convey the best estimate of the disposal system's performance.
The Agency believes that an indicator of central tendency would be more appropriate, provided
that the final rule also impose many inherently conservative assumptions on the performance
assessments. One such requirement is the threshold probability of 1 in 10,000 over 10,000 years
which applies to processes and events. As another example, performance assessments must
employ random sampling techniques that sample across the full range of possible values that a
given parameter may assume, even from those values which are both unlikely and which could
contribute to larger releases from the disposal system. The influence of these requirements will
be conveyed to the CCDFs which are generated per the requirements of section 34 of the final
rule and would obviate the need for a non-conservative CCDF to be used to test compliance.
With these constraints in mind, the Agency believes that the best test for compliance can be made
using some measure of the central tendency of the family of CCDFs.
The Agency chose to require that some measure of the reliability of the calculated value or a
"confidence limit" should be established for the tested CCDF, regardless of whether that CCDF
were the mean, median or a percentile. For a particular group of CCDFs, the mean CCDF can be
calculated to within a more precise range of accuracy than the percentile CCDF. In other words,
the uncertainty surrounding the numerical value of the mean CCDF would be less than the
uncertainty surrounding the numerical value of a CCDF at a chosen percentile. This property of
the mean CCDF makes the mean a reliable indicator to be used to test compliance.
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Further comments have suggested that the mean CCDF be used, but without the 95 confidence
requirement. These comments stated that the recommendations contained in Appendix C of
40 CFR part 191 with regard to which CCDF must comply with the containment requirements
were not incorporated into 40 CFR part 194. Specifically, the comments state that Appendix C
requires that the mean CCDF comply with the containment requirements without requiring that
there be 95 percent confidence in this compliance. Appendix C did, in fact, leave open the
question of requiring a confidence level. The Agency further notes that Appendix C was
designated as non-binding.
The above alternate methods — using a percentile value or the mean, but without the confidence
measure — discarded the Agency's requirement that there be a 95 percent confidence of
compliance. This suggestion was at odds with the Agency's need for assurance that the WIPP be
in compliance with the containment requirements, since it would have removed the objective
measure used to assess this assurance. In contrast, the alternate methods provide only for a
comparison of the mean CCDF, as calculated from all the CCDFs generated to test compliance,
with the containment requirements. While the Agency believes that useful information might be
gleaned from such a comparison, the Agency views as essential a measure of the confidence of
the mean's compliance. Hence, the Agency retained the original approach in final rule, 40 CFR
part 194.
The final rule at 40 CFR part 194 requires that the mean or average value of all the CCDFs
generated be compared to the quantitative containment requirements of section 13 of the disposal
regulations. The containment requirements limit the sizes of releases of radionuclides that might
occur over the 10,000-year regulatory time frame. The size of a release is calculated using the
instructions in Appendix A of 40 CFR part 191 and represents a contribution from the predicted
number of curies of each radionuclide that is predicted to be released over 10,000 years. Per the
containment requirements, the mean CCDF cannot predict that a 10,000-years' release of size
"one" is more than 10 percent likely to occur, or, further, that a release of size "ten" is more than
0.1 percent likely to occur. Releases of these sizes are of sufficient magnitude such that, were
these releases predicted to be more likely than these small percentage values permit, the disposal
system's ability to isolate waste would be questionable. The Agency will assess compliance by
evaluating the value of the mean CCDFs at the two relevant sizes of release, one and ten.
In addition, the Agency has retained the requirement that the mean CCDF must be in compliance
with a 95 percent level of statistical confidence. Statistical confidence levels are a measure of the
"trueness" of a calculated number. Should the mean CCDF be found in compliance with a high
level of confidence, such as 95 percent, then the assertion that it is in compliance is likely to be a
"true" prediction, based on the present conceptual understanding of the WIPP's performance.
Absolute confidence — in effect 100 percent confidence — cannot be established without making
an infinite number of calculations.
Demonstrating 95 percent confidence of compliance can be easier or harder to achieve depending
where the value of the mean CCDF lies with respect to the numerical limits of the containment
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requirements. The demonstration becomes easier if the mean CCDF shows compliance by a
comfortable margin but becomes harder if the mean is close to violating the standard. For
example, assume that a mean CCDF is computed that shows an extremely low likelihood — say 1
in 1,000 — that a release of size "one" can occur. This falls well below the maximum likelihood
that the standard permits, 1 in 10 or a 10 percent chance. In this situation, fewer calculations
would be necessary to establish that the requirement for 95 percent confidence has been satisfied.
However, if the mean CCDF falls close to the limit of 10 percent likelihood for a size "one"
release, then a far greater number of calculations would be necessary to satisfy the requirement
for 95 percent confidence. Of course, a demonstration of the required confidence limit is only
possible if the mean itself is in compliance.
Certain comments have suggested that an impracticably large number of calculations would be
required to show that the mean CCDF is in compliance with a 95 percent confidence limit. As
just noted above, the number of CCDFs required to establish 95 percent confidence will vary
depending on the margin with which the mean itself complies with the containment
requirements. The exact number of calculations that would be necessary can be determined by
statistical methods.
Certain comments stated that the requirement for 95 percent confidence was not consistent with
the containment requirements of 40 CFR 191.13. In 40 CFR part 191 -- the "disposal
regulations" which apply to all highly radioactive waste repository — the Agency recognized that
absolute proof of a repository's successful compliance with the containment requirements could
never be established. See §191.13(b). The requirements set the maximum likelihood with which
predicted releases of waste could occur, but left open the question of what would be necessary
for a specific disposal system, in this case WIPP, to show compliance. The 95 percent
confidence requirement in 40 CFR part 194, discussed above, represents an appropriately
rigorous level of proof given the limitations of an analysis which predicts performance 10,000
years into the future.
Certain comments stated that the rule appeared to specify that the 99th percentile CCDF must
comply with the containment requirements of 40 CFR part 191.13. (The 99th percentile denotes
that CCDF which would be exceeded by only 1 in 100 CCDFs, if an infinite number or
"population" were to be generated. This value can be estimated, but never absolutely
determined, by computer calculations.) The 99th percentile is determined separately at each
value of cumulative release, i.e. at each point on the CCDF that corresponds to a different point
on the horizontal axis. The final rule, 40 CFR part 194, places this requirement on the CCDFs
only at cumulative releases of 1 and 10. Cumulative releases are calculated according to Note 6
of Table 1, Appendix A of 40 CFR Part 191.) In 40 CFR part 194, the Agency does not require
that the 99th percentile CCDF be calculated, or be compared to the containment requirements in
order to assess compliance. Rather, the DOE must determine only the probability with which the
99th percentile will be exceeded. This differs from an actual calculation of the numerical value
of the 99th percentile CCDF; the probability of exceeding that quantity is determined based on
the statistical properties of the complete group of CCDFs.
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Issue C: Requirements regarding CCDFs should define terms more precisely, consider
effects on scenario selection, and limit generation requirements to reasonable levels.
1. EPA is correct in stating that the mean is a more suitable representation of the range of
CCDFs than the median. However, the regulatory compliance purpose of the 99th percentile is
not clear in the proposed rule and should be stated explicitly. (SNL-C)
2. The requirement placed on the maximum CCDFs generated is excessive and could result in
significant quantities of computer time. The criteria should say that number of CCDFs generated
shall be sufficient to establish the distribution of the population In general, enough CCDFs
should be run and sufficient statistical assessments made in order to provide a reasonable
expectation of the performance required. (DOE-D, C-28)
3. If a CCDF based upon a single realization demonstrates compliance, that maybe enough. If it
does not, the whole should not be thrown out with out examining a sufficient family of CCDFs to
clearly demonstrate the total system behavior to reveal a behavior that may have a remedial
correction. (IV-D-51)
4. The definition of "population of CCDFs" needs clarification as to whether it means the entire
population of CCDFs which would be generated from sampling values of parameters through an
infinite number of iterations, or the CCDFs generated from sampling of particular values and
generation of specific vectors using the sampling results—the "parameter values used in
compliance assessments." (NMAG-D)
5. "Population of CCDF's" should refer to the CCDFs used in compliance demonstration
generated from the probability distribution of uncertain disposal system parameter values, not an
infinite number of CCDFs. The "population of estimates" definition should be restricted to
reasonable estimates. (DOE-D, WEC-D)
6. The inclusion of the words "all possible" in the definitions of "population of CCDF's" and
"population of estimates" make these definitions impossible to implement. The definitions of
"population of CCDFs" and "population of estimates" should be amended to read: "Population of
CCDFs means a sufficient number of CCDFs generated so that the maximum CCDF exceeds the
90th percentile with 90% confidence," and "population of estimates means a sufficient number of
estimates generated so that the maximum estimate exceeds the 90th percentile with 90%
confidence." (DOE-D, SNL-C)
7. It is suggested that the requirement of a minimum number of data points would usefully
inhibit the formulation of probability distribution functions which are entirely subjective. The
form and parameters of the probability distribution function should be justified objectively by its
proponents. (NMAG-D)
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8. In reference to the processing time required to meet the requirement of 95% confidence that
the maximum CCDF exceeds the 99th percentile, DOE should present more than unsupported
assertions as to the nature of the distribution and the time to perform iterations. (NMAG-D)
9. Basing compliance on a single realization is recommended against. To arrive as a "best
estimate" value for each of many variable parameters would be very difficult since the
performance assessment includes multiple coupled nonlinear processes. (NMAG-D)
10. The test of 95% confidence to account for sampling error should be sufficient. (NMAG-E)
11. 40 CFR part 191 states that a comprehensive performance assessment would be the basis for
determining reasonable expectation of compliance while 40 CFR part 194 states new
requirements in §§194.21 through 194.27 for a basis for determining compliance. In addition,
Appendix C of 40 CFR part 191 requires a single CCDF to show compliance while §194.34(d)
requires only the mean CCDF. The proposed rule does not establish an adequate relationship
with 40 CFR part 191 because it does not specify what the applicant must do to comply with
40 CFR part 191. (SNL-A, SNL-C)
12. Clarify if probability applies to events taken collectively, or taken individually. (NMAG-G)
Response to Issue 1 l.C:
As some of the comments correctly note, the population of CCDFs is the ensemble consisting of
an infinite number of CCDFs. The Agency recognizes the limitations imposed by this infinite
size, and as a result the final rule does not require a calculation of the population of CCDFs.
Nonetheless, it is possible to make statements about the relationship of statistical features of
finite number of CCDFs to features of this infinite population. One statistical feature of both the
finite and the infinite group of CCDFs is the 99th percentile CCDF; specifically, this CCDF
would exceed 99 out of 100 CCDFs. (As noted in an earlier response in this section, the 99th
percentile CCDF may be a different CCDF at each different value of cumulative release, which is
the horizontal axis on the CCDF.) This CCDF can be found simply enough with a finite group of
CCDFs by ranking the CCDFs from highest to lowest and choosing the top one percent. For the
infinite population, the value of this CCDF which exceeds 99 out of 100 CCDFs — the "top one
percent CCDF" — cannot be determined due to the limits of computation.
Information about the infinite population of CCDFs is essential because the infinite population is
a truer representation of the possible results of the performance assessment. In particular,
information about the CCDF which exceeds the 99th percentile CCDF can be useful as well. In
recognition of this, the Agency requires that the relationship be established between this CCDF
from the finite group and that of the infinite population. In the final rule, this requirement is
stated as the probability that the top one percent CCDF of the finite group be 95 percent likely to
exceed 99 out of 100 CCDFs of the population. In other words, the highest-valued CCDFs that
are generated by computer must be similar to the highest-valued CCDF that would be found if
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the computers were run indefinitely. As noted, this cannot be determined by a direct comparison
of numerical values of the CCDFs of the finite group and infinite population, since such values
are impossible to calculate, but can be evaluated using standard statistical methods.
The Agency believes that this requirement is essential to provide assurance that the full range of
possible results of the performance assessment be represented. To reiterate, the Agency agrees
with concern raised by comments that the numerical values of the infinite group of CCDFs
cannot be calculated. Nonetheless, these probabilistic relationships can be established with a
finite number of CCDFs, and hence the Agency has retained these requirements.
Comments have expressed concern that DOE would be permitted to make non-conservative
assumptions in its analyses of compliance with the containment requirements. The Agency has
required that parameter values used in computing CCDF's be randomly selected from across the
full range of possible values for that parameter. Such a requirement would preclude the
Department from pre-selecting non-conservative values for parameters (values that predict
relatively small releases of radionuclides) and generating a mean CCDF that is itself non-
conservative.
Comments have stated that paragraph 194.34(b) of 40 CFR part 194 would require very large
numbers of calculations to be performed and is thus impracticable. The Agency's requirement is
less burdensome than was interpreted by these comments, however. This section requires that a
sufficient number of CCDFs be generated by computer runs such that there be a high likelihood,
.95 probability, that one of the CCDFs generated will exceed the 99th percentile. (As noted
above, the 99th percentile denotes that CCDF which would be exceeded by only 1 in 100
CCDFs, if an infinite number or "population" were to be generated. As noted in an earlier
response in this section, the 99th percentile CCDF may be a different CCDF at each value of
cumulative release, which is the horizontal axis on the CCDF.) The comments mis-interpreted
this requirement to mean that the numerical value of the 99th percentile must be determined to
within a .95 probability. However, determining compliance with the Agency's requirement
requires an evaluation of the statistical properties of the complete group of CCDFs generated.
This calculation will likely require significantly fewer calculations than would a direct
calculation of the value of the 99th percentile CCDF.
Some comments have stated that the Agency has not clarified the purpose of requiring that the
99th percentile be exceeded with .95 probability. In essence, this requirement ensures that a
sufficient number of CCDFs are generated by computer runs such that the range of all possible
CCDFs is represented. The notion of a "range" refers to the collection of CCDFs, starting with
the CCDFs that predicts the smallest size of releases of radionuclides and ranging to the CCDF
which predicts the largest size of releases. Requiring that this range of CCDFs is generated
ensures that the mean CCDF will include a contribution from relatively "pessimistic" predictions
of disposal system performance as well as "optimistic" predictions.
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Some comments correctly state that the "population of CCDFs" as defined in 40 CFR part 194, is
composed of an infinite number of CCDFs; therefore it cannot be calculated. While this is
indeed true, the final rule, 40 CFR part 194, does not contain any requirement that would
necessitate generating this ensemble of infinite CCDFs. In actuality, all that is required to be
included in the application is that a group of CCDFs that is finite in number be generated.
Other comments have requested clarification on the relationship between compliance with
40 CFR part 191 and the term "reasonable expectation." This term is used to designate that only
a reasonable expectation of compliance, not absolute proof, is required since absolute proof of
compliance cannot be achieved for such long-term predictions. This term appears in the
containment requirements — §191.13 of 40 CFR part 191 — in which the Agency states that a
reasonable expectation of compliance with the containment requirements is required on the basis
of the record before the implementing agency.
Comments have also noted that the analyses will contain methodological value judgments which
should also be evaluated by EPA. In judging the adequacy of these analyses, the EPA intends to
review the numerical calculations of compliance as well as the non-numerical scientific
judgments which accompany them.
Further comments have noted that recommendations contained in Appendix C of 40 CFR
Part 191 with regard to which CCDF must comply with the containment requirements were not
incorporated into 40 CFR part 194. Specifically, the comment states that Appendix C requires
that the mean CCDF comply with the containment requirements without requiring that there be
95 percent confidence in this compliance. Appendix C recommends the use of CCDFs to
determine compliance with the containment requirements but did not address the question of
requiring a confidence level. Appendix C is non-binding guidance.
The EPA published the Appendix C guidance in 1985, before EPA was legally required to
regulate the WIPP. The guidance was not designed with the WIPP specifically in mind. Hence,
the assumptions presented do not necessarily reflect the site characteristics of the WPP, but
instead attempted to make statements that would apply to a repository located in any salt bed at
any location in the United States. Further, the guidance was made general enough to apply to all
three highly-radioactive types of waste: spent nuclear fuel, high-level radioactive waste (from
reprocessing of spent fuel) and transuranic radioactive waste. Because of this generality, the
guidance could not be tailored to fit the technical challenges posed by transuranic waste such as
is proposed for disposal in the WIPP. This specific application of a general standard to a specific
site with a unique set of technical challenges was part of the statutory mandate of 40 CFR
part 194. Consider, for example, that 40 CFR part 194 contains a section on waste
characterization that was designed by keeping in mind the highly heterogeneous character of the
transuranic waste proposed for the WPP. In developing 40 CFR Part 194, the Agency found that
only some of the guidance of Appendix C had specific relevance to the WPP. Today's action
has been guided by only those aspects of Appendix C that the Agency has determined, based on
technical and policy considerations, to be applicable to the WIPP.
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Commenters have requested clarification regarding whether the threshold probability of 1 in
10,000 over 10,000 years, found at section 194.32 applies to individual or to categories of
processes and events. For the purposes of this screening requirement, processes and events
must be analyzed in the most general formulation possible; for example, the probability of
dissolution must be set equal to the probability of all types of dissolution occurring anywhere
in the Delaware Basin during the regulatory time frame. Performance assessments should,
however, conduct separate analyses of the different dissolution fronts which occur in the
Delaware Basin so as to account for the different hydrogeologic characteristics of each. To
ensure that the analysis to exclude a process and event is sufficiently rigorous and documented,
the final rule, at section 194.32(e) requires documentation showing why any processes and events
or sequences and combinations of processes and events that may occur in the regulatory time
frame and may affect the disposal system are not included in performance assessment results.
In the proposed rule, the Agency had requested comment on whether some alternate method for
generating CCDFs might be found that used the results of only one iteration to test for
compliance. Regardless of what method is chosen, to be appropriate for the performance
assessments of the WIPP, the method chosen for calculating CCDFs must achieve at least two
goals: the method must account for both the many different scenarios which can occur at the
WIPP and the many values within its full range that each parameter can assume. As currently
envisioned, each CCDF taken individually accounts for the impacts of many different scenarios,
but uses the same set of values from the range of possible values of each parameter. Only by
generating many CCDFs, each using newly chosen parameter values, can the full range of
possible values of each parameter be considered. The Agency had sought comment on whether
an alternate method of calculation could account for this full range of values. The Agency has
concluded that, by requiring that large numbers of CCDFs be generated, and that all significant
processes and events be considered, the requirements of the final rule will be sufficient ensure
that the two goals mentioned above will be realized and therefore has declined to require an
alternate method in the final rule.
Issue D: Procedures are overly-reliant on statistical theory.
1. One should be careful to avoid attempting textbook application of statistical methods to an
extent that becomes unrealistic. (IV-D-51)
2. Reliance on probabilistic theory for project evaluation is inadequate and probably self-
defeating. (CARD-B, A-43)
3. EPA should delete 40 CFR 194.34. EPA should require that the application include a
discussion of alternative conceptual models, the conservatism employed, and the sensitivity of
the results to parameter variations. EPA should use this information in making its decision on
certification. (NRC)
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4. The statistical criteria that EPA plans to apply to the population of CCDFs are ambiguous and
inappropriate. The EPA instead should provide guidance to DOE on the level of detail in the
performance assessment results that EPA believes is adequate to allow judgments to be made on
compliance with the containment requirements of 40 CFR part 194. (NRC)
5. The compliance criteria should not be overly restrictive on allowable sampling techniques.
EPA should replace its requirements in 40 CFR 194.34 with guidance that allows that applicant
flexibility in its choice of sampling techniques and methods for demonstrating the adequacy of
the sampling strategy used. (NRC)
Response to Issue 1 l.D:
Some comments have questioned the appropriateness and the adequacy of the statistical
requirements place on CCDFs. The Agency chose to include statistical requirements in the final
rule because such requirements assess the reliability of the calculations used in performance
assessments. For example, the requirement that the 99th percentile of the population of CCDFs
must be .95 likely to be exceeded ensures that the computer generated CCDFs collectively will
cover an appropriately broad range, from optimistic to pessimistic. Additionally, the final rule
requires that the mean CCDF must comply with a 95 percent level of statistical confidence. This
requirement provides assurance that the value of the mean can dependably reproduced if the
calculations were repeated. The Agency believes that this additional assurance is essential as
part of demonstrating that there is a reasonable expectation of compliance with the disposal
regulations of 40 CFR part 191. The existence of the statistical requirements in no way indicates
that the Agency will ignore the non-numerical aspects of the analysis. As one comment suggests,
the Agency does intend to review the alternate conceptual models, DOE's analysis of parameter
sensitivity and the appropriateness of conservative assumptions when evaluating the sufficiency
of the application for certification.
The Agency recognizes that the statistical properties of the CCDF, by themselves, do not
adequately assess the reliability of the entire performance assessment. To this end, for example,
the Agency has required extensive documentation and rationales for various stages of the
performance assessment, such as the selection and development of conceptual models. As a
second example, the final rule places quality assurance requirements on, among other things, the
data that will be used to calculate the CCDFs. The Agency will assess the degree to which these
and all of the many other requirements are met by the compliance application during the
rulemaking on certification conducted pursuant to section 8(d) of the WIPP Land Withdrawal
Act.
The Agency believes requiring the chosen method to sample randomly from the full range of a
parameter's value still leaves the DOE with sufficient flexibility. For example, the technique of
Latin Hyper-cube Sampling (LHS) would be allowable under this requirement.
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Issue E: The rule should require DOE to demonstrate compliance with the containment
requirements with a percentile curve other than the mean.
1. The Agency must require DOE to show compliance with the containment requirement at the
level of the 85th to 90th percentile. Probability distribution functions must be supported by data.
(NMAG-D)
2. The use of the mean CCDF as the primary basis for determining compliance with the
containment requirements may encourage DOE to produce many CCDF's with non-conservative
assumptions in order to skew the mean. (SRIC-C, SRIC-E)
3. Compliance with the containment requirements of 40 CFR part 191 should be tested by a 95th
percentile curve, with a 99% tolerance limit, in addition to the mean curve plus a 95% confidence
limit. (NMAG-B)
4. The Agency should require that subjective uncertainty be resolved by basing a compliance
determination on the 95th percentile value. (NMAG-F)
5. The selection of the determinative curve should be made with knowledge of the level of
assurance which the Agency contemplated compliance would be shown. (NMAG-D)
6. The proposed rule and the Background Information Document (BID) could be construed to
determine compliance on the basis of the 99th percentile rather than the mean, and are thereby
inconsistent with § 194.34(d). (SNL-C)
7. A reasonable way to address the question of uncertainties is to carefully examine the range of
fractiles corresponding to the mean in the consequence distribution (supplied by Sandia National
Laboratories). In the WIPP case, the choice of the mean conditional on a set of hypotheses was
based on the long-term nature of the project, the fact that the computation of the mean is more
robust than that of specified fractiles, and that the means (given the uncertainties) are likely to be
among the high-fractiles anyway. (NMAG-E)
8. Depending on how far the current means are (assuming full probabilistic treatment of
hypotheses) from a reassuring (but not sacred) 95% fractile, it may be appropriate to ask for
additional analysis or a change in risk management strategy. (NMAG-E)
Response to Issue 11 .E:
The Agency declined to base compliance with the containment requirements on a percentile
value, such as the 95th percentile, as suggested in the comments. Instead, the Agency chose the
mean CCDF as the value which must be in compliance. In developing the proposed rule, the
Agency considered basing compliance with the containment requirements on some point other
than the mean. For example, the median (50th percentile) and other percentile values were
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considered as possible choices. The mean was determined preferable for two reasons. First, like
the median, the mean is an indicator of the central tendency of the larger group or "family" of
CCDFs. Second, the mean is more influenced by the CCDFs that predict the highest releases
than other indicators of central tendency.
The final rule at 40 CFR part 194 requires that the mean or average value of all the CCDFs
generated be compared to the quantitative containment requirements of section 13 of the disposal
regulations at 40 CFR part 191. The containment requirements limit the sizes of releases of
radionuclides that might occur over the 10,000-year regulatory time frame. The size of a release
is calculated using the instructions in Appendix A of 40 CFR part 191 and represents a
contribution from the predicted number of curies of each radionuclide that is predicted to be
released over 10,000 years. Per the containment requirements, the mean CCDF cannot predict
that a 10,000-years' release of size "one" is more than 10 percent likely to occur, or, further, that
a release of size "ten" is more than 0.1 percent likely to occur. Releases of these sizes are of
sufficient magnitude such that, were these releases predicted to be more likely than these small
percentage values permit, the disposal system's ability to isolate waste would be questionable.
The Agency will assess compliance by evaluating the value of the mean CCDFs at the two
relevant sizes of release, one and ten.
Certain comments stated that the rule appeared to specify that the 99th percentile CCDF must
comply with the containment requirements of 40 CFR part 191.13. (The 99th percentile denotes
that CCDF which would be exceeded by only 1 in 100 CCDFs, if an infinite number or
"population" were to be generated. This value can be estimated, but never determined by
computer calculations.) In 40 CFR part 194, the Agency does not require that the 99th percentile
CCDF be calculated, or compared to the containment requirements in order to assess compliance.
Rather, the DOE must determine only the probability with which the 99th percentile will be
exceeded. This differs from an actual calculation of the numerical value of the 99th percentile
CCDF; the probability of exceeding that quantity is determined based on the statistical properties
of the complete group of CCDFs. See also the responses to Issues 1 l.B and 1 l.C.
Issue F: The requirements for performance assessment are incomplete, because they
consider only some types of uncertainty. DOE's analysis should also consider that the
fundamental assumptions regarding radiation risk are not conservative.
1. The application for certification of compliance should also demonstrate that the assumptions
underlying the performance assessment as to health effects of radiation exposure, exposure
pathways, and release models are conservative. (NMAG-D)
2. The 1992 performance assessment constitutes a conditional risk assessment, predicated on
certain fundamental assumptions. Whether the EPA assumptions or the DOE assumptions are
conservative as judged by the outcome of a full probabilistic risk assessment of the WIPP
repository is not known. It is important to find out what the level of release risk obtained given
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the combination of EPA and DOE assumptions and the results of the corresponding conditional
risk analysis. (NMAG-E)
3. Because of the controversial nature of the treatment of epistemic uncertainties by Bayesian
probabilities, the solution is often to do only what can be considered a partial uncertainty
analysis, focusing on randomness in statistical samples and on distributions for the variables
explicitly included in the model. (NMAG-E)
4. EPA cannot simply frame a conditional risk analysis based on certain assumptions and then
claim without checking that the conditional means resulting from this analysis necessarily
support "reasonable expectation" of human safety. EPA must show that the combination of
"reasonable expectation" for the PA and conservatism (if it is so) of the health effect model
provides "reasonable assurance" of actual safety. (NMAG-E)
5. EPA should be required to fully reveal the models that they have used to come up with the
release standards and list all major assumptions that they have made; then to ask the applicants to
show that the combination of these models, hypotheses and their own performance analysis
supports the requirement that the current conditional mean is indeed "above" the marginal
(overall) mean, and then altogether, the assumptions are in fact "conservative." (NMAG-E)
6. The application should contain a complete description and justification of performance
assessment methodology, indicating the theoretical bases for the methodology and demonstrating
the accuracy or conservatism. (NMAG-D)
7. DOE must identify the major hypotheses in its PA and show the effects of those hypotheses
on the family of release curves. (NMAG-E)
8. The final rule should state that DOE include all of the methodological value judgments that
were part of determining the range of CCDFs included in Performance Assessment. (CCNS-B)
Response to Issue 11 .F:
Assumptions regarding radiation risks and the level of protection of human health were
incorporated in the disposal regulations of 40 CFR part 191, Subparts B and C, as part of the
underlying analysis used to establish the containment requirements, individual requirements, and
ground water requirements. The criteria in 40 CFR part 194 are not intended to establish a new
or more stringent level of protection, but to implement the level of protection embodied in the
disposal regulations. The WIPP LWA calls for EPA in this rulemaking to implement (not to
fundamentally re-examine) the binding disposal regulations, which were the product of extensive
technical analysis, and have undergone public rulemaking and judicial review. The criteria do
not and can not amend 40 CFR part 191.
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The Agency included statistical compliance criteria on the results of performance assessments to
provide an additional level of assurance that the mean CCDF is in compliance, if the
performance assessment in fact demonstrates that this is the case. The Agency believes that this
additional assurance is essential to demonstrating a reasonable expectation of compliance with
the disposal regulations of 40 CFR part 191. The existence of the statistical requirements in no
way indicates that the Agency will ignore the non-numerical aspects of the analysis. As one
comment suggests, the Agency does intend to review the alternative conceptual models, DOE's
analysis of parameter sensitivity and the appropriateness of conservative assumptions when
evaluating the sufficiency of the application for certification.
Issue G: It is important to know where the mean would fall if methods other than expert
elicitation were used to obtain probability distributions for input variables. (NMAG-E)
Issue H: Concerning the selection of variable parameters for PA, the test should be
whether the variations of an input value across the possible range could change the final
decision. (NMAG-E)
Response to Issues 11 .G and 11 .H:
The final rule requires that performance assessments must be conducted using computational
techniques which draw random samples from across the entire range of probability distributions.
As noted in the preamble to the final rule, parameters of lesser sensitivity in performance
assessments may be held constant, provided that such constant values can be justified as
sufficiently conservative. These requirements, combined with statistical measures on the
maximum CCDF, ensure that CCDFs generated by performance assessments represent the full
range of possible outcomes and do not allow for "optimistic" solutions to dominate. The
Department is precluded from pre-selecting non-conservative values for parameters (values that
predict relatively small releases of radionuclides) and generating a mean CCDF that is itself non-
conservative.
Even if random sampling is conducted, the results of performance assessments can be affected by
the assumed or measured distributions for input parameters. The distributions for some
parameters maybe established through expert elicitation processes, if the necessary information
cannot be reasonably obtained through data collection or experimentation. To ensure that the
results of expert elicitation represent the full range of technical views on topics, EPA has placed
requirements on the composition of expert panels, and required that outside groups be allowed a
reasonable opportunity to present technical views [§194.26]. The Agency believes these
standards are sufficiently rigorous to ensure that expert elicitation will not produce parameter
distributions which are unduly "optimistic" or unduly conservative. The Agency does not
believe that expert elicitations will always produce results which are less conservative that actual
values would be, if they were available.
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Thus, the final rule contains several criteria to ensure that parameter distributions are developed
and used in a manner that produces unbiased results for performance assessments. In most cases,
it is not possible to determine how a parameter distribution determined through expert elicitation
would differ if developed from actual data; in fact, if such data were readily available, a
parameter distribution could not be established through expert elicitation, according to the
requirements of the final rule.
Issue I: Identification of critical performance parameters to be included in a
comprehensive list of criteria parameters that EPA will require in the application should be
decided through colloquy between DOE, EPA, and New Mexico Environment Department
(NMEDX (SGNM-D)
Response to Issue 1 I.I:
The final rule requires that probability distributions for all uncertain parameters distributions be
included in compliance applications. Parameters of lesser sensitivity in performance assessments
may be held constant, provided that such constant values can be justified as sufficiently
conservative, and that justification is included as part of the compliance application. The EPA
has not chosen to specify in the rule what parameters must be addressed in performance
assessment. The EPA may consult with outside parties, such as the New Mexico Department of
Health. However, it would be inappropriate to discuss or assign consultative rights, in this rule,
to parties that do regulate the long-term disposal of transuranic waste at the WIPP.
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Section 12: HUMAN INTRUSION: SECTIONS 194.32 and 194.33
Issue A: Retain 40 CFR part 191. Appendix C.
1. Retain currently existing 40 CFR part 191, Appendix C to preempt a separate examination of
each type of human-initiated process. (WEC-D)
2. No justification is given by the EPA on its decision to abandon the guidance provided in
Appendix C of 40 CFR part 191. (DOE-D, WEC-A, C-12, A-56)
3. EPA's reversal on the applicability of Appendix C may lead to decisions that inadvertently
increase safety and environmental risks associated with other DOE environmental clean-up
activities. (WEC-A, C-29)
4. The limits set in 194.33(b)(4) are more stringent than the 40 CFR part 191 Appendix C
guidance because the EPA has omitted the concept of drilling frequency per unit of repository
area. Omitting this concept broadens the consideration of intrusion to cover the entire disposal
system, which makes the required analyses more complex. (SNL-C)
5. Proposed abandonment of Appendix C to 40 CFR 191 will result in significant changes,
costly retrofits, and significant schedule delays. (DOE-D)
6. It appears that EPA is attempting to of the proposed rule to change what has already been
enacted into law in 40 CFR part 191, Appendix C. The changes may result in schedule delays
and costly retrofits which could be devastating to programs at the generator sites. (IV-D-111)
7. Revise 40 CFR 194.43 to acknowledge that the assumptions used in the final disposal
standards are valid. This includes the assumption [embodied in Appendix C] that systematic and
persistent exploitation is deterred and the assumption that inadvertent intrusion can be deterred
for as long as markers are effective. (DOE-E)
8. The consequences of human intrusion on disposal-system performance should be limited by
the guidance to 40 CFR part 191. How the situation is modeled should be the DOE's
responsibility to determine and defend. (SNL-D)
Response to Issue 12.A:
The EPA determined that it would be inappropriate to apply Appendix C in its entirety to the
compliance criteria for several reasons. The Appendix C guidance to 40 CFR part 191 was
deemed necessary because 40 CFR part 191 is a generally applicable standard, meaning that the
standard applies to all disposal sites for spent fuel, high-level and transuranic waste repositories
(except for Yucca Mountain or other sites characterized under section 113 (a) of the Nuclear
Waste Policy Act). To regulate an individual site, therefore, the Department or Agency that
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implements the standard would be required to develop criteria describing what requirements
must be fulfilled to demonstrate compliance with 40 CFR part 191 for that site in particular.
When EPA published the Appendix C guidance in 1985, the guidance was not designed with the
WIPP specifically in mind. Hence, the assumptions presented do not necessarily reflect the site
characteristics of the WIPP, but instead attempted to make statements that would apply to a
repository located in any salt bed at any location in the United States. Further, the guidance was
made general enough to apply to all three highly-radioactive types of waste: spent nuclear fuel,
high-level radioactive waste (from reprocessing of spent fuel) and transuranic radioactive waste.
Because of this generality, the guidance does not necessarily fit the technical issues posed by
transuranic waste such as is proposed for disposal in the WPP. For example, the final rule,
40 CFR part 194, contains a section on waste characterization that was designed by keeping in
mind the highly heterogeneous character of the transuranic waste proposed for the WIPP.
The guidance is non-binding. The guidance was published in 1985 accompanied by a statement
declaring it non-binding on the implementing agency, which became EPA in 1992 with the
passage of the WPP Land Withdrawal Act. Unlike 40 CFR part 191, the regulation which it
accompanied, the guidance was not issued pursuant to the Administrative Procedure Act notice
and comment rulemaking requirements. See 5 U.S.C. 553.
Accordingly, while Appendix C reflects the Agency's contemporaneous assumptions and
recommendations regarding the implementation of the disposal regulations, EPA believes it
should not follow the guidance without first examining whether it is consistent with the legally
binding disposal regulations and determining whether it should apply in the specific
circumstances associated with the WIPP. The Agency found in developing 40 CFR part 194 that
only some of the guidance contained in Appendix C had specific relevance to the WIPP. For
example, EPA determined that the screening criteria for including scenarios in performance
assessments (e.g., probability greater than 1 in 10,000 over 10,000 years) was reasonable to
incorporate in 40 CFR part 194 because the reasoning that led that screening criterion is not
affected by specific conditions at the WIPP. Other aspects of Appendix C have not been applied
to the WIPP because site-specific conditions invalidate the assumptions in the guidance. For
instance, while EPA believes that inadvertent and intermittent intrusion by exploratory drilling
for resources is the most severe scenario at the WIPP, EPA has also required consideration of
excavation mining because there are economically viable resources currently being mined within
the Delaware Basin. Similarly, EPA has found that current practice in the vicinity of the WPP
cannot support the assumptions that markers can deter all drilling for resource development, or
that drilling methods are sufficient to soon warn intruders of the presence of the disposal system.
Therefore, these and other positions described in Appendix C have not been adopted in the
compliance criteria. The final rule and preamble clarify the instances when Appendix C has
guided or informed the development of the WPP compliance criteria. Given their relative legal
standing, 40 CFR part 194 should everywhere be construed to supersede the Appendix C
guidance.
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Issue B: Definitions of "human intrusion" and "human activity" should be clarified.
1. The definition for "human intrusion" could be construed as extending the consideration of
human intrusion to any location anywhere within the Delaware Basin. (SNL-A, SNL-C)
Response to Comment 12.B.1:
In performance assessments, scenarios involving human intrusion anywhere in the Delaware
Basin must be analyzed if they could have an effect on the repository, per § 194.32(a). Section
194.32 establishes the scope of processes and events that need be considered in performance
assessments (PA). The final rule logically limits the scope of PA to those events that may affect
the disposal system during the regulatory time frame [§ 194.32(a)]. The final rule has clarified
the definitions of "human intrusion" and "human activity" as described below and elsewhere in
this document.
2. The terms "human intrusion" and "human activity" should be used to replace "human-initiated
processes". The expression "human-initiated processes and events (60 FR 5788)" is misleading
because the only disruptions initiated by human beings that are to be considered in performance
assessments are drilling events. (SNL-C)
3. The definitions for "human intrusion" and "human activities" are not consistent with the usage
of related terms in the supporting documents that contributed to the development of the standard.
For example, see Chapter D-4.0 in report EPA 520/4-79-007D. (SNL-C)
4. The definition of "human activity" overlaps the definition of "human intrusion" and both are
inconsistent with 40 CFR part 191 Appendix C with regard to the location of the waste in the
disposal system. Appendix C clearly refers to intrusions in the repository, not intrusions into the
disposal system. (DOE-D, WEC-D, SNL-A, SNL-C)
5. Human activity should be defined as (1) drilling or mining for resource exploration; (2)
drilling or mining for resource extraction; (3) drilling or mining for underground injection of
fluids; (4) water use and management activities; (5) other human activities that could affect waste
disposal system. (SRIC-A, SRIC-C)
6. "Human activity" should be defined to include activities which have as their target a horizon
above the disposal rooms; "human intrusion" should mean all drilling which has as its target a
horizon at or below the disposal rooms. (NMAG-B)
7. The Agency is requiring additional "human activity" events to be evaluated that go beyond the
"human intrusion" events that have been evaluated by the program. These analysis of these
human activity events would unnecessarily delay disposal of waste in the repository. (IV-D-40)
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8. "Human activity" means those human activities that may affect the disposal system, but not
necessarily intercept the repository; "human intrusion" means those human activities that
intercept the repository, except intentional drilling or mining with knowledge of the repository.
(EEG-C)
9. By the proposed definitions, undisturbed performance would exclude human intrusion but
include human activities, which is inconsistent with 40 CFR part 191. (SNL-C)
10. "Intentional intrusion" should be defined more clearly. (NMAG-G)
11. There is no such thing as "inadvertent" drilling; the meaning of "intermittent" is highly
obscure. (NMAG-B)
12. It is recommended that evaluations of the "undisturbed performance" of the repository do not
include any human-initiated processes and events. (NRC)
Response to Comments 12.B.2 through 12.B.12:
In §194.32 and §194.33 of the final rule, the Agency has provided further clarification on which
activities fall within the scope of human intrusion, and, in response to public comments, has
modified the terms used to avoid confusion. Section 194.33 of the final rule requires that two
types of activities be analyzed — deep drilling and shallow drilling. Deep drilling (referred to as
"human intrusion" in the proposed rule) is defined as drilling events in the Delaware Basin that
reach or exceed a depth of 2150 feet below the surface (the level of the waste in the disposal
system). Shallow drilling (referred to as "human activity" in the proposed rule) is defined as
those drilling events in the Delaware Basin that do not reach a depth of 2,150 feel below the
surface relative to where such drilling occurred. Thus, in addition to revising the nomenclature
to clarify its consideration of deep and shallow drilling, the final rule clarifies the depth at which
an event is classified as deep or shallow, using the depth of the disposal system as the
benchmark. However, EPA believes it is reasonable and practical to use the actual depth, not the
target depth. The definitions of the terms are found in §194.2 of the final rule.
Consistent with the changes in defined terms, §194.33 in the final rule is titled Consideration of
drilling events in performance assessments (rather than Consideration of human-initiated
processes and events, the title used in the proposed rule). This clarifies the Agency's intent that
neither deep drilling nor shallow drilling events shall be considered in analyses of undisturbed
performance of the disposal system. The term human intrusion should not be interpreted as
being confined to drilling only. The preamble accompanying the final rule explains the various
types of drilling activities encompassed by the terms deep and shallow drilling. Further, as
discussed in §194.33(c)(l), those ancillary activities which are associated with drilling, such as
borehole sealing, are within the scope of this term. In response to public comments, EPA has
also required consideration of excavation mining events as described in §194.32(b).
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The consideration of human intrusion is limited to those events which are made without
knowledge of the repository's presence. This type of event would constitute an "inadvertent
intrusion." Any disruptive event that might result from sabotage, for example, should be
classified as an intentional intrusion and should not be analyzed.
Issue C: The rule should consider a broader range of activities as possibilities for human
intrusion and human activity.
1. All types of mining and drilling (including potash) must be considered based on recent
practices in the local area. (DOE-D, SGNM-A, EEG-B, EEG-C, NMAG-A, NMAG-B, CCNS-B,
C-14, C-28, A-08, S-12, S-58, IV-D-13, IV-D-14, IV-D-15, IV-D-16, IV-D-17, IV-D-18,
IV-D-19, IV-D-20, IV-D-21, IV-D-22, IV-D-23, IV-D-24, IV-D-25, IV-D-26, IV-D-30, IV-D-31,
IV-D-32, IV-D-33, IV-D-34, IV-D-35, IV-D-37, IV-D-38, IV-D-42, IV-D-43, IV-CM6, IV-D-47,
IV-D-48, IV-D-52, IV-D-53, IV-D-54, IV-D-55, IV-D-56, IV-D-57, IV-D-58, IV-D-59, IV-D-60,
IV-D-61, IV-D-62, IV-D-63, IV-D-66, IV-D-67, IV-D-68, IV-D-69, IV-D-70, IV-D-71, IV-D-72,
IV-D-74, IV-D-75, IV-D-79, IV-D-80, IV-D-83, IV-D-87, IV-D-88, IV-D-92, IV-D-99)
2. EPA should require in the criteria consideration of the potential effects of mining on the
WIPP disposal system. (SGNM-C, EEG-A, EEG-B, NMAG-B, SRIC-G)
3. The human intrusion criteria need to include future mining, future oil and gas drilling.
(NMAG-B, S-12)
4. Delete Section 194.33(b)(l). This WIPP site requires a full consideration of existing and
anticipated activities and can not be limited to drilling as the most severe scenario. (EEG-C)
5. The following subsections should be added to Section 194.33(b)(3)(ii):
(B) Underground blowouts during drilling.
(C) Water and brine injection adjacent to the WPP Site.
(D) Fluid injection to enhance petroleum recovery on adjacent properties.
(E) Human induced crossfiow between formations.
(F) Actual well abandonment practices on BLM properties. (EEG-C)
6. It is incumbent upon EPA to look closely at how EPA addresses secondary oil recovery by
water flooding in surrounding areas. (SGNM-C)
7. Add the following subsections to Section 194.33(b)(6)(b):
(3) Water flooding for petroleum resources within five miles of the WIPP Site Boundary
and within the WIPP Site will reflect the experience in Southeast New Mexico in fields
overlain by the Salado Formation.
(4) Potash will be mined by either conventional methods or by solution mining.
(5) Assumptions about well abandonment practices will follow the future states
assumption. (EEG-C)
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8. Human intrusions and activities to be considered cannot be limited to drilling and should
include mining, waste water disposal, enhanced petroleum recovery efforts, and other activities.
The exclusion of "human activity" from analysis of individual and ground-water protection
would not be justified. (NMAG-D)
9. EPA should require the facility to demonstrate compliance under conditions of nearby
solution mining in addition to multiple boreholes penetrating the site. (SRIC-G)
10. Let the DOE decide for themselves what is the most severe human intrusion. Do not let
them off of the hook by limiting their scope of considerations. (NMAG-G, IV-D-06)
11. The compliance criteria on mining and drilling are not stringent enough. (A-01, A-08, A-18,
A-26, A-46)
12. It is suggested that EPA exclude site characterization activities from contributing to rates of
human intrusion or human interference with the repository. (NRC)
Response to Issue 12.C:
The final rule requires consideration of oil and gas drilling and various other drilling activity,
whether deep or shallow, that involve creating a borehole. In response to public comments, EPA
has expanded the scope of human intrusion compared to the requirements of the proposed rule.
The final rule requires that DOE specifically consider the effects of deep drilling, shallow
drilling, and mining in performance assessments. In addition, performance assessments must
account for the potential effects over the regulatory time frame of boreholes and other resource
extraction activities which exist at the time the compliance application is prepared.
Many comments suggested that analysis of the long-term effects of conventional mining
performed using shafts and tunnels should be required. The proposed rule had excluded
excavation mining from consideration, but EPA has re-evaluated this position in light of
numerous public comments on this issue. On the one hand, EPA believes its position in the
proposed rule that inadvertent and intermittent intrusion by drilling for resources is the most
severe and therefore the most important human intrusion scenario to be examined. Nevertheless,
some known natural resources in the vicinity of the disposal system can be extracted by mining.
These resources lie within geologic formations found at significantly shallower depths than the
mined portion of the disposal system, and do not lie vertically above the repository. Thus,
mining could not result in direct penetration of waste drums in the disposal system. However,
EPA believes that mining could alter the hydrologic properties of overlying formations —
including the most transmissive layer (for groundwater travel) in the disposal system, the Culebra
dolomite — so as to either increase or decrease ground water travel times to the accessible
environment. For the purposes of modeling these hydrologic properties, this change can be well
represented by making corresponding changes in the values for the hydraulic conductivity, or the
rate at which water moves through the geologic units of the disposal system. The Agency has
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conducted a review of the data and scientific literature discussing the effects mining can induce
in the hydrologic properties of a formation. Based on its review of available information, the
Agency expects that mining can, in some instances, increase the hydraulic conductivity of
overlying formations by as much as a factor of 1000, although smaller or even negligible changes
can also be expected to occur.
The final rule requires DOE to consider the effects of mining in performance assessments (PA).
The assessment by DOE of the effects of mining may be limited to changes in the hydraulic
conductivity of the hydrogeologic units of the disposal system from excavation mining for
natural resources [§ 194.32(b)]. Thus, in order to consider the effects of mining, DOE may use
the location-specific values of hydraulic conductivity (established for the different spatial
locations within the Culebra dolomite), and treat them as sampled parameters with each having a
range of values varying between unchanged and increased 1000-fold relative to the value that
would exist in the absence of mining. The Agency recognizes that other numerical changes to
the hydraulic conductivity values might be more appropriate for use in representing the effects of
mining. If DOE were to use other values, then the Department would need to support those
values in the compliance application. The Agency further recognizes that some parameter other
than hydraulic conductivity might be demonstrated to incorporate, equally and perhaps better, the
potential effects of mining in PA. The DOE may elect to use another parameter, provided that
DOE can demonstrate that the use of this parameter is equally or more appropriate than hydraulic
conductivity in reflecting the potential effects of mining on the disposal system. The final rule
and preamble require that the effects of mining be analyzed as described above. The
consideration of mining in terms of the effects of examining excavation mining on hydraulic
conductivity is consistent with the Agency's position that resource-specific extraction techniques
cannot be assumed to occur in the future except in a very general way (i.e., digging a hole for
mining, or drilling a hole). This principle is discussed in greater detail in the following
paragraphs.
Comments also suggested that the final rule require analysis of disposal of brine that
accumulated during the extraction of oil and of secondary recovery of oil performed using water-
flood injection. The Agency considered this comment in the larger context of the nature of
potential human intrusion during the 10,000-year regulatory time frame, and of what assumptions
might hold true during that time. First, the Agency recognized that, because oil is a depletable
resource, the techniques specific to its extraction are unlikely to be in use during much of the
10,000-year regulatory time frame. Nonetheless, the Agency must still provide a method by
which to establish the future drilling rate. To accomplish this, the Agency assumes that today's
drilling activities will act as surrogates for the type of drilling activity that will occur in the
future. Specifically, while the resources drilled for today may not resemble those drilled for in
the future, the Agency believes it is reasonable for the average rate to be projected over the next
10,000 years, based on the assumption that while oil and natural gas maybe depleted, other
resources (which are not currently economical to recover, or whose uses are not yet evident) may
become more valuable. This assumption leads to the conclusions that it is reasonable to project
oil and gas drilling rates (based on the historical record) over the regulatory time frame; and
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second, that since these rates are surrogates for other potential resources, it is inappropriate to
include consequences of activities or secondary recovery techniques specific to oil drilling.
Thus, over the long term the final rule requires consideration of making a borehole, but not the
specific techniques that might be used to recover a particular resource. However, in the short-
term, some limited predictions can be made. Specifically, there are existing oil leases
surrounding the WIPP and it is likely that they will ultimately be developed. Therefore, the final
rule at §194.32(c) requires consideration of any activities that occur in the vicinity of the disposal
system prior to disposal as well as activities that are expected to occur soon after disposal,
including fluid injection activities.
Similarly, the historical record of the past 100 years of resource extraction activities in the
Delaware Basin provides a reasonable basis for predicting the nature of future mining activity.
Accordingly, the Agency examined the records of past mining of mineral resources in the
Delaware Basin, using data supplied by the U.S. Bureau of Land Management. The Agency
found that the areal extent of mining in the immediate vicinity of the WIPP over the past 100
years covered roughly one percent of the land area of the entire Delaware Basin and used this
information to predict the likelihood that a mining event would occur in succeeding centuries.
Accordingly, the final rule requires performance assessments to assume that, in each century after
closure of the repository, there will be a 1 in 100 chance that a single mining event will occur
within the controlled area. The assumed mining event would remove all of the existing mineral
deposits lying within the controlled area that are of similar quality and type to those minerals
currently extracted in the Delaware Basin. The mineral deposits that will be mined in the future
may consist of minerals of current economic interest, or of materials not useful or valuable in
present-day terms. The final rule specifies that mining should be assumed to occur within the
controlled area, with the size and shape of the mine conforming to existing mineral deposits,
because it would be too speculative to use other means to try to establish the size and shape of
future mines. Thus, EPA has chosen to use existing mineral deposits as "stand-ins" to be used to
determine the size, shape and depth of the unknown mineral deposits that might be mined in the
future.
In summary, the final rule requires that, when determining the drill rate, DOE must include all
boreholes used for exploration or recovery of resources in the Delaware Basin, including those
used for secondary recovery. (However, a borehole should not be "counted" twice, if it was used
for more than one purpose — e.g., for both exploration and recovery.) In addition, boreholes
drilled for the purpose of site characterization should not be used in calculating future drilling
rates. Analyses of the consequences of drilling events should be confined only to the drilling
activity (i.e., making a hole) and the subsequent effect of the borehole's presence (including the
likelihood it is sealed and the type of seal it has), but need not include an analysis of extraction
and recovery activities which would occur subsequently. In a similar fashion, the chance of a
mining event occurring in the controlled area during the regulatory time frame is based on the
historical record of the past 100 years of resource extraction activities in the Delaware Basin.
The size and location of the mining event is based on existing minerals deposits similar in quality
and type to those currently being extracted in the Delaware Basin. Finally, the consequences of
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mining events are confined only to the effects of making a hole — i.e., changes in hydraulic
conductivity, but do not include an analysis of extraction and recovery activities which occur
subsequently. A more detailed analysis of the potential effects is not appropriate because it
would overrely on the exact method used for mining.
The Agency recognizes that resource extraction and fluid injection activities which are currently
performed in the Delaware Basin can alter the hydrogeologic properties of the initial state of the
disposal system (i.e., at the start of the 10,000-year regulatory time frame). The final rule
requires that performance assessments and compliance assessments must include the effects of
all types of fluid injection (including solution mining) and all boreholes which can have an effect
on the disposal system and which have been or will have been drilled prior to or soon after
disposal, based on existing plans and leases for drilling. See paragraph 194.32(c). Those
boreholes shall be assumed to affect the properties of the disposal system for the entire 10,000-
year time frame.
The final rule also requires consideration of well abandonment practices, as suggested by
commenters. The final rule requires performance assessments to assume over the regulatory time
frame that the fraction of boreholes that are sealed by humans are consistent with current
practices in the Delaware Basin.
Issue D: Limits on drilling rates should be dropped or modified.
1. Maximum and minimum drilling rates are arbitrary and indefensible. (DOE-A, EEG-A,
EEG-B, SNL-A, SNL-C, SRIC-C, A-43, A-45, A-48, S-ll, S-12, S-17, S-39, IV-D-35)
2. It is recommended that EPA refine its application of bounds on the drilling rates used in the
performance assessment. EPA should establish bounds on the drilling rates used in the
performance assessment using available drilling rate information, rather than rates using the rates
assumed in the derivation of the generally applicable environmental standard. (NRC)
3. The minimum drilling rate in §194.33(b)(4)(ii) is reasonable. (EEG-D)
4. The number of boreholes per square kilometer may not be enough due to secondary oil
recovery which may have as much as 41 boreholes per km2 x 2.5 = 102.5. (SGNM-D)
5. To be consistent with the earlier guidance provided in 40 CFR part 191, the guidance in
40 CFR part 194.33 should re-establish the upper limit of inadvertent and intermittent
exploratory drilling for natural resources at 30 boreholes/km2 of repository area/10,000 years as
the most reasonable worst-case assumption. The guidance should not include a lower limit
different from that in Appendix C to 40 CFR part 191. (SNL-D)
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Response to Issue 12.D:
The final rule eliminates the proposed upper cap and lower cap (62.5 or 25 boreholes per square
kilometer per 10,000 years, respectively) on the rate of deep drilling into the disposal system.
The Agency concluded that the rate of drilling into the disposal system used in performance
assessments should be derived solely from the historical record of drilling in the region
surrounding the WIPP and are not bounded by rates assumed in the derivation of the general
disposal regulations. The future rate of drilling is based on the average rate of actual drilling in
the Delaware Basin in the past, and is not based on the maximum drilling density allowed by
current drilling regulations (which, as noted in a comment, is 41 boreholes per square kilometer).
The final rule specifies that the rates of both deep drilling and shallow drilling are to be set based
on data from the 100-year record of resource extraction activities ending at the time when DOE
prepares the compliance application.
Issue E: Borehole sealing assumptions should be based on current practices. (WEC-D,
SNL-C)
Response to Issue 12.E:
The treatment of sealing of boreholes must assume, per §194.33(c) of the final rule, that borehole
depths, diameters and seals will remain consistent with current practice in the Delaware Basin.
In addition, an examination of current practice must be used to determine the fraction of
boreholes which are sealed by humans (as opposed to natural processes).
Issue F: The 50 year time frame for drilling rates is inappropriate.
1. The past 200 years should be used for the Delaware Basin. (C-14)
2. Use 100-year time frame since this is the period of known drilling in Delaware Basin. (A-45)
3. The 50-year period for drilling rates in the Delaware Basin is inappropriate. (S-47)
4. Change the 50-year time frame to state "the complete time period during which exploratory
drilling has occurred in the Delaware Basin." No rationale is given for selecting this 50-year
time period. (SNL-C)
5. Using the record over the past 50-year time frame is inappropriate because resources will
become more desirable due to scarcity in the future. (C-03)
6. Use 75-year human-initiated event period rather than 50 years. The total rate of human
intrusion should be the sum of the rates of each type of human intrusion. (DOE-D)
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7. Compliance criteria should evaluate all human intrusions using the analysis of historic record
which Criteria currently recommend only for its human activity estimations. (CCNS-B)
Response to Issue 12.F:
Because future drilling is treated probabilistically in the disposal regulations, the criteria must
establish a rate of drilling to be projected into the future. The Agency notes that any rate is
expressed as a quantity per time, such as miles per hour. Therefore, it is necessary to divide the
number of boreholes by a time period so that drilling can be expressed as boreholes per area per
year. (The drill rate is expressed as boreholes per area per year, which also requires division by
an area; this decision is discussed in the response to Issue 12.G.) In the proposed rule, the
Agency suggested that the past 50 years of drilling history be used to establish the historical
record of drilling in the region surrounding the WIPP. The Agency also proposed to bound this
rate based on drilling rate assumptions made in deriving the general disposal regulations. Several
comments suggest that other time frames would be more appropriate.
The Agency recognizes that some resources may become scarce or may increase or decrease in
economic value in the future, but believes that no basis exists that would permit speculation
about such changes and their effects on fluctuations in future drill rates. The extrapolation for
10,000 years of the average drill rates, calculated from a fixed period in the past, may be based
on reliable data, and foregoes the need for unbounded speculation. Because the historical drilling
rate will be applied over a 10,000-year regulatory time frame, acting as a surrogate for unknown
future resources (not solely oil or natural gas), EPA believes it is appropriate to use the longest
historical record for which reliable drilling data is available. That is, EPA recognized that
drilling activity has been at a maximum in the past 50 years because of intense exploration and
development of petroleum resources. Examination of drilling records for the past 100 years
shows a broader range of drilling rates, more appropriate for application over the long-term
future, when it can be expected that drilling rates will consist of periods of high and low drilling
activity, as specific resources may become more or less valuable. Further examination of
available records in Texas and New Mexico led the Agency to conclude that reliable data for
drilling in the Delaware Basin can be found dating back nearly 100 years. Therefore, the final
rule specifies that the rates of both shallow drilling and deep drilling are to be set based on data
from the 100-year period ending at the time DOE prepares the compliance application.
Issue G: The Delaware Basin should be carefully defined in the rule.
1. Subareas of the Delaware Basin may be used to develop historical drilling rates if their
structural characteristics are similar to those of the WPP site. (SNL-C, C-4)
2. The Capitan reef should not be included in the Delaware Basin because this inclusion would
result in higher drilling rates. (DOE-D, SNL-C)
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3. The Delaware Basin should be defined as the area of sedimentary rock within the inner
boundary of surface and subsurface expressions of the Capitan Reef, and the projection of the
reef where it's absent to form an enclosed basin. (DOE-D, DOE-E)
4. It is inappropriate to exclude the Capitan Reef from the definition of the Delaware Basin. The
reality of the Delaware Basin being a leading potash mining area must be recognized in certifying
whether or not WPP will comply with the disposal regulations. (SRIC-C)
5. The Delaware Basin, as defined in the geologic community, appears to be reasonable.
Whether the entire basin should be used, or a subset, depends upon what a drilling activity map
looks like. (A-29, IV-D-51)
6. The rule should state that the Delaware Basin includes all the surface and subsurface areas
within the central basin area and the area overlying the Capitan Reef. (NMAG-D)
7. The definition of the Delaware Basin should exclude the Captain Reef and the immediately
adjacent sedimentary rocks deformed by the presence of the reef. (SNL-D)
8. In reference to a definition of the Delaware Basin, a 1955 source was used to characterize the
Salado Sea. It would be advisable to research a more current author. (SGNM-D)
Response to Issue 12.G:
The final rule includes a definition of the term "Delaware Basin," used to establish the area over
which past drilling is to be averaged in order to calculate the rate of drilling used in performance
assessments of the 10,000-year regulatory time frame. Many comments discuss whether the
Capitan Reef should or should not be included as part of the "Delaware Basin." In arriving at its
decision on this issue, the Agency weighed these concerns and re-examined information on the
geologic and hydrologic formations which contain the WPP versus those of the Capitan Reef.
The EPA determined that the Capitan Reef is more permeable to the flow of water and was
formed from organic material which differs markedly from the salt formation that immediately
surrounds the WIPP. In addition, as noted in several comments, the reefs distinct structural
characteristics influence the type and quality of resources found there, as compared with the
interior of the Delaware Basin. Thus, the Capitan Reef differs markedly from the interior of the
Delaware Basin in terms of geology, hydrology, and natural resources. Because the "Delaware
Basin" defined in the rule will be used to derive historical drilling rates to be used in performance
assessments, EPA believes that the area defined by the term should fully encompass the area
within the vicinity of the WIPP, be sufficiently large to provide a reliable population of data, and
be representative of the characteristics of the WPP site. For these reasons, consistent with its
stated intent to define the Basin to be the largest contiguous area that has similar geologic
properties to the WPP, the final rule defines the Delaware Basin as those formations which lie
inside the inner-most edge of the Capitan Reef. In those places along the perimeter where the
Capitan Reef is absent, the boundary of the Delaware Basin shall be those features lying on a
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straight line drawn from the southeastern point of the Davis Mountains to the most southwestern
point of the Glass Mountains. This definition can be found in the final rule at §194.2. This
encompasses an area of approximately 9700 square miles. The Background Information
Document for the final rule describes the information sources used to define the boundaries of
the Delaware Basin and Capitan Reef; the Agency has made every effort to update references.
Regarding mining, the chance of mining in the future has been based on the historical record of
mining over the past 100 years in the Delaware Basin, as defined in the final rule; see response to
Issue 12.C for further discussion of the treatment of mining in the final rule.
Issue H: Treatment of human intrusion is not satisfactory.
1. It should be assumed with certainty that there will be human intrusion. DOE's performance
assessment should analyze the various reasonable human intrusion scenarios for their
consequences and for potential mitigation measures. (SRIC-F)
2. The rule provides unrealistic limitations related to the possibility of human intrusion. (C-29)
3. The human intrusion scenario is unrealistic. (WEC-A, C-03, C-14)
4. It is very difficult to predict the likelihood of human intrusion in the next 10,000 to 240,000
years. (IV-D-05)
5. The human intrusion scenarios should increase the likelihood of intrusion. (A-53)
6. Intrusion scenarios must be considered with as much realism as possible. (S-37)
7. What kind of guarantees do we have that the human-intrusion scenario has been considered
with the utmost seriousness? (S-l 1)
8. DOE has been generally silent about the expert panel's predictions on inadvertent human
intrusion in the WIPP. (IV-D-05)
9. The proposed rule should be based on a smaller borehole density and a realistic assessment of
future drilling activities, perhaps 40 acres per borehole for oil drilling and 10 acres for tertiary
recovery. (IV-D-40)
Response to Issue 12.H:
The Agency has developed the human intrusion criteria to prevent unbounded speculation about
future drilling, while at the same time accounting for the presence of natural resources near the
WIPP (and the associated potential for future human intrusion). The Agency does not believe it
is possible to state with absolute certainty that human intrusion will penetrate the disposal
system, just as EPA does not believe it is supportable to declare that human intrusion will
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definitely not disturb the disposal system. Thus, EPA established systematic methods to estimate
future drilling rates and mining probabilities and consequences as realistically as possible, while
limiting highly uncertain speculation about the future.
For example, the final rule states that drilling should be assumed to occur randomly in space,
rather than assuming that current drilling patterns — based primarily on oil — will endure
throughout the regulatory time frame. The final rule requires that performance assessments
analyze human intrusion, in recognition of the history of drilling for resources in the Delaware
Basin. As discussed in the response to Issue 12.C, the Agency assumes that today's drilling
activities will act as surrogates for the type of drilling activity that will occur in the future.
Because the resources drilled for today may not resemble those drilled for in the future, and since
these historical rates are surrogates for other potential resources, it is inappropriate to include
consequences of activities or secondary recovery techniques specific to oil drilling.
In order to make drill rates as objective and site-specific as possible, the Agency concluded that
the rate of drilling into the disposal system used in performance assessments should be derived
solely from the historical record of drilling in the region surrounding the WPP. The final rule
eliminates the proposed upper cap and lower cap ( 62.5 or 25 boreholes per square kilometer per
10,000 years, respectively) on the rate of deep drilling into the disposal system. The final rule
specifies that the rates of both deep drilling and shallow drilling are to be set based on data from
the 100-year period ending at the time when DOE prepares the compliance application.
The requirements in the final rule regarding treatment of mining in performance assessments are
also based on historical records and current practices in order to minimize speculation about the
patterns and methods of future mining. As with drilling scenarios, the minerals currently mined
in the Delaware Basin act as a surrogate for future minable resources, since it is not possible to
predict what those might be. The probability of mining occurring in any given century during the
regulatory time frame is derived from the historical record of mining in the Delaware Basin over
the past 100 years. The size and shape of a future mine in the controlled area is based on
currently mined resources in the Basin; it would be extremely speculative to try to establish with
other methods what such a mine would look like, since the size and shape of mines are highly
irregular. As noted in the response to Issue 12.C, analysis of the consequences of mining are
limited to changes in hydraulic conductivity — the effects of "making a hole." The DOE is not
required to examine resource recovery techniques such as solution mining, since these methods
depend on the specific resource being mined.
The EPA does recognize that resource extraction and fluid injection activities which are currently
performed in the Delaware Basin could alter the hydrogeologic properties of the initial state of
the disposal system. Thus, while the consequences of such activities will not be analyzed under
future human intrusion scenarios, performance assessments and compliance assessments must
analyze the effects of all types of fluid-injection and all boreholes which can have an effect on
the disposal system and which have been or will have been drilled prior to or soon after closure.
These boreholes shall be assumed to affect the properties of the disposal system for the entire
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10,000-year regulatory time frame. The Agency believes that the final rule provides an objective
and reasonable method to project the effects of drilling and mining activities for unknown future
resources over the regulatory time frame.
Issue I: Other issues with regard to drilling need to be addressed.
1. Only exploratory drilling is inadvertent and intermittent and this is the only drilling that
should be considered. (DOE-D, SNL-C)
2. It is unrealistic to assume that in the drilling of an exploratory well, the core would not be
examined and the waste discovered. (C-14)
3. "Exploratory well" and "development" should be added as definitions to distinguish which
human intrusions are intentional and those that could be inadvertent. (WEC-D)
4. The EPA should clearly define the use of exploratory wells in the development of intrusion
rates to be consistent with the technical basis for the final disposal standards. (DOE-E)
5. There is no reason to believe that any type of well would be less intrusive than any other type
of well drilled through the repository. Non-exploratory holes should be used to project future
drilling rates. (SGNM-D)
6. The mode of human intrusion that will be considered in performance assessments should be
exclusively limited to inadvertent and intermittent exploratory drilling for natural resources. Any
incorporation of human-initiated processes and events, other that exploratory drilling for
resources, in 40 CFR part 194, would result in an unjustified departure from the bases and
assumptions applied during the promulgation of 40 CFR part 191. (SNL-D)
7. Consistent with the underlying rationale of the guidance to 40 CFR part 191, the consideration
of human intrusion in performance assessment analyses should be limited to inadvertent and
intermittent exploratory drilling for natural resources. (SNL-D)
8. Drilling activities to be considered in assessing the likelihood and consequences of human
intrusion may not be limited to exploratory drilling. It cannot be assumed that exploratory
drilling would disclose the presence of the repository. (NMAG-D)
9. When establishing the frequency of inadvertent intrusions into the repository, 40 CFR
part 194 should address only intermittent exploratory drilling for resources; production or
development drilling or mining should not be included. (DOE-E)
10. The simple deletion of the word "exploratory" in §194.33(b)(l) has expanded the range of
human-initiated processes and events to include frequency estimates for developmental and
production activities, as well as for exploratory drilling. Appendix C guidance reflects the
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Agency's assumptions relative to human intrusion and should be retained, unchanged, in 40 CFR
part!91.(IV-D-112)
11. The application of drilling rates for all types of drilling is more restrictive (i.e., results in a
more restrictive interpretation of 40 CFR part 191) than the application of drilling rates for
exploratory drilling. The reasoning for this deviation from the intent of the original rule is not
explained by the EPA, giving the impression that the EPA is arbitrarily reversing its policy
without having a rational basis for the reversal. (SNL-D)
12. It is recommended that "human intrusion" and "human activity" include only exploratory
drilling (without resource extraction). (NRC)
Response to Comments 12.1.1 through 12.1.12.:
The Agency does not exempt developmental wells from being included in the calculation of the
rate of human intrusion. Several comments suggested that by including consideration of
developmental wells, EPA was violating the assumptions outlined in the Appendix C guidance to
the disposal regulations. As noted in the response to Issue 12. A of this document, EPA
determined that it would be inappropriate to apply Appendix C in its entirety to the compliance
criteria for several reasons. First, the guidance is non-binding on the implementing agency, in
this case EPA. Second, Appendix C was not designed to apply to the specific characteristics of
the WIPP site or of transuranic waste. As a result, the Agency found in developing 40 CFR
part 194 that only some of the guidance contained in Appendix C had specific relevance to the
WIPP.
The Appendix C guidance provides that "inadvertent and intermittent intrusion by exploratory
drilling for resources...can be the most severe scenario assumed by the implementing agencies."
The commenters provide insufficient evidence, based on current drilling practice, to support the
conclusion that developmental drilling that may affect the disposal system will be precluded by
exploratory drilling. Future exploratory wells that find resources yet miss the disposal system
may nonetheless be followed by several developmental wells, any of which could strike the waste
in the disposal system. One cannot assume that, out of one set of exploratory wells plus
associated developmental wells, the exploratory wells would be the first to affect the disposal
system or that even if an exploratory well detected waste, that associated development would
necessarily be abated. In determining the drilling rate, performance assessments therefore may
not assume that drill operators would detect the waste during exploration and then cease the
current drilling or otherwise mitigate the consequence of their actions. Even if future drilling
practices were such that the disposal system would be detected by drill operators, the disposal
system may not be discovered until after several developmental wells have been drilled. Hence,
the Agency declines to exclude developmental wells when establishing the historical drilling rate
for use in performance assessments.
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13. It is certain that human intrusion that passes through the Salado Formation will encounter
large amounts of brine under sufficient pressure to flow to the surface. (SRIC-F)
14. Claiming to understand the brine in the Castile formation based on only two boreholes is
ludicrous. (CARD-B, A-12, S-21)
Response to Comments 12.1.13 and 12.1.14:
The final rule requires that performance assessments shall consider natural processes and events,
mining, deep drilling, and shallow drilling that may affect the disposal system during the
regulatory time frame. The analysis of consequences for excavation mining has been limited to
changes in hydraulic conductivity. The examination of the consequences of drilling may be
limited to the effects of "drilling the hole," and need not consider specific resource recovery
techniques for future drilling events. The final rule has not established other limitations on the
analysis of consequences, and has not dictated what specific release scenarios must be included
in PA. Pursuant to §194.32(a), performance assessments shall consider processes and events that
may affect the disposal system during the regulatory time frame; any decision to exclude
processes, events, or sequences and combinations of processes and events from analysis under
PA must be documented and justified [see §194.32(e)]. Further, §194.14 and §194.25 require
detailed information relative to the geology and hydrology of the disposal system. As part of its
review of any compliance application, EPA will examine all information contained therein and
determine if the conclusions drawn are consistent with the quality and breadth of the available
data described in the application.
Issue J: Clarifications are needed regarding "current practice" for drilling and borehole
sealing practices.
1. The Agency must make clear how the "current practice in the Delaware Basin
(§194.33(b)(6))" and the borehole sealing (§194.33(b)(l)) will be established. (NMAG-D)
2. The following should be added to §194.33(b)(6) "seals will isolate all ground water zones
consistent with the NM State Engineer's Rules and 4-20.2 &4-19.1." (SGNM-D)
3. To be consistent with §194.33(b)(6), the wording of paragraph 194.33(c)(l) should be revised
to read: Boreholes will be sealed at a rate consistent with regulatory requirements of the State of
New Mexico for the Delaware Basin when the certification application is submitted. (SNL-D)
Response to Comments 12.J.1 through 12.J.3:
The final rule states that, in performance assessments, the Department shall assume that future
drilling practices and technology will remain consistent with practices in the Delaware Basin at
the time a compliance application is prepared [§194.33(c)(l)]. The rule further states that such
drilling practices shall include (but not be limited to) the types and amounts of drilling fluids;
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borehole depths, diameters, and seals; and the fraction of such boreholes that are sealed by
humans. Such drilling practices shall not include techniques used for resources recovery
subsequent to the drilling of the borehole, since performance assessments are required to analyze
the consequences only of drilling a borehole. The analyses of current practice must be
substantiated in any compliance application, showing references and the factual basis used to
establish "current practice." The Agency believes that the criteria in the final rule provide
adequate direction to DOE.
The human intrusion criteria are used to establish drilling rates and assumptions regarding the
consequences of potential future drilling over the 10,000-year regulatory time frame. The rate
and the consequences are based on past and current practices, because EPA believes that they are
appropriate surrogates for exploration and recovery of future resources which may or may not be
similar to resources currently being extracted.
4. In §194.33(second b)(2), a reference to the existence of older, abandoned wells including the
drilling, completion, and plugging procedures in use at the time and the potential for degradation
should be made. (SGNM-D)
Response to Comment 12.J.4:
The final rule requires DOE to examine the effects of activities that occur in the vicinity of the
disposal system prior to disposal and of activities that are expected to occur in the vicinity of the
disposal system soon after disposal. The boreholes resulting from such activities shall be
analyzed for their effects on the properties of the disposal system for the entire 10,000-year
regulatory time frame. Predictions about the effects of such existing boreholes should be based
on the actual characteristics of the boreholes, as far as it is practicable to determine them. Such
characteristics would include drilling, completion, and plugging procedures.
Issue K: The probability of second and subsequent human-initiated processes and events
should be adjusted upwards from the random value to reflect the success of the initial
intrusion. (NMAG-D)
1. Why should human-initiated processes occur at random intervals in space? Exploration for
mineral resources has always been a structured and planned exercise. (C-28)
Response to Issue 12.K:
The proposed rule would have required that drilling in performance assessments be assumed to
occur at random intervals in space and in time. This approach would not allow for assumptions
that drilling would occur in specific patterns, either on land area or over time. Some comments
suggested that the final rule should require performance assessments to assume that drilling will
occur in cluster patterns similar to those which occur when a successful exploratory well is
immediately followed by the drilling of several nearby developmental wells. The fact that
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drilling activity is planned does not mean that its placement or orientation can be predicted with
confidence over 10,000 years. Conversely, an unsuccessful exploratory well could indicate a
lack of useful resources and lead to a time period with reduced drilling rates or the absence of
drilling activity in an area. Geophysical techniques may supplant reliance on exploratory
drilling. Economic considerations, including factors unrelated to resource recovery, may affect
an individual or organization's decision to drill or not drill in a particular time or place, as may
land usage or land ownership factors.
In developing the final rule, the Agency considered that such patterns are associated with a
specific resource; oil wells have their own distinct practices which may affect the configuration
of exploratory and developmental boreholes. In contrast, other resources, such as water, employ
different practices, and can have different orientations or can be devoid entirely of discernable
patterns. As a further consideration, the Agency realized that it is nearly impossible to anticipate
which resources not currently used may be of future interest. It is also doubtful that any one of
today's resources will last for the entire 10,000-year regulatory time frame. Further, it is very
difficult to predict to what extent resources currently used but not present in economically viable
quantities may have an economic demand in the future. The EPA believes there is little value in
engaging in unsupportable speculation regarding what resources will be of interest over the next
10,000 years, whether there may be any associated drilling "pattern," or what constitutes a
"typical" or "characteristic" drilling pattern. Therefore, the Agency has retained the requirement
in the final rule that performance assessments assume drilling events to occur randomly in space
(throughout the Delaware Basin) and time during the regulatory time frame [§194.33(b)(2)].
Issue L: Section 194.33(b)(4)(iv) should be deleted in response to DOE's concern about
confusing language. (EEG-D)
Response to Issue 12.L:
The final rule retains the provision from the proposed rule which would have permitted DOE to
decrease the rate of human intrusion in performance assessments, based on the forecasted
effectiveness of passive institutional controls. The final rule allows the Department to propose
reductions in the likelihood of future human intrusion that is used in performance assessment by
an amount corresponding to the predicted effect of PICs, as demonstrated in the compliance
application. The EPA has clarified in the preamble to the final rule that this reduction cannot be
a 100 percent reduction and must be limited to no more than approximately 700 years past the
time of disposal. This issue was addressed by the WIPP Review Committee of the National
Advisory Council for Environmental Policy and Technology (NACEPT) at a public meeting in
New Mexico in September, 1995. The Committee agreed that PICs are likely to have a positive
influence on deterring intrusion for a relatively short time period and should be implemented at
the site. However, like many commenters, the Committee expressed skepticism over whether
such controls would be effective for more than a small fraction of the 10,000-year regulatory
time frame. Hence, the final rule limits the time frame over which EPA may even consider
approving credit to no more than approximately seven percent of the regulatory time frame, and
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such credit, or a smaller credit, will be approved only if DOE demonstrates, to the satisfaction of
the Administrator, that the PICs described in the compliance application will be effective in
reducing the likelihood of human intrusion. See Section 15 of this document for further
information.
Issue M: In defining analogs to the controlled area for the purpose of establishing rates of
human activity, the analog areas should have similar type and quality of resources as well
as similar recoverable quantities as the controlled area. (SNL-D)
1. § 194.33(b)(5)(ii) allows for the identification of analogs to the controlled area for the purpose
of establishing rates of human activities while not fully describing the characteristics that make
an area an analog. If 191.33(b)(5) is retained, an upper limit on the rate of human activity
should be added and justified. (SNL-C)
Response to Issue 12.M:
The Agency recognizes that certain resources can vary in quality from one area to the next within
the Delaware Basin, and that the uses for that resource can vary with that quality. For example,
water that is unfit to drink may still be useable for dust control. The Agency also recognizes that
the frequency with which water, for example, is extracted for one purpose may differ
significantly from the rate it is extracted for other uses. The final rule allows for shallow drilling
rates (referred to as "human activity" in the proposed rule) to be based on the historical rate of
drilling for resources of similar type and quality to those in the controlled area. Any compliance
application must substantiate the choice of such "similar" resources based on the type and
quality. The Agency does not believe it is relevant to compare recoverable quantities in different
geographic areas when determining resources of similar type and quantity to those in the
controlled area. Different quantities of resources will be reflected in the number of boreholes
drilled. The DOE must include all boreholes, for drilling resources of similar types and quality,
within the Delaware Basin (as defined in the final rule) when determining historic drilling rates
for shallow drilling.
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Section 13: ACTIVE INSTITUTIONAL CONTROLS: SECTION 194.41
Issue A: The effectiveness of active institutional controls (AIC) is questionable.
1. It is overly optimistic to assume that any active institutional controls would be sustained more
than a decade or two, much less a century. (CARD-B )
2. Accurately determining the contribution of the institutional controls to compliance is heavily
dependent on assumptions as to future-states conditions. (SGNM-A)
3. It is recommended that EPA use the presence of institutional controls to limit the scenarios
that need to be considered when evaluating the effect of human-initiated processes and events on
the behavior of the repository, similar to the way used by NRC in 10 CFR 60.2. (NRC)
Response to Comments 13.A.I through 13.A.3:
The final rule allows DOE to account for the effectiveness of active institutional controls (AICs)
when conducting performance assessment (PA) calculations. The presence of active controls
could be used to limit the scenarios considered in PA, or to reduce the probability of occurrence
of scenarios in PA calculations, if such assumptions can be supported. For instance, active
institutional controls may be designed to limit access to the WIPP site and thus discourage any
potential drilling into the disposal system.
The EPA recognizes that the success of active institutional controls to deter access to the WIPP
depends on the continued existence of numerous legal and social structures. The effectiveness of
active institutional controls may not be assumed based solely on the future states assumptions of
§194.25. Any assumptions about the effectiveness of controls in reducing releases must be
described and justified [§ 194.41 (a)]. Because of the uncertainty in how society will change,
credit for the effectiveness of active institutional controls has been limited to 100 years. Credit
for active institutional controls being effective for 100 years will not be automatically assumed
by EPA. The DOE must demonstrate, to EPA's satisfaction, that the active institutional controls
provided for in DOE's compliance application will effectively deter human intrusion for the
number of years specified in the application, not to exceed 100 years. The active institutional
controls submitted by DOE will be a part of the certification application; therefore it will be open
to public scrutiny and comment.
4. Effectiveness of active institutional controls should be established by expert judgment/peer
review. (NMAG-G)
5. Further requirements for active institutional controls should require DOE to present evidence
of the feasibility and effectiveness of the plan and the methodology, in the form of records and
evidence about the application of similar methods at other sites. (NMAG-C)
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Response to Comments 13.A.4 and 13.A.5:
The EPA will decide whether or not to grant credit for the use of active institutional controls and
for what time period such credit is granted. This decision will be made in the certification
rulemaking and, therefore, is subject to review and comment by the public. The final rule
requires DOE to document and demonstrate the effectiveness of active institutional controls for
EPA to evaluate. As part of its demonstration, DOE may rely on peer review or expert elicitation
to establish effectiveness of active controls if such expert judgement does not substitute for
information that could reasonably be obtained through data collection or experimentation. For
example, DOE may support proposed credit based on expert judgment about whether current
examples of effective controls at other sites (such as those with security needs similar to the
WIPP) could be successfully applied and implemented at the WIPP. Any such process is subject
to the expert judgment criteria at §194.26.
Issue B: Limiting AICs to 100 years has not been substantiated.
1. Limiting active controls to 100 years is contrary to current practices. (C-12)
2. The proposed rule limits the consideration in the application for contributions from active
institutional controls to 100 years. There is no apparent basis for this limitation in the
Supplementary Information of the Background Information Document. It is not necessary to
arbitrarily stipulate this limitation in the rule. (A-41, IV-D-76)
3. Requirements to limit the human control to only 100 years are unrealistic. (C-18)
Response to Issue 13.B:
The limitation of 100 years for credit for the effectiveness of AIC's in performance assessment
calculations is required by §191.14(a): ". . . [Performance assessments that assess isolation of
the waste from the accessible environment shall not consider any contribution from active
institutional controls for more than 100 years after disposal." Not only did EPA promulgate this
requirements, it was reinstated by the LWA, Section 8(a)(l). The limitation is a legal
requirement which has gone through the public rulemaking process, judicial review, and
legislative review, and cannot be changed without a new rulemaking on 40 CFR part 191.
Credit for the effectiveness of active institutional controls has been limited to 100 years because
of uncertainty about how society will change. The EPA agrees that it will be prudent for DOE to
continue to implement and maintain active institutional controls beyond the 100-year time
period; it is not, and was never, the Agency's intention to require or recommend that DOE cease
such controls 100 years after closure. In fact, §191.14 provides that active institutional controls
should be continued for as long as is practicable. The final compliance criteria, at §194.41, call
for DOE to demonstrate, in its compliance certification application, the period of time that the
controls are proposed to remain active.
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Issue C: Strengthening the requirements for AICs is necessary.
1. It is imperative that some kind of physical devices be created to warn potential intruders and
negate their activity. The surface structure would be insufficient. (IV-D-73)
Response to Comment 13.C.I:
Active institutional controls are measures that require human attention in order to perform their
intended function. For example, these controls may include guard patrols, human-operated
cameras or detectors, site maintenance, remediation or clean-up, etc. The comment relates more
to "passive," as opposed to "active" institutional controls. Passive institutional controls, required
under §194.43, encompass physical devices requiring no human attention and which warn
against or minimize the effects of human intrusion. The final rule requires more than a surface
structure of the repository alone. Therefore, the commentor's concerns are addressed by the
requirements under §194.43.
2. The active control regulations should be strengthened. (A-68)
Response to Comment 13.C.2:
The final rule is stringent while simultaneously providing DOE with flexibility in determining
how to meet the requirements. Any compliance certification application presented by DOE must
be well justified in order to demonstrate to EPA and the public that any amount of credit should
be granted; and in no case shall credit be granted for a period exceeding 100 years.
Issue D: Excluding the possibility that clean-up and controls may be needed is not
appropriate. (A-41)
Response to Issue 13.D:
Nothing in the final rule excludes the possibility that clean-up and controls may be needed at the
WIPP site. In fact, §191.12 defines active institutional controls as "...maintenance operations or
remedial actions...controlling or cleaning up releases at a site..." This definition applies as well
to the final rule.
Issue E: DOE should show specific financial and contractual commitments made to
support a system of controls. (NMAG-B)
1. The following subsection should be added to the rule in §194.41, "The application for
certification of compliance shall include specific financial and contractual commitments made to
support the operation of the active institutional controls." (NMAG-D)
2. The application for certification cannot be allowed to assume a higher level of active controls
than those specifically provided for in law or in binding contractual agreements. (SRIC-G)
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3. Compliance criteria should direct performance assessments to consider the disruption of
active institutional controls, either through funding cuts or societal disruption. (CCNS-B)
Response to Issue 13.E:
In EPA's review of DOE's compliance certification application, EPA will evaluate, with public
input, whether DOE's assumptions regarding AICs and their effectiveness are reasonable. This
would include consideration of whether AICs are likely to be disrupted. Specific funding or
contractual commitments by DOE could increase confidence that active controls will be
implemented as described in a certification application. If EPA certifies compliance, then DOE
must implement all measures and conditions that are the basis of EPA's certification, or DOE
must seek modification of the certification. Any activities which depart from the basis on which
EPA determines compliance will subject any compliance certification to modification,
suspension or revocation, as described in §194.4. Any modification or revocation of a
certification in turn is subject to notice and comment rulemaking and judicial review. Therefore,
DOE will be held "accountable" to implementation of the active institutional controls included in
its certification application.
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Section 14: MONITORING: SECTION 194.42
Issue A: By requiring pre-closure monitoring, EPA is exceeding its authority.
1. The scope of the proposed operational monitoring system is outside the scope of this
regulation. (DOE-D, SNL-C)
2. Monitoring during waste emplacement is not authorized by 40 CFR 191 subparts B and C.
(SNL-C)
3. The EPA cannot require pre-closure monitoring under its certification authority. (DOE-D)
4. The requirements for monitoring the disposal rooms of WIPP during waste operations and
prior to closure of the repository are not required in 40 CFR 191 subpart A. (DOE-D)
5. Criteria should be provided for monitoring after disposal consistent with 40 CFR part 191.
Providing a monitoring program prior to the certification and during the operational time frames
is clearly a modification of existing regulations which Congress did not authorize. (WEC-D)
6. Pre-closure monitoring program is technically infeasible and would result in significant risk to
operating staff. (DOE-D)
7. Should require pre-closure monitoring of parameters relevant to repository performance, to
verifying modeling reliability, or providing data useful for recertification. (SRIC-C)
8. The EPA clearly has the authority to conduct pre-closure monitoring at the WIPP. (SRIC-G)
Response to Comments 14.A.1 through 14.A.8:
Provided that the WIPP receives a certification of compliance from the Agency, EPA is required
to make a determination of continued compliance (re-certification) five years after the initial
receipt of waste and every five years thereafter until the end of the decommissioning phase.
Through the re-certification process, EPA must ensure that the conditions under which the initial
compliance certification was granted are still acceptable, including the actual performance of the
disposal system compared with the expected performance based on DOE's performance
assessment submitted with the initial compliance application. The 1992 WIPP LWA
[sec.8(f)(l)] gave the Agency the authority to determine continued compliance of the WIPP after
the initial certification. The primary reason for this re-certification process is to evaluate whether
the WIPP is performing as expected. Without data from pre-closure monitoring, this evaluation
cannot occur.
The Agency has determined that pre-closure monitoring will provide valuable insight into the
post-closure performance of the disposal system. The information gathered during the pre-
closure monitoring phase will form the basis of any future evaluation for releases of
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radionuclides, which in turn will be the basis of any future re-certification decisions. The
Agency believes it is within EPA's authority to impose such a requirement for DOE to examine
and determine which pre-closure monitoring parameters are important to waste containment and
feasible to monitor without jeopardizing the containment of waste in the disposal system. The
determination of whether it is feasible to monitor a certain parameter should also take into
account any increase in risk to operating personnel. The results of this analysis, as well as a
detailed pre-closure monitoring plan, will be submitted to the Agency as part of the initial
compliance application.
9. The EPA is planning on implementing, developing, and issuing criteria or guidance for the
management of the storage phase and therefore we believe that requirement quite properly
belongs in guidance for 40 CFR part 191, Subpart A. The criteria for 194 applies solely to the
disposal phase. (EEG-B)
Response to Comment 14.A.9:
The Agency has the authority to include requirements in the compliance criteria which
implement the requirements of 40 CFR part 191, Subparts B and C. Since monitoring of
disposal systems is required to detect substantial and detrimental deviations from expected
performance [§191.14(b)], it is appropriate to address any pre-closure monitoring which can
provide a baseline for detecting deviations from expected performance.
10. It is inappropriate to use the terms "pre-closure" and "closure" in these proposed regulations.
(SNL-C)
Response to Comment 14.A.10:
The Agency believes that pre-closure monitoring is necessary to determine baseline performance,
which will be used in determining continued compliance after closure (the time at which the
shafts of the disposal system are backfilled and sealed), should an initial certification of
compliance be granted. The inclusion of pre-closure monitoring provides a 20-30 year
opportunity during which information can be gathered about important parameters of the disposal
system, within the disposal system itself, without jeopardizing waste containment.
11. Contaminant movement should not be addressed in certification criteria. (DOE-D)
Response to Comment 14.A.11:
Not all types of contaminant movement are addressed under the compliance criteria. Compliance
with 40 CFR part 191 will ensure that releases of certain radionuclides into the environment do
not exceed the limits established in § 191.13(a). The Agency acknowledges, however, that some
contaminant movement within the controlled area is allowed under the disposal regulations.
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12. It is appropriate for the Agency to seek pre-closure monitoring and to obtain monitoring data
before an initial determination of compliance for the purpose of assisting the compliance
determination. (NMAG-D)
13. The final rule should require that monitoring be implemented at the WPP as soon as the
compliance criteria become effective. (SRIC-G)
Response to Comments 14.A. 12 and 14.A. 13:
The purpose of the compliance criteria is to implement 40 CFR part 191, subparts B and C
specifically at the WIPP site. While the disposal regulations do not explicitly require pre-closure
monitoring, EPA has determined that such monitoring is a necessary adjunct of post-closure
monitoring. The purpose of pre-closure monitoring is related to re-certification. The Agency
believes it is appropriate for the monitoring plans required in § 194.42(e) to be reviewed by EPA
and the public as part of the certification rulemaking before extensive resources are expended to
implement the plans.
The final rule requires in §194.42(c) that, "[pre-closure] monitoring shall begin as soon as
practicable; however, in no case shall waste be emplaced in the disposal system prior to the
implementation of pre-closure monitoring." It is unclear to the Agency how pre-closure
monitoring data obtained before an initial certification of compliance would be used, since waste
cannot be emplaced in the disposal system until a certification is granted. The DOE is currently
monitoring the site; and the data obtained, to the extent that they relate to the disposal standards,
should be part of the compliance application.
Issue B: A subsection should be added to 194.42 stating that monitoring shall comply with
the provisions of 40 CFR 191.140)). 194.14.194.41.194.43. and 194.44: Subsection
194.42(b)m should be deleted. (DOE-D. SNL-O
Response to Issue 14.B:
The criteria of §194.42 have been developed to meet the requirements of §191.14(b) and in many
places take the language directly from §191.14(b). In order to meet the requirements of §194.42,
the DOE must perform an analysis of parameters to be monitored and develop monitoring plans
based on the results of this analysis. The plans that are developed must specify a length of time
to monitor each parameter, and describe how each parameter will be used to evaluate the
performance of the disposal system. Any compliance application must demonstrate that the
requirements of § 194.42 have been met.
The criteria of §194.14 describe the content of the compliance application and include
requirements regarding monitoring data. The EPA does not believe that the requirements, as
written, conflict with one another. Therefore, it is unnecessary to refer in §194.42 to other
sections of the final rule.
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Issue C: Clarification of portions of the rule is requested.
1. Section 194.42(b)(I)(4) requires the monitoring of the facility parameters (presumably with
waste in the facility) yet the rule suggests that placement of the waste is precluded until the
monitoring is completed. (WEC-D)
Response to Comment 14.C.I:
The final rule has been clarified in §194.42(c) to state that pre-closure monitoring must be
conducted of significant disposal system parameters identified in DOE's analysis required in
§ 194.42(a). Such monitoring must begin as soon as practicable; however, in no case can waste
be emplaced in the disposal system prior to the implementation (versus "completion") of pre-
closure monitoring. The Agency is requiring the pre-closure monitoring plan to be in effect prior
to the emplacement of any waste, to continue throughout the emplacement period, and to end
when the shafts of the disposal system are backfilled and sealed. Following closure of the
facility, the post-closure monitoring plan will become effective.
2. On page 5778, par. (3), this misleading phrase appears: "tracers intentionally released to the
ground water in the repository." There is no such water in the repository. There is some above
the repository. (IV-D-51)
Response to Comment 14.C.2:
The ground water mentioned in the paragraph is above the disposal system. Any such references
in the future will clarify this point.
3. The compliance criteria should specify that the monitoring plan should cover the time frame
"until there are no concerns," which is the point at which all the radionuclides have decayed
(therefore, longer than 10,000 years). Also, clarification is needed that monitoring cannot
jeopardize the isolation of the waste. Furthermore, EPA should set guidelines as to the levels of
monitored parameters that will trigger action (and DOE should have to report the results of
monitoring and any variations in results). (NMAG-G)
Response to Comment 14.C.3:
The Agency concurs with this comment and clarified in §194.42(d), pursuant to §194.14(b), that
the disposal system must be monitored until "the Department can demonstrate to the satisfaction
of the Administrator that there are no significant concerns to be addressed by further
monitoring." The inclusion of a specific monitoring requirement exceeding 10,000 years exceeds
the requirements set forth in the disposal regulations, which specifies a 10,000-year regulatory
time[§191.13(a)].
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The final rule clarifies in §194.42(d), pursuant to §194.14(b), that post-closure monitoring shall
be conducted with techniques that "do not jeopardize the containment of waste in the disposal
system."
Regarding "trigger levels," the final rule requires in §194.4(b)(3)(ii)-(iii) that DOE notify EPA
within 24 hours if radionuclide releases, radiation doses, or radionuclide concentrations have or
are expected to exceed the containment, individual, or ground water requirements, respectively,
of 40 CFR part 191.
Issue D: The requirements are excessive and not consistent with good management
practices.
1. The requirements for performance monitoring of the repository performance after the closure
that do not affect performance of the repository appear to be infeasible with present technology.
(DOE-A)
2. It is not appropriate for EPA to require DOE to provide monitoring for radionuclides at WIPP
after disposal, because no contaminant migration is expected to occur at WIPP. All contaminant
movement should be dealt with under Subpart A of 40 CFR part 191 and should not be addressed
in the certification criteria. (IV-D-111)
3. The regulations for monitoring could place the DOE in the position of expending resources on
the development of unnecessary, or even unachievable, monitoring. (SNL-C)
4. The subject of monitoring can easily expand into a monster in which much money is spent to
continuously measure zeros with great accuracy. The DOE should define and propose a
monitoring program that is realistic and cost effective; this should not be specified by the EPA.
(IV-D-51)
5. It is recommended that EPA review the proposed pre-closure monitoring requirements and
include only those aspects which are characteristic of an operational facility rather than of a test
facility. The proposed rule should continue to require that DOE conduct a study of monitoring
for both the pre-closure and post-closure periods and to recognize that it may not be technically
nor economically feasible to implement a monitoring program which will not compromise
containment integrity. (IV-D-100)
6. Since monitoring methods must be tailored to fit site, technology, and design constraints, it is
recommended that their regulation under this standard be flexible. (NRC)
Response to Issue 14.D:
The Agency is requiring monitoring of the disposal system to confirm that the disposal system is
performing as predicted in the performance assessments and confirm that radiation from the
disposal system poses no more risk to the public than allowed by the disposal regulations. The
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Agency recognizes the balance between developing requirements that would provide meaningful
data and developing requirements which may not be practicable. In recognition of this balance,
the final rule has been clarified so that no specific pre-closure monitoring parameters are required
to be monitored pursuant to § 194.42(c). Instead, the parameters the EPA believes to be
important are now listed under § 194.42(a), which includes parameters that must be analyzed to
determine if they are significant to the containment of waste in the disposal system or to the
verification of predictions about future performance of the disposal system. These parameters
(brine quality, flux, composition, and spatial distribution; gas quantity and composition; and
temperature distribution) are believed by the Agency to provide indications on the expected
performance of the disposal system and have been linked to performance of the disposal system
through previous performance assessments.
The determination of whether monitoring a parameter is practicable should include an evaluation
of technical feasibility, cost/benefit considerations, and inherent value of expected results.
Infeasible monitoring technologies may be screened out with the proper justification. However,
the Agency will thoroughly review each screened technology to confirm that potentially valid
monitoring techniques have not been excluded.
Issue E: EPA should re-examine the requirement that monitoring be consistent with
RCRA regulations.
1. The EPA must realize that monitoring consistent with the regulations under RCRA could
result in a conclusion that no monitoring is needed. RCRA does not require an applicant to
pursue monitoring in a particular media if it can be shown that there is no possibility of migration
through that media. (WEC-D)
2. Literal application of 194.42(a)(l) with respect to incorporating RCRA-based monitoring
criteria is incompatible with 40 CFR 191.14(b) strictures regarding protection of the disposal
system. (NMAG-B, SNL-C)
3. Monitoring programs should be complementary rather than consistent. The terminology
"shall be consistent [60 F.R. 5789]" is not clearly explained in the proposed rule itself or in the
Supplementary Information. (DOE-D, SNL-C)
4. It is appropriate to require radionuclide and federal hazardous waste monitoring programs to
be consistent; it will require coordination between NMED and EPA. (SGNM-D)
Response to Issue 14.E:
The final rule has been clarified to require that monitoring conducted pursuant to § 194.42 must
be complementary to monitoring conducted under applicable requirements of the Resource
Conservation and Recovery Act (RCRA), contained at 40 CFR Parts 264, 265, 268, and 270.
The requirement has been clarified to eliminate potential overlap, so that information yielded by
one monitoring program is not required to be duplicated by the other.
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As noted in several comments, a situation could exist where no monitoring is required under
RCRA. In such an instance, the Agency believes that it would still be necessary and appropriate
for DOE to conduct monitoring in order to confirm that the disposal system is performing as
expected. In order to clarify that monitoring must be conducted to meet the requirements of the
compliance criteria (even if not required by RCRA), the final rule has been revised to require that
monitoring in §194.42 must be complementary (versus "consistent") to the RCRA requirements.
Issue F: The prescriptive list of parameters is not justified.
1. The prescriptive list of parameters for monitoring is made without technical justification; the
monitoring programs should be based on results of performance assessment analyses. (DOE-D)
2. The regulation prescribes operational activities for monitoring that are not consistent with
good management practices. (WEC-A)
3. It is premature and technically inappropriate to specify (by rule) the specific components of
any monitoring system (either pre- or post-operational). (SNL-C)
4. The operational activity related to monitoring are not consistent with good management
practices; the requirements in §194.34 are premature and not likely to be necessary. (C-29)
5. Monitoring requirements should be required for all specific parameters listed. (C-03)
6. Monitoring program should give special attention to gas generation. (CARD-B)
Response to Issue 14.F:
The Agency believes the following parameters can affect the containment capability of the
WIPP: brine quantity, flux, composition, and spatial flux, gas quantity and composition, and
temperature distribution. As requested by one of the comments, attention has been given to
monitoring gas quantity and composition because such parameters may indicate potential
explosions.
In the final rule, EPA requires DOE to analyze parameters found to be either significant to the
containment of waste in the disposal system or significant to the verification of predictions about
the future performance of the disposal system. While EPA believes the parameters listed above
are significant for at least one of the reasons just described, the final requires that the parameters
be analyzed first to confirm that they are indeed appropriate parameters to be monitored. The
parameters listed in paragraphs §194.42(a)(l)-(7) are parameters that the Agency believes could
be useful indicators of disposal system performance. The Agency believes that establishing the
minimum parameters to be included in the analysis is reasonable, and does not impose undue
burden on DOE.
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Issue G: Compliance criteria should include a Best Available Technology requirement for
monitoring equipment. (CCNS-B)
Response to Issue 14.G:
The term Best Available Technology (BAT) is used by the Agency when referring to process
changes and treatment methods for complying with the Clean Water Act (CWA). Direct use of
this definition is not appropriate for 40 CFR part 194 requirements, which implement the 1992
WIPP Land Withdrawal Act and 40 CFR part 191, subparts B and C. In general, BAT and
similar terms usually refer to an achievable reduction in some pollutant, or a percent reduction in
contaminant levels. For example, BAT is defined in the CWA as the very best control or
treatment technologies that have been or are capable of being achieved. This is not a useful
concept for monitoring (as opposed to control) technology, which must weigh different factors
not as easy to quantify, such as whether the technique does not jeopardize the containment of
waste [see §194.42(d)].
Issue H: Monitoring should be required and should be thorough.
1. Ensure that everything has been done so that the waste will not escape that site. (S-06, S-l 1)
2. Permanent, on-site, long-term monitoring should be required. (A-68, IV-D-12)
Response to Issue 14.H:
In §191.13, the Agency included numerical requirements for the containment of radionuclides in
the disposal system which limit releases into the environment. Although absolute proof that
radionuclides will not escape the disposal system is impossible, the limits on the releases set
forth in the disposal standards are intended to provide a reasonable expectation that there will not
be a release of radionuclides toward the accessible environment.
Additionally, the Agency included assurance requirements in §191.14. These requirements are
meant assure that wastes are not released into the environment above the desired level of
protection. The monitoring requirements outlined in §194.42 implement the assurance
requirement set forth in § 191.14(b). The Agency believes that the monitoring, along with the
other assurance requirements, will provide the additional level of protection necessary to assure
that releases to the environment will not exceed acceptable levels.
The inclusion of a specific requirement for permanent monitoring falls outside of the Agency's
authority to implement the disposal regulations, since § 191.13(a) specifies a regulatory time
period of 10,000 years. The Agency states in the compliance criteria [§194.42(d)] that
monitoring should be conducted until there are "no significant concerns to be addressed by
further monitoring." A certification of compliance will not be granted by EPA unless the
monitoring plan included in the compliance application satisfies this requirement.
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Issue I: Explosive materials need to be closely monitored.
1. I am concerned about the salt slabs falling down in many-ton chunks, and landing on the
casks of possibly explosive waste. (S-38)
2. Explosive material is of concern for operational activities and is outside the scope of these
proposed regulations. (SNL-C)
3. There is the possibility that a critical mass build-up would occur resulting in a more
dangerous explosion than just the gaseous one. (S-03, S-38)
4. The radioactive waste materials placed in containers could very well explode. (S-42)
Response to Issue 14.1:
The Agency is concerned with explosive hazards and has indicated its concern to the
Department. The DOE will be evaluating the explosion scenario to determine the probability and
impact on the performance assessment. If parameters related to explosiveness affect
containment, then they must be analyzed, as required in § 194.42(a). Effects of potential
explosions other than those on containment are addressed by other regulations, such as those
under the Occupational Safety and Health Act (related to worker safety) or the Resource
Recovery and Conservation Act (related to the hazardous properties of materials).
Issue J: The establishment of monitoring criteria and additional requirements is
necessary.
1. DOE should supply necessary data before a monitoring regulation is developed. (NMAG-B)
2. The EPA should require the use of specific monitoring methods which should be updated with
new scientific technology. (C-03)
3. In reference to the CAG, DOE should be asked to submit evidence of the feasibility and
effectiveness of the monitoring approaches planned, and the Agency should take on the
responsibility for determining that the methods will be feasible and effective. (NMAG-C)
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Response to Comments 14.J.1 through 14.J.3 :
The monitoring approach taken by EPA is consistent with the approach taken elsewhere in the
final rule. The EPA has established criteria requiring DOE to thoroughly analyze disposal
system parameters that may affect the containment of waste in the disposal system and develop
pre- and post-closure monitoring plans for inclusion in the compliance application. EPA will in
turn review the adequacy of the analysis and submissions during the public certification
rulemaking. The Agency believes this to be a reasonable approach which is consistent with the
WIPP Land Withdrawal Act and 40 CFR part 191.
In general, EPA believes it is the responsibility of DOE, as owner and operator of the WIPP, to
research and substantiate the feasibility of monitoring techniques proposed for use at the WIPP.
The DOE is required to submit the results of the analyses performed pursuant to § 194.42(a) in its
compliance application. The EPA, as regulator, will evaluate, during the public certification
rulemaking, the quality and feasibility of DOE's monitoring plans as part of the Agency's review
of the compliance application.
4. It is simply not credible that the natural barriers would fail during a several hundred year
period, and that site-wide monitoring would show any evidence of radioactive contamination for
the WIPP. The issue should be that the project identify performance goals for the release of
radionuclides for the repository sealing system and develop engineering plans and technologies
to meet them. (IV-D-40)
Response to Comment 14.J.4:
The Agency included monitoring requirements in the final rule because: (1) such requirements
are set forth in §191.14(b); and (2) monitoring will serve as means to confirm that the disposal
system is performing as expected. By establishing in the disposal regulations a limit on
radionuclide releases to the environment, the Agency has developed performance goals for the
disposal system. It is up to the Department to meet these standards. If the commenter is correct
in saying that natural barriers would not fail, then any detection of releases would be a significant
discovery.
5. This section should not limit monitored parameters to those that may "affect the transport" of
radionuclides. This section should also include those parameters that "indicate the movement of
radionuclides" which would be the ultimate test of satisfying §191.14. (SGNM-D)
Response to Comment 14.J.5:
The final rule does not limit monitoring to only those parameters that may affect the transport of
radionuclides. Section 42(a) of 40 CFR 194 requires that DOE analyze "the effects of disposal
system parameters on the containment of waste in the disposal system," and use the results of
such analysis to develop plans for pre-closure and post-closure monitoring. Parameters that may
affect the containment of waste may very likely include parameters that "indicate movement of
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radionuclides," as mentioned by one of the commenters. Further, the DOE must substantiate
decisions not to monitor parameters analyzed pursuant to § 194.42(a) based on two criteria:
whether the parameter is insignificant to the containment of waste, or whether the parameter is
insignificant to the verification of predictions about the future performance of the disposal
system.
6. Monitoring results should include radiological and RCRA constituent background
concentrations and should not update the established background concentrations, but should be
used to determine constituent releases or deviations from background levels and should continue
through the "post-closure care period," 30 years for 40 CFR 264.117 and an unspecified duration
for 40 CFR 191.14. (SGNM-D)
Response to Comment 14.J.6:
The purpose of the monitoring assurance requirement set forth in §191.14(b) is to "detect
substantial and detrimental deviations from expected performance." The EPA expects that
monitoring results will be analyzed in this context, but may also be used to refine performance
assessments and thus predictions of post-closure performance. Post-closure monitoring must be
used to determine constituent releases or deviations from baseline performance.
The final rule requires that monitoring conducted under §194.42 be complementary to
monitoring required under RCRA, in order to eliminate duplication between the two sets of
requirements. However, it is not the purpose of the final rule to enforce RCRA regulations. The
EPA's final rule at 40 CFR part 194 implements 40 CFR part 191, subparts B and C at the WPP
regarding radioactive waste disposal standards. The requirement for complementary monitoring
does not mean that monitoring conducted according to the compliance criteria will be identical to
that required by RCRA. For example, while 40 CFR part 264 may require monitoring for 30
years following closure of the facility; §194.42 requires that post-closure monitoring continue
until the Department can demonstrate that there are no significant concerns to be addressed.
Similarly, §194.42 may require monitoring of non-radiological parameters if they can have an
impact on the containment or release or radionuclides from the disposal system, or if they can be
used to verify predicted performance of the system. It is beyond the scope of this rulemaking to
require that DOE monitor RCRA hazardous constituents if they are not relevant to the
requirements of the disposal regulations. The requirements of RCRA are established and
enforced independently from those of the disposal regulations and compliance criteria.
7. A study of the effects of the disposal system parameters on waste containment shall include
subsidence caused by withdrawal of oil/gas resources. (SGNM-D)
8. Long-term, remote, and intra-repository monitoring of the geomechanical parameters is not
feasible. It would be more appropriate to include an engineered barrier to compensate for
migration of radionuclides and/or hazardous materials through this pathway. (SGNM-D)
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9. "Brine and repository horizons"should be added to the list of media requiring background
concentrations. (SGNM-D)
Response to Comments 14.J.7 through 14.J.9:
The final rule does not explicitly require that DOE monitor subsidence, or brine and repository
horizons. However, pursuant to §194.42(a), if these parameters are significant to the
containment of waste in the disposal system or to verification of predictions about the future
performance of the disposal system, then they should be considered when developing monitoring
plans. According to §194.42(b), DOE is required to substantiate, based on these criteria, any
decision not to monitor a particular disposal system parameter.
The development of monitoring plans should take into account the feasibility of monitoring a
particular parameter, the ability of the monitoring parameter to provide useful information
regarding performance of the disposal system, and the potential for the monitoring method to
jeopardize the containment of waste in the disposal system. Monitoring specific parameters,
such as geomechanical parameters, is not required if it is determined to be infeasible, of
insignificant value in confirming disposal system performance, or jeopardizes waste
containment.
Engineered barriers are addressed separately in §194.44 of the final rule.
Issue K: There is a motivation to sabotage either the monitoring signals or the resulting
data by spiking ground water with radionuclides or implanting contaminated material.
This threat should be addressed. (IV-D-51)
Response to Issue 14.K:
The threat of sabotage to the monitoring program should be addressed by the Department in the
active institutional controls requirements (§ 194.41). An effective active institutional controls
program will minimize any concerns of sabotage to the monitoring data.
Issue L: The monitoring should be administered by an independent agency.
1. The EPA should require independent monitoring of the post disposal phase. This phase
should be on-going. (IV-D-06, IV-D-26, IV-D-28, IV-D-92)
2. The monitoring systems should be designed and administered by an independent agency.
(CARD-B, S-17)
Response to Issue 14.L:
There is no indication that DOE will misrepresent monitoring results. Therefore, the Agency
does not believe it is necessary or appropriate to require independent monitoring of the disposal
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facility. However, the inspections requirements in the compliance criteria allow the Agency to
obtain samples, including split samples, for independent analysis in order to monitor and
measure disposal system performance [§194.21(d)]. Further, the Agency may be obtaining the
assistance of experts in the monitoring field to review and determine the adequacy of the
monitoring plan submitted by the Department.
Issue M: The following passage should be added to §194.42 "at least one parameter should
be monitored during the disposal phase and for as long as practicable following closure."
(SGNM-D)
Response to Issue 14.M:
The final rule has been modified in § 194.42(d) to clarify that post-closure monitoring must
continue until "the Department can demonstrate to the satisfaction of the Administrator, that
there are no significant concerns to be addressed by further monitoring." The EPA does not
believe it would be prudent to require at least one parameter to be monitored, since such a
requirement could be fulfilled by monitoring a parameter which does not provide information
relevant to disposal system performance.
As part of the certification rulemaking, EPA will determine if DOE's post-closure monitoring
plan adequately implements §191.14(b). As required in §194.42(e), this monitoring plan must
identify the parameters that will be monitored, indicate how each parameter will be used to
confirm disposal system performance, and discuss the length of time over which each parameter
will be monitored. The Agency does not believe it is appropriate to specify a parameter to be
monitored prior to DOE's analyses, which will be submitted in the compliance application.
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Section 15: PASSIVE INSTITUTIONAL CONTROLS: SECTION 194.43
Issue A: The effectiveness of passive institutional controls (PICs) is dubious.
1. Use of monuments should be regarded as having the effect of increasing, not decreasing, the
likelihood of inadvertent human intrusion. (CARD-B, SRIC-E)
Response to Comment 15.A.I:
The final rule [§194.43(a)J requires that "[a]ny compliance application shall include detailed
descriptions of the measures that will be employed to preserve knowledge about the location,
design, and contents of the disposal system." The EPA recognizes that monuments alone could
have the effect of increasing the likelihood of inadvertent human intrusion into the WIPP due to
the innate curiosity of man. However, the full implementation of the PICs requirements includes
both markers (e.g., monuments) and archival records; specifically, section 191.14(c) of the
disposal regulations requires that disposal sites be designated by the most permanent markers,
records, and other passive institutional controls practicable to indicate the dangers of the wastes
and their location. In adopting these provisions of the disposal regulations, the Agency generally
assumed that passive institutional controls "should reduce the chance of inadvertent intrusion
compared to the likelihood if no markers and records were in place." See 50 Fed. Reg. 38080.
This statement reflects the conclusion based on a balance of considerations that PICs are more
likely than not to deter intrusion.
In developing this section of the final rule, the Agency considered the treatment of PICs in the
disposal regulations, the input received in public forums and the public comments received on
the proposed rule. The EPA recognizes that there will always be a chance that some individuals
will overlook or misunderstand the markers. However, in adopting the final disposal regulations,
the Agency examined whether PICs should be taken into account to some degree when
estimating the likelihood of inadvertent human intrusion and concluded that "a limited role for
passive institutional controls would be appropriate when projecting the long-term performance of
mined geologic repositories to judge compliance with [the containment requirements of 40 CFR
Part 191]." See 50 Fed. Reg. 38080. At the same time, the Agency explicitly determined that
PICs should not be assumed to completely prevent the possibility of inadvertent human intrusion.
As noted in the Supplementary Information for 40 CFR part 191, "[t]he types of inadvertent
human activities that could lead to significant radiation exposures or releases of material from
geologic repositories appear to call for much more intensive and organized effort than those
which could cause problems at, for example, an unattended surface disposal site. It is reasonable
to assume that information regarding the disposal system is more likely to reach (and presumably
deter) people undertaking such organized efforts . . . [50 FR 38080]." PICs designed especially
for the WIPP may convey information to future generations about the hazards of the disposal
system for a limited period of time. The final rule also requires any compliance application to
"include the period of time passive institutional controls are expected to endure and be
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understood." See § 194.43(b). Thus, in evaluating the adequacy and efficacy of PICs during the
compliance certification public rulemaking EPA will examine to what extent the particular PICs
proposed are expected to be understood.
2. We see no assurance that DOE can keep people away for 10,000 years. (A-07, A-25, S-40)
3. Given that: (1) all languages change; (2) all civilizations eventually collapse and suffer
language loss; (3) the difficulties of deciphering written languages; and (4) meanings become
different over time, it is inconceivable that we can send a message 10,000 years ahead. (A-10)
4. The EPA cannot guarantee that markers can be placed that would be understandable in 10,000
years. (SPJC-A, A-34, A-35)
5. How can we expect warnings that we post over WIPP to deter folks 500, 1,000, 5,000 years
from now, or even understand its meaning? (S-09, S-29)
Response to Comments 15.A.2 through 15.A.5:
The DOE must demonstrate in its compliance application the period of time PICS are expected to
endure and be understood by potential intruders. The description of PICs proposed to be
employed, as presented in DOE's compliance application, will be reviewed and judged by EPA
and the public through the certification rulemaking process. The DOE may propose in its
compliance application to reduce the rate of human intrusion by a fractional amount, extending
over a technically supportable period of time, and must justify this "credit" using the plans for
the implementation for PICs and associated evidence of their effectiveness.
The Agency agrees with the commenters that PICs in no instance should be assumed to protect
against human intrusion for the entire 10,000-year regulatory time frame. The final rule
constrains the period over which EPA may entertain credit for PICs to no more than "several
hundred years." Thus, after considering the public comments regarding PICs, the Agency
decided that it would not consider granting credit for a time period of more than several hundred
years.
This does not mean that PICs are without benefit and should not be required. Nor does it mean
that it is inappropriate for EPA to consider the potential efficacy of PICs in reducing the
likelihood of human intrusion for some limited period of time.
While the Agency recognizes that some languages have been lost over long time periods, it is
also true that other written languages have survived for hundreds of years. Historic cultures also
did not have the advantages of the global knowledge which is available today. This global
knowledge allows for the transmission, dissemination, translation, and archival of information at
a speed and of a magnitude that was not available to historic cultures. The EPA recognizes that
the message is more likely to endure and be understood if it is conveyed in multiple languages
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and on durable materials. The EPA will consider such factors in its evaluation of DOE's plan to
implement PICs.
While §191.14(c) requires that PICs should be designed to be as permanent as practicable,
40 CFR part 194 does not require that the entire message conveyed by passive institutional
controls be effective for the entire 10,000-year regulatory time period. And while the Agency
may consider approving a limited reduction in the likelihood of human intrusion, such reduction
will not be approved by the Administrator unless DOE adequately demonstrates that the PICs
described in the compliance application will be effective for the proposed period of time. See
also response to Comment 15.A.I.
6. At the rapid pace of change, another great concern is how well the site will be marked to
ensure that the waste will be kept from the public and the environment. (S-l 1)
7. Ensure that monuments around the WIPP site will reduce future drilling and mining. (S-03)
Response to Comments 15.A.6 and 15.A.7:
The final rule requires the compliance application to include detailed descriptions of the PICs
that will be employed to preserve knowledge about the location, design, and contents of the
disposal system [§194.43(a)J. Further, with respect to markers, the compliance application must
demonstrate that identification of the controlled area by markers will be designed, fabricated, and
emplaced to be as permanent as practicable [§194.43(a)(l)J. The EPA will evaluate this
information in conjunction with the Agency's review of the compliance certification application.
The message conveyed by passive institutional controls may not be completely effective or
understood for the entire 10,000-year regulatory time frame. The passive institutional controls
required are intended to reduce the uncertainty associated with predicting long term performance
of the repository, but cannot be expected to eliminate the likelihood of human intrusion.
Issue B: Passive institutional controls are likely to be effective and should be included in
the rule.
1. Any human civilization living 1000 to 10,000 years from now will be smart enough to
understand records and markers. (C-24)
Response to Comment 15.B.I:
While it is possible that society will continue to evolve and that records and markers will be
understood, the possibility also exists that, while knowledge of current languages may exist in
future societies, such knowledge may not be widespread. For example, while the archeology
department of any major university today probably has scholars who can read and understand
markers written in 10th-century English, ancient Egyptian or Babylonian, very few people in the
general population can do so. For a marker to be effective in deterring intrusion, it must be
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understood by the person contemplating or attempting intrusion, not by a scholar in a location
remote from the WPP. Furthermore, the possibility also exists that, in the distant future, society
may suffer a decline through war, climate change, or other force which cannot be predicted. In
addition, for passive institutional controls to deter human intrusion, the message provided by the
controls must first survive and second, be discovered. The EPA will evaluate these factors in its
review of the compliance application, but in no case may the Department assume that PICs will
eliminate the potential for human intrusion entirely, or decrease the rate of human intrusion for a
time period longer several hundred years past the time of disposal.
2. References to statements that passive institutional controls have failed are inaccurate and
inappropriate. The consideration of passive controls in the performance assessment is appropriate
and consistent with past guidance. (DOE-D)
Response to Comment 15.B.2:
The Supplementary Information to the proposed 40 CFR part 194 discusses the historical record
regarding passive institutional controls. The historical record is an important source of
information about what factors could influence the ability of a marker to survive and effectively
convey its message. While EPA generally believes that PICs can reduce the likelihood of
inadvertent human intrusion for some period of time, EPA believes it is appropriate and
reasonable to discuss uncertainty regarding performance of PICs, and to examine past examples
of markers, both successful and unsuccessful. After consideration of public comments and
NACEPT recommendations, EPA determined that it is appropriate to constrain the period of time
over which EPA will consider granting credit for PICs to several hundred years. To further
acknowledge uncertainty, the Agency will not allow such credit to eliminate entirely the potential
for inadvertent human intrusion.
Issue C: Credit for and the quantification of the PICs should not be considered.
1. It is unwise for the criteria to assume that if the DOE constructs monuments it will reduce
future mining and drilling in the area. The DOE should not be allowed to take credit for such
passive institutional controls. (A-43, IV-D-43)
2. No or minimal "credit" should be given for passive institutional controls used at the site. This
seems inconsistent with purpose of the assurance requirements. (CARD-B, EEG-A, EEG-B,
EEG-C, NMAG-A, NMAG-B, SRIC-A, SRIC-C, SRIC-G, A-08, A-18, A-60, S-3, IV-D-13,
IV-D-14, IV-D-15, IV-D-16, IV-D-17, IV-D-18, IV-D-19, IV-D-20, IV-D-21, IV-D-22, IV-D-23,
IV-D-24, IV-D-25, IV-D-30, IV-D-31, IV-D-32, IV-D-33, IV-D-34, IV-D-37, IV-D-38, IV-D-42,
IV-D-46, IV-D-47, IV-D-48, IV-D-51, IV-D-52, IV-D-53, IV-D-54, IV-D-55, IV-D-56, IV-D-57,
IV-D-58, IV-D-59, IV-D-60, IV-D-61, IV-D-62, IV-D-63, IV-D-66, IV-D-67, IV-D-68, IV-D-69,
IV-D-70, IV-D-71, IV-D-72, IV-D-74, IV-D-75, IV-D-79, IV-D-80, IV-D-83, IV-D-87, IV-D-88,
IV-D-99)
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3. It is not appropriate for performances assessments to consider contributions from passive
institutional controls. (SRIC-E)
4. The Compliance criteria must be changed so that no credit is received for providing warning
against future drilling. (S-39)
5. No guidance is provided as to what is required to justify taking credit for passive institutional
controls in the performance assessment. This guidance should be provided in the regulation.
(DOE-D, SNL-C)
6. There is no need to quantify benefits of implementing passive institutional controls. (EEG-B)
7. The approach of using passive institutional controls to reduce the rate of human intrusion and
human activities is acceptable. (SNL-C)
8. Delete §194.33(b)(4)(iv) and §194(b)(5)(iv). (EEG-C)
9. The EPA is vague on the issue of passive controls. Markers and records are not that effective.
(NMAG-B,A-41)
10. The EPA should provide additional context for the applicant to propose credit for the
presence of passive institutional controls. It is recommended that EPA adopt an approach that
establishes additional context for evaluating the contributions of institutional controls. (NRC)
11. The EPA should require DOE to provide sufficient information in its application to enable
EPA to make a regulatory decision, if the Administrator decides that no credit, or less than
proposed credit, will be awarded for the effectiveness of the institutional controls. (NRC)
12. No credit maybe allowed for the supposed effectiveness of passive institutional controls in
reducing human intrusion. If there can be a criterion to determine the effectiveness of passive
institutional controls, the Agency must set it forth in compliance criteria. (NMAG-D)
13. The proposed provision, at 40 CFR part 194.43(c), that the Administrator "shall" allow
credit for passive institutional controls provided DOE can demonstrate that such credit is
justifiable should be retained. If defensible credit for the effectiveness of passive controls is not
allowed, the resulting analysis will be inconsistent with the conceptual basis of 40 CFR part 191.
(SNL-D)
14. It is encouraged that the inclusion of credit be given for passive controls in 40 CFR part 194;
however, as discussed in the specific comments that follow, it is suggested that it may be
appropriate to revise 40 CFR part 194.43(c) slightly for clarification purposes. (SNL-D)
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15. Revise the second sentence of § 194.43(c) to say: The Administrator shall allow such credit,
or a smaller credit, to be taken if the Department demonstrates, consistent with a reasonable
expectation, that such credit is justified because the passive institutional controls can be expected
to endure and be understood by potential intruders for the period of time postulated. (SNL-D)
16. The EPA should continue to allow credit for the planned implementation of passive
institutional controls. If defensible credit for the effectiveness of passive controls is not allowed,
the resulting analysis will be inconsistent with the conceptual basis of 40 CFR part 191. It is
recommended that 40 CFR 194.43 be revised to acknowledge that the assumptions used in the
final disposal standards are valid. This includes the assumption that systematic and persistent
exploitation are deterred and that inadvertent intrusion be deterred for as long as markers are
effective. In addition, 40 CFR 194.43(c) should be revised as follows:
"The Administrator shall allow such credit, or a smaller credit, to be taken in the
Department demonstrates, consistent with a reasonable expectation, that such credit is
justified because the passive institutional controls can be expected to endure and be
understood by potential intruders for the period of time postulated." (DOE-E)
17. In its performance as part of its demonstration of compliance with the disposal regulations,
no markers or assumptions should be allowed to permit DOE to assume that there will not be
human intrusion. (SRIC-F)
Response to Issue 15.C:
As explained in the preamble of the final rule, EPA believes it is consistent with the disposal
regulations and appropriate as a policy matter to consider the effect of PICs in reducing the
likelihood of human intrusion in the performance assessment for the WPP. At the same time,
after considering public comments and the recommendations of the WIPP Review Committee of
the National Advisory Council for Environmental Policy and Technology (NACEPT), EPA does
not think it is reasonable to expect that PICs will endure and be understood for the entire 10,000-
year regulatory time frame. At a NACEPT public meeting in New Mexico in September 1995,
the Committee agreed that PICs are likely to have a positive influence on deterring intrusion for a
relatively short time period and should be implemented at the site. However, like many
commenters, the Committee expressed skepticism over whether such controls would be effective
for more than a small fraction of the 10,000-year regulatory time frame. Thus, in the final rule
EPA constrains the time frame that credit for PICs may be considered to several hundred years
and provides that in no case shall PICs be assumed to eliminate the likelihood of human intrusion
entirely. Both restrictions are consistent with the disposal regulations which contemplated some
role albeit a limited one for PICs in projecting long-term performance of mined geologic
repositories and determined that PICs not be assumed to completely prevent the possibility of
inadvertent human intrusion. See 50 FR 38080 (Sept. 19, 1985). Further, entertaining a limited
role for PICs in reducing the likelihood of human intrusion creates an additional incentive for
DOE to use effective, enduring, comprehensive PICs.
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In the final rule, the Agency allows the Department to reduce the likelihood of future human
intrusion that is used in performance assessment by a proposed amount corresponding to the
predicted effect of PICs, as demonstrated in the compliance application. However, as noted, this
reduction cannot be a 100 percent reduction and must be limited to no more than approximately
700 years past the time of disposal. Hence, the final rule limits possible credit to no more than
approximately seven percent of the regulatory time frame, and such credit, or a smaller credit,
will be approved only if DOE demonstrates, to the satisfaction of the Administrator, that the PICs
described in the compliance application will be effective in reducing the likelihood of human
intrusion. Any decision about the actual credit to grant for PICs in reducing the likelihood of
human intrusion will be made by EPA in the public certification rulemaking reviewing DOE's
WIPP compliance application. During the rulemaking on certification, EPA could determine that
the compliance application does not adequately justify the degree of proposed credit assumed by
DOE and therefore disallow some or all of the proposed credit.
Issue D: Criteria for the records and granting credit need to be established.
1. Criteria should be more detailed about what kinds of records need to be kept. (NMAG-G)
Response to Comment 15.D.I:
The disposal regulations at 40 CFR § 191.14(c) provide that "[disposal sites shall be designated
by the most permanent markers, records, and other passive institutional controls practicable to
indicate the dangers of the wastes and their location." PICs are defined to include "public records
and archives." 40 CFR § 191.12. These provisions are general and EPA has broad discretion in
implementing them at the WIPP. The comment does not identify a specific deficiency with the
records required to be kept and therefore is difficult to evaluate. The final compliance criteria for
the WIPP require compliance applications to include detailed descriptions of the measures that
will be employed to preserve knowledge about the location, design, and contents of the disposal
system. Regarding records, the final compliance criteria also require the placement of records in
the archives and land record systems of local, State, and Federal governments, and international
archives, that would likely be consulted by individuals in search of unexploited resources. The
criteria require the records to identify: (1) the location of the controlled area and the disposal
system; (2) the design of the disposal system; (3) the nature and hazard of the waste; (4)
geologic, geochemical, hydrologic, and other site data pertinent to the containment of waste in
the disposal system, or the location of such information; and (5) the results of tests, experiments,
and other analyses relating to backfill of excavated areas, shaft sealing, waste interaction with the
disposal system, and other tests, experiments, or analyses pertinent to the containment of waste in
the disposal system, or the location of such information. The final rule establishes specific
criteria about the kind of information that must be provided, without specifying actual records.
The EPA will review the information provided in response to these criteria in the certification
rulemaking, which will include significant opportunity for public input.
2. Information placed in records should explain the nature of the biohazard. (CARD-B)
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Response to Comment 15.D.2:
Material placed in archives is required to explain "[t]he nature and hazard of the waste
[§194.43(a)(2)(iii)]." The more general term "hazard" includes biohazards.
3. Concerning record archives, the records to be included should be carefully selected so as to
not overburden future agencies. (IV-D-51)
Response to Comment 15.D.3:
Section 194.43(a)(2)(i)-(v) states that, "[s]uch records shall identify: (i) [t]he location of the
controlled area and the disposal system; (ii) [t]he design of the disposal system; (iii) [t]he nature
and hazard of the waste; (iv) [g]eologjc, geochemical, hydrologic, and other site data pertinent to
the containment of waste in the disposal system; and (v) [t]he results of tests, experiments, and
other analyses relating to backfill of excavated areas, shaft sealing, waste interaction with the
disposal system, and other tests, experiments, or analyses pertinent to the containment of waste
in the disposal system." The final criteria require placement of records in archives that would
likely be consulted and to describe the period of time PICs are expected to endure and be
understood. In evaluating the plan for PICs contained in the compliance application, EPA
intends to consider whether the sheer volume of material will diminish the likelihood that the
information endures, causing it to be lost, discarded, or whether the sheer volume of material will
render it unlikely to "be consulted by individuals in search of unexploited resources"
4. Information is the key to the success of passive institutional controls. These markers should
be codified so their definitions can be referenced in libraries as well as other places where checks
and balances are applied to zoning, purchase/sale of property, and permits for buildings, drilling,
exploration. (CCNS-B)
Response to Comment 15.D.4:
Section 194.43(a)(2) requires, "[placement of records in the archives and land record systems of
local, State, and Federal governments, and international archives, that would likely be consulted
by individuals in search of unexploited resources." This requirement includes records used for
zoning; purchase/sale of property; and permits for buildings, drilling, and exploration.
5. Neither the Supplementary Information nor the proposed rule tells how
credit for passive institutional controls is to be taken. Both the Supplementary Information and
§194.43(b) need to provide specific criteria for allowing credit for passive institutional controls.
The effectiveness will be established by the Department. (DOE-E)
6. Guidance is needed for establishing how credit for passive institutional controls is to be
evaluated. (SNL-D)
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7. The role of the "reasonable expectation" concept is not clearly defined in the context of
40 CFR part 194.43(c). The "reasonable expectation" concept from 40 CFR part 191 must be
included here. Credit for passive institutional controls would be incorporated into the
calculations to determine compliance with the containment requirements. (SNL-D, DOE-E)
Response to Comments 15.D.5 through 15.D.7:
The final rule provides that DOE may propose in its compliance application to reduce the rate of
human intrusion by a fractional amount, extending over a technically supportable period of time
(but within the time limit stated in the final rule), and must justify this using the plans for the
implementation for PICs and associated evidence of their effectiveness. This credit may take the
form of a constant reduction in the rate of human intrusion lasting several hundred years or may
be a reduction in the rate which tapers off in size over several hundred years. Such credit cannot
be assumed to eliminate completely the possibility of human intrusion, even for a short period of
time after the active institutional controls at the WIPP are assumed to be ineffective. During the
rulemaking on certification, the Agency could determine that the description of the PICs does not
adequately justify the degree of proposed credit assumed by DOE and therefore disallow some or
all of the credit proposed by DOE in the compliance application.
Issue E: Changes are needed to Section 194.43 (references to 40 CFR 191).
1. Paragraph 194.43(a) except for subparagraphs (1) and (2) and paragraph (b) are appropriate
material for 40 CFR part 194. In the remainder of this section, EPA is exceeding its authority.
(WEC-D)
Response to Comment 15.E.I:
Paragraph 191.14(c) of the disposal regulations requires that, "[disposal sites shall be designated
by the most permanent markers, records, and other passive institutional controls practicable to
indicate the dangers of the wastes and their locations." In § 194.43 paragraphs (a) and (b), EPA
requires the compliance application to include detailed descriptions of the PICs to be
implemented and the period of time the PICs are expected to endure and be understood, in
accordance with the requirement for use of the most permanent PICs practicable. Subparagraphs
(1) and (2) of § 194.43(a) address the requirement for markers and records, both of which are
PICs specifically required in the disposal regulations. The compliance criteria are derived
directly from the disposal standards and EPA has not exceeded its authority in implementing
compliance criteria for PICs at the WIPP.
2. The requirement to install markers prior to submitting the compliance certification application
should be amended such that this requirement would be in effect after the compliance
certification application is submitted. (SNL-C)
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Response to Comment 15.E.2:
The final rule clarifies in §194.43(a)(l) that the Agency does not require markers to be in place
prior to the submission of a compliance certification application. The rule states that, "[a]ny
compliance application shall include....identification of the controlled area by markers that have
been designed, and will be fabricated and emplaced..."
3. The list of record requirements in 40 CFR 194.43(a)(2) proposed by the EPA is generally
appropriate with the exception of the requirement to include all test results. (SNL-C)
Response to Comment 15.E.3:
The test results required in §194.43(a)(2)(v) are those related specifically to how the system is
backfilled and sealed, how the waste is expected to interact within the disposal system, and other
tests pertinent to the containment of the waste. This is a limited subset of tests which will
provide the most useful information to future generations. The Agency recognizes that such test
results are not typically included in government archives and land records and, as other
commenters have noted, too much information may diminish the likelihood that it endures;
therefore, this provision of the rule has been revised to include an alternative that the location of
such test results may be included in the archives and records.
4. A subsection should be added to 194.43 stating that passive institutional controls shall comply
with the provisions of 40 CFR 191.14(c), 194.14, 194.41, and 194.44. (DOE-D, SNL-C)
Response to Comment 15.E.4:
Section 194.43 of the compliance criteria is the specific implementation of §191.14(c) of the
disposal regulations. Therefore, it is not necessary to reference the § 191.14(c) requirements in
§ 194.43. The Agency believes that the provisions of 40 CFR part 194 are internally consistent,
and that it is unnecessary to refer to §194.14, §194.41, or §194.44.
Issue F: There is no easy answer for the implementation of PICs. (NMAG-G)
Response to Issue 15.F:
Passive institutional controls are a complex issue on which EPA has sought input from numerous
technical experts, other regulatory agencies, the public, social scientists, and others. The EPA
appreciates the recognition of the complexity of this issue.
Issue G: DOE should erect a fence/wall/barrier around the WIPP. That barrier would
seem to obviate a lot of controls that would otherwise be needed. (IV-D-06)
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Response to Issue 15.G:
The EPA has not specified a particular type of passive marker/barrier because it is unclear what
type of passive institutional control would provide the best level of protection and last the
longest. A fence/wall/barrier, depending on its construction, maybe subject to collapse, erosion,
or burial due to shifts in the sand caused by wind, rain, or other natural forces. In addition, a
fence may not effectively convey the hazards of the WIPP. DOE, as owner and operator of the
facility, is responsible for demonstrating in its compliance certification application that it has
employed the type of markers that will be most effective. The DOE must demonstrate that PICs
will endure and be understood in order to fulfill the PICs assurance requirement.
Issue H: Requirement for placement of records in "local, state, federal,...and international
archives (60 F.R. 5789)" overlooks placement with Mexican government entities and Native
American governments. (CARD-B)
Response to Issue 15.H:
Native American governments are within the scope of "local" governments from a regional
geographic standpoint. Native American governments and the Mexican government would also
be considered "international" because of their status as independent and self-governing nations.
Issue I: Passive institutional controls should be considered part of DOE's "defense in
depth" approach. (CCNS-B)
Response to Issue 15.1:
As stated in § 191.14 of the disposal regulations, the purpose of assurance requirements is to
"provide the confidence needed for long term compliance . . . ." In the compliance criteria, the
Agency addresses this needed confidence by implementing the six assurance requirements for the
WIPP. Passive institutional controls are an element of the assurance requirements. See also
response to Issue 15.C.
Issue J: The DOE should be considered in violation if it cannot persuasively demonstrate
the probable delivery of warning communication at least to the 10.000-year horizon.
(CARD-B, A-38)
Response to Issue 15.J:
Consistent with 191.14(c) of the disposal regulations, the final rule requires that DOE's
compliance certification application contain the most permanent markers, records, and other PICs
practicable to indicate the location of the wastes and their danger. Neither the disposal
regulations nor the compliance criteria require that PICs be definitively effective for 10,000
years; both regulations require that the most permanent measure practicable must be employed.
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The EPA will evaluate the adequacy of PICs, including the period of time they are expected to
endure and be understood, in EPA's review of the compliance certification application. Further,
with respect to the 10,000-year time frame, specifying "at least to the 10,000-year horizon"
implies regulation beyond the regulatory time frame prescribed in the disposal regulations. See
also response to Issue 15.C.
Issue K: Converting certification requirements to conditions subsequently denies them any
force and defeats public process. The DOE should present evidence of financial support
for and commitment to construction of markers. Rulemaking must be reopened to
determine whether plan is actually carried out. (NMAG-B)
1. The following subsection should be added to the rule in §194.43, "The application for
certification of compliance shall include specific financial and contractual commitments made to
support the implementation of the plans as to passive institutional controls." (NMAG-D)
Response to Issue 15.K:
Section 43 of 40 CFR part 194 requires DOE to describe in its compliance application passive
institutional controls that will be employed to preserve knowledge about the location, design, and
contents of the disposal system. Consistent with the rest of the application, that plan will be
subject to public scrutiny during the certification rulemaking. The Agency will fully consider
public input before EPA certifies compliance with the radioactive waste disposal standards.
With respect to PICs, EPA must be satisfied that the measures described by DOE in the
application will actually be implemented as planned.
To further ensure that DOE fulfills all commitments made in the compliance application, any
activities which depart from the basis on which EPA determines compliance will subject any
compliance certification to modification, suspension or revocation, as described in §194.4.
Among other things, §194.4 states that any modification (or change in condition) of the
certification is to be conducted in a public rulemaking. A rulemaking re-opening the initial
certification would also be subject to judicial review.
There may be instances, however, where departing from the certification could be more
protective because of advances in technology. While disposal system changes would be subject
to review, they may actually provide further protection.
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Section 16: ENGINEERED BARRIERS: SECTION 194.44
Issue A: The EPA is exceeding its authority (references to 40 CFR part 191).
1. Part 191 requires a total systems approach and does not specify barriers as a discrete
subsystem. (DOE-D)
Response to Comment 16.A.1:
"Barriers," both engineered and natural, are specified in the WIPP Land Withdrawal Act [Public
Law 102-579, Sec. 8(g)] and the disposal regulations in §191.14(d). Engineered barriers are
explicitly required [§191.14(d) and §194.44] as an "assurance" requirement intended to provide
the confidence needed for long-term compliance with the containment requirements. The
assurance requirements of §191.14 identify six elements, including engineered barriers. The
compliance criteria do not specify engineered barriers as a "subsystem" of the "total disposal
system."
2. Section 194.44(a) imposes substantial new requirements with regard to compliance at the
WIPP facility. (WEC-D)
Response to Comment 16.A.2:
Section 194.44(a) implements §191.14(d) which states, "[b]oth engineered and natural barriers
shall be included."
3. Subsections 194.44(b), 194.44(e), 194.44(c)(l)(ii), 194.44(c)(l)(iv), and 194.44(c)(l)(vi)
should be eliminated. (DOE-D, SNL-C)
4. A combination of engineered barriers should be required to provide additional assurance for
the integrity of the repository in view of the inherent uncertainties in projecting the long-term
performance of the repository. (EEG-D)
5. The EPA should delete "public" in 40 CFR 194.44(c)(l)(vi). The evaluation should consider
increased or reduced confidence in the performance of the disposal system and should not be
limited to public confidence. (NRC)
Response to Comments 16.A.3 through 16.A.5:
When DOE analyzes an engineered barrier option [as in DOE's 1991 Engineered Alternatives
Task Force (EATF) Report on Engineered Alternatives for the WIPP, DOE/WPP 91-007], some
barriers, when combined with others, may show marked improvement or, in some cases,
significant reductions in disposal system performance. The nine factors specified in
§194.44(c)(l) combine to give a complete evaluation of a potential engineered barrier. For
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example, the risk to workers from increased handling activities, and to the public and the
environment from increased transportation, are essential concerns in considering engineered
barriers. The evaluation criteria were chosen to ensure that 1) engineered barriers are thoroughly
examined and 2) fulfilling the requirement does not inadvertently lead to actions which could
compromise the overall system performance or increase overall risk.
The EPA recognizes that "public confidence" is difficult to measure; therefore, this factor was
changed in the final rule to "public comments requesting specific engineered barriers," the intent
of which is to ensure that DOE consider the public's input before selecting the engineered
barrier(s) for the disposal system.
6. Subsection 194.44(e) should cross reference compliance standards contained in 40 CFR
194.41, 194.42, 194.43, and 194.44. The requirement to consider transportation and worker
exposure in evaluating engineered barriers is outside the scope of this proposed rule. (SNL-C)
Response to Comment 16.A.6:
The WIPP facility as a whole must comply with the disposal standards set forth in 40 CFR
part 191. The EPA believes the compliance criteria are internally consistent, and that it is not
necessary to cross reference standards contained in one section of the rule to all other sections
where they may be applicable. The EPA believes that it is essential that the implementation of
an engineered barrier (or combination of barriers) not increase the overall risk to the public and
the environment. For that reason, the increased or reduced risk from transporting or handling the
waste is a part of a comprehensive engineered barrier evaluation. See also the response to
Comment 16.A.3.
7. The imposition of such cost/benefit studies would impose substantial new time and cost
constraints not previously indicated by 40 CFR part 191. (DOE-D, WEC-D, SGNM-A, EEG-B,
SRIC-C, C-28, A-ll, A-13, A-45, IV-D-56)
8. The EPA should use the results of their research to assist in setting reasonable criteria within
the scope of the Land Withdrawal Act, and the 40 CFR 191 regulations. (IV-D-40)
9. The inclusion of the requirement for the engineer barrier study in the proposed rule is
inappropriate. (DOE-A)
10. The wisdom of mandating the preparation of an analysis of benefits and costs related to
engineered barriers is questioned. These criteria should provide guidance relating to appropriate
actions to be undertaken by the applicant. (SGNM-C, EEG-A, EEG-B)
11. It is not appropriate for EPA to require DOE, by rule, to perform the study. This is not
specified in 40 CFR part 191 and it is doubtful whether such a study would add any real value to
enhance health and safety. (IV-D-111)
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Response to Comments 16.A.7 through 16.A.11:
The assurance requirements of § 191.14 require the use of engineered barriers. As a result of
discussions at public meetings, DOE has already agreed to undertake an evaluation of engineered
barriers. The nine factors specified in the final rule in § 194.44(c)(l) are intended to rationalize
and guide the evaluation. The engineered barriers evaluation provides an objective mechanism
for justifying decisions made regarding the implementation of the engineered barriers
requirement in § 191.14(d). The requirements for the evaluation outline the information that must
be included in an evaluation, and presented in a compliance application.
Issue B: Other engineered barriers need to be considered.
1. Waste should be emplaced in glass or cement and the walls between the rooms should also be
barriered to minimize the inevitability of human intrusion. (C-03)
2. Vitrification and other barriers (plugs and seals) mentioned should be evaluated to reduce the
potential for the waste migration. (CARD-B, SRIC-C, SRIC-E, A-41)
3. The EPA must insist that DOE build more durable containers to help isolate the waste. (S-l 1,
IV-D-82, SRIC-G)
4. Canisters are inappropriate due to gas generation. (C-03)
5. The compliance criteria should require waste containers to meet standards of resistance to
corrosion, crushing, and inadvertent drilling. (A-68)
6. The criteria must specify which engineered barriers are required and what information on
them must be in the application. (S-37)
7. Criteria for barriers, containers, and protection must be specified and strengthened and control
of remote handled wastes. Old packaged wastes should not be exempt form review and
necessary repackaging. (IV-D-12)
8. Without a criterion, the engineered barrier requirement is substantially reduced in
effectiveness. (NMAG-C)
9. The EPA should indicate how it plans to seal off the doors after it puts the material in the
rooms. (C-08)
10. Engineered barriers should contain some form of alarming identity to hazardous material if
encountered by human intrusion. In addition, prior to cementing drilling contractors should
sandblast to insure a better bond. (SGNM-D)
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11. The criteria should mandate the use of properly engineered backfill; plugs and seals in drifts,
panel entries, and shafts; and complete sealing of any drill holes. (SRIC-G)
Response to Issue 16.B:
Several options are required to be evaluated as part of the engineered barriers evaluation.
Specifically, §194.44(b) states, "[i]n selecting engineered barriers for the disposal system, the
Department shall evaluate the benefit and detriment of engineered barrier alternatives, including,
but not limited to: cementation, shredding, supercompaction, incineration, vitrification,
improved waste canisters, grout and bentonite backfill, melting of metals, alternative
configurations of waste placements in the disposal system, and alternative disposal system
dimensions." It is DOE's role as facility owner and operator to propose the engineered barrier(s)
to be used at the WPP and to justify and support the choice(s). It is EPA's role as regulator to
evaluate the adequacy of DOE's decision, and this will be accomplished through the compliance
certification rulemaking. The EPA believes it is inappropriate to require the use of specific
barriers without an evaluation of their impact on the overall system. The Agency believes
barriers should be selected based on an objective evaluation, and has specified the criteria for
such a process. For comments regarding performance standards, see also the response to
Comment 16.F.
Issue C: The evaluation of the engineered barriers needs to be extended over a longer time
period.
1. WIPP should be considered in a state of non-compliance if acceptable safeguards are not in
place. (S-28)
2. The compliance criteria should require DOE to analyze the effects of engineered barriers on
reducing uncertainties over 100,000 years, as its own regulation requires for any other repository.
(SRIC-E, SRIC-F)
Response to Issue 16.C:
Section 191.13(a) limits consideration of significant processes and events that may effect the
disposal system to 10,000 years. The WIPP Land Withdrawal Act in Section 8(a)(l) reinstated
this requirement of 40 CFR part 191. The compliance criteria implement the 40 CFR part 191
disposal standards. As EPA noted in promulgating the disposal standards of Part 191, "[tjhere
was no intention to indicate that times beyond 10,000 years were unimportant, but the Agency
felt that a disposal system capable of meeting the containment requirements for 10,000 years
would continue to protect people and the environment well beyond 10,000 years [50 FR 38076]."
The 10,000-year regulatory time frame of the disposal standards was reviewed and supported by
the EPA Science Advisory Board.
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Issue D: The EPA needs to clarify its responsibility related to WIPP.
1. The LWA does not authorize DOE to reject engineered barriers; rather, that is EPA's
responsibility. (EEG-B)
Response to Comment 16.D.1:
Neither the LWA, 40 CFR part 191, nor therefore 40 CFR part 194 prescribe the type, number, or
performance standards of engineered barriers. The EPA established criteria to be considered in
the selection or rejection of engineered barriers with the intention that DOE would systematically
evaluate potential barriers. The results of this evaluation will indicate options that optimize
protection of the public and the environment at a reasonable cost. If EPA were to require specific
engineered barriers to be used, the Agency would be designing the facility and then approving its
own design; this is the type of self-regulation the WIPP LWA aimed to avoid. Under the law, it
is DOE's responsibility, not EPA's, to design the facility. In the certification rulemaking, EPA
will thoroughly review DOE's evaluation and have final say, informed by the public, on the
adequacy of engineered barriers proposed for the WIPP.
2. The EPA's decision to require the applicant to enhance public confidence attempts to shift
from EPA to the applicant the responsibility for public health and environmental protection.
(A-ll)
Response to Comment 16.D.2:
The WIPP Land Withdrawal Act clearly defines the roles and responsibilities for EPA and DOE.
Both agencies have the responsibility to protect public health and the environment: the EPA is
responsible for implementing the disposal regulations specifically at the WPP; and DOE is
responsible for designing and operating the WIPP in a manner that is consistent with the
requirements in the compliance criteria. The reference in §194.44(c)(l)(vi) to evaluate the
increased or reduced public confidence in the performance of the disposal system (60 F.R. 5790)
was intended to measure the perception of safety within the public at large. In the final rule, this
factor has been revised to require DOE to consider public comments requesting specific
engineered barriers. This does not shift responsibility but provides an opportunity for public
input to DOE's analysis, in addition to an opportunity EPA will provide to the public in
reviewing the adequacy of the evaluation in the certification rulemaking.
Issue E: Performance standards should be specified for engineered barriers.
1. Of the four approaches for EPA to use its authority regarding engineered barriers in the
"Background Information," the approach which assigns minimum performance objectives to
major sub-elements of the disposal system so as to lessen uncertainty is recommended. (SRIC-F)
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2. The EPA must give a specific guide for how long prevention of any contaminant release to the
environment is expected to be ensured by the inclusion of engineered barriers. This would help
to clarify the intention that engineered barriers are an essential requirement. (DOE-D)
3. It is recommended that EPA address areas of regulatory uncertainty, such as "substantially
delay," "all conceptual models not considered (60 F.R. 5790)" (§194.23), the application of
future state assumptions (§194.25), and ambiguities in the protected individual (§194.51). (NRC)
4. The EPA should require engineered barriers and prescribe performance measures to assess
their efficacy, similar to those found in 10 CFR 60.113. (EEG-B, EEG-C)
5. A performance target for the engineered barriers is suggested. This would provide an
effective decision making tool for the DOE and a compliance measurement tool for the EPA.
(EEG-C)
6. The DOE opposes specifying performance standards for engineered barriers and believes that
such action would require changing Part 191 disposal regulations through rulemaking. (DOE-D)
7. The EPA shouldn't adopt a performance standard for evaluation of engineered barriers.
(SNL-C)
8. A performance standard similar to that specified in 10 CFR Part 60 should not be adopted.
(SNL-C)
9. A provision needs to be added to state that for contact-handled transuranic waste and remote-
handled transuranic waste, the barriers should maintain the integrity of the barrier such that no
more that one part in 100,000 per year of the radionuclide inventory of the barrier shall be
released from the container. (NMAG-D)
10. The final rule should require specific containers with performance standards to prevent any
releases from remote-handled waste. (SRIC-G)
Response to Issue 16.E:
The disposal regulations clearly establish standards in §191.13(a) for performance of the overall
disposal system. By definition, in §191.12(a), "'[disposal system' means any combinations of
engineered and natural barriers that isolate spent nuclear fuel or radioactive waste after disposal."
Thus, performance of the disposal system is not evaluated by examining discrete elements
independently, but by evaluating the disposal system as a whole. Further, EPA believes 40 CFR
part 191 contains a relevant standard, which is "to [prevent] or substantially delay the movement
of water or radionuclides toward the accessible environment" [see §191.12(d)]. This standard
has been employed in the final compliance criteria. Due to the complexity of the WIPP system, it
is difficult to know, a priori, whether a barrier is helpful to containment or not. The evaluation
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of engineered barriers required in the final rule will ensure that DOE's decision on what
barrier(s) to include is based on the best possible information. To ensure that the rationale for
DOE's selection of engineered barriers is made public, the requirements for the evaluation
outline the information that must be presented in a compliance application.
Under the final criteria, DOE, as owner and operator of the facility, must thoroughly analyze the
appropriate engineered barrier(s) to employ, and EPA, as regulator, will judge the
appropriateness of this determination.
Issue F: The EPA should require that, pending compliance certification, DOE take no
action rendering it substantially more difficult for DOE or EPA to apply the engineered
barrier requirement. For example, DOE should not repack waste or mine waste rooms in
such a way that an engineered alternative such as shredding or different disposal room
dimensions becomes more expensive, thereby prejudicing an analysis based in part on
"total system costs." (NMAG-G)
1. The following text should be added to § 194.44, "In considering the benefit and detriment of
alternative disposal system dimensions, the benefit and detriment of alternative dimensions for
parts of the disposal system now constructed (as of 1994) as well as parts to be constructed (after
1994) shall be considered." (NMAG-D)
Response to Issue 16.F:
The EPA does not expect the evaluation of engineered barriers to be prejudiced, and, in
§194.44(b), DOE is required to examine alternative disposal system dimensions. In addition,
EPA does not believe that it is appropriate to impose a ban on certain WIPP-related activities due
to a bias concern.
Issue G: The inclusion of criteria for evaluating engineered barriers is needed.
1. Engineered barrier options should be studied by DOE and results included in the certification
submission, but the EPA should not specify in detail what is to be included. (SGNM-C, EEG-C,
IV-D-51)
2. Proposing criteria for selecting engineered barriers is undesirable micro management.
(IV-D-06)
3. The EPA shouldn't specify by rule the criteria to be used to evaluate engineered barriers.
(SNL-C)
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Response to Comments 16.G.I through 16.G.3:
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Section 44 of the compliance criteria balances not specifying particular engineered barriers at this
juncture with establishing criteria for what is to be included in the evaluation of engineered
barriers to be submitted with the certification application. The regulation allows DOE reasonable
flexibility. The EPA has, however, specified the minimum information that is necessary for
DOE to make an informed decision. The nine factors that are specified ensure that each barrier
considered receives a balanced evaluation. For example, if transportation risk were not a
required factor for consideration, a barrier that shows significant reduction in the uncertainty with
respect to projecting long term repository performance may have a substantial "hidden" risk to
the public and the environment due to increased transportation risk.
4. The EPA must specify that the effect of engineered barriers must be considered in the pre-
certification review of all design evaluations, quality assurances, and safety margins. The criteria
must require these plans to consider the inclusion of engineered barriers from their initial
planning stages. (CCNS-B)
Response to Comment 16.G.4:
Engineered barriers, an assurance requirement, are required "to provide the confidence needed
for long-term compliance with the requirements of 191.13" (See §191.14). Engineered barriers
will fall under the same rigors of quality assurance as all other areas of WIPP design. In
addition, the engineered barrier evaluation required in § 194.44(b) must be subject to peer review
as required in §194.27(a)(3). See also response to Comment 16.F.1.
5. The proposed rule provides no criteria or basis for the selection of engineered barriers other
than the outcome of the benefit/detriment analysis. (EEG-A, SNL-C)
Response to Comment 16.G.5:
The evaluation factors specified in §194.44(c)(l)(I)-(ix) were chosen to ensure that: (1)
engineered barriers fulfill the purpose of the assurance requirements; and (2) fulfilling the
assurance requirement does not inadvertently lead to actions which could compromise the overall
system performance or increase overall risk. The EPA believes that the results of the evaluation
will provide an adequate basis upon which decision makers can base their conclusions with
regard to fulfilling the requirement in §194.44(a).
6. The compliance criteria must require DOE to use engineered barriers that are designed to
eliminate releases from the environment. (A-09, A-08, A-18, IV-D-28)
Response to Comment 16.G.6:
Some releases within the controlled area are acceptable. The compliance criteria implement the
disposal regulations by requiring use of engineered barriers that "prevent or substantially delay
the movement of water or radionuclide toward the accessible environment" [see §194.44(a)].
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7. The EPA should provide specific criteria for evaluating alternative engineered barriers in
terms of total system performance for compliance with 40 CFR 191.13(a). (WEC-D)
8. The regulations for engineered barriers are weak and need to be strengthened. There is
particular concern with the dependence on the benefit/detriment analysis to make decisions as
outlined in the proposed rule. (EEG-B, EEG-C)
9. Consideration of single engineered barriers alone is an inappropriate exercise when
undertaken without consideration of the total system. (SNL-C)
Response to Comments 16.G.7 through 16.G.9:
The WIPP must comply with the requirements set forth in § 191.13(a). Engineered barriers are
required "to provide the confidence needed for long-term compliance with the [containment]
requirements of 191.13" (see §191.14). The evaluation of engineered barriers must take into
account total system performance in reducing uncertainty and risk. The nine factors specified in
§194.44(c) describe a total system approach. See also the responses to Issues 16.B and 16.E.
0. The DOE should be requested to complete its study of engineered barriers promptly, and the
Agency should use the study in drafting an engineered barrier criterion. The Agency's criterion
should place a limit on releases from the room. (NMAG-B)
11. Specifics need to be developed on engineered barriers to prevent water intrusion. (A-68)
12. Engineered barriers should virtually eliminate any release of radioactivity. Current criteria
only require DOE to study various barriers. (EEG-B, NMAG-A, A-09, A-29, A-46, IV-D-13,
IV-D-14, IV-D-15, IV-D-16, IV-D-17, IV-D-18, IV-D-19, IV-D-20, IV-D-21, IV-D-22, IV-D-23,
IV-D-24, IV-D-25, IV-D-30, IV-D-31, IV-D-32, IV-D-33, IV-D-34, IV-D-37, IV-D-38, IV-D-42,
IV-D-43, IV-D-46, IV-D-47, IV-D-48, IV-D-51, IV-D-52, IV-D-53, IV-D-54, IV-D-55, IV-D-56,
IV-D-57, IV-D-58, IV-D-59, IV-D-60, IV-D-61, IV-D-62, IV-D-63, IV-D-66, IV-D-67, IV-D-
68, IV-D-69, IV-D-70, IV-D-71, IV-D-72, IV-D-74, IV-D-75, IV-D-79, IV-D-80, IV-D-83, IV-
D-87, IV-D-88, IV-D-92, IV-D-99)
Response to Comments 16.G.10 through 16.G.12:
The engineered barrier evaluation includes evaluation of an engineered barrier's ability to
"prevent or substantially delay the movement of water or radionuclides toward the accessible
environment" [see §194.44(a)]. For further discussion of performance standards, see the
responses to Comments 16.A.7 through 16.A.11, Issues 16.B, 16.E, 16.F, and Comment 16.G.6.
13. The DOE should be required to incorporate barriers into WIPP, not just study them. (A-60,
CARD-B)
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14. Engineered barriers are required by 191 and LWA, and must be required by 194. (SRIC-C)
Response to Comments 16.G.13 and 16.G.14:
The DOE is required to incorporate engineered barriers into the disposal system by §191.14 (d),
and this requirement is reiterated by the WIPP LWA in section 8(g). Section 194.44 of the
compliance criteria implements this requirement, while allowing DOE enough flexibility to
design its own facility. The evaluation that is required in § 194.44(b) is intended to provide DOE
with a means to select engineered barriers based on a reasonable combination of performance,
cost, risk, etc. Engineered barriers may be used to meet the containment requirements, but must
be used to meet the assurance requirements.
Issue H: The criteria for engineered barriers should be eliminated.
1. Resources would be used more efficiently if only a few engineered barriers were chosen as
opposed to the numerous barriers listed in 194.44(b). (SNL-A)
Response to Comment 16.H.I:
The purpose of the engineered barrier evaluation is to determine the most effective engineered
barriers based on a variety of relevant factors. In addition, §194.44(c)(2) allows DOE to reject a
particular engineered barrier if the Department can demonstrate that such barrier should be ruled
out before evaluating all nine factors. Thus, resources will be allocated appropriately.
2. Engineered barriers that will not be implemented do not need to be studied. (SNL-A)
Response to Comment 16.H.2:
The only prudent way to determine which barriers should be implemented is to evaluate and
compare the various alternatives. The provision under §194.44(c)(2) allows DOE to rule out
unreasonable engineered barriers early in the process (see response to comment 16.H.I).
3. 40 CFR 194.14 and 194.15 should be revised to clarify that design criteria are applicable only
to the engineered barrier components of the disposal system. (SNL-C)
Response to Comment 16.H.3:
The inclusion of design information as specified in §194.14 and §194.15 is not limited to the
engineered barrier components of the disposal system.
4. The requirement for evaluation of specifically identified engineered barriers should be
eliminated from 194.44(b). (SNL-C)
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Response to Comment 16.H.4:
The EPA believes that the barriers specified in §194.44(b) are among appropriate barriers to be
considered. Further, these barriers have been included in past DOE evaluations such as the 1991
EATF Report [DOE/WIPP 91-007].
5. The proposed rule imposes de facto requirements for the incorporation of multiple engineered
barriers in the disposal system beyond those that would be required to provide the assurance
mandated by 40 CFR 191.14(d). (SNL-C)
Response to Comment 16.H.5:
Section 191.14 requires the use of one or more engineered barriers. Section 194.44 does not
intend to require the use of multiple engineered barriers; it simply implements 40 CFR part 191
at WIPP. The DOE must evaluate and propose in its compliance application engineered barriers
necessary to comply with the containment and assurance requirements of the disposal
regulations.
Issue I: The cost-benefit studies allow DOE to self-regulate.
1. A cost-benefit study of engineered barriers conducted by EPA should include a risk analysis.
(A-41)
Response to Comment 16.1.1:
The DOE, as owner and operator of the facility, is required to conduct the evaluation of
engineered barriers. The compliance criteria require that risk be one of the factors that must be
considered in DOE's evaluation. For example, §194.44(c)(l) requires, "(ii) the impact on worker
exposure to radiation both during and after incorporation of engineered barriers; . . . (iv) the
increased or reduced risk of transporting the waste to the disposal system."
2. Directing DOE to determine benefits and detriments and determine what should be used
allows the DOE to regulate itself. (NMAG-B, SRIC-A)
3. These regulations would instruct DOE to do the underlying analysis, which involves self-
regulation. The EPA should do the necessary studies. (NMAG-A)
Response to Comment 16.1.2 and 16.1.3:
The disposal regulations at §191.14(d) state, "[disposal system shall use different types of
barriers to isolate the waste from the accessible environment. Both engineered and natural
barriers shall be included." To gain the most assurance that the public and environment will be
protected, an evaluation of possible engineered barrier alternatives is required by 40 CFR part
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194. It is DOE's role, as facility owner operator, to evaluate and propose the engineered barriers
to be used at the WPP and to justify and support those choices. It is EPA's role, as regulator, to
evaluate thoroughly the adequacy of DOE's decision. The EPA believes it is inappropriate to
require the use of specific barriers without an evaluation of their impact on the overall system.
The Agency believes barriers should be selected based on an objective evaluation, and has
specified the criteria for such a process.
Issue J: Engineered barriers is the least that can be expected from the public in order to
preserve our safety. (S-16)
Response to Issue 16.J:
Engineered barriers are required by the disposal regulations in order to protect the public and the
environment. The EPA will grant a compliance certification only if this requirement is fulfilled.
Issue K: As an assurance requirement, the engineered barriers requirement independent
of and separate from the containment requirements.
1. It is a fundamental mistake for the Agency to accept the idea that engineered barriers shall be
adopted, or not, based on whether they improve performance measures under the containment
requirements. (NMAG-C)
2. Since every effort should be made to control the future internal state of the repository, the EAs
need to support confidence in the long-term performance of the repository. (SGNM-D)
3. The engineered barrier requirement must be given independent force. It is not satisfied by a
showing of compliance with the containment requirement, because of the uncertainties in such a
showing and the nonconservatism of that rule. (NMAG-D)
4. Engineered barriers are a requirement out of 40 CFR part 191 and should be included in the
proposed rule. (NMAG-D)
5. Reject the notion of using engineered barriers as component of the Containment Requirement
of 40 CFR part 191. To be consistent, maintain engineered barriers as an Assurance
Requirement. (EEG-D)
Response to Issue 16.K:
While engineered barriers are required pursuant to the assurance requirements at §194.14(d),
engineered barriers are not necessarily required to meet the containment requirements at §191.13.
However, DOE may choose to use an engineered barrier(s) to meet compliance with the
containment requirements.
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By definition, in §191.12(a), "'[disposal system' means any combinations of engineered and
natural barriers that isolate spent nuclear fuel or radioactive waste after disposal." Thus,
performance of the disposal system is not evaluated by examining discrete elements
independently, but by evaluating the disposal system as a whole.
Consistent with the requirements found in §191.13, that DOE analyze the performance of the
complete disposal system, any engineered barriers that are implemented at the WIPP must be
considered by the Department and, ultimately, by EPA when evaluating compliance with both the
containment requirements in § 191.13 and the assurance requirement in § 191.14(d). The effects
of engineered barriers employed at the WIPP must be considered in performance assessments;
excluding such barriers from consideration would result in inaccurate modeling of the disposal
system as defined in §191.12(a).
Issue L: The Agency should obtain the results of the engineered barrier study promptly
from DOE so that this issue will be addressed promptly rather than being further
postponed. (NMAG-D)
1. The engineered barrier study should be submitted one year in advance of the application.
(NMAG-D)
2. Any study of engineered barriers must be submitted to EPA at least one year before a
compliance application to allow adequate time for public and agency review. (SRIC-G)
Response to Issue 16.L:
The engineered barrier evaluation required under §194.44 is part of the overall compliance
application that will be submitted to EPA by DOE. As such, the evaluation, along with the rest
of the application, will be reviewed by EPA and the public as part of the certification rulemaking.
The EPA will base its certification decision on the total application, all of which must
demonstrate compliance with the disposal standards of 40 CFR part 191, as well as the
compliance criteria of 40 CFR part 194. The EPA believes this approach is consistent with the
approach taken elsewhere in the compliance criteria.
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Section 17: CONSIDERATION OF THE PRESENCE OF RESOURCES:
SECTION 194.45
Issue A: Consideration of resource recovery is inconsistent with 40 CFR part 191.
1. "Resource Recovery" activities fall outside the scope of the limitations. (SNL-C)
2. The Supplementary Information, by requiring consideration of "resource recovery" is
inconsistent with the basis for 40 CFR part 191, particularly with the basis for promulgation of
the release limits. (SNL-C)
3. The scope of the required evaluation in the Supplementary Information is inconsistent with
the proposed wording of the rule. (SNL-C)
Response to Issue 17.A:
The final rule has been revised from the proposed rule to clarify EPA's intentions regarding the
assurance requirement for presence of resources, § 191.13(e). The final rule states that the
compliance application must demonstrate that the favorable characteristics of the disposal system
compensate for the presence of resources in the vicinity of the disposal system and the likelihood
of the disposal system being disturbed as a result of the presence of those resources. The final
rule further provides that the requirements of §191.13(e) and §194.45 will be fulfilled if
performance assessments, taking into account human intrusion, predict that the numerical release
limits of the disposal regulations will be met. This approach reasonably implements § 191.13(e)
at the WIPP because performance assessments must account for the increased potential for
human intrusion into the disposal system due to the presence of resources, based on historical
rates of drilling and of mining in the vicinity of the WIPP. Analysis of human intrusion must
consider exploratory and developmental drilling of all resources in the Delaware Basin, as well
as mining, consistent with the disposal regulations which state that performance assessments
must consider events that may affect the disposal system during the regulatory time frame.
The 40 CFR part 191, Appendix C guidance which discussed exploratory drilling is non-binding
on the implementing Agency, which is EPA for the WPP. Appendix C was designed to apply to
all geologic repositories for the disposal of highly radioactive wastes, not necessarily to the
specific site characteristics of the WIPP and not only to transuranic waste. As a result, EPA
found in developing the final rule that only some of the guidance contained in Appendix C has
specific relevance to the WIPP. In the case of developmental drilling, the EPA has determined,
based on technical and policy considerations, that the Appendix C guidance is not applicable to
the WIPP. As noted in the responses to Section 12 of this document, EPA has found
unpersuasive the contention that exploratory drilling would definitely locate the disposal system,
or, even if it did, that it would necessarily eliminate the likelihood of related exploration and
development. Thus, the Agency has retained its requirements to consider developmental drilling
under human intrusion. See responses to Section 12 of this document for further discussion of
this issue.
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Issue B: The WIPP has conducted previous research into the presence of resources with
the first important study being conducted in 1981. It is not apparent how additional
research would benefit the project nor the EPA to coming to a compliance determination.
(IV-D-40)
Response to Issue 17.B:
Section 194.45 does not necessarily require research of past or potential future resource
exploration and recovery activities beyond what is already required to document compliance of
performance assessment (PA) results with EPA's containment requirements under 40 CFR
part 191 and the compliance criteria. As noted in the prior response, the final rule clarifies that
the requirements of §191.13(e) and §194.45 will be fulfilled if performance assessments, taking
into account human intrusion, predict that the numerical release limits of the disposal regulations
will be met. This approach reasonably implements § 191.13 (e) at the WPP because performance
assessments must account for the increased potential for human intrusion into the disposal
system due to the presence of resources, based on historical rates of drilling and of mining in the
vicinity of the WIPP. Past exploration and extraction of resources in the vicinity of the WIPP
will be used as the basis for modeling potential future human intrusion into the disposal system,
as specified in §194.32 and §194.33 of the final rule.
Issue C: The rule should be more explicit about what resource information is needed.
1. The rule should state the scope and level of exposure scenarios presentation necessary to
satisfy "full consideration of potential effects" of resource recovery activities. (CARD-B)
2. EPA should explicitly delineate scope, specificity, and presentation format of resource
information needed. (SGNM-C, IV-D-56)
Response to Issue 17.C:
The proposed compliance criteria provided that "[a]ny application for certification of compliance
shall include information that demonstrates that the favorable characteristics of the disposal
system compensate for the presence of resources in the vicinity of the disposal system and the
likelihood of future human-initiated processes and events as a result of the presence of those
resources [60 FR 5790]." In the Supplementary Information to the proposal, the Agency
elaborated: "If, after full consideration of the potential effects of resources recovery activities the
WIPP is still predicted to meet the requirements of 40 CFR part 191, then the Agency will
assume that the requirements of this part and section 14(e) of 40 CFR part 191 have been
fulfilled [60 FR 5780]." The Agency requested additional comment on this approach.
As explained in the prior responses, EPA has explicitly adopted this approach in the final rule.
The final rule provides that EPA will assume that the assurance requirement will be met if
performance assessment (PA) results demonstrate compliance with the containment requirements
of 40 CFR part 191. Thus, to fulfill this requirement, a full consideration of the potential effects
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of resource recovery activities at the WIPP must include the following: 1) PA analyses for
"disturbed scenarios" must consider potential human intrusion for resources, including drilling
and excavation mining, according to the criteria in §194.32 and §194.33, and as explained in the
preamble to the final rule; and 2) PA analyses and compliance assessments for "undisturbed
performance" must consider the effects on the disposal system of any activities that occur in the
vicinity of the disposal system prior to disposal and of activities that are expected to occur in the
vicinity of the disposal system soon after disposal (based on development of existing leases).
The scope of performance assessments and accompanying documentation are in turn clearly
specified in the final rule.
Issue D: Resources should be identified and extracted before waste is stored.
1. All resources should be extracted before the radioactive waste is stored. (A-53)
2. Drilling should take place in the present to identify potential resources to avoid the possibility
of future drilling. (C-12)
Response to Issue 17.D:
The EPA is primarily concerned with consideration of resource recovery activities as potential
mechanisms to release waste accidentally from the repository, and thus is most concerned about
drilling in the controlled area at the WIPP. The EPA has considered that allowing or even
requiring recovery of known resources above the WIPP in the immediate future could be a way to
reduce the potential for future intrusions related to recovery of these resources. This approach
was rejected because of the possibility that active mining or drilling above the repository could
create unexpected new pathways for movement of radionuclides from the disposal system and
compromise its performance. In addition, mining presently identified resources cannot mitigate
intrusion for resources not currently identified, or resources which are not now, but could
become, economically feasible to recover. Finally, Congress has specifically prohibited, under
the WIPP LWA, "surface or subsurface mining or oil or gas production, including slant drilling .
. . on lands on or under the Withdrawal" area containing the WIPP site [Public Law 102-579,
Sec. 4(b)(5)(A)]. The EPA's rulemaking cannot and does not affect this prohibition. For these
reasons, EPA has not changed the final rule to allow or encourage recovery of resources above
the WIPP site.
For similar reasons, EPA concludes that it is inappropriate to pursue drilling now to identify
potential resources. Resources in the vicinity of the WIPP have been documented and mapped.
The potential of identifying resources that have not been documented, and the uncertainty in
speculating about resources that may become valuable, does not outweigh the risk of creating
additional release pathways and, in any event, does not overcome the statutory prohibition on
drilling.
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Issue E: Special provisions for consideration of resources is unnecessary since this will be
handled through performance assessment. (DOE-D)
Response to Issue 17.E:
As noted, the final rule provides that the resources assurance requirement will be met if PA
results which take into account resource recovery activities demonstrate compliance with the
Agency's requirements under 40 CFR parts 191 and 194. This presupposes that performance
assessments fully consider the effects of resources, as specified in this part, and are rigorous and
well-documented. See responses to Issues 17.A and 17.C of this section for more information.
The final rule has been revised to clarify EPA's intent in determining compliance with the
assurance requirement.
Issue F: Consideration of resource conflicts in compliance certification should also include
increased likelihood of intrusion occurrence and severity based on real-life regulatory
experience with extractive industries. (CARD-B)
Response to Issue 17.F:
The effects of actual experience are accounted for in performance assessments that require the
likelihood for human intrusion to be calculated based on the historical drilling and mining
activity in the Delaware Basin. Further, EPA requires that DOE implement active institutional
controls [§194.41] at the WIPP site in addition to passive institutional controls (PICs) [§191.43],
which include government ownership and regulations regarding land or resource use. Active
institutional controls include monitoring and any means other than PICs of controlling access to a
site, such as walking patrols at the site perimeter. The final rule limits reductions in the
likelihood of human intrusion that maybe allowed for implementing active institutional controls
to the first 100 years after disposal, and any such reductions must be supported by the DOE. The
final rule also limits the time period for which PICs may be assumed to reduce the likelihood of
human intrusion to several hundred years after disposal. Further, the presence of PICs can never
be assumed to eliminate the possibility of human intrusion. The EPA believes that the
implementation of active and passive controls, as required by the final rule, will deter attempts to
recover resources in the vicinity of the WPP. However, in recognition of the uncertainty
surrounding the effectiveness of these measures, the final rule limits the assumptions which may
be made regarding the effectiveness of such controls in performance assessments by, among
other things, placing constraints on the time period for which they may be considered in reducing
the likelihood of inadvertent human intrusion.
Issue G: No waste should be stored at WIPP if there are resources and/or mining activity.
1. Radioactive waste should not be stored where there is mining activity and active or potential
drilling for oil reserves. (S-56)
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2. Many valuable resources are in the area and it is 100 percent certain that the WIPP site will be
invaded by a drilling rig in the 10,000 years it is being planned for. (S-23)
3. The WPP site should be disqualified from consideration if there are oil, gas, and potash
resources near the site. (S-17)
4. The rich natural resources of the area need to be addressed since something like WIPP is
supposed to be placed where there are no such resources. (A-35, S-12, IV-D-07)
5. The WIPP is in an area that contains valuable resources that are of great interest to industry.
We see no benefit that would compensate for the contamination as a result of mining or drilling
near the WIPP site. (S-40)
6. Because WPP is located on some oil, gas, and potash-rich area, EPA must evaluate the WPP
from another characteristic that would justify violating existing EPA regulations. (EEG-A, A-09,
A-33, A-43, A-48, A-54, A-64)
7. The siting of WIPP in a resource rich area does not meet basic EPA regulations. (EEG-C,
S-21, IV-D-26, IV-D-73, IV-D-91)
8. A demonstration that the favorable characteristics of the WIPP compensate for resource
considerations should have been considered as long ago as when the site was selected. (EEG-C,
IV-D-06, IV-D-28, IV-D-51)
9. Contrary to claims by some parties, recent updated information on mineral resources near the
WIPP does not cause the WIPP to be in violation of the EPA's regulations. (DOE-E)
Response to Issue 17.G:
The presence of resources and resource-related activity at the WIPP does not necessarily
disqualify it from use as a radioactive waste disposal facility. When EPA was developing the
final radioactive waste disposal regulations, EPA proposed to prohibit use of sites where there is
a reasonable expectation that future exploration for scarce or easily accessible resources might
occur. See 47 FR 58205 (Dec. 29, 1982). In adopting the final radioactive waste disposal
standards, EPA concluded that the presence of resources should not disqualify a site that may
have compensating features. Thus, the final disposal regulations provide that:
Places where there has been mining for resources, or where there is a reasonable
expectation of exploration for scarce or easily accessible resources, or where there is a
significant concentration of any material that is not widely available from other sources,
should be avoided in selecting disposal sites. . . . Such places shall not be used for
disposal unless the favorable characteristics of such places compensate for their greater
likelihood of being disturbed in the future.
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See 40 CFR 191.14(e) (emphasis added).
Congress authorized development of the WIPP in section 213(a) of the Department of Energy
National Security and Military Applications of Nuclear Energy Authorization Act of 1980 (1980
DOE Act): "The Secretary of Energy shall proceed with the Waste Isolation Pilot Plant
construction project authorized to be carried out in the Delaware Basin of southeast New Mexico
(project 77-13-F) in accordance with the authorization for such project as modified by this
section. Notwithstanding any other provision of law, the Waste Isolation Pilot Plant is
authorized as a defense activity of the Department of Energy ... for the express purpose of
providing a research and development facility to demonstrate the safe disposal of radioactive
wastes resulting from the defense activities and programs of the United States. . .." See Pub. L.
No. 96-164. In the 1992 WIPP LWA Congress withdrew WIPP and surrounding lands from the
public domain and reserved such lands "for the use of [DOE] for the construction . . . of WIPP as
set forth in section 213 of the [1980 DOE Act] and this Act."
In the final compliance criteria for the WIPP, EPA has provided that the provisions §191.14(e)
will be fulfilled if performance assessments predict that the disposal system meets the
containment requirements. The EPA has in turn revised the performance assessment
requirements in the final rule to ensure that they include consideration of relevant resources,
including "mining for resources" in the vicinity of the WIPP, even though inadvertent drilling for
resources is the most severe human intrusion scenario at the WIPP. Thus, at this stage in the
regulatory process, the performance assessments for the WIPP provide a rigorous analytical
methodology to determine with reasonable certainty whether the WIPP has compensating
features to provide overall protection of public health and the environment notwithstanding the
presence of resources.
Issue H: The WIPP requirements could harm resource recovery industries.
1. The WIPP requirements for boreholes would limit the development and production of
possible petroleum reserves in the area. (S-47)
2. The WIPP regulations would have a harmful affect on the potash and mining industries. (C-
20, C-21)
Response to Issue 17.H:
Congress specifically prohibited, under the WIPP LWA, "surface or subsurface mining or oil or
gas production, including slant drilling from outside the boundaries of the Withdrawal... on
lands on or under the Withdrawal" area containing the WIPP site. [See Public Law 102-579,
Sec. 4(b)(5)(A).] There are currently active mineral and petroleum leases and drilling permits
(managed by the U.S. Department of the Interior) on lands adjacent to the WIPP Land
Withdrawal Area.
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Because of the likelihood of future resource exploitation, the final compliance criteria require
that DOE consider the potential effects on disposal system performance from resource
exploration and recovery near the WIPP; such effects are included in the performance assessment
(PA) scenarios. Drilling and mining rates established under the criteria apply to hypothetical
scenarios to be included in PA calculations, based on historical drilling and mining activities.
The compliance criteria do not establish limits on drilling and mining in the area outside the
Withdrawal.
Issue I: It is not clear how an evaluation of "favorable characteristics" can be done; the
term implies a comparison, and sites to be compared are not identified. EPA should
specify hypothetical disposal systems to be built in areas which are not exploration targets.
Then, comparisons of sites should be done by an objective test. (CARD-B, NMAG-B,
NMAG-G)
1. The following section should be added to §194.45, "Such demonstration shall compare that
disposal system with alternative systems which would be located at sites which contain no
resources and shall show that the likelihood or releases in violation of the disposal standards is
lower at the WIPP site than at such other sites." (NMAG-D)
2. In order to demonstrate that the favorable characteristics compensate for resources near the
WIPP, the rule should require DOE to compare the WIPP to other disposal sites without the
presence of such resources, and to demonstrate that the likelihood of releases from the WPP is
lower than at such other sites. (SRIC-G)
Response to Issue 17.1:
The regulatory text provides that: "Such places [with resources] shall not be used for disposal of
the wastes covered by this part unless the favorable characteristics of such places compensate for
their greater likelihood of being disturbed in the future." See 40 CFR 191.14(e). The language
does not expressly mandate a comparison with other disposal sites. The regulatory text can be
construed to call for comparison of the characteristics of a disposal system under consideration—
an evaluation of the favorable characteristics of a site in comparison with the greater likelihood
that the site will be disturbed due to its unfavorable characteristics, the presence of resources.
Moreover, Congress has ratified the selection of WIPP as a proposed radioactive waste disposal
site in section 213(a) of the Department of Energy National Security and Military Applications of
Nuclear Energy Authorization Act of 1980 (1980 DOE Act) and again in the 1992 WIPP LWA
when, among other things, Congress withdrew the site from the public domain for specific
consideration for transuranic radioactive waste disposal. See Pub. L. Nos. 96-164 & 102-579.
Congress called for EPA to issue specific criteria to certify whether the WIPP facility will
comply with the general radioactive waste disposal regulations at the same time it withdrew the
WIPP site from the public domain for specific consideration. The EPA has acted consistently
with Congressional action by developing criteria to rigorously evaluate whether the WIPP
facility complies with the disposal regulations. In light of Congressional action ratifying the
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WIPP as a candidate disposal site and calling for specific regulatory examination of the WIPP
site, EPA declines to require an examination of whether some other site might comply with the
disposal regulations or have characteristics more favorable than the WIPP site.
Nevertheless, EPA has revised the final rule to ensure that resources at the WIPP site are fully
examined. The EPA proposed to require the WIPP performance assessment to evaluate drilling
activities at the WIPP, because drilling for resources is the most severe human intrusion scenario.
Because the final rule allows DOE to rely on the results of the performance assessments to
demonstrate whether their are compensating characteristics for the presences of resources at the
WIPP, EPA has expanded the scope of WIPP performance assessment to include the effects of
mining for resources. This approach ensures a comprehensive analysis of the potential
detrimental affects from the presence of resources, consistent with the assurance requirement of
§191.14(e).
The EPA also notes that DOE has examined alternatives to the WIPP in its environmental impact
analysis of the WIPP site pursuant to the National Environmental Policy Act.
Issue J: The types of resources need to be addressed.
1. The nature of resources found at WIPP should be taken into consideration. Some minerals,
such as those present in attractive quantities at WIPP are more prone to inveterate intrusion than
others. (CARD-B)
Response to Comment 17.J.I:
This concern regarding the nature of resources at the WIPP is addressed in §194.32 and §194.33,
which address the type of resources to be included in consideration of human intrusion. The
final rule requires consideration of drilling activities for potash, water, and other resources in
addition to oil and gas, if they have the potential to affect the waste disposal system, and also
requires consideration of excavation mining, based on resources which are currently extracted in
the Delaware Basin. See Section 12 of this document for further discussion of drilling and
mining rates and consequences.
The second issue raised by this comment is the possibility that minerals present in attractive
quantities could prompt extreme efforts to recover the resources found near the WIPP. The
primary concern here is that extraction industries might ignore drilling regulations in their quest
for valuable resources. See response to Comment 17.F of this Section for a discussion of this
issue.
In the final rule, EPA clarified its expectations for demonstrating compliance with §194.45; this
demonstration is tied directly to PA results and consideration of human intrusion processes and
consequences. Sections 194.32 and 194.33 address the range of resources to be considered in
performance assessments.
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2. The resources should be of the same type, quality, and quantity as resources in the controlled
area. (SNL-C)
Response to Comment 17.J.2:
The Agency agrees that the type and quality of resources present in the vicinity of the WIPP
should be considered in evaluating their impact on the WPP. The final rule states that, for
shallow drilling, historical rates could be determined based on "resources of similar type and
quality of resources in the controlled area [§194.33(b)(4)(iii)]." It is difficult to determine
directly the quantity of resources in the controlled area; rather, EPA chose to take this into
account by examining historical records of drilling near the WPP site (i.e., in the Delaware
Basin). Further, predictions of undisturbed performance of the disposal system must account for
effects of past and current drilling, which are related to the estimated quantity of resources near
the WPP.
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Section 18: REMOVAL OF WASTE: SECTION 194.46
Issue A: The EPA has exceeded its authority (references to 40 CFR part 191).
1. The requirement for the WIPP to prepare plans for the removal of the waste is unnecessarily
restrictive given the safeguards that exist with the rule in demonstrating compliance with 40 CFR
part 191. (IV-D-40)
2. Requiring a plan for removal of the waste is unnecessary, because it inappropriately extends
the requirements of 40 CFR part 191. To meet this assurance requirement, it only need be
technologically feasible to be able to mine the sealed repository and recover the waste. (SNL-C)
3. Part 191 says removal shall not be precluded for a reasonable period after disposal, Part 194
should require and evaluation of preclusion, not a removal plan. (C-12, C-28)
Issue B: The waste removal proposal is infeasible and unnecessary.
1. EPA's proposal for development of a removal plan is unmeaningful and virtually impossible.
(DOE-D, WEC-D, C-03)
2. EPA's proposal for retrieval of wastes is unnecessary. (C-26, IV-D-40)
3. It is not meaningful to require development of a removal plan when there is no intent to
remove the waste, and until a reason for removal is established, a meaningful plan cannot be
established; the rule should be reworded so that a discussion of the feasibility of waste removal is
achieved instead of a plan. (DOE-D)
Response to Issues 18.A and 18.B:
Upon consideration of these comments, EPA agrees that development of a removal plan is
unnecessary, and has deleted this requirement in the final rule. The EPA believes that any plan
will be based on the specific circumstances necessitating removal, and the technology available
at the time. However, §194.14(f) provides that "[disposal systems shall be selected so that
removal of most of the wastes is not precluded for a reasonable period of time after disposal."
The preamble accompanying the adoption of the disposal regulations explained "that future
generations should have options to correct any mistakes that this generation might
unintentionally make [50 FR 38082]." To implement the disposal regulations, the final rule
requires that the compliance application include documentation which demonstrates that removal
of waste from the disposal system is feasible for a reasonable period of time after disposal. The
final rule also requires that DOE submit in its compliance application an evaluation of the
technical feasibility of mining the sealed disposal system, given current technology levels at the
time the compliance application is prepared.
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Issue C: Guidance for waste removal is requested.
1. Removal criteria are mentioned but are not specified. (A-68)
Response to Comment 18.C.I:
The EPA declines to dictate in the compliance criteria what represents a reasonable period of
time after disposal. The EPA believes that judgment may properly be made in the compliance
certification based on the compliance application and public input. Further, as noted above, EPA
believes that it would be difficult and may be impossible to develop a meaningful removal plan
without knowing the reasons or conditions for undertaking removal of the waste. For the same
reason, EPA believes that specifying removal criteria would be inappropriate, and none have
been included in the final rule.
2. Criteria should require the DOE to provide more specificity to the standard's "reasonable
period" for removability of waste. The longer the waste is accessible, the better the chance of
taking advantage of advances in technology. (NMAG-B, IV-D-06)
3. The EPA should specify time frame for removal. (NMAG-G)
Response to Comments 18.C.2 and 18.C.3:
The disposal regulations at 40 CFR part 191, §191.14(f), require that "[disposal systems should
be selected so that removal of most of the wastes is not precluded for a reasonable period of time
after disposal." The preamble accompanying the adoption of the disposal regulations explained
"that future generations should have options to correct any mistakes that this generation might
unintentionally make [50 FR 38082]." The final rule requires that DOE document the
technological feasibility of mining the sealed disposal system, given current technology levels at
the time the compliance application is prepared. Such an evaluation is expected to help provide
the basis for an informed judgment about what period of time is reasonable.
Issue D: Waste removal plan must be consistent with DOE's obligations under its
agreement with New Mexico. (NMAG-B)
Response to Issue 18.D:
As explained above, the requirement for DOE to develop a plan has been revised in the final rule.
The EPA's responsibility in this rulemaking is to implement 40 CFR part 191, subparts B and C,
not to implement of enforce the independent agreement between the State and DOE. In any
event, the EPA's review of the agreement in question indicates it applies to operational activities
of the repository, and is not affected by the removal requirements of § 194.46 of the final rule.
Subpart A of 40 CFR part 191 is concerned with operation of the WPP facility; Subpart A
guidance will be issued by the Agency at a later date if deemed necessary.
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Issue E: The EPA should ask for separate retrieval plans for pre-and post-closure time
periods to cover the problem of entering the disposal facility after all access has been back-
filled. (CCNS-B)
Response to Issue 18.E:
The Agency agrees that significantly different conditions would exist for removal of waste from
the repository after closure compared to retrieval during operation of the facility. For example,
removal of waste after closure could be complicated by backfill material placed in shafts during
repository closure. The EPA's disposal regulations and compliance criteria do separately address
the issues of pre- and post-closure retrieval of waste. Pre-closure retrieval is covered under
§ 194.04(b)(l), which requires that waste be retrieved (to the extent practicable) if certification is
revoked. Removal of waste after closure of the repository is addressed by the requirements of
§ 194.46. The EPA does not believe that it is appropriate to require plans for implementing
removal in either situation, since it is difficult to predict what conditions would necessitate
removal of the waste. Neither the WPP LWA nor the disposal regulations of 40 CFR part 191
require submission of a plan. For further discussion of this issue, see response to Issue 18.A and
Section 2 of this document.
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Section 19: INDIVIDUAL AND GROUND WATER PROTECTION: SECTION 194.51
through SECTION 194.55
Issue A: The rule needs to address reasonable expectation criteria with regard to
individual protection and ground water protection. (DOE-D)
Response to Issue 19.A:
Sections 191.15 and 191.24 of the disposal regulations require that the disposal system be
designed to provide a "reasonable expectation" that the undisturbed performance of the system
will not cause an exceedance of the annual committed effective dose in any individual or an
exceedence of radioactivity in any underground source of drinking water (USDW) above
applicable regulatory levels. The Agency applied the term "reasonable expectation" to the
Individual and Ground Water Protection Requirements in acknowledgment of the analytical
uncertainties which stem from conducting compliance assessments over a 10,000-year regulatory
period. The term "reasonable expectation" denotes EPA's recognition that "unequivocal
numerical proof of compliance is neither necessary nor likely to be obtained [58 FR 66412]."
Compliance with the Individual and Ground Water Protection Requirements is demonstrated
through the use of compliance assessments. Similar to performance assessments, which are used
to demonstrate compliance with the Containment Requirements, a compliance assessment
examines the performance of the disposal system over the 10,000-year regulatory period. Unlike
performance assessments, however, the compliance assessment only examines the undisturbed
performance of the disposal system. Nevertheless, a compliance assessment projects disposal
system performance over a long period of time (10,000 years) giving rise to a number of
uncertainties. Due to the uncertainties, projections cannot be shown to be unequivocally correct.
As a result, EPA requires that a "reasonable expectation" of compliance be demonstrated. The
final rule applies the concept of "reasonable expectation" to compliance assessments by
establishing statistical requirements on the results of compliance assessments to ensure that
uncertainties in compliance assessments are treated systematically and thoroughly.
Section 194.55 specifies that the number of estimates of doses to individuals and of radionuclide
concentrations in ground water shall be large enough that the maximum estimates of doses and
concentrations exceed the 99th percentile of the population of estimates with at least at 0.95
probability. The final rule does not require that the 99th percentile CCDF be calculated; rather
the DOE must determine only the probability with which the 99th percentile will be exceeded,
based on the statistical property of the complete group of CCDFs generated. This requirement is
essential to provide assurance that the full range of possible results of the compliance assessment
will be represented. The mean estimate provides a measure of compliance that expresses the
average impacts of the disposal system on individuals and ground water as well as the
probabilities of uncertain disposal system parameter values; the median estimate provides a
measure of compliance that expresses the central tendency of a population of estimates. Insofar
as both statistics provide useful information, the final rule requires that both the mean and the
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median of the range of estimated radiation doses and the range of estimated radionuclide
concentrations must meet the requirements of the disposal regulations (§191.15 and 40 CFR
part 191, subpart C, respectively) with at least a 95 percent level of statistical confidence.
Consistent with the requirements in the disposal regulations regarding "reasonable expectation, "
the final rule does not require that compliance be demonstrated with a 100% level of statistical
confidence. However, the EPA believes it is essential to provide for an objective measure of the
confidence in compliance. The exact number of calculations required to establish 95 percent
confidence will vary depending on the margin with the mean and median demonstrate
compliance with the requirements of the disposal regulations. Thus, the statistical requirements
described above represent EPA's interpretation of "reasonable expectation of compliance," and
are fully within the Agency's authority in implementing the disposal regulations. See also the
response to Issue 19.G of this document.
Issue B: No mention is made of whether or not criteria identified in qualitative
requirements set forth in Sections 21 through 27 of the regulation need to be met for
individual and ground water protection. (SNL-C)
Response to Issue 19.B:
The General Requirements of the final rule (§194.21 through §194.27) must be met by all
portions of and all activities associated with compliance applications; this includes compliance
assessments related to the individual and ground water requirements. For example, it is
important that the experimental data used to support predictions of disposal system performance
be adequately quality assured, regardless of whether such data are used in performance
assessments or in compliance assessments. Section 194.22 provides quality assurance
requirements to ensure that this occurs. Application of the General Requirements to compliance
assessments is clarified in the preamble to the final rule.
Issue C: Some references to Subpart C of 40 CFR part 191 are not relevant. (SNL-C,
DOE-D)
Response to Issue 19.C:
To demonstrate compliance with 40 CFR part 191, Subpart C, Environmental Standards for
Ground Water Protection, a compliance assessment must show that the undisturbed performance
of the disposal system over the 10,000-year regulatory period will not result in releases of
radionuclides to an underground source of drinking water (USDW) in the accessible environment
above allowable regulatory limits. These limits, specified in 40 CFR Part 141, are the maximum
permissible levels of a contaminant in an USDW. Proposed Sections 194.51 and 194.52,
Consideration of the protected individual and Consideration of exposure pathways, respectively,
were relevant to the individual protection requirements and were not intended to be applied to the
ground water protection requirements, for the reasons discussed below. It is not necessary to
know the location of the person who might ultimately consume water obtained from a USDW in
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order to demonstrate compliance under the ground-water protection limits. Similarly, the
exposure pathways from the disposal system to an individual and the amount of water consumed
by that individual also are not applicable to demonstrating compliance with the ground-water
protection requirements. Rather, the concentration of radionuclides found in the USDW itself is
the determining factor of compliance, as specified in Subpart C of the disposal regulations.
Section 194.53 of the final rule, Consideration of underground sources of drinking water, applies
to the ground water protection standards; that section addresses relevant consideration of
USDWs and the contaminant migration pathways from the disposal system to the USDWs. The
final rule has been revised from proposal to clarify applicability of §§194.51-191.53.
Issue D: Sections 194.51 and 194.52 would require the individual to reside at two different
locations to satisfy calculational assumptions. The individual should thus be assumed to
reside outside the controlled area. (SNL-C)
Issue E: Section 194.51 would require significantly different assumptions about the
protected individual depending on whether the exposure pathway being considered is
drinking water or other pathways. (SNL-C)
Response to Issues 19.D and 19.E:
In the preamble to the disposal regulations which established limits on radiation doses to
individuals, EPA explained that "[gjround water withdrawn for consumption directly from within
the controlled area need not be included in the analyses because geologic media within the
controlled area are an integral part of the disposal system's capability to provide long-term
isolation [58 FR 66403]." In the December 1993 Response to Comments For Amendments to
40 CFR part 191, EPA further stated that ". . . if an individual intrudes into the controlled area to
obtain water for drinking or other purposes, such exposures are not to be considered in the
context of the individual or ground-water protection requirements [EPA 402-R-93-072,
pp. 2-10]." Consistent with these statements, §191.15 and §191.24 of the disposal regulations
specify that the exposed individual and affected USDW are located in the accessible
environment. The accessible environment is defined in §191.12(k) as that area ". . .beyond the
controlled area." Similarly, both §194.51 and §194.52 of the final rule require that the exposed
individual be assumed to reside in the accessible environment only.
Compliance assessments should separately estimate doses to the exposed individual pursuant to
§191.15, and doses and radionuclide concentrations pursuant to subpart C of 40 CFR part 191.
For the purposes of these different analyses, the protected individual is treated separately for each
set of requirements; therefore, different assumptions may be applied (and different locations
assumed) for the individual requirements compared to the ground water requirements. These
differences in conducting compliance assessments are necessary and reasonable because different
measures of compliance are specified in the disposal regulations for individual requirements (at
§191.15) and ground water requirements (subpart C of 40 CFR part 191). While the protected
individual for the purposes of the groundwater protection requirements must be using water from
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an underground source of drinking water, and is therefore assumed to be located at a USDW, the
protected individual under §191.15 could be located anywhere in the accessible environment,
whether or not there is a USDW at that location. See response to Issue 19.C for further
discussion of this issue.
The language in §194.52 of the proposed compliance criteria could have been interpreted to
mean that different locations should be assumed in calculating the total radiation dose to an
individual from all exposure pathways (pursuant to § 191.15). The final rule has been revised to
clarify that, for the purpose of analyzing doses to individuals, compliance assessments should
separately analyze the doses received by individuals from each pathway. However, compliance
assessments should assume that the protected individual resides at the single geographic point
where the maximum dose would be received, calculated by the sum of all pathways.
Issue F: 40 CFR part 194 evidences no standards for protection of non-human animals,
plants, nor soil. This should be remedied. (IV-D-06)
Response to Issue 19.F:
The EPA's responsibility in this rulemaking is to implement the disposal regulations of
Subparts B and C at 40 CFR part 191 for the WIPP. The disposal regulations are binding for the
disposal of transuranic waste at the WIPP. The disposal regulations clearly establish that the
releases of regulatory concern at a disposal facility such as the WIPP are 1) radionuclide releases
to the accessible environment, 2) radiation doses to humans from all exposure pathways, and
3) radiation exposure and radionuclide concentrations in underground sources of drinking water.
The disposal regulations do not contemplate separate standards for protection of non-human
animals, plants, or soil; protection of these elements is afforded through the release limits of the
disposal regulations, which limit radionuclide releases to the accessible environment (which is
defined to include all areas outside the controlled area of the WIPP). In this rulemaking, EPA is
developing criteria to implement the disposal regulations specifically at the WPP; and therefore,
revisions which are outside the purview of 40 CFR part 191 are outside the scope of this
rulemaking.
Issue G: There is no definition needed for unlikely natural event.
1. No definition of "unlikely natural event" is needed. (SNL-C)
2. There is no definition needed for "unlikely natural event;" "undisturbed performance" should
be classified to exclude human activities. (DOE-D)
3. It is recommended that additional clarification on the delineation between the categories of
"likely" and "unlikely" events. The clarification should not make it more difficult to submit or
review an application through the introduction of uncertainty or ambiguity; move the focus of the
review away from the issue of how the repository performs under a range of likely perturbations;
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or arbitrarily remove from consideration of events, processes, or combinations of processes and
events with a similar probability of occurrence as those required for the analysis of the "disturbed
performance" of the repository. (NRC)
4. EPA may wish to provide guidance, without applying a strict numerical limit, on the processes
and events that are to be considered for evaluations of the "undisturbed performance" of the
repository. (NRC)
5. It is appropriate that EPA define "unlikely natural events" and develop a list of probabilities
for qualifying events specific for the WIPP. (SGNM-D)
Response to Comments 19.G.I through 19.G.5:
Unlike the containment requirements, the individual and groundwater protection requirements do
not apply to cumulative releases nor do they contain probabilistic requirements, such as the
requirement that certain releases be less than 1 in 1,000 likely to be exceeded (191.13). Instead,
the individual and groundwater requirements apply to the doses received during one individual's
lifetime, versus 10,000 years for the containment requirements. Further, the expected value of
the dose received — the mean value — must be less than the applicable dose limit, for example, 15
mrem in the case of the individual protection requirements. There is no regulatory significance
to the probability with which the dose limit will be exceeded, and hence these requirements
cannot be treated analogously to the probabilistic containment requirements. Therefore,
providing a numerical cut-off for probability, such as the 1 in 10,000 threshold test applicable to
performance assessments, would not be applicable. However, some screening of processes and
events was contemplated in 40 CFR Part 191, which in the definition of "undisturbed
performance" in 40 CFR Part 191 state that compliance assessments may exclude from
consideration any unlikely natural processes and events.
Several differences emerge upon examination of the performance assessments needed for the
containment requirements and the compliance assessments needed for the individual and
groundwater protection requirements. For example, the individual protection requirements apply
only to the accumulation of dose over an individual's lifetime versus 10,000 years in the
containment requirements. Second, as just explicated, the individual and groundwater protection
requirements are not probabilistic, unlike the containment requirements. Third, whereas the
focus of the individual and groundwater protection requirements is on the contribution of natural
processes and events to doses to individuals, the containment requirements focus on the
contribution such processes and events make toward releases of radionuclides to the accessible
environment. In view of these considerations, the Agency recognized that the significantly
different form of the containment requirements versus the individual and groundwater protection
requirements necessitated a different treatment of the screening of processes and events.
In compliance assessments, therefore, the Agency requires that a qualitative judgment be made
regarding the likelihood with which groundwater and individual exposure pathways will be
affected, over the time scale of an individual's lifetime (not 10,000 years as in the containment
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requirements) by the occurrence of different natural events. Although the universe of processes
and events considered in the performance assessments (for the containment requirements) will
closely resemble that of compliance assessments, the different regulatory requirements attending
each analysis, as noted above, might allow for subtle differences regarding whether the
individual events should be included in the analysis. As with performance assessments, the final
rule at 194.54(a) requires compliance applications to document why any processes and events or
sequences of processes and events that may occur over the regulatory time frame were not
included in compliance applications.
In the preamble to the proposed rule, EPA solicited comment on whether or not there is a need
for clarification of what constitutes an "unlikely" natural event within the context of undisturbed
performance. Only one comment suggested that additional clarification be provided. The
comment stressed, however, that such clarification should not: (1) cause or introduce additional
uncertainty or ambiguity, (2) change the focus away from how the disposal system is likely to
perform, or (3) arbitrarily remove from consideration processes and events having a similar
probability as those required in evaluating disturbed performance. Instead of defining
"unlikely," EPA has chosen in the final rule to require that DOE document, in any compliance
application, why any processes, event, or sequence of processes and events which may occur
over the regulatory time frame is not included in compliance assessments. The Agency believes
its review of DOE's compliance application during the public certification rulemaking will
ensure that the full range of possible events which could occur during the regulatory time frame
have been analyzed to determine their impact on compliance with the individual and ground
water requirements.
6. The definition of undisturbed performance should be clarified as follows: "undisturbed
performance means the predicted behavior of a disposal system, including characterization of the
uncertainties in predicted behavior, if the disposal system is not disturbed by human intrusion,
human activities, or the occurrence of unlikely natural events." (SNL-C)
Response to Comment 19.G.6:
Undisturbed performance is defined in §191.12(p) as "the predicted behavior of a disposal
system . . . if the disposal system is not disrupted by human intrusion . . . [§191.12(p)]." In the
context of 40 CFR part 191, the term "human intrusion" is meant to include all those activities
caused by humans which may have an effect on the disposal system performance. The proposed
rule used the broader term, "human-initiated processes and events" to describe this same concept
with respect to the WIPP. "Human-initiated processes and events" were subdivided into "human
intrusion" and "human activity." In response to public comments, and to minimize confusion,
EPA in the final rule replaced the terms "human intrusion" and "human activity" with "deep
drilling" and "shallow drilling," respectively. "Deep drilling" includes those drilling events that
reach or exceed a depth of 2,150 feet below the surface relative to where such drilling occurred.
"Shallow drilling" includes those drilling events that may affect the disposal system, but do not
reach a depth of 2,150 feet below the surface relative to where the drilling occurs. Section
194.33, named Consideration of Human-initiated processes and events in the proposal, has be re-
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named Consideration of drilling events in performance assessments in the final rule, consistent
with the use of this term in 40 CFR part 191 and in the definition of undisturbed performance. In
the final compliance criteria, "human intrusion" includes both deep drilling and shallow drilling,
as well as mining. Since all these activities are included under "human intrusion, and since all
are events which may occur inside the boundaries of the controlled area, they fall under the
category of disturbed performance. The change in terminology for human intrusion clarifies that
potential future drilling and mining, as well as ancillary activities (such as borehole sealing),
need not be considered in undisturbed performance scenarios. See Section 12 of this document
for further discussion.
The Agency recognizes that resource extraction and fluid injection activities which are currently
performed in the Delaware Basin can alter the hydrogeologic properties of the initial state of the
disposal system (i.e., at the start of the 10,000-year regulatory time frame). The final rule
requires that performance assessments and compliance assessments must include the effects of
all types of fluid injection (including solution mining) and all boreholes which can have an effect
on the disposal system and which have been or will have been drilled prior to or soon after
disposal, based on existing plans and leases for drilling. Those boreholes shall be assumed to
affect the properties of the disposal system for the entire 10,000-year time frame. The final rule
requires, in paragraph 194.54(b), that performance assessments must analyze the effects on the
disposal system of existing boreholes in the vicinity of the disposal system, with attention to the
pathways they provide for migration of radionuclides from the site; and of any activities that
occur in the vicinity of the disposal system prior to or soon after disposal.
Issue H: To what "member" (most exposed or average) does 40 CFR part 191 limit doses?
(IV-D-06)
Response to Issue 19.H:
The disposal regulations at § 191.15 limit doses to "any member of the public in the accessible
environment." Thus, the limits apply to the most exposed individual, rather than an individual
subject to average exposure. The final rule has clarified that compliance assessments that
analyze compliance with §191.15 shall assume that an individual resides at the single geographic
point on the surface of the accessible environment where that individual would be expected to
receive the highest dose from radionuclide releases from the disposal system (see §194.51).
Compliance assessments should separately analyze the doses received by individuals from each
pathway, and then assume that the individual resides at that single point on the surface where the
maximum dose would be received, calculated by the sum of all pathways.
Issue I: Should specify that maximally exposed individual resides on the surface. The term
"exposure" should not be used to make the rule clearer. (NMAB-B, NMAG-G)
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Response to Issue 19.1:
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The final rule specifies that the exposed individual should be assumed to reside on the surface;
also, the term "exposure" has been replaced in the final rule with the term "dose." The final rule
has clarified that compliance assessments that analyze compliance with §191.15 shall assume
that an individual resides at the single geographic point on the surface of the accessible
environment where that individual would be expected to receive the highest dose from
radionuclide releases from the disposal system (see §194.51). Compliance assessments should
separately analyze the doses received by individuals from each pathway, and then assume that the
individual resides at that single point on the surface where the maximum dose would be received,
calculated by the sum of all pathways.
Issue J: EPA should revise the proposed approach to compliance certification to be
consistent with the International Commission on Radiation Protection (ICRP) approach, or
to clarify the basis for this inconsistency in the Supplementary Information supporting
issuance of the final rule. (IV-D-76)
Issue K: EPA should ensure that the individual protection standards should be sufficiently
strict.
1. The rule should be made so that incidences of cancer and the incidences of brain damage and
breast cancer are minimized to a much greater extent. (S-23)
2. The EPA should stand by what has been set forth as standards of testing, standards of safety,
and protection for future generations in Southern New Mexico. (S-09)
Issue L: EPA must take into account another rate, the rate of lowering exposure standards
over the last 50 years. (S-17)
Issue M: It is not well understood how much radiation actually harms people, and the
numbers are rather arbitrary. (S-09)
Response to Issues 19.J through 19.M:
The EPA's responsibility in this rulemaking is to implement the disposal regulations of
Subparts B and C at 40 CFR part 191 for the WIPP. The disposal regulations are binding for the
disposal of transuranic waste at the WIPP. The disposal regulations clearly establish that the
releases of regulatory concern at a disposal facility such as the WIPP are 1) radionuclide releases
to the accessible environment, 2) radiation doses to humans from all exposure pathways, and
3) radiation exposure and radionuclide concentrations in underground sources of drinking water.
The disposal regulations established specific standards for each of these areas based on radiation
dose-response effects consistent with the widely held views of national and international
scientists. There is no evidence that 40 CFR part 191 standards are unsound or inappropriate.
Specific methods are required to be used for calculating annual committed effective doses to
exposed individuals, according to Appendix B of the disposal regulations. These methods were
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established consistent with the International Commission on Radiation Protection (ICRP)
Publication 60 guidelines available at the time that the disposal regulations were developed.
Appendix B of 40 CFR part 191 is an integral part of that standard, and underwent proposal and
public notice and comment when the disposal regulations were promulgated. Nowhere does
40 CFR part 191 contemplate using a different methodology. In this rulemaking, EPA is
developing criteria to implement the disposal regulations specifically at the WIPP; and therefore,
revisions which are outside the purview of 40 CFR part 191 are outside the scope of this
rulemaking.
Issue N: EPA should take into account the potential for worker exposure and the As Low
As Reasonably Achievable provisions established by DOE Order 5480.11 for DOE's
Government Owned Contractor Operated facilities. (IV-D-11)
Response to Issue 19.N:
The EPA is also concerned about limiting worker radiation exposures. Several comments have
suggested that required waste characterization under the proposed rule would subject workers to
unnecessarily high radiation exposures. The EPA believes that the waste characterization
requirements of the final rule balance flexibility with prescription to assure that waste
characterization is rigorous and reliable for those waste parameters important to containment of
waste in the disposal system. The Agency shares the concern for occupational exposure to the
workers who are involved in characterizing the waste, but believes it is also inappropriate to
jeopardize future generations from potential releases to the accessible environment because this
generation failed to study and characterize the waste that could significantly impact the total
performance of the repository.
As to the ALARA principle, DOE is responsible for implementing radiation protection measures
with its work force, and is explicitly obligated through its Orders to address ALARA; this is not
an EPA regulatory function. The EPA has tried to afford sufficient flexibility to DOE to carry on
an effective ALARA program for its workers while also addressing the important issue of
protection of the public and the environment through demonstration of compliance with EPA
disposal regulations. For further discussion of this issue, see response to Issue 6.L of this
document.
Issue O: The rule should consider the entire cycle of transuranic wastes.
1. Consideration should be given to health risks for the complete cycle for transuranic wastes
and decisions regarding performance assessment in nuclear waste disposal in a repository be
evaluated in light of environmental risk of maintaining the current status quo. (IV-D-40)
2. The consideration of Underground Sources of Drinking Water should be system-wide in
scope. It should include the current storage of transuranic wastes at existing facilities, and that
the consideration be given to the detriment to ground water at existing facilities be included as
part of the WIPP compliance determination. (IV-D-40)
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Response to Issue 19.O:
Under the 1992 WIPP LWA, Congress directed EPA to implement the disposal regulations of
Subparts B and C at 40 CFR part 191 for the WIPP, not to examine the comparative risks of
nuclear waste management policies. The disposal regulations are binding for the disposal of
transuranic waste at the WIPP. Subparts B and C of 40 CFR part 191 address requirements for
disposal of transuranic waste, and for releases and exposures which may occur from waste during
the 10,000-year regulatory time frame after disposal. The requirements of the final criteria
involve activities during the operational phase (i.e, while waste is being emplaced, and before the
disposal system is sealed) only insofar as information on activities or performance are necessary
to support compliance applications relative to the disposal regulations. In this rulemaking, EPA
is developing criteria to implement the disposal regulations specifically at the WIPP; and
therefore, revisions which are outside the purview of 40 CFR part 191 are outside the scope of
this rulemaking. The DOE is required by a number of environmental statutes to manage
currently stored transuranic waste in a manner which is protective of human health and the
environment. See also the response to Comment 6.F.13.
Issue P: The EPA should address, and resolve if necessary, the potential inconsistency
between the water consumption rates established in the compliance criteria and those
recommended in the EPA draft guidance on public exposures. (NRC)
Response to Issue 19.P:
Section 194.52 states that it shall be assumed that individuals consume 2 liters per day of
drinking water from any underground source of drinking water in the accessible environment. As
stated in the preamble to the proposed rule, this approach was selected to be consistent with the
Safe Drinking Water Act requirements. The draft guidance to which the comment refers is
discussed in a December 23, 1994, Federal Register Notice [59 FR 66414]. In this notice, EPA
proposed recommendations for the development of new guidance concerning radiation protection
from all sources to the general public. The EPA noted that any new guidance developed in
response to the December 23, 1994 notice would not supersede any statutory responsibilities of
Federal agencies. Rather, the Agency's intent in proposing to develop the guidance would be to
provide a common framework for the consistent and protective management of radiation
exposure in the United States. The guidance examines the combined radiation exposure to an
individual from all sources, while the individual protection requirements in the final compliance
criteria examine the radiation exposure to an individual from one source, in this case WPP. The
Agency emphasizes again that, in this rulemaking, EPA is developing criteria to implement the
disposal regulations specifically at the WIPP; and therefore, revisions which are outside the
purview of 40 CFR part 191 are outside the scope of this rulemaking.
Issue Q: It is suggested that EPA establish clear guidance that addresses the consideration
of the protected individual. It is also suggested that this guidance be consistent with the
framework established under 40 CFR 194.25. (NRC)
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Response to Issue 19.0:
The final rule considers protection of individuals by implementing the individual protection
requirements of the disposal regulations. The final rule clarifies that compliance assessments
should analyze the doses received by individuals from each pathway. Compliance assessments
should then assume that the protected individual resides at the single geographic point on the
surface where the maximum doses would be received, calculated by the sum of all pathways.
Regarding §194.25 of the final rule, future state assumptions, the preamble to the final rule
clarifies that the general requirements of the compliance criteria (i.e., §§194.21-27) must be met
by all portions of and all activities associated with compliance applications, including
compliance assessments. Therefore, assumptions about the future state of society, as used in
compliance assessments, must be established in accordance with the requirements of § 194.25.
See also the responses to Issues 19.B, 19.D, 19.E, 19.H, and 19.1.
Issue R: The implementation strategy in 194.52 should not simply parallel that for §194.34
because the latter implementation strategy is not totally applicable to 194.51,194.52, or
194.53. (SNL-C)
Response to Issue 19.R:
Compliance with the Individual and Ground Water Protection Requirements is demonstrated
through the use of compliance assessments. Similar to performance assessments, which are used
to demonstrate compliance with the Containment Requirements, a compliance assessment
examines the predicted performance of the disposal system over the 10,000-year regulatory time
period. In this sense, compliance assessments and performance assessments are similar and
therefore would necessitate a similar overall methodology. Unlike performance assessments,
however, the compliance assessment examines only the undisturbed performance of the disposal
system. In addition, the results of the computational techniques used for compliance assessments
as opposed to performance assessments are dissimilar. Performance assessment analyses are
used to generate complementary cumulative distribution functions, while computational
techniques for compliance assessments are used to generate a range of (1) estimated radiation
doses and (2) estimated radionuclide concentrations. As a result, the methodology at this point
diverges. This is reflected in §194.54 and §194.55 of the final rule. Section 194.54 limits the
scope of compliance assessments to undisturbed scenarios; only existing boreholes and other
activities which occur before disposal must accounted for in compliance assessments (since such
current human activities constitute part of the baseline site characterization). Section 194.55 of
the final rule establishes statistical measures to ensure that the results of compliance assessments
demonstrate a reasonable expectation of compliance with the limits established in the disposal
regulations. The EPA believes it is necessary and reasonable to establish such statistical
requirements. See also the responses to Issue 19. A and Issue 19.G of this document.
Issue S: The impermeability of the site and exposure pathways warrant further study.
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1. The Criteria don't address the problem of permeable layers at the salt layer. (A-06)
2. The extent of the salt deposits needs to be studied further. (A-47)
3. It was originally believed that the WIPP site was dry and the salt formations were
impermeable, which was later demonstrated not to be the case. Numerous pathways no exist for
the movement of radioactive materials. Where are the materials traveling to? (S-37)
Response to Issue 19.S:
40 CFR part 191 requires that performance assessments and compliance assessments be
conducted to show that there is a reasonable expectation of compliance with the disposal
regulations and, therefore, that human health and the environment will be protected over the
regulatory time frame. 40 CFR part 194 provides criteria which apply specifically to the WIPP's
compliance with these standards. The criteria include requirements for the consideration of all
applicable and relevant information. For example, in conducting the performance and
compliance assessments, information regarding the site and its surrounding environmental media
must be taken into account. This would include information concerning the permeability of the
salt and anhydrite layers of the Salado Formation as well as any pathways (existing and
potential) from the disposal system to the accessible environment.
Issue T: In reference to consideration of protected individual, guidance regarding the
assumptions that should or should not be made is appropriate for Part 191 and should be
handled accordingly. (WEC-D)
Response to Issue 19.T:
The final rule provides criteria for certifying and determining whether the WIPP complies with
the disposal regulations set forth in 40 CFR part 191. The criteria provide further information,
clarification, and explanation of how compliance with the disposal regulations may be measured
or determined. Given the complexity of performance and compliance assessment analyses and
the length of the regulatory time period over which compliance must be projected, EPA believes
that it is appropriate to specify certain assumptions in the criteria; providing criteria regarding
assumptions ensures that such assumptions are transparent, and are applied consistently
throughout analyses. For example, the final rule at §194.51 states that it should be assumed that
the protected individual is residing at the single geographic point on the surface of the accessible
environment where that individual would be expected to receive the highest dose from
radionuclide releases from the disposal system. Were this assumption provided as non-binding
guidance, the analysis could be conducted using other locations inconsistent with the intent of the
40 CFR part 191 disposal regulations. It is entirely within EPA's authority to specify such
assumptions as part of implementing the disposal regulations specifically at the WIPP.
Issue U: "Likely" should be clarified to mean "reasonable expectation;" not over 50%
probability. (NMAG-G)
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Response to Issue 19.U:
The ground water requirements of subpart C of 40 CFR part 191 apply to doses received from
and concentrations of radionuclides in "underground sources of drinking water" (USDWs) only.
These requirements apply only to USDWs that are located outside of the controlled area. The
proposed implementing criteria provided that the DOE analyze those USDWs outside the
controlled area that are "likely to be affected by the disposal system over the regulatory time
frame [60 FR 5790]." The term "likely" was used to confine the analysis to those USDWs which
could be reached by pathways from the disposal system within 10,000 years. A "likely" USDW
would therefore not include USDWs whose location is sufficiently remote from the WPP or to
which no known pathway for travel of ground water exists. The EPA has clarified in the final
rule that compliance assessments for the ground-water protection requirements shall consider all
USDWs in the accessible environment that are "expected" to be affected by the disposal system
over the regulatory time frame.
Unlike the containment requirements, the individual and groundwater protection requirements do
not apply to cumulative releases nor do they contain probabilistic requirements, such as the
requirement that certain releases be less than 1 in 1,000 likely to be exceeded (191.13). Instead,
the individual and groundwater requirements apply to the doses received during one individual's
lifetime, versus 10,000 years for the containment requirements. Further, the expected value of
the dose received — the mean value — must be less than the applicable dose limit, for example, 15
mrem in the case of the individual protection requirements. There is no regulatory significance
to the probability with which the dose limit will be exceeded, and hence these requirements
cannot be treated analogously to the probabilistic containment requirements. Therefore,
providing a numerical cut-off for probability, such as the 1 in 10,000 threshold test applicable to
performance assessments, would not be applicable. However, some screening of processes and
events was contemplated in 40 CFR Part 191, which in the definition of "undisturbed
performance" in 40 CFR Part 191 state that compliance assessments may exclude from
consideration any unlikely natural processes and events.
Several differences emerge upon examination of the performance assessments needed for the
containment requirements and the compliance assessments needed for the individual and
groundwater protection requirements. For example, the individual protection requirements apply
only to the accumulation of dose over an individual's lifetime versus 10,000 years in the
containment requirements. Second, as just explicated, the individual and groundwater protection
requirements are not probabilistic, unlike the containment requirements. Third, whereas the
focus of the individual and groundwater protection requirements is on the contribution of natural
processes and events to doses to individuals, the containment requirements focus on the
contribution such processes and events make toward releases of radionuclides to the accessible
environment. In view of these considerations, the Agency recognized that the significantly
different form of the containment requirements versus the individual and groundwater protection
requirements necessitated a different treatment of the screening of processes and events.
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In compliance assessments, therefore, the Agency requires that a qualitative judgment be made
regarding the likelihood with which groundwater and individual exposure pathways will be
affected, over the time scale of an individual's lifetime (not 10,000 years as in the containment
requirements) by the occurrence of different natural events. Although the universe of processes
and events considered in the performance assessments (for the containment requirements) will
closely resemble that of compliance assessments, the different regulatory requirements attending
each analysis, as noted above, might allow for subtle differences regarding whether the individual
events should be included in the analysis. As with performance assessments, the final rule at
194.54(a) requires compliance applications to document why any processes and events or
sequences of processes and events that may occur over the regulatory time frame were not
included in compliance applications.
The final rule also requires that in determining whether underground sources of drinking water
(USDWs) are expected to be affected by the disposal system, underground interconnections
among bodies of surface water and USDWs must be considered. In reviewing the DOE's
compliance application, EPA will, with public input, ensure that these requirements are
adequately fulfilled.
Issue V: If no releases are expected to the accessible environment, no further work should
be required.
1. The proposed regulation would require compliance with 40 CFR part 191, Subpart C by
determining whether the Maximum Contaminant Levels (MCLs) for radionuclides in ground
water are exceeded. This process should be reversed. (DOE-D, SNL-C)
2. There is no justification for requiring characterization of ground waters and analyses of
commingling and interconnection between aquifers unless releases are expected. (SNL-C)
3. If releases of radionuclides to ground water outside the controlled area are not expected to
occur, no further work should be required. (DOE-D)
Response to Issue 19.V:
Compliance with the Ground Water Protection Requirements is demonstrated through the use of
a compliance assessment, which examines the undisturbed performance of the disposal system
over the 10,000-year regulatory time frame. If it has been determined through the compliance
assessment that a release might occur, then all USDWs that are located in the accessible
environment and are expected to be affected by the disposal system must be examined. Upon
identification of such USDWs, the radionuclide concentration in those USDWs should be
calculated to determine if the MCL has been exceeded. If no releases are expected to occur over
the regulatory time frame, then the number of USDWs expected to be affected by such release
would obviously be negligible, but any such assertions must be rigorously supported.
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The disposal regulations, which are being implemented specifically for the WPP by this
rulemaking, require specifically that compliance with the groundwater protection requirements
be demonstrated relative to maximum contaminant levels (MCLs) established at 40 CFR
part 141. The EPA believes that compliance could not be demonstrated without an examination
of how predicted releases to groundwater relate to such MCLs.
Issue W: The geological and hydrological aspects of the WIPP need to be more thoroughly
examined.
1. The Pecos River must be monitored at various places downstream, and the salt lagunas must
be checked for radionuclides. (C-03)
2. Two boreholes into the Castile are insufficient to adequately characterize the brine in the
Castile. (S-10)
3. The Dewey Bed water flow and the Rustler aquifer have not been fully characterized. (S-10)
4. Before any consideration of the site is put forward, a complete review of all past geological
evaluations needs to be made. (IV-D-95)
5. Not enough is really known about the hydrology and the geology of the site to safeguard
valuable water resources nearby. (A-38, A-48, A-54, A-58, S-27)
6. No waste should not be put in place until it is known how much water flows through the site
and where the recharge and discharge is. (C-03)
7. Geohydrology at WIPP has not been studied comprehensively. (CARD-A, A-07, A-28, A-58)
8. There are significant geological problems at WPP: 1) Pressurized brine; 2) Brine in the salt
rock; 3) Rock fractures; 4) Karst; 5) Pressurized gases; and 6) Climate changes. (IV-D-29)
9. The basic hydrogeology of the area needs to be completely studied, not only in a computer
model. (CARD-B, S-12)
10. The geological makeup of the WIPP site makes it unlikely that the DOE can ensure
containment. (S-40)
11. WIPP is very dangerous with the water and other geologic factors. (S-38)
Response to Issue 7.W:
40 CFR part 191 requires that performance assessments and compliance assessments be
conducted to show that there is a reasonable expectation of compliance with the disposal
regulations. The rule provides criteria which apply specifically to the WIPP's compliance with
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these standards. The criteria contain requirements for the consideration of all applicable and
relevant information, including that of the site and its surrounding environmental media. For
example, DOE must provide a description of the geology, geophysics, hydrogeology, hydrology,
and geochemistry of the disposal system and show these conditions are expected to change and
interact over the regulatory time frame.
In submitting its application for certification of compliance, therefore, DOE is required to
provide this information (see §194.14). Compliance assessments must consider all USDWs
which are expected to be affected by the disposal system. The final rule clarifies that in
determining whether underground sources of drinking water are expected to affected by the
disposal system, compliance assessments must consider underground interconnections among
bodies of surface water, ground water, and underground sources of drinking water.
Compliance assessments must demonstrate a reasonable expectation that concentrations of
radionuclides in ground water will not exceed specified limits over the regulatory time frame
after disposal. In addition, the requirements of § 194.25 state that DOE should consider and
document the effects of potential future hydrologic, geologic and climatic conditions over the
regulatory time frame. The EPA believes that these requirements are reasonable and adequate to
ensure that ground water in the vicinity of the WIPP is protected.
Issue X: EPA should conduct an independent evaluation.
1. A full and thorough new survey should be made by the EPA totally independent of DOE for
geological evaluations. (TV-D-95)
2. As well as relying on basic statistics that are gathered independent of DOE, EPA should
develop its own model for ground water flow and transport. EPA should adopt NRC's
exemplary policy of relying on the fastest water flow time in determining compliance. (CARD-B)
Response to Issue 19.X:
The DOE must submit a compliance application containing any and all necessary evaluations,
studies, and modeling to demonstrate compliance with the applicable environmental regulations.
The EPA is responsible for: (1) developing the criteria for implementing the radioactive disposal
regulations at the WIPP, (2) determining whether the WIPP complies with those regulations, and
(3) enforcing DOE's continued compliance with those regulations, if initial certification is
granted. In its regulatory oversight role, EPA will thoroughly evaluate the information presented
by DOE in a public certification rulemaking and has authority to require or obtain additional
information if warranted.
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Issue Y: Water protection regulation should extend to a 10,000-year period of regulation
and beyond. (IV-D-97)
Response to Issue 19.Y:
The EPA's responsibility in this rulemaking is to implement the binding disposal regulations of
Subparts B and C at 40 CFR part 191 for the WIPP. The regulatory time frame of 10,000 years
after disposal was established in Subparts B and C of 40 CFR part 191. The provisions of the
disposal regulations and of the final rule require that compliance assessments predict affects of
the disposal system on ground water over the entire 10,000-year regulatory time frame. The
EPA believes that a disposal system which demonstrates compliance over a 10,000-year time
frame will likely contain waste effectively for a longer time period. However, it is outside the
scope of this rulemaking to extend the regulatory time frame. In this rulemaking, EPA is
developing criteria to implement the disposal regulations specifically at the WIPP; and therefore,
revisions which are outside the purview of 40 CFR part 191 are outside the scope of this
rulemaking.
Issue Z: These requirements must include water use or irrigation and grazing
downstream. (C-03)
Response to Issue 19.Z:
The EPA believes that the final rule ensures that all relevant exposure pathways will be
considered. The final rule requires that compliance assessments consider doses to individuals
from all exposure pathways. In addition, compliance assessments must demonstrate that
projected radionuclide concentrations in groundwater, due to releases from the disposal system,
will not exceed specified levels during the regulatory time frame.
Issue AA: Gas build-up may force out brine slurries resulting in liquid radioactive
contamination of the waterways and channels. (S-3)
Response to Issue 19.AA:
Compliance with the Ground Water Protection Requirements is demonstrated through the use of
a compliance assessment, which examines the undisturbed performance of the disposal system
over the 10,000-year regulatory period. Section 194.54 requires an evaluation of the effects of
potential processes, events or sequences of processes and events that may occur over the
regulatory time period. This would include the consequences of gas buildup should that
occurrence be identified as a potential process, event or sequence of processes and events
expected to occur during the regulatory time frame.
Issue BB: The phrase "sequence of processes and events" must be replaced with
"processes and events" throughout Subsections 194.54(a) through 194.54(c) and the
Supplemental Information. (DOE-D, SNL-C)
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Issue CC: Defining combinations (not sequences) of processes and events in §194.55
Results of compliance assessments, is not applicable to the definition of undisturbed
conditions. (SNL-C)
Response to Issues 19.BB and 19.CC:
Compliance with the Individual and Ground Water Protection Requirements is demonstrated
through the use of a compliance assessment, which examines the undisturbed performance of the
disposal system over the 10,000-year regulatory period. In conducting a compliance assessment,
processes and events are identified and evaluated to estimate the potential consequences. In a
10,000-year time period, a number of processes and events could occur in any given area. Such
processes and events can be organized into sequences (more commonly referred to as scenarios)
to determine the cumulative effect of their occurrence. The decision as to whether the processes
and events should be organized as a sequence is dependent upon the type of processes and events
which are being considered. The term "combination of processes" have been removed from the
final rule.
Issue DP: Clarification of §194.55 is necessary.
1. Neither 194.55(b) nor 194.55(d) address compliance appropriately. (SNL-A, SNL-C)
2. §194.55 is not clearly related to certification of compliance with 40 CFR part 191. (DOE-D,
SNL-C)
3. Paragraph 194.55(b) should be amended to reflect a percentile with a .90 probability.
(DOE-D, SNL-C)
4. It is recommended that EPA delete 40 CFR 194.55 from the compliance criteria. It is also
recommended that EPA provide guidance to the applicant on the level of detail in the compliance
assessment results that EPA believes is appropriate to allow judgments to be made on
compliance with the individual and ground water protection requirements of Part 191. (NRC)
Response to Issue 19.DP:
Section 194.55 places specific requirements on the analysis necessary to show compliance with
two specific parts of the disposal regulations, the individual protection requirements and the
ground water protection requirements. As mandated by the WIPP Land Withdrawal Act, the task
of rulemaking for 40 CFR part 194 is to establish the criteria which must be met in order to show
that the WIPP is in compliance with these disposal regulations. Accordingly, the section in
question, entitled "results of compliance assessments," is necessary to establish the various
procedures to be followed by DOE in analyzing doses to individuals and contamination of
ground water. The Agency has included therein specific criteria on the treatment of uncertainty
in values for parameters and the treatment of these parameters in computational (computer)
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techniques. A criterion was also included which established the procedure for comparing the
results of the analyses to the numerical requirements of 40 CFR part 191 as described below.
In 40 CFR part 194, the criteria for WIPP's compliance, the Agency has specified that the mean
and median "estimate" - the computed dose to individuals through all pathways, and dose from
the concentrations present in ground water — must be in compliance with the numerical limits of
40 CFR part 191 with a 95 percent level of confidence. The appropriate limits are found in
§ 191.15, for individual protection all pathways, and 40 CFR part 191 Subpart C for ground water
requirements. Statistical confidence levels are a measure of the "trueness" or "falseness" of a
calculated number. Should be the mean estimate be found to be in compliance with a high level
of confidence, such as 95 percent, then the result of the calculations was likely to be a "true"
prediction of the dose and concentrations, based on the present conceptual understanding of the
WIPP's performance. For further discussion of the statistical requirements placed on the results
of compliance assessments, see response to Issue 19.A and Issue 19.G.
Issue EE: The "population of estimates" definition should read: Population of estimates
means all possible estimates that can be generated from sampling disposal system
parameter values an infinite number of times, conditioned on specific probability
distribution functions. (NMAG-D)
Response to Issue 19.EE:
The comment correctly notes that the population of estimates refers to a theoretical, infinite
number of estimates, as stated in similar terms in the definition in the final rule. While the
definition in the final rule does not require that estimates be conditioned on specific probability
distribution functions, §194.55 of the final rule does, in fact, contain this requirement.
Specifically, §194.55 requires that computational techniques used in compliance assessments
draw random samples from across the entire range of values of each probability distribution.
Therefore, the definition of "population of estimates" in the final rule (at §194.2), taken together
with the requirements of § 194.55, have the same effect as would adopting the definition
suggested in the comment.
Issue FF: Compliance assessments should consider the effects of natural and human-
initiated processes and events for 100,000 years after closure, in order to provide additional
confidence in the results of CCDFs. (SRIC-G)
Response to Issue 19.FF:
The EPA's responsibility in this rulemaking is to implement the binding disposal regulations of
Subparts B and C at 40 CFR part 191 for the WIPP. The regulatory time frame of 10,000 years
after disposal was established in Subparts B and C of 40 CFR part 191 and was the product of
extensive policy and technical analysis, as well as rigorous pubic and judicial review. The
provisions of the disposal regulations and of the final rule require that compliance assessments
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predict affects of the disposal system on ground water over the entire 10,000-year regulatory time
frame. The EPA believes that a disposal system which demonstrates compliance over a 10,000-
year time frame will likely contain waste effectively for a longer time period. However, it is
outside the scope of this rulemaking to extend the regulatory time frame and, in any event,
commenters have offered no specific or compelling basis to re-examine the central, underlying
standards. Similarly, the disposal regulations specify that compliance with the individual and
ground-water protection requirements must be demonstrated based on undisturbed performance
of the disposal system over the regulatory time frame, specifically excluding examination of
human intrusion in compliance assessments. In this rulemaking, EPA is developing criteria to
implement the disposal regulations specifically at the WIPP; and therefore, revisions which are
outside the purview of 40 CFR part 191 are outside the scope of this rulemaking. In order to
ensure that a reasonable expectation of compliance is demonstrated, the final rule establishes
statistical requirements on the results of compliance assessments (see §194.55).
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Section 20: PUBLIC PARTICIPATION: SECTIONS 194.61 through 194.67
Issue A: There should be more public participation in the regulatory process.
1. Compliance criteria should be amended to include public involvement at critical junctures
including in EPA's consideration of DOE's Draft Compliance Certification Application, any
determination by the Administrator which questions the continued emplacement of waste at
WIPP, on EPA's plans to modify, suspend or revoke WIPP's certification, and on inspection
reports. (SGNM-B, SGNM-C, CCNS-A, CCNS-B)
2. There is not enough public participation in the regulatory process. (S-50)
3. The EPA should provide every opportunity for feedback and comment on the assumptions and
rationale EPA adopts in its decision making process. (CCNS-B)
4. The public needs to be considered in all aspects of rulemaking (such as inspections, access to
models, communications, determinations of completeness, evaluations of compliance with any
conditions, etc.). The rule, as written, is grossly deficient in this process. (NMAG-G)
5. It is important to include public comment on the notice of proposed rulemaking. (NMAG-B)
6. The public should be invited to comment on whether DOE's application is sufficient to show
compliance after it has been determined to be complete. A public hearing where proponents of
the application testify should be held both before the Agency prepares its proposed decision and
after the proposed decision is published. (NMAG-B, NMAG-G)
7. Additional public hearings should be held after an application is deemed complete. Such
hearings should allow unrestricted time for qualified experts to testify. (SRIC-G)
Response to Issue 20.A:
Section 8 of the WIPP LWA calls for EPA's certification by the rulemaking procedures at 5
U.S.C. § 553 and within one year of application receipt. The WIPP LWA also provides that
periodic re-certification under section 8(f) of the Act may not be subject to judicial review and
calls for EPA's determination whether the WPP continues to be in compliance within 6 months
of receiving documentation from DOE. The EPA is committed to providing ample opportunity
for public participation in the certification and re-certification process, consistent with the WPP
LWA. The final compliance criteria bind EPA to specific public participation procedures.
Subpart D of the compliance criteria binds the Agency to provide opportunities for public input —
written comments and public hearings — at critical junctures in the certification rulemaking
process, including when an application is received and when EPA proposes its certification
decision. Any modification or revocation of a certification will also be done by rulemaking (see
§ 194.4), including Federal Register notices and opportunities for public comment. Subpart D of
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the final rule has been revised to clarify the procedures to modify or revoke a certification; see
§§194.65-194.66. In instances where actions are not subject to rulemaking, such as for re-
certification or for some inter-Agency communications, EPA is committed to ensuring public
access to information by promptly placing information in public dockets, as described in § 194.67
of the final rule.
The Agency values public participation and input and intends to place inspection reports or other
relevant information in the docket for public examination. At the same time, EPA will be
performing many activities in implementing the compliance criteria. Neither the WIPP LWA nor
40 CFR part 191 require EPA to specify in the WIPP compliance criteria that inspection reports
be made publicly available. The EPA thinks it more appropriate to address this and other similar
implementation issues in policy statements and in how the Agency elects to exercise its
discretion in implementing the compliance criteria, considering the circumstances that arise
during the implementation phase. It is not possible or reasonable to codify in the rule all
commitments and procedures for information exchange among EPA, DOE and the public. For
further discussion of inspection reports, see the response to Issue 3.C of this document.
In the discussion below, EPA addresses the comments about specific issues. Further discussion
of pre-application procedures, the process for completeness determination, and procedures for
modification is provided in Sections 1 and 2 of this document.
Issue B: More opportunities for public comment are requested.
1. Actual hearings in New Mexico are desired, not merely the opportunity for them. (IV-D-06)
2. New Mexico does not have any power to determine its own future. (A-36)
3. After the Notice of Proposed Rulemaking, criteria are needed for the public hearing to be held
in New Mexico. In addition, a public comment period should be made available after the Notice
of Proposed Rulemaking. (NMAG-D)
Response to Comments 20.B.I through 20.B.3:
The EPA is committed to providing ample opportunity for interested parties to participate in the
certification process. The EPA has held hearings in New Mexico numerous times in the past,
including December 1992 (explaining EPA's oversight role at the WIPP); February 1993
(hearings on proposed waste disposal regulations, 40 CFR part 191); March 1995 (hearings on
proposed WIPP compliance criteria, 40 CFR part 194). Hearings were held in multiple locations
across the State, in Carlsbad, Albuquerque, and Santa Fe.
Section 8(d) of the WIPP LWA calls for EPA to certify whether the WIPP facility complies with
the disposal regulations by rule pursuant to 5 U.S.C. § 553. Section 553 of Title 5, United States
Code, authorizes but does not require EPA to provide "opportunity for oral presentation." The
final compliance criteria, in §194.61, provide that EPA will hold a public hearing on an Advance
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Notice of Proposed Rulemaking (ANPR), if a written request is received by EPA within 30 days
of ANPR publication. The EPA would hold any such public hearing in New Mexico. The final
rule, in §194.62, has been revised to state that a public notice will "announce public hearings in
New Mexico" on the Administrator's proposed decision regarding compliance certification.
Thus, the Agency is firmly committed to holding hearings in New Mexico on the Notice of
Proposed Rulemaking (NPR). The final rule also provides a public comment period of at least
120 days following publication of the NPR regarding certification.
4. After EPA has published regulations outlining the substance of a performance assessment,
DOE should be required to submit a report that is exposed to public comment. (NMAG-F)
Response to Comment 20.B.4:
The EPA's requirements for compliance applications are clearly outlined in the final WIPP
compliance criteria (40 CFR part 194), which have been developed with substantial opportunity
for public input. Compliance applications must describe and justify the scope of performance
assessments, including exclusion of scenarios (see §194.32 and §194.33); and must document
and substantiate all models and codes used to support any compliance application (see §194.23).
In addition, compliance applications must display the full range of complementary cumulative
distribution functions (CCDFs) generated, and must demonstrate that the results fulfill specific
statistical requirements related to the containment requirements (see §194.34). The EPA will
place any draft performance assessments received from DOE in the public certification
rulemaking docket. The Agency will provide substantial opportunity for public comment once
EPA has received a final compliance application. There are numerous opportunities for public
input at critical junctures in the certification decision-making process. These measures will
provide ample opportunity for public review and comment on the performance assessment and
other aspects of the compliance application.
5. A number of inadequacies exist in current DOE plans for assisting state, tribal, and local
governments in meeting their respective responsibilities related to the WIPP. (IV-D-97)
Response to Comment 20.B.5:
The WIPP LWA requires DOE to provide specific coordination with State and Tribal
governments, related, for example, to transportation of waste. These provisions of the WIPP
LWA directly apply to DOE. By contrast, EPA's authority in this rulemaking is to establish
criteria for determining whether the WPP facility complies with EPA's general radioactive waste
disposal regulations. The disposal regulations deliberately do not address transportation and such
issues are outside the purview of this rulemaking. The EPA is committed to providing public
access to information pertaining to this rulemaking, the certification rulemaking and re-
certification decisions and will continue to place relevant information received by the Agency in
public dockets for inspection [see §194.67 of the final rule].
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Issue C: Certain organizations need to be explicitly included in the public participation
process.
1. The rule should include provisions for including NAS, EEG, State and public. (NMAG-C,
NMAG-G)
2. The EPA should establish a procedure that recognizes the additional participation that some
parties can have. (SRIC-E)
3. The State, NAS and EEG should have free and timely access to data relating to health, safety,
or environmental issues at WIPP and be able to verify the results of computer simulations. DOE
and all other parties to the rulemaking should mail a copy of all communications filed with the
Administrator in connection with certification to all other parties to the rulemaking. (NMAG-D)
4. Interested persons or organizations should be granted "party status" and thus gain access to all
communications between EPA and DOE. (SPJC-G)
5. Subpart D must contain several additional subsections covering such issues as "party status"
to the certification rulemaking, pre-application procedures, processes for completeness
determination, and procedures for modification or change. (SRIC-E)
Response to Comments 20.C.I through 20.C.5:
Section 17 of the WIPP LWA contain provisions requiring DOE to provide certain information
to the State of New Mexico, the New Mexico Environmental Evaluation Group (EEG), and in
some instances the National Academy of Sciences. Sections 17 and 20 of the WPP LWA also
address responsibilities that DOE has to consult and cooperate with EEG and the State of New
Mexico. These are responsibilities independent of EPA's compliance criteria that directly apply
to DOE under the WIPP LWA.
In this rulemaking, implementing criteria for determining whether the WPP facility complies
with the disposal regulations, EPA has maintained and established specific docketing procedures
to ensure all members of the public have access to relevant information. Thus, the EPA will
facilitate public access to information by promptly placing copies of relevant information
received by the Agency into public dockets in New Mexico and Washington, D.C., as established
in §194.67 of the final rule. Subpart D of the compliance criteria binds the Agency to certain
procedures to provide ample opportunity for public input — written comments and public
hearings — at critical junctures in the certification rulemaking process, including when an
application is received and when EPA proposes its certification decision. Any modification or
revocation must also be done by public rulemaking. The EPA considers input from all
commenters at the public forums, and declines to establish in this rulemaking special status for
particular parties. See also Section 5 of this document.
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6. Tribal officials need to be included in the regulatory process. (A-23)
Response to Comment 20.C.6:
Several tribal organizations are included on EPA's WPP mailing list and receive EPA
publications as they are produced. The EPA also maintains a toll-free WIPP hotline to
disseminate information to the public. The EPA is exploring ways that it can work with Tribal
organizations to pass on information of EPA's WIPP oversight to their constituencies. As noted
in the response to Comment 20.C.I, the final compliance criteria bind EPA to provide advance
notice of its certification rulemaking, to maintain dockets in New Mexico and Washington, B.C.,
and to provide ample opportunity for written and oral comments to facilitate public input. The
Agency will consider input from all commenters at the public forums (i.e., public hearings and
written public comments) provided for in Subpart D of the final compliance criteria. Also see
response to Issue 20.A.
Issue D: Public education has never been done in Spanish. (A-28)
Response to Issue 20.D:
The EPA has made concerted efforts to provide WIPP information in Spanish. Several Hispanic
organizations are included on the WIPP mailing list and receive documents in Spanish as they are
produced. Spanish translators are also available at many public meetings and all public hearings
in New Mexico. Numerous documents and fact sheets are available in Spanish, including EPA
and the WIPP, EPA's Role Under the Land Withdrawal Act, Proposed and Final Amendments to
40 CFRpart 191. A brochure explaining EPA's WIPP public participation program will soon be
published in Spanish and English. The EPA also produced and made available a Spanish
translation of the proposed compliance criteria (40 CFR part 194) for public comment.
The toll-free WPP Information hotline offers a recorded message about current EPA WPP
activities in both Spanish and English; information cards advertising the telephone line are also
printed in Spanish. Newspaper announcements for public meetings and hearings are published in
Spanish newspapers.
The EPA will continue these efforts and is also exploring new ways that it can work with
Hispanic community-based organizations to pass on WPP information to their constituencies.
Issue E: Hearings should be modeled after 40 CFR Part 124 subpart F.
1. The hearing for the final approval/disapproval should be modeled after 40 CFR Part 124
subpart F. (CCNS-A)
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2. The inclusion of a nonadversary hearing process both before the completeness determination
and before the notice of final rule is recommended. In addition, EPA should include an
interactive hearing process for its final approval or disapproval of WIPP. (CCNS-A, CCNS-B)
3. The Agency must develop procedures for public hearings. (NMAG-F)
Response to Issue 20.E:
Section 8(d) of the WIPP LWA calls for EPA to certify whether the WIPP facility complies with
the disposal regulations using the informal rulemaking procedures set out at 5 U.S.C. § 553. The
40 CFR part 124, subpart F contains formal hearing procedures that apply to permitting actions
under other environmental statutes that EPA administers. The formal hearing procedures provide
an opportunity for cross-examination, briefing, and appeal to EPA's Environmental Appeals
Board. These procedures fulfill different purposes recognizing various areas of expertise within
the agency.
The EPA declines to adopt the formal hearing procedures for entirely different practical and legal
circumstances. Instead, EPA has exercised its discretion, consistent with 5 U.S.C. § 553, to hold
informal public hearings during its WPP certification rulemaking. Subpart D of the final
compliance criteria allows for public comment and hearing upon receipt of an application for
certification of compliance, and again after EPA announces its proposed decision on certification
of the WPP. In addition, EPA will ensure that the application for certification of compliance is
made available for public inspection and comment. These procedures will allow ample
opportunity for interested parties to raise substantive issues pertinent to the application review
and certification decision, and to have these concerns addressed by EPA. As with the prior
informal public hearings EPA held, for example, in conjunction with the compliance certification
rulemaking, EPA will provide advance notice of the public hearings and allow interested persons
to present oral views to a panel of EPA officials.
Issue F: The public needs an opportunity to comment on the completeness of the
application.
1. The public needs an opportunity to comment on the completeness of DOE's final application
for approval. (NMAG-B, NMAG-C, S-37)
2. Compliance criteria should specify an opportunity for public comment on the completeness of
DOE's application before EPA goes on to evaluate its content. (S-27)
3. The EPA should provide for a public comment period on application completeness.
(SGNM-A, CARD-B, SRIC-C, CCNS-A, CCNS-B, S-09, S-37, IV-D-12, IV-D-56)
4. The section on completeness and accuracy of compliance applications must be totally revised
to allow for public comment on the completeness issue. (NMAG-C)
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5. The EPA should refrain from including a formal completeness review process in the
certification criteria. Adoption of any additional public hearings not mentioned in the Land
Withdrawal Act would likely keep the Agency from meeting that deadline with little, if any,
offsetting benefit relative to the final approval, or disapproval, of the application. (SNL-D)
6. The rule needs to establish provisions in the event that application is not complete or the case
where additional information is requested. These provisions should include additional public
hearings and advance notices. (NMAG-D)
7. Should the occasion arise for the Agency to consider seeking further information, the public
should have an opportunity to comment on the scope and form of the request. (NMAG-D)
8. The determination of whether an application is complete must be subject to public comment
and public hearings. (SRIC-G)
Response to Issue 20. F:
The concept of "completeness" is an administrative tool EPA is utilizing to screen a final
compliance application received from DOE that because of incompleteness does not even
warrant further EPA and public scrutiny. If EPA determines a final compliance application
"complete," then the compliance application will be subject to public notice-and-comment
rulemaking procedures pursuant to 5 U.S.C. § 553 and as elaborated in the final compliance
criteria. The determination of completeness will be made by the Administrator, who will then
inform DOE in writing of any such decision, pursuant to §194.11 of the compliance criteria. Any
such written notification to DOE would also be placed in the dockets, described under §194.67 of
the final rule, for public examination.
Upon receipt of a final compliance application from DOE and before a determination of
completeness is made, EPA will publish in the Federal Register an Advance Notice of Proposed
Rulemaking announcing receipt of the application. A copy of the application will be made
available for inspection in the Agency docket, written public comments will be accepted, and a
hearing will be held if requested. This comment period will allow interested parties to comment
on all aspects of the application, including any aspects that commenters believe are incomplete or
inadequate.
Issue G: The public needs to be involved in other aspects of the rulemaking.
1. The public should be informed of all activities between EPA and DOE concerning
modifications, suspensions, changes in conditions, or activities pertaining to the disposal system
that depart from the application. (CCNS-A)
2. It is contrary to the WIPP LWA for EPA to conduct procedures affecting the validity of terms
of certification in any forum other than an open public rulemaking. Any proposal by DOE to
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obtain EPA's consent to changes in the terms of certification must be announced to the public;
EPA and others must have ample time to obtain information (see §194.C-1) and comment; and
EPA must respond to the comments. In particular, to allow DOE to make changes in operations
so long as it gives at least 30 days notice is unacceptable. (NMAG-G)
Response to Comments 20.G.I and 20.G.2:
The terms of certification, if it is granted, are established at the time of initial certification, based
on the compliance application submitted at that time. The terms of certification at the WPP can
be changed only through modification or revocation rulemakings. Re-certification is aperiodic
review, but is not a process to be used to change a certification in effect. If review of information
submitted for re-certification, or review of other information, indicates that information,
activities or conditions depart significantly from those upon which certification has been based, it
may be necessary to modify the terms or conditions of certification. Any such modification
would be conducted by rulemaking (including published notices in the Federal Register and
opportunity for public comment), as described in §194.65 and §194.66, to allow for the same
level of public scrutiny as the initial certification received. The results of such a modification
rulemaking re-opening the initial certification would also be subject to judicial review. The
definitions of modification, suspension, and revocation in the final rule clarify that these actions
apply to the certification, if any, in effect at the WPP, and are thus subject to the public
participation provisions of the final rule. Further, as provided in the final rule, EPA will docket
all relevant information received from DOE. If any member of the public believes that a change
in condition or activity at the WPP facility has occurred that warrants modification, suspension
or revocation of the underlying certification, then they may petition EPA for action pursuant to
5 U.S.C. § 553(e).
3. EPA should address public's role in development of guidance. (EEG-A, EEG-B, SGNM-A)
Response to Comment 20.G.3:
The EPA understands that the public has an interest in the development of compliance
application guidance (CAG). The CAG is intended to summarize and interpret the final
compliance criteria to provide non-binding guidance regarding the contents of a complete
compliance application and is expected to be issued some time after the compliance criteria. The
CAG will not undergo formal rulemaking procedures since it is non-binding guidance and not a
regulation. However, in recognition of public interest, EPA published a notice of availability
(among other steps) for the draft guidance in the fall of 1995 [60 FR 53921-53922, October 18,
1995]. At that point, a copy of the draft CAG was made available for inspection in EPA's WIPP
dockets, and public comments were accepted for 60 days. These comments are being considered
in revising the guidance. The Agency believes it is inappropriate to codify such procedures in the
rulemaking establishing the binding compliance criteria.
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4. The EPA must insist that DOE include enough technical background in its application that the
public can reproduce and confirm DOE calculations. Compliance criteria should clearly state
levels of uncertainty in a way that the public can understand. (CCNS-B)
Response to Comment 20.G.4:
The EPA has endeavored to make compliance certification for the WIPP as objective and
straightforward as possible. The EPA will require that DOE include sufficient technical
background in its application so that EPA can interpret the information and determine whether
compliance has been demonstrated. However, given the long-term nature of performance
assessments (PA) and their associated uncertainties, compliance certification is necessarily
technical and complex.
The Agency has worked to increase its own and public confidence in the results of performance
and compliance assessments by requiring that data and analytical methods used by DOE undergo
rigorous quality assurance and peer review (§194.22, §194.23, §194.26, §194.27). In addition,
compliance applications received by EPA will be made available promptly (upon receipt by the
Agency) for inspection in the WIPP dockets, to allow as much time as possible for interested
parties to analyze the document with the means available to them (§194.61, §194.64). Finally,
EPA and DOE have held several technical exchanges to discuss some of the complex issues
related to PAs; all these meetings have been announced on the WIPP hotline and open to the
public to allow opportunities for public education and discussion of technical issues.
Thus, while the PA and compliance assessment calculations are very complex, EPA has and will
continue to provide opportunities for public access and education on these topics.
5. Another hearing is requested so that the public has the opportunity to point out the omitted
issues with 40 CFR part 194. (S-l 1)
Response to Comment 20.G.5:
Two series of public hearing have been held since 1992 in Carlsbad, Santa Fe, and Albuquerque,
New Mexico. The hearings held in March 1995 provided an opportunity for the public to
comment on the proposed compliance criteria. In addition, EPA provided multiple opportunities
for interested parties to submit written comments on the proposal. An initial 90-day comment
period opened on January 30, 1995, when the proposal was published in the Federal Register.
In response to a written request to re-open the public comment period for at least 30 days, the
comment period was re-opened for 45 days (from August 1 to September 15, 1995) to allow
additional time and opportunity for public comments. The EPA believes that the opportunities
for public comment have been adequate, especially in view of the statutory deadlines for
promulgating the final rule and lawsuits filed to compel the agency to expeditiously finalize the
criteria. See also discussion in Section 1 (General Comments and Issues) of this document.
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6. EPA should include public hearings and comment on the retrieval plan. (NMAG-B, CCNS-A)
Response to Comment 20.G.6:
The final compliance criteria, under §194.4, revise the requirement for a retrieval plan as part of
compliance applications. The criteria require retrieval, to the extent practicable, if certification
of the facility is revoked. Any revocation decision would be made pursuant to rulemaking,
including public notices and opportunity for comment on proposed actions. In addition, the
criteria, at §194.46, require the compliance application to include documentation demonstrating
that removal of waste from the disposal system is feasible for a reasonable period of time after
disposal, including an analysis of the technological feasibility of mining the sealed disposal
system, given technology levels at the time a compliance application is prepared. This
documentation will be subject to public scrutiny during the compliance certification rulemaking
proceeding. See also Section 1 and Section 18 (Removal of waste) of this document.
7. A comment period of longer than 90 days on the proposed criteria is necessary so that the
public can examine how the draft application affects the Compliance Criteria. (SRIC-C)
8. The EPA should have provided a longer time for comment when the public comment period
was re-opened, as the Agency pledged to do in April 1995. (SRIC-G)
Response to Comments 20.G.7 and 20.G.8:
In total, EPA provided 135 days of formal public comment period. An initial comment period
was in effect from January 31 to May 1, 1995. The comment period on the proposed compliance
criteria was re-opened for 45 days (August 1 to September 15, 1995) in response to public
comments. The comment period was re-opened after EPA received the second of two parts of a
draft application submitted by DOE to EPA. The re-opening provided an opportunity for the
public to comment on the proposed compliance criteria in light of DOE's draft compliance
certification application, which was placed in EPA's docket A-93-02 for public inspection. The
EPA also accepted and considered all public comments received by the Agency in the time
between the formal comment periods (i.e, from May 1 to July 31, 1995). The EPA has also
endeavored to fully consider all late comments.
The EPA was sued in two separate lawsuits for its failure to meet the WPP LWA October 30,
1994 statutory deadline for the final compliance criteria. See New Mexico v. EPA. No. 95-1273
(D.C. Cir. filed May 26, 1995) & Southwest Research and Information Center v. EPA. No. 95-
1285 (D.C. Cir. filed June 1, 1995) (The latter case was filed by the commenter above, who is
requesting longer time for public comment.) These two petitions asserted that EPA had
unreasonably delayed issuance of the final compliance criteria and requested the D.C. Circuit to
issue an order requiring EPA to promulgate the final criteria by December 31, 1995. The
petitions, and subsequent requests for rehearing, were rejected by two separate panels of the D.C.
Circuit. See New Mexico. No. 95-1273 (D.C. Cir. July 19, 1995) (Judges Silberman, Sentelle
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and Tatel) & Southwest Research and Information Center v. EPA. No. 95-1285 (B.C. Cir. Aug.
14, 1995) (Judges Wald, Ginsburg and Randolph). The court's orders reasoned that while EPA
had not issued the final compliance criteria by the statutory deadline, the agency's delay was not
so egregious to warrant a writ of mandamus, particularly in view of EPA's plans to reopen the
public comment period (see 60 Fed. Reg. 39,131, Aug. 1, 1995) and issue final compliance
criteria by February 1996. In light of the court orders, EPA has undertaken additional steps to
expedite the rulemaking and ensure that it issues the final compliance criteria by February 1996,
including closing the public comment period on September 15, 1995. See also the response to
Comment 20.G.5 and discussion in Section 1 of this document.
Issue H: With regard to continued compliance, there is no provision for public hearings,
notice of proposed decision, response to public comments, statement of fact finding,
conclusions, or rationale. (NMAG-B, NMAG-G)
1. In reference to continued compliance, criteria are needed for the public hearing to be held in
New Mexico. In addition, a public comment period should be made available after the public
hearing. (NMAG-D)
Response to Issue 20.H:
Section 8(f) of the WIPP LWA specifically exempts from rulemaking or judicial review the
Administrator's determination whether or not the WPP facility continues to be in compliance
with the disposal regulations. The WPP LWA also establishes a statutory review period of six
months for re-certifications. [See §194.4(a) of the final rule, and Section 2 of this document for
further discussion of the statutory review period.] The Agency is committed to allowing public
participation in the re-certification process, to the extent permitted by the constraints established
by the statute. To that end, the final rule [§194.64] specifies that EPA will docket all re-
certification documentation materials submitted to EPA by DOE; will publish public notices
upon receipt of such materials; will provide a public comment period and accept written public
comments regarding re-certification; and will publish a public notice announcing the
Administrator's decision (and rationale) on whether or not to re-certify the WIPP facility. The
EPA believes these provisions provide adequate opportunity, within the requirements of the
WIPP LWA, for public input on re-certification decisions.
Issue I: Dockets should be maintained in New Mexico in a timely fashion (§194.65).
(NMAG-F, NMAG-G)
Response to Issue 20.1:
The EPA makes every effort to keep the dockets current. The Agency recognizes the importance
of providing timely information, since the dockets are the source of many documents pertinent to
public participation in EPA's WIPP rulemakings and other activities. The final rule addresses
dockets in §194.67.
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Issue J: The public needs to be informed of all releases.
1. DOE must notify the public of all releases, even those which are considered to be within the
standard. (CCNS-B)
2. The public should be informed if DOE informs the administrator that a release has occurred or
is likely to occur. (EEC-A, CCNS-A)
3. When it comes to reporting releases, the people living around the site need to know if
something has escaped the facility. (S-16)
4. DOE should be obligated to report releases of waste from the disposal system to the
environment in excess of what is permitted under the disposal regulations. (NMAG-D)
Response to Issue 20.J:
In the final compliance criteria, DOE is required to notify EPA within 24 hours if the Department
determines that a release of waste to the accessible environment in excess of the release limits
(under 40 CFR part 191) has occurred or is expected to occur [§194.4(b)(3)(ii)-(iii)]. If EPA
determines that such a release is related to factors involving the long-term containment of waste,
then the Agency may take action to modify, suspend, or revoke a certification. The
Administrator may suspend a certification to mitigate an immediate hazard to the public. Any
action to modify or revoke certification will be done through formal rulemaking procedures (see
§194.4(b)(l)) including public notices in the Federal Register. The DOE must also submit
information on releases from the WPP below the release limits, if such releases indicate
conditions that depart from those that formed the basis of a certification of compliance (see
§ 194.4(b)(3)). The EPA will docket any information the Agency receives on releases of waste
from the WIPP so that such information will be available to the public. See §194.67 of the final
rule; see also Response to Comments 20.G.I and 20.G.2.
Issue K: Access to information is critical for the compliance determination; it is suggested
that EPA regulate access to the data by Agency staff so the compliance determination
process in not be impeded by disputes over access to data. (NMAG-B, NMAG-F)
Response to Issue 20.K:
The EPA agrees that information and data will be very important for the Agency to thoroughly
scrutinize the compliance application and make a sound decision regarding compliance for the
WIPP. The final compliance criteria establish detailed documentation requirements that DOE
must address in its compliance application. The EPA will accept public comment on DOE's
application and, before beginning an evaluation of compliance, must determine that the
application is complete and accurate (and so notify the Secretary — see § 194.11). The EPA may
request DOE to submit additional information in order to qualify an initial application as
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complete and accurate. Any requests for additional information will be by written
correspondence; both EPA's request and DOE's response will be docketed and available for
public review. Because the evaluation of compliance does not begin until after the application is
deemed complete, the criterion is a strong incentive for the Department to provide timely and
accurate information to EPA.
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APPENDIX A:
LIST OF COMMENTERS
Public Hearings on the proposed 40 CFR 194 were conducted in three New Mexico sites. The
dates of the proceedings were as follows: Carlsbad, March 21, 1995; Albuquerque, March 22,
1995; Sante Fe, March 23 and 24, 1995. The following is a list of those individuals who testified
including their place of residence, title and affiliation, if applicable. An asterisk (*) is used to
denote that the individual submitted written documentation to complement his/her oral
testimony.
Carlsbad Hearing
C-01 George Dials, Manager of Carlsbad Area Office, Department of Energy.
C-02 Gary Perkowski, Mayor of Carlsbad and President of the New Mexico Municipal
League.
C-03 Betty Richards.
C-04 Dick Manus, Manager of Carlsbad Resource Area, Bureau of Land Management.
C-05 * Carl Cox, General Manager, Westinghouse Electric Corporation.
C-06 Richard White, White City, New Mexico.
C-07 Robert Light, State Representative of New Mexico, Eddy County.
C-08 Charles Loftus.
C-09 * Jennifer Salisbury, Secretary, New Mexico Department of Energy, Minerals,
and Natural Resources.
C-10 Randy Foot, General Manager, Mississippi Potash.
C-ll Louis Whitlock.
C-12 Mark Donham, Executive Director, Carlsbad District Department of
Development.
C-13 Cliff Stroud.
C-14 John Heaton, WIPP Task Force.
C-15 Leigh Barnes, Manager, Day and Zimmerman.
C-16 George Shoup, WIPP Task Force.
C-17 Marvin Watts, Vice President, Carlsbad Department of Development.
C-18 Mike Currier, President, Garret Title.
C-19 Lucy Janez, President, Hispano Chamber of Commerce.
C-20 Jim Wilcox, Manager of Human Resources, IMC Global Operations.
C-21 Bill Pierce, President, Union of United Steel Workers, Carlsbad, New Mexico.
C-22 Gene Hornbach, Carlsbad Chamber of Commerce.
C-23 Fred Fernandez, Safety and Environmental Manager, Western Agricultural
Minerals Company.
C-24 * Mary Gale Wood, for Congressman Joe Skeen.
C-25 V.C. (Andy) Anderson.
C-26 Larry Coalson.
C-27 Norbert Rempe, Carlsbad, New Mexico.
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C-28 * Stanley Patchet.
C-29 Dale Janway, Manager of Safety and Security, Eddy Potash Incorporated.
C-30 Louis Methola, President, United Steel Workers' of America (read by Janway).
Albuquerque Hearing
A-01 Max Bartlett, New Mexico Progressive Alliance for Community Empowerment.
A-02 * Mike McFadden, Assistant Manager of Carlsbad Area Office, Department of
Energy.
A-03 Cameron Adair, Westinghouse Electric Corporation.
A-04 Tom Metcalf.
A-05 Richard Sauder.
A-06 Dave Mitchell, President, Valencia County Concerned Citizens Association.
A-07 Dorelen Bunting.
A-08 * Lila Bird, Water Information Network.
A-09 Floy Barrett.
A-10 * Caroline Epple.
A-l 1 * Sharla Bertram, Albuquerque, New Mexico.
A-12 * Harry Willson, Albuquerque, New Mexico.
A-13 * Kenneth Nemeth, Southern States Energy Board.
A-14 * Robert Neill, Environmental Evaluation Group.
A-15 Don Hancock, Southwest Research and Information Center.
A-16 Ronald Ross, Manager for Environmental Programs, Western Governors'
Association.
A-17 Susan Diane.
A-18 Jeffrey Rich.
A-19 Glenna Voitht.
A-20 Angela Wieback.
A-21 Sally Alice Thompson.
A-22 Joe Shunkamolah.
A-23 * Mervyn Tilden.
A-24 Jock Cobb, Professor Emeritus, Department of Preventive Medicine, University of
Colorado.
A-25 Bob Anderson.
A-26 Beverly Gensemer.
A-27 * Julie Ahern.
A-28 Lauro Silva.
A-29 Jeri Rhodes.
A-30 John Leahigh, Office of Social Justice of the Catholic Archdiocese of Santa Fe.
A-31 Leif Erikkson.
A-32 Lee Simms.
A-33 Sharon Williams, National Organization for Women at University of New
Mexico.
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A-34 Caren Seglinda Neuhauser.
A-35 Sue Chavez.
A-36 Judy Pratt, New Mexico Organizing Committee.
A-37 Diana Drake.
A-38 Dave Pace.
A-39 Penny Mainz.
A-40 Damacio Lopez, Progressive Alliance for Community Empowerment (PACE).
A-41 Susan Gorman, The Sierra Club.
A-42 LilyRendt.
A-43 Eva Khoury.
A-44 William Beams, Albuquerque, New Mexico.
A-45 * Ruth Weiner, Albuquerque, New Mexico.
A-46 Robin Seydel, Albuquerque, New Mexico.
A-47 Charles Powell.
A-48 Rick Packie.
A-49 Linda Sperling, Albuquerque, New Mexico.
A-50 Jerry Messick, Vice President, Albuquerque Chapter of 1199 New Mexico Health
Care and Hospital Workers.
A-51 Silvania D' Ouville.
A-52 Mark Rudd, Instructor, Albuquerque Technical Vocational Institute.
A-53 Jim Radford, Business People Concerned About WPP.
A-54 Karen Navarro.
A-55 Don Schrader.
A-56 * John Hart.
A-57 Alan Cooper.
A-5 8 Rich Weiner, New Mexico Chapter of the National Lawyers Guild.
A-59 Janet Greenwald, Citizens for Alternatives to Radioactive Dumping (CARD).
A-60 Garland Harris, All Peoples Coalition.
A-61 Robert Light, State Representative of New Mexico, Eddy County.
A-62 Lee Shepard, Project Manager for WIPP, SandiaNational Laboratory.
A-63 Karen Boneme, Albuquerque, New Mexico.
A-64 Jack Uhrick.
A-65 John Fishburn.
A-66 Carla Callan-Fishburn.
A-67 Paul Alan Haynes.
A-68 Dan Kerlinsky, President, New Mexico Physicians for Social Responsibility.
A-69 Andy Lenderman.
A-70 Frederick Williams, Albuquerque, New Mexico.
Sante Fe Hearing, Day 1
S-01 George Dials, Manager of the Carlsbad Area Office, Department of Energy.
S-02 Cameron Adair, Westinghouse Electric Corporation.
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S-03 * Rebecca Briggs, Sante Fe, New Mexico.
S-04 Robert Light, State Representative of New Mexico, Eddy County.
S-05 Jennifer Salisbury, Secretary, New Mexico Department of Energy, Minerals, and
Natural Resources.
S-06 Bonnie Bramble.
S-07 * Jeff Radford, Business People Concerned about WIPP.
S-08 Richard Dayo.
S-09 Jean McFarland.
S-10 Sandy Clarke.
S-ll Dominique Mazeaud.
S -12 Anna Katherine.
S-13 Loretta Johnston.
S-14 Anharo Lovato.
S-15 Ray Schmidt.
S-16 Susan Hirschberg.
S-17 Margaret Reisely, Los Alamos Study Group.
S-18 * Don Hancock, Southwest Research and Information Center.
S-19 Robert Neill, Environmental Evaluation Group.
S-20 Zack Richards, Sante Fe, New Mexico.
S-21 Deborah Reade, Sante Fe, New Mexico.
S-22 Tom Udall, Attorney General of New Mexico.
S-23 Suchi Soloman.
S-24 Daniel Zelinger.
S-25 Julianna Young, Sante Fe, New Mexico.
S-26 Laurie Richards.
S-27 Rhea Goodman.
S-28 Bill Gould.
S-29 Dan Gibson.
S-30 Sosha Pyle.
S-31 Angela Lyon.
S-32 Jim Trout.
S-33 Ron Lieberman.
S-34 Elizabeth Ruben.
S-35 Mr. Christophe.
S-36 Jean Crawford, Earth First.
S-37 * Bob Pinkus.
S-38 Bonnie Bonneau.
S-39 Janet Degan.
S-40 Penelope McMullen, Sister of Loretta.
S-41 Ditto Nowakoski.
S-42 Julia Coyne.
S-43 John Ussery, New Mexico Green Party.
S-44 Margret Carde, Research Analyst, Concerned Citizens for Nuclear Safety.
A-4
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S-45 Dave Mitchell.
S-46 Amy Bunting, Sante Fe, New Mexico.
S-47 Jeremy Boak, Sante Fe, New Mexico.
S-48 Medora Raborg, Sante Fe, New Mexico.
Santa Fe Hearing, Day 2
S-49 * Wendell Weart, Sandia National Laboratories.
S-50 Karen Balkany.
S-51 Jim Tollison, Albuquerque, New Mexico.
S-52 Deirdre Boak, Sante Fe, New Mexico.
S-53 John Otter.
S-54 Peter Cummings.
S-55 * Helen Cornell
S-56 Virginia Miller, Sante Fe, New Mexico.
S-57 Leonard Trimmer.
S-58 Maurice Weisberg, Sante Fe, New Mexico.
S-59 Elaine Govando, Sante Fe, New Mexico.
S-60 Bill Doyle, Sante Fe, New Mexico.
S-61 Emmy Koponen.
S-62 Tom Morgan.
S-63 Carol Adams.
S-64 Medora Raborg.
S-65 Kathy Sabo.
S-66 * Catherine Montano, Las Vegas, New Mexico.
Written comments on the proposed rule 40 CFR 194 were submitted to Docket Number A-92-56.
There were three series used to catergorize the comments at this docket. The following is a list
of commentors, state of residence (if known), and where appropriate, the organizations they
represent.
Series IV-D (Comments received by the Agency after Federal Register publication of proposal)
IV-D-05 Benjamin Radford, Corrales, New Mexico.
IV-D-06 John Otter, Sante Fe, New Mexico.
IV-D-07 Aanya Adler Friess, Albuquerque, New Mexico.
IV-D-08 Deirdre Boak, Sante Fe, New Mexico.
IV-D-09 Paul S. & Neva Reifsnyder, Bosque, New Mexico.
IV-D-10 Sandia National Laboratories, Albuquerque, New Mexico, signed by Les
Shephard, WIPP Project Management Department.
IV-D-11 Floyd R. Hertweck, Jr., Oxford, Ohio.
IV-D-12 Barbara Conroy, Sante Fe, New Mexico.
IV-D-13 Unable to read signature.
A-5
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IV-D-14 Susanne Thobe, Albuquerque, New Mexico.
IV-D-15 Tracie J. Sipple, El Prado, New Mexico.
IV-D-16 Kathryn Zijerinc, Sante Fe, New Mexico.
IV-D-17 Oris Gene Salazar, Albuquerque, New Mexico.
IV-D-18 Tammy Prothero, Corrales, New Mexico.
IV-D-19 Bryant Roberson.
IV-D-20 Annette Velasquez-Aguayo, Albuquerque, New Mexico.
IV-D-21 Robyn L. McCormick, Albuquerque, New Mexico.
IV-D-22 Sandy Bartston.
IV-D-23 Unable to read signature.
IV-D-24 Michael McRee, Albuquerque, New Mexico.
IV-D-25 Andra Stewart, Sante Fe, New Mexico.
IV-D-26 Gina Covinn, Vallecitos, New Mexico.
IV-D-27 Thora Guinn, Albuquerque, New Mexico.
IV-D-28 Concerned Citizens of Cerrillos, Cerrillos, New Mexico, signed by Ross
Lockridge, President and Dennis Overman, Vice President.
IV-D-29 Maurice A. Weisberg M.D., Sante Fe, New Mexico.
IV-D-30 Renee Fox.
IV-D-31 Maria Gourdin.
IV-D-32 Deborah J. Lujan, Taos, New Mexico.
IV-D-33 Donald Woodman, Belen, New Mexico.
IV-D-34 Judy Chicago, Belen, New Mexico.
IV-D-35 Don Kidd, New Mexico State Senator, District 34.
IV-D-36 Robert R. Richards, Albuquerque, New Mexico.
IV-D-37 Unable to read signature.
IV-D-38 Jane Hiltbrand, Albuquerque, New Mexico.
IV-D-39 Environmental Evaluation Group, Albuquerque, New Mexico, signed by Robert
H. Neill, Director.
IV-D-40 John B. Case, P.E., Albuquerque, New Mexico.
IV-D-41 Attorney General of New Mexico, Sante Fe, New Mexico, signed by Lindsay A.
Lovejoy, Jr., Assistant Attorney General.
IV-D-42 Mabuba Rasul, Albuquerque, New Mexico.
IV-D-43 Physicians for Social Responsibility, Colorado Chapter, Denver, Colorado, signed
by Samuel H. Cole, Executive Director.
IV-D-44 Susan Diane
IV-D-45 Marjorie Williams, Albuquerque, New Mexico.
IV-D-46 Charles A. Galbreath.
IV-D-47 Nancy B. Grover.
IV-D-48 Unable to read signature.
IV-D-49 Southwest Research and Information Center, Albuquerque, New Mexico, signed
by Don Hancock, Director of Nuclear Waste Safety Project.
IV-D-50 New Mexico Chapter of the National Lawyers Guild, Albuquerque, New Mexico,
signed by Angela Cornell and Rich Weiner.
A-6
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IV-D-51 Dr. Stanley E. Logan, Sante Fe, New Mexico.
IV-D-52 Kurt Smith.
IV-D-53 Jane H. Klenck, Albuquerque, New Mexico.
IV-D-54 Teresa Holle.
IV-D-55 Rebecca J. Briggs, Sante Fe, New Mexico.
IV-D-56 Unable to read signature.
IV-D-57 John Fred Hohes.
IV-D-58 Martha J. Harlow, Albuquerque, New Mexico.
IV-D-59 Unable to read signature.
IV-D-60 Louise R. Hendrix.
IV-D-61 Patricia R.S. Hiben, Albuquerque, New Mexico.
IV-D-62 Unable to read signature.
IV-D-63 Elaine Sandoral.
IV-D-64 Rob P. Rechard, Albuquerque, New Mexico.
IV-D-65 Virginia Power, Glen Allen, Virginia, signed by M. L. Bowling, Manager of
Nuclear Licensing and Programs.
IV-D-66 Unable to read signature.
IV-D-67 Unable to read signature.
IV-D-68 Bennie J. Merideth.
IV-D-69 Unable to read signature.
IV-D-70 Unable to read signature.
IV-D-71 Gay Lynn Habegger.
IV-D-72 Joseph G. Hzilow, Albuquerque, New Mexico.
IV-D-73 Victor Ferkin, Corrales, New Mexico.
IV-D-74 Christopher B. Mixon, Albuquerque, New Mexico.
IV-D-75 Unable to read signature.
IV-D-76 Nuclear Energy Institute, Washington, DC, signed by John F. Schmitt, Director of
Radiological Protection, Emergency Preparedness & Waste Regulation.
IV-D-77 Concerned Citizens for Nuclear Safety (CCNS), Santa Fe, New Mexico, Margret
Carde, Nuclear Waste Research Analyst.
IV-D-78 Rob P. Rechard, Albuquerque, New Mexico (same as IV-D-64).
IV-D-79 Maria Gourdin.
IV-D-80 Nancy Oestreicher, Albuquerque, New Mexico.
IV-D-81 Westinghouse Electric Corporation, Pittsburgh, Pennsylvania, signed by S. A.
Green, Manager of Government ES&H Programs Environmental Affairs.
IV-D-82 Dominique Mazeaud, Sante Fe, New Mexico.
IV-D-83 Christopher L. Habegger, Sante Fe, New Mexico.
IV-D-84 Citizens For Alternatives To Radioactive Dumping (CARD), Albuquerque, New
Mexico, submitted by Garland Harris, Liason for CARD.
IV-D-85 Energy, Minerals and Natural Resources Department of New Mexico, Sante Fe,
New Mexico, signed by Jennifer A. Salisbury, Cabinet Secretary and Chair of
New Mexico Radioactive Waste Consultation Task Force.
IV-D-86 Thora Guinn, Albuquerque, New Mexico (same as IV-D-27).
A-7
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IV-D-87 Brian Sablatura.
IV-D-88 Pamela J. McCann, Albuquerque, New Mexico.
IV-D-89 Kristina Faught-Holla, Bluewater, New Mexico.
IV-D-90 Department of Energy, Washington DC, signed by Thomas P. Crumbly, Assistant
Secretary for Environmental Management.
IV-D-91 Susan Linnell, Albuquerque, New Mexico.
IV-D-92 Don Schrader, Albuquerque, New Mexico.
IV-D-93 Holly Rucker.
IV-D-94 Nuclear Regulatory Commission, Washington, DC, signed by Carl J. Paperiello,
Director of Office of Nuclear Material Safety and Safeguards.
IV-D-95 Philip Hall, Los Lunas, New Mexico.
IV-D-96 Y. M. Lee, Ramah, New Mexico.
IV-D-97 Pueblo of Acoma, Acoma, New Mexico, signed by Ron D. Shutiva, Governor.
IV-D-98 John E. Trowbridge, Deming, New Mexico.
IV-D-99 Cathy Pitt.
IV-D-100 Zordan Associates Incorporated, Murrysville, Pennsylvania, signed by Tom A.
Zordan.
IV-D-101 Southwest Research and Information Center, Albuquerque, New Mexico, Don
Hancock, Director Nuclear Waste Safety Project.
IV-D-102 Office of Attorney General of New Mexico, Sante Fe, New Mexico, signed by
Lindsay A. Lovejoy, Assistant Attorney General, New Mexico.
IV-D-103 Office of Attorney General of New Mexico, Sante Fe, New Mexico, signed by
Lindsay A. Lovejoy, Assistant Attorney General, New Mexico.
IV-D-104 Southwest Research and Information Center, signed by Don Hancock.
IV-D-105 Concerned Citizens for Nuclear Safety, signed by K. Sabo.
IV-D-106 Office of Attorney General of New Mexico, Sante Fe, New Mexico, signed
by Tom Udall, Attorney General, New Mexico.
IV-D-107 Office of Attorney General of New Mexico, Sante Fe, New Mexico, signed
by Tom Udall, Attorney General, New Mexico.
IV-D-108 Jim Bernadoni.
IV-D-109 Lisa Lopez.
IV-D-110 Department of Energy.
IV-D-111 Michael M. Strum, Boulder, Colorado. (Same as IV-D-118)
IV-D-112 Michael A. Glora, Albuquerque, New Mexico.
IV-D-113 Sandy Wander, Albuquerque, New Mexico.
IV-D-114 William E. McConnell, Jackson, Michigan.
IV-D-115 Concerned Citizens for Nuclear Safety (CCNS), Santa Fe, New Mexico, signed by
Margret Carde, Nuclear Waste Research Analyst. (Same as IV-D-77.)
IV-D-116 Merritt E. Langston, Rockville, Maryland.
IV-D-117 Walter R. Coutier, Burke, Virginia.
IV-D-118 Michael M. Strum, Boulder, Colorado. (Same as IV-D-111)
IV-D-119 Sandia National Laboratories, Carlsbad, New Mexico, signed by Les Shepard,
Manager, WIPP Project.
A-8
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IV-D-120 Attorney General of New Mexico, Santa Fe, New Mexico, signed by Lindsay A.
Lovejoy, Jr., Assistant Attorney General.
IV-D-121 Attorney General of New Mexico, Santa Fe, New Mexico, signed by Lindsay A.
Lovejoy, Jr., Assistant Attorney General.
IV-D-122 N&E Enterprises, Hampstead, North Carolina, signed by Edwin Bajada.
IV-D-123 Craig G. Walenga, Rockville, Maryland.
IV-D-124 State of New Mexico Environment Department, Santa Fe, New Mexico, signed by
Neil S. Weber, Chief, Department of Energy Oversight Bureau.
IV-D-125 Department of Energy, Carlsbad, New Mexico, signed by George E. Dials,
Manager, Carlsbad Area Office.
IV-D-126 New Mexico Environmental Evaluation Group (EEG), Albuquerque, New
Mexico, signed by Rober H. Neill, Director.
IV-D-127 Allen E. Winegard, Baldwinsville, New York.
IV-D-128 Southwest Research and Information Center, Albuquerque, New Mexico, signed
by Don Hancock.
IV-D-129 Nuclear Regulatory Commission, staff review.
Series IV-G (Comments received by the EPA after the close of the second part of the public
comment period; i.e. after September 15, 1995)
IV-G-1 U.S. Nuclear Regulatory Commission, Washington, DC, signed by Carl J.
Paperiello, Director of the Office of Nuclear Material Safety and Safeguards.
IV-G-2 State of New Mexico Environment Department, Santa Fe, New Mexico, signed by
Neil S. Weber, Chief, Department of Energy Oversight Bureau. (Same as IV-D-
124.)
IV-G-3 John S. Hart, Albuquerque, New Mexico.
IV-G-4 Southwest Research and Information Center, Albuquerque, New Mexico, signed
by Don Hancock, Director of Nuclear Waste Safety Project.
IV-G-5 Unable to read signature, Albuquerque, New Mexico.
IV-G-6 U.S. Nuclear Regulatory Commission, Washington, DC, signed by Carl. J.
Paperiello, Director of the Office of Nuclear Material Safety and Safeguards.
Series II-D (Comments pertaining to drafts previous to Federal Register publication of the
proposed rule)
II-D-09 Attorney General of New Mexico, Sante Fe, New Mexico, signed by Tom Udall,
Attorney General.
II-D-25 Attorney General of New Mexico, Sante Fe, New Mexico, signed by Tom Udall,
Attorney General.
II-D-29 Southwest Research and Information Center, Albuquerque, New Mexico, signed
by Don Hancock, Director of Nuclear Waste Safety Project.
Series II-E (EPA Memoranda of meetings prior to Federal Register publication of proposal)
II-E-12 Southwest Research and Information Center, Albuquerque, New Mexico,
submitted by Don Hancock, Director of Nuclear Waste Safety Project.
A-9
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COMMENTOR LIST FOR ORGANIZATIONS SUBMITTING
MULTIPLE COMMENTS
Ten agencies and organizations submitted multiple written and/or oral comments. To facilitate
the identification of these organizations, a separate identification scheme is employed. The
following list provides the name of the organization that submitted comments, the abbreviation
used in the above list of comments, and the letter that corresponds to the numbering scheme
produced above. For example, the denotation DOE-A represents comment C-l provided by the
Department of Energy.
Agency: Abbreviation: Identification:
Department of Energy DOE A: C-l
B: A-2
C: S-l
D: IV-D-90
E: IV-D-125
Westinghouse Electric Corporation WEC A: C-5
B: A-3
C: S-2
D: IV-D-81
State Government of New Mexico SGNM A: C-9
B: S-5
C: IV-D-85
D: IV-D-124
Citizens for Alternatives to Radioactive Dumping CARD A: A-59
B: IV-D-84
Environmental Evaluation Group EEG A: A-14
B: S-19
C: IV-D-39
D: IV-D-126
New Mexico Attorney General NMAG A: S-22
B: IV-D-41
C: IV-D-102
D: IV-D-120
E: IV-D-121
F: II-D-09
G: II-D-25
A-10
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Agency: Abbreviation: Identification:
Sandia National Laboratories SNL A: A-62
B: S-49
C: IV-D-10
D: IV-D-119
Southwest Research and Information Center SRIC A: A-15
B: S-18
C: IV-D-49
D: IV-D-101
E: II-D-29
F: II-E-12
G: IV-G-4
State Representative for New Mexico SRNM A: C-7
B: A-61
C: S-4
Concerned Citizens for Nuclear Safety CCNS A: S-44
B: IV-D-77
C: IV-D-115
Nuclear Regulatory Commission NRC IV-D-128
A-ll
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APPENDIX B:
LIST OF ACRONYMS
AEA Atomic Energy Act [42 U.S.C. §2011 et seq., as amended]
AIC or AICs Active Institutional Controls
ALARA As Low As Reasonably Achievable
ASME American Society of Mechanical Engineers
BAT Best Available Technology
BID Background Information Document
CAG Compliance Application Guidance
CCDFs Complementary Cumulative Distribution Function
CFR Code of Federal Regulations
CH Contact Handled
CWA Clean Water Act [33 U.S.C. § 1251 et seq., as amended]
DOE Department o f Energy
DOT Department of Transportation
EATF Engineered Alternatives Task Force (DOE)
EB Engineered Barriers
EEG Environmental Evaluation Group
EPA Environmental Protection Agency
FR Federal Register
ICRP International Commission on Radiation Protection
LHS Latin Hypercube Sampling
LWA Land Withdrawal Act [Public Law 102-579, 1992]
MCL Maximum Contaminant Levels
MTHM Metric Tons Heavy Metal
NACEPT National Advisory Council for Environmental Policy and Technology
NAS National Academy of Sciences
NQA Nuclear Quality Assurance
NRC Nuclear Regulatory Commission
NUREG NRC Regulation
OMB Office of Management and Budget
ORIA Office of Radiation and Indoor Air, EPA
OSW Office of Solid Waste, EPA
PA Performance Assessment
PIC or PICs Passive Institutional Controls
QA Quality Assurance
QAMS Quality Assurance Management Staff
RCRA Resource Conservation and Recovery Act [42 U.S.C. §6901 et seq., as amended]
RH Remote Handled
SDWA Safe Drinking Water Act [42 U.S.C. §300f et seq., as amended]
TRU Transuranic
USDW Underground Sources of Drinking Water
B-l
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WIPP Waste Isolation Pilot Plant
WPA Whistleblower Protection Act [5 U.S.C. §2302]
NOTE:
• Abbreviations in citations are explained under "List of Commentors."
• For definitions refer to 40 CFR Part 194 and referenced documents.
B-2
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