ML20044B584
| ML20044B584 | |
| Person / Time | |
|---|---|
| Issue date: | 10/19/1992 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-92-351, NUDOCS 9210270171 | |
| Download: ML20044B584 (36) | |
Text
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RULEMAKING ISSUE October 19, 1992 SECY-92-351 i
For:
The Commissioners From:
James M. Taylor, Executive Director for Operations l
Sub.iect:
FINAL AMENDMENTS TO 10 CFR PART 61, "LICFNSING REQUIREMENTS FOR LAND DISPOSAL OF RADI0 ACTIVE WASTE"
Purpose:
To obtain Commission approval for issuance of the final rule.
Summary:
The rule proposing clarifying revisions to 10 CFR Part 61 was issued for public comment on March 6,1992.
After considering the comments, the staff has concluded that changes to the proposed rule are not necessary and recommends that NRC adopt the proposed amendments to Part 61 without change. Adoption of this rule will result in clarifying that Part 61 is applicable to the licensing of above-ground LLW disposal facilities - facilities built on the surface of the earth without an earthen cover - like the above-ground vault.
This clarification is provided by amending the definition of l
" land disposal facility" in 5 61.2 and by amending the
" Disposal Facility" discussion in the Concepts Section in 1
5 61.7(a)(1). The amendments clearly establish that an above-ground disposal facility will have to meet the Subpart C performance objectives of Part 61 in order to be licensed. The amendments also replace the phrase " quality control program" with the phrase " quality assurance program,"
tailored to LLW disposal; update the Paperwork Reduction Act Statement; and identify the correct NRC recipient of copies of the licensee's annual report. NRC received five letters l
on the proposed rule. An analysis of the comments is l
included in the Statement of Considerations to the final rule.
l NOTE:
TO BE MADE PUBLICLY AVAILABLE l
WHEN THE FINAL SRM IS MADE CONTACT:
AVAILABLE J., Lambert, RES l
492-3857 i
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Backaround:
In SECY 91-394, the staff proposed clarifying revisions, two substantive and two administrative, to Part 61 and recommended that they be issued for public comment.
By SRM dated January 6, 1992, the Commission approved the proposed revisions and directed the staff to publish the proposed rule in the Federal Register. The proposed revisions to Part 61 were issued on March 6, 1992, and the public comment period 2
expired on April 6, 1992. On April 7, 1992, NRC received a letter from the Illinois Department of Nuclear Safety dated April 3,1992, requesting a 30-day extension of the public comment period in order to consider its commentary. Through discussions between NRC staff and the Illinois Department of Nuclear Safety staff, it was determined that a formal extension was not necessary because Illinois was able to complete its review and submit its comments to NRC within 10 working days of the originai expiration date. Thus, the comments were available to NRC staff in sufficient time to be considered during the preparation of the final rule.
Discussion:
The most significant modification to Part 61 cl?rifies that the Part 61 Subpart C performance objectives are applicable to above-ground disposal of LLW. As a result, an applicant for an above-ground LLW disposal license will know that NRC expects such a proposed facility to meet the same safety requirements and dose limits that now apply to any licensed LLW disposal in a facility with an earthen cover.
At this time the staff has not developed technical requirements or guidance for licensing above-ground disposal facilities.
In SECY 91-394, the staff recommended to the Commission, and the Commission agreed, not to provide criteria or guidance for above-ground designs as part of this rulemaking. The staff continues to support that L
recommendation. Should NRC receive an application for above-ground disposal, criteria would be developed on a case-by-case basis. The staff anticipates that the public will be provided ample opportunity to review the technical criteria through mechanisms available to NRC for encouraging public involvement.
The other substantive change that will be made to Part 61 corrects the terminology in 5 61.12(j) so the applicant will develop a " quality assurance program" for the facility rather than the " quality control program" specified in the existing regulation. The Commission had directed staff to make this change in the November 8, 1990, Staff Requirements Memo for SECY 90-331.
The other two (administrative) changes update compliance provisions of the Paperwork Reduction Act and correct the identification of the recipient of copies of.
licensee's annual reports.
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The Commissioners 3
In SECY 91-394 the staff informed the Commission that "the change in the applicability of Part 61 to above-ground disposal should be useful in resolving the issue of Pennsylvania Agreement State status." At that time, the staff anticipated that Pennsylvania would require an above-ground uncovered facility, which would have been unaddressed by the existing requirements of Part 61.
However, since that time, it has become. clear that the Pennsylvania facility will be an above grade facility with an earthen cover.
Therefore, the existing requirements would be relevant to this facility.
Although promulgation of the final rule is no longer necessary to address the Pennsylvania question, it will facilitate licensing where the applicants wish to employ above-ground disposal of LLW.
Summary of Public Comment:
(
Five comment letters were submitted on the proposed rule.
Two of the letters came from States (Illinois, and Massachusetts) one from a citizens group, one from ERM Program Management Company, an environmental consulting 6
company, and one from a private citizen. Three of the commenters wrote only to offer support for the proposed i
rulemaking. The other commenters, the State of Illinois and ERM, recommended that the revisions to Part 61 not be issued because of concerns relating to the provisions that clarify the applicability of Part 61 to above-ground disposal.
Based on its analysis of the comments offered on the proposed rule, the staff has concluded that no changes are necessary for the final rule. The staff's analysis of public comment is included in the enclosed statement of considerations for the rulemaking.
Issue of Compatibility for Aareement States:
Under the existing NRC compatibility policy and guidelines, two of the changes adopted in this rulemaking would be matters of compatibility for the NRC Agreement States.
The change to the definition of land disposal facility in S 61.2 is a matter of Division I compatibility, and the "QC" to "QA" change in S 61.12(j) is a matter of Division II compatibility.
Those Agreement States that have assumed NRC's regulatory authority for the disposal of LLW under Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, will be required to incorporate the new definition of " land disposal facility" essentially verbatim directly into their State regulations for LLW disposal.
The incorporation of the change related to "QA" is also required.
However, in the case of the "QA" related change, the w
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Agreement States have more flexibility than for the Division I change. The language adopted need not be identical to the t
NRC regulations, but the effect'cannot be less stringent.
Based on the existing guidelines, the changes would have to be incorporated within 3 years after this final rule is issued.
In SECY-92-243, which is currently before the Commission for consideration, the staff provided the Commission with a proposed policy statement on. Agreement State compatibility for LLW disposal licensing requirements.
If Commission action on that paper results in an NRC compatibility policy for LLW disposal different from that recommended, NRC may have to modify the above positions on the compatibility of the changes that are being made to Part 61.
Coordinatier The Office of the General Counsel has no legal objection.
Recommendation: That the Commission:
(1) approve publication of the final rule (Enclosure 1).
(2)
Certify that this rule, will not have a significant economic impact on a substantial number of small entities in order to satisfy the requirements of the Regulatory Flexibility Act (5 U.S.C 605(b)).
(3)
Note that:
(a)
A regulatory analysis has been prepared for this rulemaking action (Enclosure 2) and will be available in the Public Document Room.
(b)
An environmental assessment has been prepared for this rulemaking action (Enclosure 3).
(c)
The Subcommittee on Nuclear Regulation of the Senate Committee on Environment and Public Works, the Subcommittee on Energy and Power of the House Committee on Energy and Commerce, and the Subcommittee on Energy and the Environment of the House Committee on Interior and Insular Affairs will be informed of this rulemaking action (Enclosure 4).
(d)
Portions of the rule would be a matter of Agreement State compatibility. State comments and participation were solicited.during the development of this rule.
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D The Commissioners 5
(e)
The final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act.
(f)
The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification and the reasons for it as required by the Regulatory Flexibility Act.
(g)
That a public announcement will be issued (Enclosure 5).
(h)
That the Advisory Committee on Nuclear Waste has reviewed the proposed rule and the public comments submitted on the rule and had no comments.
(i) Resources to implement this rulemaking are included in the FY 93-97 Five Year Plan.
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Enclosures:
1.
Notice of Final Rulemaking 2.
Regulatory Analysis 3.
Environmental Assessment 4.
Congressional Letters 5.
Public Notice Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB, Monday, November 2, 1992.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Monday, October 26, 1992, with an infor-mation copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
This paper is tentatively scheduled for affirmation at an Open Meeting the Week of November 2, 1992.
Please refer to the appropriate Weekly Commission Schedule, when published, for a specific date and time.
DISTRIBUTION:
OPA Commissioners OPP OGC REGIONAL OFFICES OCAA EDO OIG ACNW OCA SECY
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j NUCLEAR REGULATORY COMMISSION l
10 CFR Part 61 RIN 3150-xE00 Licensing Requirements for Land Disposal of Radioactive Wastes AGENCY:
Nuclear Regulatory Commission.
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ACTION:
Final rule.
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SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations containing licensing requirements for low-level radioactive waste (LLW)
- i disposal facilities. These amendments (1) clarify that 10 CFR Part 61 also applies to the licensing of above-ground disposai facilities; (2) replace the phrase " quality control program" in s 61.12(j) with the phrase " quality assurance program," tailored to LLW disposal; (3) update the Paperwork Reduction Act Statement in 161.8, and (4) identify the correct NRC recipient of copies of the licensee's annual reports. The changes are intended to simplify LLW disposal facility licensing interactions for NRC, the NRC Agreement States, and potential applicants for LLW disposal licenses.
EFFECTIVE DATE: ( 30 days after publication in the Federal Register).
ADDRESSES:
Copies of the regulatory analysis, the environmental assessment f
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2 and finding of no significant impact, and the comments received on the rule may be examined at the NRC Public Document Room at 2120 L Street NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Janet Lambert, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555; telephone (301) 492-3857.
SUPPLEMENTARY INFORMATION:
Background
The NRC published a rule in the Federal Register on March 6, 1992, (57 FR 8093-8096) that proposed to make four specific changes to 10 CFR Part 61 (hereafter referred to as "Part 61" or "the regulation").
Part 61 sets out licensing requirments, licensing procedures, and performance objectives for the land disposal of LLW waste. A review of Part 61 against the backdrop of current State and Compact efforts to site and develop LLW disposal facilities identified the need to modify the regulations as follows:
(1) clarify that 10 CFR Part 61 also applies to above-ground disposal facilities; (2) replace the phrase " quality control program" in 61.12(j) with the phrase " quality assurance program," tailored to LLW disposal; (3) update the Paperwork Reduction Act Statement in s 61.8; and (4) identify the correct NRC recipient of copies of the licensee's annual reports. A 30 day comment period expired on April 6, 1992. Comments were received from five respondents.
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I Summary and' Analysis of Public Comments Two of the letters came from States, one from a citizens group, one from.
an environmental consulting company and one from a private citizen. Three of the commenters provided no actual comments but only wrote to indicate their support Tor"the proposed rulemaking.
The other two commenters, the State of n
Illinois and the consulting company, objected to certain provisions of the proposed rule and provided comments on those provisions. The objections raised by these two commenters focused on the change which clarifies that Part 61 also applies to above-ground LLW disposal facilities. One of the commenters raised a concern about shallow land burial that was not germane to this rulemaking.
t Based on the following analysis of public comment,- the NRC has concluded that no changes are necessary for the final rule.
Issue: Abandonment of the systems approach.
The two commenters expressed concern that the proposed amendments to clarify the applicability of Part 61 to above-ground disposal amounted to more than simple clarification. The two commenters took the view that the proposed amendments constituted a significant change in, or even abandonment of, the regulatory concept that was the foundation of Part 61 and referred to as the
" systems approach." The consulting company stated that two of the basic concepts of the systems approach in Part 61 were that "the site should make a i
significant contribution to the long-term isolation of the wastes," and "as 3
9 reliance on the long-term performance of engineered features decreases over time, reliance on the site must increase over time in order to compensate."
The same commenter stated that the site would play a significantly less important role in assuring the long-term isolation of the waste for above-ground disposal facilities without soil covers than it would for disposal facilities built into the ground with soil covers. The commenter stated that there would have to be overwhelming reliance on the above-ground engineered structures not only to contain the wastes over the short-term, but to provide long-term isolation as well. The commenters argued that this situation is an abandonment by NRC of the system approach to LLW disposal, t
Response.
The systems approach to safe disposal of LLW was and still is the foundation of licensing under Part 61. The NRC is not abandoning that regulatory concept in the process of clarifying that Part 61 can be used to i
license above-ground disposal facilities.
In pursuing the concept of the systems appre ch during the development of Part 61, NRC assumed that for LLW disposal facilities to meet the performance objectives in Subpart C, there would have to be an integrated performance of all of the disposal system components (i.e. the site, the waste form, the engineering or facility design, the operation, and the closure of the facility).
Each component of the disposal system would make some particular contribution to the containment or isolation of the waste, albeit dependent upon the particular design. As an integrated system the components would work with each other to protect the public health and safety. This assumption applies to any LLW disposal facility, whether it is in the ground or above-ground. As noted in the 4
1 Statement of Considerations for the proposed rule, technical criteria, analogous to those presently in 10 CFR 61 but specific to above-ground disposal, do not exist. Nor is the NRC providing either technical criteria or guidance for above-ground disposal designs in this rulemaking.
It is expected that should NRC receive an application for above-ground disposal, criteria will be developed on a case-by-case basis.
In any case, whether an LLW facility is in the ground or above ground, it will have to meet the Part 61 performance objectives to be licensed for LLW disposal, and performance assessments will evaluate the interactions of the site, design, etc., to determine if they will result in a safe facility.
Issue: NRC oromotion of an unproven and ouestionably safe disposal technoloav.
The public health and safety implications of the proposed action were.
also a major concern to the consulting company. That commenter objected to the proposed rule on the grounds that the NRC could not ensure that the public
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i health and safety would be protected because the Agency had not evaluated the safety of an above-ground disposal facility over the 500 years during which there would be a radiological hazard at such a facility. The commenter also asserted that the NRC had not demonstrated through the proposed rule that an overall disposal system of such a design could, with reasonable assurance, meet the performance objectives of Subpart C, as such a facility would be required to do before an LLW license could be granted.
In addition, the l
commenter stated that above-ground disposal technology.was not specifically 1
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evaluated in the Environmental Impact Statement (EIS) for the existing Part 61 and noted that no additional assessment was offered as part of the proposed rulemaking.
From this commenters perspective, by proposing the changes to authorize the use of above-ground disposal, NRC is promoting an unproven and questionably safe disposal technology.
Response.
The structure of Part 61 is that all land disposal facilities must meet the performance objectives of Subpart C.
The Subpart C performance objectives are the safety objectives, intended to protect the general population T-om releases of radioactivity, to protect individuals from inadvertent intrusion, and to protect individuals during facility operations. The license application for any LLW land disposal facility must demonstrate compliance with these objectives.
If NRC received a license application for an above-l ground facility, NRC would perform a safety evaluation as a necessary part of the licensing process to determine if the required performance objectives would be fulfilled.
NRC's analysis and evaluation for such a facility would i
be based on site-specific information and data obtained during the licensing process to assess compliance with the performance objectives. Additionally, in accordance with 10 CFR Part 51.80(a), the NRC will prepare an EIS for the facility as it is required to do for any LLW disposal facility license issued under 10 CFR Part 61.
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Jssue: ' Lack of technical reouirements for above-around disposal - more complicated licensina process.
Both of the commenters who objected to the proposed. rule also objected I
because it did not contain technical requirements for above-ground disposal.
Part 61 contains detailed technical requirements specifically for near-surface disposal facilities but no equivalent technical requirements for above-ground 1
facilities are present in the existing Part 61, nor were any proposed through the rulemaking. The commenters maintain that it is not desirable to promulgate a rule extending the applicability of Part 61 to above-ground disposal facilities without appropriate technical guidance.
The consulting company also objected to the proposed rule because the commenter believes that NRC's intentions to develop technical requirements after an application is received would increase uncertainty and complicate, rather than simplify, the licensing process. The commenter stated that developing the requirements at the same time a license application is under review would expose the license review to undesired debate about the adequacy of the regulati os and the manner in which they were developed. The commenter argued that NRC should develop the technical requirements for above-ground i
disposal now, as part of this rulemaking.
i Response.
i The NRC continues to support its earlier decision not: to issue technical criteria for above-ground disposal with this rulemaking. While some States have considered above-ground disposal, no State has actually decided to build 1
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Thus, NRC may not even receive an application to license an above-ground facility. Therefore, NRC believes that it is a more efficient use of NRC resources to develop technical criteria when there are actual plans for an above-ground facility rather than speculate at this time as to how such a facility might be designed.
Although the decision to defer development of the technical criteria for an above-ground disposal facility will introduce some uncertainty into the licensing process, the Commission does not believe that this deferral will substantially interfere with the development of a license application for such a facility or the NRC review of such a license application. As noted previously, the performance objectives of Subpart C must still be met, and furthermore, the near-surface disposal requirements currently in s 61.50, s 61.51, and s 61.52 may be useful to a potential license applicant in preparing a license application for an above-ground disposal facility.
i Issue:
Increased reaulatory uncertainty for above-oround disposal.
I The commenter expressed concern that if an Agreement State receives an application for above-ground disposal and WRC has not developed technical requirements, the Agreement State will have to develop its own technical requirements which could be different from those developed by another Agreement State or by the NRC. The commenter's view is that the differences in requirements could raise issues that would ultimately have to be resolved i
by NRC or by the courts.
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Response.
NRC recognizes that different States might utilize different technical criteria appropriate to the particular design proposed to them.
NRC is considering but has reached no formal conclusion regarding the degree to which Agreement States may adopt requirements more stringent than or different from Part 61. The guidelines provided herein regarding compatibility are interim in nature.
Until such time as the Commission does develop such criteria, any criteria developed for this type of facility by the Agreement States would be acceptable as long as they are consistent with the performance objectives of Subpart C.
NRC will provide assistance to the extent practical to facilitate States' efforts in LLW licensing according to the LLRWPAA.
Issue:
LLW licensina on an ad hoc basis.
According to one of the commenters, the proposed changes which include facility review and criteria development on a case-by-case basis, raise the specter of above-ground disposal facilities that are designed, licensed, constructed, operated, and closed, on an ad hoc basis. The commenter believes such licensing would be a retreat to the method of licensing used before the promulgation of Part 61.
Response.
The NRC does not believe that the term "ad hoc" accurately describes the licensing decisions it will make on above-ground disposal.
NRC has dealt with 9
and will continue to deal with many specifi: licensing issues on a case-by-case basis. However, since the promulgation of Part 61, the licensing process for LLW disposal is directed at attaining reasonable assurance that the licensed facility will meet the performance objectives of Subpart C.
Granted there will likely be new and different issues associated with licensing an above-ground facility, but NRC will deal with these issues as it has in the past, making sure that adequate conservatism has been incorporated in the design or the siting of the facility to ensure the public safety.
Issue:
Not disposal but lona-term storace.
One of the commenters objected to the concept of above-ground disposal as nothing more than a 500-year hold-for-decay, storage facility. The commenter notes that long-term storage of LLW is inconsistent with Commission policy.
The commenter urged NRC to make a clear case that an above-ground disposal facility without an earthen cover is substantially different from a 500-year storage facility.
Response.
The NRC would not treat an above-ground disposal facility as a storage facility. A performance assessment would need to demonstrate long-term performance and stability as required by Part 61. The facility would be licensed as a permanent disposal facility and would be evaluated for compliance with the Performance Objectives in Subpart C.
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Issue:
Lack of public role in the reaulatory orocess.
Another issue raised was that the approach NRC intends to use to license above-ground disposal will not ensure adequate opportunity for public involvement in the regulatory process. The commenter noted that in the proposed rule NRC specified its intent to develop technical requirements for:
above-ground disposal' facilities after an application is received and on a case-by-case basis.
The commenter assumed that such an approach would not afford the public the opportunity to be actively involved in the development and review of such requirements.
Response.
b There has been opportunity for public participation in the establishment of the performance objectives in Subpart C, which were established by rulemaking.
In addition, there will be ample opportunity for the public to be involved in the regulatory process related to licensing an above-ground disposal facility. As discussed previously, the technical review criteria for an above-ground disposal facility will be developed after an application is received on a case specific basis. On a case specific basis the Commission will determine what mechanism to use to establish the technical requirements for the facility license and the method for involving the public in the development of such requirements.
Additionally, the public also can petition to intervene in the licensing process itself. NUREG-1274 describes the licensing process, including procedures for compliance with 10 CFR Part 2, NRC's " Rules of Practice for 11
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Domestic Licensing Proceedings and Issuance of Orders." Federal Register Notices (FRN) are published when an application-is tendered, when an application is determined to be acceptable for docketing, when the Draft Safety Evaluation Report (DSER) and Draft Environmental Impact Statement (EIS) are completed, and when public hearings are scheduled. NRC will also publish a Notice of Intent to issue a license and a Notice of Issuance.
The public, States, tribes, and local governments can petition to participate in the licensing process and can request hearings.
In summary, NRC has considered the above comments on the proposed rule and has decided that no changes are necessary for the final rule. _ Thus, the revisions NRC is adopting to Part 61 are identical to those in the proposed rule.
Discussion of the Revisions I.
Amend the definition of " land disposal facility" in 9 61.2 to specify that the term refers to LLW disposal facilities which are on or protrude through the earth's surface and do not have an earthen cover, in addition to those that are in the ground and have an earthen cover. The purpose of this change is to clarify the regulatory applicability of Part 61 to the licensing of "above-ground" disposal designs like the "above-ground vaul t, " in particular, the applicability of the performance objectives of Part 61 to these designs.
The change that NRC is making to the definition of " land disposal facility" in Part 61 clarifies that the regulation can be used by NRC to 12 t
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license above-ground disposal facilities.
However, at this time the NRC is not issuing specific technical criteria for above-ground disposal facilities that are analogous to the near-surface disposal requirements of 95 61.50(a),
61.51(a), and 61.52(a) of Subpart D because of the special technical characteristics of above-ground disposal facilities. Only those portions of the regulation that apply generically to " land disposal facilities" are directly applicable to the licensing of above-ground disposal facilities.
Specifically, this means that the overall performance objectives of Subpart C will apply to above-ground disposal facilities, as well as the Part 61 administrative and procedural requirements, the environmental monitoring requirements, the financial assurance requirements, the waste transfer and manifest requirements, and the general institutional requirements.
Establishing the applicability of the Subpart C performance objectives to above-ground disposal is particularly important. Any applicant for a license
-i for an above-ground disposal facility under Part 61 will have to demonstrate to the NRC that the proposed facility can meet the same safety requirements and dose limits that apply to any LLW disposal facility that has an earthen cover. The demonstration of compliance will have to address the unique features of the above-ground design, the special technical considerations associated with those features, their potential hoalth and safety consequences, and reconcile them with the Subpart C performance objectives.
Even though some of the requirements in Subpart D are only applicable to near-surface disposal, the Commission still believes they would be _useful to a prospective license applicant as guidance for planning an above-ground facility and to the NRC or Agreement States in the development of technical requirements for such facilities.
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To provide further clarification regarding the applicability of Part 61 to the licensing of above-ground disposal facilities, NRC also is amending the
" Disposal Facility" discussion in the Concepts Section - 61.7.
The change to 9 61.7(a)(1) clarifies the distinction made by the NRC between near-surface disposal and above-ground disposal, to emphasize that near-surface LLW disposal facilities built partially or totally above-grade have protective earthen covers, while similar facilities constructed without earthen covers l
are considered to be "above-ground disposal facilities."
NRC is not providing either technical criteria;or guidance for above-ground disposal designs with these amendments.
It is expected that, should NRC receive an application for above-ground disposal, criteria will be developed on a case-by-case basis.
II.
Replace the term " quality control program" in 6 61.12(j) with the term " quality assurance program, tailored to LLW disposal." The purpose of this change is to clarify what steps an applicant for an LLW disposal facility license must take in order to assure that the facility will perform as intended, and also to assure that the necessary records and documentation are available for evaluation and performance assessment by NRC or an Agreement State at the time of license submittal.
Quality assurance is a broad term
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that encompasses quality control and also includes managerial controls and audits.
III.
Revise 9 61.8 to indicate that the NRC requested and obtained OMB i
approval for the information collection requirements in Part 61. Under the OMB guidelines that were in effect when the original Part 61 was issued, OMB approval of the Part 61 information collection requirements was not necesary because the regulation was expected to affect less than 10 licensees.
Subsequently the OMB guidelines changed, and Part 61 was no longer exempt from 14
the OMB approval requirement. Accordingly, NRC submitted Part 61 for 0MB review and obtained the OMB clearance that is required by the Paperwork Reduction Act. The purpose of this change is to update 6 61.8 to correctly reflect this approval.
IV.
Revise 9 61.80(i)(1) to identify the correct NRC headquarters-recipient of copies of the annual report.
Issue of Compatibility for Agreement States Under existing NRC policy and guidelines, two of the changes adopted in.
this rulemaking would be matters of compatibility for the NRC Agreement States. The change to the definition of land disposal facility in 9 61.2.is a matter of Division I compatibility, and the "QC" to "QA" change in 9 61.12(j) is a matter of Division II compatibility. This means that those Agreement States that have assumed NRC's regulatory authority for the disposal of LLW under Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, will be required to incorporate the new definition of " land' disposal facility" essentially verbatim directly into their State regulations for LLW disposal.
The incorporation of the Division II change is also required; however, the Agreement States have more flexibility than for the Division I change.
For the Division 11 change, the language adopted need not be identical to the NRC regulations, but the effect cannot be less stringent.
Based on the existing guidelines, the changes would have to be incorporated within 3 years after-this f'.al rule is issued.
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i Finding of No Significant Environmental Impact:
Availability l
The Commission has determined under the National Environmental Policy Act of 1969 as amended, and the Commission's regulations in Subpart A of-10 CFR Part 51, that this rule is not a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. Three of the proposed changes - the " quality control" to " quality assurance" change in i 61.12(j), the update of the Paperwork Reduction Act Statement in i 61.8, and the correction of the organizational inconsistency in 9 61.80(i)(1) are the types of actions described in categorical exclusion 9 51.22(c)(2). As such they are considered by the Commission to be corrective and nonsubstantive in nature and l
will not have an impact on the environment. The remaining changes, which clarify the applicability of Part 61 to the licensing of above-ground LLW disposal, also will not have an impact on the environment in that these amendments do not change the required level of overall performance for'LLW disposal facilities.
Furthermore, any environmental impact of operating such a facility will be addressed as a part of the licensing action for that specific facility under 10 CFR Part 51. The environmental assessment and i
finding of no significant impact on which this determination is based are available for inspection at the NRC Public Document Room, 2120 L Street NW.
(Lower Level), Washington, DC.
Single copies of the environmental assessment and the finding of no significant impact are available from Janet Lambert, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3857.
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Paperwork Reduction Act Statement This final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
Existing requirements were approved by the Office of Management and Budget, approval number 3150-0135.
Regulatory Analysis The Commission has prepared a regulatory analysis on this final regulation. The analysis examines the alternatives considered by the Commission and explains the decision to revise Part 61. The analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW.
(Lower Level), Washington, DC.
Single copies of the analysis. may be obtained from Janet Lambert, (301) 492-3857.
Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),
the Commission certifies that this rule does not have a significant economic.
impact on a substantial number of small entities. The changes made to Part 61 i
in this rule will only affect those entities that decide to apply for a license to build and operate an LLW disposal facility.
In the low-Level Radioactive Waste Policy Act of 1980 (LLRWPA) and the Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA), Congress mandated that the individual States or groups of States called compacts should provide the LLW 17
n 1
disposal capacity for the LLW generated within each of their borders. Thus j
1 the licensees for LLW disposal facilities will either be States or private operators which are not small entities under the size standards established by the Nuclear Regulatory Commission on November 6, 1991 (56 FR 56671).
In addition, this rule will not have a significant economic impact because the changes to Part 61 are clarifying in nature, and only a small number of licensees are likely to be affected.
i Backfit Analysis The NRC has determined that the backfit rule, 10 CFR 50.109, does not j
apply to this final rule, and therefore, that a backfit analysis is not required for this final rule because these amendments do not involve any i
provisions which would impose backfits as defined in 10 CFR 50.109(a)(1).
List Of Subjects i
Part 61 - Criminal penalty, Low-level waste, Nuclear materials, Reporting and recordkeeping requirements, Waste treatment and disposal.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, j
as amended and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR Part 61.
t 4
PART 61 - LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADI0 ACTIVE WASTE I
18
o 1.
The authority citation for Part 61 continues to read as follows:
AUTHORITY: Secs. 53, 57, 62, 63, 65, 81, 161, 182, 183, 68 Stat. 930, 932, 933, 935, 948, 953, 954, as amended (42 U.S.C. 2073, 2077, 2092, 2093, 2095, 2111, 2201, 2232, 2233); secs. 202, 206, 88 Stat. 1244, 1246, (42 U.S.C.
5842, 5846); secs. 10 and 14, Pub. L.95-601, 92 Stat. 2951'(42-U.S.C. 2021a and 5851).
I i
For the purposes of Sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
Tables 1 and 2, il 61.3, 61.24, 61.25, 61.27(a), 61.41 through 61.43, 61.52, 61.53, 61.55, 61.56, and 61.61 through 61.63 are issued under sec. 161(b), 68 Stat. 948, as amended (42 U.S.C. 2201)(b); il 61.9a, 61.10 through 61.16, 61.24 and 61.80 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
t 2.
In i 61.2, the definition of land disoosal facility is revised to read as follows:
5 61.2 Definitions.
As used in this part:
Land disoosal facility means the land, buildings, and equipment which are intended to be used for the disposal of radioactive wastes on the surface or into the subsurface of the land.
For purposes of this Chapter, a " geologic repository" as defined in Part 60 is not considered a " land disposal i
19 i
facility."
3.
In 5 61.7, paragraph (a)(1) is revised to read as follows:
9 61.7 Concents (a) The Disposal Facility.
(1) Part 61 is intended to apply to. land disposal of radioactive waste and not to other methods such as sea or extraterrestrial disposal.
Part 61 contains procedural requirements and performance objectives applicable to any method of land disposal.
It contains specific technical requirements for near-surface disposal of radioactive waste, a subset of land disposal, which involves disposal in the uppermost portion of the earth, approximately 30 meters. Near-surface disposal includes disposal in engineered facilities which may be built totally or partially above-grade provided that such facilities have protective earthen covers. Near-surface disposal does not include
- i disposal facilities which are partially or fully above-grade with no protective earthen cover, which are referred to as "above-ground di spo s al. " Burial deeper than 30 meters may also be satisfactory.
Technical requirements for alternative methods may be added in the future.
20
/
6 4.
Section 61.8 is revised to read as follows:
5 61.8 Information collection reouirements: OMB aooroval (a) The Nuclear Regulatory Commission has submitted ~ the information collection requirements contained in this part to the Office of Management and Budget (0MB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the information collection requirements contained in this part under control number 3150-0135.
(b) The approved information collection requirements contained in this part appear in 96 61.3, 61.6, 61.9, 61.10, 61.11, 61.12, 61.13, l
61.14, 61.15, 61.16, 61.20, 61.22, 61.24, 61.26, 61.27, 61.28, 61.30, 61.31, 61.53, 61.55, 61.57, 61.58, 61.61, 61.62, 61.63, 61.72, and 61.80.
5.
In 6 61.12, paragraph (j) is revised to read as follows:
6 61.12 Specific technical information.
}
i 1
1 (j) A description of the quality assurance program, tailored to LLW disposal, developed and applied by the applicant for the determination of 21 Y
r natural disposal site characteristics and for quality assurance during the design, construction, operation, and closure of the land disposal facility and the receipt, handling, and emplacement of waste.
r 6.
In 5 61.80, (i)(1) is revised to read as follows:
I 61.80 Maintenance of records. recorts. and transfers.
(i)(1) Each licensee authorized to dispose of waste materials received from other persons, pursuant to this part, shall submit annual reports to the appropriate Commission regional office shown in Appendix D of Part 20 of this chapter, with copies to the Director, Division of Low-Level Waste Management -
and Decommissioning, Office of Nuclear Material Safety and Safeguards, 22 i
U.S. Nuclear Regulatory Commission, Washington, DC, 20555.
Reports must be submitted by the end of the first calendar quarter of each year for the preceding year;
[ratW wt Rockville, Maryland, this day of
, 1992.
For the Nuclear Regulatory Commission.
7 Samuel J. Chilk, Secretary of the Commission.
I 23
?
REGULATORY ANALYSIS FOR FINAL RULEMAKING:
CLARIFYING REVISIONS TO 10 CFR PART 61 1.
Statement of the Problem 5
NRC and the Agreement States expect to use 10 CFR Part 61, " Licensing Requirements for Land Disposal of Radioactive Waste," or equivalent and compatible Agreement State regulations to license the new LLW disposal facilities which must be developed as stipulated by the Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA). The NRC staff has identified two instances in the regulation where the current wording is imprecise and does not convey the actual intent of the NRC staff when the regulation was originally developed. These provisions are contributing to confusion or regulatory uncertainty for the States and Compacts. One is that Part 61 incorrectly uses the term " quality control program" instead of " quality assurance program" as intended by the staff responsible for developing the regulation. The second is the question of the regulatory applicability of Part 61 to above-ground disposal facility designs such as above-ground vaults, which may be considered by the States and Compacts.
NRC has also identified two places where administrative changes are necessary to update the regulation: one where a reporting requirement is inconsistent with the present organization of NRC; the second to reflect that subsequent to the original issuance of Part 61, NRC has requested and obtained Office of Management and Budget (OMB) approval for the Part 61 information collection requirements.
The staff believes that Part 61 should be revised to clarify existing staff positions and minimize the uncertainties in these areas, so the process established in the LLRWPAA is not disrupted.
2.
Ob.iective The purpose of this rulemaking is to clarify NRC regulatory positions in Part 61 on two issues whose resolution is of importance to the licensing of LLW disposal facilities and to correct administrative inconsistencies in the existing regulation.
3.
Alternatives Proposed Action:
Proceed with a regular rulemaking including the publication of a proposed rule for public comment, then conclude with the publication of a final rule that considers any public comments received. The public comment period will be limited to 30 days.
Alternative: No action:
Because the NRC staff generally acknowledged the need to make the changes to Part 61, this alternative was unacceptable.
i
~4.
Conseouences Codifying the planned changes'to Part 61 will reduce current regulatory uncertainties and should help the States and Compacts to proceed in the development of their LLW facilities, as mandated by the LLRWPAA.
5.
Decision Rationale The approach for this rulemaking was recommended because it will correct known inaccuracies in Part 61.
It also provided the public an opportunity to comment on the proposed changes.
I
ENVIRONMENTAL ASSESSMENT FOR THE RULEMAKING TO REVISE 10 CFR PART 61
" LICENSING REQUIREMENTS FOR THE LAND DISPOSAL OF RADI0 ACTIVE WASTES" THE FINAL ACTION:
The Nuclear Regulatory Commission (NRC) is making four specific changes to 10 CFR Part 61, its regulation containing licensing requirements for. low-level radioactive waste (LLW' disposal. One is to clarify the regulatory applicability of Part 61 to include above-ground disposal facilities, such as disposal in above-ground vaults.
This change would be accomplished by modifying both the definition of " land-disposal facility" in 5 61.2 to include facilities constructed on the earth's surface without an earthen cover, and changing the discussion of disposal facility in the Concepts Section - 5 61.7 -
to define above-ground disposal. The second change modifies b 61.1(j) to require the applicant for an LLW disposal license to develop a " quality assurance" program tailored to a LLW disposal facility," rather than a
" quality control" program as is currently required. The third change will update S 61.8 to correctly indicate that subsequent to the original issuance of Part 61, NRC requested and obtained Office of Management and Budget (0MB) approval for the Part 61 information collection requirements. The last change will correct an administrative error in S 61.80(1)(1) which improperly identifies the Director, Division of High-Level Waste Management as the designated recipient of the annual report required of the LLW disposal licensees.
These amendments will incorporate established and documented NRC staff positions into Part 61 and will not result in extensive changes to the actual text of the regulation. The changes are intended to simplify LLW disposal facility licensing interactions for the NRC, for the NRC Agreement States, and for potential applicants for LLW disposal licenses.
NEED FOR THE ACTION:
Congress enacted the " Low-Level Radioactive Waste Policy Act of 1980,"
LLRWPA. This act was subsequently amended by the " Low-Level Radioactive Waste Policy Amendments Act of 1985," LLRWPAA. These Acts made the individual States responsible for the management and safe disposal of all of the commercial LLW generated within their borders. Congress also mandated that the States, either alone or in groups called Compacts, were to develop the capability to dispose of their LLW by January 1, 1993. States failing to meet this deadline face significant penalties including economic penalties and the potential loss of access to any available LLW disposal capacity.
Given the approaching deadline, applications for LLW disposal licenses are already under review, and additional applications will be filed in the next few years either with the NRC or appropriate NRC Agreement States (States
b that have assumed the NRC's regulatory authority for LLW disposal).
Part 61 or the equivalent and compatible Agreement State regulations will be used to determine the acceptability of the proposed LLW disposal facilities.
It is important that the governing regulations and guidance be as clear and precise as possible so that the licensing process can proceed as Congress intended.
With these goals of clarity and precision in mind, NRC has reviewed Part 61 and has identified several places in the regulation where the current wording is imprecise and does not convey the actual intent of the NRC staff when the regulation was originally developed. These errors are contributing to regulatory uncertainty and confusion for the States.
Part 61 is being revised to clarify existing staff positions and minimize the uncertainties in the four pi nes identified so the process established in the LLRWPAA is not disrupted.
ALTERNATIVES:
Action:
Proceed with a regular rulemaking including the publication of a proposed rule for public comment, then conclude with the publication of a final rule that considers any public comments received.
The public comment period was 30 days.
Alternative : No action.
Because the NRC staff generally acknowledged the need to make the changes to Part 61, this alternative was unacceptable.
ENVIRONMENTAL IMPACT OF THE ACTION:
The final rulemaking will make four changes to Part 61. The Commission has determined under the Environmental Policy Act of 1969 and the Commission regulations in Subpart A of 10 CFR Part 51 that two of the changes - the
" quality control" to " quality assurance" change in 5 61.12(j), the correction to 5 61.8, and the correction of the administrative error in 5 61.80(i)(1) are the types of actions described in categorical exclusion 5 51.22(c)(2). As such they are considered by the Commission to be corrective and nonsubstantive in nature and will not have an impact on the environment.
The remaining changes, clarifying the applicability of Part 61 to the licensing of above-ground LLW disposal also will not have an impact on the environment. The act of including the subset of land disposal facilities constructed "on" the land surface, under the regulatory scope of Part 61 does not change the environmental impact of using the regulation to license the disposal of LLW and does not change the required level of overall performance of LLW disposal, so the rule change itself will have no environmental impact.
Further, the amendment will not have an effect until a license application for.
an above-ground disposal facility is developed and received. Any environmental impact of operating such a facility will be addressed as a part of the licensing action for that facility under 10 CFR Part 51.
The change is also of a nonsubstantive nature from the environmental perspective because the formal recognition that above-ground LLW disposal facilities can be considered for a license under Part 61 means that they will have to be evaluated against the generally applicable performance objectives 2
t in Subpart C and the procedural, environmental monitoring, waste transfer end manifest, institutional, and financial requirements of the regulation. As is-explained in Chapter 3 of the Draft Environmental Impact Statement (DEIS) for Part 61, both the performance objectives and the near-surface technical requirements for LLW disposal facilities were developed in response to health and safety and environmental problems at existing LLW disposal facilities.
The performance objectives and other requirements were the product of the extensive safety and environmental analyses performed for, and presented in the EIS for Part 61. As such they define and establish the level of safety that must be provided at an LLW disposal facility. They will provide the basis for evaluation of all land disposal of LLW, regardless of whether the land disposal facility.is h.elow or on the land surface.
Further environmental analysis is not necessary to support the inclusion of "on land" disposal concepts under the regulatory scope of Part 61.
ENVIRONMENTAL IMPACT OF THE ALTERNATIVES:
Because the alternatives proposed were procedural ("no action" or rulemaking), there would be no environmental impact.
AGENCIES CONSULTED:
It was not necessary to consult with other agencies in considering the effects of this rulemaking because there are no environmental impacts associated with the proposed changes to Part 61.
3
paarcuq s
"yn UNITED STATES 3
/a E NUCLL.,.. REGULATORY COMMISSION WASHINGTON D.C. 20556 The Honorable Bob Graham, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United Statc.; Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of the final rule amending 10 CFR Part 61, " Licensing Requirements for Land Disposal of Radioactive Waste," that will be published in the Federal Reaister.
The Nuclear Regulatory Commission is making four clarifying changes to Part 61.
First, the term " quality control program" that appears in 5 61.12(j) is being changed to " quality assurance program, tailored to LLW disposal" to reflect correctly the intentions of NRC staff throughout the development of Part 61.
Second, the regulation is being revised to clarify that above-ground disposal methods, such as an above-ground vault with no earthen cover, are included within the regulatory scope of Part 61 and must meet the performance objectives of Subpart C.
The third change updates 5 61.8 to correctly indicate that subsequent to the original issuance of Part 61, NRC requested and obtained the Office of Management and Budget (0MB) approval of the Part 61 information collection requirements. The last change corrects an inaccurate address in the reporting requirements of 5 61.80(i)(1). No other changes are being made to Part 61 through this rulemaking.
This clarifying action is being taken to minimize confusion and to eliminate regulatory uncertainty in these areas for the States and Compacts that are trying to license LLW disposal facilities pursuant to the " Low-Level Radioactive Waste Disposal Act Amendments of 1985" (LLRWPAA).
The revisions NRC is adopting to Part 61 through this action are identical to those recommended in the proposed rule. After considering the public comments submitted on the proposed rule, NRC decided that no changes were indicated for the final.
Sincerely, Dennis Rathbun, Director Office of Congressional Affairs
Enclosures:
j 1.
Public Announcement j
2.
Federal Register Notice 1
l cc: Senator Alan K. Simpson
. -. -. ~
.. ~ ~
paCacu UNITED STATES n
E aE NUCLEAR REGULATORY COMMISSION 8
WASHINGTON, D.C. 20666 o,s...../
- The Honorable Peter H. Kostmayer, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of the final rule amending 10 CFR Part 61, " Licensing Requirements.for Land Disposal of-Radioactive Waste," that will be published in the Federal Reaister.
I The Nuclear Regulatory Commission is making four clarifying changes to Part i
61.
First, the term " quality control program" that appears in S 61.12(j)'is-being changed to " quality assurance program, tailored to LLW disposal" to reflect correctly the intentions of NRC staff throughout the development of Part 61. Second, the regulation is being revised to clarify that above-ground disposal methods, such as an above-ground vault.with no earthen cover, are included within the regulatory scope of Part 61-and must meet.the performance objectives of Subpart C.
The third change updates 5 61.8 to indicate correctly that subsequent to the original issuance of Part 61, NRC requested and obtained the Office of Management and Budget.(0MB) approval of the Part 61 1
information collection requirements. The last change corrects an inaccurate address in-the reporting requirements of 5 61.80(i)(1). ' No other changes are being made to Part 61 through this rulemaking.
This clarifying action is being taken to minimize confusion and to eliminate f
regulatory uncertainty in these areas for the States and Compacts that _are I
trying to license LLW disposal facilities pursuant to the " Low-Level Radioactive Waste Disposal Act Amendments of 1985" (LLRWPAA).
The revisions NRC is adopting to Part 61 through this action are identical to j
those recommended in the proposed rule. After considering the public comments submitted on the proposed rule, NRC decided that no changes-were indicated for the final.
1 Sincerely,-
j Dennis Rathbun, Director -
Office of Congressional Affairs
Enclosures:
1 1.
Public Announcement
-i 2.
Federal Register Notice i
cc: Representative John J. Rhodes i
t
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pn Mao E#" 1 o
UNITED STATES
,E NUCLEAR REGULATORY COMMISSION (kLg v p/
WASHINGTON, D.C. 20665 The Honorable Philip R. Sharp, Chairman Subcommittee on Energy and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of the final rule amending 10 CFR Part 61, " Licensing Requirements for Land Disposal of Radioactive Waste," that will be published in the Federal Reaister.
The Nuclear Regulatory Commission is making four clarifying changes to Part
- 61. First, the term " quality control program" that appears in S 61.12(j) is being changed to " quality assurance program, tailored to LLW disposal" to reflect correctly the intentions of NRC staff throughout the development of Part 61. Second, the regulation is being revised to clarify that above-ground disposal methods, such as an above-ground vault with no earthen cover, are included within the regulatory scope of Part 61 and must meet the performance objectives of Subpart C.
The third change updates 5 61.8 to indicate correctly that subsequent to the original issuance of Part 61, NRC requested and obtained the Office of Management and Budget (0MB) approval of the Part 61 information collection requirements. The last change corrects an inaccurate address in the reporting requirements of 5 61.80(1)(1). No other changes are being made to Part 61 through this rulemaking.
This clarifying action is being taken to minimize confusion and to eliminate regulatory uncertainty in these areas for the States and Compacts that are trying to license LLW disposal facilities pursuant to the " Low-Level Radioactive Waste Disposal Act Amendments of 1985" (LLRWPAA).
The revisions NRC is adopting to Part 61 through this action are identical to those recommended in the proposed rule. After considering the public comments submitted on the proposed rule, NRC decided that no changes were indicated for the final.
Sincerely, Dennis Rathbun, Director Office of Congressional Affairs
Enclosures:
1.
Public Announcement 2.
Federal Register Notice cc: Representative Carlos J. Moorhead
NRC CHANGES REGULATIONS ON LOW-LEVEL RADI0 ACTIVE WASTE DISPOSAL i
The Nuclear Regulatory Commission is amending its regulation on disposal of commercial low-level radioactive waste (LLW) to state specifically that the regulation applies to the licensing of above-ground disposal facilities, such as above-ground vaults, as well as to the existing below-surface methods.
P Above-ground facilities are on or protrude through the earth's surface without an earthen cover. Some States have indicated a possible interest in these alternative LLW disposal methods for new LLW disposal facilities.
The Commission's current LLW regulations, 10 CFR Part 61, established the basic framework for licensing land disposal of low-level radioactive wastes.
Because the specific technical requirements and focus of the regulation were on near-surface disposal, the current wording of Part 61 has been interpreted as limiting the applicability of the regulation to disposal facilities that i
are covered with earth.
However, no endorsement of a particular technology.
was intended.
The amendments also correct Part 61 to require an applicant for an LLW t
disposal facility to develop a " quality assurance" program for the facility, consistent with original NRC staff intentions, rather than a " quality control" program as was previously required, Quality assurance is a broader term that encompasses quality control and also includes managerial controls and audits.
.n-w
The revisions that NRC is adopting to Part 61 at this time are identical to those recommended in the proposed rule that was issued on March 6, 1992.
NRC considered the comments submitted on the proposed rule and decided that no changes were indicated.
The amendments will be in effect 30 days after publication in the Federal Register.
i p
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