ML20196G976
| ML20196G976 | |
| Person / Time | |
|---|---|
| Issue date: | 06/07/1999 |
| From: | Yusko C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Kerr K, Lohaus P, Salomon S NRC |
| Shared Package | |
| ML20196G966 | List: |
| References | |
| NUDOCS 9907010312 | |
| Download: ML20196G976 (9) | |
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[ Kathaleen Kerr Rl Concurrence [ PIgi 1l p*ra u -- ^
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-4 UNITED STATES
( j NUCLEAR REGULATORY COM ISSION WASHINGTON, D.C. 20625 0001 o Constance Yusko k, *Dete:* ,od Kathaleen Kerr, Paul Lohaus, Stephen Salomon Mon, Jun 7,1999 3:52 PM
Subject:
RI Concurrence RI (Hubert J. Miller, Regional Administrator) concurs on Letter to avio J. Allard, Director, Bureau of Rad Protection -
SUBJECT:
COMPLETENESS REVIEW OF PA's DR FT REQUEST FOR AN AGREEMENT W/NRC. Mr. Miller concurred on 6/7/99 -
CC: I Duncan White, George Pangburn, Marie Fud e I (
l 9907010312 990616 PDR STPRO ESOPA PDR t 9"1Q70]0)).1
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Completeness Review Comments on Draft Pennsylvania Application Reviewers: Stephen Salomon and Richard Blanton, Office of State Programs; Paul Goldberg and James Kennedy, Office of Nuclear Material Safety and Safeguards; Douglas Weaver, Incidence Response Operations; Grace Kim, Office of the General Counsel, and Duncan White, Region I.
Draft Request Letter from Governor The draft request letter is satisfactory except that it omits the statement that the Commonwealth does not wish to assume authority for sealed sources and devices. Please include in the application a request letter that addresses the Commonwealth's intent regarding sealed sources and devices. See Section 4.1.3 below.
4.1 Legal Elements 4.1.1 Authority to Establish a Program and Enter into an Agreement Previous NRC legal analyses conducted at the time when Pennsylvania submitted an application for a Limited Agreement for low-level radioactive waste (LLW) disposal concluded that the Pennsylvania Radiation Protection Act is broad enough to enable the Commonwealth to enter into a full Agreement. In 1993, the Commission also concluded that Pennsylvania's LLW regulations, including Pennsy!vania's counterpart regulation to 10 CFR 9 61.41 (Section 236.12, Protection of the General Population and Environment ,
from Releases of Radioactivity), were compatible with NRC's regulatory program (See l Attachment 1). Central to this conclusion was the Commission's determination that l Pennsylvania's counterpart regulation to 10 CFR 9 61.41 reflected pre-closure !
operational release limit objectives, goals, or design objectives that are not to be construed as radiation protection standards. Please confirm that Pennsylvania's LLW regulations and program assumptions remain unchanged from the time of the ,
Commission's 1993 review. !
As background, Pennsylvania's LLW legislation gives the Department of Environmental Resources (now the Department of Environmental Protection) the power and duty to l develop and implement a more stringent program with respect to regulation of LLW than the NRC's program. As a general matter, a State does have the flexibility to incorporate more stringent requirements in its program. As you may be aware, however, State standards should be essentially identical to those of the NRC with respect to radiation protection standards (Compatibility Category A) and program elements with "significant transboundary implications"(Compatibility Category B). The release limits for LLW disposal facilities in 10 CFR S 61.41 are included within the category of radiation protection standards. The NRC implements this category to allow Agreement States flexibility to establish more stringent pre-closure operational release limit objectives, <
ALARA goals or design objectives, but not more stringent radiation protection standards.
ENCLOSURE 1
4.1.2 Organization of the Pennsylvania Agreement Program i I
The narrative description of the Pennsylvania Agreement program is not complete and j l needs to be expanded to describe all major program elements. Please refer to the table l l of contents to Section 4 of the Handbook for a listing of major program elements. If j possible, provide appropriate references to details found elsewhere in your application. 1 in particular, the following elements are not described in your current narrative.
- a. Procedures for Adoption of State Regulations, in addition to the Environmental i Quality Board, it is our understanding that the Independent Regulatory Review Commission plays a role in the adoptions of regulations. We note the Limited Agreement information submitted by the Commonwealth included "The Regulatory Review Process" with flow diagrams and the " Regulatory Review Act" Act of 1982, P.L 633, No.181. We recommend that you describe the process to be followed by the Commonwealth in the development and promulgation of Commonwealth regulations. Specific procedures or details essential to the process should be included as attachments to the application. ;
- b. Organization and Duties of the Bureau of Radiation Protection (BRP). The relationship between the Department of Environmental Protection, the Govemor, ,
and other State agencies is not fully described in your application nor are sufficient organizational charts provided. The narrative needs to be expanded to include more complete descriptions of the organization and duties of the BRP, its relationship to other State organizations, and the relationship and use of regional offices. Please include copies of organizational charts that show the relationship of the Department within the overall govemmental organization.
- c. Events and Allegations. Procedures on how the program will handle and respond to events and allegations were not mentioned in the narrative description. We understand that the Commonwealth has an allegation program based on the Limited Agreement material submitted (i.e., Chapter 2 of the Operations Manual,
" System Overview"). We recommend that you describe the processes that will be followed to respond to events and allegations and append any necessary supportive procedures or material,
- d. Staffing, Training and Qualification Plan. The narrative should describe the number of staff, basis, and their training and qualifications to perform the type l and quantity of work anticipated. The application should contain a copy of your l
training and qualification plan for staff.
- e. Decommissioning. There is no discussion in your application of the l Commonwealth's decommissioning program, process for oversight of complex
- decommissioning actions, or the 13 Site Decommissioning Management Plan (SDMP) sites. Your discussion should include the NRC and the Department of Environmental Protection's Memorandum of Understanding (MOU) effective July 15,1996 (61 FR 48632, September 5,1996). It should also include discussion of the position of the Commonwealth on sites undergoing l
decommissioning that will be transferred to ensure a cons 3 tent view on the implementation of decommissioning plans and requirements for the various sites.
You should describe the responsibilities for decommissioning within the BRP, and in particular, which group will be responsible for complex decommissioning actions and SDMP sites.
4.1.3 - Content of the Proposed Agreement The draft Pennsylvania Agreement follows the format and content of the sta'ndard Agreement in Management Directive 5.8, " Proposed 274b Agreements with States,"
Handbook, Exhibit 1. However, based on our review of the proposed Pennsylvania Agreement, we have identified two omissions, one of which is in the standard Agreement. Please add a provision to Article 11, that the Agreement does not provide for the discontinuance of any authority for mill tailings, i.e., Article 11, Section 6, should read:
"The regulation of byproduct materials as defined in Section 11e.(2) of the Actc' Also, please insert in the brackets of Article Ill, "5 and 6." These items provide that the Agreement may be amended in the future to include sealed sources and devices and mill tailings. Therefore, revisions are necessary to both the standard Agreement in Management Directive 5.8 and the Pennsylvania Agreement. We have enclosed a markup of the standard Agreement for your use when making necessary revisions.
4.2 Regulatory Requirements Program Elements This portion of your application has already been reviewed and comments provided by a letter from Paul Lohaus to David Allard dated April 14,1999.
4.3 Licensing Program Elements 4.3.1 Procedures for the Technical Evaluation of Proposed Uses of RAM
- a. The application does not include a description of the licensing program for Agreement material licenses, or a complete set of licensing policies, licensing procedures, forms, and guides that will be used in the licensing program. Your application includes licensing guides for the use of NARM material for academic institutions, laboratory and industrial use of small quantities, non-human broad scope, portable gauges, medical, and radiopharmacy. Section 4.3.1 of the Handbook recommends that the State submit its licensing procedures, including standard review plans and licensing guides for at least each of the Matedals Inspection Program (IMC 2800) license program codes for which an NRC license will be transferred. Please revise and include in the application your licensing procedures, including standard review plans and licensing guides, for each program code for which an NRC licensee will transfer to the Commonwealth.
Your procedures should specifically address the use of byproduct, source and special nuclear material in quantities less than a critical mass. In responding to this item, you may find useful the Consolidated Guidance About Matenals Licenses: Program-Specific Guidance (NUREG-1556 series). ,
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b.- Your application does not discuss decommissioning in general and in particular any procedures to be used for complex sites and SDMP sites. Please identify and describe the procedures that will be used in reviewing decommission lng plans and terminating licenses. The NMSS Decommissioning Handbook !
(NUREG/BR-0241) has examples of kinds of procedures that could be ;
- developed. Draft Regulatory Guide DG-4006,
- Demonstrating Compliatice with the Radiological Criteria forLicense Termination,"provides a means for demonstrating compliance with 10 CFR Part 20, Subpart E license termination regulation. Useful guidance for evaluating licensee final surveys is provided in 1 the Multi-Agency Radiation Survey and Sites Investigation Manual (MARSSIM),
NUREG-1575, EPA 402-R-97-016, December 1997, or Manualfor Conducting Radiological Surveys in Support of Ucense Termination (NUREG-5849).
4.3.3 Procedure for Conducting the Technical Evaluation of a Proposed License for a :
Low-Level Radioactive Waste (LLW) Disposal Site 1
The Commonwealth may propose to assume the regulatory authority without having proposed procedures in place. However, a State must confirm in its application that it will develop and use appropriate procedures before undertaking the evaluation of a LLW application. Your current description appears to have satisfied the certification although the detailed procedures referenced will have to be developed when the siting for a LLW disposal site resumes.
The application describes the program the Department will follow when conducting the initial LLW disposal facility license application review. The application states that the Commonwealth expects to use three licensing guidance documents. The first is a Format and Content of the LLW Disposal Facility License Application (analogous to NUREG 1199), the second, Guidance for Review of the LLW Disposal Facility License Application (analogous to NUREG 1200), and the third, a Safety Evaluation Report. This will be in addition to the license, license conditions or license denial, and a Comment and Response document.
4.3.5 Procedures for Assuring the Technical Quality of Licensing Actions and 4.3.6 Administrative Licensing Procedures The application does not include your procedures to assure technical quality and administrative control of licensing actions. Sections 4.3.5 and 4.3.6 recommend that these procedures include the following:
- a. procedures for the receipt of licensing actions, tracking, assignment to technical evaluators, license document preparation, quality assurance, signature, and transmittal of the signed license to the licensee; !
- b. peer review, supervisory review and any other methods adopted to assure the quality of licensing actions; and 1
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- c. proposed arrangements for the continued authorization of NRC licensed activities i to be transferred to the Commonwealth under the Agreement.
The application should incorporate administrative and program licensing procedures described in the above items that define how the program will function.
4.4 Inspection Program Elements 4.4.1 Procedures for inspecting Facilities Where RAM is Stored and Used
- a. The application does not include a description of the inspection program and a complete set of inspection policies, positions, forms and guides that will be used in the program. Your application includes inspection field notes for medical broad scope, commercial irradiator, radiopharmacy, remote afterloading device, nuclear medicine, teletherapy, well logging, quality management program, radiopharmaceutical therapy, high dose afterioader, brachytherapy, eye applicators, gamma stereotactic radiosurgery, medical events and misadministrations, and LLW shipments. Section 4.4.1 recommends that the State include in the application its inspection procedures for all IMC 2800 license program codes for which an NRC licensee will be transferred. This includes your inspection procedures and field notes for each category of license issued by the NRC which will be transferred to the Commonwealth. The application should include your priority schedule for inspections by license type. In responding to this item, you may find IMC 2800 useful in describing the general materials inspection program including inspection frequencies. For addressing specific license categories, a useful guide is Inspection Procedures for Specific Materials Programs (IMC 87101 through 87120).
- b. The application did not include inspection procedures for decommissioning. The application should include inspection procedures that will be used for decommissioning and SDMP sites, including those for confirmato y surveys and in-process inspections. In responding to this item, you may find useful Inspection Procedure (IP) 87104 Decommissioning Inspection Procedure for Material Licenses.
- c. The application did not provide information on laboratory facilities to be used by the Commonwealth other,than for engineering properties of waste and independent environmental monitoring. The application should include your laboratory facilities that will be used for analysis of samples taken from sites, the kinds of radiological analyses it can perform, and the level of effort it can provide for routine inspections, reactive inspections, material incidents, and decommissioning confirmatory surveys.
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- 4.4.2 ' Procedures for Assuring the Technical Quality of Inspections and inspection
~^ ' - Reports and 4.4.3 Administrative Procedures for inspections Your application does not include procedures to essure technical quality and l ' administrative control ofinspections. Sections 4.4.2 and 4.4.3 recommend that these procedures include the following:
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- a. peer review, supervisory review and any other methods adopted to assure the i
quality of inspections and inspections reports;
- b. procedures for scheduling and tracking of inspections, assignment to inspectors,
, document preparation, quality assurance, signature, and timely transfer of !
Inspection results to the licensee; and l !
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- c. procedures for processing and tracking requests for conducting licensed activities under reciprocity.
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The application should include your procedures for inspections. In addition to the items i discussed above, your application should specifically discuss the scheduling and L respective responsibilities for reviewing and issuing inspection and enforcement actions between the main office in Harrisburg and the three field offices, in responding to this item, you may find useful IMC 2800 and Processing of NRC Form 241... inspection of .
. Agreement State Licensees Operating under the Reciprocity Provisions of 10 CFR l l' 150.20 (IMC 1220). l 4.5 Enforcemen' t Program Elements The application includes standard procedures for encouraging compliance with, and enforcing, the regulations. It also includes a Memorandum of Understanding entered l Into with NRC in areas of mutual concern including transportation, regulation of a LLW disposal site, LLW packaging and shipping inspections, confirmatory environmental monitoring, and emergency information exchange. However, the application does not include administrative procedures for tracking routine and escalated enforcement actions. Please provide in the application your procedures for tracking enforcement actions.-
4.6 Technical Staffing and Training Program Elements 4.6.1 Technical Staff Organization
- a. Although the application includes biographies _ of many staff, your application does -
not include a complete analysis of the expected workload and establish an l
' appropriate staffing plan. Although your analysis considered the number of licenses to be transferred under the Agreement, it did not consider the distribution t
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I and type of licenses, except for the potential LLW disposal license. A breakdown by license type was not given and is necessary to determine the annual number of inspections and licensing actions and determine the appropriate training and experience needed by staff to carry out these functions.
The staffing plan should also indicate the number of staff assigned to specific responsibilities, such as licensing, inspection, emergency recponse, decommissioning, management / supervisory and administrative support.
Please include in the application your staffing plan to clearly reflect the deployment of staff in the areas of licensing, inspection, decommissioning, emergency response, supervisory / management and administrative support based on the expected workload.
- b. If your revised staffing plan identifies vacancies in any portion of the Agreement program, please provide a timetable for filling and training individuals by the time the Agreement goes into effect.
4.6.2 Formal Staff Training and Qualification Program The application recognizes the importance of training and experience in the narrative and contains tables of staff experience and training. However, the application did not include a formal training and qualification program for inspectors and licensing reviewers. j Section 4.6.2 recommends the submission of the State's plan for the formal qualifications '
of technical staff members. Please include in your application a copy of your l qualification program. You may find useful Formal Qualification Programs in Nuclear.
Maten'al Safety and Safeguards Program Area (IMC 1246) or the NRC/OAS Training Working Group Recommendations for Agreement State Training Programs dated i October 1997.
4.6.3 Qualifications of Current Technical Staff l Please include in your application updated information on the following aspects of your {
current technical staff: i
- a. technical personnel currently in the program with their curriculum vitae; ,
i b. organizational and funding charts; and
, c. training and experience tables deeded to clearly indicate which training qualification areas have been completed, which areas are currently ongoing and l . which areas are planned.
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' 4.7 incident and Allegation Response Program Elements i 4.7.1 Procedures for Responding to Events and Allegations The application discusses briefly the Division's process for response to events. We could find no discussion about allegations. The application does not include incident and ,
allegation response procedures. Please include in the application your incident and allegation procedures. For establishing your incident response procedures, NRC's incident response procedures for materials events in IMC 1300 - 1303 and 1330 m ' be used as a guide. For establishing allegation procedures, NRC Management Directive 8.8 may be used.
4.7.2 Procedures for Reporting Material Events, Identifying Abnormal Occurrences, and Allegations, and for Entering Event Reports into the Nuclear Material Events Database 4
The application discusses in the narrative incident and emergency response management. However, your application does not include procedures for reporting significant events to the NRC for inclusion into the Nuclear Material Events Database (NMED). Please provide your procedures. Event reporting procedures are described in OSP Procedure SA-300, Agreement State Reporting Handbook, that may be useful as a guide in establishing your reporting procedures.
Attachments:
As stated