ML20217P082

Forwards Comments Re State of Ohio Draft Application for Agreement State Status in Response to 980227 Memo

ML20217P082
Person / Time
Issue date:	05/01/1998
From:	Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Bangart R NRC OFFICE OF STATE PROGRAMS (OSP)
References
NUDOCS 9805060058
Download: ML20217P082 (12)

Text

May 1,:1998 i MEMORANDUM TO: Richard L. Bing:rt, Dirsctor 4

p ONice of Stita Programs

- FROM:. CarlJ) Paperiello, Director _ (Original signed' by)

. Omce of Nuclear Material Safety and Safeguards

SUBJECT:

NMSS REVIEW OF STATE OF OHlO DRAFT

APPLICATION FOR AGREEMENT STATE STATUS

~ In response to your memorandum dated February'27,1998, the Omce of Nuclear Material Safety and Safeguards has reviewed selected parts of the' draft application and has the attached comments. NMSS reviewed the " Sealed Source'and Device Review and Registration Program".and related parts of the overall program; the " Residual Radioactive Materials Program"; and those parts of the application concerned with reguistinn of contaminated sites, decommissioning, and low-level waste handling and disposal. Region 111

- reviewed the' materials licensing and inspection portions of Ohio's application. We understand that OSP is reviewing the regulations and that OSP will forward all Ohio regulations that differ from NRC's regulations to the appropriate division for assistance in

~ determining if the regulations are equivalent.

Attachment:

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SUBJECT:

s " NMSS REVIEW OF STATE OF OHIO DRAFT

> ' APPLICATION FOR AGREEMENT STATE STATUS A

In response to your memorandum dated February 27,1998, the Office of Nuclear Material Safety and Safeguards has reviewed selected parts of the draft application and has n- Ethe attached comments.: NMSS reviewed the ' Sealed Source and Device Review and

. Registration Program" and related parts of the overall program; the " Residual Radioactive

' 'Aaterials Program"; and those parts of the application concerned with regulation of contaminated sites, decommissioning, and low-level waste handling and disposal.' Region til -

reviewed the materials licensing and inspection portions of Ohio's application. We understand that OSP is reviewing the regulations and that OSP will forward all Ohio regulations that differ from NRC's regulations to the appropriate division for assistance in determining if the regulations are equivalent.

Attachment:

As stated-CONTACT: Paul Goldberg, INMS/NMSS .

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\ ..... p k May 1, 1998 MEMORANDUM TO: Richard L. Bangart, Director Office of State Programs FROM: Carl J. Papenello, Director f.

Office of Nuclear Material Safety

- and Safeguards -

SUBJECT:

NMSS REVIEWOF STATE OF OHIO DRAFT APPLICATION FOR AGREEMENT STATE STATUS In response to your memorandum dated February 27,1998, the Office of Nuclear Material Safety and Safeguards has reviewed selected parts of the draft application and has the attached comments. NMSS reviewed the " Sealed Source and Device Review and Registration Program" and related parts of the overall program; the " Residual Radioactive Materials Program;" and those parts of the application concemed with regulation of.

contaminated sites, decommissioning, and low-level waste handling and disposal. Region ll1 reviewed the materials licensing and inspection portions of Ohio's application. We I understand that OSP is reviewing the regulations and that OSP will forward all Ohio -

1 regulations that differ from NRC's regulations to the appropriate division for assistances in determinbg if the regulations are equivalent. i

Attachment:

As stated  ;

CONTACT: Paul Goldberg, IMNS/NMSS. >

'301 415-7842

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SEALED SOURCE AND DEVICE (SS&D) EVALUATION PROGRAM Scope:

In assessing the State's Sealed Source & Device (SS&D) evaluation program, NMSS examined information provided by the State in their draft application, reviewed staffing assignments and qualifications for staff that will be responsible for SS&D evaluations, and examined the proposed guidance documents and procedures.

Comments:

1. The State indicated that guidance documents modeled on the NRC's NUREG-1550, "A Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations", Regulatory Guide 6.g, " Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material", and Policy & Guidance Directive 84-22, Revision 1, "What Source and Device Designs Require an Evaluation", will be used as standard reviewer guidance.

a. Use of these documents implies that staff will use the template registration certificates and checklist from NUREG-1550 to assist in the review of SS&Ds and to help to ensure that all pertinent issues are addressed. The State should '

indicate whether this is the case.

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b. The State should note that NUREG-1550 is being replaced by NUREG-1556, Vol. 3, which is expected to be issued in final form in the near future.

NUREG-1556, Vol.3 DRAFT is currently available, and there should not be any significant differences between the draft and the final document. The State -

should consider review and adoption of NUREG-1556, Vol. 3.

2. The following are questions regarding information presented in the Ohio document titled, Licensing Guide - Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations:

a. In the definition of " active registration certificate", it is stated that the certificate constitutes part of the basis "for the State of Chio" to issue a license for radioactive materials. It should be noted that the certificate also constitutes part of the basis for issuance of licenses by the NRC and other Agreement States. (pg. 2) i

b. The definition of inactive vendor states that the term refers to "a vendor who l no longer may be authorized to initially distribute the sealed source or device q listed on a registration certificate but may provide services for the sealed j

- source or Jovice."L One interpretabon of this stdement can be that the i

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i. certificate is authorizing the vendor to perform services.' It is suggested that 1 L the words *be authorized to" be inserted after the word "may" in the original  ;

definition. (pg. 3) ~ j i

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c. The section on General Policies and Procedures references the following documents which should be submitted for review;

. Rule implementing Guide," Establishing Quality Assurance Programs i for the Manufacture and Distribution of Sealed Source and Devices Containing Radioactive Material" (pg.5)

. Implementing Directive, (1D) SSD-01 "What Source and Device .

Designs Require an Evaluation" (pg.5)

. Implementing Directive, (lD) SSD-02 " Source and Device Evaluation Technical Assistance Program" (pg.5)

. Administrative Code (containing the information that an applicant must submit in support of a leak test frequency longer than 6 morahs) pg 19)

d. The section on Propnetary Information states that the " reviewer, upon i receipt of such a marker document will make a determination with the

ssistence of the Program Administrator of Nuclear Materials Safety if the information is nscessary to perform a safety evaluation for the product." The State should clarify how the Program Administrator will be involved in the decision and why the reviewer would not be qualified to make this determination. (pg. 8) l l

e. The Document Flow section states that the " director" signs the certificate.

The State should clarify the purpose and scope of this review.- (pp.10,11)

f. Regarding the section for Distribution of Completed. Certificates, it should be j noted that the procedures should specify that _a copy of the completed certificate should be forwarded to the NRC for inclusion in the National -

Registry. (pg.11)

g. In the introductory paragraph to the Rules in the OAC that Address Specific )

Registration Requirements section, it states the "the State of Ohio,' other 1 Agreement States and NARM Licensing States approved for product review i perform evaluations of products that are distributed to persons located in states under NRC jurisdiction and other Agreement States or custom products used by persons located in states under NRC jurisdiction and other

' Agreement States." The wording of this appears to be unclear in reference to the custom products reviews, it should be noted that each Agreement State performs custom reviews only for those custom users located in their state, and similarly NRC performs custom reviews only for those custom l

users located in states under_ NRC jurisdiction.- (pg.12)f

. h. - Throughout the Guide there are a number of examples where references to guidance for exempt use product reviews and the specific requirements .,

l imposed on the product design that need to be addressed during the product ,

- evalushon. The wording in some of these cases leaves a possibility for .'

interpretation that Ohio is authorized to perform review of exempt use

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m L products. The wording in the document should clearly indicate that Ohio is l not authodzed to perform evaluations of exempt use products containing L byproduct matedal.:(pp. 12,13,18, Appendix A -first page information, Appendix Afsinoke detector reference in Description / Construction, Appendix A -dose limit for exempt distribution in Conditions of Use, Appendix B -reference to NUREG/CR-1156, Appendix C -reference to smoke detector standards. Appendix D -standard format for a smoke detector /gunsight)

1. In the section Devices used under General License, there appear to be inconsistencies when referring to Ohio chapters 3701-38 and 3701-3g.

3701-38 is used to refer to both the part of the regulations under which persons may use devices with general license (pg.13),~and to the part of the -

regulations under which generally licensed device must be manufactured and distributed. The State should review these references and correct as necessary.

J. Throughout the s' ection Rules in the OAC that Address Specific Registration Requirements, OAC regulations are referred to "as referenced.to the equivalent NRC regulation". In sor1e cases, it appears that the referenced -

NRC regulations are not applicable. For example, the section on radiography lists as references NRC's 10 CFR 31 (for general licenses) and

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10 CFR 39 (for well logging). The State should review all of the references and correct as necessary. (pp.13-16)

k. In the section for Sealed Sources and Devices for Me' dical Use, it states that teletherapy sources do not need to meet the listed regulations. It should be noted however, that NRC's 10 CFR 35.49(b) indicates that they do need to De manufactured and distributed in accordance with a license issued pursuant to NRUs 10 CFR 30. lf the Statew's regulations lncorporate by reference all parts of the NRC's regulations, then the States's regulations must have a matching statement. From the wording in the guidance, it may give the indication that the use of teletherapy sources are not subject to any of the regulations that the other types of medical devices and sources are subject to. The State should consider clarifying the wording in this section. (pg.16)

1. In the sections for the specifically licensed products, the statement is made l I

that the " manufacturer or distributor of the equipment may demonstrate that the equipment meets these requirements." It should be noted that a custom user may also submit the information in suppoit of issuance of a custom use l certificate. (pp.15,16)  !

, m. In the section' Limitations and Other Considerations'of Use under the main m . -

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section Writing the Certificate, it states that there are limiting conditions such as leak testing, handling, storage, use, transfer, disposal,' environmental ~  !

conditions, labeling, special headling procedures and tools and specific licensing conditions that "may be performed" by the license -  !

reviewer. It appears that this wording may be in error, and the correct

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wording to replace the bolded words should be "should be addressed".

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n. Regarding assignment of certificate numbers, it should be noted that only the NRC issues new vendor numbers, including both active and inactive vendor numbers. The guidance, however, indicates that the State will assign vendor numbers. The guidance should be modified. It should be noted that the unit number is assigned by the agency that is issuing the

' certificate after consulting the National Registry to determine the next 'i available number. (pp. 32,39, Appendix E -vendor code and unit number definitions)

o. ' In the Accompanying Documentation section of the checklist in Appendix A, it states th'at the reviewer must " verify information forwarded to NRC for update of NRC source listing." It appears that the correct reference may be to the NRC's generally licensed device listing. Also, for general license distribution, the checklist should include a check that copies of all pertinent regulations are sent.. (Appendix A)'

p. In accordance with accepted standard formatting practice, the custom user information should be contained o'1 the first page of the certificate.

(Appendix D -standard device certificate format)

q. Under the Limitations and/or Other Considerations of Use section of the standard device certificate format, the standard wording in some of the limitations states "the device shall be distributed to persons specifically licensed by the state of Ohio, the US NRC, any state with NARM regulations, or another agreement state". It should be noted that for .

products containing byproduct material, the reference to "any state with  ;

' NARM regulations"is not appropriate. (Appendix D.-standard device registration certificate format)

r. The agency code for Ohio is "OH". (Appendix E -Agency Code definition)  ;

3. The State should address the following issues which were not addressed in the application or the available guidance document: ]

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a. foreign vendors .

b. custom certificates - note the standard NRC policy is to limit the number of j custom use certificates for any one design to two or three, then strongly encourage the distributor to commercially register the design.

c. administrative procedures for combining certificates

d. identifying and reporting defects and noncompliance as required by 10 CFR 21, if this regulation has been adopted by Ohio. '

e. ' identification of principle use code definitions -note that NRC's l NUREG-1556, Vol. 3 is intended to replace both Regulatory Guides 10.10 1

' and 10.11. > >

l4. The application did not contain' a clear definiticn on what constitutes a concurrence review ' The State should submit information regarding policy on this issue. The policy should be compatible with the current guidelines in Management Directive 5.6, which -

specifically states:

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"An independent technical review of the application and proposed certificate of l registration is performed by a second individual and supports the finding that the product l is acceptable for licensing purposes. (It is important to keep in mind that the l independent technical reviewer must concur with the initial review.)", and "A concurrence review includes an independent technical review of the materials submitted by the applicant and the documents generated by the initial reviewer. The I concurrence review includes evaluation of each area addressed during the initial review l (e.g., construction of the product, labeling, and prototype testing), but the concurrence review is not to the same level of detail as the initial review (i.e., it is not necessary to ,

review every page of the applicant's submittal). The concurrence review must be focused on ensuring that the product meets all applicable regulations, that the product would not pose any health or safety concerns, and that the registration certification provides an adequate basis for licensing. This concurrence review by a second qualifieci  ;

reviewer is necessary in view of the potential health and safety implication resulting from the widespread distribution of sealed sources and devices." >

The purpose of these guidelines is to ensure that each area of the evaluation is addressed by two qualified individuals.

Full signature authority should be given only to those reviewers that are qualified to perform all areas of the evaluation. Limited signature authority to perform specific areas of the evaRation could be granted to reviewers c.ct having qualifications in all areas.

Each evaluation should be performed by two individual reviewers with full signature authority, that each perform complete evaluations. As an attemative, one of these individual reviewers may be replaced by a team, where two or more reviewers combine

~ to cover the areas in the evaluation. It should be stressed that the team must perform a complete evaluation, and that their review is independent of the individual reviewer. The designated leader for the team will sign the registration certificate. If limited signature authority and/or the team approach will be used, then the State must clearly describe how such a program will work, including identifying how it will assign review areas to each reviewer in order to ensure that all areas are adequately covered, how team i member responsibility will be documented (since the team leader signs the certificate for  !

the entire team), and what the role and responsibilities of the team leader will be. l

5. The apnlication did not cnntain information regarding the technical staffing and training of individuals that will have authority to sign SS&D evaluations. The State should provide i this information, including minimum qualifications, names of staff members that will be initially assigned, the estimated amount of time each individual will spend performing SS&D evaluations and related duties, and how the individual will spend the balance of their time.

6. The application did not contain information on how signature authority will be granted.

The current Management Directive 5.6 states:

"All initial and concurrence reviews are performed by persons having' adequate training.",'

and

.... Newly hired employees need to be technically qualified. Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences.~ Both' '

initial and concurrence reviewers should be able to:

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- Understand and interpret, if necessary, appropriate prototype tests that ensure the integrity of the products under normal. and likely accidental conditions of use,

- Understand and interpret test results,

-- Read and understand blueprints and drawings,

- Understand how the device works and how safety features operate,

- Understand and apply appropriate regulations,

- Understand the conditions of use,

-- Understand extemal dose rates, source activities, and nuclide chemical form, and

- Understand nod utilize basic knowledge of engineering materials and their properties.

The importance of a qualification program in the SS&D area should be stressed Such a program would assure that for reviewers to be given SS&D signature authority, they -

would first be evaluated to ensure that the reviewer meets established minimum standanis, through experience, training, and/or formal education, to enable the reviewer to fully address all issues in the areas for which they are being granted signature authority. The qualification program would also assure that reviewers complete a sufficient number of cases, which are critiqued by a qualifed SS&D reviewer to determine whether the reviewer adequately identified and addressed all pertinent issues.

. Signature authority must be granted prior to the reviewer signing any registration certificates, in order to obtain' experience in SS&D reviews, staff could be assigned cases to work on, with all deficiency letters being review:ed by a staff member with fuIl _

signature authority before issuance. When the reviewor-in-training believes that they have identified and addressed all issues, the certificae.s must then be reviewed IN FULL, by two staff with full signature authority, or by one staff with full signature authonty and a team. The staff that worked with reviewer-in-training can be one of the revowers.- it is recommended that the State establish a signature authority qualification program for all SS&D reviewers, including those that will be the start-up staff for the SS&D byproduct '

evaluation program.

7. The State indicates that if it identifies an area whers'they do not believe that staff has -

sufficient experience. then they have in place a. process whereby the State can seek the assistance of qugified individuals. However, the State indicates that the review area (or action) in question would be assigned to those individuals. If this process will be used,.

the State must clearly explain the process, including how the process will ensure that -

these individuals are qualified, whether they will be evaluated and granted signature authority, if not granted signature authority then how that will be integrated with the concept that the certificate be evaluated and signed only by individuals having signature authority, and how the signature for the registration certificate will be handled.

8. The State has indicated that it will review incidents involving producis evaluated and :

registered by the State to determine whether the incident indicates a product fault, and -

that the State will take appropriate action. However, the State should ' commit to'n ' policy whereby, if an incident involves a products evaluated and registered by the another Agreement State, or the NRC, then information regarding the incident will be forwarded ~

to that regulatory agency, so that they can determine whether the incident indicetcs a product fault, and take appropriate action. ,

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DIVISION OF WASTE MANAGEMENT COMMENTS ON STATE OF OHIO DRAFT

_. APPLICATION FOR AGREEMENT STATE STATUS

- 13 Ohio law 3748 appears to prohibit the " restricted release" scenario for license termination -

_ that is contained in the July 21,1997, NRC decommissioning rule. This proNbition could have a significant impact on some SDMP sites in Ohio. Section 3748.01 of Ohio law-defines " decommissioning" only as unrestrected release of a property and does not include the new definition that allows for restricted release under certain conditions.

Section 3748.10(B) states that "no person shall treat, recycle, store or dispose of any low-level radioactive waste except at a facility that is licensed fo: treatment,' recycling, storage, or disposal of that waste . . .

• Thus, under this provision, a licensee would be prohibited from " disposing" of waste by having a restricted release of the' site after license termination, in addition, the Ohio implementing regulations for their radiation protection

laws refer to our regulations in effect on June 9,1997, which is before the effective date

~ for the new restricted release provisions in the license termination rule.

' The July 21,1997, NRC decommissioning rule is a Category C matter of compatibility.

Thus, States can be more stringent in their decommissioning regulations than NRC.

Ohio has stated that it could allow restricted release of a site, but would do so without terminating the license. LWhilc, ;his apprcach is in compliance with the;r existing law and regulations, it is not clear it is more stringent than our regulations, or that it meets the critena for Category C. The title of the rule is " Radiological Criteria for License Termination". and thus an Ohio approach that does not terminate the license would seem to be in conflict with the basic intent of the new decommissioning rule.~ Second, it is not clear that relying on a license is necessarily more stringent than terminating the license.

If a license is needed and relied on to assure public health and safety, that could be less stringent than the use of passive institutional controls enforced by an independent third party, the approach contained in the rule. 4 I

It is possible that Ohio will amend their existing decommissioning rule that was l promulgated before our final rule and, if so, our concems could be resolved. However, a change to Ohio law 3748,10 would also be needed to eliminate the prohibition on disposal without a license. It is also possible that their existing rule meets thE Category C standard, but given the precedent this finding would set, and the potential impacts it would have, this should be further exolored and discussed in NRC.

Section 3748.10(B) would also be in conflict with any new recycling rule that the Commission may promulgate.  ;

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2. The number of staff in the decommissioning section in the Bureau of Radiation i

' Protection may not be sufficient for the work to be performed. The section w!!! be responsible for reviewing the decommissioning of source,' SNM, byproduct and NARM facilities, in addition to overseeing SDMP sites and the DOE sites in Ohio covered by an ,

I 4 agreement with DOE (these include Femald, Portsmouth, and Mound). The 'section currently has four staff, and there are four additional positions that are not yet filled. In j the last year, we estimate that NRC staff has expended approximately 6 FTE on the SDMP and decommissioning projects in Ohio. We expect to transfer 9 SDMP or _ j contaminated sites to the State if the application is approved by the end of the year.

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I LOhio devotes 1-2 of the four person staff to DOE projects. Thus, their current staffing

' appears to be well below what is needed, and the availability of even eight full time positions appears to be a problem.

3. The application states that both guidance and inspection procedures will be developed for decommissioning, but does not reference any documents at this time (presumably because they have not been prepared yet). The following NRC documents would be useful to them in preparing their own internal procedures:

- NMSS Handbook for Decommissioning Fuel Cycle and Materials Licensees,"

NUREG/BR-0241, March 1997. This document is an overview of the -

decommissioning process and has numerous other references they can obtain.

-Inspection Manual Chapter 2002, " Decommissioning Inspection Program for Fuel Cycle and Materials Licensees" describes the procedures for conducting inspections of licensed facilities undergoing decommissioning.

-Inspection Procedure 87104 for inspecting materials facilities undergoing -

decommissioning.

In addition, the staff has developec, other guidance that explains the new license termination rule:

-NUREG-1549, " Decision Methods for Dose Assessment to Comply with Radiological Criteria for License Termination" -

! -NUREG-1505, "A Nonparametric Statistical Methodology for the Design and l Analysis of Final Status Decommissioning Surveys"

-NUREG-1507, " Minimum Detectable Concentrations with Typical Radiation Survey Instruments for Various Contaminants and Field Conditions"

4. - Under " Scope and Applicability" the document refers to several sections of Title 1 of the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA). However, Title I of UMTRCA is inappropriate for Agreement State status for the following reasons:

a. Title I authorized the Department of Energy (DOE) to undertake a remadial action program at designated sites.' Although a State role, under a cooperative agreement, was identified for States with designated sites, it was not an Agreement State role. Note that undy 10 CFR 40.2a, NRC does not license Title I sites prior to completion of rerr edial action by DOE.

b. None of the designated sites are in the State of Ohio.

c. Other than groundwater restoration achvities at designated' sites, the -

remedial action program will end on September 30,1998. DOE will have

' custodial authority for those sites, under 10 CFR 40.27_ States do not have the option of becoming the site custodian nor of regulating a DOE custodial role.

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t If the State of Ohio wants to become an f.greement State for uranium mills and byproduct material as defined in section 11e. (2) olthe Atomic Energy Act of 1954, as amended, the appropriate program to reference is auttorized in Tit!e 11 of UMTRCA.

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