ML20138J875
| ML20138J875 | |
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| Issue date: | 01/29/1997 |
| From: | NRC |
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{{#Wiki_filter:. - - _ - - - _ - _ . . . _ ____ .- -.-. - j SUPPLEMENTAL REPORT OF THE j JOINT NRC-AGREEMENT STATE ! WORKING GROUP l FOR DEVELOPMENT OF j IMPLEMENTING PROCEDURES
- FOR l THE FINAL POLICY STATEMENT ON !
j ADEQUACY AND COMPATIBILITY i OF AGREEMENT STATE PROGRAMS i i } i l l 4 l January 29,1997 i i 3,3 O I
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1 I i i q The Joint NRC-Agreement State Working Group for Development of implementing Procedures ] for the Final Policy Statement on Adequacy and Compatibility of Agreement State Programs j submitted a report on August 21, igg 6 that was circulated for comment This supplemental report summarizes the activities of the Working Group since submission of the August report, lj princupally the analysis of commeres received from the Agreement States and the public and the i modlAcetion of the Policy Statemeat and implementing procedures in response to these l comments. This supplemental report does not change the basic tenets and explanations j discussed in the August report, but does describe specific changes to the Policy Statement and implementing procedures made in response to comments roosived. Therefore, this j supplemental report and the August report should be considered in corSunction with each other. Comments were received from rrismbers of the public, the Agreement States and NRC of5ces. j Letters were received from the Organization of Agreement States, six individual Agreement State program derectors, two industry organizations and one environmental group Comments roosived j addressed the following issue areas: (1) NRC-Agreement State cooperation, (2) compatibility, (3) { oontinuation of compatibility following effectivo date of an agreement, (4) form of regulatory l requirements, (5) Integrated Materials Performance Evaluation Program and (6) categorization i scheme and categories assigned to specific rules. Attachment 1 contains the summaries of
- public and Agreement State comments and responses drafted by the Working Group. The
- Working Gr'oup also analyzed comments provided by NRC staff and this analysis is included as j Attachment 2.
- As a result of the comments, the Working Group made modifications to the draft final Policy 1 Statement (Attachment 3) and revised the draft implementing procedures in Management l Directive 5.g (Attachment 4), Handbook 5.g (Attachment 5) and OSP Intemal Procedure B.7 (Revision 1)(Attachment 6).
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- The Policy Statement was modified to include additional language to emphasize the cooperative I naiure of the NRC Agreement State relationship as indicated by the AEA, as well as to clarify I what is meant by " adequacy" and " compatibility" and the distinction between these two
- fundamental concepts. Further, the Policy Statement was edited to conform to the legal position i
that NRC does not have the authonty to stipulate to States the form that should be used to adopt
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legally binding requirements. l In addshon, the language describing categories of prograra elements needed for compatible i programs was edited and simplified. Rather than the six designations of 1,2,3.a. 3.a.S,3.b and i 3.b*, only four categories are used: A, B, C and D. Category A (formerly Component 1) { encompasses basic radiation protection standards as defined in the Policy Statement, as well as , i related signs, symbols and definitions. Category B (formerfy Component 2) are those program j elements that have significant and direct transboundary implications, such as transportation , j regulations or sealed source and device registry sheets. Category C (formerly Components 3.a j and 3.a.8) includes those program elements that would create conflicts, duplications or gaps in l the nahonwide regulation of agreement materialif not adopted by an Agreement State. States should adopt the essential objectives of program elements in this category. Therefore, there is , no need for a separate category that specifies that program elements adopted by the States ! should be "at least as stringent as" those adopted by NRC and program elements in the former ! 3.a.S component now are included in category C. Category D (formerly Components 3.b and ! 3.b*) identifies NRC program elements which do not affect compatibility. 1 With respect to rules formerly designated as 3.b*, the Working Group noted that the Policy J } i l
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I i ! Statement in SECY 95112 offers relatively detailed criteria for compatibelsty categories, but j remains silent on the identi6 cation - either exphcitly or by enumeration of specific criteria - of ; j rules necessary for adequacy. Rather, for the program element " Legislative and Legal Authonty," , j the Policy Statement indicates that "the State should have existing legally enforceable measures ! such as generally applicable rules, license provisions, or other appropriate measures, necessary , j to allow the State to ensure adequate protection of public health and safety in the regulation of , agreement material in the State." The Working Group identified this lack of specificity as an inconsistency in the Policy Statement and concluded (1) that the Commission should be advised ! of this issue and (2) that certain NRC rules not necessary for compatibility nonetheless should be l l identined as necessary because of their particular health and safety significance. During its j analysis of regulations in appbcable parts of Title 10 of the Code of Federal Regulations, the ? Working Group developed criteria' to identify such rules that are identified in the charts in OSP Intemal Procedure 8.7 (Revision 1) by the designation "M&S* in the " Comment" column (formerly i 3.b*). The Working Group concluded that the essential elements of rules so designated should
! be adopted by Agreement States for purposes of adequacy. By adopting the essential elements j of these NRC rules, the State will afford a level of protection that is equivalent to that of the NRC ;
- program; however, the State also has the latitude to be more restrictive in those circumstances it '
j deems necessary. 1 i The Working Group identified several ways of reviewing Agreement States with respect to , l program elements identified as having particular health and safety (i.e. adequacy) significance ! (but that do not meet the compatibility criteria). These are listed below, along with possible , ! advantages and disadvantages. The Working Group recommends that the Commission adopt the first ophon which the Working Group has reflected in the attached implementing procedures, j
- 1. Each State should adopt the rules on the list identified by the Working Group as "H&S."
l The criteria developed and applied by the Working Group in development of this list will i be apphed to future NRC rulemaking actions that will be added to the list in accordance l with the implementing procedures. {
- Pros
- Greater certainty and specdicsty: a prescribed list would make it easier to achieve l consistent reviews of State programs.
1 l Protection of public health and safety is addressed. i 1 l The procedures can be implemented without further staff resources to review l existing NRC rules. i I l Policy and procedures could be implemented immediately upon approval. l ' Cons: The criteria may be difficutt to apply in some cases since different scenarios may yield different results. ' ! i l j ' To be deelonsted as having partcular health and safety sienificance, an NRC rule (1) must not t e ' i required for compatibility (i.e. it is assioned to category D) and (2) its absence from an Aeroement State i program could result directly (i.e. from two or fewer failures) in exposure to an individual in excess of the j basic radiation protection standards identified in compatibility category A. The concept embodied by *2 or
, fewer" failures is that if the essential objecilve(s) of the rule were not adopted and implemented, then an i event could occur that would not have occurred were the essential objectives adopted. This alone, or in j conjuncton with at most one other event, could result in excessive exposure to en individual.
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i CrHe% differ from the approach used in the reactor area. l Determining reasonableness is subjective. i i 2. IMPEP approach Under this approach, the NRC would not conduct a specsfic review of A0reement State regulatory requwements for the purpose of adequacy (i.e. their } acceptability from a health and safety perspective). However, the NRC would, as in all cases, conduct a review of the State's regulatory requirements in order to ensure their consistency with NRC requirements designated as necessary for compatibility. Under i IMPEP, however, the NRC would examine partscular State requirements if a performance
- problem identified during a program review could be linked to a gap or problem in the 4 State's requirements.
} Pros: States would have maximum flexibility. Consistent with performance-based review philosophy. i The procedures can be implemented without further staff resources to review l { existing NRC rules. l Cons: The review would be more subjective. i ., May be difficult to implement consistently from State to State. l l q N may be more difficult to achieve consistency among programs over time. )
- 3. Specific review of NRC rules applicable to materials licensees by NRC staff to determine )'
i which are needed to provide adequate protection of public health and safety using ! different crHaria (other than the Working Group's). While adequate protection i i designations are made for rules applicable to reactors, NRC has not employed a similar li process for materials regulations. l Pros: Clearfy identifies those rules needed for adequate protection. ! IMPEP reviews will be easier and more consistent. j Cons: Addihonal staff resources would be required to develop crHeria and review
- existing NRC rules.
Full implementation of policy would be delayed until review was completed. l 4. A combmetion of 1. and 3 (The Working Group's recommendation would be implemented
- until staff completes a review of NRC rules against new criteria.)
Pros: Would permit the immediate implementation of Policy Statement. .1 Resource costs could be spread over several years. j Cons: Decisions about earlier reviews of a state may be affected after final staff review of rules.
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f f i I Changes in a rule's compatibildy category or H&S designation from the Working j Group designation to a new one based on different criteria would not be cost
- effective from either the State's or NRC's point of view.
i ( With respect to comments concoming the categorizaten of specife NRC rules, tte Working l Group re-examined each rule categorization questened in the comments and made changes as i appropriate. Working Group members generally concurred on danges (or retention of the t 1 original designation) with the excepten of 10 CFR 35.32, the medcol quakty management rule. ! In response to a recommendation from several Agreement States that the category of sechon j 35.32 be eenged to 3.b (Category D, not required for compathikty or health and safety), the Working group reconsidered the category for Section 35.32 and agrood not to change any j paragraphs from their original 3.b' classification (not required for compatibility, but required ! because of health and safety signifcance, H&S). The Working Group also agreed to add
- paragraph (a)(5) of this section to this H&S category. Two Working Group members have l provided individual views and written explanations of their positions on the categorization of this
! partmular rule and these are included as Attachment 7 and Attachment 8.
- in summary, in response to comments, some modifcations were made to the final draft Policy Statement to clarify meanings and to simplify the descriptions of the compatibility categories.
l The Working Group continues to have concem about regulations that it identifed as having j particular health and safety sigrWficance To this end, the Working Grcup recommends that such a set of NRC regulations be established and that Agreement States should adopt the essential otsectives of these regulations for purposes of adequacy. The Working Group further recommends that those NRC rules identified as having particular health and safety signifg:ance by the Working Group using its criteria should constitute an initial set of such rules and that future rules that meet these criteria should be added to it. 5
4 ATTACHMENT 1 ANALYSIS OF AGREEMENT STATE AND PUBLIC COMMENTS l
INTRODUCTION l The Working Group Report dated August 21,1996 was distributed to Agreement States and . panebsts who participated in the November 15,1994 public meeting x) Adequacy and Compatibility and a notice of its availability was published in the Federal Register on September 19,1996 (61 FR 49357). Ten comment letters were received from six Agreement State program directors, the Organization of Agreement States, two industry organizations and one environmental group. Appendix A contains a list of the commenters. i Tiw ccmments received were summarized and grouped by issue into the following six areas: i e NRC - Agreement State Cooperation e Compatibility e Continuing Compatibility e Appropriate Form of Agreement State Regulatory Requirements ; e Integrated Materials Performance Evaluation Program (IMPEP) e Categorization Scheme and Rule Charts. J This analysis contains the summary of ccmments, the Working Group's responses and le 5% were disposed. I i l l l l I i l 1 l l 1
l i l ! ISSUE: NRC - AGREEMENT STATE COOPERATION , COnWENT: l Several Agreement State commenters noted that the Policy Statement is prefaced by stating that
- it is guidance for the States and NRC, but that the implementing procedures seemed to require
- that States adopt certain items for compatibility purposes.
! RESPONSE: The Working Group was advised that the Commission does not use policy statements, in and of j themselves, to impose requirements on licensees or Agreement States. AwdG, gly, absent j implementing reguistions, any requirements imposed on Agreement States by NRC stem derectly i from the Atomic Energy Act (AEA)itself and not from the Commission's policy statements. Section 274 requires that Agreement State programs be adequate to protect public health and i asfoty and compatible with the Commission's program and that the Commission periodically j " review such agreements and actions taken by the State under the agreements to ensure j wT-;"w with" the provisions of the Section 274. Given this framework, the Policy Statement
- on the Adequacy and Compatibility of Agreement State Programs, including the associated l implementing procedures, contains the Commission's interpretation of the requirements in i
Sechon 274 and the approach that the Commission wi!! take in fulfilling those statutory obhgabons. DISPOSITION: The Polecy Statement and implementing procedures were conformed to reflect the above possbon. COMMENT: The Agreement States recommended that program elements that are to be " required" for compatibility purposes be determined jointly by the Commission and the Agreement States and that the Policy Statement be modified to reflect this, as well as emphasizing the special co-regulator re!stionship that exists between the NRC and the Agreement States.
RESPONSE
The Working Group agrees that the special relationship between the NRC and the Agreement States that was established by Section 274 of the Atomic Energy Act should be reflected in the Policy Statement. This is not only to recognize this relationship, but also to recognize that this relationship necessitates the concept of compatibility. Section 274 states that the " Commission is authonzed and directed to cooperate with the States in the formulation of standards for ; protechon against hazards of radiation to assure that State and Commission programs for ) protection against hazards of radiation will be coordinated and compatible." With a large number i of individual radiation protection programs nationwide, the Working Group recognizes that to maintain consistent nationwide regulation for certain activities some program elements must be consistent from jurisdiction to jurisdiction. These are the program elements identified as basic redishon protection standards, those with significant and direct transboundary imphcotions, and those needed to ensure that conflicts and gaps in the nationwide pattom are avoided. Because the concept of compatibility is integral to this framework and because of the statutory direction
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, provided by Sechon 274, the Working Group recommends that those program elements l
- necessary for compatibility be determined by the Commission following consideration of the ;
l advice of the Agreement States, l 4
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. i l DISPOSITION: I l l The Policy 8tatement was revised to include language specifically addressing the issue of ;
- identincahon of program elements for adequacy and compatibility and to clattfy the States' role in l l these processes. Implementing procedures in Handbook 5.g and in OSP Intemal Procedure B.7 )
l (Revision 1), also were modified to clarify the States' role in these processes. j COMMENT: 1 l Several A0reement States commented that it is generally not NRC's job to oversee implementation of federal statutes pertaining to other federal agencies and that NRC should leave this to the State and the appropriate federal agency. Another commenter questioned how NRC wlE handle the States' capabilities under the Clean Air Act. l RESPONSE: l As a general matter, the Working Group agrees with the comment. However, there are certain j l specific circumstances in which NRC has adopted regulations to ensure a coordinated approach to regulabon (e.g., the constraint rule allowing the rocission of Subpart I pertaining to the Clean Air Act) by two Federal agencies. The Working Group concluded that such regulations should be adopted by Agreement States to ensure the same type of coordinated approach by the State and a Federal ager:cy. Such NRC regulations would be assigned to Compatibility Category C based on the rationale that they are needed to avoid gaps. 1 DISPOSITION: No changes were made as a result of this comment. COMMENT: One Agreement State commenter stated that the purpose of the Agreement State program should be to tum over all regulation of agreement materials eventually to the States and that the policy statement on adequacy and compatibility should be directed at fostering independence and mwwnuting intrusion into State programs.
RESPONSE
The Working Group belie /es that determining the purpose of the Agreement State program is beyond its scope of work. However, the Working Group also notes that the Commission currenpy is addressing this issue with its Direction Setting initiative (DSI) Number 4 NRC's Relationship with the Agreement States. DISPOSITION: No changes were made as a result of this comment. 3-
l l c i ! l ConWENT: The A,W States recommended that the phrase "confkets, duplications or gaps' not be used in me Podcy Statement and that the term ' essentially identical" be changed to " essentially equivale%"
RESPONSE
The Working Group considered removing the phrase " conflicts, duplications or gaps" and decided that it should be retained since it appears in the legislative history of Section 274 of the AEA and provides some further explanation of situations that could cause a disruption of an orderly regulatory pattom. The Working Group also considered changing " essentially identical" to
- essentially equivalent" and decided to retain the original language. This decision was based on the plain ddionary definitions of the words " identical" and " equivalent" and the opinion that in the cases of (1) radiation protection standards and related definitions, signs and symbols end (2) program elements with sigrWficant direct transboundary implications that identity, rather than ,
equivaknce, was the more appropriate term.
- DISPOSITION:
No dumges were made as a result of this comment. ISSUE: COMPATIBILI1Y COMMENTS: Goveral commenters recommended that the program elements needed to prevent conflicts, duchcates, gaps or other conditions that would jeopardize an orderfy nationwide pattom of regulation of agreement materials (componerd 3.a; now designated Category C) should be included in component 2 (those with significant direct transboundary implications; now designated Category B) and be essentially identical to those of the Commission.
RESPONSE
The Working Group believes that the Policy Statement reflects the position that States should have flexibility to implement programs as they determine necessary bawd on local conditions and competing priorities. Further, program elements necessary to preverd conflicts or gaps may not necessar#y have significant and direct transboundary implications er,d would thus be inappropriately categorized according to the Policy Statement. The Working Group considered this recommendation and did not adopt it because it would limit the flexibility the States would have in implementing their programs. DISPOSITION: No changes were made as a result of this recommendation. COMMENT: This group of comments addresses the issue of whether State regulatory requirements should be identical to or more or less sinngent than the corresponding NRC requirement. 4
i i ! One commenter recommended that State regulatory requirements must always be at least as j stdngent as, or more so, than NRC's including dose limits and other basic radiation protection l standards. l ! Several commenters recommended that State regulatory requirements should ahways be the same as those of NRC and that adophon of more stringent requirements should require j noellcohon of NRC by the State and a mechanism to nohfy the regulated community. One i commenter suggested requidng prior approval by NRC for more stringent State requirements and
- that such approval be granted based on pubiec health and safety issues and another commenter
- viewed more stringent State requirements as a conflict.
) One Agreemord State commenter stated that a choice between essentially the same as NRC or ! more stdngent than NRC was not an adequate range of choices for the States and further stated l that basic radiation prote:: tion definitions, dose and discharge limits and related standards based
- on recommendations of national and intomational standard setting bodies should be identical j with remaining requirements up to the discretion of the States. This commenter also noted the language of the [ draft) policy statement that the "guidmg concept over the years since the l
- beginnmg of the Agreement State program in the area of compatibility has been to encourage j uniformity to the maximum extent practicable while allowing flexibility, who's possible, to
- accommodate local regulatory concems" and took issue with it and questioned its basis.
The Agreemord States agreed that certain requirements usually should be as stringent as those j of NRC (those requirements with a particular health and safety significance or those involving l specific statutory dirochon), but commented that State requirements should be as effective as
- the corresponding NRC requirements.
i RESPONSE: I j The Working Group recognizes that a certain degree of consistency is necessary for the regulation of agreement material on a nationwide basis. The Working Group also recognizes that Agrooment State programs require flexibility to regulate effectively since States regulate more than just agreement material and they must address local needs and priorities while i simultaneously providing a minimal framework of consistent requirements to ensure an orderty j nationwide pattom of regulation without undue disruption f.,f interstate activities. i
- The Working Group generally agreed with the philosophy outlined in the draft Policy Statement j that the 3 categories (components) for compatibility achieved a reasonable balance between
! consistency in requirements on a nationwide basis and recognition of the need for Agreement i State flexibility to meet local situations and competing regulatory responsibilities. i 4 The condstions recommended by some commenters that (1) program elements should be
- essentially identscal in all cercumstances and (2) pdor approval by NRC for any program element to be more stringent than NRC are not consistent with the Policy Statement and provide little latitude to the States in managing their programs. The Policy Statement indicates that an Agreemord State's program is adequate to protect public health and safety if its level of j protection is equivalent to, or greater than, the level provided by the NRC program. Thus, except i for items in Category A or B, States have the latitude to be more stringent if necessary to meet i local condshons The recommendation that States always be allowed to be more stringent
- (includeg radiation protection standards)likewise was not adopted by the Working Group. The i Working Group felt that the small number of requirements such as dose limits; definitions, signs, i
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l , labels, and terms needed for a common understanding of radiation protection principles; and i those droctly affecting transboundary activities should be the same from jurisdicuon to j jurisdiction. Other program elements needed to achieve compatible programs did not necessarily i need to be identical nor did they always need to be as stringent as NRC. The latter point deals j mostly with protection of public health and safety and is property addressed by the IMPEP j process. DISPOSITION: i l No chan0es were made as a result of these comments. ColmlENT: 1 ! A number of commenters requested definitions, explanations or clarifications of terms such as
" essential objective,"
- essentially identical," *in the national interest," ' disruption of regulaten on a natienal basis" and "transboundary." Related to these comments were these of Agreement States that expressed concem that equivalent terms (e.g. stochastic and probabilistic) and 1 defirwtons (e.g. reference man) which contained more up-to-date information would not be
! viewed as compatible. 1
RESPONSE
The Working Group agrees with the comments that terms used in the Policy Statement and implemenhng procedures that are important to understand and implement the Policy should be explemed and clarified The Working Group appreciates that in a highly technical field such as radiation protection, new information is constantly forthcoming and understands that a given regulatory agency may adopt more current information than others depending on timing of rulemaking pad other factors. The Working Group believes that such differences should not be viewed as not compatible, but that equivalence of the differing provisions should be demonstrated to the astisfaction of both the State and the Commission. DISPOSITION: While the Policy Statement itself is not the appropriate vehicle to provide specific direction on these issues, the implementing procedures have been clarifed to ensure that terms are defined or explained in a glossary to the Handbook and to explain that differing provisions may be compatible (i.e. there are acceptable substitutes for NRC language). ISSUE: CONTINUING COMPATlBILITY COMMENT One Agrooment State commenter expressed the v'mw that Section 274 of the Atomic Energy Act does not requre that compatibility be maintained after an agreement is effective. This position also was reflected in the recommended changes to the Policy Statement submitted by the Organization of Agreement States. 6-I
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RESPONSE
- The Working Group does not agree with this irderpretation of the AEA. Both Sechons 274d.(2) and 274g. indscate that the Commission must find a State program to be compatible with that of I NRC's in order to enter into a Sechon 274b. agreement with the State. The Working Group l agrees with the Commission's view that, pursuant to Sechon 274, an Agreement State's program f should be compatible with NRC's program for the duration of the Agreement.
i Subsection 274g. authorizes and directs the Commiubn to cooperate with the States in the j formulebon of radiation protection standards "to assure that the State and Commission programs i for the protodion against hazards of radiation will be coordinated and compatible." This { provision demonstrates Congress' intention that the compatibility between the NRC's and j Agreement State programs should be maintained on a continuing basis. I , Sechon 274j.(1) calls on the Commission to suspend or terminste an Agreement State's program if"the State has not complied with one or more of the requirements" of the Sechon 274. The { Commission believes that this phrase "one or more of the requirements," encompasses all j requirements of Sechon 274, including the requirement for compatibility. i Finally, the lack of a continuing compatibility requirement would lead to some incongruous ' results. Under subsection 274d.(2), the Commission is authorized to enter into an agreement with a State if the Commission makes both requisite findings that the State program is j compathis with the NRC's program adequate to protect public health and safety. Absent a i continuing compatibility requirement, an Agreement State could divert from having a compatible l program the day after any agreement is signed with NRC. This would render the Commission's i initial compatibility finding required by Soci. ion 274d.(2) meaningless. Given these concoms, the l Working Group agrees with the Commission's position that it does not believe that Congress i intended such meaning for the compatibility requirement. l { DISPOSITION: ) No changes were made as a result of this comment. l ISSUE: APPROPRIATE FORM OF AGREEMENT STATE REGULATORY REQUIREMENTS ! COMMENT: Several commenters expressed concem regarding the proposal, as indicated in the Working Group report and in SECY-95-112, to require Agreement States to adopt certain regulatory provisions in the form of rules as opposed to other legally binding requirements. In addition, several commenters questioned the Working Group's proposal to require Agreement States to adopt rules for regulatory provisions applicable to four or more licensees.
RESPONSE
The Working Group agrees that the relevant guidance in SECY-g5-112 and the Working Group report deserves reconsideration and clarification. The way in which a particular state imposes regulatory requirements varies greatly from state to state due to the differing administrative procedures that exist across the country. Given this lack of consistency, the Working Group recommends that the Commission employ the following approach to address the Agreement 7
, State's regulatory requirements. Agreement States should adopt those regulatory requirements l that (1) are apphcable to aN licensees and (2) nocassary for compatibility in Categories A, B, and a C, in the form of a rule or other generic legally binding requirement. The use of generic j requiremen3 wlN help to avoid inconsistency and confusion that may result from the imposition of individual requirements on a case by case basis. Agreement States have the flexibility to impose such generic requirements in a manner consistent with a State's administrative laws. In addition, l this approach does not interfere with the Agreement States' ability to impose addstional requirements (such as individual license condstions) on specific licensees when appropriate. l The Working Group believes that requirements applicable to more than a few licensees should j be adopted in the form of a generic requirement such as rule. However, as the appropriate
- approach to sud issues will depend on the types of licensees involved, NRC should review a j State's approach to sud situations (i.e., requirements not applicable to all hcensees) on a case j by case basis and communicate any concoms it identifies to the State.
4 i DISPOSITION: i i The Policy Statement and implementing procedures were changed to conform to this position. j ISSUE: INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) i l COMMENT: l J One commenter questioned how a finding of ' compatible' or 'not compatible' will be made - whether 'and condition must be met in full or . . . be, sed on something skin to a ' preponderance of the evidence' standard" noting that the Policy Statement was unclear on this point. i RESPONSE: 1 i i Compatibikty determinations will be made as part of IMPEP reviews of Agreement State l 3 programs that are done by joint NRC/ Agreement State review tes.ms using procedures that have j been developed to provide NRC staff and the Agreement States guidance in this area. l ! Generally, all program elements for compatibility need to be adopted. At the time of each review, i any question sbout compatibility is discussed between the review team and State personnel and
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- variations will be dealt with on a case-by-case basis, i ,
l DISPOSITION: ) i ! No changes werv made in response to this comment. l ! l i ISSUE: CATEGORIZATION SCHEME AND RULE CHARTS l } l COMMENT: i j Several commenters twted that the classification scheme was complex and difficult to use
- consistently.
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RESPONSE
i The Working Group realmed that w? ^11"T icategories outhned in the Policy Statement i represented a paradigm shift from the current status. Under the cunent B.7 procedure, the four i j divisions for rules (1) are apphcable only to regulations and (2) only desenbe the "dogree of l
- idenbcalness" that an Agreement State must adopt without giving a basis for why the particular ;
, regulation is required for rz,ir? " "t .iUnder the proposed compatibihty categories as outlined in l 9te Policy Statement and classification scheme in the implementag procedures, the basis for i j . determining which program elements (including regulations) are necessary for compatibility is given, as weR as the degree of identicainess that should be adopted by the State. This may
- appear to be more complex, but in reauty provides a simpler decision scheme because the basis >
for making the compatibility determinehon is factored into the process. The Working Group i recommends that each w,,74 :^!1"r/ category be assigned a letter to make it consistent with how { the adequacy program elements are designated in the Policy Statement. l i DISPOSITION: The language of the Policy Statement section on compatibility was modified to make it simpler and easier to use, implementing procedures likewise were modified to reflect these changes. ! COMMENT: l l One commenter noted that the same regulation can easily fit several categories. I
RESPONSE
The Working Group recognized that the same regulation may indeed fit more than one category ] based on the fact that many regulations are adopted for reasons of protection of pubhc health i and safety. However, the Working Group's task was to devise implementing procedures to identify those program elements necessary for compatibility as explained in the Policy Statement. ! Therefore, issues of health and safety notwithstandmg, program elements (including regulations) were sorted based solely on the compatibikty categories in a hierarchical fashion so that they j were placed in the first category for which they met the criteria. For example, the definition of '
' becquerel" was placed in the category of radiatson protection standards since it met these critona first, although it could have been placed in the third category (requirements to avoid confhets, duplications and gaps).
DISPOSITION: No changes were made in response to this comment. COMMENT: One Agreement State commented that there is nothing in the policy to suggest what specific criteria NRC will use to decide which regulations it will require the_ states to adopt.
RESPONSE
The Working Group noted that the commenter acknowledged that this comment was made on the draft published in the July 1,1994 FR notice and resubmitted for the Minal" Policy Statement
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1 a stating that there is very little difference between the two. The
- final" Policy Statement contains
- 9te general categories for w,,TC_ N iwhich should be adopted by the Agreement States.
e These are (1) radiation protection standards and closely related provisions, (2) regulatory
- requirements with significard and direct transboundary implications, and (3) regulatory I requirements that are L cessary to avoid conflicts, duplications and gaps between and among
! programs. The specific criteria for classifying Program elements are found in the implementing procedures for the Policy Statement (Management Drective 5.9, Handbook 5.9 and OSP irdemal Procedure B.7 (Revision 1)). DISPOSITION: ! No changes were necessary in response to this comment.
- COMMENT
i An Agreement State commented that $20.2201(c) should be 3.b' (Category D) rather than 3.s l (Category C) since it is hard to see why duplicate reporting or lack thereof would create a conflict
- or gap.
I j RESPONSE: i The Working Group agrees with the commenter that duplicate reporting in $20.2201(c), or lack j thereof, would not create a conflict, duplication or gap. I
- DISPOSITION.
i l The compatibilsty category for $20.2201(c) was changed to 3.b (Category D) as recommended. - 4 l COMMENT:
- An Agreement State commenter noted that the classification of 20.2205 as 3.b* (Category D,
{ H&S) needs to be clearly explained since failure to provide an individual with a report of an actual ]' exposure does not abrogate the licenspe's duty to restrict additional exposures that could lead to a totalin excess of the basic standards. i i RESPONSE: i This regulation contains essential objectives that address individual health and safety issues j involving the responsibility of regulators to insure that radiation doses with immediate potential i health effects are accurately and sufficiently reported to those affected occupationally exposed
- workers or members of the public This section does not meet the criteria for compatibility as set j
1
' As #ie result of comments, the desi0 nations for the compatibility cate0ories were changed from i tie numberAeger combinaton format to letters. The correspondence between old and new designations is:
1 = A; 2 = B; 3.s & 3.a.8 = C; 3.b = D; 3.b' = D with the identifier H&S to indicate particular health and safety
, al0niScence. Since commenters used the old system, for the sake of clarity this analysis also will use the j old terminology and reference the new category designatons parenthetically.
1 i 10-i i l
. - . - - - . _ - . - _ . . - - - - - ___.. . - - . - - . . - ..-. - _ _-- - ~.
I I ) e i ! forth in the potoy statemord and was thus cdassined initially as 3.b' (Category D, H&S). . However, the identl6 cation of this requirement as one of health and safety significance allows j States flexibuity in the written composition while still retaining the essential health and safety J l objectives. I ! l DISPOSITION l No changes were made as a result of this comment, i l COWENT: An Agreement State commenter recommended that sections 30.35 and 40.36(a), (b) and (d) for financial assurance and recordkeeping for decommissioning should be 3.b (Category D) in its entirety, not 3.b* (Category D, H&S) while another Agreement State commenter recomtrended l that sections 30.35(d) and 40.36(a), (b) and (d) for financial assurance and recordkeeping for decommissioning should be 3.a (Category C), not 3.b' (Category D, H&S) and the comment . column should say "are" instead of "may be."
RESPONSE
]
The Working Group considered the comment and continues to conclude that this requirement moots the orMoria of a provision with health and safety significance and should remain as 3.b* (Category D H&S), indicating it is not required for compatibility purposes but should be identified as one with health and safety significance. The Working Group agrees with the language change in the " Comment" column. DISPOSITION: The compatibility category was not changed as a result of this comment. The recommended wordmg change for the " Comment" column was adopted. COMMENT: Several Agreement State commenters recommended that sections 30.36(h) and 40.42(h) ; specifpng a time frame for decommissioning a site or requesting license termination should be ! 3.b (Category D), rather than 3.b* (Category D, H&S). RESPONSE: The Working Group considered the comment and continues to conclude that this requirement moots the criteria of a provision with health and safety signifcance and should remain as 3.b' (Category D, H&S), indicating it is not required for compatibility purposes but should be idenbfied as one with health and safety signifcance. , DISPOSITION No changes were made as a result of this comment. t
1 COhMENT: 3 Several Agreement State commenters recommended that for section 30.41, in the " Comment" column, the phrase *for the implementation of a coherent national program" should be replaced j with "to proverd unnecessary restriction of interstate commerce."
- RESPONSE:
The Working Group agrees with the proposed language change to clarify that there is not a
- single nahonal program However, since activibes other than commercial ones may be
- undertaken, the Working Group suggests the more general language "to provide coherent j regulation of agreement material on a nationw6de basis."
DISPOSITION: The language change was incogorated. l COMMENT: l Several Agreement States recommended that for section 35.32, medical quality management j programs, all paragraphs should be 3.b (Category D), rather than some being 3.b* (Category D, l H&S). ! RESPONSE: } } The Working Group re-examined Section 35.32 and concluded that the provisions of this section
- meet none of the objective criteria to designate it as a 1 (Category A),2 (Category B) or 3.a or 3.a.S (Category C). Upon further examination, the Working Group continued to conclude thai i paragraphs (a)(1) through (4), (b) and (c) met the criteria to be designated 3.b* (Category D, l H&S). In addition, the Working Group concluded that paragraph (a)(5) also met the health and j safety criteria, but that paragraphs (d), (e) and (f) did not.
5 } DISPOSITION: i
- No changes were made to existing compatibility categories with the exception of paragraph (a)(5)
! that was redesignated 3.b* (Category D, H&S) from 3.b (Category D). ! COMMENT: An Agreement State commenter noted that for section 36.1, the 3.a classification (Category C) j needs to be explained. l RESPONSE: The Working group concluded the irradiator types and quantitative values specified in paragraph j (b) and irradiator types specified in paragraph (c) were essential objectives of the requirements in
- section 36.1, and therefore, should be adopted by Agreement States to avoid potential conflicts
! in the natewide regulation of agrooment material. I h l 3 DISPOSITON: ) l An explanatory comment was included in the B.7 chart that was revised to state more clearly the l l reason for the 3.a (Category C) designation. I i CO N : ! ) An A0reemord State commenter recommended that section 40.42(c), (d), (e), (g), (h), (1), 0) and l { (k) decommissioning or requesting license termination should be 3.b (Category D), not 3.b* i (Category D, H&S). !
- 1 i RESPONSE: l I The Working Group has reconsidered the compatibility categories for these sections and
] condudes that 40.42(c), (d), (e), (h), 0) and (k) (that appeared twice) should remain as 3.b* i (Category D, H&S). The Working Group agrees that section 40.42(g) and (i) do not meet the ' critoria for either 3.a (Category C) or for identification as having particular health and safety l significance, j DISPOSITION: The compatibility designations for paragraphs 40.42(g) and (I) were changed to 3.b (Category D). ' i 1 i
t i j t i 1 l APPENDIX A 4 List of Commenters j l l Letter dated October 26,1996 from Judith H. Johnsrud, Ph.D., Director, Env;ronmental Coalthon 1 l on Nuclear Power,433 Orlando Avenue, State College, PA 16603. i l
- Letter dated Odober 30,1996 from Mark A. Doruff, C.H.P., Council on Radionuchdes and
%-i.,eceuticals, Inc., 3911 Campolindo Drive, Moraga, CA 94556-1551, i Letter dated Odober 31,1996 from John L. Erickson, Acting Division Director, Dvision of Rachation Protection, Washington Department of Health, Olympia, WA 96504-7627. l I
Letter dated October 31,1996 from Thomas W. Ortciger, Drector, Illinois Department of Nuclear
- Safety,1035 Outer Park Drive, Springfield, IL 62704.
a Letter dated October 31,1996 from Richard A. Ratliff, P.E., Chief, Bureau of Radiation Control, l Texas Department m' Health,1100 West 49th Street, Austin TX 78756-3169, i i Letter dated November 6,1996 from Felix M. Killar, Jr., Director, Material Licensees and Nuclear i insurance, Nuclear Energy institute,1776 i Street NW, Washington, DC 20006-3706. j l i Letter dated November 7,1996 from Michael H. Mobley, Director, Division of Radelogical Health, i Tennessee Department of Environment and Conservation,401 Church Street, Nashville, TN 37243 1532.
- Letter dated October 3,1996 from Robert M. Quillin, Chair, Organization of Agreement States, I c/o Radiaton Control Division, Colorado Department of Public Health and Environment,4300 l Cherry Creek Drive South, Denver, CO 60222-1530.
! Letter dated November 7,1996 from Thomas E. Hill, Manager, Radioactive Materials Program, j Georgia Department of Natural Resources,4244 Intemational Parkway - Suite 114, Atlanta, GA l 4 30354. 1 j Letter dated November 12,1996 from Rita Aldrich, Principal Radiophysicist, New York State j Department of Labor, Radiological Health Unit, Albany, NY 12240. 3 d 1
)
l
ATTACHMENT 2 1 i i I l ANALYSIS OF NRC COMMENTS 1 l l i l I l I l l I I
t { Addendum i i Subsequent to the submission of the January 29, 1997, " Supplemental Report of the Joint NRC-Agreement State Working Group for Development of Implementing Procedures for the Final Policy Statement on Adequacy and Compatibility of Agreement State Programs," the following revisions were niade to the Analysis of NRC Consnents. General Comments: C0ftlENT 4: iferenIKtEE?fibliEiiiiMTdifffEG1tg Psifsii!]$Wijlisiis*iihsiFs sitit16n feridifinit16KisisYthsisass f thit;fotanotheM10iCFR^ rt 3hsadiaWCliiiifisitisat" Assigned;$t 7ditationifodthekthef OIC@FREPa lslslistedi nits thefnsiiericalfclas sificationicsde?nasihotsincluded 2 la$thoseic$. asesHthaltable shouldlbelc]eair2thatithtcodeia.isigneditoj)hslothef
**c15E*PRlie81 EsPonsg ThiIld64
%s$sg !siMUUiF#30MLtMEssiiinsEEisdlWiiiidIthEf6fiiUEsChi E.MllIEi Thil tiblisisirEIFiWis6d !t61t hdis ~ ~ afeithiIbliis t fi cit
~ " ~ ^ -~ ~~~ ~ ~16nifNm*isothiE~10
~~^ ~ ' ~ ~ ^~ ?CFR~^ ~
RaLdBalbfacketspg[117 ^ Specific Comments: C0ffiENT 8: li!$sbpaFtTK?sfl10!cFRIPiW : J0420011are?slaist fied fisich[20F'Wiitif Disp 6s11;KthfiissNIEWiiisiNimiihtiTi~n tegsfy?3?ainbutithe;requirementifadtressind^^ ' s.pecifiMdtip6 TE the14ppn cr;:yriate;sa.ItAretelassified;;asMb;EWelbelieve3at,eg icate r
%fTity^Eip:;yp?
. ;r fer ::: r di:p ::1 pr:vi:ter.: r.::d: te h r:
_ a- >
RESPONSE
The Working Group reconsidered all provisions related to ::: r di:p ::1 Misiffidiidlip6sa11tRhstgsdilis!10 CFR 20.200423thP60ghT20:2005, applying critiFla"bised^oi ths Polici Stitement. The W6FkiEg^GF6 iip ~cohcluded after re-examination that its initial categorizations were appropriate. l
i 1 CopeiENT 40: 4 i liiR10!O1t!PiFtfE617pfeil6Eilyic1EisiftidTiiDiviitEWsWibs i 1 ' :lict tWsush3teresiasgesplosiveliiat#1: 4 T pyrophorici' J' s 4
$,663NahdT6h61?arei3 Neibelieveltisoiternsysh6mid tbelit%1eastta!3 fss
! 14233 4 .. Mise 6elissitliese~~ { L _ n! _181 'ti!!aino!biaJs;te smenistatgPt 6gran]sf~~~~~ ! ESMSE$ f p
~
W ~"~"vec66tdi~iditEi~3citiiEF15tissTdRtE478dfisitisEFasisFlbid i?conniitt# Wapplyt terlatbisodionith(Pol icilStatenestiMThe~ ~ 3 tail
... cosciedidiefters examinst.iosithetiftsijattii1 Na_t~ ri htlosi_
j . (301CFA!$3:23 761 d 61s43 ? and!61:41WjiheiWorkinsterosi^~ 4
.revistohiiphou b madeltii10?tFRt61123h61f42Eand4'1jg31(iii
! it 6n E!!s? parti 1sfM6rtl66sisf?61s!3TandI61~43?sers l tified ssifmei)tissithe?iritefiadorshaVin'g!pirticulaMhealth7andfiifitj ~~~~ l kigniffhancle$ikThe?Moding'Groupicsncludedithati61!613didihotdaeetistther ! compatibility
- misnificac%[stiterf((olthejetitafiglfoditticslpshialthippdijafetf~~
i
- D_ISP0_51_TI_ON_i 10M41742 isis 7dsitihit'ed [EfiH&$7shdiaTE6EisstNiif added ifdE61!431t6Tnoti thitsitilstareadficoveredibjfParty207provisionsM0the$changestaddressed~
1 6A;t3iMH&S*f]wasiassigneditojaragraphsl(a)itolpag perggg@s!(1)lahdl(jgandj0dyasiassigned jthroughi(h)hWRCrassignedito C0petENT 41: l Ths"diEsisfii1~6siniit1Ei115is4*isd?ffiin'sliTTissWsEEsTpFsilitbis7ETThst I treated?constitentlilinfthesvariousslo;CFRfPiptsBThelebanentWispectfically ' citedithe(difforencesibetsesktheiclassifisationYefR10fCFR;70!!5fandL70:38?a d pjalljQrovi s16nsil O ILCfR1PaftsjMJind;!0f~ ~~"'~~~~~~~~~~~ Msgsti 3 1 Tlii'iWslFki JGF6Ef ~ric66fid#idTs11W6V]if6si"iFilitidif67thsic~oissnt?a66VeW
. ! Group!concludedtafterTre-examinationtthat!70125fandi701381s ThilWorki I Kshsged_ ' ifort{sith3stmil%p@visiasjjn@irtsl30jasd140Lg"~~~
01s g g!0N{ ThilifE1HilffEifishiif6FI70!25~~siFi?iEssisdifsT(fdisr]P1356)Iiilth!pifiiFiphi [a)d(dbpisdsd AC151 dMHj;(fg)Yalid? assigned!?H&S;dsjiped[isMH&Si3SJo?38:ivasisha
}ij)lahd2($)lijsol ~ ~ ~ ~ ~ ~ ~ ~
The above changes have been incorporated into the comment analysis text, which begins on the next page.
i s I.
GENERAL COMMENT
8: i COMMENT 1: i The classification scheme was found to be cumbersome and difficult to apply consistently. $ RESPONSE: ' The Working Group realized that compatibility categories outlined in the Policy Statement represented a paradigm shift from the current status. Under the current B.7 procedure, the four divisions for rules (1) are applicable only to regulations and (2) only describe the
" degree of identicainess" that an Agreement State muct adopt without giving a basis for why the particular regulation is required for compatibility. Under the proposed compatibility categories as outlined in the Policy Statement and classification scheme in the implementing procedures, the basis for determining which program elements (including regulations) are necessary for compatibility is given, as well as the degree of identicainess that should be adopted by the States. This may appear to be more complex, but in reality provides a simpler decision scheme because the basis for making the compatibility determination is factored into the process. The Working Group recommends that each compatibility category be assigned a letter to make it consistent with how the adequacy program elements are designated in the Policy Statement.
DISPOSITION: The language of the Policy Statement section on compatibility was modified to make it simpler and easier to use. Impementing procedures likewise were modified to reflect these changes. COMMENT 2: A major difference between the current classification system and the proposed classification system is that the new classification system the new classification system does not establish requirements for the Agreement States to meet in order m be considered compatible. Absent specific requirements, it would mean that Or. Agreement State would never be found 'not compatible'since NRC did not dafine thoso regulations that must be adopted by the States.
RESPONSE
The Commission does not use policy statements, in and of theinsolves, to impose requirements on licensees or Agreement States. Accordingly, absent irnplementing regulations, any requirements imposed on Agreement States by NRC stem directly from the Atomic Energy Act (AEA) itself and not from the Commission's policy statements. Section 274 requires that Agreement State programs be adequate to protect public health and safety and compatible with the Commission's program and that the Commission periodically " review such agreements and actions taken by the State under the agreements to ensure compliance with" the provisions of the Section 274. Given this framework, the Policy Statement on the Adequacy and Compatibility of Agreement State Programs, t I l including the associated implementing procedures, contains the Commission's l interpretation of the requirements in Section 274 and the approach that the Commission I will take in fulfilling those statutory obligations. I DISPOSITION: j The Policy Statement and implementing procedures were conformed to reflect the above i position. , COMMENT 3: i i Having a category of program elements that is not r3 quired for compatibility, but is l required for health and safety, begs the question - was health and safety considered in any of the other classifications and if it is not health and safety related then why is it a compatibility requirement.
RESPONSE
f 1
' The Policy Statement makes a clear distinction between the fundamental concepts of
}
- adequacy" being related to protection of public health and safety and " compatibility"
- being the core requirements for consistent nationwide regulation of agreement materials.
j The Working Group recognizes that, with the exception of a few administrative matters, all i NRC regulations have an underlying health and safety purpose. However, the compatibility { category identifies those NRC regulations that an Agreement State should adopt because j of their impacts on regulation in other jurisdictions and on the regulation of agreement
- material on a nationwide basis. As such, it was the purpose of the Working Group to j
identify those NRC program elements (which includes regulations) that are necessary to i maintain compatible programs between NRC and the States. In performing this task, the l Group noted that certain NRC regulations were of a particular health and safety ! significance although they did not meet the compatibility criteria set forth in the Policy 4~ Statement. Further, the Working Group concluded that requirements for compatibility focus primarily on the effects of State action or inaction on other jurisdictions. As such, the concept of compatibility does not directly address matters of health and safety within a particular Agreement State. The Working Group, however, also recognized that certain program elements (including regulations) while important for health and safety reasons within the State (e.g. basic radiation protection standards), should be consistent nationwide primarily for the purpose of compatibility. DISPOSITION: This issue is addressed in changes to the Policy Statement and implementing procedures. COMMENT 4: In their current format, the tables were difficult to review. In places where the regulatory citation or definition was the same as that for another 10 CFR Part, under the heading
"' Classification Assigned," the citation for the other 10 CFR Part is listed but the numerical l classification code was not included, in those cases, the table should be clear that the 2
code assigned to the other section applies. s i 1
RESPONSE
1 The Working Group agreed with this comment and revised the format of the charts. , DISPOSITION: i The tables were revised to indicate the classification from another 10 CFR Part in brackets, "I]." ) 3 II. SPECIFIC COMMENTS COMMENT 1: Sections 19.14,19.15,19.16,19.18 and 19.20 should be 3.b' rather than 3.b since ! i these sections were des gned to provide workers with protected means of bringing their concerns to the agency and for the agency to maximize its means of obtaining information about the licensee's operations. A 3.b classification may lead to reducing the effectiveness of these means and, therefore, may be a safety concern. J 4
RESPONSE
The Working Group re-examined these sections using objective criteria based on the Policy i Statement and concluded that they did not meet the criteria for health and safety. However, since these provisions (with the exception of Section 19.20) were adopted by NRC to ensure a coordinated approach to worker protection by OSHA and NRC, the Working Group concluded that Agreement States should adopt the essential objectives of these sections to ensure the same coordinated approach by the Agreement States and j OSHA. 3 DISPOSITION: Sections 19.14 through 19.19 were recategorized as 3.a (Category C). 2 COMMENT 2: ? , Sectioa 20.1001(b) contains an important policy provision and should be classified as a "1."
RESPONSE
! The Working Group considered the comment and concluded that this section docs not 4 meet the criteria for Component 1 (Category Al since it is not a radiation protection standard as defined by the Policy Statement. 4 3-
Di80SITION: No changes were made as a result of this comment. I COMMENT 3: i The definition of " declared pregnant woman" in Section 20.1003 should be classified as a )
"3.a" since it is intended to ensure that pregnant women who do not want to have their ;
tradiationi duties curtailed for purposes of reducing their doses were not forced into that i position. , i RESPONSE: I The Working Group agrees with the commenter with respect to the intent of this provision. ; However, the Working Group initially designated this as Component 1 (Category A) since it i is a definition that is necessary to understand basic radiation protection principles - ) evaluation of dose to an occupationally exposed individual. As such, the Working Group I concluded that anything other than an essentially identical definition was not appropriate and that this definition should not be designated as Component 3.a (Category C). ] DISPOSITION: l No changes were made as a result of this comment. , COMMENT 4: l in Section 20.1003, the definition of " dosimetry processor" should be classified as a "2" if NVLAP accreditation is to be required.
RESPONSE
The Working Group reconsidered this definition and concluded that it does not have significant and direct transboundary implications and, therefore, do s not meet the objective criteria for Component 2 (Category B) as set forth in the Policy Statement. DISPOSITION: No char.ges were made as a result of this comment. COMMENT 5: in Section 20.1003, the definition of " entrance or access peints" should be classified as a "1" since this tiefinition was developed to avoid misunderstandings (essential definition) in connection with entry points that are not doors or windows, as well as certain partial body irradiation situations. 4
RESPONSE: ! The Working Group considered the comment and concluded that this definition was not one that was essential to understend basic radiation protection principles. However, the I Working Group did conclude that this definition was important to avoid conflicts and gaps ( between jurisdictions and Component 3.a (Catagory C) allows a State to include additional ! information in the definition. For example, a State may consider that an " access point" l would include any access to a radiation source that would allow significant extremity ; exposure (e.g. the gap distance for a materials gauge). I DISPOSITION: I l No changes were made as a result of this comment. l I COMMENT 6: j l In Section 20.1003, the definition of " individual monitoring devices" should be classified j as a "1." l RESPONSE: I The Working Group considered the comment and continued to conclude that this dafinitior, j did not meet the criteria for a basic radiation protection standard or related definition. The designation of Component 3.s (Category C) retains the essential objective of the provision, , but allows the States flexibility to add additional examples of acceptable monitoring ' devices. DISPOSITION: No changes were made as a result of this comment. COMMENT 7: In Section 20.1003, the definition of " respiratory protection device" should be classified as a "1" if Appendix A to Part 20 is to be retained in State programs. This is an essential term.
RESPONSE
The Working Group considered the comment and continued to conclude that this definition did not meet the criteria for a basic radiation protection standard as defined in the Policy Statement. The designation of Component 3.a (Category C) retains the essential objective of the provision, but allows the States flexibility to add additional examples of acceptable I respiratory protection devices. 5-
- - .. . .- - =_. - -
DISPOSITION: No changes were made as a result of this comment. COMMENT 8: i in Subpart K of 10 CFR Part 20, " Waste Disposal," the general requirements in 20.2001 are classified as category 3.a., but the requirements addressing specific disposal are classified as 3.b. We believe category 3.a., or 3.b' is the appropriate category. l
- RESPONSE:
1 i The Working Group reconsidered all provisions related to specific disposal techniques in 10 CFR 20.2002 through 20.2005, applying criteria based on the Policy Statement. The ' Working Group concluded after re-examination that its initial categorizations were !
- appropriate. '
l DISPOSITION: 1 No changes were made as a result of this comment. d COMMENT 9: l Most of the requirements in Subpart L to Part 20 should be classified as "3.b'" since the records required by this subpart provide an important means of monitoring the safety level of a licensee's program and the degree of control the licensee has over its operations. l RESPONSE. This comment was considered by the Working Group and concluded that most of the l requirements in Subpart L did not meet the objective criteria used to classify them as 3.b' ; (Category D, H&S). The Working Group did retain its initial categorization of certain i recordkeeping requirements as Component 3.a (Category C) that it deemed important to I avoid conflicts and gaps between jurisdictions. I l DISPOSITION: l l No changes were made as a result of this comment. 1 COMMENT 10: Appendix A to Part 20 should be classified as a "1" since the wording of the materialin this appendix was selected to be compatible with national and international standards. Changes in wording may lead to subtle, but important, changes in meanin.g that may in turn affect safety. i
RESPONSE
The Working Group concluded that Component 3.a (Category C) is appropriate since it ensures that Agreement States will adopt the essential objectives of Appendix A to Part
- 20. State regulators are allowed flexibility to include additional guidance (or conservatism) as may be needed in their particular jurisdictions. This Appendix cannot be Component 1 '
(Category A) since it is not a radiation protection standard as defined in the Policy Statement. DISPOSITION: ~ No changes were made as a result of this comment. 1 COMMENT 11: Section 31.5 should be classified as a "2" since without some consistency in requirements for users in NRC and Agreement States compliance with the regulations will decrease.
RESPONSE
The Working Group concluded that Agreement States should have the flexibility to regulate the devices addressed by section 31.5 more closely than is practicable under a general license. If an Agreement State does not choose to adopt a regulation equivalent to section 31.5, it must issue, specific licenses in order to authorize licensees to possess and use these devices. Since specific licensees are regulated more stringently than general licensees, consistency in the regulation of these devices on a nationwide basis will be maintained, and compliance with the applicable regulations will remain the same or increase. DISPOSITION:
)
No changes were made as a result of this comment. COMMENT 12: Section 31.6 should be classified as a "2" since most of the vendors and service companies use this general license to conduct work in other jurisdictions without the need to file pursuant to 10 CFR 150.20. l MESPONSE: The Working Group concluded that the requirement for an out of jurisdiction licensee to file a report of proposed activity under reciprocity is an administrative matter, and does not ; carry significant and direct transboundary implications in and of itself. Therefore, this ; provision does not meet the criteria for Component 2 (Category B).
] i i DISPOSITION: }. No changes were made as a result of this comment. i COMMENT 13: g Section 31.8 should be classified as a "2" based on the distribution of the product on a j nationwide basis. i
- RESPONSE
i The Working Group concluded that Agreement States should have the flexibility to regulate i the sources addressed by section 31.8 more closely than is practicable under a general
- l. license. If an Agreement State does not choose to adopt a regulation equivalent to section
- 31.8, it must issue specific licenses in order to authorize licensees to possess and use these sources. Since specific licensees are regulated more stringently than general licensees, consistent regulation of these devices on a nationwide basis will be maintained.
DISPOSITION: l
- No changes were made as a result of this comment.
1 I COMMENT 14: The comment for Section 32.2 indicates that the term " dose commitment" is superseded by Part 20. This is not true; many of the safety criteria in Part 32 continue to use this - 4 term and the regulation is based on this term. i RESPONSE:
- The essential objective of both definitions, " dose commitment" in section 32.2 and
" committed dose equivalent" in section 20.1003, is to account for the radiation exposure extended over time resulting from internally deposited radioactive materials. Both j
j definitions require consideration of the total dose to the organs or tissues in which the radioactive materials are deposited, during a 50 year period following the intake. Thus, i the definitions are equivalent, however, the part 20 definition is stated in more current . radiation protection terminology. Agreement States should adopt the part 20 definition for j purposes of compatibility, and should simultaneously amend their regulations and/or other legally binding requirements to replace the term " dose commitment" with the term , " committed dose equivalent" at each occurrence. i i i DISPOSITION: ! The language for the comment for Section 32.2 has been clarified to reflect the response ! to this concern. ' 4 3 a 3
- I 8-J 4
~
_ _ _ _ _ _ _ ~ . . _
i j COMMENT 15: i
- The term " lot tolerance percent defective" should be classified as a "3.b" since it typically is not used by Agreement States. '
l
RESPONSE
l' The Working Group agrees that most Agreement States do not use the term. However, it I is used in section 32.110, an equivalent of which should be adopted by an Agreement I State that issues licenses under requirements equivalent to sections 32.53, or 32.61. 4 Since these sections are assigned to Component 2 (Category B), it is appropriate to assign l the definition to the same category.
)
j DISPOSITION: I { The definition of " lot tolerance percent defective" has been designated as Component 2 ' l (Category B). j COMMENT 16: Section 32.24 is assigned the category "NRC" meaning that Agreement States should not
- adopt an equivalent regulation. However, section 32.51 that is assigned to Component 2 ,
~
(Category B) references section 32.24 as licada criteria. Thus, an Agreement State i adopting a regulation equivalent to section 32.51 should adopt a requirement equivalent to l' section 32.24. Section 32.24 should be assigned to Component 2 (Category B) for i Agreement States that adopt requirements equivalent to 32.51, and an appropriate
- comment added.
i RESPONSE: i a j The Working Group agrees with the comment. DISPOSITION: The compatibility category for section 32.24 has been chariged to 2 (Category B) and a t comment has been added that cross-references section 32.51. COMMENT 17: j' Section 32.11(b) and 32.13 should be classified as a "2" because of the transboundary implications. i f RESPONSE: 2 The Working Group concluded that the transboundary implications did not rise to the j significance required for Component 2 (Category B). In the absence of any description of 4 s
- i a l
specific transboundary implications that the commenter believes are direct and have such significance, the Working Group concluded that the category should not be changed. DISPOSITION: No changes were made as a result of this comment. COMMENT 18: i Why are Sections 32.72 and 32.74 classified as "2" when the uses defined in Part 35 are not a matter of compatibility and the Part 35 regulations contain limitations that distribution activity must address.
RESPONSE
The Part 35 regulations referred to in the comment that are not matters of compatibili+y 4 apply only to licensees within the jurisdiction of the adopting agency, i.e., there are n , transboundary implications. Part 35 regulations generally address requirements imposed on users, not manufacturers or distributors. The exception is section 35.11 that specifies that a license is required to manufacture or distribute materials for medical use. However, the specific licensing requirements given in section 35.12 reference only users as 1 described in sections 35.100, 35.200, 35.300, 35.400, 35.500, and 35.600. The j requirements for manufacture and distribution are specified in sections 32.72 and 32.74. Since manufacturers or distributors in one jurisdiction may supply licensees in another jurisdiction, there are significant transboundary implications for these activities. DISPOSITION: No changes were made as a result of this comment. COMMENT 10: 1 Note that Section 34.1 is classification 3.b while 34.1(b) and (c) are 3.a.
RESPONSE
There are no sections identified as 34.1(b) and 34.1(c) in Part 34. DISPOSITION: No changes were made as a result of this comment. COMMENT 20: Why are the definitions for " permanent radiographic installation" and " storage area" classified as "3.b" - this seems to conflict with the "3.a" classification for Section 34.43(a) and (c). RESPONSE: ' The Working Group believes the designations are consistent with the Policy Statement. ! The definitions of " permanent radiographic installation" and " storage area" are not captured by Component 3.a (Category C) since their absence from a state's requirements
- would not create a conflict, duplication or gap and, thus, do not meet the compatibility .
criteria of the Policy Statement. Further, they were considered by the Working Group to be sufficiently well understood in common usage that they did not need to be redefined as regulatory definitions. With respect to 34.43(a) and (c) that deal with availability of . t survey instruments and surveys, the Working Group concluded, and continues to conclude, , that their absence from a state's requirements would create a gap and, therefore, meet the l criteria for Component 3.a (Category C). DISPOSITION: No changes were made as a result of these comments. COMMENT 21: The classifications esteblished for Sections 34.4, 34.8, 34.11 and 34.32(l) seem inappropriate given the use of a footnote to establish what appears to be a conditional j classification. '
RESPONSE
The footnote initially was intended to explain the rationale for the compatibility category ; assignment for each rule. For sections 34.8 and 34.32(l), the component assigned was ; 3.b (Category D) since they are OMB approval and Part 21-related, respectively. For 34.4 and 34.11, the component assigned was 3.a (Category C) with the footnote since maintenance of records and specific licensing requirements for radiographers were considered to be necessary given the fact that radiographers frequently work in more than ; one jurisdiction. Absence of these requirements in Agreement States would result in a gap I in the nationwide regulation of agreement material. DISPOSITION: No changes were made to the compatibility categories as a result of this comment; however, to avoid further confusion the footnote was deleted. I COMMENT 22: For Sections 34.24, 34.25, 34.26, 34.28, 34.30, 34.31, 34.32, 34.33, and 34.41, the "3.a" classification, which appears to allow states to create less restrictive regulations, raises questions as to what are the " essential objectives" of these requirements. Because 10 CFR 150.20 requires reciprocity general licensees to comply with the NRC requirements, a less restrictive state requirement would create problems in this circumstance. 4 . _ . - _ _ ._. ___ __ - _ . _ _ _ _ - .i
- - - . - ~ . . . . - - ... . . - - - _ _ - -- -..-- - - - _
i } RESPONSE: The Working Group agrees with the concem expressed by the commenter relating to the , possible establishment of a less restrictive requirement by an Agreement State and the ! impact on reciprocal recognition of licenses. The Working Group believes that by adopting j and implementing the essential objectives of a regulation, an Agreement State will meet i the intent of NRC's regulation and therefore will not be less restrictive.
- DISPOSITION
- l
! A definition of " essential objective" has been included in the Glossary to Handbook 5.9 , and a more detailed explanation of this concept is included in Part VI (Additional implementing issues) of Handbook 5.9. 1 COMMENT 23: ! For Section 34.44, " Supervision of Radiographer's Assistant," the "3.b" classification 4 indicates states are not required to adopt this requirement. This aeems inappropriate and a l would create a significant health and safety concern.
RESPONSE
Since the Working Group designated the definition of " radiographer's assistant"in section ! 34.2 as component 3.b (Category D), the same category here appears to be appropriate. l An Agreement State should not be required to have radiographer's assistants if they wish 1 i to limit the cited duties to trainees for a limited time period. The Working Group believes i this is an important flexibility matter and notes that at least one Agreement Stato does not , i have radiographer's assistants. If a state wishes to have such personnel, then these < appear to be appropriate requirements. The Working Group, however, does not believo i
- that by not having radiographer's assistants that a significant gap or conflict is created. l
~
Further, health and safety do not appear to be compromised if radiography is limited to radiographers and supervised trainees.
- DISPOSITION:
! No changes were made as a result of this comment. } j COMMENT 24: 4 The definition of " authorized nuclear pharmacist" in section 35.2, section 35.6 (Human Research) and section 35.49 (sealed source suppliers) should be 3.a, not 3.b. l
RESPONSE
The Working Group reconsidered the compatibility categories for this definition and these section . They are neither radiation protection standards as defined by the Policy Statemt.t nor do they have significant and direct transboundary implications. Absence of this definition or these provisions would not create a conflict, duplication or gap in the 1
4 regulation of agreement material on a nationwide basis or create a situation that could cause an exposure of an individual in excess of regulatory limits. Therefore, the Working
- Group concluded that they did not meet the criteria for Component 3.a (Category C), nor l did they meet the criteria to be identified as having particular health and safety significance. >
a
- DISPOSITION:
- No changes were made as a result of this comment.
COMMENT 25: There appears to be an inconsistency with respect to the compatibility level assigned to a requirement versus the associated recordkeeping requirement in Section 35.53.
RESPONSE
j The requirements to measure the activity of each dosage is fundamental for protection against gross overdoses of radiation and, thus, are identified as being of particular health 3 and safety significance. The requirement to keep records does not meet the criteria to , l identify requirements of particular health and safety significance and it is covered generally in other sections of NRC regulations. DISPOSITION: No changes were made in response to this comment. !
- COMMENT 26
- In Part 36, all definitions except for that of "hradiator" are classification "3.b" which I creates general concern because of the nationwide use of irradiators by single corporations. l
RESPONSE
The Working Group recognizes the concern expressed by the commenter, and has reconsidered whether some or all of the definitions should be changed to Component 3.a (Category C). Following further review, the Working Group continues to conclude tnet the absence of the definitions in an Agreement state's requirements would not create a significant conflict, duplication or gap. The Working Group believes the definitions are sufficiently well understood in plain language terms that they do not need to be included in
- a state's regulatory definitions for purposes of compatibility.
DISPOSITION: No changes were made in response to this comment. 13-
COMMENT 27: The classification for Section 36.13 is "3.b'" which specifies criteria as stringent as NRC's while the similar provision in Section 34.11 is "3.a" which appears to allow less restrictive requirements.
RESPONSE
Both Component 3.a (Category C) and Component 3.b' (Category D, H&S -identification of a provision as having particular health and safety significance) mean that an Agreement State should adopt, at a minimum, the essential objectives of the regulation. While both provisions should be adopted by Agreement States, the different bases for these determinations lies in the regulated activity. In section 34.11, radiography frequently involves activities in multiple jurisdictions and consistent requirements on this class of licensee is needed to avoid conflicts or gaps resulting in a designation of Component 3.a (Category C). In contrast, section 36.13 applies to fixed irradiator installations and does not meet the objective criteria for compatibility Components 1,2,3.a or 3.a.S but does meet the Working Group's criteria for identification of a requirement of particular health and safety concern and the section is thus identified as Component 3.b' (Category D, H&S). In both instances, the Agreement State should adopt the essential objective of the NRC program element. The Working Group believes that by adopting and implementing the essential objectives of a regulation, an Agreement State will meet the intent of NRC's regulation and therefore will not be less restrictive. DISPOSITION: No changes were made as a result of this comment. COMMENT 28: For SectWas 36.27, 36.35 and 36.55, the classification is "3.b" indicating the states are not required to adopt these requirements. This seems inappropriate and would create a significant health and safety vacuum.
RESPONSE
The Working Group has reconsidered the compatibility categories for these three sections and agrees that section 36.27 should be identified as meeting the criteria for having particular health and safety significance, but not meeting the criteria for compatibility. The Working Group continues to believe that sections 36.35 and 36.55 should remain as Component 3.b (Category D). The source rack protection requirement in 36.35 does not meet the health and safety criteria and the personnel monitoring requirement in 36.55 is already covered by provisions in 120.1502. DISPOSITION: .The compatibility classification for section 36.27 has been changed to Component 3.b' (Category D, H&S), identifying this provision as one with particular health and safety
.. - _ - . _ - , - - - - - . - - . . . - . - - .. .. - -. - _~ .-- - . -
i l t i ! l signifmance. The compatibility categories for sections 36.35 and 36.55 were not changed
- j. m response to this comment. !
I 1 COMMENT 29: , 2 i Does the comment for Sections 36.57,36.59 and 36.63 indicate that only the I quantitative values in these requirements are the " essential objectives" that must be 1- adopted and be as stringent as NRC7 If so, considering that the requirements are ) classified as "3.b'", what is expected of the other aspects of these requirements? ! l RESPONSE: $ i The Working Group re-evaluated the comments for these sections and concluded that the !
- essential objective encompasses more than simply the numerical values in the regulations. I The numerical values must be taken in the conte- a whole provision. For example,in
- section 36.63, an essential objective of 20 mict 2 per centimeter is virtually I meaningless. Likewise, an essential objective o. ,.aCanance of pool water conductivity 4
below a certain value is also incomplete. The essential objective is to ensure that the 4 conductivity of the pool water does not exceed 20 (as opposed to another value such as - l 25 or 40) microsiemens per centimeter. However, a state should have flexibility to ensure , its licensees meet this essential objective by whatever means is most effective for it. ! DISPOSITION: The " Comment" column of the rule charts in OSP Internal Procedure B.7 (Rev.1) for these i sections have been modified to indicate that the essential objectives of these requirement ! are more than simply the numerical values specified in the regulation. l COMMENT 30: ! l In the Part 39, all definitions except " logging supervisor" and "well logging" are i classification "3.b" which creates concern given the significant transboundary implications J associated with this licensed activity. This particularly seems conflicting to the Part 39 l requirements using the definitions which are classification "3.a" or "3.b'". j
)
RESPONSE
The Working Group recognizes the concern expressed by the commenter, and has reconsidered whether some or all of the definitions should be changed to Component 3.a (Category C). Following further review, the Working Group continues to conclude that the absence of the definitions in an Agreement state's requiremer.:s would not create a significant conflict, duplication or gap. The Working Group believes the definitions are sufficiently well understood in plain language terms that they do not need to be included in a state's regulatory definitions for purposes of compatibility. DISPOSITION: No changes were made as a result of this comment. I 1 l
i 4 I
- I COMMENT 31: '
l The classification for Section 39.13 is "3.b'" which specifies criteria as stringent as j NRC's while the similar provision in Part 34.11 is classification "3.a" which appears to j allow less restrictive requirements.
RESPONSE
1 ! The Working Group has re-examined both sections cited by th's commenter. They both
- specify specific licensing requirements for radiographer (34.11) and well-loggers (39.13).
"l Because both types of licensed activity are routinely performed in more than one i
- jurisdiction, lack of such requirements on the licensee by an Agreement State could cause
)
- a gap in the regulation of agreement material on a nationwide basis. The classification of )
! 3.s (Category C) for 34.11 is appropriate and the classification of the analogous provisions I l in 39.13 should also be so classified. l 1 DISPOSITION: I Section 39.13 was assigned to Component 3.a (Category C) to be consistent with the designation of Section 34.11. COMMENT 32: 1 i Sections 39.31(b),39.33(a) and (c),39.47 and 39.49 are classified "3.b" indicating the l states are not required to adopt these requirements. This seems inappropriate and would j create a significant health and safety concern.
RESPONSE
The Working Group has reconsidered the compatibility category assignment for these sections and has concluded that they meet the criteria for assignment to Component 3.a (Category C) (note: section 39.31(b) was already so designated). Section 39.31(a) also was reconsidered and the Working Group concluded that it, too, met the criteria for Component 3.a (Category C). DISPOSirlON: Sections 39.31(a),39.33(a) and (c), and 39.49 were changed to Component 3.a (Category C) designations. COMMENT 33: The "3.a" classification, which appears to allow the states to create less restrictive regulations, for Sections 39.39, 39.43, 39.61, 39.63, 39.65, 39.73 and 39.75 raises questions on what is considered to be the " essential objectives" of these requirements. Because 10 CFR 150.20 requires reciprocity general licensees to comply with NRC requirements in Sections 39.31 through 39.77, less restrictive state requirements in these parts and in 39.33(b) and 39.35 will create compliance problems. l l j RESPONSE: !' i The Working Group recognizes the concern expressed by the commenter relating to the li possible establishment of a less restrictive requirement by an Agreement State and the : ! impact on reciprocal recognition of licenses. The Working Group believes that when an ;
- Agreement State adopts the essential objective of a program element it will, de facto, not i
- be less restrictive and thus will remain compatible. The Working Group believes that by '
; adopting and implementing the essential objectives of a regulation, an Agreement State
- j. will meet the intent of NRC's regulation and therefore will not be less restrictive.
i DISPOSITION: l The discussion of " essential objective" in the Handbook, has been modified to clarify this ; j point. COMMENT 34: { The "3.b" classification for Section 40.20 saems somewhat inappropriate considering that j the general licenses in 40.21,40.22,40.23 and 40.25 must be included. ! RESPONSE: l The Working Group reconsidered the compatibility categories for these sections and ] concluded that they do not meet the objective criteria of the policy statement for inclusion i in Component 3.a (Category C) nor do they meet the Working Group's criteria for . identification as having particular health and safety significance. Therefore, these sections are not needed for purposes of compatibility. { DISPOSITION: l No changes were made as a result of this comment. COMMENT 35: i I The "3.a" classification for Sections 40.25 and 40.60 raise questions on what is ; j considered to be the " essential objectives" in these requirements. " Essential objective" should be defined or a guideline for use developed. ! RESPONSE: The Working Group agrees with the comment. DISPOSITION: i A definition of " essential objective" has been added in the Glossary to the Handbook and the discussion of this term in the body of the Handbook has been modified to clarify its use. i i
- - . _ . . -. . ...- -. ~ . _ _ - _ _ . - - - -_._- - _-
i , 3 COMMENT 36: How are Sections 40.34(a)(1) and 40.35(d) classified?
RESPONSE
+
These sections were inadvertently omitted from the tables and are have been assigned to Component 3.b (Category D). 2 DISPOSITION: { These sectionr. were added to the tables. 4 i ! COMMENT 37: . t 3 The "3.b" classifications for Sections 40.34(b), 40.36(e) and (f), 40.41, 40.42(k), 40.62 ) and 40.71, indicating that states are not required to adopt these requirements, seem ' j inappropriate and would create a significant health and safety concern.
RESPONSE
The Working Group reconsidered the compatibility categories for these sections and continues to conclude, with the exception of section 40.42(k), that they do not meet the objective criteria for Components 1,2,3.a or 3.a.S (Categories A, B or C) nor do they meet the criteria for identification as having particular health and safety significance. The Working Group also concluded that section 40.42(k) did not meet the compatibility criteria, ; but did meet the criteria for identification as having particular health and safety significance. DISPOSITION: The compatibility category of section 40.42(k) remains unchanged as Component 3.b (Category D), but it is identified as having particular hesith and safety significance. The compatibility categories of the other sections were not changed as a result of this comment. COMMENT 38: l The classification for Section 40.61(c) is "3.b" while the similar provision in Part 34.4 is clessified "3.a." RESPONSE: i The Working Group reconsidered the compatibility categories for each of these sections ; and continues to conclude that section 34.4, which applies to radiagraphy, should be ' similarly adopted by all jurisdictions to prevent conflicts and gaps since licensees operate in more than one jurisdiction. The Working Group concluded that the similar provision in Part 40, applicable to source material, generally would apply at a fixed installation where
4 records are not subject to the same type of conditions as those for radiography and, therefore, does not meet ths criteria for compatibility component 3.a (Category C). DISPOSITION: j No changes were made as a result of this comment. l' COMMENT 39: in Section 71.4, the definitions of "close reflection by water," " fissile material," " normal form radioactive material," and " optimum interspersed hydrogenous moderation" pertain to i j fissile material which is reserved for NRC. These should be classified as either "NRC" or
" 2. "
l RESPONSE: i i it should be r.oted that NRC reserves regulatory authority over fissile (special nuclear) i materials only if the quantity involved is sufficient to form a critical mass, or greater. Agreement States exercice regulatory authority over lesser quantities. Therefore, the Working Group does not consider the category of "NRC" for the definition of the term
" fissile material" appropriate. The term " fissile material" is used in sections 71.10 and 71.12, both of which are assigned to Component 2 (Category B) and the Working Group has concluded that this definition meets the criteria for this compatibility category as well.
The term " normal form radioactive material," applies to byproduct, source, or special nuclear (fissile) material. Agreement States exercise regulatory authority over byproduct and source material and over special nuclear (fissile) materialin quantities not sufficient to form a critical mass. Therefore, the category of "NRC" is not appropriate. The definition of "special form radioactive material" meets the criteria for, and is assigned to, Component 2 (Category B) and since " normal form" is simply radioactive material in any form other than "special form," the Working Group concluded that it also met the criteria for Component 2 (Category B). The terms "close reflection by water," and " optimum interspersed hydrogenous moderation" are not used in any regulation that the Agreement States need to adopt for purposes of compatibility. The regulations in which the terms are used apply to regulatory concerns reserved exclusively to NRC and, therefore, meet the criteria for being designated "NRC." Since the definitions do not impose regulatory requirements, Agreement States may adopt such definitions as long as they are essentially identical and would not create a regulatory conflict. DISPOSITION: The compatibility categories for the definitions of " fissile material" and " normal form radioactive material" were changed from 3.b (Category D) to 2 (Category B). The definitions of "close reflection by water" and " optimum interspersed hydrogenous moderation" were changed from 3.b (Category D) to NRC. i COMMENT 40: Many definitions in 10 CFR Part 61 previously classified as Division 1 are now category 3.b. (D), including such terms as " explosive material," "pyrophoric liquid," and " stability." ; We believe the terms should be at least a 3.a. (C). In addition, 61.23, 61.42, 61.43, and 61.61 are 3.b.; we believe these provisions should be retained in Agreement State Programs. l
~
R.ESPONSE: The Working Group reconsidered the categorization of the definitions described in the comment above, applying criteria based on the Policy Statement. The Working Group concluded after re-examination that its initial categorizations were appropriate. The Working Group also reconsidered the categorization of the provisions in 10 CFR 61.23, , 61.42,61.43 and 61.61. The Working Group concluded that revisions should be made to ' 10 CFR 61.23,61.42, and 61.43 (See Disposition below). In particular, portions of 61.23 and 61.43 were identified as meeting the criteria for having particular health and safety - significance. The Working Group concluded that 61.61 did not meet either the compatibility criteria or the criteria for particular health and safety significance. i DISPOSITION: 10 CFR 61.42 was designated as H&S, and a comment was added for 61.43 to note that
- it is already covered by Part 20 provisions. Other changes addressed 61.23: "H&S" was assigned to paragraphs (a) through (h), NRC assigned to paragraphs (i) and (j) and "D" was assigned to paragraphs k and I.
COMMENT 41: The decommissioning timeliness and financial assurance provisions are not treated consistently in the various 10 CFR Parts. The commenter specifically cited the differences i between the classification of 10 CFR 70.25 and 70.38 and similar provisions in 10 CFR Parts 30 and 40. l RESPONSE: l The Working Group reconsidered all provisions related to the comment above. The Working Group concluded after re-examination that 70.25 and 70.38 should be changed to comport with similar provisions in Parts 30 and 40. DISPOSITION: The classifications for 70.25 were changed to D (formerly 3.b) with paragraphs (a), (b), and (d) also assigned "H&S:" 70.38 was changed to D with paragraphs (c), (d), (e), (g), (h) and (k) also assigned as "H&S."
1 I COMMENT 42. l Regulations in Part 71 pertaining to quality assurance requirements that affect Type B package users, such as Sections 71.103, 71.105, 71.109, and 71.111, should be classified "3.a" rather than "3.b." Sections 71.113 (document control) and 71.115 (control of purchased material, equipment and services) should be added to the charts and i classified "3.a" and "3.b," respectively. RESPONSE: l l The Working Group concluded that Subpart H addresses administrative activities that ! provide assurance that NRC licensees will meet the safety standards contained in Part 71 l and that these administrative matters are strictly between NRC and its licensees. ; Likewise, administrative requirements imposed by an Agreement State on its licensees is strictly a matter between the State and its licensees. Therefore, the Working Group ] i concluded that the Subpart H provisions did not meet the criteria for Component 3.a j (Category C) and, therefore, are assigned to Component 3.b (Category D). These l provisions also did not meet the Working Group's criteria for identification as having 1 particular health and safety significance. DISPOSITION: I No changes in compatibility category were made in restonse to this comment. Sections 71.113 and 71.115 that were inadvertently omitted frc,m the tables have been included as Component 3.b (Category D). i COMMENT 43. Staff notes that Sections 71.18,71.20, and 71.22 are assigned classification "NRC." These Sections provide generallicenses to transport fissile material, however, the general licenses are provided only for NRC licensees.
RESPONSE
Since the Agreement States have regulatory authority over fissile materials in quantities not exceeding the formula specified in 10 CFR 150.11, an Agreement State licensee presumably could have occasion to transport fissile material under circumstances addressed.by these Sections. However, since Agreement State licensees are not granted a generallicense by the NRC regulations and the_ Agreement States should not adopt equivalent regulations for regulations classified "NRC," a regulatory gap is created. The Working Group has reconsidered this issue and, based on NRC's limitation of issuance of the general licenses only to licensees of the Commission, has concluded that these se::tions do not meet the criteria for "NRC" or for Components 1,2,3.s or 3.a.S (Categories A,8 or C). Nor do they meet the Working Group's criteria for identification as having particular health and safety significance. DISPOSITION: These sections have been assigned to Component 3.b (Category D) with the stipulation that if a State does adopt such provisions that they must be essentially identical to those of NRC. 4 ATTACHMENT 3 1 Revisions Recommended to the l I Final Polcy Statement ; on Adequacy and Compatibikty of Agreement State Programs 1 bY l l 1 The Joint NRC-Agreement State Working Group ! for Development of implementing Procedures ] January 29,1997 l l l l l l l l l l
-. _- . . . . ... _ _ . _ .. . - . . _._ . . _ . - . . ~ . . . - _ . . . .-
3 Key: 1 {, Ted to be deleted is indicated by siretoomt. 4 4 4 Ted to be inserted is indicated by NEqW 1, 9 i i
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i i l POLICY STATEMENT ON ADEQUACY AND COMPATIBILITY OF
- AGREEMENT STATE PROGRAMS PURPOSE
- . .S m . a c . ms o r. me ,. m r.ru tem.essermie:semoIWredioso8#instorialsindet en whid NisWRC:
l # ! I W M 91di M C ONWhlBelen M M E pl MILSlate i . . . . . . . s Policy Statement presents l the Nuclear Regulatory Commission's pohey for the determinhietiertef the adequacy and
- compatibihty of Agreement State programs estabkshed pursuant to Section 274 oHhe-Atomic i
! Co.riii A;;;(ACA) ef O'A, ee e.r.;rdd. This Policy Statement ie-intended-teelerify NB5is the l meaning and use of the terms " adequate to protect the pubhc health and safety" and " compatible j with the Commission's regulatory program" as applied to the Agreement State program. The j Policy Statement also desenbos the poneral framework that thesommission will hs useD6 in determining ldihW9 those NRG piijrai5 elements' that Agrement State programs should implement to be adequate to protecHhe public health and ufety and to be compatible with the t Commission's l$dileisiti program. Finally, the Policy Statement reflects principles discussed in j the Commission's Statement of Principles and Policy for the Agreement State Program which
- abould be considered in conjuncien with this Policy Statement.
1 ! This Policy Statement is intended solely es guidance for the Commission and the Agreement l States in the implementation of the Agreement State program. This Policy Statement does not ! itself impose legally bindmg requirements on the Agreement States. In addition, nothing in this l Policy Statement expands the legal authority of Agreement States beyond that already granted to them by Sechon 274 of the Atomic Energy Act and other relevant legal authonty. Implementation
- procedures adopted pursuant to this Policy Statement shall be consistent with the legal
! authortbes of the Commission and the Agreement States. l l B4CKGROUND ! The terms " adequate" and " compatible" constdtkeore (SiNis~6h0Uiidisneittai concepts in the j Agreement State program authorized in 195g by Section 274 of the Atomic Energy Act of 1g54, i as amended (AEA). Subsechon 274d. states that the Commission shall enter into an Agreement ! under subsection b., discontinuing NRC's regulatory authority over certain materials in a State, provided that the State's program is adequate to protect the public health and safety and compatible, in all other respects, with the Commission's regulatory program. Subsechon 274g. authonzes and directs the Cornmission to cooperate with States in the formulation of standards to assure that State and Commission standards will be coordinated and compatible. Subsection 274j.(1) requires the Commission to review periodecally the Agreements and actions taken by
' For the purposes of this Policy Statement," program element" or' element' means any component or funchon Wier Mblis95iG ~
of a radiation control regulatory program ii4WiiiiiistsWJs saintelid defi,ch_M;
" M~inW6i that contributes to 6
implementation of that program irs #.i; ;;-72;ere a-sNd er4 prerm-tr:1 1
1 l i j States under the Aeroements to ensure compliance with provisions of Section 274. In other l words, he Commission must review the acbons taken by States under the Agreements to ensure j that the programs contmus to be adequate to protect public health and safety and compatibb l with the Commission's program.
- i i EMiUI5ci
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- wes cudipiisowenst emtec,uoire.panne neswaie. rn. esegws .
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- T i %ps:1 cei;ita Leidety@usN#4:1pessederatsie?wherbes pii6eram eleknenesid liplenastageabiichtherjudoscGons; A AMQUACY i
i An Agreement State's radiation control program is adequate to protectem public health and
- safety if administration of the program provides reasonable assurance of protection of the public health and safety in regulatin) the use of source, byproduct, and small quantities of special nuclear material Section 274b. of the
- AEA. EdWY(hereinafter frisiil" agreement Hi material") as identified by'MsegGiot6If 3 sW61 sib
.y 5iiaNordsifbi, g tie'Tpr6psg'eWrF6(
y NRC'sy r 1 ~ ypelwhosahMasfiti?qhh#veres IsetWolection]itNesc health'iniristeti { tya siste programshoddkW ! pMW6 provide reakn61s*sissluWilerW kWgreaterMLahdisefety,'in ierarioibr swetectioriof;pd8c thanl#w level proWided by i normemord wor 6eram'shotAtconteiriKiGesentieuwoorantelementOdsinsAnd below; th6t ! Commission will u to define the scope ofits reviews of i W Agreement-State p'rograms. The Commission Ri5 will also consider, w other aspoets @ elshiiWi of an Agreement State pre,rer., ad e; isr/a e- ) regulatone, whdi appear to affect the program's abikty to provide reasonable assurance of j pubbc health and safety protechon Such consideration will occur only if concems arise.
- 4
- E! LEGISLATION AND LEGAL AUTHORITY 8 tate statutes should.
1 i i af authorize the State to establish a program for the regulation of agreement l ! material and provide authority for the assumption of regulatory ; } responsibility under an Agreement with the NRG Copimhiilih, l 1
! 2 s
I i
4 i b:N authorne the State to promulgate regulatory requirements necessary to
- provide reasonable assurance of protection of the public health and safety; i
e:N authorne the State to license, inspect, and enforce legally bindmg requirements such as regulatsons and licenses; and i 4R be otherwise consistent with Federal statutes, as appropnate, such as
- Pubic Law 95-604, The Uranium Mill Tailmgs Radiation Control Act (UMTRCA).
1 in addition, the State should have existing legally enforceable measures such as generally l appleable rules, license provisions, or other appropnate measures, necessary to allow the State i to ensure adequate protection of ths health and in the ulation of_ reement i materiale in the State i .. 31889 M _.M" 9tatesshoisdadossthi:sesenssi
~ ti:
f.E UCENSING The State should conduct appropnate evaluations of proposed uses of agreement material, before issuing a license, to assure that the proposed licensee's operations can be conducted safely. Licenses should provide for a reasonable assurance of public health and safety protection in relation to the licensed actnntees. 64 INSPECTION AND ENFORCEMENT The State should periodecally conduct inspections of licensed activities involving agreement material to provide reasonable assurance of safe licensee operations and to determine compliance with its regulatory requirements. When WilWiiiil6MRtis necessary lii#ifttals, the State should take timely enforcement action against licensees through legal sanctions authorized by State statutes and regulations. l 44 PERSONNEL l 1 The State should be staffed with a sufficient number of qualified personnel to implement its i regulatory program for the control of agreement material. l l 6E RESPONSE TO EVENTS AND ALLEGATIONS The State should respond to; and conduct timely inspections or investigations of incidents, reported events, and allegations involving agreement material [dlhinM8(aWiStedench to enowecontmuing M reasonable assurance of protection of the public health and safety. D. COMPATIBIUTY Ar' Agreement State radiation control program is compatible with the Commission's regutcy program when its program does not create conflicti, duplicationi, gaps, or other conditsons which %iildjoopardue an orderty pattom in the regulation of agreement material on a rM - "i basis. ;r, LT+;..Te,4;.4 .;; 0epp eed, te ee,T+.0;;;ty, fa OeT..T.;ee;er, wi" = 3
d i l I ^ ^ ' ~ " ' ' ^' unnamadr..r.; e T- ^ c.; ;;a-:+an?.. N'ii(M'ZWie B(iliilli$iBitTddhi@ embmann-
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- gM a litnited number of definitions, signs, labels and scienti6c terms which BM are necessary for a common understanding of radiation
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~
(e.g., transportation regiarements b]Glill66s~~dhif*siibsilidGiselhiiliti91ce
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OnMidlei) that dweetly involve such activities idrectly. JhiA0resfinint.81sts'i Ei85Ef165FMEMMC6fsmis.siors og Imm_t~otzA._488,M, a_ _ _ PJ. .tCORM.E._ONENis rer e:: et.er r.g b: bas Wr4 eLa.ea;.,
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_s,_,__ __ . 5 ..gr......._.__._._._._I..s 5 _ . . _ , a.__. __ _, _ ~ _._ s v .. %,, ts . .W., G ;, . EdWW Commission re. b'bae er4 program elements (e.g., reciprocity procedures) that are important for an Agreement State to have in order to void conflicts, duplications, gaps, or other conditions which Filwodd jeopardize an orAfy pattom in the regulation of agreement material on a nationaliilde basis. Guch Agreement State regeb;bae er
,,r.wie. T. :':T.ent $leOralf$'liiNEMEshdB4~eihtidiFheIsTirdial ot5ibilveTdi need-not-be-identiceHe the corresponding Commission rey L;.eae ei program elements, b e 'e.,
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s i l t
- U.I M M M M f D RlC N E n M
- The Agr,eement Stat,e shouldfieve M flexibility to adopt and implement M~4558'eiinsI MNjgd Commission re-;;1'
- E:Se u.4 E.re re.T.v :':.T.ere M :If:::T. te (other than i those r-e-::::: y te .T ;r/J.. eTL 2"ri, ee identified in 0.1, 01, erd 0.0.e WijWgabove) i
(. 3- } e. A AF.ers 74 ~::: .T i ef-: t er.d ;..-,:' T.er.; er.e; regt::f:{.; ud { elements within the State's jurisdiction that are not addressed by NRC. A:l r ;'-I:;; u.4 iT.we ee..c.d .r. der OO 2.;;d eTp. erd ; ;; {
- umaawumusumusuuuuputmanuensmusammuummuuuuuuuu mempwamumm aussuesuuvawww, E be compatible with those of the Commission (i.e., must % not create
- conflictR. dupleaboni, gaps, or other conditions which Ksgedd jeopardute an orderty pattom in the regulation of agreement material on a nationalblMe basis);
l in ein: , CT"C" r-:,,-d: :. e W.,mMCI ccvered w. der it.:s. I easte-1 Ed- E precludes, or effectively precludes, a practice 8within the national intemst ! without an adequate public health and safety or environmental basis related to radiation protection; or Re- M precludes, or eff:ectively precludes, the ability.of the Commission to evaluate the effectiveness of the NRC and Agreement State programs for agreement material with respect to protechon of public health and safety. l NMD6hC@$1 din $ I .;'.'i, t To foster and enhance a coherent and consistent nationalSilii program for the regulation of agreement material, the Commission encourages Agreement States to adopt and implement e;rr." : re-;;-E':t;er.e u.4 program elements which $9d are pattemed after those ed and implemented the Commission. "fsithail~5E%#fiisiiif8tatFs
~KingsrigMEGlei Tid 60{ InflecM~ Sisleict$ gallon;ts fain:adequaisosamM ,
. eisoraneidtili By adopting the criteria for uncy and compatibility as discussed in this Policy Statemord the Commission intends-to . provide Agreement States with a broad range of flexibility in the administration of an individual programi. In doing so, the Commission seeles-te allowR Agreement States to fashion their programs so as to reflect specif'c State needs and a . Practice" means a use, procedure, of activity associated with the application, possession, use, storage, or disposal of agreement material. The term " practice"is used in a broad and encompassing manner in this Policy Statement. The term encompasses both general activities involving use of radioactive materials such as industrial and medical uses and specific activities within a tractice such as industrial radiography and brachytherapy.
5 l
-- - . _ . . . . - -- ._- - . . . . .= ---.-- - ___--- - - _ _ . - . . .
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l .. f W6SBuruqNMMMJS89dIAblWitTMi5EEUlii5 I '
'...K,6 The Commission intendeio $$ mirumize the number l of NRC regulatory requrements that the States will be requested to adupt in an !
- identicalmannersesfeewiteff.e ' . compatibility componente. At the same time, M these compatibikty components ENKliilis will allow the Commission to ensure
- totan pattam for the regulation of agreement meterial exists acroseihe l
! eeuntry .. The Commission believes that this approach achieves a proper balance ' 4 between the deswe M for Agreement State flexibility and the need for coherent M I j N regulation of agreement material across the country. l 4 l
- )
i 4 } i ) 3 i I l I l i l 1 l 1 I I ! \ l l i ! I i T l 4 4 4 i N I 4 I 1 l j 6 i 1 4
ATTACHMENT 4 l l l i
4-s --a , ma _.-,+_.u-4__s: _ *.m . ..-s-,- a 4 , . _.m,... _d.r A4 _ _ . , _ - --_4--_ 6 4a I 4 ! l 1 l t Adequacy and Compatibility i of ~ Agreement State Programs l Directive 5.9 l i
i Volume 5, Governmental Relations and Public Affairs Adequacy and Compatibility of , ! Agreement State Programs Directive 5.9 4 1 i a ! Contents i ! Poucy..........................................................................................1 i
! 1 l Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 l f
i i
- Organizational Responsibilities and Delegations of Authority ................ 2 i
Executive Director for Operations (EDO) .................................. 2 t j Director, Omce of State Programs (OSP) .................................. 2 l Omce of the General Counsel ................................................. 3 J t Director, Omce of Nuclear Regulatory Research (RES) ............... 3 l l Director, Omce of Nuclear Material Safety l and Safeguards (NMSS) ............................................... 4 l 4 i ! j Director, Omco for Analysis and Evaluation ! of Operatic,nal Data (AEOD) ................................................ 4 i 4 j Regional Administrators ....................................................... 4 i i Applicability .............................................................................. 4 J t Handbook .................................................................................. 5 1 II References ................................................................................. 5 I 1 i d
J l 4 U. S. Nuclear Regulatory Commission . Volume: 5 Governmental Relations and Public i j Affairs OSP l 1 l Adequacy and Compatibility of Agreement State Programs Directive 5.9 Policy (5.901) R is the policy of the U.S. Nuclear Regulatory Commlulon to evaluate l Agreement State Prognuns established pursuant to Section 274 of the i Atomic Energy Act (AEA) of 1954, as amended, for adequacy to protect l public heald and safety and compatibility with NRC's regulatory program. ! l Objectives (5.9-02) , o To establish the process NRC staff will follow to detennine when a proposed or final Camml= Ion regulation or program element should be i adopted as a legally binding requirement by an Agreement State and whether adoption is nquired for the purpose of compatibility or health and safety as set out in the Policy Statement on Adequacy and Compatibility of Agreement State Programs. (1) Approved: (Date) 1
! U. S. Nuclear Regulatory Commission l Volume: 5 Governmental Relations and Public ! Affairs OSP i e To identify Commission ngulations and program eleents that must be ! ';'= rM as legally binding nquin===tm by an Ap a# State to ! = mat =fala a program that is adequate to protect public health and safety l and compatible with NRC's regulatory program. (2) e To describe how NRC staff should apply provisions of the Policy Statement l to curnat and future Ayant State regulations and program elements. l 0) t l Organizational Responsibilities and l Delegation of Authority ! (5.943) ( l Executive Director for Operations (EDO) (031) ) j Ovenees the program to evaluate adequacy and compatibility of Agnement State i Programs. i ! Director, Office of State Programs (OSP) l (032) 1 l e Reviews the adequacy and compatibility of Agreement State programs j through the Integrated Materials Performance Evaluation Program . (Management Dinctive 5.6). (a) e Reviews, evaluates and determines, in coordination with other NRC offices,
- those NRC program elements that an Agreement State should adopt for l compatibility or adequacy. (b)
I
\ } Approved: (Date) 2 e
i
.U. S. Nuclear Regulatory Commission Volume: 5 Governmental Relations and Public Affairs OSP 1
1 e Amists in the nylew, evaluation, and determination of those NRC , regulations that an Agrm==nt State should adopt as a legally binding l requirmnent for the purpose of compatibility or health and safety. (c) ! 1 o Coordinates, with other NRC omces, the nylew of Agreement State l regulations and program danents. (d) l Offte of the General Counsel l (033) l l e Assists in the review, evaluation, and determination of those NRC program j elements and regulations an Agnement State should adopt for the purpose l of compatibility or health and safety. (a) I o Advises staff on findings regarding the adequacy and compatibility of I Agreement State regulations and program elements. (b) Director, Office of Nuclear Regulatory Research (RES) (034) e Reviews, evaluates, and determines those NRC regulations an Agreement State should adopt as legally binding requirements for the purpose of compatibility or health and safety. (a) l e Assists in the review, evaluation, and detennination of those NRC program ! elements an Agreement State should adopt for compatibility or health and I se,fety. (b) Approved: (Date) 3
! U. S. Nuclear Regulatory Commission ! Volume: 5 Governmental Relations and Public
- Affairs OSP Director, Office of Nuclear Material Safety and Safeguards (NMSS)
! tess) Amists in the review, evaluation, and determination of those NRC program j ha and regulations an Agrs====t State should adopt for the purpose of
=npa*Ihtney or health and safety.
Director, Office for Analysis and Evaluation of Operational Data (AEOD) < (GM) i Assists in the review, evaluation, and determination of those NRC program i elements and regulations an Agreement State should adopt for the purpose of l compatibility or health and safety, t
- Regional Administrators Assists in the mvlew, evaluation, and determination of those NRC program j elements and mgulations an Agnement State should adopt for the purpose of
- compatibility or health and safety.
1 i ! Applicability I (5.9 04) ! The policy and guidance in this dinctive and handbook apply to all NRC j employnes who are msponsible for and participate in the review and evaluation of j Agnement State regulatory programs or are involved in development and promulgation of NRC regulations or program elements for byproduct, source, and special nuclear materials. Approved: (Date) 4
4 1 1 U. S. Nuclear Regulatory Commission j Volume: 5 Governmental Relations and Public 1 Affairs OSP ! Handbook ! s.se i Handhook 5.s describes the creeria and the process that will be used to
; detennine the comapatibility and health and safety components of NRC j regulations and program elements an Agreement State should adopt for en adequate and compatible program.
l References i s.Sm) l l Mde 10 of the Code of Federal Reguladons j Management Directive 5.6, " Integrated Materials Performance Evaluation l Program GMPEP)." 1 l 'Mnal Policy Statement on Adequacy and Compatibility of Agreement State i Programs,' dated [ insert effective date). ! 'Mnal ' Statement of Principles and Policy for the Agreement State Program' and j ' Procedures for Suspension and Tennination of an Agreement State Program,' " l dated [ insert effective date). l l i, i 1 1 ( Approved: (Date) 5 i i I 4
ATTACHMENT 5 l l l 1 1 1 i i 1 i l J
4 i i
- Adequacy and Compatibility
- i. of Agreement State Programs 4
0 4 Handbook : l 5.9 i i i l I i 4 1
- a l
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- l 1
1 i i e
i
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! l ! Part I i l Introduction i Overview (A) l h Policy Statement on Adequacy and Compatibility of Agreement State Programs (Policy j Statement) sets forth the approach that the Commission will use to determine those program j elements that should be adopted by an Agreement State to maintain an adequate and co.s+.tible . program. This handbook describes the speci6c criteria and process that will be used to identify < the compatibility categories of those NRC program elements that should be adopted and
- '--7 W by an Agreement State for purposes of coer+.titshty, es well u for is..@ir.g those i j program elements that have a particular health and safety sich=~ It further describes how
- NRC staffis to nely the provisions of the Policy Statement to current and future Agreement i State program elements for purposes of compatibility. However, the overall determination of l adequacy and compatibility for an Agreement State is made pursuant to Management Directive
- 5.6, b Integrated Materials Performance Evaluation Program (IMPEP).
l l Policy Statement on Adequacy and Compatibility of Agreement State j Programs (B) l An Agreement State radiation control program is compatible with the Commission's regulatory j program when the State program does not create conflicts, duplications, gaps, or other conditions that jeopardize an orderly pattern in the regulation of agreement material (source, byproduct, and l small quantities of special nuclear material as identi6ed by Section 274b. of the AEA) on a nationwide basis. As a general matter, compatibility focuses primarily on the potential effects of ! State action or inaction either on the regulation of agreement materid on m entionwide basis or on , otherjurisdictions. h concept of compatibility does not, however, directly address matters of l health and safety within a particular Agreement State; such matters are address 3d directly under j adequacy. Further, basic radiation protectidi standards and program elements with i transboundary implications, although important for health and safety within the State, should be l uniform nationwide for compatibility purposes. (1) i ! An Agreement State radiation control program is adequate to protect public health and safety if ; administration of the program provides reasonable assurance of protection of public health and
- safety in regulating the use of agreement material. & level of protection afforded by the j program elements ofNRC's materials regulatory program is presumed to be that which is j adequate to provide a reasonable assurance of protection of public health and safety. A subset of l one of the Sve elements identified to help provide such reasonable assurance is legally binding i requirements addressing protection of public health and safety within the State. (2) i 1 4 Approved (Date) 1 4
} i i _ _ . . . _ . . _. ___
I I; 1 } Based on the PoEcy Statement, NRC program elements (lad"Ag regulations) can be placed into
- four compatibility categories. In addition, NRC program elements can also be identiSed as having particular health and safety signi6cance or u being reserved solely to the NRC. These are summarised below. (3) i CompatibBity Category A (a) 1 4
NRC probram elements in Category A are those that are basic radiation protection standards and j scientiSc terms ard A.LOGws that are necessary to understand these concepts. The language of
- such program elements adopted by an Agreement State should be essentially identical to that of j NRC to provide uniformity in the regulation of agreement material on a nationwide basis.
Compatibuity Category B (b)
- NRC program elements in Category B are those that apply to activities that have direct and i
si,.L.ot transboundary implications. An Agreeraent State should adopt program elements i essentially identical to those of NRC. i CompatibBity Category C(c) ) NRC program elements in Category C are those that do not meet the criteria of Category A or B, j but the essential objectives ofwhich an Agreement State should adopt to avoid conBict, duplication, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. An Agreement State should adopt the essential j objectives of the NRC program elements. I i Compatibuity Category D (d) ! NRC program elements in Category D are those that do aot meet the compatibility criteria set
! forth in the Policy Statement and, thus, do not need to be adopted by Agreement States for ! purposcs ofcompatibility.
1 1 Health and Safety (e) l *Ihese are NRC program elements that are not required for compatibility by the criteria of the ] Policy Statement (i.e., Category D), but that have been identified as having a particular health and l l safety role (i.e., Wa7) in the regulation of agreement material within the State. Although not ! I ' required for compatibility, the State should adopt program elements in this category based on ! those ofNRC that embody the essential objectives of the NRC program elements because of l particular henhh and safety considerations. i i 3 l Approved (Date) 2 i
~
Endedre to the NRC(f) l These are NRC program elements that address areas that cannot be relinquished to Agreement ! States pursuant to the AEA. l l
)
l l J i Approved (Date) 3
Part II Categorization Criteria Several criteria are necessary to determine the compatibility category for NRC program elements. These are established in this part and are to be used in conjunction with the series of questions in Part III and the flow chart in Appendix A. Definitions for commonly used terms are compiled in Part VII(Glossary). Criteria (A) i Compatibility Category A (1) To be included in Category A, an NRC program element is to be generally applicable and is to be l a dose limit or a related concentration or release limit or a scientific term, definition, sign, or label I that is necessary to understand basic radiation protection principles (basic radiation protection standard). (a) Examples include, but are not necessarily limited to: (b) e public dose limits (e.g.,10 CFR 20.1301) plus any regulation that relates directly to these dose limits (i) l e concentration and release limits (ii) l e occupational dose limits (e.g.,10 CFR 20.1201) plus any regulation that directly ! relates to these dose limits (iii) e { doselimits in 10 CFR 61.41 (iv) .
- radiation symbol (v) e caution signs and labels (vi) l e scientific terms (e.g., conventional and Syst6me Internationale units, definitions of types of radioactive material) (vii) e definitions needed for common understanding (e.g., restricted area, year, stochastic)(viii)
Compatibility Category B (2) To be included in Category B, an NRC program element is to be one that applies to activities that have direct and significant effects in multiplejurisdictions. (a) l Examples include, but are not necessarily limited to: (b) i e transportation requirements (e.g., low level radioactive waste manifests, packaging requirements)(i) I Approved (Date) 4
1 i i I ) e requirements for approval ofproducts that are distnhted nationwide (e.g., sealed j
- i. sources and devices) Gi) ;
j e definitions of products (e.g., sources and devices) that licensees routinely transport
- in multiplejurisdictions(iii)
- e content and format of sealed source and device registration certificates. Ov) 2 i Compatibuity Category C(3) ,
i To be included in C*g~y C, an NRC program element is to be one, the essential objective (s) of which an Agreement State should adopt to avoid conflicts, duplicatics, or gaps in the regulation
- of ayeement material on a nationwide basis and that, if not adopted, would result in an
- undesirable consequence Definitions of"ema%" " duplication," and " gap" are included in Part
! VH (Glossary). (a) Examples of undesirable consequences include, but are not r-*==arily limited to: (b) l e exposure to an individual in a different jurisdiction in excess of the basic radiation i protection standards established for compatibility in Category A, above; 0) . j e undue burden on interstate commerce (e.g., additional recordkeeping or training : l requirements); Gi) ) e preclusion of an effective review or evaluation by the Commission of the NRC and : ( Agreement State programs for agreement material with respect to protection of l public health and safety;(iii) i e preclusion of a practice in the national interest; Oy) ;
- e absence or impairment of effective communication; (v) j e lack of minimum level of safety for agreement material - containing products i
distributed nationwide;(vi) j e disruption of the regulation of agreement material on a nationwide basis. (vii) ! l l Examples of program elements in this category include, but are not necessarily limited to: (d) l ] e reports oflost or stolen agreement material or misadministrations (i) i e radiation surveys for industrial radiographers and well-loggers (ii) l e documents and records required at temporaryjob sites. (iii) i j l Compatibuity Category D (5) i i NRC program elements that do not meet any of the criteria of Category A, B, or C, above, are Category D and are not required for cornpaWlity purposes. (a) l l e i . Approved (Date) 5
1 Henkh and Safety (6)
- An NRC program element that is not required for compatibility and could result directly (i.e.,2
; or fewer failures') in an exposure to an individual in excess of the basic radiation protection standards in Category A ifits essential objectives were not adopted by an Agreement State is identified as having particular health and r.afety significance. (a)
Examples of such program elements include, but are not necessarily limited to: (b) o requirement for irradiator interlocks (i) e safety checks for medical teletherapy facilities (ii) e package opening procedures. (iii) i i I i d ] i l i 1 The concept embodied by "2 or fewer failures" is that if the essential objectives of the program element were not adopted and implemented, then an event could occur that would not have taken place were the essential objectives adopted This alone, or in conjunction with at most one other event, could result in exposure of an individual in excess oflimits set by basic radiation protection standards. l Approved (Date) 6
i l 1 i Part III l Categorization Process for NRC Program Elements The protocol to be used to assign a compatibility category to NRC program elements or to identify a program element as having particular health and safety significance is diagramed in the i flow chart in Appendix A. The basis of the flow chart is a senes ofquestions that are listed
]
below. Each program element is tested by asking the series of questions below in the order given. 1 The answers to these questions determine the compatibility category for each NRC program element or identify it as having particular health and safety significance. (A) Question (1) Do the essential objectives of the program element address a regulatory area reserved solely to the authority of the NRC7 If the response to the question is "yes", the compatibility category is "NRC." If the response to the question is "no," then proceed to Question (2). (1) Question (2) Do the essential objectives of the program element address or define a basic radiation protection standard as defined by the Policy Statement or is it a
' definition, term, sign, or symbol needed for a common understanding ofradiation protection principles? If the response to this question is "yes", the compatibility category is "A." If the response to the question is "no", then proceed to Question (3).(2)
Question (3) Do the essential objectives of the program element address or denne an issue that has a significant, direct transboundary implication? If the response to this question is "yes", the compatibility category is "B." If the response to the question is "no", then proceed to Question (4). (3) Question (4) Would the absence of the essential objectives of the program element from an l Agreement State program create a conflict or gap? If the response to this question is "yes", the compatibility category is "C". If the response to the question is "no", ; then the compatibility category is "D" and proceed to Question (5) to determine I whether the program element should be identified as having particular health and safety significance. (5) Question (5) Would the absence of the essential objectives of the program element from an agreement state program create a situation that could directly result in exposure to an individual in excess of the basic radiation protection standards found in compatibility category A? If the response to this question is "yes", the program element is not required for purposes of compatibility, but is identified as having particular health and safety significance. (6) l Approved (Date) 7
Part IV
- Applicability to NRC Program Elements Current NRC Program Elements (A)
The compatibility category and identification of particular health and safety significance for current Commission program elements that are applicable to the regulation of agreement materials are found in OSP Internal Procedure B.7 (Revision I), " Compatibility Categories and Health and
- Safety Identification for NRC Regulations and Other Program Elements." B.7 will be updated periodically as Snal rules are published.
Future NRC Regulations and Program Elements (B) j The compatibility category or identification ofparticular he-ah and sathty signi6cance of a proposed rule is to be suggested at the time the rulemaking plan is formulated and is to be ~ coordinated with the Agreement States according to Management Directive 6.3, "The Rulemaking Process." Staffis to use Management Directive 5.9 to determine the compatibility 4 category or to identify particular health and safety significance for each draft rulemaking plan. OSP Internal Procedure B.7 (Revision 1) will be revised to incorporate the results of these determinations after the final rule or program element is adopted. Approved (Date) 8
; PART V Applicability to Agreement State Program Elements 4
Current Agreement State Program Elements (A) Regulations (1) ! NRC regulations that had not been required for compatibility according to OSP Intemal Procedure B.7, " Criteria for Compatibility Determinations," but, pursuant to the new Policy Statement, are included in compatibility categories A, B, or C or are identified as having health and safety significance should be adopted by the States with an effective date within three years of : the effective date of the Policy Statement and implementing procedures. (a) NRC regulations that had been required for compatibility according to OSP Internal Procedure B.7, but will not be required under the Policy Statement do not require any action by the States.
- (b) l' In addition to the foregoing, if an Agreement State's regulations had been evaluated using OSP Internal Procedure B.7 and NRC's program review procedures prior to the effective date of the l Policy Statement and found
- (c)
{ e to be compatib'e, then no furtlw action is required by the State; (i) J e to be not compatible, then the regulation deemed not compatible should be changed to conform to the Policy as expeditiously as possible, but not later than three years after the Policy's effective date; (ii) e not to have adopted a regulation in compatibility category A, B or C, then the j regulation should be adopted as expeditiously as possible, but not later than three
- years after the Policy's effective date or other date set by the Commission. (iii)
Program Elements (2) , I Program elements other than regulations had not been identiSed previously for purposes of t compatibility or for having health and safety significance Such program elements now identified under the new Policy Statement should be adopted and implemented by the States within six
, months of the effective date of the Policy 5tatement and implementing procedures. If, due to other factors, an Agreement State cannot adopt and implement such a program element within the six month time frame, then the Sate and the Commission will agree upon a mutually acceptable I ! timetable for adoption and implemotation.
i t Approved (Date) 9 l
l l Future Agreement State Program Elements (B) ! General (1) Any changes to Agreement State program elements aRer the effective date of the Policy Statement should conform to the Policy Statement and impiar=*ia: procedures set out in this handbook. Future Regulations (2) Proposed and final Aer w.: State regulations for agreement materials that will be submitted to the NRC will be reviewed in accordance with guidance provided in OSP Internal Procedures, D.7, " Reviewing State Regulations" and B.7 (Revision 1), " Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements." Results of the . evaluation will be transmitted to the State in accordance with OSP internal procedures. Note: i The overall determination of the adequacy and compatibility ofindividual Agreement State programs will be made in accordance with Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Future New or Changed Program Elements (3) ; NRC staffwill review the adoption and implam--wion of any new or revised (non-regulation) program element by an Agreement State in accordance with the. Integrated Materials Performance - Evaluation Program review procedures set out in Management Directive 5.6 at the time of the next regularly scheduled review. ; i EvaSetion of Applications for Agreement State Status (C) NRC staffwill apply the compatibility and health and safety categorization criteria and process in this handbook when reviewing the regulations and program elements contained in applications for l Agreement State status submitted aRer the effective date of the Policy Statement. Approved (Date) 10
! PART VI l AdditionalImplementing ISSUES i Use of Management Directive 5.9 and Bandbook 5.9 (A) i i For IMPEP reviews of States in accordance with Management Directive 5.6, review teams will i use Management Directive 5.9 to aness the status of the State's program elements with respect to those that should be adopted for compatibility or for health and safety reasons. Speci6c 1 Agreement State regulations will be assessed as they are submitted by the State and a summary j report will be provided to the IMPEP review team at the time of the State's next program review i However, the overall determination of adequacy and compatibility ofindividual Agreement State programs will be made in accordance with Management Directive 5.6, " Integrated Materials l Performance Evaluation Program " i i Essential Objectives (B) The essential objective of each NRC program element in compr.tibility component C or identified as having particular health and safety significance should be adopted by the Agreement State. The tenn " essential objective" is defined in Part VII (Glossary). (1) For those NRC program elements in compatibility catego:y C, adoption of the essential objective (s) by an Agreement State means that the State is compatible with respect to that program element. (2) For those NRC program elements identified as having particular health and safety significance, adoption ofthe essential objective (s) by an Agreement State means that the State is providing a level ofprotection equivalent to NRC with respect to that program element A State has the latitude to adopt essential objectives that are more stringent. (3) EssentiallyIdentical Language (C) Program elements in compatibility categories A and B should be adopted by Agreement States in identical or essentially identical language. The term " essentially identical" is de5ned in Part VII (Glossary). Iflanguage is used by an Agreement State that differs in any significant respect from that used in NRC regulations, the State should justify the equivalency of the language. An example of such language substitution that would not be considered significant would be use of the term " deterministic" in place of the term "non-stochastic." In this case, the former term is one commonly accepted in the international radiation protection community. Similarly, the use of Systeme Internationale (SI) units rather than conventional units is deemed essentially identical. Further, the adoption by States of more recent technical m' formation (e.g., with respect to reference man)is viewed as being essentially identical. Finally, changes to reflect increased scope Approved (Date) 11
I ! of State authority (e.g., use of the term " radioactive material" in place of the term " byproduct material *) or wording needed to conform to State administrative procedures (e.g., use of State j agency name in place of" Commission") would not be considered significantly different. l IgDy Binding Requirements (D) ! Where appropriate, Agreement States should adept program elements in ws.p.?vility categories ! A, B and C or those identi6ed as having particular health and safety signi6cance and applicable to ! au licensees in the form of a rule or other generic legally binding requirement in a manner j consistent with the State's administrative laws. The use ofgeneric requirements will help to avoid i hW- y and confusion that may result from the imposition ofindividual rquirements on a i c bym basis. (1) ! Further, requir .=s applicable to more than a few kaa=~s also should be adopted in the form , of a generic requirement. However, since the appropriate approach to such issues will depend on j the types and numbers of ficensees involved, the State's approach will be reviewed on a case-by-j case basis. (2) The mechanism used by the State should be legally b'mdmg on the k>a==(s) and enforceable as law. Examples of such legally binding requirements may include license conditions (m' cluding ' licensee commitments referenced in " tie-down" conditions), orders or other me'chanisms determined by the State to be legally binding and enforceable. The State has the responsibility of demonstrating that requirements adopted other than by regulation are legally binding. (3) l Time Frames for Adoption (E) Commission regulations that should be adopted by an Agreement State for purposes of compatibility or health and safety should be adopted in a time frame such that the effective date of the State requirement is not later than three years aAer the effective date of NRC's final rule. Certain circumstances (e.g., adoption of a basic radiation protection standard or other rule that will have significant impact on the regulation of agreement material on a nationwide basis, such as the low-level radioactive waste manifest) may warrant that the effective dates for both NRC licensees and Agreement State licensees be the same. In some cases, and with sufficient justification, health and safety considerations may warrant adoption by the States in less than the recommended three year (or six month) time frame. (1) Program elements, other than regulations or equivalent legally binding requirements, that have been designated as twa==ary for maintenance of an adequate and compatible program should be adopted and implemented by the Agreement States within six months of such designation by NRC. If, due to other factors, an Agreement State cannot adopt and implement such a program element within the six month time frame, then the State and the Commission will agree upon a mutually acceptable timetable for adoption and implementation. (2) Approved (Date) 12
Areas Reserved Solely to NRC(F) Certain regulatory areas cannot be relinquished to the States under 274.b agreements and remain the solejurisdiction of the federal government NRC rules promulgated to regulate these areas are reserved solely to the NRC. However, States may adopt program elements (mcluding regulations) in, or otherwise address, these areas for the purpose of clarity and ease of communication States may not adopt regulations, other legally binding requirements or program elements that would cause the State to regulate such activities. 1 l l I l l l i1 l l Approved (Date) 13
)
l Part VII 1 Glossary l l Definitions (A) i i Cog /lict means the essential objectives of regulations or program elements are different and an I undesirable consequence is likely to result in anotherjurisdiction or in the regulation of agreement material on a nationwide basis. (1) Aqplication means identicai regulations or program elements apply to the same material at the l same time. Note: this defmition applies primarily to review of Agreement State regulations. (2) Essentialobjectiw of a regulation or program element means the action that is to be achieved, modified or prevented by implementing and following the regulation or program element. In some instances, the essential objective may be a numerical value (e.g., restriction of exposures to i a maximum value) or it may be a more general goal (e.g., access control to a restricted area). (3) l l Essentially identical means the interpretatioa of the text rnue be the same regardless of the l version (NRC or Agreement State) that is ,ead. (4) Gcp means the essential objectives ofNRC regulations or program elements are absent from the Agi s.t State program and an undesirable consequer:e is likely to result in anotherjurisdiction I or in the regulation of agreement materials on a nationv ide basis. (5) : Proc #ce means a use, procedure, or activity usociated with the application, possession, use, 1 storage, or disposal of agreement material. The term " practice" is used in a broad and ; encompassing manner in the Policy Statement on Adequacy and Compatibility of Asissit State Programs The term encompasses both general activities involving use ofradioactivo materials such as industrial and medical uses and specific activities within a practice such as industrial l radiography and brachytherapy. (6) l 1 Program element means any component or function of a radiation control regulatory program, j Win 9; regulations and/or other legally binding requirements imposed on regulated persons, that contributes to implementation of that program. (7) Transboundary means acrossjurisdictional boundaries within the United States. It does not mean bere.een the United State and other nations. (8) Approved (Date) 14
)
t i i i. i APPENDIX A i Flow Chart Apprwed (Date) 15
1 Flow Chart i ion Exclusive Yes Category: NRC I No i Basic Radeten rotecten Standa , or a Related Yes Category: A Defir#on, Term, i No i Direct Transboundary Yes Category: B impicatons? No Conflict or g,c ed Yes Category: C edopt? No I 4 Health and Category: D Safgrtteria Yes
- ident as H&
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e ATTACHMENT 6 4 4 l I 1 l 1 1 l l l 1
1 i a t i i OFFICE OF STATE PROGRAMS I j Pre-med Post-Agreement Activities B.7 (Revision 1): Compatibuity Categories and i Health and Safety Identification for NRC Regulations and Other Program Elements ! 1 Introduction j i j 1.1 Parpose 1 This procedure provides guidance to NRC staff, Agreement States, and States seeking an l l Agreement on the compatibility categories assigned to NRC regulations and program elements ! l and the identification of those regulations or program elements that have particular health and l safety significance l ! 1.2 Background l \ 1.2.1 The Policy Statement on Adequacy and Compatibility of Agreement State Programs sets j forth the approach that the Commission will use to identify those program elements (including j regulations) that Agreement State programs should implement to be adequate to protect public health and safety and to be compatible with the Commission's regulatory program 1.2.2 Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs," i describes the criteria and process NRC staff follow to determine which NRC regulations arrd l program elements should be adopted by an Agreement State for purposes of compatibility as well as purposes ofhealth and safety. In accordance with Management Directive 5.9, each regulation and program element first is analyzed and categorized for purposes of compatibility and then identi6ed ifit has particular health and safety significance 1 j 1.2.3 OSP Intemal Procedure B.7 (Revision 1) has been developed and is maintained by the Office of State Programs to document, for use by NRC and State staff, the compatibility category for each NRC rule and program element and the identification of health and safety significance, as determined in accordance with Management Directive 5.9. In addition, Management Directive 5.9 provides that OSP Internal Procedure B.7 (Revision 1) should be updated at the time a new rule or program element is adopted. 2 Compatibility Categories & Health and Safety Identification The tables in Section 3, below, contain a section-by-section analysis of regulations in Title 10 of the Code ofFederal Regulations (10 CFR) and program elements that are applicable to the regulation of agreement materials. The analysis is based on the categorization criteria and process set out in Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs."
i i i The Parts of 10 CFR for which tables are provided all have been analyzed section-by-section; } those Parts that do not have a corresponding table have been determined to address areas in { which Agreement States either do not have regulatory authority or that are applicable speci6callv j to NRC's regulatory program and need not be addressed by an Agreement State. For the purpose of completeness, those Parts that totally address areas of exclusive NRC authority are hsted in j Table 1. Those Parts that generally are applicable specifically to NRC's regulatory program, but i are not areas ofexclusive NRC authority, are listed in Table 2. Any future changes to these determinations will be resected in revisions to Tables 1 and 2 and to the individual section-by-I section analysis tables in Section 3. l {. Table 1 l 4 i Specific Parts of Title 10 of the Code of Federal Regulations
! That Address Areas ofExclusive NRC Authority {
l Parts 10,11, 25, 26, 50, 51, 52, 53, 54, 55, ! 60, 62, 72, 73, 74, 75, 76, 81, 95,100,110,140, and 160. Table 2 Specific Parts of Title 10 of the Code of Federal Regulations That Address Areas That Generally Are Applicable Only to NRC's Regulatory Program Parts 0,1,2,4,7,8,9,12,13,14,15,16,218,170, and 171. 3 Regulation and Other Program Element Tables In using the following tables, staff should be aware of the following points: e The following sections are found in multiple Parts: hrrpose, Scope, Interpretations, Communications, OMB Approwul, Violations, CriminalPenalties and Impactions. They are all essentially identical from Part to Part. These requirements are not required for either compatibility or health and safety reasons. The State may elect to adopt similar sections based on its requirements
- A number of terms are defined in more than one Part in 10 CFR. For purposes of consistency, the tables show the compatibility category for the definition in the most appropriate Part and refer to that Part at all other occurrences of the term 8 The prmisions in Pat 21 derive from statwory authority in the Energy Reorgamzation Act, not the AEA, that does not apply to Agreemet States. Therefore, this Pan cannot be addressed under either compatibility or adequacy While it may be argued that there are health and safety reasons to require States to adopt the pro isions ofPart 21, States may not have the statutory authority to do so.
_ . _ __ __ - _. _ _ - . . - _ . . . - ~ _ . .
i i , t i l with the compatibility category shown in hrackets. See, for example, the definition l 3 of" restricted area" in the table for Part 19, Section 19.3.
- i 3
! e Unless otherwise indicated in the tables, the compatibility category or W Wi;on ;
of health and safety significance applies to the entire section of the Part. See, for example, the table for Part 20, Section 20.2003, where individual paragraphs are i j assigned different components. i J i j Key to categories: A= ! Basic radiation protection standard or related definitions,
- signs, labds or terms necessary for a common 4
understanding ofradiation protection that the State should j adopt with (essentially) identical language. ; 3 B= Program element with significant direct transboundary
- l implications that the State should adopt with essentially ;
i identicallanguage. ! i ! C= Program element, the essential objectives ofwhich should be adopted by the State to avoid conflicts, duplications or gaps. The manner in which the essential objectives are j addressed need not be the same as NRC provided the i essential objectives are met. D= Not required for purposes ofcompatibility; however, if ; adopted by the State, should be compatible with NRC. ; l NRC = Not required for purposes ofcompatibility; the regulatory area is reserved to NRC. However, a State may adopt these ! ) provisions for purposes of clarity and communication, as 3 long as the State does not adopt regulations or program : i elements that would,cause the State to regulate in these ; , um. l t I i H&S= Program elements identified by H&S in the Comment j column are not required for purposes ofcompatibility; i however, they do have particular health and safety ; l significa.ve. The State should adopt the essential objectives j ofsuch progrun elements in order to maintain an adequate j program. , 4 i 1
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I 1
Addendum 1 Subsequent to the submission of the January 29, 1997, " Supplemental Report of the Joint NRC-Agreement State Working Group for Development of Implementing Procedures for the Final Policy Statement on Adequacy and Compatibility of Agreement State Programs," the following revisions were made to the Internal Procedure B.7, Regulation and Other Program Element Tables. For 10 CFR 40.32, the categorization was changed from "C" to "D" for paragraphs (a) through (g); paragraph (g) was assigned to "NRC;" and "H&S" was
; assigned to paragraphs (b) and (c).
For 10 CFR 61.23, "H&S" was assigned to paragraphs (a) through (h), NRC ' assigned to paragraphs (1) and (j) and "0" was assigned to paragraphs k and 1. In addition, 10 CFR 61.42 and 61.43 were designated as H&S, and a comment was added for 61.43 to note that it is already covered by Part 20 provisions. , These changes have been incorporated into the attached tables. l 7 2 j
Part 19 - NOTICES, INSTRUCTIONS, AND REPOR13 TO WORKERS: INSPECTION AND INVESTIGATIONS i REGULATION SECTION TITLE COMPATIBILITY COMMEN13 SECTION CATEGORY ll9.I Purpose D {l9.2 Scope D {l9.3 Definitions Act D Commission D Exclusion D License [D] This definition also appears in 10 CFR f20.1003. For purposes of compatibility, the language of the Part 20 definition should be used and it is assigned to Compatibility Category D. Restricted area [A] This definition also appears in 10 CFR {20.1003. For purposes of con patibility, the language of the Part 20 definition should be used and it is assigned to Compatibility Category A. Sequestration D
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Worker C This definition is needed for a common understandmg of the term " worker" as used in the J regulation of agreement material. The same dermition should apply to persons working in , more than onejurisdiction. {l9.4 Interpretations D 19.5 Communications D l19.8 Information c' ..-tion D requirement OMB 19.11 Posting of notices to C These requirements are needed to provide a workers minimum level of'mformation to workers and to assure that this information is consistent from one jurisdiction to another since workers may work in multiplejurisdictions. Q19.12 Instructions to workers C This provision should be adopted by States to assure a minimum level of required worker training since workers may work in multiple ! jurisdictions. 2 i
REGULATION SECTION TITLE COMPATIBILITY COMMENT 3 SECTION CATEGORY 119.13 Notification and C These requirements are needed to piuN,e a reports to individuals minimum level of'mformation to workers and to assure that this information is consistent from one jurisdiction to another since workers may work in multiplejurisdictions. {l9.14 Presence of C representatives of license and workers duringinspections {l9.15 Consultation with C workers during inyections {l9.16 Requests by workers C forinspections
$19.17 Inspection not C warranted; informal review 19.18 Sequestration of C witnesses and exclusion ofcounselin interviews conducted under subpoena g 3
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REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY ' {l9.20 Employee protection D {l9.30 Violations D {l9.31 Applicatkm for D exempticms {19.32 Discrimination D prohibited {l9.40 Criminal penalties D ! l t i i i 4
Part 20 - STANDARDS FOR PROTECTION AGAINST RADIATION REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 620.1001 Purpose D 620.1002 Scope D 620.1003 Definitions Absorbed Dose A Ad D-Activity A Adult A Airborne radioactive material A I Airborne Radioactivity area A ALARA A ! Annuallimit on intake (ALI) A Background Radiation A Bionssay (radio bionssay) A i
. _ .- _ _ . ~ _ _ . _ . _ _ - - . _ _ . . - _ _ . _ - _ - _ _ - - - _ _ . _ - . . . - _ _ _ . _ _ _ - . _ . _ _ _ _ . _ - _ _ _ _ _ _ - _ _ - _ _ - _ _ _ _ _ _ _ _ _ - _ _ _ - - - . _ _ - _ _ _ _ _ _ _ - _ - _ - _ _ --- ,
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Byproduct material [A] This definition also appears in 10 CFR {150.3(c). For purposes of compatibility, thelanguage of the Part 150 definition should be used and it is assigned to Compatibility Category A. Class A Also referred to as "L,ung Class or Inhalation Class" Collective Dose A Commission D Committed dose equivalent A Committed effective dose equivalent A Controlled Area D Declared Pregnant Woman A Deep-dose equivalent A Department D Derived air concentration (DAC) A Derived air concentration-hour A (DAC-hour) 2
REGULATION SECTION TITLE COMPATIBILITY COMMENTS ' SECTION CATEGORY Dose or radiation dose D This definition is not required for compatibility. No definition is presented. Rather, several terms are referenced, which are later defined. i Dose equivalent A Dosimetry processor D Effective dose equivalent A Embryo / fetus A Entrsnce or access point C This definition provides the minimum information needed for a common understanding and because differing definitions may jeopardize an orderly regulatory pattern in the regulation of agra.nent material. Exposure A External dose A Extremity A 3
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Eye dose equivalent A The term, " Lens Dose Equivalent," ifdefined essentially identically to
" Eye Dose Equivalent"is an acceptable substitute for this term.
Generally applicable environmental A - States with This term is needed for common ' radiation standards authority to regulate c-isri -fg in applying the dose uranium mill activities limit requirements in 10 CFR (IIe.2 byproduct 20.1301 and the reporting material) requirements in 10 CFR 20.2203. These sections reference D - States without requirements that are applicable to authority the uranium fuel cycle. Govemment agency D Gray See 10 CFR $20.1004 This term is not defined in this section. Refer to the riewd section for the definition where it is assigned Compatibility Category A. High radiation area A Individual A Individual monitorina A 4
REGULATION SECTLON TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Individual monitoring devices C This definition pic/ds the minimum information needed for a common understanding of the term and because inconsistent dermitions mayjeopardize an orilerfy regulatory pattern for the regulation ofgrwra; material. Internal dose A License D Licensed material D Licen ee D Limits . A Lost or missing licensed material B His term and definition are needed for a commun unde standingin collecting and reporting information on regulation of agreement material on a nationwide basis. Member of the public A Minor A 5
REGULATION SECITON TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Monitoring A Nonstochastic effect A The term, " deterministic," if defined essentiallyidentically to "nonstochastic" is an acceptable substitute. MC D Occupational Dose A Person [C] This definition also appears in 10 CFR gl50.3(g). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category C. Planned special exposure D Public dose A s Quality Factor A Quarter D Rad See 10 CFR Q20.1004 This term is not defined in this section. Refer to the referenced section for the definition where it is assigned to Compatibility Category A. 6
i REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY l t Radiation A Radiation area A , Rio.cc man A I Rem See 10 CFR {20.1004 This term is not defined in this section. Refer to the siod soion for the definition whereit is assigned to Compatibility Category A. Respiratory protective device C Restricted area A Sanitary sewerage A Shallow-dose equivalent A Sievert See 10 CFR g20.1004 This term is not defined in this section Refer to the referenced section for the definition where it is assigned to Compatibility Category A. Site boundary D 7
i REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY i Source Material [A] This definition also appearsin 10CFR ll50.3(i). For purposes of , competeility, thelanguage of the Part 150 definition should be used and itis assigned to Compatibility Category A. Special Nuclear Material [A] This definition also appears in 10CFR fl50.30). For purposes of compatibility, the language of the Part 150 definition should be used , and it is assigned to Compatibility Category A. Stochastic effects A The term "probabilistic," if defined essentially identically to
" stochastic"is an acceptable substitute.
Survey A Total Effective Dose Equivalent A (TEDE) Unrestricted Area A
- Uranium Fuel Cycle D If a state chooses to adop' a definition ofuranium fuel cycle,it must be essentially identical.
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REGUIATION SECTION TITLE COMPATIBHErY COMMENTS SECTION CATEGORY Very High Radiation Area A Week D Weighting factor A Whole body A Working level (WL) A Working level month A (WLM) Year A 620.1004 Units ofradiation dose A 120.1005 Units ofradioactivity A 620.1006 Interpretations .D 620.1007 Communications D 620.1008 Implementation D __ {20.1009 Information colletion requ; w.~as: D OMB approval 620.1101 Radiation protection programs D H&S Occupational dose limits for adults A 620.1201 9
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REGUIATION SECTION TITLE COMPATIBILITY CDMMENTS SECTION CATEGORY
$20.1202 Compliance with requirements for A summation ofexternal and internal doses
{20.1203 Determination ofextemal dose from A airborne radioactive material E20.1204 Determination ofinternal exposure A 20.1205 Reserved {20.1206 Planned special exposures D 20.1207 Occupation dose limits for minors A l l 20.1208 Dose to an Embryo / fetus A 20.1301 Dose limits for individual members of A - paragraphs (a), the public (b),(c) and (e) D - paragraph (d) g20.1302 Compliance with dose limits for D H&S - paragraphs (a) and (b) only individual members of the public Subpart E Reserved , 420.1501 Surveys and Monitorina - General D H&S 10
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {20.1502 Conditions requiring individual D H&S monitoring ofexternal and internal occupational dose {20.1601 Control of access to high radiation D HAS areas {20.1602 Control of access to very high D H&S radiation areas Q20.1701 Use ofprocess or other engineering D H&S controls Q20.1702 Use ofother controls D H&S {20.1703 Use ofindividual respiratory D H&S protection equipment {20.1704 Further restrictions on the use of D respiratory protection equipment {20.1801 Security ofstored material D H&S E20.1802 Control ofmaterial not in storage D H&S {20.1901 Caution signs A {20.1902 Posting requirements A In adopting these provisions, States have the faxibility to omit the wordina " grave danner" II
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {20.1903 Exceptions to posting requirements D , {20.1904 Labeling containers A {20.1905 Exceptions to labeling requirements A {20.1906 Procedures for receiving and opening D H&S packages 20.2001 General requirements C Asisi.s; States should adopt the (Waste Disposal) essential objectives of provision in order to eliminate confusion regarding the disposal of agreement material on a nat' e nwide basis. {20.2002 Method for obtaining approval of D proposed disposal procedures {20.2003 Disposal by release into sanitary A - paragraphs (aX2) H&S -(aXI) only sewerage and (aX3) C - paragraph (aX4) D - paragraphs (aX1) and (b) I 620.2004 Treatment or disposal by incineration D 12
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 20.2005 Disposal ofspecific wastes D 620.2006 Transfer for disposal and manifests B
$20.2007 Compliance with environmental and D health protection regulations
{20.2101 General provisions. C The use of SIunits would be considered essentially identical. {20.2102 Records ofradiation protection D programs 20.2103 Records ofsurveys D Q20.2104 Determination of prior occupational D If a state secas to adopt dose " planned special exposure" this section should be adopted as a "C" 420.2105 Records of planned special exposures D 13
REGULATION SECTION TITLE COMPATIBILITY COMMENT 3 SECTION CATEGORY j20.2106 Recor 's ofladividual monitoring C - paragraphs (a) and Asia.. a States should adopt results (e) paragraphs (a) and (e) to eliminate confusion in obtaining information D - paragraphs (b), in support of 6.yk..m.;ation of (c),(d) and (f) basic radiation protection standards since ii.dividuals may receive exposure in more than one licensee's facility orin more than onejurisdiction. Q20.2107 Recon! of Dose to individual D ire..4,ers of the Public Q20.2108 Records of Waste Disposal D 20.2110 Form of Records D 20.2201 Reports of theft or loss oflicensed C - paragraphs (a), These requirements are needed for material -(b), (d) and (e) a common understanding in collecting and reporting D - paragraph (c) information on the regulation of agreement material on a nationwide basis. 14
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {20.2202 Notification ofIncidents C - paras i.yhs (a), All of this provision, except (b), (c) and (d) paragraph (c),is needed for a common understandmg in D - paragraph (e) collecting and reporting information on the regulation of agiwaa material on a nationwide basis. Meeting the essential objective of this regulation for the purpose of comnatibility means the State should adopt the numerical values noted in the regulation as the minimum level acceptable. Ifstate adopts planned special exposure, then the state should adopt Paragraph (e). {20.2203 Reports of exposures, etc, exceeding C - paiagraphs (a) and Paragraphs (a) and (b) provide the limits. (b) requirements that are needed for a common understasvling in D - paragraph (d) collecting and reposting information on the reguladon of NRC - paragraph (c ) ayament material on a nationwide basis. i 15
REGULATION SECTION TITLE COMPATIBILITY COMMEN13 SECTION CATEGORY
$20.2204 Reports of Planned special exposures D Ifstate adopts planned special exposure, then the state should adopt this provision.
{20.2205 Reports to individuals ofexceeding C dose limits Q20.2206 Reports ofIndividuals Monitoring D - paragraphs (aX2), (aX6),(aX7), (b) and (c) NRC -(aXI), (aX3), (aX4), and (aXS) Q20.2301 Applications for Exemptions D 20.2302 Additional Requirements D {20.2401 Violations D F20.2402 Criminal Penalties D Appendix A Protection Factors for Respirators C Ayw.~4 States should adopt this provision becauseit giv/A the minimum acceptablelevel of protection to be affo' rded by respirators. I6
REGULATION SECTION TITLE COMPATIBILITY COMMENT 3 SECTION CATEGORY Appendix B Annual Limits on Intake (ALIs). A (Tables 1,2, & 3) Derived Air Concentrations (DACs), ofRadionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sca..g; Appendix C Quantities officensed materials A requiring labeling Appendix D United States Nuclear Regulatory D Commission Offices Appendix E Reserved Appendix F Requirements for Low-level Waste B The provisions are needed in order Transfer for disposal at land disposal to provide consistency in regulating facilities and Manifest aym.. ..; material which cross ! multiplejurisdictions. Appendix G Requirements for Low-level B These provisions are needed by radioactive waste intended for Agrees cs States to pic/.h ; disposal at land disposal facilities and consistency in regulating agreement i manifests material which cross muhiple jurisdictions. 17
Part 30 - RULES OF GENERAL APPLICABILITY lt) DOMESTIC LICENSING OF BYPRODUCT MATERIAL REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECI10N CATEGORY i 30.1 Scope D l {30.2 Resolution ofConflict D . f30.3 Activities requiring C This requirement is needed for common license understanding regarding activities requiring a license. f30.4 Definitions , Act D Agreement State [B] This definition also appears in 10 CFR 150.3(b). For purposes ofcompatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category B. Alert A ; Byproduct material [A] This definition also appears in 10 CFR { l 50.3(b). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category A. Commencement of D construction Commission D i _ . - - - - _ - - - __ ~ - -
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Curie [A] This definition also appears in 10 CFR {20.1005(b). For purposes ofcompatiblity, the language of the Part 20 definition should be used and it is assigned to Compatibility Category A. Decommission C This definition is needed for effective communication regarding regulation of agreement material on a nationwide basis. Dentist (D] This definition also appears in 10CFR {35.2. For purposes of compatibility, the language of the Part 35 definition should be used and it is assigned to Compatibility Category D. Department and [D] This definition also appears in 10 CFR Department of Energy {20.1003. For purposes ofcompatibility, the language of the Part 20 definition should be used and it is assigned to Compatibility Category D. Effective dose equivalent [A] This definition also appears in 10 CFR Q20.1003. For purposes ofcompatibility, the language d 'he Part 20 definition thould be used and it is assigned to Compatibility - Category A. Government agency l D
REGULATION SECTION TITLE COMPATIBILITY COMMEN11i SECTION CATEGORY License [D] This definition also appears in 10 CFR {20.1003. For purposes ofcompatibility, the language of the Part 20 definition should be used and it is assigned to Compatibility Category D. Medical use [C] This definition also appears in 10CFR {35.2. For purposes of compatibility, the language of the Part 3.5 definition should be used and it is . assigned to Compatibility Category C. Microcurie D Millicurie D Person [C] This definition also appears in 10 CFR {l50.3(g). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category C. Physician [D] This definition also appears in 10CFR {35.2. For purposes of compatibility, the language ot' the Part 35 definition should be used and it is assigned to Compatibility Categosy D. Podiatrist [D] This definition also appears in 10CFR {35.2. For purposes of compatibility, the language of the Part 35 definition should be used and it is > assigned to Compatibility Category D. Principal activities D i i
. . . . _ _ __. . _ _ . . . . _ _ . _ _ _ _ _ -- . _ _ _ - . _ . _ . _ _ _ _ _ . _ _ ~ . _ . _ _ _ _ _ _ . . _ _ _ . .
f i REGULATION SECTION TITLE COMPATIBILITY COMMEN13 , SECTION CATEGORY Production facility [NRC] This definition also appears in 10 CFR { l 50.3(h). For purposes ofcompatibility, the language of the Part 150 definition should be used and it is assigned to Compatibihty Category NRC. Radiegipei [C] This definition also appears in 10 CFR {34.2. For purposes of compatibility, the language of the Part 34 definition should be used and it is assigned to Compatibility Category C. Radiogr$4s's assistant [D] This definition also appears in 10 CFR {34.2. For purposes of compatibility, the language of the Part 34 definition should be used and it is assigned to Compatibility Category D. i Radiography [B] This definition also appears in 10 cFR {34.2. For purposes ofcompatibility, the language of the Part 34 definition should be used and it is ' assigned to Compatibility Category B. Research and D dcvd4. .g..; Scaled source B This definition is needed fbr a common i understanding because of transboundary effects. t Site area c.Tsig ..cy A t t S i i i
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Source material [A] This definition also appears 1910 CFR fl50.3(i). For purpcses ofermpatibility, the language of the Part 150 definition shoidd be used and it is assigned to Compatibility Category A. Special nuclear material [A] This definition also appears in 10 CFR fl50.3(j). For purposes ofcompatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category A. F United States D Utilization facility [NRC] This definition also appears in 10 CFR . Ql50.3(l). For purposes ofcompatibility, the language of the Part i50 definition should be used and it is assigned to Compatibility Category NRC. {30.5 Interpretations D {30.6 Commtmications D {30.7 Employee protection D {30.8 information collection D requirements: OMB approval {30.9 Completeness and D accuracy ofinformation
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {30.10 Deliberate misconduct D {30.11 Specific exemptions D {30.12 Persons using byproduct B This provision should be adopted by A,w wa . material under certain States in an essentially identical manner since it Department ofEnergy is required by Federallaw. and Nuclear Regulatory Commission contracts {30.13 Carriers B {30.14 Exempt concentrations B {30.15 Certain items containing B byproduct material {30.16 Resins containing B scandium-46 and designed for sand-consolidation in oil wells {30.18 Exempt quantities B {30.19 Self-luminous products B containing tritium, krypton-85, or promethium-147 {30.20 Gas and aerosol B detectors containing byproduct material
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 930.31 Types oflicenses C This provision is needed to for effective communication regarding the different types of licenses. 630.32 Application for specific C - paragraph (g) H&S - paragraph (i) only licenses D - paragraphs (a), (b), (c), (d), (e), (f), (h) and (i) Q30.33 General requirements for D II&S - paragraphs (aX2) and (aX3) only issuance ofspecific licenses Q30.34 Terms and conditions of C - paragraph (b) The essential objective (s) of paragraph (b) licenses should be adopted by Agreen,ent States because D - paragraphs (a), (c), of transboundary effects in transferring material (d), (eX2), (eX4), (f), (g) through multiplejurisdictions and to avoid
&(h) conflicts and csmfission in regulation of agreement r: aterial on a nationwide basis.
NRC - paragraphs (eXI)
& (eX3)
Q30.35 Financial assurance and D II&S - paragraphs (a), (b) and (d) only recordkeeping for decommissioning States are given flexibility to allow different dollar amounts based upon jurisdhion and local conditions.
- - - - - - - - - . - - - . . - - - . - - . - . . . - . - . - - . . - - .. . = .
REGULATION SECI1ON TITLE COMPATIBILITY COMMENTS SECI1ON CATEGORY {30.36 Expiration and D H&S - paragraphs (c), (d), (c), (g), (h), G) and termination ofiiw..ses (k) only and decommissioning of sites and separate buildmgs or outdoor areas {30.37 Application for renewal D oflicenses {30.38 Application for 'D amendment oflicenses
- g30.39 Commission Action on D applications to renew or amend g30.4I Transfer ofbyproduct C This provision is needed for coherent regulation material of ay mnwn; material on a nationwide basis.
j30.50 Reporting Requirements C - paragraphs (a),(b) States have the flexibility to require a%tional and (c), except event reportinginformation. This'mformation would depend on local conditions, laws, etc. D - paragraph (c)(3) 630.51 Records C- paragraphs (a) & (b) The time required for record retention under - paragraph (b) may very in accordance with the D - paragraph (c) type of activity being licensed. g30.52 Inspections D {30.53 Tests D l ss. l
REGULATION SECTION TITLE COMPATIBILI1Y COMMENTS SECI1ON CATEGORY {30.55 Tritium reports [NRC] The provision in this section also appears in : 10 CFR 150.19 where it is applicable to licensees of Agreement States. It is assigned to Compatibility Category NRC since it requires reports to NRC. {30.61 Modification and D revocation ofIL..x. {30.62 Right to cause the D withholding or recall or byproduct material {30.63 Violations D {30.64 Criminal penalties D {30.70 Schedule A-exempt B concentrations table {30.71 Schedule B - exempt B quantity table {30.72 Schedule C-Quantities D H&S ofradioactive materials requiring consideration of the need for an aw.e.wy plan for responding to a release
h REGULATION SECTION TITLE COMPATIBILITY SECTION COMMENTS CATEGORY t i Appendix A Criteria Relating to Use D The amount of financial assurance required ofFinancial tests and should reflect the current economic conditions Parent Company Guarantees for Providing at time ofh....:%. Reasonable Assurance of funds for Decommissioning > Appendix B Quantities ofLicensed B Material Requiring Labeling Appendix C Criteria Relating to D Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning r h _ _ . _ _ _ - - . _ _ . _ _ _ _ _ _ - _ . . _ - - _ _ . _ - _ _ _ _ _ _ _ _ _ _ _ _ . - _ _ _ _ _ ., __ _ - _ - - --- _ _ _ - __ - - - --_ -- - _ - _ __- ----_- - __n
_ - - ..~.... ... .-_ - .- - --- --- - - - .- - Part 31 - GENERAL DOMESTIC LICENSES FOR BYFRODUCT MA'IERIAL REGULATION SECTION TITLE COMPATIBILITY COMMENT 3 SECTION CATERGORY 13
1.1 Purpose and Scope
D 131.2 Terms and Conditions D
$31.3 Certain devices and B Agreement States should adopt this provision equipment because it contains requirements for devices and equipment which are distributed natiomvide (31.4 Information collection D requ; o. .as: OMB approval i31.5 Certain measuring, D Ayw sa States have the flexibility to gauging or controlling authorize the use of these devices under a devices specific license rather than by Beneral license.
i31.6 Generallicense to install C Ayww.a States should adopt this provision devices generally because it recognises the need for reciprocity of licensed licenses from onejurisdiction to another fbr this ; in i 31.5 activity. States may require notification as a part of these provisions. (31.7 Luminous safety devices B Agreement States should adopt this provision for use in aircraft because it contains requirements for devices that are distributed nationwide and because of their nature they frequendy cross multiple jurisdictions. ' %31.8 Americium-241 in the D form ofcalibration or reference sources i
REGULATION SECTION TITLE COMPATIBILITY ' COMMENT 5 SECTION CATERGORY i {31.9 Generallicense to own D ' byproduct material ; l' {31.10 Generallicense for B f Ay-.a.a States should adopt this provision strontium 90 in ice because it contains requirements for devices that detection devices i are distributed nationwide. i {31.11 Generallicense for use D Ay~.~a States have the flexibihty to ofbyproduct material authorize the use of these materials under a i for certainin vitro specific license. clinical or laboratory testing l f31.12 Maintenance ofrecords D ' 631.13 Wdations D i31.14 Criminal penalties D ! l 6 l 4 i i 2 '
Part 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY f3
2.1 Purpose and Scope
D 132.2 Definitions Dose commitment [A] This term and definition are superseded by the new term and definition in 10 CFR Part 20, " committed dose equivalent," which is stated in more current radiation protection terminology and is assigned to compatibility Category A. The Part 20 term and definition should be used for purposes ofcompatibility and States should adopt this terminology consistently throughout their requirements Lot Tolerance Percent Defective B E32.3 Maintenance ofrecords D {32.8 Information collection requirements: D OMB approval Q32.11 Introduction ofbyproduct material C - paragraphs (a) and in exempt concentrations into (b) products or materials and transfer of ownership or possession: B - paragraph (c) Requirements for license
REGULATION SECTION TITLE COMPATIBILTIY SECTION COMMENTS CATEGORY
}32.12 Same: Records and material transfer C reports $32.13 Same: Prohibition ofintroduction C g32.14 Certain items containing byproduct NRC material; requirements for license to apply or initially transfer 32.15 Same: Quality assurance, prohibition NRC of transfer and labeling f32.16 Certain items containing byproduct NRC material: Records and reports of transfer
{32.17 Resins containing scandium-46 and B This provision was previously designed for sand-consolidations in designated as an area reserved to the oil wells: Requirements forlicense NRC. A review of the Statements of to manufacture, or initially transfer Considerations for this rule (32 FR for sale or distribution 4241,3/18/67) indicates that this activity can belicensed by an , Agissa State. The Commission considered that scandium-46 resins were not a product intended for use by the geseal public. Therefore, this authority could be assumed by the
, States.
2
REGULATION SECTION TITLE COMPATIBH,ITY COMMENTS SECTION CATEGORY {32.18 Manufacture, distnhtion and NRC l transfer ofexempt quantities: Requirements forlicense 632.I9 Same: Conditions oflicenses NRC {32.20 Same: Records and material transfer NRC reports Q32.22 Selfluminous products containing NRC tritium, krypton-85 and promethium-147: Requirements for i license to manufacture, process, produce, or initially transfer: l Q32.23 Same: Safety criteria NRC Q32.24 Same: Table oforgan doses B See 10 CFR { 32.51. This table should be adopted in essentially identical language since {32.51 should be so i adopted. The table may be ircurpuitsted with the Aym.,cs: State's requ;. .e.a which are - equivalent to {32.51, as appropriate, rather then terma- +i ==rately.
%32.25 Conditions oflicenses issued under NRC
{32.22: Quality Control, labeling - and reports of transfer i 3
REGULATION SECTION TITLE COMPATIBILITY SECTION COMMENTS CATEGORY j32.26 Gas and aerosol detectors NRC containing byproduct material: , Requirements forlicense to manufacture, process, produce or initially transfer f32.27 Same: Safety criteria NRC ' f32.28 Same: Table oforgan doses NRC {32.29 Conditions oflicenses issued under NRC {32.26: Quality control, labeling and reports of transfer 32.40 Schedule A: Prototype tests for NRC automobile lock illuminators i 992.51 Byproduct material contained in B devices for use under f31.5: Requirements for license to manufacture or initially transfer 432.51a Same: Conditions oflicenses B $32.52 Same: Material transfer reports and B records Q32.53 Luminous safety devices for use in B aircraft. Requirements for license to manufacture, assemble, repair or initially transfer 4 t-
1 REGULATION SECTION TITLE COMPATIBILfTY COMMENT 3 l SECTION CATEGORY 632.54 Same: Labeling ofdevices B {32.55 Same: Quality assurance, proluhtion B oftransfer f32.56 Same: Material transfer reports B f32.57 Calibration or reference sources B Am-241: Requirements forlicense to manufacture or initially transfer 32.58 Same: Labeling ofdevices B {32.59 Same: Leak testing of each source B ' G32.60 [ Reserved] j32.61 Ice detection devices containing B strontium-90; Requirements for license to manufacture orinitially transfer {32.62 Same: Quality Assurance, B prohibition of transfer $32.71 Manufacture and distribut'en of B byproduct material for certain in vitro clinical or laboratory testing under meneral license 5
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECI1ON CATEGORY {32.72 Manufacture, preparation or transfer B for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35 j32.74 Manufacture and distribution of B sources or devices containing byproduct material for medical use 32.101 Schedule B-prototype tests for B luminous safety devices for use in aircraft s32.102 Schedule C-prototype tests for B calibration or reference sources containing americium-241 32.103 Schedule D-prototype tests for ice B detection devices containing strontium 90 {32.110 Acceptance sampling procedures B under specificlicenses f32.210 Registration of product information B f32.301 Violations D f32.303 Criminal penalties D 6
Part 33 - SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERIAL REGULATION ' SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {33.1 Purpose and scope D {33.8 Information collection requirements: D OMB approval l {33.11 Types of specific licneses of broad scope D Q33.12 Applications for specific licenses of D broad scope Q33.13 Requirements for the issuance of a Type D A specific license ofbroad scope {33.14 Requirements for the issuance of a Type D B specific license ofbroad scope 533.15 Requirements for the issuance of a Type D ! C specific license ofbroad scope 533.16 Application for other specific licenses D 33.17 Conditions of specific licenses of broad D scope Q33.21 Violations D ;
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l Part 34 - LICENSES FOR RADIOGRAPHY AND RADIATION SAFEW REQUHGMENTS FOR RADIOGRAPHIC OPERATIONS REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 63
4.1 Purpose and Scope
D i 634.2 Definitions Permanent radiographic installation D i Radiographer C Radiographer's assistant D Radiographic exposure device B Radiography B , Scaled source [A] This definition also appearsin 10CFR {30.4. For purposes of compatibility,thelanguage ofthe Part 30 definition should be used and it is assigned to Compatibility Category A. Source changer B Storage acea D Storage wntains B 634.3 Applications for specific licenses D 634.4 Maintenance of records C
REGULATION SECTION TITLE COMPATIBILITY COMMENTS l SECTION CATEGORY ' {34.8 Information collection requ; .. .'s: D I OMB approval {34.11 Issuance ofspecific Ik~. for use of C sealed sourcesin Industrial - Radsgraphy N fu .. a i+;. ...,... s for 6 {34.20 B ; radiography equipment {34.21 Limits on levels ofradiation for B radiographic exposure devices and storage containers f {34.22 Locking ofradiographic exposure B devices, storage containers and source changers 634.23 Storage precautions C f34.24 Radiation surveyinstruments C ; {34.25 Leak testing, repair, tagging, opening, C ; modification, and replacement of sealed sources 634.26 Quarterly inventory C 634.27 Utilization loss B 2
- . _ . - - . - . _ - . . - - . . = . ~ _
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY 634.28 Inspection and maintenance of C radiographic exposure devices, storage containers, and source changers $34.29 Permanent Radiographic Installations D H&S f34.30 Reporting requirements C 634.31 Training C 34.32 Operating and Emergency procedures C - paragraphs (a) through (k) D - paragraph (1) 634.33 Personnel monitoring C f34.41 Security C f34.42 Post;ng C f34.43 Radiation surveys C - paragraphs (a), (b) and (c) D - paragraph (d) f34.44 Supervision of rad'mgraphers' assistant D 634.51 Applications for exempt' ens D 634.61 Violations D 3
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S T N _ E M _. M . O . C Y . T Y I __ L I R _. BO I TG E . A _. P T A MC _ O C D C 4 E g L i n a a i n a r t N r O fo I s s T e t i c C l t a j e E n b S e u P s n l a det o i n r c i m i uu qt r i r es C Ri n N ON I TO AI A L T x UC i d GE ES 3 6 n e 4 p R 3 p { A
. _ _ ._. _ _ _ _ . - . - . _ - . - . - ~ - --
Part 35 - MEDICAL USE OF BYPRODUCr MATERIAL REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY f35.1 Purpose and scope D f35.2 Definitions Address ofuse D ALARA [A] This definition also appears in 10 CFR f20.1003. For purposes ofcompatibility, the language of the Part 20 definition should be used and it is assigned to Compatibility Category A. Agreement State [B] This definition also appears in 10 CFR i150.3(b). For purposes ofcompatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category B. Ares ofuse D Authorized nuclearph i. cist D Authorized user C Brachytherapy source D
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Dedicated check source D Dental use D Dentist D Diagnostic clinical procedures D manual i Management D Medicalinstitution D Medical use C t Ministerial change D-Misadministration C States should adopt the quantitative values (e.g. : the % differences; dose equivalents) in this provision in order to meet the essential objectives of this requirement Mobile nuclear medicine service D Output D 2
.- . - . . .. . - - . - ._=
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Pharmacist D Physician D Podiatric use D Podiatrist D Prescribed dosage C Prescribed dose C Radiation safety officer D Recordable event D Scaled source [B] This definition afso appears in 10CFR {30.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category B. Teletherapy physicist D Written directive C 3 i
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$35.5 Maintenance ofrecords D
$35.6 Provisions for research involving D human subjects.
535.7 FDA, other Federal, and State D requirements l35.8 Information collection D requirements: OMB Approval
$35.11 License required [C] The general requirement for activities to be licensed appears in 10 CFR 5 30.4 which has been designated compatibility category C.
Agreement States should adopt the Part 30 provision as a minimum requirement for their licensees. l35.12 Application of ficense, D amendment, or renewal (35.13 License amendments D
$35.14 Notifications D 4
REGULATION SECTION TITLE COMPATUBILITY COMMENTS SECTION CATEGORY {35.15 Exemptions regarding Type A D specific lha of broad scope 535.18 License issuance D $35.19 Specific exemptions D {35.20 ALARA program [D] The provision for ALARA requirements appears in 10 CFR {20.1101(b) and is generaHy applicable to all licensees This provision is not required for purposes of compatibility, but does have health and safety (H&S) significance. $35.21 Radiation Safety Officer D H&S - paragraph (a) only 535.22 Radiation safety committee D {35.23 Statements of authority and D H&S - paragraph (a) only , responsibilities i 635.25 Supervision D 535.29 Administrative i+;i ..ms that D apply to the provision ofmobile nuclear medicine service i 5 i I
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY %35.3i Radiation safety program D changes t (35.32 Quality management program D H&S - paragraphs (a),(b) and (c) {35.33 Notifications, reports, and C records ofmisadministrations 35.49 Suppliers for sealed sources or D devices for medical use ' 35.50 Possession, use, calibration, and D check ofdose calibrators 35.51 Calibration and check ofsurvey [D] The generally applicable provision for instruments possession ofcahlwated survey instruments appears in 10 CFR {20.1501(b). It is not > required for purposes of compatibility, but does have heahh and safety (H&S) significance. %35.52 Possession, use, calibration, and D check ofinstruments to measure dosages of alpha- or beta-emitting radionuclides i 6
REGULATION SECTION TITLE COMPATIBILITY COMMEN'I3 SECTION CATEGORY 35.53 Measurements ofdosages of D H&S - paragraphs (a) and (b) only unsealed byproduct material for medical use Q35.57 Authorization ofcalibration and D reference sources Q35.59 Requirements for possession of D H&S ' sealed sources and brachytherapy sources Q35.60 Syringe shields and labels D Q35.61 Vial shields and labels D Q35.70 Surveys for contamination and D H&S ambient radiation exposure rate {35.75 Release ofpatients or human C research subjects containing radiopharmaceuticals or permanent implants - 7
REGULATION SECI1ON TITLE COMPATIBILITY COMMENT 3 SECTION CATEGORY Q35.80 Technical requirements that D apply to the provision ofmobile nuclear medicine services f35.90 Storage ofvolatiles and gases D Q35.92 Decay-in-storage D {35.100 Use ofunsealed byproduct D H&S material for uptake, dilution, and excretion studies Q35.120 Possession ofsurvey instruments D {15.200 Use ofunsealed byproduct D H&S material forimaging and localization studies (35.204 Permissible molybdenum-99 D H&S concentration t 8 i
i REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {35.205 Control of aerosols and gases [D] 10 CFR {20.1201 and {20.1301 specify occupational and pubhc dose limits, rewdWj, and are designated compatibility category A. Since this section directly references the Part 20 sections, it is not required for purposes of compatibility. i {35.220 Possession of surveyinstruments [D] The generally applicable provision for possession of calibrated survey instruments i appears in 10 CFR {20.1501(b). It is not required for purposes ofcompatibility, but does have health and safety (H&S) significance. Q35.300 Use ofunsealed byproduct mate- D H&S rial for therapeutic l administration l {35.310 Safety instruction D $35.315 Safety precautions D {35.320 Possession ofsurveyinstruments D (35.400 Use of sources for brachytherapy D , i 9 l l
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {35.404 Release ofpatients or human C research subjects treated with temporary implants 35.406 Brachytherapy sources inventory D H&S - paragraphs (a) and (c)only {35.410 Safetyinstruction D {35.415 Safety precautions D {35.420 Possession ofsurveyinstruments D 35.500 Use ofscaled sources for D s diagnosis {35.520 Availability ofsurveyinstrument D 35.600 Use of a scaled source in a D teletherapy unit {35.605 Maintenance and repair D H&S restrictions {35.606 License amendments D i 10
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY f35.610 Safetyinstructions D H&S 635.615 Safety precautions D H&S 635.620 Possession ofsurveyinstrument D {35.630 Dosimetry equipment D H&S Q35.632 Full calibration measurements D States should adopt the quantitative values (e.g.
% output differences and the times of calibrations) in this provision in order to meet the essential objectives of this requirement.
H&S 35.634 Periodic spot-checks D H&S 35.636 Safety checks for teletherapy D H&S facilities {35.641 Radiation surveys for teletherapy D facilities {35.643 Modification of teletherapy un:t D or room before beginning a treatment program 1I
. . . .. _ . = . - . - . - . . . _ _ . - .. - . _ _ . . - .- ,..
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {35.645 Reports of teletherapy surveys, D checks, tests, and measurements
-{35.647 Five-yearinspection D H&S
{35.900 Radiation safety of5cer D {35.901 Training for experienced D radiation safety officer 35.910 Training for uptake, dilution, and D excretion studies {35.920 Training for imaging and D localization studies
$35.930 Training for therapeutic use of D unsealed byproduct material 135.932 Training for treatment of D hyperthyroidism
%35.934 Training for thyroid carcinoma D t
{35.940 Training for use of D brachytherapy sources 12
l i REGULATION SECTION TITLE COMPATIBIIJI'Y COMMENTS SECTION CATEGORY l i {35.941 Trainin6forcphthalmicuseof D strontium-90 {35.950 Training for use ofsealed sour- D ces for diagnosis - {35.960 Training for teletherapy D {35.%I Training for teletherapy physicist D {35.970 Training for experienced D authorized users {35.971 Physician training in a three D month program i {35.972 Recentness of training D I {35.980 Tra' ming for an authorized D nuclear pharmacist !
^
{35.981 Training for experienced nuclear D Pharmacist {35.990 V~mlations D 13 i i
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY - 835.991 Criminal penalties D . $35.999 Resolution ofconflicting D requirements during transition Period t f i i i i i
+
t 14
l Part 36 - LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY !
%36.1 Purpose & Scope D - paragraph (a) States should adopt the quantitative values and irradiator types in C - paragraphs (b) and paragraphs (b) and (c) to meet the (c) essential @;.s of this requirement in order to avoid potential conflicts bet c-. jurisdictions.
l36.2 Definitions , Annually D Doubly encapsulated scaled source D Irradiator C Irradiator operafor D i Panoramic dry-source- D storage irradiator ' Panoramic irradiator D Panoramic wet-source- D storage irradiator Poolirradiator D Product conveyor system D
. Radiation room D Radiation safety officer D 1
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Scaled source [B) This definition also appears in 10 CFR {30.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category B. Seismic area D Underwater irradiator D 636.5 Interpretations D $36.8 Information collection requirements: D OMB approval 436.11 Application for a specific license D Q36.13 Specific licenses for irradiators D H&S 36.15 Start orconstruction D 36.17 Applications for exemptions D 36.19 Request for written statements D 36.21 Performance criteria for sealed B States should adopt the quantitative sources values and types of testsin this provision to meet the essential objectives of this requirement 436.23 Access control D H&S 2
REGULATION SECTION TITLE COMPATIBILITY COMMENTE SECTION CATEGORY J3p 25 Shielding D H&S l_36.27 Fire protection D H&S 636.29 Radiation monitors D H&S 636.31 Control ofsource movement D H&S ' 36.33 Irradiator pools D H&S 636.35 Source rack protection D Q36.37 Power failures D H&S Q36.39 Design requirements D H&S Q36.41 Construction monitoring and D H&S acceptance testing 36.5i Training D H&S 636.53 Operating & Emergency procedures D H&S J36.55 Personnel monitoring D 136.57 Radiation surveys D H&S States should adopt the quantitative values for surveys in this provision to meet the essential objectives of this requirement 3
REGULATION SECTION TITLE COMPATIBILITY COMMENTE SECTION CATEGORY $36.59 Detection ofleaking sources D H&S States should adopt the quantitative values for detection ofleaking sources in this provision to meet the essential objectives of this requirement {36.61 Inspection and maintenance D H&S 36.63 Pool water purity D H&S States should adopt the quantitative values for pool water purityin this provision to meet the essential objectives of this requirement. 36.65 Attendance during operation D H&S {36.67 Entering and leaving the radiation D H&S room {36.69 Irradiation ofexplosive or D H&S inflammable materials {36.81 Records and retention periods D E36.83 Reports C Q36.91 Violations D 36.93 Criminal penalties D 4
Part 39 - LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL IAGGING i REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
)
13
9.1 Purpose and Scope
D
$39.2 Definitions Field station B '
Fresh water aquifer D Injection tool D Inetrievable welllogging source D Licensed material D Wng assistant D Logging supervisor C ,. Logging tool D Personal supervision D Radioactive marker D Safety review D
E RIGULATION SECTION TITLE COMPATIBILITY COMMEN13 . SECTION CATEGORY Scaled source [B] 'Ihis definition also appears in 10 CFR 530.4. For purposes of compatibility, thelanguage ofthe Part 30 definition should be used - and it is assigned to ComdNt y Category B. Source holder D i i Subsurface tracer study D Surface casting for protecting fresh D water aquifiers ! Temporaryjobsite D ! Uranium sinket bar D t Well D t Welllogging C ' _ $39.5 Interpretations D
$39.8 Information collection D requirements: OMB approval 639.11 Application for a specific license D 639.13 Specific licenses for wellloaaina D IMS l
i
REGULATION SECTION TITLE COMPATIBILITY - COMMENTS SECTION CATEGORY
$39.15 Agreement with well owner or C operator 639.17 Request for written statements D !
{39.31 Labels, security, and transportation D - paragraph (a) precautions ' C - paragraph (b) , 39.33 Radiation detection instruments C - paragraphs (a) and H&S - paragraph (b) (c) D - paragraphs (b) and (d) 639.35 Leak testing of sealed sources C 639.37 Physicalinventory D H&S ' 39.39 Records ofmaterial use C {39.41 Design and performance criteria B for sealed sources {39.43 Inspection, maintenance, and C opening of a source or source holder 639.45 Subsurface tracer studies C 3
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {39.47 Radioactive markers D 639.49 Uranium sinker bars C {39.51 Use ofsealed sourcein a well D l without surface casing 39.61 Training C The essential objectives of these provisions should be adopted by States because they contain training requirements specific to welllogging not contained in 10 CFR gl9.12 and apply to persons who frequently work in multiple jurisdictions. g39.63 Operating & Emergency C procedures j39.65 Personnel monitoring C - paragraph (a) D - paragraphs (b) and (C) 639.67 Radiation surveys C 39.69 Radioactive contamination control C 639.71 Security C 4
_ . ~. .. _ . . . . _ _ . _ . . _ . . _ . _ . . . -. _ . _ _ . . . REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {39.73 Documents & records required at C field stations {39.75 Documents & records required at C temporaryjob sites {39.77 Notification ofincidents: aban- C - paragraphs (a), (c) donment procedures for and (d) irretrievable sources D - paragraph (b) Q39.91 Applications for exemptions D 39.101 Violations D Q39.103 Criminal penalties D e 5
~ ~ _ _ . __ .._ .. _ . _ _ _ _ . _ .
Part 40 - DONESTIC LICENSING OF SOURCE MATERIAL REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY I40.1 Purpose D I40.2 Scope D (40.2a Coverage of inactive tailings sites A - States with authority to regulate uranium mill activities (ll.c.2 byproduct material) i D - States without ! authority (40.3 License requirements C {40.4 Definitions Act D Agreement State [B] This definition also appears in 10 CFR ll50.3(b). For purposes of compatibility, the language of the Part 150 dermition should be used and it is assigned to Compatibility Category B.
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Alert [A] Dis definition also appears in 10 CFR 630.4. For purposes of compatibility, , the language of the Part 30 definition should be used and it is assigned to Compatibility Category A. ' Byproduct material [A] nis definition also appears in 10 CFR 6150.3(c). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category A. Commencement of construction [D] nis definition also appears in 10 CFR 530.4,. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to i Compatibility Category D. Commission D Decommission [C] nis defmition also appears in 10 CFR 530.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category C. r i
REGULATION SECTION TITLE COMPATIBILITY COMMENTS I SECTION CATEGORY j Department of Energy [D] Dis definition also appears in 10 CFR 620.1003. For purposes of compatibility, the language of the Part 20 definition should be used and it is assigned to Compatibility Category D. Depleted uranium A Effective kilogram D Government agency D License D Persons [C] This definition also appears in 10 CFR 5150.3(g). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category C. Pharmacist [D] His definition also appears in 10 CFR 535.2. For purposes of compatibility, the language of the Part 35 definition l should be used and it is assigned to Compatibility Category D. 3
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Physician [D] This definition also appears in 10 CFR 635.2. For purposes of compatibility, the language of the Part 35 definition should be used and it is assigned to , Compatibility Category D. Principle activities [D] This definition also appears in 10 CFR 530.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to . Compatibility Category D. t Residual radioactive material A - States with authority to regulate uranium mill activities (ll.e.2 byproduct material) D - States without ; authority Site area emergency [A] This definition also appears in 10 CFR 630.4. For purposes of compatibility, : the language of the Part 30 definition ' should be used and it is assigned to Compatibility Category A. 1 a 4
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Source material [A] This definition also appears in 10 CFR fl50.3(i). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category A. Special nuclear material [A] This definition also appears in 10 CFR 6150.3(j). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category A. Transient shipment D United States D Unrefined and unprocessed ore B Uranium enrichment facility D 5
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Uranium milling C - States with authority to regulate uranium mill activities (11.e.2 byproduct material) ' D - States without this authority f40.5 Communications D f40.6 Interpretations D . I f40.7 Employee protection D l f40.8 Information collection requirements: D , OMB approval ! f40.9 Completeness and accuracy of D information f40.10 Deliberate misconduct C 6
9EGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {40.11 Persons using source material under B certain Department of Energy and Nuclear Regulatory Commission contracts ' 040.12 Carriers B $40.13 Unimportant quantities of source B material 540.14 Specific exemptions D - paragraph (a) NRC - paragraphs (c) and (d) {40.20 Types of licenses D {40.21 General license to receive title to C source or byproduct material {40.22 Small quantities of source material B $40.23 General license for carriers of NRC tiansient shipments of natural uranium other than in the form of ore or ore residue 7
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY
$40.25 General license for use of certain C industrial products or devices 540.26 General license for possession and C - States with storage of byproduct material as authority to regulate defined in this part uranium mill activities (11e.2 byproduct material)
D - States without authority (40.27 General license for custody and NRC long-term care of residual radioactive material disposal sites (40.28 General license for custody and NRC long-term care of uranium or thorium byproduct materials disposal sites
$40.31 Application for specific licenses D H&S - paragraph (i) only 8
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY I40.32 General requirements for issuance of D - paragraphs (a) H&S - paragraphs (b) and (c) specific licenses through (g) except NRC - paragraphs (d), (e) and (g) {40.33 issuance of a license for a uranium NRC enrichment facility 140.34 Special requirements for issuance of B - paragraphs (a)(2) specific licenses and (a)(3) D - paragraphs ; (a)(1), (b) and (c) 540.35 Conditions of specific licenses issued B - paragraphs (b) pursuant to (40.34 and (c) C - paragraph (a) D - paragraphs (d), (e), and (f) 9
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY (40.36 Financial assurance and D H&S - paragraphs (a),(b) and (d) only recordkeeping for decommissioning States have the flexibility to specify different dollar amounts based on jurisdiction and local conditions. f40.41 Terms and conditions of licenses D ' g40.42 Expiration and termination of D H&S - paragraphs (c), (d), (c), (g), (h), licenses and decommissioning of (j) and (k) only sites and separate buildings or outdoor areas {40.43 Renewal of licenses D {40.44 Amendment of licenses at request of D licensee {40.45 Commission action on application to D renew or amend i40.46 Inalienability of licenses C 640.51 Transfer of source or byproduct B material 10
REGULATION SECTION TITLE COMPATIBILITY COMMENTS , SECTION CATEGORY f40.60 Reporting requirements C - paragraphs (a), (b) and (c), except D - paragraph (c)(3) f40.61 Records C - paragraphs (a) and (b) D - paragraph (c) , f40.62 Inspections D f40.63 Tests D f40.64 Reports NRC f40.65 Effluent monitoring reporting C - states with requirements authority to regulate uranium mill activities (1le.2 byproduct material) D - states without authority f40.66 Requirements for advance notice of NRC export shipments of natural uranium 11 i
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {40.67 Requirement for advance notice of NRC importation of natural uranium from countries that are not party to the Convention on the Physical Protection of Nuclear Material {40.71 Modification and revocation of D licenses $40.81 Violations D (40.42 Criminal penalties D APPENDIX A C - states with authority to regulate uranium mill activities (11e.2 byproduct material) D - states without authority 12
Part 61 - LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE REGULATION SECTION TITLE COMAFFIBILITY COMMENTS SECTION CATEGORY 661.1 Purpose & Scope D {61.2 Definitions Active maintenance D H&S Buffer zone D Chelating agent D Commencement of construction D Commission D Custodial Agency D Director D Disposal C Disposal site C Disposal unit D Engineered barrier D Explosive material D Government agency D Hazardous waste C Hydrogeologic unit D Inadvertent intruder C
REGULATION SECTION TITLE COMAPTIBILITY COMMENTS SECTION CATEGORY Indian Tribe D Intruder barrier C Land disposal facility D License [D] This dermition also appears in 10 CFR 520.1003. For purposes of compatibility, the language of the Part 20 defmition should be used and it is assigned to Compatibility Category D. Monitoring C Near-surface disposal facility D Person [C] This definition also appears in 10 CFR fl50.3(g). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category C. Pyrophoric liquid D Site closure and stabilization D D State Stability D Surveillance D 2
REGULATION SECTION TITLE COMAFTIBILITY COMMENTS SECTION CATEGORY Tribal governing body D Waste B 161.3 ,. License required C 661.4 _ Communications D 161.5 Interpretations D 161.6 Exemptions D f61.7 Concepts D H&S 661.8 Information collection requirements: D QMB approval 161.9 Employee protection D 661.9a Completeness and accuracy of D - information 661.9b Deliberate misconduct D 561.10 Content of application D 161.1I General information D f61.12 Specific technical information D {61.13 Technical analysis D H&S 661.14 Institutional information D H&S 561.15 Financial information D 3
REGULATION SECTION TITLE COMAFFIBILITY COMMENTS SECTION CATEGORY 161.16 Other information NRC 161.20 Filing and distribution of application D 661.21 Elimination of repetition D 161.22 Updating of application D 161.23 Standards for issuance of a license D - paragraphs (a) through H&S - paragraphs (a) through (h) (h), (k) and (1) NRC - paragraphs (i) and (i) f61.24 Conditions oflicenses D 661.25 Changes D 661.26 Amendment oflicense D f61.27 Application for renewal or closure D f {61.28 Contents of application for closure D $61.29 Post-closure observation and D maintenance {61.30 Transfer oflicense D 661.31 Termination oflicense D 661.40 General requirement D 4
REGULATION SECTION TITLE COMAFFIBILITY COMMEh"IS SECTION CATEGORY 561.41 Pmtection of the general population A from releases of radioactivity 161.42 Protection ofindividuals from D H&S inadvertent intrusion 161.43 Protection ofindividuals during D Covered by provisions in Part 20 operations 161.44 Stability of the disposal site after D H&S closure 661.50 Disposal site suitability requirements D H&S for land disposal 561.51 Disposal site design for land disposal D H&S 661.52 Land disposal facility operation and D H&S disposal site closure 561.53 Environmental monitoring D H&S 561.54 Alternative requirements for design D H&S and operations {61.55 Waste classification B 561.56 Waste characteristics D H&S 5
REGULATION SECTION TITLE COMAPnBILITY COMMENTS SECTION CATEGORY 661.57 Labeling D H&S States should adopt this provision for safety to prevent overexposure from mishandling of wastes with high activities. 661.58 Alternative requirements for waste D classification and characteristics 561.59 Institutional requirements D H&S {61.61 Applicant qualifications and D assurances $61.62 Funding for disposal site closure and D H&S stabilization 661.63 Financial assurances for institutional D H&S controls 561.70 Scope D 561.71 State and Tribal government D consultation 661.72 Filing of pivposals for State and D Tribal participation 561.73 Commission approval of proposals D 661.80 Maintenance of records, reports, and C transfers 6
REGULATION SECTION TITLE COMAFFIBILITY COMMENTS SECTION CATEGORY 661.81 Tests at land disposal facilities D 561.82 Commission inspections ofland D disposal facilities {61.83 Violations D i 661.84 Criminal penalties D 7 m__._ _ -. _ _ - _ - - - - . . -y _
Part 70 - DOMSTIC LICENSING OF SPECIAL NUCLEAR MATERIAL I REGULATION SECTION TITLE COMPATIBILITY COMMENT!i SECTION CATEGORY 70.1 Purpose D 70.2 Scope D '
%70.3 License requirements C Q70.4 Definitions Act D !
Agreement State [B] This definition also appears in 10 CFR ll50.3(b). For purposes ofcompatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category B. Alert [A] This definition also appears in 10 CFR {30.4. For purposes ofcompatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category A. Atomic Energy D Atomic Weapon D
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY Commencement ofconstmction [D] This definition also appears in 10 CFR {30.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category D. *! Commission D Common defense and security D Contiguous sites D Decommission [C] This definition also appears in 10 CFR 630.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category C. Department or Department of [D] This definition also appears in 10 CFR Energy {20.1003. For purposes of compatibility, the language of the Part 20 definition should be used and it is assigned to Compatibility Category D.
~
Effective dose equivalent [A] This definitmn also appears in 10 CFR Q20.1003. For purposes ofcompatibility, the language of the Part 20 definition shouki be used and it is assigned to Compatibility Category A. 2
I REGULATION SECTION TITLE COMPATIBILITY COMMENT 3 SECTION CATEGORY Effective kilograms ofspecial D nuclear material Formula quantity D Government agency D License [D] This definition also appears in 10 CFR g20.1003. For purposes ofcompatibility, the language of the Part 20 definition should be used and it is assigned to Compatibility Category D. Persons [C] This definition also appears in 10 CFR ll50.3(g). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category C. Plutonium processing and fuel D fabrication plant l Principal activities [D] Tl;is definition also appears in 10 CFR {30.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category D. Produce D 3
l REGULATION SECTION TITLE COMPATIBILTn' COMMENTS SECTION CATEGORY Research and development D Restricted data D Scaled source [B] This definition also appears in 10 CFR {30.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category B. Site area emergency [A] His definition also appears in 10 CFR {30.4. For purposes of compatibility, the language of the Part 30 definition should be used and it is assigned to Compatibility Category A. - Source material [A] This definition also appears in 10 CFR ll50.3(i). For purposes of compatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category A. Special nuclear material [A] This definition also appears in 10 CFR 150.3(j). For purposes ofcompatibility, the language of the Part 150 definition should be used and it is assigned to Compatibility Category A. i Special nuclear material oflow NRC l strategic significance 4
REGULATION SECTION TITLE COMPATIBILITY COMMENT 3 SECTION CATEGORY Special nuclear material of NRC moderate strategic significance Special nuclear material scrap D Strategic special nuclear material NRC Transient shipment NRC United States NRC Uranium enrichment facility NRC {70.5 Communications D N70.6 Interpretations D {70.7 Employee protection D. 70.8 Information collection D requirements; OMB approval Q70.9 Completeness and accuracy of D information l70.10 Deliberate misconduct D 5
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY {70.11 Persons using special nuclear B material under certain DOE and NRC contracts {70.12 Ca: Tiers B {70.13 Department of Defense NRC {70.13a Foreign military aircraft NRC {70.14 Specific exemption D {70.18 Types oflicenses D $70.19 Generallicense for calibration or C reference sources {70.20 Generallicense to own special C. nuclear material {70.20a Generallicense to possess special NRC nuclear material for transport 6
REGULATION SECTION TITLE COMPATIBILITY COMMEN13 SECTION CATEGORY g70.20b Generallicense for carriers of NRC transient shipments offormula quantities ofstrategic special nuclear material, special nuclear material ofmoderate strategic significance, special nuclear material oflow strategic significance, and irradiated reactor fuel j70.21 Filing C - paragraphs (aX1), (aX2), (aX3), (b) and (d) D - paragraph (e) NRC - paragraphs (c), (f), (g), and (h) {70.22 Contents of application D - paragraphs (a), (d) and (e) NRC - paragraphs (b), (c), (f,f (g), (h), (i),0), (k), (I), (m), and (n) 7
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY g70.23 Requirements for the approval of D - paragraphs (aXI), applications (aX2),(aX3), (aX4), (aX5), and (aX6) NRC - paragraphs (aX7),(aXs). (aX9), (aX10),(axil), and (aX12) l70.23a Hearing required for uranium NRC l enrichment facility 70.24 Critically accident requirements NRC s70.25 Financial assurance and D H&S - paragraphs (a),(b) and (d) only recordkeeping for deccmmissioning States have the flexibility to specify different dollar amounts based on jurisdiction and local conditions {70.3I Issuance oflicenses D s
REGULATION SECTION TITLE COMPATIBILITY SECTION COMMENTS CATEGORY {70.32 Conditions oflicenses D - paragraphs (aX2), (aX3), (aX8), and (aX9) NRC - paragraphs (aXI), (aX4), (aX5), (aX6), (aX7),(bX1), (bX2), (bX3),(bX4), (bX5), (c), (d), (e), (f), (g), (h), (i),0) and (k) {70.33 Renewal oflicenses D {70.34 Amendment oflicenses D {70.35 Commission action on applications D to renew or amend {70.36 Inalienability oflicenses .C 670.37 Disclaimer ofwarranties NRC 70.38 Expiration and termination of D H&S - paragraphs (c), (d), (c), (g), (h), 0) - licenses and decommissioning of and (k) only sites and separate buildings or
- outdoor areas 9
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY i {70.39 Specific licenses for the C manufacture orinitial transfer of calibration sources j70.41 Authorized use ofspecial nuclear D material {70.42 Transfer of special nuclear material B j70.44 Creditor regulations NRC g70.50 Reporting requirements C - paragraphs (a), (b) and (c), except D - paragraph (c)(3) , 670.51 Material balance, inventory, and NRC records requirements g70.52 Reports of accidental critically or NRC loss or theft or attempted theft of s special nuclear material '
$70.53 Material status reports NRC g70.54 Nuclear material transfer reports NRC '
g70.55 Inspections NRC 10
l 1 i REGULATION SECTION TITLE COMPATIBILITY COMMEN13 SECTION CATEGORY l l l70.56 Tests NRC {70.57 Measurement control program for NRC special nuclear material accounting and control
$70.58 Fundamental nuclear material NRC controls Q70.59 Effluent monitoring reporting NRC requirements 70.61 Modification and revocation of D licenses
{70.62 Suspension and operation in war NRC or national emergency (70.71 Vmlations D {70.72 Criminal penalties D i1
Part 7I - PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL REGULATION SECTION COMPATIBILITY COMMENTS SECTION TITLE CATEGORY 17
1.0 Purpose and Scope
D 671.1 Communications and Records D {71.2 Interpretations D . 671.3. Requirements for license D {71.4 Definitions A, B i Carrier B ! Certificate holder B Close reflection by water NRC l Containment System B Conveyance I' ' Exclusive use B Fissile material B Licensed material B Low Specific Activity (LSA) B material Low toxicity alpha emitters B Maximum normal operatina pressure B
REGULATION SECTION COMPATIBILITY COMMENTS ; SECTION TITLE CATEGORY Natural thorium B Normal form radioactive material B Optimum interspeosi hydrogenous NRC moderation Package B ' Fissile material package B Type B package B Packaging B Special form radioactive material B Specific activity B i State D < Surface Contaminated Object (SCO) B Transport Index B Type A quantity B i Type B quantity B Natural Uranium B Depleted Uranium B Enriched Uranium B 2 J
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REGULATION SECTION COMPATIBILITY SECTION TITLE COMMENTS CATEGORY l71.5 Transportation of Lk:ensed Material B i 71.6 Information collection requirements: D OMB approval j71.7 Completeness and accuracy of D Information 71.8 Specific exemptions D 71.9 Exemption for physicians D 71.10 Exemptions forlow level material B 71.12 General license: NRC-approved B package 71.13. Previously approved package B 71.14 Generallicense: DOT specification B container material 71.16 Generallicense: Use offoreign B approved package 71.18 General license: Fissile material, D This provision is not required for purposes of limited quantity ofpackage compatibility. However, if a State acca to adopt such a provision and issue the GL, the provisions should be essentially identk:al to those ofNRC. i 3
REGULATION SECTION COMPATIBILITY COMMENTS SECTION TITLE CATEGORY {71.20 Generallicense: Fissile material, D This provision is not required for purposes of limited moderator per package compatibility. However, if a State deca to adopt such a provision and issue the GL, the provisions should be essentially identical to those ofNRC. Q71.22 Generallicense: Fissile material, D This provision is not required for purposes of ' limited quantity, Controlled compatibility. However, if a State chooses to Shipment adopt such a provision and issue the GL, the provisions should be essentially identical to those ofNRC. 71.24 General license: Fissile material, NRC limited moderator, controlled shipment Q71.31 Contents of Application NRC 671.33. Package description NRC 671.35 Package evaluation NRC 671.37 Quality Assurance NRC Q71.39 Requirements for additional NRC information Q71.4I Demonstration of Compliance NRC l 671.43 General Standards for all packages NRC 4
REGULATION SECTION COMPATIBILITY COMMENT 3 SECTION TITLE CATEGORY
$71.45 Lifting and tie-down Standards for NRC all packages
{71.47 External radiation Standards for all NRC packages {71.51 Additional Requirements for Type B NRC packages
$71.52 Exemption for low-specific-activity NRC (LSA) packages 671.53 Fissile material exemptions NRC 71.55 General Requirements for fissile NRC material packages @71.57 Reserved '
{71.59 Standards for arrays offissile NRC material packages j71.61 Special requirements for irradiated NRC i nuclear fuel shipments $71.63 Special requirements for plutonium NRC shipments l71.64 Special requirements for NRC ' plutonium air shipments 671.65 Additional Requirements NRC t 5 i
REGULATION SECTION COMPATTBILITY COMMENTS SECTION TITLE CATEGORY 671.71 Normal conditions oftransport NRC 671.73 Hypothetical accident conditions NRC l71.74 Accident conditions for air tr wt NRC ofplutonium
$71.75 Qualification ofspecial form NRC radioactive material l71.77 Qualification ofLSA-III material NRC l71.81 Applicability ofoperating controls B
{71.83 Assumptions as to unknown NRC properties 71.85 Preliminary determinations B 571.87 Routine determinations B l71.88 AirTransportation ofplutonium B 571.89 Opening instructions B ' {71.91 Records D 671.93. Inspection and tests D
$71.95 Reports D 971.97 Advance notificat' e n ofshipment of B irradiated reactor fuel and nuclear waste 6
REGULATION SECTION COMPATIBILITY COMMENT 3 SECTION TITLE CATEGORY 671.99 Violations D {71.100 Criminal penalt'es D {71.101 Quality assurance requirements D {71.103 Quality assurance organization D 4 671.105 Quality assurance program D 67i.107 Package design control D l71.109 Procurement document control D {71.11I Instructions, procedures, and D drawings 71.I13 Document control D {71.115 Control ofpurchased material, D equipment, and services 71.117 Identification and control of D materials, parts, and components {71.119 Control ofspecial processes D 671.121 InternalInspection D 671.123 Test control D {71.125 Control ofmeasuring and test D equipment 7
REGULATION SECTION COMPATIBILITY SECTION COMMENTS TITLE CATEGORY {71.127 Handling, storage, and shipping D control _ 671.129 Inspection, test, and operating status D
$71.131 Nonconforming materials, parts, or D components 71.133 Corrective action D 671.135 Quality assurance records D 671.137 Audits D Appendix A Determination of'Al and A2 B 8
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Part 150 - EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 2M . 6 I l l I REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECrlON CATEGORY l 6150.I Purpose D 6150.2 Scope D Q150.3 Definitions {150.3(a) Act D Q150.3(b) Agreement State B Definition has significant nationwide and transboundary implications. 6150.3(c) Byproduct Material A Ql50.3(d) Commission D 6150.3(e) Government Agency D 150.3(f) Offshore Waters B Essential to the reciprocity provisions in i150.20 { ISO.3(g) Person C {l50.3(h) Production facility NRC Such facilities are outside Agrew.w..; State jurisdiction; however, if State chooses to defme the term then the definition should be essentially identical 6150.3(i) Source material A {l50.3(i) Special nuclear material A 4150.3(k) State D
REGULATION SECTION TITLE COMPATIBILITY COMMENTS SECTION CATEGORY ll50.3(1) Utilization facility NRC Such facilities are outside Agrw..c..; State jurisdiction; however, if State cim to define tie term then the definition should be essentially identical. Q150.3(m) Uranium enrichment facility NRC Such facilities are outside Agiw a..; State jurisdiction; however, if State chooses to define the term then the definition should be essentially idcritical. f150.4 Communications D 150.5 Interpretations D Q150.7 Persons in offshore waters NRC not exempt 150.8 Information collection D requirements: OMB approval 150.10 Persons exempt NRC Exemption addresses discontinuance of NRC authority in an Agreement State jl50.11 Critical mass B Defines scope of authonty that NRC can relinquish to States for special nuclear materials. This must be identical from State to State and therefore has significant and direct transboundary implications. 5150.14 Commission regulatory NRC Provision addresses continuing NRC authority over authority for physical special nuclear material. protection 2
. . . . - . . . . - . . . . _ - . - . - - - . - . - . ~ . . - - - . - . - - - . - - - . . - . _ - - . . . - . _ - - - - . - .
i REGULATION SECTION TITLE COMPATIBILITY COMMEN'I3 SECTION CATEGORY ' I l {150.15 Persons not exempt NRC Provision addresses continuinC NRC authority over [ l certain activities in Amin r^_ States. ! l 5150.15a Continued Commission NRC Provision addresses continuing NRC authority over : l k authority pertaining to certain activitiesin Agreement States. byproduct material i t i150.16 Submission to Commission NRC Although an issue within NRC exclusivejurisdiction, ofnuclear material transfer States should adopt some method to advise their reports licensees of these NRC re;--; .~.;s. {l50.17 Submission to Commission NRC Although an issue within NRC exclusivejurisdiction, ' ofsource material reports States should adopt some method to advise their I licensees of these NRC requirements. jl50.17a Compliance with NRC
; i+;im.a.. s of US/lAEA safeguards sa ia..er.; ,
i150.19 Submission to Commission NRC Although an issue within NRC exclusivejurisdiction, , of tritium reports States should adopt some method to advise their licensees of these NRC r%; -.~.;s. l 6150.20 Recognition of Agisi.w..; C - paragraphs (a) Provisions in (a) and (b) are irnportant for coherent i State f u . 2 2 and (b) regulation ofagreement material on a national basis. ! Provisions in (c) & (d) relate to NRC authority to . NRC - paragraphs (c) regulate activities in off% ore waters. ! and (d) l 3 i 1
- _ _ _ _ _ _ _ _ _ _ _ - _ _ . _ - - _ - _ - _ _ _ _ _ - _ _ _ _ _ _ _ _ ___--_'J
REGULATION SECTION TITLE COMPATIBILTTY COMMENTS SECTION CATEGORY {150.21 Transportation ofspecial NRC Provision addresses continuing NRC authority over nuclear material by aircraft activities in Agwca.: States i150.30 Violations D ll50.31 Requirements for Agfew.c.,i C - States with State regulation ofbyproduct authority to regulate material uranium mill activities (Ile.2 byproduct material) D - States without authority ll50.32 Funds for reclamation or C - States with maintenance ofbyproduct authority to regulate material uranium mill activities (IIe.2 ' byproduct material) D - States without authority $150.33 Criminal penalties D 4 m.. _ _ _ . . _ _ _ _ _ _ _ _ _ _ _ . . _. _ . _ _ __ . _ _ . _ _ - . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____
PROGRAM ELEMENTS PROGRAM ELEMENT REQUIRED FOR COMMENTS IAgisletten and tagal Authority '
.'-_xy See discussion in A% y Section of Policy Statement Regulations See Classification Tables for 10 CFR parts in OSP Internal Procedure B.7 (Rev. I)
Guidance documents and D interpretations Licensing Adequacy See discussion in Adequacy Section of Policy Statement Reciprocal recognition of C 1his program element has significant effects on the regulation of agreement material on a licemes national basis. However, States should be provided flexibility for the type of license and time period recognized under reciprocity. Although there are transboundary implications, there is not a necessity for all States to be identical, such as would be required by a classification of "B.' Written procedures C Maintenance of records, C especially for decommissioning Inspection and licensing files C Inspection and Enforcement Adequacy See discussion in Adequacy Section of Pblicy Statement Written procedures C . Radiological laboratory D support Instrumentation D l Peesonnel Adequacy Se discussion in A%_- y Section of Pblicy *- .~..;
PROCRAM ELEMENT REQUIRED FOR COMMENTS Qualification procedures C There should be minimum education and capuk.s requirements for all technical rum,. ; in RCPs nationwide. Flexibility is provided to allow for different state administrative requirements. Response to Events and Allegattens Adequacy See discussion in Adequacy Section of Policy Statement Written procedures C Major incident investigation C Need to prevent gaps in reporting effectiveness of national program procedures Procedures for investigation C of " wrongdoing
- Scaled source and device program Adequacy Non-common ruimu=.nce indicator Standard review plan C Format and content of B Need to have national consistency so that all RCPs can rely on the specific information registration certificates included in these documents i
Written procedures C Low level waste Adequacy Non-common performance indicator. Written procedures C Uranium is.. ., Adequacy Nonemmon rufmni.nce indicator. Written procedures C Exchange of information C Necessary for effective regulation of agreement material en a national basis; necessary for effective review of NRC and Ag6.. ra State programs for agreement material with respect to protection of public health and safety. Event reporting C See previous commem. Legal assistance D Technical advisory committees D Technical assistance and support D
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O s O ATTACHMENT 7 1 i 1 l l l i 1 1
MY DISSENTING RECOPMENDATIONS by John Telford The Working Group has voted to classify i 35.32, The Quality Management Rule, as compatibility category D (i.e., not required for Agreement State licensees). The reasons for this vote seem to stem from a desire for State autonomy, lack of familiarity with the details of Part 35, reliance on rationale that I am not comfortable with, or some combination of these. First, because my views differ from those of the Working Group.regarding the compatibility classification of i 35.32, I would like to offer three alternative recommendations, to be considered sequentially, and the rationale for each. Then, to address the bigger picture, I would like to offer two recommendations for the Commission's consideration as possible conclusive solutions in the medical use area.
- 1. Consider whether i 35.32 should be classified as compatibility category A because it establishes basic radiation protection standards.
Does i 35.32, like Part 20, establish dose limits which are basic radiation protection standards? Recall that the regulatory limits established in Part 20 are, in part, to conduct licensee operations so that (1) no worker receives more than 5 rems per year (i 20.1201) and (2) no member of the public receives more than 0.1 rem per year (i 20.1301). Consider that the regulatory limits established in i 35.32 are, paraphrased, to conduct medical use licensee operations so that no patient receives a therapy dose or dosage that is_not as directed by the authorized user. Also consider (e.g., teletherapy) that specific dose limits are established by a chain of requirements: (1) the written directive required by i 35.32 for a teletherapy dose; (2) the definition, in 5 35.2, of a written directive for teletherapy that requires the authorized user to specify: (a) the total dose, (b) dose per fraction, (c) treatment site, (d) and overall treatment period; and (3) the definition, also in i 35.2, of a teletherapy misadministration that specifies the dose limits are: (a) 10 percent of the total prescribed dose when the treatment consists of three or fewer fractions, (b) 30 percent of the weekly prescribed dose, and (c) 20 percent of the total prescribed dose (for greater than three fractions). Thus, for a teletherapy prescribed total dose of 5000 rads, with 200 rads per fraction, to be delivered in 25 fractions over a 5 week period the , regulatory dose limits are 300 rads for the weekly dose and 1000 rads for the j total dose. Of course, for any therapy admiilistration the same chain of l requirements will provide the dose limits when the written directive is ! completed. In addition, for misadministration (6) the dose limits of 5 rems i effective dose equivalent to an individual or 50 rems dose equivalent to any i individual organ are provided directly in the definition. j Therefore, like il 20.1201 and 20.1301, il 35.2 and 35.32 establish dose limits i which are basic radiation protection standards. The former protects workers and ) members of the public from specified overdoses, while the latter protects i patients receiving therapy doses of radiation from large overdoses, morbidity, i and mortality. , 4 Without i 35.32, would the Commission have basic radiation protection standards for patients receiving therapy doses of radiation in Agreement States? The answer
t F is no. Also without i 35.32, the Commission would be establishing radiation ! protection standards in Part 20 that focus on 5 rems per year (which has no ! immediate consequences), but not focusing any regulatory oversight on large i patient overdoses, morbidity, or mortality. This would be an incongruous result. ' Clearly the Commission attached a prominent level of importance to i 35.32 when it promulgated the Quality Management Rule in 1991, because it stated in Section i V. " Implementation Plan and Agreement State Compatibility" of the Federal l Register Notice that "...this amendment has safety significance for the Agreement ! State licer,9es as well as the NRC licensees,..." and " Additionally, the l Cosunissior, oelieves that il 35.32 and 35.33 ... are necessary to ensure adequate i protection of the public health and safety." (56 FR 34118) l This means that the compatibility category for i 35.32 and selected definitions ! in i 35.2 should be A. This also means that the Policy Statement should be ! changed in the Section on Compatibility, the first sentence under Basic Radiation 1 Protection Standards, as follows; "For_ purposes of this Policy Statement, the ! term " basic radiation protection standards" means dose limits, concentration and . release limits related to radiation protection in 10 CFR Part 20 that are ! generally applicable, and the dose limits established by 10 CFR 35.32 and i 61.412." l
- 2. Consider whether i 35.32 should be classified as compatibility category C because it is necessary to make effective the definition of misadministration and i the associated misadministration reporting requirements for Agreement State !
licensees. i Consider the effects of classifying (as the Working Group has done) as I compatibility category C the definitions for misadministration, prescribed dose ' and dosage, written directive, and the misadministration reporting requirements, l but classifying i 35.32 as compatibility category D. Recall that the definitions of misadministration, covering the various treatment modalities, depend on the definition, in i 35.2, of prescribed dose (or prescribed dosage), which in turn depends on the definition of written directive. However, if a written directive does not exist, that is, f 35.32 is not required for Agreement State licensees (i.e, category D), to specify (for example): the patient, route of administration, total dose, dose per fraction, treatment site, etc. the definition of misadministration would be rendered meaningless. While a definition for' written directive would exist in i 35.2, only i 35.32 requires that a written directive be completed. Unless i 35.32 is required for Agreement State licensees (i.e., category A or C), they could not be required to have written directives, an effective misadministration definition, and or meaningful misadministration reports. (If any doubt exists about whether this is possible among the Agreement States consider Wyoming, a non-Agreement State, with no radiation protection program for non-agreement material and California whose radiation control program director has stated in public at the All Agreement States Meeting and the Conference of Radiation Control Program Directors Meeting that California will not adopt i 35.32.) This means that the compatibility category for 6 35.32 and selected definitions in i 35.2 should be at least C. l l
I l
- 3. Consider whether i 35.32 should be classified as compatibility category C because if it is category D Agreements States would be free to not adopt it, a gap would be produced, and the orderly pattern ;n the regulation of agreement material on a national basis would be jeopardized. '
Recall that i 35.32 protects patients from therapy overdoses by requiring that the administered dose be "close to" the prescribed dose, in accordance with the
" closeness" criteria provided in the definitions of misadministration (e.g.,
within 20%). If the compatibility category for 9 35.32 were D (i.e., not required for Agreement State licensees) and all Agreement States in response to local pressures and priorities decided not to adopt f 35.32, consider whether there would be a gap between NRC and Agreement State programs to ensure adequate radiation protection for therapy patients or Kather this would jeopardize an orderly pattern in the regulation of agreement material on a national basis. Clearly the gap would be about as large as it could get, since this would be a case of the haves versus the have-nots regarding radiation protection, and there would be no orderly pattern in the regulation of agreement material. Now let's change perspectives. Regarding the overall issue as well as concern for State autonomy and flexibility, the first recommendation is to request that Congress change the Atomic Energy Act so that the NRC would be responsible for setting the performance standards and regulatory requirements for all radiation therapy sources for medical use licensees. Also, the participating States would be responsible for implementing, licensing, and inspecting those standards and requirements for their facilities; the NRC would be responsible for implementing, licensing, and inspecting the federal facilities and non-participating State facilities; and the medical use licensees would be reimbursed for the services provided to their patients if they maintained compliance with the performance standards and regulatory requirements. This approach is modeled after the Mammography Quality Standards Act. The disadvantage is that it requires changing the AEA, which is an uncertain and possibly slow process. The advantages are: that a federal agency with a national perspective and the ability to do any required research would set the performance standards and reguietary requirements; a State could decide on its own whether to participate, coulo participate in setting the national standards and requirements, and would control the compliance of licensees in its state; the licensees nationwide would have a level playing field and a clear understanding of what is required and why; and adequate protection would be ensured for patients and members of the public. The last recommendation, assuming the current scheme of things, is to tailor implementation of f 35.32 by focusing regulatory attention and resources on high risk therapy procedures (i.e., those with severe consequences, like morbidity and mortality) and using specific performance standards for licensees. This rule is already fairly focused on therapy procedures, but its scope could be refined to exclude dosages of I-131 below 1 millicurie and include changes in therapy procedures. Also, the dose limits in misadministration definition (6) could be raised from 5 rems (whole body) to an individual and 50 rems to any organ to higher levels, but below morbidity; and brachytherapy fractional treatments could be specifically included in the definition of misadministration. Performance standards would need to be established for each treatment modality. This is assuming that performance should ultimately be measured against a " standard of goodness." The currently required and reported licensee data on the frequency of
1 occurrence of each type of misadministration for each treatment modality (e.g., l
, therapeutic radiopharmaceutical dosages, teletherapy total doses, teletherapy -
weekly doses, and brachytherapy doses) would be used as the numerator for the performance standard. The denominator in each case could be provided by the ,
- licensees because they have billing records for each therapy treatment. For each licensee with " poor" performance the Commission could request that the licensee
, provide the performance data for each treatment modality and type of i misadministration (e.g., number of teletherapy weekly administered dose misadministrations divided by the total number of teletherapy weekly administered doses in the last 12 months, and over the life of the license) and the licensee's plan for preventing such poor performances. The Commission could dnide what ;
constitutes poor performance and too much patient risk (i.e., expected loss or frequency of occurrence times expected consequences) either on a case-by-case , basis or, through experience, establish specific performance standards such that the performance measurement must be less than 1 in 1000, 1 in 10,000, or 1 in
- 100,000. This would allow the inspections to focus on questions, such as, is the licensee maintaining the program, is the licensee detecting the '
misadministrations and recordable events, and does the licensee's performance measure up to the Commission's standards for each treatment modality? If the licensee's performance does measure up, then the licensee should be commended. 4 1 I i j d i i i
ATTACHMENT 8 e e
l N N 09:42 gggggpg, g, P.01 j . f, n., f.d5' rue e w CNN aans., v. enem. l SA318fSW YA NNST " l ! 4:14 soumsom serese Phoents, arts.na esoso as4e (eerines.4s4s l Fem (Set)437 07o8 1 January 3,1997 i PaulH.Lohaus DeputyDirestor
- OIBea ofStelePrograms Usked States Muelear Regulatory Comrnisalon l Washinson, DC 20$$$.0001
} l post Mr. Lahous, In reviewing the discussions related to 10CFR3.4.32. it appears that some additionalinformation should be
- provided to the Commission. I request that this accompany the attachmer, of Mr John Telford to the Ceaunission. These are my personal comments and do not represent the Working Group In reviewing 35.32, I evaluated the applicability of the various criteria of each category. The resuhing laterpretaten follows.
1. Wah regard to estagory A, I do not believe that the numerical values refWenced in tnis section qualify l as a prenary standard for radiation protection as used in the Policy Statement
- 2. With regard to category B the interstate affects of not having 35.32 are not suf5cient to justify a category B listing
- 3. With regard to category C, there will be no sep, duplication or prohibition of a necessary practice if a state does not adopt this requirement 4
The remaining category is D. The issue becomes "is there enough health and safety problems generated to requiet a HAS in the comments section. Based on the following information, I do rot believe that a NAS noteis needed A. The requirement of paragraph (a) that a licenses maintain a quality management program to provide iiigh congdenne" . The term "high conAdence is not defined and ts somewhat vague For maryle, does this mean that the program must be 90%, 95%, or 99% correct. Since it is vape, it doesn't appear to be a haakh and esibty issue. In my opinion, a health and safety issue must have spealSc limbs or guidance and time does not The associated Regulatory Guides do not adBaisedy starWy she sisustion The guides cleariy stese that they are not the requirements, only the regulations are the requrements. Funber, the section appears to oddress standards of medical practice rather then pure heakh and safety It should be noted that exposures to the 3 tene e insn=swuooud alvis zesc+stetet $l ".- /st-se-te' ee:siAd li@M~'JUW~ 2 ##
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' PaulE Loheit Page 2 l pubbe as a resuk ofreleasing a patient comaining emeessive radioactive material wouk! appear j to be reponable d's member of the public (not the pstient)is expoemd in emmens of 01 rem
- TEDE. Santiarly preysph (a)f5), again, is not doenise as to what the appropriate actions sha!!
he amt the 5cannae sney believe that the appropriate action was taken only to be second peessed i by the aspector. Assin, the lack of sped $ city indicates that this is not a een6date for i designation as NAS. l S. The remaining ponions of 35.32 are very prescriptive and detail requirements which may be i la osadict wkh receed keeping rupmmems orgroups Eke Siers Medical IJoomeing Boards and
! sisso pharmasy sends.
I i C. The NRC staff of the Working group may have ihti some in$uenos to suppen the HAS i desissadon by tbs conunents bi ths Statements of Corsideration Ibr 35 32 which indicates that the then Commission believed that the QM requirements wars of safety signincance. I de not j Anal ao in$uenced, sad therefbre, have ofered these commems 3 1 D. la reviewing 35.32 one is dtue to the conclusion that the intent ofthe rule is to address the l quality armadical praesion rather than a health and safety issue. The reguistion of the quality of mediosi practice as well as most professions is at the state level. The possible exception is j the Mammography Qualty Standards Act, but even that program has performance based rules rather than detailed prescriptive requirements 1, l Thank you for this opponunity to offer these comments i Sincerely. l l $ ) Aubrey . oodwin, ! Direc2c,r i ); 1 i 1 1
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