ML20127C392

Provides Analysis of Comments on Compatibility of Agreement States Programs & Proposed Policy Statement on Compatibilty of Agreement Statesregulations for Low Level Waste Disposal

ML20127C392
Person / Time
Issue date:	07/14/1992
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-92-243, NUDOCS 9207210159
Download: ML20127C392 (42)

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~POOCY ISSUE (Notation Vote)

July 14, 1992 SECY-92-243 g The Commissioners Erom: James M. Taylor _

Executive Director for Operations Subieq1: ANALYSIS OF COMMENTS ON THE COMPATIBILITY OF AGREEMENT STATES PROGRAMS AND A PROPOSED POLICY STATEMENT ON THE COMPATIBILITY OF AGREEMENT STATES REGULATIONS FOR LOW LEVEL WASTE DISPOSAL

Purpose:

This paper responds to Staff Requirements Memorandum (SRM)

M910611A, dated June 25, 1991. The SRM directs the staff to seek comments on the issue of compatibility from interested parties other than the regulatory community; to provide an analysis of the issues raised in the comments including those from the Agreement States; and to make recommendations on the process the Commission should follow to develop a policy on compatibility issues, in addition, the SRM directs staff to consider the joint NRC/ Agreement State task force process recommended by the Organization of Agreement States (OAS) as well as suggestions from other interested parties in its recommendation. This paper also requests -

Commission approval of a.significant policy statement on compatibility of Agreement State regulations for low-level waste disposal.

Cateaory: This paper covers major policy issues requiring Commission consideration and approval.

Summary: The staff summarizes responses to the six questions published in the December 1991 Federal Reaister (FR) Notice that solicited public comment, and the issues raised in the-March 1991 OAS Compatibility Task Force Report. There were 105 individuals or organizations that responded to the FR Notice.

290004 NOTE: TO BE MADE PUBLICLY AVAILABLE WHEN THE FINAL SRM IS MADE

Contact:

Carlton Kammerer, OSP Vandy L. Miller, OSP 504-2321 Sl Y \

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• The Commissioners 2 i

The majority of commenters support to some degree the concept of a uniform national approach to radiation safety-matters. There is no consensus, however, about how. wide the scope of uniformity should be. Some commenters state that a high degree of flexibility is needed to establish more-stringent standards; others state that strict uniformity is needed. The commenters, however, did not clearly articulate a mechanism for accommodating flexibility although the current tiered application of compatibility seems to be an acceptable approach.

With regard to the OAS Compatibility Task Force report, it states that there appears to be a fundamental disagreement between OAS's interpretation of the term " compatibility" and that held by the NRC. The OAS Task Force report states that-maximum flexibility should be allowed for States to achieve their desired goals; however, 0AS also states that some __

aspects of regulatory provisions should be identical, such  ;

as basic radiation protection terminology. 'The OAS Compatibility Task Force report strongly supports developing a new policy on compatibility and allowing the Agreement States to become involved in its development.

On the basis of the comments submitted, this Commission paper describes four options for the Commission to consider in developing a generic policy regarding compatibility. '

In addition, due to the upcoming Federal milestones for developing low level waste disposal capacity and the pressing need of some States to develop their regulatory programs in this area, the staff is submitting a proposed compatibility policy statement on low level- waste disposal for Commission consideration.

( Backaround: To provide guidance to the staff and to better implement the term " compatibility," the NRC Office of State Programs (OSP)

! in 1984 developed internal--written procedures,. " Internal Procedure B.7 -- Criteria for Compatibility Determinations."

In this procedure, which is still used by the staff, OSP .

categorizes into four divisions pertinent NRC rules according to the degree of uniformity necessary between NRC and Agreement State requirements. Division I rules constitute those provisions of the NRC regulations that States are required to adopt, essentially verbatim, into their regulations. Division 2 rules- are other provisions in NRC rules that States must address in their regulations because_ these rules include basic principles of radiation safety and regulatory functions. However, the use of language identical to that of the NRC is not necessary, provided the underlying principles are the same. The States may adopt more stringent or more restrictive rules than the

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The Commissioners 3 NRC rules in this area. Division 3 rules are-those provisions in NRC regulations that_would be appropriate for Agreement States to adopt, but do not require any degree of uniformity between NRC and-the States' rules.

Divisien 4 rules are certain regulatory functions that are reserved to the NRC pursuant to the Atomic Energy Act of 1954 as amended, and 10 CFR Part 150. Appendix A to-these-internal procedures contains a " Categorization of NRC Rules by Compatibility Type." These categorizations are decided by the staff and Commission on a case-by-case basis for each rule provision.

The Commission, in SRM M9000816A, dated October-5,-1990 directed the staff to investigate the matter of Agreement State compatibility'and to report to the Commission on the issue. The staff presented its findings to the Commission-in SECY-91-039, " Evaluation of Agreement State Compatibility-Issues," dated February 12, 1991. The paper includes a j history of the Agreement State Program with. regard to compatibility issues, lis L 12 policy factors-to be considered in making compatibility determinations, and presents three options detailing how these various factors:

l could be weighed in formulating a Commission pol. icy.

In reviewing the policy factors.and the program' review areas in SECY-91-039, the staff developed three possible options as examples of _ policies that could be _used by the Commission. Option 1 emphasizes the need for preserving a Federal leadership role, maintaining effective

, communications-between regulatory agencies', avoiding burdens on interstate commerce, ensuring the effective-implementation of specific Federal-initiatives,-conserving NRC resources, and ensuring equal' treatment of licensees. .

Option 2 embraces most of the policy factors in Option 1, and adds the need to encourage State-innovation, to promote

' the transfer of State as well as Federal initiatives, and to  :

consider local conditions and needs. Option 3 recognizes a limited area in which' uniformity is-needed to advance.

specific Federal initiatives, but otherwise encourages State innovation, considers local conditions and.needs, and l recognizes -the States'= need to provide an equal level of; L protection for all regulated sources :of radiation. The.NRC l

staff evaluates the balance of-the State program for adequacy to protect the public health and safety:

Numerous variations on these three options are possible, depending on the weight given to each of-the policy factors by the Commission. SECY-91-039 identifies a number of other-issues that need to be considered in developing a policy, on

-, The Commissioners 4 compatibility, that is, consistency of application and justification for Commission action on enforcement of compatibility, resource impacts, and States' rights-The Agreement States have been increasingly concerned about the direction of various NRC actions with regard to the I establishment of compatibility requirements. In a letter  !

dated January 24, 1991, to Chairman Carr from Thomas Hill, l Chairman of the Organization' of Agreement States (0AS), the J issue of compatibility was raised. The letter states that j the Agreement States and the NRC have a fundamental '

disagreement regarding the interpretation of the term-

" compatibility." The OAS believes-that maximum flexibility-should be allowed for States to achieve their desired go'als in a way that best suits their circumstances. In addition, the OAS Joes not believe that compatibility means

" identical," except in rare circumstances, nor does it mean "do it the NRC way." Instead, the OAS defines. compatibility.

as " existing together in harmony," or " capable of performing in harmonious, agreeable, or congenial combination with -.

another or others."

The OAS established a task force on compatibility to refine its position on the issue. In March 1991 the OAS submitted the " Report of Agreement States Task Force on Compatibility" to the Commission and on June 11, 1991, the members of the OAS Compatibility Task Force briefed the Commission on the report's findings. The report noted'that some of the NRC actions relating to compatibility appear-arbitrary and there seems to be-little thought with regard to determining compatibility. The Agreement States are-concerned that information on compatibility determinations is not shared with the States before the NRC makes a' final decision.

In SRM, M910611A, dated June 25, 1991, the Commission-directed the staff to seek comments on' compatibility. from interested parties outside the regulatory community on the.

advantages and disadvantages of a uniform national-approach to radiation safety matters. The staff.was instructed to provide the Commission with an analysis of the issues raised, along with recommendations on the process that g should be followed to develop'a policy on compatibility l issues. A FR Notice entitled " Request for Comments on the I

Compatibility of Agreement States Program's~ With NRC j; Regulatory Programs" was published on December 23, 1991, to solicit comments on six questions related to the policy,

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technical, and -legal issues associated with compatibility.

When the comment period expired on March 19, 1992, the staff had received 105 comments.

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t The Commissioners 5 Staff Analysis: The staff's summary of the responses to the six questions published in_ the FR notice and its analysis of the issues raised in the OAS Task Force report are addressed below.

SUMMARY

_QF RESPONSES TO THE SIX OVESTIONS IN THE FR NOTICE Thu 105 individuals or organizations responding to the FR notice can be placed in five general categories: (1) the industrial materials community; (2).the medical materials community; (3) the nucicar power industry; (4) environmental -

groups, public interest groups, and private citizens; and. '

(5) Federal, State, and local government agencies.

The staff did not. evaluate the substance of the' comments relating to the scope and content of the Commissicn's compatibility policy, except in the area of low level waste disposal regulations, in order to avoid making a premature commitment to a.particular substantive position. The '

substance of the compatibility policy should be determined within the context of the process that the Commission selects from among the options presented in-this paper,. The staff wi process.]lreexaminethecomments-duringthatsubsequent.

Enclosure 1 contains a more detailed summary of the comments and Enclosure 2 addresses the four key issues frequently mentioned in the comments. A list of commenters is attached as Enclosure 3.

1. Do you believe that there should be a uniform national approach to radiation safety matters?. Should the scope of uniformity Le narrowly focused or comprehensive?

The majority of commenters support the concept of a uniform national approach to radiation safety _ matters.

There is solid support -in the industrial materials community; the nuclear power industry; and Federal and State government agencies. There is majority support in the medical materials community. However, some

local government agencies do not support this concept.

.With regard to the scope of uniformity, there is no consensus among the commenters concerning the degree

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' NOTE: While the commenters did not raise the-question of compatibility in the areas of enforcement and investigations, the staff suggests that these issues be examined during the development of the compatibility policy.

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.. The Commissioners 6 l

l of uniformity desired, that is, whether the degree of uniformity should be narrowly focused or comprehensive. The commenters from the industrial

..aterials community, the nuclear power industry, and the federal government agencies strongly support a ,

comprehensive approach to uniformity in radiation 1 regulation, whereas many commenters from the medical materials connunity and State and local governments prefer a narrowly focused approach to uniformity.

Environmental and public interest groups and citizens suggest a formula in which the NRC sets a minimum standard ind Agreement States may set more stringent '

standards.

Some commenters recommend that mechanisms such as joint NRC/ Agreement States committees or open meetings that involve affected and interested parties be 1 considered as appropriate ways to resolve this issue. ]

2. a. Is the t fered approach described in the }

divisions (for compatibility) a reasonabic <

approach for regulations? For [ Agreement State l radiation control) programs as a whole? \

b. What areas of Agreement State radiation control and protection should be laentical to those of the NRC and why?

c. What arcas of Agreement State radiation control and protection should be allowed to be different from those of the liRC and why? l The commenters fall into two categories; (1) those-that want strict compatibility with NRC regulations +

and (2).those that want the States to have a high degree of flexibility to establish more stringent standards.- The majority of commenters,.however, support the tiered approach. Many members of-the

nuclear power industry and the industrial materials l licensees who cross jurisdictional boundaries (i.e.,

industrial radiographers and manufacturers)-prefor strict lines of conformity between the regulatory L programs of the NRC and the Agreement States.

Commenters from environmental groups, local governments, and some members of the medical community p greatly encourage a high degree of flexibility to ,

l establish more stringent' regulations.

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. The Commissioners 7 Commenters cite areas that should be identical to that of the flRC, including technical definitions and  :

terminology, radiation signs and symbols, and  :

radiation dose limits.

3. What mechanisms should the NRC use to allow Agreement States to have flexibility to address local needs or conditfons? What factors should the Commission consider in balancing local needs or conditions and interstate or international commerce concerns or other national interests?

The commenters from all five categories do not-directly address the question by identifying a mechanism for the f4RC to use to allow Agreement States to have flexibility in addressing local needs or conditions. Rather, they assume that the flexibility j was already an option. Given this assumption, comments are directed tuward flexibility in adoption i of rulet or flexibility in_ the inspection and enforcement procedures.  ;

Commenters identify several factors that should be _ ,

considered in balancing local needs or conditions and 1 interstate or international commerce concerns or other national interests. The most commonly mentioned '

ftctors were whether variations in rulemaking would redefine basic radiation safety principles and whether floxibility would result in uniformity-and' consistency .

between the f1RC, States, and the international community.

4. Should Agreement States be given a greater degree of flex!bility in fashioning their own standards for low-leve) waste disposal, in view of the State's increased responsibility in this area, according to the low-

_ level Radioactive Waste Policy Amendments Act of 19857 Commen?.ers' responses to this question reflect _ _

distinct differences. Commenters from the industrial i materials community, the medical materials community, and the nucioar p:wer industry respond that: States should not be given a . greater degree of flexibility-in ,

fashioning low-level waste standards. Government agencies and environmental /public interest groups- and private citizens generally support increased flexibility for Agreement States in-view of' the .

States' increased responsibilities in LLW.-

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l S. Provided the issue of compatibility is fully alred in rulemaking notices, is the current comment process sufficient for a continuing dialogue with those persons outside the llRC/ Agreement State regulatory  ;

partnership? If not, what alternative would you  ;

suggest and why?

Nearly half of the commenters did not respond to this l question. Because of this, there is no clear i delineation according to categories of commenters. ,

Most of the responders indicate that the current i process is sufficient, with some suggested .

modifications. These suggestions include allowing-comment periods on documents for at least 60 days, publish notices of rulemakings in publications other than just the FR flotice, and provide more information relative to compatibility in the rulemaking notices.

6. Should-the flRC develop exemption criteria for an ,

Agreement State that does not adopt a rule deemed a mat ter of compatibility, as described in llRC's Division 1 and 2 rules, if an Agreement State requests such an exemptlon? What factors should be considered in the criteria to assure that the exemption is justified?

Commenters from the group that includes environmental groups, public interest groups, and private citizens, and from State and local government categories -

generally state that exemption criteria should be adopted. Some commenters . reply that it was inevitable '

that States would disagree with some compatibility determinations, and that not all circumstances could be foreseen; thus exemption. criteria are warranted.

STAFF ANALYSIS OF THE OAS COMPATIBillTY-TASK FORCE REPORT <

In addition to analyzing responses to the FR flotice, the staff i? viewed the Mr.rch 1991.0AS Compatibility Task ,v.se Report. - The analysis of the major points of the OAS Compatibility Task Force Report are given below: i

1. The OAS Compatibility Task Force affirms the need for-  ;

the development and implementation of,a new L compatibillty policy.

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. The Commissioners 9 The staff believes that there is a need for a Commission approved policy on compatibility. The policy should clearly define the ter " compatibility" relative to regulations and the program areas for review of Agreement States radiation control programs.

2. The Task Force believes that States in general and.

Agreement States in partIcular should be allowed a more active involvement with the NRC in policy and.

regulations development that affect their interests.

The staff believes that more interaction between the Agreement States and the NRC is beneficial to both parties.

The staff has intensified its efforts to provide early and substantial involvement of the Agreement States since the OAS Task Force report was initially composed. The staff has-initiated open meetings at the Conference of Radiation Control Program Directors, Inc. (CRCPD) annual meetings and has made presentations at the annual All Agreement States Meeting to discuss proposed rulemakings. Additionally, the staff has continued to distribute early draft copies of proposed rulemakings and policies to the States for their comments. State comments have been included in separate -

sections in Commission papers. Two specific examples of the- -

Commission's activities are the solicitation of state views on the take title provisions of the low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) and interim storage policy issues.

3. The Task Force recommends a joint NRC/ Agreement State Committee be established to develop a compatibl1ity strategy and its application. l The staff believes that the relationship between-the .

Agreement States and the NRC can be described as a

" partnership." With this in mind, the staff believes the NRC should provide ample opportunities for-two-u y dialogue with the Agreement States on any proposed compatibility policy. This dialogue would ensure that the Commission

-understands the concerns of the-Agreement States _and the Agreement States can appreciate the Commission's concerns,.

This-type of dialogue can be generated through workshops, roundtable discussions, and small interactive meetings.

4. The Task Force believes that there should be better and more clearly defined criteria for determination of compatibility of regulations and that Agreement States should be actively involved in the development of such criteria.

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, The Commissioners 10 l

As stated previously, the staff believes that the criteria for determinations of compatibility should be set out in a Commission-approved policy. In addition, as discussed in '

number 3 above, the staff believes that early and )

substantive involvement of the Agreement States is vital in  ;

any policies affecting their programs.  ;

The considerations the OAS Compatibility Task Force proposes, in terms of making compatibility determinations, are similar to those derived in SECY-91-039 dealing with policy factors that should be considered in formulating a compatibility policy. The Agreement States believe that a compatibility policy shoulo be based on policy factors that -

(1) consider the States' need to provide for an equal level of protection for all regulated sources of radiation, (2) ,

maintain uniformity of terminology and technical definitions '

and radiation protection standards, and (3) allow  ;

flexibility for meeting local needs. The recurring nature of these policy factors gives a clear indication that they should be strongly considered in the development of-a policy  ;

statement on compatibility.

Onlipal: On the basis of comments received from the public, consideration of the views expressed in the OAS-Compatibility Task Force report on compatibility, and the staff analysis in SECY-91-039, the staff offers the- _

Commission four options for a process to. establish a generic policy on compatibility. However, because it could take up to 12 months to complete the process under the recommended option, the staff considered the desirability of the Commission adopting a separate compatibility policy with.

regard to low-level waste disposal regulations which would become effective immediately. For the reasons discussed below, the staff recommends that the Commission adopt the attached proposed compatibility policy for low-level' waste disposal regulations.

There are two decisions that have been deferred from Commission consideration pending resolution of the compatibility policy. These are the " Illinois 1-millirem issue" and Pennsylvania's proposed limited agreement for regulation of low-level waste disposal (discussed in SECY-91-047). Both Illinois and Pennsylvania have adopted more -

stringent regulations to satisfy public concerns in their L States, and in their view, to be able to successfully l license-a disposal facility. Illinois has-adopted a l-millirem release limit during the operations phase and expects to issue a license for operation of a disposal facility in late 1993. Pennsylvania has adopted statutory language that will allow the adoption of more stringent T C'-Tvr'v- ge er rvv-'i w-W4 w w-4 % "* m--# e w - -meee-+-----+--_ ---*-u -n - - - - - - _ - - - - - - - *-----------------------*--a '.--

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. The Commissioners 11 regulations to the extent allowable under federal law, and the adoption of a number of other program areas that are more stringent than and different from those of the Commission's regulatory scheme. These program areas are discussed in SECY 91-047. Under current compatibility procedures, these regulations might be considered incompatible with those of the NRC.

Pennsylvania needs a Commission decision on compatibility in '

the near future. Pennsylvania is required by the terms of its compact agreement to be the licensing body for its disposal site and the application must be submitted in less than two years. Pennsylvania could be seriously delayed complying with the LLRWPAA if a decision on the compatibility of its programs is delayed.

As a result, the staff believes that there is sufficient justification for the Commission to consider an immediate compatibility policy in the area of LLW disposal regulations. This would allow the Commission to eliminate the current uncertainty in the Pennsylvania and Illinois LLW programs, and also the Commission would not be on the critical path for any other Agreement Stater regulating LLW disposal. The staff has developed a pro used compatibility policy for LLW disposal regulations and als included it as Enclosure 4 to this paper. In developing this proposed policy statement, the staff considered the OAS letter dated January 24, 1991 to Chairman Carr from Thomas Hill; the March 1991 OAS Compatibility Task Force Report; the '

Pennsylvania Commission Paper (SECY 91-047); the conclusions and recommendations in the february 12, 1991 staff evaluations of Agreement State compatibility issues (SECY-91-039); and the comments on the December 23, 1991 FR notice. This policy would-allow the States to be more restrictive but with only a few exceptions, namely certain '

basic definitions such as units of radiation dose; the low level waste classification system; and possibly parts of the-uniform manifest / data base system. The staff believes that this policy statement. in general, is in accordance with the desires of the States based on their previous comments on

• LLW disposal. While additional direct insolvement_of the Agreement States in adopting a compatibil'ty policy on -low level waste disposal regulations may have'some benefits, the staff believes that on-balance, adoption of this policy would be viewed by the Agreement States as a positive step by the Commission.

As an alternative to immediate issuance of a policy on compatibility in the area of LLW disposal, the Commission could take up the compatibility of the Pennsylvsnia LLW

, The Commissioners 12 disposal regulations - SECY 91-047. A letter to Pennsylvania indicating general NRC a) proval of its LLW disposal regulations would indicate taat, for Pennsylvania, different and more stringent LLW disposal regulations are compatible. This compatibility decision, applicable only to the one State, would in theory allow the Pennsylvania program to move forward while preserving the general LLW disposal compatibility issue for later NRC decision after further Agreement State consultation as part of the process for develoaing a generic compatibility policy described below in t11s paper. .However, a narrow, focused decision on Pennsylvania's regulations could lead to confusion as- to NRC policy, Other States have regulations similar to Pennsylvania's regulations and there is no apparent- reason for treating one State different1y'from the others. Thus, an NRC decision limited to Pennsylvania would likely-lead to t a series of similar NRC decisions for other states, with the result that a de facto compatibility policy for LLW disposal j regulations for all Agreement states would be developed gradually with NRC perhaps perceived as conceding only reluctantly the states' special interests in this. field.

Whether or not the Commission adopts the policy statement lon LLW disposal regulations, the staff recommends that a comprehensive policy statement be developed from one of the options presented below.

! Ontion 1 Use the current process discussed below for obtaining Agreement State participation on a Commission.

policy on compatibility. Staff estimates that the implementation of a process of this type would require a resource expenditure of 1 FTE and-estimates .a time of 6 to 9 months to complete. The steps of this option are:

1. Staff develops draft Commission policy on compatibility. .The policy would consider ?ublic comments received in response to the Decem)er 1991 FR Notice on the compatibility issues; the Report of the' OAS Compatibility. Task Force of March 7,1991; Internal Procedure B.7, "Critoria for Compatibility Determinations;" " Guidelines for NRC Review AgreementStateRadiationControl. Programs;"pf and the:

program review areas and policy factors discussed in SECY-91-039.

'On May 28, 1992, the NRC revised its' general statement of policy on

" Guidelines for NRC Review of Agreement State Radiation Control Programs."-

Most of the revisions are related to regulation of iow-level radioactive waste management and disposal.

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.- The Commissioners 13

2. Staff briefs States at annually scheduled meetings, such as the All Agreement States Meeting, on the proposed changes to the compatibility policy.

3. Staff sends a copy of the draft compatibility policy to the Agreement States for their review and comment.

4. Staff analyzes the comments received from Agreement States with clear discussions on the rationale for accepting or rejecting comments from the States, and i revises draft compatibility policy. _l

5. Staff submits draft compatibility. policy for l Commission approval for publication as a draft policy l statement in an FR Notice for public comment. The. I transmittal to the Commission would include a separate section on Agreement States' views and how their views i were handled.

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6. Staff analyzes comments, revises the draft policy  !

statement on compatibility, then submits the final i policy statement for Commission approval.

Er0Ji a This option would require minimm expenditure of NRC resources on the compatibility issue.

. This option would give all the Agreement States an equal voice.

. Compatibility determinations would continue to be primarily an NRC decision.

- The Agreement States and the public would have an opportunity to participate in establishing the Commission's compatibility policy.

Cons

+ This option does not address completely the Agreement States' desire for early and substantive participation '

on policy development.

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• This option does not take full advantage of the States' technical expertise and experience.

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• The Agreement States would not be actively.

participating in the development of the compatibility

. The Commissioners 14 policy. The Agreement States would only be commenting on the compatibility policy.

Option 2 Enhance the present process of obtaining Agreement State participation by working with all the Agreement States-in the earliest possible st;ges of development of a compatibility policy. Staff estimates that this process would require an expenditure of.l.5 FTE and would take 9 to 12 months to complete. The steps in this option are:

1. Staff seeks input from all the Agreement States on a '

proposed Commission policy on compatibility. The  :

process could include working sessions at All Agreement- States meetings or regional _ workshops where the liRC and Agreement-States could begin reviewing the o items listed in bullet number one of Option I to determine the elements of the proposed pclicy. -

2. Staff w Mh the assistance of the Agreement. States would a t a proposed compatibility policy based upon the results of the NRC/ Agreement State efforts.-

3. Staff sends a copy of draft compatibility policy statement to all the Agreement-States for their review-and comment.

4. Staff analyzes any further comments received from the -

Agreement States and revises draft policy statement based upon States' comments.

5. Staff submits commission paper requesting publication of draft policy in FR Notice.

6. Staff analyzes comments and revises draft policy statement on compatibility.

7. Staff transmitt revised policy statement to all- -

Agreement States for '. heir final review and comment, and, if necessary, revises policy statement.

8. Staff submits-compatibility. policy-statement for-Commission approval.

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• This option ensures public involvement in refining the I policy.

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• All Agreement States' views could be represented and considered during the earliest possible stages of development of a policy.

• This option takes advantage of all the technical expertise and experience of the Agreement States.

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+ This option requires the expenditure of resources to develop workshops for State participation. '

+ A compatibility policy would take longer to develop.

• This option may cause some loss of flexibility for the ,

f1RC to act independently.

Dotion 3 Establish a flRC/ Agreement State Task force as described in the March 7, 1991 0AS Compatibility Task Force Report. Staff estimates that this process would require an expenditure of 1 FTE and four (4) to six (6) months.to complete. Please note that further detailed. analysis would be required to determine whether the Federal Advisory Committee Act (FACA) would be applicable to this Task Force. <

If FACA were applicable, additional time would be required to charter the Task Force and to observe the required procedures. The steps in this option are:

1. The OAS selects members to represent them on a joint tiRC/ Agreement State Task Force.

2. The llRC/ Agreement State Task Force develops draft Commission policy on compatibility. The Task Force would consider the items listed in Option 1, number 1 in its development of a policy.

3. The Task Force-develops a policy on compatibility and -

would submit it to the Commission for approval.

Pros

+ The OAS recommended process for development of a compatibility policy would be recognized.

• The OAS suggestion that no public comment _be sought on a compatibility policy would be adopted.

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- The Commissioners 16  :

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+ The views and technical expertise of all the Agreement States would not be taken into consideration.

• The views of the public would not be considered. ,

• 1here would not be early and substantive involvement of all the Agreement States, t Qption 4 Undertake rulemaking to establish a rule on the scope of interpretation of the term " compatibility" using Options 1 or 2 above. Option;3, NRC/ Agreement State Task Force process, can be considered in the rulemaking option with modifications to include public participation. 11he resources for this option would be dependent on.the option selected. However, it is apparent that this option may require additional steps such as the announcement of an advance notice of proposed rulemaking and proposed rulemaking workshops which would. require additional time and FTE efforts. The Office of Nuclear Regulatory Research (RES) requires a minimum of 1 FTE over a two year period to complete a rule development.

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+ The pros would correspond to those of the option selected. .

Cons

• Criteria to guide compatibility determinations would, ,

of necessity, have to be quite general and would be topically more suited for a policy statement.

• Th( format and structure requirements of a rulemaking will require more staff resources than any other option.

• fecause the criteria would be necessarily broad, the actual c0mpatibility determinations with regard to pheticular regulations or program areas would not, in-practicality, result in any' increase 11n

" enforceability" or enhanced-legal status.

• The. process of adopting a regulation might be perceived as an attempt to change the NRC's-relationship with the Agreement States, which-is-current 1) one of regulatory partnership rather thanf regulator / regulated entity.

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. The Commissioners 17 Resource The resources required.to implement Option 1, 2, or 3 would JsLW: be primarily from the Office of State Programs (OSP) and are included in the FY 93 through FY 97 internal program budget which will be submitted at the end of this month. The resource impact of Options 1, 2 or 3 on the Office of fluclear Material Safety and Safeguards (NMSS), Office of Nuclear Regulatory Research and the Office of the General Counsel (OGC) would be satisfied within existing resource levels.

Resources required to implement Option 4 would include resources described in the previous 3 Options and may '

require additional workshops (cost per workshop is estimated to be $20,000 and one-half FTE). In addition, RES would need a minimum 1 FTE over two years for rule development.

The RES resources are not included in the fY 93 through FY 97 internal program budget and would be redirected from existing budgeted resources.

Recommendation: The staff recommends Option 2 as an appropriate process for developing a comprehensive policy on compatibility.

The staff also recommends that the Commission adopt the enclosed proposed compatibility policy on low-level waste disposal regulations.

The staff believes that its conclusions and recommendations as presented in SECY-91-039 with regard to the factors that need to be considered in determining compatibility, and the areas in which such determinations need to be made, are still valid. Furthermore, all comments received from the December 23, 1991 FR Notice will be used to help develop the policy statement on compatibility process. The States should (1) participate early in the development of the policy and (2) continue to participate in each individual compatibility determination as it is made,'with public involvement through the FR. The staff recommends that the policy statement ba broad enough to cover not only regulations, but other program areas as discussed in SECY-91-039.

I

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The Congnissioners 18 Coordinatinn: The Office of the General Counsel has no legal objections to this paper and concurs in the proposed policy statement on low-level waste disposal regulations. 1

__ / \

Ms2 mes M. TafTor xecutive Director for Operations

Enclosures:

1. Staff Sumnary of Public Comments

2. Principal Miscellaneous issues

3. List of Commenters

4. Proposed Policy Statement on Compatibility of Agreement States low Level Waste Disposal Regulations Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Thursday, July 30, 1992.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Thursday, July 23, 1992, with an infor-mation copy to the Office of the Secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.

DISTRIBUTION:

Commissioners OGC OCAA OIG LSS IP OCA OPA OPP REGIONAL OFFICES EDO ACRS ACNW ASLBP SECY

G e

EllCLOSURE 1 STAFF

SUMMARY

OF PUBLIC COMMENTS

- staff

SUMMARY

Of PUBLIC COMMENTS \

W ESil0N 1: CONGRESS ESTABLISHED THE AGREEMENT STATES PROGRAM IN PART BECAUSE Of THE VARIOUS AND CONFLICTING PROGRAMS BEING IMPLEMENTED BY STATES. DO YOU BEllEVE THAT THERE SHOULD BE A UN!f0RM NATIONAL r

APPROACH TO RADIATION SAFETY MATTERS? SHOULD THE SCOPE Of UN1f0RMITY BE NARROWLY FOCUSED OR COMPREHENSIVE 7 PLEASE EXPLAIN THE ADVANTAGE AND DISADVANTAGE Of VIEWS EXPRESSED.

To some degree, almost all commenters support the concept of a uniform national approach to radiation safety matters. There is solid support in the industrial materials community; the nuclear power industry; environmental groups, public interest groups, and citizens; and federal and State government agencies. Although there is a majority of support in the medical materials community, a significant minority disagrees. Some local government agencies do not support the concept of a uniform national approach.

4 There are divergent views about the scope of uniformity being narrowly focused or comprehensive, . Some commenters state that strict uniformity is needed, whereas others state that a high degree of flexibility is needed to establish more stringent standards. Strong support for a comprehensive approach is expressed by the industrial materials community, the nuclear power industry, and federal agencies. Many commenters from the medical materials community prefer a narrowly focused approach. Citizen commenters interpret " narrowly focused" to mean that NRC sets minimum national standards, the States are free to set more stringent standards, and (in some cases) local governments are  !

able to set standards even more stringent than the State or NRC standards.

Many of the State and local government agencies believe a narrowly focused view is more appropriate. One State agency remarked that what counts in terms of real health and safety is how well a State conducts its program, rather than what is "on paper." Some commenters observe that without a definition of precisely what is " comprehensive" compared to " narrowly focused," it is difficult to determine which view to support. Although most commenters do not address how to resolve the issue of scope, a few suggest mechanisms, such as joint NRC/ Agreement States committees, open meetings that would include affected and interested parties, and/or rulemaking.

Commenters cite many advantages for supporting a uniform national approach.

These include the preservation of a federal leadership role; consistency in basic terms (such as radiation units and definitions) and standards (such as

dose limits); avoidance of burdens on interstate commerce; reduction of regulatory confusion; assurance of fairness and predictability in the-l regulatory process; uniform training, certification, and inspections; equal protection of the public and workers (e.g., Part 20 standards for protection i

against radiation should be implemented at- the same- time,- and Part 34 for I radiography); equal treatment of the nuclear industry (e.g., biomedical i research, industrial radiography, low-level radioactive waste (LLW) disposal,-

l and concentration averaging greater-than-Class C LLW);_better resolution of the "not in my back yarJ" syndrome; provision for uniformity in regulations, l especially for multi-State jurisdictions (e.g., emergency planning zones);

l reduction of uncertainty ir the public mind about what practices are L acceptable; and avoidance of confusion about what constitutes low levels of radiation.

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2 Disadvantages to a uniform national approach are generally framed in terms of the scope being narrowly focused or comprehensive, liowever, the medical materials community believesa that a narrow scope of uniformity, as well as, a broader practice of nuclear pharmacy in certain States, would be an advantage because it would allow the ilRC to concentrate its staff and resources on implomonting Part 20 and regulating nuclear power plants.

A number of State and local government agencies view the advantages of a narrow scope as being that State and local governments rights are protected, that citizens' wishes are made known, and that citizens will make the results known at the polls if problems develop with regulations.

Other State and local government agencies believe a comprehensive scope is an advantage because all parties are protected through consensus and a workable program can be developed for all congressionally authorized jurisdictions.

The environmental and public interest groups present their position, without citing advantages and disadvantages. First, ilRC sets minimum national standards for Agreement States that include applicable matters such as units of measure. One group also recommends full adjudicatory licensing in accordance with the Federal Administrative Procedures Act of 1946. ficxt, Agreement States can set more stringent standards and can even err on the side of caution, given the uncertainties in low-level radiation, synergistic effects of other pollutants, or acceptance of a lower level of risk. Finally, some localities should be able to set more stringent standards than those set by Agreement States or the NRC.

The concept of a uniform national approach to radiation safety matters is endorsed by almost all commenters. A sizeable minority in the medical materials community is troubled by Part 35, " Medical Use of Byproduct Material," that is in apparent conflict with (1) the application of the regulations to practitioners who are guided by rigorous medical training and State standards in medicine, and (2) accelerator-produced radioisotopes not subject to itRC or Agreement State regulations. Some commenters even believe that all States should be Agreement States for this particular radiation protection area. Some local governments believe that local control over some aspects of radioactive materials is needed. These materials include "below regulatory concern" materials, such as low-level waste, and the incineration of radioactive materials.

Most of the commenters' discussions regarding the scope of uniformity bears on the practice rather than on the concept of a uniform national approach. There is no concensus about the scope of uniformity among the commenters--whether it should be narrowly focused or comprehensive. Joint NRC/ Agreement States committees or open meetings that include affected and interested parties, and rulemaking are the only suggestions made to resolve this issue. Environmental and public interest groups, as well as citizens, have a predetermined formula in mind for the liRC/ Agreement States compatibility relationship. This formula Enclosure 1

. 3 is that NRC sets minimum national standards for Agreement States allowing Agreement States to set more stringent standards, but not less stringent .

standards.

Finally, the industrial materials community is concerned about the current non-uniform application in the Agreement States of Part 34, " Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations."

The commenters identified other areas of concern such as medical and radiographic regulations, local control over the disposal of LLW, and incineration of radioactive materials.

OVESTION 2: a. 15 THE TIERED APPROACH DESCRIBED IN THE DIVISIONS A REASONABLE APPROACH FOR REGULATIONS? FOR PROGRAMS AS A WHOLE7

b. WHAT AREAS OF AGREEMENT STATE RADIATION CONTROL AND PROTECTION SHOULD BE 10ENTICAL TO THOSE OF THE NRC AND WHY?

c. WHAT AREAS OF AGREEMENT STATE RADIATION CONTROL AND PROTECTION SHOULD BE ALLOWED TO BE DIFFERENT FROM THOSE OF THE NRC AND WHY? SHOULD THE DIFFERENCES INCLUDE: MORE STRINGENT STANDARDS? LESS STRINGENT STANDARDS? MORE COMPREHENSIVE REQUIREMENTS? OR LESS COMPREHENSIVE REQUIREMENTS? PLEASE EXPLAIN THE BASIS FOR YOUR VIEWS.

Generally, the commenters fall into two categories: those that want strict compatibility between the NRC regulations and those that want the States to have a high degree of flexibility--in the latter case, the flexibility to establish more stringent standards. The first group is mainly represented by either the nuclear power industry or industrial materials licensees who sell products or perform work in many States and thereby cross jurisdictional boundaries.

With regard to the tiered approach to compatibility, the majority of commenters indicate that this approach is reasonable. Most commenters state, however, that the tiered cpproach could be improved and clarified, and some commenters suggest implementation through a rulemaking process. Many commenters question the standards used to determine what regulatory requirement goes into each category. One of the key suggestions is for the-I development of a participatory process in determining minimum. standards for l compatibility. Some commenters feel that flexibility is inappropriate for fundamental matters of health and safety.

- A number of commenters state that Division 3 or 4 (or both) compatibility rules are unnecessary. (The four divisions are explained in the " Background" portion of the paper). There is a belief that the tiered concept should be

l. incorporated into the NRC regulations or made a Commission statement of l

policy. The reasons given by those who responded negatively are that they.

Enclosure 1 P

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1

. 4 either favor strict compatibility across the board or that the tiered approach lacks a clear statement of intent. For those commenters who feel that the tiered approach is not reasonable, their explanations center on the necessity for consistency in such standards as the Division 1 compatibility rules.

However, Division I compatibility rules currently require essentially identical language, j Commanters from State government agencies point out that there is no legislative record, agency rulemaking, or other formal document that addresses the four divisions of compatibility, nor is there an opportunity to comment during its development.

As to whether compatibility should be applied to the whole program, it is-assumed that those who reject the tiered approach reject it for the entire program, for those who responded to the specific question regarding applicability to the whole program, the general response is affirmative. .

Other commenters, although not addressing the question specifically, indicate that Agreement States should have flexibility in such areas as enforcement.

This program area is not addressed in the regulations categorized in Internal Procedure B.7.

With regard to the question of which areas of State regulations should be identical to NRC regulations, numerous commenters indicate that " technical aspects" of programs, such as definitions, terminology, signs, symbols, radiation dose limits, reporting requirements, and radiation source and device design standards, should be identical, for example, terminology must be identifiable and symbols need to be universally recognized. Standards, such as annual exposure limits, are well understood, because they are based on a wealth of scientific evidence and have been approved by international agencies that set standards, such as the International Commission on Radiation Protection. Other standards include radiation protection practices and procedures, personnel qualifications, and personnel dosimetry. In addition, commenters aoint out that non-uniformity of standards would confuse the public regarding w1at is adequate, eroding public confidence and adversely affecting interstate commerce. Uniformity facilitates training and makes such training more cost effective. States should not be allowed to vary radiation standards in one area, perhaps leading to increased exposure in another (e.g., _

decreasing the allowed dose to the general public, may result in an increase in occupational exposures).

With regard to areas in which differences should be allowed, the general consensus among environmental and public interest groups, individuals, and to some extent, local government agencies seems to be that the States should only be allowed to be different by being more stringent. Even those who feel that minimizing differences is important, indicate that the States could be allowed to be more stringent in the areas of interpretation of regulations, intrastate matters, recordkeeping, inspection frequency, contamination control, inspection policies and procedures, and administrative procedures.

Enclosure 1

i i

. 5 Additionally, having the flexibility to factor in aging of facilities, population density, earthquake faults, the number of radiation sources in an area, and transportation routes are mentioned. Those in favor of maximum '

uniformity indicate that any differences should be evaluated on a case-by-case basis.

Local governments, environmental /public interest groups, and private citizens  ;

feel strongly that the people living in a State have the right to determine i the level of risk they choose to accept. The medical community comments that the NRC should deregulate the medical community; some want Par t 35 deleted.

Others prefer a single set of regulations administered by a single regulatory agency, arguing that regulatory costs would be decreased.

The majority of commenters believe that the tiered approach to characterizing NRC regulations is reasonable and has been very effective and that some sort of tiered approach needs to be a part of any Commission policy on compatibility. Commenters emphasize the necessity for States to have the ,

authority to develop more stringent standards to serve the "best interests of i their citizens," where, for example, meltiple sources contaminate a common aquifer, but none indicate any clear definition of what the "best interests" might be.

Some commenters indicate that there is no need for Division 3 or~4 compatibility rules.

An area that few commenters address is that of applying compatibility criteria to program areas other than the regulations.

OVEST10N 3. WHAT MECHANISMS SHOULO THE NRC USE TO ALLOW AGREEMENT STATES TO HAVE FLEX 1BILITY TO ADDRESS LOCAL NEEDS OR CONDITIONS? WHAT FACTORS SHOULD THE CCMMISSION CONSIDER IN BALANCING LOCAL NEEDS OR CONDITIONS AND INTERSTATE OR INTERNATIONAL COMMERCE CONCERNS OR OTHER NATIONAL INTERESTS?

Most commenters do not respond directly to the question proposed in the Federal flggisler notice. Those commenters responding to this question assume that some type of flexibility to address local needs or conditions would be acceptable. A few commenters state that flexibility is not an option. Where i flexibility is addressed, comments are directed toward either the adoption of rules or the inspection / enforcement process. However, the majority of the comments are directed to the rulemaking process.

Commenters on the rulemaking process propose that rules promulgated to protect the health and safety of the public should be developed using a consensus i process involving both Federal and State regulators and representatives from

the private and professional sectors. An alternative to the formal consensus l process, although a somewhat similar process, is to address Federal and State ,

i concerns through joint committees or task iorces.

l Enclosure 1 2

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. 6 Some commenters from the industrial, snedical, and nuclear power industries state that the current rulemaking process is acceptable. However, other commenters from the nuclear power industry and the government agencies believe that the Agreement States should be given opportunities to be involved in the i1RC rulemaking and policy development proceedings that affect Agreement State responsibilities. Some believe that a sim)le mechanism should be _

established to bring the Agreement States into tie rulemaking process earlier and that the t1RC and the Agreement States should set up better channels of communication.

Those commenters addressing the inspection / enforcement process believe that regulators could address State and local conditions during an inspection and subsequent enforcement actions.

Some commenters address the mechanism for States to promulgate rules that differ from the ilRC regulations, in cases where the t1RC allows the States to set alternative standards, these commenters believe that the States should hold public hearings or referenda to address the issues.

Commenters from the various groups propose questions that should be considered in balancing local needs or conditions and interstate or international concerns. Most comments in this area came from the industrial materials community. The majority of that group's comments stress the importance of uniformity between the f1RC, States, and the international community.

Uniformity in the areas of basic radiation safety standards and definitions is a major concern.

The following is a list of questions proposed by the commenters:

o Will flexibility result in uniformity and consistency between the llRC, States, and the international community?

o Are alternatives available?

o Are localities imposing more restrictive requirements?

o Will flexibility adversely affect interstate or international commerce?

o Are basic radiation safety standards affected by allowing flexibility?

o Are local politics driving the need for flexibility?

o How will implementation and enforcement be affected by allowing local flexibility?

Commenters suggest that many of the factors that tend to create the need for separate standards could be addressed by allowing Agreement States early involvement in the development of liRC regulations and policy. This Enclosure 1

- 7

• broadened" procedure would thus encompass e wider variety of the issues that tend to compel the development of separate standards. Such involvement would be especially important on issues addressing basic radiation safety principles and issues affecting the interstate and international community where uniformity is a key issue.

Uniformity among regulators is a prime concern of commenters from the industrial materials community. Accounting for local variation, especially environmental conditions, is a prime concern among some local governments and the environmental community. The imposition of more restrictive State standards should not adversely affect interstate and international commerce or redefine basic radiation safety principles. The Agreement States should be involved in the rulemaking process at an early stage.

OVEST10N 4: SHOULD AGREEMENT STATES BE GIVEN A GREATER DEGREE OF FLEX 1BILITY IN FASHIONING THEIR OWN STANDARDS FOR LOW-LEVEL WASTE DISPOSAL, IN VIEW 0F THE STATE'S INCREASED RESPONSIBILITY IN THIS AREA, ACCORDING TO THE LOW-LEVEL RADI0 ACTIVE WASTE POLICY AMENDMENTS ACT OF 1985?

Responses to this question reflect a distinct difference between the regulated community and other communities. Government agencies, environmental /public interest groups, and private citizens who commented generally support increased flexibility for Agreement States in view of increased States' responsibilities regarding LLW disposal. Most of the commenters from the regulated community -- that is, the industrial materials community, the medical materials community, and the nuclear power industry -- reply that States should not be given a greater degree of flexibility in fashioning LLW standards, even though States have increased disposal responsibilities in LLW according to the Low-Level Radioactive Waste Policy Amendments Act (LLRWPAA).

Almost all commenters support federally established minimum standards for performance objectives.

Commenters from the regulated community who directly address this question offer several reasons for limiting the flexibility given Agreement States in the LLW area. Many of these commenters note that while the LLRWPAA increases the States' responsibility in managing LLW, it does not grant States or compact commissions any_ new authority to regulate LLW in a manner that would be incompatible with NRC regulations, including NRC-specified radiation protection standards. The regulated community, in general, feels that existing NRC regulations already have ample flexibility to address local conditions and that variances from NRC regulations should be-limited and justified only on a case-by-case basis. Some commenters from the regulated community express a need for an even stricter compatibility structure than l

currently exists. A few commenters from the regulated community say that.

( because NRC's regulations and compatibility criteria should reflect the best l

available technology, Agreement State flexibility should be given only for i

administrative responsibilities.

Enclosure 1

r 8

Host State and local government agencies, environmental /public interest groups "

and, private citizen commenters who directly address the States' flexibility regarding increased responsibility in LLW are a result of the LLRWPAA exhibit a strong desire for increasing Agreement State flexibility regarding LLW to better accommodate unique local conditions. Many of these commenters echo a basic position of the Organization of Agreement States (OAS) task force on .

compatibility, that there is a historical record to support the position that Agreement States can establish differing standards from NRC and, in -

particular, more restrictive standards when needed. Some government agencies and public commenters feel that States should be given more flexibility since, under the LLRWPAA, States will be required to take title to and be liable for LLW in the long term. In general, these commenters prefer a narrow approach to uniformity to NRC regulations, where Divisions 1 and 2 compatibility rules are limited only to basic definitions and measurement standards. States also r express the need for closer involvement with NRC in setting compatibility standards and establishing the process for applying those standards. Many government agencies and public commenters identify a need for greater latitude in specifying requirements for waste classification and waste form, packaging, design, monitoring, and site conditions. A_few of those commenters suggest that performance standaros, of the U. S. Environmental Protection Agency or other agencies, be used, rather than the performance objectives in Part 61.

Many commenters from the regulated community, government agencies, and the -

public identify many issues-about LLW compatibility in general, while not directly addressing the question of flexibility in relation to the States' ,

increased responsibilities. Most government agencies and public commenters ,

say that Agreement States should be given more flexibility, especially to set more stringent standards to meet local needs and desires, including local political conditions and the general concern about radiation hazards from LLW disposal. The regulated community feels that increased Agreement State flexibility in LLW disposal would increase costs of meeting different requirements for waste characterization, waste form, packaging, and disposal facility design, Some commenters from the nuclear power industry state that their operations could be seriously impaired if States are allowed to set LLW standards that cannot be achieved or that are very difficult to achieve.

Further, many industrial commenters state that interstate and international transportation of LLW would be less costly and would operate more smoothly if uniform national- standards were developed and enforced. A few industrial commenters also state that a more uniform national approach is needed to increase public confidence in LLW disposal and to get consistent progress in the siting and licensing of disposal facilities. These-industrial commenters feel that the inconsistent progress to date is the result of variability in the host States' LLW programs and that NRC has allowed incompatible conditions (e. g., in waste classification and performance objectives) in some of the LLW disposal facility projects now in the licensing stage. Further, nuclear power companies and the U. S. Department of Energy state that a relaxation of NRC's compatibility program--resulting-in variability in Agreement State LLW Enclosure 1 1

.. 9 programs--could hinder the implementation of the national energy strategy, which calls for more aggressive use of nuclear power.

In addition to the reasons summarized above for either more or less flexibility for Agreement States, commenters from all categories identify several areas of concern related to LLW that are outside the scope of this paper and analysis. These include the need for new rules for new disposal technologies and LLW storage, LLW classification in general and in relation to reprocessed and recycled materials, continued NRC exclusive jurisdiction over utility-generated waste stored on site, the Federal preemption of the States' rirhts to regulate waste that is "below regulatory concern," long-term concerns about Class C waste; DOE's responsibility for greater-than-Class C este, multiple radiation exposures of co-located nuclear facilities, and lack-of adjudicatory hearings in some States' licensing procedures.

OVESTION 5: PROVIDED THE ISSUE OF COMPATIBILITY 15 FULLY AIRED IN RULEMAKING N0llCES, IS THE CURREliT COMMENT PROCESS SUFFICIENT FOR CONTINVING DIALOGUE WITH THOSE PERSONS OUTSIDE THE NRC/ AGREEMENT STATE ,

REGULATORY PARTNERSHIP? IF NOT, WHAT ALTERNATIVE WOULD YOU SUGGEST AND WHY?

The most frequent comments call for the NRC to (1) provide more information on issues of compatibility involved in specific rulemacing notices, (2) solicit input from a wider spectrum of persons than those who may be affected by the rulemaking, (3) publish noticels of rulemaking in publications other than just the federal Reaister (FR), and (4) allow a longer comment period.

Nearly half of the commenters chose not to respond to this question either directly or in general. Most of the commenters who did respond to the question indicate that the current process is sufficient; however, most did-suggest modifications. One commenter opposes any change, expressing the concern that any alternative would unfairly favor particular parties. Nearly all those who did not feel that the current process is sufficient offer suggestions that are similar to the suggestions offered by the commenters who support the current process.

A few commenters call for limiting the discussion of compatibility issues to the NRC and the Agreement States, eliminating any dialogue with entities-outside the partnership. These comments are similar to the stand taken by the OAS and some commenters specifically reference the OAS task force report-letter. Comments offered by industry and licensees express a strong stand against any such special relationship.

Only a few commenters suggest alternatives that differ significantly from the current process. One commenter suggests forming a new Federal radiation council to develop comprehensive uniform radiation protection criteria that would be used by regulatory agencies to develop presumably uniform

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. + 10 regulations. The pubile would be given the opportunity to comment on the draft recommendations before they are promulgated by the regulatory agencies.

One significant comment is that, subsequent to NRC adopting a regulation deemed a matter of compatibility, a State is required to adopt it. Normally this involves a State going through its own public comment process.- If the rule happens to be a Division 1 matter of compatibility, the State's public comment process is essentially meaningless. The commenter, therefore, suggests that it is imperative that NRC provide public input into the compatibility determination.

Another commenter suggests that NRC establish a dialogue with the regulated entities on the issues before initiating any rulemaking, while another

• suggests that the licensees be given veto power over the provisions of the agreements with the States. . 0ne commenter calls for eliminating the Agreement States program altogether, while another calls for all rulemaking to be a joint effort involving NRC and the Agreement States. Another commenter suggests that public comment be provided to the NRC through the Agreement States. One commenter expresses concern that comments from parties in non-Agreement States might not be given the same consideration as comments from parties in Agreement States. A number of comments seem to indicate that the question or the current comment process is misunderstood. ,

The most frequent comment suggests that NRC solicit input from a wider sector of the pubitc. Mechanisms suggested to achieve this goal include holding public meetings across the country and making direct mailings to affected Agrecuent State licensees and instituting longer comment periods, at least 60 days after publication in the FR, which would consider the time it may take for a copy of the FR to reach knowledgeable individuals in the public sector or in Agreement State licensee organizations. Additionally, commenters specifically suggest notifying the public through trade jourr.als. Providing additional information on the compatibility division proposed for the rule also would satisfy a number of the suggestions.

OVESTION 6: SHOULD THE NRC DEVELOP EXEMPTION CRITERIA FOR AN AGREEMENT STATE THAT DOES NOT ADOPT A RULE DEEMED A MATTER OF COMPATIBILITY, AS DESCRIBED FOR NRC'S DIVISION 1 AND 2 RULES, IF AN AGREEMENT STATE REQUESTS SUCH AN EXEMPTION? WHAT FACTORS SHOULD BE CONSIDERED IN THE CRITERIA TO ASSURE THAT THE EXEMPTION IS JUSTIflED?

The majority of commenters state that exemption criteria should be adopted.

Some commenters say that it is inevitable that States will disagree with some compatibility determination and that not all-circumstances can be foreseen;.

therefore, exemption criteria are necessary. Some feel, however, that the criteria should be structured so that exemptions would be narrow in scope (e.g., site specific) and approved only infrequently. Others feel that any decision in this area should be based on a defensible assessment by the State and should be open to public comment. One commenter suggests that exemptions ,

Enclosure 1

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11 must be consistent with the concept of ALARA (as low as is reasonably achievable level). Examples of suggested criteria for such determinations are (1) demonstration of need, (2) local geographical considerations, (3) State experience and innovation, and (4) information requirements different from NRC's. Some suggest that any criteria be established jointly by the NRC and the States, while others suggest a formal rulemaking process. Some commenters agree to exemptions, provided they always lean toward more restrictive ,

regulations or at least an equivalent level _of health and safety. One- '

commenter suggests that, rather than establish specific criteria, an appeal process be established to handle, on a case-by-case basis, any differences of opinion on compatibility issues.

Those commentors (generally, the industrial materials-community) who believe that strict compatibility is a necessity for the most part, also believe that exemptions should not be allowed. This group feels-that uniform standards are necessary for protecting the public health and safety and that public health and safety, as a national concern, should be treated uniformly in all Agreement States. Others oppose exemptions, but only for Division 1 and 2 compatibility rules. One commenter suggests that, by allowing a greater degree of flexibility in the divisions, the need for exemations would be eliminated. Others also express that their comments on tie exemption criteria would depend on the criteria for establishing the divisions.

Although many commenters support the idea of exemption criteria, little is offered in the way of factors to be considered in the development of the criteria.

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1 ENCLOSURE 2 PRil1CIPAL MISCELLAtlEOUS ISSUES

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. PRINCIPAL MISCELLANE0US ISSUES four key issues repeatedly mentioned by the cocmmenters are discussed below. ,

a. Below Regulatorv Concern (BRC) ,

One issue eliciting a significant number of commenters is the BRC policy. Although the Commission has suspended consideration of BRC, environmental groups, public interest groups, and the private citizens object strongly to the BRC policy and celieve that NRC overstepped its authority in making BRC a matter of compatibility. This prompted a t number of respontos frorr that category of commenters similarly stating that compatibility should be defined in such a way as not to affect '

State authority to control very low levels of radioactive materials.

i

b. Medical Reaulation A number of commenters from the medical community question the Commission's involvement in the practice of medicine, commenting that neither the NRC nor the States should be regulating in areas that have traditionally been within the practice of medicine or the practice of pharmacy. From a compatibility standpoint, these commenters believe

, that the States should have the flexWility to regulate the medical rewnunity to a lesser extent than NRC. On the other hand, some commenters feel that if HRC reduces its regulatory role in medical applications, then the States should be required to do the same.

c. Nuclear Power Reaulation Commenters from the nuclear power industry address the issue of State involvement in the regulation of commercial nuclear power. The Agreement States have no authority to regulate nuclear power. plants in any way related to radiological health and safety. States, however, are involved in emergency preparedness-and issues involving LLW issues.. For-example, Agreement States currently would regulate onsite burial of LLW at nuclear power plant sites pursuant to 10 CFR 20.302,- although this issue is being reexamined. The industry feels that States should be required to have standards identical to NRC standards,

d. Radicaraohv Eight commenters from the industrial radiography area are concerned about the effects of that non-uniform standards on that. industry. These commenters are concerned about differing standards because most companies operate in multiple jurisdictions. Specific examples of current disparities are the differences in reciprocity requirements, (2) differences in fees- that give some companies a competitive advantage, and (3) the fact that some States do not require alarm ratemeters. Some .

commenters are particularly concerned about potential differences in l certification / qualification requirements for radiographers. t Enclosure 2 ,

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e El1 CLOSURE 3 LIST OF COMMEllTERS (Listed by Category and Docket flumber)

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. List of Cor.nenters*

1. Industrial Materials Community - 22 1.1 Computalog Wireline Services Inc. (1) ,

1.2 Braun Intertec Engineering Inc. (2) 1.3 Schlumberger Well Services (6) 1.4 MQS Inspection Inc. (9) 1.5 Ohmart (11) 1.6 America % Nuclear Corporation (13)-

1.7 Scientific Inspection Technology, Inc. (SITI) (17) 1.8 3M Health Physics (19) 1.9 ABC Testing Inc. (23) 1.10 Bethlehem Steel Corporation (31) 1.11 Diamond Testing (46) 1.12 Chicago Bridge & Iron Company (47)

L 1.13 Teledyne Isotopes (68) 1.14 SAM-SON Inspection & Technical Services, Inc. (70) 1.15 Appalachian Compact Users of Radioactive Isotopes (ACURI) (77) 1.16 U.S. Council for Energy Awareness (USCEA) Committee on Radionuclides and Radiopharmaceuticals (81) 1.17 fuel Cycles facilities Forum (FCFF) (82) 1.18 U.S. Council for Energy Awareness - Nuclear Fuel Supply Committee (86) 1.19 NELRAD - A Consortium of Radioactive Materials Users (91) 1.20 Amersham Corporation - Radiography Sources, Exposure Devices, and Accessories (93) 1.21 American Mining Congress (AMC) (95) 1.22 U.S. Ecology, Inc. (97)

2. Medical Mate. ials Community - 17 2.1 The University of Texas Medical Branch at Galveston (3) 2.2 Carol S. Marcus, Ph.D., M.D., Director, Nuclear Medicine Outpatient Clinic and Associate Professor of Radiological Sciences (UCLA) (8) 2.3 Health Physics Northwest (12) 2.4 Philip R. Frederick, M.D., Chairman, Radiation Safety Committee, LDS Hospital and Member, Utah Radiation Control Board (21) 2.5 Medical College of Georgia (42)

• The number in parentheses represents the number assigned to the commenter.

Please note that the numbers assigned are not reflective of the total number of comments received. During the docketing process, numbers 5, 29, and 32 were inadvertently skipped. Thus, the docketing numbering system assigns commenters up to the number "108" when actually only "105" commenters responded.

Enclosure 3

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. 2 2.6 Division of Nuclear Medicine, University of lowa Hospitals and Clinics (49) 2.7 Department of Radiology, University of Florida, College of '

Medicine (51) ,

2.8 American Association for Nuclear Cardiology, Inc. (52) 2.9 Nuclear Cardiology Systems, Inc. (53) 2.10 Institute for Nuclear Medical Education, Inc. (54) 2.11 Department of Veterans Affairs Medical Center (58) 2.12 American College of Nuclear Physicians and The Society of Nuclear Medicine (64) 2.13 Earl Budin,. M.D., Radiologist (79) 2.14 Amersham Corporation - Medi+ Physics (80) 2.15 Gordon I. Kaye, Ph.D. (98) 2.16 ICN Biomedicals, Inc. (100) 2.17 Florida Pharmacy Association (101)

3. Nuclear Power Industry - 14 3.1 Florida Power Corporation (16) '

3.2 Georgia Power Company (20) 3.3 Florida Power and Light PL (22) 3.4 Southern Nuclear Operating Company (25) 3.5 Yankee Atomic Electric Company (26) 3.6 Tennessee Valley Authority (35) 3.7 Houston Lighting and Power Company (39) 3.8 Commonwealth-Edison (40) 3.9 Washington Public Power Supply System (73) 3.10 Edison Electric Institute - Utility Nuclear Waste' and Trar,sportation Program (87) 3.11 Nuclear Management and Resources Council (NUMARC) (88) 3.12 Rochester Gas and Electric Corporation (RG&E) (94) 3.13 Energy Operations, Inc. (Arkansas Nuclear One, Units 1 & 2, Grand Gulf Nuclear _ Station and Waterford 3 Steam Electric Station (105) 3,14 Centerior Energy (106)

4. Environmental Groups, Public Interest Groups, and Private Citizens - 30 4.1 Marvin 1. Lewis (4) 4.2 Ohio Citizens for Responsible Energy, Inc. (14) '

4.3 Dooley Kiefer (18) 4.4 Health Physics Society (24) 4.5 Dr. Raymond L. Murray (27) 4.6 GE Stockholders' Alliance (33) l l

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. 3-4.7 Dr. Estelle Lit and others (36) 4.8 New England Coalition on Nuclear Pollution, Inc. (38) 4.9 Environmental Coalition on Nuclear Power (44) 4,10 Don't Waste California (45) 4.11 Taylor Against LLRW (50)_

4.1; Keith Storey (55) 4.13 Jeanne F. Fudala (56) 4.14 David Keppel (57) 4.15 Allen H. Lum (59) 4.16 Ernest fuller (60) 4.17 Concerned Citizens for SNEC Safety.(61) 4.18 Allen and Cynthia Powitz (63) 4.19 Bob Brister (65) 4.20 Nancy P. Florsheim (66) 4.21 Gibraltar Financial Services (69) 4.22 Eleanor Kuhns (71) 4.23 Fulton County Citizens Against the Radioactive Dump (74) 4.24 Liz Cullington (78) 4.25 Committee To Bridge the Gap (83) 4.26 Toledo Coalition for Safe Energy (92) 4.27 Florida Coalition for Safe Energy (96) 4.28 Kathryn A. Barnes (99) 4.29 Sierra Club, Eastern Pennsylvania Group (102) 4.30 Karl and Patricia Novak (103)

5. Federal, State, and Local Government Agencies -

22 5.1 Association of State and Territorial Solid Waste Management Officials (ASTSWMO), Headqua-ters Washington, D. C. (7) 5.2 The Commonwealth of Massachusetts, Department of Public Health (10) -

5.3 Arkansas Department of Health (15) 5.4 Alexander B. Grannis, The Assembly State of New York (28)

$.5 Ruth W. Messinger, Borough President, The City of New York,' Office of the President of the Borough of Manhattan, f ew York (30) 5.6 Cortland County, Low-Level Radioactive Waste Office, Portland, New York (34) 5.7 State of New Mexico, Environment Department (37) 5.8 The Commonwealth of Massachusetts Low-Level Radioactive Waste Management Board (41) 5.9 Commonwealth of Pennsylvania, Department of Environmental Resources (43) 5.10 State of Illinois, Department of Nuclear Safety (48)-

Enclosure 3

4 5.11 Attorneys Generals for AL, CN, FL, IA, MD, NY, DL, IL, ME, MA, MI, M0, NH, NM, OH, PA, VT, WI, MN, NV, ND, OR, UT, and WA (62) 5.12 California Department of Health Services, Environmental Health (67) 5.13 New York State Energy Office (72) 5.14 Bedford Fulton - Huntington Solid Waste Authority (75) 5.15 Senator and President Pro Tempore, State of Pennsylvania, Robert C. Jubelirer (76) 5.16 Cabir,et for Human Resources, Commonwealth of Kentucky (84) 5.17 State of We.shington, Department of Health (85) 5.18 U.S. Department of Energy (89) 5.19 Department of Health, State of Ohio (90) 5.20 Carolyn B. Maloney, Council Member, 4th District, Manhattan, City of New York (101) 5.21 Department of Health, Bureau of Radiological Health, City of New York (104) 5.22 Governor E. Benjamin Nelson, State of Nebraska (107) 4 Enclosure 3

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ENCLOSURE 4 PROPOSED POLICY STATEMENT ON-COMPATIBILITY OF AGREEMENT STATE LOW LEVEL WASTE REGULATIONS .

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t COMPATIBILITY OF AGREEMENT - STATES' LOW-LEVEL RADIOACTIVE WASTE DISPOSAL REGULATIONS; STATEMENT OF POLICY AGENCY: Nuclear Regulatory Commission ACTION: Statement of Policy

SUMMARY

This Policy Statement is not intended to have-the force and effect of law or binding effect; it is provided instead as guidance to the Agreement States, licensees, and tho public regarding the policy the Commission intends to follow in reviewing Agreement State regulations on low-level waste disposal. This statement presents the policy of.the Nuclear Regulatory Commission with respect to the interpretation' of the statutory term

" compatible" as applied to the low-level radioactive waste disposal regulations of the Agreement States. The Commission is taking up this issue separately from i larger process reconsidering the compatibility issue for all Agreement State programs in order to facilitate the Agreement States' timely compliance with the responsibilities imposed upon the States by the -Low-Level Radioactive Waste Policy Amendments Act of 1985. The policy statement contains an interpretation of the term " compatible" as applied to Agreement State low-level radioactive waste disposal regulations which allows Agreement States the flexibility to'be different or more stringent than the Commission in ' low-level radioactive waste disposal regulations to address local concerns, outside of a very few issues that require uniformity, provided that the level of protection of the public health and safety 'is equivalent to or greater than that provided by 10 C.F.R. Part.61.

EFFECTIVE DATE:

FOR FURTHER INFORMATION CONTACT: Vandy L. Miller, Office of State -

Programs, Nuclear Regulatory Commission, (301) 504-2326.

SUPPLEMENTARY INFORMATION:

Backetround I.

The word " compatible" constitutes one of the core concepts in the Commission's Agreement State Program under Section 274 - of the Atomic Energy Act of 1954, as amended (AEA). Subsection 274d, states that the Commission shall enter into an agreement under subsection b. relinquishing regulatory authority over certain materials to a State if-the State's program is " compatible" with the Commission's regulatory program. Subsection 274g. authorizes and directs the Commission to cooperate with the States in the formulation of standards to assure that = State and Commission-standards will be coordinated and " compatible." Subsection 274 (j) (1) requires the Commission to review periodically the Enclosure 4

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agreements and actions taken by the States under the agreements to l insure compliance with the provisions of section 274. 4 Although the term " compatible" represents a cornerstone requirement in the Agreement State program under Section 274 of the AEA, the term is not defined in the Act. Neither has the Commission

. provided a formal definition or formal comprehensive guidance on how the term should be interpreted in implementing Section-274.

The guiding concept over the years since the beginnings - of the-Agreement State program in 1962 has been to encourage uniformity to the maximum extent practicable while allowing flexibility where possible to accommodate local regulatory concerns. This concept has been implemented in case-by-caso decisions by the Commission and in internal procedures developed by the staff to assign designations of degrees of " compatibility" (i.e. uniformity), from

" essentially verbatim" -to "no degree of uniformity required" to sections of the Commission's regulations. More recently, the Commission has attempted to involve the States earlier in the process of developing new regulations and determining what level of

" compatibility" (i.e. uniformity) will be required of the Agreement States.

The Commission's approach to making compatibility determinations has developed slowly, in a piecemeal fashion over the life of the Agreement State program. At the same time, the Agreement State Program has expanded and developed significantly both in numbers of Agreement States, as well as depth of experience and expertise of State regulators since 1962. To improve the regulatory partnership mandated by Section 274 of the AEA, the commission has decided to i revisit comprehensively the entire interpretation and application of the term " compatible" for. Agreement State programs.

The Commission is starting a process for full consultation with the-States on the development of a new generic policy on the interpretation of the term " compatible" with regard to Agreement.

State programs and the specific application of the policy to regulations and other program areas. NRC staff will meet with the Agreement States at the All Agreement State Meeting or in regional workshops to draft the elements of a comprehensivo proposed policy on compatibility of Agreement State programs. Comments received in The Report of the Acreement States Task Force on Compatibil'ity (OAS Report), dated March 7, 1991; and the comments submitted in response to a Federal Register notice prepared by.the NRC entitled

" Request f o r -. C o m m e n t s on the Compatibility of Agreement State Program", published December 23, 1991, will also be considered in the- process. After the drafting process,- the proposed comprehensive generic statement of policy will be published in the Federal Register for public notice and comment, and finally, after revision as necessary, will be adopted by the Commission.

Following adoption, the policy statement will be applied during new Enclosure 4

. 3 rulemakings to determine the degree _of Agreement State compatibility for each new regulation.

However, this process may take some period of time _and the area of compatibility of low-level waste disposal-regulations in Agreement State programs appears to have particular urgency at this time.

The Low-Level Radioactive Waste Policy Amendments Act o f ._ 1 9 8 5 (LLRWPAA) imposed on the States the responsibility for developing new low-level radioactive waste disposal capacity. The LLRWPAA imposed deadlines on the States as well as incentives'and penalties for meeting or failing to comply with the deadlines, some of which-are already past.

By assigning these responsibilities, Congress -implicitly acknowledged the States' special capabilities. At the same time, Congress explicitly stated that nothing in the LLRWPAA or in any compact agreement could be interpreted to change or transfer any existing regulatory authority over low-level waste or low-level waste disposal. The Agreement States, in fulfilling their responsibilities under the LLRWPAA must maintain a- regulatory -

program for low-level waste disposal which is " compatible" with the Commission's. The uncertainty of awaiting a new policy of the Commission with regard to the compatibility _ of Agreement State regulatory programs for the disposal of low-level radioactive waste may have an adverse eff ect on the Agreement States' efforts to comply with the deadlines in the LLRWPAA. Thereforc, to assist those States which have already, or those States which may-wish in the future, to assume regulatory authority over the disposal of low-level radioactive waste under a Section 274b. agreement, the Commission is taking up the issue of compatibility of low-level waste disposal regulations of the Agreement States separately and on an expC ited basis.

In the formulation and adoption of this policy ' statement, the Commission has carefully -considered the views of the Agreement States as presented in the OAS Report and the comments submitted in response to the December 23, 1992, Federal Register notice.- Those State organizations which addressed the compatibility -issue as applied specifically to low-level waste: disposal regulations were unanimous in urging-the-Commission to allow the Agreement States flexibility to adopt more stringent standards. The Commission is convinced that the Agreement States in the low-level waste disposal field do indeed require flexibility to address _ local conditions and concerns. A principle focus of the low-level waste disposal regulations relates to-the specific site,_ design and operations, therefore-the offects on interstate commerce of dif fering _ State regulations should be minimal. Moreover, affording Agreement States additional flexibility in this area is in-keeping with the l underlying ' principle of the LLRWPAA that States are generally l responsible for the disposal of low-level waste.

Enclosure 4

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II. Policy Statement For the purpose of evaluating the low-level radioactive wasto-dispocal regulations of an Agreement State, the term " compatible" shall mean that all of the principles of -the Commission's regulations in 10 C.F.R. Part 61 are addressed in a manner that provides protection of the public health and safety _ that is equivalent to or greater than that provided by.the Commission's regulations. Although the Agreement States are encouraged to adopt regulations similar to those of the Commission for ease of adoption, the Agreement States' regulations need not be essentially-identical, except in only a few areas important _ for effective communication and interaction with other States and the Federal Government, and affecting interstate transportation, specifically:

certain basic definitions such as units of radiation dose; the low-level waste classification system; and possibly. parts of the uniform manifest / data base system.

Aside from these areas, there are other provisions in 10 C . F . R .

Part 61 that address basic principles of radiation safety and regulatory functions such as site design and conditions of licenses. While States must address such principles in their regulations, the States' regulations may be different from or more stringent than the Commission's regulations to. reflect local conditions, provided that the level of protection is equivalent to or greater than that provided by 10 C.F.R. Part 61. For example, an Agreement State may prohibit a method of disposal generally allowed under Part 61, such as shallow land burial, and may' adopt performance requirements for low level waste disposal facilities more stringent than 10 C.F.R. 61.41-61.44.

The Commission believes - that the Agreement States will exercise their regulatory authority in a responsible manner and will not abuse this flexibility by adopting more stringent regulations as a means to bar low-level- waste disposal altogether without an adequate safety or environmental basis.

Dated at Rockville, Maryland, this day of

, 1992.

For the Nuclear Regulatory Commission Samuel J. Chilk Secretary of'the Commission Enclosure 4