ML20128P375
| ML20128P375 | |
| Person / Time | |
|---|---|
| Issue date: | 10/03/1996 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-96-213, SECY-96-213-R, NUDOCS 9610170239 | |
| Download: ML20128P375 (428) | |
Text
_
1 .
! RELEASED TO THE PDR !
f~% i i
),);9/9t, Std i \
\,...../
t e
cate inmas POLICY ISSUE Octoher 3, 1998 (Notation Vote) ,,c,_,,_, 3 For: The Commissioners !
From: . James M. Taylor Executive Dire r for Operations Subiect: IMPLEMENTING ROCEDURES FOR THE POLICY STATEMENTS: !
" STATEMENT OF PRINCIPLES AND POLICY FOR THE AGREEMENT l STATE PROGRAM" AND " POLICY STATEMENT ON ADEQUACY AND l COMPATIBILITY OF AGREEMENT STATE PROGRAMS" l l
Puroose. ,
- 1. To obtain Commission approval of the proposed changes to the Policy Statement on Principles and Policy for the Agreement State Program and proposed implementing procedures for phasing of new agreements.
- 2. To provide the Commission the Report of the Joint NRC-Agreement State Working Group for Development of Implementing Procedures for the Final l Policy Statement on Adequacy and Compatibility of Agreement State '
Programs (Working Group), which includes proposed implementing procedures and recommended revisions to the Policy Statem^ent on Adequacy and Compatibility of Agreement State Programs. ,
l
- 3. To inform the Commission of the staff's proposed process and schedule to finalize the proposed implementing procedures for the Policy Statement on Adequacy and Compatibility of Agreement State Programs and to finalize proposed revisions to the policy statement.
1 Backaround:
l By Staff Requirements Memorandum (SRM) dated June 29, 1995 (SECY-95-112; SECY-95-115), the Commission approved two policy statements: the Policy p;
l Statement on Adequacy and Compatibility of Agreement State Programs and the h/
i Statement of Principles and Policy for the Agreement State Program. The Commission, however, deferred implementation of the policy statements until Contacts: NOTE: TO BE MADE PUBLICLY AVAILABLE WHEN THE Paul Lohaus, OSP FINAL SRM IS MADE AVAILABLE
, 415-2326 Cardelia H. Maupin, OSP 415-2312 GTATEL gg [ q -6ucAa L c q /1- 6 Q M % .
c s ; leMo '3a >Y&
./
. - - - =. . . - - . . . - . - - - . - - - . - -- -. -
The Commissioners i staff developed supporting implementing procedures. The Commission directed :
staff to complete such procedures and to provide the procedures to the -
Commission, along with any changes to the policy statements which may be required to reflect the implementing procedures.
Discussion:
A. Statement of Principles and Policy for the Agreement State Program and Related Procedures SECY-95-115, dated May 5,1995, transmitted for Commission approval the
- subject policy statement and the " Procedures for Suspension and Termination l of an Agreement State Program." The June 29, 1995 SRM provided Commission
! comments on the policy statement. The SRM also directed staff to develop i procedures for placing an Agreement State in probationary status and for implementing the phase-in of a new Agreement State program.
l The Statement of Principles and Policy for the Agreement State Program has been modified as directed by the Commission. Further revisions were made l to ensure consistency with the revised Policy Statement on Adequacy and l Compatibility of Agreement' State Programs. Additions and deletions are shown j -in line-in/line-out text (See pages 34-56 of Attachment A). The appendices i for the procedures for emergency suspension, suspension, and termination were l completed and the procedures were transmitted to the Commission by memorandum from James M. Taylor dated April 25, 1996. The procedure for placing an Agreement State in probationary status was transmitted to the Commission by memorandum from James M. Taylor dated July 3,1996. The draft Management Directive 5.8, " Proposed 274b Agreements with States," which contains a standard agreement and a protocol for phased implementation of a new Agreement State program, has received office concurrence and is contained in Attachment B. After Commission approval, the staff will request comments on the draft Management Directive 5.8 from Agreement States. Staff will analyze comments received on the Management Directive, revise the directive as appropriate, and develop a proposed final directive. The proposed final directive will be submitted for Commission approval. A Federal Reaister Notice to publish, upon Commission approval, the final " Statement of
, Principles and Policy for the Agreement State Program" is contained in l Attachment A.
1 B. Policy Statement on Adequacy and Compatibility of Agreement State Progrums Because of the need to have Agreement State perspectives, and the extent of work required in development of implementing procedures for the " Policy
! Statement on Adequacy and Compatibility of Agreement State Programs," staff 3
convened a Working Group of NRC and Agreement State staff to develop i implementing procedures for this policy statement. The Working Group completed its activities and provided a letter and report to the Director, l Office of State Programs, dated August 21, 1996 (Attachment C).
The Commissioners The report describes the makeup of the Working Group, describes the process followed in developing the proposed implementing procedures and provides a set of proposed implementing procedures. Attachments to the report include:
- 1. The Working Group Charter (Attachment 1);
- 2. Revisions Recommended to the Policy Statement on Adequacy and Compatibility of Agreement State Programs (Attachment 2); and
- 3. Proposed implementing procedures. The implementing procedures consist of:
- a. A new Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs," and Handbook 5.9, " Adequacy and Compatibility of Agreement State Programs" (Attachments 3 and 4); and
- b. A revision (Revision 1) to OSP Internal Procedure B.7,
" Criteria for Compatibility Determinations," (B.7), which has been retitled " Compatibility and Health and Safety Component Classifications for NRC Regulations and Program Elements" (Attachment 5).
The Working Group also prepared and attached to its August 21, 1996 letter, a second set of the proposed compatibility and health and safety component classification tables set out in the B.7 procedure. This second set of tables compares the classifications assigned by the Working Group under the proposed final Policy Statement on Adequacy and Compatibility of Agreement State Programs to the classifications previously assigned under current procedures.
The second set of tables is also contained in Attachment C and follows the Working Group report. The Working Group recommends that the final revision to the B.7 procedure not include the second set of tables. The Working Group report, Section 7.0, also contains a tabulation of the number of regulations required under the proposed final policy statement compared to the number required under current procedures.
Management Directive 5.9 and its associated Handbook 5.9 provide guidance to staff on how to apply the policy statement in making a determination on whether an NRC regulation or program element is required in an Agreement State program for purposes of compatibility or health and safety. The criteria and process described in the Management Directive were developed and applied by the Working Group in making compatibility component determinations for each current NRC requirement in Title 10 of the Code of Federal Regulations (CFR) l and major program element that are applicable to the regulatien of Agreement
! materials (byproduct, source and small quantities of special nuclear materials). The same criteria and process would be applied by staff in making determinations for future regulations and program elements. The revision to the B.7 procedure consists of a set of tables which identifies the compatibility or health and safety component classification for each NRC rule, i
The Comnissioners effective as of July 31, 1996, and each major program element. A separate table has been prepared for each part of.10 CFR that is applicable to agreement materials. The table contains component classifications for each section-or paragraph of the part.
As a result of its deliberations, the Working Group did identify some portions of the Policy Statement on Adequacy and Compatibility of Agreement
' State Programs that need clarification to reflect the implementing procedures.
A proposed final policy statement is attached to the report which contains suggested revisions in line-in/line-out' text necessary to reflect these clarifications (Attachment 2 to the Working Group-report).
Further, in response to the June 29, 1995 SRM, the language of the Policy Statement on Adequacy and Compatibility of Agreement State Programs was modified in those cases where the language stipulated a " requirement" as opposed to " guidance" (e.g. the term "should" was used in place of "must").
The policy statement does not. establish requirements, but rather establishes the framework and guidance on the type of requirements and program elements which should be addressed in Agreement State programs for compatibility and health and. safety. Whether an Agreement State has adequately adopted regulations and program elements identified as necessary by Management Directive 5.9 and the B.7 procedure will be determined by the NRC staff on an ongoing basis as Agreement States promulgate regulations and program eleinents.
The broader Agreement State program adequacy and compatibility finding will be ;
determined through the Integrated Materials. Performance Evaluation Program (IMPEP) review process as documented in Management Directive 5.6. The Working Group also incorporated the clarifying footnote suggested in Commissioner Rogers' vote sheet.
In addition, the Working Group identified three significant issues related to the Policy Statement on Adequacy and Compatibility of Agreement State Programs regarding: (1) the definition of the terms " adequacy" and
" compatibility;" (2) whether the Commission should require Agreement States to adopt certain regulations for the purposes of health and safety, in addition to those required for compatibility; and (3) whether Agreement States l should adopt certain legally binding requirements by regulation. The Working L Group also identified several other less significant issues associated with the implementing procedures, or their use, which are identified and described in the report and proposed Handbook 5.9. Each of the three major issues is discussed below.
- 1. Clarifying the Distinction Between the Terms " Adequacy" and
" Compatibility" The Working Group recognized that the t1rms " adequacy" and
- " compatibility" have distinct meanings and concluded that the i terms should be clarified in the final policy statement. The term " adequacy" refers to protection of public health and safety i within a particular State. This represents the core goal or purpose of any Agreement State's radiation protection program.
a- , -v - m. , _ _ . --
- - - . - , - _ , ,w .- - .- -,_
i The Commissioners l
" Compatibility," on the other hand, relates to the effects that l an Agreement State's program actions or inactions will have l outside of that Agreement State, such as impacts on other States or on the regulation of agreement material on a national basis.
Given this approach, all rules required for compatibility have
- some significant implication outside of an individual Agreement l State.
l The distinction between the two terms was described explicitly in the draft policy statement (59 FR 37269, July 21,1994).
l While the final policy statement does not contain an explicit description of this distinction, it is clearly implied by the policy statement's structure. The Working Group added draft j language to the proposed final policy statement to clarify the distinction discussed here.
- 2. Regulations Required for the Purposes of Health and Safety The Working Group identified certain regulations that have safety
- significance with respect to regulation of agreement material I within a particular State but, at the same time, are not needed for the purposes of compatibility. The policy statement, as written, does not indicate explicitly that specific regulations
. will be required for reasons of health and safety. In identifying l these regulations, the Working Group sought to determine whether l the absence of such a requirement would have the potential to l result directly in exposure to an individual in excess of the basic radiation protection standards required for compatible regulations under component 1, as described in the proposed final l policy statement. These regulations have been identified for the Commission's consideration. If imposed on the Agreement States,
! such rules would be required for the purposes of health and safety. The Working Group has also suggested changes to the l policy statement as a result of its consideration of this issue.
- 3. Legally Binding Requirements j l
One issue addressed by the Working Group relates to the degree of j flexibility afforded an Agreement State in the method followed ;
within that State to implement legally binding requirements. It I l deals with the question of whether there are certain requirements, ;
! such as Part 20, which apply to all licensees and thus, should be i adopted by a State as a regulation, as opposed to adoption through another form of legally binding requirement, such as a license ,
condition or order. It also relates to whether a State should be !
required to adopt legally binding requirements by regulation, as )
, opposed to an alternative method, when the State has more than one (or only a few) licenses that would be subject to that requirement. l l
l l
The Commissioners The Office of the General Counsel has advised the staff that the i Commission does not have statutory authority to require States to 4 adopt legally binding requirements specifically by rule. States 1 l must be provided the flexibility to adopt generic requirements by i l rulemaking or other legally binding mechanisms applicable to I groups of licensees. The staff will revise the policy statement and Management Directive 5.9, as drafted by the Working Group, to reflect this legal position.
The Working Group requested peer review of selected draft working group i
products by limited staff in the Office of Nuclear Material Safety and Safeguards (NMSS) and three Agreement States. Comments resulting from the l peer review were considered and reflected in Working Group products. One comment resulting from review by the Agreement States was that the implementing procedures should be made available for review and comment by all Agreement States before final Commission approval and issuance of the final Policy Statement on Adequacy and Compatibility of Agreement State Programs and final implementing procedures. The Working Group agreed with this comment and recommended that the Working Group report be provided to the Agreement States for review and comment. Staff provided copies of the report to the Agreement States for their review and comment by letter dated August 23, 1996. Staff requested comments by November 8, 1996. On August 23, 1996, copies of the report were also provided to key NRC Offices (NMSS, OGC, AE0D and RES) for review and comment. Preliminary review by these offices has identified no significant comments. A number of refinements and revisions to the rule tables set out in draft Internal Procedure B.7, Revision 1, have been suggested. These comments, along with any additional NRC office comments, and Agreement State comments received by November 8, 1996 will be addressed and incorporated into the proposed final implementing procedure, and proposed revisions to the policy statement, as appropriate.
In addition, during September, 1996, the staff provided the Working Group report to other stakeholders, who had been invited to serve as panelists at an November 1994 public workshop, "NRC Workshop: Proposed New Policy Statement on the Adequacy and Compatibility of Agreement State Programs."
Staff also published a notice of availability of the Working Group report in the Federal Reaister on September 19, 1996 (61 FR 49357). Any comments received from other stakeholders will also be addressed and incorporated, as appropriate.
Coordination:
l The Office of the General Counsel has no legal objection to this paper.
The Commissioners J Recommendations:
- 1. Related to SECY-95-115:
- a. The staff recommends that the Commission approve the final policy statement " Statement of _ Principles and Policy for the Agreement State Program."
- b. The staff recommends that the Commission approve the.
proposed Management Directive 5.8, " Proposed 274b Agreements with States," for review and comment by Agreement States.
Notes:
- 1. Related to SECY-95-ll5:
- a. Upon Commission approval, staff will prepare for publication in the Federal Reaister, the final policy statement,
" Statement of Principles and Policy for the Agreement State Program." ,
- b. Upon Commission approval, staff will issue the proposed Management Directive 5.8 containing the standard agreement and procedures for phasing of new agreements for review and comment by Agreement States. Subsequently, staff will analyze comments received and notify the Commission of revisions to the proposed Management Directive 5.8 before ,
final issuance.
- 2. Related to SECY 95-112:
- a. Staff will receive comments on the proposec' implementing procedures for the Policy Statement on Adecuacy and Compatibility of Agreement State Programs hntil November 8, 1996.
- b. Following November 8,1996, the staff, with continued assistance of the Working Group, will analyze and reflect comments, where appropriate, from the Agreement States, NRC offices, and other stakeholders in the proposed final implementing procedures and proposed revisions to the policy statement. Staff will prepare a proposed final Policy Statement on Adequacy and Compatibility of Agreement State Programs and proposed final implementing procedures for Commission review and approval by January 17, 1997.
- 3. Related to Management Directive 5.6 " Integrated Materials Performance Evaluation Program"
1 The Commissioners l
- a. The Integrated Materials Performance Evaluation Program l (IMPEP), used in the evaluation of Agreement State programs and NRC Regional materials programs, was implemented i' October 1, 1995, on an interim basis. Upon approval by the l Commission of the final policy statements, Policy Statement
- on Adequacy and Compatibility of Agreement State Programs l and Statement of Principles and Policy for the Agreement
! State Program, and associated implementing procedures l discussed above, staff will make, as appropriate, revisions l l to Management Directive 5.6, " Integrated Materials )
l Performance Evaluation Program."
i i
l b. Staff will then implement IMPEP as a final program and l will rescind the 1992 policy statement on " Guidelines for NRC Review of Agreement State Radiation Control Programs."
Attachments:
l A. Statement of Principles and Policy for the Agreement State Program -
Line-in/Line-out Text of Federal Reaister Notice l B. Management Directive 5.8 " Proposed Section 274b Agreements with States" C. August 21, 1996 Letter and Report of the Joint NRC-Agreement State
- Working Group for Development of Implementing Procedures for the Final Policy Statement on Adequacy and Compatibility of Agreement State Programs
, cc: SECY OCA OPA OGC Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Monday, October 21, 1996.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Cetober 11, 1996, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional review and comment, l the Commissioners and the Secretariat should be apprised of when comments may be expected.
Distribution:
Commissioners OGC OCAA OIG OPA OCA EDO SECY
[7590-01-P]
NUCLEAR REGULATORY COMMISSION Principles and Policy for the Agreement State Program; )
Final Statement of Policy l
l AGENCY: Nuclear Regulatory Comission.
. 1
- ACTION
- Final policy statement. j
SUMMARY
- The Nuclear Regulatory Commission (NRC) is publishing the final policy statement that establishes Agreement State program principles, and describes the respective roles and responsibilities of the NRC and the States in the administration of this program, which is authorized by Section 274 of 2 the Atomic Energy Act of 1954, as amended. The Policy Statement will provide guidance in delineating the NRC's and the State's respective responsibilities and expectations.
I EFFECTIVE DATE: (Upon publication in the Federal Register.)
ADDRESSES: Documents referenced in this Policy Statement are available for inspection in the Public Document Room, 2120 L Street, N.W. (Lower Level),
Washington, DC between 7:45 a.m. and 4:15 p.m.
ATTACHMENT A
l FOR FURTHER INFORMATION CONTACT: Ms. [gdil]Qiiffifg M:ri: Lop:: Otin, F:dcr:1 Licisen Office of State Programs, U.S. Nuclear Regulatory Comission,
. Washington,DC20555, telephone (301)415-[3I(-2698.
SUPPLEMENTARY INFORMATION:
I. Background On August 25, 1993, the Commission requested the NRC staff to recommend improvements to the NRC's Agreement State Program to assure adequate .
protection of the public health and safety.
t The draft Policy Statement was published in the Federal Register on August 5, 1994 (59 FR 40058). At the Comission's request, the public coment
, period, scheduled to end on October 4, 1994, was extended to December 19, 1994 (59 FR 52316). In response to the solicitation of public coments, fifteen coment letters were received. The considerations of the comments received are addressed in Section II of this Notice. This Policy Statement responds to the Commission's request regarding, " improvements in guidance and principles j
l l of operations for the Agreement State Program." The Policy Statement will l provide broad guidance in delineating the NRC's and the State's respective responsibilities and expectations.
The final Policy Statement has been prepared based on the consideration I
of the public comments as well as other activities and issues before the j Commission, e.g. the Policy Statement on Adequacy and Compatibility, issues .
I 2
I I
1
( discussed at public briefings of the Commission !/ the Organization of I
l Agreement States (OAS), and the Commission's deliberations on the Integrated Materials Performance Evaluation Program. The summary of public comments addresses the comments by categories which, for the most part, follow the sections in the Policy Statement. ,
l The staff addressed the comments with relatively few modifications to the Policy Statement. A number of comments were more applicable to the Policy Statement on Adequacy and Compatibility of Agreement State Programs and are addressed in the evaluation of public comments on that Policy Statement. Some l
comments were extraneous to the subject of the Policy Statement. Other i
l comments dealt with issues better addressed in guidance and implementation i
procedures.
This Policy Statement is intended solely as guidance for the Commission and the Agreement States in the implementation of the Agreement States l
program. This Policy Statement does not itself impose legally binding requirements on the Agreement States. In addition, nothing in this Policy Statement expands the legal authority of Agreement States beyond that already granted to them by Section 274 of the Atomic Energy Act and other relevant legal authority. Implementation procedures adopted pursuant to this Policy l
Statement shall be consistent with the legal authorities of the Commission and L the Agreement States.
t 3
1
f l
II. Summary of Public Comments Fifteen comment letters were received regarding the draft Statement of Principles, and Policy for the Agreement State Program -(Policy Statement).
Four of the letters were from Agreement States, f'.ve from members of the licensee community, two from public interest groups, three from associations, and one from a private citizen. In general, most commenters welcomed the i
l development of a Policy Statement establishing Agreement State program principles. One of the underlying themes found in a number of letters was the need for having clear and well defined criteria and procedures for the Agreement State program. Another theme found in some of the letters was the idea that an "overall national program" regarding radiation should include both Atomic Energy Act (AEA) and non-AEA material.
There were a number of letters that addressed issues such as: the perceived expansion of NRC regulation into nuclear medicine; the inequality between the fees charged to licensees by Agreement and non-Agreement States; the need for cooperation between States and Federal agencies; and the need to require States to develop Environmental Assessments (EA) and Environmental l Impact Statements (EIS), apparently based on the assumption that the National Environmental Policy Act (NEPA) is applicable to State actions. Comments addressing the role that economics should have in NRC decisions were also I made, e.g., that NRC should not impose policies or requirements that could have potential adverse economic impact.
4
Two comments questioning the approach and timing of the Policy Statement were submitted by a member of the licensee community. The first comment suggested that the Policy Statement goes beyond NRC's statutory authority and should be withdrawn. The second comment suggested that the NRC delay taking any action on the Policy Statement until it can take into consideration the results of the review of the medical program by the National Academy of Sciences (NAS).
Response
Several changes have been made to the proposed Policy Statement to provide clarification regarding the issues raised by the public comments.
Regarding the perceived expansion into nuclear medicine, the NRC is within its mandate pursuant to the AEA and with the regulations it has issued.
This Policy Statement does not add new requirements.
The inequality between the fees charged by Agreement States to their licensees and the fees charged to NRC licensees has been partially addressed by the Commission in its proposal to reduce some materials license fees presented in the FY95 fee rule published for comment (March 20, 1995; 60 FR 14670)@5djintilijdistifss@Glss.
The Commission agrees that there should be cooperation between the States and Federal agencies. The Commission strives to coordinate its i
policies and requirements so that duplication of Federal regulations on States 5 l i
or licensees is minimized or eliminated. In regard to the suggestion that the NRC require States to conduct EAs and EISs, the NRC's environmental protection regulations (10 CFR Part 51) implement the National Environmental Policy Act (NEPA). NEPA's requirements only apply to the actions of Federal agencies.
Generally, NEPA does not impose requirements on State agencies. In addition, both the language of Section 274 of the AEA and its legislative history are clear that the scope of Section 274 agreements is to be confined to radiation ,
hazards. [This general rule, however, does not apply to the area of mill tailings, see Section 274o.] Given the structure of NEPA and Section 274 of the AEA, the Commission does not require Agreement States to adopt (1) NEPA's requirements, or (2) other environmental protection measures that are unrelated to radiological protection. However, many State agencies must follow their own environmental protection procedures pursuant to State statutes.
The Commission believes that the Policy Statement is within the scope of NRC's statutory authority because it addresses the manner in which NRC and the Agreement States will implement provisions contained in'Section 274 of the AEA. The Policy Statement addresses the general framework and principles of the Agreement State program as opposed to any specific substantive area of regul ati on){sul({nj![{h'afydd@@jf@]iAS[i[iidf255][@@j@iiisdij@s.
Furth:r::r:, th: C:::i::icn exp::t: th:t the rc:cleti:n of the MAS :tedy en l l
- le:r ::dicin ::y requir: 05:3g0: 'n regel:ti:n er legi:1:tien; b th Of which :r: bey nd th ::Op: Of thi Policy St:te: nt. The Commission notes that a policy statement cannot change a regulation.
1 I
6
A. NRC/ AGREEMENT STATE RELATIONSHIP This category discusses the nature of the relationship between the NRC and Agreement States, including the concept of "co-regulators".
Sumarv of Coments:
Several Agreement State comenters recomended that the Policy Statement should more clearly address the "special relationship" between the NRC and the Agreement States as " partners" and "co-regulators".
Response
Section 274 of the Atomic Energy Act establishes a special Federal-State regulatory framework for the control of radioactive materials. Pursuant to Section 274, NRC has the discretion to discontinue its authority over certain areas of regulation to a State government. The creation of a Section 274 agreement triggers the relinquishment of NRC regulatory authority to the State for these designated areas. Within these areas, the Agreement States have the sole regulatory authority and responsibility, subject to periodic NRC oversight. The Comission acknowledges the Agreement States' role as regulators of radioactive materials, with both the NRC and the Agreement States having a special interest in joint cooperation and consultation.
This special interest can most easily be categorized as one of assuring comprehensive, ongoing, and effective comunication between NRC and Agreement 7
l t
States on matters of mutual regulatory concern. The special interest is exemplified by interactions such as periodic overview meetings, including the l l
?.gre :::t St:te: M:n:ger: Meeting :nd the All Agreement States meetings; I l
periodic Comission briefings by the OAS as well as continuing consultation with the OAS on a variety of topics; recognition of the special nature of NRC and Agreement State relationships in the implementation of the Federal l Advisory Comittee Act; and obtaining early Agreement State consultation on the development of rulemaking plans under new Section 3.9(e) of the NRC Regulations Handbook. In addition, the Commission 1: considering further involveji=entoftheAgreementStatesintheIntegratedMaterialsPerformance Evaluation Program (IMPEP), specifically participation by Agreement States on the review teams that conduct the IMPEP reviews of NRC regional programs and Agreement State programs and participation by an Agreement State Liaison representative to the Management Review Board in the evaluation of NRC Regional and Agreement State programs as part of the IMPEP process.
The Comission ::ald notei that in recognizing the special interest of Agreement States in joint cooperation and consultation, the Commission also intends to conduct these special consultations in accordance with a policy of openness in terms of public notice and availability of information.
Although the Commission recognizes the importance of Agreement State experience and perspectives in the sphere of co-regulation, the Commission
- ldemphasizejthatitalsohasaseparateandindependentresponsibility for the review of individual Agreement State programs to ensure continuing adequacy and compatibility of these programs.
8
B. LEGISLATIVE INTENT 1
1 This section addresses several comments that raised issues of 1
interpretation regarding the legislative intent of Section 274 of the Atomic Energy Ac.t. For ease of understanding, this discussion has been divided into e
several sections.
i l
- 1. No Concurrent Regulation '
s Summary of Comments:
Several commenters indicated that one of the principal purposes of Section 274 was to minimize the Federal role in regulation. In particular, one commenter from the licensee community commented that "by using its own regulatory program as the yardstick, the Commission is trying to indirectly ,
impose concurrent jurisdiction which Congress explicitly rejected." In addition, the commenter stated that one of the clear purposes of Section 274 was to minimize Federal regulation. Several other commenters' indicated that the NRC has no direct responsibility to review State programs and that NRC and the States should respect each other as regulatory equals.
Response
In passing Section 274, Congress clearly rejected concurrent regulation at the State and Federal level. ("It is not intended to leave any room for the exercise of dual or concurrent jurisdiction by the State to control 9 i
l l radiation hazards by regulating byproduct, source, or special nuclear i
materials." Senate Report No. 870, Sept. 1, 1959, 86th Cong., 1st Sess.) %e l Ccri::icn believc: that cMoncurrent or dual regulation generally involves l
! the simultaneous regulation by separate governmental bodies of the same l entities for the same purpose. There is no intent behind the Commission's Policy Statement to impose, directly or by implication, a system of dual or l
concurrent regulation. The f:ct th:t Agrec=cnt St:tc progr::: :::t provide :t lent th: :=0 level cf public protectica provided by NRC': pr:gr= MCH
! 5 5} $ $$$$IE N[N N5N NI$NIE N N d NE$55 53 E 545 5 E$NN NNM y does not mandate or create a system of concurrent regulation.
Si=ilarly, the C =10:icn': Ot:tutorily ::nd:ted Over:ight of Agrec:cnt St:tc progr=: dec: not crc:tc : yster of du:1 er centurrent regul: tion. The fact that Congress rejected dual regulation does not dampen the fact that Congress expressed the clear intent that the NRC assess the Agreement State regulatory programs to ensure that they are adequate and compatible with NRC's program. In 1978, Congress added to Section 274, among other things, the requirement that "(t)he Commission shall periodically review such agreements and actions taken by the States under the agreements to insure compliance with the provisions of this section." This amendment indicates a clear intent on the part of Congress to require NRC oversight of regulation by the Agreement States. While the Commission views the Agreement States as having regulatory authority in the area of AEA materials regulation, it cannot overlook its statutory responsibilities to review Agreement State programs for adequacy and compatibility. In its approach to the Policy Statement, the Commission has sought to balance these two competing considerations.
10 l
- 2. Continuing Compatibility Sumary of Comments:
One Agreement State comenter stated that Section 274 of the Atomic Energy Act does not require that compatibility be maintained after an agreement is effective.
Response
The Comission does not agree with this interpretation of the AEA. Both Sections 274d(2) and 274g indicate that the Comission must find a State program to be compatible with that of NRC's in order to enter into a 274b agreement with that State. Although the language is not explicit in stating a requirement-that an Agreement State must maintain continuing compatibility, the Comission believes that there is an implicit requirement for continuing compatibility in Section 274.
First, Subsection 274g authorizes and directs the Comission to cooperate with the States in the formulation of radiation protection standards "to assure that the State and Comission programs for the protection against hazards of radiation will be coordinated and compatible." This provision i demonstrates Congress' intention that the compatibility between the NRC's and Agreement States programs should be maintained on a continuing basis.
11
Second, Section 274j(1) requires the Commission to suspend or terminate '
an Agreement State's program if, among other things, "the State has not complied with one or more of the requirements" of Section 274. The Commission believes that this phrase "one or more of the requirements," encompasses all requirements of Section 274, including the requirement of compatibility.
Third, the lack of a continuing compatibility requirement would lead to some unacceptable results. Under Subsection 274d.(2), the Commission is authorized to enter into an agreement with a State if the Commission makes both requisite findings that the State program is compatible with the NRC's program and adequate to protect the public health and safety. If there were no continuing compatibility requirement, an Agreement State could divert from having a compatible program the day after any agreement is signed with NRC.
Given this framework, the Commission does not believe that Congress intended such meaning for the compatibility requirement. This approach would render the requirements of s 274d.(2) meaningless.
- 3. Statutory Basis for a National Program Summary of Comments:
Several commenters questioned NRC's proposal to consider areas of national significance in the development and implementation of the proposed policy statement. In particular, commenters indicated their confusion concerning the meaning of national significance. In addition, one commenter 12 f
l l
s
L argued that " areas of national significance" is not a statutorily cognizable term.
I i
i Response:
4 I The Commission believes that its leadership role in certain areas is essential to ensuring that there is an orderly national regulatory pattern.
which provides a clear, comon framework for the regulation of AEA materials. -
At the same time, the Comission believes that the limited nature of its leadership role will allow States, in most cases, to implement their own regulatory program in response to local conditions and needs. The Comission further believes that the language and legislative history of Section 274 of the AEA provides ample support for the NRC's leadership role. In fact, one of the six stated purposes of Section 274 is "to promote an orderly regulatory pattern between the Comission and State governments with respect to nuclear development and use-and regulation of byproduct, source,-and special nuclear material s. " Section 274 a.(3). This stated purpose expresses a clear concern on the part of Congress for the maintenance of a coherent national regulatory pattern. In addition, remarks made during the debate on Section 274 also demonstrate a concern for a consistent, national approach to radiation protection.'
' In particular, Representative Price indicated that: "Many of the States are doing far more in this area than we know at the present time.
There is a considerable amount of work being done. It is a matter of ,
coordination to be sure that all are going toward the same goal, and they !
don't have a lot of conflicting regulations that make it a little difficult to operate on a national basis." Federal-State Relationships in the Atomic Energy Field, Hearings Before the JCAE, 86th Congress, 1st Session, May 19, 20, 21, 22, and August 26, 1959, pages 131-132.
l 13
4 l
- 4. Intent of Section 274 is to Empower The States j Summary of Comment:
l l l' One commenter indicated that the legislative history of Section 274 of the AEA clearly shows that Congress intended to encourage the States to assume 3
i responsibility for the regulation of certain radioactive materials by giving :
the States jurisdiction over the uses of those materials.
Response:.
NRC does not dispute that, in passing Section 274, Congress sought to provide a vehicle to allow States to assume responsibility for the regulation of certain radioactive materials by giving States jurisdiction over the uses !
of those materials. By doing so, Congress clearly intended to empower the 4 States in this area. At the same time, Section 274 clearly requires the ,
Commission to review Agreement State programs to ensure that they are adequate and compatible.
C. EXCELLENCE This category addresses those management principles that both the NRC and Agreement States should adopt to ensure high standards of performance in assuring public health and safety.
14
l <
l l Sumary of Comments:
! Comments were received from two Agreement States, two members of the licensee comunity, and two associations. The Agreement State comments were at opposite ends of the comment spectrum, with one Agreement State generally supportive and one Agreement State unsupportive. The coments from licensees were generally supportive, but with recomendations for clarifications on how the excellence principles should be applied in Agreement State program reviews. One association argued for the use of the excellence principles in the review of Agreement State programs, while the other believed there was no legitimate basis to include excellence in the Policy Statement.
An Agreement State and an association commented that excellence should not be included in the Policy Statement, based on the inappropriateness of its inclusion, the belief that excellence is neither implicitly nor explicitly included in the Atomic Energy Act, and that the excellence concept is too open ended and could lead to uneconomic regulation. An association believed that the provision calling for Agreement State relief from pressure by the regulated comunity and the concept of a dichotomy between the regulated and unregulated public are unconstitutional. An association and two members of
~
the licensee comunity believe that the principles should not be treated merely as oratorical statements but should be used in the judgment of Agreement State programs. A member of the licensee comunity also suggested that the principles of excellence include a directive that Agreement States 1 l guard against placing their parochial interests above the national interest in f fostering coherent regulation of nuclear materials.
15 l
l
l t
Response
The Commission believes that it is appropriate to include a Reg & te g l
"r:gr= Ex::"cr.:: section in the Policy Statement l[d@@yijyjijsMM m
P_F#9._Fa_n;exc_e llence ,___- ,,.- asn ,a program mana9ement principle. Because these are State and Federal government programs, an inherent obligation exists to manage these programs effectively, efficiently, and to measure governmental organization performance against general high standards expected by the public (including 1icensees). MIM941the wa --- . C.sili1_Wnfi_d_BEf,e_Id%r..PFn~Ci.pHS1.
a---a n ~
6_F,G_6_sidM._s.inTIf16HM aa -w _ a .
r iEi sis.i!
liiRsi5iFn^
u_ ___,1_-n 5ESHUiiii6si
- + ~._~~t_i __~h.-_ij Yi 6.ssF.a_a.sersfiRi~d._iasa. Ls_a.u!I_aMisi_H.u.._fBus.Vib.nn
---n m +> as V - -
e., -g .
m.m-we.. m.
y- S.y_88S?* ~ gA.dh_ renm.ces r-
. hu- e.m t th.<homme.d.m.
mmm m _os. m s_e.n.m mp.~
- - n_c lm.l.ym.d_m.c.dm.lped_..i.
E es a_s
=
um-e . m e
oo s.urm_it_b8_f.s 4
.pum.m.xs. r me ~ ,m.m.
,. 7 4-. -
.$$m w_m._mCaSEIO9Ulw.t a 0FL34_C.t
. . _.m._. s l,-V3_.sf7i. y.s e_ssh8.Vea.b.eenf ,*u.
-m mm-wf.h,k.hsomsvh3lmc6 0. . -m _e? 9 95 <t,Equ_al..ri~t.yJmE9.f_0pd,.
_ .. m . %8 .:mmf_.mpm+e.de_a g _9Ma w ,m_rm w cens iste,,mb n pTh. e %s.
u.,_ _.w+ew4.ww_,w v h ,.w.o nc p swwsewmxw;M I%ris,l~e.s,y.
.mgww. &,i_G.m.d. 7d,_ymlat.xi.
_ww oo.wweau.w"w Fu on-w-w
-rg a.,v-w.o.g. n .w- amo>Avxm
~~i~z.~er.t_h_wfps.mtm, ow s s r,/u*;. o . .w. qng,.
.ww -
s 6 mN V 9.m_a_p evI.
u eil_ %cvigmww.wwwco*amatp(Sndgge.4x.yd.
_t ma_na9_egen_-m__,4 4.1._es
._ m
-a.+=iam-
_re._,r._0 (I:+9wd*<ew+w,*<.wexa..>,.-
m .mpT,O,V,_e,s. p,e_r,fo,rm_an_c._e.s
. ,_*.nm.woww.x <www+.y.sw.m.e, e.+++ww,iwi t-m,wdor.,_a_re,,?,p
- wwwmcw p success dore 4.__ h _omm_~_-m_g.u o
_m bopwth.7*!pwwwxwl.,ut.wxw.w.w+w_d. re. m a rss a_n.m o.m.z ,,y.
~ ,.h.+..:pp.we yt _errelu mm w.l-w;.tnmd.miwwd.
_a.e s _n._us._ryeme
. m
- t. ,u m.:.p.gf.dThmgd.x m _.e w,,ws.i o
&_mm.m.ss on gweiym3
- n, -
_ '~1g4RC. . min.~l-- tnt.,,ngnfb,,f 6..a,nn,,,
7l,.w. _a_aw a_sfs mp m e._m._en_a i_on_ro_~m._ e_se;pr iarpm_es.m.Jas+
nc i lnni., .n. nan.-nnwdg....h~ serve._a_t _e.usw.r _ i..feJ m
. ..m_ eve m - m m m... m
-wow <w.ww. .
y#mw, w~ m 9 ~.
+t m . ,,_._m_&m &$_t_# a_l_e_mA.and..si am mt.?r,e.g,U,l,a, e wmammww.- .*t,_you e_d.,s,COM_Run n
wwce.:.eeei~ty,E,mN_e,l.lpgI_6c
,en, ?C-wem.iww.nw.s.
2 e_3,,O_MB_s_s,,0_8 +.9. 1
=
-.I*l<~.7,,, h..e? <<
4
.fu Nskw+t e $+e.l,lme.~ e._VeSEet.hm _a ESU._C k p .aEr N4.y i s.,i.n.C_aP_.e._se_ma.yu myse.:syfyh.c.
U. s0 u a_s. ,. . - ,my.mm.w,km.4.b.
4.p_ar ?._O.m aIC_o_m_m.on. w m __m ~ mmm am .
_ s_ .
p>;oA .- .~,m mw . .qv,.p.gme.og g nee cul>ure4 n.wv t.yme a+,w w._a
.h.om.i a x kRCr;.w+ggd. .:., :y .hquy.Agrxmwe,hy
+w.+as~w. .n a.a. u%.m.t.w n.:.vn &.___sw
- -w.eementr.y 5t,.wt' mw.mu_a ,sw
.ao3esis xu,+ h-_are.wggw.nco+recul,a.+xtww&Mors a
_n. s w.un> _+.m anunww. _.~.svcR
-. ve w w,weuwu .. e f - .
co_r EE .i.wm Ac_mecuad.
~ L ~e:
. 9.:thv.a.ms C.m ww +i.,s_s me.m_o.mm u o_n,~e_n_co_ur._a.9este._a._c.+ceei.wx+www:w+cu.>x..g.e m om_
r_e_em_en_ts.,$._ m twat..we.tsa_
<uec+x d_pcm+i3.y s_
,m:< hsw mp:.w,i4.gilsamma. e.
~ . mm.m.."9
-- ,ie,eimml
~ g.is. w I.I m .-.f ,w.,% - ,l w..,oa .r n_c_P_eSa_o.r4H_ Sew nh_S_tO_Wn_i_re_9.u._at_o_rLJP_r.0_gm._m ra u.0t u. 0"= 4. 0 tL.0
$. . 2 0-Em m m.m w .
A4 t, f.- a .-a s ,
.Am ,4 . .
L, a an a = =
Pa-am,we,, m a u aA . t,4
. i ama -- .= nw. pg w... . 4..m.
.. e. yi.
n --a e. ..n A e. .n ===n wwny vnywwa ,4. w w = ng . k. t. m nya l.ame j
l
- e. .k...
a.u,,
v m1 1. a. .. 4 ww E.
.A.4. a. . 4. ,. = w . . a m.m,,u ,Am ,4 ==.
y==,=..=- -
.= J. ... .4= . 4, e. 4. =. .= 4 4, v. a =, k.,,u 4. L... a M.D .n.t', .==...A. e. k.a .
)
Aa-ammane
..y.ww-vn. (*
w 1. = 4.w m e . T.n . t==w= , 4. , Ln i.. cv e.a go m A 4 ,ww= 4. aw ,e
- 4. nw e. nk .= 4 4.n L a. A , wm w w u .aw ly----
-w n- .+vsat 4La nw j
i i
m . a ma u = nu n ,4 4 =,,a-al i m-= 1. .m .= =. = =. m ag m, =m 4. n.mekt.e n , o m ww-..
a n = 4. m, g a.s.n e, = y w ., y 4. --, a n.n et. ac k .s i e = 1 = = v vmy . d. e,nmon uniw= k-a m o.
7 a
gwn.m nw a iu= = 1,1. g u
u, iv d e ua.A .
=4
- w. o.nvka 44.=am.
=,
w, n u , a l. l. ame vnww w i e . im en
=1
-1 4v 4. ,, f. w=wwe n e ,. . T.ka nw =,en,4=44a=
=e,wwi== vu I
i 16 t
l l
. c. . _- ,, --
....a..a ,_
. . . . . . . . . . . . . . . . . . . . ...... ..4.+.u. ... , .,_. __,...,,+4..-.
.. .... .. 4.,-_-.+..,+.4..
...r..... ... . .+4...... 4. .
th: :de'-i:tr: tion of NRC progr :: :nd, th :, :h0uld be reflected in ^.gre::ent St:t pr:gr::: in Order t: :::ure public Confidence in the NRC :nd ^. gree ent St:te: 00110:tive effert: t: ::: re public he:lth :nd ::fety. The Comi.csion) 1
' --- " ---- '-"'" '- --+
-Ef 4 -- ' ' -- 4- '
n% th"sF"e.'f6_W
- . 1 -~' ' * -"-- + ' - + + '
~ - - --
r- -- r ~- - --~~ --~~ ---- - -~ --- ---
- ao hp n-.~-w- e
- d. i,..f. .innd, -
se
--c.~.~ don w-n 10 k.nl.. hsen-r w. .-n.n.g f the Pol i cy Statementyt.,s.,e.,nnf. L, la oir ec ,,i.nnn.i.--- &wwawpn~.-.
,t.a,a,~ilin.a.,
,~a.n.,e.w.+. ei . ~n esd lna.y,~f nc.a.
.on~x yaw.W.+ .
&# +4*.4(.vts-s ,.
ww:W,:vp/.wwwnerpe.++w.*l l .enc - +>:.y,.<.07.9 zw-.a&W~.~., - %4 STOE9OSe
.?'gvor/.f.w.%:.h.w:t4Ivehgf+>9ev ORNu. n M4<+wM,v,v4+
--u.&,e .,0aEr'
.~w,w.d F %./. RSBo t.nc.
- y.4M/#*V/*lSvet* $.O9...r__am?9X.Ce,na.
E?a aw- - -
~e.
The Comission [i@@Mi; vie = th excell:nce princip' : in the P0licy St:te ::t :: being in:Orpor:ted int 01' ::pect: Of th ::n:ge:cnt Of :n n__
e ,+-. .... _ _ _ ,
7..,._,_ . . . . m...
....,a
. .... . u.- 4._4.,..,_. +- ..
+u....,,,
4.
...u.
.. . ,. u. . u n. ..e. , -
Principle: Of C :d Regul:tien (independent, Open, Officient, c' :r, reli ble)
- re i-herent te c'1 Of HRC': pr gr :: :nd ::tivitic:. a.: cuch, these principles are not easily assessed in Agreement State program reviews by evaluation of a few specific review criteria, because of their subjective nature and their incorporation into all program activities. The Comission believes that failure to incorporate these ext:11:nce principles into an Agreement State program will be evidenced when programs or individual performance indicators are determined to be less than fully satisfactory as a result of program reviews, when the Agreement State program identifies areas for improvement as a result of its self-assessments or audits by State governmental organizations, or when the public (including licensees) calls for improved performance. For these reasons, the Comission continues to believe that specific Agreement State program review criteria to measure excellence l
I are not appropriate.
( 17 l
i The Commission agrees that the statement about inappropriate " pressure from the regulated community" should be revised. The intent of the statement was not to limit expression of views by any party, but rather to maintain objectivity and fairness in the Agreement State program even when any ,
organization representing a parochial interest is particularly vocal. The Policy Statement has been revised to reflect this change.
The Commission agrees with the comment that Agreement States should foster coherent regulation, but does not think a change to the Policy Statement is necessary. An overall objective of the Policy Statement, as reflected throughout, is to assure coherency in the collective efforts of the NRC and the Agreement States in the administration of regulatory programs. A specific statement to this effect need not be included. The new adequacy and compatibility policy will also address national coherency and consistency in -
the collective programs of NRC and Agreement State regulation.
l D.- C0HERENT NATIONAL PROGRAM l This category addresses the need to assure that disruption of the collective national program does not result from the radiation control programs of individual Agreement States. ,
Summary of Comments:
Five commenters addressed this issue; three were supportive of the Policy Statement addressing national coherency, one offered limited support, 4 18
l and one was not supportive. Those in support included an Agreement State, an asstciation and a member of the licensee community. Limited support was offered by an association. One Agreemen'. State was unsupportive. The limited support from the industry association was for coherency in basic radiation l protection standards alone. In their view, anything beyond this is contrary to law; movement of goods and services are economic matters beyond l
jurisdiction of the NRC. The Agreement State offering no support questioned the statutory mandate for a coherent national program.
The Agreement State in support indicated that a compatible national program should be established in those areas that affect the national l
l interest. The supportive member of the licensee community and association actually went beyond coherency and endorsed a uniform national approach to all l radiation safety matters and to regulation for the manufacture and supply of l.
radioactive materials. They indicated that variations in State regulation, licensing, and inspection practices increases business complexity and leads to increased costs to users of their products. They also suggested that there be i
one body within government that establishes standards for all radiation and i
another implement and enforce those regulations.
Response
i The Commission believes national coherency and compatibility as used in l Section 274 of the Atomic Energy Act are closely linked. An analysis of Section 274 of the Atomic Energy Act and its legislative history indicates i that one of Congress' concerns in the area of compatibility was the t
I
! 19 e
consistency of radiation standards throughout the country. There is no indication, however, that the term compatibility must be limited to radiation standards. Section 274d of the statute provides that the Commission shall l enter into agreements only if it finds "that the State program is in accordance with the requirements of Subsection o. and in all other respects compatible with the Commission's program for the regulation of such materials l
...(emphasis added)." Civer th:t the dr:fter: c' the legirl: tion 2ddre:::d i i
th n:rree 1:0:0 Of :::patibi'ity Of ":t:ndard " :t ::ver:1 pl:::: '- the
]
C ritt:0 repert: :nd #1 er deb:te:, it i: re : enable t conclude they j 4-tended :::: Other, bre:dcr :::n ng when they :ddrec::d corp:tibi'ity with i
""C': pre;r::
4-Secticn 274d. ;$EE6@@))]-T{he Commission believes it is reasonable to interpret " program" in Section 274d to cover a wide variety of elements within NRC's regulatory structure. Therefore, the Commission retains the concept of the need for national coherency of regulatory programs in the Policy Statement.
i l
The Commission does agree that it is reasonable to interpret the Atomic j l
Energy Act as (gui@3dj4=tting the need for national coherency to activities related to regulation of radiation safety. The Commission believes, however, that the need for coherency of regulation affecting the movement of goods and services is reasonably called for by the above interpretatior, of the 274d requirement to have Agreement State programs compatible with NRC's program in all other respects. This issue will be addressed in the NRC new adequacy and compatibility Policy Statement.
20
4 The Commission believes that it has a national leadership role in the
~
regulation of AEA materials across the country. In the adequacy and compatibility Policy Statement [(REQ 60][FR]}94Q3{, the Commission has indicated its intention to require States to promulgate and maintain identical regulatory requirements for limited areas of materials regulation under the I
Commission's compatibility review. As discussed in the compatibility response bil3G, these areas will generally be limited to radiation protection standards such as dose limits, release limits and associated definitions, whose uniformity are important in assuring that there are no harmful or disruptive duplications, conflicts, or gaps in regulation from State to State.
l The Commission believes that its leadership role in these limited areas
'is essential to ensuring that there is an orderly national regulatory pattern which provides a clear, common framework for the regulation of AEA materials.
At the same time, the Commission believes that the nature of its leadership role will allow States, in most cases, to implement their own regulatory program in response to local conditions and needs. The Commission further believes that the language and legislative history of Section 274 of the AEA provides ample support for the NRC's leadership role as set out in the Policy Statement. In fact, one of the six stated purposes of Section 274 is "to promote an orderly regulatory pattern between the Commission and State governments with respect to nuclear development and use and regulation of byproduct source and special nuclear materials." (Section 274a(3).) This i stated purpose expresses a clear concern on the part of Congress for the )
maintenance of a coherent national regulatory pattern. l 21
1 l l
The Comission is not aware of any legislation which currently l authorizes the establishment of a single body within government to establish l l standards for all regulation and one body to implement and enforce those l
l regulations, other than the Environmental Protection Agency's responsibility to establish generally applicable environmental standards.
1 On the issue of the economic impacts of regulations, once adequate health and safety is assured, the Comission Eifj[must-consider {@35]i{sljj j$3jQHy@j{$6ffHjjf6]@hM7f=h:thertheburden: it pl:::: en the regel:ted : ru':ity re rc:: enable. This includes considering the need to l
minimize regulatory burdens and utilize a cost beneficial approach to regulation, where possible.
l E. COMPATIBILITY l
l This category addresses the responsibility of NRC and Agreement States to cooperate in the administration of respective radiation control programs that are coordinated and compatible.
Summary of Comments:
I Eight comenters offered coments on the section titled " Compatible in Areas of National Interest;" three associations, two States, one public interest group, one member of the licensee comunity and one private citizen.
i Four comenters, two States, one association, and a public interest group, comented on the issue of uniformity. One of these comenters noted that l
22
there was no need for a common regulatory philosophy but noted that common definitions and standards should be required for certain basic units and limits. A second of these commenters noted that uniformity should be required for basic radiation protection standards stating that the movement of goods and services are economic matters beyond the jurisdiction of the NRC. The ,
third agreed that consistency in basic radiation protection standards, such as dose limits and release limits, was needed. The commenter suggested that the logical first step should be to achieve consistency among Federal agencies and the Agreement States regarding the basic dose limits. Finally, the fourth commenter supported compatibility in areas such as units of measure and transportation.
Four commenters, a member of the public, a public interest group, an association and a member of the licensee community, commented on the issue of allowing States to establish more stringent requirements. One indicated that the regulations of Agreement States must be no less than Federal regulations in all aspects.
l 1
Two commenters indicated that States should not be allowed to set more stringent requirements. One of these commenters stated that more stringent dose limits for particular classes of licensees should not be established by Agreement States. One commenter indicated that States should not be allowed to set less restrictive requirements. One commenter also offered a number of comments relating to the practice of medicine and noted there was a general lack of understanding of the role of the accreditation agencies, and cited examples. An association commented about impact on the practice of medicine i
23
T
- due to differing requirements between NRC and the Agreement States. The i
- commenter noted that States implementing changes incompatible with NRC requirements in Part 35 interfere with interstate transfer of qualified physicians, restrict availability of qualified physicians which involves restraint of trade issues, increases health care costs without corresponding i
) benefit and compromises safety of patients. Specific cases in Texas, Georgia, i
- j. Nebraska'and other Agreement States were cited. These coments, since they pertain to the practice of medicine, were not addressed as they deal with an i area outside of the Policy Statement.
4
- l
! One association comented that the Policy Statement involves Federal interference with State regulation of the practice of medicine and pharmacy j and should be revised to recognize State decisions.
1~
i
- Response:
I
) With respect to comments filed on the uniformity aspect of j compatibility, the Comission agrees there is need for uniformity in a limited j number of areas. As suggested by several of the comenters, the areas that l should be considered for uniformity between NRC and Agreement State regulatory
[ programs should include definitions and terminology for certain basic units and limits and basic radiation protection standards, such as dose limits and release limits.
With respect to coments on the issue of allowing States to establish more stringent requirements, there.was no clear discernable position or 24
rationale set out in the comments which would provide 2 uasis for establishment of a position different #85]ean that set out in the draft policy. The Comission agrees with the coment that, in some cases, Agreement States should not be allowed to establish less restrictive requirements. The Commission also does not believe it is necessary to require that regulations of Agreement States must be no less stringent than Federal regulations in all respects. States need flexibility in many areas to reflect individual State agency and State legislative preferences on how their programs should be administered. As noted above, there was agreement that uniformity should be achieved in certain, although limited areas of NRC and State regulation. The Comission agrees with the coment that States should not be required to adopt regulations where the State has no licensees that would be subject to the regulation and the NRC has recently implemented this approach in reviews of Agreement State regulations.
F. FLEXIBILITY This category covers coments made in regard to the Flexibility section of the Policy Statement, as well as coments made regarding the concept of allowing Agreement States greater latitude in establishing their requirements.
Sumary of Coments:
Five comenters addressed the issue of flexibility, all of them focusing on whether an Agreement State should have the right to set more stringent requirements than those of the NRC. The two comenters that supported 25
.i h
i l allowing the Agreement States to set more stringent requirements to account for State, county, or local conditions were a public interest group, and an
! Agreement State. The three comenters who opposed allowing an Agreement State f to set more stringent requirements than those of the NRC were two members of the . licensee comunity and an association.
l
Response
The Comission believes that the " Flexibility" section in the Policy j Statement strikes the right balance between maintaining the radiation j standards that are needed for a coherent national program and allowing l Agreement States flexibility to set requirements under certain conditions. It is stated in the section that "...the exercise of such flexibility should not bar or preclude, or effectively preclude, a practice authorized by the Atomic ,
l Energy Act, and in the national interest."
i G. PERFORMANCE EVALUATION This category covers coments provided on the Performance Evaluation section of the Policy Statement. The public coments concerned the review process, program consistency among the NRC and Agreement States, who should do the reviews, and the categorization of findings. Coments were received from four Agreement States, one public interest group, one association, one member of the licensee comunity, and one private citizen. The comenters generally agreed that performance evaluations were necessary, but offered suggestions for improvements.
26
1 1
Summary of Comments:
Both Agreement States and members of the licensee community agreed that a strong performance evaluation scheme is necessary and that consistency among NRC and the Agreement State radiation control programs is necessary to assure their effectiveness. However, one association believed that the criteria in the Policy Statement is vague and unworkable. Specifically, terms such as "sianificantiv deficient," " substantial period of time," "sianificant items of compatibility," and "several of the required compatibility items" are too vague. Many commenters offered suggestions regarding the findings of the reviews. Three suggested that the term marginally satisfactory was not 1
appropriate and that "needs improvement" or "needs significant improvement" be used instead. One commenter suggested that if an Agreement State program has any deficiencies, the program should be eliminated.
One Agreement State suggested that the Governor of the Agreement State, having the responsibility for public health and safety, should designate how the program review should be conducted. Options offered were (1) an internal l
State management review team, (2) a third party such as the Conference of l
Radiation Control Program Directors, Inc., or (3) the NRC. Ohjj{siiiijfjj jjj$j{i@ltNitijfitjQj!jfjiji[i$RgpMfMfMj}${jj@[{hy@ljisygjDjiD2 XE1335HE!HMitMKfMMFIEfilhE!MfiEEliis15{gDJggggIjf IIEEEliKM!!ifffylthfithgigggijgggfi1Mg@gthyrTo~GigjhalMM ElsiiMMiE4EMBE63IMMl!#Mih!IE!
27
Response
On: :: r :nter :rgge:ted th:t det:il: Of the NRC pr:gr:: ev:lt: tion U
zh::1d :p::tf10:11y ineled: Ov:le:tten Of the effi ::y Of the Agr:0 Ont St:t in:p::ti:n Of licen::::, i.e. verify th:t the in:pection: Or: uni fe:-ly th:r: ;h :nd =cet th: :::: :t:nd:rd: :: th :: conducted by the NRC. @j)]
ME91EfMtIEEWI!_fDiffiIEff#FiiEfiMBRETPERERFihe Commission does not believe that these details are appropriate for this Policy
- Statement. These issues are addressed separately in the SECY-94-011,
" Management Directive On use of Common Performance Indicators in Review of the !
l Agreement State and Regional Materials Programs." j i
)
3 With regard to the use of the " marginally adequate" finding, the l Comission agrees that this category was not sufficiently descriptive. The l Commission is proposing to use the terminology " adequate, but needs l improvement" to characterize a program where deficiencies exist, but where i
such deficiencies are not significant enough to affect the State's ability to
! protect public health and safety. l a i i
I With regard to the comments on the use of vague terms such as "significantly," " substantial," "several," etc., the NRC has used such qualifying terms to allow for professional judgement in the evaluation of complex technical issues. The Commission continues to believe that the NRC l must have latitude to apply professional judgement in the application of its technical criteria.
l l
28
With regard to the comments concerning other parties performing Agreement State program reviews, the comenter indicated that "There is nothing in the Atomic Energy Act that requires the NRC to be directly responsible to review State programs." This statement is not true. Section 274j specifically states in part that, "The Comission shall periodically review such agreements and actions taken by the States under the agreements to insure compliance with the provi~sions of this section." The Comission believes that the NRC does not have the option of delegating the ultimate decision making responsibility to the States. However, it may be possible to consider in the future the involvement of third parties in the review process.
HiZjiPROCEDURESFORSUSPENSION& TERMINATION I
This category covers coments provided on the procedures used by NRC in the reporting of review findings and the conduct of any hearings that may result.
,Sumary of Coments:
One Agreement State stated that prior to an emergency suspension of an agreement, the Governor should be notified and provided an opportunity for an expedited hearing. The comenter also expressed strong objection to the procedures as being inappropriate for co-regulators. Agreement State comenters suggested that the procedures should address the situation where termination is requested by an Agreement State or any other party. One Agreement State believed that probation should lead to suspension or 29
termination only when the Agreement State program is so inadequate as to have potential for significant impacts on public health and safety. They also suggested that during suspension, the NRC should be encouraged to contract i
with the Agreement State to provide for[i@ orderly transfer of files and3M
((@j::ntr::toutlicensingactivities{tcth ::: pended fgrc= nt St:t
- progr=.
With regard to hearings, two commenters stated that it was inappropriate for an Agreement State to be represented on the hearing board. One suggested 1
that hearings be conducted by the Atomic Safety and Licensing Board Panel (ASLBP). One commenter questioned when a Special Board would conduct a
. hearing as opposed to the Commission itself. One public interest group i opposed non-compatibility as a reason for suspension. Another believed that
! hearings should be conducted at the time a State applies for Agreement State status.
l One member of the licensee community agreed that a mandatory phased l implementation of a State's regulatory authority should be advantageous to i both the NRC and the Agreement State.
I
Response
The Commission [M)))QfMhgG6fiM6Hjly@^sisWsdj[6fysitMj28))}Gy does not believe that hearings are appropriate prior to emergency suspensions.
Such action would only be taken in emergency situations where immediate action .
is necessary to protect public health and safety. In these cases, delay for a 30
i f
hearing would not be warranted. Section 274 is clear that the NRC has'this authority. With regard to an Agreement State request for termination, it is clear that as in the past, NRC will respond to such requests, and the Commission feels that there is no need for specific criteria to address this situation.
- After evaluating the coments, .the Comission continues to believe that 4
l a Special Board, as contemplated in the proposed Policy Statement, is the most appropriate vehicle for conducting the hearing on the suspension or termination of an Agreement State program. The Comission supports the use of a Special Board to conduct suspension or termination hearings, although it'is cognizant that there may be at least an appearance of partiality from inclusion of an OAS member on the Special Board. In this regard, the Commission believes that it is in the interest of the overall Agreement State program, represented by the OAS member, to maintain the highest program f standards. Moreover, the perspectives the OAS member would bring to the ;
, Special Board are valuable and could be necessary for an informed decision on t suspension or termination.
Not only does the composition of the Special Board specifically provide Agreement State perspective and experience, but it also recognizes the special status of Agreement States in the regulatory framework.
The Comission could terminate an agreement on the basis of non-compatibility alone. With regard to a hearing when a State applies for i
Agreement. State status, Section 274 does not require such a hearing and given 31 1
I
. . . - .= - - - _ . - --- --- --.-. _.- - - . - . . - - _ -
the opportunity that already exists for public input into the criteria for qualifying as an Agreement State, there does not appear to be compelling reason for a hearing at this stage. The C:- S:Sn :g:::: Rig [ijiR@!!! the comment that probation should lead to suspension or termination only when the i
Agreement State program has the potential for significant impacts on public health and safety or is found to be inadequater-9))hjel(M@MI@{d3]iy EEdMEM5[$5fNdMI51EE[EUE$$iENdfAI0fdIEEIIIII0053 ,
NNN5$
In response to the comment regarding a request from a member of the public to suspend or terminate an Agreement State program, the Commission will carefully evaluate the merits of such requests. No specific procedural mechanism need be used for these requests. A letter providing a rationale for the requests will suffice. This reflects a change of past practice where in one instance the Commission specified the use of the petition process in 10 CFR 2.206 as the appropriate procedural vehicle for requesting suspension or termination of an Agreement State program. However, since that time, the Commission has completed an extensive evaluation of the 2.206 process, and believes that the 2.206 petition process should be confined to requests for actions against licensees, and not Agreement States.
With regard to contracting with a suspended Agreement State program to operate the program during the suspension, the Commission does not believe that this comment has merit. In circumstances where the Commission feels it is necessary to suspend an agreement, to allow the same program to operate under contract would not be in the interest of public health and safety.
32
MfjjlSSUECATEGORY: CLARITY This category covers public comments requesting explanations, definitions or contextual refinement. The category cuts across all sections of the Po.licy Statement.
Summary of Comments:
Some of the commenters asked for definitions of terms such as "significant decisions," " provision of services," " substantial period of time," and " national interest." There was also a request to detail when the Commission would conduct hearings in lieu of using the Special Board. In addition, there were a number of comments requesting contextual clarification, er additional information, e.g., the request for clarification of why the internal procedures were made part of the Policy Statement.
Response:
- In most instances where the Commission was asked to define a term, examples which would clarify the term in question have been included in the Policy Statement. For example, the sentence "Significant decisions should be documented with the rationale for such decision explained" which appears in the Regulatory Program Excellence section of the Policy Statement, has been modified to read, "Significant decisions, for example, a change in enforcement policy, should be documented with the rationale for such decisions explained."
Regarding detailing when the Commission would conduct a hearing in lieu of the 33
Special Board, this is a Commission decision made at its discretion on a case-by-case basis. All comments of a clarifying nature, not involving issues of substance, have been accommodated.
III. Discussion As stated in the Statement of Principles and Policy for the Agreement l State Program, the Commission recognizes that the NRC-Agreement State program is dynamic. The Policy addresses the general framework and principles of the l
Agreement State program as opposed to any specific substantive area of '
regulation. The NRC and Agreement States will continue to jointly assess the overall national program to identify specific changes which should be considered based on experience or to further improve overall performance and effectiveness of the national program. Further: crc, the Cc :i::icn will cycluct: the effectivenc:: cf thi: Pclicy Stcte:cnt et the ti 0 cf the c::::::ent Of the new f,dequccy cnd Cc:pctibility Pclicy Stctement.
1 IV. The Commission Policy l STATEMENT OF PRINCIPLES AND POLICY FOR THE AGREEMENT STATE PROGRAM A. PURPOSE The purpose of this Statement of Principles and Policy for the Agreement State Program is to clearly describe the respective roles and responsibilities of the U.S. Nuclear Regulatory Commission (NRC) and States in the 34
4 administration of programs carried out under Section 274 of the Atomic Energy l.
Act of 1954, as amended. Section 274 provides broad authority for the NRC to 4
establish Federal and State cooperation in the administration of regulatory I programs for the protection of public health and safety in the industrial, medical, and research uses of nuclear materials.
This Policy Statement addresses the Federal-State interaction under the l
Atomic Energy Act to: (1) establish and maintain agreements with States under
- Section 274(b) to provide for discontinuance by the NRC, and the assumption by j the State, of responsibility for administration of a regulatory program for
- the use of byproduct, source, and small quantities of special nuclear material; and (2) ensure that post-agreement interactions among the NRC and Agreement State radiation control programs are coordinated and compatible and 4
that Agreement State programs continue to provide adequate protection of the
) public health and safety.
This Policy Statement establishes principles, objectives, and goals that the Commission expects will be reflected in the implementing guidance and programs of the NRC and Agreement States to meet their respective program responsibilities and which should be achieved in the administration of these programs.
This Policy Statement is intended solely as guidance for the Commission j and the Agreement States in the implementation of the Agreement State program.
This Policy Statement does not itself impose legally binding requirements on the Agreement States. In addition, nothing in this Policy Statement expands 35
l the legal authority of Agreement States beyond that already granted to them by Section 274 of the AEA and other relevant legal authority. Implementation procedures adopted pursuant to this Policy Statement shall be consistent with the legal authorities of the Commission and the Agreement States.
B. STATEMENT OF LEGISLATIVE INTENT The Atomic Energy Act of 1954 did not specify a role for the States in regulating the use of nuclear materials. Many States were concerned as to what their responsibilities in this area might be and expressed interest in seeing that the boundaries of Federal and State authority were clearly defined. This need for clarification was particularly important in view of the fact that although the Federal government retained sole responsibility for protecting the public health and safety from the radiation hazards of byproduct, source, and special nuclear material, the responsibility for protecting the public from the radiation hazards of other sources such as x-ray machines and radium had for many years been borne by the States.
Consequently, in 1959 Congress enacted Section 274 of the Atomic Energy Act to establish a statutory framework under which States could assume certain regulatory jurisdiction over byproduct, source, and special nuclear material l in quantities less than a critical mass. The primary purpose of the legislation was to authorize the Commission to discontinue te the St:te: its regulatory authority over the use of these materials yhBM[is]nisijit]@]@
l @ lim M R H jjpj3 @l @ B ij. The Commission retained regulatory authority over the licensing of certain faciliti~es and activities such as nuclear
( 36
reactors, larger quantities of special nuclear material, and the export and import of nuclear materials. .
In considering the legislation, Congress recognized that the Federal government would need to assist the States to ensure that they developed the capability to exercise their regulatory authority in a competent and effective manner. Accordingly, the legislation authorized the Commission to provide training and other services to State officials and employees. However, in rendering this assistance, the Congress did not intend that the Commission would provide any grants to a State for the administration of a State regulatory program. This was fully consistent with the objectives of Section 274 to qualify States to assume independent regulatory authority over certain defined areas of regulatory jurisdiction and to permit the Commission to discontinue its regulatory responsibilities in those areas.
In order to discontinue its authority to a particular State, the Commission must find that the program is compatible with the Commission's program for the regulation of radioactive materials and that the State program -
is adequate to protect the public health and safety. In addition, the Commission has an obligation, pursuant to Section 274(j) of the Act, to review existing Agreement State programs to ensure continued adequacy and compatibility. Section 274(j) of the Act provides that the NRC may terminate or suspend all or part of its agreement with a State if- the Commission finds that such termination is necessary to protect the public health and safety or i
j the State has not comnlied with the provisions of Section 274(j). In these l
l cases, the Commission must offer the State reasonable notice and opportunity
! 37
for a hearing. In addition, the Commission may temporarily suspend all or part of an agreement in the case of an emergency situation.
C. PRINCIPLES OF PROGRAM IMPLEMENTATION C.1. . _ , . . +--". n- ...-.
, . . . . .. . - r'.'..._- woo~d~aR" eau'latimPrinciples onw l
l
- n. .._. r. . . u. .. . u. r . . .u. .c. .__,u.._.....,u....a
. . . . . . . . . _ u. . . +. u. . ._..u.......u._.
L J. o_,1 L a.
.L.. 41. . . . , . . 4.. ... u. k. 4. ,.. L. .
A.m.._---a..
. ~ . . . .es. +n.. . .a M
.~ . D. ~P .. a. ,-., 1.
.,+.a. . o, ..a-....,.
. L . . . u. .
... . u.- c..__._...u..+..>..a.
. . . . . ., ._..u. . .._.~_
, . .u.a _. u. n. r,.
.a..u_.A._.___.~_... . ... e..,u...
. L. .. _ . u. .
t
. . < . . .......c..._v..._..
- u. . . n. . _. ,.> u...u. ..
.,+ u...
. . . . .. . . c. +u..s..
.. . . _ .....,..........a. . . . u. a. . . a.. . 1
__,,__....-,,.._.-..m,,,.u... ....... . . ....a..u..,
a
__u.~_. __..... .. .__.,_ ,. l
+La ,+
.. . n. c. A.+. .a. .4.. ., .E.
+ . a.
4 ..~ .
-.1.
.. . +4.m.. . n .n,. . .A~. , +r f A P.A.,) .m... . n .. . 4. .,1. . . k. ... . a.. k.
. . a. . . .
+ka
+ . ~ 1.. .1. 4 4. _a A 1
4 C+,+ , +L. C+,+n.
- ..... . o..m 4.L.
. . ..~ .. u n_P .a + L. a A.m.
.~ . . . . _. n . a ~ a . .. + . ..... . L.
. .a .. . l. .a. _ e n.. +. 4.. . .... . . 1 1. ..,, 4...., )
i
- n. .. . . u. .. . . , .,+. ... ,..,.......,.,,,.,..c.c.,..+<......,
, . .. . . . ~ . . , .. . a . c. c. u. . . u. . ._, u~
a.
. . a. . ~ <. .
1
.. . .a...,u. .+<... __, . . ..u.....
I
...-+2....
. . . , _ . .. _. .... .~. . e. _ ,.u...
. u. . . . ,..a. u. . +. u. ... ..c.+.,.
r..,.....
.... .,. ,. . u. . s. u. .. .. .. .. u. . . . u. u. . ~. . , . . _a ....<..u...
. . . . , u.. . . . . . . . . . . . . .
. c. a. . . .-a..,..,..,.c.
uk,d.e. . L. .a T. +a
. ..a. ,.+ k. . . . . , c. .a s. o, ,,
,... . . . . ..a ._A m ., .. . ..h. .t. a u. ,m. .a. v,
. _e m 1 1. .a .. ._e n , + . L. ~a L. 4. , L. .. a . 4
.+..a.
.>. .c. ...u.u.._......+,u..u..+..,.,
-+u....,,.
..a..+
_ . ~ . . , . . a _r .c.,.. .. u. . . , , u. .
.~ . . . . .
.u... u. u_
. . , u. . a.
. , .r. . u. . u. . . .u.. . . u. ..., , .~ .
a ....,u..,+.u..,,
.. . . . . , . . .c..-....-..-. . _
f ww w.- ,;.e.,
.m w.%
I.%dn 9.wwmgt~.h.+v
- w;w;s 91.s,uwv
.k e o u+ C.w oewwm.a.wv a..ww +l.%+w.i<o,n s na+d.e.:
w nc pl<e t -ys d- y.,Pr.r:.ss..<.ww 4sw.wv. sso
..~%.wowMxv.
f;ed..~iood.
ww-u op..w,e 7R.-o-r egul t a:*^sx+iwwu.i.
.w .v.m.~.x wt-a4..ion a.og/to%wo##vm
. . m<.wu.w;ww.4;$.kb- v. iserve
.whm.*wue-w gw s
as per.gsfx.p*uiyde+a;wtw~;.::6wa>
w.w& VACC ,
r ot g w..%eebeund%.ww.wuM;h.ge.wAw.
th.y-w.mw ta s-wncyt wm.wd*ec
.-W.sv w.w.w---s i.m,io e.+pga.w.k*ix.xw.:~o:.wd on!!ma ng. ia.w.w
- " - - wwaw.w. M n wd <a. n v od.+.*d. tuwi.d.:
vMwh.ww4mw.*MXK+6w ua bgwh*a>.w.i.
c7*.bg e +w.sw..gmqJR ordas v.wwXhume..v.NwAWW9n%wkhww.C,.4 pp W-: A-
.s*
er nces oit ' hmv:mw.qphves ex i- -
+:.nwe:l$4HoM(wx-W.~oyees i 9:E%Ae+. .+:vtp.gytNN):o w A+clh: l mehe .-asw~ e rt rensuregth*a%stN:N e -x, s
~ - -- e.-----n.w._eserE.riw.w.vi%M a su--- nc P +n-n esshen: s h+e)lvv*vdW +o.e A9%+:r.ex%m~. .~.w-~~~a-n-u.~u
~
P %
pycxvwwl-o#tMm.wnw.+Mw.-
regu._a orym_actiwcit^t.i:pM:
. 6 -
r -
-v_e_s1_h-ame.+we a_mvet++ evu.p9vfp e_t
_h_een~so a <h_+Awe_t h'<i*mo ho.Kw.t -
w panxq.ml. -
- t. .ww.gt.;Mey.e.v ;o:d*kyiswtegv,r,gp+g4
~~m. m .
u . ...
cons i sten.tphTh_e.3nPri n+cimlem.,mh2 p _esko - _ _ _.- G*ood7 e
R_9_ul..mt_i a on
_ - cy.,_.~
- arecogn - -
i_ ze.t_h~at_.e,_tro_ng i t _s t*
_ _ _ _ _ _.-.mmm _ _ m 38 I
I I
P W
1 I
$3i O N E N N iE05I N 3 i$$ N 1[ $ ! M 3.@ @ @ @ [j @ M @ l @ { p H M M jjitj fjf @ l n
ggpe!!E @j@QI@gM.orsM.- 3M n(.[Q - - l{id]H(n])I$cg,ge; [._
ejIegu] isslog.
omm EstisiiiIMItimiliWTiaistitT5E31fBHifiHMEHiiWiisiMHitEEMM 4 t_is.i.i.3@.f,
- s. iE55t?$._tiIII?i._sa,m.m._hiY.
m A it .
Feint.i_fsBN._i_i.a_usiff.iWE._T.Emm M x.m_hi?c~6_Eii_fsi_fi_i m _
w . . s v .
- e. ,
l E_si f._GFi7thit_INitCYI_E..RH_S3?X.17EENE
-(?$fi_l_is.i,_sh.iF_i_?i_s_!E5W.,e'~gu_l.i._ti_f.s_51 A_EEsiFa_li@,. l.yL?%._HiEtiisisif
- w----- 6K,I,I_6E6G. - Fiji.s?s. i_nh_?K,gf_isi._sWil$.~tifi. HB?id_5.hf.
- ._ -m---!EifEiliE
- MTisffEIEh131116EEDF1811EiBaliMiiBYMI
! Regulatory decisions and actions should be developed and implemented in en open and publicly Credible manner and should be able to withstand scrutiny.
- l. Such scrutiny should be welcomed by the regulator. The regulator should be, 4
and appear to be, independent and impartial in its actions. Regulations and
- regulatory decisions should be based on assessments of the best available information from affected and interested individuals and organizations, as i well as on the best available knowledge from research and operational 4
experience. Significant decisions, for example, a change in enforcement policy, should be documented with the rationale for such decisions explained.
The public should have an opportunity for early involvement in significant l regulatory program decisions. Where several effective alternatives are available, the alternative that best assures safety while considering i '
differing views should be adopted, considering the resources needed to
- implement that alternative. Regulations should be necessary, and appropriate, i to assure safety, and should be clear, coherent, logical, and practical.
s Regulatory actions should be fully consistent with regulations and good public 4
{ 39 I
4 1
d I
-y v--. --_-- - _ .
I i
l
- policy and should lead to stability and predictability in the planning and i 4
implementation of radiation control programs.
4 Failure to adhere to these principles of[5f@lij{0Rigg:xcell:::: in l 1
the conduct of operations should be a sufficient reason for a regulatory program to self-initiate program changes that will result in needed improvements. All involved should welcome expressions of concern that indicate a program may not be operating in accordance with these principles of ex::ll:::: and revise their program to more completely reflect these 1
principles. l I
l It is not intended that these principles of j@Hi@ifHQ xt:11::::
be established as formal criteria against which NRC and Agreement State programs would be assessed. Rather, the expectation is that these principles will be incorporated into the day-to-day operational fabric of NRC and Agreement State materials programs. These principles should be used in the formulation of policies and programs, implementation of those policies and programs, and assessments of program effectiveness. Application of these principles will ensure that complacency will be minimized, that adequate levels of protection of public health and safety are being provided, and that government employees tasked with the responsibility for these Federal and State regulatory programs serve the public in an effective, efficient, and responsive manner. These principles are primarily for the use of materials program managers and staff in the self assessment of their programs and to use in the establishment of goals and objectives for the continual improvement of their. respective programs. Deficiencies identified during the conduct of NRC 40
l N l l
Region and Agreement State formal program performance reviews may indicate that the program is not adhering to these principles of jB@giii@~4M@
j ::: ll::::. The organization being assessed should factor the need for i
l ::: ll::::yM @ H fp@M{$1H into its actions to address identified l deficiencies.
i
, C.2. Coherent National Proaram l
i
- The mission of the NRC is to assure that the civilian uses of nuclear
, materials in the United States are carried out with adequate protection of public health and safety. NRC acknowledges its responsibility to ensure that there is a coherent national radiation control program for AEA materials and l NRC through this program establishes national radiation protection standards.
The basic elements of such a program include ability to ensure adequate protection of the public health and safety, compatibility in areas of national l
interest, sufficient flexibility to accommodate local needs and conditions, l ability to assess program performance on a consistent and systematic basis, l and ex: ll:::: @@]l@jff(@$0]lQjhjlin program administration.
i j Each of these elements is reflected and addressed in specific sections i '
of this Policy Statement.
1 C.3. Adeauate to Protect the Public Health and Safety i,
k NRC and Agreement State radiation control programs have the responsibility to ensure adequate protection of the public health and safety 4
2 41
]
2
_ _ _ _ ___.____ __.___ _ _ _ _ ___. _ _ _ _ _ _ ._ ~ _ _ . _
i f in the administration of their respective regulatory programs controlling the 1
- uses of AEA materials. Accordingly, NRC and Agreement State programs shall j possess the requisite supporting legislative authority, implementing l organization structure and procedures, and financial and human resources to 1 '
effectively administer a radiation control program that ensures adequate protection of the public health and safety.
! I 4
C.4. Compatible in Areas of National Interest !
I j i 1 NRC and Agreement State radiation control programs have the j responsibility to ensure that a consistent and compatible radiation control i
j program is administered. Such a radiation control program should be based on 1
l a common regulatory philosophy including the common use of definitions and standards. It should not only be effective, and cooperatively implemented by l NRC'and the Agreement States, but also should provide uniformity and consistency in program areas having national significance.
l
. Such areas include those affecting interstate commerce, movement of j goods and provision of services, and safety reviews for sealed source devices sold nationwide. Also necessary is the ability to communicate using a nationally accepted set of terms with common understanding, the ability to
- ensure an adequate level of protection of public health and safety that is consistent and stable across the nation, and the ability of NRC and each Agreement State to evaluate the effectiveness of the national radiation control program.
42
i C.S. Flexibility With the exception of national radiation protection standards, to the extent possible, Agreement State radiation control programs for AEA materials should be provided with flexibility in program implementation to accommodate individual State preferences, State legislative direction, and local needs and l
l conditions. However, the exercise of such flexibility should not bar or i preclude, or effectively preclude, a practice authorized by the Atomic Energy l Act, and in the national interest. That is, a State would have the flexibility to design its own program, including incorporating more stringent, or similar, requirements provided that the requirements for adequacy are still !
met, and the more stringent requirements do not preclude or effectively 1 l !
l preclude a practice within the national interest without an adequate public !
l l l health and safety or environmental basis related to radiation protection.
J D. NEW AGREEMENTS I
l D.1. Overall Process of Becomino an Aareement State Section 274 of the Atomic Energy Act requires that once a decision to seek Agreement State status is made by the State, the Governor of that State must certify to the NRC that the State desires to assume regulatory responsibility and has a program for the control of radiation hazards adequate to protect the public health and safety with respect to the materials within l the State covered by the proposed agreement. This certification will be provided in a letter to the NRC which includes a number of documents in 4
43 l
1 l
1 l
support of the certification. These documents include the State's enabling legislation, the radiation control regulations, a narrative description of the l State program's policies, practices and procedures, and a proposed agreement.
The NRC has published criteria describing the necessary content these j documents are required to cover. The NRC reviews the request and publishes notice of the proposed agreement in the Federal Register to provide an i i
opportunity for public comment. After consideration of public comments, if l l
the Commission determines that the State program is adequate and compatible, and approves the agreement, a formal agreement document is signed by the j i
Governor and the Chairman of the NRC. l D.2. Phased Implementation INS $I65DE83NkI2$$.fj@}{pgsj6@l@j$Mjjjjfid{sl?@g{@
g ,_ ,. y' , ~ ~ n T r'- - - n 7. 4%.r ,--
4 w.wse w v.www . .sws t
,,u , r - - Ari.w.
va . . . .
N@ij!!$1@E5]R[fflI@iE@jij!BJpMIg@g!#gC2Md[ajleRMhy MEBB631ERN3IMF1HRCfulpppyhi@gg@}jj[@jfjdyfi6@ij!)) _EN_ast_fr_ds_emEass_sa_rar_m_wa_s__s_a_rsri_t_ammsi.p_a_rsawanPtsird_aan_ff.> _ . - u_ m
.,.,__.___._.-_.-_._w__ __,_,v._,_________
sw; w g : - - r+ qv,9,mm.e.%o>p w y - 4 mop >. .+ny
.we, enyo' y. yn, ; p- / + .xqn>xwwmvwA6+pr.
. .s: ., qq.yn% , <. syn : ww -
xapunwyqq.n.4.g : a 1. 5 $kkkk~ , E kb$kk$~kb. * , - bkk$bbh.#:+ b .. . b bS $$ , $[i ems 3EisffEffEIElragys5pgmagig11agggg[aagasfeggjsg! KaEsiIEEiiBi6BNfE!!EWEBliEEtWBEMNWRs!DMitiiWIN ___ib. Ieppgns Ell _yLstgagge;cpapl_ f_____ egg]j.censesa __, 44
i k i w . , . . y,~ wwm,n n T.wm.v<._.,fo.wm he.wwm re vuwwwuk.hv&_uh re q+ 1tRCa p,+l anssas... axwum w+m.ye> v rwevr.p.,m.v.v.v.w 4.*.m.. .p : emen asee,h,r,n,,..nd.u:,ni -
.v.v wu. u.%w~a w.swmn w,.
._.l m,nt.c.
- s. .p.vwro.vu- mmuwM mawww.~
t,i,o,..,n,,s u ura,3a v-reements .reww.g.we.w, a w.w.mw.w.whaxce s s Aaf x/ .ssc e 93+
' A. siwi- eg:.vp:
.m _. _ 't rpas'taprac- ce w' h- gg.p.=.;.#,M-f/ egArMo,Nx4Pttiwh9.
u_NRC_l9$ivwvpi ___ _lu .b_m4,A ,kW.f.g.ypdy _ d_i,w, .msy.s _._a._e _ ___..._ a r a__i+n'4 _ang:i 4th-Mttth,,e4,.
. e ,v.au State ,t.i.e,fo /, .:., g.pw.+pW,;v/n/9.=.o,,ss._en._ res
.s +,,.e. . .
n.m .m w .w. - 4 u _ equ_at _esa_ i_co_mP_a
,i s.,q':ad_.-,,.n~-sy,n_d_g.nn.+.~wt_..i.b. l _ _s a_tro_f:.,th e.1wi_thmt_h u _.n.wn a et_ .aNR_C m_T_hmwAg_re~a-w.e... - er_ __em_en_tr.u.-. wi t_~s_e_.l _
f_mw ar ldtwo_u.- i w .w . , ,:.:.~ ~v w d,,,n,e. . ..f.
,,,yy,4 .g t.; my--
i,A.x.y -- -~.the
- - - -a -% ,e,tM,
- -e.,s,wgmyjf W.t....m aa .4ymgamw% ,3i. 4,..h c t t,w.h~e new3
, wag.w.wuawg gre,wm,y,enw
,g em ww r wm ,y.,A.mmm.,._.,~~t,y;%;w.a,t, ist* erwou.,lx.
w w,avy,%v,4w
,v assumerawe,u,, ~,,,,,mwt.h t.w.mm3w,y.w,hwu
.w,o.vym+.y,,
vuw writ
.v f w>w.- o_.+wc.<+4-- .
p: eawmcwo.+wk. OV_eMC._e.m._a_8.A_a_t8_9,Or r ws:rl' .ywr.ee 2C v;w+u+xv.i.e+uwwwf. eSio. 9xl ..i.cw ,.en;. e m.w_en.w S 9;./esswng _ee_st4_ ear Et e.~&
,im,ga:qu.9gy k ,hsm -4.i t a.u.w_o_n_i tizunxy,<.yd..m.t.+:re.q/,pf. wx+:-:pth.&%
- _ ~s + -
+3 m m m-m e _em_e_n ~ a_~e_S. ~~ mom 5 oE_.s e_
e s.e>:-.w. e. n .w. f reau atory s:.:5 # i asas.m u.w~,.w.w. 2 4l,wyth.w*ed;.y x .w a.;s *m sn.wi.. wm;:_u.s+mo.vw tia - .usl.m;g.7.yh.,m>n.y.vyc
.pswvme.d4%
as vt e t,wam .vu .h_..m,,,Sta.41 e e wi l l.wm,.s sexerc
,t.a.+gw#
- 4.w;vn-;ms+.me.v.wwwve.~ev.s a.ai.su.: u.>.af. u .*,:w'
+ww vs *l.bs+.-
- g. .-e.v .o,l*mw,.wv.%
# wwum.+-w. . ;
.vm;gvwn.a.>va:.gew..;. .w y -
#en.w we way w.w s ~x w^m, w,e.y oex au or we,<th.va:.mityAoveracate.w+wa,.w
_ . - _ ~ - ~ . - _ _ _
.:.-- y.wp,:ef. l..i.+sv.w+.eaw.vyay.w.-gor.i._esa - ..
e c._en_se_esto_fdpne n D . in
. m.~_ur.~.~gy.tuh.~wi% s_s_e.ns
-; c_om.. p.l_x.wn,i t. y,.e 5
0'9VNm//iMyP - a
. --% x0N, - M - -
A _-w est fi.lv/s.m9 - q# __3___4_____se e st'ah>Wg5t.W t*e Lerf._.vw'<tawM.l.k_$goN>w.hl 4wi.lbynx.wA ,aten,Ay.vN#-or._mza_ u _rd__w-regu. . or.y_tf_u(wx4>wt_.ei_.ww.W/g?f t_r_an.*fe,.nndya.. w.+4v..w ssm;; Now+ e,rrewmk&h.w.u.ww <.-ar-n,,,.eTh.-g.nnxa., lcenses m eireu"w nwvuwi3i4%w.v.www~.ma ,,.i..n.i~n~.,,y.*.www. vug - t .~, sc w.wa.v.+,.eg.sww.+
+-
or ssw ai, e.,._m.il .va aho s estrans lx.bny,+, f,e.+~.,rw.+rr ditw.wth,a weh.v..+:wmre --v.wwaa.e.w-hv-xh+ w oi -.e s.o ww vy w.we u n ...e <.w mw . - ex nrow o.w.-- 9 g,
. _ree_me_nt _ e tm $. -<t.w+g.,mdg:
a- eis - urisd. i.ytionattth*ep.-
-_,,._.._m_.3_.w-w~.v.__.s_,._w,__mw._os._+.s.
c i d,a t;e.w.fi r x nyhvg e i n it hw>woA.oa.x.w er g_re_em_e.n_t,:.xm_ w>www . .q? fo.v:yg.t
~ m he+ e.
r,s.,._- 7 Kv 4 e
- u. -
. wv.M:l ap .u.
at nso vop++metew. e.si,o*+y ofz.t' .h(9,c.p.wx.9.w,. mu
+~e,swen.ww.wmnnwn;wumna.w ersec v.69ww-,o. n .w.p.
d w+ h:.;c+.euv: w s.w.w_e qd.To:.v., wr.S, pi.og .q,x3 9 ;,g.th.y,gg>,; h-,,a,:.pm.s asn&%- vXwar;w.w.vm> cass sta i ev?.sn.+%.n.&4;, . w &.p,.m.s e.wenmu~.p. .. wn
+d,t i;.x.p.r v
i . y,,;.ly-mentat' m ux.e.wma.:w.n.wm+ xe,va+peon*
~ +&(
w-;. m -p . we w p w,pe mv.w.ny wmw.w.- .w-.v rw m .,-tcon m_o._u -w_w tgxe asomo NR_Cgww.o.l.~d..gv.w.94wd_uc.+mem+anwawwi._a.wev.c.uf.wm_6_w.+
- re.w+mv ewt_o it. es - +m ys.~ t -ate -maa ers e st p_ro_g_ e.mm.,.n_t.e:.c.+w ramg_r_a m.
- e. tewd_
v.u.-- .nds.m.,.gyt. h.md.s;.: Mi_liMil_iWi_Ef6Hi_iih_E.
-_- -w IEW1 -_----Gitishi PF65_fis?.~y_i'6~F,~th"a f - th a'sIditM._fli_idM,nYt_hs 9N .n. m-- - vne 9n - mu . . w Ag,,Ne:6.v,x wv au m <+-m e%uaahww- r .ex9.
+AM.hre,e.waentg mp,. mu em l.w-hwa.a.wt.w,t fo+wm>dQ en.m.,.w+
-mv a ,.~v+s on ci.o.,-- eesecondtc vmw.w,w.vfn.r+thwg+.w
%.ww - w y.w ~ . Am asel va,w w o+ +e..pw ensures u am e . - fw m h.3 +sm go.t - wt State..,
o.;.g.v. w+mn e.w.v e,q.w,un uw .u.,p.a - .u.s
;*,.vy.yt.*he. .+
am Msst
/wsn) g rogr.w.wx
% e.. .s
,.+m conm,t7,i nuesi w ma ytumm6m..,:.#wde-.++.
o1 eca oua teEto;nro aw~~.~t:., ec tw.m., 30u p
.b..H.. *s.w. w.*m.,s.s.s.,,y-u.eswl <a+.. tor e.wmowei! regu.w; 4,.w;u-:y4;'..p,.ro. ""I es'r.sw.se b;<ca am M Th
- 4. .m+n.w.vwv~.w.w.wwwah uw.w w.+.vu. ~s.w4:hw.sul.w,. w_w.w w. .s .we.-~*w...v u . %
mwk u n i. d..v.wa . . _ ...k.. ww . .- f. w_, , ,. a y.k. , ._. w A
- .... y ,s a. w .~_. . +. ., +. 4 mw.m, .m__
y.w.w ., .Awi. . = s. 4 m. n,ni..wn . e+,t, w.. 4.. m. m. . n. . mg= .ce..-
---.nw. _ - . k a m 4. +.g
=.
.nvi u
n
- .,. wi am .e...-., n sw a m. , i w,, ww y.wn ,4e @Jw,, mw w =. uwwu n
. s
_ ai iw M D f' == Anm aa-am4 nu4Aa ==
=Ju.sm. 4..=naan.e y w-w e.. n ka ww 4. L n onw .==..Aw -n rig w w urw n e+%+a.
w.m.w T. +. nw- oni s1. A w yn u. v. www 4.irok a AfemD esvT f' u ea ake%4 - a- an=== .m
- 1. A a--a=,4.
wyyw . . w.mu4s 6.g ww ww.m n 4. ny- wu
. a =.wn+ = m e. 4.. m. fv a m. un * + 4s awim. vii e..k.w a C w.w+ % &. w a f,e yn u. vy um w A =, 4 a = e4 4a. +ka uv== 1 4. w == = w.=+.afe. w e % n .swk f.1 4. +. t3%a ,e wy La fvi ww ama w 4. w. i.m.m .
niam
- 4. ym. nwww.
= -%
- inugws ma=+
ywi 4 a n.
.swi a f.
v wow amA un nv e el. wAnw k% = i.n a nma%+am. m 7 e.an== w y . .m . .A.4 e. k. . a on- a f. e. no w k n 4... 4 6 4. .= 1 n y k. . =s ,w3e n + . L. w na M D.f' w go ww.w ka%1+k en vvn. wwwnv. f4Aam-a 4.... ekn nw c e. w .s + .wa # , , s b 41, 4i +.ju +a wwi .w n e. v.ww y a+a#4 +ka
.nw y k14, n.>
w sw .w i .n
.i n wi.A w e
. .s. f.wa t.y u
.==..A -
ea =A-4 4, u +ka mman =- +ka C+%+n enne+ w --- m.e6.===6 n 4ualg - . m.
=iww ow . s n ywa .isw y . w y . wm . re.e...
. w. .irw wou.w nam.w y w w . 4. i ew n , 4 +. e k.
yw w a wwiwns1A A e. m a a - a m. +. ww C +w s t a ,e om s 4a t, nii4 e+,m+ .in .4+k nmau2.Aa yv v1 ww m. v wnau eign wwmw -. ammam.+ wyyw , i n 4. +.g,
.wii w .nw_ a m.n vu wwwi . y m yea ww a kl. am wm, e r .ru mman=== 4aw 4a u mama en-nlaw
+onwL a 4. .. ye wys =m m y m.ivi w k % u,ii4yn n m.aename4k4144.g i s w,yvnssw f. we am si w e w wwmyswn l. 4wwwneww ennene.
45
1 T. .L..a m..a r. .a.. ,m.a .,. . m u. m. .. +. L. . .a a t. t. a , + 4. u. a.
... A..,+.a.
. ,a, t. t. . 1 1 ,.m.a.a...~a.m.+., L.i n.e. ,m.1.
a
,.b...s e. .n d 4. -nr 1. . .-=- =. . +. .= +. J...a m.r u m.a...a n e. .e. . T.. m. 4. k... .m 4. m. 4. +. 4. .mr mi. L. . .= e_n , + ..L..a e.. +. .% .. + a o l. i. l. =.c. e . . ~.. a ,
i
- t. .u. l. i. m..an,..1. +..a.. ,. u, .. . .+ L.. ..a w 4. .+. u,.a. .u. a m. ., + a.n a. m.t. a ..e. .a. t. 1 4. ,. .a m.
. .e.
. a .n om ,
a t. i. n. e. _e n . r.a . . . . . e
. n-a l. a .n. 4. +. u, f%. =. 4.m.,, a k. .s. .e.
+. k. . t. .e.r. . n , 4 .L. a C +. i e. .n u. t. i. l. nam.f.
...r .
- r. a.. m. . m. . %.1 1 m..a n. .1. .%..+ a. m. .u,
- f. .. .. .m. a. .+, 4. a. m. fea, m, s. k. .a s. m..a. m. . e f. .a . m.m.a 1A.4. e. .a
. m.. e. .n .e, .
. . .A.+. + ..L.. a.. .a n. A. .a. t. 4. L. 4. . e.cm L. . . .= e. .n ,..+ L. .a ... L.f D.r
- u. ,. ,. .a..,,..+,.
....... .. + t. .e.+ . +.. a r m m., . , ... ..
,.,. 4..,,. A.....
. ,. . .a. . m. .a
+..u. ., +. +. u. . . .
n c. + ., +. .a ,m.m.a,.,..,.
, . .. _. a. m. + 4. . .m.
. .. . a e.
s.. a u.n . . . ,a..,..+..,.+,.mm,.a.
., , s. ...+ ,.. . . u ,. 4.. -. u... .., , + u. .,. m...A.. e. ., c....
a + ,, . m.. .A. . . ..,a. ., +. 4. u.,,. .,. a. +. .u. + u. . , f m-_ . .4. . .e.. e t. a ..=. # ,,, r um.,
. a ,. m..o T. C. , .%+ ..+ .L..a .a m. .A..a. t. +..L..a 4.. m. 4 4 4.
1 ol mL
- 4. ..r . .a. m.~a
. . m. 4. e.n.% n.. +
. r . . .=
..e. n , +..k..a
.A.n .m. a. a. .~a m. +. e. +. .%. . +.,a.aw.a.a, m..s . m.a.,. .=. 4. m.
. .e .s. m. . . A.
.% .A n. .a.
. .. u .% + a.e ..n. . .,n. .= +..4.. k, l. a , A.+. L.
m.. . .. . a C. +. .%.. +. L a. . .%. e.
== = a al
.J..a....a . .m. e. s. . .s..+ n .A. .. . .=. k 4 1 4. +. u, s.. a. .c .e.. u.m. . ~ . i t. k. .. a. . 4. +. .o,f. .a .m. .~a .. . m
. . a e .n ..r . .a a v 1 4...e. n n. .e. n.A. ;
1
.a.,.,. u.n +,.
. +.. 4..a.+.4.
. .e , s. u. . m... ..., 4. .m. 4. . m. ,.. .,.+.a,.4.e,
. , . . .a. c. ,. 4. ...- m. .e. .a.e.. . . .+.... ... . e.
. e. ,. m.m A.
. .. s .u. ,
e.+..,+.,. E. PROGRAM ASSISTANCE NRC will offer training and other assistance to States, such as assistance in developing regulations and program descriptions to help individual States prepare for entrance into agreements and to help them during transition periods of assumption of regulatory authority. Following assumption of regulatory authority by a new Agreement State, t_ojj,e_lext_ent, h pe yv..;.wMm t.e, yiresjurcesg;
~ .i.:.g..-Q_ p, .. g.p :.pyu.,wm..;g,,NRCcan w,,qp..op,.v prov i de t ra i n i ng =d t r;"c' and other assistance such as review of proposed regulatory changes to help States administer their regulatory responsibilities. NRC would also use its best efforts to provide specialized technical assistance to Agreement States to address unique or complex licensing, inspection, and enforcement issues. In areas where Agreement States have particular expertise or are in the best 46
position to provide imediate assistance to the NRC, the Agreement States are encouraged to do so. In addition, NRC and Agreement States shall use their best efforts to keep each other informed about relevant aspects of their programs. NRC will provide an opportunity for Agreement States to have early and substantive involvement in rulemaking, policy, and guidance development activities. Agreement States should provide a similar opportunity to the NRC to make it aware of, and to provide the opportunity to review and coment on, proposed changes in flijylitl5jifsid3Bh))]{ihildliiihE5?fd Agreement State programs, regmti=, policies, and regulatory guidance. If an Agreement State experiences difficulty in program administration, the Comission would use its best efforts to assist the State in maintaining the effectiveness of its radiation control program. Such assistance could address an imediate difficulty or a chronic difficulty affecting the State's ability to discharge its responsibility to continue to ensure adequate protection of the public health and safety. F. PERFORMANCE EVALUATION l Under Section 274 of the Atomic Energy Act of 1954, as amended, the Comission retains authority for ensuring that Agreement State programs continue to provide adequate protection of the public health and safety. In l fulfilling this statutory responsibility, NRC will provide oversight of Agreement State radiation control programs to ensure that they are adequate and compatible prior to entrance into a Section 274(b) agreement and that they continue to be adequate and compatible after an agreement is effective. The 47
I Commission, in cooperation with the Agreement States, will establish and implement a performance evaluation program to provide NRC and Agreement State. j ' management with systematic, integrated, and reliable evaluations of the j strengths and weaknesses of their respective radiation safety control programs I and identification of areas needing improvement. l l As a part of this performance evaluation process, the Commission will takeanynecessaryactionsto[QJj]ensurethatAgreementStateradiation control programs remain adequate and compatible. These actions include: (1) periodic assessments of Agreement State radiation control programs against established review criteria; (2) provision of assistance to help address , weaknesses or areas within an Agreement State radiation control program requiring improvementM51t@[shjjt}{e3]j@djFj]jlRC}@jjigij; (3) placing a State on a. probationary status for serious program deficiencies that require heightened oversight; (4) temporary suspension of an agreement and reassertion ' l of NRC regulatory authority in an emergency if an Agreement State program ; experiences any immediate program difficulties preventing the State from l l continuing to ensure adequate protection of the public health and safety; and I
/a m pension or termination of an agreement and reassertion of NRC regulatory authority if the Agreement State program experiences difficulties which jeopardize the State's ability to continue to ensure adequate protection of the public health and safety [bMEjjj@ilt[iiijftilh]i))6sjit})]j
@idsij. The basis for NRC's actions will be based on a well defined and
! predictable process and a performance evaluation program which will be consistently and fairly applied. j 48 i 1 l - -. _ l
G. LEVELS OF AGREEMENT STATE PROGRAM REVIEW FINDINGS The following discussion outlines the nature of NRC findings regarding i the NRC's Agreement State review process. I t FINDING 1-ADEQUATETOPROTECTPUBLICHEALTHANDSAFETYAND/pglh0] COMPATIBLE If the NRC finds that a State program has met all of the Agreement State program review criteria or that only minor deficiencies exist, the Commission s would find that the State's program is adequate to protect the public health and safety. If the NRC determines that a State program contains all required NRC program elemer.ts for compatibility, or only minor discrepancies exist, the program would be found compatible. [fjt(sj!NRC[dstjijiil;ii@{ hit]IlSQ{il$is?j l w . . - . ,. . . ~ . .. [$ylj(($fj(({f(({jf[{hl[pRpH@jlp[hj$fy((@jh(ES{j(((({[1]jligrli@ EiiGNESEEsHiOBEDMH6MsWikiM95HiWifiifiassela;#aarisWg6t; EEdiE!ME2 FINDING 2 - ADEQUATE, BUT NEEDS IMPROVEMENT AND/0R NOT COMPATIBLE l If the NRC finds that a State program protects public health and safety, but is deficient in meeting some of the review criteria, the NRC may find that the State's program is adequate, but needs improvement. The NRC would consider in its determination plans that the State has to address any of the deficiencies noted during the review. In cases where less significant Agreement State deficiencies previously identified have been uncorrected for a 49
significant period of time, NRC may also find that the program is adequate but 4 . .>my.w. in need of improvement. . s w,N_RCexde,.ter,~m.mi*n.,eq.t. I. .,th. er a m_.- s._s S_a "twpy$.t
.wa.Lu a t.w,,~ -mm _e . r._sprog.m_ co._n.tm w
.a..mmins #4.m p ._n .xn a -v-n.e.-_.. ~ n A
nE: .g. m swAW/A4.N w reb. 7 - RC.ipamm. wwh:4_Mer.w W44 p ro
/-m..wNwuMe s
nn~m gram +l ns 4v Marxoricom em,e,mntvn.wf. se.wmmum.vawawe*a 4WMuws.p.wwwe_Wm.i~ty.e.gran~~~.l.e atibwil:Av- s.v4twvm$Nyk<4a/ omon .y4%e.-rm -
d nor n.w,~igr.mm e
e v .m3*ev W re nc 9440:9,4%F**>>. i< 4+wwww:.Mecemp* em,s.c.ww.pa.w.+-a.smm + w.st e p..ww:ex99.9e:px+Aer,v.y.*ynlwd.s
#>roga ts..l.e.Te_x.i._s,.w.
sv.,.wa ram 1w ou.__ vw e o_u.n._d.
+mm.w.wa togww.Mo_:n b.v.oqx ib mnawso.
'+l*.w,c.ws._mp._at-W"PN.If the NRC o - -
determi nes that a State has as,p.- mmm_ rog...~>m ram ._ame sru_p_ss
+m,st_hs.nstpd_ior:***wt.w3thwe.,.-3y,
-m ..
--m-e+~m_er exor mm.,d.yapa_m z vr.~4m-a
*~lvo.p=v.s,t*ew.ww.+.mf.
. nmo po:./.c +s s a
-_-es_ R"anongi.
_ e? Col M.:.loi>o>co#Mp>xWA4t+.%.OX3yih9/Muytp.M
>mmw._oo._ m_
ect .mmu vesregu _ . ._.m_ _ uatoryre l-MA.-.<.i-ryh>:oy;pMp+x+ +,l .or.- .y:wx.'4ggw..f f.q.h.<".:usyMM/ortstof(p.-
. . ,mm_-_o._m.--w_-m -ms_m randsm%%themw.er lom_.4_.x <h.@;.y. -kt esNRCqvF#Vh
>M.*mmew ox N - - -
N.4 6 , +>a%gs.4 reggeRk.~ $- % $_c/VI.9'w9:.sgpmhpWish;.,
~ . - a_ _SS%h-~e_r'n mm x cre_a_e.s ape.'conwI.
sC_on_m+ m *m,xp.wesopfl~i_'.pwt._wo.pyv,4v'ym.99vxvmc. h A d- M+w>3<r+ew.--m m_mmg- nlre..u
#wgvw/.oMxvyl<-wtei.
sng _aEsNo.W.m_u _,ao_ns.y ~~ ,m.C. atfi-m_on't
. , ___,+ to: .u- --_ua c .4_.
- s. n....a .. _a- ,.. .---,, , _ , ,
..www...., 4..__
. . . . .. w_.,.4...,..,., . m. 4. +. u.... . . ...w rw. .. . . . . . .
.r.. 4. e. u. w .au.,. . 4...,..,..u...,
, , , . . . . . . . . _. > ...w r..
o
. . . . c.... ...+ u. - u. n. e.. . ., . ._...r.. . . . , + 4. u. n. 4. +.,. . . r., . , u, w ,. .
- t:t: ::t, the program would be found not compatible.
FINDING 3 - INADEQUATE TO PROTECT PUBLIC HEALTH AND SAFETY AND/0R NOT COMPATIBLE 1 If the NRC finds that a State program is significantly deficient in some or all of the review criteria, the NRC would find that the State's program is not adequate to protect the public health and safety. &m.~t,h._K.N.R._C1_d. una s: e ~v ml n.w yn et_.__in_,. e.w.wmm rm s e.s , N yT4w WA.? +
>-w .t.hW%..'
a g_a_ tot_a r
. pr_ogra._m; con _a. n_sr.a.-- qu. %wnd?
#AMvgS_tM't+e%.4WM/qD/M?49W.vgpM/rrMO/t:
112re i re #Mti_%cu.$ttX% NRCi.py.vAewe>heww.-.QWra - l@e.97w.e 4-- AAt.97.h~ pro.g~_mie_ _me_n s; l
/.,p +.W.
wi un
.f,..
e f comp _at_1. ev~moraon
.@w.MX.v.C+W.~1m6.O
._ _' a screp_anciesm_ex_s_t
>h4g,@-.+/.vy.+N.&l.WXp.9.+i_W4WlF.H.%.
n_ . yi_s n_or xd .i_v.ew m.M* WM.+p.g - t .xe;< sw t s .spro_
,i.gv..ggv.t6.,w.eg.w, .- gram wpx.vxwAMsW;$wcu._l a- d ;bw.e.evf_o.,fvpx@d
- _~ ,
we e e syw++,w.,, o M w h*et N_RC_idet-
*,--r m, e
.c_omp_a t+i- _e m__m._-
.b_mlwmmI-mmm; _erm_ i_nesit_a_m m;g.rx- .h.~mtyw t g _-. . si a9 p_rog_ra_mv
- a. rS_t+at_ez.h.+aes m a s_
,.. .,i_.h_mstnod. m .up_s t- .o.
i_~sr.~, we ~ n
.. ._mm.m-~
eror4 m +de.r,lm t_hn.nygne
+
yjap_a_m_er.n.mm_o_f.y r mm,r_e.gu wnw<.~ttnner.px.n m e ywera.lnntsiy ontamong,m. pmpe evwmA_o ecc
? m:t_h..&.g 4~
e_c.__ive.n.m t/nn->ll e.ws.,ww.w.rwl.m> .eguxtn,.r.. a.-oryA.e w wig w
- f. rt.m+s,s.wmf.
nfm . owv m,o.- - j l
- e. -
e wwo qsw w .. .- w g ec.o a%+3w,.me Ibm.3:p
._- m_m_om__
an ot ers reement> . - _e. =V_.-._RMe..re_a e Rbyemewd s.ym.-chmo^gA+gwwww<a.ws- .mm_ .__m_. a sw$.- t.#+twof.m-gM>. p.wgg p.3yw.ww,feS2.s'Co. A~ -- - m . C
-w d -nf}:iy.+t+S."hga.
..xem _p- S_ Wor l
we r w.* yon < A pdu*P 1catvi 1.. . waudpp on n+m:.o.emw.% w.m___m__-._&___esProLra_m;wo_u a on regul <.*twimw.n,st.h-vana*v.ew., _xgeww..l_+d _ m_w; e b_e_yfo_u.weydy.rwy+t:.we.w.w.wwtvi n_rno xc_omRa._ m ._ b.-.,l e.c., ARh M
.. ...,A.. m..
A ww.Aw M. . .k... A W. u A
. h. =% h w ...%f,.
4
.=iiww A
.A. .%w.y. = . Gilk Aw,...
M #1 P f. M h.fl.17g . . f% Wh. M. w .i
--=4aA t + a n a , 4. t. 4 nwwA .jLt. 4. . .n l. a ..m..wan. . +. 4. m. y , y n m,a n a A . . = =n ,e 4 .m.w e i
= = 4 4 u. 21 4 4.g, u. 4 4..L...4. . 4..yw.
.7- L. a .w .a. . ,yww .y .wwww 50
l I f:r th: 9 94 ' : :::p:44b41ity pelity :t:te=ent, the pr gr:= would be f end not
- tible.
H. NRC ACTIONS AS A RESULT OF THESE FINDINGS l The following discussion outlines the options available to the NRC as a result of making any of the above findings. The appropriate action will be j determined on a case-by-case basis by NRC management. 1 l l l L LETTERS ! In all cases, subsequent to an Agreement State program review, the l l findings would be recounted in a letter to senior level State management. In i I the event that the NRC finds that a State program is adequate and compatible, no further action would be requiredMMsigMHM6Efe[6fl{fiBQ{s][Qfiij
~Miliii@sEfff@Mi@iQ@j. In the case where minor deficiencies are l noted[oj[ijjiH@jMM[ii@Mifs))psHMfj;@, the State would be requested to i 1
i describe their proposed corrective action. If the corrective action appears j appropriate, no further NRC action is required. If additional clarification I of the corrective actions is needed, additional correspondence may be necessary. i FOLLOW-UP REVIEWS In the event that deficiencies are noted during the program review, NRC 1 may increase the frequency of contacts with the State to keep abreast of ; 51 i l l I 1
developments and conduct onsite follow-up reviews to assure that progress is being made on correcting program deficiencies. If, during follow-up reviews, it is shown that the State has taken corrective actions, a letter finding the , 1 State adequate and compatible would be provided. 1 l PROBATIONARY STATUS l There are three circumstances which can lead to an adequate but needs ; improvement or incompatible State program being placed in a probationary status: (I) There are cases in which program deficiencies may be serious enough to require immediate heightened oversight; (2) In other cases, Agreement State program deficiencies previously identified may have been uncorrected for a significant period of time; and (3) If the NRC determines that a State program has been late in adopting required compatibility elements l EfE!NNM[NS[NENM5EMNI$l!EY5N115NSE[N5$[55E!ff5831$51f5N15$$$ EEGFfaliTQTR@. If the NRC was not confident that the State would l address the program deficiencies in an expeditious and effectivc: manner, the Commission would place the State program on probation. i As a result of placing a State program on probation, the NRC would l communicate its findings to a higher level of State management. Notice of such probationary status would normally be addressed to the Governor of the State. Notice would also be published in the Federal Register. A copy of the letter to the Governor would be placed in the Public Document Room and a press release would be issued. 52
I Once a State program is placed on probation, the NRC would heighten its oversight of the program. This would include obtaining commitments from the State in the form of a management plan to describe actions to be taken by the State to address the program deficiencies, including specific goals and milestones. The NRC would increase observation of State program activities under the agreement to assure adequate protection of the public health and safety. If requested and in accordance with terms agreed to by the parties, the NRC would consider providing technical support for the maintenance of the regulatory program. The probationary period would last for a specified period of time. This period would not normally be more than one year, but could be extended based on extenuating circumstances. At the end of that time, if the State has not addressed the deficiencies, the NRC would institute suspension or termination proceedings. SUSPENSION l Section 274j of the Atomic Energy Act gives the Commission authority to suspend all or part of its agreement with a State if the suspension is required to protect the public health and safety, or if the State has not complied with one or more of the requirements of Section 274 of the Act. In cases where the Commission finds that program deficiencies related to either adequacy or compatibility are such that the Commission must take action to protect the public health and safety, or if the program has not complied with one or more of the requirements of Section 274 of the Act, the Commission would suspend all or part of its agreement with the State. In cases where a State has failed to respond in an acceptable manner during the probationary 53
period, suspension would be considered. If the situation is not resolved, termination will be considered. Before reaching a final decision on suspension, the-Commission will notify the State and provide the State an opportunity for a hearing on the proposed suspension. Notice of the proposed suspension will also be published in the. Federal Register. Suspension, rather than termination, would be the preferred option in those cases where the State provides evidence that the program deficiencies are temporary and 'that the State is committed to correcting the deficiencies that led to the suspension. In addition to the normal suspension authority, Section 274j.(2) of the l Act also addresses emergency situations and gives the Commission authority to-i i temporarily suspend all or part of its agreement with a State without notice or hearing if an emergency situation exists requiring immediate action to protect public health and safety, and the State has failed to take necessary action within a reasonable time. TERMINATION Section 274j of the Atomic Energy Act gives the Commission authority to terminate its agreement with a State if such termination is required to protect the public health and safety, or if the State program has not complied with one or more of the requirements of Section 274 of the Act (e.g., is found to be not compatible with the Commission's program). When the Commission 54 I l
1 finds such significant program deficiencies, the Commission would institute I i l l proceedings to terminate its agreement with the State. In cases where a State has failed to respond in an acceptable manner during tk probationary period and there is no prospect for improvement, termination will be considered. Before reaching a final decision on termination, the Commission will notify the State and provide the State an opportunity for a hearing on the proposed termination. Also, notice of the proposed termination will be published in the Federal Register. There may be cases where termination will be considered even though the State program has not been placed on probation. I. PROGRAM FUNDING Currently, Section 274 does not allow federal funding for the administration of Agreement State radiation control programs. Section 274 permits the NRC to offer training and other assistance to a State in anticipation of entering into an Agreement with NRC, however, it is NRC policy not to fund the establishment of new Agreement States program. Regarding training, given the importance in terms of public health and safety of having well trained radiation control program personnel, the NRC offers [e3([]n relevant training courses and MQlij[ invite p:rticip;ti n frc Agreement State personnel l}Qt@di[Il{Mid)MR. 55 1
l
)
J. REGULATORY DEVELOPMENT 1 i
-NRC and Agreement States will cooperate in the development of new )
regulations and policy. Agreement States will have early and substantive involvement in the development of new regulations affecting protection of the l public health and safety and of new policy affecting administration of the } Agreement State program. Likewise, the NRC expects to have the States provide i it with early and substantive involvement in the development of new Suggested State Regulations. NRC and Agreement States will-keep each other informed about their individual regulatory requirements (i.e., regulations or license conditions) and the effectiveness of those regulatory requirements so that each has the opportunity to make use of proven regulatory approaches to further the effective and efficient use of resources. K. PROGRAM EVOLUTION The NRC-Agreement State program is dynamic and the NRC and Agreement States will continue to jointly z.ssess the {6]}}j@]cver:11 national program toIIMiI6Ni]IniE1EENMdan3to identify specific changes which should be considered based on experience or to further improve overall performance A and effectiveness g Of the n: tion:1 progrr.* The changes considered may include possible legislative changes. The program should also include the formal sharing of information and views such as briefings of the Commission by the Agreement States. 56
-.. . - = - . - . - . - - - . - . .- -. . . .
1 This final policy statement does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget, approval number 3150-0029. Dated at Rockville, Maryland this day of , 1996. For the Nuclear Regulatory Commission, i ! John C. Hoyle Secretary of the Commission. I G:\SECUMB3.MLO l l l l l i t ! 57 (
_ __ ~__ _ _ PROPOSED 274b AGREEMENTS WITH STATES DIRECTIVE 5.8 l i 1 i J e ATTACHMENT B t
U.S. NUCLEAR REGULATORY COMMISSION' Volume 5: Governmental Relations and Public Affairs OSP Policy. (5.8-01 ) e it is the policy of the U.S. Nuclear Regulatory Commission to implement procedures for establishing new agreements with individual States pursuant to Section 274 of the Atomic Energy Act of 1954, as amended. I Objectives. ! (5.8-02)
]
e To establish a system for an orderly transition in the discontinuance of certain l regulatory authority by the NRC with assumption thereof by the State through l a standard agreement with a phased implementation protocol. OrgarJzational Responsibilities and Delegations of Authority (5.8-03) The Commission (031) I e Approves requests from a Governor to enter into an agreement under Section ( 274 of the Atomic Energy Act of 1954, as amended. o Approves policy matters related to NRC's Agreement States program. The Executive Director for Operations (EDO) (032) e Provides management direction and oversight for the activitics described herein, i The Director, Office of State Programs (033) l e Coordinates the review and action on State requests for 274b agreements or , amendments to agreements with cognizant regional administrator and office directors. (a) e identifies an NRC contact, prepares correspondence to the State, as appropriate, and provides a schedule for accomplishing staff work on the agreement request. (b) l 1 l l
l
- Prepares a Commission Paper that analyzes and responds to public comments in coordination with OGC and affected offices for final approval by the Commission. (c)
- Prepares approved agreement for the signature of the Chairman and Governor.
Arranges all post signing coordination for the transfer of regulatory authority l under the effective agreement. (d) ! Office Directors and Regional Administrators l (034) l e Consult with the Director, OSP, concerning the proposed agreement. (a) e Appoint principal working-level contacts for review of the proposed agreement. (b) )
- Review, comment and concur, if appropriate, on the proposed agreement and l
final Commission Paper. (c) l Regional Administrators (035) l l l e Coordinate with the State prior to the agreement on the licenses to be transferred when the agreement is effective. (a)
- During the initial phase, provide the opportunity for license reviews form the
! State seeking an Agreement to review complex licensing casework in progress l a* in6 Region. l l e Coordinate the transfer of licenses, license files and other appropriate material when agreement is effective,in accordance with the phased agreement protocol. (b) i Applicability. l (5.8-04) The policy and guidance in this directive and handbook apply to all NRC employees l who process a request for a 274b agreement. (a) Handbook. (5.8-05) Handbook 5.8 contains an overview of the process, guidelines and a standard agreement with a protocol for phased implementation of a new agreement. References. (5.8-06) i 2 l
Atomic Energy Act of 1954, as amended (42 USC. 2011 et seq.) Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Author;ty and Assumption Thereof by States through Agreement (46 FR 7540,
- January 23,1981, as amended by policy statements published at 46 FR 36969, July 16,1981, and 48 FR 33376, July 21,1983).
4 Status and Notice of Availability of Two Policy Statements Concerning the Agreement State Program (60 FR 39463, August 2,1995). l Evaluation of Agreement State Radiation Control Programs (60 FR 54734,
- October 25,1995).
- Management Directive 5.6, integrated Materials Performance Evaluation Program, approved September 12,1995.
4 Management Directive 5.9, Adequacy and Compatibility of Agreement State Programs, approved . 1 i i a 3
ra PROPOSED 274b AGREEMENTS WITH STATES HANDBOOK 5.8 l
i I j Contents ! Overview (A) l . Office of State Programs and Regional Responsibilities (B)
- Process Sequence for New Agreements (C)
Standard Agreement and Phased implementation Protocol (D) Exhibits ] 1 Standard Agreement under Section 274b l i j 2 . Protocol for Phased Implementation of the Section 274b Agreement i .[ ] l i 1
l ll Overview (A) As authorized under Section 274 of the Atomic Energy Act of 1954, as amended, the policy of the NRC is to enter into agreements with States - . (1) e Upon certification by the Governor that the State has a program for
- the control of radiation hazards adequate to protect public health and safety with respect to the materials within the State covered by the proposed agreement and the State desires to assume regulatory responsibility for such material. (a) e After a finding by the Commission that ' the State program is in
!: accordance with the requirements of Subsection o of Section 274 and in all other respects compatible with the Commission's program . , for the regulation of such materials, and is adequate to protect public health and safety with respect to the materials covered by the proposed agreement. (b) The NRC believes that a formal phased implementation process, during which a i State initially assumes authority over smaller licenses of less regulatory complexity, would be advantageous to both NRC and an Agreement State. It would provide the NRC an opportunity to provide for an orderly transition of licensed activities to the State. It may also help to identify any areas of the State's program that require additional guidance from NRC before the State assumes full responsibility over all activities covered under the Agreement. From the State perspective, it should provide new Agreement States an opportunity to gain experience with their l programs prior to having responsibility for more complex licenses. l Therefore, NRC plans a phased implementation process for future agreements. As with past practice, NRC will make a finding that the State's entire program is , adequate and compatible with that of the NRC. The Agreement itself would identify the dates at which the new Agreement State would assume authority over. certain categories of licensees (i.e., the implementation dates for the phases). In the initial phase, the State will exercise full regulatory authority over categories of l I licensees with programs of lesser complexity. During this first phase, the State will l perform all regulatory functions for the transferred licenses. The remaining categories will be transferred to the Agreement State's jurisdiction at the date fixed in the Agreement for the implementation of the second phase. To assist in the , ! phased implementation, NRC would conduct a review of the State's entire program under the integrated Materials Performance Evaluation Program prior to the date fixed in the agreement for implementation of the second phase to ensure the State's program continues to be adequate to protect public health and safety and compatible with NRC's regulatory program. (See Management Directive 5.6 for more detail about the evaluation of the State's program and Management Directive 5.9 (under development) for more detail about the adequacy and compatibility of [ l Agreement State programs.) i This management directive and handbook supplement the Criteria for Guidance of 4
- 1
l States and NRC in Discontinuance of NRC Regulatory Authority and Assumption , Thereof by States through Agreement (46 FR 7540, January 23,'1981,as amended by policy statements published at 46 FR 36969, July 16,1981, and 48 FR 33376, July 21,1983).
. Office of State Programs and _ Regional Responsibilities (8)
The Office of State Programs will- (1) e Plan, schedule and arrange meetings with the State to discuss issues related to the request for an agreement. (a) e Coordinate the protocol to be published with the proposed agreement with the State and appropriated headquarters and regional offices on the phased implementation of the agreement. (b) e Takes the lead in drafting a Commission Paper which includes the staff
- assessment, proposed agreement with phased implementation protocol and a proposed Federal Register notice publishing this information for public comment for 4 consecutive weeks according to the Atomic Energy Act. (c)
The Regional Office in which the State is located will- (2) e Invite inspectors from the State seeking an agreement to accompany regional staff on inspections conducted in that State prior to the agreement. (a) e Meet with representatives of the State seeking an agreement to describe and explain licenses and files that will be transferred to the State. (b) e Assure, to the extent practicable, that licensing and inspection backlogs are as small as possible for licensees in the State seeking an agreement. (c) e- Coordinate the transfer of license files and other appropriate material when l agreement is effective. (d) l
)
e Transfer license files for the remaining categories of licensees to the
' Agreement State if the performance of the program is adequate to protect public health and safety and compatible with the NRC programs, in accordance with the phased agreement protocol. (e)
Process Sequence for New Agreements (C) The typical sequence for NRC in processing a request for an agreement is summarized below: , e Receive a letter of intent from the Governor of the State interested in an j agreement with NRC. (1) j 2
1 I l e Provide guidance to the State on the necessary elements of an Agreement , State program and its phased implementation, including draft legislation, i regulations, and program description. (2) ; e Receive and review the request for an agreement from the Governor, the j program description, and necessary program elements. (3) i e Transmit and resolve any outstanding items with the State regarding the proposed agreement request. (4) i l e Prepare Commission Paper on the proposed agreement request, including staff assessment and Federal Register Notice with the proposed agreement and phased implementation protocol for public comment. (5) e Publish Federal Register Notice with the proposed agreement and protocol for public comment for 4 consecutive weeks according to the Atomic Energy Act. (6) j e Prepare Commission Paper that analyzes and responds to public comments and provides staff recommendations on the agreement for final approval by the Commission. (7) e Prepare approved agreement for the signature of the Chairman and Governor upon Commission approvai and arrange signing ceremony. (8) e Arrange all post signing coordination for the orderly transfer of regulatory authority under the offective agreement according to the implementing protocol. (9) Standard Agreement and Phased implementation Protocol (D) The standard agreement describes the categories of materials to be regulated by the i State and the effective date of the agreement. (1) ' The protoco! to the standard agreement deals with phased implementation of the effective t.greement and defines the categories of licenses for each implementation phase. (The Agreement itself would identify the dates at which the new Agreement State would assume authority over certain categories of licensees,i.e., the implementation dates for the phases). In the initial phase, the State will exercise full regulatory authority over categories of licensees of less regulatory complexity. The remaining categories will be transferred to the Agreement State's ; jurisdiction at the date fixed in the Agreement for the implementation of the second phase. (2) i 3
. . - , - - . . - . - - - - . - . - . - . . _ ~ _ _ - - . - - . . - - . - . . . - . _ . . . - ~
i f Exhibit 1 l i AN AGREEMENT !- BETWEEN THE UNITED STATES NUCLEAR REGULATORY COMMISSION AND i 4 THE STATE / COMMONWEALTH OF [ insert name of Statel FOR THE 1 DISCONTINUANCE OF CERTAIN COMMISSION REGULATORY AUTHORITY ! AND L RESPONSIBILITY WITHIN THE STATE / COMMONWEALTH PURSUANT TO - SECTION 274 OF THE ATOMIC ENERGY ACT OF 1954, AS AMENDED 1 a j- WHEREAS, The United States Nuclear Regulatory Commission (hereinafter referred to as
- the Commission) is authorized under Section 274 of the Atomic Energy Act of 1954, as
! amended (hereinafter referred to as the Act), to enter into agreements with the Governor of any State / Commonwealth providing for discontinuance of the regulatory authority of the i Commission within the State / Commonwealth under Chapters 6,7, and 8, and Section 161 of the Act with respect to byproduct materials as defined in Sections 11e.(1) and (2) of i the Act, source materials, and special nuclear materials in quantities not sufficient to form a critical mass; and, f' ! WHEREAS,- The Governor of the State / Commonwealth of [ insert namel is authorized ! under [ cite enabling statute] to enter into this Agreement with the Commission; and, i l' WHEREAS, The Governor of the State / Commonwealth of linsert name] certified on Idatel, i that the State / Commonwealth of [ insert namel (hereinafter referred to as the ! State / Commonwealth) has a program for the control of radiation hazards adequate to j protect public health and safety with respect to the materials within the State / Commonwealth covered by this Agreement, and that the State / Commonwealth l desires to assume regulatory responsibility for such materials; and, i WHEREAS, The Commission found on [datel that the program of the State / Commonwealth for the regulation of the materials covered by this Agreement is compatible with the Commission's program for the regulation of such materials and is 1 adequate to protect public health and safety; andi j .WHEREAS, The State / Commonwealth and the Commission recognize the desirability and 3-1 i l I 4
,- - _-. .-,..i. _
--_w
importance of cooperation between the Commission and the State / Commonwealth in the formulation of standards for protection against hazards of radiation and in assuring that State / Commonwealth and Commission programs for protection against hazards of radiation will be coordinated and compatible; and, WHEREAS, The Commission and the State / Commonwealth recognize the desirability of the reciprocal recognition of licenses, and of the granting of limited exemptions from licensing of those materials subject to this Agreement; and, WHEREAS, This Agreement is entered into pursuant to the provisions of the Atomic Energy Act of 1954, as amended; NOW, THEREFORE, it is hereby agreed between the Commission and the Governor of the State / Commonwealth acting in behalf of the State / Commonwealth as follows: ARTICLE l' Subject to the exceptions provided in Articles ll, IV, and V, the Commission shall discontinue, as of the effective date of this Agreement, and in accordance with the phased Agreement protocol attached, the regulatory authority of the Commission in the State / Commonwealth under Chapters 6,7, and 8, and Section 161 of the Act with respect to the following materials: A. Byproduct materials as defined in Section 11e.(1) of the Act; B. Byproduct materials as defined in Section 11e.(2) of the Act; C. Source materials: D. Special nuclear materials in quantities not sufficient to form a critical mass. E. The regulation of the land disposal of byproduct, source, or special nuclear waste materials received from other persons; F. The evaluation of radiation safety information on sealed sources or devices containing byproduct, source, or special nuclear materials and the registration of the sealed sources or devices for distribution, as provided for in regulations or orders of the Commission. ARTICLE II A. This Agreement does not provide for discontinuance of any authority and the Commission shall retain authority and responsibility with respect to:
- 1. The regulation of the construction and operation of any production or utilization
'If the State / Commonwealth chooses not to regulate all categories of material listed in Article 1, those categories where NRC will retain authority should be listed in Article 11, A.
2
facility or any uranium enrichment facility;
- 2. The regulation of the export from or import into the United States of byproduct, source, or special nuclear material, or of any production or utilization facility;
- 3. The regulation of the disposal into the ocean or sea of byproduct, source, or special nuclear waste materials as defined in the regulations or orders of the Commission;
- 4. The regulation of the disposal of such other byproduct, source, or special nuclear material as the Commission from time to time determines by regulation or order should, because of the hazards or potential hazards thereof, not be so disposed of without a license from the Commission:
- 5. The evaluation of radiation safety information on sealed sources or devices containing byproduct, source, or special nuclear materials and the registration of the sealed sources or devices for distribution, as provided for in regulations or orders of the Commission.2 B.8 Notwithstanding this Agreement, the Commission retains the following authorities pertaining to byproduct material as defined in Section 11e.(2) of the Atomic Energy Act:
- 1. Prior to the termination of a State / Commonwealth license for such byproduct material, or for any activity that results in the production of such material, the Commission shall have made a determination that all applicable standards and requirements pertaining to such material have been met.
- 2. The Commission reserves the authority to establish minimum standards I
governing reclamation,long-term surveillance or maintenance, and ownership ' of such byproduct material and of land used as a disposal site for such material. Such reserved authority includes:
- a. The authority to establish terms and conditions as the Commission determines necessary to assure that, prior to termination of any license fs such byproduct material, or for any activity that results in the production of such material, the licensee shall comply with decontamination, decommissioning, and reclamation standards prescribed by the Commission; and with ownership requirements for such materials and its disposal site;
- b. The authority to require that prior to termination of any license for such byproduct material or for any activity that results in the
- Include only if the State is not authorized to conduct sealed source and device reviews for purposes of registration for distribution.
' Article ll.B. is included in the agreement only if the State is authori.ed to regulate 11e.(2) byproduct material.
l 3 l l
i l production of such material, title to such byproduct material and its disposal site be transferred to the United States or the State / Commonwealth at the option of the State / Commonwealth (provided such option is exercised prior to termination of the license);
- c. The authority to permit use of the surface or subsurface estates, or both, of the land transferred to the United States or a State / Commonwealth pursuant to paragraph 2.b. in this section in a manner consistent with the provisions of the Uranium Mill Tailings Radiation Control Act of 1978, provided that the Commission determines that such use would not endanger public health, safety, welfare, or the environment;
- d. The authority to require, in the case of a license for any activity that produces such byproduct material (which license was in effect on November 8,1981), transfer of land and material pursuant to paragraph 2.b. in this section taking into consideration the status of such material and land and interests therein, and the ability of the lic9nsee to transfer title and custody thereof to the United States or a State / Commonwealth;
- e. The authority to require the Secretary of the Department of Energy, other Federal agency, or State / Commonwealth, whichever has custody of such byproduct material and its disposal site, to undertake such monitoring, maintenance, and emergency measures as are necessary to protect public health and safety, and other actior : as the Commission deems necessary; and
- f. The authority to enter into arrangements as may be approg.riate to I
assure Federallong-term surveillance or maintenance of such byproduct material and its disposal site on land held in trust b,< the United States for any Indian Tribe or land owned by an Indian tr;be and subject to a restriction against alienation imposed by the Unitod States. ARTICLE lil' With the exception of those activities identified in Articie ll.A.1 through 4, this Agreement may be amended, upon application by the State / Commonwealth and approval by the Commission, to include one or more of the additional activities specified in Article 11, paragraphs [those activities not included in the agreement], whereby the State / Commonwealth may then exert regulatory authority and responsibility with respect to those activities.
' Delete this Article and renumber the remaining articles if the State / Commonwealth assumes authority over all categories of materials in Article 11.
4
l l ARTICLE IV j 1 i Notwithstanding this Agreement, the Commission may from time to time by rule, ' regulation, or order, require that the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source, byproduct, or special nucicar material shall not transfer possession or control of such product except pursuant to . a license or an exemption from licensing issued by the Commission. ARTICLE V > This Agreement shall not affect the authority of the Commission under Subsection 161b or 1611 of the Act to issue rules, regulations, or orders to protect the common defense and security, to protect restricted data, or to guard against the loss or diversion of special nuclear material. ARTICLE VI ' 1 The State / Commonwealth agrees to cooperate with the Commission and other Agreement l States in the formulation of standards and regulatory programs of the State / Commonwealth and the Commission for protection against hazards of radiation and to assure that the State / Commonwealth's program will continue to be compatible with the program of the Commission for the regulation of materials covered by this Agreement. The State / Commonwealth and the Commission agree to keep each other informed of proposed changes in their respective rules and regulations, and to provide each other the opportunity for early and substantive contribution to the proposed changes. . The State / Commonwealth and the Commission agree to keep each other informed of events, accidents, and licensee performance that may have generic implication or , otherwise be of regulatory interest. The State / Commonwealth agrees to report to NRC all immediately reportable,24-hour reportable, and 30-day reportable events reported to the State by its licensees. ARTICLE Vil ; The Commission and the State / Commonwealth agree that it is desirable to provide reciprocal recognition of licenses for the materials listed in Article I licensed by the other . party or by any other Agreement State. Accordingly, the Commission and the State / Commonwealth agree to develop appropriate rules, regulations, and procedures by which such reciprocity will be accorded. ARTICLE Vill The Commission, upon its own initiative after reasonable notice and opportunity for hearin;f to the State / Commonwealth, or upon request of the Governor of the State / Commonwealth, may terminate or suspend all or part of this agreement and reassert ! the licensing and regulatory authority vested in it under the Act if the Commission finds l that (1) such termination or suspension is required to protect public health and safety, or : (2) the State / Commonwealth has not complied with one or more of the requirements of l Section 274 of the Act. The Commission may also, pursuant to Section 274j of the Act, temporarily suspend all or part of this agreement if, in the judgment of the Commission, an 5 i t
, _ _ . -. .. . . -- - - - . - . - . - . - .----- .- - . . . - - - . _ . . - ~ -
i i 1 i emergency situation exists requiring immediate action to protect public health and safety and the State / Commonwealth has failed to take necessary steps. The Commission shall periodically review actions taken by the State / Commonwealth under this Agreement to ensure compliance with Section 274 of the Act which requires a State / Commonwealth program to be adequate to protect public health and safety with respect to the materials . covered by this Agreement and to be compatible with the Commission's program. ARTICLE IX 5 i in the licensing and regulation of byproduct material as defined in Section 11e.(2) of the i Act, or of any activity which results in production of such material, the State / Commonwealth shall comply with the provisions of Section 274o of the Act. If in 1 such licensing and regulation, the State / Commonwealth requires financial surety i arrangements for reclamation or long-term surveillance and maintenance of such material, l .
' A. The total amount of funds the State / Commonwealth collects for such purposes l shall be transferred to the United States if custody of such material and its disposal site is transferred to the United States upon termination of the State / Commonwealth license for such material or any activity which results in the production of such material. Such funds include, but are not limited to, sums collected for long-term surveillance or maintenance. Such funds do not, however, )
include monies held as surety where no default has occurred and the reclamation or other bonded activity has been performed; and B. Such surety or other financial requirements must be sufficient to ensure compliance l i with those standards established by the Commission pertaining to bonds, sureties, ' ! and financial arrangements to ensure adequate reclamation and long-term ] management of such byproduct material and its disposal site. ' ARTICLE X j This Agreement shall become effective on [datel, and shall remain in effect unless and until such time as it is terminated pursuant to Article Vlii. In accordance with the attached l protocol, the Commission will transfer the groups of licenses as shown therein as specified j in the protocol. i Done at ICity, State] this [datel day of Imonth], [ year]. FOR THE UNITED STATES NUCLEAR REGULATORY COMMISSION s j , Chairman , FOR THE STATE / COMMONWEALTH OF ' , Governor a 4 5 Use Article IX only if the State is authorized to regulate 11e.(2) byproduct material. 6
! I i i
Exhibit 2 ATTACHMENT TO SECTION 274B AGREEMENT WITH [ State / Commonwealth] PROTOCOL FOR PHASED IMPLEMENTATION OF THE AGREEMENT INTRODUCTION A formal phased implementation process, during which a IState/ Commonwealth) assumes authority over smaller licenses of less regulatory complexity in the initial phase, is advantageous to both NRC and an Agreement State. It provides NRC an opportunity to carry out an orderly transition of licensed activities to the IState/ Commonwealth). It may also help to identify any areas of the State's program that require additional guidance from NRC before the State assumes full responsibility over all activities covered under the Agreement. It provides new Agreement States an opportunity to gain experience with their program prior to having responsibility for more complex licenses. PROCESS Therefore, upon the effective date of [ State / Commonwealth] Agreement, NRC and [ State / Commonwealth) will use a phased implementation process for transfer of the licenses. e in the initial phase, which will consist of [ time frame-example: 1 yearl the [ State] will assume full regulatory authority over priority 3 -7 groups of licensee programs as classified under Inspection Manual Chapter 2800 for the categories of Ibyproduct, special nuclear material or source material as appropriate]. During this phase, the State / Commonwealth will perform all regulatory functions for the transferred licenses. e NRC will continue to perform all regulatory functions for.the priority 1 and 2 groups of licensee programs (as classified under inspection Manual Chapter 2800) which have not been transferred. The [ State / Commonwealth) will be invited to observe all NRC inspections of priority 1 and 2 licensee programs conducted by NRC during this period for those programs under the Agreement.
- To assist in the phased implementation, NRC will conduct a review of the program (under the integrated Materials Performance Evaluation Program) prior to the date fixed in the agreement for implementation of the second phase to ensure the
[ State's/ Commonwealth's] program continues to be adequate to protect public health and safety and compatible with NRC's regulatory program, e On (datel, the remaining groups of licensees (i.e. the priority 1 and 2 licensee programs) will be transferred to the [ State / Commonwealth). G:\KXS\MDPHAZE.KNS 1
% UNITED STATES lr R NUCLEAR REGULATORY COMMISSION E
fE WASHINGTON, D.C. 3DeeMo01
'*,. . . . + ,o August 21, 1996 Mr. Richard L. Bangart Director Office of State Programs U.S. Nuclear Regulatory Connission Washington, D.C. 10555 l
Dear Mr. Bangart:
i We have enclosed the report of the Joint NRC - Agreement State Working Group i for Development of Implementing Procedures for the Policy Statement on ! 4 Adequacy and Compatibility of Agreement State Programs (Group). The report !
- outlines the Group's activities on this project since its formation in October 4
1995 and has appended to it several attachments: the Group's charter, the
. Group's recommendations for revisions to the Policy Statement, and a draft l Management Directive and its accompanying handbook. The appendices to the-handbook are the flow chart used to make compatibility and adequacy decisions and tables which present the results of the Group's analyses of 10 CFR parts and program elements which are applicable to the regulation of agreement materials. The Management Directive and handbook contain the implementing procedures for the Policy Statement. The Group proposes that Appendix B to the handbook be maintained by the Office of State Programs as a separate document to facilitate its revision when new rules are adopted without having to revise the Management Directive and handbook.
It is important to note that the report and implementing procedures, as written, reflect NRC's current policy of requiring States to adopt certain compatibility requirements in the form of rules, rather than allowing another form of legally binding requirement. The Office of General Counsel currently. is reviewing this issue and, therefore, this approach in the Policy Statement and the implementing procedures may be subject to change. We have also included a second copy of the 10 CFR tables which show the compatibility or adequacy designation assigned by the Group using the Policy Statement as well as the compatibility designation assigned under the 8.7 Procedure or determined from Statements of Consideration. The Group believes that this second set of tables will be useful to staff during their review process, as well as for the Commission when they receive the final SECY paper and reconnends that it is transmitted to them. The Group will be available to help resolve any comments received during the review process prior to transmittal to the Commission. ATTACHMENT C
Richard L. Bangart AUG 21 mi I 2 Finally, because of the importance of this Policy Statement to the Agreement States, the Group recommends that the States have the opportunity to provide i consnents prior to finalization of the Policy Statement and implementing procedures.
. Sincerely, j
DA$lMUk.haab$u CardeliaH.Maupin,Sr.ProjectManager
&b // lb '
Aubrey V/ Godwin, bir'ector Office of State Programs, NRC Arizona Radiation Regulatory Agency , Co-Chair, Adequacy and Compatibility Co-Chair, Adequacy and Compatibility j Working Group Working Group, effective 7/19/96 i- /1Av 0? , Hampton H. Newsome, III,-Attorney Robert R. Kulikowski, Ph.D., Former Office of General Council, NRC Director, New York City Bureau of Member, Adequacy and Compatibility Radiological Health Working Group Co-Chair, Adequacy and Compatibility Working Group, 10/95-7/19/96 hL ' da
~
4 1TchardL. Woodruff,ReffdIalState Roland G. Fletcher,' Ma' nager, Agreements Officer, Region II, NRC Maryland Radiological Health Program Member, Adequacy and Compatibility Member, Adequacy and Compatibility Working Group Working Group
- e. ,
Qi l'dfj?L) b ad y/f my JohnL.Tel' ford,SenhorProgramManager, Paul H. Lohaus, Deputy Director. Office of Nuclear Regulatory Research, Office of State Programs, NRC NRC Resource Representative to Meinber, Adequacy and Compatibility Adequacy and Compatibility Working Group Working Group
Enclosures:
As stated
i REPO'sT OF THE JOINT NRC-AGREEMENT STATE
- WORKING GROUP l FOR DEVELOPMENT OF i IMPLEMENTING PROCEDURES
$ FOR l l THE FINAL POLICY STATEMENT ON- l l ADEQUACY AND COMPATIBILITY ! l OF AGREEMENT S" ATE PROGRAMS I i l August 21,1996 i l l
TABLE OF CONTENTS 1.0 Ex e cutive Summary . . . . . . . . . .. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . .. . . . . . . . . . 1 2.0 Purpose and Function of the Adequacy and Compatibility Working Group ...................2 2.1 sackground.........................................................................................................2 2.2 Purpose.............................................................................................................2 2.3 Working G roup Members .. . .... .. ..... ..... ...... .. . . .. ......... .... ..... . .... . . ... . .. ... .. .. ..... ... ... .. . 2 2.4 Working Group Meeting s . . . .................. . . ... ..... ....... ............. . ........ .... ..... .. .... ......... 2 2.5 Selected Pee r Review . . ... .. ... .. .. .. .. .. .. ... . . .. . .. . . . . . . . . . . .. . . . ... ...... ... .... . ..... . . . . ......... .. . 3 3.0 Approach and Classification Process Followed by the Working Group ........................3 3.1 Approsch................................................................................................3 3.2 Classification Criteria - Compatibility Components ............. ................... ..... .... 4 3.2.1 Background . ... ....... ... ... . .. . . ... ...............................4 j 3.2.2 Compatibility Component Criteria ............... . ... . .. ........ ............. ....... 4 3.2.2.1 Compatibility Component 1 .......... . ..... ................... . ... 5 3.2.2.2 Compatibility Component 2 ... ......... .......... . ........ ...... .. 5
)
3.2.2.3 Compatibility Component 3 .... ......... ...................... ...... 6 3.2.3 Discussion of Component 3 Criteria . .. ....... . .. ............ .... .......... ......... 7 3.2.3.1 Ba ckgroun d . . .. . . . . . . . . . . . . . . . . . . .. . ... . . .. . . ... . . .... . . . . .. . . . ... . . 7 3.2.3.2 Compatibility Component 3.s .... ....... ............. .......... ... 7 3.2.3.3 Compatibility Component 3.a.S ............. ......................... 8 3.2.3.4 Compatibility Component 3.b ........................... .. . ......... 8 3.2.3.5 Compone nt 3. c . . . . .. . .. . . . . . . .. . .. .. .. . ... ... .. . .. ... . ... .... . .. ...... 8 3.3 Classification Criteria - Health & Safety Component .. . ................ .................... 8 3.3.1 Backg rou nd . . ... . .. . .. . ..... . . . . .. . . .. .. . . . . . . .. . . . . . . . ................................8 l
i. l I' 3.3.2 Health & Safety Component Criteria .....................................................9 { 3.4 Cla ssification Process ........... . ... .. ..... ... . ... . .... .... .. ........ .. .. .. ....... ... .. .... . .. .. .. . . . . .. . .. 10 4.0 Policy Statement issues Requiring Clarification ........................................................... 10 4.1 Clarifying the Distinchon between the terms " Adequacy and " Compatibility .......11 4.2 Regulates Required for the Purposes of Health & Safety ..............................12 4.3 Regulations outside Agreement State Jurisdiction .......................................... 13 l 4.4 Use of the Term "Public Dose Limits" ................................................. ............. 13 i 4.5 Clarification for Regulations and Program Elements That Must be at Least as Strin9ent as Those of NRC ............................................................ 13 4.6 Effe ct of Compatibility . .... . ..... ........ .. . ... .. . ... .. ... .. ........... ........ . ....... .. ...... . . . . .. . ...... 13 4.7 Formatting Changes for the Compatibility Components .................................... 13 4.8 Additional Recommended Changes .................................................................. 13 5.0 Implementation issues and Concoms........ .................................................................. 14 5.1 Use of Management Directive 5.9 and Handbook 5.9 ..................................14 5.2 Time Frame for Adopting Commission Regulations and Program Elements......................................................................................................14 5.3 Number of Licenses Warranting Development of Regulations .........................15 5.4 E s s e ntial Obje etive s . . .. ... .. ...... ........ .. ........ . ... ....... .... .. ........... ..... .. ..... . . . ...... ..... . . 15 5.5 Future NRC Regulations and Program Elements ................. ........................... 16 6.0 Products Generated by the Working Group ................................. . .... ......................... 16 6.1 M a na ge me nt Directive 5. 9 .............. ............ .............. .. ........ .. ... ........ ... ..... ........ 16 6.2 Handbook 5.R.................................................................................................16 6.3 Classification of Program Elements and Regulations .....................................16 7.0 Number of Regulations Required Under the Policy Statement Compared to Number Required Under Past Procedures ............................................. 16 8.0 Working Group Recommendations ................................................................. ............. 17 i
9.0 Attachments.................................................................................................................18 Attachment 1: Working Group Charter
- 4
; Attachment 2: Revisions Recommended to the Policy Statement Attachment 3: Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs."
Attachment 4: Handbook 5.9," Adequacy and Compatibility of Agreement State 4 Programs." 1,- Attachment 5: OSP Intemal Procedure B.7 (Revision 1), " Compatibility and Health and Safety Component Classifications for NRC Regulations and Program. 4 Elements." 1 I 1 i 1 i I 1 I . 1 1 4 i 1 I, I
- iii
. .._ . . - _ . . - . _ - . . _ . . - - - - - - - _ ~ _ _ _ - _._ - .- _ - - . _ . -
i l 1.0 EXECUTIVE
SUMMARY
This report describes the activities of the Joint NRC-Agreement State Working Group for !
- Development of implementing Procedures for the Final Policy Statement on Adequacy and ;
j Compatibility of Agreement State Programs. The report outlines the purpose of the Working < Group and why it was fonned, as well as administrative issues such as membership, meetings i j and interactions with other individuals. The Charter of the Working Group that identifies the i j scope of work and the milestone schedule is included as Attachment i to this report. j in developing implementing procedures for the Policy Statement, the Working Group identified l those parts of Title 10 of the Code of Federal Regulations that were applicable to the 1 j Agreement States' regulation of agreement material and a list of program elements derived from ]
- the set of indicators contained in the NRC general statement of policy on " Guidelines for NRC Review of Agreement State Radiation Control Programs." These regulations and program
- elements were analyzed and each was classified as outlined in the Policy Statement. These
! classifications were based on criteria developed by the Working Group to facilitate the classification process and to help ensure consistency in the decision-making process. I i During its deliberations, the Working Group concluded that there were certain regulations that j would not be required for compatibilMy pursuant to the Policy Statement but, nonetheless, would have a significant health and safety function within the State. In view of this, the Working Group expanded its classification criteria to identify explicitly those regulations that it considered
- necessary to maintain protection of public health and safety.
- The Working Group drafted implementing procedures for the Policy Statement and these are
! contained in a new management directive and its associated handbook. The management j directive provides guidance to staff on how to apply the policy in making a determination on ! whether an NRC requirement or program element is required in an Agreement State program i for purposes of compatibility or health and safety. Each applicable Part of 10 CFR and each { major program element with its compatibility or health and safety component assignment is contained in the Office of State Programs intemal Procedure B.7 (Revision 1)," Compatibility ! and Health and Safety Component Classifications for NRC Regulations and Program Elements." i ! In addition to the major issue of whether the Commission should require Agreement States to adopt the essential objectives of certain regulations for the purposes of health and safety, the
- Working Group identified several other issues associated with the Policy Statement or the j implementing procedures and that are described for Commission consideration and approval.
i in conclusion, the Working Group recommends that the revisions to the Policy Statement and , the implementing procedures be sent to all the Agreement States and other interested parties for comment before final approval by the Commission. l l i 1 1 4 1 i T l
. . - - . . = . _ _ _ - - - - - _ - . - - .. - _ - - . - -- _ . - -
2.0 PURPOSE AND FUNCTION OF THE JOINT NRC AGREEMENT STATE WORKING l GROUP FOR DEVELOPMENT OF IMPLEMENTING PROCEDURES FOR THE FINAL POLICY STATEMENT ON ADEQUACY AND COMPATIBILITY OF AGREEMENT ! STATE PROGRAMS (Working Group)
2.1 Background
On May 3,1995, NRC staff submitted the " Final Policy Statsment on Adequacy and Compatibility of Agreement State Programs"(Policy Statement) for Commission review and approval. By a Staff Requirements Memorandum dated June 29,1995 (SRM), the Commission approved the Policy Statement, but disapproved implemcMation of the Policy Statement until implementing procedures were finalized, in addition, the Commission recognized that some minor changes may result after the development of the implementing procedures and directed the staff to resubmit the Policy Statement, along with the implementing procedures, to the Commission for final approval. The staff was also directed to consider the comments on the Commissioners' vote sheets in carrying out these actions. 2.2 Purpose A working group consisting of officials from Agreement States and from the Nuclear Regulatory Commission (NRC) was fonned in October 1995 to respond to Commission direction in the SRM to develop implementing procedures for the Policy Statement. The Working Group developed a charter that identified (1) the scope of work it was to perform and (2) a list of tasks to be accomplished, and (3) a milestone schedule. A copy of the charter is appended as Attachment 1. 2.3 Working Group Members Members of Working Group were: Cardelia H. Maupin (NRC Office of State Programs) and Robert R. Kulikowski, Ph.D. (New York City) as co-chairs representing the NRC and Agreement States, respectively; Roland Fletcher (Maryland); Aubrey Godwin (Arizona); Hampton Newsome ' (NRC Office of the General Counsel); John Te' ford (NRC Office of Nuclear Regulatory Research); and Richard Woodruff (NRC Region 11). Paul Lohaus (Deputy Director of the NRC Office of State Programs) served as a resource representative. Robert Kulikowski resigned from j the New York City radiation control program effective July 19,1996, before all of the Working Group's tasks had been completed; however, he continued to serve the Working Group as a resource representative. Aubrey Godwin was elected to replace Robert Kulikowski as the co-chair from the Agreement States until the group had completed its work. 1 2.4 Working Group Meetings The Working Group convened six " face to face" meetings that were announced in advance on the NRC Public Meeting Notice System. The meetings were open to the public and Working Group products were made publicly available in the NRC Public Document Room. The Working Group met initially on November 1 and 2,1995 in Chicago, Illinois, in conjunction with the annual NRC All Agreement States Meeting. All subsequent Working Group meetings were held , at NRC Headquarters in Rocy'le, Maryland. I f 2 i
i ! In addition, the Wortung Group held 15 conference calls to discuss its work. These conference } calls also were announced on the NRC Public Meeting Notice System and members of the j public were invited to participate. Conference room space at NRC Headquarters and at the j Arizona Radiation Regulatory Agency (4814 South 40th Street, Phoenix, Arizona 85040) was i reserved for persons wishing to participate by telephone in the Working Group conference calls. l ! Although all meetings and telephone conference calls wors publicly noticed, only the first j :neeting held in Chicago was attended by anyone outside the Working Group. Only members of ! i the Working Group participated in meetings and calls that followed the first meeting. I 2.5 Selected Peer Review in June 1996, the Working Group essentially had completed its review of regulations in Title 10 of the Code of Federal Regulations (10 CFR) and had prepared draft implementing procedure documents. At that time, the draft documents and reviews of specific regulations were sent to a selected group of NRC and Agreement State personnel for preliminary comment and feedback. Staff in the NRC Office of Nuclear Materials Safety and Safeguards (NMSS) and in the Agreement States of Illinois, South Carolina, and Texas were asked to comment and provide feedback on the criteria developed and how the criteria were applied by the Working Group to assign compatibility components to a limited number of parts of 10 CFR. The Working Group held a telephone conference call with NMSS staff to receive comments and
)
each of the three states submitted written comments. The Working Group considered these in l further deliberations and, where appropriate, incorporated them into the draft documents. Because of the importance of the Policy Statement to NRC and Agreement States and because of the level of interest expressed by the States, the Working Group concluded that the implementing procedures (management directive and handbook) should be transmitted to the Agreement States for comment before the Commission gives its final approval to implement the Policy Statement. Working Group members have indicated that they will be available to resolve comments from the Agreement States and other interested parties. 3.0 APPROACH AND CLASSIFICATION PROCESS FOLLOWED BY THE WORKING GROUP 3.1 Approach in developing the implementing procedures for the Policy Statement, the Working Group's first task was to identify Commission regulations and program elements that were applicable to the Agreement States' regulation of agreement materials. Initially, the Working Group examined all parts of 10 CFR on a part by part basis. Those parts that were applicable to States' regulation of agreement materials were analyzed subsequently on a section by section basis. The Working Group addressed all applicable final rules published in the FederalRegisfer through July 31,1996. To identify program elements, the Working Group began with the set of indicators contained in the NRC general statement of policy on " Guidelines for NRC Review of Agreement State Radiation Control Programs." Indicators that were not progra- ^!ements were not used and additional program elements not contained in this set of indiez ; were added to arrive at the 3
list of program elements in the chart in OSP Intemal Procedure B.7 (Revision 1),' Compatibility and Health and Safety Compenent Classifications for NRC Regulations and Program Elements." Using the three-component approach outlined in the Policy Statement, the Working Group analyzed the regulations and program elements and assigned a compatibility component to each. To assist in the proces of assigning compatibility components and to help ensure consistency in its decisions, the Working Group developed a set of criteria for each ::ompatibility component and constructed a flow chart to guide the application of the criteria. During its soctson by section analysis of 10 CFR parts, the Working Group identified a number of regulations tast did not meet the criteria for compatibility requirements, but that it considered to be integral components of a radiation control program because of health and safety significance. After deliberation on how to address this issue, the Working Group decided to include a new category of regulations in its overall analysis of NRC regulations. The Working Group's rationale for its approach is discussed fully in Sections 3.2 (Classification Criteria - Competibility Components) and 3.3 (Classification Criteria - Health and Safety Component) of this report. 3.2 Classification Criteria - Compatibility Components 3.2.1 Background The Policy Statement defines a compatible Agreement State program as follows: l An Agreement State radiation controlprogramis compatible with the Commission's regulatory pmgram when its program does not create conflict, duplication, gaps, or other conditions whichJeopardize an orderly pattem in the regulation of agreement material on a nationalbasis. The Working Group initially developed compatibility classification criteria using this definition and the three component approach to implementing this definition set forth in the Policy Statement. Based on the Policy Statement, the Working Group concluded that the requirements for compatibility focus primarily on the effects of State action or inaction either on the regulation of agreement material on a national basis or on other States. As such, the concept of compatibility does not directly address matters of health and safety within a particular Agreement State. Such matters are addressed under adequacy. In addition, however, the Working Group realized that certain regulations, while important for health and safety reasons within the State (e.g., basic radiation protection standards), should be consistent nationwide primarily for the purpose of compatibility. 3.2.2. Compatibility Component Criteria Each of the three compatibility components in the Policy Statement are cited below. Following each excerpt from the Policy Statement as listed below, the Working Group has provided examples or, in some cases, a brief explanation ofits application of the specife sections of the Policy Statement. (Criteria that are quoted directly from the Policy Statement are indicated by italics.) in addition, changes to the Policy Statement that are being recommended by the Working Group are indicated in these quoted excerpts as follows: language to be deleted is 4
indicated by etniseewt and language to be added is indicated by leelne The complete text of the proposed revision of the Policy Statement is appended as Attachment 2. 3.2.2.1 Compatibility Component 1 The Agreement State should adopt basic redation protecbon standards, and the dose litnits in 10 CFR 61.41, that are essentially idernical to those of the Commission, unless Federet statutes provide the State authority to adopt dWorent standards. The term
- basic radiation protec6on standards
- means puMe dose Hmits and redation pmtection related concentration and release Nrnits in 10 CFR Part 20 that are applicable to allMcensees.
The Agreement State should also adopt, in an essentially identical tbrm, a Mmrted number of deRnitions, signs, labels, and scientiHc terms which are necessary for a common understanding of redation protechon principles among Mcensees, regulatory agencies, and members of the public.* Examples include, but are not necessarily limited to: e public dose limits (e.g.,10 CFR 20.1301) plus any regulation that directly relates to these dose limits e concentration and release limits e occupational dose limits (e.g.,10 CFR 20.1201) plus any regulation that directly relates to these dose limits e dose limits in 10 CFR 61.41 e radiation symbol e caution signs and labels e scientific terms (e.g., Systeme intemationale and conventional units, definitions of types of radioactive material) e definitions needed for common understanding (e.g., restricted area, year, stochastic). 3.2.2.2 Compatibility Component 2 l l The Agreement State should adopt regulations essentiallyidentical to those of l the AIRC Conassion for those areas of regulation that are related to activities l Involving signi6 cant transboundaryimplications. Itis the Commission's intent to limit this category to a sinali number of regulations (e.g, transportation l requirements) that directly involve such activities, i Examples include, but are not necessarily limited to: e transportation requirements (e.g., LLW manifests, packaging requirements, etc.) 5
l o requirements for approval of products that are distnbuted nationally (e.g., sealed sources and devices) l e ! definitens of products (e.g., sources and devices) that are routinely transported i by licensees in multiple jurisdictions. 3.2.2.3 Compatibility Component 3 For all other requietions and elements, the Conmssion wRIapply the foHowing approach: l a. The Agreement State shouM adopt andimplement essential objechves of certain Commission regulations andpmgram elements (e.g., reciprocrty procedures) that an important for en Agreement State to have in order to avoid conthct, duplication, gaps, or other condrbons whichjeoperdize an orderly pattem in the regulation of agreement meterial on a national basis. Such Agreement State regulations orpmgram elements neednot be identical to the corresponding Commission regulations orprogram elements;in a few cases involving *?~ statutory direcGon, howent, Agreement State regulations muet ~~~ shouM
~ ~
be at least as shingent as that those of the Commission;
- b. The Agreement State shouM have Mexibility to adopt andimplement Commission regulations and program elements in addition to those necessary to maintain compatibility, as identi5 edin B.1, B.2, and B.3.a above [ NOTE: B.1, B.2 and B.3.a are designated Sections 3.2.2.1, 3.2.2.2 and 3.2.2.3 (paragraph a), respectively, in this report.); and
- c. An Agreement State may adopt andimplement other regulations and elements within the State'sjurisdiction that are not addressed by NRC.
AII regulations covered under this third component muel abouM be compatible with those of the Commission (i.e., muet shouM not create conMict, duplication, gaps, or other conditions whichjeopardize an orderly pattem in the regulation of agreement material on a nationalbasis). In addition, Agreement Stele regulations orprogram e6ements covered under this third component should not be adopted oiimplemented in such a manner that the State: ahe precludes, or etFectively precludes, a practice within the nationalinterest without an adequate public health and safety or environmental basis related to radiation protection (for agreement material); or e-o precludes, or effectively precludes, the ability of the Commission to evaluate the et>ctiveness of the NRC and Agreement State programs 16ragreement material with respect to protection of public health and safety. 6
i 1
- 3.2.3 Oscussion of Component 3 Criteria l 3.2.3.1 Background I The criteria used to assign regulations and program elements to either Component 1 or j Component 2 are straightforward and, by their nature, are clearly evident from the Policy
, Statement. However, criteria for the third compatibility component are more subjective and not i explicitly defined by the Policy Statement. This section contains a discussion of the l considerations used by the Working Group to determine which NRC regulations and program j elements were assigned to the third compatibility component. j 3.2.3.2 Compatibility Component 3.a , This is the compatibility component assigned to NRC regulations and program elements, the
- essential objectives of which should be adopted and implemented as legally binding
, requirements (LBRs) by Agreement States to avoid conflict, duplication or gaps. The ! Agreement State LBR need not be identical to the corresponding NRC regulation or program l element, and indeed may be different, as long as the essential objectives are met. The Policy Statement uses the phrase " conflict, duplication, gaps." The Woming Group
- developed several definitions and criteria to help it apply this phrase to specific regulations and j program elements of NRC.
i e con #ict means the essential objectives of regulations or program elements are different and an undesirable consequence is likely to result in anotherjurisdiction or in the regulation of agreement material on a national basis e duplication means identical regulations or program elements apply to the same l material at the same time (Note: this definition applies primarily to the review of l Agreement State regulations by NRC staff.) e gap means the essential objectives of NRC regulations or program elements are absent from the Agreement State program and an undesirable consequence is likely to result in another jurisdiction or in the regulation of agreement materials on a national basis Examples of undesirable consequences referred to under con #ict and gap (above), include, but are not necessarily limited to: e exposure to an individualin a different jurisdiction in excess of the basic radiation protection standards in Compatibility Component 1, above; e undue burden on interstate commerce (e.g., additional recordkeeping or training requirements); e preclusion of an effective review and/or evaluation by the Commission of the NRC and Agreement State programs for agreement material with respect to protection of public health and safety; e preclusion of a practice in the nationalinterest; 7
i
- e absence or impairment of effective communication; l e lack of minimum level of safety for agreement material- containing products
' distributed nationally; 1
- e disruption of regulation of agreement material on a national basis.
3.2.3.3 Compatibility Component 3.a.S i This is the compatibility component assigned to NRC regulations, the essential objectives of i which must be adopted and implemented by Agreement States with legally binding
- requirements (LBRs) that am at least as stringent as NRC.
t i
- A regulation required by statute where Agreement States are permitted to differ i
! from that of NRC only with requirements that are more stringent than those ; j established by NRC (e.g., the federal Clean Air Act, the Uranium Mill Tailings l l Radiation Control Act) , i 3.2.3.4 Compatibility Component 3.b ] l This is the compatibility component assigned to NRC regulations and program elements that do j not meet the criteria of Components 1,2,3.a or 3.a.S and, therefore, do not need to be adopted ! and implemented by Agreement States for purposes of compatibility. See, however, Section 3.3, below. i i 3.2.3.5 Component 3.c , This category identifies those regulations and/or program elements that are adopted and ! implemented by an Agreement State radiation control program, but that are not addressed by l NRC in its regulations or program elements. ! All regulations and program elements, covered by components 3.b and 3.c, above, when ) i adopted by an Agreement State should not: (1) create conflict, duplication, gaps as identified above; (2) preclude a practice in the national interest; or (3) preclude the ability of the Commission to evaluate NRC and Agreement State programs for agreement materials with i respect to protection of public health and safety. 3.3 Classification Criteria - Health and Safety Component 3.3.1 Background The Working Group initially reviewed NRC regulations Ond program elements solely to assign a each to a compatibility component. For those NRC reguations not required for compatibility pursuant to the general criteria of the Policy Statement, Agreement States would be able to determine whether or not they would be adopted, i.e., no specific regulations would be required other than for the purpose of compatibility. However, during this process, the Working Group concluded that there were certain regulations that are not required for compatibility pursuant to the Policy Statement but, nonetheless, have a tnificant health and safety function within the State. The Working Group noted that the Policy Statement indicates that Agreement States l l 8
should have legally binding requirements in order to ensure adequate protection of public health and safety. The following language is quoted from the Policy Statement section on adequacy-In addition, the State should have existing legally enforceable measures such as generally applicable rules, license provisions, or other appropriate measures, necessary to allow the State to ensure adequate fi.-M&n of the public health and sakty in the regulation of agreement materials in the State. The Draft Policy Statement for Agreement State Adequacy and Compatibility (see SECY 349, December 21,1993) notes that the specific regulations that should be required for adequacy were to be determined from a comprehensive analysis of the Commission's regulations. However, the final Policy Statement did not appear to address the applicability of adequacy to regulations in a specific way. The Working Group expanded its classification criteria to identify explicitly those regulations 'and program elements that it concluded were needed to maintain public health and safety. These have been identified in the tables in OSP Intemal Procedure B.7 (Revision 1) by the designation "3.b'" signifying that they are not required for purposes of compatibility (indicated by the 3.b), but that they are of health and safety significance for the regulation of agreeme, # 1sterial within a State and, therefore, should be addressed by the Agreement State (indicated by the asterisk). Because of the health and safety implications of this category of requirements the Working Group believes that the State should adopt the essential objectives of the NRC requirement through an LBR. Additionally, the Working Group also believes in this case that the State should have flexibility to adopt a regulation or program element that is more, but not less, stringent than NRC. The Working Group also concluded that the Policy Statement should be revised to include this category of regulations although it is not strictly a compatibility issue. The Working Group further concluded that the absence of one or more of such regulations would not necessarily result in a finding that a State is not adequate to protect public health and safety; the overall finding of adequacy and compatibility is to be determined by the Integrated Materials Performance Evaluation Program (IMPEP) process (see also Sections 4.1 and 4.2, below). 3.3.2 Health and Safety Component Criteria in making the determination of which regulations should be included in this component, the Working Group assigned a regulation to this component if (1) it failed to meet all of the compatibility criteria and, therefore, would be categorized 3.b on this basis and (2) its absence in an Agreement State program could directly result (i.e., two or fewer failures') in exposure to an individualin excess of the basic radiation protection standards identified in compatibility component 1.
' The concept embodeed by "two or fewer failures
- is that if the essential objectives of the regulation were not adopted and implemented in a legally binding manner, then an event could occur that would not have taken place were the essential objeceves adopted. This alone, or in conjunction with at most one other event, could result in exposure of an individual in excess of limits set by basic radiation protection standards.
i 9 l
3.4 Classification Process The Working Group developed an classification process using a flow chart (Appendix A to ) Handbook 5.g) and the classification criteria discussed in Sections 3.2 and 3.3, above. The basis of the flow chart was a series of questions that are listed below. Each program element and regulation was tested by asking these questions in the order given. The answers to these questions determined the compatibility or adequacy component assigned to each regulation and program element.
- 1. Do the essential objectives of the regulation or program element address a regulatory area reserved solely to the authority of the NRC7 ff the response to the question is 'yes',
the compatibility component is "NRC." If the response to the question is 'no,' then proceed to Question 2.
- 2. Do the essential objectives of the regulation or program element address or define a '
basic radiation protection standard as defined by the Policy Statement or is it a definition, term, sign or symbol necessary for a common understanding of radiation protection principles? If the response to this question is 'yes', the compatibility component is "1." If the response to the question is 'no', then proceed to Question 3.
- 3. Do the essential objectives of the regulation or program element address or define an issue that has a significant, direct transboundaryimplication? If the response to this question is 'yes', the compatibility component is "2." if the response to the question is
'no', then proceed to Question 4.
- 4. Do the essential objectives of the regulation or program element address or define an issue related to UMTRCA, the federal Clean Air Act, or other statute that requires states to adopt regulations that are at least as stringent as NRC7 If the response to this question is 'yes', the compatibility component is "3.a.S." If the response to the question is 'no', then proceed to Question 5.
5. Would the absence of the essential objectives of the regulation or program element from an Agreement State program create a conflict or gap? If the response to this question is
'yes', the compatibility component is "3.a." If the response to the question is 'no', then proceed io Question 6.
6. WouM Ine absence of the essential objectives of the regulation or program element from an Agreement State program create a situation that could directly result in exposure to an individualin excess of the basic radiation protection standards found in compatibility component 17 ff the response to this question is 'no', then the compatibility component is *3.b." If the response to this question is 'yes', the health and safety component is "3. b* .* 4.0 POLICY STATEMENT ISSUES REQUIRING CLARJFICATION As directed by the Commission, the Working Group concluded that several portions of the Policy Statement should be clarified to reflect the implementing procedures. Some portions of the Policy Statement also were revised based upon guidance provided in the Commissioners' vote sheets accompanying the SRM. Other changes were editorialin nature. The details of the Working Group's substantive changes are discussed below. 10
i J 1 j 4.1. Clarifying the Distinction Between the Terms " Adequacy" and " Compatibility" t i After review and discussion of the final and draft Policy Statements, the Working Group l concluded that the distinction between the terms " adequacy" and " compatibility" should be l clarified and emphasized in the Policy Statement. The term " adequacy" refers to an Agreement i State's protection of public health and safety within a particular state. This represents the core i goal or purpose of an Agreement State's radiation protection program. " Compatibility," on the + other hand, relates to the effects that an Agreement State program's actions or inactions have , on the regulation of agreement materials on a national basis or in another state. The distinction between the two terms was described in the draft Policy Statement (59 Federal i Register 37269, July 21,1994). Although the final Policy Statement does not contain an explecit ! description of this distinction, such a distinction is implied by the Policy Statement's structure. i Without this explicit description in the final Policy Statement, the Working Group encountered ! difficulties in applying the terms " adequacy" and " compatibility." The Working Group . l recommends that additional language, in the form of an another paragraph in the Background l I section, be added to the final Policy Statement to clarify the distinction discussed here. ) i l ! The Working Group believes that this clarification is necessary in order to help ensure l consistent application of the policy in the future. The distinction between the two concepts I creates a clear means to view NRC's approach to Agreement State reviews. For instance, NRC probably would not require an Agreement State to adopt identical requirements for the purposes j of adequacy. In other words, Agreement States could be more stringent than NRC under j adequacy, in considering compatibility, however, NRC can choose to require Agreement States ! to adopt identical regulatory provisions in those cases in which consistency is needed as l indicated in the Policy Statement, notwithstanding the health and safety function of the j regulation. ! ~ l The Working Group also believes that this approach is consistent with the draft Policy Statement, the final Policy Statement, and the legislative history of Section 274 of the AEA. As . discussed in more detail in the Federal Register notice prepared for the final Policy Statement j (see SECY 95-112), the legislative history suggests that the purpose of compatibility is the avoidance of conflict, duplication, and gaps caused by an Agreement State program and the facilitation of uniform basic radiation standards across the country. Both of these considerations suggested by the legislative history involve an Agreement State's relationship to other states and to NRC (i.e., the extemal or nationalimpacts of an Agreement State program). Accordingly, the concept of compatibility clearty involves issues related to the impact that an Agreement State program has on the regulation of agreement material on a national basis or in another State. The Working Group believes that this approach to compatibility, which focuses on the national impacts of an Agreement State program, has a sound policy basis consistent with statutory guidance. The primary purpose of an Agreement State program is the protection of public health and safety within that particular state. These public protection concems reflect the core ' goal of any regulatory agency concemed with safety. Given their legal and functional responsibilities, Agreement State regulatory cgencies have a clear incentive and duty to protect the citizens of that State. NRC reviews Agreement State actions in this regard under adequacy. The impact that an Agreement State program has on a national basis, however, may not always occupy that same position of importance as does the more immediate concem of public health 11 l
1 ! and safety within the State. For example, Agreement States generally would not focus the ! emphasis of their efforts on such issues as (1) the need for consistent transportation i requirements, (2) the need for clear communication of radiation protection principles across the ! country, (3) the goal of avoidir.g unreasonable burdens on firms operating in multiple states, and ! (4) NRC's need to conduct effective and efficient reviews of Agreement State programs. j Clearty, Agreement States do consider the impact of their programs on other states or on the i nation as a whole. However, the same incentives and pressures that drive the regulation of i public health and safety within the state do not exist in relation to the effects of the Agreement l State's program on a national basis. Accordingly, the type of NRC oversight in the area of
- compatibility as reflected in the new Policy is justified in order to ensure that Agreement State programs reflect these national concoms.
l
- The Working Group concluded that it is important to emphasize and explain the distinction between the concepts of adequacy and compatibility in order to make it easier to implement the j Policy in the future. The Working Group further noted that there is some overtap between the
- coverage of these two concepts. Regulations that are required for purposes of compatibility 4
according to the Policy Statement are, nonetheless, important to have for ensuring the protection of public health and safety. Because the process that the Working Group used to j categorize regulations and program elements addressed compatibility issues before health and i safety issues, regulations that have important health and safety bases and that meet the i compatibility criteria are required for compatibility purposes. While not dismissing the health j and safety significance of such regulations, the Working Group interpreted the Policy Statement
- to mean that there were compelling reasons to have certain regulations consistent throughout j NRC and Agreement State jurisdictions, e.g., those designated as compatibility component 1.
l j 4.2 Regulations Required for Purposes of Health and Safety
- As discussed in Section 3.3, above, the Working Group concluded that certain regulations in 10 l CFR were of health and safety significance for the regulatio 1 of agreement material within a State and that the essential objectives established by those regulations should be required of Agreement States. To reflect this in the Policy Statement, the Working Group proposes additional language to be added to the last paragraph in the section on legislative and legal authority.
Although no changes to the Policy Statement appear to be needed to address this topic other than those discussed above, IMPEP procedures may need to be modified to incorporate the health and safety regulations into the IMPEP review process if this approach is approved by the Commission. Specifically, the Working Group viewed that adoption and implementation of regulations and program elements in this health and safety component by an Agreement State should be addressed in a manner similar to that used for other performance indicators in IMPEP For example, the non-common performance indicator 't.egislation and Regulations
- could be modified to include how the State has addressed adoption of regulations and program elements in this component and this finding would be factored into the overall adequacy determination made for the State. This approach would be consistent with that used for i performance indicators such as licensing or inspections, where there is some judgment exercised in assessing the covered activities to support a finding of " satisfactory."
12
- _ ~ . _ . _ _ _ - - - . . .
4.3 Regulations Outside of Agreement state Jurisdiction The Working Group also identified NRC regulations that involve matters outside of the jurisdiction of the Agreement States. The Policy Statement does not specifically address this issue. As indicated in the attached criteria and procedures, the Working Group assigned the designation "NRC" to such regulations. Although the Working Group does not recommend any changes in the Policy Statement to address this particular issue because jurisdictional limitations are clear from NRC's statutory authonty, this issue will be addressed in the specific implementing procedures found in Handbook 5.g to Management Directive 5.g. 4.4 Use of the Term "Public Dose Limits" in discussing Component 1 of the compatibility section, the Policy Statement indicates that the term " basic radiation protechon standards" means public dose limits and radiation protection , related concentration and release limits in 10 CFR Part 20 that are applicable to all licensees. ! To avoid confusion regarding the applicability of occupational dose limits, the working group l recommends that the word "public" be eliminated from this description so that the meaning of ;
" basic radiation protection standards" applies to all dose limits, both public and occupational.
4.5 Clarification for Regulations That Must be at Least as Stringent as Those of NRC A clarifying phrase was added to paragraph a. of the third compatibility component. During Working Group meetings, the reason for indicating that a limited number of Agreement State regulations had to be at least as stringent as NRC was identified as being based in the federal Clean Air Act (40 CFR Part 61, Subpart I rescissio1 issues). Therefore, the Working Group designated as component 3.a.S those regulations rouired by statute (e.g., the federal Clean Air Act, the Uranium Mill Tailings Radiation Control Act) and proposes this clarifying change to the Policy Statement. 4.6 Effect of Compatibility The Working Group proposes to add one sentence at the end of the description of the third compatibility component to clarify that although a State's program is compatible, the State still has an explicit obligation to maintain an adequate program. 4.7 Formatting Changes for the Compatibility Components Finally, the working group recommends some minor formatting changes to the Policy l Statement. These changes are: (1) replacing "NRC" with the word " Commission" in the l description of the second compatibility component; and (2) designating items "d." and "e." with bullets to reflect that they are not part of the series of items encompassed by "a." through "c." in the description of the third compatibility component. 4.8 Additional Recommended Changes As notsd in Commissioner Rogers' vote sheet, the Working Group recommends adding his suggested footnote for Compatibility Component 1 to ensure consistency with the Commission's decision in the low level waste area to allow Agreement States flexibility to establish pre-closure operational release limit objectives, ALARA goals or design objectives at levels the State deems 13
I i l necessary or appropriate as long as the level of protection is equivalent to that provided by the ! Commission. i I 5.0 IMPLEMENTATION ISSUES AND CONCERNS I 5.1 Use of Management Directive 5.9 and Handbook 5.9 i Management Duvetive 5.g, ' Adequacy and Compatibility of Agreement State Programs," and its i associated handbook descnbe the criteria and approach that is to be used to assign compatibility and health and safety components to NRC regulations and prog am elements. The results of such classifications are tabulated in OSP Intemal Procedure B.7 (Revision 1). l Agreement State regulations and program elements that are required for purposes of compatibility or health and safety are reviewed by NRC staff in accordance with OSP intemal Procedure D.7, " Procedure for Reviewing State Regulations." The results of such reviews for a ' particular state are provided to the Agreement State at the time the staff review is completed and are used by the IMPEP team at the time of the State's next program review and this ! information is factored into the overall adequacy and compatibility finding for the State in
.accordance with Management Directive 5.6, " integrated Materials Performance Evaluation l Program."
5.2 Time Frame for Adopting Commission Regulations and Program Elements The Working Group considered the appropriate time frame for the adoption of NRC regulations j ' by Agreement States. Under current policy, this time frame is 3 years; however, this is not based in any statutory requirement, but rather on experience of the time necessary for a State j to promulgate and adopt a rule under its rulemaking process. Wdh respect to this three (3) year time frame, the Working Group concluded that there is no significant reason to change it. It should be clarified, however, that the effective date of the State regulation should be within ! three years of the effective date of the NRC regulation. The Working Group identified that certain circumstances (e.g., adoption of a basic radiation protection standard or other rule that j will have significant impact on the regulation of agreement material on a national basis, such as the low level radioactive waste manifest) may warrant that the effective date of the rule for both { NRC licensees and Agreement State licensees be the same. , in addition, the Working Group concluded that Commission regulations that have been identified as being required for purposes of health and safety should also be adopted by the Agreement States with an effective date not later than three years after the effective date of NRC's final rule. With sufficient justification, health and safety considerations may warrant adoption by the States in less than the three (3) year time frame in which case concurrent adoption by NRC and the States, as discussed in the preceding paragraph, may be the desirable course of action. The Working Group also concluded that program elements that have been designated as necessary for maintenance of an adequale and compatible program should be adopted and implemented by the Agreement States within six (6) months of such designation by NRC. If, due to other factors, an Agreement State cannot adopt and implement such a program element within the six (6) month time frame, then the State and the Commission will agree upon a mutually acceptable timetable for adoption and implementation. 14
i l 5.3 Number of Licensees Warranting Development of Regulations i The Working Group considered the issue of requiring certain provisions to be adopted in the l . form of regulations. The Working Group believed that, in general, if an Agreement State does . not have any licensees that would be subject to a particular NRC regulation determined to be i required for purposes of compatibility or health and safety, the State should not be required to j adopt or address that NRC regulation. However, if a State were to acquire such a licensee, j then the provisions of the Policy Statement would be invoked and would have to be implemented as described in the handbook to Management Directive 5.9. Similariy, if a State , has not assumed authonty under its agreement to regulate in a given area (e.g., uranium mills) there would be no requirement to adopt or address NRC regulations or program elements in l that area for purposes of compatibility. In addition, the Working Group concluded that, for the reasons provided below, rules designated as required for compatibility should be addressed by Agreement States as regulations rathe'r l than as an attemative legally binding requirement in the following circumstances: i 4^ e the requirement is generally applicable to all licensees; e the requirement is applicable to UMTRCA and LLRW disposal facilities,
- regardless of the number.of licensees regulated by the State; or i e there are four or more materials licenses in the State that would be subject to the regulation.
l The reasons for using regulations in these cases include: i i e to assure consistency in the state's regulatory program over time; e to assure public (including licensee) participation in the development of requirements applied to multiple licensees; e to assure adequate ability to enforce requirements; e reciprocity; e to facilitate NRC review of programs; and e to ensure national equivalency in distribution of products containing agreement material. Otherwise, the Agreement State may adopt the essential objectives of the NRC rule in any manner that is legally binding and enforceable on the licensee. 5.4 Essential Objectives The Working Group noted that the essential objectives of each NRC regulation or program element required for compatibility or health and safety should be addressed by the Agreement State. The essential objective of a regulation or program element means the action that is meant to be accomplished by implementing and following the regulation or program element. In some instances, an essential objective may be a numerical value (e.g., restriction of exposures to a maximum value) or it may be a more general goal (e.g., access control to a restricted area). If the essential objectives are not readily apparent or discemible from a source such as the Statements of Consideration, the Working Group believes that the NRC and the States should determine the essential objectives cooperatively. The Working Group recommends that during development of a rule pursuant to Management Directive 6.3, "The Rulemaking Process," the essential objectives of each section of the rule should be identified. 15 I
_m ___ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ . . __ ___ _ _ __._.__ _ . i i .I 1 5.5 Future NRC Regulatione and Program Elements 1 i The Working Group believes that the development and assignment of the compatibility and I health and safety component ( y future NRC regulations or program elements applicable to
- the regulation of agreement rr .Jals should be coordinated with the A0feement States. To j implement the assignment of compatibility or health and safety components of future NRC l regulations, the Working Group recommends that Management Directive 6.3 should be revised
- to require staff to classify proposed regulations in accordance with proposed Managemant
! Directive 5.9. Part of this classification should be the identdicatson of the essential objectives of { each sechon of the regulation.
- In order to facilitate earty and substantive input on draft rulemaking and in accordance with j Management Directive 6.3, the staff should use Handbook 5.9 to assign a proposed
- compatibility or health and safety component for each draft rulemaking plan when it is provided i to Agreement States for comment. Also, as appropnate (i.e., for components 3.a,3.a.S and j 3.b*), the essential objectives should be identified at this time. The staff should evaluate j
j comments, incorporate them as appropriate, and describe the disposition of those comments < i when presenting the rulemaking plan to the Commission for approval.
- 6.0 PRODUCTS GENERATED BY THE WORKING GROUP
) 6.1 Management Directive 5.9 ! The Working Group developed a draft Management Directive that outlines the procedures to 1 implement the Policy Statement in accordance with NRC's Management Directive system. The j management directive and its handbook incorporate the recommendations of the Working Group, as prescribed in this report. The Management Directive is appended as Attachment 3. 6.2 Handbook 5.9 The handbook to Management Directive 5.g describes the criteria and the process that will be used to identify which Commission regulations and program elements should be needed for an adequate and compatible Agreement State Program. The complete handbook is appended as Attachment 4. 6.3 Classification of Program Elements and Regulations The results of the Work Group's analyses of NRC regulations and program elements using the classification criteria and process described in Parts il and 111 of Handbook 5.g are documented in a revision to OSP Intemal Procedure B.7, " Criteria for Compatibility Determinations." The revised version will be designated ' Revision 1" and will be re-titled " Compatibility and Health and Safety Component Classifications for NRC Regulations and Program Elements.* B.7 (Revision 1) should be maintained by OSP and updated at the time a new regulation or program element is adopted. Intemal Procedure B.7 (Revision 1) is appended as Attach:nont 5. 7.0 NUMBER OF REGULATIONS REQUIRED UNDER THE POLICY STATEMENT COMPARED TO NUMBER REQUIRED UNDER PAST PROCEDURES An analysis was performed to oetermine the change in number of regulations required for compatibility under the new Policy Statement compared to the number of regulations required 16
i I for compatibility under past procedures. Overall, there is a decrease in the number of requirements for the Agreement States from 656 to 447 out of 1180. This represents a l decrease from 56% of regulations required solely for compatibility to 38% of regulations j required either for compatibility or health and safety purposes. This is a not decrease of l approximately one-third. No comparison can be made for program elements since these were not required for ! compatibility in the past. i The following table provides further details of these comparisons. .I l I
- j. NEW Ct.ASSIFICATION OLD Ct.ASSIFICATION Number of Regulations by Component Number of Regulations by l Division Total i
i 1 2 3.a. 3.a.S 3.b* 3.b NRC 1 2 3 4 1180 88 105 138 5 111 600 133 298 358 406 118 i 8.0 WORKING GROUP RECOMMENDATIONS The Working Group recommends that its report, which includes: e proposed revisions to the Policy Statement e draft implementing procedures contained in draft Management DirectNe 5.9 and its associated handbook and OSP Intemal Procedure B.7 (Revision 1) be provided to the Agreement States and other interested parties for review and comment before the Policy Statement and implementing procedures are issued in final form. 17 , i I l
9 1 9.0 ATTACHMENTS 18
l l l l l l l
I a l 1 2 Joint NRC-Agreement State Working Group for the Development of 4 Implementation Procedures for the Adequacy and Compatibility Policy
- Statement CHARTER i PURPOSE 1
l A working group consisting of representatives from Agreement States and from the Nuclear Regulatory Commission (NRC) has been formed to respond to Commission direction in Staff l Requirement Memorandum (SRM) dated June 29,1995, which instructed staff to develop ! implementing procedures for the Policy Statement on Adequacy and Compatibility of Agreement j State Programs (Policy Statement). j BACKGROUND i On May 3,1995, the staff submitted the " Final Policy Statement on Adequacy and Compatibility j of Agreement State Programs," for Commission review and approval. In SRM dated June 29, i 1995, the Commission disapproved implementing the Policy Statement until implementing j procedures are finalized. In addition, the Commission recognized that some minor changes j may result after the development of the implementing procedures and directed the staff to - resubmit the Policy Statement, along with the implementing procedures, to the Commission for ! j final approval. The staff was also directed to consider the comments on the Commissioners' j vote sheets in carrying out these actions. 1 The Policy Statement establishes a basis for adequacy and compatibility determinations for ; l Agreement State Programs. The Policy Statement ind: cates that the phrase," adequate to ! protect the public health and safety," in Section 274, is synonymous with the phrase, "provides i reasonable assurance of protection," for purposes of NRC's adequacy determination. An l Agreement State radiation control program is adequate if administration of the program provides
- reasonable assurance of protection of the public health and safety. The level of protection 1
provided by the elements of NRC's program is presumed to be that which is necessary to provide reasonable assurance of protection of the public health and safety. { s The elements of an adequate program have been developed to reflect those which are essential to ensuring protection of the public health and safety, and are consistent with the elements which will be evaluated as common and non-common performance indicators under the Integrated Materials Performance Evaluation Program (IMPEP). The need for consistency with IMPEP was first identired by the Commission in SRM dated April 20,1994, which was issued in response to "SECY-93-349 - Draft Policy Statement for Agreement State Adequacy and Compatibility." The SRM provided the following:
"At the conclusion of the pilot program on the use of common performance indicators (as identified in SECY-94-011) and following considerations of the public comments on the draft Policy Statement and, aspuming that the idea of using common performance indicators is valid, the staff must reconcile the proposed elements of an adequate program with the common performance indicators."
2
i in addition, SRM dated June 27,1995, in response to "SECY-95-047 - Staff Analysis and 1 Recommendations on the integrated Matenals Performance Evaluebon Program," provided, "The staff should assure, to the extent practicable, that the five performance Indicators in SECY-95-047 are the same as those set forth in SECY-95112
- . (proposed Policy Statement on Agreement State Adequacy and Compatibsity)
. with the exception of the first element in the Policy Statement - Legislative and Legal Authonty- which can be treated separatet/." i The Policy Statement identifies five essential elements which an Agreement State Program will i be requested to implement for an adequacy finding: i l 1. Legislation and Legal Authonty; l 2. Licensing; }
- 3. Inspection and Enforcement; l 4. Personnel; and
- 5. Response to Events and Allegations.
} The Policy Statement establishes that the level of protection provided by these elements in an j Agreement State Program should be equivalent to, or more stringent than, the level of j protection provided by the NRC regulatory program for a finding of adequacy. If the element is j implemented in a manner different from the corresponding NRC element, the NRC would determine whether the overall level of protection of the public health and safety provided by the State program is equivalent to, or greater than, the level of protection provided by the NRC program. The Policy Statement also modifies the approach for interpretation of '.he term " compatible" so that it is more consistent with the framework and intent of Section 274. The Policy Statement no j longer treats the term " compatible" as being solely synonymous with the term " identical." l Instead, the Policy Statement has a three component approach to the interpretation of the term
" compatible" predicated on the basic assumption that the term "cor .patible" means consistent or harmonious. The Policy Statement indicates that an Agreement State radiation control program is compatible when its program does not create conflicts, duplication, or gaps and otherwise does not jeopardize an orderly pattem in the regulation of a0reement materials on a national basis.
The Policy Statement recognizes that there are a limited number of requirements and elements of nuclear materials regulation that require a high degree of uniformity from State to State. The Policy Statement also reflects the position that, in most other cases, States would have flexibility to fashion their own programs and to adopt different requirements and elements, or to administer requirements and elements in a manner different from the NRC, to meet individual State needs or preferences. The Policy Statement identifies three basic components for determining Agreement State compatibility:
- 1. The Agreement State should adopt basic radiation protection standards, and the dose limits in 10 CFR 61.41, that are essentially identical to those of the Commission, unless federal statutes provide the State authority to adopt different standards. The term " basic radiation protection standards" means public dose 3
__ _ _ _ . - _ _ _ _ ~ _ _ _ _ _ _ . . _ _ __ _ ___ _ _ _ __ i i limits and radetion protection related concentratson and release Imts in 10 CFR
, Par 120 that are apphcable to all licensees.
The State should also adopt, in an essentially identical form, a limited number of definitions, signs, labels, and scientific terms which are necessary for a common understanding of radiabon protection principles among hoonsees, regulatory agencies, and members of the public.
- 2. The Agreement State should adopt regulations essentally identscal to those of the NRC for those areas of regulation that are related to activities involving significant transboundary implications. It is the Commission's intent to lirnit this category to a small number of regulatons (e.g., transportation requirements) that directly involve such activitses
- 3. For all other regulatons and elements, the Commission will apply the following approach:
- a. The Agreement State should adopt and implement essential objectives of certain Commission regulations and program elements (e.g., reciprocity procedures) that are important for an Agreement State to have in order to avoid conflicts, duplications, gaps, or other conditions which jeopardize an orderfy pattom in the regulation of agreement material on a national basis. Such Agreement State regulations or program elements need not be identical to the corresponding Commission regulations or program elements; in a few cases, however, Agreement State regulations must be at least as stringent as that of the CcJnmission.
- b. The Agreement State should have flexibility to adopt and implement Commission regulations and program elements, in addition to those necessary to maintain compatibility, as identified in 1,2, and 3.a. above; and 1
- c. An Agreement State may adopt and implement other regulations and elements within the State's jurisdiction that are not addressed by NRC.
All regulations and elements covered under this third component must be compatible with those of the Commission (i.e., must not create conflict, duplication, gaps, or other conditions which jeopardize an orderly pattom in the regulation of agreement material on a national basis). In addition, regulations covered under this third component should not be adopted or implemented in such a manner that the State:
- d. precludes, or effectively precludes, a practice within the national interest without an adequate public health and safety or environmental basis related to diation protection; or
- e. precludes, or effectively precludes, the ability of the Commission to evaluate the effectiveness of the NRC and Agreement State Progran;s for agreement material with respect to protection of public health and safety.
Finally, to foster and enhance a coherent and consistent national program for the regulation of agreement material, the Commission encourages Agreement States to adopt and implement similar regulations and program elements which are pattemed 4 a . -
j
' after those adopted and implemented by the Commission.
j SCOPE OF WORK . f The common and norH:c~ r NCe:e indicators of the integrated Materials Performance ! Evaluation Program (IMFM M w! k % adequacy component under the " Policy Statement on Adequacy and Compatibi% 3 m ant State Programs." The efforts of the Working Group will also
- reflect experience obtairE ;,.e..yh Le interim implementation of IMPEP to ensure ease of application l for the Policy Statement implem ..dy procedures when used to conduct Agreement State program
. reviews. In devek ;:ng implementin0 procedures for the Policy Statement, the Wortung Group will l analyze Commission program elements and regulations and determme which program elements and j regulations should be identical and which program elements and regulations an Agreement State should
! incorporate into its program, but may incorporate in a manner different from the NRC, i.e., assign each to ; a compatibility component, as necessary.
i i TASKS
- In development of the implementing procedures for the " Policy Statement on Adequacy and 1
Compatibility of Agreement State Programs," the Working Group will be performing the following tasks:
- 1. Identification of program elements (excludes regulations) which should be considered as j being necessary for compatibility.
i j 2. A. Analyze each NRC regulation applicable to the regulation of certain Atomic j Energy Act (AEA) materials (those covered by an AEA 274b Agreement) and determine the compatibility component to be assigned to each, as necessary. B. Analyze each program element identified in 1 above, and determine the j compatibility component to be assigned to each, as necessary. ) 3. Develop draft implementing procedures for the Policy Statement which address the , following: j A. Regulations necessary for compatibility by Agreement States which should be i adopted by the States with an effective date as soon as possible after adoption i by NRC, but in no case later than three (3) years following the effective date of 1 the NRC final rule. ! B. Program elements (other than regulations) that are needed for compatibility by ! Agreement States within six months of notification by NRC. However, if adoption ! of such an element requires public notice and comment pursuant to an j Agreement State's Administrative Procedures Act, the NRC and the State will 3 establish a mutually acceptable adoption date. i C. Regulations and program elements that are reserved solely to NRC and may not be adopted by the States. i D. i. Development of Commission approved guidance for when an Agreement l j State need not adopt a specific regulation if the State has no licensees ! 1 that would be subject to that regulation. The guidance will provide that in i such cases the State would need to commit to adopt the regulation to , i
- s 1 :
l 4 ' j
1 ! impose the regulation through license condshons or through other legally binding measures, if an application for that type of license were to be t received by the State. )' li. Development of Commission-approved guulance for when an Agreement State may adopt and implement regulatory requirements for specific i classes of licensees, through imposition of the requirement as a Isoonse condebon or through other legally binding requirements (e.g. orders), instead of formal regulations. The guidance will provide that basic } radiation protection standards in 10 CFR Part 20 and other regulations j apphcable to all licensees that are necessary for compatibility should be j adopted by regulation. E. Recommend modifications, including any addshonal areas that should be covered , under IMPEP, as necessary, based upon completed implemenhng procedures. j i i MAJOR MILESTONES Date Milestone December 1,1995 Task 1 complete January 5,1996 Task 2 complete February 21,1996 Brief OAS Executive Committee in preparation for briefing of Commissioners March 15,1996 Tasks 3A, B, and C complete , April 1996 WG Meeting { May 1,1996 First draft of WG report July 1,1996 Tasks 3D and 3E complete August 1,1996 Finalize WG report and WG meeting August 10,1996 WG report to OSP September 30,1996 Transmittal of SECY to Commission 6
COMMITTEE ORGANIZATION AND OPERATIONS Cardelia H. Maupin, NRC, OSP, and Robert R. Kulikowski, New York City have been selected as co-chairs by the NRC and Agreement States, respectively. Other members are Aubrey Godwin, Arizona; Roland Fletcher, Maryland; Hampton Newsome, NRC, Office of General Counsel (OGC); John Telford, NRC, Office of Nuclear Regulatory Research (RES); Richard Woodruff, NRC, Region 11; and Paul Lohaus, NRC, OSP will serve as a resource person. The Working Group collectively will be responsible for devoleping a work plan, monitoring progress, preparing drafts and developing the implementing procedures. Logistical and travel support for Working Group meetings, including travel and per diem expenses for Agreement i l State members, will be provided by the NRC. COMMITTEE MEETINGS Working Group meetings will be announced in advance through the NRC Public Meeting Notice System. Maximum use will be made of other appropriate media for facilitating interaction with the Working Group, e.g., conference calls, facsimiles, and electroriic mail. Workir$g Group meetings will be open to the public and will be held in the Washington, DC area, or other locations as agreed upon by the Working Group members. Persons attending Working Group meetings will be welcome to provide comments to the Working Group for its consideration in either written form or orally at times specified by the Working Group co-chairs. j i 7
1 l i Attachment 2 i l 1 e i 4 1 t
I l Revisions Recommended to the i Final Policy Statement on Adequacy and Compatibility of Agreement State Programs i by The Joint NRC-Agreement State Working Group for Development of implementing Procedures August 21,1996 i
Key-Text to be deleted is indicated by edoewt Text to be inserted is indicated by retEne,; i l l
l POUCY STATEMENT ON ADEQUACY AND COMPATIBILITY OF AGREEMENT STATE PROGRAMS 1 PURPOSE i This Policy Statement presents the Nuclear Regulatory Commission's policy for the determination of the adequacy and compatibility of Agreement State programs established pursuant to Sechon 274 of the Atomic Energy Act (AEA) of 1954, as amended. This Policy Statement is intended to clarify the meaning and use of the terms " adequate to protect the l public health and safety" and " compatible with the Commission's regulatory program" as applied l to the Agreement State program. The Policy Statement also describes the general framework that the Commission will use in determining those NRC elements' that Agreement State programs should implement to be adequate to protect the public health and safety and to be compatible with the Commission's program. Finally, the Policy Statement reflects principles. discussed in the Commission's Statement of Principles and Policy for the Agreement State Program which should be considered in conjunction with this Policy Statement. This Policy Statement is intended solely as guidance for the Commission and the Agreement States in the implementation of the Agreement State program. This Policy Statement does not itself impose legally binding requirements on the Agreement States, in addition, nothing in this Policy Statement expands the legal authority of Agreement States beyond that already granted to them by Section 274 of the Atomic Energy Act and other l relevant legal authority. Implementation procedures adopted pursuant to this Policy Statement l shall be consistent with the legal authorities of the Commission and the Agreement States. l l BACKGROUND The terms " adequate" and " compatible" constitute core concepts in the Agreement State program authorized in 1959 by Section 274 of the Atomic Energy Act of 1954, as amended j (AEA). Subsection 274d. states that the Commission shall enter into an Agreement under l subsection b., discontinuing NRC's regulatory authority over certain materials in a State, l provided that the State's program is adequate to protect the public health and safety and compatible, in all other respects, with the Commission's regulatory program. Subsection 274g. authorizes and directs the Commission to cooperate with States in the formulation of standards , j to assure that State and Commission standards will be coordinated and compatible. Subsection l l 274j.(1) requires the Commission to review periodically the Agreements and actions taken by l States under the Agreements to ensure compliance with provisions of Section 274. In other words, the Commission must review the actions taken by States under the Agreements to ensure that the programs continue to be adequate to protect public health and safety and l compatible with the Commission's program. Bedaon 274 of the AEA requires that Agreement State programs ~be~ both "adeq' uate ~to protect the public health and safety" and " compatible with the Commission's program." These
~~~
separate Dndings should be based, on consideration of two differord oyeckves.1First,_an
' For the purposes of this Policy Statement, " program element" or " element" means any component or function of a radiation control regulatory program that contributes to
} implementation of that program including regulations adopted and promulgated. 1 i l
Agreement State program should provide for an~acceptablehot protection for pubhc health and safety in an Agreement State (the " adequacy" &c.T@e.wa)/ Secondly, the' Agreement, State program should also ensure that its program serves an oversE nehonal interest in radiation protechon (the "compshbikty" component)fAs discussed in more detsu belowl;an;"adequalej program'ahould consist of those reguistions and program elements deemed necessary to _ fnaintain 'an war *% level of protection of the 'pubbe health and asfety.within an Agreement State, fA " compatible" program should consist'of those regulations and program elements d ' eemed necessary by the Commission to? meet.a larger national. interest in radiation protectio]n The requirements for adequacy focus on the protection'c( pubhc health and iinfety within,a particular State, whereas the requirements for compebbihty focus"on the 'eNects of State; action or W States. _enhor on the regulationgegreemen[ materials on s_ nehonsLQ.0Lon_cM - - l A. AMQUACY An Agreement State's radiation control program is adequate to protect the public health and safety if administration of the program provides reasonable assurance of protection of the public health and safety in regulating the use of source, byproduct, and small quantities of special nuclear material (hareinafter " agreement material") as identified by Section 274b. of the AEA. A State radiation control program for agreement material should contain five essential l elements necessary to provide reasonable assurance of protection of the public health and safety. The overall level of protection of public health and safety provided by the elements of a i State program should be equivalent to, or more stringent than, the level of protection provided by the NRC program. The level of protection provided by the elements of NRC's program is presumed to be that which is necessary to provide reasonable assurance of protection of the public health and safety. The Commission will use the five elements, identified below, to define the scope of its reviews of Agreement State programs. The Commission will also consider, when appropriate. l other aspects of an Agreement State program, such as elements or regulations, which appear to affect the program's ability to provide reasonable assurance of public health and safety protection. Such consideration will occur only if concems arise.
- 1. LEGISLATION AND LEGAL AUTHORITY State statutes should:
- a. authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under an Agreement with the NRC;
- b. authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of protection of the public health and safety;
- c. authorize the State to license, inspect, and enforce legally binding requirements such as regulations and licenses; and 2
1
i i i d. be otherwise consistent with Federal statutes, as appropriate, such as Public Law g5404, The Uranium Mill Tailings Radiation Control Act j (UMTRCA). l l 1' . j in addition, the State should have existing legally enforceable measures such as generally applicable rules, license provisions, or other appropriate measures, necessary to i allow the State to ensure adequate protechon of the public health and safety in we regulation of j agreement materials in the State. Specifically,* Agreement States should adoptisfEinited hiimber "
- of Commission regulallons beoeuse'of the particulaf healthand'asfety significancEof mese fuies.l.in adopting these mgulabons, A0reernent States should {mpos_e regaremeniis that;aire al
- !*=t = stanseat a thou of th(Comminim,.
- 2. LICENSING
! The State should conduct appropnate evaluations of proposed uses of agreement
- material, before issuing a license, to assure that the proposed licensee's operations can be j conducted safely. Licenses should provide for a reasonable assurance of public health and
- safety protection in relation to the licensed activities, i
l 3. INSPECTION AND ENFORCEMENT j The State should periodically conduct inspections of licensed activities involving
- agreement material to provide reasonable assurance of safe licensee operations and to I
determine compliance with its regulatory requirements. When necessary, the State should take i timely enforcement action against licensees through legal sanctions authorized by State statutes and regulations.
- 4. PERSONNEL The State should be staffed with a sufficient number of qualified per . nnel to implement its regulatory program for the control of agreement material.
- 5. RESPONSE TO EVENTS AND ALLEGATIONS The State should respond to, and conduct timely inspections or investigations of incidents, reported events, and allegations involving agreement material to ensure continuing reasonable assurance of protection of the public health and safety.
B. COMPATIBlUTY An Agreement State radiation control program is compatible with the Commission's regulatory program when its program does not create conflict, duplication, gaps, or other conditions which jeopardize an orderly pattem in the regulation of agreement material on a national basis. In implementing this approach to compatibility, the Commission wiu use the following three component approach: 3
l 4
- 1. The Agreement State should adopt basic radiation protection standards, and the j dose lets in 10 CFR 61.41 I , that are essentially identical to those of the
; Commission, unless Federal statutes provide the State authonty to adopt i different standards. The term " basic radiation protechon standards" means ; publes dose limits and radiation protection related concentration and release j hrnets in 10 CFR Part 20 that are apphcable to all boonsees.
1 The Agrooment State should also adopt, in an ==EN/ denbcal i form, a limited number of definibons, signs, labels and scientsfic terms which are necessary for a
) common understanding of radiation protechon principles among licensees, ! mgulatory agencies, and members of the pubhc. ; 2. The Agreement State should adopt regulations essentially identical to those
! of the NRC Commission for those areas of regulation that are related to actnnties i involving sighificant tri5sboundary implications, it is the Commission's intent to i limit this category to a small number of reguisbons (e.g., transportation ! requirements) that directly involve such activities. j 3. For all other regulations and elements, the Commission will apply the following j approach: 1 ] a. The Agreement State should adopt and implement essential objectives of l certain Commission regulations and program elements (e.g., reciprocity j procedures) that are important for an Agreement State to have in order to
- avoid conflicts, duplications, gaps, or other conditions which jeopardize an orderly patiem in the regulation of agreement material on a national
{ basis. Such Agreement State regulations or program elements need not j be identical to the corresponding Commission regulations or program j elements; in a few cases involving' specific statutorpidirection, however, Agreement State regulations must should, be at least as sinngent as that j those of the Commission;
- b. The Agreement State should have flexib,2ty to adopt and implement Commission regulations and program elements in addition to those necessary to maintain compatibility, as identified in B.1, B.2, and B.3.s
- above; and a
- c. An Agreement State may adopt and implement other regulations and elements within the State's jurisdiction that are not addressed by NRC.
l All regulations and elements covered under this third component mwot should be j compatible with those of the Commission (i.e., must should not create 6onflict, I
% Commission"interids toimplement Moomponent' con' istentWth s ks~earGeir i decision in the 11W area to allow Agreement States flexibihty to' establish pre-closure ~
j operational roisase limit objectives. ALARA goals;or design' objectives at such levels ~as' the
- - State may deem necessary or appropriate, so long as the level of safety is eqwalent to that affo[ded byfie Ccenissionj^~"
'~~~-
protection of public health an ) 4 i f k i
duplication, gaps, or other conditions whsch jeopardize an orderly pattom in the regulation of agreement material on a national basis). In addition, A0reementState regulations tipograr(elements covered under this third component should not be adopted oIlmplementedlnid6h a manner that the State: p precludes, or effectively precludes, a prachce* withm the natsonal interest without an adequate pubiec health and safety or environmental basis related to radiation protection; or
% precludes, or effectively precludes, the ability of the Commission to evaluate the effectiveness of the NRC and Agreement State programs for agreement material with respect to protection of .
public health and safety. 5!F;, i To foster and enhance a coherent and consistent national program for the regulition of agreement material, the Commission encourages Agreement States to adopt and implement similar regulations and program elements which are pattemed after those adopted and implemented by the Commission. lindNy, the fact that"an' Agreement State's' program is~ compatible'with~that of the comminion don not affect that State s obligeson to:mainteirihadeqdaie_ l pros == = daarib'dAthis Metaistemait. 1 By adopting the criteria for adequacy and compatibility as discussed in this Policy Statement the Commission intends to provide Agreement States with a broad range of flexibility in the administration of an individual program. In doing so, the Commission seeks to allow Agreement States to fashion their programs so as to reflect specific State needs and preferences. The Commission intends to minimize the number of NRC regulatory requirements that the Agreement States will be requested to adopt in an identical manner as a result of the compatibility components. At the same time, these compatibility components will allow the Commission to ensure that an orderly regulatory pattom for the regulation of agreement material exists across the country. The Commission believes that this approach achieves a proper balance between the desire for Agreement State flexibility and the need for coherent regulation of agreement material across the country, 8 "Practica" means a use, procedure, or activity associated with the application, possession, use, storage, or disposal of agreement material. The term " practice" is used in a broad and encompassing manner in this Policy Statement. The term encompasses both general activities involving use of radioactive materials such as industrial and medical uses and specific activities within a practice such as industrial radiography and brachytherapy. 5
i i l Attachment 3 l i i 1 I l i l l l l 1 1 I i i I l l l l r 1 i l i
..- m ..m._ _ m . . _- a a _#, _
a 4 Adequacy and Compatibility of i Agreement State Programs ! . l ] Directive ! 5.9 s i Volume 5, Governmental Relations and Public Affairs Adequacy and Compatibility of Agreement State Programs Directive 5.9
i Contents . Policy .......................................................................................1 ob,iectives .................................................................................. 1 Organizational Responsibilities and DW of AuGs %y ................ 2 Executive Director for Operations (EDO) .................................. 2 Director, Omce of State Programs (OSP) .................................. 2 Omce of the General Counsel ............................... .................. 3 Director, Omce of Nuclear Regulatory Research (RES) ............... 3 l 1 Director, Office of Nuclear Material Safety I and Safeguards (NMSS) ............................................... 3 ; Director, Omce for Analysis and Evaluation of Operational Data (AEOD) ................................................ 3 Regional Administrators ....................................................... 4 Applicability .............................................................................. 4 Handbook ..................................................................................4 References .................................................................................5 I l I i .i a
! U. S. Nuclear Regulatory Commission i Volume: 5 Governmental Relations and Public 4 Affairs OSP 1 Adequacy and Compatibility of Agreement l State Programs Directive 5.9 Policy (5.9-01) It is the policy of the U.S. Nuclear Regulatory Commlulon to evaluate Agreement State Programs established pursuant to Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, for adequacy to protect public health and safety and compatibility with NRC's regulatory program. Objectives (5.9-02) ! e To establish the process NRC staff will follow to determine when a I proposed or final Commission regulation or program element should be adopted as a legally binding nquirement by an Agreement State program and whether adoption is required for the purposes of compatibility or health and safety as set out in the Policy Statement on Adequacy and Compatibility of Agreement State Programs. (1) e To identify Commluion regulations and program elements that must be implemented as legally binding trquirements by an Agreement State to maintain a program that is adequate to protect public health and safety and compatible with NRC's regulatory program. (2) e To describe how NkC staff should apply provisions of the policy statement I to current and future Agreement State regulations and program elements. (3) Approved: (Date) 1
U. S. Nuclear Regulatory Commission Volume: 5 Governmental Relations and Public Affairs OSP Organizational Responsibilities and Delegation of Authority (5.9-03) Executive Director for Operations (EDO) (031) Oversees the program to evaluate adequacy and compatibility of Agreement State Programs. Director, Office of state Programs (OSP) (032) e Reviews the adequacy and compatibility of Agnement State programs through the Integrated Materials Performance Evaluation Program (Management Dinctive 5.6). (a) e Reviews, evaluates and detennines, in coordination with other NRC offices, program elements that am needed in Agreement State programs for compatibility or adequacy. (b) e Assists in the review, evaluation, and determination of NRC ngulations needed by Agnement States for compatibility or health and safety. (c) e Coordinates, with other NRC offices, the nview of Agnement State regulations and program elements. (d) Approved: (Date) 2
i l U. S. Nuclear Regulatory Commission Volume: 5 Governmental Relations and Public Affairs OSP j Office of the General Counsel l (033) j e Assists in the review, evaluation, and detennination of NRC program elements and regulations needed for compatibility or health and safety. (a)
- e Advises staff on findings regarding the adequacy and compatibility of 3 Agnement State regrlations and program elements. (b) j Director, Office of Nuclear Regulatory Research (RES) j (034) i j
- Provides review, evaluation, and determination of NRC regulations needed i by Agreement States for compatibility or health and safety. (a) I l
i 4 e Assists in the review, evaluation, and determination of program elements l needed by Agreement States for compatibility or health and safety. (b)
- 1 1 l
- 1 j Director, Office of Nuclear Material Safety and Safeguards (NMSS)
) (035) 1
- Assists in the nylew, evaluation, and detenninstion of NRC program elements and regulations needed for compatibility or health and safety.
Director, Office for Analysis and Evaluation of Operational Data (AEOD) (036) Assists in the review, evaluation, and detennination of NRC program elements and regulations needed for compatibility or health and safety. Approved: (Date) 3 1 1 1
U. S. Nuclear Regulatory Commission Volume: 5 Governmental Relations and Public Affairs OSP l Regional Administrators (037) Amists in the nylew, evaluation, and determination of NRC program elements and regulations needed for compatibility or health and safety. Applicability (5.9-04) The policy and guidance in this directive and handbook apply to all NRC , employees who are responsible for and participate in the review and ! evaluation of Agreement State regulatory programs or are involved in development and promulgation of NRC regulations or program elements for byproduct, source, and special nuclear materials. Handbook (5.9-05) Handbook 5.9 describes the criteria and the process that will be used to determine the compatibility and health and safety components for Ca==laton regulations and program elements needed for an adequate and compatible Agreement State program. Approved: (Date) 4
1 i U. S. Nuclear Regulatory Commission Volume: 5 Governmental Relations and Public Affairs OSP f References (s.S46) l Thie 10 of the Code of Fedem! Regulations Management Directive 5.6, " Integrated Materials Performance Evaluation j Program (IMPEP)."
- " Final Policy Statement on Adequacy and Compatibility of Agreement State Programs," dated [ insert effective date).
i " Final ' Statement of Principles and Policy for the Agreement State Program' and
' Procedures for Suspension and Termination of an Agreement State Program,' "
dated [ insert effective date]. i i l s n l I i I Approved: (Date) 5 l l 1 i l l 1 l j l l l l l l l I l i i
l l Adequacy and Compatibility l of l Agreement State Programs 1 i l Handbook 5.9 i l
1 I i Volume 5, Governmental Relations and Public Affairs ) Adequacy and Compatibility of Agreement State Programs 1 Handbook 5.9 Parts I- VI Contents Part I I n t rod u c ti o n ..... . .. ...... ..... .. ....... .. .. ... .. .. .... 1 Ov e rview ... ........... . ....... .... ... ........... ................. . . . .... ... . ... I 1 Policy Statement on Adequacy and Compatibility of A g reem en t Sta te P rog ra m s ................................................................. 1 Part II Criteria for Component Classification ........................... 3 Definition.............................................................................................................3 Criteria..............................................................................................................3 Part III Component Classification Process for NRC Regulations and Program Elements .............. ................ 7 l Part IV Applicability to NRC Regulations and P rog ra m E l e m e n ts ................................................................... 9 Current NRC Regulations and Program Elements .. ....... .......... ........... 9 Future NRC Regulations and Program Elements ......... .......................... ..... 9 Part V Applicability to Agreement State Regulations and P rog ra m E l e m e n ts ....................... .. ....... ......................... 10 Current Agreement State Regulations and Program Elements .....................10 i l
Future Agreement State Regulations and Program Elements .......................10 Evaluation of Applications for Agreement State Status ................................. 11 Part VI Additional Implementing Issues ... .................. ............ 12 1 Use of Management Directive 5.9 aad Handbook 5.9 ..... ............................ 12 f Essen tial Objectives.. . .......... ................. .................... .................. ......... 12 Essentially Identical Language .................................... ..... .. ..... ........ .. 12 Number of Licenses Warranting Development of Regulations .............. .....12 Ti m e Fra m es fo r A d op tion ............................................................................... 13 A rea s Rese rved Solely to NRC ......................................................................... 14 Alternative Legally Binding Req uirements .................................................... 14 APPENDIX Appendix A Flow Chart il
Part I Introduction l Overview (A) The Policy Statement on Adequacy and Compatibility of Agreement State Programs (Policy Statement) sets forth the approach that the Commission will use when determining which ofits regulations and program elements should be adopted by an Agreement State to maintain a compatible program. The Policy Statement also specifies that an Agreement State should have ; legally binding requirements to ensure adequate protection ofpublic health and safety. This 1 handbook describes the criteria and process to determine those NRC regulations and program - elements that should be adopted and implemented by an Agreement State for purposes of l compatibility, as well as for purposes of health and safety. It further describes how NRC staffi', to apply the provisions of the Policy Statement to current and future Agreement State regulat:ons , and program elements. l l Policy Statement on Adequacy and Compatibility of Agreement State ) Programs (B) ! i An Agreement State radiation control program is compatible with the Commission's regulatory I program when the State program does not create conflict, duplication, gaps, or other conditions 1 that jeopardize an orderly pattem in the regulation of agreement material on a national basis. As ) a general matter, compatibility focuses primarily on the potential effects of State action or inaction either on the regulation of agreement material on a national basis or on other States. The concept of compatibility does not, however, directly address matters of health and safety within a particular Agreemen't State; such matters are addressed directly under adequacy. Further, basic radiation protection standards and regulations with transboundary implications, i although important for health and safety within the State, should be uniform nationwide for l compatibility purposes. (1) l An Agreement State radiation control program is adequate to protect public health and safety if administration of the program provides reasonable assurance of protection of public health and safety in regulating the use of source, byproduct, and small quantities of special nuclear material as identified by Section 274b. of the AEA. A subset of one of the five elements identified to help provide such reasonable assurance is legally binding requirements addressing protection of ) public health and safety within the State. (2) Based on the Policy Statement, NRC regulations and program elements can be categorized into four components, three of which address compatibility and one of which addresses health and safety. These are summarized below. (3) Approved: (Date) 1
. .- . . . -. -. - - - . - - - . . . _ _ . - . . _~ -
Compatibility Component I (a) NRC regulations and program elements classified as Component I are those that deal with basic radiation protection standards and with scientific terms and defmitions that are necessary to understand these concepts The language of such regulations and program elements adopted by an Agreement State should be essentially identical to provide uniformity in the regulation of agreement material on a national basis. Compatibility Composest 2 (b) NRC regulations and program elements classified as component 2 are those that apply to activities that have direct and signi6 cant transboundary implications. An Agreement State should adopt regulations that have language that is essentially identical to that ofNRC. Compatibility Component 3 (c) NRC regulations and program elements that are classified as Component 3 are those, the essential objectives of which an Agreement Staie should adopt to avoid conflict, duplication, l gaps, or other conditions that would jeopardize an orderly pattern in the regulation ofagreement i material on a national basis. Such Agreement State regulations or program elements need not be identical to the corresponding Commission regulations or program elements (Component 3.a); in a few cases, however, Agreement State regulations must be at least as stringent as those of the l Commission (Component 3.a.S). All other NRC regulations and program elements that are not classified as Component 1,2,3.a, or 3.a.S are not required for compatibility purposes (Component 3.b). Health and Safety Component 3.ba (d) NRC regulations and program elements classified as Component 3.b' are those that are not i required for compatibility by the criteria of the Policy Statement, but that have a health and l safety role in the regulation of agrec.. ent material within the State. Because of health and safety considerations, the State should adopt regulations and program elements in this component that are at least as stringent as those of NRC. l i l l , Approved: (Date) 2
i, ! Part II I Criteria for Component Classification i Several criteria and definitions are necessary to determine the compatibility or health and safety
- component ofNRC regulations and program elements. These are established in this pan and are j to be used in conjunction with the series of questions in Part E and the flow chart in Appendix l A-i l l
! Definition (A) { ~ The essential objectiw of a regulation or program element means the action that is to be i i accomplished by implementing and following the regulation or program element. In some I instances, the essential objective may be a numerical value (e.g., restriction of exposures to a l maximum value) or it may be a more general goal (e.g., access control to a restricted area). i Criteria (B) ! Compatibility Component 1 (1) i j To be classified as Component 1, an NRC regulation is to be applicable to all licensees and is to ! be a dose limit or a related concentration or release limit (basic radiation protection standard), a { scientific term, definition, sign, or label that is necessary to understand basic radiation protection principles. (a) l j Examples include, but are not necessarily limited to: (b) }
- public dose limits (e.g.,10 CFR 20.1301) plus any regulation that directly relates
- to these dose limits (i) e concentration and release limits (ii)
- occupational dose limits (e.g.,10 CFR 20.1201) plus any regulation that directly j relates to these dose limits (iii) ;
- e 1
dose limits in 10 CFR 61.41 (iv)
- radiation symbol (v)
- caution signs and labels (vi)
!
- scientific terms (e.g., conventiona! and Syst6me Internationale units, definitions i of types of radioactive material) (vii)
- definitions needed for common understanding (e.g., restricted area, year, !
4 stochastic)(viii) i Approved: (Date) 3
Compatibility Component 2 (2) To be classified as Component 2, an NRC regulation or program element is to be one that applies to activities that have significant effects in multiplejurisdictions. (a) Examples include, but are not &=ily limited to: (b) e transportation requirements (e.g., low level radioactive waste manifests, ; Packaging requirements)(i) j e requirements for approval of products that are distnhted nationally (e.g., scaled i sources and devices)(ii) j e definitions of products (e.g., sources and devices) that licensees routinely j i transport in multiplejurisdictions. (iii) - 1 Compatibility Component 3.a (3) To be classified as Component 3.a, an NRC regulation or program element is to be one, the essential objective of which an Agreement State should adopt to avoid conflict, duplication, or gaps in the regulation of agreement material on a national basis and that, if not adopted, would result in an undesirable consequence. (a) i The following definitions of conflict, duplication and gap and the examples of undesirable l consequences provide additional guidance for classifying regulations or program elements as l Compatibility Component 3.a. (b) l e Conflict means the essential objectives of regulations or program elements are l different and an undesirable consequence is likely to result in anotherjurisdiction ) or in the regulation of agreement material on a national basis. (i) l
- Duplication means identical regulations or program elements apply to the same i
material at the same time. Note: this definition applies primarily to review of Agreement State regulations. (ii)
- Gap means the essential objectives of NRC regulations or program elements are absent from the Agreement State program and an undesirable consequence is likely to result in another jurisdiction or in the regulation of agreement materials on a national basis. (iii)
Examples of undesirable consequences include, but are not necessarily limited to: (c) l
- exposure to an individual in a different jurisdiction in excess of the basic radiation protection standards established for compatibility under Component 1, above; (i) l l
l Approved: (Date) , 4 l l l
i I i l i e undue burden on interstate commerce (e.g., additional recordkeeping or training i l requirc=nts);(ii) e preclusion of an effective review or evaluation by the Commission of the NRC l j and Agreement State programs for agreement material with respect to protection ofpublic health and safety;(iii) . e preclusion of a practice in the national interest; (iv)
- e absence or impairment of effective communication; (v) i e lack of minimum level of safety for agreement material - containing products j distributed nationally;(vi) e disruption of the regulation of agreement materials on a national basis. (vii)
! Examples of regulations in this component include, but are not necessarily limited to: (d) i l e reports oflost or stolen agreement material or misadministrations (i) e radiation surveys for industrial radiographers and well-loggers (ii) l e documents and records required at temporaryjob sites. (iii)
- Compatibility Component 3.a.S (4) ;
1 f j To be classified in Component 3.a.S, the NRC regulation or program element is to be one that is j promulgated pursuant to a statute where the Agreement State must establish requirements that i j are at least as restrictive as those of the NRC. (a) Examples include, but are not necessarily limited to, NRC regulations adopted pursuant to: (b) i
- the federal Clean Air Act (i)
!
- the Uranium Mill Tailings Radiation Control Act. (ii) i Compatibility Component 3.b (5) i To be classified as Component 3.b, an NRC regulation or program element is to be one that does j not meet any of the criteria of Components 1,2,3.a, or 3.a.S, above. (a) l Health and Safety Component 3.ba (6) l To be classified as Component 3.b', the NRC regulation or program element is to be one that is l not required for compatibility and could result directly (i.e.,2 or fewer failures') in an exposure i
8 l he concept anhaded by *2 or fewer fadures" is that if the essential objectives of the regulanan I were not adopted and isap1=a==d in a legally bedag manner Iben an event could occur that would not have taken place were the essential objectives adopeed. his alone, or in conjuncnon with at anost one other event,
! could result in exposure of an bdividual in excess of Innits set by basic radianon prosecnon standards.
4 l Approved: (Date) 5 i
1 to an individual in excess of the basic radiation protection standards identified in Component 1 if its essential objectives were not adopted by an Agreement State as an LBR. (a) l Examples of such regulations include, but are not necessarily limited to: (b) e requirement for irradiator interlocks (i) 1 e safety checks for medical teletherapy facilities (ii) e package opening procedures. (iii) l 4 i i i i 4 Approved: (Date) 6
)
4 ; ! I Part III ! Component Classification Process for NRC Regulations and Program Elements
- The protocol to be used to assign the compatibility or health and safety component to NRC i
regulations and program elements is diagramed in the flow chart in Appendix A. The basis of the flow chart is a series of questions that are listed below. Each program element and regulation j
- is to be tested by asking the series ofquestions below in the order given The answers to these l questions determine the compatibility or health and safety component for each NRC regulation i i
or program element. (A) ! ) , Question (1) Do the essential objectives of the regulation or program element address a l regulatory area reserved solely to the authority of the NRC? If the respcnse to the question is 'yes', the compatibility component is "NRC." If the response to the ! question is 'no,' then proceed to Question (2). (1) i ; i Question (2) Do the essential objectives of the regulation or program element address or define a basic radiation protection standard as d-fined by the Policy Statement or is it a j definition, term, sign, or symbol needed for a common understanding of radiation
- protection principles? If the response to this question is 'yes', the compatibility
- component is "1." If the response to the question is 'no', then proceed to Question l (3)(2) l Question (3) Do the essential objectives of the regulation or program element address or define i
an issue that has a significant, direct transboundary implication? If the response to this question is 'yes', the compatibility component is "2." If the response to the question is 'no', then proceed to Question (4). (3) i i Question (4) Do the essential objectives of the regulation or program element address or define an issue related to UMTRCA, the federal Clean Air Act, or other statute that requires states to adopt regulations that are at least as stringent as NRC? If the i response to this question is 'yes', the compatibility component is "3.a.S." If the ] response to the question is 'no', then proceed to Question (5). (4) ! Question (5) Would the absence of the essential objectives of the regulation or program ! element from an Agreement State program create a conflict or gap? If the
- response to this question is 'yes', the compatibility component is "3.a." If the
! response to the question is 'no', then proceed to Question (6). (5) J i i Approved: (Date) 7 1 l
- - . - _ . . . - . - . . - - .- . ~ . . . . - . - . - . - _ _ -
Question (6) Would the absence of the essential objectives of the regulation or program element from an agreement state program create a situation that could directly result in exposure to an individual in excess of the basic radiation protection standards found in compatibility component 17 If the response to the question is
'no', then the compatibility component is "3.b." If the response to this question is l 'yes', the health and safety component is "3.b*." (6) 1 i
l l I i I l Approved:(Date) 3
3 4 Part IV ! Applicability to NRC Regulations and Program Elements
! Current NRC Regulations and Program Elements (A)
The compatibility and health and safety components assigned to current Commission regulations and program elements that are applicable to the regulation of agreement materials are found in
- OSP Internal Procedure B.7 (Revision 1), " Compatibility and Health and Safety Component Classifications for NRC Regulations and Program Elements." B.7 will be updated periodically as final rules are published.
Future NRC Regulations and Program Elements (B) i i The compatibility or health and safety classification of a proposed rule is to be suggested at the
- time the rulemaking plan is formulated and is to be coordinated with the Agreement States in
- accordance with Commission approved guidance in Management Directive 6.3, "The i Rulemaking Process." Staffis to use Management Directive 5.9 to assign a proposed compatibility or health and safety component to each draft rulemaking plan. OSP Internal j Procedure B.7 (Revision 1) will be revised to incorporate the results of these determinations after the final rule or program element is adopted. (1)
} i i 1 I 2 4 W i j 1 ( Approved: (Date) 9 i i
PART V Applicability to Agreement State Regulations and Program Elements Current Agreement State Regulations and Program Elements (A) NRC regulations that had not been required for compatibility according to OSP Internal l Procedure B.7, " Criteria for Compatibility Determinations," but are required under the new Policy Statement should be adopted by the States with an efective date within three years of the I effective date of the Policy Statement and implementing procedures. (1) NRC regulations that had been required for compatibility according to B.7, but will not be required under the Policy Statement do not require any action by the States. (2) In addition to the foregoing, if an Agreement State's regulations had been evaluated using OSP Internal Procedure B.7, and NRC's program review procedures prior to the efective date of the Policy Statement and found:(3) e to be compatible, then no further action is required by the State; (a) e to be not compatible, then the incompatible regulation should be changed to conform to the Policy as expeditiously as possible, but not later than three years after the Policy's effective date; (b) e not to have adopted a regulation still required by the Policy, then the regulation should be adopted as expeditiously as possible, but not later than three years after the Policy's effective date or other date set by the Commission. (c) Program elements had not been required previously. Those program elements required under the new Policy Statement should be adopted and implemented by the States within six months of the effective date of the Policy Statement and implementing procedures. If, due to other factors, an Agreement State cannot adopt and implement such a program element within the six month time frame, then the State and the Commission will agree upon a mutually acceptable timetable for I adoption and implementation. (4) j Future Agreement State Regulations and Program Elements (B) General (1) Any changes to Agreement State regulations af.er the efective date of the Policy Statement are to conform to the Policy Statement and implenenting procedures set out in this handbook. Approved: (Date) 10
Future Regulations (2) Proposed and final Agreement State regulations for agreement materials that will be submitted to the NRC will be reviewed in accordance with guidance provided in OSP Internal Procedures, D.7, " Reviewing State Regulations" and B.7 (Revision 1), " Compatibility and Health and Safety Component Assignments for NRC Regulations and Program Elements." Results of the evaluation will be transmitted to the State in accordance with OSP internal procedures. Note: The overall determination of the adequacy and compatibility ofindividual Agreement State programs will be made in accordance with Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Future New or Changed Program Elements (3) NRC staff will review the adoption and implementation of any new or revised program element by an Agreement State in accordance with the Integrated Materials Performance Evaluation Program review procedures set out in Management Directive 5.6 at the time of the next regularly scheduled review. Evaluation of Applications for Agreement State Status (C) NRC staff will apply the compatibility and health and safety classification criteria in this handbook when reviewing the regulations and program elements contained in applications for Agreement State status submitted after the effective date of the Policy Statement. l l Approved: (Date) g3
PART VI i AdditionalImplementing ISSUES Use of Manage' m ent Directive 5.9 and Handbook 5.9 (A) For IMPEP reviews of States in accordance with Management Directive 5.6, NRC staffwill use Management Directive 5.9 to assess the status of the State's regulations and program elements with respect to those that should be adopted for compatibility and for health and safety reasons. Specific Agreement State regulations will be assessed as they are submitted by the State and a summary report will be provided to the IMPEP team at the time of the State's next program review. However, the overall determination of adequacy and compatibility ofindividual Agreement State programs will be made in accordance with Management Directive 5.6,
" Integrated Materials Performance Evaluation Program."
Essential Objectives (B) The essential objective ofeach NRC regulation or program element required for compatibility o for health and safety reasons should be addressed by the Agreement State. If the essential objective is not readily apparent or discernible from a source such as the Statements of Consideration or rulemaking plan, NRC and the States should determine the essential objectiv cooperatively. Essentially Identical Language (C) Certain regulations required for compatibility should be adopted by Agreement States in identical or essentially identical language. Iflanguage is used by an Agreement State that differs in any significant respect from that used in NRC regulations, the State should justify the equivalency of the language. An example of such language substitution that would not be considered significant would be use of the term " deterministic" in place of the term"non-stochastic." In this case, the former term is one commonly accepted in the international radiation protection community. Further, the adoption by States ofmore recent technical information N. (e.g., with respect to reference man)is to be viewed as being essentially identical. Finally, changes to reflect increased scope of State authority (e.g., use of the term " radioactive material" in place of the term " byproduct material") or wording needed to conform to State administrative procedures (e.g., use of State agency name in place of" Commission") also would not be considered significantly different. Number of Licensees Warranting Development of Regulations (D) There are general situations where an Agreement State would not be expected to address one o more required regulations or program elements: (1) the State does not have legal authority to Approved: (Date) 12 l
i i l regulate the activity or (2) the State has the legal authority to regulate, but has no licensees or l applicants that engage, or propose to engage, in the regulated activity. (1) In general, if an Agreement State does not have any licensees that would be subject to a ) panicular NRC regulation determined to be required for purposes of compatibility or health and j safety, the State is not required to adopt or address NRC's regulation. However, if a State were 3 to acquire such a licensee, then the provisions of the Policy Statement would be invoked and i j would have to be implemented as described in this handbook. Similarly, if the State does not j have the authority to regulate in a given area there would be no requirement to adopt or address NRC regulations or program elements in that area for purposes of compatibility or health and { j safety. (2) ; i j Rules designated as required for compatibility or health and safety should be addressed by
- Agreement States as regulations rather than as an alternative LBR in the following
- circumstances
- (3) i
- the requirement is generally applicable to all licensees; (a) j
- the requirement is applicable to UMTRCA and LLRW disposal
! facilities, regardless of the number oflicensees regulated by the State; or (b) !
- there are four or more materials licenses in the State that would be subject to the j regulation. (c)
- Otherwise, the Agreement State may address the essential objective of the NRC rule in any manner that is legally binding and enforceable on the licensee. (4)
! Time Frames for Adoption (E) i j Commission regulations that should be adopted by an Agreement State for purposes of j compatibility or health and safety should be adopted by the State in a timeframe such that the effective date of the State regulation is not later than three years after the effective date of NRC's j final mle. Certain circumstances (e.g., adoption of a basic radiation protection standard or other ! rule that will have significant impact on the regulation of agreement material on a national basis, such as the low-level radioactive waste manifest) may warrant that the effective date for both
- NRC licensees and Agreement State licensees be the same. In some cases, with sufficient justification, health and safety considerations may warrant adoption by the States in less than the i recommended three year time frame. (1) i Program elements that have been designated as necessary for maintenance of an adequate and j compatible program should be adopted and implemented by the Agreement States within six
, months of such designation by NRC. If, due to other factors, an Agreement State cannot adopt l l- and implement such a program element within the six month time frame, then the State and the Commission will agree upon a mutually acceptable timetable for adoption and implementation. (2) Approved: (Date) 13 i ]
1 1 i l Areas Reserved Solely to NRC (F) i Certain regulatory areas cannot be relinquished to the States under 274.b agreements and remain the solejurisdiction of the federal government. NRC rules promulgated to regulat these areas j are reserved solely to the NRC. However, States may adopt regulations in, or otherwise address, 4 these areas for the purpose of clarity and ease of communication. States may not adopt regulations, other LBRs or program elements that would cause the State to regulate such i activities. 1 4 } Alternative Legally Binding Requirements (G) i Except as specified othe wise in this handbook, Agreement States may adopt the essential i objectives of NRC regulations designated as compatibility and adequacy requirements by a i method other than a regulation. Such means should be legally binding on the licensee (s) and j enforceable as law. Examples of such legally binding requirements may include license conditions (including licensee commitments referenced in " tie-down" conditions), orders or other j mechanisms determined by the State to be legally binding and enforceable. The State will have
- the responsibility of demonstrating that requirements adopted other than by regulation are legally
- binding.
i 4 } 1 1 i j ) i 4 l i l i i . Approved: (Date) 14 i 1 i
1 l l l i 1 1 l l APPENDIX A Flow Chart l l l l l 1
Flow Chart R a n D NRC - Yes Category: NRC Pr ram Junsdction? Element
/
No Basic Radiaton N ' Category: 1 Yes DeAnibon, Term Sgn or No LHrect Transboundary Yes Category: 2 Implications? No Statutory: State required to be at least [ Yes Category: 3.a.S
!M@
No Connet or gap if Category: 3.a Yes not adopt? l No i Sa et Cnt na No Category: 3.b Met? { v.s
; Category: 3.b.*
i 4 4 d 1 Attachment 5 - 4 l l l l l i t l k l
.i 1
1 1 i i 1
__ __.-___ _ _ _._ _ __ ..__~______ _ ___ _ _ _ _ _ _ _ I OFFICE OF STATE PROGRAMS Pre-and Post-Agreement Activities B.7 (Revision 1): Compatibility and Health and l Safety Component Classifications for NRC ! Regulations and Program Elements 1 Introduction l 1.1 Purpose l This procedure provides guidance to NRC staff, Agreement States, and States seeking an l Agreement on the compatibility and health and safety components assigned to NRC regulations and program elements.
1.2 Background
1.2.1 The Policy Statement on Adequacy and Compatibility of Agreement State Programs sets forth the approach that the Commission will use when detennining which ofits regulations and program elements should be adopted by an Agreement State to maintain a compatible program. The policy statement also specifies that an Agreement State should have legally binding requirements to maintain adequate protection of public health and safety. 1.2.2 Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs," describes the criteria and process NRC stafffollow to determine which NRC regulations and program elements should be adopted by an Agreement State for purposes of compatibility as well as purposes of health and safety. In accordance with Management Directive 5.9, each regulation and program element is analyzed and classified in a specific compatibility or health and safety component. 1.2.3 OSP Internal Procedure B.7 (Revision 1) has been developed and is maintained by the Office of State Programs to document, for use by NRC and State staff, the assigned compatibility or health and safety component for each rule and program element, as determined in accordance with Management Directive 5.9. The component classifications are set out in individual tables as described further below. In addition, Management Directive 5.9 provides that OSP Internal Procedure B.7 (Revision 1) should be updated at the time a new rule or program element is adopted. 2 Compatibility & Health and Safety Component Classifications The tables set out in Section 3, below, contain a section-by-section analysis of regulations in Title 10 of the Code ofFederal Regulations (10 CFR) and program elements which are applicable to the regulation of agreement materials. The analysis is based on the classification l criteria and process set out in Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs." i f l
i i The Parts of 10 CFR far which tables are pr vided all have been analyzed section-by-secti::n; i those Parts which do not have a corresponding table have been determined to address areas in I which Agreement States either do not have regulatory authority or are applicable specifically to i NRC's regulatory program and need not be addressed by an Agreement State. For the purpose 1 of completeness, those Parts which totally address areas of exclusive NRC authority are listed in Table 1. Those Parts which generally are applicable specifically to NRC's regulatory program, 2 but are not areas of exclusive NRC authority, are listed in Table 2. Any future des e s to these i detenninations will be reflected in revisions to Tables 1 and 2 and to the individual section-by-j section analysis tables contained in Section 3. Table 1 i ! Specific Parts ofTitle 10 of the Code ofFederal Regulations Which Address Areas ofExclusive NRC Authority l ! Parts 10, 11, 25, 26, 50, 51, 52, 53, 54, 55, j 60, 62, 72, 73, 74, 75, 76, 81, 95,100,110,140, and 160. l Table 2 l l Specific Parts of Title 10 of the Code of Federal Regulations j Which Address Areas That Generally Are Applicable Only to NRC's Regulatory Program ) Parts 0,1, 2, 4, 7, 8, 9,12,13, .14,15,16, 218,170, and 171. i 3 Regulation and Program Element Tables In using the following tables, staff should be aware of the following points: o The following sections are found in multiple Parts: Purpose, Scope, i interpretations, Communications, OMB Approwl, Violations, Criminal l i Penalties and frupections. They are all essentially identical from Part to Part. ! i These requirements are not required for either compatibility or health and ! l safety reasons. The State may elect to adopt similar sections based on its ! requirements. ) l e A number of terms are defined in more than one Part in 10 CFR. For l purposes of consistency, the tables show the compatibility determination for ! the definition in the most appropriate Part and refer to that Part at all other ; a l l l ' The provisions in Part 21 derive from statutory authority in the Energy Reorganization Act, not the AEA,
- which does not apply in Agreement States. 'Iberefore, this Part cannot be addressed under either compatibility or adequacy. While it may be argued that there are health and safety r=aaan e require States to adopt the '
j provisions of Part 21, States may not have the statutory authority to do sc. l l l i
_ . __ . _ ._ _. _ _ _ _ _ _ _ _ _ . . _ . . ~ _ _ _ _ . _ _ _ _ _ _ _ . _ _ _ _ _ _ { occurrences cf the term. See, for exampl3, the definition cf " restricted area" in the table for Part 19, Section 19.3. l e Unless otherwise indicated in the tables, the compatibility or health and safety l designation applies to the entire section of the Pan. See, for example, the table for Part 20, Section 20.2003, where individual paragraphs are assigned different components. Key to classifications: 1= Basic radiation protection standard or other i regulation which the State should adopt with , l (essentially) identical language. I 2= Regulation / program element with significant
- trandw==vbry implications which the State should adopt with essentially identical language.
3.a = Regulation / program element, the essential i objectives of which should be adopted by the' State, to avoid conflict, duplication or gaps. The
- manner in which the essential objectives are addressed need not be the same as NRC provided the essential objectives are met.
3.a.S = Regulation / program element involving specific statutory direction, the essential objectives of which should be adopted by the State in a manner at least as stringent as NRC. 3.b = Not required for purposes of compatibility; however, if adopted by the State, must be compatible with NRC. NRC = Not required for purposes of compatibility; the regulatory area is reserved to NRC. However, a State may adopt these provisions for purposes of clarity and communication, as long as the State does not adopt regulations or program elements which would cause the State to regulate in these areas. 3.b' = Not required for purposes of compatibility; however, required for purposes of health and safety. The State should adopt the essential objectives in a manner at least as stringent as the NRC. f l
. . _ . .._ .._..__..__m_-_.__ . _ .. _ . ._.. - _ ._ __ _ _ _ _ __.. ._. ...._. _ ._ . - _ ._. _ . _ .. _ __ __.~ ..._. . ... _ ...__ ._
Part 19 - NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS: INSPECTION AND. INVESTIGATIONS REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED {l9.1 Purpose 3.b. fl9.2 Scope 3.b. {l9.3 Definitions Act 3.b. Commission 3.b. i Exclusion 3.b. License See 10 CFR {20.1003 Restricted area See 10 CFR {20.1003 t Sequestration 3.b. ! Worker 3.a. This definition is needed for a common i understanding of the term, " worker," as used in the regulation of radioactive materials because of ! persons working in more than onejurisdiction. i [
i i 1 ! REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED i 1 g19.4 Interpretations 3.b. ll9.5 Communications 3.b. g19.8 Information collection 3.b. j requirement OMB . approval (19.11 Posting ofnotices to 3.a. These requirements are needed to provide a workers minimal level ofinformation to workers. In addition, these requirements assure that this information is consistent from onejurisdiction to , another since workers may work in mukiple jurisdictions. {l9.12 Instructions to workers 3.a. This provision should be adopted by States to assure a minimum level of required worker training between jurisdictions since workers many work in multiplejurisdictions. 2
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED These requirements are needed to provide a minimal level ofinformation to workers. In addition, these i@..~. assure that this
^
information is consistent from onejurisdiction to another since workers may work in multiple jurisdictions. fl9.14 Presence of 3.b. representatives of licensees and workers duringinspections {l9.15 Consultation with 3.b. workers during inspections i19.16 Requests by workers 3.b. forinspections
$19.17 Inspection not 3.b.
warranted; informal review 3
i REGULATION SECTION TITLE CLASSIFICATION COMMENTS I SECTION ASSIGNED {l9.18 Sequestration of 3.b. j witnesses and l exclusion ofcounsel m - interviews conducted under subpoena j {l9.20 Eii;y cyx protection 3.b. i {l9.30 Violations 3.b. i {l9.31 Application for 3.b. exemptions l {l9.32 Discrimination 3.b. , prohibited ! i {l9.40 Criminal penalties 3.b. t 4
Part 20 - STANDARDS FOR PROTECTION AGAINST RADIATION REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 620.1001 Purpose 3.b. 120.1002 Scope 3.b. 620.1003 Definitions Absorbed Dose 1 Act 3.b. Activity 1 Adult i Airborne radioactive material 1 Airborne Radioactivity area 1 ALARA 1 Annual limit on intake (ALI) 1 Background Radiation 1 Bioassay (radio bioassay) 1 Byproduct material See 10 CFR i 6150.3(c)
f REGULATION SECTION TITLE CLASSIFICATION COMMEN'IS ; SECTION - ASSIGNED Class 1 Also referred to as " Lung Class or Inhalation Class" Collective Dose 1 Commission 3.b. Committed dose equivalent I Committed effective dose equivalent I Controlled Area 3.b. t Declared Pregnant Woman 1 Deep-dose equivalent I Department 3.b. i Derived air concentration (DAC) I t Derived air concentration-hour 1 (DAC-hour) j t 2 i
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED Dose or radiation dose 3.b. This definition is not required for compatibility. No definition presented. Rather, several terms are referenced, which are later defined. Dose equivalent i Dosimetry processor 3.b. Effective dose equivalent 1 Embryo / fetus 1 Entrance or access point 3.a. This definition is needed for a common understanding because differing definitions may jeopardize an orderly regulatory pattern in the regulation of agreement materials. Exposure 1 External dose 1 Extremity 1 3
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED Eye dose equivalent 1 The term,
- lens Dose Equivalent," if defined essentially identically to " Eye Dose Equivalent" is an acceptable substitute for this term.
Generally applicable environmental 1 for States with radiation standards This term is needed for common authority to regulate understanding in applying the uranium mill dose limit requirements in 10 t activities (11.e.2 CFR 20.1301 and the reporting byproduct material) requirements in 10 CFR 20.2203. or These sections reference requirements that are applicable to 3.b. for States the uranium fuel cycle. without authority to regulate uranium mill activities Government agency 3.b. Gray See 10 CFR 620.1004 High radiation area 1 Individual 1 4 l l 1 I
i REGULATION SECTION TITLE CLASSIFICATION COMMEN'IS SECTION ASSIGNED Individual monitoring i Individual monitoring devices 3.a. His definition is needed for a , common understanding because ; differing definitions may jeopardize an orderly regulatory pattern for the regulation of agreement materials. Internal dose 1 License 3.b. Licensed material 3.b. Licensee 3.b. Limits 1 Iest or missing licensed material 2 His term and definition are needed for a common understanding in collecting and reporting information on regulation of agreement materials on a national basis. 5
I REGULATION SECTION TITLE CLASSIFICATION COMMENTS . SECTION ASSIGNED Member of the public 1 Minor I i Monitoring i i Nonstochastic effect i The term, " deterministic," if defined essentially identically to "nonstochastic" is an acceptable substitute. , NRC 3.b ! Occupational Dose 1 i i Person 3.a. The term, " person," is needed for j compatibility in order to avoid i conflicts in iw.fa.T.c.. ting the ; regulation of agreement materials frein onejurisdiction to another. i Planned special exposure 3.b. i Public dose 1 ! Quality Factor 1 ' Ouarter 3.b. i l 6 i I I i t i i
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED I Rad See 10 CFR This term is not defined in this 670.1004 section. Refer to the referenced section for the definition and the compatibility determination. . I Radiation i Radiation area - 1 Reference man ; . Rem See 10 CFR This term is not defined in this , 620.1004 section. Refer to the referenced section for the definition and the l compatibility 'ietermination. Respiratory protective device 3.a. Restricted area 1 Sanitary sewerage i Shallow-dose equivalent i Sievert i Site boundary 3.b. 7 i 1 e
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED Source Material See 10 CFR ll50.3(i) Special Nuclear Material See 10 CFR I150.3(i) __ Stochastic effects i Survey 1 Total Effective Dose Equivalent I (TEDE) Unrestricted Area i Uranium Fuel Cycle 3.b. However, if a state chooses to adopt a definition of uranium fuel cycle, it must be essentialy identical. Very High Radiation Area 1 Week 3.b. Weighting factor 1 Whole body 1 8
i t i REGULATION SECTION TITLE CLASSIFICATION COMMENTS l SECTION ASSIGNED i Working level (WL) I ; Working level month I i (WLM) ! i Year 1 j 120.1004 Units of radiation dose 1 [ , 620.1005 Units of radioactivity 1 .
$20.1006 Interpretations 3.b.
620.1007 Communications 3.b. , 120.1008 Implementation 3.b. 520.1009 Information colletion requirements: 3.b. '! OMB approval [ 120.1101 Radiation protection programs 3.b.* Occupational dose limits for adults 1 120.1201 , 120.1202 Compliance with requirements for 1 summation of external and internal doses : i 9 i l I I. _ _ - _ . ._ _ _ . _ _ _ - _ _ _ _ _ . _ _ _ _ . . _ _ _ _ _ - _ _ _ _ _ _ _ _ ___-_-_______ ___-__-____ -__ - _----_______ - _ __---
r t b i i REGULATION SECTION TITLE CLASSIFICATION COMMENTS ! SECTION ASSIGNED i 520.1203 Determination of external dose from I airborne radioactive material l 620.1204 Determination ofinternal exposure 1 620.1205 Reserved
- 520.1206 Planned special exposures 3.b.
l 620.1207 Occupation dose limits for minors I I 620.1208 Dose to an Embryo / fetus I 620.1301 Dose limits for individual members i for all sections, This provision, except paragraph of the public except (d) which is (d), contains radiation protection 1 3.b. standards. 520.1302 Compliance with dose limits for 3.b.* for all sections *Ihis provision, except paragraph individual members of the public except, (c) which is (c), contains requirements that are 3.b. needed because of their health and ; safety significance. i j 620.1501 Reserved. 3.b.* Surveys and Monitoring - General . 520.1502 Conditions requiring individual 3.b.
- monitoring of external and internal occupational dose :
10
4 I REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 620.1601 Control of access to high radiation 3.b.* j areas 520.1602 Control of access to very high 3.b. * ; radiation areas 520.1701 Use of process or other engineering 3.b. * : controls , 620.1702 Use of other controls 3.b. * ! t (20.1703 Use ofindividual respiratory 3.b.
- protection equipment
$20.1704 Further restrictions on the use of 3.b.
respiratory protection equipment i 1
'520.1801 Security of stored material 3.b.* .
620.1802 Control of material not in storate 3.b. * ! 620.1901 Caution signs 1 l
$20.1902 Posting requirements 1 In adopting these provisions, States have the flexibility to omit ;
the wording " grave danger. i 520.1903 Exceptions to posting recuirements 3.b. 11 ! b
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED i 620.1904 Labeling containers 1 620.1905 Exceptions to labeling requirements 1 (20.1906 Procedures for receiving and 3.b. * ; opening packages ' 520.2001 General requirements 3.a. Agreement States are required to (Waste Disposal) adopt this provision in order to ' eliminate confusion regarding the disposal of agreement material on a national basis. (20.2002 Method for obtaining approval of 3.b. t proposed disposal procedures 620.2003 Disposal by release into sanitary (a)(1) is 3'b *; (a)(2) sewerage and (a)(3) are 1; (a)(4) is 3.a.; and (b) is 3.b. 620.2004 Treatment or disposal by 3.b. incineration (20.2005 Disposal of specific wastes 3.b. 12
r t b REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED ! 520.2006 Transfer for disposal and manifests 2 Agreement States are requirext to j adopt these provisions to provide [ consistency in regulating the transist of agreement materials which frequently cross multiple jurisdictions. ; 620.2007 Compliance with environmental and 3.b. ! health protection regulations l 620.2101 Genemi pmvisions. 3.a. De use of SI units would be considered essentially identical. i i 520.2102 Records of radiation protection 3.b. Programs j i 120.2103 Records of surveys 3.b. 620.2104 Determination of prior occupational 3.b. However if a state chooses to dose adopt " planned special exposure" this section should be adopted as a "3.a." 120.2105 Records of planned special 3.b. exposures 13 i
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 620.2106 Records ofindividual monitoring (a) and (e) are 3.a; Agreement States are requiral to results (b), (c), (d), and (f) adopt paragraphs (a) and (c) to are 3.b. eliminate confusion in obtaining information in support of implementation of basic radiation protection standards since individuals may recieve exposure in more than one licensee's facilities and in more 'than one jurisdiction. 620.2107 Records of Dose to individual 3.b. members of the Public 620.2108 Records of Waste Disposal 3.b. 620.2110 Form of Recorde 3.b. 620.2201 Reports of theft or IAss oflicensed 3.a. These requirements are needed for material a common understanding in collecting and reporting , information on the regulation of ' agreement materials on a national basis. l t i 14 i I
i REGULATION SECTION TITLE - CLASSIFICATION COMMENT!i SECTION ASSIGNED i 3.a. for all sections, All of this provision, except 520.2202 Notification of Incidents except (e) is 3.b. paragraph (e), is needed for a : common understanding in j collecting and reporting i information on the regulation of ! agreement materials on a national ; basis. l Meeting essential objective of this i , regulation for the purpose of ; compatibility requires the State to ! adopt the numerical values noted r in the regulation as the minimal level acceptable. If state adopts ; planned special exposure, then the t state should adopt paragraph (e). ; l 520.2203 Reports of exposures, etc, (a), (b) are 3.a.; e is Paragraphs (a) and (b) provide exceeding the limits. NRC; and (d) is 3.b. requirements that are needed for a common understanding in collecting and reporting information on the regulation of agreement materials on a national basis.
]
15 ,
REGULATION SECTION TITLE CLASSIFfCATION COMMENTS SECTION ASSIGNED 620.2204 Reports of Planned special 3.b. If state adopts planned special exposures exposure, then the state should adopt this provision. 620.2205 Reports to individuals of exceeding 3.b.* dose limits 520.2206 Reports ofIndividuals Monitoring (a)(1),(a)(3),(a)(4), and (a)(5) are NRC. (a)(2),(a)(6),(a)(7), (b) and (c) are 3.b. 620.2301 Applications for Exemptions 3.b. I (20.2302 Additional Requirements 3.b. 520.2401 Violations 3.b. 520.2402 Criminal Penalties 3.b. Appendix A Protection Factors for Respirators 3.a. Agreement States are required to adopt this provision because it provides the minimal acceptable level of protection to be afforded bYrespirators. 16
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED Appendix B Annual Limits on Intake (ALis), I (Tables 1,2, & 3) Derived Air Concentrations (DACs), of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage I Appendix C Quantities oflicensed materials 1 i requiring labeling Appendix D United States Nuclear Regulatory 3.b. Commission Offices Appendix E Reserved Appendix F Requirements for Low-level Waste 2 The provisions are needed in l Transfer for disposal at land order to provide consistency in l disposal facilities and Manifest . regulating agreement materials which frequently cross multiple State iurisdictions. 17
i i REGULATION SECTION TITLE CLASSIFICATION COMMEN13 SECTION ASSIGNED + t Appendix G Requirements for low-level 2 These provisions are needed by radioactive waste intended for Agreement States in order to i disposal at land disposal facilities provide consistency in regulating , and manifests agreement materials which ; frequently cross multiple 1IState jurisdictions. ; i r f, i t i e t t 18 ' i i
Part 33 - SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERLSL REGULATION SECTION TITLE CLASSIMCATION COMMENTS SECTION ASSIGNED 633.1 Purpose and scope 3.b. 633.8 Information collection requirements: 3.b. OMB approval 533.11 Types of specific licneses of broad 3.b. scope (33.12 Applications for specific licenses of 3.b. bruad scope {33.13 Requirements for the issuance of a 3.b. Type A specific license of broad scope 533.14 Requirements for the issuance of a 3.b. Type B specific license of broad scope 633.15 Requirements for the issuance of a 3.b. Type C specific license of broad scope 133.16 Application for other specific licenses 3.b. = - - - ---
533.17 Conditions of specific licenses of broad 3.b. scope 533.21 Violations 3.b. 533.23 Criminal penalties 3.b. 633.100 Schedule A 3.b. 2
____ . _ _ _ _ ._ _ .. _ _.._. _ . . . _ _ _ _ . _ _ _ _ _ . . . . _ _ _ . _ . ~ . . . . . _ _ . _ . _ ____ .._. _ I i Part 34 - LICENSES FOR RADIOGRAPIIY AND RADIATION SAFETY REQUIREMENTS FOR RTsDIOGRAPHIC OPERATIONS , REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 63
4.1 Purpose and Scope
3.b. 634.2 Definitions Pennanent radiographic installation 3.b. Radiagrapher 3.a.' Radiographer's assistant 3.b. i Radiographic exposure device 2 - Radiography 2 i Scaled source See 10 CFR 630.4 i Source changer 2 i Storage area 3.b. i Storage container 2 634.3 Applications for specific licenses 3.b. 634.4 Maintenance ofrecords 3.a.' g34.8 Information collection requirements: 3.b. OMB approval
F REGULATION SECTION TITLE CLASSIFICATION COMMENTS ; SECTION ASSIGNED ' g34.11 issuance of specific licenses for use of 3.a.' sealed sources in Industrial Radiography I {34.20 Performance requirements for 2 i radiography equipment
$34.21 Limits on levels ofradiation for 2 radiographic exposure devices and r
storaRe containers
$34.22 Locking ofradiographic exposure 2 devices, storage containers and source i
channers t 434.23 Storage precautions 3.a.' 634.24 Radiation survey instruments 3.a.'
$34.25 Leak Testing, Repair, Tagging, 3.a. '
Opening, !
- Modification, and Replacement of scaled Sources i
l 634.26 Quarterly Inventory 3.a.' j 634.27 Utilization loas 2 i l i
. t l 2 i t
+
I 1 I f1l \\l1 I{!! S T N E M M O C N O I TD s . n b. sno3b. AE o CN i i3 t t s cs ci I FI G ei e) I S s) I sd r( r( SS A S ot fotp f p A *. .e ' .
.e . .
b. b.
'a. 'a.. 'a. c 'a.
- a. cx b. b.
L C 'a.. b. . x 'a.. 3 3 a. 3 3 e 3 3 3 3 3 3 3 3 3 e 3 t e g s n s e a a n r t s r o o u i s i d s t s s t a e a l c foeg s e
,r l a o 'st s E t s
r p c n L einc n y h o T c va I c p i t n eh c a p I ad c s n r T n e ee i hp t n e g g g m N r c a e r n o e x O t n ur i s u r g m e i r s i d a e s e a oo o e m o y r r i I T mps i i r E i t n e v f fo l t a u o dn exdn d n C a q d n o r u n s n e E ai ca R e r a m s o o s P S nh t g n n oprs g l i i n e o s t o l a a e e n g n n y g i v a n it r n n i n i t n t n i t r c i t a i c gi a t r i a o i r a e i l m e a o n r s u i t i p p l o pi ot e m p i c s d p i n r a p r e e o a u i r sd e e r R S A V C Inar c o O P R T P S P N O I N TO An L ;a 3 Ut 2 3 i 2 3 4 1 1 GE 8 9 0 1 3 3 3 4. 4 4 4. 5. 6 6. 2 2 3. .
- 4. 4 E S 4 4 4 4 4 4 4 4 4 4 4 3 3 3 3 3 3 3 3 R 3 6
3 3 6 3 6 3 6 6 6 6 $ 6 6 6 6
l l REGULATION SECTION TITLE SECTION CLASSIFICATION COMMENTS ASSIGNED Appendix A Required subjects for training 3. a. ' instruction
' Ay ec..4..t States are required to adopt these provisions for the purpose ofcompatibility to avoi regulations ofindustrial radiography since this activity frequently involves persons working under recip 4
i Part 35 - MEDICAL USE OF BYPRODUCT MATERIAL REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 535.1 Purpose and scope 3.b. 535.2 Definitions i Address of use 3.b. ! ALARA See 10 CFR 620.1003 Agreement State See 10 CFR fl50.3(b) L Area of use 3.b. Authorized nuclear pharmacist 3.b. i Authorized user 3.a. Brachytherapy source 3.b. Dedicated check source 3.b. Dental use 3.b. i t
REGULATION SECTION TITLE CLASSIFICATION COMMENIS SECTION ASSIGNED Dentist 3.b. Diagnostic clinical procedures 3.b. manual Management 3.b. Medical institution 3.b. Medical use 3.a. Ministerial change 3.b. Misadministration 3.a. States are required to adopt the quantitative valves in this provision since they contain the essential objectives of this requirement. Mobile nuclear medicine 3.b. service Output 3.b. 2
^
6 l REGULATION SECTION TITLE CLASSIFICATION COMMENTS ; SECTION ASSIGNFE i Pharmacist 3.b. Physician 3.b. I t Podiatric use 3.b. i Podiatrist 3.b. t l Prescribed dosage 3.a. l . Prescribed dose 3.a. i Radiation safety officer 3.b. l Recordable event 3.b. i Scaled source See 10 CFR 630.4 Teletherapy physicist 3.b. written directive 3.a. 635.5 Maintenance of records 3.b. 3
i REGULATION SECTION TITLE CLASSIFICATION COMMEN'IS i SECTION ASSIGNED i i 135.6 Provisions for research 3.b. ; involving human subjects. 535.7 FDA, other Federal, and State 3.b. 1 requirements (35.8 Information collection 3.b. - requirements: OMB Approval
- 535.11 License required See 10 CFR 630.3 ,
635.12 Application of license, 3.b. 1 amendment, or renewal i 135.13 License amendments 3.b. 035.14 Notifications 3.b. 635.15 Exemptions regarding Type A 3.b. i specific licenses of broad scope ' 035.18 License issuance 3.b. ' 4 1 h
REGULATION SECTION TITLE CLASSIFICATION COMMEN13 SECTION ASSIGNED 635.19 Specific exemptions 3.b. 635.20 ALARA program See 10 CFR 520.1101 635.21 Radiation Safety Officer (a) is 3.b.*; and (b) is 3.b. ; 635.22 Radiation safety committee 3.b. 635.23 Statements of authority and (a) is 3.b.*; and responsibilities (b) is 3.b. t i 535.25 Supervision 3.b. $35.29 Administrative requirements 3.b. that apply to the provision of mobile nuclear medicine service 635.31 Radiation safety program 3.b. changes 5 i
REGULATION SECTION TITLE CLASSIFICATION COMMENIS SECTION ASSIGNED 635.32 Quality management program 3.b* for all sections except, (a)(5), (d), (c) and (f) are 3.b. 635.33 Notifications, reports, and 3.a. records of misadministrations $35.49 Suppliers for scaled sources or 3.b. devices for medical use 635.50 Possession, use, calibration, 3.b. and check of dose calibrators $35.51 Calibration and check of See 10 CFR 620.1501 survey instruments 635.52 Possession, use, calibration, 3.b. and check of instruments to measure dosages of alpha- or beta-emitting radionuclides $35.53 Measurements of dosages of (a), (b) are 3.b.*; and unsealed byproduct material for (c) is 3.b. ; medical use 6 i
l l 3 i REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 535.57 Authorization of calibration and 3.b. reference sources i 535.59 Requirements for possession of 3.b.* sealed sources and brachytherapy sources 135.60 Syringe shields and labels 3.b. 635.61 Vial shields and labels 3.b. 135.70 Surveys for contamination and 3.b.* ambient radiation exposure rate 635.75 Release of patients or human 3.a. > research subjects containing radiopharmaceuticals or permanent implants 535.80 Technical requirements that 3.b. apply to the provision of mobile nuclear medicine services 7
. - . . .... . .. .. .._.. - - - - ....-.. . ~ . . . _ . . - .... ..-.- - .- .... - ... . - . - . . . . - . - . . - - . . - . . - - .
I ! i P l REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED i l 535.90 Storage of volatiles and gases 3.b. ' 635.92 Decay-in-storage 3.b. 635.100 Use of unsealed byproduct 3.b.* material for uptake, dilution, and excretion studies i (35.120 Possession of survey 3.b. - instruments 535.200 Use of unsealed byproduct 3.b.* material for imaging and localization studies 635.204 Permissible molybdenum-99 3.b.* concentration ; 635.205 Control of aerosols and gases See 520.1301 535.220 Possession of survey See 520.1501 instruments 8 l l
REGULATION SECTION TITLE CLASSIFICATION COMMENTS , SECTION g ASSIGNED ! e ' 4 i 635.300 Use of! unsealed byproduct ma- 3.b.* terial d.w therapeutic admindtration ; a
$35.310 Safety instruction 3.b. l
~
~t i 635.315 Safety precautions 3.b.
535.320 Possession of survey 3.b. instruments i l _ 535.400 Use of sources for 3.b. ! brachytherapy i 535.404 Release of patients or human 3.a. [ research subjects treated with temporary implants i 135.406(a) & (c) Brachytherapy sources (a) and (c) are 3.b. , inventory and (b) and (d) are 3.b. ' 635.410 Safety instruction 3.b. i 9 t
REGULATION SECTION TITLE CLASSIFICATION COMMEN13 SECTION ASSIGNED h 535.415 Safety precautions 3.b. 635.420 Possession of survey 3.b. instruments $35.500 Use of scaled sources for 3.b. diagnosis ' 535.520 Availability of survey 3.b. instrument 535.600 Use of a scaled source in a 3.b. teletherapy unit 135.605 Maintenance and repair 3.b.* , restrictions 535.606 License amendments 3.b. ' 635.610 Safety instructions 3.b.* 135.615 Safety precautions 3.b.* 10 __ ___m . _____._ ___ _ _ _ _
REGULATION SECTION TITLE CLASSIFICATION COMMENTS [ i SECTION ASSIGNED i 135.620 Possession of survey 3.b. - instrument i 535.630 Dosimetry equipment 3.b.* *
$5.632 Full calibration measurements - 3.b.* States are required to adopt the quantitative values in this l provisia. sinz they are ;
essential objectives of this requirement. ! i
?
035.634 Periodic spot-checks 3.b.* '
$35.636 Safety checks for teletherapy 3.b.*
facilities t 535.641 Radiation surveys for 3.b. ! teletherapy facilities 535.643 Modification of teletherapy unit 3.b. or room before beginning a ! treatment program i Ii , l l i
~
f i REGULATION SECTION TITLE CLASSIFICATION COMMENT!i SECTION ASSIGNED i i 535.645 Reports of teletherapy surveys, 3.b. checks, tests, and measurements , 635.647 Five-year inspection 3.b. *
$35.900 Radiation safety officer 3.b. :
t I 535.901 Training for experienced 3.b. [ radiation safety officer : i 535.910 Training for uptake, dilution, 3.b. and excretion studies ! i 535.920 Training for imaging and 3.b. i localization studies 635.930 Training for therapeutic use of 3.b. unsealed byproduct material j 635.932 Training for treatment of 3.b. hyperthyroidism I 12 I i
?
_-. ._- ._ _ _ . _ . _- .- - - ___ - ._-__- - --____- O
t REGULATION SECTION TITLE CLASSIFICATION COMMEN13 > SECTION ASSIGNED i 635.934 Training for thyroid carcinoma 3.b. i 635.940 Training for use of 3.b. brachytherapy sources , 535.941 Training for ophthalmic use of 3.b. t strontium-90 ! t 535.950 Training for use of sealed sour- 3.b. ces for diagnosis 635.960 Training for teletherapy 3.b. - r l 535. % 1 Training for teletherapy 3.b. physicist 635.970 Training for experienced 3.b. authoried users l 635.971 Physician training in a three 3.b. month program (35.972 Recentness of training 3.b. 13 l l l .
REGULATION SECTION TITLE CLASSIFICATION COMMEN13 SECTION ASSIGNED
$35.980 Training for an authorized 3.b.
nuclear pharmacist 535.981 Training for engi;crM 3.b. nuclear pharmacist i t 535.990 Violations 3.b. i 535.991 Criminal penalties 3.b. 535.999 Resolution of conflicting 3.b. ; requirements during transition period i i i 14 i i' r i
4 i Part 36 - LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIA1DRS i i REGULATION SECTION TITLE CLASSIFICATION COMMEN13 SECTION ASSIGNED i 636.1 Purpose & Scope (a) is 3.b.; (b) and (c) States are required to adopt the are 3.a. quantitative values in Paragraphs (b) and (c) since they are essential objectives of i this requirement. ! 636.2 Dermitions i Annually 3.b. Doubly encapsulated sealed source 3.b. Irradiator 3.a. Irradiator operator 3.b. Panoramic dry-source- 3.b. storage irradiator Panoramic irradiator 3.b. Panoramic wet-source- 3.b I storage irradiator Pool irradiator 3.b. Product conveyor system 3.b. I
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED Radiation room 3.b. Radiation safety officer 3.b Scaled source See 10 CFR 630.4 f Seismic area 3.b. l Underwater irradiator 3.b. ! 136.5 Interpretations 3.b. l 536.8 Information collection 3.b. requirements: OMB approval 636.11 Application for a specific license 3.b. 636.13 Specific licenses for irradiators 3.b.* 536.15 Start of construction 3.b. 636.17 Applications for exemptions 3.b. 536.19 Request for written statements 3.b. 636.21 Performance criteria for sealed 2 States are required to adopt the sources quantitative values in this provision since thy are essential objectives of this requirement. 2
t l REGULATION SECTION TITLE CLASSIFICATION COMMENTS i SECTION ASSIGNED ! t i 636.23 Access control 3.b.* 636.25 Shielding 3.b.* t r 636.27 Fire protection 3.b. 536.29 Radiation monitors 3.b.* 536.31 Control of source movement 3.b.* 636.33 Irradiator pools 3.b.* 136.35 Source rack protection 3.b. i
$36.37 Power failures 3.b.* i
\
$36.39 Design requirements 3.b.*
t 636.41 Construction monitoring and 3.b.* i accept =. testing 536.51 TraiQg 3.b.* ! t i 536.53 Operating & Emngcxy procedures 3.b.* i t 636.55 Personnel mordtotM 3.b. t 6 t 3 i 1
REGULATION SECTION TITLE CLASSIFICATION COMMEN13 SECTION ASSIGNED 636.57 Radiation surveys 3.b.* States are required to adopt the quantitative values in this provision since they are l t essential objectives of this requirement. 136.59 Detection of leaking sources 3.b.* States att required to adopt the quantitative values in this provision since they are essential objectives of this requirement. 636.61 Inspection and maintenance 3.b.* 636.63 Pool water purity 3.b.* States are required to adopt the quantitative values in this provision since they are essential objectives of this requirement. 136.65 Attendance during operation 3.b.* 636.67 Entering and leaving the radiation 3.b.* room (36.69 Irradiation of explosive or 3.b.* inflammable materials 4
l
)
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 536.81 Records and retention periods 3.b. l 536.83 Reports 3.a. ; i 636.91 Violations 3.b. l l 536.93 Criminal penalties 3.b. I it t t [ t t l 5 l
k i Part 39 - LICENSES AND RADIATION SAFETY REQUIREMEN'IS FOR WELL IDGGING t i t REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 4 i 63
9.1 Purpose and Scope
3.b. , 539.2 Definitions Field station 2 Fresh water aquifer 3.b. j Injection tool 3.b. ! 1 Irretrievable well logging source 3.b. ! [ Licensed material 3.b. ! Ingging assistant 3.b. i Imgging supervisor 3.a. l i Imgging tool 3.b. ! t Personal supervision 3.b. Radioactive marker 3.b. i Safety review 3.b. Scaled source See 10 CFR 530.4
REGULATION SECTION TITLE CLASSIFICATION COMMEN13 i SECTION ASSIGNED , Source holder 3.b. Subsurface tracer study 3.b. i Surface casting for protecting 3.b. fresh water aquifiers Temporary jobsite 3.b. + Uranium sinker bar 3.b. Well 3.b. Well logging 3.a. 139.5 Interpretations 3.b. 639.8 Information col:ection 3.b. requirements: OMB approval 539.11 Application for a specific license 3.b. 639.13 Specific licenses for well logging 3.b.*
$39.15 Agreement with well owner or 3.a.
operator (39.17 Request for written statements 3.b. 2
REGULATION SECTION TITLE CLASSIFICATION COMMEN13 SECTION ASSIGNED 639.31 Labels, Security, and (a) is 3.b.; and Transportation precautions (b) is 3.a 639.33(a), (c), & Radiation detection instruments (a), (c) and (d) are (d) 3.b.; and (b) is 3.b* 639.35 12ak testing of sealed sources 3.a. 639.37 Physical inventory 3.b.*
$39.39 Records of material use 3.a.
139.41 Design and performance criteria 2 for sealed sources
$39.43 Inspection, maintenance, and 3.a.
opening of a source or source holder 639.45 Subsurface tracer studies 3.a. 639.47 Radioactive markers 3.b. 639.49 Uranium sinker bars 3.b l l 639.51 Use of scaled source in a well 3.b. ! without surface casing 3
REGULATION SECTION TITLE SECTION CLASSIFICATION COMMENTS ASSIGNED
$39.61 Training 3.a. 'Ihese provisions should be adopted by States because they contain training requirements not contained in (619.12) or other sections and apply to persons who frequently work in multiplejuristictions.
639.63 Operating & Emergency 3.a. procedures 539.65 Personnel monitoring (a) is 3.a.; (b) and (c) are 3.b. 539.67 Radiation surveys 3.a. 639.69 Radianctive con-famination 3.a. control 639.71 Security 3.a. 539.73 Documents & Records required 3.a. at field stations 4
1 I REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED i 139.75 Documents & records required at 3.a. temporary job sites [ t 539.77 Notification ofincidents: aban- (a), (c) and (d) are donment proced-ures for irretrie- 3.a.; (b) is 3.b. ! vable sources (39.91 Applications for exemptions 3.b. 639.101 Violations 3.b. i 539.103 Criminal penalties 3.b. i l i 5 t
- m. __ . . _ _ . _ _ . _ . _ . . _ _ . . . . . . _ . _ _ _ _ . _ . . . _ _ . . _ . . _ . _ . _ . . _ . - _ _ . _ _ . . _ . _ . _ _ _ _ _ _ . - . _
Part de - DOMESTIC LICENSING OF SOURCE MATERIAto REGULATION SECTION TITLE CLASSIFICATION COMMENTS i SECTION ASSIGNED
$40.1 Purpose 3. b.
540.2 Scope 3. b. i 140.2a Coverage of inactive tailings sites I for States with Agreement States with authority to ; authority to regulate U- regulate uranium mill should adopt ; mill activities. (II.e.2 this term and definition. byproduct material or 3.b. for States without authority
$40.3 License requirements )
- 3. a. '
t i 540.4 Definitions , I Act 3. b. ' i Agreement State See 10 CFR ll50.3(b) ! Alert See 10 CFR $30.4 l i i Byproduct material See 10 CFR fl50.3(c), applies if UM1RAC State t i Commencement of construction See 10 CFR 530.4 Commission 3.b.
. i
REGULATION SECTION TITLE CLASSIFICATION COMMENTS . SECTION ASSIGNED i r I Decommission See 10 CFR 630.4 Department of Energy See 10 CFR 920.1003 Depleted uranium I i
\
Effective kilogram 3.b. l Government agency 3.b. License 3.b. i Persons See 10 CFR 520.1003 Pharmacist See 10 CFR 535.2 I Physician i' See 10 CFR 535.2 Principle activities See 10 CFR 530.4 I f Residual radioactive material I for States with Agreement States with authorky to authority to regulate U- regulate uranium mill should adopt mill activities. (ll.c.2 this term and definition. byidudad material or 3.b. for States without ' authority Site area emergency See 10 CFR 530.4 2
REGULATION SECTION TITLE CLASSIFICATION COMMEITTS SECTION ASSIGNED Source material See 10 CFR 6150.3 ; Special nuclear material See 10 CFR 5150.3 Transient shipment 3.b. United States 3.b. Unrefined and unprocessed 2 < Uranium enrichment facility 3.b. Uranium milling 3. a. for States with ! authority to regulate i uranium mill activities or
- 3. b. or States without this authority !
640.5 Communications 3.b. ! P (40.6 Interpretations 3.b. 640.7 Employee protection 3.b. I i {40.8 information collection requirements: 3.b. OMB approval i
. I 3 i I
.. . _ . -~ -. -
l t REGULATION SECTION TITLE CLASSIFICATION COMMENIS ; SECTION ASSIGNED t r
$40.9 Completeness and accuracy of 3.b.
- information "
$40.10 Deliberate misconduct 3.a. '
I t
$40.11 Persons using source material under 2 certain Department of Energy and Nuclear Regulatory Commission i contracts i 540.12 Carriers t 2
540.13 Unimportant quantities of source . 2 l' material t 540.14 Specific exemptions (a) is 3. b.; (c), and (d) ~ are NRC
$40.20 Types oflicenses 3.b.
$40.21 General license to receive title to source 3.a.
or bir.vdat material 540.22 Small quantities of source material 2
$40.23 General license for carriers of transient NRC shipments of natural uranium other than in the form of ore or ore residue i
4
REGULATION SECTION TITLE CLASSfFICATION COMMEIES SECTION ASSIGNED ! $40.25 General license for use of certain 3.a. l industrial products or devices , 140.26 General license for possession and 3. a. for States with storage of byprodtici iiistcrial as defined Ile.(2) byproduct in this part material authority ~, 540.27 General license for custody and long- NRC term care of residual radioactive material disposal sites
$40.28 General license for custody and long- NRC term care of uranium or thorium byproduct materials disposal sites 940.31 Application for specific licenses All sections are 3. b.,
except (i) is 3b* 940.32 General requirements for issuance of All sections are 3. a., specific licenses except (d) and (e) are NRC l 140.33 Issuance of a license for a uranium NRC enrichment facility 140.34 Special requirements for issuance of (aX2) and (aX3) are 2; specific licenses and (b) and (c) are 3.b. I 5
I REGULATION SECTION TITLE CLASSIFICATION COMMEPRS SECTION ASSIGNED
$40.35 Conditions of specific licenses issued (b) and (c) are 2; (a) is pursuant to $40.34 3. a.; and (c), (e), and (f) are 3. b.
{40.36 Financial assurance and recordkeeping (a), (b), and (d) are for decommissioning 3.b.*: (c), (e), and (f) are3.b. 140.41 Terms and conditions oflicenses 3.b. 540.42 Expiration and termination of licenses (c), (d), (e), (g), (h), and decommissioning of sites and (i), (j), and (k) are separate buildings or outdoor areas 3.b.*; (I) is 3.a.s; (a), (b), (f), (k) are 3.b. 540.43 Renewal oflicenses 3.b. 540.44 Amendment oflicenses at request of 3.b. licensee {40.45 Commission action on application to 3.b. renew or amend
$40.46 Inalienability oflicenses 3.a.
540.51 Transfer of source or byproduct 2 material {40.60 Repotting requirements 3.a. 6 - = __= _ - _ _
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED $40.61 Records 3.a. for all sections, s except (c) is 3.b. 540.62 Inspections 3.b. 640.63 Tests 3.b. 540.64 Reports NRC 540.65 Emuent monitoring reporting 3. a. S. for States with requirements uranium mill authority I $40.66 Requirements for advance not'a of NRC export shipmerts of natural uranium 540.67 Requirement for advance not'a of NRC importation of natural uranium from countries that are not party to the Convention on the Physical Protection of Nuclear Material 640.71 Modification and revocation of licenses 3.b. 540.81 Violations 3.b. 540.42 Criminal penalties 3.b. 7
REGULATION SECTION TITLE CLASSIFICATION COMME!WS SECTION ASSIGNED APPENDIX A 3.a. S. for States with i ile.2 byproduct material authority or 3.b. for
- States without authority ;
l l i i l i e 3 i i L
- . . . . . . . - - .....~ -.._.-.-.-- - ....- --- . _-.-..-.- ..-_-. _ ..- - - .----.-- - - -.
l Part 61 - LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE 1 l REGULATION SECTION TITLE CLASSIFICATION COMMEN'IS i SECTION ASSIGNED i (As detennined by B.7) 661.1 Purpose & Scope 3.b. I 561.2 Definitions ' Active maintenance 3.b.* Buffer zone 3.b. > Chelating agent 3.b. t t Commencement of construction 3.b. Commission 3.b. ' Custodial Agency 3.b. Director 3.b. l Disposal 3.a. Disposal site 3.a. Disposal unit 3.b. Engineered barrier 3.b. Explosive material 3.b. l Government agency 3.b. l Hazardous waste 3.a. l l l
. - . . . - .-. - - - . . . . . . _ - - . _ . . . . -. . . - - ~ - . . .-
1 REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED (As deterweined by B.7) ! Hydrogeologic unit 3.b. ! Inadvertent intruder 3.a. ' t Indian Tribe 3.b. Intruder barrier 3.a. I Land disposal facility 3.b.
- License See 10 CFR 620.1003 Monitoring 3.a.
Near-surface disposal facility 3.b. , Person See 10 CFR 520.1003 i Pyrophoric liquid 3.b. Site closure and stabilization l - 3.b. t State 3.b. ! Stability 3.b. i Surveillance 3.b. . t Tribal governing body 3.b. Waste 2 2 [ l.
l l l l REGULATION SECTION TITLE CLASSIFICATION COMMEN13 SECTiON ASSIGNED (As detennined by B.7) 661.3 License required 3.a. 661.4 Communications 3.b. 661.5 Interpretations 3.b. 661.6 Exemptions 3.b. 661.7 Concepts 3.b.*
$61.8 Information collection requirements: 3.b.
QMB approval 661.9 Employee protection 3.b. 661.9a Completeness and accuracy of 3.b. information i 661.9b Deliberate misconduct 3.b. 661.10 Content of application 3.b. ! 661.11 General information 3.b. l 661.12 Specific technical information 3.b. 661.13 Technical analysis 3.b.* ! i 661.14 Institutional information 3.b.* 561.15 Financial information 3.b. 3 l i t
i i l t t
?
I REGULATION SECTION TITLE CLASSIFICATION COMMENTS , SECTION ASSIGNED (As determined by B.7) i 661.16 Other information NRC : 661.20 Filing and distribution of application 3.b. !
$61.21 Elimination of repetition 3.b.
i Updating of application 661.22 3.b. i 661.23 Standards for issuance of a license 3.b.
$61.24 Conditions of licenses '3.b.
661.25 Changes 3.b. 661.26 Amendment oflicense 3.b. 661.27 Application for renewal or closure 3.b. : 561.28 Contents of application for c'wre 3.b. 661.29 Post-closure ca.stion and 3.b. maintenance 661.30 Transfer of license 3.b. ' 561.31 Termination of license 3.b. 661.40 General requirement l i 3.b. 661.41 Protection of the general population 1 from releases of radioactivity ! i i 4 t
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED (As determined by B.7) 661.42 Protection ofindividuals from 3.b. inadvertent intrusion (61.43 Protection of individuals during 3.b. operations 661.44 Stability of the disposal site after 3.b.* closure 561.50 Disposal site suitability requirements 3.b.* for land disposal i l 661.51 Disposal site design for land disposal 3.b.* j $61.52 . Land disposal facility operation and 3.b.* i disposal site closure l 561.53 Environmental monitoring 3.b.* i 661.54 Alternative requirements for design 3.b.* and operations (61.55 Waste classification 2 561.56 Waste characteristics 3.b.* i 5
t i REGULATION SECTION TITLE CLASSIFICATION COMMENTS l SECTION ASSIGNED (As ddermined by B.7) i 1 561.57 Labeling 3.b.* States are required to adopt this pnwision for safety to >~a overexposure from mishandling of wastes with high activities.
$61.58 Alternative requirements for waste 3.b.
' classification and characteristics i
$61.59 Institutional requirements 3.b.*
161.61 Applicant qualifications and 3.b. ! assurances ; I
$61.62 Funding for disposal site closure and 3.b.*
stabilization 661.63 Financial assurances for institutional 3.b.* controls i l 561.~70 Scope 3.b. 661.71 State and Tribal government 3.b. W consultation p 661.72 Filing of proposals for State and 3.b. Tribal participation 661.73 Commission approval of proposals 3.b. 6 i 6 I f I
i I REGULATION SECTION TITLE CLASSIFICATION COMMEN13
- SECTION ASSIGNED *
[ , (As detennined by B.7) : 561.80 Maintenance of records, reports, and 3.a. j transfers i L C51.81 Tests at land disposal facilities '3.b. ! 661.82 Commission inspections of land 3.b. f disposal facilities ! t 661.83 Violations 3.b. 661.84 Criminal penalties 3.b. i 6 7 i i f i i
Part 70 - DOMSTIC LICENfsNG OF SPECIAL NUCLEAR MATERIAL REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 570.1 Purpose 3. b. 4 670.2 Scope 3. b. 670.3 License requirements 3. a. 570.4 Definitions Act 3. b. Agreement State See 10 CFR ll50.3(b) Alert See 10 CFR 630.4 Atomic Energy 3. b. Atomic Weapon 3. b. , Commencement of construction See 10 CFR 530.4 - Commission 3. b. Common defense and security 3. b.
I REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED Contiguous sites 3. b. Decommission See 10 CFR 630.4 Department or Department of Energy See 10 CFR 630.4 Effective dose equivalent See 10 CFR 620.1003 Effective kilograms of special 3. b. nuclear material Formula quantity 3. b. Government agency 3.b. License See 10 CFR 520.1003 Persons See l') CFR 520.1003 Plutonium processing and fuel 3.b. fabrication plant Principal activities See 10 CFR 630.4 Produce 3. b. 2
S T N E M M O C N O I i
)
(
)
j ( 4 4 TD 0 0 AE 0 3 0 3 5 5 CN I G 5 6 l f l l FI R R R R I S F F F F S S S C C C C A A 0 0 0 0 L b b
. 1 1 1 1 C C .
C C C C . . e e ee e e e e R R b R R R N N 3 3 S S S S 3 N N N 3 t e a r e l a d w o o p i r e E l m a r t a L t n f o f o c s m T I e l l l l r T m a a a a a p i r i r i r i r e N o y e ee c eec e l c l e c t a t an t a n t a u t O v n m ma ma m n e n I e e c c T d a g r l a r a ri f ri f r l a m C d t a e e i r e ai en ai en ae i c p s E n d c r m e l c l cig l cig l c e p i h e S a u e t a u us us u s s t a h d e o s a m n n c n c n c t n S t c t c e i e r a i d r a e c l a l i ag l i ag l a g i d e t r e r i c iect i ct e i c t e s n e s e s e l a e u e ea ea e a a i t n R R c i t o p pr pr p t r r S S S S Ss t Ss t S S T U N O I N TO AI L T UC E G E S R l ll!
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED Uranium enrichment facility NRC 170.5 Communications 3. b. 670.6 Interpretations 3. b. 670.7 Employee protection 3. b. 670.8 Information collection requirements; 3. b. OMB approval 670.9 Completeness and accuracy of 3. b. information 670.10 Deliberate m;sconduct 3. b. 670.11 Persons using special nuclear I material under certain DOE and NRC contracts 670.12 Carriers 2 670.13 Department of Defense NRC 670.13a Foreign military aircraft NRC I 4
REGULATION SECTION TITLE CLASSIFICAT!ON COMMENTS , SECTION ASSIGNED : 170.14 Specific exemption 3. b. ! i 170.18 Types of licenses 3. b. .[ 670.19 General license for calibration or 3. a. [ reference sources ; 670.20 General license to own special 3. a. nuclear material ; i 570.20a Genemi license to possess special NRC l nuclear material for transport j l 670.20b General license for carriers of NRC l' transient shipments of formula , quantities of strategic special nuclear ! material, special nucicar material of l moderate strategic signifx:ance, ; special nuclear material of low l strategic significance, and irradiated j reactor fuel 670.21 Filing (a)(1), (a)(2), (a)(3), (b) and (d) are 3.a.; ! (c), (f), (g), and (h) are NRC; (e) is 3.b. l 5 f i
I REGULATION SECTION TITLE CLASSIMCATION COMMENTS SECTION ASSIGNED ! i l.- t r i t i 3.a. i
- 570.22 Contents of application (a), (d) and (e) is 3.b.;
(b), (c), (f), (g), (h), (i), (j), (k), (1), (m), i' and (n) are NRC 570.23 Requirements for the approval of (a)(1), (2), (3), (4), applications (5), and (6) are 3.b.; i (a)(7), (8)(a)(1) thru (7) are 2; (aX9), (a)(10), ! (axil), and (a)(12) are rule 4 570.23a Hearing required for uraniem NRC enrichment facility !
$70.24 Critically accident requirements NRC !
I t i 6
REGULATION SECTION TITLE CLASSIFICATION COMMEN'IS SECTION ASSIGNED l 670.25 Financial assurance and 3.b* recordkeeping for decommissioning 670.31 Issuance of licenses 3. b. l 570.32 Conditions of licenses (a)(1), (a)(4), (a)(5), (a)(6), (a)(7), (b)(1), i i (bX2), (bX3), (b)(4), i (b)(5), (c), (d), (e), (f), ; (g), (h), (i), (j) and (k) are NRC; (a)(2), (aX3), (aK8, and (aK9) i are 3.b. 670.33 Renewal oflicenses 3. b. 670.34 Amendment of licenses 3. b. 670.35 Commission action on applications to 3. b. renew or amend 670.36 Inalienability of licenses 3. a. 570.37 Disclaimer of warranties NRC 7
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 570.38 Expiration and termination of 3.a. licenses and decommissioning of sites and separate bu;1 dings or outdoor areas 570.39 Specific licenses for the manufacture 3. a. or initial transfer of calibration sources
$70.41 Authorized use of special nuclear 3. b.
material 570.42 Transfer of special nuclear material 2 670.44 Creditor regulations NRC 670.50 Reporting requirements See 10CFR 620.0001 thru 20.006 570.51 Material balance, inventory, and NRC records requirements 570.52 Reports of accidental critically or NRC loss or theft or attempted theft of special nuclear material 8
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED j i 670.53 Material status reports NRC 670.54 Nuclear material transfer reports NRC 670.55 Inspections NRC 570.56 Tests NRC 170.57 Measurement control program for NRC special nuclear material accounting and control , 670.58 Fundamental nuclear material NRC controls - t i 670.59 Effluent monitoring reporting NRC i requirements $70.61 Modification and revocation of 3. b. : licenses i t t 570.62 Suspension and operation in war or NRC national emergency j 570.71 Violations 3. b. 9 i
- __ . _ . . _ _ . - . _ _ . . . _ _ . . _ _ . _ . _ _ ~ . _ . _ _ . . _ - . . . . . . . . _ . . . _ - _ . . _ . _ _ . . _ . _ - _ _ . . . . . . . _ _ _ _ _ . _ _ .
t 6 REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 670.72 Criminal penalties 3. b. ! a I r i I r f F 6 4 i t t i 1 l i k 10 i
t l Part 71 - PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL , i l REGULATION SECTION CLASSIFICATION COMMENTS SECTION TITLE ASSIGNED ; l 17
1.0 Purpose and Scope
3.b e i 171.1 Communications and Records 3.b i 671.2 Interpretations 3.b l 671.3. Requirements for license 3.b
$71.4 Definitions
- A, 2 Carrier 2 4
Certificate holder 2 - I Close reflection by water 3.b States not required to adopt, but if they do, i should be essentiallyidentical. i Containment System 2
- t Conveyance 2 Exclusive use 2 '
\
Fissile material 3.b ' States not required to adopt, but ifthey do, should be essentiallyidentical. ! Licensed material 2 i Iow Specific Activity (LSA) 2 ; i material - Low toxicity a!aha emitters 2 l t
i REGURATION SECTION CLASSIFICATION COMMENTS SECTION TITLE ASSIGNED Maximum normal operating 2 , pressure l Natural thorium 2 i Normal form radioactive material 3.b States not required to adopt, but if they do, should be essentiallyidentical. ; Optimum interspersed hydrogenous 3.b States not required to adopt, but if they do, moderation should be essentiallyidentical ! i Package 2 - 1 Fissile material package 2 Type B package 2 Packaging 2 i Special form radioactive material 2 ; i Specific activity 2 State i 3.b i Surface Contaminated Object (SCO) 2 Transport Index h' 2 Type A quantity 2 L. l Type B quantity 2 ! i
- Natural Uranium 2 l
Depleted Uranium 2 I l 2 i t
REGUIATION SECTION CIASSIFICATION COMMENTS SECTION TITLE ASSIGNED Enriched Uranium 2-671.5 Transportation of Licensed Material 2 {71.6 Information collection requirements: 3.b OMB approval {71.7 Completeness and accuracy of 3.b Information g _171.8 Specific exemptions 3.b 671.9 Exemption for physicians 3.b 671.10 Exemptions forlowlevel material 2 571.12 Generallicense: NRC-approved 2 package 671.I3. Tid ~ di approved package 2 {71.14- Generallicense: DOT specification 2 container material g71.16 Generallicense: Use of foreign 2 apyic.d package 571.18 Generallicense: Fissile material, NRC limited quantity ofpackage l71.20 Generallicense: Fissile material, NRC limited moderator per osckame 3 e
i REGURATION SECTION CLASSIFICATION COMMEPITS SECTION TITLE ASSIGNED , ! i i {71.22 General license: Fissile material, NRC limited quantity, Controlled Shipment l {71.24 Generallicense: Fissile material, NRC limited moderator, controlled shipment 171.31 Contents of Application NRC 171.33. Packase description NRC 671.35 Packene evaluation NRC 671.37 Quality Assurance NRC (71.39 R+;....a..;s for additional NRC informa+ ion r 671.41 Demonstration ofCompliance NRC 171.43 General Standards for all packages NRC !
$71.45 Lifting and tie-down Standards for NRC -
all packages l71.47 External radiation Standards for all NRC packanes
$71.51 Additional Reqd.A...; .:s for Type B NRC packases
$71.52 Exemption for low-specific-activity NRC !
(LSA) packanes i 4 l 1 f
SECTION CLASSIFICATION COMMENTS REGULATION SECTION TITLE ASSIGNED 171.53 Fissile material exemptions NRC l71.55 General Requirements for fissile NRC material packages 671.57 Reserved l71.59 Standards for errays offissile NRC material packages {71.61 Special requirements for irradiated NRC nuclear fuel shipments {71.63 Special requirements for plutonium NRC shipments j71.64 Special requirements for NRC plutonium air shipments l71.65 Additional Requirements NRC 671.71 Normal conditions of transport NRC 471.73 Hypothetical accident conditions NRC 671.74 Accident conditions for air transport NRC ofplutonium
$71.75 Qualification ofspecial form NRC radioactive material 671.77 Qualification of LSA-III material NRC 671.81 Applicability ofoperatina controls 2 5
REGULATION SECTION CLASSIFICATION COMMENTS SECTION TITIE ASSIGNED $71.83 Assumptions as to unknown NRC properties 671.85 Preliminary determinations 2 671.87 R.outine determinations 2 671.88 Air Transportation ofplutonium 2 671.89 Opening instructions 2 i 671.91 Records 3.b 671.93. Inspection and tests 3.b 671.95 Reports 3.b g71.97 Advance notification ofshipment of 2 irradiated reactor fuel and nuclear waste 671.99 Violations 3.b 671.100 Criminal penalties 3.b 671.101 Quality assurance requirements 3.b 671.103 Quality assurance organization 3.b 671.105 Quality assurance program 3.b 671.107 Package design control 3.b 671.109 Procurement document control 3.b 6
REGULATION SECTION CLASSIFICATION COMMENTS SECTION TITLE ASSIGNED l71.111 Instructions, procedures, and 3.b drawings l71.117 Identification and control of 3.b materials, parts, and components i 471.119 Control of special processes 3.b 471.121 Internal Inspection 3.b
$71.123 Test control 3.b 571.125 Control ofmeasuring and test 3.b ,
siis d (71.127 Handling, storage, and shipping 3.b control , 671.129 Inspection, test, and operating status 3.b , {71.131 Nonconforming materials, parts, or 3.b components 71.133 Corrective action 3.b 671.135 Quality assurance records 3.b 671.137 Audits J.b A;,,,,... dix A Determination of Al and A2 2 7
Part 150 - EXEMITIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSifORE WATERS UNDER SECTION 274 I REGULATION SECTION TITLE CLASSIFICATION COMMEN'IS SECTION ASSIGNED
~
6150.1 Purpose 3.b (150.2 Scope 3.b (150.3 Definitions il50.3(a) Act 3.b il50.3(b) Agreement State 2 Definition has significant national and transboundary implications. fl50.3(c) Byproduct Material 1 i fl50.3(d) Commission 3.b Il50.3(c) Government Agency 3.b fl50.3(f) Offshore Waters 2 Essential to the reciprocity provisions in (150.20 Il50.3(g) Person See 10 CFR , 620.1003 fl50.3(h) Production facility NRC Such facilities are outside Agreement State i jurisdiction; A, ..s, if State chooses to define the definition should be essentially identical. t fl50.3(i) Source material 1 fl50.3(j) Special nuclear material 1 t fl50.3(k) State 3.b r 5 e4 _ _- ._._- _-- - - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____ -_______________ _ ___ D
i REGULATION SECTION TITLE CLASSIFICATION COMMFRIS - SECTION ASS!GNED 6150.3(1) Utilization facility NRC Such facilities are outside Agreement State jurisdiction; however, if State chesscs to defice the definition should be essentially identical. i il50.3(m) Uranium enrichment facility NRC Such facilities are outside Agreement State jurisdiction; Levct, if State chooses to define the definition should be essentially identical. 5150.4 Communications 3.b t (150.5 Interpretations 3.b
$150.7 Persons in offshore waters NRC . Not within Agreement Statejurisdiction.
not exempt 6150.8 Information collection 3. b requirements: OMB approval 6150.10 Persons exempt NRC Exemption addresses discontinuance of NRC authority in an Agreement State i 5150.11 Critical mass 1 Definition essential to identifying scope of Agreement State authority pursuant to Section 274b of the AEA, thus ensuring a common understanding 5150.14 Commission regulatory NRC Provision addresses continuing NRC authority over authority for physical special nuclear material. protection 1150.15 Persons not exempt NRC Provision addresses continuing NRC authority over certain activities in Agreement States. 2
REGULATION SECTION TITLE CLASSIFICATION COMMENTS . SECTION ASSIGNED il50.15a Continued Commission NRC Provision addresses continuing NRC authority over authority pertaining to certain activities in Agreement States. l byproduct material 6150.16 Submission to Commission NRC Although an issue within NRC exclusive of nuclear material transfer jurisdiction, States should adopt some method to . reports advise their licensees of these NRC requirements. 5150.17 Submission to Commission NRC Although an issue within NRC exclusive i of source material reports jurisdiction, States should adopt some method to advise their licensees of these NRC requirements. : i ll50.17a Compliance with NRC requirements of US/lAEA ! safeguards agreement ; i 6150.19 Submission to Commission NRC Although an issue within NRC exclusive of tritium reports jurisdiction, States should adopt some method to , advise their licensees of these NRC requirements. 5150.20 Recognition of Agreement (a) & (b) are 3.a Provisions in (a) and (b) are important for Msw.t State licenses (c) & (d) are NRC regulation of agreement materials on a national basis. Provisions in (c) & (d) relate to NRC authority to regulate activities in offshore waters. (150.21 Transportation of special NRC Provision addresses continuing NRC authority over nuclear material by aircraft activities in Agreement States 6150.30 Violations 3.b 3
REGULATION SECTION TITLE CLASSIFICATION COMMENTS SECTION ASSIGNED 6150.31 Requirements for 3.a.S UMTRCA requirements. Agreement State regulation of byproduct material I (150.32 Funds for reclamation or 3.a.S UMTRCA requirements. maintenance of byproduct material 1150.33 Criminal penalties 3.b i r i 4 + l
PROGRAM ELEMENTS PROGRAM El r* fENT REQiflRED FOR COMMENTS legislation and legal Authority Adequacy See discussion in Adequacy Section of Policy Statement
-- Regulations See Classification Required wht 'e than three material licenses are affected by the regulation in the Tables for 10 CFR jurisdiction. Exceptions are low level radioactive waste, uranium recovery regulations, ,
parts and those regulations affecting all licensees. Guidana documents and 3.b interpretations t IJeensing Adequacy See discussion in Adequacy Section of Policy Statement t Reciprocal recognition of 3.a "This program element has significant effects on the regulation of agreement materials on a licenses national basis. However, States should be provided~ flexibility fbr the type oflicense and ' time period recognized under reciprocity. Although there are transboundary implications, : there is not a necessity for s!! States to be identical, such as would be required by a classification of "2." ' Written procedures 3.a Maintenance of records, 3.a especially for decommissioning Inspection and licensing 3.a files Inspection and Ecforcement Adequacy See discussion in Adequacy Section of Policy Statement Written procedures 3.a Radiological laboratory 3.b support Instrumentation 3.b Personnel Adequacy See discussion in Adequacy Section of Policy Statement
PROGRAM ELEMENT REQUIRED FOR COMMENTS
- Qualification procedures 3.2 There should be minimum education and experience requirements for all technical personnel in RCPs nationwide. Flexibility is provided to allow for different state administrative requirements.
Response to Events and Adequacy See discussion in Adequacy Section of Policy Statement Allegations Written procedures 3.a
- Major incident investigation 3.a Need to prevent gaps in reporting effectiveness of national program procedures
- Procedures for investigation 3.a of " wrongdoing" Scaled source and device program Adequacy Non-common performance indicator Standard review plan 3.a Format and content of 2 Need to have national consistency so that all RCPs can rely on the specific information registration certificates included in these documents.
Written procedures 3.a Low level waste Adequacy Non-common performance indicator. Written procedures 3.a Uranium recovery Adequacy Nonammor. performance indicator. Written procedures 3.a Exchange of Information 3.a Necessary for effective regulation of agreement materials on a national basis: necessary for effective review of NRC and Agise-(nt State programs for agreement nrterial with respect to protection cf public health and safety. Event reporting 3.a See previous comment. Legal assistance 3.b. Technical advisory committees 3.b
a w e 1 J i . , I
- 8 i
i . l 1 i 4 i I M j C , sa. I O W I E
- 5
- o w
, M D D D
' & & & l I N E . , i 1 i i w a 1 g 1 i W E
. g .E
- 2 ,R F E*
g g I
=
la gg I3 is 13 i
# II J.i R
4 4
i i COMPARISON TABLES SHOWING i PROPOSED NEW COMPATIBILITY [ OR HEALTH AND SAFETY ! COMPONENT CLASSIFICATIONS ! FOR NRC REGULATIONS AND l PROGRAM ELEMENTS ! COMPARED TO l COMPATIBILITY CLASSIFICATIONS l PREVIOUSLY ASSIGNED UNDER l CURRENT PROCEDURES - l l l 1 l l l
- 1 l
I 4 August 21,1996
___.__...s Part 19 - NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS: INSPECTION AND INVESTIGATIONS REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) {l9.1 Purpose 3.b. 3 {l9.2 Scope 3.b. 3 {l9.3 Definitions - 1 (Exceptie s - Act, Commission and License) Act 3.b. 3 Commission 3.b. 3 Exclusion 3.b. I License See 10 CFR {20.1003 3 Rntricted area See 10 CFR {20.1003 1 Sequestration 3.b. 1 l
REGULATION SECI1ON TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Worker 3.a. 1 This definition is needed for a common understanding of the t term, " worker," as used in the regulation ofradioactive i materials because ofpersons ! working in more than one jurisdiction. l {I9.4 Interpretations 3.b. 3 (19.5 Communications 3.b. 3 (19.8 Information collection 3.b. 4 requirement: OMB approval il9.11 Posting ofnotices to 3.a. 2 These r@.m..a..;s are needed to workers provide a minimallevelof information to workers. In addition, these requirements assure that this m' formation is j
, consistent from onejurisdiction to another since workers may i work in multiplejurisdictions.
2 i.
't t
k
_ . . - . . . - ~ - . - - - - . - . - . - . - . - . _ - . - . - _ . - . . - REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS l SECTION ASSIGNED CLASSIFICATION (As determined by B.7) ! {l9.12 Instruction to workers 3.a. 2 This provision should be adopted by States to assure a minimum level ofrequired worker training - kt-a.. jurisdictions since workers many work ir, mukiple jurisdictions. {l9.13 Notifications and 3.a. 2 These requiremen".s are needed to ., reports to individuals provide a minime! level of information to wcders. In ; addition, these requirements assure that this informationis ! consistent from onejurisdiction to another since workers may workin multiplejurisdictions. > i fl9.14 Presence of 3.b. 2 representatives of licensees and workers duringinspections {I9.15 Consultation with 3.b. 2 workers during inspections 3
1 S T N E M
- M O
C
)
N7 OB I LTy AA db NCe I I n GFi I I RSS rem O At e Ld Cs A ( 2 2 3 3 3 3 3 3 N O I 4 TD AE CN FI G I I S S S A S A L C
- b. b.. b. b.. b. b. b. b..
3 3 3 3 3 3 3 3 r fo ns E s i ow s e n L r e l a ui v o T I kr m l c r it s f x e re c e T o r oe nd t e fo i r t t n fo t l N w y on on n n nd i o r o a n O b sn ni ; it a iu p ns i t a e I nd as l d e s on nd e p T ts o oe r ese e a n ye n o it o i l a C si ec t i t t c n t s s ntc e e ai t mi t n u es oduuo o i cp ib E ue e a w pri r e p l p t a i l pm ri i S qp qt n ch m l e s s a v cnb m o pe s o i S wocsou eif r nwre Ae x iDpr i Ri n I E V C N O I N T0 A1 1 L ; L Ui G E S 6 7 8 0 0 E 1 1 1 2 3 1 3 2 3 0 4 R 9 9 9 9 9 9 9 9 1 1 l 1 l l 1 l 5 6 f 5 { { f {
! Part 20 - STAF :0ARDS FOR PROTECTION AGAINST RADIATION i l t l REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS _
- SECTION ASSIGNED CLASSIFICATION l
' (As determined by B.7) i 120.1001 Purpose 3.b. 3 i 620.1002 Scope 3.b. 3 620.1003 Definitions 1 (Exceptions - Act, ! Commission, Government Agency) Absorbed Dose 1 1 Act 3.b. 3 Activity 1 I , Adult 1 1 Airborne radioactive 1 1 i material t Airbome Radioactivity 1 1 area AMM 1 1 Annual limit on intake 1 1 (ALI) Backaround Radiation i 1
- l l!l il1l1f1lil ,
s s l a C g n S u T L N s s "s E aa l M oC t M d n O eo r C f ri ea t l ea rh on sI l r Ao N O D. L ITyB AAb NCde I GMn I I d ' RSS ner O At e Ld CsA 1 1 1 ( 1 1 1 1 3 I 1 1
)
N (c O I 3 TD 0 5 2 AE l CN l FG I I I R F S S C S S AA 0 1 L e C e b. b. b. 1 S 1 1 3 1 1 3 1 i 3 t E e n e L l a v t l - T i i t n a r e e c a a v I T o e s s et e n i u i t a o o f n f e r g e q N d a m D n d el a A r e t O r o d dei v d P e n - I ( y )y t c u e v i s s te ne t t u e de n s o e m T - t t l a a i i i l i q i d-C s s s s d o s t c e m mav me m ar a p t r a E aa r p s a l m miu mes t n l ce om e p - oo o l S o c y o o oq e e DW l i Bb i B C C C Ce Cd C D D - N O I N TO AI LT UC GE ES R _' If ,l I t l (( l(Illl \t 11l c
L l REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As ddermined by B.7) Derived air 1 1 l concentration (DAC)
~
! Derived air 1 1 l concentration-hour (DAC-hour) Dose or radiation dose 3.b. 1 "Ihis definition is not required l for compatibility. No definition presented. Rather, l several terms are referenced, which are later defined. Dose equivalent i 1 Dosimetry processor 3.b. 1 Effective dose 1 1 equivalent Embryo / fetus 1 1 3
i REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION . (As deterndned by B.7) Entrance or access 3.a. I Dis definition is needed for a . point common understanding because differing definitions may l jeopardize an orderly : regulatory pattern in the regulation of agreement materials. Exposure 1 I i External dose 1 1 Extremity i I Eye dose equivalent i 1 The term, " Lens Dose Equivalent," if defined essentially identically to " Eye { Dose Equivalent" is an l acceptable substitute for this ' term. i 4 . i P *
.__._._._-_.______._.i_._____-_ _ _ _ _ _ -
l REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As ddermined by B.7) Generally applicable I for States with 1 'Ihis term is needed for environmental authority to regulate common understanding in radiation standards uranium mill activities applying the dose limit (11.e.2 byproduct requirements in 10 CFR ; material) 20.1301 and the reporting or requirements in 10 CFR 20.2203. 'Ihese sections 3.b. for States without reference requirements that are authority to regulate applicable to the uranium fuel uranium mill activities cycle. Government agency 3.b. 3 Gray See 10 CFR 620.1004 1 High radiation area l 1 Individual 1 1 Individual monitoring i 1 5
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Individual monitoring 3.a. 1 This definition is needed for a devices common understanding because differing definitions may jeopardize an orderly regulatory pattern for the regulation of agreement materials. Internal dose 1 1 License 3.b. 3 Licensed material 3.b. I Licensee 3.b. 1 Limits 1 1 i i 5 6 b e __m_.____________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ - _ - _ _ _ _ _ _ _ __-m__ _ _ _ _ _ _ - - - _ _ - _ _ _ _ _ _ _ _ _ - _ _ _ _ _m____ _ _ _ . _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _
l!\ . lf Ii1llljjI) l i l I d n f y e a s i l l
", a i
r g s c a n n a ci 3 n o i t c onl t b i t s e t n na 1 i t nle n ea i niid se N i n ol omn t mctoieio i E i m y "c ui emnmgn t f aetr a rl l M eait t s d oi r a a t i etnsb a su M d c go f d eh O nanfnon a rdi ",s s c n so i C oe l mfongol a nia metsb a r t t rd n eenno edersi t rl tai e r t i p sdede pga out ei f w i hen T nureem r h Tdte a"o c Tl N) _ O7 L ITyB AAb NCd I I e GFi n I I RSS m er O At e - Ld Cs A 1 1 I 1 1 1 1 ( N O I TD 7 AE CN I FG I I S S S S AA L C b. 2 1 1 i i 3 1 c E i l t c e L b e s u T l a p f f e o I T gi e D n r e ht c l N i s t i t a s a f g s a n O i o n o I m m r i r h c i t T rd e e r o o a p C os b m o i t n t s C u E t n s n o n R c S Li l oce M e i M M N o N O c N O I N 6 9 TO AI 9 LT 1 UC 2 2 GE ES T t R _ Fs u Ag Ru DA _ l' '
i DRAFT ' August 22,1996 I i REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 I SECTION ASSIGNED CLASSIFICATION (As determined by B.7) : Person 3.a. I 1he term, " person," is needed [ for compatibility in order to - avoid conflicts in implementing
- the regulation of agreement materials from onejurisdiction !
to another. , h Planned special 3.b. I ! exposure i i Public dose 1 1 !
~
Quality Factor i 1 f Quarter 3.b. 1 i t Rad See 10 CFR 620.1004 1 This term is not defined in this section. Refer to the referenced section for the i definition and the compatibility determination. i Radiation 1 1 i i 8
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS l SECTION ASSIGNED CLASSIFICATION (As determined by B.D l Radiation area 1 1 Reference man i 1 Rem See 10 CFR 620.1004 1 This term is not defined in this section. Refer to the referenced section for the dermition and the compatibility determination. i Respiratory protective 3.a. I device Restricted area l 1 Sanitary sewerage i 1 Shallow-dose 1 1 equivalent l Sievert i 1 me boundary 3.b. 1 Source Material See 10 CFR 6150.3(i) 1 9
I DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Special Nuclear See 10 CFR fl50.3(j) 1 Material Stochastic effects 1 1 Survey 1 1 Total Effective Dose 1 1 Equivalent (TEDE) Unrestricted Area l 1 Uranium Puel Cycle 3.b. I However, if a state chooses to adopt a definition of uranium fuel cycle, it must be essentialy identical. Very High Radiation 1 1 Area Week 3.b. I Weighting factor 1 1 Whole body 1 1 10
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Working level (WL) 1 I Working level month 1 1 (WLM) Year 1 1 620.1004 Units of radiation dose i 1 620.1005 Units of radioactivity 1 1 l 620.1006 Interpretations 3.b. 3 620.1007 Communications 3.b. 3 . 620.1008 Implementation 3.b. 3 620.1009 Information colletion 3.b. 4 requirements: OMB . approval 620.1101 Radiation protection 3.b.* 2 ! programs f 11
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 620.1201 Occupational dose 1 I limits for adults
$20.1202 Compliance with 1 I requirements for summation of external and internal doses 520.1203 Determination of 1 I external dose from airborne radioactive material 520.1204 Determination of i 1, except (c) is 2 internal exposure 620.1205 Reserved 620.1206 Planned special 3.b. I exposures
$20.1207 Occupation dose limits 1 I for minors 12
DRAFT , August X 1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 620.1208 Dose to an i I Embryo / fetus . (20.1301 Dose limits for i for all sections, I for (a) and (b); and 3 This provision, except individual members of except (d) which is for (c) and (d) paragraph (d), contains the public 3.b. radiation protection standards. (20.1302 Compliance with dose 3.b.* for all sections 1 This provision, except limits for individual except, (c) which is paragraph (c), contains i 4 members of the public 3.b. requirements that are needed because of their health and safety significance. 620.150! Reserved. 3.b.* 2, except (c) is 1 Surveys and Monitoring - General (20.1502 Conditions requiring 3.b.
- 2 individual monitormg of external and internal occupational dose 13
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 620.1601 Control of access to 3.b.
- 1, except (e) is 2, and high radiation areas (f) is 3.
520.1602 Control of access to 3.b.* 1 very high radiation are_as (20.1701 Use of pmcess or 3.b.
- 1 other engineering controls
$20.1702 Use of other controls 3.b.
- 1
{20.1703 Use ofindividual 3.b.* 1, except (a)(3)(v) is 2 respiratory protection equipment
$20.1704 Further restrictions on 3.b. 3 the use of respiratory protection equipment 520.1801 Security of stored 3.b.
- 2 I material 14 -
l
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As deterndned by B.7) 520.1802 Control of material 3.b.
- 2 not in storage 520.1901 Caution signs 1 1 (20.1902 Posting requirements 1 1 In adopting these provisions, States have the flexibility to omit the wording " grave ,
danger. (20.1903 Exceptions to posting 3.b. 3 requirements 520.1904 Labeling containers 1 1 520.1905 Exceptions to labeling 1 1 requirements 520.1906 Procedures for 3.b.
- 2 receiving and opening i
=ch.ec 15
l l l DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS l SECTION ASSIGNED CLASSIFICATION (As determined by B.7) ! 620.2001 General requirements 3.a. 2 Agreement States are required t t (Waste Disposal) to adopt this provision in order ( to eliminate confusion ! regarding the disposal of l agreement material on a national basis. i l 120.2002 Method for obtaining 3.b. 2 approval of proposed , disposal procedures 620.2003 Disposal by release (a)(1) is 3b*; (a)(2) 2 into sanitary sewerage and (a)(3) are 1; (a)(4) is 3.a.; and (b) is 3.b. 520.2004 Treatment or disposal 3.b. 3, except 20.2004 (b) is by incineration 4 520.2005 Disposal of specific 3.b. 3 wastes 16 _ _______ ---_ _ - - _ _ _ _ _ _ ___.__J
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSRFICATION (As detmnined by B.7) (20.2006 Transfer for disposal 2 2 Agreement States are required I and manifests to adopt these provisions to I provide consistency in regulating the transfer of l l agreement materials which frequently cross multiple - jurisdictions. 520.2007 Compliance with 3.b. 3 environmental and health protection regulations (20.2101 General provisions. 3.a. 3 The use of SI units would be considered essentially identical. , 520.2102 Records of radiation 3.b. 3 protection programs 1 l 620.2103 Records of surveys 3.b. 3 l 17 t
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL SECTION COMMENTS ASSIGNED CLASSIFICATION (As detm, *ned by B.7) 520.2104 Determination of prior 3.b. 1, except for 20.2104(f) occupational dose However if a state chooses to is 3. adopt " planned special exposure" this section should be ador,ted as a "3.a." 520.2105 Records of planned 3.b. 3 special exposures
$20.2106 Records ofindividual (a) and (e) are 3.a; 3 monitoring results (b), (c), (d), and (f) Agreement States are required are 3.b. to adopt paragraphs (a) and (e) to climinate confusion in obtaining information in support ofimplementation of basic radiation protection standards since individuals may recieve exposure in more than one licensee's facilities and in more than one jurisdiction.
620.2107 Records of Dose to 3.b. 3 individual members of the Public 18
- - 1
i j DRAFT August 22,1996 l REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION i (As determined by B.7) 520.2108 Records of Waste 3.b. 3 Disposal 120.2110 Form of Records 3.b. 3 520.2201 Reports of theft or 3.a. 2, except (c) is 3 These requirements are needed
- Ioss oflicensed for a common understanding in i material collecting and reporting information on the regulation of agreement materials on a national basis.
19
DRAFT I August 22,1996 . REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detenined by B.7) ; i 120.2202 Notification of 3.a. for all sections, 1, except (e) is 3 All of this provision, except Incidents except (e) is 3.b. paragraph (c), is needed for a j common understanding in i collecting and reporting - information on the regulation , of agreement materials on a i national basis. Meeting essential objective of - this regulation for the purpose of compatibility requires the State to adopt the numerical , values noted in the regulation as the minimal level acceptable. ! If state adopts planned special exposure, then the state should ! adopt paragraph (e). a i 20 l t i i -
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) (20.2203 Reports of exposures, (a), (b) are 3.a.; e is 2 Paras ipis (a) and (b) provide etc, exceeding the NRC; and (d) is 3.b. requirements that are needed j limits. for a common understanding in collecting and reporting information on the regulation of agreement materials on a national basis. (20.2204 Reports of Planned 3.b. 2 If state adopts planned special special exposures exposure, then the state should adopt this provision. 620.2205 Reports to individuals 3.b.* 3 of exceeding dose limits
$20.2206 Reports ofIndividuals (a)(1),(a)(3),(a)(4), 3, except (a) is 2 Monitoring and (a)(5) are NRC.
(a)(2),(a)(6),(a)(7), (b) and (c) are 3.b. (20.2301 Applications for 3.b. 3 Exemption:; l l 21 i
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED ~ CLASSIFICATION (As deterndned by B.7) (20.2302 Additional 3.b. 3 Requirements
$20.2401 Violations 3.b. 3 i
520.2402 Criminal Penalties 3.b. 3 ! Appendix A Protection Factors for 3.a. 1 Agreement States are required ' Respirators to adopt this provision because , it provides the minimal acceptable level of protection to be afforded by respirators. 22
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS ; SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Appendix B Annual Limits on i 1 (Tables 1,2, & 3) Intake (ALis), ; Derived Air Concentrations l (DACs), of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage Appendix C Quantities oflicensed 1 1 materials requiring labeling Appendix D United States Nuclear 3.b. 3 Regulatory Commission Offices Appendix E Reserved 23
DRAFT August 22,1996 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Appendix F Requirements for 2 2 'Ihe provisions are needed in Low-level Waste order to provide consistency in Transfer for disposal regulating agreement materials at land disposal which frequently cross multiple facilities and Manifest State jurisdictions. Appendix G Requirements for 2 2 These provisions are needed by Low-level radioactive - Agreement States in order to waste intended for provide consistency in disposal at land regulating agreement materials disposal facilities and which fmquently cross multiple manifests !IState jurisdictims. 24
Part 30 - RULES OF GENERAL APPLICABILITY 'IU DOMESTIC LICENSING OF BYFRODUCT MATERIAL REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS SECTION ASSIGNED CLASSIMCATION (As determined by B.7) 630.1 Scope 3.b 3 (30.2 Resolution of Conflict 3.b 3 630.3 Activities requiring 3.a. 2 This requirement is needed for license common understanding regarding activities requiring a license. 630.4 Definitions I (Exceptions are noted below) Act 3.b 3 Agreement State See 10 CFR fl50.3(b) 1 Alert 1 1 Byproduct material See 10 CFR ll50.3(c) 1 Commencement of 3.b I construct'en Commission 3.b 3 Curie See 10 CPR 620.1005 1
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Decommission 3.a. I Dis definition is needed for effective communication regarding the national program for agreement materials. Dentist 3.b 3 Department and See 10 CFR 620.1003 1 Department of Energy Effective dose See 10 CFR 670.1003 1 equivalent Government agency 3.b 3 License See 10 CFR 620.1003 3 Medical use See 10 CFR 535.2 1 Microcurie 3.b i Millicurie 3.b I Person See 10 CFR 620.1003 1 Physician 3.b 3 Podiatrist 3.b 3 1 Principal activities 3.b I 2
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Production facility See 10 CFR fl50.3(h) 3 Radiographer See 10 CFR 634.2 2 Radiographer's assistant See 10 CFR 634.2 2 Radiography See 10 CFR 634.2 2 Research and 3.b I development Scaled source 1 I This definition is needed for a common understanding because of transboundary effects. Site area emergency i I Source material See 10 CFR fl50.3(i) 1 Special nuclear material See 10 CFR fl50.3(j) I United States 3.b 1 Utilization facility See 10 CFR 6150.3(1) 3 630.5 Interpretations 3.b 3 630.6 Communications 3.b 3 l630.7 Employee protection 3.b 3 f 3
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 530.8 Information collection 3.b 4 requirements: OMB apptuval 130.9 Completenns and 3.b 3 accuracy of information 630.10 Deliberate misconduct 3.b 3 ' 530.11 Specific exemption 3.b I (30.12 Persons using 2 1 *Ihis provision must be adopted byproduct material by Agreement States in an under certain essentially identical manner sina Department of Energy it is required by Federal law. and Nuclear Regulatory Commission contracts 130.13 Carriers 2 1 ; (30.14 Exempt concentrations 2 (a), (d) = 1 (b), (c) = 3 630.15 Certain items containing 2 1 byproduct material ; 4 l i i _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ __- - _ _ _ _ _ _ - . _ -+ -
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 530.16 Resins containing 2 1 scandium-46 and designed for sand-consolidation in oil wells
$30.18 Exempt quantities 2 1 830.19 Self-luminous products 2 1 containing tritium, krypton-85, or promethium-147 530.20 Gas and aerosol 2 1 detectors containing byproduct material 630.31 Types oflicenses 3.a. 2 This provision is needed to for effective communication regarding the different types of licenses.
530.32 Application for specific (a),(b),(c),(d),(c),(0 & (a),(b),(c),(d),(g), & (i) licenses (h) are 3.b; are 2; (g) is 3.a; and (c),(0, and (h) are 3 (i) is 3.b' 5
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 530.33 General requirements (a)(1),(a)(4),(a)(5) & (a) is 2; and for issuance of specific (b) are 3.b; (b) is 3 licenses (a)(2) & (a)(3) are 3.b* 130.34 Terms and conditions of (a),(c),(d),(e)(2),(c)(4), (a),(b),(c),(e), & (h) are Paragraph (b) is needed by licenses (f),(g), & (h) are 3.b; 2; Agmement States because of (e)(1) & (e)(3) are (d),(f), & (g) are 3 potential transboundary effects in NRC; and transferring material through (b) is 3.a. multiplejurisdictions. In addition, provision is needed to avoid conflicts and confusien in regulation of agreement . materials. l 630.35 Financial assurance and (a),(b), & (d) are 3.b*; 2 States may be given flexibility to recordkceping for (c),(e),(f), & (g) are allow different dollar amounts decommissioning 3.b based upon jurisdiction and local conditions. 530.36 Expiration and (a),(b),(f), & (i) are 2, except (a)(2) which is termination oflicenses 3.b; 3 and decommissioning of (c),(d),(e),(g),(h),(j), & sites and separate (k) are 3.b' buildings or outdoor areas 6
~ . . - . _ _ - . . - - . . . . . - - . - . - . - _ - - _ _ _ - . - - - _.
i REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determ: nod by B.7) l 630.37 Application for renewal 3.b 3 ! of licenses - 630.38 Application for 3.b 3 amendment of licenses . 530.39 Commission Action on 3.b 3 , applications to renew or amend 530.41 Transfer of byproduct 3.a. 2 This provision is needed for the t material implementation of dient national program for the i regulation of agreement materials. , 530.50 Reporting Requirements (a) through (c) are 3.a. 2 States have the flexibility to except for (c)(3) which require additional event reporting is 3.b information. This information j would depend on local conditions, laws, etc. i 530.51 Records (a) & (b) are 3.a; 3 1he time required for record (c) is 3.b retention under paragraph (b) may vary in ra.curu.ce with the i type of activity being licensed. 530.52 Inspections 3.b 3 1 7
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 530.53 Tests 3.b 3 4 530.55 Tritium reports See 10 CFR 6150.19 4 530.61 Modification and 3.b 3 revocation oflicenses
$30.62 Right to cause the 3.b 3 withholding or recall or byproduct material 630.63 Violations 3.b 3 530.64 Criminal penalties 3.b 3 530.70 Schedule A - exempt 2 1 concentrations table (30.71 Schedule B - exempt 2 1 quantity table 630.72 Schedule C- Quantities 3.b* I of radioactive materials '
requiring consideration of the need for an emergency plan for i responding to a release 8
n L REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS , SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Appendix A Criteria Relating to Use 3.b 2 Amount of financial assurance i i of Financial tests and required should reflect the Parent Company current economic conditions at ! Guarantees for time of decommissioning. Providing Reasonable Assurance of funds for ! Decommissioning Appendix B Quantities of Licensed 2 2 i Material Requiring ! Labeling i Appendix C Criteria Relating to 3.b 2 i Financial Tests and Self i Guarantees for Providing Reasonable Assurance of Funds for i Decommissioning I t i 9 f I
i a Part 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL i REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detennised by B.7) ! 63
1.1 Purpose and Scope
3.b. 3 131.2 Terms and Conditions 3.b. 3 i {31.3 Certain devices and 2 1 Ayunas; States are required to - equipment adopt this provision becauseit contains requirements for devices ! and equipment which are : distributed nationally. ! i {31.4 Information collection 3.b. 4 i requirements: OMB . approval ; 631.5 Certain measuring, 3.b. 2 Ayaaaa; States have the gauging or controlling flembility to authorize the use of devices these devices under a specific i license. {31.6 Generallicense to 3.a. 2 Ay~..u; States are ig:M to L install devices generally adopt this provision becauseit ; licenses recognizes the reciprocal in 6 31.5 recogni; ion officenses from one l jurisdiction to another. States ! may require notification as a part f of tk K inOvisions. i i I r i i
i I REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determeined by B.7) I {31.7 Luminous safety 2 2 Ayu..a..; States are required to l devices for usein adopt this provision because it aircraft contains requirements for devices l which are distributed nationally. In addition, by the nature of their ! use and application, they devices ; frequently cross mukiple jurisdictions. 531.8 Americium-241 in the 3.b. 3 i form ofcalibration or reference sources I
$31.9 Generallicense to own 3. b. 3 ;
byproduct material {31.10 Generallicense for 2 2 Aya..aa; States are required to ! l strontium 90 in ice adopt this provision becauseit l detection devices contains sq ;i...aa;s for devices { l which are distributed naticamPy. l l 531.11 Generallicense for use 3.b. 2 Asia.a..; States have the ofbyproduct material flexibility to authorize the use of for certain in vitro these devices under a specific clinical orlaboratory license. ~ testing i 631.12 Maintenance ofrecords 3.b. i 3
/
i t i 2 i t i i
. i
I REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION ' (As determeined by B.7) 131.13 Violations 3.b. 3 631.14 Criminal penalties 3.b. 3 i i 3 t I
_ _ _. _ _ _ _ . . _ ~ . Part 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENT SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 13
2.1 Purpose and Scope
3.b. 3 632.2 Definitions Dose commitment See 10 CFR 1 This term and definition are 120.1003 superseded by the new term and definition in 10 CFR Part 20, " committed dose equivalent." Thus, if the 10 ' CFR Part 20 term and definition are adopted by a State, the adoption of this term and definition are not needed. Imt Tolerance Percent 3.a. 1 Defective i 132.3 Maintenance of records 3.b. 3 $32.8 Information collection 3.b. 4 requirements: OMB approval
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENT SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 532.11 Introduction of byproduct Paragraphs (a) and 2 material in exempt (b) are 3.a.; and concentrations into products or paragraph (c) is 2. materials and transfer of ownership or possession. Requirements for license. 532.12 Same: Records and material 3.a. 2 transfer reports
$32.13 Same: Prohibition of 3.a. 2 introduction 132.14 Certain items containing NRC 4 byproduct material; requirements for license to apply or initially transfer 632.15 Same: Quality assurance, NRC 4 prohibition of transfer and labeling
$32.16 Certain items containing NRC 4 byproduct material: Records ;
and reports of transfer I 2 l l
! REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENT SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) Resins containing scandium-46 2 4 This provision was previously 632.17 and designed for sand- designated as an area consolidations in oil wells: reserved to the NRC. A Ryuirements for license to review of the Statements of manufacture, or initially Considerations for this rule l transfer for sale or distribution. (32 FR 4241,3/18/67) l indicates that this activity can . l be licensed by an Agreement State. The Commission i considered that scandium-46 i resins were not a product t I intended for use by the i general public. Therefore, this authority could be # assumed by the States. 632.18 Manufacture, distribution and NRC 4 ; transfer of exempt quantities: Requirements for license 632.19 Same: Conditions oflicenses NRC 4 532.20 Same: Records and material NRC 4 transfer reports 3 > i
l ' t i l : l r REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENT i SECTION ASSIGNED CLASSIFICATION - (As determined by B.7) i t 1 532.22 Selfluminous products NRC 4 i containing tritium, krypton-85 ! and promethium-147: . Requirements for license to manufacture, process, produce, or initially transfer: - t (32.23 Same: Safety criteria NRC 4 i 632.24 Same: Table of organ doses NRC 4 632.25 Conditions oflicenses issued NRC 4 under 632.22: Quality Control, labeling and reports of transfer (32.26 Gas and aerosol detectors NRC 4
- containing byproduct material
Requirements for license to manufacture, process, produce or initially transfer 632.27 Same: Safety criteria NRC 4 632.28 Same: Table of organ doses NRC 4 4
. REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENT SECTION ASSIGNED CLASSIFICATION (As deterinined by B.7) 132.29 Conditions oflicenses issued NRC 4 under 632.26: Quality control, labeling and reports of transfer 532.40 Schedule A: Prototype tests for NRC 4 automobile lock illuminators (32.51 Byproduct material contained in 2 2 devices for use under 631.5:
Requirements for license to manufacture or initially transfer 132.51a Same: Conditions oflicenses 2 2 532.52 Same: Material transfer reports 2 2 and records (32.53 Luminous safety devices for 2 2 use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer 632.54 Same: Labeling of devices 2 2 632.55 Same: Quality assurance; 2 2 ! prohibition of transfer
\
5 l. =__ _ _ _ _ _ _ _ _ _ _ _ _ _ __. _ ._ _ _ . _ . . _ . _ . . _ _ . , ,
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENT SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) ; ! 132.56 Same: Material transfer reports 2 2 632.57 Calibration or reference sources 2 2 - Am-241: Requirements for , license to manufacture or i initially transfer 532.58 Same: 12beling of devices 2 2 i 632.59 Same: Irak testing of each 2 2 source 632.60 [ Reserved] i (32.61 Ice detection devices containing 2 2 strontium-90; Requirements for lt license to manufacture or i initially transfer i 632.62 Same: Quality Assurance; 2 2 prohibition of transfer t i 632.71 Manufacture and distribution of 2 2 i byproduct material for certain in vitro clinical or laboratory testing under reneral license 6 l i
+
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENT SECTION ASSIGNED CLASSIFICATION (As determined by B.7) - 632.72 Manufacture, preparation or 2 2 transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35 532.74 Manufacture and distribution of 2 2 sources or devices containing byproduct material for medical use 632.101 Schedule B-prototype tests for 2 2 luminous safety devices for use in aircraft 632.102 Schedule C-prototype tests for 2 2 calibration or reference sources containing americium-241 632.103 Schedule D-prototype tests for 2 2 ice detection devices containing strontium 90 632.110 Acceptance sampling 2 2 procedures under specific ' licenses 7
I l REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENT ! SECTION ASSIGNED CLASSIFICATION (As determined by B.7) l ( 632.301 Violations 3.b. 3 i 532.303 Criminal penalties 3.b. 3 l 2 s I 8 i
Part 34 - LICENSES FOR RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR RADIOGRAPHIC OPERATIONS REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As deterimined by B.7) 63
4.1 Purpose and Scope
3.b. 3 {34.2 Definitions 2 (exceptions noted below) Permanent radiographic 3.b. 2 installation ' Radiographer 3.a.' 2 Radios i,'.,.fs assistant 3.b. 2 Radiographic exposure device 2 2 Radiography 2 2 Scaled source See 10 CFR 630.4 2 Source changer 2 2 Storage area 3.b. 2 Storage container 2 2 {34.3 Applications for specific 3.b. 3 licenses 434.4 Maintenance ofrecords 3.a.' 3 b
i ii REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As deterneined by B.7) (34.8 Information co!!cction 3.b. 4 requirements: OMB approval {34.11 Issuance ofspecific licenses for 3.a.' 2 use ofsealed sources in
- Industrial Radiography
{34.20 Performance requirements for 2 2 radiography ceaipment (34.21 Limits on levels ofradiation for 2 2 radiographic exposure devices and storage containers {34.22 Locking ofradiographic 2 2 exposure devices, storage containers and source changers
$34.23 Storage precautions 3.a.' 2 134.24 Radiation survey instruments 3.a.' 2
{34.25 Leak Testing, Repair, Tagging, 3.a.' 2 Opening, Modification, and Replacement ofsealed Sources 634.26 Ouarteriv Inventory 3.a.' 2 !
. i i
2 !
i REGULATION SECI1ON TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As deterunimed by B.7) 634.27 Utilizationlogs 2 2 {34.28 Inspection and maintenance of 3.a.' 2 radiographic exposure devices, storage containers, and source changers {34.29 Permanent Radiographic 3.b.* 3 Installations 634.30 Reporting requirements 3.a.' 2 634.31 Training 3.a.' 2 . {34.32 Operating and Emerge..cy 3.a.' for sections, 2 i procedures except (1)is 3.b. i 634.33 Psw .;! monitoring 3.a.' 2
.t
$34.41 Security 3.a.' 2 y t: 634.42 Posting 3.a.' 3 -
.i
{34.43 Radiation surveys 3.a.' for sections, 2 y except (d)is 3.b i (34.44 Supervision ofradiographers' 3.b. 3 assistant 634.51 Applications for exemptions 3.b. 3 i 3 t i
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detersnised by B.7) 134.61 Violations 3.b. 3 134.63 Criminal Penalties 3.b. 3 Appendix A Required subjects for training 3.a.' 2 instruction 8 Agreement States are required to adopt these provisions for the purpose ofcompatibility to avoid conflicts in the regulations of l industrial radiography since this activity frequently involves persons working under reciprocity. ! t I i 4 1 f
_ . _ . - - - ~ . . . . - . . - . . . _ .- ~___-. - . - - . . - . - _ _ . Part 35 - MEDICAL USE OF BYPRODUCT MATERIAL REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) 635.1 Purpose and scope 3.b. 3 l 535.2 Definitions I (Exceptions indicated below) Address of use 3.b. 3 ALARA See 10 CFR 620.1003 1 Agreement State See 10 CFR fl50.3(b) 1 Area of use 3.b. 3 Authorized nuclear pharmacist 3.b. 1 Authorized user 3.a. 1 L Brachytherapy source 3.b. 3 Dedicated check source 3.b. 3 i Dental use 3.b. 3 :
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) t Dentist 3.b. 3 Diagnostic clinical procedures 3.b. 1 I manual Management 3.b. 3 i Medical institution 3.b. 3 Medical use 3.a. 1 Ministerial change 3.b. 3 Misadministration 3.a. I States are required to adopt the quantitative values in this prwision since they contain , th . essential objectives of this requirement. Mobile nuclear medicine 3.b. 3 service Output 3.b. 3 i l 2
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS SECTION ASSIGNED CLASSIFICATION . (As detennined by B.7) l l Pharmacist 3.b. I Physician 3.b. 3 Podiatric use 3.b. 3 Podiatrist 3.b. 3 Prescribed dosage 3.a. 1 Prescribed dose 3.a. I Radiation safety officer 3.b. 3 Recordable event 3.b. I Scaled source See 10 CFR 630.4 1 Teletherapy physicist 3.b. 3 Written directive 3.a. 1 635.5 Maintenance of records 3.b. 3 t 3 i
i REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As determined by B.7) ,. 635.6 Provisions for research 3.b. 2 involving human subjects. 135.7 FDA, other Federal, and State 3.b. 3 requirements ; 535.8 Information collection 3.b. 4 , requirements: OMB Approval 635.11 License required See 10 CFR 630.3 3 635.12 Application of license, 3.b. 3 ' amendment, or renewal 635.13 License amendments 3.b. 3
$35.14 Notifications 3.b. 3 535.15 Exemptions regarding Type A 3.b. 3 specific licenses of broad scope ;
635.18 License issuance 3.b. 3 4 i
REGULATION SECTION TITLE CLASSIRCATION ORIGINAL COMMEN'IS SECTION ASSIGNED CLASSIFICATION (As deteriaised by B.7) l 535.19 Specific exemptions 3.b. 3 535.20 ALARA program See 10 CFR 620.1101 3 135.21 Radiation Safety Officer (a) is 3.b.*; and 3 (b) is 3.b. 535.22 Radiation safety committee 3.b. 3, except (b)(2) is 2 535.23 Statements of authority and (a) is 3.b.*; and 3 responsibilities (b) is 3.b. 635.25 Supervision 3.b. 2 535.29 Administrative requirements 3.b. 3 that apply to the pmvision.of mobile nuclear me icine service 635.31 Radiation safety program 3.b. 3 changes 5
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detertnined by B.7) 535.32 Quality management program 3.b* for all sections 2 except, (a)(5), (d), (e) and (f) are 3.b. 535.33 Notifications, reports, and 3.a. 2 records of misadministrations $35.49 Suppliers for sealed sources or 3.b. 3 devices for medical use $35.50 Possession, use, calibration, 3.b. 2 and check of dose calibrators $35.51 Calibration and check of See 10 CFR 620.1501 3 survey instruments $35.52 Possession, use, calibration, 3.b. 2 and check of instruments to measure dosages of alpha- or beta-emitting radionuclides $35.53 Measurements of dosages of (a), (b) are 3.b.*; and 2 unsealed byproduct material (c) is 3.b. for medical use 6
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS . SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 135.57 Authorization of calibration 3.b. 3 and reference sources 535.59 Requirements for possession 3.b.* 3 i of sealed sources and brachytherapy sources 135.60 Syringe shields and labels 3.b. 3 535.61 Vial shields and labels 3.b. 3 635.70 Surveys for contamir.ation and 3.b.* 3 , ambient radiation exposure rate 635.75 Release of patients or human 3.a. 3 ; research subjects containmg ; radiopharmaceuticals or permanent implants : ll [ t r 7 i L_____._.__.. _ _ _ _ _ _ _ . _ _ _ _ _ __ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ . _ __ _ _________ _ ____ _ __:
t l REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIMCATION ! l (As determined by B.7) c (35.80 Technical requirements that 3.b. 3 ! apply to the provision of i mobile nuclear medicine - i services l l 535.90 Storage of volatiles and gases 3.b. 3 l 535.92 Decay-in-storage 3.b. 3 . 635.100 Use of unsealed byproduct 3.b.* 3 material for uptake, dilution, i and excretion studies l i I (35.120 Possession of survey 3.b. 3 : instruments 135.200 Use of unsealed byproduct 3.b.* 3 material for imaging and localization studies l r 135.204 Permissible molybdenum-99 3.b.* 3 concentration 635.205 Control of aerosols and gases See 520.1301 3 8 ! i
REGUI -t TION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SEC% ION ASSIGNED CLASSIMCATION (As deterudned by B.7) 635.220 Possession of survey See (20.1501 3 instruments
$35.300 Use of unsealed byproduct 3.b.* 3 material for "u%wtic administration
$35.310 Safety instruction 3.b. 3 535.315 Safety precautions 3.b. 3 535.320 Possession of survey 3.b. 3 instruments
$35.400 Use of sources for 3.b. 3 brachytherapy 535.404 Release of patients or human 3.a. 3 research subjects treated with temporary implants 635.406(a) & (c) Brachytherapy sources (a) and (c) are 3.b.*; 3 inventory and (b) and (d) are l 3.b. !
i 9 i
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIMCATION (As determined by B.7) 3 i 135.410 Safety instruction 3.b. 3 135.415 Safety precautions 3.b. 3 635.420 Possession of survey 3.b. 3 instruments
$35.500 Use of sealed sources for 3.b. 3 diagnosis 635.520 Availability of survey 3.b. 3 instrument 535.600 Use of a sealed source in a 3.b. 3 teletherapy unit 635.605 Maintenance and repair 3.b.* 3 restrictions 135.606 License amendments 3.b. 3 635.610 Safety instructions 3.b.* 3 .
10 i 1-
SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS REGULATION SECTION ASSIGNED CLASSIMCATION (As detennined by B.7) l 535.615 Safety precautions 3.b.* 3 635.620 Possession of survey 3.b. 3 instrument i 635.630 Dosimetry equipment 3.b.* 3 l 535.632 Full calibration measurements 3.b.* 3 States are required to adopt the quantitative values in this provision since they are l essential objectives of this l requirement. l 635.634 Periodic spot-checks 3.b.* 3 l l 535.636 Safety checks for teletherapy 3.b.* 3 l facilities (35.641 Radiation surveys for 3.b. 3 teletherapy facilities
$35.643 Modification of teletherapy 3.b. 3 unit or room before beginning a treatment program 11
_ _.. _ _ _ _ .. _ _ _ __ _ . _ ._ _ _ . _ --- - s i REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS j SECTION ASSIGNED CLASSIMCATION (As determained by R.7) 535.645 Reports of teletherapy sur- 3.b. 3 veys, checks, tests, and measurements (35.647 Five-year inspection 3.b.
- 3
- 635.900 Radiation safety officer 3.b. 3 535.901 Training for exg
- crM 3.b. 3 ,
radiation safety offurr 635.910 Training for uptake, dilution, 3.b. 3 ! and excretion studies ; i 635.920 Training for imaging and 3.b. 2 ; localization studies ; i 635.930 Training for tkivetic use of 3.b. 3 unsealed byproduct material : 535.932 Training for treatment of 3.b. 3 hyperthyroidism j 12 6 I
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS SECTION ASSIGNED CLASSIMCATION (As deterndeed by B.7) 135.934 Training for thyroid 3.b. 3 carcinoma 535.940 Training for use of 3.b. 3 brachycei yy sources 135.941 Training for ophthalmic use of 3.b. 3 strontium-90 635.950 Training for use of sealed 3.b. 3 sources for diagnosis 535.960 Training for teletherapy 3.b. 3 535. % 1 Training for teletherapy 3.b. 3 physicist , 635.970 Training for experienced 3.b. 3 authorized users 635.971 Physician training in a three 3.b. 3 month program 13
l REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) i l 635.972 Recentness of training 3.b. 2 l 535.980 Training for an authoriral 3.b. 2 nuclear pharmacist l I (35.981 Training for experienced 3.b. 2 nuclear pharmacist l l 535.990 Violations 3.b. 3 535.991 Criminal penalties 3.b. 3 635.999 Resolution of conflicting 3.b. 3 requirements during transition 14 i
Part 36 - LICENSES AND-RADIATION SAFETY REQUIREMENTS FOR IRRADIATURS , REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) - 136.1 Purpose & Scope (a) is 3.b.; (b) and (c) 3 States are required to l are 3.a. adopt the quantitative ! values in paragraphs (b) I and (c) since they are f essential objectives of , this requirement. ; $36.2 Definitions 2 (Exceptions noted below) Annually 3.b. 2 [ t Doubly encapsulated sealed 3.b. 2 source Irradiator 3.a. 2 Irradiator operator 3.b. 2 : i Panoramic dry-source- 3.b. 2 i storage irradiator Panoramic irradiator 3.b. 2 Panoramic wet-source- 3.b 2 storage irradiator l I
I t 1 t REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS ! SECTION ASSIGNED CLASSIFICATION ! (As determined by B.7) l i L Pool irradiator 3.b. 2 Product conveyor system 3.b. 2 l i Radiation room 3.b. 2 ; t Radiation safety officer 3.b 2 ?
- Scaled source See 10 CFR 630.4 2 [
Seismic aita 3.b. 2 i Underwater irradiator 3.b. 2 ; 636.5 Interpretations 3.b. 3 t 636.8 Information collection 3.b. 4 i requirements: OMB approval
$36.11 Application for a specific 3.b. 3 i i
license ' 536.13 Specific licenses for irradiators 3.b.* 2 ! 1 636.15 Start of construction 3.b. 2 ! t j 636.17 Applications for exemptions 3.b. 3 ; i l 636.19 Request for written statements 3.b. 2 1 i i i (
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) , 136.21 Performance criteria for sealed 2 2 States are required to sources adopt the quantitative values in this provis~ mn since they are essential objectives of this requirement. 636.23 Access control 3.b.* 2 636.25 Shielding 3.b.* 2 536.27 Fire protection 3.b. 2 536.29 Radiation monitors 3.b.* 2 536.31 Control of source movement 3.b.* 2 536.33 Irradiator pools 3.b.* 2 536.35 Source rack pmtection 3.b. 2 636.37 Power failures 3.b.* 2 636.39 Design requirements 3.b.* 2 636.41 Construction monitoring and 3.b.* 2 mp6 ice testing 536.51 Training 3.b.* , 2 , 3 i I i
i i r REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIMCATION : (As determirmi by B.7) : ! 536.53 Operating & Emergency 3.b.* 2 l procedures ; l 136.55 Personnel monitoring 3.b. 2 i 636.57 Radiation surveys 3.b.* 2 States are requiral to l adopt the quantitative . values in this provision since they are essential objectives of this i requirement. i 136.59 Detection ofleaking sources 3.b.* 2 States are required to adopt the quantitative values in this provision since they are essential objectives of this requirement. 536.61 Inspection and maintenance 3.b.* 2 636.63 Pool water purity 3.b.* 2 States are required to adopt the quantitative values in this provision since they are essential objectives of this requirement. 4
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As deterndeed by B.7) 636.65 Attendance during operation 3.b.* 2 136.67 Entering and leaving the 3.b.* 2 radiation room 536.69 trradiation of explosive or 3.b.* 2 inflammable materials $36.81 Records and retention periods 3.b. 3 136.83 Reports 3.a. 2 (36.91 Violations 3.b. 3 636.93 Criminal penalties 3.b. 3 i 5'
f Part 39 - LICENSES AND RADIATION SAFETY REQUIREMEN13 FOR WELL IAGGING , J REGULATION SECTION CLASSIFICATION ORIGINAL. COMMENTS SECTION TITLE ASSIGNED CLASSIFICATION (As detennised by B.7)
]
$3
9.1 Purpose and Scope
3.b. 3 039.2 Definitions > Field station 2 2 Fresh water aquifer 3.b. 3 t injection tool 3.b. 2 Irretrievable well logging 3.b. 3 i source , Licensed material 3.b. 2 i Imgging assistant 3.b. 2 ' Imgging supervisor 3.a. 2 Ingging tool 3.b. 2 Personal supervision 3.b. 2 ' Radioactive marker 3.b. 2 ! Safety review 3.b. 3 . t ___.____m_- __ .._ ___-.____.____..__.____.________.________m. _ _ . . _ _ . _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ - _ _ _ _-___ __ - m __.___m- - ___---____-_-m_m_m m___ _ ___. -_m__ v -- - -
REGULATION SECTION CLASSIFICATION ORIGINAL COMMEN13 i SECTION TITLE ASSIGNED CLASSIFICATION l (As deterndeed by B.7) ; Scaled soun:e See 10 CFR 630.4 2 Source holder 3.b. 2 l Subsurface tracer study 3.b. 2 1 . I Surface casting for 3.b. 2 pmtecting fresh water j aquifers : l Temporary jobsite 3.b. 3 i t Uranium sinker bar 3.b. 2 - j Well 3.b. 3 - i i Well logging 3.a. 3 t 639.5 InEiy.e.tions 3.b. 3 539.8 Information collection 3.b. 4 requirements: OMB apprwal ; 539.11 Application for a specific 3.b. 3 license I 2 i l
SECTION CLASSIFICATION ORIGINAL COMMENTS REGULATION SECTION TITLE ASSIGNED CLASSIFICATION (As detenmined by B.7) 639.13 Specific licenses fo. well 3.b.* 3 logging $39.15 Agreement with well 3.a. 2 owner or operator 639.17 Request for written 3.b. 3 statements $39.31 Labels, Security, and (a) is 3.b.; and 2 Transportation precautions (b) is 3.a 539.33 Radiation detection (a), (c) and (d) are 2 instruments 3.b.; and (b) is 3.b* 139.35 leak testing of sealed 3.a. 2 sources $39.37 Physical inventory 3.b.* 2 539.39 Records of material use 3.a. 2 539.41 Design and performance 2 1 criteria for sealed sources 539.43 Inspection, maintenance, 3.a. 2 and opening of a source or source holder 3
REGULATION SECTION CLASSIFICATION SECTION ORIGINAL COMMENTS i TITLE ASSIGNED CLASSIFICATION (As deterndeed by B.7) 639.45 Subsurface tracer studies 3.a. 2 639.47 Radioactive markers 3.b. 3 639.49 Uranium sinker bars ' 3.b 1 2 l 539.51 Use of sealed source in a 3.b. 2 well without surface casing 139.61 Training 3.a. 2 These prwisions should be adopted by States because they contain training requirements not contained in (19.12 or other sections and apply w persons who frequently work in multiple juristictions. 539.63 Operating & Emergency 3.a. 2 procedures 4
.....m.,
i i REGULATION SECTION CLASSIFICATION ORIGINAL COMMENTS SECTION TITLE ASSIGNED CLASSIFICATION (As detennined by B.7) 639.65 Personnel monitoring (a) is 3.a.; (b) and 2 (c) are 3.b. 539.67 Radiation surveys 3.a. 2 639.69 Radioactive con-tamination 3.a. 2 control 639.71 Security 3.a. 2 639.73 Documents & Records 3.a. 3 required at field stations
$39.75 Documents & records 3.a. 2 required at temporary job sites $39.77 Notification ofincidents: (a), (c) and (d) are 2 aban-donment proced-ures 3.a.; (b) is 3.b.
for irretrie-vable sources 139.91 Applications for 3.b. 3 exemptions
$39.101 Violations 3.b. -
3 5
REGULATION SECTION CLASSIFICATION ORIGINAL COMMENTS SECTION TITLE ASSIGNED CLASSIRCATION i (As determined by B.7) 139.103 Criminal penalties 3.b. 3 t I l I i a l : l 6 , f i f 1 _ __ _ ___ ___ _ _ _ _ _ _ - -
t Part 40 - DOMESTIC LICENSING OF SOURCE MATERIAL , i
~
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7)
$40.1 Purpose 3. b. 3
, 640.2 Scope 3.b. 3 140.2a Coverage of inactive tailings I for States with (a) is 4 and (b) is 2 for Agreement States with ; sites authority to regulate U- lie.(2) States authority to regulate : mill activities. (11.e.2 uranium mill should byproduct material or adopt this term and 3.b. for States without definition. authority !' 540.3 License requirements 3. a. 3 040.4 Definitions 1 i Act 3.b. 3 l Agreement State See 10 CFR fl50.3(b) I Alert See 10 CFR 630.4 1 l i Byproduct material See 10 CFR fl50.3(c), 1 applies if UMTRAC ' State t _--- j
REGULATION SECTION TITLE ' CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As deterndned by B.7) Commencement of See 10 CFR 630.4 1 . construction Commission 3.b. 3 Decommission See 10 CFR 530.4 1 Department of Energy See 10 CFR 620.1003 1 Depleted uranium i 1 Effective kilogram 3.b. I Government agency 3.b. 3 License 3.b. 3 Persons See 10 CFR 620.1003 1 Pharmacist See 10 CFR 635.2 1 Physician See 10 CFR 535.2 3 l Principle activities See 10 CFR $30.4 1 2 - t
CLASSIFICATION ORIGINAL ' COMMENTS REGULATION SECTION TITLE- ' SECTION ASSIGNED CLASSIFICATION (As determined by B.7) . Residual radioactive material I for States with i Agreement States with authority to regulate U- authority to regulate mill activities. (ll.c.2 uranium mill should , byproduct material or adopt this term and 3.b. for States without dermition. authority
- i Site area emergency See 10 CFR 530.4 1 i
1 Source material See 10 CFR 6150.3 1 ! i Special nuclear material See 10 CFR 6150.3 1- i Transient shipment 3.b. I United States 3.b. I Unrefined and unprocessed 2 1 Uranium enrichment facility 3.b. I Uranium milling 3. a. for States with I authority to regulate uranium mill activities ; or 3. b. or States j without this authority f f I 3 5
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 640.5 Communications 3.b. 3 640.6 Interpretations 3.b. 3 140.7 Employee protection 3.b. 3 540.8 Information collection 3.b. 4 requirements: OMB appmval 540.9 Completeness and accuracy of 3.b. 3 information 640.10 Deliberate misconduct 3.a. 3 540.11 Persons using source material 2 1 under certain Department of Energy and Nuclear Regulatory Commission contracts $40.12 Carriers 2 2 540.13 Unimportant quantities of 2 I source material 540.14 Specific exemptions (a) is 3. b.; (c), and (d) I are NRC 4
SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS R FEULATION SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) 640.20 Types of licenses 3.b. (a) is 2; (b) and (c) are 4 640.21 General license to receive title 3.a. 3 for ll.e(2) States - to source or byproduct material 640.22 Small quantities of source 2 1 material 140.23 General license for carriers of NRC 4-transient shipments of natural uranium other than in the form of ore or ore residue 640.25 General license for use of 3.a. 3 certain industrial products or devices 640.26 General license for possession 3. a. for States with 2 for lle.(2) States ; and storage of byproduct f le.(2) byproduct material as defined in this part material authority 640.27 General license for custody NRC 4 and long-term care of residual radioactive material disposal sites 5 i l i
REGULATION SECTION TITLE CLASSIFICATION ORICINAL COMMFRIS SECTION ASSIGNED CLASSIFICATION (As determined by B.7)
$40.28 General license for custody NRC 4 and long-term care of uranium or thorium byproduct materials disposal sites $40.31 Application for specific All sectio..s are 3. b.,
licenses except (i) is 3b* 640.32 General requirements for All sections are 3. a., 2 issuance of specific licenses except (d) and (e) are NRC Q40.33 Issuance of a license for a NRC 4 uranium enrichment facility (40.34 Special requirements for (a)(2) and (a)(3) are 2; 2 issuance of specific licenses and (b) and (c) are 3.b. {40.35 Conditions of specific licenses (b) and (c) are 2; (a) is 2 issued pursuant to 640.34 3. a.; and (c), (c), and (f) are 3. b. 640.36 Financial assurance and (a), (b), and (d) are 2 recordkeeping for 3.b.*; (c), (e), and (f) decommissioning are 3.b. 6
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 140.41 Terms and conditions of 3.b. 2 licenses 640.42 Expiration and termination of (c), (d), (c), (g), (h), 3 licenses and decommissioning (i), (j), and (k) are of sites and separate buildings 3.b.*; (1) is 3.a.s; (a), or outdoor areas (b), (f), (k) are 3.b. 540.43 Renewal of licenses 3.b. 3 ; 640.44 Amendment of licenses at 3.b. 3 l request of licensee , 640.45 Commission action on 3.b. 3 j application to renew or amend !
$40.46 Inalienability of licenses 3.a. 3 I
640.51 Transfer of source or 2 2 i byproduct material i 540.60 Reporting requirements 3.a. 2 l
$40.61 Records 3.a. for all sections, 2 except (c) is 3.b.
540.62 Inspections 3.b. 3 i 7
e REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS ! SECTION ASSIGNED CLASSIFICATION (As determined by B.7) ! 140.63 Tests 3.b. 3 ; l 640.64 Reports NRC 3 540.65 Effluent monitoring reporting 3. a. S. for States with 2 requirements uranium mill authority (40.66 Requirements for advance NRC 4 notice of export shipments of ! natural uranium ! 640.67 Requirement for advance NRC 4 notice of importation of natural uranium from ! countries that are not party to the Convention on the Physicci Protection of Nuclear Material .: 140.71 Modification and revocation 3.b. 3 i of licenses t 540.81 Violations 3.b. 3 i t 640.42 Criminal penalties 3.b. 3 I
.I 8
i
l REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENIS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) APPENDIX A 3.a. S. for States with 2 for lle.(2) States Ile.2 byproduct material authority or 3.b. for States without authority 9
~
Part 61 - LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 661.1 Purpose & Scope 3.b. 3
$61.2 Definitions I (exceptions noted below)
Active maintenance 3.b.* I Buffer zone 3.b. I Chelating agent 3.b. I Commencement of 3.b. I construction Commission 3.b. 3 Custodial Agency 3.b. I Director 3.b. 3 Disposal 3.a. I Disposal site 3.a. I Disposal unit 3.b. 1 Engineered banier 3.b. 1 Explosive material 3.b. 1 .
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS : SECTION ASSIGNED CLASSIFICATION (As determined by B.7) i Government agency 3.b. 3 Hazardous waste 3.a. 1 Hydrogeologic unit 3.b. 1 Inadvertent intruder 3.a. I Indian Tribe 3.b. 1 Intruder barrier 3.a. I Land disposal facility 3.b. I License See 10 CFR 620.1003 1 Monitoring 3.a. I Near-surface disposal facility 3.b. 1 Person See 10 CFR 620.1003 1 I l Pyrophoricliquid 3.b. I Site closure and stabilization 3.b. 1 State 3.b. I Stability 3.b. I Surveillance 3.b. I
SECTION TITLE CLASSIFICATION ORIGINAL - COMMENTS REGULATION SECTION ASSIGNED CIASSIFICATION (As determeined by B.7) Tribal governing body 3.b. I Waste 2 l 661.3 License required 3.a. 2 Communications 3.b. 3 {61.4 Interpretations 3.b. 3 661.5 661.6 Exemptions 3.b. 3 ! 161.7 Concepts 3.b.* 3 {61.8 Information collection 3.b. 4 requirements: QMB approval . i 661.9 Eirig,k ic; protection 3.b. 3 ; i {61.9a Completeness and accuracy of 3.b. 3 information 661.9b Deliberate misconduct 3.b. 3 {61.10 Content of application 3.b. 2 661.11 Generalinformation 3.b. 2 t {61.12 Specific technicalinformation 3.b. 2 r 661.13 Technical analysis 3.b.* 2 3 t f r i
i REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS i SECTION ASSIGNED CLASSIFICATION (As detersnined by B.7)
.t 661.14 Institutionalinformation 3.b.* 2 661.15 Financialinformation 3.b. 2 i'
661.16 Other information NRC 4 561.20 Filing and distribution of 3.b. 3 application i 661.21 Elimination ofrepetition 3.b. 3 i (61.22 Updating of application 3.b. 3 I i 561.23 Standards forissuance of a 3.b. 2' license ! 661.24 Conditions oflicenses 3.b. 2 661.25 Changes 3.b. 3 161.26 Amendment oflicense 3.b. 3 {61.27 Application forie..;ws: or 3.b. 2 closure i
$61.28 Contents of application for 3.b. 2 closure .
t {61.29 Post-closure observation and 3.b. 2 i maintenance ' i t _ _ _ _ _ . _ _ _ _ . . _ . _ _ _ _ _ _ _ _ . . _ _ . . _ _ . _ _ _ _ . _ _ _ _ . _ _ . .________ ____ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ . _ _ _ _ _ _ ~ ,-
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 661.30 Transfer oflicense 3.b. 2 1 161.31 Termination oflicense 3.b. 2 161.40 General requirement 3.b. 2 {61.41 Protection of the general i I population from releases of radioactivity l {61.42 Protection ofindividuals from 3.b. 2 inadvertent intrusion {61.43 Protection ofindividuals 3.b. 2 during operations
$61.44 Stability of the disposal site 3.b.* 2 after closure
{61.50 Disposal site suitability 3.b.* 2 requirements for land disposal {61.51 Disposal site design forland 3.b.* 2 disposal {61.52 Land disposal facility operation 3.b.* 2 and disposal site closure 661.53 Environmental monitorina 3.b.* 2 5 l l . i_-____ _ - ___ _ ____ - ______- _ - - -__ -. -
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 61.54 Alternative requirements for 3.b.* 2 design and operations 661.55 Waste classification 2 1 661.56 Waste characteristics 3.b.* 2 {61.57 Labeling 3.b.* 2 States are required to adopt this provision for safety to prevent overexposure from mishandling ofwastes with high activities. {61.58 Alternative requirements for 3.b. 4 waste classification and characteristics 661.59 Institutional requirements 3.b.* 2 {61.61 Applicant qualifications and 3.b. 2 assurances 61.62 Funding for disposal site 3.b.* 2 closure and stabilization {61.63 Financial assurances for 3.b.* 2 institutional controls 661.70 Scope 3.b. 4 6
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detenenned by B.7) {61.71 State and Tribal government 3.b. 4 consultation i (61.72 Filing ofproposals for State 3.b 4 and Tribal participation j f61.73 Commission approval of 3.b. 4 proposals {61.80 Maintenance ofrecords, 3.a. 3 ; i reports, and transfers i 161.81 Tests at land disposal facilities 3.b. 2 , i i {61.82 Commissioninspections of 3.b. 2 , land disposal facilities l 661.83 Violations 3.b. 3 t 161.84 Criminal penalties 3.b. 3 l , i
)
l t [ 7 l l : l ! i
- . _ _ _ - _ _ - 1
Part 70 - DOMSTIC LICENSING OF SPECIAL NUCLEAR MATERIAL REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) 670.1 Purpose 3.b. 3 670.2 Scope 3.b. 3 i 670.3 License requirements 3.a. 3 570.4 Defimitions I (Exemptions noted below) Act 3.b. 3 Agreement State See 10 CFR fl50.3(b) I Alert See 10 CFR 630.4 1 Atomic Energy 3.b. 3 Atomic Weapon 3.b. 3 Commencement of See 10 CFR 530.4 1 construction Commission 3.b. 3 Common defense and security 3.b. 3' Contiguous sites 3.b. 1 Decommission i See 10 CFR 630.4 1
, _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . . _ _ . _ _ . _ . _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ i
2 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Department or Department of See 10 CFR 530.4 1 Energy _ Effective dose equivalent See 10 CFR 520.1003 1 Effective kilograms of special 3.b. I nucicar material Formula quantity 3.b. I Government agency 3.b. 3 License See 10 CFR 620.1003 1 Persons See 10 CFR 620.1003 1
. _ _ ~
Plutonium processing and fuel 3.b. I fabrication plant Principal activities See 10 CFR 630.4 Produce 3.b. 1 Research and development 3.b. I Restricted data 3.b. 1 Scaled source See 10 CFR 530.4 1 Site area emergcr.cy See 10 CFR 530.4 1 2
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) Source material See 10 CFR 6150(i) 1 Special nuclear material See 10 CFR f150(j) i Special nuclear material of low NRC 1 strategic significance Special nuclear material of NRC 1 moderate strategic significance Special nuclear material scrap 3.b. I Strategic special nuclear NRC 1 material Transient shipment NRC 1-United States 3.b. I Uranium enrichment facility NRC 1 570.5 Communications 3.b. 3 670.6 Interpretations 3.b. 3 670.7 Employee protection 3.b. 3 170.8 Information collection 3.b. 4 ratuirements: OMB approval 3 l
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) 670.9 Completeness and accuracy of 3.b. 3 information 570.10 Deliberate misconduct 3.b. 3 670.11 Persons using special nuclear i 1 > l material under certain DOE l and NRC contracts I 670.12 Carriers 2 2 670.13 Department of Defense NRC 4 670.13a Foreign military aircraft NRC 4 670.14 Specific exemption 3.b. 1 ! 670.18 Types of licenses 3.b. 2 {70.19 General license for calibration 3.a. 3 or reference sources
$70.20 General license to own special 3.a. 3 nuclear material 670.20a General license to possess NRC 4 special nuclear material for transport 4
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As detennined by D.7) General license for carriers of NRC 4 570.20b transient shipments of formula quantities of strategic special nuclear material, special nuclear material of moderate strategic significance, special nuclear material of low strategic significance, and irradiated reactor fuel 170.21 Filing (a)(1), (a)(2), (a)(3), 3 (b) and (d) are 3.a.; (c), (f), (g), and (h) are NRC; (e) is 3.b. 670.22 Contents of application (a), (d) and (e) are (a) thru (e) are 3; (f) thru 3.b.; (b), (c), (f), (g), (n) are 4 (h), (i), (j), (k), (I), (m), and (n) are NRC 670.23 Requirements for the approval (a)(1), (a)(2), (a)(3), (a)(1) thru (a)(7) are 2; and of applications (a)(4), (a)(5) and remainder of rule is 4 (a)(6) are 3.b.; (a)(7), (a)(8), (a)(9), (a)(10), (a)(l1), and (a)(12) and (b) are NRC 570.23a Hearing required for uranium NRC 2 enrichment facility 5 l l I l____________ - _ _ _ . - _ _ _ _ - _ _ - _ - _ _ _ _ _ _ _ _ - - _ - _ _ _ _ _ _ _ - - _ _ _ __ _ ~
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN'IS t SECTION ASSIGNED CLASSIFICATION (As detennined by B.7) (70.24 Critically accident NRC 4 requirements 570.25 Financial assurance and 3.b* 3* recordkeeping for
- decommissioning
$70.31 Issuance of licenses 3.b. 3 570.32 Conditions of licenses NRC for all sections 3 except (a)(2), (a)(3),
(a)(8), and (a)(9) are 3.b. 570.33 Renewal of licenses 3.b. 3 670.34 Amendment of licenses 3.b. 3 ! t (70.35 Commission action on 3.b. 3 - applications to renew or amend
$70.36 Inalienability of licenses 3.a. 3 570.37 Disclaimer of warranties NRC 3
)
670.38 Expiration and termination of 3.a. 2 licenses and decommissioning of sites and separate buildings or outdoor areas 6 t t
1 1 { l l
,lll 11 S
T N E M M O C
)
7 N.D O I y L Tb AAd NCe I n GRin I I RSn Se O Ld Ae t CsA ( 3 2 3 2 4 3 4 4 4 4 1 N 0 0 O I 0 T 0 2 A 6 ' C I D R6 FE F0 I SN C0 SG 0 20 AI C 1 C C C C C L SS . b. R e ur R R R R R CA 3 a. 3 2 N Steh N N N N N y r l f e , l ad s r y ce r n a os it t p r E a l a e e L h et r i c l c u t s n t t nn ee i r c ea mr s f s n T I t l ri tae s e s p n s e vm n ie l t tat al e c t r o a r T n m n r u p foirc l r t de on n u f o a o e ,i eu e l N i c i r r a si er os l e t a i cq O e a u ne it l cf s i r s n o n s r p cei a u l i s u q ar e I T eeo ue t f g e r l as ah t ce t a t a s d a o e f t n C E i l cr i t ut a em z r r g n bd r o oro sp l s m r o c cr l rl a c s l a i S ab i r r fea o i tr ss oi f a i as t c i f fi c ua l oa i s r t t r o ier er oot r r e et r e f te i i e hle ne d p pl t l co p pa nc t e ad e rh ea a up s u uc at t f a r e n Smo An Tm r C R Mna Rot m M Nr e I N O I N TO AI LT UC E 9 1 2 4 0 1 2 3 4 5 G 4 5 5 5 5 5 5 E S 3 4 4 0 0 ) 0 0 0 0 0 0 0 R 7 7 M
' 7 5
7 6 7 6 7 5 7 ( 7 5 7 6 $ l l
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMEN13 SECTION ASSIGNED CLASSIFICATION (As detersnised by B.7) 670.56 Tests NRC 3 670.57 Measurement control program NRC 4 for special nuclear material accounting and control 670.58 Fundamental nuclear material ' NRC 4 controls 570.59 Effluent monitoring reporting NRC 4 requirements
$70.61 Modification and revocation of 3.b. 3 i licenses 870.62 Suspension and operation in NRC 4 war or national emergency 670.71 Vio!stions 3.b. 3
$70.72 Criminal penalties 3.b. 3 l :
t l l + 8 ! ! i i
Pod 71 - PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL l
?
REGULATION SECTION CLASSIFICATION ORIGINAL COMMENTS SECTION TITLE ASSIGNED CLASSIFICATION i (As determined by B.7) 67
1.0 Purpose and Scope
3.b 3 E71.1 Communications and Records 3.b 3 171.2 Interpretations 3.b 3 ! 671.3. Requirements fbrlicense 3.b 3 [ t 671.4 Definitions ! A, 2- I f Canier 2 1 [ Certificate holder 2 1 Close reflection by water 3.b i States not required to adopt, l but if they do, should be ; essentiallyidentical. I Containment System .2 1 ! Conveyance 2 1 Exclusive use 2 1 l Fissile material 3.b 1 States not required to adopt, l but ifthey do, should be ; essentially identical. i Licensed material 2 1 i i i l
REGl]LATION SECTION CLASSIFICATION ORIGINAL COMMENTS ! SECTION TITLE ASSIGNED CLASSIFICATION t (As deto..iad by B.7) Low Specific Activity (LSA) 2 1 4 material Low toxicity alpha emitters 2 1 Maximum normal operating 2 1 pressure , i Natural thorium 2 1 r
- Normal form radioactive 3.b i States not required to adopt material but if they do, should be essentially identical.
l Optimum interspersed 3.b i States not required to adopt, i hydrogenous moderation butif they do, should be essentially identical. ; Package 2 1 Fissile material package 2 1 Type B package 2 1 Packaging 2 1 Special form radioactive 2 1 ; material i Specific activity 2 1 l State 3.b 1 Surface Contaminsted Object 2 1 (SCO) , 2 1
t REGULATION SECTION CIASSIFICATION ORIGINAL COMMENT 3 , SECTION TITLE ASSIGNED CLASSIFICATION (As determined by B.7) ; Transport index 2 I Type A quantity 2 1 < Type B quantity 2- 1 Natural Uranium 2 1 ! i Depleted Uranium 2 l Enriched Uranium 2 l l
.t
$71.5 Transportation ofLicensed 2 1 Material '
i l71.6 Information collection 3.b 4 r requirements: OMB approval ; f71.7 Completeness and accuracy 3.b 3 ofInformation - f71.8 Specific exemptions 3.b 3 ; 671.9 Exemption for physicians 3.b 3 {71.10 Exemptions forlowlevel 2 1 material ! i {71.12 Generallicense: NRC- 2 2 ! a,pis.d package [ 671.I3 Fie. 6 4ie.,.,.c.d M === 2 2 i t i f 3 i i _ _ _ - - _ _ _ _ __ _____ _ _ .__ _. _ ~ _ _ - _ _- - _ t
. - - ~ . . _ . . _ . _ _ . - - - - . . .. -.. . - - . _. . . - _ . - . -.. . . . . . _ . _ .
REGUIATION SECTION CLASSIFICATION ORIGINAL COMMENTS I SECTION TITLE ASSIGNED CIASSIFICATION (As determined by B.7) l {71.14 Generallicense: DOT 2 2 l specification container material i {71.16 Generallicense: Use of 2 2 fcreign approved package 571.18 Generallicense: Fissile NRC 4 material, limited quantity of package
$71.20 Generallicense: Fissile NRC 4 material, limited moderator per package
{71.22 Generallicense: Fissile NRC 4 material, limited quantity, Controlled Shipment (71.24 Generallicense: Fissile NRC 4 material, limited moderator, controlled shipment 671.3I Contents of Application NRC 4 671.33. Package ia.;piion NRC 4 671.35 Package evaluation NRC 4 l l {71.37 Quality Assurance NRC 4 {71.39 Requirements for additional NRC 4 i information t I _ _ _ = _ _ _ _ __ __ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ - - - _. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ - - _ _ _ .-_ - _____ _ ___ _ __ __-__.n
REGULATION SECI' ION CLASSIFICATION ORIGINAL COMMENTS SECTION TITLE ASStGNED CLASSIFICATION (As determined by B.7) 671.41 Demonstration of Compliance NRC 4 i _{71.43 General Standards for all NRC 4 . packages
$71.45 Lifting and tie-down NRC 4 Standards for all packages !
{71.47 Externalradiation Standards NRC 4 for all packages
$71.51 Additional Requirements'for NRC 4 i Type B packages 1
l
$71.52 Exemption for low-specific- NRC 4 i activity (LSA) packages 671.53 Fissile material exemptions NRC 4 t
{71.55 General Requirements for NRC 4 i fissile material packages ! 171.57 Reserved l {71.59 Standards for arrays offissile NRC 4 material packages l l 571.61 Special requirements for NRC 4 [ t irradiated nuclear fuel i shipments .
- f71.63 Special requirements for NRC 4 l plutonium shipments !
i i 5 , l i
REGULATION SECTION CLASSIFICATION ORIGINAL COMMENTS SECTION TITLE ASSIGNED ' CLASSIFICATION (As deta..Z.-d by B.7) Special requirements for NRC 4 {71.64 plutonium air shipments , 171.65 Additional Requirements NRC 4 g71.71 Normal conditions of NRC 4 transport
~
g71.73 Hypothetical accident NRC 4 conditions
$71.74 Accident conditions for air NRC 4 transport ofplutonium
{71.75 Qualification ofspecial form NRC 4 radioactive material {71.77 Qualification ofLSA-III NRC 4 material {71.81 Applicability ofoperating 2 7 controls (71.83 Assumptions as to unknown NRC 4 properties 671.85 Preliminary determinations 2 2 671.87 Routine determinations 2 2 (71.88 Air Transportation of 2 2 plutonium 671.89 Openinainstructions 2 2 6
_.m... . _ . . . . _ _ . _ _ _ . _ . _ _ _ . _ _ _ _ _ . . . _ . _ . _ _ . _ . . . _ . _ . . . _ _ - _ . . _ . . _ _ _ _ . _ . _ _ _ _ _ . . _ _ _ _ _ . _ _ _ . . _ . . . _ _ . . . _ _ i . ORIGINAL REGULATION SECTION CLASSIFICATION COMMENTS SECTION TITLE ASSIGNED CLASSIFICA110N (As determined by B.7) 671.91 Records 3.b 3 ; 671.93. Inspection and tests 3.b 3 671.95 Reports 3.b 3 i {71.97 Advance notification of 2 2 ! shipment ofirradiated reactor fuel and nuclear waste
- 471.99 Violations 3.b 3 i
671.100 Criminal penalties 3.b 4 {71.101 Quality assurance 3.b 3 i requirements
$71.103 Quality assurance 3.b 3 i organization t (71.105 Quality assurance program 3.b 3 t t
$71.107 Package design control 3.b 3
{71.109 Procurement document 3.b 3 i control t {71.11I instructions, procedures, and 3.b 3 i drawings i i {71.117 Identification and control of 3.b 3 materials, parts, and - ' components 671.I19 Control ofspecial processes 3.b 3 7
REGULATION SECTION CLASSIFICATION ORIGINAL COMMENTS SECTION TITLE ASSIGNED CLASSIFICATION (As determined by B.7) 671.121 Intemal Inspection 3.b 3 671.123 Test control 3.b 3
$71.125 Control of measuring and test 3.b 3 equipment $71.127 Handling, storage, and 3.b 3 shipping control 571.129 Inspection, test, and operating 3.b 3 status $71.131 Nonconforming materials, 3.b 3 I
parts, or components 71.133 Corrective action 3.b 3 671.135 Quality assurance records 3.b 3 f71.137 Audits 3.b 3 Appendix A Determination ofAl and A2 2 1 8 L - _ - - - - - - - - - - - -
Part 150 - EXEMITIONS AND CONTINUED REGULATORY AUTIIORITY IN AGREEMENT STATES AND IN OFFSIIORE WATERS UNDER SECTION 274 REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.'D 6150.1 Purpose 3.b 3 5150.2 Scope 3.b 3 5150.3 Definitions ll50.3(a) Act 3.b 3 il50.3(b) Agreement State 2 1 Definition has significant national ami transboundary implications fl50.3(c) Byproduct Material 1 1 fl50.3(d) Commission 3.b 3 Il50.3(e) Government Agency 3.b 3 fl50.3(f) Offshore Waters 2 3 Essential to the reciprocity provisions in 1150.20 fl50.3(g) Person See 10 CFR 1 120.1003 il50.3(h) Production facility NRC 3 Such facilities are outside Agreement Statejurisdiction; however, if the State chooses to define this term, the definition should be essentially identical.
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) Il50.3(i) Source material 1 1 fl50.3(i) Special nuclear material I I il50.3(k) State 3. b 3 1150.3(1) Utilization facility NRC 3 Such facilities are outside Agreement Statejurisdiction; however, if the State chooses to define this term, the definition should be essentially identical. Il50.3(m) Uranium enrichment NRC 3 Such facilities are outside facility Agreement Statejurisdiction; however, if the State chooses to define this term, the defmition should be essentially identical. I150.4 Communications 3.b 3 5150.5 Interpretations 3.b 3 5150.7 Persons in offshore waters NRC 4 Not within Agreement State not exempt jurisdiction. 1150.8 Information collection 3.b 4 requirements: OMB approval 2
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 6150.10 Persons exempt NRC 4 Exemption addresses discontinuance of NRC authority in an Agreement State 6150.11 Critical mass 1 1 Definition essential to identifying scope of Agreement State authority pursuant to Section 274b of the AEA, thus ensuring a common understanding 5150.14 Commission regulatory NRC 4 Provision addresses authority for physical continuing NRC authority protection over special nuclear material. 5150.15 Persons not exempt NRC 4 Provision addresses continuing NRC authority over certain activities in Agreement States. Il50.15a Continued Commission NRC 4 Provision addresses authority pertaining to continuing NRC authority byproduct material over certain activities in Astreement States. 3 l t __. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ -_______-- _____-_____ -_- ______ - - _ _ - - - - - _ - _ - _ _ - - _ _ - _ _ _ - _
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 6150.16 Submission to NRC 4 Although an issue within Commission of nuclear NRC exclusivejurisdiction, material transfer reports States should adopt some method to advise their licensees of these NRC requirements. 5150.17 Submission to NRC -4 Although an issue within Commission of source NRC exclusivejurisdiction, material reports States should adopt some method to advise their licensees of these NRC requirements. ll50.17a Compliance with , NRC 4 requirements of US/lAEA safeguards agreement
$150.19 Submission to NRC 4 Although an issue within Commission of tritium NRC exclusivejurisdiction, reports States should adopt some method to advise their licensees of these NRC reauirements.
4 i L
REGULATION SECTION TITLE CLASSIFICATION ORIGINAL COMMENTS SECTION ASSIGNED CLASSIFICATION (As determined by B.7) 6150.20 Recognition of Agreement (a) & (b) are 3.a 1 Provisions in (a) & (b) are State licenses (c) & (d) are NRC important for coherent . i regulation of agreement materials on a national basis. Provisions in (c) & (d) relate to NRC authority to regulate activities in offshore waters. 6150.21 Transportation of special NRC 4 Provision addresses nuclear material by continuing NRC authority , aircraft over certain activities.in Agreement States. . 1150.30 Violations 3.b 3 6150.31 Requirements for 3.a.S 2 UMTRCA requirements. Agreement State regulation of byproduct material 6150.32 Funds for reclamation or 3.a.S 2 UMTRCA requirements. maintenance of byproduct ' material 1150.33 Criminal penalties 3. b 3 4 _ _ _ _ _ _ _ _ . _ . . _ _ _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _}}