ML20056G727
| ML20056G727 | |
| Person / Time | |
|---|---|
| Issue date: | 08/17/1993 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Synar M HOUSE OF REP., GOVERNMENT OPERATIONS |
| Shared Package | |
| ML20056G728 | List: |
| References | |
| NUDOCS 9309070095 | |
| Download: ML20056G727 (55) | |
Text
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/p""%A UNITED STATES i
NUCLEAR REGULATORY COMMISSION
/
wash NGTON D.C. N1 August 17, 1993 f
y 1
The Honorable Mike Synar, Chairman l
Subcommittee on Environment, Energy and Natural Resources 1
Committee on Government Operations l
United States House of Representatives Washington, D.C. 20515 i
1
Dear Mr. Chairman:
Pursuant to Mr. David Berick's request of August 9, 1993, regarding information on the "NRC Compatibility Workshop," held on July 26-27, 1993, in Rockville, Maryland, enclosed please find the following documents:
1.
Agenda for the workshop.
I 2.
Workshop sign in sheet, g
3.
State Agreements Program, Division I, Internal Procedures, 8.7 -
Criteria for Compatibility Determination, Appendix 2 and Appendix A, dated 1/25/84.
. 4.
Working paper " Issues for a Proposed Policy on Compatibility for Discussion at the Workshop on July 26-27, 1993," dated 3:ne 29, 1993.
5.
SECY-91-039 " Evaluation of Agreement State Compatibility Issues,"
dated February 12, 1991.
6.
Transcript of the workshop.
I hope you will find this information complete and satisfactory.
If you need any additional information, please feel free to contact me.
s)
Sincerely, I
s cutive Di ector for Operations
Enclosures:
-lh f
As statd 3,
cx u
cc: Rep. J. Dennis Hastert (w/ enclosures)
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j lNMh P A 25013a f
)D 9309070095 930817 PDR STPRC E999EN PDR-
The Hon:rable Mik2 Synar, Chaiman Ags 9
Subcommittce cn Environment, Energy and Natural R;sturc;s Committee on Government Operations United States House of Representatives Washington, D.C. 20515
Dear Mr. Chairman:
Pursuant to Mr. David Berick's request of August 9, 1993, regarding information on the "NRC Compatibility Workshop," held on July 26-27, 1993, in Rockville, Maryland, enclosed please find the following documents:
1.
Agenda for the workshop.
2.
Workshop sign in sheet.
3.
State Agreements Program, Division I, Internal Procedures, 5.7 -
Criteria for Compatibility Determination, Appendix 2 and Appendix A, dated 1/25/84.
4.
Working paper " Issues for a Proposed Policy on Compatibility for Discussion at the Workshop on July 26-27, 1993," dated June 29, 1993.
5.
SECY-91-039 " Evaluation of Agreement State Compatibility Issues,"
dated February 12, 1991.
6.
Transcript of the workshop.
I hope you will find this information complete and satisfactory.
If you need any additional information, please feel free to contact me.
drNfdSbDY James 14. Taylor James M. Taylor Executive Director for Operations
Enclosures:
As stated cc: Rep. J..Bennis Hastert (w/ enclosures)
W Distributted g^'
DIR RF CXammerer Synar File (Transcript of Compatibility Workshop EDO RF SSchwartz is in Compatibility File)
JMTaylor, ED0 JSurmeier HLThompson, DEDS RKishore PDR TCombs, OCA 0fC,, OSP:SLIR f,0SPdH)/O
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NRC COMPATNBILITY WORKSHOP DISCUSSION OF THEISSUES FOR THE PROPOSED POLICY ON COMPA TIBILITY OF A GREEMENT STA TES July 26-27,1993 Ramada inn Rockville at CongressionalPark Rockville, Maryland Moderator: Nicholas Mann MONDA Y. JUL Y 26.1:00a.m.- 7:00p.m.
e Opening Remarks Commissioner Remick e
Open Discussion
- Issue 1 - Basics What is/are the core elements of a compatible program?
A.
Uniform NationalStandards B.
Radiation Protection Standards / Regulations C.
Interstate Commerce and Reciprocity D.
Improved Public Health and Safety E.
Adoption Time Frame F.
Scope of Policy
],
TUESDA Y JUL Y 27.1993. 8:30 a.m. to 5:00 a.m.
e Open Discussion
- Issue 2 - Flexibilitv A.
Regulations B.
Non-regulation Aspects
- Issue 3 - Communications A.
Communication Between Regulators B.
NRC and Agreement States share "Gdod News "
- Issue 4 - Imolementation I
A.
Early and Substantive Input On Rulemaking B.
Transition C.
CRCPD standing, if any, in compatibility determinations D.
Program Review Areas Affectedby the Scope of the Policy
- Issue 5 - Revocation 2
i
COMPA TIBil.lTY WORKSHOP SIGN IN SHEET
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COMPA TIBILITY WORKSHOP SIGN IN SHEET 4
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il*
l APPENDIX 2 k
STATE AGRttMENTS PROGRAM i
DIV!5!0N I l
Internal proceduits i
- g. policy j
8.7 - Criteria for Compatibility
. Determinations
[
I.
Beckeround l
5ection 174d.(2) of the Atomic Energy Act of 1954 as amended.
requires that before entering into an agreement wIth any State the Comission shall make a determination that the State's program,is j
comoatible 'with the Comission's program. Section 274g. authorizes 3
i ano streets the Comission to cooperate with the States in the formulation of standards to assure that State and Comission j
programs will be coordinated and :omoatible. Section :74j(1)
{
requires that the Comission perioctesily review such agreements and actions taken under the agreements to ensure compliance with Section 274 Sections 274d(2 3
the Act that address the conce)pt of compatibility.and 274. are th Jt should be '
noted that both sections refer to the compatibility of " programs.'
i It is evident that Congress intended that the Comission address more than just regulations in its review, and since the earliest i
i days of the State Agreements Program the Comission has used the term " compatibility in relation to not only regulations, but also to such however, program areas as licensing and compliance. This procedure, j
wi'1 address compatibility only as it affects regulations.
i j
The Comission has never formally defined compatibility or provided i
sere than minimal guidance as to how the term should be interpreted. The basic objective has been to achieve uniformity 1
among the various rep 1 story programs to the maximum extent
{
practicable recognizine that the States must be allowed some flekibility to accommodate local conditions. With regard to i
i regulations it has been more or less understood that certain i
regulations such as 10 CFR part 20 were considered to be " matters i
of tempatibility" and that States were re that had essentHally identical language. qvfred to have regulations With respect to other of the regulations it was less clear what requirements were tdered "antters of compatibility" and why. In 1961. the i
ssion pubitshed criteria for the guidance of States and the l
Cautission relating to the discontinuance of Coumission authority under the terms of the agreement.- The criteria require that 'The State regulatory program shall adopt a set of sundards for protection against radiation... It is taportant to strive for uniformity in technical definitions and terminology. particularly
}
as related to such things as units of measurement and radiation i
suse. There shall be eniformity en anximum permissible doses and i
levels of radiation and eencontrattens ff radioactivity, as fixed i
by part 20 of the [Connission) regulattens based on officially approved radiation protection guides." Nowever. questions remain 3i as to how precisely State regulattens must reflect NRC regulations.
4 1/25/84,
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.l
.t.
1
's
/f In addition. MC has always encouraged snifomity in re other than those listed above, but no specific guidance has provided.
Act and the Nuclear Weste Policy Act well as NRC to incorporate certain elements in their t
financial (assur,ances)onmental assessments land ownersh programs e.g.
envir 4
. These re included in the categorisation. quirements have been appro.priately In light of the above, this procedum establishes criteria better defining compatibility and determining the decr States regulations must show uniformity with Cesnission regulations.
II. Rule Cateeorization been implicit in compatibility determinations. H however, has never been given substance,in the form This notion, procedures.
Under this procedure pertinent NRC rules are r
NRC and Agreement State requirements. categoriz i
Four categories are established as follows:
Division 1 Rules There are certain' provisions in NRC regulations tha adoet, essentially verbatim. into their re A
us provisions include those that form the bas'sistions. These agencies and the regulated community. protectio c language of radiation formulated and agreed to by national and internationalW s organizations from consensus standards followed by in dose.' and
- rad." radiation protection s government.
i occupational e vre limits, offivent release limits, and legal definitions s as f
" occupational dose " or ' byproduct material.' ' restricted area
- sad regulatory programs.
These provisions are so basic to the in numerous and difficult problems including inte int
.as Mvision 1 evles and Agreement State p ially identical provisions.
Mvision 2 Rules There are other provisions in NRC regulations that ad principles include generally apprinciples of radiation personnel monitoring and ALARA.plicable safety requirements such as While States aust address such princ requirements such as detailed in part 13.
their regulations, the States may adopt requirements more
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' fa letC ruics is not nec s'sary provided the un
- V are the same. For example Certain notices to worsqrs.10 CFR 19.11 addresses the posting of While we believe that it is important that Agreement State licensees be required to make available
{
workers certain documents, the menner. location and time i
constreints under which they are i
i the corresponding NRC provisions. posted may differ somewhat from more stringent requirements than those of 19.11. Local kircumsta would be included in this category include basic proceduralOthe i
i requirements necessary for licensing, inspection authority incident reporting, and radiation safety requirements for.
i industrial radiographers. Such provisions are designated Div j
2 rules.
Division 3 Rules There are a great number of provisions in NRC regulations whic would be appropriate for Agreement States to adopt but which do For example. NRC has found group medical lice i
improved method of Itcensing the medical uses of rat)ionuclides t
States utilising a different procedure in licensing medical uses radionuclides would not be hindering interstate cosnerce or deviating in an or procedures. y manner from basic radiation protection standards strictly matters between the regulatory agency a i
comunity within its jurisdiction are designated Division 3 rules.
i Such rules include adutinistrative requirements as well as te i.
criteria which the agency feels the licensee must address in to meet the basic radiation standards.
j encouraged to adopt the regulatory approach taken by NR rules, but are not required to do so.
Division 4 Rules t
pursuant to the Atom <
c Energy Act and 10 CFR Part 150There are 3
pertaining to these areas are designated Division 4 rules.
Rules 1
rules include those concerning reactor regulation, distributio
{
Such consumer disposal. products, exports and imports, and high level waste State regulations should not address these areas.
{
111. Listine of perti ar.t **C Rules l
as Appendix A of this procedure is a listing of a'11 t NRC rules 71, and 150) by c(ompatibility type Parts 1g ro. 30. 31 32 33 34 35, 40 61 of the Suppested State Regulations can. Yhe c,orre,spon, ding s i
Procedure A.2.
be found in Internal i
I
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Ii 1/25/84 I -
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2..
l i
APPDEDIX A I1 l
CATEGORIZATION DF NRC RULES BY COMPATIBILITY TYPE j
i l
w.:en 1 Rules i
19.3 Definitions Definitions ((Exceptions - Act. Comission. G Exceptions - Act. Commission. Ifeense) 20.3 j
license) 20.4 Units of radiation dose j
20.5 Units of radioactivity i
i 20.101 Dose limits i
20.102 Prior dose 20.103 1
Concentrations in restricted areas i
20.104 Exposure of minors 20.105 Levels in unrestricted areas i
20.106 Radioactivity in effluents 20.203 Cautionsigns,etc.,except(c)(6)&(7) i 20.403 Notifications of Incidents j
Part 20 Appendix B and Appendix C l
30.4 Definitions (Exceptions - Act. Commission. Gov't Agency.
license, production facility, utilization facility) j 30.11 Specific exemptions j
30.12 Contractor exemptions 30.14 Exempt concentration i
30.15 Exempt items 1
30.16 Sc-46 resins exemption 30.1L Exempt quantities j
30.19 Self-luminous products i
30.20 Gas and aerosol detectors 30.70 Exempt concentrations schedule i
30.71 Exempt quantities schedule 31.3 Certain devices and equipment I
i 32.2 Definitions
(
40.4 pharmacist, physician) Definitions (Exceptions-Act.Co i
i 40.11 DOE & NRC contractor esemptions j
40.13 Unisportant quantities 40.M Specific esemptions j
40 5 3as11 quantities of source material 51.E Protection of general populationDefinitions (Eaceptio i
- 51. 4 i
51.55 lieste classification 70.4 Definitions (Eaceptions-Act.AtomicWeapon.Constission.
1 Common defense and security. Gov't Agency) 70.11 DOE & NRC contractor exemptions 70.14 Specific esemptions 4
i 71.4 Transportation of licensed materialDefinitions (those 71.5 71.10 Exemptions for low level materials 1/25/84 A-1 4
.n,
=
part 71 Appendix A j
150.3 Definitions 150.11 Critical mass (b). (c). (g). (1) and (j) 150.20 Reciprocity
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Division 2 Rules 19.11 posting of Notices 19.12 Instructions to Workers 19.13 Notifications 19.14 presence of worter representatives 19.15 Consultation with workers 19.16 Requests for inspection 19.17 Inspection not warranted 20.1(c)
ALARA 20.108-81osssay Services 20.201 Surveys j
20.202 personnel Monitoring I
20.203 (c)(6)and 7 500 rem /hr rule picking up.(re)ceiving, and opening package 20.205 20.207 Storage & control in unrestricted areas 20.301 Waste Disposal - General Requirements 20.302 Approval of disposal procedures i
20.303 Sewage disposal 20.311-Transfer for disposal 20.402 Reports of Theft or loss 20.405 Reports of overexposures 20.408-Monitoring Reports on termination part 20 Appendix A 30.3 Activities requiring license 30.13 Carrier Exemption 30.31 Types of Licenses 30.32 Application for specific license 30.33 Eeneral requirements 30.34 30.41 Terms & Conditions Transfer of byproduct asterial 30.55 Tritium reports (to be deleted) 31.3 Certain measuring, gauging and controlling devices 31.6 Installation of E gauges 31.7 Luminous safet,d Introduction e esempt concentrationsr devices for use in 32.11 t
32.12 Material transfer reports 32.13 Prohibition of introduction 32.51 Manufacture of E gauges 32.
Manufactere of E 32.
32
- j. Transfer reports gauges E gauges Manufactere of luminous safety devices 32.54 Labeling of luminous safety devices 32.55 OIL - luminous safet Transferreports.;rdevices 32.56 Manufseture of Am.241 reference sources'usinous safety 32.57 32.58 Labe11ag of An-241 sources 32.59 Leak testing of An 241 sources 32.61 Manufacture of Sr-90 ice detection devices IA5 /84 l
A-2
32.62 04 - ice detection Crices i *j 32.70 M6nufacture of Medical GL esterial 32.71 ~
Manufacture of in vitre kits' 32.72
.i Manufacture of radiopharmaceuticals 32.73 Manufacture of generators and reaitent kits j
(
32.74 Manufacture of sources for sedica' use i
32.101 Schedule B - tests for luminous safety devices i
32.102 Schedule C - tests for An-241 sources 32.103 Schedule D - tests for Sr-90 ice detection devices 32.110 Sempling procedures 4
34.2 Definition 34.11 Specific licenses for radiography 34.21 Levels of radiation 34.22 Locking of devices 34.23 Storage precautions i
34.24 Survey Instruments 34.25 Leak testing, etc.
1 34.26 Quarterly inventory 34.27 Utilization logs 34.28 Inspection and maintenance I
34.31 Training 34.32 i
Operating and emergency procedures 34.33 Personnel Monitoring 34.41 Security-i 34.43 Surveys i.
Part 34 Appendix A
{
40.2a Inactive tailings sites i
1 40.12 Carrier exemptions 40.20 Types of licenses 40.26 40.31(f) GL - possession 8 storage of tailings
&(h)
License for source asterial milling i
40.32 General requirements 40.34 Manufacture of depleted uranium products for GL 40.35 Terms and ConditionsManufacture of depleted uranium p 40.41 t
40.51 Transfer of source asterial 40.65 Effluent monitoring Part 40 Appendix A 61.3 License required i
61.10 Content of application j
61.11 General infersetton L
61.12 Specific Technical inforestion 61.13 Technical analyses i
61.14 Institutional inforamtien 1
61.3F Financial inforestion i
61.23" Standards for issuance 1
)
61.24 Conditions of Itcenses 61.27 Application for renewal or closure i
61.28 Contents of application for closure 61.2g post-closure observation 61.30 Transfer 61.31 Termination j
61.40 General requirement l
1/25/84 A-3 I
i'
I 51.42
!a Protection Cf individuals from ttrusion 61.43 Protection of individuals during operations
(
51.44 Stability of site after closure i
61.50 Site suitability. requirements 61.51 Site design
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61.52 Facility operation and site closure i
61.53 Environmental monitoring 61.54 Alternative requirements 61.56 Waste characteristics 61.57 Labeling 61.59 1
Institutional requirements t
61.61 Applicant qualifications i
61.62 Funding for closure and stabilization 61.63 Financial assurances j
61.81 t
Tests at disposal facilities 61.82 Comission inspections 70.11 Carrier esemption 70.18 Types of ifcenses i
70.23(a) Requirements for approval 70.39 Manufacture of Pu calibration sources i
70.42 Transfer of SNM 71.12 GL for NRC approved packages i
i 71.13 Previously approved Type 8 packages 71.14 GL: DDT containers 71.16 GL foreign approved packages i
71.81 Operating controls and procedures 71.65 Preliminary determinations 71.87 Air transport of PuRoutine determinations (except fissi
(
71.88 71.89 Opening instructions 150.31 UMTRCA j
150.32 UKTRCA 1
f Division 3 Rules s
~
i 19.1 Purpose i
19.2 Scope 19.4 Interpretations i
19.5 Casuunications 19.20 Employee protection 19.30 Violations
(
19.31 1
Applications for exemptions 19.32 Discristnation prohibited i
j 20.1 (a &
Sco)pe (b) purpose 20.2 20.6 Interpretations 4
20.7 Casuunications i
20.107 Medical diagnosis & therapy j
20.204 posting exceptions 20.206 Instrwetion of personnel i
20.305 Disposal by incineration 1
20.306 Siemedical waste rule 20.401 Records
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20.409 Notifications and Reports to Individuals i
20.501 Applications for exemptions j
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20.502' Additional Requirements 5,
i 20.601 Violations 30.1 Purpose & Scope 1
30.2 Resolution of conflict i
30.5 Interpretations 30.6
. Communications i
30.7 Employee protection 30.36 Expiration of licenses 30.37 Applications for renewal i
30.38 Applications for amendment i
30.39 Comission Action to renew or amend i
30.51 Records i
30.52 Inspections 1
30.53 Tests 30.61 Modification and revocation of licenses t
30.62 WiOholding of byproduct material i
30.63 Violations j
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1.1 Purpose and Scope
i 31.2 Terms and conditions
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31.8-Am-241 reference sources i
31.9 GL to own material t
31.10
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33.1 purpose and scope 33.11 Broad license requirements 33.12 n
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33.14 Broad iteense requirements 33.15
. Broad license requirements 33.16 Broad license requirements a
33.17 Broad license requirements
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34.1 Purpose and scope 34.3 Applications for specific licenses 34.29 Pemanent radiographic installations 34.42 Posting
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34.44 rvision of radiographer's assistants 34.51 11 cations for esemptions 35.1 e and scope 1
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35.4(bbDefinition of ' physician
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35;11 Licenses for human use i
35.12 Licenses for individual physician's 35.13 Munen use of source 6 35.14 Group medical licensing 35.21 Teletherapy calibrations I
35.22 Teletherapy spot-checks
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35.42 Misseministration reporting 35.43 Misadministration reporting 1
35.44 Misadministration reporting 35.45 Misadministration reporting i
35.100 Medical Groups 40.1 Purpose 1
40.2 Scope 40.3 License requirements i
40.5 Comunications
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40.6 Interpretations 40.7 Employee protection 4
40.21 GL-title to source material 4
j 40.25 EL depleted uranium 40.31 (a)-(e). (g) applications for specific licenses j
40.42 Expiration 1
40.43 Renewal of licenses 40.44 Amendment of licenses 40.45 i
Comission action to renew or amend 40.46 Inalienability i
40.61 Records i
40.62 Inspections a
40.03 Tests 40.64 Reports 40.71 Modification, etc.
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40.81 Violations 61.1 Purpose and scope 61.4 Comunications l
61.5 Interpretations J
4 61.6 Exemptions 61.7 Concepts 61.9 Employee protection 61.20 Filing application
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61.21 Repetition 61.22
' Updating of application 61.25 Changes 61.26 Amendment of license i
61.80
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70.1 purpose i
70.2 Scope 4
70.3 License reevirements 1
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70.7 Employee protection 70.19 GL for pistonis reference source 70.20 SL to own SIM i
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70.37 Disclaimer of warranties
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70.41 Authorized use of $NM i
70.55 Inspections 70.56 Tests i
70.61 Modification and revocation j
70.71 Violations j
71.0 purpose and scope 71.1 Coenunications 71.2 Interpretations i
71.3 Requirement for license i
71.7 Specific exemptions i
71.9 Exemption of physicians 71.91 Records j
71.93 Inspection and tests 71.95 Reports 1
71.99 Violations i
71.101-71.137 QA i
150.1 purpose 1
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150.4 Comunications j
150.5 Interpretations
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150.30 Violations 4
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32.14 Manufacture of exempt items 32.15 QA - exempt items 4
32.16 Transfer reports - exempt items 32.17 Manufacture of Sc-46 resins 32.18 Manufacture of exempt quantities 32.19 Conditions of licenses - exempt quantities 32.20 Transfer reports - exacipt quantities 32.22 Manufacture of self-luminous products i
32.23 Safety criteria - self-luminous products 32.24 Table of organ doses - self-luminous products i
22.25 Transfer reports '- self-luminous products 32.25 Manufacture of gas and aerosol detectors j
32.2F Safety criteria - gas and aerosol detectors 32.28 Table of organ doses - gas and aerosol detectors 32.2g Transfer reports - gas and aerosol detectors 32.40 Schedule A
- L 61.8 Reporting
- 04 approval 61.16 Other information 61.58 Alternative requirements 61.70 Scope 51.71 State and Tr15a1 consultation
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70.52 70.53 Reports of criticality 70.54 Material status reports 70.57 Transfer reports 70.58 Measurement control program 70.59 Nuclear material controls 70.52 Effluent monitoring 71.18 - 71.24 Suspension and operation in war 71.31 - 71.77 Fissile material NRC package approvals 71.83 Assumptions -unknown properties 150.7 Persons in offshore waters 150.10 Persons exempt 150.14 150.15 Physical Protection Persons not exempt 150.15a Continued Conenission authority 150.16 Material transfer reports 150.17 Material transfer reports 150.17a US/IAEA Safeguards requirements 150.1g Tritium reports 150.21 SM by aircraft 4
1/25 /84
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ISSUES FOR A PROPOSED
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POLICY ON COMPATIBH2TY FOR DISCUSSION AT THE WORKSHOP ONJULY 26-27,1993 l
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l June 29, 1993 l
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g Issess Poa TEs PROPOSED POLICY ON COMPATIsILITY OF ASREEMENT STATES June 29, 1993 i
SUMMARY
The program established by Congress by section 274 of the Atomic Energy Act of 1954, as amended, is unique in its provisions.
j At i
the heart of the program is a discontinuance of regulatory i
authority by the NRC (formerly AEC) for certain specified j
activities and the assumption of that authority by a state j
through a formal agreement with the NRC.
The purposes of the section are contained in section M4a. and provide some general guidance on the type of relationship between the states and NRC.
The phrases " recognize the interests of the states," " establish
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programs for cooperation," " promote an orderly regulatory
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pattern," and " provide for coordination of the development of '
radiation standards for the guidance of Federal agencies and cooperation with the states" constitute the fundamentals'of this i
program.
Some of these fundamentals are reiterated in the agreements entered into with individual States.
The relationship of the NRC with the Agreement states has evolved since 1962 (the year of the first Agreement state) from an informal relationship with little or no explicit oversight role by NRC to a fairly formalised relationship.
)
The formalized relationship currently exhibits itself primarily through the periodic review of each Agreement state and, to some extent, through " incident or event" reporting, through NRC's data collectica efforts and joint NRC/ Agreement meetings and n
workshops.
There is an additional informal relationship existing between NRC and each Agreement state (and sometimes with Agreement states collectively) that is carried out on a daily basis.
These informal relations are carried out routinely and 2
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T encompass such things as information exchange, technical and l
regulatory advice, and numerous matters which are necessary for each party to carry out their respective regulatory programs in an efficient and effective manner.
However, there has been concern expressed regarding che NRC's oversight role, its emphasis on uniformity in regulations, and the amount.of flexibility requested by the Agreement states in ordar to consistently regulate all sources of radiation in accordance with local conditions.
This paper initiates a discussion of the NRC/ Agreement State relationship which will
. culminate in a draft commission Policy on compatibility to be presented for commission approval in November 1993.
BACKGROUND Neither the Atomic Energy Act nor the legislative history of Section 274 provides a definition of " compatibility."
- However, the legislative history makes it clear that uniformity (or j
rather, lack of conflict) between the Federal program regulating nuclear materials and the proposed State programs was a prime consideration.
This led to the adoption of the language l
requiring that proposed state programs be " compatible" with the j
commission's program.
The " compatibility" of Agreement ~ state regulatory programs with l
'the NRC has been the center of many policy discussions.
Concerns
'j l
on compatibility have been raised repeatedly by Agreement state personnel.
- 3. -
In an atte p to respond to the concerns of the Agreement stetes, i
the regulated concuni,ty and the general public, the commission has directed the staff to develop a commission Policy on compatibility.
A working group has been established to perform 3
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i this task with input from the organization of Agreement states.
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The working group's draft issue's paper was discussed with the a
j Agreement States on May 20, 1993 during a public meeting i
following the annual meeting of the conference of Radiation a
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Control Program Directors, Inc.
i In addition to the working group, representatives of the 1
regulated community, the non-Agreement states, and the general I
public will participate in a July 1993 public workshop on the 4
l compatibility policy issues.
The draft Commission Policy on compatibility will be discussed with the Agreement states during
{
their October 1993 annual meeting.
The working group plans to t
j present the draft policy to the Commission in November 1993 for i
publication in the Federal Register for public comment.
In framing the issues pertinent to a Commission Policy on j
compatibility both NRC and the Agreement States have presented j
views which diverge as'well as those which are consistent,with j
one another.
The common focal point of both the WRC and the i
f Agreement States is adequate protection of the public health and worker safety within the limits of their respective statutory authority.
The main disparity lies in the degree to which NRC l-and the Agreement State radiation control programs sust be j
essentially identical.
While no one seriously supports the i
1 extreme positions of " carbon copy" and "no equivalence required,"
3 there is still sentiment to support a wide range of a
j possibilities.
j The tenden g to prefer a rigid standard for compatibility would
)
appear to h counter to a philosophy of enhanced recognition of
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States' ri $ts, the reason for the Agreement State program in the first place.
States have traditionally been responsible for i
assuring the health and safety of their citizens.
In viewing a
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l-j these two positions a number of statements can be made.
The k
principal views of the working group concerning federal f
oversight, state discretion, and the relationship of the NRC and i
the Agreement states are as follows:
i t
)
1.
The overriding requirement for both NRC and the Agreement l
states is to provide for adequate protection of the public
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health and safety from potential hazards arising from the i
use of regulated materials.
The compatibility of their i
j respective programs or regulations is an adjunct to the j
basic requirement and should be supportive of that j
reguirement.
4 J
j 2.
The individual Agreement states and their employees and NRC j
and its employees share a common function and should be l
considered partners in carrying out their respective i
1 regulatory functions.
Both NRC and the states have either a mandate or an inviolable sovereignty that, in their dealings with one another, sets them apart from the general public or i
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I members of the regulated community.
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3.
Due to the extensive interaction of the NRC and the i
Agreement states and the interrelationship of many aspects 3
of their respective regulatory programs, there is a need for i
early and substantive involvement of Agreement states in the
[
development of policies and regulaticas necessary for the I
conduct of offactive regulatory programs.
A program of cooperation and consultation is essential to the 1(
implementation of this principle.
a 2
l 4.
It is sed that each regulatory agency may be fiaced with physical and/or environmental conditions, operational i
needs of the regulated community, and policy directives of 4
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4 their legislative or administrative bodies which affect j
their; respective regulatory programs.
such conditions require a recognition of the need for flexibility in p
l implementing their ret,vlatory programs which could, for instance, result in rayulations differing from NRC and other Agreement States.
Suca flexibility should not jeopardize l
the regulatory agency's ability to adequately protect the i
public health and safety.
J l
5.
It is recognized that States' innovation has created new i
regulatory approaches.
Innovative approaches should be 1
encouraged, and impediments to such innovation should be
(
j discouraged.
i l
It is recognized that there is no single way of conducting 6.
j effective regulatory programs.
Regulatory programs of l
' Agreement States must be responsive to each state's citizens, legislature, and administrative officials.,
NRC j
and each Agreement State must operate within their j
respective governmental systems.
Effective regulation of j
the uses of radioactive material is the key provision
[
whether accomplished through formal adoption of regulations
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or through license conditian or by administrative order, j
etc.
It is further recognized that while each regulatory j
agency may have direct or indirect interest in the other's program or in individual events such as incidents, the
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agency with regulatory jurisdiction must be allowed to 1
1 manage those matters without undue involvement of other 4
j regulatory agencies.
4 I
7.
Consistant with the partnership principle stated in number 2 j
ebove, it is recognized that NRC and the Agreement States can complement each other in addressing certain issues or i
2
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4 i
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j responding to incidents or events.
Each has experience and j
expertise, although the expertise and depth of resources may vary considerably among the regulatory agencies.
states may be called on to supplement the NRC in some cases, and NRC may supplement the Agreement states in others.
The individual and collective resources and expertise of all the regulatory agencies should be recognized and utilized to j
their mutual benefit.
i 4
j s.
The key to implementation of an effective policy is how it i
is administered.
Arbitrarir,ess should be avoided, fairness l
applied, and soundly based jiadgement used in arriving at 4
j decisions.
4 It is recognized that the NRC has consideraole resources to 9.
contribute to research and development on requirements necessary to protect the public health and safety from radiation hazards.
j 10.
NRC has the unique responsibility to assess State programs j
to gauge nationwide adequacy to protect the public health l
and safety from radiation hazards associated with Atomic Energy Act material.
i J
j 11.
NRC is in a position to gather information on the uses of i
Atomic Energy Act radioactive materials to provide trend and 3-
{i pattern analysis on a national basis and to gauge the effectiveness of the nation's radiation regulatory program pertalaing to Atomic EnerWY Act material.
12.
A regulatory program is not a statistical program of numbers of inspections, numbers og maanama ts, etc.
Its value is to the user-beneficiary:
Bow well is the regulatory program 4
7
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working (on either local or national scale) to assure that the benefits are available with minimal risk to workars, the l
public, and the environment.
l t
13 critaria for determination of compatibility should consider f
balancing flexibility in light of the adequacy of the-j program and other factors, such as the federal leadership, local conditions, State's rights and the protection of i
j public health and safety.
)
1 POLTcY TESUES 1
In section 174 of the Act the terms " cooperation," " orderly i
regulatory pattern," " coordination," and " adequate" appear in the i
text'before the first use of the term " compatible".
E
" compatible" is not defined and where used it is in association with the term
" program."
To achieve an " orderly regulatory pattern" that is -
coordinated and compatible, regulatory programs presumably must:
- 1) Protect the citisans within their jurisdiction, 2) Not. result i
j in any adverse effect on citisans in other jurisdictions and 3) t minimites conflicts between the Federal and State regulatory programs and between States.
I i
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1.
Adquate protection of citisans:
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Protection of citizens must be paramount; presumably, again,
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through whatever means are available to the regulatory agency.
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The radiation control program should assure consistent t
understanding between and ancet l',censees, workers, the public j
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and the @ tory program, to 1>
'en adequate program it must i
meet certalk minin"= natio. 1 r'Autards to protect the public
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health and safety while allowing for a certain degree of
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flexibility in accommodating local needs.
Radiation protection
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standards and assential regulations must be consistent 4
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Changes of safety significance should be implemented i
j when known to the regulatory agency through any offactive j
mechanism available to it; other key requirements and procedures i
should be adopted in a timely fashion.
l 2.
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Assurance that one jurisdiction's actions do not impact the citizens of another jurisdiction:
j Requirements affecting interstate commerce (such as relating to i
packaging, shipping, manufacturing of consumer products, or Work f
to'be performed by out of state companies) should adhere to the i
same basic rules as required nationally and internationally.
s Any i
differences should not interfere with the conduct of trade.
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(More stringent regulatory requirements could preclude certain l
activities and possibly shift the impact to other jurisdictions
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while still enjoying the benefits, e.g.,
forbidding low level waste disposal in the state yet allowing industry that produces j
LIM.)
Nationally, there should be confidence in each others j
licensing actions so that sources and devices approved in one i
State or by NRC can be readily accepted and licensees from one 1
j state or locale can be recognized as acceptable in another state j
or locale without undue delay in re-examining their manufacture, labeling or individual qualifications.
1 It is beneficial for
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j.
l jurisdictions to have the same exempt quantities and exempt i
concentrations to prevent releases occurring in one jurisdiction from impacting another.
However, considerations for flexibility in regulatory approaches should be weighed.
j There should be
!I sufficient communication from one State to another and from each state to the NRC on such matters to allow a reasonable interchange of information and to improve radiation safety nationally.-
1
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Finally, there should be oversight of the ' national' program (NRC i
and Agreement States) to assure consistency and adequacy 4
9 4
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throughout the nation without compromising the need for flexibility in implementation. ~ This oversight must include the j
ability of the NRC to revoke or withdraw Agreement State status for cause.
i 1'
IEEUE 1 - RAEICS l.
What is/are the core elements of a compatible program?
i j
As discussed in SECY-91-039, the Commission has discretion to' l
define compatibility and its scope.
This means that the NRC can review its regulations and practices and categorize them using the State Programs 1984 Internal Procedures categories (or some 3
other categories).
However, NRC has never articulated those factors that should be considered in any new categorization.
I While assuring that a State regulatory program provides for adequate' safety is important, adequate safety will seldon, if.
ever, require verbatim adoption of an NRC regulation or practice.
l Thus, if adequate protection is the only consideration, there j
l vould be no need for any Division 1 rules, because Division 2
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rules, requiring adoption of the same underlying safety principle f
by the States but permitting more stringent regulations, would be f
. sufficient.
Therefore, in identifying factors which lead to l
categorization of Division 1 rules (rules States must adopt
[
essentially verbatim), matters other than direct safety I
significance play the predominant role.
In this regard, the following Policy Factors (from SECY-91-039) can be considered in deciding the degree of uniformity that is necessary or desired.
These Policy Factors were written to bound the range of options; analyzing them out of context should be avoided, since an unintended'hias may be construed.
The purpose of referring to these policy factors is to capture these concepts to assure a well-rounded public discussion prior to drafting a proposed policy on compatibility.
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i 1.
Need to preserve a Federal leadership role because of I
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greater expertise in some areas and need to have a' uniform j
national approach to radiation safety matters.
l 2.
l Need for effective communications between regulatory
- agencies, e.g., uniformity of terminology and technical l
definitions.
4 i
j 3.
Need to avoid burdens on interstate commerce, e.g.,
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uniformity of safety design and labeling of consumer j
products.
i 4.
Need to assure the effective implementation of specific i
Federal initiatives, e.g., recordkeeping in support of a Federal study that is only useful if uniform records are kept.
4 f
5.
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Need to consider NRC r0 sources available to evaluate, i
Agreement state programs and train state staff.
Uniformity j
allows for the use.of standard reviews and requires less NRC u
resources.
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6.
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Need to provide for equal treatment of licensees froc State to state to avoid licensees shopping around for a lenient t
i regulatory program.
I 7.
Need to promote development of competency of Agreement State j
personnel.
8.
Need to amoeurage state innovation and promote the transfar j
of state as well as Federal initiatives.
9.
Need to consider local conditions and needs.
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Need to recognize the States' need to provide an equal level 1
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of protection for all regulated sources of radiation, e.g.,
NORN, NARM, x-ray machines, accelerators.
j 11.
Need to have uniform concepts of acceptable practice to deal
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with public concern as to what is acceptable.
h 12.
Need to preclude variations in State practices that could lead to local safety benefits at the expense of risks elsewhere.
i In the staff summary to sEcY-92-243 it was observed that
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" numerous commenters indicate that ' technical aspects' of j
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programs, such as definitions, terminology, signs, symbols,
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radiation dose limits, reporting requirements, and radiation k
source and device design standards, should be identical.
For example, terminology must be identifiable and symbols need to be
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universally recognized.
Standards, such as annual exposure
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limits, are well understood, because they are based on a wealth j
of' scientific evidence and have been approved by international
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agencies that set standards, such as the International commission
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on Radiation Protection.
Other standards include radiation
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protection practices and procedures, personnel qualifications,
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and personnel dosimetry.
In addition, commenters point out that non-uniformity of standards would confuse the public regarding what is adequate, eroding public confidence and adversely
{-
affacting interstate commerce.
I Uniformity facilitates training and makes such training more cost offactive.
states should not E
- be allower,te vary radiation standards in one area, perhaps 1[
1eading to increased exposure in~another (e.g., decreasing the allowed does to the general public, may result in an increase in i
occupational exposures).*
On the other hand, there is a great desire for state flexibility to a h nte local needs.
i It is a
12 1
}-
l also noted that U.S. DOE standards vary somewhat fron NRC/ Agreement state regulations and worker re-training is required when workers move from a DOE work environment to the r
i NRC/ Agreement state realm and vice versa.
The question,
{
therefore, is what provisions (the core elements) must be essentially the same for the NRC and from state to state?
A.
Uniform National Standards It is generally agreed that some national standards are needed to protect.the health and safety of the people against radiation hazards.
This is specifically true for regulation of Atomic Energy Act material and generally true for NARM and machine-produced radiation.
These " minimum" standards should include uniformity in maximum permissible dosas, levels of radiation, and concentrations of radioactivity, as fixed by Part 20 of the NRC' regulations based on recognized national and international guidance and consensus standa-4s followed by industry and'.
government.
In addition, it is important to strive for uniformity in technical definitions and terminology, particularly as they relate to such things as units of measurement and radiation dose.
It should be understood that certain regulations best serve our collective goals by being identical in language, although modification may be necessary to ancompass radiation sources not regulated by NRC.
Bowever, the question remains as to how much flexibility the states should have to impose additional requirements to protect public health and safety for
" agreement materials" and to provide for more stringent standards wherespeedh1conditionsareineffect.
Should a especific list of required standards be part of the Policy statement or can this list be prepared and updated through ongoing NRC/ Agreement state interaction?
Are only certain provisions of 10 CFR Park 20 to be considered as the basic standard, with the other sections of 13
~
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l I
Part 20 being derived from the basic standard, or is the artire Part 20 to be considered as the " standard"?
B.
Radiation Protection Standards / Regulations f
In addition to the national standards which address f
maximum permissible doses, levels of radiation and concentrations of radioactivity, other state and NRC radiation protection
}
regulations, practices, and implementation procedures should be in agreement with standards / regulations, health and safety i
principles and other guidance published by national and l
international bodies.
The work of organizations such as the NCRP, ICRP, and CRCPD should be consulted wherever possible in order to take advantage of research and deliberations that have taken place.
Can these secondary standards, principles, and guides be expressed as " goals" or " guidelines" rather than j
specific regulations?
i l
C. Interstate Commerce and Reciprocity 4
~
one area where a high degree of uniformity should be considered
{
is in the regulations that affect people and products moving j
across jurisdictional boundaries (this particularly relates to
}
sources manufactured for distribution throughout the U.S. and mobile licensees such as industrial radiographers).
There is
}
i concern that actions-taken in one state or region should not impede trade or create barriers to the procurement of goods and j
services.
Bowever, local needs may still carry great weight and i
the questA5m any be when is there undue interference with i
interstata er international commerce?
~
What provisions are
}
required, and conversely what provisions cannot be changed, to
[
avoid,burdans on interstate commerce e.g., uniformity of safety I
design, labels, signs, and symbols affixed to radioactive 4
d J
i i
l products which are transferred from person to person, and basic terminology.
1 i
some additional requirements may not prove to be an impediment to
- commerce, e.g., the requiring of two person radiography crews, i
provided they do not restrict an otherwise acceptable practice
{
entirely out of existance.
In fact, differences between the j
states may be good in that they make licensees think about the f
radiation safety significance of the difference rather than always doing things by routine.
i 1
j It is generally held'that certain provisions must be adopted, essentially verbatim, because they form the basic language of e
j radiation protection essential for effective communication 1
i i
between regulatory agencies and the regulated community.
f These provisions have been formulated and agreed to by national and -
)
international organizations, from consensus standards followed by I
industry and government.
They include technical definitiqns such j
as " curie," " dose,* and " rad," radiation protection standards such as occupational exposure limits, effluent release limits, j
and legal definitions such as for " byproduct material,"
l
" restricted aread and " occupational dose."
These provisions are i
so basic to the regulatory programs that their modification by a state may result in numerous and difficult pro' lens including
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u interference in interstate commerce.
I 2
E-The question is which provisions must be essentially identical I
from one radiation control program to the next?
D.
Improved Public Realth and safety j
There maybe instances when a new regulation is so important for j
the protection of public hamith and safety that it should be t
15 a'
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3, t
g adopted immediately nationwide.
Early and substantial involvement of the states in the NRC regulatory process is imperative when health and safety are at stake.
In addition, NRC i
could solicit state suggestions for alternative approaches and l
then conduct research to determine whether a suggested
{
alternative approach is effective as a substitute for the j
regulation or as temporary measure until regulations can be i
modified by the state.
The states could also build into their f
regulatory mechanism a procedure that will allow them to adopt'a new regulation, essentially verbatim, whenever such a regulation
)
will lead to a significant improvement in the protection of j
public health and safety.
Although most states do have a j
procedure for the emergency adoption of regulations, there is j
usually a sunset provision that takes effect within a short i
period of time after the emergency promulgation unless the t
administrative procedures act has been followed for the normal -
{
promulgation of regulations.
It would improve the protection of l
- public health and safety if the states were able to have a, j
mechanism for the automatic adoption of a regulation that makes demonstrable improvement in the protection of public health and j
safety.
?
E. Adoption Time Frame i.
l t
The states, with few exceptions, indicated that three years i
i should be enough time to adopt compatibility requirements.
}
However, some instances were identified where more time may be t
necessary.
Some States indicated that difficulties tend to be i
tied to inadequate funding and staffing.
For State Radiation Control staffs that are small and already strained, very little j
time is available from their regular duties for drafting j
regulations.
l Also, for those rare instances where there is a
.need for involvement of the State legislature, three years may be i
16 i
i i
j.
l l.
j difficult for states whose legislature only meets every two years.
1 Another problem star
. rom situations where certain regulations pertain to areas that are sometimes outside of the direct control of the State Radiation Control Program Director, thus delays may exceed the three-year time period.
Furthermore, " agreement materials" control is only part of the states' radiation control j
program and some states expressed the view that it is more
{
efficient to revise the States' radiation control regulations
{
completely'rather than in a piecessal fashion within the three-j year timeframe.
I f
The three-year interval has been based on what the States, generally, have been able to meet.
Over the years the process by 1
{
which states adopt regulations has undergone significant change.
some States are now required to go through a much more detailed process to amend their regulations.
state management, their l
legal counsels and other non-radiation control staff are taking a
{
more active role in reviewing proposed changes to state regulations.
In many instances they look for their radiation control program to operate under the same policies and procedures i
as other public health and safety programs, such as hazardous I
materials.
As a result, the process has become much more complex 2
and a number of Statas have found it difficult to meet the three-year requirement.
Alternatives to codifying new regulations in less than three years should be addressed beginning with the early and
{
substantial State involvement in the regulatory process, including changes to regulatory guidas, standards, procedures, i
etc.
This assures opportunity for timely input and allows the i
state tc work on their own unique solutions simultaneously.
j, r
i 17 l
4 j;
_..,. _.~._._ _ _..- _._ _ ___. _ ____.._.._._._._.. _._... ___.
l Implementing appropriate regulatory changes could be by any, mechanism that works for the state.
There should be recognition of the economic impact of regulation changes especially when the l
state has few or no licensees that may be impacted.
While regulation changes should be encouraged for ease of comparison j
from state to state, any method, such as license condition, agency issued order, or some other unique approach may be acceptable provided the citizens are adequately protected.
Any concerns of safety significance could be addressed within one year of notification while changes required in regulations, such as for meeting minimum national standards, should be accomplished l
within three years of the publication date of the final NRC regulation.
Getting states up to speed with current regulation development is addressed under Issue 4 - Implementation.
1 e
i If a time based implementation requirement is necessary, use of
}
the publication date should be considered for the " starting point" since the final text of the rule is then known.
- However,
}
it may be necessary to consider allowing states the same delay in j
the affactive date of the regulation.
This would allow State j
licensees the same " grace" period as allowed NRC licensees.
The j
effective date of the regulation may also be given greater weight since protecting the public health and safety should be the focus j
of the rule and implementation is the key.
1,.
i j
F. Scope of Policy i
i The last issue under the " basics" is "how far does one go in j
. seeking to show that the core elements of radiation control j
programs are compatible?"
sections 274d. (2) and 274g. are the
)
only sections of the Act that address the concept of
)
compatibility.
It should be noted that both sections refer to i
the compatibility of " programs."
section 274d. states that "The 4
J 4
18 j.-
e.
i j
Commission shall enter into an agreement under subsection b.
of
}
this section with any State if...the Commission finds that the i
State ggggEa3 is compatible with the Commission's program for the regulation of such materials..." (Emphasis added.)
The use of j
the word " program
- rather than " regulation" indicates that the i
concept of compatibility was meant to apply to aspects of.a I
j radiation control program other than just the regulations.
This might include the technical aspects of 1icensing actions and the
~
4 j
state's compliance program.
As examples, this could apply to j
criteria for approving certain licensed activities as detailed in j
NRC licensing. guides or to such areas as the inspection priority
)-
system.
It could also be interpreted to include administrative matters such as staffing level and budget.
Also, the "whole l
program" approach allows agency to impose requirements by order, I
license c:ondition or other method rather than be restricted to regulations.
1 3
j since the earliest days of the state Agreements Program the j
Commission has used the term " compatibility" in the review l_
guidelinas in relation to not only regulations, but also to such program areas as licensing and compliance.
However, in recent practice only regulations have been considered as matters of compatibility during periodic reviews.
r i
The question is how much of the state's program:
regulations j
only, regulations plus certain program elements such as licensing i-and compliance, or the entire state program, should be reviewed l
by NRC and considered in determining " compatibility" with its i
national program?
l m
{
Tasur' 2 - prmrvart.ver j;
What degree of flexibility should be afforded the Agreement
' states in carrying out their programs?
i 3
I s
2 19 7
I I
d i-
- _ - -... - _ _ _ _.. ~. - _... -. -, - - _ _..
l l'
}
j Agreement states, in addition to assuming regulatory authority-l over agreement materials, have the responsibility for ensuring l-public health and safety from ionizing radiation from such non-l agreement sources as NARN (naturally-occurring and accelerator-
)
i produced radioactive materials) and machine-produced radiation.
In some cases, regulation of non-ionizing radiation is also a
)-
mandated function.
Such responsibility compounds the regulatory j
scheme for states since, in principle, all sources of radiation i
need to be regulated in an equivalent manner.
The ability to implement within'the confines of applicable law more complex j
radiation control programs requires a great deal of flexibility.
j Judgements regarding the performance of a regulatory program need to be both qualitative and quantitative.
i 4
j i'he term aflexibility" as used in this document means the ability i
)
of any agreement jurisdiction to have a regulatory program which is able to address sources of radiation other than agreement materials, as~well as local circumstances or concerns wittiin the i
j limits prescribed by federal, state or local law.
Flexibility allows for innovations in regulatory program development.
For the purposes of this discussion, a regulatory program can be divided broadly into two areas: regulations and other non-regulation policies, procedures, etc.
l j
A. Regulations I
i From a practical perspective, only if there is a need to regulate a particular activity, should regulations be required.
For example, states that will never host a low level radioactive j
waste disposal facility do not need to have regulations equivalent to 10 CFR Part 51.
Likewise, an agency which legally l
does not have authority over a particular activity, as is the l
case in New York State where several agencies implement the e.
e 20 2.
I i
i 4
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agreement, do not need to address that activity in regulations.
Further, circumstances where only one or two licensees will be l
engaged in an activity should be considered for regulation by
{
means other than formal rules.
This can be judged on a case-by-
}
}
case basis taking into account such factors as adequacy of
{
protection of public health and safety, extent of the activity in scope and time and available resources.
B. Non-regulation aspects
. However,- it must be recognized that different jurisdictions have
{
differing needs and responsibilities with respect to the j
j regulated community served, demographics, location, geography and so forth.
To a greater or lesser degree such factors will i
influence the regulatory approach taken and to achieve effective l
regulation, such factors must be integrated into the agency's -
i programs.
A potential avenue to accommodate this required j
flexibility is through policies and procedures which are,not formal rules.
These may govern such aspects of the program as i
licensing procedures, inspection frequency, enforcement actions, fees, or areas which have been addressed in regulation by NRC, l
but were not deemed " matters of compatibility" at either the
{.
Division 1 or 2 level under NRC Procedure 3.7.
i i
Given that basic standards equivalent to those of NRC have been
. promulgated by States, other guidance and policies will be bound by applicable regulation and law.
Bence, this principle will I
guide the latitude of flexibility allowed.
But within the l
confines of applicable law, consideration should be given to l
. allow the segulatory agency freedom to implement its programa in the way it deems best and appropriate to protect public health
{
and safety; however, this must be balanced against other factors, j
'such as the effects on interstate commerce, effective i
i-21 Ie f
i-1 1
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l 3
A i
J communications between regulatory. bodies, and uniform j.
recordkeeping.
l l
TEEUE 3 - CC. ;JTiicATION i
what licensee-regulator interactions should be shared through i
j communications in order to build a reliable data base for
{
evaluating the Agreement State and NRC radiation protection programs for source, byproduct,.and less than critical quantities j
1 s
j
'A.
Communication Between Regulators l
Agreement states and the NRC maintain independent regulatory i
programs.
While there is a degree of autonomy required for the J
management of an independent program, these programs need to f
maintain open communications among each other to assure that their constituencies are receiving equivalent treatment.,.Since the institution of the Agreement States Program, State regulators
(
have obtained increased experience with Atomic Energy Act materials and have gained additional experiences through
{
regulations 9f NMtN and machine-produced sources of ionizing j
radiation.
The resultant asturing of State regulatory programs highlights the need for effective sharing of experience between
{
State and Federal regulators.
This sharing of experience could i
be at the levels of both the management and the technical staff.
A forum for senior Agreement State and NRC officials could focus
}
on consunication, strategic planning, priority setting, and on improving esoadination and cooperation in enforcement, while
}
technical ' staff would address innovative approaches they have
[
used or problems they foresee in licensing and inspecting users i
of radioactive materials.
i a
22 i
Agreement State staffs and their NRC counterparts have increasingly used topical workishops to discuss solutions to common problems encountered in the regulation of radioactive materials.
These workshops have supplemented the annual All Agreement States Meeting and the more routine interaction and consunications with regional and headquarters State Programs staff.
These workshops, meetings and All Agreement States letters have been the principal means of communication for NRC and the Agreement States.
There are a number,of opportunities to improve the nature and amount of information moving between the NRC and the Agreement States.
One is in the analysis of radiation-related events and incidents for early trends on the performance of individuals and equipment.
Regulators should be aware of both poorly performing individuals and devices.
This could include common standards for device evaluations, common reporting requirements for malfunctions and defects and a registry of individuals cited for significant wrongdoing.
B.
'NRC and Agreement States share " Good News" l
NRC reviewers or States could identify State regulatory activities that are considered improvements in the program and l
disseminate that information to other states and NRC.Innovation is then recognized and put into use.
Instm 4 - Tuor--;-1Aerow How shou NRC involve the Agreement States in the rulemaking process t#)eovide for meaningful early and substantive interaction?
Bow should a new policy on ocupatibility be implemented?
How should the performance of radiation control L
23 L
l-j
-.. _ -..,. _......., _ -, _ _ ~... _... _ _ _ _ _ _ _ _ _ _ _ _. _ _ _ _,.. _ _.... _ _ _.... _...
i 1
4 i
i programs be measured to see where improvements in real performance (protecting citizens) are needed?
l The NRC is mandated in $274 (j) to periodically review agreements i
and actions taken by states under the agreements to ensure compliance with the provisions of $274 of the Act.
It can be 3
argued that during periodic reviews formal regulations should be j
judged for equivalence of results (i.e. Do they achieve the same j
goal as NRC's regulations, although not necessarily with j
identical languaga?) and the remainder of the prograa judged to f
be adequate to protect health and safsty.
It can be safely 1
j assumed that if these two criteria are met, then the program will j
be adequate to protect health and safety and compatible with j
those of the NRC.
There could.be greater flexibility in the way j
the NRC reviews state programs, taking into account the wide j
variations in state programs and problems, and state efforts to j
be innovative and creative about problem resolution.
I 4
r i
Agreement states' technical expertise and closer interaction with licensees could be used in a teamwork approach along with the NRC in developing new initiatives.
Teams of managers and staff from many regulatcry programs could work together to address the issues.in a holistic fashion.
2 4
The importance of quality staff should also be emphasized.
l Basic qualifications and on-going training are important in assuring that the performance of the radiation control program is adequate to protect the public.
Certification of staff coul,d be achieved j
through thy reviews now done by the NRC during program reviews or through a M formal training, testing, and certification program.
Bowever, rigorous staff qualification requirements could be problematic, especially if personnel rules or union contract provisions conflict with the certification concept.
j-24 l
1 I
__..._,.,,,._..__._...._..,_-.___...._m,,._..
...m
l o
i 1-A.)
Early and substantive input on rulemaking j
The present practice of Agreement State involvement in rulemaking j
through workshops and public meetings is on-going.
Consideration
}
should also be given to Agreement state early involvement in NRC policy and practices.
The first step, however, is problem j
identification.
(See also Issue 3 - Communication) Once a j
problem is identified it should be announced so others may j
contribute to possible solutions.
This could be OSP, AEOD or the regions or Agreement States discovering and/or defining a t
problem.
Someone would then take the lead in developing potential solutions (not limited to regulations).
Details should be presented before asking for any decisions, even on policy or j
' general direction'.
This is because seeringly minor word changes can totally change the meaning of the material in
{
question.
An initial determination that a regulation may be a.
)
" matter of compatibility" will help focus attention on the rule, recognizing that the final decision by the commission on,the j
level of compatibility will not be determined until the rule is
[
final.
Closer, more substantive interaction with Agreement j
states could also be accomplished by establishing an Agreement i
State Advisory Committee, formally constituted under the Federal j
Advisory Committee Act.
There are various issues on this subject j
that need to be discussed particularly addressing as to whether f
such an arrangement would inhibit the frequent communications j
between NRC and the Agreement States that are necessary to l-fulfill the expectations of the " partnership."
i It is alse[important to consider the issue of whether Agreement State and y licensees are being provided with equal
[
opportunities for fair and effective input into the rulemaking process.
It was brought up that Agreement state licensees do not j
learn about proposed regulations until the Agreement State begins 1
4 e
25 I
i 4
l l
l the process to adopt the regula. tion, which in many instances is a
).
" matter of compatibility" and not subject to change through l'
licensee input.
Therefore, for Agreement State licensees to have f
an effective and fair opportunity to consider regulations which i
vill eventually be imposed on them, they should be made aware of 4
i the proposed regulation at least at the same time and in the same manner as NRC licensees.
B.
Transition i
-How should the new policy on compatibility be
]
implemented?
over what time period?
4j
--How should new regulations (ready to be published in j
final) and regulations in progress be handled?
j
--Impact on states actively pursuing an agreement with e
respect to implementation of the 1981 Commission policy statement as amended.
--Need to update State Programs Internal Procedure B.7 1
-Need to review new regulations adopted since R.7 was
{
formulated in 1984 C.
What_ standing, if any, should the CRCPD - Suggested State i
Regulations for the Control of Radiation have in compatibility l..
determination?
D.
Program Review Areas Affected by the scope of the Policy i
j 1
The following Agreement State program review areas are l
identified where the degree ~of uniformity needs to be specifically addressed in implementing the policy.
1.
Basic radiation protection standards.
These are stamameds which have been developed and endorsed by national and international standards setting bodies such as NCRP, ICRP and IAE.
These standards include, but are not necessarily limited to, the occupational (and in the new Part 20, general public) dose limit in 10 CFR Part 20, as 26 i'
~
j.
l l
1 3
well as the maximum permissible concentration 3a effluents.
i i
2.
Important dafinitions.
This would include terms such as dose j
radiation are,acurie, radiation area, high etc, that are necessary for the t
i effective commu,nication between radiation control l
personnel.
{
This would also include radiation signs, radiation symbols, etc.
3.
i l
Radiation protection principles.
These would
)
j include those requirements in 10 CTR Part 20 that address fundamental health physics practice j
as AIARA, requirements for radiation surveys,,such and personnel monitoring.
These areas, although not i'
necessarily established standards by standards j
setting bodies, are well established principles, l
acknowledged by experts in the fields of health physics as being part of any adequate radiation i
protection program.
These are typically not j
numerical values, so that evaluation for 1
uniformity is somewhat more ditficult.
4.
4 Indirect or emeondary radiation protection i
standards.
Some NRC regulations have indirect i
standards that are based on basic radiation j
protection standards.
Examples are the limits on the transportation of radioactive materials.
5.
j Licensina policy and procedures.
This is a broad
(
category that encompass the decisions on how j
radioactive materials in regulated through the licensing process.
This would include policy on j
licensing fees, exemptions, general licensing, and the criteria used for evaluating the training and
{
experience of users, the equipment and facilities
{
for using radioactive materials, and the i
procedures followed.
i 6.
connliance policy and procedures.
This is a broad j
L category including inspection practices, i-enforcement options inspections priorities, etc.
[
This concerns issues, such as the consistencies of civil penalties applied by the A j
and NRC for the same violation. greement States 7.
Information requirements.
There are many requirements such as, for example, reports of 4
1 4.-
27 I
1
-~
i incidents, overexposure, loss of material, etc..
that are for information gathering purposes.
l ISSUE 5 - REVOCATION t
i What are the legal, policy, health and safety bases for reasserting NRC authority in an Agreement state?
l
[
Section 274j(1) of the Atomic Energy Act of 1954, as amended, i
provides the basis for termination or suspension of an agreesent, or part of an agreement, with a state, either at the request of the Governor or upon the initiative of the NRC, under certain circumstances:
I.
I J
(1) The commission, upon its own initiative after i
reasonable notice and opportunity for hearing to the i
state with which an agreement under subsection b. has become effective, or upon request of the Governor of j
such state, may terminate or suspend all or part of its agreement with the State and reassert the licensing and
]
regulatory authority vested in it under this Act, if j
the commission finds that (1) such terminatian er j
yspension is raeruired to nroten t the public health and i
safety, or (2) the State has not c=-4-lied with one or i
~
~
more or the requirements or this section.
The i
0 - asion snan periodically review sucE agreements and actions taken by the States under the agreements to j
insure compliance with the provisions of this section.
The commission has not formulated formal written criteria or 4
procedures to implement these provisions.
Neither has the commission h commenced action on it's own initiative to terminatedesuspendallorpartofanagreementundersection i
274 j (1).
Bowever the Commission has reasserted its regulatory authority at the request of the Governor over all or part of an 28 i
5 e
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_n,~,.,,n
-,,,.,nnw w,,w-.nw.
n.,
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i agreement in several instances., The transfer of regulatory l
authority was handled smoothly in each case.
i The necessity for NRC to terminate or suspend an agreement on its i
own initiative has never arisen, in part because the Commission has relied on the many forms of interaction and cooperation with i
the Agreement states to provide early notice and resolution of any problems developing with a state program.
In accordance with the last sentence of.section 274j (1), the Commission conducts formal reviews of each State's regulatory program every two years and an informal-visit in the alternate years when there is no formal review.
The Commission makes a determination of "adequa,cy to protect the public health and safety" and " compatibility" regarding each Agreement State program.
Agreement state Programs have been evaluated based on the policy statement 'NRC Review of Agreement State Radiation control Programs, last amended and published at 57 FR 22495 (1992).
The i
program review indicators identified in this policy statement are divided into Category I -Direct Searing on Realth and safety and i
category II - Essential Technical and administrative support.
The appliestion of the findings of a review and the determination of ade M to protect the public health and safsty to the termination or suspension of an agreement is discussed as follows in the policy statements l
l i
29 u
~..,
l l
In reporting findings to state management, the NRC will indicate the category of,each comment made.
If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety and is compatible with the NRC's program.
If one or more significant Category I comments are provided, the state will be notified that the program deficiencies may seriously affect the public health and safety and that the need for improvement in a particular program is critical.
The NRC would request an immediate response.
If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, the staff may offer findings of adequacy and compatibility as appropriate or defer such offering i
until the state's actions are examined and their effectiveness confirmed in a subsequent review.
If I
additional information is needed to evaluate the state's actions, the staff may request the information through follow-up correspondence or perform a follow-up or special, limited review.
NRC staff may hold a j
special meeting with appropriate state representatives.
No significant items will be left unresolved over a M 1ongen - iod.
If the state p h am coes not
~
j improve or if additional significant Category I deficiencies have developed, a staff finding that the i
program is not adequate will be considered and the NRC may institute proceedings to suspend or revoke all or i
part of the Agreement in accordance with section 274j of the Act.
The compatibility of the state's regulations with the NRC program is also considered in the review under the policy statement l
procedures:
l The NRC feels that it is i enant to strive for a high degree _of uniformity in technical definitions and logy, particularly as related to units of and radiation does.
Maximum permissible doses abd levels of radiation and concentrations of radioactivity in unrestricted areas as specified in 10
.CFR part 20 are considered tc be important enough to require states to be essentially equivalent in this area in order to protect public health and safety.
l 30 l
1
o Cartain procedures, such as those involving the licensing of products containing radioactive material intended for interstate commerce, also require a high degree of uniformity.
If no serious performance problems are found in an Agreement State program and if its standards and progran proceduras are compatible with the NRC program, a finding of adequacy and compatibility is made.
The second criterion in section 274j (1) for termination or suspension of all or a part of a state agreement is "the state has not complied with one or more of the requirements of this section" (section 274).
The NRC legal interpretation of that section concludes that sections 274d(2) and 274g encompass a continuing requirement for an Agreement state program to remain compatible with the NRC regulatory program.
Therefore a finding that an Agreement state program is not compatible could theoretically serve as cause to terminate or suspend an agreement j
under 274j (1).
As stated earlier, the Commission has never commenced any action on its own initiative under section 274j.
i j
i several Agreement states disagree with NRC's legal interpretation, holding instead that " compatibility" relates to j
the initial status of the Agreement state regulatory program and
{
that, once an agreement is signed, compatibility takaa on the j
nature of a goal towards which the Agreement state pledges its
{
i "best effeg8ts'.
i 4
31
!I i
i l
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,b. '
1'
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Under section 274j(2) the commission also has authority to j
temporarily suspend all or a part of an agreement under certain circumstances:
1 (2) The Commission, upon its own motion, or upon i
request of the Governor of any State, nay, after i
notifying the Governor, temporarily suspend all or part i
of its agreement with the state without notice or j
hearing if, in the judgment of the cosaission:
1 (A) an emergency situation exists with respect to f
any material covered by such an agreement creating
{
danger which requires immediate action to protect j
the public health and safety of persons either within or outside of the state, and (S) the state has failed to take steps necessary I
to contain or eliminate the cause of the danger within a reasonable time after the situation
{
arose.
1 Although there is no Commission policy statement or set of procedural rules' interpreting this provision, the office of state 1.
Programs has an internal procedure, D.13 Guidelines for Temporary suspension of a section 274b Agreement, which sets forth some criteria for applying the emergency temporary suspension i
t described ih section 274j(2).
As stated within the procedure, the authority to tosporarily suspend an agreement would be invoked only in a very unusual emergency situation resulting in i
I i
exposures or releases greater than a stated magnitude, after 1
- $ 1 1
levels are (1) Exposure of the whole body of any indi to 25 reas or more of radiation; exposure of the i
skin of the abole body of any individual to 150 rams or more of radiation; or exposure of the feet, ankles, hands or forearms of j
any individual to 375 reas or more of radiation; or equivalent exposures from internal sources; or (2) The release of J
q 32 i
considering the adequacy of the actions taken by the State, the urgency of temporarily supplemer. ting the state's capability, and the timeliness of the state's response.
The state would he kept fully informed of NRC actions and would be promptly informed that the temporary suspension is no longer in effect when the conditions which initiated the suspension no longer exist.
l l
l l
1 l
["
L radioacti b terial to an unrestricted area in concentrations which, if everaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, would exceed 5,000 times the limits specified for such antarials in Appendix B, Table II of 10 CFR Part 20.
33 i-l l
'i February 12, 1991 (Information)
SECY-91-039 For:
The Commissioners From:
Harold R. Denton Director Office of Governm, ental and Public Affairs
Subject:
EVALUATION OF AGREEMENT STATE COMPATIBILITY ISSUES
Purpose:
The purpose of this paper is to present to the Commission the results of the interoffice task force evaluation on the compatibility of Agreement State Programs.
Sunnary:
The attached evaluation of the Compatibility Task Force is in response to Staff Requirements Mescrandum (SRM), " Collegial Discussion of Items of Commissioner Interest,' (M900816A) dated October 5,1990. This evaluation provides the Cosmission with a review of the compatibility of Agreement State Programs as requested in the SRM. It discusses factors which can be used in developing a policy on compatibility, as well as,-
program areas which would be affected by the scope of the polig.
Yarious options are derived from the factors to illustrate how the weighing of the factors could affect a resultig< BRCpolig, a poll y which would ispect on the current issues o Pennsylvania a,pplication for a LLW Limited Agreement.the Background-, The 'compatibili of Agreement State regulatory programs with the NRC has n the center of many polig discussions recently. Conce3s on compatibility have been raised repeatedly by Agreement State personnel. The issue of
,.~
Agreement State cagatibility was also raised in the context of the apeng's Below Regulatory Concern (BRC) polin when the Office of General Counsel (0GC) performed an analysis of the Cassission's lega1
Contact:
S. Schwartz, GPA 49-21771 Q..L o M 0 1. 5 e
m__
The Commissioners 2-9 authority under the compatibility standard in section 274 of the Atomic Energy Act. Most recently, questions on compatibility of a State's regulatory program was raised in the review of the Pennsylvania draft proposal for &
Limited Agreement with the NRC to regulate low-level waste disposal.
In Staff Requirements Memorandum (SRM) dated October 5,1990,
~
the Commission directed the formation of an interoffice group to evaluate the compatibility issue. As a result of this directive, the Compatibility Task Force (CTF) was formed. The CTF consists of representatives from the Office of Governmental and Public Affairs (GPA), Office of the General Counsel (OGC), and the Office of Nuclear Material Safety & Safeguards (MSS). The primary focus of CTF was to stuqy past compatibility practices and to provide policy reconsnendations and options for Commission consideration.
In addition, staff was requested to provide answers to the following questions:
What is the legal basis for compatibility a.
determinations? What is the relationship between compatibility determinations and protection of the public health and safety?
b.
Are these determinations limited to State statutes and regulations only, or do they also include other aspects such as programs staffing, and policies?
What is NRC's basis for r,equiring States to adopt compatible regulations within a three-year timeframe?
How often does NRC review State regulations after the c.
Commission enters into an Agreement with a State to ensure continued compatibility of the program?
d.
If M C determines that a State Program is not
. compatible with NRC's program for sistlar materials.
T.': -
i what options does the Commission have to encourage D; -
. ?*
and/or require compatibility?
In light of the answers to the above questions, r-e.
should the Internal Procedure B.7 be revised or modified? Should these procedures be published for review and comment by 5tates and members of the public?, Should the existing categorization of NRC requirements be reevaluated?
9 O
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l The Commissioners i i
1 f.
Discuss the various arguments, pro and con, related to the question whether the Low-Level Radioactive i
i Waste polic;y Amendments Act of Ig85 and its j
that Agreement States are to be given a greater legislative history provide a basis for concluding degree of latitude in fashioning their own standards i-forlow-levelwaste(LLW) disposal,inviewofthe i
States' increased responsibility in this area?
The T6sk Force addressed the questions raised by the Commission in their evaluation and provided the following conclusions, recommendations, and options for Commission j
consideration.
==
Conclusion:==
The Agreement States have natured over the years, as i
evidenced by their increased competence and the expanded f
scope of their programs. The NRC and the States have i-worked well together as regulatory partners, protecting j'
the pubite health and safety from radiological hazards.
{
From the Review of the Legislative History 1
1.
Ry adding Section 274 to' the Atomic Energy Act' in Ig5g, Congress gave the States a role in the regulation of nuclear materials consistent with j.
their traditional role in the area of public 4-health and safety.
a 2.
The legislative history of Section 274 makes it i
clear that uniformity between the Federal program for regulating nuclear materials and the 4
i proposed State I,rograms was a prime consideration.
This led to the-adoption of the language requiring 4
j
~
Commission's program. However, in practice, the that proposed State programs be " compatible" with the i
~ Commission has never insisted upon strict uniformity. -
i 4
Neither the Atomic Energy Act nor the legislative il, ;3.
history of Section 274 provides a priscriptive t
definition of compatibility. Therefore, the task force believes that the Commission can define compatibility by taking into account all relevant factors.
From the Review of past Commi5sion Action,and Decisions 4
1.
-In 1961, the Commission first published its criteria for States to enter into 274b. agreements. That criteria required uniformity of radiation standards, l
I i
l i.
- I-The Commissioners l i
with emphasis on technical' definitions and terminology, j
maximum permissible doses, levels of radiation and i
concentrations of radioactivity, labels, signs and symbols'. This action affimed the Commission's theoretical authority to establish requirements for uniformity by Agreement States.
2.
In 1962, the Commission develoMrd standard language for each formal agreement whth would commit the States as well as the Commiissi.,n, to put forth their besteffortsinmaintainingcompatibleprograms.
This action affirmed the Commission's commitment to working with States cooperatively in the development of radiation standards.
3.
In 1962, the Commission instituted a program of conducting sectings with state personnel to promote compatibility.
In these periodic appraisals, the staff had not distinguished between compatibility and adequay to protect public health and safety.
4.
In 1965, the Commission initiated annual redeterminations of cospatibility which included adequacy determinations, as a consequence of the Walsh-Healy Act.
5.
In 1981, the Commission established a polig of making separate compatibility and adequacy determinations in the review of State radiation control programs.
6.
The Commission has, on a number of occasions, allowed Agreement States to adopt standards or program procedures both more and less restrictive
~
than Commission standards. See section II of the evaluation for specific cases.
- e. J 7.
In general, development of compatibility criteria and w
categorization of NRC regulations have been made by 5., f the Commission or the staff without State involvement.
8.
The Commission has, on a number of occasions, seemed
-f to require a high degree of uniformity from Agreement States.
For example the Commission has required Stateswithlow-levelmastesitingregulationsto adopt essentially vert >atin the performance objectives of 10 CFR part $1.
9.
The Commission has benefitted frasi Agreement State regulatory fenovation. The State of California devised the group medical licensing concept. The
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1 The Commissioners l 4
States, through the CRCPD, developed regulations for wireline service operations which became the model j
for 10 CFR Part 39. The State of Texas develo j
radiograpV testing and certification program. ped a i
i
- 10. The issue of Agreement State compatibility has evolved over the history of the Agreement State j
program and the criteria for compatibility i
determinations have changed in the process. There i
are a number of significant issues coming up, such as BRC, part 20, decommissioning, which suggest that i
this is an opportune time to establish a clear and
]
sound polig on compatibility.
~
Policy Recommendation i
and Options:
In developing a Comission policy on compatibility, the Task Force recommended that the following two j
areas be considered: Policy Factors and the Program 3
Review Areas.
i
{
Policy Factors i
{
The Commission has discretion to define compatibility and a
its scope. This means that the NRC can review its
{
regulations and practices ~and categorize them using the 5 tate Programs 1984 Internal Procedures categories (or some other categaHes). however, NRC has never articulated those factors that should be considered in any j
new categorfration.
Whila assuring that a State i
regulatory program provides for adequate safety is important, adequate safety will seldom, if ever, require i
verbatim adoption of an NRC regulation or practice. Thus, if adequate protection is the only consideration there would be no need for arty Division I rules, becaus,e j
.. Division 2 rules, requiring adoption of the same underlying safety principle by the States but permitting
'-p:
i more strin
,' Therefore, gent regulations would be sufficient.
i in identifying factors which lead to i
categorization of Division I rules (rules Statps must adoptessentiallyverbatim),mattersotherthandirect safety significance pity the predominant role. In this j
i regard, we offer the following Policy Factors to be 1
considered in deciding the degree of uniformity that is necessary or desired.
1.
Need to preserve a Federal leadership rolk because of greater expertise in some areas and need to have a j
. uniform national approach to radiation safety matters.
g e
L.
I
~
The Commissioners ;
1 2.
Need for effective comununications between i
regulatory agencies, e.g., uniformity of I
L terminology and technical definitions.
i i
3.
Need to avoid burdens on interstate comunerce e.g., uniformity of safety design and labeling of consumer products.
4 l
Need to assure the effective implementation of -
4.
specific Federal initiatives, e.g., recordkeeping in support of a Federal stu@ that is only useful if uniform records are kept.
4 5.
Need to consider NP.C resources available to i
evaluate Agreement State programs and train State staff. Uniformity allows for the use of j
standard reviews and requires less NRC resources, i'
6.
Need to provide for equal treatment of licensees i
from State to State to avoid licensees shopping j
around for a lenient regulatory program.
7.
Need to promote development of competency of j
Agreement State personnel.
4' l
8.
Need to encourage State innovation and prorote i
the transfer of State as well as Federal initiatives.
4 i.
j 9.
Need to consider local conditions and needs.
1 3
- 10. Need to recognize the States' need to rovide an equallevelofprotectionforallregu$ated j
sources of radiation, e.g. NORM, MARM, x-ray machines, accelerators.
1
^
j h.. 11.
Need to have uniform concepts of acceptable practice to deal with public concern as to what is acceptable.
i
. d, 12.' Need to preclude variations in State practicas that could lead to local benefits' at the expense of risks
./
r elsewhere.
~
Program Review Areas Affected by the Scs-5 of i
the Pol 1CY There are a immber of Agreement State program review areas that would be i cted by a Commission po. icy on compatibility.
Task Force identified the following
.. areas where the degree of uniformity needs to be specifically addressed in implementing the policy.
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The Commissioners l l
1.
Basic radiation trotection standards. These are standsrds which m ye been developed and endorsed by national and international standards setting bodies such as NCRP, ICRP and IAEA. These
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standards include, but are not necessarily 1
limited to, the occupational (and in the new l
Part 20, general public) dose limits in 10 CFR part 20, as well as the maximum permissible concentrations in effluents.
2.
Important definitions. This would include terms such j
as dose, curte, radiation area, high radiation area, i
etc that are necessary for the effective communication between radiation control personnel. This would also j
include radiation signs, radiation sym6ols, etc.
J 3.
Radiation protection princi >1es. These would include j
those requirements in 10 CF t Part 20 that address t
fundamental health physics practices such as ALARA, requirements for radiation surveys, a,nd persor.nel j
monitoring. These areas, although not necessarily i
i established standards by standards setting bodies, i
are well mstabitshed principles, acknowledged by experts in the field of health physics as bein of any adequate radiation protection program. g part j
These are typically not numerical values so that evaluation j
for uniformity is somewhat more difficult.
2 4.
Indirect radiation protection standards. NRC regulations currently have many Indirect standards that are based on the basic standards. Examples are 4
j
. the limits on the transpot tation of radioactive material.
f 5.
Licensine poli g and procedures. This is a broad category that encompassing the decisions on how i-radioactive material is regulated through the licensing process. This would include policy on licensing fees exemptions, general licensing, and 4
w.
the criteria us,ed for evaluating the training and experience of users, the equipment and facilities for
- using radioactive material, and the procedures
.. followed.
4 6.
Compliance polig and procedures. This is a broad category including inspection practices ~, enforcement options, inspection priorities, etc. This concerns issues such as the consistency of civil penalties i
applied by the Agreement States and NRC for the same violation.
i j
}
4 j
f The Commissioners -
4 l
7.
Information requirements. There are many requirements such as, for example reports of incidents,
{
overexposures, loss o,f material, etc. that are for i-information gathering purposes.
i In reviewing the Polic Areas described above,y Factors and the Program Review a number of policy options could be developed. The Task Force identified the following possible options as examples that could be selected by i
the Commission.
I s
Option 1 - A policy emphasizing the need to preserve a L
Federal leadership role effective coemunications between regulatory agencies, avo,id burdens on interstate i
commerce, assure the effective isplementation of specific Federal initiatives j
equaltreatmentoflicensees. conserve NRC resources, and provide In this case, regulations i
such as Part 20, those regarding ifcensing activities (includingallmedicallicensingprovisions), low-level i
waste requirements, and arty new regulations implemented j
as a result of the NRC's BRC policy, would be matters of strict cospatibility.. Furthermore, when evaluating other t.
program areas as part of the Commission's Agreement' State of uniformity in ifcensing procedures, the State srev compliance program, etc.
<~
{
Option 2 - A policy es6 racing most of the Policy Factors 1.
j In option I plus the need to encourage State innovation, promote the transfer of State as well as Federal initiatives and consider local conditions and needs.
This policy would be similar to the program currently in place where certain standards would be required to be j
essentially identical to NRC's but flexibility would be granted in certain areas allowing for State innovation.
t
, $ome regulations such as the basic limits of Part 20 would i
G.,.. still require a high degree of uniformity, howe i
i requirements, and areas such as BRC, LLW, etc. would be I
dealt with on a case-by-case basis.
3 Option 3 - A policy of which would recognize a limited area where uniformity was needed to advance specific Federal initiatives but which would otherwise encourage i
State innovatica, consider local conditions and needs, and 4,
recognize the States' need to provide an equal level of
' protection for all regulated sources of radiation.
The balance of the State 3rogram would be evaluated for adequacy to protect tte public health and safety.
In addition, the Task Force noted that:
I.
i i
The Commissioners 9-i A.
Once the Comnission establishes a poli g, the 4
staff will need to develop a program to implement the polig. This program could i
involve modificttion of the criteria for States
)
i entering into agreement, the guidelines for 4
evaluation of State programs, and the current categorization of rules as detailed in the staff's internal procedures for compatibility-determinations..
1.
- 3. -
The states have expressed the desire to i
participate in the Commission's deliberations i
on compatibility from two perspectives.
1 (1) The States wish to have their views j
considered in the development of the i
Commission's criteria and polig on l
compatibility.
I (2) The States wish to participate, on a 1-continuing basis, in the determination of j
compatibility as new regulations are,
]
developed.
C.
With regard to isiplementation procedures, the i
i Commission should consider explicitly stating in a compatibility polig that the Commission 4
expects that compatibility determinations will i
i be made at an early stage in the regulation development process and that there will be j
continuing State involvement in this process.
Coordination: This paper has been coordinated with and concurred in by i
the Office of the Executive Director for Operations and the Office of General Counsel has no legal objection.
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1..
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j
.7' :.
Harold R. Denton, Director
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Office of Governmental and
]
public Affairs
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Attachment:
As stated DISTRIBUTION:
4 Commdssioners F.DO OGC ACRS OIG ACNW GPA ASLBP j
REGIONAL OFFICES ASIAP SECY d
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I EVALUATION OF AGREEMENT STATE COMPATIBILITY ISSUES FEBRUARY 1991 S
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TABLE OF CONTENTS
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fag I.
m RooucrION.'....................... 1 II. COMPATIBILITY QUESTIONS................... I 1.
Legal Basis...................... 2 A.
Background.................... 3 B.
Isplementation................... 12 2.
Relationship to Health and Safety........... 15 3.
Scope of Determinations................ 17 4.
Basis for Three. Year Timeframe............. 18 I
5.
Frequency of Review of State Regulations........ 19 5.
Options for Requiring Compatibility.......... 19
-7.
Revisions to Internal Procedures............. 20 l
l 8.
Low Level Radioactive Waste.............. 21 r
i l
l III. CONCLUSIONS.........................
26 IY.
POLICY REcolttENDATIORS AND OPTIONS............. 28
- Y. ' OTHER CONSIDERATIONS'.................... 31
- APPENDII Af.- PEFERENCES
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I. - INTRODUCTION
~
i The commission has stated that a clear and sound policy on compatibility is needed for reviews of Agreement State programs and for NRC rulemakings i
affecting State programs.
In Staff Requirements Memorandum (SRM) dated j
October 5,1990, the Commission directed the femation of an interoffice group to evaluate the compatibility issue.
Compatibility Task Force (CTF) was formed.As a result of this directive, the
(
The CTF consists of representatives 4
Deputy Director; the Office of the General Counsel (0G
}.
i Deputy General Counsel for Licensing and Regulation; and the Office of Nuclear i
Material Safety and Safeguards (MSS), Gyy A. Arlotto, Deputy Director.
i addition, the following persons served as resource persons to the task force:
In 1
Cardelia Maupin. Health Physicist, GPA, Stata Programs; John McGrath, Regio i
~ State Agreements Officer; Jane Mapes, Senior Attorne 1
}
Director, Division of Industrial and Medical Nuclear Safety.
j The CTF evaluated past compatibility practices and developed policy recommendations and options for Commission consideration.
j In addition, the Task Force identified the need to define and apply concepts of compatibili
}
more carefully, with more input from Agreement States, and offered suggestions on how this could be accomplished.
However, the Task Force did not make The Task Force believes that matters of definition and a i
compatibilit j
evaluation, y policy require a Commission decision.
In performing this Agrere nt State policies and State Programs files on Agree j
addition the Task Force considered views from staff; detailed analyses from i
In i
Regional State Agreements Officers; the July 12, 1990, report entitled, j
November 1990 All Agreement State Meetinit; and the with the Agreement States Compatibility "ask Force as sources,of informatio 1991 meeting In addition, the Task Force considered the January24, 1991 letter from Thomas Hill to Chairman Carr in this stusly.
evaluation is attached as Appendix A. A list of references cited in this The documents are available from State Programs, GPA.
On January 18, 1991, the Task Force met with the Agreement State Task Force on l
Compatibilit in Austin, TX.
Wayne Kerr (y ) with Greta Dicus (AR), Larry Anderson The Agreement State "ask Force is chaired by IL i
and Roland Fletcher 00) as members.
(Mr Fletcher was not present at this i
meeting.)
the development of the criteria for cespatibility as we
{
determinations on new regulations.
~
j
_ II. COMPATIBILITY QUESTIONS 1
The Staff Requirements Memorandum dated October 6, 1990 posed j
guestions that the Task Force should address in its stusty of ccapatibility.
What is the legal basis for compatibility determinations?
a.
public health and safety? relationship between compatibility deter What is the i
1.
sf r
j
~
u
3 2
j i
1 1
b.
l Are these determinations limited to State statutes and regulations only, or do they include other aspects such as programs, staffing, and policies?
i What is NRC's basis for requiring States to adopt compatible regulations within a three year timeframe?
I How often does NRC review State regulations after the Commission enters c.
into an Agreement with a State to ensure continued compatibility of the j
programs?
i d.
If NRC determines that a State's program is not compatible with NRC's program for similar materials,'what options does the Commission have. to j
encourage and/or require compatibility?
3 i
e.
In light of the answers to the above questions, should the Internal j
Procedure 8.7 be revised or modified? Should these pr>cedures be pubitshed for review and comment by States and members of the public?
Should the existing categorization of NRC requirements be reevaluated?
j f.
Discuss the various arguments, pro and con, related to the question whether the Low-Level Radioactive Waste Policy Amendments Act of 1985 and its legislative history provide a basis for concluding that Agreement States are to be given a greater degree of latitude in fashioning their
{-
own standards for low-level waste (LLW) disposal, in view of the States' increased responsibility in this area?
This section contains the responses to these questions.
1.
What is the leoal basis for comoatibility deteminations?
4 i
The legal basis for compatibility determinations is Section 274 of the Atomic Energy Act of 1954, as amended. Subsection 274d.(2) states:
'd. The Commission shall enter into an agreement under subsection b. of this section with ary State if-a a
a a
a a
a a
(2) the Commission finds that the State program is in accordance with j
the requirements.of subsection o. and in all other respects s
comoanible with the Commission's program for regulation of such
)
mater' als, and that the State program is adequate to protect the public health and safety with respect to the meterials covered by the i
{
proposed agreement." (Emphasis added) j S esection g. of Section 274 also uses the word " compatible" as follows:
.i i
"g. The Commission is authorizad and directed to cooperate with the States in the formulation of standards for protection against hazards of radiation to assure that Stata and Commisalon programs for protection 1
against hazards of radiation will be coordinated and compatible.'
j (Emphasis added) 1 i
These are the on?y two uses of the tem " compatible" in Section 274.
The following is a discussion of the histery of the concept aind some important i
i milestones in the Commission's Agreement State program in the area of cespatibility. -
1 i
I i.
j 4
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3 A.
Backcround In looking at the question of " compatibility of Agreement State Programs" it is important to examine and understand the regulatory atmosphere prior to the i
_ passage of Section 274 of the Atomic Energy Act in 1959, and the way the Agreement State Program has evolved since then.
Prior to the enactment of the i
Atomic Energy Act of 1954, nuclear energy activities in the United States were j
largely confined to the Federal Government. The Act made it possible for i
private commercial firms to enter the field for the first time. Because of the huards associated with nuclear materials, Congress determined that these activities should be regulated under a Federal Itcensing system to protect the i
health and safety of workers in the nuclear industry and the public.
The
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Atomic Energy Commission, the Nuclear Regulatory Commission predecessor, was the Federal agency charged with this responsibility.
t' The Atomic Energy Act of 1954 did not specify a role for the States in nuclear j
natters, although the protection of the public's health and safety had i
l traditionally been a State responsiht11ty.
Because the Atomic Energy Act of i-1954 was silent in this area, many States developed their own regulatory programs for these materials, which included requirements for registration and
{
inspection. Thus, many States were independently defining their roles in the regulation of nuclear materials. State involvement in the regulation of j
nuclear materials at the time was discussed as follows during the hearings i
which lead to the Section 274 amendment:
i 4
j "Approximately 29 States have either legislated on the matter of
(
controlling radiation activities or adopted regulations.
Both the
}
1egislative actions and the regulations vary considerably in scope and approach.
Eighteen States have enacted legislation specifically authorizing or l
directing State agencias to adopt radiation protection regulations.
Most of this 'egislation became effective since the beginning of 1957, and thus j
in 11 instances the State agencies delegated authority have not acted to adopt regulations of the scope contemplated by the applicable statutes.
i-i In no casa does the leg!slation recognize any areas of exclusive Federal authority, but general'y the legislation directs the State agency to adopt l
reculations dealing with all radiation activities within the State....No effort is being made to ITait the stata reguistion to actTvTties other t
than those licensed by the Commission and in a few States a license or i
perait is required in addition to 3 ~AEC license " (Emphasis added)
{
" Federal-State Relationships in Ihe Aton"Te Energy Field," Hearings before
~
the JCAE, May 20,1959, 86th Cong., 1st Sess., pp.128-129, 131.
4 i
These programs were varied in nature and sometimes conflicted with the Federal i
regulations. National Bureau of Standards Naneook 61 Recommendations of the i
National Committee on Radiation Protection, December't, 1955, " Regulation of
~
Radiation Exposure by Legislative Means," page 10, which was submitted as part i
of the testimony on the hearing before the Joint Committee on Atomic Energy i
(JCAE) on May 19, 1959 states'the following:
4e
'"...Up to the present time, four major efforts leading to radiation t
control have been undertaken by States. One State order, which has been -
in effect for several years, requires neither license nor registration.
4
}'
4
?
l.
~4 l
i
~
Another ' calls for registration along lines proposed in this report.. A i
third proposes registration in a manner so elaborate that it almost
{
amounts to licensing. A fourth proposal calls for registration of all radioactive sources of activity greater than background. Superinposed on these will be the almost certain Federal licensing of AEC produced l
radioisotopes.
Confusion is well on its m " (Emphasis added)
}.
An example of the " confusion on its way" cited during the JCAE hearings was
~
i State statutory authority implemented by the Minnesota State Board of Health, I
which adopted on December 4,1958, Regulations on Ionizing Radiation.
Minnesota Regulation 1158." Nuclear reactors and facilities," provided the.
[
following:-
i "b. Before the construction of any nuclear reactor or facility is started j
within this State a general description thereof shall be submitted to the Board of Health containing such infomation as may be necessary or i
appropriate to a determination of any actual or potential hazard to or j
effect upon the public health..."
"c.
No part of the construction of a nuclear reactor or facility shall be j
started within this State without the express approval of the Board of i
Health until 30 days after the submission to it of such description and i
infomation."
(Federal-State Relationships in the Atomic Field, Hearings j.
before the JCAE, May 20, 1959 pp.264-271, at p.'269.)
Th response to these situations was clearly characterized by Representatives 1
Carl T. Durham, North Carolina and Melvin Price, Illinois of the Joint Committee on Atomic Energy (JCAE).
Representative Duthan stated, "I think the i
same thing concerns you that concerns us on the committee, the fear of overregulation; the danger of duplication by the State agencies and by the i
Federal Government." In addition, Representative Price stated, "Many of the j
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 j
be sure that all are going toward the same goal, and they don't have a lot of conflicting regulations that salw it a little difficult to operate on a 4
j national basis." (Federal-State Relationships in the Atomic 'inergy Field, i
Hearings Before the JCAE, 86th Congress, 1st Session, pages 131-132.)
i-i With regard to the need for unifomity, National Bureau of Standards Handbook i
'61, December 9, 1955, page 4, states the following:
"The problem in the U.S. is different free that in a country with a single centralized government.
In the extreme, 48 different types of l
radiation regulations could be developed.
For the nation as a whole j
this would be a chaotic and uneconomical situation.
It.is our endeavor therefore to aid the States in arriving at a common understanding of the
}
problem--to the end that regulation, if any, any be developed along l-reasonably unifom lines." (Esphasis added)
Thus, from the statamenta above, it is clear that throughout the process which i
1 culminated in the enactment of section 274, emphasis was placed on the importance of and the need for continuing compatibility-between Federal and j
State regulatory programs.
standard set out in section 274d.(2) and g. cited above.This concern was ref i
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1
'O e
a
5 1
j The legislative history in the analysis of these sections of the Atomic Energy
}
Act provided the following:
L "52section d. provides for certification by the Governor, and a finding l
by the Ceaufssion, before arty agreement may be entered into.
It is i
intended to protect the public health and safety by assuring that the j
State program is adequate before the Commission may withdraw its regulatory responsibilities."
" Subsection g. provides that the Commission is authorized and directed to cooperate with the States in the fomulation of standards for the j
protection of public health and safety from radiation hazards and to.
assure that State and Commission programs for protection against radiation hazards will be coordinated and compatible.
In most cases, it is intended that State and local standards should be the same as Federal standards in j
order to avoid confilet, duplication, or gaps."
)
"5.
The Joint Committee believes it taportant to emphasize that the radiation standards adopted by States under the agreements of this bill i
should either be identical or compatible with those of the Federal j
Government. For this reason the committee removed the language 'to the extent feasible' in subsection g. of the original AEC bill considered at j
hearings from May 19 to 22, 1959. The committee recognizes the importance of the testimony before it by numerous witnesses of the dangers of I
conflicting, overlapping, and inconsistent standards in different jurisdictions, to the h' ndrance of industry and jeopardy of public safety." Joint Coenittee on Atomic Energy (JCAE) Report to accompany I
H.R. 8755 (H.R. Report No.1125, September 2, 1959, 86th Cong., 1st Sess.)
j at pp.9-11.
(Esphasis added) s on September 23, 1959, Section 274 was signed into law, Public Law 86-373 (73 Stat. 688). The punose of this section was as follows:
i
"(1) to recognize the interests of the States in the peaceful uses of atomic energy, and to clarify the respective responsibilities under this j
Act of the States and the Commission with respect to the regulation of j
byproduct, source, and special nuclear materials; i
(2) to recognize the needs and establish programs for cooperation between i
the States and the Commission with respect to control of radiation hazards j
associated with use of such materials; i
j (3) to promote an orderly reaulatory pattern between the Commission and Stato severnments with respect to nuc' ear development and use a,nd 1
regu' atton of Dyproduct, source, and special nuclear materials; (4),to establish procedures and criteria for discontinuance of certain of t
![
the Commission's regulatory responsibilities with respect to byproduct, States; source, and special nuclear asterials, and the assimption thereof by the r
r.
4 (5) to provide for coordination of the development o'f radiation standards for the guidance of Federal agencies and cooperation with the States; and 1
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i (6) to recognize that, as the States improve their capabilities to
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regulate effectively such materials, additional legislation may be
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desirable." (Emphasis added) i
~
i h term " compatibility" was not defined by Congress in its development of Section 274. With no clear definition of compatibility provided in the
}
Atomic Energy Act, the Commission sought to implement the Section 274 Agreement State Program using the legislative history and the ' language of the amendment for guidance. After the establishment of the Agreement State Program, the staff sought to fulfill purpose "(4)" of the amendeent which was to establish -
i criteria for States to enter into an Agreement with the Commission under Section 274.
After discussions with various State officials, the Commission 1
drafted proposed criteria.
On August 22 and 23, 1960, the Commission's i
Advisory Committee of State Officials met and avaivated the proposed criteria.
-The proposed criteria were rewritten after full consideration of the t
4 Committee's recommendations. W criteria for States to enter into Agreements l
with the Commission were approved on February 7,1961 and were first published j
en March 24, 1961.
1
^
With respect to unifomity of radiation standards this criteria as initially i
proposed on page 15 of AEC 957/12, February 12, 1960, " Transfer of Federal
}
Regulatory Authority Over Byproduct Source and Special Nuclear Materials,"
contained the statement, "8y uniformity is meant no more and no less than those
)
standards fixed b i
Part 20 of the AEC regulations' However,7nT 957/16, January 3,1961, { Proposed Criteria for Discontinuing AEC Regul Over Byproduct Source, and Special Nuclear Materials " page 2 the following statements were given for the deletion of this wording from the criteria for entering into Agreements:
i
- 5. "With respect to uniformity of standards, Criterion No. 3, as proposed, i.
defined uniformity as 'no more and no less than those standards fixed by l
Part 20.'
that it was too inflexible.There was considerable objection to this language 4
In view of the undesirability of inconsistent l'
'l standards in diffemnt jurisdictions, every effort was made to obtain acceptance of this concept.
The language was clarified to require uniformity on maximum permissible doses, levels, and concentrations based i
on officially approved radiation protection guides. N 'no more and no i
less' clause was deleted.
W re is still room for flexibility in the State's power to exercise its exemption authority under Criterion 12 or through the educational process on an individual-case basis where an activ'ty warrants mere or less restrictive requirements due to unusual
. circumstances."
i When the Ceemission policy for entering inta Agreements with States, " Criteria j
and Assumption Nroof bfor Guidance of States and AEC in Discontinuance of A
?
y States Through Agreements," was approved on March 24 j
1961, (26 FA 2536-2539) it stated, "3.
Uniformity in radiation standards.
It is important to strive for j
uniformity Tri technical definitions and terminology, particularly as related to such things as units of mehsurements and radiation dose.
There shall be uniformity on maximum permissible doses and levels of i'
y 1
4 1
.......... ~..
4 7
radiation and concentrations of radioactivity, as fixed by Part 20 of i
the AEC regulations based on officially approved radiation protection guides."
i
- 6.
Labels, sions symbols.
It is desirable to achieve uniformity in
~
labels, signs and symbols, and the posting thereof. However, it is i
~
essential that there be uniformity in labels, signs, and symbols affixed to radioactive products which are transferred from person to j
person. "
I i
It was clear from the language of Section 274 and its legislative history that t
a State was to be " compatible" and " adequate to protect public health and l
safety" before it could become an Agreement State. Additionally, it was clear i
. from Section 274j, " Termination of Agreement," that a State had to continue to i
be " adequate to protect the public health and safety" to maintain its Agreement
{
State status.
However, Section 274 was silent on " continuing compatibility."
]
The Commission addressed this issue by placing in each agreement language i
recognizing the importance of asintaining compatible programs.
j Each agreement contains an article pledging the use of best efforts on the part of the Commission and the State to achieve coordinated and compatible programs.
In the first three Agreements signed (Kentucky, 3/26/62; Mississippi, 7/1/62; and California, 9/2/62), each State agreed to:-
"use its best efforts to maintain continuing compatibility between its L
program and the program of the Commission for the regulation of like j
saterials.
To this and the State will use its best efforts to keep the j-Commission informed of proposed changes in its rules and regulations, and j
licensing, inspection, and enforcement policies and criteria, and of proposed requirements for the design and distribution of products j
the comments and assistance of the Commission there i
[
and the Commission agreed to:
"use its best efforts to keep the State informed of proposed changes in i
its rules and regulations, and enforcement policies and criteria and to i
obtain the comments and ~ assistance of the State thereon."
(
j with the Commission in its formulation of regulation i
j working together to estabitsh compatible regulatory programs.
[
the negotiations of the New York Agreement (16/15/62),
However, during j
State, this provision was changed to clearly emphasize that States and the at the request of the Commission should work together in achieving " coordinated and compatible" th's article states: regulatory programs for radioactive materia
- s. _In all subsequent Agreements, t
[
~
"The Commission will use its best efforts to cooperate with the State and L
ether Agreement States in the femulation of standards and regulatory 1-programs of the State and the Commission for protection against hazards of i
radiation and to assure that State and Commission programs for protection against hazards of radiation will be coordinated and compatible.
a State will use its best efforts to cooperata with the commission and other The 4
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Agreement States in the formulation of standards and regulatory programs of the State and the Commission for' protection against hazards of radiation and to assure that the State's program will continue to be compatible with the program of the Commission for the regulation of like materials. The State and the Commission will use their best efforts to keep each other informed of proposed changes in their respective rules and l-regulations and ifcensing, inspection and enforcement policies and criteria, and to obtain the comments and assistance of the other party thereon."
These provisions were made to reflect 274g.."The Commission is authorized and directed to cooperate with the States in the formulation of standards...to l
assure that State and Commission programs for protection against hazards of radiation will be coordinated and compatible." Additionally, these provisions i
reflected purpose a. (3) of Section 274, "to promote an orderly regulatory pattern between the Commission and State, nevernments." (Emphasis Added)
In spite of these provisions, the idea of " continuing compatibility" of Agreement States continued to be a concern as the Agreement State Program developed. In November 1962, the Atomic Energy Labor-Management Advisory Committee passed the following resolution:
"Before the AEC enters into an agreement with a State to transfer certain regulatory functions to the State Government, the AEC must be satisfied that the State Program is compatible with AEC's standards of radiation protection.
However, as AEC does not appear to have the right to insist
~
on continuing compatibility once the agreement is signed, AEC should initiate appropriate action, including legislative action if necessary, to empower AEC to take measures to assure continuing compatibTTity--which means no significant departure, either toward decreased or increased restrictione, from the AEC standards of radiation protection." (AEC-R 10VI, April 8,1963) (Esphasis added)
On April 17, 1963, the Commission considered this resolution and requested the l
0GC's opinion on continued compatibility under Section 274 of Agreement State programs. On May 9, 1963, the General Counsel in an opinion addressed to the Commission stated:
"Section 274 authorizes the relinquishment of Federal authority and responsibility.
It does not establi,sh a program under which the States merely inspect against and enforce Federal standards.
Section 274 contains no requirement that* compatibility be meintained by the States. -Nor does the statute authorize the AEC to terminate or suspend an agreement on arty other ground other than that the action is required to protect the public health and safety. Although it is readily apparent that the turnover of responsibility will work satisfactorily only if Federal and State regulatory programs are compatible, the section L
reflects Congressional confidence that such compatibility will be achieved -
l through cooperation. A unilateral power to require compatibility would appear to be inconsistent with both the nature of the program established and the underlying philosopfty of the statute." (AEC-R 10V2, MW 25,16C3, page 4) 0
,~
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4 After considering DGC's opinion, the Commiss(on decided that additional legislation requiring " continuing compatibility" of Agreement States was not needed. This decision was based on the fact that at this time, (1) all i
agreements contained "best efforts" commitments to maintain compatibility; (2) the current standards of Agreement States were " highly compatible;" and I
(3) that "as long as this trend continues " the existing procedures would be adequate (AEC-R 101/9 Feb.2, 1967, page 7).
l l
In the' initial period after the first agreement in 1962, continuing compatibility of Agreement State Programs was promoted through meetings with each of the Agreement States. Originally the purpose of these meetings was j
almost entirely to exchange infomation, such as to offer advice and assistance
]
on regulatory matters.
In the absence of a standard femat for meeting reports, the pre-1965 meetings were " free-flowing, frank and 'infomal
'exchangss of views" (AEC/R 101/9, Feb.2,1967 p.18). During these early meetings, some meeting reports, but not all, show conclusions on compatibility of these early Agreement programs. However, there was no attempt made by the j
Commission during this period to reviet; the States' programs for adequacy or compatibility. "he States were essentially expected to carry out the j
regulatory risponsibilities under the Agreement without " oversight" by the commission.
Suggested Stata Regulations for Control of Radiation (SSRCR) wara originally published by the Council of State Governments in 1962 and are updated on a
.i periodic basis by the Conference of Radiation Control Program Directors, Inc.
j (CRCPD). The purpose of the SSRCR is to assist the States in the development j
and maintenance of their radiation control regulations. The SSRCR is a set of j
model regulations which are developed by the CRCPD with concurmnce by i
affected Federal agencies, such as NRC, Federal-Drug Administration and l
Environmental Protection Agency. State 'rograms staff works closely with CRCPD to draft changes to the SSRCR in response to an effective NRC rule or a
rule change.
1 For Agreement States; the $$RCR serves as a guide.for keeping abreast of 3
j important changes to NRC regulations and ensuring continued compatibility with l
NRC regulations.
For non-Agreement States which are considering a Section 274b agreement, the SSRCR serves as a model for developing regulations that are consistent with NRC philosophy and will meet the compatibility requirements of the Act. NRC, as a matter of practice, has considered State regulations which adopt CRCPD language to be compatible.
In this sense, the
{
j SSRCR' serves as a kind of regulatory guide to,an adequate and compatible compendium of State regulations.
i
}
In 1965, however, the Commission decided to make a formal annual redetamination of the compatibility of Agreement States (May 28,1965 to the j
Honorable W. Willard Wirtz and Commission Meeti 229 (AEC/R101/8). This j
measure was mainly to counter a proposal of the rtment of Labor (00L) to j
impose its own radiation safety standards. This unendment would have subjected
[
some Commission and some State licensees to dual regulation. After extensive negotiation, the DDL agreed ts' consider all Commission licensees and State j
licensees of agreement materials automatically in compliance with the Walsh-Healy standards. liowever, to assure itself that the regulatory standards of the States would remain compatible with those of the Walsh-Healy Act, DOL i
1
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i proposed that it would make determinations of the status of State i
compatibility. However, the Commission decided in the May 28, 1965 letter from Chairman Seaborg to the Secretary of Labor that the Commission would make the
~
redetermination of State compatibility.
In turn, the Commission developed a j
acre formalized system for evaluating and reviewing Agreement State Programs.
I It is also important to note that in 1965 during the Commission's discussions i
. of annual redetermination of Agreement States compatibility, the Commission considered legislation to amend Section 274j, " Termination of Agreements," to obtain authority to tarininate Agreements based on " incompatibility" of the State with the Commission (AEC-R 101/8, " Status of the Agreement States with Respect to Continued Compatibility,").
However, the Commission chose not to go forward with this proposed amendment.
It appears that the Commission still preferred to use " mutual cooperation between the States and the Commission" as 1
the vehicle for assuring compatibility (AEC-R 101/9, February 2,1967, page 32).
b After the Commission established the redetermination of compatibility policy,
{
it also provided a definition of this ters.
In Commission Pt,11cy 919-02, j
August 15,1966,"compat{tility"wasdefinedas, s
\\
"' Compatibility means... substantial uniformity, as between AEC and the States, of regulatory standards and policies without their necessarily i
being identical' and '... adequacy to protect health and safety.'"
j AEC-R 101/8, December 28, 1965, paragraph 11.
i In AEC-R 101/9, February 2,1967, page 8, the Commission staff defined a
[
i i
" compatible State" as one which is " practical, workable, and substantially l
l unifors (but not identical) with the AEC's program."
3
~
After the 1965 policy was established on redetermination of " compatibility,"
j i
each State was evaluated against the Commission's 1961 criteria for transfer of regulatory authority in terms of its adequacy and compatibility.
These i
evaluations were called " Compatibility Reviews of Agreement States." On June 21, 1973, the determinations for " adequacy" and "compatibilit j
. This was the result of the publication of the Commission's first, [ Guide forchanged i
Evaluation of State Radiation Control Programs Under Agreement." This guide i
provided for a more indepth review of State programs and established degrees of adequacy and compatibility of State Programs. The guide stated the i-following in this regard, 1
"As a result of the review of a State program, the AEC determines that the Agreement State's program is either:
3 j
1) adequate to protect the pelle health and safety; or 1
2) adequate to protect the public health and safety although in need of taprovement in specified areas; or
-inadequate to protect the pelic health and safety.
j 3) i j
A determination is also,made that the program is either:
4 1) compatible with the AEC Regulatory program; or 4
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2) compatible with the AEC Regulatory program except in areas i
unrelated to public health and safety; or 3) incompatible with the AEC regulatory program.
Presently, adequacy determinations are applied in the total review of a program i
for public health and safety related matters and compatibility is only applied j
to regulations; however, if a State is found to be inadequate, then a finding of compatibility is also withheld. This change appears to have occurred after i
the establishment of the December 4,1981 policy statement on the review of i
Agreement States. The 1981 " Guidelines for NRC Review of Agreement State i
Radiation Control Programs" (46 FR 59341 at 59344, December 4,1981) states, "In making a finding of adequacy, the NRC considers areas of the State program which are critical to its primary function, i.e., protection of l
the public health and safety... If no serious performance problems are found in an Agreement State program and if its standards and program procedures are compatible with the NRC program, a finding of adequacy and compatibility is made.
In a case where a State has not formally updated
{
radiation standards in important areas, but other areas of the prgram are not deficient, a State could be found to be adequate but not compatittle 4
l with the NRC program...."
j With the passage of the Uranium Mill Tailings Radiation Control Act (UMTRCA) of
{
1978, the Commission was given additional statutory authority to assure continued compatibility of Agreement State Programs.
UMTRCA, which gave the Commission i
authority to regulate uranium and thorium mill tailings (11e.(2) byproduct j
materials), also amended section 274j, " Termination of Agreements."
Prior to j
the UMTRCA amendment, section 274j provided for the suspension or termination j
of an agreement only when it was required to protect public health and safety.
j UMTRCA, in section 204d added language which broadened the Commission's authority in the area of temination of Agreements. The 1 gislative history
(
of UMTRCA shows that original language, confined to mill-tailings, was j
deliberately broadened so that the till, as amended, gave NRC authority to terminate or suspend an Agreement for noncompliance with any of section 274's requirements.
Section 274j (1) presently reads, e
"(1) The Commission, upon its own initiative after reasonable notice and i
opportunity for hearing to the State with which an agreement under i
subsection b. has become effective or upon request of the Governor of such State, may terminate or suspen,d all or part of its agreement with the i
State and reassert the licensing and regulatory authority vested in it i
under this Act, if the Commission finds that (1) such temination or suspension is required to protect the public health and safety, or (2) the 1
State has not complied with one or more of the requirements of this section.
The Commission shall periodically review such agreements and actions taken by the States under the agreements'ta insure compliance with j
the provisions of this section."
1 This language gives the Commission the authority to terminate an Agreement for not maintaining compatibility (see Memorandum dated November 1, 1990 to William C. Parler from Stuart Treby, " Remedies for Incompatibility").
In addition, this amenchent directed the Commission to periodically review the i
4 t
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l agreement to ensurts compliance with Section 274. Thus, the States are L
continuously subject to all regulatory changes made by the Commission even though the States have entered into an agreement. To date, and the UKTRCA legislative change notwithstanding, no Agreement Stata program has ever been considered a candidate for suspensten or termination on the basis of compatibility.
3.
Implementation of Compatibility Determinationsf (1) When have we allowed States to be different and why?
The history of compatibility determinations reveals that it has been implessnted with some degree of flexibility. For example:
(a) When New York proposed Agreement State status in 1962, the Commission Paper (AEC-R 94/3 dated October 6,1962) forwarding the proposed i
agreement to the Commission for approval identified a variation in the States occupational dose limits.
The staff paper states, "New York permits an occupational dose of 3 reas in 13 consecutive weeks compared with 11/4 reas per calendar quarter permitted by 10 CFA 20."
The paper concludes, however, that the differences were not regarded by the staff as providing a basis for rejection of the New York program, indicating that although the regulations were different, they were compatible. The Commission approved the New York Agreement and it was signed on October 15, 1962.
(See response to Question 2 on page 15 for more detail.)
(b) In regards to State Programs which are more restrictive a large I
number of Agreement States inspect their licensees moro, frequently than the NRC. Mar general licenses. y Agreement States require the inspection of I
States like California and New York have not I
adopted the NRC's biasedical wasta rule under 10 CFR 20.306 which is a rule the States had flexibility in adopting, a Division 3 rule under Internal Procedure 8.7, which is discussed further in this Section.
This makes these States more restrictive in the disposal of trititan and carbon-14.
Moreover, some States who had operating low-level waste facilities at the time Part 61 was adopted, such as Nevada, did not adopt all of Part Gl's performance objectives.
This was approved by the Commission'because~ operating low-level waste sites could not be retrofitted in mary cases. The State of Tennessee requires wasta brokers to return treated waste back td generators in States out of compliance with the LLRWPAA.
In addition, Texas requires industrial radiographers, including those working under reciprocity, to pass an examination before conducting radiographic operations in its State boundaries, which has been cited as a commendable program.
(c) On the other hand, there are some Agreement States which are not as restrictive as the NRC. Mary states do not have civil penalties for violation of license conditions and some Agreement States cannot e
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1 charge license application fees.
Louisiana pemits the disposal of certain concentrations of iodine-125 without regard to its 4
radioactivity, which was evaluated by NRC and found to be an j
acceptable standard.
The State of Texas established regulations permitting the disposal of certain concentrations of radioactive waste in solid waste sites before the NRC developed its BRC policy.
i In addition, some States permit the calibration of survey instruments i
for industrial radiographic operations at 'an. interval of every 6 1
months as opposed to every 3 months as required by the NRC.
(d) j There is one example where Agreement State adequacy and compatibility issues were not resolvable within the framework of the i
Agreement.
In 1986, the Governor of New Naxico requested that NRC 3
reassert its authority over uranium milling and mill tailings in the State.
The Governor stated that because of severe budget constraints, as well as other compe111pg reasons, the State could no j
longer assume regulatory responsibility.
The other reasons given i
included:
(1) inability to develop State regulations compatible
~j i
with 10 CFR Part 40, Appendix A, and thereby receive an amended agreement; (2) inability to establish adequate sureties for.
j reclamation of the tailings; and (3) inability to maintain adequate 2
staff to oversee the program.
regulate uranium milling facilities.The NRC reasserted authority to i
Federal Register publication ($1 FR 19432) on May 29,1986.This a Upon staff rssources to address deficiencies in the areas ofreas i
l (1) inspection; (2) licensing; (3) decommissioning and reclamation; and (4) financial surety arrangements.
In analyzing the areas above in which the Commission has permitted f i
the Task Forces notes the following: (1) nonconformity has been permitted in L
basic radiation standards; (2) the objective of some of the States' practices i
has been to protect pubite health and safety to a greater degree, e.g., more i
frequent inspections; (3) the Task Force is not aware of any circumstances where these practices have interfered with interstate commerce; (4) the Task j
Force knows of no circumstances where these
{
State specific concerns.l standards; and (5) practices have eroded the establishment of nationa j
many of the differences reflect i-(2)
When have we insisted on unifomity and why?
As stated in the history section, the Atomic Energy Commission (AEC) 1961 1
" Criteria for Guidance of States and the Commission in Discont i
provided areas in which States should be unifom with th technical definitions and ters'nologycriteria provide that State regu These uniformity on anximum permissible doses and levels 1
{
2-especially Criterion 3 at p. 2537.) concentrations of radioactivity,..."
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i 24 On July 21, 1983, the Commission revised Criterion 9 of the " Criteria" which deals with radioactive waste disposal.
The purpose of the revision of j
Criterion 9 was to point out those portions of 10 CFR Part 61 and Part 20 (manifest systas) which must be adopted by a State to enter into an Agreement i
in the area of low-level radioactive waste (LLNW) disposal. The July 1983 l
policy statement provided the.following:
9.
Radioactive Waste Disposal.
j (a) Waste disposal by material users....
Requirements for transfer of waste for the purpose of ultimate disposal at a land disposal facility (waste transfer and manifest system) shall be in accordance with 10 CFR 20.
i l
The waste disposal standards shall include a waste classification 1-scheme and provisions for waste form, applicable to waste generators, that is equivalent to that contained in 10 CFR Part 61.
s (b) Land disposal of waste received from other persons. The State 4
shall prosulpate regulations containing ifcensing requirements for land disposal of radioactive waste received from other persons which j
are compatible with the applicable technical definitions, performance i
ob.jectives, technical requirements and applicable supporting sections j
set forth in 10 CFR Part 61.
Ade terms established by regulation) quate financial arrangements [under shall be required of each' waste i
disposal site licensee to ensure sufficient funds for decontamination, i
closure and stabilization of a disposal site.
In addition, Agreement i
State financial arrangements for long-ters monitoring and maintenance of a specific site must be reviewed and approved by the Commission prior to relieving the site operator of licensed responsibility (section 151(a)(2), Pub. L.97-425).
n 1
i These policy statements do not have the force and effect of law.
]
Moreover the language of these policies is sometimes ambiguous. For example, with respect 1
- to Part 61, the wording varies free "shall be in accordance with," to the i
requirement to be " equivalent to " and eventually to the requirement to be j
simply " compatible."
i In order to provide guidance to the staff ~and to better implement the ters j
"comoatibility " 5 tate Programs in 1984 adopted internal written procedures,
" Internal Procedures, 5. Policy, 8.7 - Criteria for Compatibility j
Determinations."
In the 8.7 internal procedures, State Programs categorized j
pertinent IRC rules according to the degree of uniformity necessary between NRC j
and Agreement'5 tate requirements. Four categories were established as follows:
i j
Division 1 Rules constitute those provisions of the NRC regulations that i
5tates are required to adopt, essentially verbatim, into their regulations.
i For example, these rules include maximum permissible dose limits, i
definition of basic radiation terminology, radiation sigh and symbols, and 1
legal definitions.
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l Division 2 Rules are other provisions in NRC rules that States must i
address in theG ngulations because these rules include basic principles
)
' of radiation safety and regulatory functions. However, the use of i
underlying principles are the same. The States may adopt more stringent identical language to that of the NRC is not necessary, provided the l
or restrictive rules than the NRC in this area.
t
]
Division 3 Rules are those provisions in NRC regulations which would be j
appropriate for Agreement States to. adopt, but which do not require any
{
degree of uniformity between NRC and States rules.
i Division 4 Rules are certain regulatory functions which are reserved to j
the NRC pursuant to the Atomic Energy Act and 10 CFR Part 150.
i Appendix A to these internal procedures contains a " Categorization of MRC Rules by Compatibility Type." These categorizations are decided by the staff and
)
l Commission on a case-by-case basis.
i 2.
What is the relationship between cosostibility determinations and public health and safety?
]
Section 274 states that, prior to entering into an agreement, the Commission is required to find that the State's program is (a) compatible with the j
Commission's program for the regulation of such materials and (b) adequate to i
protect the public health and safety.
During the early years of the Agreement j
State program, there was a Ifnkage between " adequacy" and " compatibility."
Commission Paper AEC/R101/8. " Status of the Agreement States with Respect to s
(
Continued Compatibility" dated December 28, 1965 states that in the periodic j
appraisals that were conducted of the States "...the staff has not i
distinguished between, nor treated separately, compatibility and adequacy to protect health and safety." In this regard, however, early reports of i
" Exchange of Information" meetings with States sometimes contained a
" conclusion" section which offered separats findings on adequacy and i
compatibility. As the Agreement State profan evolved, compatibility became i
separated from adequacy insofar as the NRC s evaluation of State regulations was concerned. The above referenced Commission Paper, AEC/R101/8 established the policy whereby the Commission began to make an annual redetermination of 4
compatibility.
I The intent of NRC regulations, in general, is to protect public health and I
safety and therefore, States must have accomp'lished an adequate level of l
protection. It is recognized, however, that not all of NRC's regulations are equally important in terms of public health and safety.
In 1984, the staff developed an internal precedure for dealing with these differences in importance.
(See Section II 1.B (2) of th"s report.) Division I rules are those requiring the highest degree of uniformity.
4 It has t;een suggested that a#y regulation affecting protection of the public i
i health and safety should be a matter of compatibility. However, there is no i
legislative basis for doing so'.
Certain regulations which are based on 1-internationally eccepted radiation protection standards, such as those in the 1.
occupational exposure limits of Part 20, are certainly for the purpose of i
protecting public health and safety and should be considered important for 9
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16 l-i States to adopt.
always been absolutely required.But even as to these regulations, strict conformit As indicated earlier in this report, when New 4
York proposed Agreement State status in 1962, the Commission Paper (AEC-R 94/3 1
dated October 6,1962) forwarding the proposed agreement to the Commission for i
approval identified a variation in the States occupational dose limits.
j staff paper states that:
The
" Maximum permissible levels of radiation and concentrations of radioactivity are uniform with the values published in AEC 10 CFR 20, except that:
New York permits an occupational dose of 3 rems in 13
(
consecutive weeks compared with 11/4 rems per calendar quarter permitted i
by 10 CFR 20."
t' The paper concludes, however, that the differences are not regarded by the although the regulations are different, they are compatible. staf i
i In a more detailed discussion of the differences the paper states that:
i i
'The persissible occupation dose Itaits specified in the three New York j
Codes are patterned after the radiation guides of the Federal Radiation i
Council and the National Committee on Radiation Protection and j
Nessurements as are the corresponding limits in AEC regulations.
the two differ in several respects including the following:
- However, 4
licensee has determined, using a prescribed form and method ofUnless the computation, the accumulated occupational radiation dose at his last birthday, the AEC limits his whole bo# dose to 11/4 rams per qsarter,
{
while New York limits the dose to 3 rems in any 13 consecutive weeks or 5
]
rems in any 52 consecutive weeks.
If the licensee had determined the accumulated dose at the last birthday, the AEC permits doses as high as 3 i
rems per quarter, provided such doses, when added to the accumulated whole i
bo # dose shall not exceed 5 (N-18), where N is the age of the employee his last birthday. A corres j
although worded differently,ponding provision of the New York regulations, is essentially identical in effect.
Lesser variations exist in permissible quarterly doses to the skin and
(
permissible annual 1 faits by three rather than four as i
arriving at the limits in 10 CFR Part 20.
requirements also vary slightly from AEC requirements in order toNew Yo accommodate the New York approach to maximia permissible doses."
~
j The New York case is significant in that the differences in the regulatio'ns i
have existed since 1962 with no apparent effect regarding the protection of i
public health and safety.
Also rules can be more or less conser,vative than NRC regulation. depending
{
i
. at Cintiches, Inc., an NRC and State licensee, an extremity-exposure to anIn a individual was determined to be above NRC limits thereby indicating that the Stata regulations are, but below State limits, less stringent than NRC regulations.
However, it would not be difficult to describe a scenario in i
which the State regulations would be more stringent than the NRC regulatio i
For example are for ary,13 consecutive weeks.the NRC limits are per calendar quarter while i
theoretically receive 3 reas on March 31 and 3 rems on April 1..Unde rules, this would be a violation.
Under New York l
I l
4
~
17 l
[
There are many other regulations which are intended to protect public health I
and safety but have not been considered necessary for States to adopt from i
a compatibility standpoint.
For example,10 CFR Part 35 contains certain.
provisions governing the medical use of byproduct material.
i In that part, NRC i
has certain requirements for the establishment of a rad 4 tion safety committee and establishes requirements for that committee concerning membership, duties and responsibilities, all of which are intended to provide protection for the public health and safety.
However, NRC has not made these matters of j.
compatibility in the sense of insisting that States adopt them.
1 The relationship between compatibility and public health and safety can also be i
i evaluated with regard to program areas other than regulations. The performance of inspections is an area directly related to a program's ability to protect the i
public health and safety.
The Commission does not have a compatibility j
standard regardira inspection frequencies, however, the Commission's program j
review criteria states that the minimum inspection frequency for Agreement States should be no less~ than the NRC inspection interval. Most Agreement
}
States inspect licensees at more frequent intervals than NRC.
This is viewed as one of the positive results of the Agreement State program.
Since States are closer to licensees, they are able to interact with their licensees to a j
auch greater extent than NRC.
- t i
3.
)
Are these determinations limited to State statutes and reculations only, or do they include other asoects such as orocrams, staffino, j
and oo11cies?
I The Task Force found that the legislation speaks to the compatibility of i
" programs," however, in actual practice, staff determinations have been app 4
only to statutes and regulations.
When Section 274 of the Atomic Energy Act j
was enacted it stated in paragraph d. that "The Commission shall enter into an Commis sion fint.. that the State orocram is comagreement under subs progrus for the regulation of such materials..patible with the Commission's 4
i (Esphasis added.) The use of the word " program" rather than " regulation" indicates that the ters i
other than just the regulations. compatibility was meant to apply to aspec 1
This might include licensing actions and the State's compliance program.the technical aspects of i
j apply to criteria for approving certain licensed activities as detailed in NRCAs licensing guides or to such areas as the inspectjpn priority system.
j also be < nterpreted to include administrative mag 4ers such as staffing level It could j
and budget.
Historically, the Commission has never withheld a finding of j
compatibility based on arty program area other,than the status of the State's i
regulations.
finding of adequacy, a finding of compatibility is also withheld.O L
i staff, however, does review other aspects of Agreement State programs for The NRC j
uniformit actions, y with the NRC program. For example, during the review of licensing L
the staff ankas a determination that the Stata has or has not rev j
the technical aspects of the proposed licensed activity in auch the same manner as the NRC.
Agreement State Radiation Control Programs" dated JuneThe NR 4, 1987 (52 FR 21132)
}
contains 29 indicators of Agreement State performance.
Each of these indicators addresses program areas that are assessed for uniformity with NR program.
With regard ta licensing, the policy statament states that:
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"It is necessary in licensing byproduct, source, and s'pecial nuclear materials that the State regulatory agency obtain information about the proposed use of nuclear materials, facilities and equipment, training and experience of personnel, and operating procedures appropriate for 3
'detemining that the applicant can operate safely and in compliance with the regulations and ifcense, conditions. An acceptable licensing program includes: preparation and use of internal licensing guides and policy memoranda to assure technical quality in the licensing program (when appropriate, such as in small programs, NRC Guides may be used);
i prelicensing inspection of complex facilities; and the implementation of j
administrative procedures to assure documentation and maintenance of.
adequate files and records."
For the most part, Agreement States use NRC licensing guidance. There are
[
exceptions, however, and during on site reviews of State programs, NRC staff frequently (Jentify differences in licensing policy of varying degrees.
Each
- i of these differences are evaluated on a case-by-case basis with a view towc.rds the effect of the differences on public health and safety.
4.
What is NRC's basis for requiring States to adopt compatible regulations within a three year timeframe'l i
i The three year interval has been based on what the States, generally, have been able to meet.
Because of changing technology, new standards, and regulatory experience leading to new regulatory requirements, NRC frequently mates changes i
to its regulations.
From the early days of the Agreement State program, it was
{
recognized that States would have to periodically update their regulations in order to maintain compatibility with NRC regulations.
It was also recognized j
that the States needed some lead time to make the necessary changes.
Some States do not have the technical, legal, or administrative resources to amend i
i their regulations with the same regularity as the NRC.
Prior to 1973 NRC had j
no specific requirement concerning the amount of time Statas had to update j
their regulations, however, in AEC-R 101/8 dated December 8,1965, the i
Commission found that "It has been observed that most States, as a general i
practice, formally incorporate amendments in their regulations to conform with changesintheCommission'sregulationsonlywhentheygreparegeneral j
revisions for reprinting." That stu(y also noted that the intervals between Commission re three years."gulations and State regulations in extreme cases have been up to i
This appocred to be r toasonable standard to apply to all States.
This standard was formalfred when the Commission first established
" Guide for Evaluation of Agreement State Radiation Control Programs" in 1973.
{
Over the years, the process by which States adopt regulations has undergone significant change.
. detailed process to amend their regulattens.Some States are now required t l
In some cases, leglslative j
approval is need for regulation changes. As a result more Stata staff, outside the radiation control program are involvsd in the process.
In past years, i
i State radiation control person,nel were able to draft proposed changes to their regulations and, using the compatibility requirement, obtain concurrence from their management and any other nec6ssary offices, without too much difficulty.
j Now, States have accumulated a great deal of experience in dealing with a host of environmental and public health issues related to hazardous materials.
State management are taking a more, active role in reviewing proposed changes to St j
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i regulations.
In many instances they look for their radiation control program to operate under the same policies and procedures as other public health and safety progrant, such as hazardous materials. As a result, the process has
~
become much more complex and some States have found it difficult to meet the i
three year requirement resulting in the Commission having to withhold a finding j
of compatibility on a number of occasions.
5.
How often does NRC review State reculations after the Commission enters into an Acreement with a State to ensure continued compatibility of the programs?
d
}
At the present time,' the Regional State Agreements Officers and other staff j
visit each program arwally. Fomal program reviews are conducted every other
~ year.. On alternate yer.rs, the staff conducts an infomal review visit which is l
meant to assist the State in preparing for the femal review and also to assess any significant developments in the program. During the femal review, the staff evaluates the State's program against the " Guidelines for NRC Review of j
Agreement State Radiation Control Programs." One indicator of the criteria is
" Status and Compatibility of Regulations." The review of this indicator i
involves evaluating recent changes to State regulations against the Chronology of NRC Amenhents. Usually, this review does not involve an evaluation of the entire set of regulations. Pat'iodically States may amend their regulations in their entirety. NRC is given an opportunity to comment on these redrafts and j
will, if deemed necessary, review the entire package.
Additionally, States periodically submit draft regulations to'the NRC'when the'y i
make amendments to their regulations. These draft regulations are reviewed and i
commented on by State Programs and OGC.
Thase comments are forwarded to the j
States.
l i
6.
If NRC detersinns that a State orocras is not compatible with NRC's 8
procras for similar materials, what ootions does the Commission have to 3
l eFo urage and/or reovire comoetibility?
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Typically, the NRC determines that a State program is not compatible when, during a femal review, the staff finds that the State has not adopted an NRC regulation, that is a setter of compatibility, within three years of its effective data.
As a mattar of practice, for comments related to compatibility of regulations, the comment letter to State management indicates the deficiency and requests a response from the State.
If, in the: State's response, they j
recognize the fact that their regulations are not yte-date and discuss their plans to amend their regulations, the NRC ace' pts this and indicates that the e
issue will be reviewed again during the next review, which can be a follow-up
,L review or an interia review visit.
with their commitment and the regulations are updated before the next NR l~
i review.
The policy statement states that "No significant items will be left i
unresolved over a prolonged period."
There have been, hewever, cases where regulations have gone unamended for a number of years. -At one point in time a
j.
the California regulations were ten years aut of date.
(The State eventually amendedtheirregulationsinFebruary.1987.) Currently, the New York State 1
Department of Health regulations have set been amended in eleven years.
(The 1-Department is currently in the prova of amending its regulations and the j
~
staff is reviewing a draft proposal 1 9
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In the 1965 Commission Paper AEC/R101/8, it states that "Section 274 of the 1
~
Atomic Energy Act does not establish the explicit legal requirement that an i
Agreement State's program must be compatible with AEC's program on a contin j
basis."
The paper goes on to discuss the "best efforts" paragraph of the continuing compatibility. individual agreements as the mechanism for ad i
i as follows:
The "best efforts" article of each agreement reads 5
I 1
"The Commission will use its best efforts to cooperate with the State and other Agreement States in the fomulation of standards and regul.atory 1
programs of the State and the Commission for protection against hazards of i
radiation and to assure that State and Commission programs for protection against hazards of radiation will be coordinated and compatible.
j The State will use its best efforts to cooperate with the Commission and other j
Agreement States in the fomulation of standards and regulatory programs
{
of the State and the Commission for protection against hazards of radiation and to assure that the State's program will continue to be compatible with the program of the Commission for the regulation of like asterials.
The State and the Commission will use their best efforts to i
keep each other infomed of proposed changes in their respective rules and
}
regulations and licensing, inspection and enforcement policies and t
criteria, and to obtain the comments and assistance of the other party
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thereon.'
4 i
This paragraph reflects the approach to date on compatibility matters:
F remedy for non-compatibility is pointed discussion and persuasion.
the
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been no femal consideration given to date to changing this policy There has notwithstanding the UNTRCA law giving NRC the legal power to enforce i
compatibility that was lacking when this language was adopted.
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7.
Trocedure 8.7 be revised or modified?In light of the answers to i
Should these procedures be published for review and comment by States and ma I
l Internal Procedure 8.7 " Criteria for Compatibility Determinettons" was las updated on January 25, 1984 At the very least, 5.7 neek to be updated to include NRC i
date.
(
that have become effective since January 1964.
i procedure has been useful to the staff in the review of Agreement StateSin i
requistions.
proposed Stata regulations are reviewed by the NRC staff, L
specific differences between the State wording of a particular r, quirement a i-the corresponding NRC requirement are noted.
e the specific IRC rule in question detemines, at least to some extentThe "
4 j
degree of uniformity that the staff will look for in eva
, the p
designation for NRC rules in tems of compatibilit U
States in commenting ~on proposed NRC rule changes,y. This would help the where the " Division"
-regulations to eventually be unifers. designation would indicate the e
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It would seen appropriate to reevaluate and possibly modify the existing categorization of NRC requirements in li the Commission policy developed on the issue of compatibility.
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also appropriate to publish the 8.7 procedure as'an NRC statement o It would be b,~
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in much the same way as the. Agreement State program review guidelines, which included early consultation with the States and publication for public comment.
State and public review of the " Division" designations could legitimize the use i
of the concept and would result in greater acceptability.
I
~
i 8.
Discuss the various arguments, pro and con, related to the question I
whether the Low-Level Radioactive Waste Policy Amendments Act of 1985 and its legislative history provide a basis for concluding that Agreement States are to be given a oreater decree of latitude in fashionino their own standards of low-level waste (LLWD disoosal. in view of the States' increased resoonsibility in this arest The LLRWPAA did not change the regulatory framework applicable to Atomic Energy Act materials.
The responsibilit'es of the Commission and the States for i
' licensing and regulating these asterials in order to protect the radiological health and safety of the public continue to be governed by the provisions of j
section 274 of the Atomic Energy Act of 1954, as amended. Under this regulatory scheme, a State is preempted by Federal law from exercising a
regulatory authority over the radiological hazards of Atomic Energy Act materials unless the State has entered into a Section 274b agreement with the Commission.
The retention of this existing regulatory framework was clearly j
emphasized ih the legislative hearings culminating in the LLRWPAA.
i 1
One of the clearest examples that Congress intended to preserve the existing
{
regulatory framework is contained in the.following excerpt from Senate Report j
99-199 to accompany S.1517, Senate Committee on Energy and Natural Resources November 22, 1985, 99th Cong. 1st Session. at p.9.
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" Paragraph (3) emphasizes the continued Federal preesption of authority to regulate Atsic Energy Act materials for radiological health and safety.
This authority is relinquished only through the execution of an agreement pursuant to Section 274b. of the Atomic Energy Act.
i Neither the Low-Level Radioactive Waste Policy Act, nor this Act, nor any compact ratified under j
its terms is intended to affect or alter the Federal-State relationship j
i under the Atomic Energy Act.
The Committee also views this paragraph as providing guidance to compact commissions and host States that health,,
safety, and environmental requirements should take precedence over the 4
i economic or institutional concerns of the host State or the cespect region.
A
" Paragraph.... [5] provides that excep.t as expressly provided in the i
j Low-Level Radioactive Waste Policy Act, nothing containbd in the Act p.
gggg, diminishes or otherwise affects State law. (Esphasis added) i The Ceamittee intends to preserve State law in all instance [ sic) except those in which the operation of State law would undermine the Federal
~
y policy set forth in the Act.
" Paragraph... [4] preserves Federal law and jurisdiction of Federal agencies with respect to previsions of this Act or the regional compacts..."
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The language that Congress decided to use to clearly express its belief that the existing regulatory framework should be preserved was contained in the LLRWPAA.
"Sec. 4(b)... (3) EFFECT OF COMPACTS ON FEDERAL LAW.--Nothing contained i
in this Act or any compact may be construed to confer any new authority on any compact commission or State-...
I
"(4) FEDERAL AllTHDRITY.--Except as expressly provided in this Act, nothing i
contained in this Act or any compact may be construed to limit the applicability of any Federal law or to diminish or otherwise impair the l'
jurisdiction of any Federal agency, or to alter, amend, or otherwise
{
im> air the jurisdiction of any Federal agency, or to alter, amend, or
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ot wrwise affect any Federal law governing the judicTFreview of any j
action taken pursuant to any compact.
"(5) STATE AUTHORITY PRESERVED.--Except as expressly provided in this nothing contained in this Act expands, diminishes, or otherwise affects j
State law." (Emphasis Added) 1 From the discussions above States were not given a greater degree of latitude j
LLRW under section 274.under the LLRWPAA in developing their Agreement St j
However, this legal analysis does not answer the more significant policy questions: Given the important role assigned to the States the LLRWPAA, should NRC insist on uniformity in LLW standards and programs f
Under section 274d.(2) of the Atomic Energy Act, the Commission may enter into 4
an agreement with a State for the assumption of Stata regulatory authority only if "the Commission finds that the State program is in accordance with the 1
requirements of-subsection o. and in all other respects compatible with the 4
Commission's program for the regulation of such materials, and that the State l
saterials covered by the proposed agreement." program is adequate The focus in this report is on the tem " compatible."
j-The application of compatibility has ranged fros~ total State flexibility in some matters to i
essentially identical for other matters such as basic radiation protection j
standards.
i The NRC in 1981 pelished criteria for the guidance of States and the State authority under the terms of an Agrounent.Consission rela i
Commission intends to consider-in approving new or t
i i
1 are not intended to limit Commission discretion in viewing individual They
- agreements or amendments...."
These criteria provide that State regulatory i
programs shall " strive for unifomity in technical definitions and terminology, particularly as related to such things as units of measurement and radiation dese," and that there "shall be unifomity on anximum pomissible doses and i
levels of radiation and concentrations of radioactivity...." (48 FR 7540, January 23, 1981, especially. Criterion 3 at p. 7541.)
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23 On July 21, 1983, the Commission revised Criterion 9 of the WRC's policy statement which deals with radioactive waste disposal. The purpexe of the revision of Criterion 9 was to point out those portions of 10 CFR Part 61 and Part 20 (aanifest system) which must be adopted by a State to enter inte an Agreement in the area of low-level radioactive waste disposal. Criterion 9 was discussed in detail in Section II of this report on page 14.
As noted in Section II, the language of Criterion 9'is ambiguous.
While it uses tha term " compatible " it does not indicate precisely whether, as applied to Part 61's substantive licensing standards, the tem means strict confomity with NRC requirements.
However. < n order to provide guidance to the staff and to better implement the term " compatibility," the State Programs staff adopted internal written procedures, " Internal Procedures, 8. Policy, 8.7 -Criteria for Caspatibility Determinations." As discussed earlier, in the 8.7 internal procedures State Programs categorized pertinent NRC rules according to the degree of unifomity necessary between NRC anJ Agreement State requirements.
Appendix A to these internal procedures contains a " Categorization of NRC Rules by Compatibility Type." This Appendix lists the following sections of 10 CFR 4
Part 61 as Division 1 Rules:
61.2 Definitions (Exceptions - Commission, Director, Gov't Agency) -
61.41 Protection of general population 61.55 Waste classification There are some States who intend to license alternative methods of disposal, such as above-land grade disposal facilities. Their LLRW statutes and regulations have been developed in a manner to reflect this preference.
Although this type of disposal is described in an NRC Branch Technical Position, (NUREG-1241, " Licensing of Alternative Nethods of Disposal of Low-Level Radioactive Waste," December 1986), it is not covered literally by Part 61.
which in theory could be licensed by NRC itself in a non-Agre the general standards of 10 CFR Parts 30, 40 and 70.
In practice, NRC would likely apply technical and performance objective requirements of Part 61 in a review of an above-land grade disposal facility application.
Because of this preference for alternative disposal methods, some States' regulatory programs differ from that af the NRC in a number of respects.
The most notable differences are as follows:
State statutes and regulations prohibit the se of shallow land burial.
With liatted exceptions, State statutes and regula'tfons direct the State to use an alternative method of disposal. One purpose appears to be to facilitate retrievability, a concept not recognized by 10 CFR Part 61.
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In some cases States have more stringent regulatory requirements, j
e.g., a longer period of institutional control. Also, although not i
directly related to the choice of disposal technology, in nne case a j
State has sought'to reserve general authority to impose requirements j
on LLRW disposal that are more stringent than NRC's.
3 ISSUE 1: IS THE.PRONIBITION OF SHALLOW LAND BURIAL _ COMPATIBLE WITH NRC'S I
REGULATORY PROGRAM 7 1,
As an example, Pennsylvania, which is seeking a Limited Agreement for i
the regulation of LLRW, defines the tare " shallow land burial" as i
"the disposal of low-level radioactive waste directly in subsurface trenches without additional confinement in engineered structures or i
by proper packaging in containers as determined by t.he law of the i
host state." This tem is not included in 10 CFR Part 61, which, for i
regulatory purposes, uses more general terms (i.e., "near-surface j
disposal" and "near-surface disposal facility") instead.
The terms "near-surface disposal" and "near-surface disposal facility" are i
broad enough to encompass " shallow land burial." At the same time, they are also associated with specific regulatory requirements applicable to the siting, design, operation and closure of near-surface d.isposal facilities see, e.g., 10 CFR 61.50(a),
61.51(a) and 61.52(a) b
"(t]he Commission may, M, g e, 1 R 61.54 which provides that upon request or on its own initiative, a
authorize provisions other than those set forth in II 61.51 through j
61.53 for the segregation and disposal of waste and for the, design j
and operation of a land disposal facility on a specific basis, if it finds reasonable assurance of compliance with the performance j
objectives of subpart C of this part.") Thus, contrary to the situation in some States, " shallow land burial" is not by its terms prohibited by Part 61. However, the NRC permits disposal by " shallow i
land burial" only to the extent that it is carried out in accordance j
with the Commission's regulations, including, among others, those in 10 CFR Part 61.
j more stringent than NRC's i.e.
it prohibits a practice which Part j
As a result, this aspect of some State programs is 61 may, at least in some c,ases,, allow.
The NRC staff's (OGC, SP, and LLWN) preliminary review of the Pennsylvania statutes and regulations in 1988 Cid not indicate any 3
difficulty with the " prohibition of shallow land burial" provision.
This issue surfaced only during the review of the Pennsylvania draft Limited. Agreement application as a hatter to be approved by the
~
Commission.
l--
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As discussed in a memorandum dated ust 16, 1990 to Harold Denton j
from Carlton Kammerer, there are six cts and four unaffiliated States which have banned the use of shallow-land burial.
Included i
are several Agreement States, Illinois, Nebraska, New York, Texas and i
This prohibition has not been an impediment to
[
making continuing compatibility determinations in those States in the Pas
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~ Moreover, the Commission did not object to this prohibition of i
shallow land burial in entering into an Agreement with the State of 1
Illinois. The 1111acis Low-Level Radioactive Waste Management Act of l
1983 (ILLRWA) was reviewed by NRC offices as part of the 1986 i
Illinois application for a full Agreement. The ILLRWA in Section L
241-6(c), " Waste Facilities - Requirements," provides, "Such regulations adopted for the requirements and performance standards of l
a disposal facility shall not provide for the shallow land burial of low-level radioactive wastes." In addition, this Act states in j
Section 241-8(e), " Waste facility Itcensing-Requirements," "No person shall operate and the Director shall not issue any pemit under this i-Section to operate any disposal facility for the shallow land bu' ial r
j.
i of low-level radioactive wastes in Illinois." Illinois defined shallow land burial aa "a lar.d disposal facility in which radioactive i
waste is disposed of' in or within the upper 30 meters of the earth's surface.
However, this definition shall not include an enclosed, engineered, structurally re-enforced and solidified bunker that j.
extends below the earth's surface."
i j
While these provisions in other State laws have not been objected to 4
by NRC, it is fair to say that until now this past practice say not have been the focus of Commission review.
C.
ISSUE 2: ARE PROVISIONS FOR AN ALTERNATIVE METHOD OF LLRW DISPOSAL COMPATIBLE WITH THE NRC'S LLRW PROGRAM 7
}
Part El as written is not literally applicable to some types of alternative technologies for the disposal of LLRW specified by some States' laws and regulations. Therefore, NRC in theory would need to apply the very general criteria in 10 CFR Parts 30, 40 and 70.
- Thus, these aspects of States' regulatory programs present a variation on 1
i_
Issue 1 above - are States' regulatory programs for LLRW compatible even though a particular disposal technology is preferred and, insofar as 10 CFR Part El criteria would not apply, these States' criterie j
are more fully developed and specific than NRC's.
o l
ISSUE 3: COULD A STATE'S PROVISIONS FOR MDRE STRINGENT REGULATIONS l
BE COMPATIBLE WITH THE NRC?
Issue 3 presents still another variation on Issue 1 -should a State be able to reserve a general right to impose more stringent requirements on LLRW of sposal.
~
L To illustrata, in addition.to' specific regulatory requirements which are more stringent than those established by NRC, some State laws 1
j contain language which purports generally to allow the State to adopt more stringent regulations to the extent authorized or allowable by j
' Federal law.
Exaspies include the Pennsylvania Low-Level Radioactive Waste Disposal Act (LLWA) and the Appalachian States Low-Level Radioactive Wasta Compact Act (ALLWA): Article 3. Section (F)(b) of i
the Pennsylvania ALLWA states, "To the extent authorized by Federal L
law, a host State any adopt more stringent laws, rules or regulations j
f than required by Federal law."
[.
In addition, Section 301 of the LLWA i'
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provides, "The department shall develop and implement a comprehensive l
program for the regulation...and disposal of low-level radioactive 4
waste to the extent allowable under Federal law or State law, j
whichever is more stringent."
i Another example of a State that has sought to establish a standard l
more stringent than that of the NRC is the State of Illinois, j
Section 606.30(d)(4) of the Illinois regulations provides.-"The i
facility shall be operated so that no person outside the facility
{
boundary receives a radiation dose in excess of 1 millires per year to the whole bocty as a result of the facility operation."
The Commission's policy from the earliest days of the Agreement State Program 1
was to maintain some degree of uniformity among the various regulatory programs j
and still recognize that States must be allowed some flexibility to accommodate i
local conditions. The responsibilities vested in States by the LLRWPAA can j
serve as a policy basis for permitting substantial flexibility in the j
development and evaluation of State regulatory programs for LLRW disposal so long as the programs are adequate to protect public health and safety.
!~
A rigid compatibility policy in this area could have far-reaching impacts on States which are developing low-level waste disposal capacity.
Regulatory 3
1 programs of Agreement States such as Nebraska and Illinois and the Agreement i
program proposed by Pennsylvania are planning to use alternative methods of j
disposal.~ A finding of non-compatibility in this area might lead to a j
reevaluation of the acceptability of other Agreement State low-level waste regulatory programs and radiation control programs and impact the j
1-implementation of the LLRWPAA. On the other hand, it would be inconsistent
{
to permit flexibility in regulation of LLRW but insist on conformity on BRC f
matters.
I III. CONCLUSIONS r
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A.
General Conclusion t,
t The experience of the Agreement State Program has been positive. The Agreement States have natured over the years, as ev' danced by their increased competence i
and the expanded scope of their programs. The NRC and the States have worked j
well together as regulatory partners, protecting the public health and safety from radiological hazards.
of the Agreement State Program, pelished in January 1983, NGA co j
the Agreement State Program is one of the most successful State / Federal i
partnerships yet established in terms of 1) the flexibility provided States in i
ass eing regulatory responsibility, 2) successful State performance of j
regulatory duties. and 3) consultatinn with States in the preparation of new l
regulations.
j E.
From the Review of the Lecislative History 1.
gy adding Section 274 to the Atomic Energy Act in 1959 Congress
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gave the States a role in the regulation of nuclear materials consistent with their traditional role in the area of public health and safety.
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2.
j The legislative history of Section 274 askra it clear that uniformity between the Federal program for regulating nuclear materials and the j
proposed State programs was a prime consideratir.9.
This led to the adoption of the language requiring that proposed State programs be i
" compatible" with the Commission's program.
However, in practice, the Commission has never insisted upon strict uniformity.
3.
Neither the' Atomic Energy Act nor the legislative history of Section i
274 provides a prescriptive definition of compatibility.
Therefore, the task force believes that the Commission can define compatibility j
by taking into account all relevant factors.-
i C.
From the Review of past Commission Action and Decisions i
1 1.
In 1961, the Commission first published its criteria for States to l
enter into 274b. agreements.
That criteria required uniformity of j
radiation standards, with emphasis on technical definitions and f
terminology, maximum permissible doses, levels of radiation and concentrations of radioactivity, labels, signs and symbols. This 1
action affirmed the Commission's theoretical authority to establish
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requirements for uniformity by Agreement States.
1 2.
In 1962, the Commission developed standard language for each femal l
agreement which would commit the States, as well as the Commission, to put forth their best efforts in maintaining' compatible programs.
This action affimed the Commission's commitment to working with i
j States cooperatively in the development of radiation standards.
l 1
j 3.
In 1962, the Commission instituted a program of conducting meetings with State personnel to promote compatibility.
In these periodic j
appraisals, the staff had not distinguished between compatibility and adequacy to protect public health and safety.
i 4.
In 1965, trie Commission initiated annual redeterminations of compatibility, which included adequacy determinations, as a consequence of the Walsh-Healy Act.
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5.
In 1981, the Commission esiablished a policy of making separate j
compatibility and adeqtacy determinations in the review of State radiation control programs..
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6.
The Commission Aas, on a number of occasions, alleived Agreement i-States to ad pt standards or program procedures both more and less i
vestrictive than Commission standards. See section II of this paper i
for specific cases..
7.
-In general, development of compatibility criteria and categorization i
of lutC regulations have been ande by the Commission or the staff 1
without State involvement.
L 8.
The Commission has, on a number of occasions, seemed to require a
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high degree of uniformity from Agreement States. For example, the 1
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Commission has required States with low-level waste siting i
regulations to adopt essentially. verbatim the performance objectives j
of 10 CFR Part 61.
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9.
The Commission has benefitted from Agreement State regulatory i
innovation. The State of California devised the group medical 1
licensing concept. The States, through the CRCPD, developed l
regulations for wireline service operations which became the model i
for 10 CFR Part 39. The State of Texas developed a radiographer i
testing and certification program.
j
- 10. The issue of Agreement State compatibility has evolved over the'
- history of the Agreement State program and the criteria for compatibility determinations have changed in the process. There are a number of significant issues coming up, such as BRC, Part 20 j
decommissioning, which suggest that this is an opportune time to j
establish a clear-and sound policy on compatibility.
IV. POLICERECDP91ENDATIONSANDOPTIONS In developing a Commission Policy on compatibility, the Task Force recommends that the following areas be considered: Policy Factors and Program Review j
Areas.
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A.
Policy Factors I
As discussed previously, the Commission has discretion to define i
compatibility and its scope. This means that the NRC can review its regulations and practices and categorize them using the State Programs i
1984 Internal Procedures categories (or some other categories).
- However, NRC has never articulated those factors that should be considered in any new categorization. M ile assuring that a State regulatory program l
provides for adequate safety is important, adequate safety will seldom, if ever, require vert >atia adoption of an NRC regulation or i
practice.
Thus, if adequate protection is the only consideration, there would be no need for arty Division 1 rules, because Division 2 rules, requiring adoption of the same underlying safety States but permitting more' stringent regulations, principle by the j
would be sufficient.
Therefore, in identifying facters which lead to categorization of Division 1 rules (rules States hust adopt essentially verbatis), matters other than direct safety significance play the predominant role.
i In this regard, we offer the following Policy Factors to be considered in
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. deciding the degree,of uniformity that is necessary or desired.
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1.
Need to preserve a Federal leadership role because of greater i
expertise in some areas and need to have a uniform national approach
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to radiation safety matters.
2.
Need for effective communications between regulatory agencies, e.g.
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uniformity of terminology and technical definitions.
3..
Need ta avoid burdens on interstate commerce, e.g. uniformity of
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safety design and labeling of consumer products.
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Need to assure the effective implementation of specific Federal j
initiatives, e.g. recordkeeping in support of a Federal study that is only useful if uniform records are kept.
5.
Need to consider.NRC resources available to evaluate Agreement State programs and train State staff.
Uniformity allows for the use of i
standard reviews and requires less NRC resources.
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6.
Need to provide for equal treatment of licensees from State to State j
to avoid ifconsees shopping around for a lenient regulatory program.
l 7.
Need to promote development of competency of Agreement State.
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8.
Need to encourage State innovation and promote the transfer of State
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as well as Federal initiatives.
I i-9.
Need to consider local conditions and needs.
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- 10. Need to recognize the States' need to provide an equal level of protection for all regulated sources of radiation, e.g. NORM, NARM, j
x-ray machins:s, accelerators.
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- 11. Need to have unifo5m concepts of acceptable practice to deal with public concern as to what is acceptable.
- 12. Need to preclude variations in State practices that could land to local safety benefits at the expense of risks elsewhere.
B.
Procram Review Areas Affected by the Scope of the Policy 4
There are a number of Agreement State program review areas that would be impacted by a Commission policy on compatibility.
The Task Force identified the following areas where the degree of unifomity needs to be j
specifically addressed in implementing the policy.
i, 1.
Basic radiation protection standards. These are standards which have i
been developed and endorsed by national and international standards setting bodies such as NCRP, ICRP and IAEA. These standards include, but am not necessarily limited to, the occupational (and in the new i
part-20, general public) dose limit j
the anximum permissible concentratio,s in 10 CFR Part 20, as well as ns in affluents.
2.
Zaportant definitions. This would include terms such as dose, curie, radiation area high radiation area, etc. that are necessary for the effective commu,nic:;1c.,between radiation control personnel.
This would alsc include radiation signs, radiation symbols, etc.
k Radiation pro'metion erinciples. 'These would include those 3.
i requirements in 10 CFR Part 20 that address fundamental health i
ptqysics pract0ces, such as ALARA, requirements for radiation surveys, and personne1*aonitoring. These areas, although not necessarily L
' established standards by standards setting bodies, are well j
9
30 established principles, acknowledged by experts in the field of health physics as being part of any adequate radiation protection program. These are typically not numerical values, so that evaluation for uniformity is somewhat more difficult.
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4.
Indirect or secondary radiation protection standards.
NRC regulations currently have many indirect standards that are based on the basic standards. Examples are the limits on the transportation of radioactive material.
5.
Licensino policy and procedures. This is a broad category that encompasses the decisions on how radioactive material is regulated through the licensing process. This would include policy on licensing fees, exemptions, general licensing, and the criteria used for evaluating the training and experience of users, the equipment and facilities for using radioactive material, and the procedures followed.
6.
Compliance policy and procedures. This is a broad category including inspection practices, enforcement options, inspection priorities,
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This concerns issues such as the consistency of civil penalties etc.
aplied by the Agreement States and NRC for the same violation.
7.
Information requirements. There are many requirements such as, for example, reports of incidents, overexposures that are for infomation gathering purposes., loss of material, etc.
C.
DPTIONS In reviewing the Policy Factors and the Program Review Areas described above, a number of policy options could be developed by the Commission.
The Task Force identified the following possible options as examples that could be selected by the Commission.
Option 1 - A policy emphasizing the need to preserve a Federal leadership role, effective communications between regulatory agencies, avoid burdens on interstate commerce, assure the effective implementation of specific Federal initiatives, conserve NRC reseurces, and assure equal treatment of licensees.e In this case, regulations such as Part 20, those regarding Itcensing activities (including all medical licensing provisions), low-level wasta requirements, and any new regulations innlemented as a result of the NRC's BRC' policy, would be matters of strict compatibility.
Furthemore, when evaluating other program areas as part of the Commission's Agreement State reviews, the Coastssion staff will look for a high degree of uniformity in licensing procedures, the State's compliance program, etc.
Mion 2 - A policy embracing most of the policy Factors in Option 1 plus
" w need to encourage State ' nnovation, promote the transfer of State as well as Federal initiatives and consider local conditions and needs.
This policy would be similar to the program currently in place where certain standards would be required to be essentially identical to NRC's, but flexibility would be granted in certain areas allowing for State O
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innovation. Some regulations such as the basic limits in Part 20 would i
1 still require a high degree of uniformity, however, areas like medical licensing could be subject to differing State requirements, and areas such as BRC, LLW, etc. would be dealt with on a case-by-case basis.
l Dotion 3 - A policy which would recognize a limited area where uniformity
. was needed to advance specific Federal initiatives but which would othemise encourage State innovation, consider local conditions and needs, 3
and recognize the States' need to provide an equal level of protaction for.
j all regulated sources of radiation.
The balance of the State program would be evaluated for adequacy to protect the public health and safety.
j The Task Force provides these options as examples of the bounding cases and the j
current program. Neerous variations are possible, depending on the weight i
given to each of the. Policy Factors by the Commission.
1
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5 V.
OTHER CONSIDERATIONS i
i The Task Force identified a number of other issues that need to be considered i
in developing a policy on compatibility.
Consistency of Application t
The Commission would need to institute procedures to assure.that the
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enforcement of the compatibility requirement was consistently applied, J
from State to State as well as' from rule to rule.
If State A chose to i
adopt a different standard and the Commission initiated action to teminate the agreement. when the Commission found that State B had i
adopted a standard substantially the same as State A, the Consission would likewise have to initiate proceedings against State 8.
Also, when the f -
Commission determined that rule A and rule B were matters of rule B, Commission action would need to be consistent. compa i
For example, Commission action against State A that did not implement a BRC requirement 4
should not be handled differently from State B that did not adopt the deletion of the exemption for glass enamel frit.
1 Justification for Commission Action on Enforcement of compatibility
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An action,.such as the temination of an agreement for incompatibility i
would be-a significant Commission action which would have a great deal of 1
pi&liefisterest.1Terminationofaninadequatestateprogramisonething,
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teminaties of an adequate program because the State adopted a more
. stringent er merely equivalent requirement is quite another.
i In the extreme case,'tamination for incompatibility can easily be perceived as j
contrary ta safety and protection of the regulated fodustries.
[
Resource Iapacta It is likely that ary change in Commission policy would result in resource fapacts.
For example, the termination of an agreement with a State would 7
require the NRC to expend additional resources for licensing and j
compliance.
The 1989 report on " State Sharing of Costs of MRC Sponsored Training". indicated that the Agreement State Program saves the NRC 214
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FTEs in staff.
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- ~ States' Rights Consission action to construct a rigid standard for compatibility would appear to run countar to a philosophy of enhanced recognition.of States rights, the reason for the Agreement Stata program in the first place.
States have traditionally been responsible for assuring the health and safety of its citizens.
Examples range from auto inspection programs, physician and pharmacy ifcensi and food preparation.
In line with this perspective on States' rights, utive Order 12912 of October 26, 1987 on Federalism, in part, states:
"With respect to national policies administered by the States, the national government should grant the States maximum administrative discretion possible.
Intrusive Federal oversight...is neither necessary nor desirable."
"When undertaking to formulate... policies... agencies shall...
encourage States to develop their own policies... refrain from establishing uniform, national standards...and when national standards are required, consult with... States in developing those standards."
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Appendix A l
REFERENCES i
' Addendum to AEC-R 101/1 - Recossendation of Labor-Management Advisory Committee Concerning State Compatibility with AEC Standards of Radiation Protection," AEC-R 101/2, My 25,1963.
j "AEC Review and Determination of the Adequacy and Compatibility of Agreement State Regulatory programs," AEC-R 101/9. February 2,1967.
Commission Po11gr 919-02, August 15,'1966.
t
" Criteria for the Guidance of States and the Commission Relating to i
Discontinuance of Commission *sthority and Assumption of State Authority j
under the Terms of an Agreesm.t," 48 FR 7540, January 23, 1981.
d i
" Criteria for Guidance of States and AEC in Discontinuance of AEC i
Regulatory Authority and Assumption Thereof by States Through Agreements " 26 FR 2536-2539, March 24, 1961.-
i
- Federal-State Relationships in the Atomic Energy Field," Hearings before i
the Joint cosnittee on Atomic Energy, May 20,1959, 86th Cong.,1st i
Sess.
" Guidelines for NRC Review of Agreement State Radiation Control j
Programs " $2 FR 21132, June 4, 1987.
Joint Committee on Atomic Energy Report to accomparty H.R. 8755 (H.R.
i Report No.1125, September 2, 1959, 86th Cong.,'Ist Sess.
" Proposed Criteria for Discontinuing AEC Regulator Byproduct, Source and Special Nuclear Materials," y Authority Over i.
AEC 957/16, ~
l January 3,1961.
j Policy Statement on the Review of Agreement States, December 4,1981.
(
- Recsamendation of Labor diana 9 ament' Advisory Committee Concerning State Compatibiljty with AEC Standards of Radiation Protection,*, AEC-R 101/1, j
April 8, 1905..-
"Regulatten of Radiation Exposure by Legislative Means," National Rureau of Standards Naneook 61. Recommendations of the National Committee on Radiation Protection, December 9,1955.
i*
- Results of Compatibility Survey of State Views," July 12, 1990.
" Revision of Criterion 9 of the NRC's Polter Statement on Discontinuance of Authority," July 21,19R3.
9 J
3 1
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- 5taff Requirements Namorandus - Collegial Discunions of Items of i
commission Interest " Memorandum dated October 5,1990 to l
Hilliam Parler and Harold R. Denton from Samuel J. Chilk.
i i
State Programs " Internal Procedures, 8. Policy, 8.7-Criteria for
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Compatibility Determinations," Appendix 2, Jeauary 25, 1984.
j
' Status of the Agreement States with Respect to Continued Compatibility,"
l AEC-R 101/8, December 28, 1965.
'The Agreement State Program: A State Perspective,' National Governors' Association Committee on EnerEy and Environment, January 1983.
' Transfer of Federal Regulatory Authority Over Byproduct, Source, and Special Nuclear Materials," AEC 957/12 February 12, 1960.
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