ML20046A826

Provides Commission Results of Staff re-evaluation of Compatibility Divisions Assigned to Performance Objectives in 10CFR61.41-61.44 & Provides Basis for Making Determination on Illinois 1 Mrem Provision

ML20046A826
Person / Time
Issue date:	03/26/1993
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-93-080, SECY-93-80, NUDOCS 9307300108
Download: ML20046A826 (46)

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g i nu inmv3 e \\..... p$ POLICY ISSUE-O March 26, 1993 SECY-93-080 Ep.r: The Commissioners From: James M. Taylor Executive Director for Operations Subiect: RE-EVALUATION OF THE. COMPATIBILITY DIVISIONS ASSIGNED TO THE PERFORMANCE OBJECTIVES IN 10 CFR 61.41 THROUGH 61.44 AND EVALUATION OF THE ILLINOIS 1 MILLIREM PROVISION EurppAe: To provide the Commission.the results of staff re-evaluation of the compatibility divisions assigned to the performance objectives in 10 CFR 61.41 through 61.44 and to-provide-a basis for making a determination on the Illinois 1 millirem provision. Summary: The re-evaluation of the compatibility levels of 10 CFR 61.41 through 61.44'is in response to Staff Requirements Memorandum. (SRM) dated January 22, 1993. This re-evaluation considers-the rationale upon which previous compatibility determinations were l made for these sections. After re-evaluating these compatibility l determinations in light of the past practices in interpreting.and-implementing the compatibility divisions, the rationale for retaining the current compatibility levels of these sections is explained. This. paper also provides options regarding the compatibility of the Illinois 1 millirem provision.with NRC's regulations. j ( Backuround: 1 provides a discussion of State Programs' internal procedures covering compatibility determinations and a copy of these procedures. -.i i NOTE: TO BE MADE PUBLICLY AVAILABLE

Contact:

Cardella Maupin, OSP WHEN THE FINAL SRM IS-MADE j-504-2312 AVAILABLE i l l lh0095 9307300108 930326 " I PDR SECY. 93-OBO PDR k .)

The Commissioners 2 i 10 CFR Part 61, " License Requirements for Land Disposal of Radioactive Waste, Subpart C, contains four performance objectives. The four performance objectives in sections 61.41 through 61.44 were developed specifically for the disposal of low-level radioactive waste (LLRW). At the time 10 CFR Part 61 was developed, it was believed that environmental releases-indicated in 10 CFR Part 20 did not adequately address LLRW sites since releases from these facilities would be more difficult to coatrol than pipe or stack releases. Additionally, the long-term environmental impact had to be considered for LLRW facilities. i In.'.ight of these factors and the absence of EPA environmental standards, the NRC developed the four performance objectives a thrcugh rulemaking. The primary purpose of these objectives was to protect public health and safety and to minimize the burden of -) long-term care of these facilities. j Discussion i In the staff re-evaluation of 10 CFR 61.41 through 61.44, the staff not only considered the various compatibility divisions described in Attachment 1, but also past NRC practice in j interpreting and implementing these provisions. This was done especially with regard to Division 1 rules. The following elaborates on the published Division 1 criteria and its use in the re-evaluation of 10 CFR 61.41 through 61.44. Division 1 regulations include: 1) Provisions that are basic radiation orotection E andards. These are standards which are widely used and t are well-established since they are based on principles established by national and/or international standards setting bodies such as NRC, EPA, National Committee on Radiation Protection (NCRP), International Commission on Radiological Protection (ICRP), and the International Atomic Energy Agency (IAEA). These provisions are followed by industry and government. Basic radiation protection standards normally refer to numerical values assigned to dose limits and maximum permissible concentrations in effluents. 2) Provisions that are needed.for effective communications between regulatory agencies. These provisions would include basic radiation protection terminology and technical definitions, and legal definitions. 3) Provisions that are needed to avoid burdens on j interstate commerce. These provisions would include the-design and labeling requirements of consumer products. i i 1

l The Commissioners 3 10 CFR 61.41, " Protection of the General Population from Releases of Radioactivity," is presently categorized as a Division 1 rule. This section provides that concentrations of radioactive material released to the general environment in. groundwater, surface water, air, soil, plants or animals must not result in an annual -dose exceeding an equivalent of 25 millirems to the whole body, 75 millirems to the thyroid, and 25 millirems to any other organ. of any member of the public. In addition, this section.provides' l that reasonable efforts also must be made to keep releases of radioactivity in effluents to the general environment as low as reasonably achievable (ALARA). These release limits apply at the j site boundary. J When the NRC developed the requirements in 10.CFR 61.41, the l analyses supporting 10 CFR Part 61 demonstrated that these limits could be met by the disposal technology that was being used at the typical regional LLRW sites. The typical regional LLRW sites at that time used shallow land burial. Presently, with the development of new disposal technologies, some State regulatory programs have established ALARA goals or design objectives lower' than the performance objectives in 10 CFR 61.41. The dose limits adopted in 10 CFR 61.41 were categorized in the 1984 compatibility procedure as Division 1 rules. Additionally, che radiation standards in 10 CFR 61.41 were consistent with other environmental limits, e.g. the EPA limit for uranium fuel l cycle in 40 CFR Part 190. The " Statement of Consideration" for i 10 CFR Part 61 states: "With regard to the specific performance objective for i releases to environment, the Environmental Protection Agency commented that the establishment of an individual exposure limit at the site boundary for releases as proposed in S 61.41 is appropriate. They stated that the range of 1 to 25 mrem /yr analyzed by the Commission was a reasonable range that should encompass any standard which EPA might derive for low level waste disposal facilities." The SRM dated January 22, 1993, also refers to the' provisions in 10 CFR 61.41 as specifying " radiation protection standards." The SRM ste: vs the following: "In keeping with the principles of ALARA, such pre-closure operational release limit objectives at LLW disposal facilities may be used to keep the annual doses received by any member of the public at a small fraction of the radiation protection standards specified in 10 CFR 61.41." (Emphasis added)

y av The Commissioners 4. o 1 Thus, 10 CFR 61.41 should be retained as a Division 1 compatibility rule because it serves as a radiation protection standard specifying the dose limits to the public.from the use.of LLRW disposal. 10 CFR 61.42, " Protection of Individuals from Inadvertent-l Intrusion," is presently categorized as a Division 2. compatibility rule. This section provides that the design, operation and closure of the facility must ensure. protection of any individual who inadvertently enters or occupies the site or. who comes in contact with the waste after.the: institutional control period' ends. 10 CFR 61.42 addresses aLradiation ] protection principle for~ protection of the: general public, which: falls under the Division 2 compatibility criteria. This is'an appropriate categorization of this rule since it'does not meet the Division 1 compatibility criteria which includes basic radiation standards, rules affecting interstate. commerce andL l rules essential for effective communication between regulatory agencies. Moreover, the Division 2 categorization of.10 CFR 61.42 assures that the States address this provision in their regulations, yet it allows the States flexibility in. implementing this rule. 10 CFR 61.43, " Protection of Individuals during Operations," is currently a Division 2 compatibility rule. This section'provides-that the operations at the' land disposal facility must comply with the radiation protection requirements of 10'CFR Part 20, except for the release limits-of the site-which is governed by.-10 CFR 61.41. The objective of this~section,.accordingfto the 10 CFR Part 61 " Statement of Consideration," was for the Commission r to affirm that the provisions of 10 CFR Part 20 would apply to all aspects of radiation protection during operation'except for releases of radioactivity from the site which would be' governed by the more stringent requirements of 10 CFR.61.41. This rule'is linked to 10 CFR Part 20 requirements by reference. However, it should be noted that when a section of the regulation references another-portion of the regulations, the division of compatibility of the referenced portion-is not changed by the division of~the referencing section. 10 CFR Part 20 requirements.are currentlyg categorized as Division 1 rules, as. Division 2 rules;and Division 3 rules. The provisions of'10 CFR Part 20 which include, definitions, units of radiation' dose, dose limits and effluent-release limits are categorized as Division 1 rules. The' aspects of Part 20 which deal with basic principles of radiation safety such as ALARA, surveys,,and personnel monitoring'are DivisionL2 rules. Additionally,:those aspects.of 10 CFR Part 20 which are ~ appropriate for adoption-by states but do not' require any' degree of uniformity, such as personnel monitoring reports and. records are Division 3 rules. In summary, Division 1 rules in 10 CFR' l a.-

\\ f' y' /sL The Commissioners 5 r, Part 20 will remain as Division 1 provisions even though 10 CFR 61.43 is a Division.2 rule. 10 CFR 61.43 does not meet the criteria for a Division 1. rule since it dees not contain basic radiation protection standards, i it does not' affect regulatory communication nor interfere with interstate commerce. However, it is a provision that Agreement-States should address and the States should have'ftexibility in' implementing. Moreover, section 61.43 provisions address a radiation protection principle which should be considered in-f decisions on a LLRW site. The current compatibility level of L i Division 2 is appropriate for section 61.43. 10 CFR 61.44, " Stability of the Disposal Site after Closure," is- ~ presently a Division 2 rule. The purpose of this section is-to-provide that all functions, from siting to closure, associated with a LLRW facility should be designed to achieve long-term stability and to eliminate the need for ongoing active maintenance. 10 CFR 61.44 does not meet the current criteria for-a Division 1 rule because it is not a basic radiation standard, ^ it does-not affect effective communications between regulatory l agencies nor.does it have an impact on interstate commerce. However, it does address an important regulatory issue"which should be a part of the States' programs'but the. States'should. have flexibility in implementing it. The categorization of 10 CFR 61.44 as a Division 2' rule provides the States flexibility. Thus, 10 CFR 61.44 should be retained as a Division 2 rule. Evaluation of Illinois 1 Millirem Provision Although the staff was not directed to evaluate the Illinois 1 3 millirem provision, staff believes that this provision:should be evaluated in light of the guidance given'in the January 22, 1993.. SRM. Additionally, the staff would recommend resolution of this issue. The delayed decision has caused the staff during certain routine reviews of the Illinois program to make a finding of compatibility which is contingent upon the resolution of-the 1 l millirem matter. provides a side-by-side comparison of the relevant. statuatory and regulatory provisions of the States of Pennsylvania and; Illinois and' staff comments regarding the compatibility of these provisions. Commission attention :is drawn to Page 2 of Attachment 2 where the Illinois "1 millirem'per i year" offsite dose rate limit is compared to the Pennsylvania's requirement that.an "offsite radiation measurement" that exceeds natural background requires prompt abatement. In either case, the EDO and staff interpret these provisions as requirements and ~ not as objectives as described in the January 22, 1993 SIU4.

i The Commissioners 6 Options: In view of the above, the following options are presented: Option i Use the decision on Pennsylvania as discussed in to determine that Illinois is also compatible with NRC's regulation and endorse the definition of " radiation protection standard" for low-level waste disposal regulation purposes as applying only to specific provisions of 10 CFR 61.41. Pros This option would avoid confrontation with the State of Illinois. This option is consistent with the approach taken to analyze Pennsylvania's low-level waste disposal regulations. This option would further emphasize State regulatory flexibility in the low-level waste field. Cops This option would suggest that a State has broad power to adopt more stringent low-level waste requirements so long as the label " basic radiation protection standard" is avoided and the State incorporates 10 CFR 61.41 verbatim somewhere in its regulations. Since the term " basic radiation protection standard" carries over as a benchmark for a Division 1 regulation in areas other than low-level waste disposal regulations, the commission may have difficulty adopting a compatibility policy in other areas different from the policy in the low-level waste regulation area. Thus this approach may make uniformity difficult. Option 2 Find the Illinois 1 millirem provision incompatible ~ with NRC's regulatory program. Pros This option could prompt the State of Illinois to provide an unambiguous basis for the NRC finding its-provision acceptable. This option could also prompt the State of Illinois to-amend its regulations to remove the 1 millirem provision, which would completely eliminate this issue. r s

t The Commissioners 7 9 Cons The staff has not identified a clear basis for distinguishing Pennsylvania's regulation, which has been found to be compatis3e, from Illinois 1 millirem provision. Illinois may also refuse to amend-or clarify the standard further, forcing the NRC to consider revoking the Illinois low-level waste regulatory. portion of the Illinois agreement as too stringent and therefore '. incompatible. The result could be confusion and litigation in which the NRC is cast in an apparent anti-safety role. Ontion 3 Reconsider the guidance given in SRM dated January 22, 1993 to allow flexibility in Agreement States for LLRW disposal facilities. Pros This option could potentially clarify for staff the-application of compatibility in the area of LLW on a generic basis. This option could potentially clarify for the-States NRC's position on the application of. compatibility in the area of LLW on a generic basis and, by less. emphasis on the " basic radiation protection standards" as requiring strict compatibility, and more. emphasis.on the role of the States in low-level waste disposal, avoid setting any precedent outside the low-level waste disposal regulatory area. Cons This option could bring into question the Commission's action in finding the Pennsylvania LLRW program compatible. The Commission could appear indecisive by changing the basis for the Pennsylvania decision. j i i

I The Commiss'ioners 8 Recommendation': The staff believes that either Option 1 or 3 is acceptable. Both would adequately protect public health and safety and'both would allow some imposition of more stringent related requirements by the State. 'Since the SRM of January 22, 1993 was a Commission policy decision reflecting considerable thought and analyses, the-staff feels it is inappropriate to-recommend a single, specific option. Coordination: The Office of the General Counsel has no legal objection. J mes aylor xecutive Director for Operations Attachments: As stated Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Friday, April 9, 1993. Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Friday, April 2, 1993,'with an infor-mation copy to the Office of the Secretary. If.the paper is of such a nature that-it requires additional review and-comment, the Commissioners and the Secretariat should be apprised of when comments may be expected. DISTRIBUTION: Commissioners i OGC OCAA OIG OPP j EDO SECY 1 i

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-) l t# l STATE AGREEMENTS PROGRAM? 5 3 DIVISION I Interna 1' Procedures ? i B. Policy ' B.7 - Criteria for Compatibility 1 Deteminations j I. Backcround 1 Section ~274d.(2) of the Atomic Energy Act of 1954, as amended, I requires that before entering into an agreement with any State, the-l Comission shall make a detemination that the State's program is-compatible with the Commission's program. Section 274g. authorizes and directs the Comission to cooperate with the States in the ' formulation of standards. to assure that State and Comission i programs will be. coordinated and compatible. Section274j(1) requires that the Comission periodically. review such agreements ' e 'i and actions taken under the agreements to ensure compliance with-Section 274. the Act that address the conce)pt of compatibility. Sections 2 It should be. noted that both sections refer to the compatibility of " programs."- It is evident that Congress intended that the Commission address. more than just regulations'in its review, and since the earliest days of the State Agreements' Program the. Commission has used the. 1 term " compatibility. in relation to not only regulations, but also. to-such however, program areas as' licensing and compliance.will ad This procedure.- .i The Comission.has never formally defined compatibility or provided

• more than minimal guidance as-to how the tem should 'be interpreted. The basic objective has been to achieve'unifomity:

among the various regulatory programs to the maximum extent - practicable recognizing that the States must be allowed some 1 flexibility to accomodate local conditions.. With regard to i regulations, it has been more or less understood that certain-I regulations such as 10 CFR Part 20 were considered to be " matters of compatibility" and that States were n that'had essentially identical language. quired to have regulations 1 - With respect to other-i parts of the regulations it was less clear what requirements were considered " matters of compatibility" and why. In 1961, the j . Comission published criteria for the guidance of States and the 'l Comission relating to the discontinuance of Commission authority under the tems of the agreement. The criteria require that."The 1 State regulatory program shall adopt a set-of standards for: protection against radiation...-It is important to strive for-. j unifomity in technical definitions and terminology, particularly as related to such things as units of measurement and radiation-j dose. There shall'be unifomity on enzimum pemissible' doses and t levels of radiation and concentrations of radioactivity.-as fixed by part 20 of the (Commisston1 regulations ~ based on officially-1 approved radiation protection guides." However, questions remain as to how precisely State regulations must reflect NRC regulations. i 1/25/84 4 i ATTACHMENT 1 I e ..m.-

.~ -t-l 1 In addition, NRC has always encouraged unifomity in regulations other than those listed above, but no specific guidance has been-provided. O ~N 'It should be noted that the Uranium Mill Tailings Radiation ~ Control 4 Act and.the Nuclear Waste Policy Act require Agreement States ~as =! well as' NRC to incorporate certain' elements'in their regulatory i programs' (e.g., environmental assessments, land ownership, 1 financialassurances). These requimments.have been appropriately included in the categorization. u better defining compatibility and detemining the degree to which. ] In light of the above, this procedure establishes criteria for-States regulations must show uniformity with Comission regulations. } JI. RuleCa$gorization Historically, the notion of degrees of compatibility has always been implicit in compatibility deteminations. This notion, however, has never been given substance,in the fem of policies or procedures. Under this procedure pertinent NRC rules are categorized according to the degree of uniformity necessary between HRC and Agreement-State requirements. Four categories are. 1 established as follows: Division 1 Rules ~ There are certain provisions'in NRC regulations that' States'must l adopt,~ essentially verbatim, into their regulations. These. A 1 provisions include those that form the basic language of radiation protection essential for effective comunication between regulatory agencies and the regulated comunity. These provisions have been-i formulated and agreed to by national = and international organizations, from consensus standards followed by industry and. j 1 government. They include technical definitions such as " curie." j dese," and " rad," radiation protection standards such as - occupational exposure limits, effluent release limits,.and legal ~ definitions such as for " byproduct material," " restricted area"'and... " occupational dose.". These. provisions are so basic to the regulatory programs that their modification by a State would result in numerous and. difficult problems including interference -in ; interstate comerce. These provisions are collectively referred to as Division 1 rules and Agreement States are required to adopt essentially identical provisions. j Division 2 Rules There are other provisions in NRC regulations that address basic principles of radiation safety and regulatory functions s such-principles include generally applicab e safety requirements such 'as personnel monitoring and ALARA, and procedural _ requirements such-as detailed in part 19. While States must address 'such principles in their regulations 'the States may adopt requirements more - s 1/25/84 y

3, restrictive than NRC rules.. The use Gf language identical to that in NRC rules is not necessary provided the' Underlying principles are the same. For example.10 CFR 19.11 addresses the posting of certain notices to workers. While we believe that it is important that Agreement State licensees be required to make available to workers certain documents, the manner. location and time 8-constraints under which they are posted may differ somewhat from the corresponding NRC provisions. Local circumstances may dictate more stringent requirements than those of 19.11. Other rules that would be included in this category include basic procedural requirementt. necessary for licensing, inspection authority, incident reporting, and radiation safety. requirements for-industrial radiographers. Such provisions are designated Division 2 rules.

Division 3 Rules There ars'a great number of provisions in NRC regulations which would be appropriate for Agreement States to adopt, but which do not require any degree of uniformity between NRC and States rules. For example, NRC has found group medical licensing to be an improved method of licensing the medical uses of radionuclides. States utilizing a different procedure in licensing medical uses of-radionuclides would not be hindering interstate comerce or deviating in any manner from basic radiation protection standards or procedures. Such rules, some of which relate to areas which are strictly matters between the regulatory agency and the regulated comunity within its jurisdiction are designated Division 3 rules. Such rules include administrative requirements as well as technical-criteria which the agency feels the licensee must address in order-to meet the basic radiation standards. In all cases. States are encouraged to adopt the regulatory approach taken by NRC in such rules, but are not required to do so. Division 4 Rules There are certain regulatory functions which are reserved to NRC pursuant to the Atomic Energy Act and 10 CFR Part 150. Rules pertaining to these areas are designated Division 4 rules. Such rules include those concerning reactor regulation. distribution of-consumer products, exports and imports, and high level waste disposal. State regulations should not address these areas. III. Listing of Pertinent NRC Rules Attached as Appendix A of this procedure is a listing of all pertinent NRC rules-(Parts 19, 20, 30, 31. 32, 33, 34, 35, 40, 61, 70, 71, and 150) by compatibility type. The corresponding section of the Suggested State Regulations can be found in Internal Procedure A.2. 1/25/B4 9

~- g ; c, _ Q-y,7 APPENDIX A-N '1

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CATEGORIZATION DF NRC RULES l

BY COMPATIBILI7 TYPE H Division 1 Rules i 19.3 Definitions (Exceptions - Act Comission, license) 20.3 Definitions (Exceptions - Act Comission, Gov't Agency, license) 20.4 Units of radiation dose 20.5 Units of radioactivity 20.101 Dose.-limits 20.102 PricIr dose 20.103 Concentrations in restricted areas

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'20.104 -Exposure of. minors j 20.105 Levels in'_ unrestricted areas i 20.106 Radioactivity in effluents .i 20.203 Caution _ signs,etc.,except(c)(6)A(7) ~ 20.403 Notifications of Incidents ~ 1 Part 20 _ Appendix B and Appendix C 1 30.4 Definitions:(Exceptions - Act, Commission Gov't Agency, i license., production facility, utilization facility) 30.11 SpecificLexemptions; 30.12 . Contractor exemptions 30.14-Exempt concentration .( 30.15-Exempt-1tems-30.16 Sc-46 resins exemption i 30.18 Exempt quantities y 30.19 ~Self-luminous products 30.20

Gas and aerosol detectors 30.70.

Exempt concentratters schedule 30.71 Exempt quantities schedule-1 31.3 Certain devices:end equipment i 32.2 Definitions 40.4 Definitions:(Exceptions e Act Comission,~ Gov't Agency,- J Phamacist' physician) 40.11 DOE & NRC contractor exemptions 40.13 . Unimportant quantities 40.14 Specific exemptions-40.22 Small, quantities of source material 61.2-Definitions (Exceptions.- Comission, Director, Gov't Agency)- 61.41 Protection of general population 61.55' Waste classification-70.4: Definitions (Exceptions - Act Atomic Weapon Comission, q Commondefense;andsecurity, Gov'tAgency)' 1 70.11' DOE & NRC contractor exemptions ~ 1 -70.14' ~ Specific ezamptions: 71.4 Definitions (those relating to materials. transportation)-

1 71.5 Transportation'of licensed material' 1

i 4. 71.10. Exemptions for low-level materials 1/25/84-A-1 o l m

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g j t v~ = f.' @' J LPart 711 Appendix A. ^ !150.3: " Definitions (b ~ Critical mass ).-(c) (g).l(1), and (j) s ~150.11 ~ w

150.20L Reciprocity.

~ 7 ? Division 2 Rules: g' 4 19.11 Posting of Notices:.' ~ 19.12-Instructions to Workers 19.13-Notifications 19.14-Presence of worker representatives 19.15-Consultation with workers 1 19.16.. Requests for' inspection 1 19.17 ~ Inspection not warranted 1! p 20.1(c) ALARA' j J 20.108 Bionssay Services 1 20.201 Surveys-i! 20.202 Personnel Monitoring 1 m 20.203 (c)t6)and'(7 500 rem /hr rule. Picking up, re)ceiving, and. opening packages ~ 20.205 / 20,207-Storage & control in unrestricted areas 20.301. Waste Disposal - General Requirements a 20.302 Approval of disposal procedures ~~ R 20.303-Sewage disposal 20.311 Transfer for disposal. 20.402 Reports of Theft or loss-20.405.' Reports of.overexposures 0 '20.408. Monitoring Reports on, termination Part'20 Appendix A.. 1 '30.3 Activities requirin Carrier Exemption g license i 30.13- .L 30.31 Types of Licenses 30.32 Application for specific license 30.33 Genera 1' requirements .^ 30.341 ~ Terms & Conditions. "] 30.41-Transfer of byproduct material.. 30.55 ~ Tritium; reports (tobe' deleted) 31.5 Certain measuring, gauging and: controlling devices 31.6 Installation ~of GL gauges 31.7 Luminous safety devices for use in aircraft. 32.11-Introduction of: exempt concentrations-32.12 Material transfer reports; 32.13 Prohibition of introduction 32.51 Manufacture of GL; gauges 32.51a' Manufacture of GL gauges 32.52-Transfer reports - GL gauges 32.53-Manufacture of. luminous safety devices 32.54 Labeling of luminous safety devices ^_ 32.55 -QA, luminous safety devices- - 32.56 Transfer reports ---luminous safety devices 32.57' . Manufacture of Am-241 reference sources 32.58 . Labeling of Am-241 sources 32.59 Leak testing of Am-241 ~ sources.. - 32.61 Manufacture of Sr-90 ice detection' devices 1At5/84: A-2 b j Y Ft

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,c m, - ....,..._____.__________m a u -m-

n. 1 32.62. -QA - ice detection devices l -g 32.70 Manufacture of Medical SL material a '32.71 ~ Manufacture of in vitro kits' 3 32.72 - Manufacture 'of radiophamaceuticals j cj-32.73 Manufacture of generators and reagent kits j 32.74. Manufacture of sources for medical use ' i

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32.101 Schedule 8 - tests for luminous safety devices i 32.102-Schedule C - tests for Am-241 sources j 32.103 Schedule D - tests for Sr-90. ice detection devices i 32.110 Sampling procedures 34.2- ' Definition .34.11 Specific licenses for radiography-34.21 Levels of radiation i 34.22' Locking of devices 34.23 Storage precautions i 34.24 Survey Instruments 34.25 Leak testing, etc. 34.26 Quatterly inventory 34.27 Utilization logs '34.28 Inspection and maintenance 34.31 Training 34.32 Operating and emergency procedures 34.33 Personnel Monitoring 34.41 -Security 34.43 Surveys Part 34 Appendix A i 40.2a Inactive tailings sites 40.12 - Carrier exemptions 40.20 Types of licenses 40.26 GL - possession & storage.of tailings i 40.31(f) & (h) License for source material milling 40.32 General requirements 40.34' Manufacture of depleted uranium products for GL 40.35 Manufacture of depleted uranium products for. GL. R 40.41 Tems and Conditions-i 40.51 Transfer of source material 40.65 Effluent monitoring Part 40 Appendix A 1 61.3 License required 61.10 Content of application j 61.11 General infomation 1 l 61.12 Specific Technical infomation 61.13 Technical analyses j 61.14 Institutional information 61.15 Financial ~information 61.23 Standards for issuance j i 61.24 Conditions of licenses 61.27 Application for renewal or closure j 61.28 - Contents of application for closure 61.29 Post-closure observation 61.30 Transfer 61.31 Temination 61.40 General requirement ,f 1/25 /84 3 A-3 1 1 \\ u l

61.42 Protection of individuals from intrusion 61.43 Protection of individuals during operations 61.44 Stability of site after clesure 61.50 Site suitability requirements 61.51 Site design 61.52 Facility operation and site closure 61.53 Environmental monitoring 61.54 Alternative requirements 61.56 Waste characteristics 61.57 Labeling 61.59 Institutional requirements 61.61 Applicant qualifications 61.62 Funding for closure and stabilization 61.63 Financial assurances 61.81 Tests at disposal facilities 61.82 Comission inspections 70.12 Carrier exemption 70.18 Types of licenses / 70.23(a) Requirements for approval 70.39 Manufacture of Pu calibration sources 70.42 Transfer of SNM i 71.12 GL for NRC approved packages 71.13 Previously approved Type B packages 71.14 GL: DDT containers j 71.16 GL: foreign approved packages 71.81 Operating controls and procedures 71.85 Preliminary determinations 71.87 Routine detertainations (except fissile related) 71.8B Air transport of Pu f 71.89 Opening instructions i 150.31 UMTRCA 150.32 UMTRCA Division 3 Rules ~ 19.1 Purpose 19.2 Scope 19.4 Interpretations 19.5 Corrnunications 19.20 Employee protection 19.30 Violations 19.31 Applications for exemptions 19.32 Discrimination prohibited 20.1 (a)&(b) Purpose 20.2 Scope 20.6 Interpretations 20.7 Comunications j 20.107 Medical diagnosis & therapy i 20.204 Posting exceptions 20.206 Instruction of personnel 20.305 Disposal by incineration 20.306 Biomedical waste rule 20.401 Records 1/25/84 A-4

,_y .m. - m,. _ - - - EN 4 s l.*. .l 0 J ' [, 20.407' PersonnelMonitoringrehorts 1 / 20.409-Notifications and Reports to Individuals 4 20.501i - Applications for exemptions - ~! ~ 20.5022 : Additional Requirements 20.601 --Violations - 1 i '30.1 Purpose &: Scope-1 30.2 Resolution of conflict d 30.5 Interpretations-30.6 Comunications. 30.7-Employee protection'- 30.36-

Expiration of: licenses 30.37 Applications for renewal l

30.38 . Applications for amendment c; 30.39' Comission Action to renew or-amend ' 1 30.51 Records ~ ~2 30.52 Inspections 4 30.53 Tests - l '30.61 Modification and revocation of licenses. 1 30.62 Withholding of byproduct material. 30.63 Violations-' 3

1.1 Purpose and Scope

{ 31.2 Terms and conditions-31.8 Am-241 reference sources-31.9 GL to own material 31.10 Sr-90 ice' detection devices 1 31.11 In-vitro GLt. 1 32.1 . Purpose and scope 33.1-Purpose and.' scope 1 a -{ 33.11 Broad license requirements 33.12 Broad license 1 requirements 33.13. Broad license requirements j 33.14 Broad license. requirements 33.15' ' Broad license requirements; 33.16 Broad license requirements J 33.17-Broad license requirements

1. j 33.100 Schedule A-34.1 Purpose and scope 34.3 Applications for specific;1icenses 34.29 Pemanent radiographic installations 34.42 Posting-34.44 Supervision.of radiographer's assistants

.l 34.51 Applications' for exemptions 35.1 Purpose and scope 35.2 Medical license requirement 35.3(a) Definition of " Human.Use"~- j 35.3(b) : Definition of " physician

• 35.4-

-Application form M 35.11 Licenses for human"use. 35.12 35.13- - Licenses for individual-physician's j Human use of sources? -35.14-Group medical licensing /! 35.21 Teletherapy calibrations-35.22 Teletherapy spot-checks -35.23 Instrument calibration' l9 . t 1/25/84: j A :j j /

i 9 _. ,s 8 35;24! Qualified expert: I m -35.25: Teletherapy room monitor.- 35.261 5-year inspection and servicingc 35.27: Records -35.31? . Medical GL" j 35.41: Misadministration reporting-W, '35.42. Hisadministration reporting - 35.43' Misadministration reporting-35.44: Misadministration reporting 35.45'. Misadministration reporting" 35.100 Medical. Groups 40.1 Purpose-40.2 Scope; 40.3 License requirements 40.5 Comunications. !40.6 Interpretations-d 40.7 Employee protection 40.21 GL-title to. source material ,40.25 . GL-depleted uranium j e'40.31. (a)-(e), ~(g) applications for specific licenses' N 40.42 Expiration-. ~ ti 40.43 Renewal of licenses 40.44 Anendment of licenses 1 40.45 Comission action to renew or amend y 40.46 Inalienability. 40.61 Records 40.62 Inspections i; 40.63-Tests-40.64-Reports 1 ~ 40.71 Modification, etc. 40.81 ~ Violations 61.1. . Purpose and scope 61.4 Communicatiens i 61.5 _ Interpretations 61.6-Exemptions. i 61.7 Concepts 61.9 Employee protection : 61.20~ Filing application 61.21 Repatition-61.22 Updating of application 61.25 Changes 61.26 Amendment of license o 61.80 ' Maintenance of records j - 61.83 Violations 70.1-Purpose' j 3 - 70.2 Scope 70.3 -License requirements .j 70.5 Comunications: j' 70.6-Interpretations. 1 ~ 70.7' ' Employee protection-1 70.19 GL for plutonium reference source-1 .70.20 .GL to'own SNM. = .i 70.21 Filing) Applications (a),(b.ic),(d),(e) Contents of applications-i 70.22 1/25/84s A-6 O

~ 4

.j,

70.31 Issuance of licenses 70.32 Conditions of-licenses (Except statements' strictly applicable 4 tostrategicquantitiesofSNM) JC 70.33-Renewal of licenses - .i 70.34-Amendment of licenses 70.35-Comission Action to renew or amend 70.36 Ina11enability; 70.37 Disclaimer of warranties 70.41 Authorized use of SNM 70.55 Inspections 70.56 Tests 70.61 Modification and revocation 70.71 Violations 71.0 Purpost and scope 71.1 Comunications j 71.2 Interpretations 71.3 Requirement for license 71.7 Specific exemptions 71.9 Exemption of physicians 71.91 Records 71.93 Inspection and tests 71.95 Reports 71.99-Violations 71.101-71.137 QA 150.1 Purpose 150.2 . Scope 150.4 Conrnunications b 150.5 Interpretations .) 150.30 Violations Division 4 Rules 4 ~ 32.14 Manufacture of exempt items 32.15 QA - exempt items 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 - exempt quantities 32.22 Manufacture of self-luminous products 32.23 Safety criteria - self-luminous products 32.24 Table of organ doses - self-luminous products 32.25 Transfer reports '- self-luminous products 32.26 Manufacture of gas and aerosol detectors. 32.27 Safety criteria - gas and aerosol detectors 32.28 Table of organ doses - gas and aertsol. detectors 32.29 Transfer reports - gas and aerosol detectors-32.40 Schedule A 61.8 Reporting: OMB approval 61.16 Other inferination 61.58 Alternative requirements 61.70. Scope 61.71 State and Tribal consultation 61.72 Filing of proposals 1/25/84 A-7

3 61.73L l Comission~ approval 70.13-D00 J.- ^ -70.13a-Foreign aircraft - 70.20s . Strategic ~ quantities of SNH l_ 70.20b-Carriers of SNM-70.22. (f),(g),(h),(1),(j),(k)'and(1). <70.23(b) Requirements for approval

Pu processing g

70.24 Criticality R 70.44 Creditor re!?ulations 70.51 Material ba' ance, etc. 70.52 Reports of criticality 70.53 Material status reports 70.54 Transfer reports 70.57 Measurement control program 70.58-Nuclear material controls 70.59 Effluent monitoring 70.62 Sus' pension and operation in war 71.18 - 71.24 Fissile material '71.31 - 71.77 NRC package approvals 71.83 Assumptions -unknown properties 150.7 Persons in offshore waters '150.10 Persons exempt 150.14 Physical Protection 150.15 Persons not exempt 150.15a Continued Commission authority 150.16 Material transfer reports 150.17 Material transfer reports 150.17a US/IAEA Safeguards requirements 150.19 Tritium reports 150.21 SNM by aircraft i 1/25 /84 A-B G m a

T COMPARISON AND ANALYSIS OF RELEVANT STATUTORY AND REGULATORY PROVISIONS OF PENNSYLVANIA AND ILLINOIS I. Reaulations compatible with 4 61.41: 8 PENNSYLVANIA-ILLINOIS 5 236.13 Protection of the S 601.190 Performance ~ general population and Objectives - Protection of the environment from releases of General Population. from radioactivity. Releases of Radioactivity Concentrations of radioactive Concentrations of radioactive material which may be released material which may be released to the general environment in to the general environment in groundwater, surface-water, ground water, surface water, air, soil, plants or animals air, soil, plants, or animals may not result in an annual must not result in an annual dose exceeding an equivalent of dose exceeding an equivalent of 25 millirems to the whole body, 25 millirems to the whole body, 75 millirems to the thyroid and 75 millirems to the thyroid, i 25 millirems to any other organ and 25 millirems to any other of any member of the public. organ of any member _ of the Releases of radioactivity in public. The licensee shall effluents to the general assume initiatives which are environment shall be within the necessary to maintain releases most restrictive Federal and of radioactivity in effluents Commonwealth regulations and to the general environment as standards which are applicable. low as is reasonably achievable. COMPARISON: The Pennsylvania and Illinois regulations are virtually identical to each other and to 10 CFR S 61.41. The one significant i difference between the two regulations cited above is that the Pennsylvania regulation concludes with a requirement that releases i of radioactive effluents shall be "within the most restrictive Federal and Commonwealth regulations and standards which are applicable," while the Illinois regulation concludes with the requirement. to maintain releases "as low as is reasonably achievabk. ' (ALARA). 1

1 2 II. Additional relevant reculation: PENNSYLVANIA ILLINOIS 5 236.409. Monitoring plan. Section 606.30 Requirements for

Design, Construction, (d)

An offsite radiation Operation, Monitoring, and measurement that exceeds the Maintenance of the Low-Level natural background, as Radioactive Waste Disposal established during Facility preoperational environmental monitoring, shall be reported immediately to the Department and host municipality _and (d) Operation and Maintenance - county. Actions shall be Requirements initiated by the licensee to identify and abate the source of the offsite radiation that exceeds natural background. 4) The facility shall be operated so that no person outside the facility boundary receives a radiation dose in excess of 1 millirem per-year to the whole body as a result of the facility operations. COMPARISON: Both regulations appear unequivocally to require a specific radioactive release rate lower than 10 CFR S 61.41. The Pennsylvania regulation, requires the licensee immediately to notify parties and to initiate actions to identify and abate any offsite measurable radiation release in excess of natural background. The regulation does, by implication, recognize that there may be such a release, but by requiring that the release be abated by the licensee, there is a requirement that the status of zero release be restored. It is stated in terms of an absolute requirement. The Illinois regulation directly requires that the facility be operated so no member of the public receives a dose of 1 millirem. This regulation is also stated in terms of an absolute requirement.

4 3 III. Statute cited as authorizina or recuirina reculations: PENNSYLVANIA ILLINOIS Pennsylvania Low-Level Illinois Low-Level Radioactive Radioactive Waste Disposal Act Waste Management Act Section 305. Facility design S 241-6. Waste facilities-and operational management Requirements regulations. S6 (a) Requirements for Waste The department shall Facilities. The Department establish by. regulation minimum shall promulgate rules and engineering design and regulations establishing operational management eriteria standards applicable to for the regional facility. facilities for the

storage, These criteria shall be in treatment or disposal of low-addition to those required by level radioactive wastes away j

regulations adopted under the from the point of generation Atomic Energy Act of 1954. necessary to protect human Shallow land burial, as defined health and the environment. j in this act, is prohibited. An Such rules and reaulations above-land grade facility is shall reflect the best required unless other designs avallable manaaement provide significant improvement technolooies which are in recoverability, monitoring, economically reasonable, j public health and environmental technoloaically feasible and protection. The facility shall environmentally sound for the have the coal of a zero release storace, treatment and disposal capacity. The criteria shall of such wastes and shall j include, but not be limited to, establish, but need not be provisions for enhanced limited to the establishment containment, recoverability, of: long-term passive isolation, minimization of risks from (1) Requirements and water intrusion, protection performance standards for the from inadvertent intruders,

design, construction, monitoring and special operation, maintenance and requirements for various monitoring of such low-level classes of wastes which shall radioactive waste facilities; include, but not be limited to,

[ Emphasis provisions for the segregation added] and recoverability of Class C waste. [ emphasis added] COMPARISON: Pennsylvania's statute requires a coal of zero release capacity for its disposal facility. As explained by Pennsylvania (see following

4 discussion), the adoption of $236.409 was chosen to implement the zero release goal. Illinois' statute requires that its regulations reflect the " best available management technologies which are economically reasonable, technologically feasible and environmentally sound." This is very similar to the AIARA concept. As set forth following, in the letter from Thomas W.

Ortciger, Director,. Illinois Department of Nuclear Safety, to Kenneth M.

Carr, Chairman, NRC, dated-September 7, 1990, Illinois believes that its 1 millirem regulation implements this requirement. 6 'l l 1

e f 5 IV. Rationale offered by the State for the subiect reculation: PENNSYLVANIA Pennsylvania Bulletin, Volume 19, Number 43, Page 4666 (October 28, 1989): Goal of Zero Release Section 236.13 (relating to protecting the general population and environment from releases-of radioactivity) establishes the standard for release of radidactive material to the general environment. Many comments expressed concern that this performance objective undermines the intent of the act and its-specifications for a disposal facility with a goal of zero release capacity. Many of these same comments are aware that this specific requirement is classified by the imC as division I (must be adopted essentially verbatim) and they recommended that the Department challenge the NRC on this issue. The comments cited the state of Illinois' 1 millirem release standard as a case that deviates from the NRC's division I-classification and a basis for making such challenge. In response to the comments received, and for the purpose of its interest in compatibility issues, the Department submitted a letter to the NRC. That letter proposed to amend the requirements of S 236.13 to zero release. It also asked for the' NRC's comments on Illinois 1 millirem release standard.. The NRC responded to the Department's request by indicating that since the requirement is-division I it must be adopted essentially verbatim and I the proposed change would not - be comptible ; with. the - NRC's regulatory program. Without .a-compatible regulation the Department will.be unable to secure NRC approval of its regulatory package which is necessary to. obtain Limited Agreement Status. Limited Agreement Status is necessary to secure regulatory jurisdiction 1 'l over the facility In addition, the NRC also indicated' -that Illinois' regulations have not yet received a compatibility ' review. Follow-up discussions. with NRC staff suggests that the Illinois 1 millirem release-standard would not be compatible with :the NRC's regulatory program. After considering the N7C's response to the Department's proposed amendment to $~236.13, the Department decided that it would not amend S 236.13-to specify zero release. However, the Department did amend SS 236.11 (relating to

a. .6 scope), 236.401 (relating to scope and purpose) and 236.409 (relating to monitoring plan) to further address the act and its specification for a facility with a goal-of zero release capacity. The last change that was made in addressing the goal of zero release capacity was to add as additional requirement to S 236.409 (relating to monitoring plan). It specifies that for any offeite radiation measurement that exceeds natural background, the licensee shall initiate actions to Inodify %d abate the source. a ILLINOIS Letter from Thomas W. Ortciger, Director, Illinois Department of i Nuclear Safety, to Kenneth M. Carr, Chairman, NRC, dated September 1 { 7, 1990:

j h

d'he regulation containing the 1 millirem criterion ~ was adopted pursuant to Section 6 of the Illinois i Radioactive Waste Management Act (Management Act) which l provides, in part, as follows: l "The Department shall promulgate. rules and regulations establishing standards applicable to facilities for the' storage, treatment or disposal of low-level radioactive wastes away from the point of generation necessary to -l protect human health and the environment. l j Such rules and regulations shall reflect the best available . technologies which are economically reasonable, technologically feasible and environmentally sound for the storage, treatment and disposal of such wastes (Ill. Rev. Stat. 1989, ch :111%, par. 241-6(a)) We believe the intent of the General Assembly in adopting this statute was very similar to the intent of the ALARA principle. The regulation containing the 1 millirem criterion would apply only to a facility for the disposal of low-level. radioactive wastes away from the point of generation.- We believe that the regulation is consistent with the statute and can be satisfied by the facility operator. We do not, however, consider the 1 millirem

7 criterion to be just a design goal. The facility can and will be designed to meet the criterion. Calculations will be done to establish that.the criterion is satisfied. In addition, gamma radiation at the facility will be monitored by both the licensee and by IDNS. Further, the 1 millirem per year requirement will serve to meet the ALARA provisions of Sections 340.1000(b), 601.210, and 606.30 as regards external radiation i exposures. We believe the rule is necessary, is adequate to protect-public health and safety, and is compatible ~ with NRC requirements. We expect to implement it as planned. Also, letter from Thomas Ortciger, Director, Illinois Department of Nuclear Safety, to Carlton Kammerer, NRC, dated January 13, 1993 (Attachment 5): Our position on the 1 millirem per year does limit for the boundary of the disposal site has been covered in several letters from IDNS to the NRC....- In succinct terms, this standard was necessary to facilitate progress in developing a new low-level radioactive waste disposal facility.... This standard was deemed necessary.... t 5 6 9 l ? b

8 V. Analysis of the Illinois 1 millirem provision oursuant to the January 22. 1993 SRM In evaluating the Illinois' 1 millirem provision, the staff used the guidance given in the SRM dated January 22, 1993. This SRM provides that Agreement States should be allowed sufficient flexibility to establish pre-closure operational release limit objectives, as low as reasonably achievable (ALARA) goals, or design objectives at such levels as the State may deem necessary or appropriate, so long as the level of protection of the public health and safety is not less than is afforded by 10 CFR Part 61. The SRM points out that this is in keeping with the principles of ALARA.

Moreover, the SRM provides that these pre-closure operational release limit objectives may be a small fraction of the radiation protection standards specified in 10 CFR 61.41, and that the Agreement States may adopt whatever requirements they deem necessary to enforce such pre-closure operational limit objectives, ALARA goals or design objectives.

However, the SRM also provides that these provisions are not to be construed as radiation protection standards. The Commission explicitly found that Pennsylvania's low-level radioactive waste disposal regulations are compatible with the NRC's regulations according to these criteria. Illinois, like Pennsylvania, has set forth radiation protection standards that are compatible with NRC standards contained in 10 I CFR 61.41 (See IDNS rule 601.190)! However, Illinois has also explicitly applied what the staff believes to be the ALARA concept in establishing an operational release limit objective, which could be considered as pre-closure, in its low-level waste regulations. IDNS Rule 606.30(d) (4) provides: The facility shall be operated so that no person outside the facility boundary receives a radiation dose in excess of 1 millirem per year to the whole body as a result of 1 the facility operations. The letter from Thomas Ortciger to Chairman Carr, dated September 7,

1990, stated that this regulation was adopted pursuant to Section 6 of the Illinois Radioactive Waste Management Act, and "We believe the intent of the General Assembly in adopting this statute J

was very similar to the intent of the ALARA orinciple." (Emphasis added). The SRM states: "In keeping with the principles of ALARA, i such pre-closure operational release limit objectives at' LLRW i disposal facilities may be used to keep the annual doses received by any member of the public at a small fraction of the radiation { protection standards specified in 10 CFR 61.41." It would appear that the Illinois 1 millirem release limit which applies to facility operation would be permitted by the SRM. The Pennsylvania regulation which requires any release above natural background be abated, was identified by the statement in i the Pennsylvania Reaister as a method of implementing the statutory ) j a

i i 9 1 zero release design goal. Both the Illinois rationale of the. ALARA ] principle and the Pennsylvania rationale of the zero release goal were recognized in the SRM, which states: " Agreement States should be allowed sufficient flexibility to establish pre-closure operational release limit objectives,- ALARA goals, or design objectives at such levels as the State may - deem necessary or appropriate, so long as the level of protection of the public health and safety is not less than is afforded by 10 CFR Part 61." l Both the Illinois and the Pennsylvania regulations seem to impose unequivocal requirements of a lower release rate that may be enforced by the State. The SRM stated that it was acceptable for the Agreement States to " adopt whatever requirements they deem j necessary to enforce such pre-closure operational limit objectives, j ALARA goals or design objectives." The Illinois intention to l enforce 1 millirem release regulation appears acceptable under this 1 specification of the SRM. There does not appear to be any basis to distinguish the Pennsylvania provision that releases in excess of natural background "shall be abated" from the Illinois requirement' that the facility "shall be operated" so that no outside person gets a dose in excess of 1 millirem. In neither case does.the regulation H specifically provide for any operational flexibility. To be sure, the Illinois regulation reads more like a radiation protection standard because it is phrased in terms of a maximum permissible i dose, but the Pennsylvania regulation also. incorporates a maximum permissible dose by referring to natural background. Accordingly, under the criteria set forth in the January 22, 1993 SRM, the staff finds no basis to distinguish the Illinois 1 millirem provision from the Pennsylvania regulation which has been found to be compatible by the Commission. t

~* 7-p g. l STATE or ILLINOIS l ~ DEPARTMENT OF NUCLEAR SAFETY 1035 OUTER PARK DRIVE SPRINGFIELD,IL 82704 (217) 785-9900 THOMAS W. ORTCsoER JAMES R. THoMPeoN. September 7. 1990 1 q q The Honorable Kenneth k. Carr Chairman / U.S. Nuclear. Regulatory Connission i Washington, D.C. 20555

Dear Chairman Carr:

This letter is in response to your letter of June =15.11990..My origina1L intent was to respond.to your letter after meeting with_ NRC staff and obtaining further information on the concerns raised in~your__ letter. That meeting had been scheduled for August 8 but _at-the. request of _ NRC staff, was; i postponed indefinitely. '8efore specifically discussing the regulation containing the 1 millires criterion we would like to present-our views on the issue of compatibility. After addressing the 1 millires criterion, we will l again explain our' position on tbt other regulations ~ cited in your letter.. The authority for NRC and A State to enter into an' agreement under which the State assumes regulatory ra,;,casibility for, radioactive materials 1. controlled under the _ Atomic Energy Act is found in Section 274 of that'Act. As you observed. Con 274 to provide that gress enacted Section 274 fu 1959. : We do not read Section uniformity.of Federal and State basic radiation

trotection standards is necessary to properly carry out the respective; regulatory responsibilities of the Federal-government and the States,"Las:

stated in your letter. ~0ne of the' two conditions for entry into an agreement' ~ seder Section 2741s that "the Ctanission-firds:that the State.pregram is.in . acccreance with the requirements 'of_ subsection (o)~and infall other respects compatible with the Cosnission's program for the~ regulation of:such materials, and that the State program is adequate to protect the public health and safety '- with respect to materials' covered by the proposed agreement.' 42 U.S.C. 2021J (d). In our view, compatibility of programs is not the.same as uniformity'or. - identity.of regulations'.-

In paragraph (g) of Section 274 Congress ~authortred and directed'the NRC.

• to cooperate with the States.in the formulation of standards for. protection against hazards of radiation to assure that State and Commission. programs 'for -

protection against hazards of radiation will be. coordinated and compatible." C:-42U.S.C.2021(g). Although Congress authorized and directed NRC to' cooperate with the States in the formulation of radiation protection standards-ATTACHMENT"5.. ,9 }

<E The Honorable Kenneti... Carr %N Page 2 Septemoer 7,-1990 1 "1 I to assure that programs of.the Commission.and the States.wouldLbe coordinated-and compatible.-it is'our understanding that NRC has made compatibility. determinations on an ad hoc basis.. 4 ..q It is our understanding that it has been NRC's practice ~ to require that- { Agreement State standards must be. identical to NRC. standards in very few- ? instances. NRC has required identity for'the Agreement State counterparts of. I exposure and effluent limits in 10 CFR Part 20'and when essentially uniform 'l regulation is necessary to avoid. interference.with the flow of radioactive materials in interstate commerce or the operation of certain businesses across i State lines, j It appears, however, that NRC has taken a much more rigid position'in recent years as to the' meaning of compatibility.- Such a position was not; developed'by NRC in cooperation with the States, despite Congress directive 3 to NRC[and could well lead to judicial or Congressional review of NRC's-y recent position. It;further appears that.NRC's recent position is in large' ] part related to States' activities under the Low-Level Radioactive Waste Policy Act, an Act under which Congress gave the. States, not the NRC, the. Li responsibility to develop capacity for the disposal of low-level radioactive a waste. We agree with Commissioner Curtiss' views on this issue. .i We do not believe that Congress intended that Agreement States must: adopt: and maintain standards for protection against the hazards 'of. radiation that i are identical to standards adopted by the NRC. Furthermore, IDNS does'not believe that it.has been NRC's practice to require such identical-standards - g except as stated above. We are aware of many situations;in'which Agreement-a States have, with NRC's acquiescence, adopted radiation protection standards- .i different from those of the NRC -- both more stringent standards and less stringent standards. To our knowledge, there have been no 'significant. problems arising from the adoption of different radiation protection' standards. 1 by Agreement' States. t Congress provided for withdrawal of Agreement ~ 5 tate authority from an. 1 Agreement State in Section 274(j) of the Atomic Energy Act.Lwhich provides, in .: t part. as follows o "The Comission, upon its on initiative after reasonable notice l and opportunity for hearing to the State with which'an' agreement. under-subsection 7(b)' of j this section has = become effective. or; 1 pon request of the' Governor of such: State, may. terminate /:r : H suspend'all or part of its agreement with.the State and reassert? l the licensing Land ~ regulatory authority. vestediin' it under this; j chapter, if the Commission - finds: that _(1) such temination'or j suspension'is required to protect the public health' and safety ' or.(2)' the State has Enot : complied with one. or" more c of the i requiraments off this sections The: Commission shall pertedically l review such agreements and 'actionsLtaken by the States under the, section." (42U.S.C.52021(j))- ' d agreements to ensure comp 11anceL with ^ the provisions 'of this. i Congress' expressly provided for withdrawal of Agreement State authority' j if.such action'is~ required."to protect the public health and safety." While 4 .an Agreement State standard that is less stringent than an NRC standard could- . j j n ,~

The Honorable Kenneth .g. Carr Page 3 September 7, 1990 conceivably fail to protect the public health and safety, we do not see how an Agreenent State standard that is more stringent than an NRC standard could do f so. We believe it is significant that Congress did not require or authorize NRC to take action against an Agreement State that has a radiation protection standard that is more stringent than NRC's. Contrary to the Comission's justification of its position on compatibility as expressed in your June 15 letter and the NRC's BRC Policy Statement published in the Federal Recister on July 3, there is ample legislative history that supports the view that states are not prohibited from imposing more stringent standards. We understand that Congress' position on this issue under the Atomic Energy Act is generally consistent with its position under other statutes pertaining to other federal agencies. A116 wing Agreement States to adopt radiation protection standards more stringent than those of the NRC is, we believe, not only consistent with the Atomic Energy Act, but also consistent with fundamental precepts of federalism, as embodied in Presidential Executive Order 12612. We are uncertain as to what exactly NRC means by a " basic radiation protection standard." The term is not defined in either the Atomic Energy Act or the NRC's regulations. Since we are unsure exactly what NRC means by a " basic radiation protection standard," we are unable to state whether we consider the 1 millirem per year criterion in Section 606.30(d)(4) to be such a standard. We ' note that the regulation is not a State counterpart of exposure and eft luent limits in 10 CFR Part 20 and would not burden interstate comerce. The regulation containing the 1 millirem criterion was adopted pursuant to Section 6 of the Illinois Low-Level Radioactive Waste Management Act j (Management Act) which provides, in part, as follows: "The Department shall promulgate rules and regulations establishing standards applicable to facilities for the storage, treatment or disposal of low-level radioactive wastes away from the point of generation necessary to protect human health and the environment. Such rules and regulations shall reflect the best available r nagement technologies which are economically reasonable, technologically feasible and environmentally sound f:r the storage, treatment and disposal of such wastes....- (Ill. Rev. Stat.1989, ch.1111, par. 241-6(a)) ) s We believe the intent of the General Assembly in adopting this st'atute was j very similar to the intent of the ALARA principle. The regulation containing the 1 millires criterion would apply only to a facility for the disposal of low-level radioactive wastes away from the point of generation. We believe that the regulation is consistent with the statute and can be satisfied by the facility operator. We do not, however, consider the 1 millirem criterion to be just a design goal. The facility can and will be designed to meet the criterion. Calculations will be done to establish that tha criterion is' satisfied. In addition, gama radiation at the facility i will be monitored by both the licensee and by IDNS. Further, the 1 millirem

~ 9 i i The Honorable Kennet.... 'Carr -Page 41 September 7.-1990 per year requirement will serve to meet the ALARA. provisions!of Sections-j ?, 340.1000(b), 601.210, and 606.30 as regards external radiation exposures. :We' believe the rule-is necessary,.is adequate to protect public health and safety, ar planned. jp is compatible with NRC requirements. We expect to implement it as j You identified four other concerns in the penultimate paragraph of your June 15 letter concerning the regulations in Part 606. We explained each of-d these provisions to the NRC staff during their review cffour program-in. l February. Nevertheless, we are providing the following additional' discussion 1 of these items for the purpose of enhancing the NRC' staff's understanding. NRC Coment No.1 NRC had concernr regarding, "the meaning of the costplete containmer.t requirements for the design and construction of a. disposal facility in Section 606.30'{ a)(4)." IONS Response .Section 606.30(a)(4) states, as a performance objective, thatL the disposal facility shall-be designed and constructed to provide for the.. _ complete containment of waste and waste constituents., We interpret complete'- i containment to mean no detectable releases.of radioactive materials into the unrestricted environment. Our interpretation of how this will be applied is shown on the enclosed-Figure 1 entitled, " Application of Dose Haits' to the Illinois LLW Disposal Facility." k Our reasons for adopting this requirement are as follows:: a) Section 6 of the Management Act provides, in part, that: H "The Department.shall promulgate rules and regulations establishing standards applicable to facilities for the... disposal of low-level _ radioactive' wastes awaya from the i q point ofL generation necessary to protect human l health and. the environment.. Such rules and regulations ~shall ~ reflect- 'i the best available mana economically reasonable, gement-technologies which are technologically feasible -and i avironmentally sound for-the... disposal _of such wastes.*- f.111.Rev. Stat.,ch.111hpar,241-6)_ We believe that the requirement for complete containment of' waste and waste-constituents reflects the capability of such technologies.: i b) We anticipate that the low-level waste disposal facility.heing-- developed will be licensed to accept mixed _ waste. -Since complete-H containment of wastes.is a requirement for hazardous ~ waste disposal facilities, Jit seems prudent to require that 'the facility be-- designed to completely._contain wastes. ' NRC Coment No. 2 NRC stated that-it has concerns regarding "the practicability of meeting o.-.. d

=

i The Honorable Kennei.A.'Carr

Page 5 f

September 7, 1990 N disposal module requirements.for no structural degradation in Section ~ !p 606.30(b)(6)(D) and (E)." 3 IONS Response The purpose.of Section 606.30(b)(6)(D) is to specify that if the strength of1 structural reinforcement is taken into account to satisfy design requirements.- the maximum value that can be attributed to such reinforcement is its' minimum-anticipated strength experienced during the_ design life of the facility. g Similarly Section 606.30(b)(6)(E) specifies that a disposalfmoddle must .'f be designed to achieve requisite structural integrity, independent of any-physical properties of the waste' (anticipated to be' solid and contained in concrete overpacks) that may provide additional structural support to a module, especially to its roof. i Neither of these requirements' preclude or. prohibit structural. degradation-of components of an engineered disposal facility. as implied by this staff 1 Rather, these requirements merely provide that structural integrity coment. of disposal units must be achieved independent.of any contribution that might ? be made by reinforcement compon2nts that are not expected to perform during 4 the entire design period or by the physical properties-of the waste.- NRC Coment No. 3 NRC indicated that it is concerned with "the ambiguity of the-(. requirements in Section 606.30(b)(5) for the design and construction of the disposal unit to withstand all natural phenomena including precipitation for-l five hundred years.' IONS Response ThepurposeofStetton606.30(b)(5)isto'specifythatforanengineered facility the design bases for natural phenomena events (such as an earthquake. j a er a probable maximum precipitation event) are the maximum. natural events that would be anticipated over a 500 year time frame.. This appears to'be' straight-j forward and not ambiguous as suggested by this staff comment. NRC Coment No. 4 -MRC stated it is concerned that Section_606.80 states that the facility; must be closed in a manner that requires only minor custodial care despite other requirements for active maintenance throughout the section.- - 10NS Response Section 606.80 clearly _ states that the closure, post-closure __, and-maintenance and institutional care shall be consistent with the. performance' objectives of Parts 606 and 601 fths performance objective in Section 601.220 y" isnearly.verbatimwithSection$1.44ofNRC's-10CFRPart61). Active- - maintenance is specified for the 10-year post-closure period during which the. licensee retains res maintenance program ponsibility for the facility.is' described in Section 606.80 The need for l y The sco 1 ongoing activities at the disposal-site following.c(c)(1).lpe of losure and transfer to the Stateisaddressed:in' subsection 606.80(d). That section says the plan shall j 9 7 y g-1 ,,,m'f ~ ~ - ---.- -E- -s~ s--- e ~

v-N l .a l :ja. \\The Honorable Kenneth M. Carr i T-

'Page 6.

1;', '

Septemoer 7, 1990.

1 be consistent with the performance objectives.of. this part'and,32LIll.-Adm.- Code 601.. Section 601.220 provides.in~part that the facility is tofbe closed-to eliminate, to the extent practicable, the need;for ongoing-active maintenance of the disposal site following closure'so that only' surveillance, monitoring, or minor custodial' care a' re required.*E We note that NRC'uses'the -

i term " maintenance" during its.five-year observation period discussed.in-

~ _ Section 61.7(c)(3) of Part 61 in the same manner as criticized in this coment. I hope this explanation will assist your staff in better understanding-the'1111nois regulatory provisions. Sincerely, s l \\ / \\ g homas W. tc(ge.- Director 4 TWO/vh - Enc. i y q I i ? ^ q J .I 'I l r o e4 V ,.me, n'.: >e-w- w,, ge +, v 9 4 p-

- - - - - -. - ~. - e suu;s a ~ APOLICATION OF DOSE LIMITS TO Tile _lLLINOIS:

LLW DISPOSAL FACILITY N

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W +, {l Th: 4 f.... Y.. - ' ), n: L STATE OF ILLINOIS ~ DEPARTMENT OF NUCLEAR SAFETY l F ^ D .1035 OUTER PARK DRIVE' t Y SPRINGFIELD, IL 62704 (217) 785-9900 News W. Omcen Ju EocAn' -i January 13, 1993 ocerm . 3 f Carlton Kammerer, Director h Office of LState Programs U.S. Nuclear Regulatory Commission Nail Stop 3-D-23. Washington, D.C. 20555 .j h

Dear Mr. Kammerer:

This-is in response to your letter dated March 2'6,'1992,. describing.the 1 review of the Illinois radiation control program for agreement materials..We - are pleased that you have found the Illinois. program.is adequate to protecti. the public health and safety, which is the-finding required by section 274(j)(1)- of the Atomic Energy Act. Our detailed responses to'your. recommendations' are ~ shown in Attachment I. I do want to comment on your contingent l compatibility findingscas-. expressed in the Conclusion section on page 2 of Enclosure 2 to your letter. z Our' position onLthe 1 millirem per year. dose limit for the boundary of the, disposal: site has been covered in detail in/several letters from--IDNS:to the, NRC.. The most recent'was my letter to former Chairman Carr dated September 7;. 1990,.which contains our rationale for this! requirement.and~ourfintent-to ~ implement it. In addition we met with Commissioners Curtiss and.de Planque.-on: ~ August 27,.1992 and provided.a thorough explhnation of~our views. In, succinct' -terms, this standard was necessary to f acilitate progress in.developingf a new: low. level radio. active waste ~ disposal f acility' ^ pursuant to: State responsibilities under Public, Law' 99-240, " Low-level Radioactive Waste Policy. 6 -Amendments Act of.1985." This standard was= deemed necessary by-the. Governor. 1 - -Legislature, the citizens of Illinois and by IDNS to assuresadequate-protection' of the-public health and. safety. In regard to the contingent. finding on variances in the State's rules 7on . financial assurance for decommissioning and medical misadministration,. weLhave provided our rationale in the attachment. The' differences have been A. thoroughly considered and are-insignificant. r recy W too n ATTACHMENT 4'- p r

P.4 14~ N41 13 '93 ' 03:4!.F11 ItiG I+2PECTOFSffC o-j.. Carlton Kammerer January 13, 1993 Page 2 In light of our comments, I request you reconsider your contingent findings of compatibility and withdraw them. I do appreciate the professionalism of the NRC staff during the review and your comments on our program. ' incerel i Thom Ortcigir Director TWO: gas Attachment cc: James Lynch, NRC Region 111 State Agreement Program Officer i

k [ jhii3293i03:45FtifN G.DIFD"'TCPS C C ~ ' P 14 ] c ?. 3 k ATTACHMENT 1 j Re_sponse to'NRC Aareement State Procram-Review Comments and Recommendations = 1 1. ' Status and Compatibility of Reoulations. f -[ i

i Decommissioning Rule 1

The State uses the term reclaimino'instead of decommissionina.. f Reclaimina means returnina__DroDertv~ to a condition or-state such-that l 'the DroDerty no lonaer Dresents a Dublic health._or safety hazard or; j L threat to the environment.5-Section-- 210-10(5). of the Radiation. 1 Protection Act of.1990. authorizes the Department to require licenseesLto.- i provide adequate financial. assurances ton" protect: the State'against' costs. in. the event of site abandonment or failure of a licensee 2 toj meet the Department's~ requirements, as well as the costs.ofEsite reclamation ..." - The statute:only authorizes collection of money, forLreclamation, i not decommissioning. The difference is -insignificant. i n j .i The State's rule exemots all educational institutions; nuclear: j oharmacies and: medical institutions. State. local and other-aovernmental-aaencies are exemot from the _reovirements unless they are .ma.ior orocessors or waste handlino licensees.- This wasLa policy decision made.by the Department. The-State did not'want toLdivert resources towards surety for= these particular agencies _ andJinstitutions. O The 'use of radioactive materials at these facilities representso only1a' small fraction of the total facility-function. If.the facility ceases-i to use' radioactive. material, the facility or-agency will continue' operating, and the Department will still have.a: responsible entity to j pursue until the facility is reclaimed. For example, if-a universityL 'i stops using radioactive material, the university will continue with:its? primary directive: the education of students. As.a result, the. Department will still be able to deal 'with the institution ~ to' assureLall. e areas are properly reclaimed or decommissioned. There__are no provisions in' the rule for' recordkeepino reouirements;. ' lhe Department has. commented on NRC's latest revisions to'the decommissioning recordkeeping requirements,'and; plans;to propose'. y recordkeeping requirements'when the latest proposed revisions to_NRC's. .l rules become final. (The Department has, intthe-past,- tried tot. incorporate rule ~ changes'before NRC's rule. amendments'become effective, r and that has caused problems. See first item under " Misadministration. Rule.") j I ~$ 1, .l = q S .;-] s_

o P.6/14 fi41 13 '93 03i46H1 IIdG NFECT075 (CC L Page 2-b Response to NRC Comments Misadministration Rule The State us_es the term "reoortable event'" instead of misadministration. The definitions _are the same. - At the same time th: 0 apartment was proposing new medical rules which delete references to medical groups, the NRC was considering amendments to their medical rules. In order to streamline the rulemaking process, the Department's proposed medical rules incorporated some.information the NRC was developing at the time. Unfortunately, the word " reportable event" in the draft working document ' j was changed to " misadministration" in NRC's. Final Rule. By the time t NRC's rules were final, the Department had already ' adopted the term " reportable event." As acknowledged in your comment,- the definitions are the same, and the only difference appears to be' insignificant. The Department's rule accomplishes the same purpose and we do not plan to- ] change it. The "wrono route of admini_stration" is a criteria for a reoortable event - involvino a radiopharmaceutical dosaoe creater than 30 microcuries of l-175 or 1-131. - As indicated above, when proposing the new medical;. rules, the Department incorporated information NRC was proposing at the time. Correspondence to this. Department from NRC in January, 1991. included " wrong route of administration" under this section. When NRC's Final Rule was published (July 25, 1991), the phrase was deleted,.but 'l the Depar tment's medical rules were already final (July 15, 1991). The Department has no plans to change the rule at this. time. The State's rule soeaks to "ascertainino and confirmino" that a =l reonrtable event has occurred. - The NRC uses the term __"_ discovery" of a

l misadministration. - The Department decided that the words " ascertaining

1 and confirming" were more specific than the word _" discovery " Many

j licensees " discover" something they think.is a misadministration and contact the Department, but when they " ascertain and confirm" it,.they usually find it to be only a recordable event.

Licensees are reouired to notify the oatient of the reportable event-within 15 days after the licensee ascertains and confirms that a reportable event has occurred. - The Department decided to require a report to the patient within 15 days'to allow the licensee: to perform a. thorough investigation into the reason for the reportable event and steps to be taken to prevent it'from happening again. There is nothing .j in this requirement that would prevent a physician from discussing the event with the patient sooner than the'15 days. Further, we discussed j this at some length with our Medical'.Use Advisory Board which aided us in arriving at this position.

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.W I G '93 03:46PM IN G MFfCTOF$ (FC_ P.D34 Response to NRC Comments Page 3 2. Technical Quality of _Licensina Actions The_aonlicant should submit _the_omitted Section 3.1.2.1.1 in Volume 4 rel_ated to the monitorino of the primary infiltration collection and det_ection system (ICD) (p. 3.3-14) - The omitted section is 3.1.2.1.6 (p. 3.3-14). The second round of interrogatories included requests for ICD system information. The Department intended to address additional concerns of the ICD system in the third round of interrogatories. The aonlicant should identify the specific construction __ controls to be Le_ quired for placement moisture content on soil fill materials. - eSpecification Section 02224 states that low permeability soil shall be compacted to a homogenous condition with a moisture content / density relationship as presented in Figure 1. Specification 01400, Construction Quality Control, specifies control of the moisture content and moisture / density relationship for soil fill materials through a minimum test frequency. In addition, in response to the second round of interrogatories, the applicant committed to testing and documenting all soil material prior to placement. Adequacy of these controls was under review when licensing activities were halted on October 9,1992. The anolicant should provide leaible drawinas with clear toooorachic contours to assist in the assessment of the 100 year flood and probable maxim _um flood (PMF) levels on the performance of the disposal f acilitv. - Such a map (Figure 2.4-6, Vol. Vill) has been provided in the applicant's response to interrogatory 135(EEI) which requests more detail of floodplain delineation on better mapping. Responses to several second round interrogatories concerning the PMF and 100 year flood were in the process of review when licensing activities were halted on October 9, 1992. Jh.e__ayplicant should_ conduct " state of the art" field permeability tests hin a test fill on_ the low-oermeability soils to verify that established desion_ values for hydraulic conductivity can reasonably be attained with _the planned construction eautoment and procedures. - lhe Department has discussed the construction of a test pad and field permeability testing with the applicant [ Meeting of April 14, 1992; CNSI DVC No. 92-04-02]. The composite liner beneath the Illinois low-level radioactive waste disposal' facility was not intended to prevent leachate migration, as do composite liners beneath municipal and hazardous waste disposal facilities. These disposal facilities also incorporate, under current regulations., continuous monitoring and pumping activities associated with the collection of leachate within the disposal trench which current. regulation of low-level radioactive waste disposal facilities prohibits. ~ 'The composite liner beneath the Illinois radioactive waste disposal ~ facility was intended, primarily, to facilitate monitoring of the effectiveness of the cover system to prevent water penetration. Al so,

. P. 8e l.J .J W 13 '93 03*.f F11'II(G DIFCCTOFS OFC ut d Response to NRC Comments Page 4 the composite liner.beneath the facility prevented groundwater infiltration which would interfere with the monitoring of the cover system into the area beneath the disposal. modules. Therefore, as applicable to the composite liner beneath the facility, field permeability tests such as the Sealed Double-Ring Infiltrometer (SDRI) are not considered essential. As regards the cover system, IDNS may-require field tests to verify that the construction materials and methods produce a cover system that meets the design requirements. The applicant should assess the lona-term performance of facility drainace structures after closure particul_arly with reaard to their erosion resistance and potential underminina of.the northernmost di_srosal modules. - The applicant has provided plan drawings indicating-the anticipated site drainage at 50 years (Dwg. No. 02-52-C-008) and 160 years (Dwg. No. 02-50-C-009) in response to the Department's.first round. of interrogatories. The Department requested, and was in the process of reviewing, further information regarding site drainage and erosion when licensing activities were halted on October 9,1992. The annlicant should assess the_ performance of the Droposed__drainagt sumps. which because of their indicated d_epths and in reco_qnition_ of the-hiah water table elevation. may recuire_lona term active maintenance. This would be in conflict with current State reaulations. - The applicant has revised its closure plan to comply with State regulations. The Department asked several questions in its second round of interrogatories concerning the closure plan including the passive drain system and infiltration Collection and Detection (ICD) system. The responses to these interrogatories were under review when licensing activities were halted on October 9,1992. The annlicant should develop a clear plan with sufficient drawinas and sectiona) views of pronosed borrow fill excavation ODer_3tions to ensure that soil material with the reauired enaineerinq_ properties are available and deliver _able under expected construction operations. - The applicant has provided borrow area drawings (Dwg. Nos. 15-52-C-001 and 15-52-C 002). The Department's concerns involving quality control relative to ensuring available and deliverable soil materials of the required engineering properties was addressed in the second round of interrogatories. The responses to these interrogatories were under review when licensing activities were halted on October 9,1992. The licensina staff should reassess _ (ertain information reauest_s from the consul _tants to verify the reasonableness ___and importance of their comments in r_e_achina reaulatory conclusions on facility licensino and The Department has emphasized to.its consultants the safety issues _4-need to evaluate information requests in accordance with the regulation. Also, the Department has instructed its consultants to reference the request to a particular regulatory requirement and to state the request i

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3. Al[ 13_lI'93103i CF11.3[46 DIFfCTMS OFC P.9 14 1J-

.y Response to.NRC Comments Page 5 l clearly in order to minimize misinterpretation of the question?and the data being requested. fach consultant should cite the appropriate reaulatory sections-that ~ provide the basis for the information reouested from the apolicant in-a. fonnat similar to that used by Envirodyne. - The Department has; emphasized the citing of_ appropriate regulatory sections'to'its consultantc. J 3. Licensina Procedures l "I Because of the sianificance of the " tow-level:Licensina Review Manual" in support of the ultimate licensina decision.'we encouraQe the State to l finalize the development of this document. A final draf t' of-the

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manual was prepared in April 1992. This document.is currently underf 'i revision based on additional comments _ received from Departmental staff;.. g e Even though LLW license application review activities.have ceased, staff. continues to work on this final version of:the Review Manual, andLit will be completed before review of a new application is initiated. ] We recommend that the draft conceptual plan' be expanded and dev' eloped - into complete insocction procedures that will held ensur_e_.that:the_ Low-Level Radioactive Waste Disposal-Facility is constructed as desianed and-- approved. - The Department is in the process of developing a detailed. comprehensive long-range plan concerning all regulatory activitiesL associated with the LtW disposal facility which we anticipate will be completed before review of a new application is initiated. Detailed .j construction oversight inspection procedures will be an integral part of. i this plan. -l ~; ti ,p

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P.11'14 - JtW 13 '93 03:4F11 IMIS MPECTCES Crc Page 7 Response to NRC Comments 4. AdecuaCY Of Product Evaluations Separate and re-evaluate the recistration (Certificate No. 11.-136-5-289-S) for the Models VD and VD(HPl source. Request a completed. updated anolication from Amersham that_better definns the source caosule size._isotones. and activities. This recornmendati_on was made in the form of _a succestion to vour staff durinQ the last Drocram review. - As you know, the evaluation for these sources was performed many years ago by the State of Louisiana. Amersham Corporation has since purchased Gamma Industries and is responsible for these sources. Amersham Corporation has not requested that the registry for these sources be amended. We will try to perform this review as you request; however, a complete review of this registry as you recommend would require an extensive use of the limited resources we currently possess to perform sealed source and device evaluations. If the NRC has concluded that the updating of this registry is a high priority,_ perhaps much of the work could be performed by NRC staff under a technical assistance request from the Department. NRC staff then could personally address those issues it finds most troublesome with the current

registry, i

prototvoe testina should_be cerformed on all sources and devices, if a manufacturer states that the device has an assessed ANSI classification. then the manufacturer must submit information _that allows the reviewer to make an independent determination. Further. if_ap.plicable. the manufacturer must demonstrate compatibility of their source desion with competitor's eouipment. - We concur that prototype testing must be performed on all sources and devices. Your statement that the reviewer must make an independent determination that the device has been assessed the proper ANSI classification may need some clarification. The Department requires the applicant to submit all available information, including pictures if they are available, which documents that the required prototype testing was actually performed. The Department also queries the applicant about the QA program employed for the prototype testing and the results of each test performed. If the information appears reasonable then we have made our ' independent determination" that the proper ANSI classification has been assigned. Submission of testing results from an independent third party testing company would be j i an acceptable alternative. Certainly, we do not, nor does the NRC on a routine basis, actually perform an independent prototype test to ensure conformance with the ANSI standard assigned. Staff was not certain what was meant by your statement that, "if applicable, the manufacturer must demonstrate compatibility of their source design with competitor's equipment." Each device evaluation identifies the sources authorized for use in that particular device. Conceptually, this comment carries implications far beyond the Illinois program.

j .W i 13 *93 03:49F11 IItG.IiIFECTOPS (CC P.12 14- -4 Response to NRC Comments Page 8 The Environmental Conditions section of the certificate should include the uses of the sealed sources (and devices). and the conditions they will be subjected to under normal conditions __of use. If known. the temocrature. Dressure._an_d humidity rances and other environs _that the lources or devices are desianed to withstand should be specified. Also the expected workino life of the product should be stated. - The Department agrees that the items listed in this section should be li.ted s on evaluations. The " expected working life of the product" is a new item for the NRC and Agreement State evaluations. We will make a concerted effort to include this item on future registrations. In listina the external radiation levels.__use the actual levels as measured by the manufacturer, if the manufacturer cannot provide the radiation levels. then conservative calculated levels should be listed. Care __should be exercised when extrapolati_na _ beta measurements. In all cases._a_ theoretical calculation thould be Derformed to check the manufacturer's meas rements. - The Department is careful to perform theoretical calculations to ensure that the manufacturer's radiation levels are appropriate. The Department is cautious when extrapolating beta measurements and neutron radiation levels. The current policy on the labelina_ of _ sources include the identification-of the model of the source. If a model number were placed on all new sealed sources. lost sources could be easily identified as to manufacturer, isotooe. activity. etc. - The_ Department concurs with this statement; however, it is not always physically possible or the most efficient _way of identifying a wide variety of sources..This recommendation obviously is directed at the use of product codes by Amersham Corporation. Product codes are more specific to the use and activity of a specific source than model numbers. In order to have a new source listed in the registry, the model number is purposely general for all source strengths in that grouping, and can be broken down to specific customers and source strengths by product code. The manufacturer can provide more specific information about a source if a product code is given rather than a model number. The Department is investigating the possibility of obtaining a document that cross-references Amersham product codes to model numbers. In addition, if the NRC is. concerned about. responding to incidents with Amersham sources, Amersham representatives are available on pager 24 hours a day to respond to emergencies or provide information.

- P.13 > 1-1 , JM 13 '93 03: 19F11 II4G DIFO* TOPS Orc 4 Response to.NRC Comments Page 9 5. fnforcement Procedures We recommend that the State develoo written procedures for handlina escalated enforcement cases of varyino deorees. - The Department does not agree that additional procedures are needed for handling escalated enforcement cases, since NRC stated that all reviewed enforcement cases appeared to be appropriate. Existing written procedures outline available enforcement tools, and state that these may only be initiated after concurrence between the Head, Inspection and Enforcement and the Chief, Division of Radioactive Materials. The factors that are considered in deciding which enforcement method is used include: l. Health and Safety considerations (such as presence of contamination and exposure to the public), 2. Past enforcement actions against the licensee, and 3. The licensee's demonstrated cooperation with the Department in trying to resolve the situation and correct the violation. The Department's legal office has always been consulted before any enforcement action is taken, because orders must be prepared by counsel. Orders are only prepared after the Manager, Office of Radiation Safety formally requests assistance from the Department's Chief Legal Counsel. W_e recommend that the State complete their enforcement policy on _ inadvertent diso_osal of small cuantities of radioactive materials. and also provide a copy to our Reaion III Office for review and comment prior to implementation. - The Department's policy regarding loss or theft of small quantities of radioactive materials has existed in most of its present form since before Illinois became an Agreement State. Until recently, however, the policy had not been formalized in a memorandum from the Chief, Division of Radioactive Materials. It has been implemented under the discretion of the Head, Inspection and Enforcement. A copy of the formal memorandum is enclosed for your information. No comments are requested or expected. As a general comment we take some exception to the' two coments in Section 5. We have. procedures and policies that, in our opinion, are effective, albeit, not as highly structured as those of the NRC. Further, we have no intention'of seeking review and comment from NRC prior to implementation of new or modified policies and procedures.}}