ML20058P881

Informs Commission of Three Draft Policy Options on Compatibility of Agreement State Regulatory Programs

ML20058P881
Person / Time
Issue date:	10/20/1993
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-93-290, NUDOCS 9310250276
Download: ML20058P881 (24)

Text

(zzzzamm

...... _.. m..........

nasncm mema i _n/ g' D R

_.cc.... _ d n...:i y~

POLICY ISSUE October 20, 1993 SECY-93-290 EOB:

The CommEAl1VEsCONSENT)

O FROM:

James M. Taylor Executive Director for Operations

SUBJECT:

DRAFT POLICY OPTIONS ON COMPATIBILITY PURPOSE:

To inform the Commission of three draft policy options on the compatibility of Agreement State regulatory programs that the staff plans to discuss at the October 24-27, 1993 All Agreement State Meeting.

SUMMARY

As discussed at the August 30, 1993 Commission briefing on results of the Agreement State Compatibility Workshop, the staff plans to discuss draft policy options for determining compatibility of Agreement State programs with those of the NRC at the annual All Agreement States Meeting on October 24-27, 1993.

Three draft policy options are discussed in the alternatives section of this paper.

In preparation for this discussion, the staff plans to disseminate the three draft policy options to the Agreement States in slide presentation format to obtain Agreement State views on the draft options and to solicit options proposed by the Agreement States.

BACKGROUND:

The compatibility of Agreement State regulatory programs with the NRC has been of concern in many recent policy discussions between the Commission and the Agreement States.

In order to respond to these concerns, the Commission directed the staff to develop a Commission policy on compatibility.

A working group was established to perform this task with input from the Organization of Agreement States.

The working group's draft issues paper was discussed with the Agreement States on May 20 1993 during a public meeting following the annual meeting the Conference of Radiation Control Program Directors, Inc.

Contact:

Sheldon Schwartz, OSP 504-2325 NOTE:

TO BE MADE PUBLICLY AVAILADLE WHEN THE FINAL SRM IS MADE Cardelia Maupin, OSP AVAILABLE 504-2312 v/L Y

-1 1700.N b[OM M D l

ggggfMgMYMMMMMMMA Y

5 r

i rr The Commissioncrs 2

In addition to the working group, representatives from the Agreement States, the regulated community, the non-Agreement States, and the general public participated in a July 1993 public workshop on the compatibility policy issues.

The results of these efforts were discussed with the Commission during the August 30, 1993 briefing.

Lectislative Backaround:

The working group relied upon Section 274 of the Atomic Energy Act of 1954, as amended and its legislative history for guidance in the development of draft policy options on compatibility.

A i

review of the legislative history revealed that neither the Atomic Energy Act, nor the legislative history of Section 274 provides a definition of " compatibility."

However, the legislative history indicates that the general concept of uniformity and avoiding conflicts arad overlaps between the Federal program regulating nuclear materials and the proposed-i State programs were a prime consideration during the development of this legislation.

This led to the adoption of the language requiring that proposed State programs be " compatible" with the Commission's program.

l Compatibility can be defined to incorporate regulations, policies, procedures, and/or program elements.

A broad-scope definition is indicated by the statutory requirement that the

" program" be compatible.

A compatibility policy could be geared toward providing flexibility to address local conditions or uniformity with the NRC's regulatory program or a combination of flexibility in some areas and uniformity in others.

Moreover, any compatibility policy should consider principles based upon l

Section 274.

These principles are:

1.

Recognize the interests of tne States in the regulation i

of byproduct, source, and special nuclear materials.

2.

Recognize the need and establish programs for cooperation between the States and the Commission with respect to control of radiation hazards associated with the use of byproduct, source, and special nuclear materials.

3.

Promote an orderly regulatory pattern between the Commission and State governments with respect to control of radiation hazards associated with use of byproduct, source, and special nuclear materials.

4.

Provide for coordination of the development of radiation standards and other policies through coope.ation with States (early and substantive involvement).

,,n

,-,-,---,w

-n.,,-,,-m,.,,,-s-m, w-e e -,

e-,-

m,,n-,.ww,.e---

.o,~-,

e

--wnw,-,

y-n,w--.

a-o,-

j i

The Commissioners 3

h Any compatibility policy must strike a balance among these l

principles.

For example, in looking at Principle 1, d

considerations are made for flexibility to accommodate local 1

conditions end needs and State innovation must be examined.

}

Principle 2 provides for Federal safety initiatives and for national leadership in the area of radiation safety, such as the establishment of uniformity in the collection of information from the States in order to improve the national materials regulatory program (e.g., uniformity in misadministration reporting and event reporting).

Principle 3 considers the need for uniformity l

of radiation protection standards, uniformity in terminology and technical definitions, dose limits,. effluent releases, etc.

Principle 3 also concerns the avoiding of burdens on interstate commerce.

Principle 4 takes into consideration the staff I

proposed changes to the early and substantive involvement of the Agreement States in NRC's rulemaking process.

In addition, in light of the discussions at the August 30, 1993 j

commission briefing on a policy which would combine adequacy and compatibility, the compatibility working group also examined I

Section 274 of the Atomic Energy Act provisions which requires that Agreement State Programs be both " adequate" and

" compatible."

There is no legislative guidance on the meaning of

{

" adequate to protect the public health and safety," but a i

reasonable meaning can be deduced from the context: a program with all its elements, including standards, organization, and l

resources, is " adequate" if it at least has those attributes considered necessary by the commission to maintain some minimally l

acceptable level of protection.

As noted, there is some legislative guidance regarding the intended meaning of " compatibility."

However, since the term is 1

not defined in the statute, the Commission has the broad authority to define the term " compatibility," as well as, the factors and components that make a State radiation control program " compatible."

The Commission determinations should be exercised in a non-arbitrary fashion and a rational distinction i

should be maintained between " adequate to protect public health and safety and " compatible with NRC regulatory programs."

Discussion:

The question posed by the current task to develop a compatibility policy centers on making a determination of what components or elements of a State radiation control program are needed over and above those required for an adequate program.

As the foregoing discussion indicates, those elements necessary for adequate protection cannot fall into this " extra" category of compatibility since they are already required for adequacy.

This poses a difficult question to the policy maker seeking to define compatibility.

The policy maker must identify considerations other than maintaining a minimally acceptable level of protection

/

The Commissioners 4

that are sufficiently important from a national perspective that NRC would suspend or revoke an " adequate" State program which lacked them.

A definition of compatibility may emerge by answering four distinct questions:

)

1.

Should the State program include additional elements which, while not essential for adequate protection, are part of NRC's program for the same materials and considered useful and appropriate to improve safety beyond the minimum?

A guide could be the backfit rule 4

in 10 CFR 50.109 which authorizes the Commission to l

require incremental power reactor safety improvements beyond the level of adequate protection so long as the increment will result in a substantial increase in overall protection and the costs are justified by the benefits.

Procedural and organizational matters as well as substantive safety standards could be included.

Some examples:

An NRC regulation defining adequacy, for example revised Part 20, could be incorporated into an

" adequate" State program by effective orders and J

license conditions while a " compatible" program would require State regulations identical, or nearly identical to selected provisions of 10 CFR Part 20.

A State program that has an enforcement program could be " adequate", but compatibility could require the authority to levy civil penalties.

2.

Should the State be permitted to adopt more stringent requirements than NRC?

In most cases a more stringent State requirement or program element will be adequate, but there is the possibility that some stringent provisions would adversely affect other parts of the program, or persons or property outside the State.

An example:

A State program inspects licenses at a frequency that is greater than that of the NRC and places all of its resources on the inspection program; and consequently, the technical quality of licensing actions suffer and enforcement actions are not completed.

3.

Should the State program be identical to NRC's program in some particular aspect because of some overriding interest in national uniformity notwithstanding that

r i

j r

The Commissioners 5

i the State program achieves the same level of protection or safety as NRC?

For example-l i

A State could achieve the same level of protection as NRC but use different definitions which make l

communication with other States and NRC difficult.

A State program could require a label on consumer products which, while essentially identical in content to the label approved by NRC and other i

States, is sufficiently different in format to pose difficulties to manufacturers for the interstate market.

}

4.

Should the State program include some attributes solely l

or primarily to support an NRC safety initiative?

For example:

NRC plans to study trends in misadministrations l

nationwide in order to improve its regulatory program, and wants to impose a uniform misadministration reporting system on States in order to facilitate the study.

In each of these areas NRC might have an interest in compatibility as distinct from adequacy.

In each of these areas NRC would be in a reasonable position to suspend or revoke an incompatible but adequate program, although in all cases the overriding national interest must be identified clearly.

It is also fair to say that in each of these areas the consequences of incompatibility are less severe and probably less immediate than the usual consequences which may flow from inadequacy.

Without some clear concept of compatibility (as distinguished from adequacy),

the Commission cannot articulate how it intends to resolve NRC Agreement State Program inconsistencies, and any NRC review to identify matters of compatibility will be inconsistent.

For example, without some underlying concept of compatibility, how could we distinguish between two State programs that seem to provide equal protection.

What is there about these differences which would cause NRC to revoke both programs, or one but not the other, or neither?

Finally, without some common understanding of the compatibility concept, a State cannot comment intelligently, let alone persuasively, in response to NRC proposals to make rules a matter of compatibility.

The staff recommends that a conceptual definition which addresses the above four questions be used as the basic element of a new compatibility policy.

This conceptual definition could also serve as a useful framework to pose the essential policy issue to the Commission --- in each of these areas does the Commission favor Agreement State flexibility, as urged by the Agreement

The Commissioners 6

States and Executive Order 12612 (1987), or does it favor national uniformity.

The remaining part of the policy could identify national and local factors that would be relevant in answering each of the four questions.

The staff has developed three draft policy options with these issues in mind.

Alternatives:

The policy options identified below are premised on the concept that the adequacy of a State program would be the fundamental starting point in the approval or review of a State program. As a basis for the adequacy finding, the staff would determine what regulations and other program elements are necessary to ensure adequate protection of the public health and safety.

The compatibility finding would then be based on what elements would be necessary, over and above that required for adequacy, for a State to have a compatible program.

These compatibility requirements would be guided by the development of a broad Commission policy based on the consideration of the following four issue areas:

Issue 1:

Should the State program include additional elements which, while not essential for adequate protection, are part of NRC's program for the same materials and considered useful and appropriate to improve safety beyond the minimum?

Issue 2:

Should the State be permitted to adopt more stringent requirements than the NRC?

Issue 3:

Should the State program be identical in some particular aspect because of some overriding interest in national uniformity notwithstanding that the State program is directed at the same level of safety?

Issue 4:

Should the State program include some attributes solely or primarily to support an NRC safety initiative?

Under this approach, three options are available for a general compatibility policy.

The staff has not identified the existing compatibility methodology set forth in Internal Procedures B.7 as one of the options.

Each option would require revision of the existing Internal Procedures B.7.

Under the existing B.7 procedures, issues of adequate protection are intertwined with compatibility issues, which results in a fairly complicated process.

The proposed compatibility policy options attempt to more clearly separate the factors that are important to adequacy, from the factors that are important to compatibility.

The Commissioners 7

OPTION I - OVERALL PRESUMPTION OF FLEXIBILITY Under this option, the application of the four issues identified above to any particular regulation or program element would be guided by the presumption of flexibility.

For example, in terms of Issue 1, it would be presumed that a State program would not be required to include any additional elements that cre part of the NRC's program for the same materials in order for the State program to be found compatible. Likewise, the States would be presumed to have the flexibility to adopt more stringent standards, keeping in mind that unc'.er all of these options, a State would already be required as a matter of adequacy, to have adopted the basic regulatory framework necessary to provide adequate protection for the public health and safety.

In any given instance, this presumption could be rebutted, either in the initial staff evaluation, or in response to State comments on the proposed compatibility assignment.

A presumption of flexibility would be consistent with the Commission's compatibility determination in regards to the low-level waste regulations of the Commonwealth of Pennsylvania and the State of Illinois.

In those determinations, the Commission decided that the States should be allowed significant flexibility to establish more stringent low-level waste requirements so long as these are not construed as radiation protection standards or essential for adequate protection.

Under Option I (as well as options II and III), a State would be required to implement basic i

radiation protection standards in order to establish an adequate program. Option I would then provide the State with the flexibility, similar to that provided by the Commission in the Illinois and Pennsylvania decisions, to establish more stringent requirements.

Option I is also consistent with the recent Executive Order 12866, " Regulatory Planning and Review," dated October 4,

1993, (XO 12866) which sets forth the principle that j

"the American people deserve regulatory approaches that respect the role of State, local, and tribal governments."

Although the NRC is not included within the definition of agency in XO 12866, executive branch agencies are "wherever feasible, asked to seek the views of appropriate State, local, and tribal i

officials before imposing regulatory requirements that might significantly or uniquely affect those governmental entities."

Finally, a presumption of flexibility would be consistent with the move to place more emphasis on the adequacy finding and less emphasis on the compatibility finding because the consequences of incompatibility would be now be less severe than the usual consequences which may flow from inadequacy.

i OPTION II - OVERALL PRESUMPTION OF UNIFORMITY Under this option, the application of the four issues identified above to any particular regulation or program element would be guided by the presumption of uniformity.

For example, in terms i

h

The Commissioners 8

of Issue 1, it would be presumed that a State program would be j

required to include any additional elements that are part of the NRC's program for the same materials in order for the State program to be found compatible.

Likewise, it would be presumed that the States could not adopt more stringent regulations under Issue 2.

However, in any given instance, this presumption could be rebutted, either in the initial staff evaluation, or in response to State comments on a proposed compatibility assignment.

OPTION III - PRESUMPTION OF UNIFORMITY OR FLEXIBILITY BASED ON THE INDIVIDUAL ISSUE Under this option, the Commission would assign the presumption of uniformity or flexibility depending on the particular issue.

For example, it would be a legitimate policy choice for the Commission to assign a presumption of uniformity to areas where there is an overriding interest in national uniformity, for example, a national interest in promoting uniformity in basic radiation protection standards and clear communication through the use of identical definitions, while assigning a presumption of flexibility that would allow the States to adopt other more stringent regulations.

The benefits of Option III would be to l

allow the Commission to tailor the presumptions according to the particule policy area.

For example, the staff has previously identified several discrete, and sometimes competing, policy factors for determining the degree of compatibility required (see SECY 91-039, " Evaluation of Agreement State Compatibility, February 12, 1991).

These factors include encouraging State I

innovation in radiation protection, providing for a Federal leadership role in radiation protection, ensuring clear communication in terminology, preventing burdens on interstate commerce and discouraging " pollution havens", and providing for the consideration of local conditions and needs. These policy factors could be more easily accommodated in the tailored approach of Option III than they could in the blanket approaches in Options I and II.

Under any of the options, the presumption can be rebutted.

Therefore, all three options provide some flexibility to the j

staff and the Commission in assigning compatibility requirements to a specific regulation or program elem'nt.

Coordination:

The Office of General Counsel has no legal objection.

_ _ _ _.. ~

l 1

I i

~

The Commissioners 9

I Note:

Staff plans to discuss slides outlining these options with the Agreement States at the annual All Agreement State Meeting on October 24-27, 1994 unless instructed otherwise by the Commission.

m

/

L Tay1/N Jan s M.

r i

Ex cutive Direct l

for Operations l

Enclosure:

As stated l

SECY NOTE:

In the absence of instructions to the contrary, SECY will notify the staff on Thursday, October 21, 1993, that the Commission, by negative consent, assents to the action proposed in this paper.

DISTRIBUTION:

Commissioners

)

OGC i

OCAA OIG OPA OCA OPP EDO ACNW ASLBP SECY l

I I

l i

..-.-... --.~..

._,._.m.

1 STATE AGREEMENTS PROGRAM DIVISION I Internal Procedures i

B. Policy B.7 - Criteria for Compatibility Deteminations

===1.

Background===

Section 274d.(2) of the Atomic Energy Act of 1954, as amended, requires that before entering into an agreement with any State, the Comission shall make a determination that the State's program is compatible with the Comission's program. Section 274g. authorizes and directs the Comission to cooperate with the Sta,tes in the formulation of standards to assure that State and Comission programs will be coordinated and compatible. Section 274j(1) requires that the Comission periodically review such agreements and actions taken under the agreements to ensure compliance with Section 274 Sections 274d(2) and 274g. are the only sections of the Act that address the concept of compatibility.

It should be noted that both sectio'1s refer to the compatibility of " programs."

It is evident that Congress intended that the Comission address more than just regulations in its review, and since the earliest days of the State Agreements Program the Comission has used the term " compatibility" in relation to not only regulations, but also to such program areas as licensing and compliance. This procedure, however, will address compatibility only as it affects regulations.

The Commission has never formally defined compatibility or provided more than minimal guidance as to how the term should be interpreted. The basic objective has been to achieve uniformity i

among the various regulatory programs to the maximum extent practicable recognizing that the States must be allowed some flexibility to accomodate local conditions. With regard to regulations, it has been more or less understood that certain regulations such as 10 CFR Part 20 were considered to be " matters of compatibility" and that States were required to have regulations that had essentially identical language. With respect to other parts of the regulations it was less clear what requirements were considered " matters of compatibility" and why.

In 1961, the Corrnission published criteria for the guidance of States and the Commission relating to the discontinuance of Comission authority under the terms of the agreement. The criteria require that "The State regulatory program shall adopt a set of standards for protection against radiation... It is important to strive for uniformity in technical definitions and terminology, particularly as related to such things as units of measurement and radiation dose. There shall be unifomity on maximum pemissible doses and i

levels of radiation and concentrations of radioactivity, as fixed j

by % rt 20 of the [ Commission] regulations based on officially approved radiation protection guides." However, questions remain

)

as to how precisely State regulations must reflect 'RC regulations.

N

)

1/25/84

j, In addition, NRC has always encouraged unifomity in regulations other than tho3e listed above, but no specific guidance has been i

provided.

i It should be noted that the Uranium kill Taii sgs Radiation Control i

Act and the Nuclear Waste Policy Act require Agreement States as i

well as NRC to incorporate certain elements in their regulatory programs (e.g., environmental assessments, land ownership, financial assurances). These requirements have been appropriately included in the categorization.

In light of the above, this procedure establishes criteria for

~

better defining compatibility and detemining the degree to which States regulations must show unifomity with Commission regulations.

II. Rule Cateoorization Historically, the notion of degrees of compatibility has always been implicit in compatibility deteminations. This notion, i

however, has never been given substance in the fom of policies or procedures. Under this procedure pertinent NRC rules are categorized according to the degree of unifomity necessary between NRC and Agreement State requirements.

Four categories are established as follows:

Division 1 Rules There are certain provisions in NRC regulations that States must acapt, essentially verbatim, into their regulations.

These 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 fomulated and agreed to by national and international organizations, from consensus standards followed by industry and They include technical definitions such as " curie,"

government.

" dose," and " rad," radiation protection standards such as occupational exposure lirnits, effluent release limits, and legal i

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.

Division 2 Rules There are other provisions in NRC regulations that address basic principles of radiation safety and regulatory functions. Such principles include generally applicable 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 4

1/25/B4

restrictive than NRC rules. The use of 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 3

that Agreement State licensees be required to make available to i

workers certain documents, the manner, location and time 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 requirements 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 are 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 racionuclides.

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 j

or procedures. Such rules, some of which relate to areas which are strictly matters between the regulatory agency and the regulated j

comunity within its jurisdiction are designated Division 3 rules.

i 1

Such rules include administrative requirements as well as technical criteria which the agency feels the licensee must address in order i

to neet 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.

4 Division 4 Rules 4

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 i

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.

1/25/84

APPENDIX A e.

CATEGORIZATION DF NRC RULES BY COMPATIBILITY TYPE Division 1 Rules 19.3 Definitions (Exceptions - Act, Commission, license) l 20.3 Definitions (Exceptions - Act, Cosmission, Gov't Agent;y, license) 20.4 Units of radiation dose 20.5 Units of radioactivity 20.101 Dose limits 20.102 Prior dose 20.103 Concentrations in restricted areas 20.104 Exposure of minors

}

20.105 Levels in unrestricted areas 20.106 Radioactivity in effluents 20.203 Cautionsigns,etc.,except(c)(6)&(7) 20.403 Notification of Incidents Part 20 Appendix B and Appendix C 1

30.4 Definitions (Exceptions - Acts, Cossnission, Gov't Agency,

)

license, production facility, utilization facility) i 30.11 Specific exemptions 30.12 Contractor exemptions 30.14 Exempt concentration 30.15 Exempt items 30.16 Sc-46 resins exemption 30.18 Exempt quantities 30.19 Self-luminous products l

30.20 Gas and aerosol detectors l

30.70 Exempt concentrations schedule l

30.71 Exempt quantities schedule 31.3 Certain devices and equipment 32.2 Definitions l

Definition Misadministration 35.2 40.4 Definitions (Exceptions - Act, Commission, Gov't Agency, Phannacist, physician) 40.11 DDE & NRC contractor exemptions 40.13 Unimportant quantities 40.14 Specific exemptions 40.22 Small quantities of source material 61.2 Definitions (E ytions - Comunission, Director, Gov't Agency) 61.41 Protection of general populat bn i

61.55 Waste classifictlion 70.4 Definitions (Exemptions - Act. Atomic Weapon Commission, Connon defense and security, Gov't Agency) i 70.11 DC. & NRC contractor exemptions 70.14 Specific exemptions 71.4 Definitions (those relating to materials transportation) 71.5 Transportation of licensed material 71.10 Exemptions for low-level materials A-1 l

4 i

I Part 71 Appendix A

~

150.3 Definitions (b),(c), (g), (1), and (j) i 150.11 Critical mass 150.20 Reciprocity Division 2 Rules 19.11 Posting of Notices 19.12 Instructions to Workers 19.13 Notifications 19.14 Presence of worker representatives 19.15 Consultation with workers 19.16 Requests for inspection i

19.17 Inspection not warranted 20.1(c)

ALARA i

20.108 Bioassay Services i

20.201 Surveys 20.202 Personnel Monitoring

]

20.203 (c)(6) and (7) 500 ren/hr rule 20.205 Picking up, rectiving, and opening packages 20.207 Storage & contrel c *nrestricted areas i

20.301 Waste Disposal - i.- o al Requirements i

20.302 Approval of disposu procedures 20.303 Sewage disposal 20.311 Transfer for disposal 20.402 Reports of theft or loss 20.405 Reports of overexposures i

20.408 Monitoring Reports on termination Part 20 Appendix A i

i 30.3 Activities requiring license 30.13 Carrier Exemption 30.31 Types of Licenses - includes emergency planning 4

30.32 Application for specific license 30.33 General requirements 30.34 Terms & Conditions - includes bankruptcy 30.35 Financial assurance and record keeping for decomissioning 30.36 Expiration and termination of licenses 30.41 Transfer of byproduct material 30.72 Schedule C 31.5 Certain measuring, gauging and controlling devices 31.6 Installation of GL gauges J

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 i

32.57 Manufacture of An-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 A-2

.__.-..__-___._,_.__.._.L___.__

32.62 QA - ice detection i

32.71 Manufacture of in vitro kits 32.72 Hanufacture of radiopharmaceuticals 32.73 Manufacture of generators and reagent kits 32.74 Manufacture of sources for medical use 32.101 Schedule B - tests for luminous safety devices

(

32.102 Schedule C - tests for An-241 sources 32.103 Schedule D - tests for Sr-90 ice detection devices 32.110 Sampling procedures 34.2 Definition 34.11 Specific licenses for radiography 34.20 Performance requirements for radiography equipment 34.21 Levels of radiation 34.22 Locking of devices 34.23 Storage precautions i

34.24 Survey Instruments 34.25 Leak testing, etc.

34.26 Quarterly inventory 34.27 Utilization logs 34.28 Inspection and maintenance 34.31 Training 34.32 Operating and emergency procedsres 34.33 Personnel Monitoring 34.41 Security 34.43 Surveys a

Part 34 Appendix A 35.33 Records and reports of misadministrations 39.2 Definitions 39.13 Specific license for well logging 39.15 Agreement with well owner or operator 39.31 tabels, security, and transportation precautions 39.33 Ra:!iation detection instruments 39.35 Leak testing of sealed sources 39.37 Physical inventory 39.39 Records of material use 39.41 Design and performance criteria for sealed sources 39.43 Inspection, maintenance, and opening of a source holder 39.45 Subsurface tracer studies 39.47 Radioactive markers 39.49 Uranium sinker bars 39.51 Use of a sealed source in a well without surface casing 39.61 Training 39.63 Dperating and emergency procedures 39.65 Personnel monitoring 39.67 Radiation surveys 39.69 Radioactive contamination control l

39.71 Security 39.73 Documents and records required at field stations 39.75 Documents and records required at tempory jobsites 39.77 Notification of incidents; abondonment procedures for irretrievable sources A-3

40.2a Inactive tailings sites 40.12 Carrier exemptions 40.20 Types of licenses 40.26 GL - possession and storage of tailings 40.3)(f)

& (h)

License for source material milling 40.31(1) License - decommissioning requirements 40.31(j) Uranium Hexaflouride - emergency plan 1

i 40.32 General requirements 40.34 Manufacture of depleted uranium products for GL 40.35 Manufacture of depleted uranium products for GL

{

40.41 Te ms and conditions 40.42 Expiration and termination of-license

{

4 0.51 Transfer of source material 4

40.65 Effluent monitoring Part 40 Appendix A 61.3 License required 61.10 Content of application 61.11 General information 61.12 Specific Technical infomation 61.13 Technical analyses 61.14 Instituticnal information 61.23 Standards for issuance 61.24 Conditions of licenses 61.27 Application for renewal or closure 61.28 Contents of application for closure 61.29 Post-closure observation 61.30 Transfer 61.31 Termination 61.40 General requirement 61.42 Protection of individuals from intrusion 1

61.43 Protection of individuals during operations 61.44 Stability of site after closure 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 Financia'. 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 70.25 Financial assurance and record kaaping for decessiissioning 70.38 Expiration and termination of licenses 70.39 Manufacture of Pu calibration sources 4

i A-4 i

~

~

~

70.42 Transfer of SNM 71.12 GL for NRC approved packages 71.13 Previously approved Type B packages

)

71.14 GL: DDT containers 71.16 GL: foreign approved packages i

71.81 Operating controls and procedures 71.85 Preliminary determinations 71.87 Routine determinations (except fissile related) 71.88 Air transport of Pu 71.89 Opening instructions 71.97 Advance notification of shipment of nuclear waste 150.31 UMTRCA 150.32 UMTRCA i

Division 3 Rules 19.1 Purpose 19.2 Scope 19.4 Interpretations 1

19.5 Comunications 19.20 Employee protection i

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 20.107 Medical diagnosis and therapy 20.204 Posting exceptions 20.206 Instruction of personnel 20.305 Disposal by incineration 20.306 Biomedical waste rule 20.401 Records 20.407 Personnel Monitoring reports 20.409 Notifications and Reports to Individuals 20.501 Applications for exemptions i

20.502 Additional Requirements 20.601 Violations 3

0.1 Purpose and Scope

30.2 Resolution of conflict r

30.5 Interpretations i

30.6 Comunications 30.7 Employee protection 30.9 Completeness and accuracy of information j

l 30.37 Applications for renewal 30.38 Applications for amendment 30.39 Comission Action to renew or amend 30.51 Records 30.52 Inspections l

l A-5

~

l i

30.53 Tests i

30.61 Modification and revocation of licenses 30.62 Withholding of byproduct material i

30.63 Violations Appendix A - Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Decomissioning 3

1.1 Purpose and Scope

1 31.2 Terms and conditions 31.B Am-241 reference sources i

31.9 GL to own material 31.10 Sr-90 ice detection devices 31.11 Invitro GL 31.12 Maintenance of records 32.1 Purpose and scope 32.3 Maintenance of records 32.210 Registration of product information 33.1 Purpose and scope 33.11 Broad license requirements 4

33.12 Broad Itcense requirements 33.13 Broad license requirements 33.14 Broad license requirements 33.15 Broad license requirements 33.16 Broad license requirements 33.17 Broad license requirements 33.100 Schedule A 34.1 Purpose and scope 34.3 Applications for specific licenses 34.4 Maintenance of records 34.29 Permanent radiographic installations 34.30 Reporting requirements 34.42 Posting 34.44 Supervision of radiographer's assistants 34.51 Applications for exer.ptions 35.1 Purpose and scope 35.2 Definitions (exceptmisadministration) 35.5 Maintenance of records 35.11 License required 35.12 Appliation for license 35.13 License amendments 35.14 Notifications 35.18 License insurance 35.19 Specific exemptions 35.20 ALARA program 35.21 Radiation Safety Officer

)

35.22 Radiation Safety Comittee 35.23 Statements of authority and responsibilities 35.25 Supervision 35.27 Visiting authorized user 35.29 Requirements of mobile nuclear medicine service 35.31 Radiation safety program changes 35.49 Suppiters 35.50 Possession, use, calibration and check of dose calibrators j

35.51 Calibration and check of surv,ey instruments A-7

-~

35.53 Measurement of radiopharmaceutical dosages 35.57 Authorizatoin for calibration and reference sources 35.59 Requirements for possession of sealed sources and brachytherapy sources 35.60 Syrir.ge shields and labels 35.61 Vial shields and labels 35.70 Surveys for contamination and ambient radiation exposure rate 35.75 Release of patients containing radiopharmaceuticals or permanent implants 35.80 Technical requirements that apply to the provision of mobile nuclear medicine service 35.90 Storage of volatiles and gases 35.92 Decay-in-storage 35.100 Use of radiopharmaceuticals for uptake, dilution, and extraction studies 35.120 Possession of survey instrument 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies 35.204 Permissible molybdenum-99 concentration 35.205 Controls of aerosols and gases 35.220 Possession of survey instruments i

35.300 Use of radiopharmaceuticals for therapy 35.310 Safety instruction 35.315 Safety precautions 35.320 Possession of survey instruments 35.400 Use of sources for brachytherapy 35.404 Release of patients treated with temporary implants 35.406 Brachytherapy sources inventory i

t 35.410 Safety instruction 35.415 Safety precautions 35.420 Possession of survey instruments 35.500 Use of sealed sources for diagnosis 35.520 Availability of survey instrument 35.600 Use of a sealed source in a teletherapy unit 35.605 Maintenance and repair restrictions 35.606 License amendments 35.610 Safety instruction 35.615 Saftey precautions 35.620 Possession of survey instrument 35.630 Dosimetry equipment l

35.632 Full calibration measurements 35.634 Periodic spot-checks 35.636 Safety checks for teletherapy facilities 35.641 Radiation surveys for teletherapy facilities 35.643 Modification of teletherapy unit or room before beginning a treatment program 35.645 Reports of teletherapy surveys, checks, tests, and measurements 35.647 Five-year inspection i

i l

l A.8 l

35.900 Radiation Safety Officer 35.901 Training for experienced Radiation Safety Officer

~

35.910 Training for uptake, dilution, and excretion studies 35.920 Training for imaging and localization 35.930 Training for therapeutic use of radipharmaceuticals 35.932 Trainng for treatment fo hy >erthyroidism 35.934 Training for treatment of tityroid carcinoma 35.940 Training for use of brach therapy sources 35.941 Training for opthalmic use of strontium-90 35.950 Training for use of sealed sources for diagnosis 35.950 Training for teletherapy 35.961 Training for teletherapy physicist 35.970 Training for experienced authorized users i

35.971 Physician training in a three month program 35.972 Recentness of training l

35.990 Violations l

35.999 Resolution of confifeting requirements during transition I

period 39.1 Purpose and scope 39.5 Interpretations 39.11 Application for a specific license 39.17 Request for written statements 39.91 Applications for exemptions 39.101 Violations 40.1 Purpose 40.2 Scope 40.3 License requirements 40.5 Communications 40.6 Interpretations 40.7 Employee protection 40.9 Completeness and accuracy of information 40.21 GL - title to source material 40.25 GL - depleted uranium 40.31 (a)-(e), (g) applications for specific licenses 40.43 Renewal of licenses 40.44 Amendment of licenses 40.45 Comission action to renew or amend 40.46 Inalienability i

40.61 Records 40.62 Inspections 40.63 Tests 40.64 Reports 4 0.71 Modification, etc.

40.81 Violations 61.1 Putpose and scope 61.4 Comunications 61.5 Interpretations 61.6 Exemptions 61.7 Concepts 61.9 Employee protections 61.9a Corpleteness and accuracy of information A-9

61.20 Filing application 51.21 Repetition 61.22 Updating of application 61.25 Changes 61.26 Amendment of license 61.80 Maintenance of records 61.83 Violations 70.1 Purpose 70.2 Scope 70.3 License requirements 70.5 Comunications 70.6 Interpretations i

70.7 Employee protection 70.9 Completeness and accuracy of information 70.19 GL for plutonium reference source 70.20 GL to own SNM 70.21 Filing)Ap(c),ications pl 70.22 (a),(b,

(d),(e) Contents of applications 70.31 Issuance of license 70.32 Conditions of licenses (Except statements strictly applicable to strategic quantities of SNM) 70.33 Renewal of licenses 70.34 Amendment of licenses 70.35 Comission Action to renew or amend 70.36 Inalienability 70.37 Disclaimer of warranties i

70.41 Authiorized use of SNM 70.55 Inspections 70.56 Tests 70.El Modification and revocation l

70.71 Yiolations 71.0 Purpose and scope 71.1 Corrnunications 71.2 Interpretations 73.3 Requirement for license 71.Ea Ccmpleteness and accuracy of information 71.7 Specific exemptions 71.9 Exemption of physicians 71.9)

Records 71.93 Inspection and tests 71.95 Reports 71.99 Violations 71.101-71.137 QA 150.1 Purpose 150.5 Interpretations 150.30 Violations Division 4 Rules 19.8 DMS approval i

20.8 OMB approval Part 20 Appendix D - Regional Offices

(

A-10 i

l

l 30.8 OMB approval 30.55 Tritium reports 31.4 OMB approval 32.8 OMB approval 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 1

32.19 Conditions of ifcenses - 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 a96 aerosol detectors 32.28-Table of organ doses - gas and aerosol detectors 32.29 Transfer reports - gas and aerosol detectors 1

32.40 Schedule A 33.8 OMB approval 34.8 OMD approval 35.8 OMB approval 39.8 OMB approval AD.B OMB approval I

40.23 General license for carriers of transient shipments of natural uranium other than in the form of cre or ore residue 40.27 GL for custody of Title I sites 40.28 GL for custody of Title II sites 40.66 l

Requirement for advance notice of export shipments of natural uranium 40.67 Requirement for advance notice for importation of natural uranium from countries that are not party to the Convention on the Physical Protection of Nuclear Material 61.8 Reporting: DMB approval i

61.16 Other information 61.58 Alternative requirements 61.70 Scope 61.71 State and Tribal consultation 61.72 Filing of proposals 61.73 Commission approval 70.8 OMB approval 70.13 D0' 70.13a Foreign aircraft 70.20a Strategic quantities of SNM 70.20b Carriers of SNM 70.22 (f),(g),(h),(1),(j)(k and(1)

Requirements for app, rov)al - Pu processing 70.23b 70.24 Criticality I

i A-11

l i

70.44 Creditor regulations i

70.51 Material balance, etc.

70.52 Reports of criticality 3

70.53 Material status reports 70.54 Transfer reports 70.57 Measurement control program 70.58 Nuclear material controls 70.59 Effluent monitoring I

70.62 Suspension and operation in war 71.6 OMB approval 71.18 - 71.24 Fissile material 71.31 - 71.77 NRC package approvals 71.B3 Assur.ptions - untnown properties 150.7 Persons in offshore waters 150.8 DMB approval 150.10 Persons exempt 150.14 Physical Protection 150.15 Persons not exerpt 150.15a Continued Commission authority 150.16 Material transfer reports 150.17 Material transfer reports 150.17a US/IAEA Safeguards requirements i

150.19 Tritium reports 150.21 SNM by aircraft

~

A-12 y

_---1 y

y-p

_,,_