ML20056E040
| ML20056E040 | |
| Person / Time | |
|---|---|
| Issue date: | 05/03/1993 |
| From: | Kammerer C NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL |
| Shared Package | |
| ML20056C038 | List: |
| References | |
| NUDOCS 9308190246 | |
| Download: ML20056E040 (86) | |
Text
I e>>* **
- vq t
UNITED STATES
(
.j NUCLEAR REGULATORY COMMISSION t
WASHINGTON, D.C. 2DMH001 g
1 5
4y My - 3 g 1
ALL AGREEMENT STATES NRC PUBLIC MEETING - MAY 20, 1993 (SP-93-046) i
-i Enclosed you will find the agenda and pertinent materials for the NRC Public Meeting with Agreement States which will follow the Conference of Radiation Control Program Directors, Inc. (CRCPD)
Annual Meeting.
The meeting will be held on May 20, 1993, beginning at 2:00 p.m. in the Westin St. Francis Hotel.
It is our intention to provide you with sufficient time for review of the materials so we may have meaningful discussions.
In i
addition, in an effort to provide you with an opportunity for early input, our agenda includes discussions of notential i
rulemakings which are not yet in the proposed stage.
Please let us have your thoughts on those at the meeting.
Please note the allotted time for the presentations.
We expect to have focussed discussions, but will allow as much time as possible to hear your views.
The Office of State Programs is fully committed to implementing the commission's mandate to l
ensure that Agreement States are provided with opportunities for early and substantive input into NRC rulamakings and regulatory j
actions that may affect your pr i
r Carlton Kammerer, Director Office of State Programs
Enclosures:
j As stated
_r
.f i
l 9308190246 930802 PDR STPRO ESGGEN PDR
Agenda NRC Public Neeting with Agreement States May 20, 1993 2:00 p.m. - 3:30 p.m.
Discussion of the Compatibility Draft Policy Statement Speaker: Sheldon A. Schwartz 3:30 p.m. - 4:00 p.m.
10 CFR Part 20 Potential rulemaking to enhance ability to implement Part 20; Speaker: Donald Cool revision of criteria for releases into sanitary sewers; clarification of patient release limits.
4:00 p.m. - 4:30 p.m.
10 CFR Part 21 Requirements to Report Defects and Noncompliance of Materials at Speaker: Bill Morris Facilities.
4:30 p.m. - 5:00 p.m.
10 CFR Parts 31 Requirements for Possession of and 32 Industrial Devices; Accessible Speakers:
Bill Morris Air-Gap for Generally Licensed Donald Cool Devices.
5:00 p.m. - 5:30 p.m.
10 CFR Part 34 Potential Revisions to the Radiography and Radiation Safety Speaker: Donald Cool Requirements for Radiographic Operations. -
5:30 p.m. - 6:00 p.m.
10 CFR Part 35 Radiopharmacy rule; Minimizing Radiation to Embryo, Fetus, or l
Speaker: Bill Morris Breast-feeding Child.
i 6:00 p.m. - 6:30 p.m.
10 CFR Part 61 Potential Rulemaking to Require Financial Assurance for Long-Term Speaker:
Bill Morris Care of Low-Level Waste (LLW)
Facilities; Performance Objectives for Above-Ground Disposal of LLW; i
LLW Uniform Manifest.
6:30 p.m. - 7:00 p.m.
Other Items Self-Guarantee for Financial of Interest Assurance for Decommissioning.
Speakers: Bill Morris i
Financial Assurances for Accident Cleanup at Ma.terial Facilities.
1 Donald Cool Enhanced Participatory Rulemaking.
a o
%e 4
DRAFT ISSUES FOR THE PROPOSED POLICY ON COMPATIBILITY OF AGREEMENT STATES May 5, 1993
SUMMARY
The program established by Section 274 of the Atomic Energy Act of 1954, as amended, is unique in its provisions.
At the heart of the program is a discontinuance of regulatory authority by the NRC (formerly AEC) for certain specified activities and the assumption of that authority by a State through a formal agreement with the NRC.
The purposes of the section are contained in Section 274a. and provide some general guidance on the type of relationship between the States and NRC.
The phrases
" recognize the interests of the States", " establish programs for cooperation", " promote an orderly regulatory pattern", and
" provide for coordination of the development of radiation standards for the guidance of Federal agencies and cooperation with the States" constitute the fundamentals of thi.s program.
Some of these fundamentals are reiterated in the agreements entered into with individual States.
The relationship of the NRC with the Agreement States has evolved since 1962 (the year of the first Agreement States) from an informal relationship with little or no explicit oversight role by NRC to a fairly formalized relationship.
The formalized relationship currently exhibits itself primarily through the periodic review of each Agreement State and, to some extent, through " incident or event" reporting, through NRC's data collection efforts and joint NRC/ Agreement meetings and workshops.
There is an additional informal relationship existing between NRC and each Agreement State (and sometimes with 1
I)It/LFT
^
Agreement States collectively) thtt is carried out on a daily basis.
These informal relations are carried out routinely and encompass such things as information exchange, technical and regulatory advice, and numerous matters which are necessary for each party to carry out their respective regulatory programs in an efficient and effective manner.
However, there has been concern expressed regarding the NRC's oversight role, its emphasis on uniformity in regulations, and the amount of flexibility requested by the Agreement States in order to consistently regulate all sources of radiation in accordance with local conditions.
This paper initiates a discussion of the NRC/ Agreement State relationship which will culminate in a draft Commission Policy on compatibility to be presented for Commission approval in November 1993.
BACKGROUND Neither the Atomic Energy Act nor the legislative history of Section 274 provides a definition of " compatibility."
- However, the legislative history makes it clear that uniformity (or rather, lack of conflict) between the Federal program regulating nuclear materials and the proposed State progrhms was a prime consideration.
This~ led to the adoption of the language requiring that proposed State programs be " compatible" with the Commission's program.
?
The " compatibility" of Agreement State regulatory programs with the NRC has been the center of many policy discussions.
Concerns on compatibility have been raised repeatedly by Agreement State personnel.
In an attempt to respond to the concerns of the Agreement States, the regulated community and the general public, the Commission i
l 2
i l
4 DRAFT has directed the staff to develop a Commission Policy on compatibility.
A working group has been established to perform this task with input from the Organization of Agreement States.
The working group's draft issues paper will be presented to the Agreement States by May 6, 1993 to be discussed during the May 1993 annual meeting of the Conference of Radiation Control Program Directors, Inc.
In addition to the working group, representatives of the regulated community, the non-Agreement states, and the general public will participate in a July 1993 public workshop on the compatibility policy issues.
The draft Commission Policy on compatibility will be discussed with the Agreement States during their October 1993 annual meeting.
The-staff plans to present the draft policy to the Commission in November 1993 for publication in the Federal Register for public comment.
In framing the issues pertinent to a Commission Policy on compatibility both NRC and the Agreement States-have presented views which diverge as well as those which are consistent with one another.
The common focal point of both the NRC and the Agreement States is adequate protection of the public health and worker safety within the limits of their respective statutory authority.
The main disparity lies in the degree to which NRC and the Agreement State radiation control programs must be essentially identical.
While no one seriously supports the extreme positions of " carbon copy" and "no equivalence required",
there is still sentiment to support a wide range of possibilities.
1
^
3
)
e
4 DRAFT The principal views concerning federal oversight, state discretion, and the relationship of the NRC and the Agreement States are as follows:
1.
The overriding requirement for both NRC and the Agreement States is to provide for adequate protection of the public health and safety from potential hazards arising from the use of regulated materials.
The compatibility of their respective programs or regulations is an adjunct to the basic requirement and should be supportive of that requirement.
2.
The individual Agreement States and their employees and NRC and its employees share a commonfunction and should be considered partners in carrying out their respective regulatory functions.
Both NRC and the States have either a mandate or an inviolable sovereignty that, in their dealings with one another, sets them apart from the general public or members of the regulated community.
3.
Due to the extensive interaction of the NRC and the Agreement States and the interrelationship of many aspects of their respective regulatory programs, there is a need for early and substantive involvement of Agreement States in the development of policies and regulations necessary for the conduct of effective regulatory programs.
A program of cooperation and consultation is essential to the implementation of this principle.
4.
It is recognized that each regulatory agency may be faced with physical and/or environmental conditions, operational
9 4
DRAFT needs of the regulated community, and policy directives of their legislative or administrative bodies which affect their respective regulatory programs.
Such conditions require a recognition of the need for flexibility in implementing their regulatory programs.
Such flexibility should not jeopardize the regulatory agency's ability to adequately protect the public health and safety.
5.
It is recognized that States' innovation has created new regulatory approaches.
Innovative approaches should be encouraged, and impediments to such innovation should be discouraged.-
6.
It is recognized that there is no single way of conducting effective regulatory programs.
Regulatory programs of Agreement States must be responsive to each State's citizens, legislature, and administrative officials.
NRC and each Agreement State must operate within their respective governmental systems.
It is further recognized that while each regulatory agency may have direct or indirect interest in the other's program or in individual events such as incidents, the agency with regulatory jurisdiction must be allowed to manage those matters without undue involvement of other regulatory agencies.
7.
Consistent with the partnership principle stated in Principle number 2 above, it is recognized that NRC and the Agreement States can complement each other in addressing certain issues or responding to incidents or events.
Each has experience and expertise, although the expertise and depth of resources may vary considerably among the i
regulatory agencies.,
States may be called on to supplement 5
l
9 a:
4 DRAFT g
%.cag A--xp an.7plement the Agreement 13 Criterin'fr
._, _ o,, - M 4=d collective resources balancing:
~a y
,g.a w 2 agencies should be program ~
~ ~ _ _n,~ m. -,
=:::a1 benefit.
n local c public
- zg c aaeatri' = sdfective policy is how it g 4
= cer::wn s uld be avoided, fairness POLICY'I R sawemad t e= ant used in arriving at In Sectic regulate.
~
72 % A MM70*
- its considerable resources to s
l i
.;;c3a2.= t.r= irre opment on requ rements "Pregi-
~
~
ic health and safety from Coorf' m.
7;
, ; +,.n~Wahs 1n'.
_,., ~
s qO*ce-s;::::sibility to assess State programs
. a~_
W 2rf to Protect the public health g g grw m 3:
mv.
c.c..m** @ e ' radiation hazards.
. _J c gwuA :r :: ?ather information on the uses of sw4:gec:A3 :: provide trend and pattern analysis
, % ; w h cs zad to gauge the effectiveness of the
_,,g e c e res=latory program.
,gacq pe.:=u is not a statistical program of numbers 3 4 % c:=m s m;;=lers of amendments, etc.
Its value is to
%,s;Swd.7Rdx. y: How well is the regulatory program x&,
g g s ca e x lecal or national scale) to assure that
%, 3 p % e available with minimal risk to workers, the 9,;4. sw *::x environment.
6
- w.
\\
4 DRAFT mechanism available to it; other key requirements and procedures should be adopted in a timely fashion.
2.
Assurance that one jurisdiction's actions do not impact the citizens of another jurisdiction:
Requirements affecting interstate commerce (such as relating to packaging, shipping, manufacturing of consumer products, or work to be performed by out of state companies) should adhere to the same basic rules as required nationally and internationally.
Any differences should not interfere with the conduct of trade.
(More stringent regulatory requirements could preclude certain activities and possibly shift the impact to other jurisdictions while still enjoying the benefits, e.g.,
forbidding low level waste disposal in the state yet allowing industry that produces LLW.)
Nationally, there should be confidence in each others licensing actions so that sources and devices approved in one State or by NRC can be readily accepted and licensees from one State or locale can be recognized as acceptable in another State or locale without undue delay in re-examining their manufacture, labeling or individual qualifications.
It in beneficial for jurisdictions to have the same exempt quantities and exempt concentrations to prevent releases occurring in one jurisdiction from impacting another.
However, considerations for flexibility in regulatory approaches should be weighed.
There should be sufficient communication from one State to another and from each State to the NRC on such matters to allow a reasonable interchange of information and to improve radiation safety nationally.
Finally, there should be oversight of the ' national' program (NRC and Agreement States) to assure consistency and adequacy 8
DRAFT the NRC in some. cases, and NRC may supplement the Agreement States in others.
The individual and collective resources and expertise of all the regulatory agencies should be recognized and utilized to their mutual benefit.
8.
The key to implementation of an effective policy is how it is administered.
Arbitrariness should be avoided, fairness applied, and soundly based judgement used in arriving at decisions.
9.
It is recognized that the NRC has considerable resources to contribute to research and development on requirements necessary to protect the public health and safety from radiation hazards.
10.
NRC has the unique responsibility to assess State programs to gauge nationwide adequacy to protect the public health and safety from certain radiation hazards.
11.
NRC is in a position to gather information on the uses of radioactive materials to provide trend and pattern analysis on a national basis and to gauge the effectiveness of the nation's radiation regulatory program.
12.
A regulatory program is not a statistical program of numbers of inspections,' numbers of amendments, etc.
Its value is to the user-beneficiary: How well is the regulatory program working (on either local or national scale) to assure that the benefits are available with minimal risk to workers, the public, and the environment.
i i
6 t
1
g DRAFT 13 Criteria for determination of compatibility should consider balancing flexibility in light of the adequacy of the program and other factors, such as the federal leadership, local conditions, state's rights and the protection of public health and safety.
POLICY ISSUES In Section 274 of the Act the terms " cooperation," " orderly regulatory pattern," " coordination," and " adequate" appear in the text before the first use of the term " compatible".
" Compatible" is not defined and where used it is in association with the term
" program".
To achieve an " orderly regulatory pattern" that is coordinated and compatible, regulatory programs presumably must:
- 1) Protect the citizens within their jurisdiction, 2) Not result in any adverse effect on citizens in other jurisdictions and 3) minimizes conflicts between the Federal and State regulatory programs and between States.
1.
Adquate protection of citizens:
Protection of citizens must be paramount; presumably, again, through whatever means are available to the regulatory agency.
The radiation control program should assure consistent understanding between and among licensees, workers, the public and the regulatory program.
To be an adequate program it must meet certain minimum ~ national standards to protect the public health and safety while allowing for a certain' degree of flexibility in accommodating local needs.
Radiation protection standards and essential regulations must be consistent nationwide.
Changes of safety significance should be implemented when known to the regulatory agency through any effective 7
DRAFT mechanism available to it; other key requirements and procedures should be adopted in a timely fashion.
2.
Assurance that one jurisdiction's actions do not impact the citizens of another jurisdiction:
Requirements affecting interstate commerce (such as relating to packaging, shipping, manufacturing of consumer products, or work to be performed by out of state companies) should adhere to the same basic rules as required nationally and internationally.
Any differences should not interfere with the conduct of trade.
(More stringent regulatory requirements could preclude certain activities and possibly shift the impact to other jurisdictions while still enjoying the benefits, e.g.,
forbidding low level s
waste disposal in the state yet allowing industry that produces LLW.)
Nationally, there should be confidence in each others licensing actions so that sources and devices approved in one State or by NRC can be readily accepted and licensees from one State or locale can be recognized as acceptable in another State or locale without undue delay in re-examining their manufacture, labeling or individual qualifications.
It is beneficial for jurisdictions to have the same exempt quantities and exempt concentrations to prevent releases occurring in one jurisdiction from impacting another.
However, considerations for flexibility in regulatory approaches should be weighed.
There should be sufficient communication from one State to another and from each State to the NRC on such matters to allow a reasonable interchange of information and to improve radiation safety nationally.
4 Finally, there should be oversight of the ' national' program (NRC and Agreement States) to assure consistency and adequacy 8
l
4 DRAFT throughout the nation without compromising the need for flexibility in implementation.
This oversight must include the ability of the NRC to revoke or withdraw Agreement State status for cause.
ISSUE 1 - BASICS What is/are the core elements of a compatible program?
As discussed in SECY-91-039, the Commission has discretion to define compatibility and its scope.
This means that the NRC can review its regulations and practices and categorize them using the State Programs 1984 Internal Procedures categories (or some other categories).
However, NRC has never articulated those factors that should be considered in any new categorization.
While assuring that a State regulatory program provides for adequate safety is important, adequate safety will seldom, if ever, require verbatim adoption of an NRC regulation or practice.
Thus, if adequate protection is the only consideration, there would be no need for any Division 1 rules, because Division 2 i
rules, requiring adoption of the same underlying safety principle by the States but permitting more stringent regulations, would be sufficient.
Therefore, in identifying factors which lead to j
categorization of Division 1 rules (rules States must adopt essentially verbatim), matters other than direct safety significance play the predominant role.
In this regard, the following Policy Factors can be considered in deciding the degree of uniformity that is necessary or desired.
I 1.
Need to preserve a Federal leadership role because of 4
greater expertise in some areas and need to have a uniform national approach to radiation safety matters.
~
i i
DRAFT 2.
Need for effective communications between regulatory
- agencies, e.g., uniformity of terminology and technical definitions.
3.
Need to avoid burdens on interstate commerce, e.g.,
uniformity of safety design and labeling of consumer products.
4.
Need to assure the effective implementation of specific Federal initiatives, e.g.,
recordkeeping in support of a Federal study that is only useful if uniform records are kept.
5.
Need to consider NRC resources available to evaluate Agreement State programs and train State staff.
Uniformity allows for the use of standard reviews and requires less NRC resources.
6.
Need to provide for equal treatment of licensees from State to State to avoid licenstes shopping around for a lenient regulatory program.
7.
Need to promote development of competency of Egreement State personnel.
5 8.
Need to encourage State innovation and promote the transfer of State as well as Federal initiatives.
t 9.
Need to consider local conditions and needs.
10 r
p
I)ILAJFT i
10.
Need to recognize the States' need to provide an equal level of protection for all regulated sources of radiation, e.g.,
NORM, NARM, x-ray machines, accelerators.
i 11.
Need to have uniform concepts of acceptable practice to deal with public concern as to what is acceptable.
12.
Need to preclude variations in State practices that could lead to local safety benefits at the expense of risks elsewhere.
In the Staff Summary to SECY-92-243 it was observed that
" numerous commenters indicate that ' technical aspects' of programs, such as definitions, terminology, signs, symbols, j
radiation dose limits, reporting requirements, and radiation source and device design standards, should be identical.
For example, terminology must be identifiable and symbols need to be universally recognized.
Standards, such as annual -exposure limits, are well understood, because they are based on a wealth of scientific evidence and have been approved by international agencies that set standards, such as the International Commission on Radiation Protection.
Other standards include radiation protection practices and procedures, personnel qualifications, and personnel dosimetry.
In addition, commenters point out that non-uniformity of standards would confuse the public regarding what is adequate, eroding public confidence and adversely affecting interstate commerce.
Uniformity facilitates training j
and makes such training more cost effective.
States should not j
be allowed to vary radiation standards in one area, perhaps 1
leading to increased exposure in another (e.g., decreasing the allowed dose to the general public, may result in an increase in 11 j
DRAFT occupational exposures)."
On the other hand, there is a great desire for State flexibility to accommodate local needs.
It is also noted that U.S. DOE standards vary somewhat from NRC/ Agreement State regulations and worker re-training is required when workers move from.one regulatory sphere to the next.
The question, therefore, is what provisions (the core elements) must be essentially the same for the NRC and from state to state?
A.
Uniform National Standards It is generally agreed that some national standards are needed to protect the health and safety of the people against radiation hazards.
These standards should include uniformity in maximum permissible doses, levels of radiation, and concentrations of radioactivity, as fixed by Part 20 of the NRC regulations based on recognized national and international guidance and consensus standards followed by industry and government.
In addition, it is important to strive for uniformity in technical definitions and terminology, particularly as they relate to such things as units of measurement'and radiation dose.
It should be understood that certain regulations best serve our collective goals by being identical in language, although modification may be necessary to encompass radiation sources not regulated by NRC.
However, the question remains as to how much flexibility the States should have to impose additional requirements to protect public health and safety for " agreement materials" and to provide for more stringent standards where special conditions are in effect.
Should a specific list of required standards be part of the Policy statement or can this list be prepared and updated through ongoing NRC/ Agreement State interaction?
12
DRAFT B.
Radiation Protection Standards / Regulations In addition to the national standards which address maximum permissible dose, levels of radiation and concentrations of radioactivity, other State and NRC radiation protection regulations, practices, and implementation procedures extent of agreement with standards / regulations, health and safety principles and other guidance published by national and international bodies should be examined.
The work of organizations such as the NCRP, ICRP, and CRCPD should be consulted wherever possible in order to take advantage of research and deliberations that have taken place.
Can these secondary standards, principles, and guides be expressed as
" goals" or " guidelines" rather than specific ragulations?
C.
Interstate Commerce and Reciprocity One area where a high degree of uniformity should be considered is in the regulations that affect people and products moving across jurisdictional boundaries (this particularly relates to sources manufactured for distribution throughout the U.S. and mobile licensees such as industrial radiographers).
There is concern that actions taken in one state or region should not impede trade or create barriers to the procurement of goods and services.
However, local needs may still carry great weight and the question may be when is there undue interference with interstate or international commerce?
What provisions are i
required, and conversely what provisions cannot be changed, to avoid burdens on interstate commerce e.g., uniformity of safety design, labels, sign's, and symbols affixed to radioactive products which are transferred from person to person, and basic terminology.
13
DRAFT Some additional requirements may not prove to be an impediment to com=erce, e.g., the requiring of two person radiography crews, provided they do not restrict an otherwise acceptable practice entirely out of existence.
In fact, differences between the states may be good in that they make licensees think about the radiation safety significance of the difference rather than always doing things by routine.
It is generally held that certain provisions must be adopted, essentially verbatim, because they form the basic language of radiation protection essential for effective communication between regulatory agencies and the regulated community.
These provisions have been formulated and agreed to by national and international organizations, from consensua standards followed by industry and government.
They include technical definitions such as " curie," " dose," and " rad," radiation protection standards l
such as occupational exposure limits, effluent release limits, and legal definitions such as for " byproduct mater'ial,"
restricted area" and " occupational dose."
These provisions are a
so basic to the regulatory programs that their modification by a State may result in numerous and difficult problems including interference in interstate commerce.
The question is which provisions must be essentially identical from one radiation control program to the next?
D.
Improved Public Health and Safety l
There maybe instances when a new regulation is so important for i
the protection of public health and safety that it should be adopted immediately nationwide.
Early and substantial involvement of the States in the NRC regulatory process is 14
i i
i I)ILAJP1' 1
imperative when health and safety are at stake.
In addition, NRC could solicit State suggestions for alternative approaches and then conduct research to determine whether a suggested alternative approach is effective as a substitute for the regulation or as temporary measure until regulations can be modified by the State.
The States could also build into their regulatory mechanism a procedure that will allow them to adopt a new regulation, essentially verbatim, whenever such a regulation will lead to a significant improvement in the protection of public health and safety.
Although most states do have a procedure for the emergency adoption of regulations, there is usually a sunset provision that takes effect within a short period of time after the emergency promulgation unless the administrative procedures act has been followed for the normal promulgation of regulations.
It would improve the protection of public health and safety if the States were able to have a mechanism for the automatic adoption of a regulation that makes demonstrable imprevement in the protection of public health and safety.
E. Adoption Time Frame The states, with few exceptions, indicated that three years should be enough time to adopt compatibility requirements.
However, some instances were identified where more time may be necessary.
Some States indicated that difficulties tend to be tied to inadequate funding and staffing.
For State Radiation control staffs that are small and already strained, very little time is available from their regular duties for drafting regulations.
Also, for those rare. instances where there is a need for involvement of the State legislature, three years may be
~
15
DRAFT difficult for States whose legislature only meets every two years.
Another problem stems from situations where certain regulations pertain te areas that are sometimes outside of the direct control of the State Radiation Control Program Director, thus delays may exceed the three-year time period.
Furthermore, " agreement materials" control is only part of the States' radiation control program and some States expressed the view that it is more efficient to revise the States' radiation control regulations completely rather than in a piecemeal fashion within the three-year timeframe.
The three-year interval has been based on what the States, generally, have been able to meet.
Over the years the process by which states adopt regulations has undergone significant change.
Some States are now required to go through a much more detailed process to amend their regulations.
State management, their legal counsels and other non-radiation control staff are taking a more active role in reviewing proposed changes to State 1
regulations.
In many instances they look for their radiation control program to operate under the same policies and procedures as other public health and safety programs, such as hazardous j
materials.
As a result, the process has become much more complex j
and a number of States have found it difficult to meet the three-year requirement.
Alternatives to codifying new regulations in less than'three j
years should be addressed beginning with the early and substantial State involvement in the regulatory process, including changes to regulatory guides, standards, procedures, 16 l
DRAFT etc.
This assures opportunity for timely input and allows the state to work on their own unique solutions simultaneously.
Implementing appropriate regulatory changes could be by any mechanism that works for the state.
There should be recognition of the economic impact of regulation changes especially when the state has few or no licensees that may be impacted.
While regulation changes should be encouraged for ease of comparison from state to state, any method, such as license condition, agency issued order, or some other unique approach may be acceptable provided the citizens are adequately protected.
Any concerns of safety significance could be addressed within one year of notification while changes required in regulations, such as for meeting minimum national standards, should be accomplished within three years of the publication date of the final NRC regulation.
Getting States up to speed with current regulation development is addressed under Issue 4 - Implementation.
If a time based implementation requirement is necessary, use of the publication date'should be considered for the " starting s
point" since the final text of the rule is then known.
- However, it may be necessary to consider allowing States the same delay in the effective date of the regulation.
This would allow State licensees the same " grace" period as allowed NRC Licensees.
The effective date of the regulation may also be given greater weight since protecting the public health and safety should be the focus of the rule and implementation is the key.
F.
Scope of Policy The last issue under the " basics" is "how far does one go in seeking to show that the core elements of radiation control programs are compatible?"
Sections 274d.(2) and 274g. are the O
17
)
1 I)ItAJFT i
l only sections of the Act that address the concept of compatibility.
It should be noted that both sections refer to
]
the compatibility of " programs".
Section 274d. states that "The Commission shall enter into an agreement under subsection b. of this section with any State if...the Commission finds that the State procram is compLtible with the Commission's program for the regulation of such materials..." (Emphasis added.)
The use of the word " program" rather than " regulation" indicates that the concept of compatibility was meant to apply to aspects of a radiation control program other than just the regulations.
This might include the technical aspects of licensing actions and the State's compliance program.
As examples, this could apply to criteria for approving certain licensed activities as detailed in NRC licensing guides or to such areas as the inspection priority i
system.
It could also be interpreted to include administrative matters such as staffing level and budget.
Also, the "whole program" approach allows agency to impose requirements by order, license condition or other method rather than be restricted to regulations.
i Since the earliest days of the State Agreements Program the Commission has used the term " compatibility" in the review
\\
i guidelines in relation to not only regulations, but also to such program areas as licensing and compliance.
However, in recent practice only regulations have been considered as matters of compatibility during periodic reviews.
The question is how much of the State's program: regulations only, regulations plus certain program elements such as licensing and compliance, or the entire State program, should be reviewed 18
I)FLAIrr by NRC and considered in determining " compatibility" with its national program?
i ISSUE 2 - FLEXIBILITY What degree of flexibility should be afforded the Agreement States in carrying out their programs?
Agreement states, in addition to assuming regulatory authority over agreement materials, have the responsibility for ensuring public health and safety from ionizing radiation from such non-agreement sources as NARM (naturally-occurring and accelerator-produced radioactive materials) and machine-produced radiation.
In some cases, regulation of non-ionizing radiation is also a mandated function.
Such responsibility compounds the regulatory scheme for states since, in principle, all sources of radiation need to be regulated in an equivalent manner.
The ability to implement, within the confines of applicable law, nore complex radiation control programs requires a great deal of flexibility.
The term " flexibility" as used in this document means the ability of any agreement jurisdiction to have a regulatory-program which is able to address sources of radiation other than agreement materials, as well as local circumstances or concerns within the limits prescribed by federal, state or local law.
Flexibility allows for innovations in regulatory program development.
For the purposes of this discussion, a regulatory program can be divided broadly into two areas: regulations and other non-regulation policies, procedures, etc.
A. Regulations 1
19
I)ILALFl From a practical perspective, only if there is a need to regulate a particular activity, should regulations be required.
For example, states that will never host a low level radioactive waste disposal facility do not need to have regulations
)
equivalent to 10 CFR Part 61.
Likewise, an agency which legally does not have authority over a particular activity, as is the case in New York State where several agencies implement the agreement, do not need to address that activity in regulations.
1 Further, circumstances where only one or two licensees will be engaged in an activity should be considered for regulation by means other than formal rules.
This can be judged on a case-by-case basis taking into account such factors as adequacy of protection of public health and safety, extent of the activity in scope and time and available resources.
B. Non-regulation aspects However, it must be recognized that different jurisdictions have differing needs and responsibilities with respect to the regulated community served, demographics, location, geography and j
so forth.
To a greater or lesser degree such factors will influence the regulatory approach taken and to achieve effective regulation, such factors must be integrated into the agency's i
programs.
A potential avenue to accommodate this required flexibility is through policies and procedures which are not formal rules.
These may govern such aspects of the program as licensing procedures, inspection frequency, enforcement actions, fees, or areas which have been addressed in regulation by NRC, but were not deemed " matters of compatibility" at either the Division 1 or 2 level under NRC Procedure B.7 4
i 20 I
DRAFT Given that basic standards equivalent to those of NRC have been promulgated by states, other guidance and policies will be bound by applicable regulation and law.
Hence, this principle will guide the latitude of flexibility allowed.
but within the confines of applicable law, consideration should be given to i
allow the regulatory agency freedom to implement its programs in the way it deeme best and appropriate to protect public health and safety; however, this must be balanced against other factors, such as the effects on interstate commerce, effective communications between regulatory bodies, and uniform recordkeeping.
ISSUE 3 - COMMUNICATION What licensee-regulator interactions should be shared through communications in order to build a reliable data base for evaluating the Agreement State and NRC radiation protection programs for source, byproduct, and less than critical quantities of special nuclear materials?
Communication Between Regulators Agreement States and the NRC maintain independent regulatcry programs.
While there is a degree of 4
autonomy required for the management of an independent program, these programs need to maintain open communications among each other to assure that their constituencies are receiving equivalent treatment.
Since the institution of the Agretment States Program, State regulators have obtained increased experience with Atomic Energy Act materials and have gained additional experiences through regulations of NARM and machine-produced sources of ionizing radiation.
The 21
DRAFT resultant maturing of State regulatory programs highlights the need for effective sharing of experience between State and Federal regulators.
Agreement State staffs and their NRC counterparts have increasingly used topical workshops to discuss solutions to common problems encountered in the regulation of radioactive materials.
These workshops have supplemented the annual All Agreement States Meeting and the more routine interaction and communications with regional and headquarters State Programs staff.
These workshops, meetings and All Agreement States letters have been the principal means of communication for NRC and the Agreement States.
There are a number of opportunities to improve the nature and amount of information moving between the NRC and the Agreement States.
One is in the analysis of radiation-related events and incidents for early trends on the performance of individuals and equipment.
Regulators should be aware of both poorly performing individuals and devices.
This could include common standards for device evaluations, common reporting requirements for malfunctions and defects and a registry of individuals cited for significant wrongdoing.
NRC and Agreement States share " Good News" i
e NRC reviewers or States could identify State regulatory activities that are considered improvements in the program and
~
i I
22
4 4
DRAFT disseminate that information to other states and NRC.
Innovation is then recognized and put into use.
ISSUE 4 - IMPLEMENTATION How should the NRC involve the Agreement States in the rulemaking process to provide for meaningful early and substantive interaction?
How should a new policy on compatibility be implemented?
How should the performance of radiation control programs be measured to see where improvements in real
~
I performance (protecting citizens) are needed?
The NRC is mandated in $274 (j) to periodically review agreements and actions taken by states under the agreements to ensure compliance with the provisions of $274 of the Act.
It can be i
argued that during periodic reviews formal regulations should be J
judged for equivalence of results (i.e. Do they achieve the same
{
goal as NRC's regulations, although not necessarily with identical language?) and the remainder of the program judged-to be adequate to protect health and safety.
It can be safely assumed that if these two criteria are met, then the program will be adequate to protect health and safety and compatible with those of the NRC.
The Commission recognizes Agreement States' technical s?pertise and closer interaction with licensees; NRC's greater resources i
for research.
Commission places level of trust in ' team work',
the group process that leads to better quality decisions, recognizing AS/NRC interaction in developing regulations and l'
determining compatibility level.
23 e
DRAFT Early and substantive input on rulemaking The present practice of Agreement State involvement in rulemaking through workshops and public meetings is on going.
The first step, however, is problem identification.
(See also Issue 3 -
Communication) Once a problem is identified it should be announced so others may contribute to possible solutions.
This could be OSP, AEOD or the reg'ons or Agreement States discovering and/or defining a problem.
Someone would then take the lead in developing potential solutions (not limited to regulations).
Details should be presented before asking for any decisions, even on policy or ' general direction'.
This is because seemingly minor word changes can totally change the meaning of the material in question.
Closer, more substantive interaction with Agreement States could also be accomplished by establishing an Agreement State Advisory Committee, formally constituted under the Federal Advisory Committee Act.
There are various issues on this subject
~
that need to be discussed particularly addressing as to whether such an arrangement would inhibit the frequent communications between NRC and the Agreement States that are necessary to fulfill the expectations of the " partnership."
o Transition
--How should the new policy on compatibility be implemented?
over what time period?
--How should new regulations (ready to be published in final) and regulations in progress be handled?
24
DRAFT
--Impact on States actively pursuing an agreement with respect to implementation of the 1981 Comminsion policy statement as amended.
--Need to update State Programs Internal Procedure B.7
--Need to review new regulations adopted since B.7 was formulated in 1984 What standing, if any, should the CRCPD - Suggested State Regulations for the Control of Radiation have in compatibility determination?
Program Review Areas Affected by the Scope of the Policy The following Agreement State program review areas are identified where the degree of uniformity needs to be specifically addressed in implementing the policy.
1.
Basic radiation protection standards.
These are standards which have been developed and endorsed by national and international standards setting bodies such as NCRP, ICRP and IAE.
These standards include, but are not necessarily limited to, the occupational (and in the new Part 20, general public) dose limit in 10 CFR Part 20, as well as the maximum permissible. concentration in effluents.
2.
Important definitions.
This would include terms such as dose, curie, radiation area, high j
radiation area, etc, that are necessary for the effective communication between radiation control personnel.
This would also include radiation signs, radiation symbols, etc.
i 3.
Radiation protection erincicles.
These would include those requirements in 10 CFR Part 20 that address fundamental health physics practice, such as ALARA, requirements for radiation surveys, and.
personnel monitoring.
These areas, although not necessarily established standards by standards setting bodies, are well established principles, 25 i
DRAFT acknowledged by experts in the fields of health physics as being part of any adequate radiation protection program.
These are typically not numerical values, so that evaluation for uniformity is somewhat more difficult.
4.
Indirect or secondary radiation protection standards.
Some NRC regulations have indirect standards that are based on basic radiation protection standards.
Examples are the limits on the transportation of radioactive materials.
5.
Licensino policy and procedures.
This is a broad category that encompass the decisions on how radioactive materials in regulated through the licensing process.
This would include policy on licensing fees, exemptions, general licensing, and the criteria used for evaluating the training and experience of users, the equipment and facilities for using radioactive materials, and the procedures followed.
6.
Coroliance policy and procedures.
This is a broad category including inspection practices, enforcement options, inspections priorities, etc.
This concerns issues such as the consistencies of civil penalties applied by the Agreement States and NRC for the same violation.
7.
Information requirements.
There are many I
I requirements such as, for example, reports of incidents, overexposure, loss of material, etc.
that are for information gathering purposes.
ISSUE 5 - REVOCATION l
What are the legal, policy, health and safety bases for reasserting NRC authority in an Agreement State?
Section 274j (1) of the Atomic Energy Act of 1954, as amended, provides the basis for termination or suspension of an agreement, or part of an agreement, with a State, either at the request of l
26
DRAFT the Governor or upon the initiative of the NRC, under certain circumstances:
1 (1) The Commission, upon its own initiative after reasonable notice and opportunity for hearing to the State with which an agreement under subsection b. has become effective, or upon request of the Governor of such State, may terminate or suspend all or part of its agreement with the State and reassert the licensing and regulatory authority vested in it under this Act, if the Commission finds that (1) such termination or suspension is required to protect the public health and safety, or (2) the State has not complied with one or more of the requirements of this section.
The Commission shall periodically review such agreements and actions taken by the States under the agreements to insure compliance with the provisions of this section.
The Commission has not formulated formal written criteria or procedures to implement these provisions.
Neither has the Commission ever commenced action on it's own initiative to terminate or suspend all or part of an agreement under section 274 j (1).
However the Commission has reasserted its regulatory authority at the request of the Governor over all or part of an agreement in several instances.
The transfer of regulatory authority was handled smoothly in each case.
t The necessity for NRC to terminate or suspend an agreement on its own initiative has.never arisen, in part because the Commission-has relied on the many forms of interaction and cooperation with e
27
DRAFT the Agreement States to provide early notice and resolution of any problems developing with a State program.
In accordance with the last sentence of section 274j(1), the Commission conducts formal reviews of each State's regulatory program every two years and an informal visit in the alternate years when there is no formal review.
The Commission makes a determination of " adequacy to protect the public health and safety" and " compatibility" regarding each Agreement State program.
Agreement State Programs have been evaluated based on the policy statement "NRC Review of Agreement State Radiation Control Programs, last amended and published at 57 FR 22495 (1992).
The program review indicators identified in this policy statement are divided into Category I -Direct Bearing on Health and Safety and Category II - Essential Technical and Administrative Support.
The application of the findings of a review and the determination of adequacy to protect the public health and safety to the i
termination or suspension of an agreement is discussed as follows in the policy statement:
In reporting findings to State management, the NRC will indicate the category of each comment made.
If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety and is compatible with the NRC's program.
If one or more significant Category I 28
DRAFT comments are provided, the State will be notified that the program deficiencies may seriously affect the public health and safety and that the need for improvement in a particular program is. critical.
The NRC would request an immediate response.
If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, the staff may offer findings of adequacy and compatibility as appropriate or defer such offering until the State's actions are examined and their effectiveness confirmed in a subsequent review.
If additional information is needed to evaluate the State's actions, the staff may request the information through follow-up correspondence or perform a follow-up or special, limited review.
NRC staff may hold a special meeting with appropriate State representatives.
No significant items will be left unresolved over a prolonged period.
If the State program does not improve or if additional significant Category I deficiencies have developed, a staff finding that the program is not adequate will be considered and the NRC may institute proceedings to suspend or revoke all or part of the Agreement in accordance with Section 274j of the Act.
The compatibility of the State's regulations with the NRC program is also considered in the review under the policy statement procedures:
The NRC feels that it is important to strive for a high degree of uniformity in technical definitions and terminology, particularly as related to units of measurement and radiation dose.
Maximum permissible doses and levels of radiation and concentrations of radioactivity in unrestricted areas ac specified in 10 CFR part 20 are considered to be important enough to require States to be essentially equivalent in this area in order to protect public health and safety.
Certain procedures, such as those involving the licensing of products containing radioactive material intended for interstate commerce, also require a high 29
DRAFT degree of uniformity.
If no serious performance problems are found in an Agreement State program and if its standards and program procedures are compatible with the NRC program, a finding of adequacy and compatibility is made.
The second criterion in section 274j(1) for termination or suspension of all or a part of a state agreement is "the State has not complied with one or more of the requirements of this section" (section 274).
The NRC legal interpretation of that section concludes that sections 274d(2) and 274g encompass a continuing requirement for an Agreement State program to remain compatible with the NRC regulatory program.
Therefore a finding that an Agreement State program is not compatible could theoretically serve as cause to terminate or suspend an agreement under 274j(1).
As stated earlier, the Commission has never commenced any action on its own initiative under section 274j.
Under section 274j (2) the Commission also has authority to temporarily suspend all or a part of an agreement-under certain circumstances:
(2) The Commission, upon its own motion, or upon-request of the Governor of any State, nay, after notifying the Governor, temporarily suspend all or part of its agreement with the State without notice or hearing if, in the judgment of the Commission:
(A) an emergency situation exists with respect to any material covered by such an agreement creating danger which requires immediate action to protect 30
4 DRAFT the public health and safety of persons either within or outside of the State, and (B) the State has failed to take steps necessary to contain or eliminate the cause of the danger within a reasonable time after the situation arose.
Although there is no Commission policy statement or set of procedural rules interpreting this provision, the Office of State Programs has an internal procedure, D.13 Guidelines for Temporary Suspension of a Section 274b Agreement, which sets forth some criteria for applying the emergency temporary suspension described in section 274j(2).
As stated within the procedure, the authority to temporarily suspend an agreement would be invoked only in a very unusual emergency situation resulting in 1
exposures or releases greater than a stated magnitude, after considering the adequacy of the actions taken by the State, the urgency of temporarily supplementing the Stc,te's capability, and the timeliness of the State's response.
The State would be kept fully informed of NRC actions and would be-promptly informed that 1
The minimum levels are. (1) Exposure of the whole body of any individual to 25 rems or more of radiation; exposure of the skin of the whole body of any individual to 150, rems or more of radiation; or exposure of the feet, ankles, hands or forearms of any individual to 375 rems or more of radiation; or equivalent exposures from internal sources; or (2) The release of radioactive material to an unrestricted ares in concentrations which, if averaged over a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, would exceed 5,000 times the limits specified for such materials in Appendix B, Table II of 10 CFR Part 20.
31
)
t y
.(
t i
.i
' DRAFT i
t
'I the temporary suspension is no longer in effect when the t
conditions which initiated the suspension no longer exist.
{
r l
1 I
t
.' fi s
T
.. y
?
5 I
?
i l
t i
i E
I t
32 1
1, t
D PRESENTATION TO CONFERENCE OF RADIATION CONTROL PROGRAM' DIRECTORS 0N REGULATORY INITIATIVES
,p vouq
- s l FRANK A. COSTANZl, DEPUTY DIRECTOR DIVISION OF REGULATORY APPLICATIONS OFFICE OF NUCLEARLREGULATORY. RESEARCH
' SAN FRANCISCO, CALIFORNIA MAY 20,1993
. REPORTING 0F DEFECTS AND NONCOMPLIANCE (10 CFR FAni 21)
APPLICATION OF CURRENT REQUIREMENTS TO MANY NONREACTOR LICENSEES AND-IHEIR SUPPLIERS MAY NOT BE APPROPRIATE BECAUSE MOST NONREACTOR LICENSEES CONDUCT ACTIVITIES WHERE DEFECTS ARE LESS LIKELY TO PRESENT A SUBSTANTIAL SAFETY HAZARD.
AMENDMENTS WOULD CLARIFY REQUIREMENTS AND MAKE THEM MORE APPROPRIATE AND LESS BURDENSOME FOR NONREACTOR LICENSEES.
DRAFT RULE UNDER REVIEW BY AGREEMENT STATES.
1
REQUIREMENTS.FOR.THE POSSESSION OF INDUSTRIAL DEVICES (10 CFR PARTS 31 AND 32)
CURRENT REGULATIONS LACK REQUIREMENTS FOR PROPER
- HANDLING, DISPOSAL, AND ACCOUNTING FOR GENERALLY LICENSED DEVICES CONTAINING RADIOACTIVE MATERIAL.
e AMENDMENTS TO PARTS 31 AND 32 WOulD ENSURE THAT LICENSEES KNOW AND UNDERSTAND REQUIREMENTS FOR
'THE POSSESSION OF DEVICES AND PROPERLY HANDLE AND 1
ACCOUNT FOR THEIR DEVICES.
1 e-FINAL RULE EXPECTED TO BE PUBLISHED DURING l
MAY 1993.
. ~. _.. ~... _. _ _ -.. _ _ - - -, _. _, _. - _ _ _ _ -. _. - - -..... _ _ _ _.. ~.. _,. _ _ _ -..... _ _ _
?
L PREPARATION AND USE OF BYPRODUCT MATERIAL FOR MEDICAL USE
~
(10 CFR PARTS 30, 32, AND 35)
PROPOSED AMENDMENTS ADDRESS 1 ACNP-SNM PETITION TO PROVIDE GREATER FLEXIBILITY FOR PROPERLY QUALIFIED NUCLEAR PHARMACISTS AND PHYSICIANS TO PREPARE AND USE RADIOACTIVE DRUGS.
DISCUSSED WITH ACMUI IN MAY AND OCTOBER 1992, L
WITH THE AGREEMENT STATES IN JULY 1992, AND IN A COMMISSION MEETING ON MARCH 9,1993 (SECY :
050).
THE PROPOSED RULE IS EXPECTED TO BE PUBLISHED l
DURING JUNE 1993.
L i
ISSUE OF MINIMIZING RADIATION TO
- EMBRY0, FETUS, AND BREAST-FED INFANT (10 CFR PART 35)
AN
- EMBRYO, FETUS, OR BREAST-FED INFANT COULD BE HARMED BY AN UNINTENTIONAL ADMINISTRATION OF BYPRODUCT MATERIAL GIVEN TO A PREGNANT OR BREAST 4
FEEDING PATIENT.
STAFF RECOMMENDED A COURSE OF ACTION FOR COMMISSION CONSIDERATION IN MAY 1992.
STAFF IS CURRENTLY DEVELOPING RESPONSES TO SPECIFIC COMMISSION QUESTIONS ON COSTS, FREQUENCY OF OCCURRENCE, AND EXISTING PRACTICES ON THIS ISSUE.
FINANCIAL ASSURANCE REQUIREMENTS (10 CFR PART 61)
PART 61 LACKS FINANCIAL ASSURANCE REQUIREMENTS FOR POST-CLOSURE MAINTENANCE AND MONITORING OF LLW DISPOSAL SITES.
e NUCLEAR WASTE POLICY ACT OF 1982 GIVES NRC L
AUTHORITY TO ESTABLISH SUCH REQUIREMENTS.
AMENDMENTS TO PART 61 WOULD ENSURE THAT LLW DISPOSAL. SITE LICENSEES MAKE ADEQUATE FINANCIAL ARRANGEMENTS FOR MAINTENANCE AND MONITORING DURING INSTITUTIONAL CONTROL PERIOD.
e OPTIONS FOR FINANCIAL ASSURANCE MECHANISMS ARE BEING EVALUATED.
e PROPOSED RULE FOR AGREEMENT STATE COMMENT EXPECTED BY SEPTEMBER 1993.
SELF-GUARANTEE AS AN ADDITIONAL FINANCIAL ASSURANCE MECHANISM (PARTS 30, 40, 50 AND 72) e SELF-GUARANTEE OF DECOMMISSIONING FUNDS BY QUALIFIED LICENSEES WOULD REDUCE LICENSEE COSTS AND MAINTAIN FINANCIAL ASSURANCE.
PROPOSED AMENDMENTS TO-PARTS 30, 40, 50, 70 AND 72 ADD SELF-GUARANTEE AS AN APPROVED FINANCIAL ASSURANCE MECHANISM FOR NON-UTILITY LICENSEES.
PROPOSED RULE PUBLISHED JANUARY, 1993 NRC STAFF NOw EVALUATING COMMENTS.
e FINAL RULE EXPECTED IN JULY 1993.
EXTENSION OF APPLICABILITY OF 10 CFR PART.61 PERFORMANCE OBJECTIVES TO AB0VE-GROUND DISPOSAL OF LOW-LEVEL RADI0 ACTIVE WASTE
- SRM, DATED FEBRUARY 18, 1993, ON FINAL RULE PACKAGE.
FINAL RULE PACKAGE REVISED AND SUBMITTED TO -
e COMMISSION ON APRIL 9, 1993.
FINAL FEDERAL REGISTER NOTICE EXPECTED DURING MAY e
L1993.
'^
.,_a-_
.=___,-..-._- _ -
m m
m
LLW UNIFORM MANIFEST (10 CFR PARTS 20 AND 61)
PROPOSED RULE, APRIL 21, 1992.
BASED ON PUBLIC. COMMENTS, MODIFICATIONS TO SIMPLIFY REPGRTING WORKED OUT BETWEEN D0T AND NRC
- MARCH 1993.
-e BASED ON. REQUEST FROM LLW FORUM CONDUCT PUBLIC MEETING TO CLARIFY PURPOSE, EXPLAIN CHANGE AGREED TO WITH DOT, AND GET FURTHER INPUT FROM INTERESTED PARTIES.
SCHEDULE FOR PUBLIC. MEETING JUNE 15, 1993.
DETAILED SCHEDULE FOR FINAL RULE TO BE DEVELOPED AFTER PUBLIC-MEETING.
ESTIMATE FINAL RULE IN EARLY CY 1994.
I
-... _ -... _. - -. _ -. - -,. _. -.., _ _.. - _. _ _ -.... _. -.. _ _ _..., ~.
_-._._._~..~.-...-..-.,.--,._1-,-
-. -.... _ _ _.. _........ _. - _. - - -.. -.. - _ _ _ - _ _ _. -... _ _ _ _ _ _ _ _ _ _. ~ _,
2.'
8
- p. ' s,
! w g, United States
- %,,,,,fi Nuclear Regulatory Commission.
PUBLIC MEETING WITH AGREEMENT STATES -
1993 CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS SAN FRANCISCO, CALIF 0$NIA 1
MAY 20,1993 Dr. ' Donald A. Cool Radiation Protection and IIealth Effects Branch l
i L
.+' %s (W, f}1-United States
\\W.,,
Nuclear Regulatory Commission 10 CFR PART 20 Substantive Changes to Part 20 4
2 my n. m3
!,"*"c p
United States
\\,,,f}y Nuclear Regulatory Commission Deletion of Controlled Area
/
Problem
" Controlled Area" can be established "for any reason", and has been confused with " restricted area" Term was intended to apply to situations other than radiological 4
3 unear,sns
_. _.7 s
y ~.
1 United States
...../
Nuclear Regulatory Commission p
b Deletion of Controlled Area
/
Solution Delete " controlled area" from nde Make clear in preamble statement that licensee can control access to areas for reasons other than radiological Rulemaking will not increase burden or impact to licensees and willnot change worker or public health and safety l
l 4
Mar M. In3
- - - - - - - - - - - - - - - -. - - ~ _ _ _ _ _ - - _ _ _ _ _ _ _ _ _,. _ _ _ _ _ ___ _ __,
s
.-y W
/'
b 1
. United States
\\.:....- l Nuclear Regulatory Commission l
.e Definition of Occupational Exposure
/
Problem Occupational dose is defined as the dose receivedin a restricted area or in the' course of employment where the individuals assigned duties involve exposure A member of the public entering a restricted area is subject to occupational dose under the present definition 9
's ~
uar n. sm
..-.__..__,_._....x.._
.u.-.
~
4 p~%
l 1
United States
\\,,,,,)
Nuclear Regulatory Commission Definition of Occupational Exposure
/
Solution Define Occupational Dose as dose received as a result of individuals employment which involves exposure to radiation and/or radioactive material Make conforming changes to definition of public exposure
.-Definitions would clarify distinction between workers and v.
members of the public.
Change in definition should not increase burden or impact to licensees and will not change worker' health and safety and would increase health and safety for members of the public 6
u n. im
+
'N-f~s
}
United' States
.,...../
Nuclear Regulatory Commission Training for Occupationally Exposed Individuals
/
Probiern 10 CFR Part 19.12 requires radiation protection training for aH individuals entering a restricted area Workers who are occupationaHy exposed, but do not enter a restricted area do not have training requirements i
4
' Members of the public who enter a restricted area are required to have worker training, although this may not be necessery for a brief escorted visit or tour I
{
l 7
ue n, sm l~
l'
7~ ~
{
}
United States:
,,,,,/
Nuclear Regulatory Commission t
Training for Occupationally Exposed Individuals l
/
Solution Revise 10 CFR Part 19 to require training commensurate with hazards present for all persons who will be occupationally exposed Rulemaking would provide requirement for appropriate training
^>-
for all workers, irrespective of their. location Members of the public would not be required to have occupationalexposure training 8
uws. sm
~..~.:-
.. -. ~. - - -,
f n
p
/%,
~,.
1 United States i
',,,,)
Nuclear Regulatory Commission f
n e
Schedule
/
Proposed rule currently under preparation
/
Publish for public comment in July,1993
/
Staff believes rule would be most useful if thw final is available before January,1994 9
u y n. im i.
]
1 c
p" ~ %,,,
!1
<s United States
's,,.....)
Nuclear Regulatory Commission 10 CFR PART 20 Criteria for Release into Sanitary Sewers 10 M N. IM
. ~
m
7 6
h
.p s,.
(
United States
^
'\\,,,,,.
Nuclear Regulatory Commission e
History P
/
Contamination events have occurredin a number oflocations Events involved a number of different isotopes including Co, Am,U Events generally attributable to release of dispersible materials, such as metal flakes or particulates 11 ser n, am I
m,,,
.~.-m,..__..
.4,,,
u,.
..-,-m._
m.--.
m
. -. ~
4 a
s
,f ~ s United States
!\\,,,,f}1 Nuclear Regulatory Commission History
/
Revision of 10 CFR Part 20 Revision deletedprovision to dispose of dispersible material, but
. retained provisions for soluble and dispersible biologicalmaterial Revision reduced concentration values for radionuclides Revision retained 1 Ci total quantity limit Revision retained exemption of sewer disposals from public dose limits u n, tm 12 n
., _ _ ~
_,.. ~
... -... ~. -, - -. _ - -. -. -
~
... - ~.
p.~ ~ s
!,<3
^ United States
'%,,,,, /
Nuclear Regulatory Commission l
e issues to be Resolved
/
Continued use of single, total quantity, release limit versus.
radionuclide specific quantity release limits
/
^ Continued exemption ofsewerreleases from public dose limit
/
Potential for reconcentration of soluble radionuclides in secondary and tertiary sewer treatment systems
/
Impacts of reducing total quantity release limits on smaH licensees and university /research institutions 13 u r n,im
'9
[
p~ ~ %,,,
United States Nuclear Regulatory Commission Rulemaking Schedule
/
Proposed rulemaking appmach to EDO -- June 1993
/
Draft proposed rule for Agreement State and OfHce review --
September 1993 *
/
Office concurrence on proposed rule -- November 1993
- I
/.
ACNW review --JDecember 1993 * '
/
Proposed rule to EDO -- January 1994 *
/
Final Rule to EDO -- December 1994
- If the rulemaking approach includes an ANPR, these dates would slip by 6 to 9 months.
14 n, n, im e
=weem-
-- m=s-e**e.2ede-ani-seo e 4 e--we a4.s
-tu eai&
W L m e ep's-=.e4e e- '41miwmur-ta ',ws--w-a erut**PI-99-e rk med?f W Tem' n-hip 4T1w me e mi o e*e-r8tes14 m*T ermen e #me-l* %ei re1D w enMw 'iiswtWrevedspww--m--wwetTha&':'rtemw9 &s tirege t"v = 0*
utwge*T's T wd*eu.w=u* war
+
ar-etdsw 1m a++w sumsaw
g
}
,e s,,
(, <
United States
%,,,,,,/
Nuclear Regulatory Commission 10 CFR PARTS 20 and 35 I
Patient Release Criteria 4
uer, sm n
15
y; e
r-
- ~%
1
- United States
^
Nuclear Regulatory Commission e
History 1
Petitions for rulemaking Dr.
Carol S.
Marcus, Revise 10 CFR Parts 20 and 35, February 1991 American College of Nuclear Medicine, Revise 10 CFR Part 35, April 1992 (Amended Petition) l l.
mr, sm n
16'
R 1
p' ~%,,
United States
(%,,,,f}1 Nuclear Regulatory Commission History
/
Agreement States, Medical Regulation Workshop, Atlanta, GA, July 1992
/
Advisory Committee on Medical Use of isotopes, Medical
. Regulation Workshop, Rockville, MD, October 1992 4
1 17 war u, sm
)
l
/* *%s, l
<j United States
- %,,,, /
Nuclear Regulatory Commission Major Provisions
/
' Modify the application of the public dose limit in 10 CFR 20.1301 to exclude the dose received from patients released under the provisions of 10 CFR 35.75
/
Modify 10 CFR 35. 75 to specify a 500 mrem (5 mSV) annual Total Effective Dose; Equivalent dose limit cdtenon for the individuallikely to receive the greatest dose
?
1 4
.18 uer n, im 1
..- =.
- a. -.
.r s
p-~%,
! w
,i United States
\\,...../
Nuclear Regulatory Commission Major Provisions
/
Modify 10 CFR 35.75 to require that when the dose to an individual is likely to exceed 100 mrem (1 mSv) from any patient release:
Licensees provide written information on risks of radiation and methods for reducing the exposure ofindividuals Licensees keep a record of the release for 5 years ner, sm n
19
F Y
}
Nuclear Regulatory Commission United States
(
%,,,,,,/
Major Provisions
/
Modify 10 CFR 35.75 to delete the 5 mrem per hour release restriction in 35.75(a)(1) and (b)
/
Modify 10 CFR 35.75 to delete the 30 mCipatient release restriction in 35.75(a)(2) 20 mr 20,Im i
g t
i' E
p ~ s,,,
g United States
- [
\\,,,,,,/
~ Nuclear Regulatory Commission 1
Major Provisions f
Statement of Considerations forproposedrule willoutline the contents of a Regulatory Guide which would be published with the Final Rule
/
. Regulatory Guide 'would provide:
Table of radionuclides with cumulative total activity needed to achieve exposures-of 100 mrem ahd 500 mrem (1 mSv and 5 mSv)
Acceptable methodology for calculation of case specific dose estimates Iinformation on the acceptable contents of written information Information on records necessary to demonstrate compliance v.
. 21.
marn, ms L
'e's aamh-
--m_--____m_--ma.__A-7Ae_tpu e
.*rw aemA Ar am th.
ms-eA' s.-42.+-eewwwe
-saw J
'*,C_mm'sa___
m ePde ue a eo e w M m es.N-eE--
a-1
---are se amerer we e-e NMeW Fe
-.T*w-ww9ahN se
-7 eve eko 1 eervT+ve-m-m-e-
-m?MF-ww mmm--: =-d
y ~%,,
i 1
United States 5
e
,,,,,/
Nuclear Regulatory Commission
-t
.e Schedule
/
Draft to Agreement States in May,1993
/
Public Comment-
/
Final Rule in December,1993 4
22 ner 20, tm
=
T, R
o i
/ "*%,
l
}
United States
%,,,,,,/
Nuclear Regulatory Commission e
10 CFR PART 32 ACCESSIBLE AIR-GAP FOR GENERALLY LICENSED. DEVICES 4
23 Men,2993
- j i
/*' %,,
!, "<l/
t United States Nuclear Regulatory Commission
\\,......
History
/
Proposed Rule published for public comment November 27, 1992
/
Comment period expired March 29,1993 4
a 24 unn, am
.- ~-.. -.
8
.s- ~y,,,
United States
!\\,,,,,)y Nuclear Regulatory Commission l
l Proposed Rule Provisions o
.f Gauges may be distributed under generallicense provided:
The air gap between the radiation source and detector of the device is less than 45 cm (18 in)
The airgap of the device would not allow insertion of a 30 cm i
(12 in) diameter sphere into radiation beam without removal of.
a barrier 4
The dose rate in the radiation beam at 45 cm (18 in) from a radiation source with device does not exceed 1.25 mSv (125 mrem) per hour f
I 25 M *'
p
~%,,
United Staes
,i sr
.,,,f Nuclear: Regulatory Commission i
Proposed Rule Provisions e-
/.
A device installed in a vessel (e.g., pipe or tank) may remain under generallicense if:
\\the vessel does not need to be entered under any foreseeable circumstance, and casual entry is prohibited, or if device meets previous criteria regarding air gap and radiation levels.
26 uwn, sm
......-=_.,a.-.--
~. -...:
g 1
I!
U
/'~%s United States s
5 i
',,,,, /
~ Nuclear Regulatory Commission fi Proposed Rule Consequences e
/
Licensees would have option ofmaking the airgap of existing gauges inaccessible by; Building a barrier around the air gap Locking the area where the air gap exists Installing interlocks so that no one can enter the area while the radiation source is in the exposed position
/.
Manufacturers and users would be given 3 years to achieve compliance 27 sern, sm
, {
-t p.- ~s.,,
'y
' Nuclear Regulatory Commission United States.
(
\\,,,,,,/
Comments
/
Total of S comments, 3 from manufactures and 2 from users
/.
Commenters agreed with 3 year implementation interval
/
'4 commenters stated that NRC and Agreement State L
requirements should be identical I
/
2 commenters made recommendhtions regarding use of
'45 cm andlocation of reference measurement 4
28' nier N,I M.1
.,; 1
_y n
E,:
f - s.,,
}
United States l
i
%,...../
Nuclear Regulatory Commission Comments k
/
1 commenter requested definition of entry to avoid ambiguity
. with OSHA definition
/
1 commenter requested use of accessibility bylocation as an option in addition to physical modification
/
1 commenter felt that generallicensed devices should not be categorically eliminated for use on vessels / tanks
+
29 marn, sm
\\
p z.
i p-r%.,;
United States s
s I
/
Nuclear Regulatory Commission
,[ :
Schedule
/
Evaluation of changes suggested by public comments
/
Office Concurrence in July,1993
/
Final Rule to Commission in November,1993 4
30 isn sm TM*1-a er-e e-1
+
&B-a3wmv
- au e r e
w->-6=.ev--p'^wA-twM*6 57 e-T-
--' ^
w=N %
m:
- e T
4-m
- ' + --=^
F-ama a
- 1 3
[, c
,1, p' %
United States
\\,...../
Nuclear Regulatory Commission 9
10 CFR PART 34 RADIOGRAPHY Z
4 I'
my n, ms
" ~ ' - - - - - -
2-_,_ _ _ _ _ __ _ _ _ _
y I
t 75 t
United States.
\\,,,,,/
Nuclear Regulatory Commission r
Development of the Revision
/
Suggestions solicited from the agreement states at the October 1991 all Agreement States meeting in Sacramento, CA
/;
Agreement States workshop heldin Dallas, TXin November 1992 to discuss State recornmendations
/
. Conceptual inodel of' the revised
- regulation sent to the Agreement States on April 12,1993
/
Comments due to the NRC by May 7,1993
/
Proposed rule due to the commission by June 30,1993 i
33 w n, m3 n
4 m
---.Es...m-.
e.= --
v v,
E-v-.,--.
a.. ~
~. - -.
--mm.--
. ~...
-a.-
m
.w.--+...-s
-.....i..4
. - +,..
-~-v
I
.,. ~ ~,
s' United States
\\,,,,,)
Nuclear Regulatory Commission Major Provisions of the Conceptual Model e
f Adoption of a two-person rule for ternporaryjobsites 9
Could use 2 radiographers or 1 radiographer and 1 assistant Responds to petition received from the IUOE 4
A 33 ue n. sm
. =
3
=,
i.;
f %,,
l
<g United States
%,.,,,,/
Nuclear Regulatory Commission Major Provisions of the Conceptual Model
/
Radiation safety officer requirements.
Specifies qualifications and duties Similar to Texas regulations Qualifications include 2 years experience as a radiographer plus 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of specialRSO training
.u u., n. ms i
=
. - - _ _.. _..,. ~ _ _ - -. _. -. _ _ _ _. _
- r
~
E 7*
p.
t United States I
e/
Nuclear Regulatory Commission Major Provisions of the Conceptual Model
/
Additional training for radiographers' assistants Training in applicable parts of NRC regulations (19, 20, 30, 34 and 71) and their NRC license
/
Testing requirements for depleted uranium To confirm integrity of the device t
ne n, am 35.
w
=w-g m---n e--
h4-4"i---
me-
-ma. m a
u
-=t--*r-a-4r-u e - --
'hv m-m a----
m.
ear'd--
e
.f-a a
ea---me%---
w-mum--
m 4--
-4.
u m --mmm----- -.
.9-
..S S
- f:
n f s, t.
United States
...../
Nuclear Regulatory Commission
't i
Major Provisions of the Conceptual Model e
/
Re-definition of a permanent radiographic installation.
i Requires all shielded rooms to have installed alarms
/
Reduction in the number of fieldinspections Reduced from quarterly inspections to semi-annualinspections i
l
/
Availability oflicense documents l
Certain documents would be required to be available'at field stations and temporaryjob sites l
l:
?
uer. Im u
36
~.....
p
~%,,
(
}
United States
\\,...../
Nuclear Regulatory Commission
- Agreement State Compatibility
/
if promulgated, 'this rulemaking would be a Division l compatibility for definitions
/
ifpromulgated, the remainder of the rule revisions would be Division 11 compatibility E
i l
uns, am n
37 l'
. o y~%
(, <,,y United States
\\,,,,,,/'
Nuclear Regulatory Commission 4
10 CFR PARTS 30,40,70 FINANCIAL ASSURANCE FOR ACCIDENT CLEANUP 38 u r n, sm
--. r
_c-w,%
- r..,..,
-n
, ~ _,,.,.~
e.,v.,,.,r..,,
,,.,--.,e
,,.-,,*..,,y--
sw e..
ram _,--.
..x---
,.e
.s
~
.}
y y%,,
't United States
%,,,,)
Nuclear Regulatory Commission History
/
ANPRM issued June,1985
/
Commission directedstaffreviewin 1990in conjunction with Large irradiator Rule
/
Agreement State meeting in October,1991 MarN, Ins
-39
(
l
..-=.-.....-....-.a......-
.-.-.-..-.-: --.......---....--.=.-. -..
j
- r
. /* *%,
n United States v
..... /
Nuclear Regulatory Commission 4
ANPRM Comments f
159 Comment letters received 40% opposed to rulemaking 40 % neutral, but believed they should be exempt 20 % in favor of rulemaking
/
Agreement States were generally in favor of rulemaking l
40 uern,Im i-.__-.___,___._..________________________.,__ _, _ _ _ _ _. _ _ _ _ _ _ _ _ _ _ _ _, _ _ _, _ _ _ _ _ _ _ _
i p"~%
United States 1
s
\\,,,,,,)
Nuclear Regulatory Commission Review of Information
/
NUREG/CR-4825 Preliminary Evaluation of the Economic Risk for Clean-up of Nuclear Material Licensee Contamination incidents (SNL)
/
NUREG/CR-5381 Economic Risk of Contamination' Clean-up Costs Resulting From Non-reactor Nuclear Material Operation (SNL) k
(
/
NUREG/CR-4958 Impact of Proposed Financial Assurance Requirements on Nuclear Materials Licensees (PNL)
/
Additional review by SC&A to update, collate, and analyze t
previous NUREG's 4
41.
. un n, am
m
. 7"'N t
United States Es,...../
Nuclear Regulatory Commission Results
/
Majority of concern was alleviated by decommissioning financial assurance rule in 1988
/
States have not imposed similar financial assurance requirements on their licensees
/
Licensees which: have the potential for a
signiHcant contamination event (e.g.,
fuel ' cycle) have insurance' adequate to pay for on-site and off-site clean-up 42 m n, ms
^*=,--s_
A s --- 2 m-s m-m
- - uE~,,,u.~.---m--
m.w-a--.= = = --rw-<
e m*-
m-
-,m-v%m rw-_+w
- -=e-,,,*e-~,-_s v-eewww.---w,emy--
~-awas e
vw-m.a
.. - -. + - < - <.
+ --
ma v.-vsw--
.t a,v-.
-N
-~
],
},
l f-~s i
t United States
...**/
. Nuclear Regulatory Commission Status
/
Selected States surveyed to determine if rulemaking is still needed Survey indicated that those States did not believe there was a need to proceed with rulemaking
/
Staffrecommendation thatrulemakingisnotneededcurrently
.before the Commission 43 n n, am w
-__,_..m._-
...m.
_ _ _....., _ _ _______ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _ -