ML20203J955
| ML20203J955 | |
| Person / Time | |
|---|---|
| Issue date: | 12/23/1996 |
| From: | Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Faircloth L SENATE, ENVIRONMENT & PUBLIC WORKS |
| Shared Package | |
| ML20203J328 | List:
|
| References | |
| FOIA-97-384 NUDOCS 9712220141 | |
| Download: ML20203J955 (1) | |
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UNNED STATES f
l8 NUCLEAR REGULATORY COMMISSION waemeneron, o,c. memesa
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December 23, 1996 l
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Th Honorable Lauch Faircloth, Chairman ommittee on Clean Air, Wetlands, Private, Property and Nuclear Safety l
Committee on Environment and Public Works i
United States Senate Washington, DC 20510
Dear Mr. Chairman:
The NRC has sent to the Office of the Federal Register for publication the enclosed dental of a petition for rulemaking submitted by the Heartland Operation to Protect the Environment. The petitioner requested that the NRC amend its regulations to adopt a rule regarding government ownership of a low-3 level radioactive waste (LLW) disposal s<te that is consistent with the petitioner's view of Federal statute, specifically the Nuclear Waste Policy Act of 1982 (WPA), as amended. The petition implies that the NRC' regulations t
should require private land ownership of the site during the operational life of the facility, and after closure convert title to the site to the Federal l
Government.
l The petition is being denied for the following reasons. First, the NRC believes the petitioner is incorrect and that the current regulations are not inconsistent with the WPA; second, the NRC has the authority to require Federal or State land ownership as a condition for licensing a LLW disposal facility and continues to believe the existing regulatory procedures are I'
appropriate; and third, the NRC continues to believe that there would be a negative impact if the change proposed by the petitioner were implemented.
Sincerely, ff i
Dennis K. Rathbun, Director 4
g-Office of Congressional Affairs b
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Enclosure:
Federal Register Notice E
cc: ' Senator Bob Graham g22g1971217 l
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[7590-01-P)
NUCLEAR' REGULATORY COMMIS$10N 10 CFR Part 61 (Docket No. PAN-31-3)
Heartland Operation to Protect the Environment: Denial of Petition for Rulemaking AGENCY: Nuclear Regulatory Commission.
ACTION: Denial of petition for rulemaking.
SUMMARY
- The Nuclear Regulatory Commission (NFiC) is denying a petition for rulemaking (PRM-61-3) submitted by the Heartland Operation to Protect the Environment.
The petitioner requested that the NRC amend its regulations to adopt a rule regarding government ownership of a low-level radioactive waste (LLRW) or (LLW) disposal site that is consistent with petitioner's view of the applicable Federal statutes.
The petition is being denied because the NRC l
believes there is no conflict between Section 151(b) of the Nuclear Waste Policy Act (NWPA) and its regulations requiring that LLW disposal facilities be sited on land owned by Fe'6ral or State government.
The NRC has the authority to require Federal a State land ownership as a condition for i
licensing a LLW disposal facility and continues to believe the existing regulatory procedures are appropriate.
ADDRESSES:
Copies of the petition for rulemaking, the public comments received, and the NRC's letter to the petitioner are available for public l
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inspection or copying in the NRC Public Document Room 2120 L Street NW.
(Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT:Mark Haisfleid, Office of Nuclear Regulatory 20555-0001, Research, U.S. Nuclear Regulatory Commission, Washington, DC telephone (301) 415-6196, E-mail MFH9nrc. gov.
SUPPLEMENTARY INFORMATION:
Background
On August 3, 1994 (59 FR 39485), prior to receipt of the petition (PRN-61-3), the NRC published an advance notice of proposed rulemaking (ANPRM) in the Federal Register regarding land ownership. The ANPRM announced that the NRC was considering amending its regulations in 10 CFR 61.59(a) to allow private ownership of the land used for a LLRW disposal facility site as an On alternative to the current requirements for Federal or State ownership.
July 18,1995 (60 FR 36744), the NRC published in the Federal Register a notice withdrawing the ANPRM because the rule change was not warranted or needed. The basis for this decision was the general indication from States and compacts that they do not need, nor would they allow, private ownership, and that the rule change under consideration could be potentially disruptive to the current LLW program.
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The Petition j
On January 9,1996 (61 FR 633), the NRC published a notice of receipt of a petition for rulemaking filed by the Heartland operation to Protect the l
Environment (HOPE). The petitioner states that the NRC's present regulation (10 CFR 61.59(a)), which permits disposal of LLW 'only on land owned in fee by l
the Federal or a State government," is in conflict with a provision in Section 151(b) of the Nuclear Waste Policy Act of 1982, as amended.
The NWPA authorizes the U.S. Department of Energy (00E) 'to assume title and custody of j
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-low-level radioactive waste and the land on which such waste is disposed of, t
upon request of the owner of such waste and land and following termination of i
the license issued by the Commission for such disposal...."
Therefore, the petitioner proposes that the' NRC regulations should conform to the NWPA
. provision and require private land ownership during operations and closure of the facility, then converting title to the site to the DOE.
The petitioner, who also commented on the ANPRM, further states that the notice withdrawing the ANPRM contains no documentation or statement of any issue of public health and safety as the basis for the regulation. Therefore, the petitioner believes that public health and safety cannot be an issue upon which the NRC regulation is based.
The notice of withdrawal contains the statement: "The Commission believes that the potential negative impact of disrupting the current process j
far outweighs any potential benefits that might be derived from making a
-generic rule change at-this time."
In response, the petitioner asserts that l
the Commission's role is to regulate nuclear material in a manner that 3
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j protects-public health and safety and the environment, that~ tts role is not to r
f facilitate specific-processes,' i.e., the current LLRW disposal process.
The petitioner references the'following quotation the NRC used in the withdrawal notice.
This quotation came from one of the comments received on f
a the ANPRN.
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for over three decades the public has been led to believe that all
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LLW disposal sites would necessarily be owned and controlled by either a.
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- Federal or state government. This, we believe, has been an important j
f factor in convincing many proponent groups and State and local LLW advisory groups that-LLW can and will be disposed of in a safe manner.
To now try and convince these groups that Federal or State ownership of LLW disposal sites is not required, may be difficult and generate a l
significant credibility problem.
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i In. response, the petitioner states that "... credibility problems occur when misrepresentations -- i.e. government ownership is necessary in order to assure proper LLRW management -- are initially made, and that such credibility i
problems are exacerbated the longer such misrepresentations are allowed to continue." The petitioner asserts that there would appear to be a larger credibility problem for the Commission to maintain 10 CFR 61.59(a) that is, in v
-the petitioners's view, in direct conflict with a statute (i.e., Section 151(b).of the NWPA). The petitioner offers that, "The Commission might reflect.on-the Department of Energy's recent' efforts to gain credibility by coming clean.on past _ misrepresentations -- i.e. secret radiation studies."
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i Pubite Comments on the Petition i
The noiice of receipt of the petition for rulemaking invited interested
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The NRC received persons to submit written comments concerning the petition.
six comment letters. Three coment letters were received from States, one from the DOE, one from the Nuclear Energy Institute (NEI), and one from an environmental organization. The comments generally focused on the main element of the petition, that the Comission amend its regulations to adopt a rule regarding government ownership of a LLW disposal facility that mirrors Onecommentersupporth the NWPA or the resultant impact of this rule change.
The the petitioner and the other five believe the petition should be denied.
coments and responses were reviewed and considered in the development of NRC's decision on this petition.
These coments are available in the NRC Public Document Room. A sumary of the significant comments follows:
The comenter that supported this petition for rulemaking was the State of Nebraska.
Nebraska had also comented on the ANPRM discussed above, and its position continues to support the petitioner's view that the current NRC rule conflicts with the NWPA.
Its coment also states that, "... there is very little connection between promulgating regulations deemed necessary or desirable to protect public health or to minimize danger to life and property and the current regulation which requires low-level waste disposal on land owned by the federal or state government before a facility can be licensed.
While there 'may be a need for having the state or federal government involved in owning the property AFTER the operation and closure of a facility, this is not what.the current rule does.
Instaad, it requires state or federal ownership prior to the license being issued" (emphasis in the original).
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The' positions and specific comments fra the five commenters who believe the petition should be denied are basically covered in the " Reasons for l
1 Denial" Section.
t Reasons for Denial i
The NRC is denying the petition for the following reasons:
First, the-NRC believes the petitioner is incorrect that the current regulations are inconsistent with Section 151(b) of the NWPA; second, the NRC has the authority to require Federal or State land cwnership as a condition for licensing a LLW disposal facility and continues-to believe the existing l
regulatory procedures are appropriate; and third, the NRC continues to believe that there would be a negative impact if.the changes proposed by the j
petitioner were implemented.
L 1.
The NRC agrees with those commenters who believe the petitioner has incorrectly interpreted the language and intent of the NWPA.
Section 151(b) l
-of the NWPA merely authorizes, but does not require, the DOE to take title to r
- LLW disposal facility sites following temination of an NRC license for such disposal. This is demonstrated by the discretionary language of the statute.
For example, ender Section 151(b), as quoted by the petitioner, "The Secretary
.(DOE) (sic] shall have the [ sic] authority to assume title and custody of low-leve1' radioactive waste and the land-on which such waste'is disposed of,_upon request by (sic] the owner of_such waste and land and following termination of_
the license issued by the Commission-(NRC) [ sic] for such disposal...." 'The-NRC believes that there is no conflict between Section 151(b) of the NWPA and 10 CFR 61.59(a).
NRC's requirement under i 61.59(a), that facilities be
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e sited on land owned by Federal or State government, does not prevent DOE from exercising its authority under Section 151(b) of the WPA to assume title and custody after license temination. The DOE is a Federal entity and thus could.
satisfy the i 61.59(a) requirement for governmental land ownership.
The NRC For regulation in i 61.59(a) is broader than the statutory requirement.
example, ' assuming for purposes of argument, if DOE lacked the authority under
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Section 151(b) of the WPA to own a disposal site prior to license terminstion, NRC's regulations would allow another Federal or State entity to own the land as required by i 61.59(a). The focus of 5 61.59(a) is on Federal or State land ownership, whereas the focus of Section 151(b) is on DOE's authority to assume title and custody of a LLW disposal facility.
Further, under Section 151(b)(2), "If the Secretary assumes title and custody of any such waste and land under this subsection, the Secretary shall maintain such waste and land in a manner that will protect the public health and safety, and the environment." The WPA thus allows the DOE, if it so chooses, to assume title and custody of the waste and land after license termination.
The discretionary nature of the statutory language indicates that the petitioner's conclusion is incorrect.
Finally, ! 61.59(a), on its face does not impose any obligation on the States, rather it imposes a condition with respect to land disposal of low-level waste, namely that the Commission will permit disposal of low-level waste only on land owned by a Federal or State entity. Thus, we see no conflict with the holding in New York v. United States,112 S. Ct. 2408 (1992) that Congress does not have the authority under the Constitution to compel the
. States-to take affirmative action with regard to waste disposal.
Similarly, 4
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o NRC's regulation, t 61.59(a), does not direct or compel the States to take affirmative action with regard to waste disposal.
2.
As stated'in the notice of withdrawal of the ANPRM, the ' Commission believes there is adequate statutory authority for the NRC to require federal or State land ownership.' This authority comes from the Atomic Energy Act of 1954, as amended, in Section 161b which gives the Commission the authority to promulgate regulations deemed necessary or desirable to protect health or to minimize danger to life or property.
The requirement for Federal or State government ownership of land for disposal of waste at a land disposal facility has been a requirment in the Commission's regulations since the inception of comercial disposal operations (NRC promulgated the land ownership requirement b) 1961 (26 FR 352, January 18,1961)).
In exceptional cases an exemption from this requirement may be granted in the public interest if life or property is not endangered pursuant to 10 CfR 61.6.
The granting of an exemption by the State of Utah from State land ownership regulations led the Commission to issue the ANPRM in order to solicit comments regarding the possible desirability of changing the rule, but the majority of comments received in response to that solicitation convinced the Commission that no change should be mr.de. The NRC continues to believe that the requirement for governmental land ownership in i 61.59(a) will ersure control of the disposal site after closure, and thereby reduce the potential for fnadvertent intrusion, better ensure integrity of the site, and facilitate monitoring of
- site performance.
Further, the NRC staff believes that requiring government ownership prior to licensing is beneficial so that a potential licensing issue is settled prior to the facility beginning operation.
The experience of the State of California in obtaining Federal land for the proposed Ward Valley 8
-disposal facility is a case in point that transfer of land is not automatic
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and should not be assumed at the time the license is granted.
therefore, requiring governmental land ownership prior to licensing is an appropriate regulatory requirement.
3.
In addition,_ as discussed in the notice of withdrawal of the ANPRM and by several of the cossenters, the proposed change in the requirements could have a de-stabilizing effect on the ongoing efforts by the States to
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license LLW disposal facilities. The NRC believes that because there would be f
no health and safety benefit from the proposed change in requirements,-it is inappropriate to take an action which could have an adverse impact on the timely development of safe Lt.W disposal facilities.
For reasons cited in this document, the NRC denies the petition.
Dated at Rockville, Maryland, this day of 1996.
For the Nuclear Regulatory Commission, f
EL-J e'M.,Taylorf xe tive Direftor for Operations.
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NUCLEAR REGULATORY COMMISSION j'
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j December 30, 1996 (Ibe Honorable Lauch Faircloth, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Puolic Works United States Senate Washington, DC 20510 l
Dear Mr. Chairman:
In the near future, the Nuclear Regulatory Commission (NRC) intends to publish in the Federal Realster the enclosed notice of withdrawal of a Petition for Rulemaking (PRM 35-14), submitted by isoStent, Inc. The petitioner requested that the NRC amend its regulations by adding a new section to address permanently implanted intraluminal stents, including phosphorus-32 and strontium-89 radioisotope stents. The petitioner also requested that the NRC add a new section to specify training and experience requirements for qualified phyr"'ans responsible for placing radioisotope stents in patients. The petitioner is withdrawing its petition for rulemaking based on public comments received by the NRC on the petition, and other information.
Sincerely, 0.= h k /
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice ec: Senator Bob Graham
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[7590-01 P]
NUCLEAR REGUI.ATORY COMMISSION 10 CFR Pad 35
[ Docket No. PRM-3514]
looStent, Inc.; Withdrawal of Petition for Rulemaking AGENCY : Nuclear Regulatory Commission.
ACTION: Petition for rulemaking: Withdrawal.
1
SUMMARY
- The Nuclear Regulatory Commission (NRC) is withdrawing, at the petitioner's request, a petition for rulemaking (PRM-35-14) filed by IsoStent, Inc. By n i
letter dated May 9,1996, the petitioner requested that the NRC amend its regulations by adding a new section to address permanently implanted intraluminal stents, 3
incleding phosphorum-32 and strontium-89 radioisotope stents. The petitionar also requested that the NRC add a new section to specify training and experience requirements for qualified physiciana responsible for placing radioisotope stents in patients. The NRC published a Federal Register notice on June 27,1996 (61 FR 33388) announcing receipt of the petition. Recently, in another letter dated October 24, i
1996, the petitioner requested that the petition be withdrawn based on public comments received by the NRC on this petition, and other information.
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2 ADDRESSES: A copy of the petitioner's letter requesting the withdrawal of the petition is available for public inspection, or copying for a fee, at the NRC Public Document Room,2120 L Street, NW. (Lower Level), Washing 6on, DC.
Single copies of the petitioner's letter may be obtained free of charge by writing to the Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Chief, Rulos Review Section, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, ll.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Telephone: 301-415-7163 or Toll Free: 800-368 5642, or E mail MTL@NRC. GOV.
Dated at Rockville, Maryland, this 2[ day of December 1996.
For the Nuclear Regulatory Commission.
' John C. Hoyle, Secretary of the Commission.
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e UNITED STATES NUCLEAR REGULATORY COMMISSION 4
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December 30, 1996
-t T e Honorable Lauch Faircloth, Chairman ubcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, D.
C.
20510 ksar Mr. Chai want in ace?rdxce with Section 9 of the Federal Advisory Committee Act, the Nuclear Regulatory Commissim, (NRC) hereby files the required Charte N for the. Advisory Committee on Reactor Safeguards and the Licensing Support, System Advisory Review Panel.
The enclosed charters for these committees update the documents previously filed by NRC in December 1994, and extends the lives of the committees through December 23, 1998 and December 19, 1998 respectively.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs l
Enclosures:
As Stated cc:
Senator Bob Graham y.
A A
UNITED STATES NUCLEAR REGULATORY CONNISSION CHARTER LICENSING SUPPORT SYSTEN ADVISORY REVIEW PANEL 1.
Establi=b--at and Official Damianation The Nuclear Regulatory Commission's (NRC) Rules of Practice in 10 CFR Part 2, Subpart J, establish the basic procedures for the submission and management of records and documents relating to the licensing of a gcologic repository for the disposal of high-level radioactive waste (HLW).
The procedures include the use of an electronic information management system known as the Licensing Support System (LSS).
Pursuant to 10 CFR 2.1011(E) (1) there is established an advisory committee designated as the LSS Advisory Review Panel.
2.
Obiectives, Scone of Activity, and Duties The LSS Advisory Review Panel shall provide advice tot the Department of Energy (DOE) on the fundamental a.
issues of the design and development of the LSS.
b.
the LSS Administrator, NRC, on the operation and maintenance of the LSS.
The LSS Advisory Review Panel chall provide advice on:
format standards for the submission of documentary a.
material to the LSS such as ASCII files, bibliographic headers, and imagesi b.
procedures and standards for the electronic transmission of filings, orders, and decisions during both the pre-licensing application phase and the high-
-level waste licensing proceeding; c.
access protocols for raw data, field notes, and other items; d.
protocols on digitizing equipmenti e.
a thesaurus and authority tables; f.
reasonable s'equirements for headers, the control of duplication, retrieval, display, image delivery, query response, and " user friendly" design; and n..
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2 other relevant activities related to the design, g.
operation and maintenance of the LSS and the format and procedures for LSS material as directed by the LSS Administrator.
The LSS Advisory Review Panel will also develop recommendations on establishing priorities for the loading of documentary material and will review and comment on proposals on whether particular categories of documentary material should be included in the Topical Guidelines.
After commencement of the high-level waste repository licensing proceeding, the primary focus of the LSS Advisory Review Panel will be on broad, long-term, technical issues relating to the design and maintenance of the LSS and continuing assessments as to how and whether LSS is performing its intended function and serving users' needs.
3.
Duration The LSS Advisory Review Panel is expected to be needed on a continuing basis through the conclusion of the hearing on i
t the license to emplace waste at the repository.
4.
Official to Wham the C-4ttee Renorts The Panel reports to the LSS Administrator, NRC.
5.
Anancy Resnonsible for Providina Necessary succort The Nuclear Regulatory Commission will provide the necessary support through the Office of the LSS Administrator.
6.
Membership Membership initially included representatives who wished to participate from those organizations who served on the NRC High-Level Waste Licensing Support System Advisory Committee.
This includes representatives of the State of Nevada, the Department of Energy, the Nuclear Regulatory Commission, the affected units of local government in Nevada, the National Congress of American Indians, and the coalition of industry groups.
Selected Federal agencies with substantial experience in electronic information management systems may also be included on the Panel.
Consistert with the Federal Advisory Committee Act, the LSS Administrutor may appoint additional representatives, giving particular consideration to potential parties to the HLW licensing proceeding and those who later acquire actual party status..The NRC representative will serve as the Chairman of the Panel.
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Estimated Number and Fremuency of Meetinas The LSS Advisory Review Panel is expected to meet approximately two to three times a year and to save travel costs will utilize the computer based capabilities of the internet system to communicate on a newly established I
"LSSNET".
8.
Estimated 1= anal operatina costs The estimated annual operating costs for the LSS Advisory i
Review Panel are $P,500 and 0.1 persou-year.
Filed with the Nuclear Regulatory Commission:
December 19, 1996 M
2. 8 Jer Andrew L. Bates Advisory Committee Management officer e
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Au9ust 12, 1997 l
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'p Honorable Lauch Faircloth United States Senate Washinpton, D.C. 20510 9175
Dear Senator Faircloth:
On October 8,1996, you wrote concoming the National Academy of Sciences, institute of 1
Medicine report entitled, Radiation in Medicine: A Need for Regulatory Reform." On December 6,1996, I provided an interim reply. Since then, the Commission has taken action to evaluate the Nuclear Regulatory Commission's (NRC) future role in regulating the medical use of radioactive material.
Based on the findings of NRC's strategic assessment and rebaselining efforts, which considered the findings of the National Academy of Sciences, institute of Medicine report and i
comments from the regulated community, professional organizations, NRC's Agreement States, other Federal spencies, and the public, the Commission decided to retain its regulatory authority for the medical use of byproduct material, and directed the staff to modify -
the current program.
,On June 30,1997, the Commission approved the staffs plan for revising 10 CFR Part 35, associated guidance documents, and, as necessary, the Commission's 1979 Medical Policy
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Statement, following a risk-informed, more performance based approach to regulation. The staff recently published a Federal Reaister notice and press release announcing the initiative.
I have enclosed background documents associated with this issue. If I can be of further assistance to you, please contact me.
Sincerely,
?la &, J.
Shiriey Ann Jackson
Enclosures:
- 1. DSl Nos. 7 and 12 l2 COMSECY-96-057
- 3. SECY 97-115 7
- 4. SECY-97131 5,' SRM-SECY-97115
o Dimetion Setting issues Papers Numbers 7 and 12 F
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STRATEGIC ASSESSMENT ISSUE PAPER p.
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J 051 7: MATERIAL 5/NEDICAL DVER5!GNT INTRODUCTION In August 1995, the Nuclear Regulatory Consission (NRC) l l
project.
i in Strategic Assessment and Rebaselining take a new look at the MC by conducting a reassessment of N by order to redefine the basic nature of the work of the agency and ii which that. work is accomplished, and to apply to these redefi rigorous screening process to produce (or rebaseline) a new l
ass eptions, goals, and strategies for the NRC.
d are intended to provide an agency-wide Strategic Plan which and implemented to allow the NRC to meet the current and f A key aspect of this project was the identific fhe These issues fall into three categories, this work is accomplished.first category includes 4
Subsumed issues are those that i
(D51s).
The second category inciddes subsumed issues.The third category includes related should be considered along with the DSIs.These are issues tha as pset of the project, other issues.
Also These are not strategic a de:1sion on the option (s) for a 05I.
issues of an operatf onal nature were identitled. l l
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the issue papers.
Following the reassessment of 1:RC.etivities, issue papers w i
f provide a discussion of DSIs and subsumed issues, and to discussion of the options as well as summaries of the consequ these broad, high-level issues.
l Final decisions related to the DSIs will influence the related issues which are listed, bu options related to the D51s.
blic.
the issue papers are being provided to interest issue paper.
l After to provide a form to discuss and receive counse i
decisions concerning the D51s and options. In suusary, the Strategic Assessment to develop a Strategic Plan for the NRC.
and Rebaselining Project will analyse where t l
fonrard in a changing environment.
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I 051 7 i
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RELEASE DATE: SEPTEMBER 16, 1996
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MATERIALS / MEDICAL OVERSIGHT D5! 7 I
SLNIARY A.
Direction-Setting Issue The Nuclear Regulatory Commission (NRC) sypr-duct Materials Program currently regulates approximately 6,400 specsfic and 3!.300 general licenses for the possession and use of nuclear materials in medical, academic, and industrial
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The Materials Program includes licensing and inspection applications.
activities, primarily administered by the NRC regional offices, arid exempt distribution licenses and sealed source and device (55&D) reviews, which are l
The various regulated products and uses range f
handled by NRC Headquarters.
6 f*om large quantities of radioactive materials in compigx devices or in the mLuufacture of radiopharmaceuticals to small quantities in radioactive tracer i
The hAC is evaluating the level of control and studies or in simple devices.
Many of regulation needed to oversee its diverse Nuclear Materials p and State agencies. Specifically, the NRC has been considering whether to continue to regulate or to revise its oversight of the medical uses of nuclear To obtain input on the medical regulation issue, the NRC byproduct materials.
contracted with the National Academy of Sciences (NAS), Institute of Medicine (ION), to perform an external review and to assess the adequacy and i
The ION final report, appropriateness of the current regulatory framework.A Need for Regulatory
' Radiation in Medicine:
recommendations to give regulatory authority over medical uses to the states, l
with a Federal agency other than the NRC providing leadership and guidance'.
A decision on the Medical Use Program may effect a rethinking of the NRC's i
fundamental philosophy on the extent to which it should regulate other nuclear This issue paper pr svides options associated with the Direction-materials.
Setting Issue (DSI) of what should be the future role and scope of the NRC's i
Nu::1, ear Materials program, and in particular NRC's regulation of the medical The options include expanding; retaining and use of nuclear material.
retaining in part, or eliminating the Nuclear Byproduct Materials l
revising,ith particular emphasis on medical use, Program w i
8.
Options Increase Regulatory Responsibility Nith Addition of X-Ray, Option 1:
Accelerators, and Naturally Occurring and Accelerator-Produced Radioactive Materials This option would transfer the regulatory responsibility for non-Atomic Energy Act of 1954, as amended (AEA), sources of ionizing radiation, such as x-rhy, linear accelerators, and naturally occurring and accelerator-produced
' See Attachment, ' Regulation of Radiation in Medicine - 10M !ssues" DSI 7 RELEASE DATE:
5EPTEF.8ER 16, 1996 2
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4 D$1 7 MATERIALS / MEDICAL OVERSIGHT 1
radioactive materials (NARM). from other Federal agencies and the states to the NRC. An Agreement states Progrha would continue.
Legislation would be required to implement this option.
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Option 2: Continue Ongoing Program (With Improvements) l This option would maintain the current regulatory responsibility of the NRC and the States, while making continual improvements to increase efficiency and revising replations to be more risk-informed and performance-bassd rather s
than prescr'ptive.
Soms of these improvements are currently ongotna (business process reengineering [BPR]) or are on temporary hold (revision of Part 35 of Legislation Title 10 of the Code of Federal Reaulations [10 CFR Part 35]).
would not be required.
Option 3: Decrease oversight of Low-Risk Activities With continued Emphasis of High-kisk Activities j
This option would decrease regulatory responsibility for all materials that pose a low risk to the workers and the public. Examples of these materials include diagnostic nuclear medicine, gas chromatographs, some portable gauges, and so on. The NRC would retain oversight of $5&D reviews, manufacturers and distributors, and high-risk applications, such as medical therapy, radiography, arid large irradiators.
Specific regulations and guidance in the high-risk area would be revised to make them more risk-informed and perfomance-based.
Option 4: Discontinue Regulation of All Nedical Activities Except NRC Oversight of Devices and Manufacturers (National Academy of Sciences 1
5.eco%dndation)
In this option, the regulatory authority over all medical uses of byproduct in a material would be given to the States, with a Federal agency (not NRC)iews, guidance leadership role. The NRC would retain authority for SS&D rev manufacturers and uistributors, and all nonnedical applications.
Findings under section 81 of the AEA for exemption or legislation would be required to discontinue NAC responsibilities over medical uses.
Legislation would be required to give authority to the States and to name a lead Federal agency.
Option 5: Discontinue Naterials Program In this option, the regulatory authority for byproduct material applications would be given to another Federal agency or the States, with the assumption
- that an acceptable level of safety would be maintained. The NRC would have no remaining authority for any byproduct materials oversight.
Legislation would be required.
RELEASE DATE:
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II. DESCR!pTION OF ISSUES e
A.
Background / Bases The key considerations in reexamining the role and scope of NRC's Cyproduct Katerials Program, and specifically its regulation of the medical use of byproduct material, are NRC's responsibilities as defined by the AEA to protect pub lic iwalth and safety, the cosmon defense, arid the environment.
Although the Syproduct Materials Program must be performed in response to the AEA, the AEA also-provides NRC with. broad authority regarding the standards This issue and processes that it applies in iuplementing this responsibility.
necessary to ensure adequate p otection in the use of byp Section 81 of the AEA directs the NRC to regulate the manufacture, production, transfer, receipt in interstate commerce, acquisition, ownership, possession, import, and export of byproduct material. Among other things, Section 81 authorizes the NRC *to issue general or specific licenses to applicants gyproduct material is defined in Section seeking to use byproduct material."
11e(1) of the AEA as nuclear materials created or made radioactive by exposure As provided to the radiation during the fissioning process in a reactor.
The under the AEA, the NRC also regulates Federal licensees in-all states.
NRC has only limited responsibility, however, for regulating uses of nuclear material by the Department of Energy or the Department of Defense.
The nuclear materials licensees can be categorized into several major groups covering various products and uses regulated by the NRC and the Agreement states, under either a-specific license or a general license.2 1.
Specific Licensed Nuclear Materials These groups include (1) broad-scope materials licenses; (2) manufacturers and distributors; (3) hospitals, clinics, nuclear pharmacies, and private physicians; (4) limited research and development operations; (5) measuring systems; (6) irradiators; (7) industrial radiography; (8) well logging;- and (g) other material licenses. All of these licensees are regulated under applicable provisions in 10 CFR parts 19, 20, and 30 for byproduct materials.
In addition, individual. sections of Title 10 provide specific requirements for some activities, such as medical, radiography, and irradiators.
L In addition, the Csamission has> exempted certain nuclear material a
The most widely exempted uses, activities, and products from regulation.
products are residential smoke detectors that contain small quantities of americium-241.
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a.
Broad-Scope Materials Licenses The broad-scope licensees include universities, medical schools, large medica centers, large manufacturers, and research and development facilities that
)
i cannot operate under a more limited specific license without seri i
variety of activities, including research and development, laboratory testing, disrupting their programs.
J Broad-scope licenses authorize the use of and medical diagnosis and therapy.
any byproduct material by anyone in accordance with review and approval Under procedures and criteria established by the radiation safety committee.
the broad-scope license, the NRC places significant reliance on the j
organization's radiation safety consittee and radiation safety officer to ensure that NRC's regulatiens are met.
300 broad-scope licensees.
b.
Manufacturers and Distributors Manufacturers and distributors of nuclear materials include those that fabricate SS&Ds (e.g., brachytherapy sources, portable gauges, radiography The manufacturers cameras), as well as those that make radiopharmaceuticals.
usually use unsealed nuclear materials that must be controlled to a greater extent than sealed materials. Currently, NRC licenses 12g manufacturers and distributors under 10 CFR Part 32. Twenty of these manufacturers also have received broad-scope licenses from the NRC.
Hospitals, Medical Clinics, Nuclear pharmacies, and Private physicians c.
The Medical Use Program represents approximstely one-third of NRC's nuclear materials licensees and includes uses of byproduct saterial in medical diagnosis, therapy, and research. Currently, there are approximately 1,000 NRC licenses authorizing the medical use of byproduct material under i
10 CFR part 35.
j d.
Limited Research and Development Operations Research and development licenses are issued for possession and use of specifically designated radionuclides in academic institutions, industrial The NRC regulates facilities, and medteal institutions for nonnedical use.
approximately 500 timited research and development licensees under applicabl sections of 10 CFR Parts 20 and 30.
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~ Nessuring Systems _
e.
Measuring system licenses are. issued for the possession and use of measuring devices and are regulated under applicable sections of 10 CFR P&rts 20, 30, Measuring systems include fixed gauges for measuring or controlling and 70.-
parasaters, such as material density, flow,' thickness, or weight; portable gauges, such as moisture-density gauges used at fixed locations; x-rayThe NRC regu fluorescence analyzers; gas chromatographs; and others.
i approximately 2,200 measuring system licensees.
f.
Irradiators Irradiator licensees use radiation for purposes such as sterilizing blood products, disposable medical supplies, and food and polymerizing compounds in Irradiators are also used for some research applications.
wood finishes.
Approximately 40 irradiator licensees are authorized, pursuant to 10 CFR Part L
36, to possess radioactive material in excess of 1C,,000 curies each for use in irradiation activities.
Several commercial NRC-licensed irradiator licensees use more than 6 million curies to process materials in their facilities. The NRC regulates 204 irradiator licensees.
g.
Industrial Radiography In inaustrial radiography, radiographers use sealed radiation sources to make i
Radiography is x-ray-like pictures of metal objects such as pipes and valves.
[
a form of nondestructive testing that uses radiation from sealed sources l
(principally iridium-1g2 and. cobalt-60) to examine the internal structure of objects. The portable radiography devices may contain radioactive sources The NRC l
with as much as 200 curies of iridium-Ig2 or 100 curies of cobalt-60.
has issued about 160 industrial radiography licenses pursuant to 10 CFR part 34.
h.
Well Logging In well logging, sealed nuclear sources, unsealed radioactive trace material, and radioactive markers are used for subsurface surveying to obtain reological i
information. The testing procedures are primarily used in oil, gas, and mineral exploration to identify subsurface geologic formations. NRC licenses about 60 firms for well logging under the provisions of 10 CFR Part 39.
i.. Other Material Licenses The other types of materials uses that require a specific license include such diverse activities as nuclear laundries, which clean protective clothing containated with radioactive material; leak test and other service companies that provide services to other licensees to leak test sealed sources or
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devices containing sealed sources, to analyze leak test samples, to calibrate radiation survey or monitoring equipment, or to repair devices containing sealed sources; waste disposal services; and others.
The NRC has about 900 licensees performing these remaining diverse activities.
2.
Seneral Licensed Devices Although specific licensees must submit a license application to the NRC and receive a written specific license, this is not the case for most general licensees.. An NRC general license becomes effective on the basis of the In most cases, a general general license provisions in WRC's regulations.
license is effective without the filing of an application with the Commission j
l or the issuance of a licensing document to the license holder.
An example would be the acceptance of a nuclear materials product at the point of sale, which would make the buyer a general licensee, General license' provisions authorire a variety of activities, such as holding title to licensed material, as well as use of licensed material contained in a t
device. The generally licensed devices must meet regulatory standards for design and manufacture so that they may be used by persons with minimal instruction in their proper use.
(ks previously discussed, manufacturers and distributors of devices intended for use under a general license must be l
specifically licensed for this purpose.)
Examples of these devices include static eliminators, nuclear gauges, and self-luminous signs. An NRC database indicates that there are approximately 35,000 general licensees that use about 600,000 regulated devices.
3.
Exempt Distribution Licenses In addition to specific and general license products and uses, the Commiission has exempted certain nuclear material products, quantities, or concentrations l
from the requirements for a license and from the regulations. These exemptions have been made with prior findings that such exemptions will not constitute an unreasonable risk to the cosenon defense and security and to the I
health and safety of the public.
Exemptions have been authorized for products l
such as gemstones, watches with tritium paint, and smoke detectors, once there I
l has been an initial transfer or distribution of the pronuct.
4.
Sealed Source and Device Reviews
[
The 23C further exercises its statutory responsibilities by the certification or registration of SS&Ds. $$&D manufacturers submit specific information on manufacturing techniques, prototype test results, and other data related to engineering and radiation safety to the NRC or the appropriate Agreement
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maintains a registry of $$&Ds approved by the NRC and the Agreement States.
Applicants for specific licenses can reference these apprgved products in t>eir applications.
B.
External Factors Notwithstanding the aforementioned oversight process, the operational history and knowledge base inherent in the current nuclear materials industry allows The nuclear opportunitivs for streamlining NRC's Regulatory Program.
materials industry, with an operational history exceeding 40 years, has a firm foundation in the knowledge and under:tanding of the properties of nuclear materials and the applicable handling and -radiation safety procedures, as wel as the metallurgical and engineering requirements for fabricating SS&Ds.
However, even with such an operational history, some f actors, such as technological advances and aging equipment, may affect streamlining considerations, i
1.
Technological Advances The nuclear materials industry has been and will continue to be affected by For example, advanced computer technological advances in other fields.
technology has been combined with the use of sealed source and devices.
advent of the gamma knife (used for brain radios rgery) and r6este Technological enhancements are not afterloading brachytherapy devices.As the SS&Ds are affected by more limited to radiation medicine.
sophisticated nonnuclear technology, the regulations, 4
l In the case of the gamma knife, for example, there are no
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specific medical use requirements in 10 CFR Part 35. although the regulations may change.
do address procedures for conventional cobalt-60 teletherapy devices.
2.
Aging Equipment Additionally, with a nature industry, some licensed nuclear material d 1
are becoming old and/or obsolete. Aging devices may warrant special consideration metallurgical problems.
and if the NRC undertakes to streamline its Regulatory Program, especially in the areas of routine inspections and guidance to licensees.
- 3. - External Interest Unlike the organized opposition to nuclear reactors or nuclear waste disposal, the public (in most cases) has been supportive (at times, by remaining silent)
There on the use of nuclear materials in medicine, industry, and commerce.
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have been. times, however, when the public has expressed concern about new uses -
For of nuclear radiation (e.g., opposition to irradiation of fresh foods).
the most part, the external interests in the Materials Program have involved a few concerned citizens, licensees and their associations and professional societies, and the news media. The print media have published in-depth articles on issues such as radiation medicine misadministrations that have resulted in deaths; radioactively contaminated sites whose licenses have been terminated; and reconcentrated radioactive sewage sludges found at sewer treatment facilities. Additionally, Congress has shown and continues to show interest in,the Nuclear Materials Programs of both NRC and the Agreement States.
An example of this external interest is found in the medical use of byproduct During the past several years, the medical comunity, regulated by t.aterials.
NRC and Agreement States, has been very vocal on specific requirements of In general, this medical comunity, including physicians, Part 35.
physicists, pharmacists, hospitals, professional associations, and others, regards the detailed prescriptive requirements of Part 35 as unnecessarily A specific target has been the regulation on " Quality Management burdensome.
Program and Misadministrations' (the QM rule), which became effective on January 27, 1992. The medical consnunity has asserted that the requirements are an intrusion into medical practice, are cost-ineffective, and have no utility. The QM rule was strongly opposed by several professional societies,In which made their views known to the Office of Management and Budget (OMB).
June 1992, OMB disapproved the record collection requirements of the QM rule on the basis that the NRC had not demonstrated that the rule would yield significant benefits. The NRC Coussissioners overrode the OMB determination, citing the necessity of the information collection requirements for public health and safety.
In addition, the American College of Nuclear Physicians and the Society of Nuclear Medicine took the NRC to court to overturn the QM rule. The court ruled in favor of the NRC. Shortly after, in November 1992, a patient in Indiana, Pennsylvania, died as a result of a therapy misadministration. A month later, the Cleveland Plain Dealer ran a week-long series entitled " Lethal Doses: Radiation That Kills.' These events resulted in congressional hearings on NRC's Medical Radiation Program and its Agreement States Program that raised questions about the adequacy of control of theAs a medical use of byproduct material by the NRC and the Agreement States.
result of the two opposing, strongly held views of the regulated medical community, and Congress and the media, the Comunission directed the staff to reevaluate the Medical Use Program with the assistance and advice of the NAS.
To that end, the staff contracted with the Institute of Medicine of the NAS to perform the external review mentioned earlier in this issue paper. The report of that review, " Radiation in Medicine: A Need for Regulatory Reform,' is discussed in the Attachment to this paper, " Regulation of Radiation in Medicine - 10M Issues" RELEASE DATE:
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- 4.. Full Cost Recovery Another significant external factor is the Omnibus Bu 1
4 The n eber of NRC licensees has declined since about 1990 dueTh authority.
j primarily to'the requirement for full fee recovery.
continue, with the number of licensees decreasing by about one third if Sta that are currently negotiating agreements (Massachusatts, Pennsylvania and Oklahoma) become Agregnent States and additional States continue to pu The reduced number of NRC licensees will further compound the full-fee-recovery cost issue, even though the BPR efforts will likely reduceA this status, licensing fees for s -s categories of NRC licensees.buoming an Agreement state training and technical assistance.
C.
Internal Factor In addition to the described external factors, an ongoing internal initiative could affect any decision on the role and scope of the Nuclear Materials Program.
Business Process Reengineering In 1994, the staff began a major reevaluation of the regulatory proce IRC's oversight of licensed materials. Phase I was completed in the spring of 1995.
This phase was directed toward proposing a fundamentally new approach to as part of a BPR effort.
licensing designed to (1) perform at least an order of magnitude faster than l
the current system; (2) be supported by clear, consistent, and timely l
ensure that no adverse effect on public health regulatory guidance; and (3) implementation. The new process will use modern and safety results from its i
The new approach focuses on infomation technology to streamline operations.
i including performance requirements in NRC's regulations, discontinuing the current practice of incorporating licensee practices and procedures in license As conditions, and considering changes to the duration of materials licenses.
l part of these efforts, a rulemaking has been promulgated to extend qualif
- materials licenses for an additional 5 years.
It is envisioned that the BPR will have a significant impact on the entire The number of Nuclear Materials Program during the next several years.
licensing actions should significantly decrease, as should the required review time.
Overall, as a result of the reengineering efforts, streamlined or eliminated.
the NRC's Materials Program snould be significantly more efficient and During the past several years, responsive to both the public and licensees.the NRC's Materials Prog DSI 7 RELEASE DATE: SEPTEMBER 16, 1996 10 E
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However, in fiscal year 1997 the program will begin to staff and resources.
This dec) ease in both staff and technical assistance contractual support.
decrease is due, partially, to the increased efficiencies,in licensing and inspection anticipated from BPA, and partially from additional-Agreement States.
III. DISCUSSIONS A.
Discussion of Direction-Setting Issue The key considerations in reexamining the role and scope of NRC's Byproduct i
Naterials Program, and specifically its regulation of the medical use of byproduct material, are NRC's responsibilities as defined by the AEA to protect public health and safety, the common defense, and the environment, Although the Byproduct Materials Program must be performed in response to the i
AEA, the AEA also provides NRC with broad authority regarding the standards and processes that it applies in implementing this responsibility.
Also to be coi.:'dered is the interpretation that the Cosmiission hat adopted and implemented that medical patients are included in the "public."
The options on the role and scope of the Nuclear Materials Program are the i
result of management and staff review and subsequent initiatives such as the Medical Management Plan, BPR, and planned revisions to 10 CFR Parts M and 35.
i Other factors influencing the development of options included resource 1bitations, growth in the number of Agreement states, a desire for increased efficiency and effectiveness, and the reconnendations of the 10M.
i Although the primary focus of the Byproduct Materials Program is on protecting public health and safety, it must also ensure that the extent of control is tempered by the risk to the public. The focus should be on the safety-significant issues and on providing timely and consistent guidance and licensing that will allow licensees to meet the regulations and standards in j
the most efficient and economic way.
In turn, these considerations need to be viewed in terms of a broader, changing environment.
For example, it is anticipated that the number of Agreement States will increase over the next 5 The NRC will need years, significantly reducing the neber of NRC licensees.
1 to consider what steps to take to account for the anticipated reduction in 1
Although the BPR process is a step in the right direction,
=
resources.
additional steps need to be initiated. The NRC may also have to consider changes in Pew it regulates areas of low public risk. This issue paper i
addresses the extent or scope of a Byproduct Materials Oversight Program necessary to ensure adequate protection in the use of byproduct materials.
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Discussion of subsumed Issue typroduct Materials ProgramAs a part of selecting an opt the following strategic is considered and resolved as a, result of this issue paper. sues sho s
Issue:
nuclear material?What should be the role of NRC in regulating 1
Under the AEA, NRC has responsibility for two categories o use.
Regulation of these two broad cate on medicin Tird of NRC's Nuclear Materials Program.gories represents approximately one is nuclear medicine, which employs radioactiva drugsOne categor These drugs usually contain only very small quantities (radiopharmac material Nuclear m,edicine occasionally includes the use of radioactive unsealed radioactive material for therapy, especially for dis es of thyroid gland.
The other category of radiation medicine is radia (radiation oncology).
In radiation therapy lar material, usually in the form of sealed sour,ces,ger quantities of radioacti treatment.
to and within a patient. Sealed quantities of radioactive materia Sealed radiation sources regulated under the AEA used in about 25 percent of radiotherapy treatments.
linear accelerators, is used in the other 75 p Therapeutic radiation devices,'such as a gamma knife and 6,000 curies microcurie or, mil 11 curie quantities.while eingnostic nuclear me may contain more than By authority of the AEA and Commission policy, the NRC re use of nuclear materials as necessary to provide for the es the medical workers and the general public.
intrusion into medical judgments affecting pat of t
traditionally considered to be the practice of medicine agency's i
o other areas that physicians have primary responsibility for the protectiThe N patients.
NRC regulations assume that authorized physician users on of their appropriate trainin of their patients. g and experience, will make decisions in the best inte
, with Over the years, the Commission has m strengthen the Medical Use Program. ade a concerted effort to improve and patient overexposures at Riverside Methodist Hospital in Colum i
took action to upgrade its regulation of radiation sources i t
Also s, Ohio, NRC in February 1979, NRC issued a policy statement to guide Progr,am in the medical area.
n medical use.
A fundamental tenet in the policy statement is L
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-the commitment to protect patient safety without intrusion into the pract ce of medicine. However, there has been frequent tension with the regulated i
4 medical community on a number of medical use regulatory irl tiatives that have L
i been opposed by members of the regulated community as an intrusion into the i
l practice of medicine.
This tension and opposition to NRC's re ulation of the medical uses of byproduct material have been a continuing prob em.
l Additional problems arise from the jurisdictional responsibilities for the Jurisdiction over various aspects of the l
different sources of radiation.
regulation and use of ionizing radiation in medicine is exercised by both the i
+
Federal Government. Primarily through the Department of Health and Human l
services, the Food and Drug Administration (FDA) and the WRC, and the States.
Within this regulatory framework, the NRC has jurisdiction over the medical-use of byproduct and special nuclear material and regulates radiation safety associated with the actual use of these products.
The FDA regulates the manufacture and dist;ibution of radiopharmaceuticals, biologics, ar# medical devices for safety and efficacy. For the most part, FDA does net rsgulate at l
the user level. The States have broad regulatory authority over the general i
public health and safety of their residents. This includes authority over the use of all sources of ionizing radiation, except AEA material, which is regulated by the NRC.
The States control most of radiation medicine, but the degree to which they exercise control varies from State to State.
In 19g2, the staff began to develop a Medical Management Plan to guide the conduct d the Medical Use Regulatory Program. Although delayed as a result of staff actions in response to a radiation therapy misadministration and the associated patient fatality, media interest, and congressional hearings, the In parallel, the staff was plan was subsequently completed and initiated.
directed by the Commission to initiate an external review of the Medical Use Regulatory Program.
As a result, NRC contracted with the NAS in 1994 for the 10M to conduct that external review, addressing not only the role of the NRC but also the roles of The 10M has completed its review and the FDA and the States in this area.
recommended that regulatory authority over medical uses of byproduct material be given to the-States. The 10M also recommended that only licensed users have access to byproduct material and identifies the Department of Health and Himan Services (DitlS) as the agency that should exercise a leadership role in the radiation safety community. Further, the report suggests that DHHS assist in developing recommended State laws and regulations, act as.an information clearinghouse, and distribute resources for training and research.
The NRC has reviewed the 10M recommendations at length and has held several As of August,~1996, the NRC had received 41 comments public meetings on them.
on the subject. Although some commentors supported the recommendations, the l'
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DHHS program and the absence of Federal authority in the medical use area.
stated that it could not :upport the recommendation that it provide the leadership role suggested by 10M. A more extensive summar,y of the recommendations and comments appears in the Attachment to this paper,
" Regulation of Radiation in Medicine - ION Issues
- IV. OPTIONS In this section, the five options described earlier are detailed, including, if applicable, required regulatory or legislative changes, impacts, resource implications, and the reaction of stakeholders.
i Increase Regulatory Responsibility Nith Addition of X-ray, Accelerators, and Naturally occurring and Accelerator-Produced Radioactive Option 1:
Materials Option Under this option, the NRC would continue with its ongoing program and improvements and seek legislation for regulatory oversight of other sourc ionizing radiation, including x-ray, accelerators, and discrete NARM Discrete sources of NARM include radium sources used in medicine and industry wastes resulting from cyclotrons and linear accelerators.
An wastes from the mining and processing of radium or other radionuclides.
This option would significantly Agreement states Program would continue. increase NRC's jurisd result in responsibility being taken away from other Federal agencies and the Variations of this option could include consideration of limiting states.
oversight to specific applications, such as industrial and cosmarcial uses, on to only those applications that pose a high risk (option 3).
Regulatory changes Legislation would be needed to remove the responsibility for the regulation c s
these sources of radiation from other Federal agencies and the States and to Coupled with this action would be new and revised polic3 transfer it to NRC.
statements, such as the 1979 Medical Policy Statement, memoranda of understanding with other Federal agencies, and agreements with the Agreement 4
Rulemaking to expand and modify existing regulations and generation States.
or revision of the companion guidance doctaments for the NRC staff and licensees would be necessary.
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i Impacts This option would ensure increased uniformity and consistepey in the It would avoid regulation of all sources and uses of ioni::ing radiation.
non-AEA substantive differences in regulations and oversight between AEA ar.:
sources of radiation. Also, it_ could eliminate regulatory advantage of one radiation modality over another for a given application (e.g., x-rayThis option w radiography _ versus gamma radiography).
of NRC's technological base to include specialists in x-ray and accelerator equipment,. and the medical and commerciel uses of this equipment. It would result in a significant increase in the number of NRC licensees (which would This increase would multiply 5 to 10 times), especially in the medical area.
require additional personnel and physical resources, including the possibility Such wide sweeping legislation may be of additional regional offices.
difficult to support in the absence of a capelling safety problem.
The resources required to develop the neces*,ary lagislation would include resources from the other Federal agencies currsntly providing some radiation protection or source and device oversight (e.g., FDA, the Environmental A corprehensive program that would 4
protection Agency LEPA]), as well as NRC.
implement such leglslation, that is to regulate all discrete NARM, including promulgation of regulations, guidance development, and inspection at frequencies comparable to those of similar NRC licensees, could require several hundred full-time equivalent (FTE) positions.
The Advisory Committee on Medical Uses of Isotopes (ACMUI) would need to be expanded to include other areas of expertise such as diagnostic and interventional radiology.
Reaction of Stakeholder:
As described in more detail in Option 4, the Agreement Statss that now have authority-for non-AEA sources support the approach for a single Federal agency to be responsible for all radiation use.
Option 2: Continue Ongoing program (With Improvements)
Option Under this option, the current regulatory responsibility of NRC and the States l
would be maintained. However, there would be continual improvements to increase efficiency and revision of regulations to make them more risk-informed and performance-based rather than prescriptive. Some of these l
improvements are ongoing or are on temporary hold (e.g., BPR and Part 35 revisions),
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-DSI 7 The ongoing SPR of the licensing process will result in the u Center in which technical members of the materials-licensi community can interact face to face or by way of the computer, to design and
-prepare the regulatory products necessary to support, maintain, and enhance the new licensing process; (2) improved processing of licenses through reviewer-perfomed and computer-assisted licensing, using a graded approach commensurate with the safety hazards the application poses; and (3) d on BPR a new way i
The agency-wide team concept, base of working in agency-wide teams.
philosophy, will include such attributes as collaborative team-based decisions l
and parallel concurrences.
l In additioli, NRC is identifying regulations that are obsolete, unnecessarily burdensome, too prescriptive, or that overlap or duplicate the regulations of other agencies. As part of this effort, NRC is-reviewing Part 35 to evaluate whether it can be revised to reflect a more risk informed, performance-based regulation. To this end, the staff has requested input from the ACMUI and the Agreement States on what revisions should be made to Part 35 if NRC were to retain its current statutory authority and also if NRC were to ramp down in Examples of staff-identified and staff-the regulation of patient safety.
suggested requirements needing revision or possible rescission include the As Low As it Reasonably Achievable (ALARA) Program, the Quality Management Program, the misadministration oefinitions and reporting, dose calibrator checks, surveys, calibration of devices (using industry standards where Other sections of the possible), and training and experience requirements.
regulations pertaining to materials are also being reviewed for appropriate l'
revisions.
Regulatory Changes
.No legislative changes are needed to implement this option. However, rulemaking would have to be initiated to revise the byproduct materials i
regulations, such as Part 35. In addition, internal guidance documents (e.g.,
inspection procedures, standard review plans, etc.) as well as several regulatory guides, including Regulatory Guide 10.8, would have to be revised i
to reflect the proposed changes.
I Impacts This option would result-in the development of more risk-informed, i
perfomance-based regulations and increased agency efficiencies obtained by implementation of BPR iniiiatives.
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Amending the regulations and modifying guidance documents and. associated regulatory guides has already been budgeted as part of the' Medical Management No additional resources would beinecessary for the Jeedical use area.-
plan.
Also, an overall reduction in needed materials resources is anticipated over the natt 5 years. This reduction is predominantly due to the increased efficiencies anticipated with the implementation of planned 8PR initiatives, l
as well as anticipation that there will be an increase in the numkr of.
Agreement States within the next 5 years. This possibility could result in a reduction of approximately to FTEs by the year 2000.
Reaction of'Stakeholoers Based on IOM interviews and consents on the 10M report, many medical licensees would continue to support NRC's divesting itself of responsibilities in the medical area.
Option 3:
Decrease Oversight of Low-Risk Activities With Continued Emphasis s
of High Risk-Activities Option l
This option places priority on the tenet that the regulation of byproduct materials should be consistent with the risk involved. Although the NRC has effectively regulated areas of high risk (e.g., unufacturers, large irradiators, etc.), it may be overregulating areas that involve low-risk i
activities or sources.
Low-risk hetivities could include the use of devices such as gas chromatographs and ce'.*tain gauges, and diagnostic nuclear medicine. The oversight of these low-risk activities may be an unnecessary expenditure of resources because of the limitoo additional protection it provides.
Under this option, the NRC would modify its existing regulatory responsibility of low-risk activities and maintain its current responsibility (with some program modifications) for high-risk activities. This could be accomplished l
G rough policy decisions on decreasing or discontinuing oversight in certain l
areas, rulemaking, or an agreed-upon definition of low risk _ established and l
coordinated with other Federal agencies, the States, and the conduct of a public connent process. This option would encompass the overall Materials-program and would affect medical as well as nonnedical progress. The low-risk applications could be placed in a category of licenses (such as general licenses) that warrants minimal regulatory oversight with no formalized inspection-frequency and minimal licensing requirements.. However, some audit activity might have to be established to periodically assess the general licensee's byproduct material possession and performance.
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MATERIALS / MEDICAL OVERSIGHT DSI 7 Once low risk has been defined, this option would necessitate reevaluation of those licensees currently licen:ed by the general license provisions, as well as those activities previously determined to be exempt frpm regulatior,.
A reassessment of these licensing categories may result in moving activities and uses from one category to another.
In this option, the NRC would probably maintain its current level of regulatory oversight for the manufacturers of radiopharmaceuticais and sealed sources because these activities would most likely be considered higher risk activities.. The NRC would also maintain its current level of regulatory oversight for other high-risk applications, such as therapeutic uses of For the byproduct material, large irradiators, and industrial radiography.
high-risk applications, the existing specific regulations would be revised to be more risk-informed and performance-based, or consideration may be given to limiting oversight to Part 20 compliance only.
Regulatory Changes The transfer of some of the current specific licenses to general licenses or to some other category that warrants minimal regulatory oversight would not require legislative changes..The transfer of low-risk activities to general licenses would require modifications to current general licenso regulations in Part 31, as well as modifications to current licensing regulatory guides, internal standard review plans, and inspection procedures.
Impacts This option would result in increased efficiency and effectiveness within the agency by focusing NRC's limited resources on higher risk activities and those licensees that warrant enhanced oversight because of poor performance. This option might result in the elimination of approximately 50 percent of the NRC's current specific licerisee base.
For the remaining high-risk licensees, the NRC would revise the applicable regulations and guidance documents using a risk-informed, performance-based approach.
It is anticipated that a few FTEs over about a year would be required to complete an analysis and recategorize licensees.
If NRC completely discontinues its oversight of the low-risk activities, associated legislative efforts may also require several FTEs over several years.
With NRC either completely discontinuing its regulatory oversight of lower risk activities or reducing its oversight, the current specific licensee base could be decrassed by about half. Allowing for some resources to track and audit general licensees, a reduction of approximately 50 FTEs from current licensing, inspection, and other materials activities might be realized. This reduction includes those FTEs eliminated by the BPR.
RELEASE DATE: SEPTEMBER 16, 1996 18 DSI 7
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Option 4:. Discontinue Regulation of all Medical Activities Except NRC _
j Ovet sight of Devices and Manufacturers (National Academy of Sciences Institute
- of Ned' cine Recommendation)
Option Under this option, the NRC would request that Congress (I) discontinue NRC's i
regulatory authority over all medical uses of byproduct material (including biomedical research), (2) give this rer'1 story authority to the States, and j
The (3) name another Federal agency (not IW.) to a guidance leadership role.
Tha ION report has recommended that this kderal agency be the DHHS.
leadership role would be nonregulatory and would assist in developing i
recommended State laws and regulations, act as an information clearinghouse,
+
and distribute resources for training r.nd research.
In this option, the NRC would retain responsibility for oversight of the manufacture and distribution of byproduct material (including 55&Ds) used in medicine.
Further, NRC would condition-these licenses to require that products could only be distributed to Also, the Conference of Radiation control users who were licensed by a State.
program Directors (CRCPD) would continue to develop its model regulations for The CRCPD would be expected to continually reevaluate adoption by the States.
j its regulations to maintain congruence with any scientific advances in knowledge on radiation bioeffects, and benefits and risks of the medical uses of ionizing radiation. The NRC's ongoing program for nonnedical licensees would remain as in option 2.
Regulatory Changes i
Legislation would be needed to remove responsibility for the regulation of the medical uses of byproduct material from the AEA.
In lieu of legislation, if NRC made the requisite findings under Section 81 of the AEA, the NRC could by
" exemption" eliminate this aspect of the Materials program.
Rulemaking to i
rescind or modify regulations in Parts 30, 33, and 35, among others, would follow. This route would require public notice and comment rulemaking.
Coupled with these actions would be a revision or rescission (in whole or in g
part) of the 1979 Medical Policy Statement, the enforcement policy, agreements l
with the 2g Agreement States, and the memorandum of understanding with the FDA, as well as NRC regulatory guides, manuals, and directives, lapacts j
This option would result in the elimination of approximately one-third of the INtt's current' specific licensee base.. The. States would be responsible for all radiation medicine applications, which would result in the potential for increased uniformity of the regulation of all radiation medicine within a given State. However, the level of oversight may vary considerably from State to State because currently some States provide oversight (licensing and -
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MATERIALS / MEDICAL OVERSIGHT 05! 7 inspection) through $thte radiologic health personnel, and _others by a simple f
Additionally, inconsistencies could develop between-i registration process.
dical and nonnedical applications.
. regulation of basic radiation safety in meFinally, W M5 does not sup leadership role.
Same of the non-Agreement states may lack the resources, including qualified personnel, to set up their own safety programs and decid the action ps an unfunded mandate. Also, revision of the agreements with each Additionally,.the event of the 29 Agreement States would b9 necessary.
database would no longer include misadministrations or events involvir.g overexposures to workers or members of the public (non-patients) as a result Federal facilities would be of the medical use of byproduct material.
responsible for self-regulation of the medical uses of byproduct material, prowsed legislation would need to address State regulation of Federal l
autaorities or facilities.
For those facilities conducting both biomedical and nonnedical research, there would continue to be a dual system of regulation.
Resources asscciated with efforts for le61slation and rulemaking would entail a few FTEs for a period of about 5 years.
The Medical Use program includes approximately 50 FTEs, which would be l
The majority of these FTEs, approximately 70 percent, come from eliminated.
the regional materials licensing, inspection, and event evaluation activities.
Also, the number of medical consultants under contract to NRC could be reduced These.
from approximately 12 (current).to less than half that number.
consultants are used on an as-needed basis in response to medical misadmin%trations resulting in an overexposure, as well as t.onnedical events that might require the services of a physician or a scientist consultant to Currently, the assess radioactive dose estimater and possible consequences.
majority of provided services is in response to medical misadministrations.
Reaction of Stakeholders As of the end of August 19s6, the staff had received 50 tritten comments on The two major categories of responses are either in support the IOM report.
of, or opposition to, the overall recommendations of the ION committee.
However, within each of these major categories, there are subsets with respect None of the comments to the specific direction or focus of the comments.
- received specifically indicated that there should be no Federal involvement.
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MATERIALS / MEDICAL OVERSIGHT DSI 7 The Secretary of the Department of Health and Human Services (DHHS), the Federal agency that would be most directly affected by the-10M recommendations, indicated that the report does not make a compelling pub health' agreement for DHHS to assure the recommended new roie.
Furthermore, DW45 raised a concern that Congress would not provide resources commensur with the added responsiblitties.
The majority of consents received (32 out of 47) did not endorse the fu11 Four of the 15 ringe of recommendations put forth by the ION committee.
respondents,that supported the recommendations indicated that the The recoseendations should encompass all uses of byproduct materials.
Department of Veterans Affairs, in its support of the IOM report, indicated that legislative initiatives should ensure that Federal facilities are not subject to State and local regulations.
The comments that did not support all the 10M recommendations variedThe degree dramatically in the focus of their viewpoints and opinions.
merits of the issues raised by the ION committee to a n The non-Agreement States that restructuring of the regulatory program.
responded were particularly concerned about the substantial financial impact of the recommendations and the issue of this being, in effect, an unfunded l
For example, as indicated in the response from Hawaii, Federal mandate.
public health and safety could be jeopardized in those Sta The Department of Defense response, which summarized the byproduct materials.
responses from the three Service Medical Departments (Army, Navy, and Air Force), supported the need to re-evaluate the current regulatory structure, There were but emphasized the need for a uniform regulatory authority.se of radiation.
The Organization of Agreement States response provided a summary of the consensus of the participants of the NRC and. Agreement State technical which included that all radiation use workshop conducted March 5-6, Igg 6,ld be consolidated under one Federal (medical and non-4sedical uses) shouThe CRCPD prepared a position pap role of a single federal agency for all forms of ionizing radia agency.
May 6 meeting.:
3 to the Attachment to this Issue paper.
l-l DSI 7 RELEASE DATE: SEPTEMBER 16, 1g96 21
l MATERIALS / MEDICAL OVERSIGHT DSI 7 Option St. Discontinue Materials Program Option Under this option, the NRC would request that Congress discontinue NRC's regulatory authority over all byproduct material uses, give this regulatory authority to the States, and name a Federal agency (not NRC) to a guidance role for all sources of radiation, as discussed in Option 4.
This option presumes that an acceptable level of safety would be maintained by the States.
The NRC would have no remaining authority for any byproduct materials oversight. This option is an extension of the previous option to all materials uses.
Also, there would be no change in the proper disposal of byproduct materials at low-level waste disposal sites.
Regulatory Changes This might bo viewed as subject to the procedures of the Unfunded Mandate Legislation would be needed to remove responsibility for the legislation.
Rulemaking would regulation of all uses of byproduct material from the AEA.
be needed to rescind the rer.ations in 10 CFR Parts 30 through 39, and certsin policy statements anu memoranda of understanding would have to be rescinded or drastically revised. Also, all agreements with the 29 Agreement States would have to be rescinded.
Impacts In addition to the impacts described in Option 4, this option would result in elimination of NRC's oversight of all specific and general byproduct materials licenses, thereby dramatically decreasing the resources of the Office of Mu: lear Material Safety and Safeguards (NMSS) and the Office of State Programs.. The States would be responsible for all medical, academic, and commercial applications of byproduct raterials.
The lead Federal agency could possibly serve as a safety backup if a Stste The lead Federal agency role could be filled by an requested assistance.
existing Faders 1 agency such as the epa, DHHS, or the Occupational Safety tr.d Health Administration, with legislation modifying its authorities and Alternatively, a new agency or office within an existing responsibilities.
agency could be created, thereby consolidating activities currently vested among several agencies. Gr9ater eniformity might be achieved by consolidating However, because each State would be a guidance role in one fedt ral agency.
responsible for implementing its regulatory program as it deems appropriate, there could potentially be quite diverse programs among the 50 States.
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MATERIALS / MEDICAL OVER$1GHT DS! 7 Resources associated with efforts for legisittion and rulemaking woL1d entail sav6ral FTEs over a period of 5 to 7 years.
c The pt'aber of budgeted FTEs for the Byproduct Materials Pr'ogram is approximately 140 FTEs in Headquarters anf the regions. These FTEs inclues all managers and technical, administeative, and support staff.
Nearly all of these FTts could be eliminated or redirected, in part, to other activities, recognizing that a few FTEs would be needed to handle residual acti ities.
In addition, staff from other NRC offices who support the NMSS Byproduct Materials Pnograw could be reduced by the current number of FTEs that handle byproduct materials issues or provide support to this NMSS Program.
Reaction of Stakeholders Reaction from the regulated comunity could depend on whether consensus develops among the States to follow the guidance established by the federal Manufacturers of some sources and devices could be particularly agency.
concerned about the possibility of having to cceply with a multiplicity of State requirements.
The Agreement States might support this optit,a to the extent they find it consistent with their consensus view described in Option 4.
Federal agencies would self-regulate.
Some indicated in their coments on the IGM report that they did not have the resources necessary to develop and implement an oversight program, as indicated in the Department of Defense's comments on that report.
V.
RELATED ISSUES After the Cosmiission has made decisions concerning the Direction-Setting and Substaeed Issues discussed above, additional issue (s) such as those related to implementation details will be addressed as the Strategic Plan is implemented.
The Related Issues are listed in this section to provide a more complete understanding of the higher level Direction-setting and Subsumed Issues.
A.
Is escalated enforcement effective in preventing future violations by materials licensees? Would it be more effective to augment the inspection process than to impose civil penalties 1 This is a Commission issue because it involves the Commission's reconsideration of its policy on its Enforcement Program for materials licensees and may lead to rulemaking.
It is related to the DSI because NRC's enforcement policy for materials must reflect the pl31osophy established by the DSI.
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DSI 7 MATERIALS / MEDICAL OYERSIGHT reflect the extent to which the materials licensee conntnity follows NRC's enforcement activities and will be addressed in more detail than is appr6priate for the DSI.
B.
What should be the NRC's policy relative to the need for and the frequency
- of renewals for materials licenseeJ7 This is a Commission issue be:ause a change to the current frequency of renewals will involve policy and pernaps rulemaking.
This issue is related to the DSI because the DSI will establish how important materials license renewals will be in the future.
It is a related issue rather than a subsumed-issue because different classes ci' materials licensees may require different renewal policies.
Such differentiation will lead to more detail than is appropriate for the DSI. The staff is actively engaged in addressing this issue.
C.
What should be NRC's policy relative to frequency of renewals for fuel fabrication facility licenses?
This is a Consission issue because a change in the current frequency of-renewing fuel fabrication facility licenses will involve policy and perhaps rulemaking. The issue is r:1sted to the DSI because the philosophy for renewing fuel fabrication facility licenses should be consistent with the philosophy for renewing materials licenses to be developed here.
It is a related issue rather than a subsumed issue because it will reflect such aspects of fuel fabrication facility regulation as criticality concerns, which are beyond the scope of this DSI.
D.
Does NRC have an acceptable program, given that history and operating experience have required revocation of very few licenses?
Is there a set of l
licensees that NRC should be regulating differently?
Rather than revoke licenses or reject applications, NRC generally help oring weak licensees and applicants up to acceptable standards.
Such activities are often very staff-intensive and include multiple deficiency letters, pre-licensing meetings, and site visits; confirmatory action letters; increased inspection frequencies; enforcement conferences; and imposition and monitoring of *Get Well Programs.' Although such activities generally bring weak licensees up to acceptable standards, this may not be the most cost-effective use of NRC's limited materials resources.
This issue, originally a subsumed issue, goes beyond the question of whetner NRC should regulate a certain materials area and concentrates on the "how" or the methodology of regulation.
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MATERIALS / MEDICAL OVERSIGHT DSI 7 For these evaluation that is Wyn-d the-scope of the current issue paper.
reasons, and depending on decisions by the Commission, this subsumed issue will be addressed as a related issue.
E.
Should a single Federal agency regulate radiation safety?
This issue is directly linked to the Agreement States' comments on the 10M reconnendations in which the Agreement States technical staffs said that "All should be consolidated under gne radiation use (medical and nonnedical uses)l, and machine-produced radiation.
Federal agency to include NARM, AEA materia Consensus was not reached as to which Federal agency should have the authority, or whether it should be an existing agency."'
It appears most appropriate to consider the issue of single agency As stated above, a single agency
.jurisdictica from several perspectives.
could be responsible for radiation regardless of source, to include AEA Alternatively, a single material, NARM, and machine-produced radiation.
agency could hold all authorities, to include such authorities as standard-setting (now vested in EPA), approval of medical devices and I
radiopharmaceuticals (now in DHHS),and applications (now in NRC).
l l
This is a Commission issue because it involves policy concerns that are fundamental to NRC's mission, that in fact go beyond NRC's regulation of It is materials to include its regulation of nuclear reactors as well.
clearly a related, rather than a subsumed, issue, because it is well beyond the scope of this DSI.
Y.
COMMISSION'S PRELIMINARY VIEWS Staff actions regarding the various options should be held in abeyance pending the Comaission's final decision on this issue paper.
The commission preliminarily favors a combination of Option 2 (Continue the Ongoing Program with Improvements) and Option 3 (Decrease Oversight of Low-Risk Activities with Continued Emphasis of High-Risk Activities).
In implementing Option 3, the NRC would utilize the risk-informed performance based approach, as discussed in DSI 12, to determine which activities in the materials trea, and specifically in the medical area, are low-risk activities.
The general approach described in Option 3 of this OSI appears to be a reasonable starting point for identifying the types of activities that can be affected by this process.
8eport of,loint NRC/ Agreement State technical workshop, March 5-6, 1966 3
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In implementing these options with regard to the NRC's medical prog NRC would consult with its Advisory Committee on the Medical Uses of Radioisotopes (ACMUI) for guidance on low-risk medical ac3ivities, re The NLC would also to 10 CFR 35, and >ossible implementation methods.
evaluate the feasibility of using professional med i
guidance that would be adhered to by NRC medical licensees and c adopted by the NRC as regu a ory requirements.
lt In the publje comments on this issue, the NRC particularly solicits t j
of other affected organizations such as the organization of Agreement St and the CRCPD on applying a risk-informed performance ba oversight of medical activities.
the feasibility and desirability of NRC's striving to have the remaining non-In Agreement States acquire Agreement State aut; agency should regulate radiation safety.
comments on the Attachment to this issue paper titled " Regulation of R in Medicine - 10M Issues.'
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MATERIALS / MEDICAL OVERSIGHT DSI 7
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ACRONYMS ACMUI Advisory Committee on Medical Uses of Isotopes AEA Atomic Energy Act ALARA As Low as is Reasonably Achievable
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BPR Business Process Redesign CFR Code of Federal Reculations Conference of Radiation Control Program Directors CRCPD DHHS Department of Health and Human Services DSI Direction-setting Issue EPA Environmental Protection Agency FDA Food and Drug Administration FTE Full-Time Equivalent IOM Institute of Medicine Natu' rally Decurring and Accelerator-Produced Radioactive NARM Materials i
NAS National Academy of Sciences Office of Nuclear Material Safety and Safeguards NMSS f
NRC Nuclear Regulatory Commission
~
OMB Office of Management and Budget QM. RULE Quality Management Program and Misadministrations SS&D Sealed Source and Device i
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I MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT
-REGULATION OF RADIATION IN MEDICINE - IOM ISSUES' I
INTRODUCTION Under the Atomic Energy Act (AEA), the Nuclear Regulatory Comission (NRC) regulates the medical use of reactor - generated radioactive asterials to It also provide for the radiation safety of workers and the general public.
NRC's regulates the radiation safety of patients when justified by the risk.
responsibilities include the regulation of radiopharmaceuticals and sealed sources, but not machine-produced x-rays nor naturally occurring or accelerator produced radioisotopes.
Over the years, NRC has had a concerted effort to improve and strengthen its In these efforts, it has repeatedly addressed two Medical Use Program.
difficult issues; how can it best protect patient safety without intruding into the practice of medicine; and how can it best deal with the numerous To obtain jurisdictional responsibilities for different sources of radiation?
external advice on these and other issues, in 1994 the NRC contracted with the Institute of Medicine (IOM) of the National Academy of Sciences (NAS) to review NRC's Medical Use Program and to address the roles of the regulatory agencies in this area.
In December, 1995, the ION provided NRC with a prepublication copy of its report, " Radiation in Medicine - A Need for Regulatory Reform." The final report was issued in March 1996.
The report documents the comittee's consideration of seven alternative regulatory systems, ranging from no regulation (laissez-faire) to Federal Between these extremes, the committee control of all aspects of medical care.
considered a variety of Federal and State regulatory systems.
The committee concluded that the Federal government should relinquish regulation of radiation in medicine to the States, with the. Department of Health and Human To Services (OHHS) providing support, coordination, ard guidance to them.
bring about this change, the committee made eight re.omendations; two to Congress, three to the NRC, and three to the Conference of Radiation Control Program Directors and the States.
This document provides an overview of the comittee's report, including issues identified by the NRC staff about each of the recommendations, and a summary of the public comments received to date.
Some of the text in this paper closely parallels text in the Institute 1
of Medicine report which is the subject of this paper.
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t MATERIALS / MEDICAL OV MSIGHT DSI 7 ATTACHMENT The second section of this report ' Background," briefly discusses the use of radiation in medicine, the regulatory authorities of the Federal and State -
agencies, NRC's particular responsibilities, regulations, and activities, and a susmary of the history of the NRC program which led the agency to seek a review of its Medical Use Program.
The third section of this report sumarizes the ION comittee's view of the present situation, and describes the seven alternative regulatory systems-considered by the comittee.
It describes each alternative and presents the coimittee's views of the posit.ive and negative aspects of that alternative.
It concludes with the comittee's basis for selecting its preferred alternative, State Regulation with Federal Guidance.
l, The fourth section of this report addresses the comittee's recomendations associated with the preferred alternative.
It contains a brief description of each recommendation, a sumary of the comittee's rationale for the recommendation, the NRC staff's principal issues, and some pertinent public comments.
The fifth section documents NRC actions on the report to date and provides a general sumary of the 47 coments received so far.
Lists of specific commentors and brief summaries of their comer.ts appear in appendices.
II BACKER 00ND This section contains a brief description of the ways ionizing radiation is used in medicine, followed by a discussion of the Federal and State regulatory authorities over that radiation.
It then sumarizes NRC's medical use program including its applicable regulations, its licensee comunity, and its activities.
It then sketches the history of NRC's efforts to improve the program, including the events and issues that led NRC to seek a review by the NAS. Finally, the section documents NRC's goals for the study and the recommendations NRC requested from NAS.
Ionizing radiation is used for both diagnosis and treatment.
Diagnostic uses are classified under two basic headings; radiology and nuclear medicine.
In iadiology, (such as the use of x-rays) the radiation administered is external to the patient; in nuclear medicine, it is internal. Nuclear medicine employs radioactive drugs (radiopharmaceuticals).
When used for diagnosis or followup, these drugs usually contain only very small quantities of radioactive material.
-Ionizing radiation used for treatment is also typically classified into categories depending on whether the scurce of radiation is external cr internal to the patient.
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i sources), brachytherapy (internal) and therapeutic nuclear medicine (internal).
Brachytherapy and teletherapy use sealed sources; therapeutic In radiation therapy, larger nuclear medicine uses radiopharmaceuticals.
quantities of radioactive material,_ usually in the form of sealed sources, are used primarily in cancer treatment. _ Sealet radiation sources regulated under Radiation the AEA are used in about 25 percent of radiotherapy treatments.
produced by devices not regulated under the AEA, such as linear accelerators, is used in the other 75 percent of_ therapy.
- Regulatory authority over ionizing radiation in medicine is widely dispersed among several government-agencies at the Federal, State, and local levels.
At the Federal level, by authority of the Atomic Energy Act (AEA) and Commissior. policy, the NRC regulates the medical use of byproduct material NRC to provide-for the radiation safety of workers-and the general public.
also regulates the radiation safety of patients when justified by the risk to patients.,NRC's regg) tory authority is limited to byproduct mat as cobalt or iodine
, so it does not regulate naturally occurring or For accelerator produced materials (NARM), or accelerator produced radiation.
example, NRC does not regulate the use of radium or x-ray equipment in medicine.
The Food and Drug Administration (FDA) in the Department of Haalth and Human Services (DHHS) oversees the_ approval ol' radiation-producing devices-In (including x-ray equipment) and radiophs.rmaceuticals (including NARM).
addition to these approvals, FDA's reSJiatory program includes review of j
problem repcrts, enforcement actions including product removal and recall, and i
civil prosecution of manufacturers.
The Department of Transportation (DOT) regulates the transportation of radionaclides. The Environmental Protection r
Agency (EPA) sets generally-applicable environmental standards to protect the public from radiatton, and the Occupational-Health and. Safety Administration l
(OSHA) is responsible for worker safety.
States have broad regulatory authority over the general public health and safety of their residents, including authority ov6r all sources of ionizing radiation excep the authority preempted by the Federal Government as i
discussed above[.
The AEA does permit States to obtain authority to regulate L
. byproduct material by t>ecoming. one of NRC's Agreement States. In that case,
~
a Byproduct material is defined as nuclear material created or made radioactive.by exposure-to radiation during the fissioning process in a reactor.
Although Federal pre-emption applies to source-and special nuclear 3
material as well as byproduct material, regulation of those materials is-t>eyond the scope of this document i-
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i MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT the NRC formally relinquishes its regulatory authority to a State based on the NRC's determination that the State's program is adequate and compatible with NRC's.
(As provided under the AEA, the NBC retains regulatory authority over Federal licensees in all States.)
Presently there are 29 i
Agreement States.
The degree to which States exercise control over all medical uses of radiation varies from State to State. The Agreement States normally apply the standards which they have developed for NRC materials to other sources of radiation within their State, although there is no requirement that they do so.
Likewise, there is no requirement for non-Agreement States to reg" hte the sources of radiation for which they are responsible.
This situation has led to inconsistencies in the regulation of other sources of radiation in those States.
NRC's (and its Agreement States') regulation of radiatior, in medicine is based principally on two parts of the Code of Federal..wulations(CFR); 10 CFR Part r
20, Standards for Protection Aaainst Radiation, and 10 CFR Part 35, Medical j
These regulations limit the amount of radiation V.se of Bvoroduct Material.
)
that a worker or member of the public may receive, establish the controls that a licensee must exercise over radioactive materials, establish training and experience requirements for users of the materials, set quality management and reporting requirements, and provide a number of technical and administrative requirements for the possession and use of the materials.
NRC's medical program constitutes about one-third of its Nuclear Mater'.als Program.
Currently there are about 2,000 NRC licensees authorized for the In addition, the 29 medical use of byproduct material under 10 CFR Part 35.
Agreement States have issued about 4,500 licenses authorizing the n.edical use L
of nuclear material. These medical-use licensees include hospitals, clinics, j
and physicians in private practice.
l NRC's reg'J1atory program consists of develeping reguir.tions and guidance, issuing new licenses, and ensuring compliance. NRC promulgates new regulations and modifies existing ones through staff-initiatives or in
)
response to petitions. NRC provides guidance to its staff and licensees by NRC's issuing regulatory guides for licensing end procedures for inspection.
medical licensing activities include issuing about 85 new licenses a year, and approving about 1,400 neendments. NRC ensures compliance with its regulations by teamunicating safety issues to licensees, inspecting them to observe their performance, and exercising its enforcement authority over licensees who are in violation.
~ Over the years, and especially since the mid 1980s, the Comission has made a concerted effort to improve and strengthen the medical use program.
In 1967 the Atomic Energy Conaission codified its medical regulations into 10 CFR Part
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35.
Following a 1976 report.of hundreds of patient overexposures at Riverside NRC took action to upgrade its-i Methodist Hospital in Columbus, Ohio, dical use. In February 1979, NRC issued a l
regulation of radiation sources in me po icy statement to guide its regulatory program in the medical area. A key issue in the policy statement is NRC's commitment to protect patient safety without intrusion into the practice of medicine.
NRC regulatet the radiation safety of patients when justified by the risk to patients, but dinimizes the i
agency's intrusion intc medical judgments affecting patients and into other areas traditionally considered to be the practice of medicine. The NRC 4
recognizes,that physicians have primary responsibility for the protection of NRC regulations assume that authorized physician users, with their patients.
appropriate training and exserience, will make decisions in the best interest J
Since taen, the tension inherent in NRC's comitment nas i
of their patients.
arisen in a. number of key medical-use regulatory initiatives that have been opposed by members of the regulated comunity as-an intrusion into the practice of medicine. The doctor / patient relationship and NRC's regulation of medical use of nuclear material has been a continuing problem, up to the present.
A second set of problems arises from the jurisdictional responsibilities for the different sources of radiation.
As discussed above, jurisdiction over various aspects of the use of ionizing radiation in medicine is exercised by a number of agencies in the Federal Government and by the States. Because of 1
the diversity of, and occasionally overlapping, responsibilities, dual regulation or gaps in regulation may cccur.
In 1992, the staff began to develop a medical management plan to guide the conduct of the medical use regulatory program. The plan was delayed as a result-nf staff actions in response to a radiation therapy misadministration and the associated patient fatality, media interest, and congressional hearings on administrations in both the Scncte and the House.
The staff subsequently completed th; medical maangecnt plan, and, in parallel, was directed by the Commission to initiate an external review of the NRC's and the Agreement States' medical use regulatory progrm.
As a result, in January 1994,- NRC contracted with the ICM to conduct that external review, including a review of NRC's regulations, policies, practices, and procedures.
NRC set three goals for the study; 1) exambiation of the overall risk associated with the use of ionizing radiation in medicine; 2) examination of the broad policy issues that underlie the regulation of the medical uses of radioisotopes; and 3) a critical assessment of the current framework for the regulation of the medical use of byproduct material.
The NRC sought specific recossendations an two stjor issues.
First, it requested reco1mendations on a unifors natiorial approach to the regulation of ionizing radiation in all medical applications, including consideration of how the regulatory authority and responsibility for medical devices sold in interstate REL. EASE DATE:
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commerce for application to human beings should be allocated among Federal
- Second, Government agencies and between the Federal and State governments.
the NRC requested recommendations on appropriate criteria to measure the effectiveness of regulatory programs needed to protect public health and safety.
1 ION REPORT - ALTERNATIVES This section presents 10M alternatives and recommendations, it begins with the ION broad view of the regulation of radiation in medicine to provide insight into the basis for 10M decisions on the regulatory alternatives it considered and the recommendations it made.
1) 10M committee's View of the Current situation The ION committee noted that NRC regulates only 10% of all ionizing radiation found in medicine, and that public health and safety would be better served by It therefore concluded that NRC's current uniform regulation of all such use.
system of regulation and enforcement should be revised and that regulation of all radiation uses in medicine shoulri be conducted by the States.
The committee examined the existing regulatory system and identified several problems that it concluded needed to be addressed.
In particular, it judged the NRC's present set of regulations and its approach to regulation to be burdensome, costly, and unduly prescriptive.
In addition, it found that actions taken by tht NRC against user institutions, in its public announcements and its unrealistic paperwork demands, tended to be disproportionate to the violations.
The couaittee determined that the benefits resulting from the NRC's efforts to reduce adverse events may not be commensurate with the constraints imposed.
It stated that the NRC's regulatory policy, although seemingly effective, might have gone beyond the point where "an additional dollar sr~nt on regulation achieves an equivalent dollar benefit to patients o: the public.*
The committee judged that, given the strength and leadership of the Conference
-of Radiation Control Program Directors (CRCPD) and the Suppested State Regulations for the Control of Radiation (SSRCR) which the CRCPO promu1 gates, that State programs would remain intact and expand to cover byproduct use if Federal regulation were to be relaxed.
The committee believed that all sources of ionizing radiation would be treated more uniformly, in that they would all be subject to State regulation.
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The committee's recommendation would eliminate NRC's medical use program, but retain the basic structure of federal regulation and responsibility.
In particular, the committee would have Federal agencies retpin responsibility L
for the generation, transport, non-medical use, and disposal of radionuclides and for the approval of radiopharanceuticals and of equipment that generates ionizing radiation. A Federal agency would assume a guidance role for the
-States.
2)
Alternative Regulatory Systems The comaittee considered NRC's request for recommendations on a uniform f
national approach to regulation broadly. -It examined a wide spectrum of alternative structures through which all ionizing radiation in medicine might l
be regulated. The committee report discusses seven alternatives, which are A
Continue the Existing Situation
.B Laisser-Faire -(No Regulation)
C State _ Regulation Only D
State Regulation with Federal Guidance E
State Regulation with Reserve Federal Authority F
Centralized Federal Regulation G
Health Finance Agency After considering the alternatives, the com?ittee found Alternative D State Brief l
Regulation with Federal Guidance, to be its preferred choice.
descriptions of the seven alternatives, and the basis for the connittee's choice follow.
A Continue the Existing situation The committee considered two ways to continue the existing situation, which it describes as A1, Status Quo, and A2 Status Quo Modified.
Alternative Al, 3
Status Quo, would be for the NRC to continue to operate exactly as it does Alternative A2, Status Quo Modified, would have the NRC eliminate, ur today.
announce that it will not enforce, its requirements for quality management programs (10 CFR Part 3C. 32) and for notifications and records of The committee's considered this misadministrations (10 CFR Part 35.33).
modification because NRC has received considerable criticism from the med community for promulgating these requirements.-
The committee found no positive aspects to the Status Quo.- It found a i
positive aspect'of the Modified Status Quo in that this Alternative would not require legislative change and thus would be the easiest way to change the Further, in the
. existing. system to address the medical community's concern.
cocinittee's view, the NRC could make useful changes to its work culture. The-l committee found the negative aspects of the Status Quo to be that this f
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alternative did not address.two of the consittee's concerns; first, that l
ionizinp radiation in medicine is not treated consistently - sources used r
regularyinthepracticeofmedicinearetreatedunevenly.Thecommittee l
i ra' sed the Issue of whether NRC regulation is necessary, given that NARM and i
- Second, l
machine-produced regulation has been left to the States and the FDA.
this alternative does not address the cosmittee's concern that safety can be
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maintained at lower cost.
t B
Laissez-Faire (No Regulation) i In this diternative, all forms of regulation, Federal and State, wo:.1d be.
ft ld be left to medical
. eliminated and responsibilities for radiation sa e y wou practice, medical societies, and the marketplace.
l The cosmittee found that a positive aspect of Laissez-Faire would be the cost a
savings resulting from an absence of regulation.
The committee found negative aspects of this Alternative to be that not everybody is conscientious about radiation protection, and the committee had little expectation that the marketplace, the malpractice system, and the professional societies could, by themselves, weed out incompetent practitioners and ineffective procedures.
Further the cosmittee noted that most States now regulate ionizing radiation to some degree and it seemed unlikely that they could all be convinced to This approach would be unwieldy, as the existing follow this alternative.
federal regulatory structure for radiation control of non-medical applications would cont 9nue unchanged.
C State Regulation Only This Alternative would eliminate NRC control of medical uses of byproduct material and would give regulatory authority to the States.
Under this alternative, byproduct materials would be reguisted the same way x-ray machines, linear accelerators, pharsaceuticals and other medical devices and
'i Under this alternative, Federal agencies materials are currently regulated.
would still have a number of responsibilities; FDA would continue to regulate safety and efficacy of radiopharmaceuticals and radiation devices, 00T would continue to regulate the transportation of byproduct material, and NRC would license the manufacture of byproduct material.
The committee noted that this alternative would permit States to choose the laissez-faire approach.
However, the-cosmittee expected that under this Alternative, the CRCPD would l
encourage States to, adopt its Suggested State Regulations for Control of Radiation (SSRCR).
-The committee found the positive aspect of this Alternative to.be the assumption that all States with existing programs would continue and expand
- them based on the SSRCR and thus reinforce the movement toward greater uniformity. The committee found negative aspects to be that it had no e
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assurance that States want this responsibility, that not all States currently have strong regulatory programs in place for NARM and machine-produced l
J' radiation, and that some State legislatures might be respgnsive to strong i
The comittee also felt that the lack of antirepulatory interest groups. leadership under this Alternative would make it diffic:
Federa j
States to adopt CRCPD guidelines and that States might abandon the radiation l
safety programs now in place without the incentive from a Federal agency to l
continue operating them.
t D
State Regulation with Federal Guidance This Alternative modifies Alternative C by identifying a Federal Agency, other than the NRC, to exercise a leadership role in the radiation safety community, with DHHS as a suggested agency. This is the comittee's preferred Alternative.
As the committee has developed this Alternative, the Federal agency would I
assist in developing recommended State laws and regulations for all ionizing R i
it could work with CRCPD to enhance the existing SSRC radiation in medicine, and promote their adoption.
The comittee felt that development of guidelines through a collaborative process with the Federal agency, the States, the CRCPD, and professional organizations would result in successful implementation by all participants.
Additional functions of the Federal Agency could include assisting States, investigating crises, educating the public, collecting risk data, conducting research, and monitoring the effects of shifting responsibility for regulating radiation in medicine to the States.
Under this Alternative, States would have to establish a regulatory program that includes byproduct material.
Since, under this Alternative, the NRC and Agreement States would continue to regulate the manufacture of byproduct l
material, manufacturers would not be able to distribute byproduct material to their users unless the users were licensed by their States.
Consequently this i
requirement would provide an inducement to States to expand or revise their existing radiation control pregrams to include byproduct material.
Federal facilities would be encouraged to either expand their existing procedures for NARM to include-byproducts or adopt the SSRCR for byproduct material.
The comittee found several positive aspects of this Alternative.
It includes the advantages of Alternative C, State Regulation Only, with the additional advantage of a Federal agency to provide non-regulatory oversight and:
leadership. The committee would expect the Federal agency to assume a.
leadership role for the Federal government as a whole.
In addition.-this Alternative would ensure that a $ tate would be required to have a regulatoryThe program for byproduct material for that material to be used in the State.
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committee found negative aspects of this Alternative to be the costs of the Federal agency, and that the esency could not guarantee either the quality of i
any State program or the safety of ionizing radiation in, medicine, E
State Regulation with Reserve Federal Authority This Alternative would go beyond Alternative D, State Regulation with Federal
'3 Guidance, end empower the Federal agency identified in that Alternative to exercise regulatory authority over any State unwilling or unable to enact a regulatory, structure that encompasses ionizing radiation in medicine.
I This Alternative would be identical to Alternative D, with the exception that if a State did not have a radiation control program it would become subject to the regulations for byproduct material devised for Federal medical-centers.
The Federal agency would enforce its authority only if the State did not assume any responsibility to adequately protect public health and safety.
This authority would be analogous to the NRC's present authority to resume regulatory control over an Agreement State.
i The committee found this alternative to have all of the positive aspects of Alternativos C and D, with the advantage that placing DHHS in the leadership role would, in the committee's view, yield more reasonable regulations if they are needed.
The committee found negative aspects to be the need to set minimum standards for State programs and the need to assess those programs.
This would have the effect that all States would become similar to NRC's present Agreement States.
The committee was also concerned about funding, and Federal authority over what it expected to be a minority of States.
F Centralized Federal Regulation This Alternative would make a Federal agency responsible for regulating medical uses, not only of byproduct material, but of NARM and machine-produced radiation as well. The Alternative would federalize regulation of all ionizing radiation in medicine, including standard-setting, licensing, and inspection.
If this Alternative were to be adopted, the committee would recommer.d centralization within DHHS rather than NRC because the connittee considered it best suited to administer public health programs and because it already has various levels of authority over ionizing radiation in medicine.
If NRC were to be the lead federal agency, its legislative authority would need to be expanded beyond byproduct materials.
The cosanittee-found positive aspects of this alternative to include promotion of unifomity in regulation of radiation in medicine, provision for States who do not want responsibility for radiation control programs, and the development of national. standards.- The cosnittee noted that the positive aspects of the Federal role described in Alternative D State Regulation with Federal RELEASE DATE:
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Guidance, also apply to this. Alternative. The committee found negative i
aspects to include the increased Federal costs of such a role, and the difficulty in' achieving uniforwity due to the regulatory jnvolvement of a l
in addition to the connittee's number of Federal agencies (DOT, EPA OSHA)d that since NRC would continue to Finally, the committee note proposed DHNS.
De responsible for the non-medical uses of byproduct material, it would be i
l necessary for NRC and DHHS to work very closely together to avoid incansistencies.
G Health Finance Agency This Alternative would place regulatory authority for all health tare into a The new l
j single, centralized agency to counter inconsistency and inefficiency.
agency would acquire the regulatory power now held by the medical components The agency would have the power to regulate of the NRC and by parts of,DHHS.
health care, broadly eliminating practices that were shown not to be effective l
or beneficial. The committee considered this Alternative an extreme approach for addressing a very specific issue and recognized that it had not been i
l' The committee considered an advantage developed to its full logical extent.
to this approach is that it could improve minimal standards and define the goals of safety and high quality care. However, such a centralized system would mean a large increase in bureaucracy and reduce provider incentives and responsibility.
1 3)-
Assessment of Alternatives l
i The committee documented its consideration of the above alternatives by examining the extremes and moving toward its preferred alternative.
It j
rejected Alternative A, Continue the Existing Situation, because it did not address the committee's concern that all. ionizing radiation in medicine be administered and regulated more consistently.
It rejected Alternative 8, Laissez-Faire, because many committee members were not convinced that the marketplace, the malpractice system, and the professional societies could, by l
l themselves, weed out incompetent practitioners and ineffective procedures. The couaittee rejected Alternative G, Health Finance Agency, because it was an all-encompassing and overwhelming solution to a very specific problem.
The committee rejected Alternative' F, Centralized Federal Regulation, because from j
a cost-benefit perspective the committee as a whole saw little reason to pursue this alternative. Thus the committee focussed on Alternatives C, State J
Regulation Only, D, State' Regulation with Federal Guidance, and E. State 4,
- Regulation with Reserve Federal Authority.
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I committee found that Alternative E. State Regulation with Reserve Federal Authority, could result in a program very much like NRC's present Agreement 4
State program which would not resolve the committee's conperns about that The committee program's funding characteristics and practical drawbacks.
therefore arrived at its preferred choice, Alternative D, State Regulation
[
with Federal Guidance.
As discussed above, Alternative D would give regulatory authority over medical
'i The States would expand their uses of byproduct material to the States.
j existing radiation control programs that apply to NARM to include byproduct The committee recommends that a Federal agency, DHHS, satorial as well.
The leadership exercise a leadership role in the radiation safety community.
role would be non-regulatory and would assist in developing recommended state 4 -
laws and regulations, acting as an information clearinghouse, 6nd distributing The Federal agency would work in resources for training and research.
conjunction with the CRCPD and other professional organizations to develop recommended state laws and regulations for all ionizing radiation in medicine.
The NRC would retain responsibility for the manufacture and distribution of l
byproduct material (including sealed sources and devices) used in medicine.
l Further, NRC would condition these licenses to require that products could only be distributed to users who were licensed by a State.
IV ION REPORT - REC 0fWlENDAT10N5 To implement its preferred alternative, the committee made a total of eight specific recommendations; two to Congress, three to the NRC, and three to the j
First, the comittee recommended that Congress: 1)
CRCPD and States.
eliminate all aspects of the NRC's medical use program to include 10 CFR Part i
35 and applicable activities conducted under 10 CFR Part 20; and 2) direct the Secretary of Health and Human Services to support, coordinate, and encourage activities involving regulation of all ionizing radiation in medicine including support the operation of the CRCPD, assist States in implementation of regulations, oversight of State programs, enhance training and standards i
for health care personnel, and investigate future significant radiation medicine incidents.
The recommendations to the NRC were to: 1) immediately relax enforcement of 10 CFR 35.32 and 35.33; 2) if Congress fails to act within 2 years to the committee's recomendations above, initiate formal steps under the Administrative Procedures Act to revoke 10 CFR Part 35 in its entirety; and 3)
. separate the costs of formulating regulations from costs of administering y'
those regulations.
The recommendations to the CRCPD and the States were to: 1) incorporate into the $$RCR any relevant concepts from 10 CFR Part 35; 2) enact legislation to incorporate _the regulation of reactor-generated byproducts into existing state RELEASE DATE:
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i MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHMENT regulatory programs; and 3) continually reevaluate regulations and procedures to ensure congruence with evolving scientific understanding of radiation bioeffects and associated risks and benefits.
A The comittee did not reach total unanimity on the final recomendations.
cosmittee member stated that federal regulatory authority should be refomed, not repealed.
This dissenting opinion is included as a separate Appendix to the report.
Each section The following sections discuss the recomendations individually.
contains a brief description of the recomendation, a sumary of the consnittee's rationale for the recomendation,1the NRC staff's principal concerns, and some pertinent public coments.
RECOMMENDATIONS TO CONGRESS The comittee recomends that Congress elininnte all aspects of the A1.
NRC's Medical Use Program,10 CFR Part 35, and those regulatory activities conducted under 10 CFR Part 20 that are applicable to nedical uses.
DESCRIPTION By this action, Congress would relinquish responsibility for regulation of NRC would retain byproduct material used in medicine to each state.
regulatory authority over manufacturers of byproduct material used in medicine. Other federal agencies, such as the FDA, the DOT, and the EPA, would retain their regulatory authority over radiation.
10M RATIONALE The intensity with which the byproduct area of radiation medicine is being regulated at the federal level far exceeds the rest of ionizing radiation used in medicine and.wst of the rest of medical practice and_has little if any justification. In fact, the cot. centration of resources spent to reduce adverse events involving byproduct material, although seemingly effective, appears to have gone beyond the point at which the additional dollar spent on regulation achieves an equivalent dollar benefit.
j
' A list of commentors organized by comentor affiliation, a itst of f
consentors by general view, and a sumary of specific coments appear in j
Appendices 1.-2 and 3, respectively.
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MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHNENT All ionizing radiation, with th exception of byproduct material, is currently States have the regulated or subject to regulation at the State level.Although the, committee can abL11ty to regulate radiation effectively.
guarantee that states will effectively regulate byproduct mat believes they will.
consortium of states for the purposes of implementation and oversight.
Rescission of authority at the federal level for regulation of the medical use of byproduct material has three benefits:
- 1) it eliminates prescriptive and
- 2) it shifts costly regulations that yield marginal risk reduction;Ning state gover responsibility, by ;izens; and 3) it promotes uniform treatment, in that radionuclides and machine-produced radiation are regulated by a single le s.fety of their cit of government at equal intensity, regardless of their source.
NRC STAFF ISSUES The' committee recognizes that not all states currently have strong regulatory programs in place for NARM and machin 1.
medicine. What assurance does the comittee, or Co byproduct material?
This recomendation assumes that federal facilities 2.
medicine - what existing regulations currently apply to federal facilities (other than those of the NRC)7 How would the goal of " uniform treatment" and re 3.
and rulemaking giving responsibility to the States.
PUBLIC Col 91ENTS About one third of NRC has received 47 coments on the comittee's report.the coas These comentors included the Department of recomendations as well.
Veteran's Affairs, several State agencies, four professional societies Several associated with the use of radiation in medicine and six individuals.
of these commentors not only supported this recommendation, but believed tha NRC should discontinue all of its regulation of byproduct materials, and give that responsibility to the States.
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A second third of the comunentors supported the concept of regulatory reform, bu' with retention of Federal authority. These commentors included three Federal agencies, three professional societies involved it radiation in medicine,10 States and NRC's Advisory Comunittee on the Me) dical Us Isotopes (ACMUI). Nine of these coaunentors favored continued regulation by the NRC, eight were not specific on which Federal agency should have authority, and two, the State of California and the ACMUI would vest authority with DHHS.
Four commentors, including the State of New Jersey favored regulatory refom, but only after additional analysis.
Nine commentors supported the concept of uniform regulation for all radioactive materials, including NARM, with Federal oversight.
Several specific comments are of interest.
The EPA felt that the report reflected the concerns of the regulated community more than tnose of the public at large. The Department of Defense indicated that the Federal regulatory authority over medical use of byproduct material should be reevaluated and perhaps relaxed and restructured, but not abolished. The States of Utah and Virginia were concerned that State legislatures might view this as an unfunded mandate and would need additional Federal support. The CRCPD does not support the recommendation.
"CRCPD is concerned that elimination of the entire program, as recommended, could have tsumediate and l
undesirable consequences on citizens in non-Agreement States which cannot or will not have developed a state program consistent with the national model prior to Congressional action, in addition, the absence of federal authority in the medical use area may also have long ters consequences for Agreement States as they try to maintain a nationally consistent' program in the face of budget cutbacks and a changing regulatory philosophy.'
Several non-Agreement States indicated that they had neither the resources nor the capability to develop a program to adequately protect public health and safety.
I A2.
Congress direct the Secretary of Health and Hunan Services to support, coortlinate, and encourage the following activities involving regulation of all loninn; radiation in nedicine:
supporting the operation of the CRCPD; a.
b.
providing a venue for the review and evaluation of Suggested State Regulations for Control of Radiation; i
CRCPD position on the NAS report, reached at their meeting in 5
l Albuquerque, New Mexico, on May 8,1996 l
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l DS! 7 ATTACHMENT assisting states in inglenentatton of their regulations; c.
-d.
siding in assesseent of the effectiveness of state progress through the collection and analysis of data; helping develop survey nethods by which the rate of' adverse events for a t
e.
wide range of procedures and devices night be nessured; nonitoring the effects of deregulation; lth care personnel; and f.
enhancing training and standartis for hea 9h.
Investigating future significant radiation nodicine incidents.
DESCRIPT!DN i
4.
1.
In addition to the above, DHHS would educate the public for the primary Purpose of "... putting radiation risk in a more accurate and balanced e
perspective." Adverse events for investigational drugs and blood products must be reported to FDA as are adverse events involving radiation devices j
resulting in serious injury or death, i
As noted in the previous reconnendation, NRC and Agreement States would l
^
continue to regulate the manufacture of byproduct material for use in i
radiation devices and radiopharmaceuticals; thus manufacturers would not be able to distribute radioactive byproduct material to users unless they were licensed by their states, i
10M RATIONALE l
A Federal agency, such as DHHS, would assist states to establish regulatory proprams; train state radiation control personnel; build liaisons between saa ler states that wish to share regulatory systems; develop survey methodology; and monitor the success of-regulatory programs.
DHHS has an extensive history in regulating radiation in medicine.
Within DHHS, FDA exercises direct authority to determine the safety and effectiveness, and to approve the marketing, labelling, and manufacture of all
['
radiation products used in medicine.
FDA has promulgated regulations establishing quality control standards and a certification program for medical facilities that provide mannography services.
FDA has issued guidelines and recommendations regarding public exposure to ionizing and non-ionizing radiation.
The NRC sho91d not regulate the education and training of h3alth care 1
personnel - it sho*ild be done by professional organizations and-by the states.
NRC-STAFF ISSUES 1.
Would DHHS.have any regulatory responsibility for Federal facilities other than the Public Health Service?
If not, who would have authority j
over Federal facilities?
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Current reporting requirements for FDA are not id l
2.
injury (to manufacturer) or death to FDA).
There tre no reporting requirements for radio harmaceutic is other than investigational drugs except on a voluntary asis. To what extent should administration errors be reported?
r In view of the overall reduction in federal spending, whether DHHS would be provided any appropriations to carry out these additionalWith the re 3.
respnnsibilities cannot be predicted.
spending and with the knowledge that the NRC is~ supported by user fe!
rather than taxpayer dollars, would Congress appropriate sufficient l
funds for even the minimal expenses of this agency?
The report states How would the effects of deregulation be monitored?
that the committee did not possess the requisite expertise to address l
d.
the issue of appropriate criteria for measuring the effectiveness of regulatory programs.
PUBLIC COMENTS 1
As mentioned above, about a third of the commentors support thisA number of
{
recommendatior, along with all the committee's reconnendations.
comentors support the role of a Federal agency described in thisMany of these la recommendation, but do not necessarily endorse DHHS.
commentors believe that the Federal agency should have at least some authority and that it should be responsible for at least NARM as well as byproductC material. The CRCPD view is illustrative.
i single federal agency with a strong leadership role, and believes that o
consolidation of authority presently found in several agencies includ OHHS, OSHA, and EPA is very desirable. states, do not support the consider that radiatipn protection should be a major responsib lead-agency. The OAS that-a single federal agency should be directed (by Congress) to support, l
coordinate, and oversee specified activities involving regulation of all ionizing radiation in medicine. The OAS did not reach consensus on which agency should have the responsibility-The agency most affected by this recommendation is OHHS, who does not suppo DHHS does not find the committee's arguments' compelling and does notFurther, it.
consider the legislation recommended by the committee likely.
0AS coment provided the recommendations of and consensus reached-
'N at a Nm...)d Agreement State technical workshop conducted on March 6,1996.
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.j MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT event of such legislation, DHHS considers the probability low that it would receive funding from Congress commensurate with its additional 3
responsibilities.
I KCOMMEMnATIONS TO THE NRC The NRC should fanedtately relax enforcenent of 10 CFR 35.32 snd 35.33 91.
through its present nechanisns.
DESCRIPTf'0N NRC's 10 CFR Part 35.32, Duality Manaaement Proaram, requires, among other things, that medical licensees have written procedures to ensure that direction for a therapeutic administration is made in writing, that the patient's identity is verified by more than one method, that unintended deviation from the written directive is evaluated, and that the licensees review this program at least once every 12 months.
NRC's 10 CFR Part 35.33, Notifications. Reoorts. and Records of Misadmininrations, requires, in part, that medical licensees notify the NRC within one calendar day of the discovery of a misadministration, and that they submit a written report within 15 days, and that they retain a record of each misadministration for five years.
NRC The information required by 10 CFR 35.33 would not be entirely abandoned.
could contir.ue to cooperate with the FDA as provided in their MOV to obtain data on devices, drugs, and biological products that relate to device malfunction, serious injury, or death.
10M RATIONALE NRC's Quality Management (QH) rule lacks the basic elements of a QM program:
comprehensive process and outcomes data, feedback mechanisms for health care providers, education of clinicians to achieve continuous improvement, and follow-up measurement to monitor change / improvement.
The regulation of byproduct material greatly exceeds the regulation of chemotherapy, surgery. anesthesia, and the use of general pharmaceuticals except for controlled substances, all of which are unregulated at the federal level.
A lower rate of adverse incidents in radiation medicine is not a result of The more detailed reporting and enforcement stricter regulatory oversight.
systems required for byproduct materials do not seem to result in even a marginal decrease in risk to providers, patients, or mJmbers of the public.
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0517 ATTACHMENT The leve1*at which the NRC currently enforces 10 CFR 35.32 and 35.33, through detailed and voluminous documentation, reporting, and penalties, is inconsistent with the NRC's Medical Policy Statement, which favors minimum regulatory intrusion into the practice of medicine.
l The Joint Cosmission on Accreditation of Healthcare Organizations (JCANO) has a performance standard which requires intensive assessment when performance varies from recognized standards, but does not specifically require reporting l
of medication errors except in accordance with written procedures of the hospital...-
Elimination of the OM rule would not lessen the radiation protection of the 1
public, occupational worker, or the patient.
The regulated community has expressed reservations about seeking advice from the NRC, fearing that they might become the target of punitive reprisals.
When the NRC levies a fine, the agency also issues a press release describing the violation and the fine.
Licensees assert that adverse economic impact of such press releases is considerable.
NRC STAFF ISSUES The lack of data for comparing byproduct material, NARM and machine-1.
produce radiation limited the scientific basis of the committee's How can we achieve improved data collection on actual findings.
incidence and rates of adverse incidents and misadministrations?
Is there a need for improved databases?
What is the rationale or basis for the necessity for immediate action?
2.
Assuming that NRC were to immediately relax enforcement, NRC would be in 3.
the posStion of having a regulation for which there would have been no monitoring or enforcement.
If NRC were to follow this recomendation, what followup actions should NRC conduct in the event of a misadministration resulting in serious injury or death?
If NRC lacked statutory or regulatory authority governing the medical 4.
and biomedical research use of byproduct material, why should_NRC continue to pather data on user errors, drugs, and biological products to share with FDA under the MOU (unless reimbursed by another Federal agency)?
l
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MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHMENT PUBLIC C0f9fENTS A t. umber of cossentors supported the concept that many of, NRC's requirements are overly prescriptive and burdensome.
CRCPD supports relaxation of these requirements because it finds them overly prescriptive and unnecessarily The Organization of Agreement States believes that NRC should burdensome.
1emediately relax enforcement of these requirements, and further considers that the Quality Management Rule should not be an item of Agreement State compatibility.
The comittee reconeends that the NRC initinte femal steps utider the 92.
Adninistrative Procedure Act to revoke Part 35 in its entirety, if Congress fatis to act within two years in response to the two reconeendsttons to Congress stated above.
DESCRIPTION NRC's 10 CFR Part 35, Medical Use of Byeroduct Material, contains technical and adm'nistrative require'nents that apply specifically to medical applications, it sets quality management and reporting requirements, and establishes training and experience criteria for users of byproduct material.
It sets requirements including dose calibration, leak testing, source inventory, patient release, instructions to nurses, and survey requirements as l
well as use of syringe shields and storage of waste for decay.
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10M RAT 10NALE In addition to NRC's overly stringent enforcement, the regulations themselves t
l are excessive and duplicative.
10 CFR Part 35 covers areat that either are i
already regulated at the institutional level or are best left tt 'he states, to professional societies, and to patients in consultation with seir doctors.
States regulete the medical uses of other forms of ionizing radiation and, could easily fold byproduct material into their regulatory programs.
l The CRCPD could add byproduct material to its suggested state regulations.
These additior.s could incorporate relevant concepts currently in Part 35.
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Doctors have ethical obligations, codified in professional standards, for I
informing patients of medical errors. The relatively low misadministration rate could be maintained by less stringent programs that are administered at the state level by professional societies, snd by existing liability lav.
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SEPTEMBER 16, 1996 20 051 7 ATTACHMENT
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MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHMENT The FDA collects data on adverse effects of radiopharmaceuticals and incidents of failure of radiation-emitting riedical devices, and it could assume the j
monitoring responsibilities of the liRC.
Public safety in the medical use of ionizing radiation would yet exist in the fact that the NRC would still retain responsibility for the licensing of manufacturers and, consequently could ensure that byproduct material was withheld from any state that failed to license users and regulate the use and safety of byproduct material.
The committee strongly endorses the formal route of notice and coment rulemaking, subject to the Administrative Procedure Act, to accomplish the rescission of all of Part 35.
NRC STAFF ISSUES This recomendation presupposes Congress will not act, and therefore
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This could result in the will not vest DHHS with a leadership role.
1aissez faire or state control regulatory structures, both of which were rejected by the comittee. How would this recomendation achieve the goal of the preferred alternative?
With the lack of data cited in the report, on what scientific basis 2.
might NRC make a finding that there is no w...easor,able risk to public health and safety, and thereby exempt medical use nf byproduct material from the requirements of a license, as set forth in Section 81 of the Atomic Energy Act?
PUBLIC COPMENTS Many commentors, to include professional organizations, State agencies, and individuals, were in favor of the need to revise Part 35. While CRCPD considers that a major revision to 10 CFR Part 35 is needed, it does not support this recommendation. 0AS believes that 10 CFR Part 35 should be revised significantly, but that it should not be revoked in the absence of legislation. 0AS believes that a minimum level of radiation protection must be available.
The committee recommends that the NRC separate the costs of fonnulating I
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regulations from the cost of administering those regulations.
i RELEASE DATE: SEPTEMBER-16, 1996 21 DSI 7 ATTACHMENT
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MATERIALS / MEDICAL OVERSIGHT -f DSI 7 ATTACHMENT DESCRIPTION The Omnibus Budget Reconciliation Act of 1990 recuires NijC to recover 100% of As.1 result, NRC its budget by charging fees to NRC applicants anc licensees.
licensees bear all of the agency's costs both of developing its regulations and of administering them.
Separating these costs would enable NRC to recover development costs from its licensees differently than it recovers its adminirtrative costs.
IOM RATIONALE Only NRC-licensed institutions should bear the NRC's costs of licerising and inspection, whereas the costs of developing standards should be borne by all institutions, whether or not they are located in NRC-regulated states.
Licensing fees charged to health care facilities to meet the cost of the existing NRC program are becoming more expensive as more states become Agreement States.
Several individuals interviewed during site visits voiced concern that excessive costs force laboratories to stop using radionuclides, which in turn delays or prohibits the development and implementation of new uses of radionuclides in medicine.
NRC STAFF ISSUE If NRC were to separate the costs of formulating i gulations from the cost of administering these regulations, how would the Agreement State licensees bear the cost of developing standards?
PUBLIC ComENT!
CRCPD supports this recommendation and recommends that Congress provide 0AS general funds to support development of essential regulatory standards.
identified the issue of how Agreement States would bear the costs of developing standards if NRC were to accept this recomendation.
RECOMENDATIONS TO THE CRCPD AND THE STATES C1.
The connittee reconnends that the Conference of Radiation Control Progran Directors incorporate into its Suggested State Regulations for 1
l Control of Radiation any relevant concepts from 10 CFR Part 35 that are I
not already integrated in those saggested regulations.
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ION RATIONALE f
All states will be able t provide regulatory oversight (9r AEA material in a l
manner similar to that provided for non-AEA material through the adoptions of CRCPD's suggested State Regulations for the Control of Radiation.
- [T]he d t d in the state coenittee expects that byproduct materials can be accormo a e systems.'
and administrative practices vary, States l
7 Although State laws, regulations cananddoachievealevelofunIformityinmanyareasthroughcooperative, l
l voluntary, and informal arrangements.
l Although States cannot be compelled to accept'the voluntary guidelines or the a
55RCR, a variety of forces can greatty influence them to do so such as a collaborative effort, professional peer pressure, consumer groups and the l
media, and State-medical-societies.
D CRCPD will continue to provide SSRCRs of the current level of quality without the assistance of the NRC, but with another federal agency providing
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' voluntary guidelines and model regulations for states" NRC would continue to fund the CRCPD's efforts with respect to all nonmedical i
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uses of byproduct material.
NRC STAFF IS$UES Will the states voluntarily adopt the CRCPD's $5RCR in the absence of 1
For any real compelling mandate placed on either CRCPD or the states?
l exagle, in the case of the recently passed managraphy law,-Congress provided a compelline reason for hospitals and c1hnics to meet the 1.e., in order to be reimbursed for mammography quality standards:
services, the hospital or clinic must be certified as meeting the standards.
The level to which the states currently adopt the 55RCR varies fror 2
Would there be greater uniformity under the proposed state to state.
recommendation?
PU8LIC Col 04ENTS.
CRCPD considers that it alreaiy has accomplished this.-
The comalttee reconnends that all state legis1stures enact enabling Ct.
legislation to incorporate the regulation of reactor-generated byproducts into existing state regulatory programs.
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SEPTEMBER 16, 1996 23
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MATERIALS / MEDICAL OVERSIGHT
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DS! 7 ATTACHMENT 10M RATIONALE States have effectively regulated r.aturally-occurring any NARM in the past ano Therefore all States can regulate the medical use of continue to do so.
byproduct material effectively.
Congress will modify the AEA to revoke the NRC's authority to regulato the medical use of byproduct material, give another Federal agency the responsibility for providing guidance, and allow all States, at their option, to exercise regulatory authority over the medical use of byproduct materials.
All States will devote the additional necessary resources to provide :dequate protection of the public health and safety related to the medical use of byproduct materials with "little", if any, additional fedaral funding.
The possibility of precluding users from obtaining byprodegt material from manufacturers in those " states that did not include byproduct material into their existing regulatory programs" would be acceptable to Congress and the public.
NRC STAFF ISSUE Will all States in fact have the will, the resources, and the competence to regulate the medical use of all sources and uses of ionizing radiation safely?
PUBLIC COP 9 TENTS OAS endorses this recommendation, but as applied to all ionizing rad. tion.
CRCPD endorses the reconnendation, although it recognizes that not all States will choose to establish comprehensive programs that include byproduct However, the CRCPD continues to sbl port consistent application of saterials.
radiation protection standards nationwide and believes that this can be best j
accomplished by having all radiation programs in a single state agency which can deal comprehensively with all forms of ionizing radiation within the l
state.
The connittee reconnends that the Conference of Radiation Control C3.
Progran Directors and the states continually reevaluate their regulations end procedures pertaining to radiation nedicine to ensure congruence with evolving scientific understanding of radiation bioeffects and to be in accorti with advances in knowledge regarding benefits and risks related to nedical and bionedical research uses of ionizing radiation in medicine.
1 RELEASE DATE:
SEPTEMBER 16, 1990 24 051 7 ATTACHMENT
MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHMENT ION RATIONALE Continual reevaluation and maintaining congruence is a neqessary step for proviiing adequate protection of the pubite health and safety.
The CRCPD and all states will devote the necessary resources to maintain congruence with evolving scientific understanding of radiation bioeffects and be in accord with advancis in knowledge regarding the benefits and risks of the medical use of ionit.ing radiation.
NRCSTANhSSUE Many states have adopted regulations for non-AEA materials that are similar to those that NRC irplements for AEA materials and requires Agreement States to adopt as items of compatibility (e.g., NRC's GM rule for cobalt teletherapy Will the CRCPD be able versus State regulations for accelerator teletherapy).
to effectively ' ensure congruence
- of the States' regulations and procedures to "be in accord with advances in knowledge regarding benefits and risks..."
by usinq voluntary mechanisms in the absence of the regulatory presence and resource support of liRC7 PUBLIC COP 91ENTS Both OAS and JRCPD '.ndorse this recomendation, ir NRC ACTIONS AND COMMENT
SUMMARY
A NRC Actions to hte The IOM provided NRC with a prepublication copy of the comittee's report in December 1995. The NRC provided copies of the report to all Agreement States and non-Agreement States Md Territories, appropriate Federal agencies, CRCPD, OAS, Congressional Oversight Comittees and NRC's Advitory Comitten on the Medical Uses of Isotopes (ACMUI).
In addition, the NRC published a federal Reaister notice (61 FR 1648) on January 22, 1996, and issued a press release acknowledging receipt of the rvport and requesting comments on the possible impacts of the report to incluoe any views on policy, legislative, rulemaking, and guid6nce issues.
The Comission directed the staff to consider the report and coments received within its Strategic Assessment and Rebaselining efforts. While the report is being considered, the NRC is continuing to implement the ongoing medical use program.
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SEPTEMBER 16, 1996 25 051 7 ATTACHMENT
t MATERIALS / MEDICAL 'VERSIGHT DSI 7 ATTACHMENT The ACMUI met Several public meetings have betn held to discuss the report.and subseq on February 21-22, 1996 to discuss their recomendations.
Briefly, the ACMUI diq not recommend any of specified alternatives.
Thy reached consensus that the medical use regulatory program should be rebuilt, reassessing the objectives of the regulations and encompassing all uses of ionizing radiation in medicine, and that States should be federally mandated to administer the prograri, with appropriate incentives to encourage States to comply.
State programs should i
be monitored by a Federal agency with an overa!1 medical use perspective (e.g.,DHHS).
The OAS and the members of the 10M committee briefed the Comission on February 26 and 27, 1996, respectively.
In addition, the report was discussed at a joint NRC and Agreement State technical workshop on March 5-6, 1996.
The workshop included representatives of 18 Agreement States and two non-Agreement More recently, the report was discussed with the Conference of States.
Radiation Control Program Directors on May 6, 1996.
B Co m ENTS ON 10M REPORT As of the end of August 1996, the staff had received 47 written coments on The two major categories of responses are either in support of, the report.
- However, or opposition to, the overall recomendations of the 10M comittee.
within each of these major categories, there are subsets with respect to the specific direction or focus of the coments. None of the coments received specifically indicated that there should be no Federal involvement.
The Secretary of the Department of Health and Human Services (DHHS), the Federal agency that would be most directly affected by the IOM recomendations, indicated that the report does not make a compelling public health agreement for DHHS to assure the recomended new role.
Furthermore, DHHS raised a concern that Congress would not provide resources commensurate with the added responsibilities.
The majority of coments received (32 out of 47) did not endorse the full Four of the 15 range of recomendations put forth by the 10M committee.
respondents that supported the recomendations indicated that the recomendations should encompass all uses of byproduct materials. The Department of Veterans Affairs, in its support of the IOM report, indicated that legislative initiatives should ensure that Federal facilities are not subject to State and local regulations.
The coments that did not support all the 10M recomendations varied dramatically in the focus of their viewpoints and opinions. The degree of regulatory reform perceived to be necessary ranged from simply recognizing the RELEASE DATE:
SEPTEMBER 16, 1996 26 051 7 ATTACHMENT
MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT merits of the issues raised by the 10M committee to a need for a complete The non-Agreement States that restructuring of the regulatory program.
responded were particularly concerned about the substantini financial impac of the recommendations and the issue of this being, in effect, an unfunded For example, as indicated in the response from Hawait, Federal. mandate.
public health and safety could be jeopardized in those States with insufficient resources or capability to adeouately implement the regelatio The Department of Defense response, whir,5 summarizec the byproduct materials. responses from the three Service Medical Departme Force), supported the need to re-evaluate the current regulatory structure, There were but eghasized the need for a uniform regulatory au hority.s of radiation.
The Organization of %greement States respor.se provided a summary of the consensus of the pa"ticipants of the NRC and Agreement State ',echnical workshop conducted March 5-6, 1996, which included that all radiation use (medical and non-medical uses) should be consolidated role of a single federal agency for all forms of ionizing rad agency.
May 6 meeting.
the specific recommendations to which they apply.
The NRC will continue to evaluate comments as part of the strategic assessme A summary of the comments is provided in and rebaselining efforts.
Attachments 1-3.
051 7 ATTACHMENT
SEPTEMBER 16, 1996 27
MATERIALS / MEDICAL OVERSICHT DSI 7 ATTACHMENT Categories of Responses Received on 10M Report a
faderal Acencies:
Department of Defense (D00) - consolidates views for three services Department of Health and Human Services (DHHS)
Department of Labor, Occupational Safety and Health Administration (OSHA)
Department of Vetert.ns Affairs (DVA)
Environmental Protection Agenc." (EPA)
Aaremment Stgigti Arkansas California Florida (Office Radiation Control) - R Florida (State Health Office) - H 1111nois Kentucky Maryland New Mexico New York (Dept. Environmental Conservation) - E New York (Dept. Health) - H Hew York (Dept. Labor) - L Tennessee Texas Utah Vermont Washington Non-Aareement States / Territories:
Alaska American Sataca Delaware Hawaii Massachusetts New Jersey Virginia Wyoming 28 1
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MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHMENT I
ggggnirations/Commiitens!
AmericanAssociationofPhysicistsinMedicine(AAPfj)
American College of Cardiology (ACC)(ALNP)iety of Ame-ican College of Medical Physics American College of Nuclear Physicians / Soc (ACNP/SNM)
Amer 4can College of Nuclear Physicians - California chapter (ACNP-CA)
-American College of Radiology (ACR) (APHA)
American Pharmaceutical Association American Society of Nuclear Cardiology (ASNC)
Conference of Radiation Control Program Directors (CRCPD)
HRC'sAdvisoryCoraitteeonMedicalUsysofIsotopes(ACMul)
Organization of Agreement States (OAS)
Other Resoondents:
CBeasley, St. John's Regional Health Center, Springfield, M0 MHafermann, Virginia Mascn Cancer Center, Seattle, WA o
DJones, Northwest Medical Physics Center, Lynnwood, WA CMarcus, University of California, Los Angeles, CA CPerez, Washington University, St. Louis, M0 GPotent, OH JRieke, Virginia Mason Cancer Center, Seattle, WA DSchumacher, Northwest Medical Physics Center, Lynnwood, WA MSelikson, RSO, University of Pennsylvania, Philadelphia, PA St. John's Hospital, Jackson, WY The OAS comment provided the recommendations of and consensus views 7
The session on the reached at the NRC and Agreement State Technical workshop.
NAS report included representatives from 18 Agreement States-(CA, NY, SC, NV, IL, WA, TX, MS, TN, GA, NE, CO, KY KS, NYC, FL, AR, AZ) and two non-Agreement
-States (OH, PA).
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MATERIALS / MEDICAL OVERSIGHT DS! 7 ATTACHNENT General Coments on 10M Report Rannendents in favor of A ree-- ---- r.dati ons !
Support 10M report /reconeendstfons as written:
AAPM ACNP/SNM ASNC DVA,
NM MHafermann ('.;rginia Mason Cancer Ctr)
DJones (Northwest Medien1 Physics Ctr)
CMarcus (UCLA)
CPerez (Washington Univ)
JRieke (Virginia Mason Cancer Ctr)
DSchumacher (Northwest Medical Physics Ctr)
Support 10M report /reconeendations, but as applied to all materials:
FL (R)
NY (H)
NY (L)
ACNP-CA 9
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O MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACHMENT Rest,cndents not in ant:-- nt with 10M rec = ndations:
t Support concept of regulatory refod but retain Feders! Authority :
DHHS overs 10iit: ACHUI, CA NRC oversight:
EPA, ACMP, ACR, HI, KY, NY(E), UT, WA, GPoteat(OH)
Unspecified oversight:
DHHS, 000, ACC, AK, DE, TN, VA, WY Support cancept of regulatory reforn, but after additions! analysis:
C8easley (St John':: Regional Health Center)
MSelikson (RSO, Univ, of Pennsylvania)
NJSt. John's Hospital Support connpt of unifornity for all radioactive naterials regulation with Feders1 oversight:
CRCPD OAS APHA AR (NRC as lead agency)
FL (H)
IL M
MD TX It should be pointed out that the degree of regulatory reform perceived to be necessary by different respondents varied from recognizing the concerns raised by the 10M to a drastic change in the approach to regulation of medical uses.
Some States (e'g., VA, WY, DE) were primarily concerned with the substantial financial impact of the NAS recommendations and the issue of unfunded Federal mandates, rather than more specific concerns on the overall approach for regulation.
DHHS did not address the issue of regulatory reform. Federal authority, or concerns raised by the 10M, but focussed on the implications of the recomendation to DHHS.
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MATERIALS / MEDICAL OVERSIGHT i
DS! 7 ATTACHMENT tenmandants indicatine resort under r wiew 1
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L DSI 7 ATTAC}MEllT MATERIALS / MEDICAL OVERSIQlT 4
Specific Comments on 10M Report w ar~
Cate, "
Seepense
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^-- A SEEEifiE c8EE"t8 SESPGWEWIS 38 AENEE8ENT 18818 im REONOWWeticW5 pga flee veterene meetth Adelnistretten seeincotty conews m*2h and endorsee the findlege support Itst report /
g, g, g,,, p,g g g
,, gg g g g g, tien se tten repotetten of Federot entMitles and stee the regutetten of medlcet research programs.
g,,ggenge,
Agrees with im recememdetten that Congrees resswe regwtetlen of paeseesten and ese of noterlod on6)ect to AEA free ueC's purvleu. Swte teederehty rete of guns se torg es ett stetes uninteln regutetery prograno that secoure (
.. i..twe standards of performance and ef feettwenees.
ampeg AArei fisulamentotty supporte peeltlen, cenetuelene, and recommendettene of the im report. set should be removed from its current regutetery rete for medicot asse.
Esteldisin progreso for layinmenting States' regutettens amnitored by egyrepriate Federet heetth esency with eselstance of user cemuneilty erut profeestenet organitetlene.
ACnP/SNM flte AtuP eruf Wet heileve time report proposes e oeund and thoughtfut egyrowh to the reputetlen of nutteer sedictae and em NaC to lagdeusmt time IEBt recommendatione, ett wing for comment en speelfle seens to oc45 ewe leptementation.
ASEC Concur ulth the let's tenetuelene and seppert their recesemdetiene for e eedfone l
peticy to be set et federet level editch con be enforced ty the States. Seus shendd '
t incitale medical redletten oefety es part of e-o heetth core _
__; plan.
l gesegenumrei Endorses recommendatione of IM. Does not agree with sent8msnts of asbert Adler in l
Appendte L.
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MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACMENT
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S *CIfle C e
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, C Category of Seepense mESPONSEWt3 le ACKEMNT WitE 1896 SEtpeENDATIONS Evuturees recommendettene of 158. Does not agree ulth sentleunte 'of tubert Adler in I
DJones Sigport im report /
We L.
i recenumenentien so written Supports the 158 report and espresses disegreement witte statemente made br Robert atercus Adler in ble engsplementet stetesent (appreuHa L) j E.wi__; otrerg eigport for emw of recommundstions.
CPeter Jalete Eeulerees recesumerutetlens of 10M. Does not agree with sentleents of Robert Adler in Appendte L.
Oscineseecher Supporte reconmendetions p., _ _ by toit esmalttee.
wt idee of delegotleg regutetten of medical "., * :t noteriet to etetes in flerlde Se:pport IGE report /
recesumendettens, but es apptled (ted. Centrol) additlen to att agreement enterlete.
'II "" #
sew verk Sigport the 10M's eenetwelen thet the repetetten of sedicot tsee of byprestset meteriets seiould be corried out et the stete level. Encourages the NRC to not tielt (sept. neelth) z to the ten report to tese norreu usedleet focus of ttie repset.
i ts. --,
Suggmerts the Ist's recesserndellen that WRC discentinue rey '.atec of medicot woe of gew yerg (eept. Labor)
Isupredwt meterlete, but considere it !ttes:cet u t heit Ae rawwusstlen to this one aree (eheutd Incteste saatteer pherameles, manufacttsre's, distrikters, and r
leutsstelet users)
NRC's entire meteriets progren'should Ip= glwen to the States ord federet entittee AcuP-CA t
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J MATERIALS / MEDICAL OVERSIGHT DSI 7 F~ACMENT Category of.
spec 1fle Cemente
- m --
af9POWENTS WUf IW AGREEMWT 18178 Itul SElXpeIEMBATIONS 8048f l'efic*ted e preference fer a wortant of the Itpl preferred etternettve in dich apart Siggsert conegt of reJuletery there eeutd be endustentlet Federet oversight of State progress with a sectienten to refer
- l'ut reteln Federet ensure cesptlance of states and users. stete prograno should lie sanitored br e authority Federet agency with everett sedlcet use perspective (88515).
i seport does not sehe e cespetting gehtic licotth erguemt for SaW5 toting en e SWR 5 a:Asetentlet none role. The pretsabltity le teu tleet Cenerees would prowlde eduposte resources. SENS does not enggert the receamendation.
i Federet regutetery authority ever enlical vee of tsypredact esterlot should Ise ges reewetuated and perhaps retened emi restructured, tsut not shottehed in fewer ef a
(
wettestery or State-eperated systems.
i Report reflects the concerne of the reguteted esseunity more then the pdstic et EPA torge. There easy be especte of Mac's program that can but leproved, but NRC should continue to eseure pielle is protected.
i Transfer of evereld t of the medical use of lootspes to the States seems reemenebte.
i ACC mouever, strongly onesurage Federet everel$t of thle etete inttlettwe. an abwleus i
drM uould be if ett stetes had ecperate reputette's for licensure and
{
comptience.
thoperte flee need for e dreetic change in regutetten of redletten lei sedkot use acy,
including use of Adrieery Penets (comprised of users, omnufacturere, e*4 pestic) to determine the regutegory f raseeerlt to tse opptled uniferely in endicot geiteselen.
Current regutetlone eheutd tue modtfled.
in lleu of Cergreselenet actlen to eliminete met's medicot use program, the ACR aca bellewee thet uRC's medical use progree must tue setesitt and its objectives tteoroughty reeeeeemed.
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DSI 7 ATTACHMENT MATERIALS / MEDICAL OVERSIGHT 2
Sgwcific Cesenate
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CatW of Deepene gEspeleswis sof te AenEEEEnf UlfR ItBI gEt2peEgeafl0BS (continued)
Ateeke ff le veutd not he e cost effective nor efflc5ent reform for Ateeke. It le in the 8'49 **"**P' #
best later-et of the State to seaport ;)e enletleg method of repeteting nuclear
- In F gg medicine licensees br e Federet opency.
f California la view of optit repstetery authority et federet levet and apparent reluctance of unc to espond jtsrledletten, agree that Congrees reenve ERC's authority. BENS should be
[
i glwen suthority to ensure that every etste saintelne e redletten program that asete minness,(_.. -____lve, i__ u etenderde of performance esd ef fecttwessees.
petenere the lepect of the Itpl receamendetiene usutd be sidsetentlet in torno of our. Sacreeeed need for fundlag, steffing, training and Infrastructure esgottm s,a j
t g,eegg pees not have resources or capability to ednpsetely laytammt regutetten of hypreekset i
meterlete. Without emelstence (training and deveteyssent) to states, the rasswet of gaC's authority any elyolficantly Jesperdire peddle heetth used eefety.
Kantacty A better egyre.Je would be to have NRC revlee its medical program to go atens with the recessmendatione the Institute hoe glwen la preferred etternettwe e.
g, yerg geeny enforeseen consegsences any occur if acA le modified. Casaleelen eheuto proceed (Sept. Envirers.
cautieunty in pureutne itse recessmandetlene that euer etter the present AEA.
C -. tlan)
White the findlege of the Camelttee have some serit, theee le no conctuelve esoport Tenneesee prowls %d to docesamt theen. seseeping changes are not mett thought out and mer residt in chets.
State testoletures mer vlees thle es another infteded fedaret mondete and any prevlde Utah no additlenet segsport to the State program. IIedical ceasemity should work with mat, States, and other parties to resolve the repstetten leeue.
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Spectfle Commente 2 r-^-. :
Cet-Y of a
pEsPeuSEWIS 507 35 GENEfMEuf UlfE 1150 WEttpeqEseAtleet (cantinued) the Commesuseellh le In no peeltlen to assume enr additlenet erwheidad Federet of reputotory V(reinfo Condo enty sesume regadetery reopene9bility if WRC prowlere fireds to suandetes.
e in federot defrer cost of laylementive the program.
g.,g,7 gmyg umC should focus en redletten safety of tserher and vian-pottent peditic (overel# of umebineten preeksetlen, distritnstlen, and tiendtlas of Inype.dset musteriets) odelle protectlen of pottent le lieet hasufted thW state heerde et endiclar and f _v.
The eenetuslene of the report neglect the censiderable herdutily to he incurred by vyes.Ing asnetter, tese poputense, and tese effluent States. Ordy thrensWe continised federet regutetery participetten con the emete of indformity and pnette access to tefe medicot precedtsres be schleved.
Potentist decresee In safety esy retwit fress a transfer to State registoters of WRC's GPeteet sisthority. Iolner changes are necessary Inst everett NRC's reewlettens tietence the need to protect esorters, patient and the paddle eith the regsfreasents of endicot practice.
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Category of seegence
^ ^
Specifle Commesets 3MWfS EUt IN AlmEEEE9ff WITE tet REODUEspeitent (contlemed)
Sesquert concept of regedetery gew Jersey If 54 chose not to luecame en Agreesent State, pnMic eny not he sneered of m@e i
reform, inst ef ter adff f fenet protectlen. If edupting the recommmeutettene, set and Congrees eheidd not act precipitwely, best etteu the States to prepare for seenenIng repstetery progress in I
snetysle orderly feeblen.
g,dveralty of Before spring in toe directleet of a State-booed decenttellaed erstese, o b'etter renneytvente evetuetlen of potentlet both for increased risk to Ilie padstic and increened east to a
ttee audicel leutsstry is necessery.
j o
l St. John's Urges WRC to glwe every consideretten to let report, particesterly time revleu of rIset menpit.
esses =ent.
ce,setey flee report elseed port of its steted intevuted goet to revlees the current eyutes of regutetten (ttie leeues of uniformity among etetes ese not fatty euptored). Propoe-o revleu in more detell the regatetten of non-susclear endleine redletegy and upseetten et uselforelty luetween otetes.
sigiport concept of todfonelty ont At INIC/ Agreement State fechnicet tserketiep,,__
use reactned timet ett %tleri esse (registoted currently teuter letC, FSA, EPA, and gent) eineistd lie connotidoted trater for ett redleective esterfele a single Federet egency.
regutetten witti tederet CRCPB sessence of federet ersthority In medical use eroe may have lesedlete eng g,,grefreeste l
consegsences en citlaene in non-Agreement States erud torg ter* N fier Agressant States trying to mainteln a netlenotty eeneletent prearms. CatPC does seet engport autesmetic setectlen of guns se the egency to pege ide teederstily rete, aph4 Att lenialne redletlen sheistd be greigned together touter e endform repstettori.
Trenefer reopenelbility for medicet uses of any lentring redletten to the States.
Some Federet easthority should reenin over the medicot esses of lenining redletlen (NBC or a eletter federet egency).
38 G
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t MATERIALS / MEDICAL OVERSIGHT DSI 7 ATTACIMENT Category of b - -
Lv 1 ;
Speelfte f"m==nte ogspoupEWTS sof 14 AcatEMET telts test RECtBUIEWDAf teWE (centleesed)
The WRC should ceneider etternettve A2 (stetus y endif fed). If se}er charges are Artensee seppert concept et efferedty to be sede, centrattratten of resetetten within ene Federet egency (umC) essutd be the for ett r d escH w en
,ga best approoch for ett uses of redletlen. Congrees usutd be reepstred to empend the
"'g role of WRC and a change in the esecy unutd be necessery. Espend current Agreement g
State prograr.
Floride Seppert ideo that regutetery mutteority of o_t,1 ogrecuent esterlete be tearned over te the states with eeneetidotten of federet radietlen eversight, guldence, erst (neelth offlee) regutetery functlene Inte one agency, not neceseerity Dams.
Ittinele Prefer Catre proposed new orgentrettenet concept thet recensende sene conostidstlen of att redletten reputetery functlene et federet level. eevlee et and 7 __ - y rules. Prepore iAlte paper to use es a peticy boele to eteerty dellneote the respective authority and reopenelbilities of verleue Federet sJJ State opencies.
Iteryland nother then rmde unt's authority and repeet the f ateret rWettene, such authority shMd be empended to lacorporate unnes, and the federet regulatione eheutd be -
thereuhhty revleerd and amended to clarify regutetery reopenelbility. DerRS does not i
have necessery espertlee.
senseechusette De not caggert elleutnetten of att espects of NRC's sedicel progree, but seppert reteeetion of everty prescriptive end moviecesserity cootty reepstremente. Segpert Intent of eingle Federet agency providing e single tenderehlp rete but do not sippert automatic selectlen of DWNS.
the boele for the repert's recessurrelottens do not seem to be steetontleted. The 9,,,,
serging of ett federot redletlen centret eversight Inte a single regutetery progres eheutd be ceneidered. 1he met should erdience the partnerehlp alth the States to jointly deteemine cespotibility reepstremente.
4 39
_ _.. _ _ _ _ _ _ _ _ _ _ _. _ _. ~
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I j
STRATEGIC ASSES $NENT ISSUE PAPER
/
j RISK-INF0MED, PERFORMANCE-BASED RCGULATION DSI 12:
IKfR000CTION-In August 1995, the Nuclear Regulatory Commission (NRC) s Strategic Assessment and Rebaselining Project.
take a new look at the NRC by conducting a re which that work is accmplished, and to apply to these redefined ac rigorous screening process to produce (or rebaseline) a new set o assumptions, goals, and strategies for the NRC.
are intended to provide an agency-wide Strategic Plan which ca and implemented to allow the NRC to meet the current and future A key aspect of this project was the identificatio The These issues fall into three categories.
this work is accomplished.
first category includes broad issues defined as Direct (DSIs).
Subsumed issues are those that The second category includes subsumed issues.The third category includes related should be considered along with the DSIs.
These are issues that should be considered after th Also, as part of the project, other issues.
a decision on the option (s) for a DSI.
These are not strategic issues of. an operational nature were identified.
issues and are appropriately resolved by the staff, and are not disc the issue papers.
Following the reassessment of NRC activities, issue papers were pre l
provide a discussion of DSIs and subsumed issues, and t discussion of the options as well as suunaries of the consequences of
'these broad, high-level issues.
Final decisic'.s related to the DSIs will influence the related issues which are listed, but not discussed, in ea options related to the DSIs.
As part of the Strategic Assessment and Rebaselining Project I
the issue papers are being provided to intereste issue ptper.
After l
to provide a forum to discuss and receive commen p
t decisions concerning the DSIs and options. In summary, the Strategic Assessment
/
to develop a Strategic Plan for the NRC.
and Rebaselining Project will analyze where the N forward in a changing environment.
DSI 12 RELEASE DATE:
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RISK-INFORMED, PERFORMANCE-BASED REGULATION DSI 12 I.
$UMARY A.
Direction-Setting Issue The Commission has established the policy that, to the extent practical, risk insights shall be incorporated into all nuclear regulatory activities. ' As a result of this policy, the staff has developed a framework for applying probabilistic risk assessment (PRA) methods and techniques in reactor regulation (SECY-95-280, ' Framework for Applying Probabilistic Risk Analysis in Reactor Regulation") in order to ensure consistent and appropriate r
application of PRA methods. The staff has also identified a number of i
regulatory applications associated with reactor regulation that appear
-amenable ta the expanded use of PRA - such as inservice testing of pumps and valves, inservice inspection, technical specifications, and graded quality j
j In these areas, the staff is developing PRA standards and guidance assurance.
to help clarify and _ facilitate the use of risk-informed, performance-based regulation for both the NRC and the industry.
Industry and NRC efforts to develop and apply similar approaches to nuclear The complexity of materials programs are not as advanced as reactor programs.
power reactors and the potentially severe consequences of a reactor accident led to the development of analysis methods to provide better estimates of I
risk. The consequences of an accident in the nuclear materials area would be less severe and the event sequences would be less complex than the consequences of an accident in the reactor area. The need for a better understanding of risk for cosmarcial power reactors resulted in detailad development of reactor risk analysis methodology before such methodology was develop 6d for the relatively simpler, but more diverse, nuclear materials Also, power reactor risk analysis techniques are more developed than area.
nuclear materials risk analysis techniques because the commercial nuclear power industry'is actively seeking regulatory relief in numerous areas using risk-informed, performance-based insights to help justify the request for relief.
Considering the general direction provided by the Commission and Congressional directives to various Government agencies to proceed to use risk-based and cost-benefit criteria, and recognizing the resources needed to implement
-risk-informed, performance-based approaches to regulation the following direction setting-issue (DSI) was identified:
What criteria should NRC use in expanding the scope in applying a d
risk-informed, performance-based approach to rulemaking, licensing, inspection, and enforcement?
i SELEASE DATE: SEPTEMBER 16, 1996 2
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RISK-INFORMED, PERFORMANCE-BASED REG DSI 12 h
all The Commission's decision on this issue will be framework for *how fast" and 'how far" the agency will go i d regulatory activities in the application of risk-informed, perform risk-informed, performance-based regulatory approaches.
approaches.
sample criteria for expanding the scope within the con direction are discussed in Appendix A.
B.
Options.
Continue current Process 0; tion 1:
l tion The current process for pursuing risk-informed, performance-b could be characterized as an incremental process.
determined applying risk-informed, performance-based regulatory approa Priority by balancing external and internal goals and available resources i
ily criteria (Appendix A) are applied and the scop f
This approach covers both reactor ih implementation, and available resources.
and nuclear materials areas but there is more activity associat lined in risk-informed regulatory approaches for reactor applications as the PRA Implementation Plan (SECY-95-079).
More Rigorously Assess Relationship to Public Health an Option 2:
i uld Before pursuing risk-informed, performance-based approache require that for new initiatives, the NRC determine that there lic health potential for a substantial increase in overall protection to p sue and safety that would justify the level of resources necessary to pu Priority additional risk-informed, performance-based regulatory initiatives ches and scope in applying risk-informed, perform d to benefit to the public health and safety. Priority criteria are weighted toward greates qualified before proceeding.The scope of risk-informed, perfomance-ba ll would be primarily determined by considering the cost / benefit, i
safety benefit.
This impact on the NRC and regulated industry, and available resourc l
d option would provide additional focus for moving toward risk d
performance-based regulation and potentially m l
DSI 12 RELEASE DATE:
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I PERFORMANCE-BASED REGULATION RISK-INFORMEDs D5! 12-Perform a Comprehensive Assessment of NRC Regulatory Ap Option 3:
- This is a proactive, aggressive option for moving toward r,isk-info This option would maximize internal self-assessment and include exploring all regulatory areas to det perforiaance-based regulation.
ht whether risk-informed, performance-based regu and regulatory processes to determine areas that could be im area.
Priority for risk-informed, performance-based regulatcry approa l
i The scope of impacts on safety, burden reduction, and efficiency.
by risk-informed regulatorv approaches under this option would be considering agency responsiveness to stakeholder initiatives, the s benefit / significance of the approach, and the effect on NRC and l Ease of implementation and available resources are secondary scoping considerations (i.e., if the activity is d efficiency.
the state-of-the-art to the level necessary to support the desired goal).
Consider Risk-Informed, Performance-Based Approaches P Option 4:
Response to Stakeholder Initiatives This option is the most responsive to industry and stakeholder i Priority and scope in applying risk-informed, performance-based re approaches would be primarily determined by stake The risk-informed, performance-based approaches to reduce regulatory implementation.
scope of risk-informed regulatory approaches under this option w primarily determined by nature of the initiative. cost / be approach.
l II. DESCRIPTION OF ISSUES
Background
A.
Since the early 1970s, the NRC has expended significant resource i
development and appitcation of PRA technology. breaking l
itled "NRC Statement the NRC issued a policy statement ent Light of of Risk Assessner.t and the Reactor Safety Study Report (WASH-14 18, 1979, 0n January t
the Risk Assessment Review Group Report" [ Risk Assessment R In addition to addressing specific criticisms of WASH-1400, h
the 1979 policy statement articulated limitations in the use of PRA NURFG/CR-0400).
Many of these limitations have been addressed, h regulatory arena.
sepe still remain' pertinent today.
I DSI 12 RELEASE DATE:
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RISK-INFORMED, PERFORMANCE-BASED RE i
DS! 12 d probabilities of characterization of uncertainties associated with calculate for identifying and characterizing the range of uncertaint,y.
reactor accidents.
t of The Three Mile Island accident in 1979 substantially chang the analysis'of severe accidents worldwide.In addition, both major e ded prog an on severe accident phenomenology.
that PRA techniques be used more widely to i
l In 1984, the NRC nonprobab!1istic methods of analyzing nuclear t in risk analysis techniques.
An In early 1991, the NRC published NUREG-1150, " Severe Ac Assessment for five U.S. Nuclear Power Plants."
improved PRA techniques to assess the risk associated This study was a significant turning' point in the use of risk tly concepts in the regulatory process and enabled the Comunissi j
plants.
damage improve its methods for assessing containment performance g initiation and subsequent accident progression.
in quantitative and results from, these studies provided a valuable foundation risk techniques.
i ities PRA methods have been applied successfully in several regula i
i and have proved to be a valuable complement to trad d different enhancement of traditional regulation rather than a s engineering approaches.
technology.
based, in part, on PRA methods and insights.
l for the (10 CFR 50.109, 'Backfitting"), the Policy Statement on " Saf h
21, 1986), t e Operation of Nuclear Power Plants," (51 FR 30028; August Future Commission's ' Policy Statement on Severe Reactor Accidents Designs and Existing Plants" (50 FR 32138; A nt PRA methoos also for Nuclear Power Reactors" (58 FR 39132; July 22,1993).
(ATWS) were used effectively during the anticipated tra i
l in the generic issue prioritization and resolutian process.
t been found in the use of ' Risk-Based Inspction Guides" to fo insnector efforts and make more efficient use of NRC inspecti Probabilistic analyses were extensively ured in the developm 100 recently proposed rule change to reactor siting criteria i h Safe (59 FR 52255; October 17,1994),
Shutdown Earthquake ground motion for a nuclear reactor site.
DSI 12 RELEASE DATE: SEPTEMBER 16, 1996 5
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I RISK-INFORMED, PERFORMANCE-BASED REGULATION
-D$1 12 Currently; the NRC is using PRA techniques to assess the safety importanc operating reactor. events and as an integral part of the design certificatio In addition, the Individual review process for advanced reactor designs.
Plant Examination (IPE) Program and the Individual Plant Examination -
External Events (IPEEE) program (an effort resulting from the implementation of the Commission's " Policy Statement on Severe Reactor Accidents Regardin Future Designs and Existing Plants") have resulted in commercial reactor
-licensees using risk-assessment methods to identify any vulnerabilities reading attent9on.
The Commission has been developing performance assessment methods for low-level and high-level waste since the mid-1970s, and This work involved the development of conceptual models and computer Because waste disposal systems are 1990s.
codes to model the disposal of waste.
passive, certain analysis methods used for active systems in PRA studies fo power reactors had to be adapted to provide scenario In regard to high-level waste, the NRC staff participates in a variety of international activities (e.g., the Performance Assessment Advisory Nevada.
4 Group of the Organization for Economic Cooperation and Development, Nuclect Energy Agency) to ensure that consistent performance assessment methods are used to the degree appropriate.
In mid 1994, the NRC staff proposed a PRA policy statement to the Commission in SECY 218, " Proposed Policy Statement on the Use of Probabilistic Risk In that Commission Assessment Methods in Nuclear Regulatory Activities."
paper, the staff proposed that an overall policy on the use of probabilistic risk assessment (PRA) methods in nuclear regulatory activities should be established and that the use of PRA technology in NRC regulatory activities The staff also forwarded SECY-94-219, " Proposed should be increased.
Agency-Wide Implementation Plan for Probabilistic Risk Assessment (PRA)," to the Comission.
The NRC established its regulatory requirements to ensure that nuclear facilities can be operated and nuclear materials can be used without undue 1
These requirements are largely risk to the health and safety of the public.
based on deterministic engineering criteria, involving the use of multiple barriers and application of a defense-in-depth philosophy.
Beyond its deterministic criteria, for commercial power reactors, the NRC has additionally formulated guidance, as in the safety goal policy statement, that The safety goal policy utilizes quantitative, probabilistic risk measures. statement establishe The safety goals provide guidance on where plant risk nuclear power plants.
- Also, is sufficiently low so that further regulatory action is not necessary.
DSI 12 RELEASE DATE: SEPTEMBER 16, 1996 6
o RISK-INFORMED, PERFDRMANCE-BASED REGULATION d
D$1 12 as noted above, the Commission has been using PRA in performing regulatory
~
analyses for backfit of cost-beneficial safety improvements at operating f years.
-reactors (as required by 10 CFR 50.109) for a number o The application of PRA to nuclear regulatory activities has evolved with improvements in PRA techniques and data bases. PRA techniques can be used to derive valuable insights, perspectives, and general conclusions as a result of the integrated and comprehensive examination of the plant design and a i
For a structured examination of plant and operator response to events.
nuclear power plant, ions where appropriate plant-specific mode insights and conclus are available and used appropriately.
PRA sensitivity studies are particularly useful in focusing designers, operators, and regulators on important aspects of design, operation, and maintenance.
The Commission has considered recent improvements in nuclear technology and accumulated experience with risk assessment methods, and concluded that increased use of these techniques as an integral part of the regulatory Consequently, in its policy decision-making process is now justified.
statement, 'Use nf Probabilistic Risk Assessment Nethods in Nuclear Regulatory Activities" (60 FR 42622, August 16,1995), the Commission adopted the policy that the use of PRA should be encouraged and the scope of PRA applications in nuclear regulatory matters should be expanded to the extent supported by the state-of-the-art methods and data.
Bases The bases for rules and standards issued by the NRC are the Atomic Energy Act Administrative procedures of 1954 (AEA), the Energy Reorganization Act, theThe AEA generally requires i
I Act, and other legislation.
regulatory standards to govern its licensing determinations.
The AEA (section 161(b)) provides NRC with broad authority regarding the standards and processes that the NRC must apply in exercising its licensing and regulatory responsibilities.
In the reactor area, the AEA (sections 101 and 103) requires a license for each utilization facility and requires technical specifications (section 182)
The AEA allows for amendments to the licenses to be part of the license.
(section 187) and includes requirements for holaing hearings in the emending L$nder the Energy Reorganization Act of 1974, NRC of licenses (section 189).
)
is responsible for these licensing and regulatory functions. The procedures and requirements governing issuance and modification of these licenses are contained in the NRC's regulatiens (primarily in 10 CFR parts 2 and 50).
RELEASE DATE:
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i RISK-INFORMED, PERFORMANCE-BASED REGULATION m
DSI 22 i
In the nuclear materials area, the AEA requires general or specific licensing for distribution and use of special nuclear material (section 53), source As a material (sections 62 and 63), and byproduct material (ser, tion 81).
consequence of the statutory responsibilities for licensing the' distribution and use of nuclear materials and the use of utilization and production facilities, the NRC regulates medical, industrial, academic, and other i
commercial uses of nuclear materials.
The AEA provides the broad authority for inspection to ensure compliance with the provisions of the Act. NRC inspections provide an independent verification of licensees' activities to ensure that the activities are in compliance with agency regulations.
Inspections-are primarily discussed in 10 CFR Parts 19, 30, and 50.
The AEA authorizes the NRC to undertake enforcement activities relating to violations of the licensing requirements, such as notices of violations and the imposition of civil monetary penalties. The NRC is also authorized to issue Orders that may lead to the suspension, revocation, or amendment of licenses.
10 CFR Part 2 describes the procedures for issuing notices of violation and Orders, and imposing civil penalties.
B. External Factors 1.
Executive Branch and Congress Congressional and Executive requirements regarding regulatory reform, changes in international standards, and advances in understanding risk and the biological effects of radiation may affect the regulation of the nuclear industry. As late as 1995, Congress was considering legislation concerning risk assessment (Title III of H.R. 9, the Risk Assessment and Communication Act of 1995).
2.
Standards-Setting Organizations International and national standards-setting committees may influence the j
transition toward risk-informed, performance-based regulations.
Translations r
l between dose and risk usually use international consensus factors.
In the nuclear materials area,' NRC has traditionally used radiological dose as the endpoint for rulemaking and compliance assessment. That is, in certain nuclear materials areas, regulatory decisions are related to the acceptability of dose as a surrogate for risk.
The International Commission on Radiological Protection (ICRP) dose limits reflect ICRP recommendations for acceptabla risk selections for radiation workers and tha_ public. The NRC makes use of recommendations from the ICRP, the National Council on Radiation Protection, and the National Academy of Sciences.
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3 RISK-INFORMED, PERFORMANCE-BASED REGULATION-05! 12
= /
3.
Federal Agencies has undertaken 4, number of The Environmental Protection' Agency (EPA)ies that affect activities licensed regulatory initiatives under its authoritSubstantial differences have arisen or otherwise regulated by the NRC.'
between the two agencies and have included the underlying bases and approaches In 1995, the NRC and the EPA developed a joint used to develop standards.
paper entitled " White paper on Risk Harmonization" to help explore ways to i
" harmonize
- risk goals and to develop mutually agreeable approaches for risk assessment methodologies to assess radiological risk.
As previously discussed, the Paperwork Reduction Act of 1995 is ti.. basis for agency and OMS activities related to infermation collections.
It requires controls to limit and reduce the burden on the public for collecting agency In 5 CFR 1320, which implements the Paperwork Reduction Act, OM8 information.
requires agencies to submit plans for new, revised, and extended inforntion collections to OMB for approval. However, the NRC, as an independent E
regulatory agency, may override OMB decisions.
4.
Nuclear Industry In the reactor area, comunercial nuclear power utilities and industry organizations are using risk insights to identify and reduce unnecessary Where NRC review and approval is necessary before reducing the burdens.
l In the burden, the industry is actively engaging the staff to seek relief.
nuclear materials area, there is less demand for regulatory change based on risk insights than in the reactor area.
In some instances the nuclear materials industry may not be supportive of risk-informed, performance-based
' initiatives due to perceived high cost, impact on small number of licensees, i.
and little perceived additional safety benefit.
4 5.
public The public will likely play a substar.tial role in the transition to risk-informed, performance-based regulation.' In order to maintain public confidence, the bases for and implications associated with risk-informed, performance-based regulatory approaches should be well defined and easily 4-understood.-
C. Internal Factors 1.
Nuclear Materials Initiatives The Commission's decision on the future role and scope of the NRC's nuclear 4
materials program-(in particular NRC's regulation of the medical use of nuclear material) will potentially affect the priority and scope for pursuing RELEASE DATE: SEPTEMBER 16, 1996.
9 DSI 12
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4 R!sK-INFORMED, PERFORMANCE-BASED REGULATION D$1 12 risk-infomed, performance-based regulatory approaches in nuclear materials The National Academy of Sciences recommended that the NRC-.
t program areas. reduce or eliminate its eversight of the medical uses of nuclear materia The basis for a decision regarding NRC oversight of the medical uses of nuclear material may affect the oversight and regulation of other material licensees and, consequently, the extent to which the agency may pursue The Business Process risk-informed, psrformance-based approaches.
i Reengineering effort is examining ways to gain efficiencies in licensing of l
nuclear materials and the results of this effort may affect the extent to which risk-informed, performance-based approaches could improve the effectiveness and afficiency of the licensing process.
2.
Caumission's PRA Policy Statement The Commission's PRA Policy Statement encourages the use of PRA and seeks to expand the scope of PRA applications in all nuclear regulatory matters to the extent supported by the state-of-the-art in terms of methods and data.
performance-based regulation is an implicit element of the Policy Statement.
Depending on the Commission's decision for proceeiling toward risk-informed, performance-based regulatory approaches (e.g., more aggressive (0ption 3) or l
less aggressive (0ption 4)), activities associated with the PRA Policy Statement and the companion PRA Implementation Plan may be refocused and staff l
resources may be redirected.
3.
Defense-in-Depth The Commission has recognized that reliac 4 Tar safety should not be placed on any single element of design, construction, @vration, maintenance training or other activity' associated with nuclear facilities or the use of nuclear Our current regulations are generally deterministic and were i
materials.
Risk insights provide a constructed around this concept of defense-in-depth.
more structured way to assess relative importance of the levels of Risk-informed, defense-in-depth and can lead to enhanced defense-in-depth.
performance-based regulations may need to consider the potential adverse cumulative effect of reducing conservatism and providing additional performance-based initiatives are considered flexibility on defense-in-depth.
for activities where failure to meet the performance criteria results in I
tolerable conditions for which appropriate corrective action will be taken.
Therefore, a key element of a transition toward risk-informed.
E performance-based regulation is maintaining " defense-in-depth" for risk-informed, performance-based approaches by appropriately balancing l
deteministic-based and performance-based requirements so that defense-in-depth is not compromised.
1 DSI 12 RELEASE DATE:
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RISK-INFORMED, PERFORMANCE-BASED REGULATION DSI 12 s
Policy and Legal Issues: Compliance with performance-gased Regulations 4.
-substantive policy and legal issues are likely to emerge a; increased reliance is placed on probabilistic-and performance-based approaches to support Issues such as using risk to regulatory requirements and licensing decisions.
assess the severity level of en enforcement action or determining compliar.:e l
with performance-based regulations will need to be addressed to ensure that there is an appropriate balance between deterministic-based and performance-i-
based regulations so that defense-in-depth is not compromised.
III.
DI$chSSIONS A.
Discussion of Direction-Setting Issue The casumission's decision on this directico-setting issue will be used to establish the overall framework for expanding agency activities in applying After deciding on the risk-informed, wrformance-based regulatory approaches.
overall approaci for pursuing risk-infor::nd, performance-based regulation, criteria for expanding the scope in applying a risk-informed, l"
performance-based approach to rulemaking, licensing, inspection, and enforcement activities can be applied in the context of the overall Commission direction.
In order to provide agency focus, these criteria can be sufficiently broad so that the criteria can be applied to both the reactor and i
nuclear materials areas. However, given the diverse nature of nuclear materials applications and the differences between commercial nuclear power and other nuclear materials areas in regard to their amenability for risk-informed, performance-based regulations, these criteria may need to he applied differently for different regulatory activities.
Appendix A contains i
i sample ' priority and scoping" criteria that can be applied to better tocus l
agency activities once the Commission decides the overall approach for j
pursuing risk-informed.- performance-based regulatory approaches.
B.
Discussion of Subsumed Issues After the Commission decides on the overall approach for pursuing risk-informed, performance-based regulation, six subsumed strategic issues Four of these will be resolved in the context of the overall direction.
subsumed issues can be directly resolved through resolution of the direction-setting issue. The resolution for the two other subsumed issues will be greatly influenced by the Commission decision on this direction setting issue.
The four issues most directly resolved through implementation of the Commission decision for 'how fast" and 'how far" the agency will go in expanding activities in the application of risk-informed, performance-based regulatory approaches are:
RELEASE DATE:
SEPTEMBER 16. 1996 11 DSI 12 1
I RISK-INFORMED, PERFORMANCE-BASED REGULATION DSI 12 What should be NRC's strategy and philot.ophy with respect to changing NRC's responsibilities and authority in areas of little public risk?
What approach should NRC take in modifying the matcrials regulations to move toward risk-informed, performance-based regulation, recognizing the requirements will vary as-a result of the range of products and the divergence of the licensees that use or possess byproduct nuclear mater a17 Should NRC revise its regulations to address the uses of materials If resulting from technolog' cal advances and changing human factors?
the effects of equipment failures and human factors /
L What should be the approach for licensing material uses with various levels of inherent risks?
The first two issues should be completely resolved by the Commission's decision on this direction-setting issue and the Commission's decision on the direction-setting issue concerning the future role and scope of the NRC's nuclear materials program (in particular, NRC's regulation of the me6 cal use of nuclear material).
The agency is required by the Atomic Energy Act of Ig54 health and safeti, as well as to promote the common defense and security, in Although the scope of actions necessary to attain its regulatory activities.
this level of protection from the use of AEA teaterials is relatively clear.in areas of high risk, it is not so easily defined for those activities and -types of material that generate a relatively small risk to the public from their Such areas include, but not limited to, the use of generally licensed devices, exempt-distribution of consumer products, the definition and use.
regulation of source material, review of formerly licensed sites and As the agency stabilization and long-term control of uranium mill tailings.
seeks to improve the efficiency and effectiveness of its regulatory programs, these low risk activities will be scrutinized in order to make informed decisions about how the agency should proceed.
to its regulatory The Commission's philosophy for considering change:
activities, including areas of responsibilities and authorities for areas of r
little public risk is, in part, contained in the Commission's Final policy Statement on the use of probabilistic risk assessment in nuclear regulatory activities.
In the Final policy Statement, the Commission conveys an
- Pen-minded approach for cor.sidering strategic-type ch the policy statement are:
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First, that the NRC staff, licensees, licensee applicants, and l
Commission must be prepared to consider changes to regulations, to guidance documents, to the licensing process, and to,the inspection f
Second, the NRC staff and the Commission must be cosmiitted to program.
a shift in the application of resources over a period of time based on risk findings.
l The current agency-wide strategy for increasing the use of risk assessment and risk management in regulatory decision-making is captured in the agency's PRA Implementatkn Plan. -Therefore, the Commission decision on "how fast' and "how far' the agency should go in 2xpanding activities associated with the application of risk-informed, performance-based regulatory approache:r will further define the approach and support the bases for considering changes to j
regulations, responsibilities and authorities.
The third issue explicitly recognizes the diverse nature of r.uclear materials applications and the differences between reactor and nuclear materials areas in regard to their amenability for risk-informed, performance-based regulations.
For example, events associated with industrial and medical uses of nuclear materials generally involve a simple system, involve radiation Because of overexposures, and result from human error, not equipment failure.
these characteristics of medical and industrial events, analysis of these These events using relatively simple techniques may yield ussful results.
results may lead to the establishment of standards with broad risk-informed, j
performance-based objectives and critaria. Conversely, these results may lead to a conclusion that more prescriptive requirements for equipment design and In these cases, risk insights lead to procedural compliance are appropriate.
risk-informed, deterministic regulations not risk-informed, performance-based J
Similar to the first subsumed issue, this subsumed issue will regulations.
also be resolved by the Commission's decision on this direction-setting issue and the aforementioned direction-setting issue concerning regulation of nuclear materials.
The fourth substaned issue concerns licensing for nuclear materials when there is determined to be a wide range of inherent risks because of the diverse use of the materials. These risks vary from very low-risk smoke detectors to relatively high-risk irradiators. Although the Commission must license all of these uses in response to the AEA, the Commission has flexibility in how it Currently, the Commission provides for three types approaches the licensing.
of licensing: (1) exempt distribution, (2) general licenses, and (3) specific licenses.
For exempt distribution devices (e.g., smoke detectors), the Ceamission oversees and controls their manufacture and distribution by istuing specific licenses to the manufacturers and distributors. The individual users of these low-risk devices are not licensed. A review of the internal and external factors and ongoing activities has not identified any strategic issues associated with exempt distribution devices.
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RISK-INFORMED, PERFORMANCE-BASED REGULATION l
D$l 12 The generally licensed devices consist of radioactive material containe i
sealed sources that are designed with inherent radiation safety features.
~
Approximately 1.5 million genatally licensed devices are under theNRC's r jurisdiction of the Agreement strtes and the NRC.
devices.is essentially limited to the maintenance of a general license database, ahich contains the names of the general licensees and the produ For general licenses, issues associated with control and accountability were discussed in SECY-g5-139, which reports that ma they possess.
licensees are not aware of their responsibilities under the general license.
[
The staff has previously noted that there are incorisistencias in terms of For example, in risk, both among and acr:ss these three levels of activities.
SECY-g0.-175, *$e staff identified certain generally licensed gauges that may be better controlled through specific licensing and also identified certain generally licensed devices that are suitable for exemption from regulat In this regard and in accordance with recommendations contained in SECY-g5-239, the staff has established a joint Agreement State-NRC workin 3roup to rvaluate the current regulations concerning generally an specifically licensed devices.
,1une 1996.
As previously mentioned, issues associated with determining an approach considering risk in the licensing of material uses will also be resolved in the context of the overall Commission decision on this direction-setting issue and the diredion-setting issue concerning the future role and scope of the materials program (in particular, NRC's regulation of the ERC's nucleat medical use of nuclear material).
A fifth subsumed issue concerns the information necessary for developing and implementing risk-informed, performance-based regulation. The subsumed is, stated as follows:
Given the new Government-wide goals for reducing Federal information collections, how should the agency prepare for possible reductions in its budget ceiling for information collection without compromising public health and safety?
The paperwork Reduction Act of 1995 is the basis for agency and OMB activ It requires controls to limit and reduce related to information collections.
In 5 CFR-1320, the burden on the public for collecting agency information.
which implements the paperwork Reduction Act, OMB requires agencies to s plans for new, revised, and extended.information collection approval.
By majority vote, the commission can choose not to abide by by 018 decisions.
an OMB decision.
DSI 12 i
RELEASE DATE: SEPTEMBER 16, 1996 14
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RISK-INFORMED, PERFORMANCE-BASED REGULATION DSI 12 O
The new Paperwork Reduction Act sets a goal of 10-percent annual reduction in information collections for 1996 and 1997 followed by a 5-percent reduction 1998, 1999, 2000, and 2001.
It is uncertain Aow ON8 will each year in implement this goal.
Depending on individu-1 agency plans to achieve the NRC reductions, OM8 could assign specific reduction goals to each agency.
could be required to reduce its information collection burden before imposing This could affect any additional burden through new or amended collections.
the rulemaking process, especially since risk-informed, performance-based regulatory approaches may well require licensees to collect more information for the NRC, i
The commission's decision on expanding agency activities in applying risk-informed, performance-based regulatory approaches will influence the In response to extent and iepact of additional information requirements.
several-comments concerning the potential data collection implications of the Commission's PRA Policy Statement, the Coenission agreed that it should make every effort to avoid any unnecessary regulatory burdent in connection with The collecting reliability and availability data (60 FE 42622 at 42626).
Commission also indicated that, in the context of risk-informed regulation, this was an implementation issue and that data and information collection will be addressed in conrection with proposed data collection requirements when the requirements are published for comment.
In a -strategic sense, information collection requirements and burdens should not define the direction that the agency takes regarding risk-informed, l
performance-based approaches. Regardless of the option selected for proceeding toward risk-informed, performance-based regulatory approaches, the Commission could consider information collection options independently.
The Commission may (1) look for efficiencies in information collection and storage l
methods and identify areas that could be made more efficient, (2) wait until 0MB publishes its guidance to agencies for implementing the provisions of the new Paperwork Reduction Act and address any issues on a case-by-case basis with each rulemaking, or (3) report WRC's case to 0MB now and request a level or increased ceiling to accounodate future.information collection needs associated with risk-informed, performance-based regulatory approaches.
Finally, a sixth subsumed issue concerns interagency implications associated with moving toward a more risk-informed, performance-based regulatory framework. Specifically:
How should a risk-informed, performance-based regulatory philosophy l
influence NRC's handling of dual regulation?
As previously mentioned, the Environmental Protection Agency (EPA) has undertaken a number of regulatory initiatives under its authorities that affect activities licensed or otherwise regulated by the NRC.
Substantial l
i
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D51 12 I
differences have arisen between the two agencies i
In 1995,.the-standards and acceptaH e methods for meeting these standards.
NPI and the EPA developed a joint paper entitled "
autually agreeable approaches for risk assessment methodologies to asses radiological risk.
l As the NRC and other government agencies mo promote a common unoerstanding of the technical bases for regulatory The cc en desire for increasing the use of risk in all government agencies helps. define the common goals, but ther approaches.
interagency work necessary to ensure that there is a s the underlying bases for the regulatory approach, including agreement o policy issues, such as agency safety goals, and technic should go in expanding activities associated with th the agencies.
level of agency resources devoted to reconcile differences in conflicting interagency regulatory approaches.
Important Aspects of Risk-Informed, Performance-gased Regulation C.
Three important aspects of expanding agency activities in applying risk-informed, performance-based approaches concern 4
with uncertainties in regulatory decision-making, and strategically considering how to ensure regulatory coherence during the transition from deterministic-based regulations to risk-informed, performance-based regulations.
Discussion of terms
- Deterministic-Based," ' Risk-Informed.
Deterministic-gated,*
- performance-Based,' and " Rick-Informed, 1..
performance-Based
- The NRC has generally regulated the use of nuclear Deterministic-based. material (including nuclear materials and reactors) based approaches._ Deterministic approaches to regulation consider a set of 4
challenges to safety and specify how those challenges should be mitigated.
Simply stated, the deterministic approach establishes requirements for us nuclear materials and for engineering margin and quality assurance in design, annufacture, construction, and operation of nuclear facilities.
r DSI 12 RELEASE DATE:
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RISK-INFORMED, PERFORMANCE-BASED REGULATION 0$I 12 s.
Y The NRC escablished its regulatory requirements to ensure that a facility is designed, constructed, and licensed to operate without undue risk to the These requirements are 1proely based r:n health and safety of the public.
In Eddition, this approsch assumes that detersinistic engineering criteria.
adverse conditions can exist (e.g., equipment failures and human errors) and It then requires that the licensed establishes a set of design basis events.
facility design include safety systems capable of preventing and/or mitigating i
i the consequences of those design basis events to protect the public health and The deterministic approach contains implied elements of probability.
For example, reactor vessel rupture is considered too improbable to beHow safety.
included as an accident to be analyzed.
emergency core cooling system or system train would not fu single failure where requirsd.
Risk-informed, deterministic-based. A risk-informed, deterministic approach to regulation enhances and extends this traditional, deterministic approach, (a) allowing consideration of a broader set of potential challenges to saft;y,-(b) providing a logical means for prioritizing these challenges based by:
on like19 hood and risk significance, and (c) allowing consideration of a A risk-informed broader set of resources to defend against these challenges.
approach can be used to focus deterministic regsilations by considering risk in a more coherent and comprehensive manr.or.
By considering risk insights, L
operating experience, and engineering judgment, the NRC and its licensees can focus regulatory approaches and licensee activities on those items most important to public health and safety.
regulatory approach can be used to reduce unnecessary conservatism in deterministic approaches or can be used to identify areas with insufficient conservatism and provide the bases for additional requirements.
Deterministic-based regulations have been successful in protecting the public health and safety and risk insights are most-valuable when they serve to focus the deterministic-based regulations and support the defense-in-depth philosophy.
performance-based.
A performance-based regulatory approach requires at least four keyLelements:
There are measurable parameters to monitor acceptable plant and licensee
=
performance.
Objective performance criteria are established to assess performance.
There is licensee flexibility to determine how to meet established perfomance criteria.
1 i
l DSI 12 l'
RELEASE DATE: SEPTEMBER 16, 1996 17
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RISK-INFORMfD. PERFORMANCE-BASED REGULATION i
D$1 12 Failure to meet a performance criterion must not result in uracceptable l
consequences.
In theory, a performance-based approach can be implemented without the use of i
risk insights. This type of performance-based approach would require that objective performance criteria be based on deterministic analysis and perfomance history. This approach would provide additional flexibility to However, the not the licensee to determine how to meet performance criteria.
j impact on public health sind safety would be difficult to determine.
Risk-informed, performance-based.
Risk-informed, perfomance-based approaches use risk insights, together with deterministic analyses and performarce history, to develop measurable parameters for monitoring plant and licensee performance, as well as for developing criteria for performance assessment, and focus on the results as the primary means of regulatory oversight.
i-Similar to a risk-informed, deterministic-based approach, a risk-informed, perfomance-based regulatory approach can be used to reduce unnecessary conservatism in deterministic approaches or can be ded to support additional In addition, a risk-inforan/ perfomance-based regulatory requirements.
approach can further focus performance-based approachi by defining the goal or purpose of the approach in terms of performance characteristics and safety significance and permitting the licensee additional flexibility in meeting the regulation. performance-based initiatives can be considered for activities where objective performance criteria can be established for performance monitoring. Additional evaluation of perfomance-based approaches may result in a determination that a number of functional areas are not amenable to performance-based treatment.
The NRC Inspection Manual has tailored tW concepts of arisk-informed" and
- performance-based" for inspections into a single definition of
- performance-based inspection." According to Inspection Manual Chapter 0610, performance-based inspection is inspection that focuses on issues of safety and reliability, with an emphasis on field observation rather than in-office procedural or records review. The emphasis on safety and reliability borrows
' from risk studies, incorporating PRA and individual plant examination insights to structure inspections that focus on systems or components most important to plant safety.
In addition, performance-based inspection tends to focus more en results than on process and method.
1.
Uncertainties in Regulatery Decision-Making The treatment of uncertainties is an important issue for regulatory decisions.
Uncertainties exist in any regulatory approach and these uncertainties are derived from knowledge limitations.
These uncertainties and limitations existed during the development of deterministic regulations and attempts were made to accommodate these limitations by imposing prescriptive, and what was
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-s.
051 22 5
hoped t) be, conservative regulatory requirements.
A probabilistic approach has exposed some of these limitations and provided a framework to assess their d
significancs and assist in developing a strategy to accounqpdate them in the regulatory process.
Hissan performance is an important consideration in both deterministic and I
probabilistic approaches. Assessing the influence of errors of comeission and organizational and management issues on human reliability is an example that 5
illustrates Were current PRA methods are not fully developed.
Although this
-lack of knowledge contributes to the uncertain'.y in estimated risks, the PRA framework offers a powerful tool for logically and systematically evaluating 3
Improved PRA the sensitivity and importance to risk of these uncertainties.
techniques and models te address errors of commission and the influence of organizational factors on human reliability are currkntly being developed.
Given the dissimilarities in the riature and consequences of the use of nuclear materials in reactors, industrial situations, waste di:.posal facilities, and medical applications, the Commission has recognized that a single approach for incorporating risk analyses into the regulatory process may not be appropriate. However, PRA methods and insights will be broadly applied to ensure that the best use is made of available techniques to foster consistency in NRC risk-informed decision-making. Activities that lead to regulatory coherence will also redure uncertainty in regulatory decision-making.
3.
Regulatory Coherence l
Regulatory coherence is essential in order to ensure that the direction the Caission takes in expanding agency activities in applying risk-informed, performance-based regulatory approaches promotes a stable and predictable Regulatory coherence is achieved when the regulatory l
regulatory environment.
programs or processes are well undustood and proceed in a logical and orderly fashion.
In this paper ' regulatory coherence"-means:
l (a) integration of risk-informed, regulatory approaches based on a consistent pattern or framework
.b) implementation of risk-informed, perfomance-based approaches in a
(
l' suitable or orderly way that promotes and ensures mutual understanding development of risk-informed, performance-based approaches that are (c).
governed by rational principles and that ensure systematic.
nuterrelatedness.
The Commission has recognized the importance of coherence for increasing the l
use of PRA and the Commission's policy statement on the use of probabilistic L
risk assessment methods in nuclear regulatory activities (60 FR 42622)
RELU3E DATE:
SEPTEM8ER 16, 1996 19 DSI 12
=
.. - ~ - -
l RISK-INFORMED, PERFORMANCE-BASED REGULATION DSI'12-i promotes regulatory coherence. Through the *PRA Implementation Plan"' the staff monitors PRA-related activities and helps ensure consistent application The PRA Implementation P14n explicitly
-of PRA methods and techniques.
contains activities that have, as a principal goal, the achievement of 1
Recently, the schedule for completing several regulatcry coherence. activities in the PRA laplementation Plan dealing with regulatory standard revisw plans (SRPs) for reactor pilot applications have been Arguably, the accelerated to improve and promote regulatory coherence.
increased use of PRA methods and techniques itself promotes regulatory coherence.by integrating regulatory decisions using risk, allowing systematic mparisons of approaches, and enhancing mutual understanding of those items that are most ir.portant to safety.
Another way that the Commission is promoting regulatory coherence for The safety operating reactors is through the safety goal policy statemen establishes top-level objectives to help ensure safe operation of nuclear The safety goals provide guidance on where risk is i
power plants.
sufficiently low that further regulatory action is not necessary. The concept j
of a " safety goal" has not been firmly established for NRC licensees, other than commercial power reactor licensees.
Eventually, the Commission could consider rulemaking, adoption of a nationci standard for performing PRAs, or more detailed regulatory guidance to help t
ensure uniformity in the quality and application of risk-informed, The Commission and senior NRC performance-based regulatory approaches.
i management could define staff requirements more precise articulate its expectations for industry use of risk-informed, performance-based approaches to support regulatory decisionwaaking.
i Finally, regulatory coherence for a risk-informed, performance-based approach j
may not be achieved unless there is a cohesive approach that can be used as The Commission could guidance for both the NRC and the regulated industry.
encourage industry /stakeholders to develop solutions or processes that help To help ensure regulatory coherence for industry
)
ensure regulatory coherence.
J processes or industry appliestion of a risk-informed, performance-based approach,'a part of the burden could be assumed by the regulated industry.
For example, if the varying levels of-quality for individual PRAs contribute to regulatory incoherence, the industry could develop a PRA " certification" process.or develop criteria for detailad peer reviews.
'As discussed above, regulatory coherence is essential in order to ensure that the' direction the Commission takes to expand agency activities in applying j
risk-informed, performance-based regulatory approaches promotes a stable and predictable regulatory environment.
DSI 12
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RISK-INFORMED, PERF0PMANCE-BASED REGULATION s
_D5! 12 J
IV.
OPTIONS Option 1:
Continue Current Process This option would continue the current process for determining priority andThe i
scope of risk-informed, performance-based activities.
policy statement on 'Use of Probabilistic Risk Assessment in Nuclear j
Regulatory Activities
- establishes an overall policy on the use of PRA method in nuclear regulatory activities so that the many potential applications of PRA can be implemented in a consistent and predictable manner that would The priority and scope for promote regulatory stability and efficiency. regulatory activities PRA Implementation Plan.
NRC Program There is flexibility associated with the PRA Implementation Plan.
Offices principally determine the priority and scope in applying The PRA risk-informed, performance-based regulatory approaches.
Implementation Plan is periodically updated to reflect progress for plan activities, to indicate areas that are determined to be not yet amenable to risk-informed approaches, or to add new areas where the staff is pursuing l
Under the current process, the prictity and scope risk-informed approaches.
in applying risk-informed, performance-based approaches are determined by L
Priority balancing external and internal goals with available resources.
criteria are applied and the scope of activities is primarily determined by considering the industry demand, the safety benefit, the ease of implementation, and available resources.
The current process is responsive to industry initiatives in reactor-related areas.
In part, this is because the potential benefits for reducing unnecessary industry burden, onhancing safety decision-making, and improving Consequently, resources in the staff efficiency are more readily apparent.
reactor area are focused on developing additional regulatory guidance and supplementing tha standard Review Plan to address areas such as inservice inspection, inservice testing of pumps and valves, graded quality assurance, and technical.specificatiens.
There is no widespread industry demand to consider risk-informed approaches in many of the nuclear material areas and it is not apparent whether some nuclear material. areas will significantly benefit from imp'aeontation of risk-informed As a result, in the PRA Implementati:4 r.81an, there is less approaches.
emphasis on incorporating risk-informed approaches in the nuclear materials areas.
A performance-based approach is an implicit element for some PRA Implementation Plan activities and a necessary element for other activities in For example, there have been several performance-based initiatives the plan.
DSI 12 RELEASE DATE:
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e
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l RISK-INFORMED, PERFORMANCE-SA$E0 REGULATION l
l D51 12 t
discussed in the PRA Implementation Plan, such as l
l J
i The PR) Implementation requirements, and maintentace rule implementation. plan pf j
l I
As data from inservice inspection contain performance-based aspects.
j performance monitoring of structures, systems and components are and made available to the agency, the staff evaluates the performance data,l where appropriate, tu determine the offectiveness of the approach.
l Under this. eption - the modification of rules and regulations to move tow performance-based regulation wsuld proceed at a pace consistent with thl As areas amenable to activities under the pRA Implementation plan.
risk-informed, performance-based regulation are. Ihntified and as r..ourcesin the!
become available the staff may initiate rulemaking, areas,technologIcelchangesandchanginghumanfactorsmayaffectthespee In and scope of risk 'nformed, performance-based revisions to regulations.
areas involving dual reguistion, the current emphasis and level of activity devoted to resolving issues affected by dual regulation would continue and pace of these activLties would be consistent with the safety benefit, the e of implementation, and available resources.
i since this option is the current process, no change in resource allocation is necessary to implement it. The resource and progruunatic consequences are gradual and incremental.
More Rigorously Assess Relationship to Public Health and safety Option 2:
1 M 1ar to the Continue Current process option discussed above, this aption mid pristrily continue the current approach for moving toward moreHowever, under t risk-informed, performance-based regulatory approaches.
option, the relationship of new activities to public health and safety would need to se more rigorously assessed. The results of this safety assessment In other words, would determine whethur the agency would pursue the activity.
those activities where there could be a s6stantial increase in overa P
protection to public health ano safety wi)1 be given the highest priority.
Underlying both this option and the continue current p The and will continue to be adequate, to protect public health and safety.
Com.inue Current process option pursues enhancement to current regulatory f
j processes through risk-informed approaches to regulation, is exploratory i nature and app 1 es a threshold for pursuing such activities.
pursues enhancements to our current regulatory processes through risk-However, this option is more narrowly focused than approaches to ragulation.
Option 1 and applies a higher threshold for pursuing activities, i
DSI 12 RELEASE DATE: SEPTEMBER 16, 1996 22 i
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RI$K-INFORMED, PERFORMANCE-BASED REGULAT!0N 081 12
...s Under Option 2, priority and scope in applying risk-informed, i
perfemance-based regulatory approaches would be primarily ' determined by ti pre.jected cost of the approach compared to benefit to the safety.
and a methodology developed in order to provMe a meaningful assessment.The sco priority criter a are weighted toward greatest safety benefit.
risk-informed, performance-based approaches is primarily j
industry, and availa le resources.
For example, consider some of the current activities in the reactor regulation Several of these activities are in response to industry demand and have 4
The safety benefit of these area.
as a principal goal to reduce unnecessary burden.There has been an assumption i
activities is not well defined.
burden has I,een reduced, those resources made available through that reduction in burden would be made available to focus on activities that are of greater Homver, this safety benefit is difficult to quantify.
safety in9ortance.
In the nuclear materials area, there is less industry demand to reduce unnecessary burden through risk-informed, performance-based approaches to The nature of the interaction between regulation than in the reactor area.the NRC and its materials licens the NRC and commercial power reactor licensees.
Any with simple systems and the primary contributor to risk is human error.
j safety benefit associated with a risk-informed, p**formance-based approach may also be difficult to quantify.
Under option 2, the current emphasis on reconciling regulatory differences arising from dual regulation may be
- reduced, j
priority criteria for new initiatives are used as a threshold but weighted Scoping criteria from Appendix A most useful toward greatest safety benefit.
in this approach are cost / benefit, safety significance,1stgest impact, and J
available resources.
perfom a Comprehensive Assessment of NRC Regulatory Approaches Option 3:
This approach would involve a comprehensive review of our regulations and regulatory processes to determine areas that could be imoroved throughThe ag risk-informed, performance-based regulatory approaches.
a for activities would be established based on consideration of the cumu impacts on safety, burden reduction, and efficiency..
This is the most proactiva, aggressive option for moving toward risk-informed, l
This option would maximize internal perfomance-based regulation.self-assessment and include exploring all whether risk-informed, performance-based regulation should be oursued in that OSI 12 RELEASE DATE:
SEPTEMgER 16, 1996 23 veis go.,ie-c4..=eei. gesw-d
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D51 12 t
i The purpose for the review under Option 3 is not just to enha l
arsa.
deterministic regulations.
change, in a comprehensive manner, the bases to our requistions and process for those areas that are amenable to a risk-informed, performance-based l
l i
approach.
under Option 3, priority for refulatory activities would be establis on consideration of the cumulat ve impacts on safety, burden reduction, and The scope of risk-informed regulatory approaches under this efficiency.
option would be determined by considering agency responsiveness to stakeho initiatives, the safety benefit / significance of the approach, and the effect Ease of implementation and available en NRC and licensee efficiency.
resources are secondary scoping considerations (i.e., if the activity is l
detemined to be a high priority then resources will be made available and efforts made to improve the state-of-the-art to the level necessary to support the desired goal).
In the reactor area, the staff and industry have already identified several areas that may be conducive to risk-informed, performance-based re9ulatory The Commission has already performed a systematic review of the approaches.
many current rules and regulations to identify opportunities for eliminating unnecessary regulations.
In 1993, the NRC established the Regulatory Review troup (RAG) to conduct a structured review of power reactor regulations with
_spectal attention on the opportunity to reduce unnecessary regulatory burdens The RRS recommendations to reduce the regulatory burden included the 1
suggestion to use more risk-based approaches in quality assurance, inservice The P.RG recommendations were documented in inspection, and inservice testin9 SECY-94-003.
Option 3 would build on the RRG review results with a more tightly focused assessment on the bases of those regulations and on identifying and prioritizing regulations that are amenable to a risk-informed, performance-based approach.
In the nuclear materials area, a similar systematic assessment of rules ano However, several recent initiatives, regulations has not been conducted.
including an anterials licensee regulatory impact study and the Business i'
Process Reengineering initiative, may result in changes to nuclear materials Option 3 would initiate a thorou9h review of the bases regulatory approaches.
for nuclear materials regulations and process and would identify and prioritize those areas that are amenable to a risk-informed, perfomance-based As a result of this assessment, a framework, similar to the approach.
framework for applyhig PRA in reactor regulation in SECV-95-280,' could be developed for other nuclear materials uses.
tocause the purpose of Option 3 is to change the bases of our regulations and.
process for those areas that are amenable to a risk-infomed, performance-based approach, this option is the most resource intensive option.
p DSI 12 RELEASE DATE:
SEPTEMBER 16, 1996 24
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DS! 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION s
J Additional resources would be needed to train the staff, develop a strategy for review, complete the assessment, and implement rulemaking or procedural changes.
Under Option 3, the staff would likely intensify its efforts to resolve issues associated with dual regulation. The agency would more aggressively pursue a systematic interrelatedness among approaches and mutual understanding and agreement on the underlying bases for the regulatory approaches, including agreement on key policy issues, such as agency safety goals, and technical issues confronting the agencies.
Because it is the most resource intensive, this W 'on would alsc be the most costly to licensees in the form of fees to pay for 5e reviews, guidance development, and rulemakings to be undertaken. Tha participation in and support for such activities could well depend on the extent to which they perceived near term, concrete benefits accruing to their own operations.
Option 4: Consider Risk-Informed, performance-Based Approaches Primarily in Response to Stakeholder Initiatives This option is the most responsive to stakeholder interests. The agency would deteristne for new initiatives the priority and scope in applying risk-informed, performance-based regulatory approaches through consideration of stakeholder demand and ease of implementation. The scope would be Primarily esta?11shed to meet the demand or request.
Under this option, reducing industry burden would be the primary result.
The safety review for proposed risk-informed, perforiaance-based aporoaches would be to ensure that the proposed approach maintains an acceptable level of safety.
Staff and industry efficiency may be collateral benefits of this approach.
Another potential consequence of selecting this option is that the agency could be perceived to be reactive and not making the best use of available inforntion and technology to reach decisions. The agency's expertise in risk-informed regulatory approaches may be limited by the demand for that expertise. Therefore, in the future there might be a substantial burden associated with ' ramping-up to speed' to deal with emerging safety issues.
V.-
RELATED ISSUES After the Commission has made decisions concerning the Direction-Setting Issue discussed above, additional issue (s) such as those related to implementation details will be addressed as the Strategic Plan is implemented. The related issues are listed in this section to provide a more complete understanding of the higher level Direction-Setting Issue.
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D$1 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION What is the appropriate level of resources that the NRC should devote
{
1 ever the next few years to reduce the number of licensing requirements no longer required for safety and to develop risk-informed, performance-based approaches in order to achieve long-term reductions in l
the resource burden of both the licensee and the NRCf What levels of residual radioactivity are acceptable for decommissioning a haterials licensed facility?
VI.
Colm!8SION's PRELIMINARY VIEWS staff actions regarding the various options should be held in abeyance pending the Commission's final decision on this issue paper.
The Commission's preliminary views are:
The Commission recognizes that, in order to secomplish the principal mission of the NRC in an efficient and cost effective manner, it will in the future have to focus on those regulatory activities that pose the greatest risk to the public. This can be accomplished by building upon probabilistic risk assessment cancepts, where applicsble, or other approaches that would allow a risk-graded approach for determining high and low risk activities.
In i
poneral, those activities that are of a higher risk should be the primary focus of the agene)'s offorts and resources. The level of staff activity associated with lower risk activities should be determined based on a consideration of the cumulative impacts on safety, stakeholder initiatives and burden reduction, and the effect on agency and licensee efficiency.
The stofT should continue with the current efforts, in cooperation with the industry (0ption 1), including pilot programs. The' objective of this initiative is to obtain additional information regarding the appropriateness of a risk-informed, performance-based approach for the subject activities.
These activities and their schedule, are presently captured in the agency's PRA Implementation Plan. As data from performance monitoring of structures, systems and components are accumulated, the staff should evaluate the performance data to determine the effectiveness of the approach on the subject activity.
1 The staff should proceed in the direction of enhancing the pRA Implementation plan (i.e., moving towards implementation of elements of Option 3) by building on the Regulatory Review Group's (RRG) results, wt.ch were initially focused on reducing the regulatory burden, with a more focused assessment of those regulations which are amenable to a risk-informed, performance-based approach.
In determining the priority and scope of regulatory activities to be included in moving in the direction of partial implementation of option 3, the staff should consider the emulative impacts on safety, stakeholder initiatives and burden reduction, and the effect on NRC and licensee efficiency.
This RELEASE DATE:
SEPTEMBER 16 Igg 6 26 D51 12
- - ~
RISK-INFORMED, PERFORMANCE-BASED REGULATION D8! 12
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approach should result in a further focusing of resources, on the various i
arees that the Commission regulates, that is commensurate with its risk significtnce, potential burden reduction and effect on eff,1clency.
The staff should evaluate and clarify any technical and/or administrative issues. associated with performance-based approaches to regulation (e.g.,
inspection activities, enforcement, etc.).
The staff should also perform a thorough review of the basis for nuclear materials regulations and process, and should identify and prioritize those areas that are either now or can be made with.sinimal additional effort / resources, amenable to a risk Informed, performance-based approach. This assessment should evectually lead to the development of a framework for applying PRA to nuclear material uses, similar to the one developed for reactor regulation (SECY-g5-280), where appropriate.
In the public comments on this issue, the NRC particularly solicits how NRC should deal with dual rey % tion when applying a risk-informed, performance-based regul a.ry rM 1osophy.
l 4
RELEASE DATE: SEPTEMBER 16, Igg 6 27 DSI 12 J
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I 05! 12 RISK-INFORMED, PERFORMANCE-BASED REGULATION Appendix A l
sample Criteria for Determining the priority and scope Within the Context of the Strategic Direction I
I.
Applying the Criteria The weightins of criteria to determine the priority and scope associated with applying a.rlsk-informed, performance-based approach to rulemaking, licensing, inspection, and enforcement for new initiatives will be governed by the option that the Commission chooses for proceeding toward a risk-informed, performance-based regulatory franework.
Several sample criteria for establishing the scope and priority in applying a risk-informed, performance-based regulatory are discussed under this issue paper. Except as noted, the criteria can be applied to reactor and nuclear materials areas.
The staff notes that the expected benefit of an activity may elevate its priority.
However, if the scope of the activity necessary to explore that expected benefit is resource intensive, then the priority may be lowered.
!!. priority Criteria priority criteria can be broadly defined by the relationship of the activity er proposed activity to the agency's commitment to good regulation, priority criteria also reflect a balance between the need for a revised approach and an assessment of whether the revised approach is achievable. The priority foe applying a risk-informed, performance-based regulatory approach can be i
illustrated by assessing an activity or proposed activity using the following high-level criteria:
Safety lapact:
To what extent will the activity result in enhanced safety decision-making or increase the level of public health and safety? Conversely, to what extent will the activity potentially reduce the level of public health and safety?
Burden Reduction:
To what extent will the activity reduce unnecessary burdens on the staff or the industry by eliminating unnecessary requirements?
Efficiency:
To what extent will the activity promote a better use of staff or industry resources by focusing on those activities that are more important to safety?
RELEASE DATE:
SEPTEMBER 16, Igg 6 28 D51 12 A
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III. Scoping Criteria Scoping criteria ran be broadly defined by the extent and, timing of the r
The scope defines resource canaitment necessary to achieve a certain goal.
the nature and character of the activity and conveys an agency resource The scope in applying a risk-informed, performance-based commitment.
regulatory approach for new initiatives can be determined using a criterion or combinations of criteria. Sample criteria are listed below.
Responsive to.
Sco n is determined by the extent needed to be responsive to stakeholders staceholder initiatives, d
safety Benefit:
Scope is determined by the exter,t needed to achieve the desired impact on reduction in risk or positive impact on public health and safety.
Efficiency:
Scope is determined by the extent needed to achieve the desired impact on staff efficiency.
1 Cost / Benefit:
Scope of an activity is pursued to the extent that is supported by a cost / benefit analysis. The scope of an activity may be established to optimize the cost / benefit ratio.
i public Scope of an activity is limited to those areas that the Confidence:
public is willing to support.
Largest Impact:
scope is determined by the extent needed to provide a large-scale programmatic or systemic impact, i
Available scope is determined by the extent supported by available NRC Resources:
and licerisee resources.
Scope is determined by the maturity of the technology and Ease of Implementation:
how easily the technology can be incorporated into the regulatory framework.
. RELEASE DATE:
SEPTEMBER 16, 1996 29 DSI 12 J.-,._,-._,...
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RISK-INFORMED, PERFORMANCE-BASED REGULAT!DN D3! !!
ACRONYMS 1
o Atomic Energy Act of 1954 AEA anticipated transient without scram ATV5 business process reengineering BPR direction-setting issue 05!
Environmental Protection Agency EPA International Commission on Radiological Protection ICRP Individual Plant Examination IPE Individual Plant Examination-External Events IPEEE Office of Management and Budget ORB PRA probabilistic risk assessment RRG Regulatory Review Group SB0 station blackout SNM special nuc19ar material SRP standard review plan 1
i l
RELEASE DATE:
SEPTEMtER 16, 1996 30 D51 12
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UNITED STATE 5 f
NUCLEAR REGULATORY COMMISSION
(
WAl***,CTON.O C PH H DMt March 20, 1997 MCenHW I
MEMORANDUM TO:
L. Joseph Callan Execut ve D rector for Operations b
FROM:
Job C.
oy e, Secretary
SUBJECT:
S AFF REQUIREMENTS - COMSECY-96-057 MATERIALS / MEDICAL OVERSIGHT (DSI 7)
With respect to the overall materials program, the Commission continues to support its preliminary views on this issue which were a combination of two options -- Continue the Ongoing Program with Improvements (Option 2) and Decrease Oversight of Low-Risk Activities with Continued Emphasis in High-Risk Activities (Option 3). For the longer term, the Commission also believes that consideration should be given to broadening NRC's regulatory oversight to include one or more of the higher-risk activities identified in Option 1.
With respect to the medical program, the Commission was not persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report that recommends that NRC should not be the Federal agency involved in the regulatisn of ionizing radiation in medicine.
The Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued.
The Commission continues to support the use of ACMUI and professional medical organizations and societies in developing regulatory guides and standards as was proposed in the Commission's preliminary views.
In the longer term, the Commission would be willing to cos. sider taking on broader regulatory responsibilities for higher risk activities involving other sources of ionizing radiation but such efforts should not divert resources from the 10 CFR Part 35 rulemaking discussed below.
In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a program for commission approval for revising 10 CFR Part 35, and associated guidance documents,-and the Commission's 1979 Medical. Policy Statement, if necessary.
The program should describe how 10 CFR Part 35 can be restructured into a risk-informed, more performance-based regulation by a suspense date of 6/30/99.
In developing the program the staff should consider the followings i
l VU [
(1)
Focusing Part 35 on those prc edures that pose the highest risk.
(2)
For diagnostic pr.cedures, staff should consider regulatory oversight alternatives consistent with the lower overall risk of these procedures.
(3)
The staff should address how best to capture not only relevant safety-significant events, but also precursor events.
(4)
Changing the nomenclature from " misadministration" to medical event" or comparable terminology.
a (5)
Part 35 should be redesigned so that it can i.. orporate necessary regulatory requirements for new treatment modalities in a timely rsnner.
(6)
The Quality Management Program provisions (10 CFR Part 35.32) should be re-evaluated and revised to focus on those requirements that are essential for patient
- safety, e.g.,
confirming patient identity, requiring written prescriptions and verifying dose.
To the maximum extent possible, the requirements should be revised to be risk-informed.
Given this objective, a mixed appreach of performance-based rules and otherwise prescriptive regulations should be pursued.
(7)
The staff should consider the viability of using or referencing available industry guidance and standards within Part 35 and related guidance to the extent that they meet NRC needs.
(8)
The staff should consider a rulemaking process that provides more opportunity for input from potentially affected parties than is provided by the normal notice and comment rulemaking process but would be less consumptive of resources and time than.the process recently used in the development of NRC's rule on radiological criteria for license termination.
The staff w program to implement the above should be submitted to the Commission for its consideration no later than June 6, 1997.
The program should target June.30, 1999 as the date for completing tha rulemaking process.- This ruleraaking and associated guidance development is a very high priority for the Commission.
The Commission-is prepared to provide additional resources'to the extent necessary to complete the rr'.emaking process on this schedule.
-(tmSS/RES),(EDO - Program)
(SECY Suspense:
6/6/97) 97000 (NMSS/RES) (EDG - Complete Rulemaking)
(SECY Suspense:
6/30/99) 97000
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Commissioner Rogers i
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RUl.EMAKING ISSUE (Notation Vote)
SECY-97-115 June 5, 1997 EQB:
The Commissioners FROM L. Joseph Callan Executive Director for Operations
SUBJECT:
PROGRAM FOR REVISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL
- AND ASSOCIATED FEDERAL _ REGISTER NOTICE PURPOSE:
To obtain Commission approval of: (1) the staffs proposed program for revising 10 CFR Part 35, associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary; and (2) a Federal Reaister notice (FRN) of proposed rulemaking for publication to solicit public comments regarding 10 CFR Part 35 restructuring into a risk-ir. formed, more performance-based regulation.
GATEGORY:
This paper addresses significent rulemaking issues requiring Commission consideration and approval.
BACKGROUND:
Tha Commission, in its " Staff Requirements Memorandum (SRM) COMSECY 96-057, Materials / Medical Oversight (DSI 7)," directed the staff to submit a program, for Commission approval, for revising Part 35, associated guidance documents, and, as necessary, the Commission's 1979 Medical Policy Statement (Attachment 1).
CONTACTS: Catherine Haney, NMSSIIMNS SECY NOTE:
TO BE MADE PUBLICLY AVAILABLE AT COMMISSION BRIEFING (301) 415 6825 ON JUNE 13, 1997 Susanne Woods NMSS/IMNS (301) 415-7267
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1 l
The Commissioners 2
- The staff was also direded to desonbe how Part 35 could be restructured into a risk informed, more performance based regulation. In addition, a listing of issues was l
provided for staff consideration during development of the program. The staff reviewed the Commission's direction and is prepared to move forward with the revision to Part 35 and associated guidance documents.
t i
' DISCUSSION:
I The staff plans to establish a steering group and a working group. This approach is der oribed in Management Directive 6.3,"The Rulemaking Process." The steering group will l
l
. be compnood of representatives, at the Division Director level or higher, from the following 1
offices: Office of Nuclear Material Safety and Safeguards (NMSS); Office of Nucisar i
Regulatory Research (RES); Office of the General Counsel (OGC); Offee of Enforcement (OE); and Office of State Programs (OSP). The Director, Division of Industrial and Medical Nuclear Safety, NMSS, will chair the steering group, in addition, the steering group will include...* greement State Program representative. The working group will be comprised of i
Nuclear Regulatory Commission staff and representatives from both an Agreement State and a non Agreement State.' Representation willinclude NMSS, RES, OGC, and OSP The i
i nominated Agreement State reprotentative is also a member of the Conference of Radiation Control Program Directors (CRCPD), Inc., Suggested State Regulation Committee (SSR) on Medical Regulation. The staff plans to work toward parallel development of the NRC rule and the CRCPD suggested state regulations to facilitate state development of their corresponding
^
rules. describes the staffs proposed program for the revision to Part 35 and i
associated documents. The staff plans to use a fresh start approach, solciting initialideas and suggestions from the medical community and the pubile. Previously identified issues will also be factored into the revision, including: recommendations of the Indiana, Pennsylvania, incident investigation Team; recommendations from intomal staff audits; open rulemakings and results of analyses in medical issues papers.
The staff plans to use a process tur revising Part 35 and associated guidance documents that t
provides more opportunity for input from potentially affected parties than is provided for by the typical notice and comment rulemaking process. This process includes solicitation of public comment on several occasions. The first opportunity begins with the publication of an FRN (Attachment 3) that solicits initial input into the development of Medical Policy Statement options and regulatory altematives. To the extent possible, commentors will be asked to provide specific examples of draft rule language. During this period, two public meetings are planned to further solicit the initial public input. The second opportunity for public input will include a public comment period and a set of facilitated public meetings based upon dratt rulemaking attomatives; The staff plans to provide the draft rule altomatives to the Commission prior to soliciting comment. During these meetings the staff wi" wrk with participants to review and refine the details of the proposed rule. Based upon the results of c
these public interactions, a proposed rule, regulatory analysis, and envronmental assessment 3
-l I
i
'The Organization of Agreement States recommended that the non Agreement States J be represented on this working group.
I
1 1
)
3 The Comm6ssioners i
will be prepared, siong with draft guidance documents. Following Commission l
proposed rule will be publeshed for comment, and a second set of facilitated would be completed. The meetings are expected to be focussed upon areas of controver l
and upon the draft guidance, as a mechanism to refine the rule and guidance into j_
The revision of the medical regulations will be a complex and controversial process, bec l
of the diversity of activities, modalities and risk that fall within the umbrella of medica the ceiigsr. ding diversity in medical community positions, and the varied availability professional codes and standards. Given these facts, the proposed program represl aggresolve schedule. The staff emphastres that the proposed plan does not accouj possible requests for extensions on public comment periods arociated with the in the notice requesting comment on the rulemaking attematives, or on the proposed rule.
5 Requests for comment extensions cannot be granted without causing a change to t dates for the final rulemaking. The staff projects that the final rule will be published in A 7
2000 (Attachment 2).
i The staff plans to provide NRC's medical licensees, professional medical societies, andl Agreement States (for distribution to their licensees) with copies of the initial FRN of i
proposed rulemaking. The staff plans to meet with and solicit comments from several (1) Society of Nuclear Medicine; professional societies, including, among others:
i (2) American College of Nuclear Physicians; (3) Health Physics Society; (4) American Association of Physicists in Medicine; (5) the American College of Cardiology; and (6) the American College of Radiology, The staff will also attempt to identify patient's rights groups and forward them copies of both the FRN and applicable documents for their comment. To this end, the staff arranged for a two hour discussion with the American College of Nuclear Physicians and Society of Nuclear Medicine at their combined meeting in San Antonio, Texas, on June 4,1997. The stafilntends to make documents pertaining to this rulemaking and electronic comment submittel available on the intemet, using a separate page within the current RES rulemaking bulletin board.
r Contractors and consultants are expected to assist the staff during the rulemaking r$tocess.
i Contractors, in particular, will be used to consolidate public comments and prepare the regulatory analyses for the revised rule, in addition, the staff will pursue the use of tech medical experts as consultants to the wortdng group. Specifically, the project is expected to enlist experts for diagnostic and therapeutic uses of radioactive material. Further, the use o contracted facilitators for public meetings is being considered, in addition to the support of i
the OGC Special Counsel for Public L.lason and # ;wment State Programs.
The staff believes that, at this time, providing the Commission with a description of how Part 35 can be restructured, without the beneit of public comment, is premature and that it may lead stakeholder groups to bokeve that the staff has already decided on a particular e
approach. Ideas generated at the ',*,rst stages of comment will be validated and tested dur the subsequent facilitated public meetings planned for spring 1998 and earty 1999. The -
result will be the staff's proposed rule and assocated guidance for Commission consideration in December 1998.
The staff used the guidance in the Strategic Assessment Direction Setting issues Papers Number 7, ' Materials / Medical Regulations," and Number 12,
- Risk Informed, Performance-
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i The Commissioners 4
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Based R$fss," as well as the SRM (COMSECY.g6 057) to prepare a proposed FRN l
and associated press release (Attachments 3 and 4). The FRN of proposed rulemaking contains a list of issues, presented in the form of questions, for consideration by the public.
The staff recognizes that the questions are to assist with the formulation of comments and that the commentary received need not be limited as response to the questions presented.
3 Rather, the overriding issues are both the identifiestion of necessary changes (additions and f
i deletions) to Part 35 requirements and the assessment of risk for a risk infomied, more performmoe-based regulation with sufficient oversight of public hesith and safety. The staff j
siso poses the question of whether quantitative or qualitative criteria should be considered in l
determining the "r6sk" for each modality. Public comments, the Commission SRM issues, and the staff reports on medical issues (as previously noted) will be used for developing the framework and associated text of the proposed rule.
j The staff discussed revision of Part 35 with the Advisory Committee on the Medical Uses of lootopes (ACMul) at the April igg 7 Committee meeting. As a mechanism for generating l
discussion during the last two public meetings of the ACMUI, the staff identified a possible
- approach for restructuring Part 35 by modality (e.g.; teletherapy, radiopharmaceutical therapy), based upon risk. ACMul comments addressing the Part 35 revision are summarued in the proposed FRN (Attachment 3). The ACMUl's discussion will be available as additional background information for public commentors, and will be considered by the working gro'ap in preparing rulemaking proposals. The staff litends to continue active involvement of the ACMUI in the ongoing development procriss, including Committee meetings, additional reviews of guidance documents develond during the Part 35 revision process, and possible supplemental technicalinput from ACMUl subcommittees.
RESOURCES:
(
The Offices of Nuclear Materist Safety and Safeguards Research, General Counsel, and State Programs have identified the following resource requirements for this effort in their recent budget submissions. These resource levels will be considered in the FY iggg budget review process.
FY 1998 FY 1999 FY 2000 t
QlRES E
.EIR E
.UE E
.UE NM3S 3g 3.0 60 3.0 0
0.3 l
RES 150 1.g 50 1.0 OGC*
0 0 3 0.6 0
0.3 0.6 OSP 0
0.5 0
0.5
?OGC effort includes any process design and the possible option of facilitation support for the public meetings from the Special Counsel for Public Liaison and Agreement State Programs.
NMSS management wiel monitor resource use closely for this rulemaking, I
i
. i
c The Commissioners 5
r ftECOMMENDATION That the Commission approve the following: (1) the proposed Part 35 revision program; (2) iss'.sance of the attached FRN; and (3) the attached press release.
COCRDINATION:
OGC reviewed this paper and has no legal objection. The Chief Financial Officer has no objection to this paper. The Office of Chief Information Officer has reviewed the plan for information management implications and concurs in it; however, since the revision to 10 CFR Part 35 contains information collection requirements, it must be submitted to the Office of Management and Budget for review no later than the date the proposed rule is puolished in the Federal flooister.
dA 1
L. Joi ph Callan Executive Director for Operations Attachments: 1. SRM dated March 20, Igg 7
- 2. Program for Revising 10 CFR Part 35 and Associated Documents
- 3. Proposed Federal Reaister notice
- 4. Press Release DISTRIBUTION:
Commissioners OGC OCAA OIG OPA OCA CIO CFO EDO SECY i
commissioners' comments or consent should be provided directly to the Office of the-Secretary by COB Friday, June 20, 1997.
Commission staff office comments, if any, should be submitted to the Commissioners NLT June 13, 1997, with an informption copy If t'Ke paper is of such a nature to the Office of the Secretary.
that it requires additional review and comment,.the commissioners and the Secretariat should be apprised of when comments may be expected.
are: : Date 'tP :"v' N
3:, :!:
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UNITED STATES Inompso-NUCLE AR REGULATORY COMMISSION
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'% ch 20, 1997 Ross, AE00 SGC8tf7ANY L. Joseph Callan MEMORANDUM TO:
Exe ut ve D rector for Operations b
FROM:
Job ~
C.
oy e, Secretary COMSECY-96-057 S AFF REQUIREMENT.:
SUBJECT:
MATERIALS / MEDICAL OVERSIGHT (DSI 7) the Commission to the overall materials program, With respect its pre.iminary views on this issue which continues to support were a combination of two eptions -
Continue the Ongoing Program with Improvements (Optien 2) and Decrec,e Oversight of Low-Risk Activities with Continued Enghasis in High-Risk Activities the Commission also believes For the lenger term, (Option 3).
consideration should be given to broadening NRC's regulatory that to include one or more of the higher-risk activities oversight identified in Option 1.
With respect to the medical p;.- it, the Commission was not Institute of persuaded by the National Academy of Sciences,recc,mmends that NRC should no Medicine (IOM) report that Federal agency involved in the regula:'.on of ionizing radiation in medicine.
The Commission continues to onlieve that the conclusions in the report were not substantiated and that the recommendations should not be pursued.
the use of ACMUI and The Commission continues to support professional medical organizations and societies in developing regulatory guides and standards as was proposed in the Commission's preliminary views.
In the longer term, the Commission would be willing to consider taking on broader regulatory responsibilities for higher risk activities involving other sources of ionizing radiation but such efforts should not divert resources from the 10 CFR Part 35 rulemaking discussed below.
In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a program for Commission approval for revising 10 CFR Part 35, and associated guidance if documents, and the Commission's 1979 Medical Policy Statement, 35 can be The program should describe how 10 CFR Part necessary.
restructured into a risk-informed, more performance-based regulation by a suspense date of 6/3C/99.
In developing the program the staff should consider the following:
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i For diagnostle procedures. staff should cent dar regulatory oversigl.t alternatives consistent with the l
(2) lower ovt s11 risk of :hese procedures.
The staff should address how best to captu l
(3) 1 events.
Changing the nomenclature from " misadministration" to 1
merlical event" or comparable term!nology.
(4) j it can incorporate Part 35 should be redesigned so that a
necessary regulatory requirements for new treatment 4
(5) moda12 ties in a timely m.nnu..
(10 OTR Part Pregram provisions The Ouality Manage:..entshould be re. evaluated and rev: sed to focus en
.fi 35.32) are essential for patient those requirements that requiring
- safety, e.g., confirming patient identity, To the written prescriptions and verifying dose.the requirements should be maximum extent possible, Given this objective,.a revised to be risk-informed.
mixed approach of performance-based rules and otherwd.se dans shov1d be pursued.
prescriptive regulat The staff should consider the viability of using or referencing available indust y guidance and st (7) they meet NRC needs.
The staff should consider a rulemaking process that provides more opportunity fer input from potent 18) and comment rulemaking process'but would be less consumptive of resources and time than the process recently used in the development of WRC's rule on radiological criteria for license termination.
b h uld be submitted to
.The staff's prgram to implement the above s othe Commissio 1997.
1999 as the date for The program should target June 30, This rulemaking and
- associated guidance development is a very high priority for the completing the rulemaking process.
The Commission is prepared to provide additional resources to the extent necessary to complete the rulemakirg Commission.
process on_this schedule.
6/6/97) 970006!
(sECY_ Suspense:
5/30/99) 970006!
(MS5/RES) (500 '- Program)
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ATTACHMENT 3
[7590-01 P)
NUCLEAR REGULATORY COMMISSION RIN 3150 AF74 Medical Use of Byproduct Material:
Issues and Request for Public Comment AGENCY, Nuclear Regulatory Commission ACTION:
Notice of Proposed Rulemaking The U. S. Nuclear Regulatory Commission (NRC) is developing a program for
SUMMARY
revision of 10 CFR Part 35, " Medical Use of Byproduct Material." The decision to revise Part 35 resulted from the NRC Strategic Assessment and Rebaselining initiative (SA), a process involving identification of the direction setting issues and associated options for the fu' a of NRC activities. Specifically, the SA effort included medical use regulation. With this notice, the Commission is initiating a proposed rulemaking action which will culminate in the developement of a final rule for approvalin late 1999. This notice describes issues proposed to be included in this rulemaking. The Commission plans to further propose specific rulemaking text for public comment during 1999 (approximately February 1999).
In order to provide the public the most effective opportunity to participate in developing the rule text, the Commission is requesting public comment on the issues identified by the questions in this notice within 90 dayh of the issuance of this notice. Comments received after this initial 90 day period will be considered along with the comments received on the proposed text anticipated for publication in 1999. However, because of schedule requirements, it may not be practicable for the Commission to consider those comments received after the 90 day period in preparing the detailed proposed rulemaking text.
DATES:
The comment period expires (90 days after the FRN is issued).
ADDRESSES: Send wntten comments and suggestions to Secretary, Nuclear Reguhtory Commission, Washington, DC 20555-0001, Attention: Dock.eting and Service Branch. Hand-Deliver comments to 11555 Rockville Pike, Rockville, MD, between 8:00 a.m. and 4.00 p.m. on Federal workdays.
Written comments may also be submitted electronically on the Intemet via NRC's interactive rulemaking web site, through the NRC home page (http://www.nrc. gov). This site provides the ability to upload comments as files (any format), if your web browser supports this function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415 5905; e-mail CAG@nre gov.
i i
1 l
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i FOR FURTHER INFORMATION REGARDING THIS NOTICE CONTACT:
l l
Catherine Honey, Office of Nuclest Material Safety and Safeguards, Nuclear l
l Regulatory Commission, Washington, DC 20555 0001, telephone (301) l i
4154825 or Susanne Woods, Ollce of Nucient Material Safety and Safeguards, Nuclear Regulatory Commission Washington, DC 20555-0001, telephone (301) 415-7267.
1 SUPPLEMENTAL INFORMATlON:
Backaround l
l NRC exammed the issue of Ms medical use program in great detail during the last four years.
This process started with NRC's 1993 intomal senior management review report; conti,1ued wth the 1996 independent ertemal review report by the National Academy of Sciences, Instdute of Medicine; and culminated in NRC's SA process. In particuiar, medical oversight was addressed in the Strategic Assessment Direction Setting lesue Paper Number 7 (DSl 7) i (released September 16,1996).
in their " Staff Requirements Memorandum (SRM) COMSECV 96-057, Materials /Modical Oversight (DSI 7)," dated March 20,1997, the Commission dirseted staff to revise Part 35, 4
associated guidance documents, and, if necessary, the CommisGn's 1979 Medical Policy StaterMnt. Further, the SRM stated,'Wth respect to the medical program, the Commission was not persuaded by the National Academy of Sciences, institute of Medicine (IOM) report-4 that recommends that NRC should not be the Federal agency involved in the regulation of ionizing radiation in medicine The Commission continues to balieve that the conclusions in the report were not substantiated and that the recommendations should not be pursued."
?
The Commission SRM specifically directed the restructuring of Part 35 into a risk-informed, i
more perfonnancetued regulation. Further, during development of the rule and associated guidance, as well as Gring review of the Medical Policy Statement, the NRC staff was directed to consider the Mowing issues:
- 1. Focusing Part 35 on those procedures that pose the highest risk.
- 2. Regulatory oversight attematives, for diagnostic procedures, that are consistent with the lower overall risk of these procedures.
- 3. The best way to capture not only relevant safety eignl6 cant events, but also precursor events.
- 4. The need to change from the term " misadministration" to " medical event" or other comparable terminology, i
5.- Redesignmg Part 35 so that regulatory requirements for new treatment modalities can i
be incorporated in a timely manner,
- 6. Revising the requirement for a quainy management program (10 CFR 35.32) to focus on those requirements that are essential for patient safety,
- 7. The viabilty of using or referencing available industry guidance and standards, within Part 35 and related guidance, to the extent that they meet NRC needs.
The NRC staff discussed items 17 and solicited preliminary views from the Advisory CommNtee on the Medical Uses of isotopes (ACMUI) at the April 1997 Committee meeting.
[Transcnpts of this meeting are available by contacting the NRC Public Document Room and
i 1
i on the intemet (as specified in the reference information provided).]
j i
The ACMUI docussed their views and recommendations during a briefing of the Commission l
on May 8,1997. The ACMUl concurred with NRC's position to continue the ongoing medical program with improvements, and to decrease oversight of low-nsk activities with continued i
, emphasis of high risk activities. The commetoe supported the use of professional medical
(
organizations and soceties in developing a performance based regulation. _ The ACMUl l
recommended consideration of a quality improvement approach as an alteristive to the present Qualty Management Program. Further, the commetoe recommer%d, to the Commission, that the 1979 Medical Policy Statement be revoed to reflect that NRC will l
regulate radiation safety of patients only where justified by the nok to the patients and only
}'
where voluntary standards or compliance with the standards are inadequate. The ACMUI believed that the assessment of the risks justifying regulations should referonos comparable l
nsks and comparable modes of regulation for other types of medical practice. In addition, they beloved that the NRC should not intrude into medical judgments affecting patients and 1
into other areas that the ACMUI considered to be traditione!!y a part of the practice of I
I medicine.
This notice initiates a proposed rulemaking action which will culminate in the development of a final rule for approval in 1999 in order to provide the public the most effective opportunity to participate in developing the rule text, the Commission is requesting public comment on the issues identified by the questions in this notice and on the ACMUI recommendations within 90 days of the issuance of this notice. Comments received after this initial 90 day penod will be considered along with the comments received on the proposed text that is anticipated for publication in 1999. However, because of schedule requirements, it may not be practicable for the Commission to consider those comments received after the 90 day penod in prepanng the detailed proposed rulemaking text.- Further, the staff recognizes that the questions are to assist with the formulation of comments and that the commentary received need not be limited as response to the questions presented. Rather, the ovemding i
issues are both the identification of necessary changes (additions and deletions) to Part 35 3
requirements and the assessment of nok foi a risk-6nformed, more performance-based 1
regulation with sufficient oversight of public health and safety. The NRC staff is interested in ideas, proposals, and comments on the structure and content of a revned Part 35, given the Commission guidance and direction as desenbod above. To the extent possible, commentors are asked to provide specific examples of draft rule language.
Reauests for Comments on General Considerations NRC has identified the following areas of Part 35 for consideration and is seeking comments on these issues, as wel: as any others, offered for onnsideration during the revision to Part 35:
1.
How should the Part 35 'equirementt be revned to be risk-informed and more performance based? How should performance be measured to provide both NRC licensees and NRC with an objective basis for determining regulatory complance?
2.
How should risk be assessed for medical uses and the regulation be modifed to focus on procedures posing the highest risk? What quantitative or
qualitative enteria should be considered in determining the *nsk" for each modality?
3.
What oversight should exist for diagnostic procedures that is commensurate l
with the associated risks?
4, What specific events or incidents should be reported to NRC7
[e.g., machine failure, leaking source, software failure, hardware failure] What criteria should be used for determining if the event is reportable (e.g.,
threshold)7 Are there modality speerfic events that should be reported?
Should the term " misadministration" be changed to " medical event *' or comparable terminology?
5.
How should the regulation be redesigned to incorporate necessary regulatory requirements for new modalities? Should Part 35 be structured such that requirements for a particular modality are g*ouped together?
Which Quality Management Program provisions should be re-evaluated and 6.
revised b focus on requirements that are essential for patient safety? Are different provisions appropriate for each of the different modalities?
7.
Which standards and guidance developed by professional societies and other organizations sie applicable to NRC regulated medical uses of radioactive material and how could they be incorporated within the regulatory framework of Part 35 and/or associated guidance?
8.
How should the issues of training and experience be addrsssed? What individuals or groups should be subject to such requirements?
g.
Which new issues / modalities should be incorporated into Part 357 10.
Should the 1979 Medical Policy Act Statement (44 FR 8242) be modified to increase flexibility for a nsk-informed, more performance-based approach to medical regulation?
Reference information 1.
Strategic Assessment Direction-Setting issues Paper Number 7 is available by wnting to the U.S. Nuclea-Regulatory Commission Attention: NRC Public Document Room, Washington, DC 20555 001. [ Telephone: (202) 634 3273; fax: (202) 634 3343).
2.
The memorandum " Management Review of Existing Medical Use Regulatory Progrom (COMIS g2 026)" (dated June 16,1993) is available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-001. [ Telephone: (202) 634 3273; fax: (202) 634 3343).
3.
Radiation in Medicine: A Need for Regulatory Reform (1996) is available from
the National Academy Press at 2101 Constitution Avenue, N.W., Box 285,
~
Washington, DC 20055.
4.
Summary minutes and transcripts of the ACMUl April 1997 meeting or transcripts of the May 8,1997, Commission briefing are available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washir'gton, DC 20555401. [ Telephone: (202) 634 3273; fax:(202) 634 3343).
- Transcripts of the May 8,1997 briefing are also available by Intemet at http:#www.nre. gov.
5.
The NRC Medical Poiicy Act Statement of 1979 was published in the Endstral Reaister, Volume 44, page 8242, on February 9,1979.
Dated at Rockville, Maryland, this day of May,1997.
For the U. S. Nuclear Regulatory Commission John C. Hoyle, Secretary of the Commission 1
4 s.
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RULEMAKING ISSUE (Information)
June 20, 1997 SECY-97-131 EQR The Commissioners FROM:
L. Joseph Callan Executive Director for Operations
SUBJECT:
OUPPLEMENTAL INFORMATION ON SECY-97115 " PROGRAM FOR REVISION OF 10 CFR PART 35,' MEDICAL USES OF BYPRODUCT MATERIAL,' AND ASSOCIATED FEDERAL REGISTER NOTICE" PURPOSE:
l To provide the Commission with supplemental information and an attemative program for the revision of 10 CFR Part 35.
CATEGORY:
This paper addresses significant rulemaking issues requiring Commission consideration and approval.
BACKGROUND:
On June 5,1997, in SECY-97-115, the staff requested Commission approval of: (1) its proposed program for revising 10 CFR Part 35, associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary; and (2) a Eederal Reaister notice (FRN) of proposed rulemaking, for publication, to solicit public comments about restructuring Part 35 into a risk-informed, more performance-based regulation.
I CONTACTS: Diane S. Flack, IMNS/NMSS NOTE: TO BE liADE PUBLICLY AVAILABLE (301) 415-5681 IN 5 WORKING DAYS FROM THE DATE OF i
THIS PAPER Susanne Woods, IMNS/NMSS (301) 415-7267 1
44 O c e 7 tet,,- w l
3 The Comrnissioners 2
On June 13,1997, the staff bnefed the Commission on rts proposed program for revising Part 35 as desenbod in SECY 97-115. In adc;1 ion, the staff and the Commission discussed an attemative approach to revising the regulation. The Commission requested that the staff _
supplement SECY-97-115 with a desenption of the sitemative approach, as well as with the estimated resources,to complete the rulemaking, if this altemative were implemented.
plSCUSSION t describes the staff's attemative approach for revising Part 36 and the associated guidance documents. Under the attemative, the staff would immediatcly begin preparing proposed rule language and altomatives using a 'modalityi approach (Attachment 2). The attemative differs from the orogram recommended in SECY 97-115 in several respects. First, there would be no formai public opportunity for comment at the beginning of the process. The staff would consider comments and rule language attematives beginning immedia'ely, but the first more formal opportunit/ or public interactions would be f
donng facilitated public meetings in the fall of 1997. The staff would, under the attemative, provide a proposed rule; associated documents such as the regulatory analysis, environmental assessment, and finding of no significant environmental impact; and the Office of Management and Budget clearance package to the Commission in May 1998', At that same time, the staff would expect to provide the Commission with draft guidance documents for each of the proposed rule modalities, and its recommendations regarding the need for any changes to the 1979 Medical Policy Statement. Following Commission approval, the proposed rule and draft documents would be published for public comment. The legal minimum time for public comment on a proposed rulemaking is 75 days. The staff would expect to provide a final rule, associated documents, and final guidance documents lor Commission approval in May 1999.
I Under the altomative, there would be more public interactions than the usual rulemaking and comment process of the Administrative Procedure Act, in the following respects. First, public input would begin immediately and continue throughout the development of the rule altematives and facilited public meetings in the fall of 1997. Consideration of comments would be cut off at a point approximately two-three months before providing the material to the Commission for approval. Rulemaking attematives and drafts would be made publicly available on an ongoing basis, including posting them on an INTERNET page, and the staff would make available the comments received, both in the PDR, and to the extent possible, electronically in the INTERNET. If the attemative revision progrom described in this i
suppl 6 mental information is approved, statt would revise the Federal Renister notice in SECY-97-115 to notify the public of the approved program and the availauility of documents on the INTERNET, The staff would continue, as proposed in the original program outimed in SECY-97115, to solicit comments and specific rule text proposals from various professional societies, The staff would also continue its proposal to use both consultants, and a working group and steering group approach to the development of the documents. -The staff would particularly look into obtaining consultants or other information sources that can provide an indication of the current trends in medical practice, in addition to vigorously using the -
'As the staff proceeds with this rulemaking, the staff will be alert to issues or I.
areas where more immediate rulemaking is appropnate.
j.
L
i 6
The Commissioners 3
Advisory Committee on the Medical Uses of isotopes.
J RESOURCES:
Resource projection,s associated with revising Part 35 and associated documents for fiscal years (FY) 1998, FY 1999, and FY 2000 were provided to the Commission in SECY 97115.
Staff does not anticipate any change in the resources needed, in FY 1998 and FY 1999, to i
compivte the rulemaking effort by May 1999.- The pnmary resource needs are based upon development of the rule, associated documents, and corresponding guidance. Sints this task i -
is unchanged, the resource estimates are unchanged. Since the rulemaking effort would be
+
completed in FY 1999, the resources identified in SECY 97-115 for FY 2000 would be used in other areas of the medical program.
RECOMMENDATION That the Commission approve the Part 35 revision program described in the attachment to this document.
r COORDINATION The Office of the General Counsel reviewed this paper and has no legal objection. The Chief Financial Officer and Chief Information Officer have no objection to this paper.
4 soph h llan Ex cutive Director for Operations Attao'ments:
- 1. Altemative Program for Medical Revision
- 2. Modality Outline for 10 CFR Part 35 DISTRIBUTION:
Comissioners OGC OCAA OIG OPA OCA CIO CFO EDO
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ALTERNATIVE PROGRAM FOR MEDICAL REVISION The followmg is an attemative program for the revision of 10 CFR Part 35, as discussed with the Commission on June 13,1997.
The attemative consists o? the following program elements.
1.
The staff would immediately initiate development of draft language and rule attematives, and make these materials publicly available on an ongoing basis, including posting them on an INTERNET page, and would consider comments, suggestions, and other attematives that result from these interactions. Public input would begin immediately and continue throughout the development of rule attematives, facilitated public meetings in the fall of 1997, and development of the proposed rule. The staff would interact with professional societies and the pubhc to solicit, on an informal basic, comments and rule text. In addition, staff would prepare a Federal Reaister rmtice to notify the public of the approved Part 35 program and the availabihty of documents on the INTERNET.
2.
Per Management Directive 6.3, the staff proposes to conduct this rulemaking using a group approach. Development of rule text attematives, including draft guioance documents, would use a working group (or groups) and steering group approach. The staff proposes to enhance the State participation in the process through the inclusion of State individuals in both the working group and the steenng group. This participation would facihtate the Conference of Radiation Control Program Directors' (CRCPD's) development of corresponding rules in its suggested State regulations, and would allow the State staff to fonus on potentialimpacts of Nuclear Regulatory Commission draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treanent, or research in the States.
3.
Facihtated public round table meetings in the fall of 1997 would be used to focus discussion on speific rule text and attematives. Discussions would also be held in meetings with the Advisory Committee on the Medical Uses of isotopes (ACMUI), and with the Organization of Agreement States. The exact timing of the meetings would depend on the process to convene and facilitate these meetings, but it is expected that the meetings could be conducted in the late September to November 1997 timeframe.
4.
Based on the informal and formal public interactions, the staff, using the working group and steering group approach, would develop the proposed rule and associated documents including the regulatory analysis, environmental assessment, finding of no significant environmental impact, and Office of Management and Budget clearance for Commission review and approval. The staff would also develop draft guidance documents for each medical modality of the proposed rule, for publication as drafts for comment, in parallel with the proposed rule, and would provide for Commission consideration, any recommendations regarding changes to the 1979 Medical Policy Statement. During the development process, the staff would continue to make drafts publicly available, but would need to cut off consideration of comments at a point approximately two-threa months before providing the material to the Commission for approval. Comments received after that time would be considered as part of the ATTACHMENT 1
2 ongoing interaction process, and as part of the comments received during the formal public comment penod on the proposed rule after Commission approval.
5.
Following Commission approval, the proposed rule and draft documents would be published fot public comment. The legal minimum time for public comment on a '
proposed rulemaking is 75 days. The staff would make the drafts available on the INTERNET, and would accept comments electronically. The staff would also hold two public meetings, during the formal comment penod, to facilitate comments.
6.
Development of the final rule, associated documents, and final guidance would be through the working group and steering group. The staff would continue to make draft documents available, but would not be able to consider further extomal input beginning approximately four months before the submission of the final documents for Commission approval. The staff would discuss the final documents with the ACMUI, and we the Agreement States, prier to submission to the Commission. The staff would expect to provide the final documents for Commission approval in May 1999.
l ATTACHMENT 1 l
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1 ALTERNATIVE PROGRAM FOR REVISING ic CFR PART 35, ASSOCIATED GUIDANCE DOCUMENTS, AND THE 1979 MEDICAL POLICY STATEMENT m
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S W W of y Staff Developrnent of Proposed Rule and Draft Guidance Documents y
Proposed Rule and Draft l
Informal Putdle Interactions i
pg FactHtsted Pubtle Meetinge Fx Public W Comenloelon RowleastApproval Draft Rule Public Comment-Proposed PutWie CommentW Rule Rule Staff Develcpenent of Final Rule and Goldence Staff Development of Finst Rule and Guidance Documents y Submit toCommission for Apal -
Submit to Commloelon for Approvst 5 j
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I
' MODALITY OUTLINE FOR 10 CFR PART 35 i
in developing the revisions to 10 CFR Part 35, the staff proposes to move the rule to an entirely modality based approach, as discussed with the Commission on June 13,1997. This spproach is described briefly below.
- Part 35 is currently p mixture of modality specific requirements, and generally applicable roouirements. The staff proposes to reexamine the current divisions, and, based on risk, develop a set of requirements that are specific to each modality. At this time, the staff antN:ipates that the following modahties would be addressed:
1.
low dose unsealed materials (diagnostic nuclear medicine);
. 2. _
high-dose unsealed materials (nuclear medicine therapy);
3.
low dose sealed source applications; 4.
teletherapy; 5.
Ngh-dose-rate remote afterloaders; 6.
gamma stereotactic surgery; and 7.
emerging technologies.
The above list is not viewed as all-inclusive. Additional categones may be developed, depending on the breadth of the areas to be covered, and the similanty of requirements in a given area.
The modality approach envisioned tvould place all requirements for a given type of treatment into a single section of the regulation, including who or what organization is licensed; what type of license is issued; the necessary technical requirements, such as surveys and calibration; the training and experience requirements the event recording and reporting requirements; and the quality improvement and management objectives. Thus, requirements can be tailored more specifically for each modahty (as listed above), with those posing lower risks having fewer or simpler requirements, and those posing higher nsks having e.orrespondingly more stringent requirements.
P.e advantage of organizing Part 35 to be entirely modality-driven is that the rule can be modified to incorporate new modalities by simply adding a new subpart to address the activity. The staff envisions that new approaches would initially be licensed under the emerging technologies modality, where the rule requirements would be general in nature, and the specifics would be contained in license conditions. As experience was gained in the regulation of that modality, a rulemaking to add a new subpart to address the specisc modality could then be undertaken, and there would be no need to revise the regulations for the other modalities.
The downside of the modality approach is that there would need to be some repetition between the subparts, since some of the requirements would be similar for at least some of the modalities. However, the staff believes at this time that this type of organization would make for a more flexible and usable regulation.
i ATTACHMENT 2 e
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4-The following is a set of questions that have been developed for determining the contents of each modality section.' This list is not intended to be all-inclusive.
= Who and/or what (e.g., facility) should be licensed?
1.
2.
- What type of license (e.g., is registration a possibility)?
i 3.
What terms should be defined?
4.
Should there be an operational definition of ' adequate protection," such as performance enteria or a " safety goal *?
5.
What are the 1echnical issues
- that should be addressed (e.g., surveys, calibration, access controls, etc.)? -
6.
What training and experience (T&E) is necessary for what types of personnel involved in the modality?
a.
Should T&E include not only physicians and radiation safety officers, but associated professional personnel (e.g., medical physicists)?
b.
Should the focus of T&E be radiation safety or extend to medical or other
= credentials? Is it sufficient to simply require the requisite licensure arid credentials required by the State, for the medical speciahy being practicad?
c.
Are there needs to maintain qualifications and undertake periodic
. requalifications?
7.
What duties and responsibilities should be set forth, and for which personnel?
?-
8.
What reports of
- safety significant* rwdical events or "procursof events should be required?
h g.
What should be the necessary Quality Management objectives that are essential for patient safety? Are there any additional specifications needed in addition to the basic
'l objectives?
i-10.
What records should be kept?
11, What provisions relative to enforcement should there be?
l 12.
What provisions for amendments, renewals, exemptions, etc., should be included in the rule?
13.
What, if any, provisions are needed for the protection of human research subjects?
14.
Are there industry guides and standards available that either the regulation or guidance can rely on?
15.
What interactions are there with other regulations, parti,ularly 10 CFR Parts 20,30, 32, and 33?!
1 ATTACHMENT 2 -
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D SR-SECY-97-115
_ Action: Paperielle, NMSS_
e nog UNITED STATES Cys: Callan
- 4 NUCLE AR REGULATORY COMMISSION hQP50" waswmotos. o c resss-oooi
.)
Norry June 30, 1997 Blaha Thadani, RES o**ect or THE Bangart, SP 8'C"#"*
Shelton, CIO Meyer. ADM-CHaney, NMSS SWoods, NMSS MEMORANDUM TO:
L. Joseph Callan Exec - 'v Dife tor for Operations C
FROM:
John Hoy e, ecretary
SUBJECT:
STAFF REQUIREMENTS - SECY-97-115 - PROGRAM FOR REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIV"EO FEDERAL REGISTER NOTICE The Commission has approved the staff proposal to revise 10 CFR Part 35 consistent with the alternative program proposed in SECY-97-131 and subject to the following comments.
1.
The staff should not only consider what regulations will be affected by the change to Part 35, but should also take a close look at existing guidance and draft guidance to determire what changes would be needed.
To ensure that all regulatory rulemaking and guidance development potentially affecting medical uses will be consistent with the Commission's direction in DSI 7, the staff should identify in the public meetings and Federal ~Recister notices all regulatory actions and proposed actions relating to or affecting Part 35 licensed activities.
When appropriate, public comment should be invited.
2.
The staff should continue to solicit input from members of the poalic to ensure, to the degree possible, that all interests-are represented.
The staff should include grcups representing radiopharmacists and medical technologists, and other experts, as appropriate.
3.
The staff should prepare alternatives with specific rule
^
text to help focus the discussion during the first-round of facilitated meetings and assist the staff in developing draft rule language for publication and comment.
SECY NOTE:
SECY-97-115 WAS RELEASED TO THE PUBLIC ON JUNE 17, 1997.
THIS SRM, SECY-97-131, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL j
COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
1 i
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c-
. 4.
The staff should look for-potential resource savings (FTE, consultants, and-funds) that can be achieved through use of the internet, teleconferencing, etc.
In making documents available over the internet, some_ caution should be exercised to ensure that the number of and versions of-available documents for comment are not so large and varied that they will overwhelm commenters and lead to confusion on the part of the staff and: management responsibis #or the rulemaking, A Federal Recister_ notice and press release should be issued
-reflecting the-approach outlined in SECY-97-131, attachments 1 and 2, and published in time to support the facilitated public
- meetings,
% BG4- (NMSS)
(SECY Suspense:
0./5/K:.)
9700065 8/29/9/
c::. Chairman Jackson Commissioner Rogers Commissioner Dieus Commissioner Ditz 4
Commissioner McGaffigan OGC CIO CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
a
/p ** *8og#c, s,
UNITED STATES f
NUCLEAR REGULATORY COMMISSION WASHINGTON. D C. 20565 4 001 June 30, 1997 0FFICE 0$ THE SECAttARY COMMISSION VOTING RECORD DECISION ITEM:
SECY-97-115 TITLE:
PROGRAM FOR REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE The Commission (eith all Commissioners agreeing) disapproved the scarf proposal as contained in this paper, but instead approvea the alternativr., approach provided in SECY-97-131, as recorded in the Staff Rcquirements Memorandum (SRM) of June 30, 1997.
This Record contains a summary of voting on this matter together with the individual vote sheets, views and comments of the Commissioners, and the SRM of June 30, 1997.
b gdhn C. Hoylb Secretary of the Commission attachmentsi
- 1. Voting Summary
- 2. Commissioner Vote Sheets
- 3. Final SRM cc:
Chairman Jackson Commissioner Rogers Comissioner Dieus Comissioner Dia Connissioner McGaf figan OGC EDO PDR DCS
VOTING
SUMMARY
- SECY-97-115 EECf)RDED VOTES NOT APRVD DISAPRVD ABSTAIN PARTICIP COMMENTS DATE CHRM. JACKSON X
X 6/27/97 COMR. ROGERS X
X X
6/25/97 COMR. DICUS X
X 6/30/97 COMR. DIAZ X
X 6/26/97 COMR. McGAFFIGAN X X
6/26/97 COMMENT RESOLUTION In their vote sheets, all Comissioners approved alternative approach provided in SECY-97-131 with some additional coments.
Subsequently, the coments of the Comission were incorporated into the guidance to staff as reflected in the SRM issued on June 30, 1997.
1 l
I i
o
l N OT ATION VOT E FESPONSE SHEEI TO:
John C. Hoyle, Secretary FROM:
CHAIRMAN JACKSON SECY 97115 PROGRAM FOR REVISION OF
SUBJECT:
10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE Approved Disapproved xx Abstain Not Participating Request Discussion COMMENTS:
I disapprove the original program to revise 10 CFR Part 35,*Medice! Uses of Byproduct Material
- proposed in SECY 97115; however, I approve the altamative program proposed in SECY 97-131.
b SIGN TGRE June 27, 1997 ReleaseVote /xx /
DATE Withhold Vote /
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I NOT ATION VOTE RESPONSE SHEET TO:
John C. Hoyle, Secretary FROM:
COMMISSIONER ROGERS SECY-97115 - PROGRAM FOR REVISION OF
SUBJECT:
10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL Rggl STER NOTICE in Approved"tu*ifL' Disapproved"tyf Abstain Not Participating Request Discussion COMMENTS:
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. Commissioner Rogers' comments on SEC -Y 97-115 and SECY-97-1312 35
?I' approve the staff's program for revision of-10 CFR Part as described in-the attachment to SECY-97-131 and subject'to the-following comment:
The facilitated meetings should be-focussed not so much on' alternative approaches for alternative rule text as on concrete, resolving discrete, specific, long-standing areas of controversy related to Part 35.
The meetings should be preceded by distribution of a paper which identifies and, in an even-handed.
way, discusses these issues and alternatives for resolving them The paper should convey the sense that in a rulemaking context.
the NRC is open to alternatives that may develop during workshop discussions.
To illustrate my thinking, I'would appeal-to the same example that I mentioned in my comments on SECY-97-054.
Specifically, It seems clear that en essential aspect of a OM that the patient is program is a set of procedures to assu.cso clear and has been an What is not given the "right' dose. area of contention is how close the delivered dose must be to. be the *right" dose.
I believe'that we prescribed dose for it considerations from a full airing of might learn some important this issue in a facilitated meeting.
I would expect that actual rule text-could be developed quite quickly after the meetings and I would hope that the meetings could be moved forward in time by focussing them on issue resolution rather than the detailed wording of draf t text.
I believe the discussions would be more fruitful for In any case.
NRC.
I disapprove publication of the Federal Reciater notice.
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N0TATION VOTE RESPONSE SHEET T0:
John C. Hoyle Secretary of the Comission FROM:
COMMISSIONER DICUS
SUBJECT:
SECY-97 115 PROGRAM FOR REVISION OF 10 CFR PART 35.
"HEDICAL USES OF BYPROD')CT HATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE Approved XX Disapproved Abstain Not Participating Request Discussion COMMENTS:
SEE ATTACHED
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COMMENTS OF COMMISSIONER DICUS ON SECY 97-115 I approve staffs program to revise Part 35 as modified by the supplemental information in SECY-97-131 subject to the following actions:
1)
The staff should not only consider what regulations would be affected by the revised Part 35, but should also take a close look at existing guidance and draft guidance to determine what changes would be needed. To ensure that all regulatory rulemaking and guidance development potentially affecting medical uses will be consistent with the Commission's SRM on DSI 7, the staff should identify in their public meetings and Federal Register notices all regulatory practices end proposed actions relating to or affecting Part 35 licensed activities. For example, draft Regulatory Guides for licensing of the production and distribution of radioactive materials used in meoicine may need revision. When appropriate, public comment should be invited.
2)
When soliciting comments, the staff should include groups representing radiopharmacists and meCical technologists.
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NOT ATION VOTE RESPONSE SHEET-TO:
John C. Hoyle, Secretary FRC!A:
COMMISSIONER DIAZ
SUBJECT:
SECY 97-115 - PROGRAM FOR REVISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE Approved i Disapproved Abstain
'v/
Not Participating Request Discussion COMMENTS:
I concur with the approaches presented in SECY:97-131 with the proviso that staff should look for resource savings (FTE consultants, and funds) that can be achieved through the use of the internet, teleconferencing, ect.
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Release Vote / " I b ~ 9 b~97 DATE Withhold Vote !
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Entered on "AS" Yes No q e, h, w,*7_ 'j
NOT ATIO N VOTE i
RESPONSE SHEET 4
TO:
John C. Hoyle, Secretary FROM:
COMMISSIONER MCGAFFIGAN
SUBJECT:
SECY-97-115 PROGRAM FOR REVISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE St e V-17 -t 5 Approved i
Disapproved Abstain Not Participating Request Discussion COMMENTS: g gkh),
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b JG!97 ReleaseVote /x /
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Withhold Vote /
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- OmlSS10NER MMFIGAN'S ComENTS ON SECY-97115 AS SUPPLEMENTED BY SECY 97-131:
I approve of the staff's plan (including the modality a time line for revising Part 35 as described in SECY-97 pproach) and proposed 131 since it meets the time line and goals established by the Comission in the SRM on DSI 7 while providing enhanced opportunities for participation by licensees, pufessional organizations, the Agreement and non Agreement States, the public, and the ACMul. Indeed. the new staff plan provides more meaningful opportunities for public cuments than the previous plan despite saving nine months because it will focus the process earlier on real issues as opposed to general discussion which has already gone on for years.
I agree with Comissioner Dicus' coments, but I disagree with those of Comissioner Rogers. During the facilitated public meetings. I believe that specific rule text and alternatives, couched to encourage a free flow of ideas, will help focus the discussion and assist the staff in developing draft rule isnguage. We should not postpone rule language options-until after these meetings.
I also believe that we need to go forward with a Federal Reaister notice and press release modified to reflect the SECY 97131 approach. The heart of these documents would be attachments 1 and 2 to SECY 97131.
The staff should continue to try and to identify sources of input from members of the public to ensure, to C e degree possible that all interests are g-represented. As I have notec previously. I found the candid remarks of Robert Adler, a member of the National Academy of Sciences comittee that conducted the medical program study useful and worthwhile for the Comission as it considered the NAS findings.
I suggest that we include Mr. Adler among the individuals from whom we will speci.ically solicit coments.
I comend the staff for identifying non traditional methods to solicit public coments such as making documents available over the Internet. However, some caution should be exercised to ensure that the number of, and versions of.
available documen'.s for coment are not so large and varied that they vill overwhelm comenters and lead to confusion on the part of staff and management responsible for t!.e.ulemaking.
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION g
j WASHINGTON. D C. 20555-0001 i
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June 30,'1997 0FFICE OF THE SECRf 7ARY MEMORANDUM TO:
L. Joseph Callan Exec
'v D
e tor for Operations 4
FROM:
Jo
. Hoy e, ecretary
SUBJECT:
STAFF REQUIREMENTS - SECY-97-115 - PROGRAM FOR REVISION OF 10 CFR PART 35, ' MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCY:"JD FEDERAL REGISTER NOTICE The Counission has approved t.he staf f proposal to revise 10 CFR Part 35 consistent with the alternative program proposed in SECY-97-131 and subject to the following comments.
1.
The staff should not only consider what regulations will be affected by the change to Part 35, but should also take a close look at existing guidance and draft guidance to determine what changes would be needed.
To ensure that all regulatory rulemaking and guidance development p tentially affecting medical vses will be consistent with the Commission's direction in DSI 7, the staff shou *d identify a
in the public meetings and Pederal'Recister notices all regulatory actions and proposed actions relating to or effecting Part 35 licensed activities.
When appropriate, public coment should be invited.
2.
The staff should continue to solicit input from members of the pablic to ensure, to the degree possible, that all interests are represented.
The staff should include groups representing radiopharmacists and medical technologists, and other experts, as appropriate.
3.
The staff should prepare alternatives with specific rule text to help focus the discussion during the first-round of facilitated meetings and assist the staff in developing draf t rule 1snguage for publication and comment.
SECY NOTE:
SECY-97-115 WAS RELEASED TO THE PUBLIC ON JUNE 17, 1997.
THIS SRM, SECY-97-131, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
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2-4.
The staff should look for potential resource savings (FTE, consultants, and funds) that can be achieved through use of f
the internet, teleconferencing, etc.
In making documeits
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available over the internet, some caution should be
/'
exercised to ensure that the number of and versions of i
available documents for comment are taot so large and varied that they will overwhelm comenters and lead to confusion on the part of the staff and management responsible for the rulemaking.
A Federal Recister notice and press release should be issued reflecting the tpproach outlined in SECY-97-131, attachments 1 and 2, and published in time to support the facilitated public meetings.
(EDO)
(SECY Suspense 9/5/!7)
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cc Chairman Jackson f
Commissioner Rogers Commissioner Dicus i
Commissioner Diaz Commissioner McGaffigan OGC I.
CIO CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
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