ML20195D081
| ML20195D081 | |
| Person / Time | |
|---|---|
| Issue date: | 10/05/1988 |
| From: | Parler W NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | |
| Shared Package | |
| ML20195D086 | List: |
| References | |
| FOIA-88-529, TASK-RINC, TASK-SE SECY-88-284, NUDOCS 8811040189 | |
| Download: ML20195D081 (20) | |
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October 5, 1988 RULEMAKING ISSUE SECY-88-284 T
(NEGATIVE CONSENT)
For: The Comissioners From: William C. Parler General Counsel
Subject:
TNITIATION OF THE PRICE-ANDERSON %TIATED RULEMAr,1NG
Purpose:
To request Comission approval of the format and schedule for the Price-Anderson negotiated rulemaking background: On August 20, 1988, the President signed into law the Price-Anderson Amendments Act of 1988, P.L. 100-408. Section 19 of the Act requires the Nuclear Regulatory Commission (NRC) to conduct a variant of a negotiated rulemaking to determine ,
whether to enter into indemnity agreements witn persons licensed by tne Comission or by an Agreement State for the nanufacture, production, possession, or use of radioisotopes or radiopharmaceuticals for medical purposes ('radiophamaceutical licensees'). Within thirty days after enactment (September 19, 1988), the NRC was required to designate a convenor, from a list of individuals Conference of recomended the United bStates (yconduct ACUS), to the Administrative the "negotiated rulemaking". Within seven months of enactment (March 20, 1989), the convenor is to provide recomendations on a proposed rule regarding whether the Commission should enter into indsnity agreements with radiopharmaceutical licensees. .
If the convenor recommends that the C: mission indemnify any of these licensees, the convenor must also submit to the Commission a draf t proposed rule setting forth the terms and conditions of such indemnification. If the convenor recommends that indemnity be provided, the Commission must publish 'the recomendations as a notice of proposed rulemaking.
The staff has prepared a draf t Federal Register _ notice
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(Enclosure A) that initiates the negotiated rulemaking proceeding required by the Act, and invites participation in the proceeding by persons who may be affected by the rulemaking.
CONTACT: -
F.X. Cameron 0GC x21623 ,
SECY NOTE: In the absence of instructions to the contrary, SECY will notify tho staff on Tuosday, October 11, IMO , that the Ceraission, b tive consoncr-assents to the action proposed in this paper.
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Convenor. On August 24, 1988, the ACUS submitted a list of thTrty-two potential convenors to the NRC. After evaluating these candidates, the Comission, in SECY-88-251, consented to the designation of Mr. Howard S. Bellman as the convenor for this rulemaking proceeding.
ACUS Procedures. Section 19 of the Price-Anderson Amendments Act of 1988 requires the Comission, to the extent consistent with the provisions of the Act, to cceduct the "negotiated rulemaking" in accordance with the guidance provided in ACUS Recomendation 82-4, "Procedures for Negotiating Proposed Regulations." 1 CFR 305.82-4. Although the Act requires the Commission to conduct a "negotiated rulemaking," the proceeding -
renuired by the Act deviates in some frportant respects from the usual nodel for a negotiated rulerraking. Consequently, sone of the ACUS recorrendations will not be relevant to the Price-Arderson "negotiated rulemaking".
Traditienally, the agency itself makes the determination that a
' particular issue within its jurisdictinn might be effectively addressed through the use of negotiated rulemaking. A convenor is then retained by the agency to evaluate the feasibility of conductier the negotiated rulemaking, including the identifice.. ton nf the Sr.npe of issues te bc ddressed, i,iie interesta that may be affected by the rulemakirig, the parties that would represent those interests, and an assessment of their willingness to participate in good faith in the negotiated rulemaking proceeding. In this instance, the Price Anderson Amendments Act of 1988 requires the Comissic to conduct the ' negotiated rulemaking', apart frcm any initial decision by the Cemission on the necessity or desirability of the rulemaking or any assessment of feasibility by the i convenor. In addition, the Act establishes a schedule for completion of the rulemaking.
l Ordinarily, the objective of negotiated rulemaking is to l: develop a consensus on a pro >osed rule. Consensus, in the j context of negotiated rulema ting, is usually defined as no objection being made by any participant to the draft rulemaking text. Unless consensus is reached on the draft rulemaking j -
tort, the agency is free to decide whether to proceed with a j proposed rule, ano what form such a proposed rule should take, t In the proceeding contemplated by Section 19 of the Act, however, the convenor is required to submit a recorrendation on the indemnification issue to the Ccmiss!:n regardless of whether consensus is reached by the participads. Furthemore, j
if the convenor recccuends that indemnity be provided for radiophamaceutical licensees, he.is required to sutait a proposed rule setting forth the tems and conditions of such l
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indemnification together with the procedures for execution of such indemnification agreements. In this circumstance, the Comission is then required to publish the recomendations of the convenor as a notice of proposed rulemaking, regardless of whether any censensus was reached among the participants.
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Therefore, the Section 19 "negotiated rulema cing" proceeding contains elements of both consensus-building and arbitration.
Based on consultations with the convenor, the staff has modified ?e fo, mat for this proceeding in order to confonn to this unique statutory mandate. 'decause this proceeding -
involves arbitration, the staff recomends that the :'-
Commission itself not establish a negotiating comittee, in order to avoid excluding any potential 5y affected interests.
Rather, the convenor will form the negotiating comittee w,ea on the detailed position statements required of any person who wishes to participate in the proceeding. -
In addition, because of the er.tremely abbreviated stidutory schedule for the submission of the convenor's report to the Comnission, the convenor will not have the opportunity to solicit, individually, the participation of affected interests, or to initially discuss the rulemaking issues with the potentially affected inte:ests. The convenne intend < tn establish the scope of issues based on the positior. statements '
required of any person who wishes to participate in the proceeding.
Schedule. Five sessions have been scheduled for the negotiated j rulenaking proceeding-- ;
- 1. November 14, 15, 1988. l
- 2. . December 5, 6, 7, 1988. ;
- 3. December 19, 20, 1988.
- 4. January 11, 12, 1989.
- 5. February 9, 10, 1989. j The session on November 14 and !$ 1988, will be devoted to the oral 3resentation of position statements by the participants i
and tie exchange of tie detailed, written position statements required for participation in the proceeding. At this t
meeting, the convenor will also address the guidelines for the '
proceeding. The session scheduled for December 5, 6, 7, 1988, i
will be devoted to responses to the position statements. The
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4 remaining sessions will be devoted to attempting to develop a consensus on any proposed rule that may be desirable.
The meetings in Ois proceeding will be open to the public.
Furthermore, rembers of the public will be given the opportunity to express their opinions at a designated time during each meeting. In addition, the prepared statements of the participants in the proceeding, and any minutes of the !
proceeding, will be placed in the Comission's Public Document !
Room.
Participation in the rulemaking proceeding. ,
The Act establishes a br'ad scope for the negotiated ('
rulemaking. The issue of concern is the indemnification of "persons licensed by the Comission or by an Agreement State for the manufacture, production, possession, or use of .
radioisotopes or radiopharmaceuticals for medical purposes."
Howevor, any recomendation developed in the negotiated '
rulemaking proceeding, either by a consensus of the !
participants, or by the convenor, may be confined to any '
subclass of these licensees. The staff has identified the 4
i following interests as being potentially affected by this -
i preceeding -
- private practice physicians !
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- clinics hospitals :
- nuclear pharmacies
' ' radiopharmaceutical manufacturers mobile nuclear medicine services
' medical radioisotope rianufacturers
' teletherapy services j
- in vitro blood testing labs !
patient associations i Agreement States !
- comercial insurers
' other Federal agencies such as the Food l and Drug Administration l i i
' transporters of radioisotopes or radiopharmaceuticals to be used for t.edical purposes l envirorecntal interest organi:ations Any person who desires to participate in the rulemaking proceeding must notify the Secretary of the Comission of its i
intent to participate. Such notification must be postinarked no i later than November 7,1988 and must be accompanied by a l l
- detailed, written position statement that addresses the t
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person's interest in the proceeding, and a rationale for its position on the issues.
Negotiator. The staff recomends that Mr. Stuart A. Treby, Assistant Gerieral Counsel for Rulemaking and Fuel Cycle Office "e . !
of the General Counsel, be designated L serve as the Comission's negotiator and to represent it in the negotiated rulemaking proceeding. Mr. Treby will be supported by an intraagency negotiating team composed of representatives from the Offices of Governmental and Public Affairs, Nuclear Material Safety and Safeguards, Nuclear Reactor Regulation, and Research The negotiating team is proceeding to prepare the Comission's initial negotiating positions on the rulemaking istues. Staff support for the negotiating team will be provided by the Rulemaking and Fuel Cycle Division, Office cf the General Counsel.
Recomenda tion: That the Comission approve:
- 1. the designation of Mr. Stuart A.
Treby as the Comission's .'-
negotiator for this proceeding.
?. the Federal Recister notice initfa' ting the Price Anderson ne A)gotiated rulerraking (Enclosure Note: 1. This paper has been coordinated with SMSS, NRR, RES, and GPA.
- 2. Due to the extremely abbreviated statutory schedule for this rulernaking, the staff intends to Rejister notica for transmit the attached federal publication unless the Ccmiss ion directs otherwi t e
>y October 11, 1988.
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Ceneral Counsel .
Attachment:
A. federal _Registernotice
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e NUCLEAR REGULATORY COMMISSION 10 CFR PART 140 INDEMMIFICATION Of LICENSEES THAT MANUFACTURE, PRODUCE, POSSESS, OR USE RA010 PHARMACEUTICALS OR RA010!S0 TOPES FOR MEDICAL PURPOSES AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of intent to conduct a r.egotiated rulemaking and schedule for the negotiated rulemaking proceeding.
SUMMARY
- Under Section 19 of the Price-Anderson A.mendments Act of 1988 requires the NRC to conduct a "ragotiated rulemaking" to determine whether to enter into indemnity agreements with persons licansed by the Commissien nr hy an Agreerent State for the manufacture, production, possession, or use of radioisotopes or radiopharmaceuticals for medical purposes r
("radiopharmaceuticallicensees"). This notice establishes the schedule and format for the negotiated rulemaking proceeding.
DATE: The first session of the negotiated rulemaking proceeding will be held I on November 14 and 15, 1988, beginning at 9:00 a.m. and concluding at 5:00 p.m. each day. The session will be held in Room 2 F-21 of NRC Headquarters, I
! One White Flint Ncrth, 11555 Rockville Pike, Rockville, Maryland. The cession will be cocn to the public and will be transcribed.
FOR FURTHER INFORMATION CONTACT:
Francis X. Cameron, 0,ffico of the General
! Counsel, U.S. Nuclear Regulatory Commission, Washington D.C. 20555. Telephone:
301-492-1623, '
1
2-SUPPLEMENTARY INr7MATION:
Background
On August 20, 1988, the President signed into law the Price-Anderson Amendments Act of 1988, P.L.100-408. Section 19 of the Act requires the Nuclear Regulatory Comission (NRC) to conduct a variant of a negotiated rulemaking to determine whether to enter into indemnity agreerrents with persons licensed by the Comission or by an Agreement State for the n'anufacture, production, possession, or use of radioisotopes or radiophamaceuticals for medical purposes ("radiophamaceutical licensees").
Within thirty days after enactment (September 19,1988), the NRC was required to designate a convenor from a list of individuals recomended by the Administrative Conference of the United States (ACUSl tn conduct the "negotiated rulemaking". Within seven months of enactment (Farch 20,1989),
the convenor is to provide recon 7rendations on whether the Comission should enter into indemnity agreen ents with radiopharmaceutical licensees. If the ccnvenor recomends that the Commission indemnify any of these license.es, the convenor must also submit to the Comission a draft proposed rule setting forth the tems and conditions of such indemnificatien. If the convenor recomends that indemnity be provided, the Comission must publish the recomendations as a notice of proposed rulemaking.
The Comission is hereby announcing its intent to initiate the negotiated rulenaking proceeding required by the Act, and it inviting participation in the proceeding by persons who may be affected by the rulemaking.
Convenor On August 24, 1988, the ACUS submitted a list of thirty-two potential convenors to the NRC. After evaluating these candidates, the Commission has designated Mr. Howard S. Bellman as the conveno' r for this rulemaking proceeding. Mr. Bellman, a former Secretary of the Wisconsin Departrnent of Industry, Labor, and Human Relations, has served as the Comission's convenor and facilitator for the negotiated rulemaking on the high-level radioactive l waste Licensing Support System. He not only has experience in the negotiated l rulenaking process, but also knowledge of the NRC regulatory framework and the federal regulatory process. In addition, he has substantial arbitration and i
=tdiation experience. Mr. Bellman can be reached at 119 Martin Luther j King, Jr. Boulevard, Madison, Wisconsin 53703, Telephone: 608-255-9393.
- Procedures 1
Section 19 of the Price-Anderson Amendments Act of 1988 requires the l
. Commission, to the extent consistent with the provisions of the Act, to I
{ conduct the "negotiated rulemaking" in accordance with the Acninistrative Procedure Act. 5 U.S.C. 553, and the guidance provided in ACUS Recomendation I 82-4, "Procedures for Negotiating Proposed Regulations." 1 CFR 305.82-4.
i Although the Act requires the Comission to conduct a "negotiated rulemaking,"
.he proceeding required by the Act deviates in sane important respects from i the usual redel for a negotiated rulemaking, r,cnsequently, tome of the ACUS recomendations will not be relevant to the Price-Anderson rulemaking.
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In negotiated rulemaking, the representatives of persons who may be affected by a rule, including the agency, convene as a group over a period of
! time to try to reach consensus en a draft proposed rule. The agency then uses
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this consenrus as the basis for a proposed rule which the agency issues for notice and coment. Traditionally, the agency itself makes the determination k that a particular issue within its jurisdiction might be effectively addressed i
j through the use of negotiated rulemaking. A convenor is then retained by the
! agency to evaluate the feasibility of conducting the negotiated rulemaking, l including the identification of the scope of issues to be r.ddressed, the
)1 interests that may be affected by the rulemaking, the parties that would
! represent those interests, and an assessment of their willingress to J
- participate in good faith in the negotiated rulemaking proceeding. In this t
i instance, the Price-Anderson Amendments Act of 1988 requires the Cornission to 1
l conduct the "negotiated rulemaking", apart from any initial decision by the i
! Co, mission on the necessity or desirability of the rulemaking or any assessment of fcssi'uility by the convenor. In addition, the Act establishes a l schedule for ccepletion of the rulemaking.
I l Ordinarily, the objective of negotiated rulemaking is to develop a e
! consensus on a proposed rule. Consensus, in the context of negotiated i
l rulemaking, is usually defined as no objection being made by any participant l
l to the draft rulemaking text. Unless consensus is reached on the draft i
i rulemaking text, the agency is free to decide whether to proceed with a l
l proposed rule, and what form such a proposed rule should take. In the proceeding contemplated by Section 19 of the Act, bewever, the convenor is
- required to submit a recomendation on the indemnification issue to the i
Comission regardless of whether consensus is reached by the participants.
Furthemore, if the convenor recomends that indemnity be provided for l
radiophamaceutical licensees, he is required to submit a proposed rule D
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setting forth the terms and conditions of such indemnification together with the procedures for execution of such indemnification agreements. In this ;
i circumstance, the Commission is then required to publish the recomendations J j of the convenor as a notice of proposed rulemaking, regardless of whether any j j consensus was reached among the participants. Therefore, the Section 19 l l
"negotiated rulemaking" proceeding contains elements of both
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consensus-building and arbitration.
1 The Comission has modified the fonnat for this proceeding in order to l
! conform to this unique statutory randate. The Comission has considered the l following recomendations from ACUS Recommendation 82-4 as appropriate to this I
' t, rulemaking-- l
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- "An agency should select and consult with a convenor at the earliest L i
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] practicable time about the feasibility of the use of negotiated (
I rulemaking" ( ACUS Recomendation 4).
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As required by the Price-Anderson Amendments Act of 1988. the Comission
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has selected a convenor from the list of individuals recomended by ACUS.
"If the agency and the convenor agree that regulatory negotiatiot, is f j appropriate, the convenor should be responsible for determining primarily the interests that will likely be substantially affected by a proposed j
rule, the individuals that will represent those interests in
- negotiations, and the scope of issues to be addressed, and a schedule for j 1
'l completing the work" (ACUS Recomendation 5).
As noted above, the Price-Anderson Arendments Act of 1988 mandated l
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that the Comission conduct a "negotiated rulemaking" on the !
l i indernification of "radiopharmaceutical licens'ees." Therefore, the r l'
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general scope of the rulemaking has already been estabitshed. The l Comission has consulted the convenor on the scope of the issues in the l rulemaking and how potentially affccted interests shoulei be identified.
The convenor, due to the short statutory time schedule for the i
rulemaking, will not have the opportunity to solicit, individually, the !
participation of affected interests, or to discuss the ruiemaking issues i with the potentially affeC0tJ interests. The convenor intends to !
establish the scope of issues based on the position statemen?.s required of any persen who wishes to participate in the rulemaking proceeding. l, Because this "negotiated rulemaking" proceeding involves ;
arbitration, in that the convenor is required to make a binding l
. recomendation to the Comission regardless of whether consensus is -
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l reached, the Comission has not itself established a negotiating j comittee in order to avoid the exclusion of any affected interest. [
Rather, the convenor will fom the negotiating comittee based on an t i
evaluation of the detailed pcsition statements required of any person wno l desires to participate in the proceeding.
l The Comission has also consulted with the convenor on the fomat f and schedule for the rulemaking proceeding.
"To ensure that the appropriate interests have been identified and have had the opportunity to be represented in the negotiating group, the agency should publish in the Federal Register a notice that it is contemplating developing a rule by negotiation and indicate in the notice i the issues involved and the participants and interests already involved" t
(ACUS Recomendation 7),
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The Comission is issuing this notice to alert potentially affected interests of the proceeding, and to invite participation by those
! affected interests. A copy of the notice will be mailed to NRC 4 ;
i Itcensees, Agreement States, and other organizations that the Comission i
- believes may be interested in participating.
"The agency should designate a senior official to represent it in the j negotiations and should identify that official in the Federal Register J notice" (ACUS Recomendation 8). l The Comission has designated Mr. Stuart A. Treby Assistant General '
){ Counsel for pulemaking and Fuel Cycle, Office of the General Counsel, to
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serve as the Comission's negotiator and to represent it in the j proceeding. l I -
'*lt may be that, in particular proceedings, certain affected interests [
will require reimbursement for direct expenses to be able to participate [
at a level that will foster broadly based successful negotiations...and l
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the agency should consider reimbursing the expenses of such participants" {
( ACUS Recorrnendation 9), (
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Because of the arbitration aspects of this rulemaking proceeding, !
4 i i the Comission does not believe that it is appropriate to reimburse any J
l of the participants in the proceeding. [
4 1 "The goal of the negotiating group should be to arrive at a consensus on [
t the proposed rule" (ACUS Recomendation 11).
t As noted above, in the proceeding contemplated by Section 19 of the l
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j Act, the convenor is required to submit a recomendation on the indemnification issue to the Comission regardless of whether consensus l
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! is reached by the participants. However, the convenor will attempt to !
develop a consensus of the participants in this proceeding as a basis for ;
any proposed rule that he might recomend to the Commission, l l
- "The negotiating group should be authorized to close its meeting to the public only when necessary to protect confidential data or when, in the judgment of the participants, the likelihood of achieving consensus would i besignificantlyenhanced"(ACUSRecommendation12).
The meetings in this proceeding will be open to the public, i
- Furthermore, members of the public will be given the opportunity to
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express their opinions at a Jesignated tire during eacn meeting. In
- adottion, the prepared statementr of the partir
- 1 pants in the proceeding, ,
) and any minutes of the proceeding, will be placed in thd Comission's .
i 4 Public Document Room, 2120 L Street NW, Washington D.C. 20036. l 1 ,
Schedule i
l Five sessions have been scheduled for the negotiated rulemaking proceeding-- l
- 1. November 14, 15, 1988. ,
- 2. Mcember 5, 6, 7, 1988. l j 3. December 19, 20, 1988.
- 4. January 11, 12, 1989. l l
- 5. February 9, 10, 1989.
! All meetir;s will begin at 9:00 a.m. and end at 5:00 p.m. each day, and will be held at the Commission's headquarters, One k'hite Flint North,11555 {
1 Pockville Pike, Rockville, Maryland. l The session on November 14 and 15, 1988, will be devoted to the oral j
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presentation of position statements by the participants and the exchange of f f
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4 the detailed position statements required for participation in the proceeding.
' The time allotted for each presentation will be detennined by the number of j participants. At this meeting, the convenor will also address the guidelines ;
for the proceeding. The session scheduled for December 5, 6, 7, 1988, will be :
l devoted to responses to the position statements. The remaining sessions will l
.J be devoted to attempting to develop a consensus on any propot,ed rule that may 4
be desirable. In connection with these later sessions, the participants ,
I thould be prepared to engage in the drafting of proposed rules that they would i
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- find acceptable.
Participation in the rulemaking proceeding -
The Act establishes a broad scope for the proceeding. The issue of j l
concern is the indemnification of "persons licensed by the Comissif.n or by an f i
Agreement State for the manufacture, production, possession, or use of ;
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radicisotopes or radiopharmaceuticals for medical purposes." However, any l'
! recorrendation developed in the proceeding, either by a consensus of the ;
i i participants, or by the convenor, may be confined to any subclass of these i i
l licensees. The Commission has identified the following in'.erests as being j i
potentially affected by this proceeding-- l j '
private practice physicians
- clinics l f I
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nuclear pharmacies l
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mobile nuclear medical services j 1 t teletherapy services !
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- in vitro blood testing labs medical radioisotope manufacturers radiophamaceutical manufacturers patient associations Agreerent States connarcial insurers other Federal agencies such as the Food and Drug Administration
- transporters of radioisotopes or radiophamaceuticals to be used fer medical purposes environmental interest organizations Any person who desires to participa'te in the rulemaking proceeding must notify the Secretary of the Cormission. U.S. Nuclear Regulatory Cornission.
Washington DC 00555, of its intent to participate. Such notification must be postmarked no iater than November 7, 1988. In addition, such notification must be accorpanied by a detailed written position statement that addresses the follewing issues--
th> representative of the person or organization who will participate in the proceeding the nature of the person's interest that may be affected by the rulemaking the nature and extent of the risk to public health and safety posed by the activity of concern
- whether financial protection for such risk is available to licensees from comercial sources the position of the person on whether a proposed rule on indemnification I of radiopharmaceutical licensees, or any class thereof, is necessary, end a rationale for the position any other facts pertinent to the indemnification issue A copy of the notification and the written position statement should also be forwarded to the convenor, Mr. Howard S. Bellman,119 Kartin Luther King Jr. Boulevard, Madison, Wiscensin 53703.
l Persons with similar interests are enco9 raged to consolidato their
! position statements and their participation in the proceeding. The convenor, j if necessary for the efficient conduct of the proceeding, has the authority.to
- require the con'olidation of participants who have substantially the same
! interest that may be affected by the proceeding. The convenor also has the 1
) authority, based on his evaluation of whether a person has submitted the i
- detailed information required in the written position statement, to determine who will participate in the proceeding other than as a member of the public.
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Dated at Rockville, Maryland this day of 1988, 1
a For the Nuclear Regulatory Cornission, 1
l Samuel J. Chilk, 4
1 l 5ecretary of the Conrnission.
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/""%, UNITED STATES
/ 4 "i 1 NUCLEAR REGULATORY COMMISSION N / Offlee of Govemmental and Pub 5o Affaire
% .ll. . # WashhW D.C. 20066 No.88-143 FOR IMMEDIATE RELEASE Tel. 301/492-0240 (Friday, October 14,1988)
NRC TO HOLD NEGOTIATED RULEMAKING ON INSURANCE PROVISIONS FOR MEDICAL LICENSEES The Nuclear Regulatory Commission is inviting parties who may be affected to participate in a negotiated rulemaking to determine whether persons '
licensed to manufacture, possess or use nuclear materials for medical purposes should be covered by the insurance provisions of the Price Anderson Act.
The first session of the negotiated rulemaking proceeding will be held November 14 and 15, 1988, from 9:00 a.m. to 5:00 p.m. each day. The session will be held in Room 2 F-2 of HRC Headquarters, One White Flint North, 11555 Rockville Pike, Rockville, Md.
Future sessions will be held on December 5, 6 and 7, 1988; December 19 and 20, 1988; January 11 and 12,1989; and February 9 and 10,1989, at the same times and location as the first session. All sessions will be open to the public, and members of the public will be given an opportunity to express their opinions at a designated time during each meeting.
Originally passed in 1957, the Price Anderson Act established a no-fault -
insurance arrangement for the nuclear industry, along with a cap on liability, for personal injury and property damage resulting from a nuclear accident. In addition to raising the cap, or liability limit,1988 amendments to the Act require the Nuclear Regulatory Comission to initiate a negotiated rulemaking to determine whether radiopharmaceutical licensees should be indemnified (or not liable for damages in excess of a specified amount) under the Price Anderson Act.
Within 30 days af ter enactment of the amendments to the Act (Septecter 19,1988), the NRC was required to designate a "convenor" from a list of individuals recomended by the Administrative Conference of the United States to conduct the negotiated rulemaking. The Comission selected Howard S.
Bellean, a former Secretary of the Wisconsin Department of Industry, Labor and Hunan Relations who served as convenor and facilitator for another NRC negotiated rulemaking.
Within seven months af ter enactment of the amendments to the Act (March 20,1989), the convenor is to provide recorrrendations on whether the Comission should enter into indemnity agreements with radiopharmaceutical licensees.
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4 If the convenor recomends that any of these licensees should be
- indemnified, the convenor must submit to the Comission a draf t pro >osed rule setting out the terms and conditions for the indemnification, and tie Comission must publish the recommendations as a proposed regulation.
1 The Comission has identified the following interests as being potentially af'ected by a new rule in this area: private practice physicians, clinics, hospitals, nuclear pharmacies, mobile nuclear medical services, teletherapy services, in vitro blood testing laboratories, medical radioisotope manufacturers, radiopharmaceutical manufacturers, patient associations, Agreement States, comercial insurers, other Federal agencies such as the Food and Drug Administration, transporters of radioisotopes to be used for medical purposes and environmental interest organizations.
I Any persons who wish to participate in the rulemaking proceeding should l notify the Secretary of the Comission, U.S. Nuclear Regulatory Comission, Washington, DC 20555, of their intent to to participate. The notification
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must be postmarked no later than November 7 D88. It should be accompanicJ i by a detailed written position statement indicating:
i
- The representative of the person or organization who will participate in the proceeding, 1
l The nature of the person's interest that may be affected by the i rulema king, l
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The nature and extent of the risk to public health and safety posed by j the ac.tivity or concern,
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- Whether financial protection for such risk is available to licensees
) from comercial sources, i
- The position of the person on whether a proposed rule on
! indemnification of radiopharmaceutical licensees, or any class thereof, is 1 necessary, and a rationale for the position and i
Any other facts pertinent to the indemnification issue, i
1 A copy of the notification and the written position statenent should also
- be forwarded to the convenor, Howard S. Bellman, 119 Martin Luther King Jr.
I Boulevard, Madison, Wisconsin 53703.
j Further details on the negotiated rulemaking procedures are contained in a Federal Register notic? published on October 14, 1988.
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