ML20205C731
| ML20205C731 | |
| Person / Time | |
|---|---|
| Issue date: | 10/12/1988 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-53FR40233, RULE-PR-140 PR-881012, NUDOCS 8810260560 | |
| Download: ML20205C731 (11) | |
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10 CFR PART 140 INDEMNIFICATION OF LICENSEES THAT MANUFAct?'RE, PRONCE, POSSESS, OR USE RADI0 PHARMACEUTICALS OR RADI0 ISOTOPES TOR MED.JAL PURPOSES L
AGENCY:
Nuclear Regulatory Comission.
ACTION:
Notice of intent to conduct a negotisted rulemakin0 and schedule for the regotiated rulemaking proceeding.
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SUMMARY
- Section 19 of the Price-Anterson Anendments Act of 1988 requires the NPC to conduct a "negotiated rulenaking" to determine whether to enter l
into indemnity agreements with persons licensed by the Commission or by an Agreement State for the manufacture, production, possession, or use of 1
radioisotopes or radiopharmaceuticals for medical purposes
("radiophamaceutical licensees"). This notice establishes the schedule and t
femat for the negotiated rulemaking proceeding.
CATES: The first session of the negotiateo rulenaking 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, i
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ADDRESSES: The session will be held in Room 2 F-21 of NRC Headquarters.
l One White Flint North,11555 Rockville Pike, Rockvi'le, Maryland. The session l
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will be cpen to the public and will be transcribed.
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FOR FURTHER INFORMATION CONTACT:
Francis X. Cameron, Office of the General
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j Counsel, U.S. Nuclear Regulatory Cocnission, Washington D.C. 20555 Telephone:
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301-492-1623.
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SUPPLEMENTARY INFORMATION:
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 with persons licensed by the Commission or by an Agreement State for the manufacture, production, possession, or use of radioisotopes or i
4 radiopharmaceuticals for medical purposes ("radiopharmaceutical licensees").
Within thirty days after enactment (September 19,1988), the NRC was required to designate a convenor from a list of individuals recommended by the Administrative Conference of the United States (ACUS) to conduct the "negotiated rulemaking". Within seven months of enactment (March 20,1989),
the convenor is to provide recommendations on whether the Commission should enter into indemnity agreements with radiopharmaceutical licensees.
If the convenor recommends that the Commission indemnify any of these licensees, the convenor must also submit to the Commission a draft prcposed rule setting forth the terms and conditions of such indemnification. If the convenor reconnends that indemnity be provided, the Commission must publish the recommendations as a notice of proposed rulemaking.
The Commission is hereby announcing its intent to initiate the negotiated l
rulemaking proceeding required by the Act, and is inviting participation in I
the proceeding by persons who may be affected by the rulemaking, i
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e.
Convenor On August 24, 1988, the ACUS submitted a list of thirty-two potential convenors to the NRC. After evaluating these candidates, the Comission has designated Mr. Howard S. Bellman as the cervenor for this rulemaking proceeding. Mr. Bellman, a fomer Secretary of the Wisconsin Department of Industry Labor, and Human Relations, has served as the Comission's convenor and facilitator for the negotiated rulemaking on the high-level radioactive waste Licensing Support System. He not only has experience in the negotiated rulemaking process, but also knowledge of the NRC regulatory framework and the federal regulatory process.
In addition, he has substantial arbitration and nediation experience. Mr. Belle,an can be reached at 119 Martin Luther King, Jr. Boulevard, Madison, Wisconsin 53703. Telephone: 608-255-9393.
Procedures Section 19 of the Price-Anderson Amendments Act of 1988 requires the Commission, to the extent consistent with the provisions of the Act, to conduct the "negoti6ted rulemaking" in accordance with the Administrative Procedure Act, S U.S.C. 553, and the guidance provided in ACUS Recornendation 82-4, "Procedures for Negotiating Proposed Regulations." 1 CFR 305.82-4.
Although the Act requires the Comission to conduct a "negotiated rulemaking,"
the proceeding required by the Act deviates in some important respects from the usual model for a negotiated rulemaking. Consequently, some of the ACUS recomendations will not be relevant to the Price-Anderson rulemaking.
In negotiated rulemaking, the representatives of persons who may be affected by a rule, including the egency, convene as a group over a period of tine to try to reach consensus on a draft proposed rule. The agency then uses
4 this consensus as the basis for a proposed rule which the agency issues for notice and coment. Traditionally, the agency itself makes the determination 1
that a particular issue within its jurisdiction might be effectively addressed through the use of negotiated rulemaking. A convenor is then retained by the agency to evaluate the feasibility of conducting the negotiated rulemaking, including the identification of the scope of issues to be addressed, the interests that may be affected by the rulemaking, 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 Comission to conduct the "negotiated rulemaking", apart from any initial decision by the Comission en the necessity or desirability of the rulemaking or any assessment of feasibility by the convenor.
In addition, the Act establishes a schedule fer completion of the rulemaking.
l Ordinarily, the objective of negotiated rulemaking is to develop a consensus on a proposed rule. Consensus, in the context of negotiated 1
rulemaking, is usually defined as no objection being made by any pr.rticipant l
to the draft rulemaking text. Unless consensus is reached on the draft rulemaking text, the agency is free to decide whether to proceed with a j
proposed rule, and what fem such a proposed rule should take.
In the proceeding contemplated by Section 19 of the Act, however, the convenor is i
required to submit a recomendation on the indemnification issue to the
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Comission regardless of whether consensus is reached by the participants.
Furthemore, if the convenor recomends that indemnity be provided foi radiophamaceutical licensees, he is required to submit a proposed rule
setting forth the terms and conditions of such indemnification together with the procedures for execution of such indemnification agreements.
In this circumstance, the Cosnission is then required to publish the recomendations of the convenor as a notice of proposed rulemaking, regardless of whether any consensus was reached among the participants. Therefore, the Sec*,1on 1g "negotiated rulemaking" proceeding contains elements of both consensus-building and arbitratio..
The Consission has modified the format for this proceeding in order to conform to this unique statutory mandate. The Connission has considered the following recomendations from ACUS Recomendation 82-4 as appropriate to this rulemaking--
"An agency should select and consult with a convenor at the earliest practicable time about the feasibility of the use of negotiated rulemaking" (ACUS Recomendation 4).
As required by the Price-Anderson Amendments Act of 1988 the Comission has selected a convenor from the list of individuals recomended by ACUS.
"If the agency and the convenor agree that regulatory negotiation is appropriate, the convenor should be responsible for determining primarily the interests that will likely be substantially affected by a proposed rule the individuals that will represent those interests in negotiations, and the scope of issues to be addressed, and a schedule for completing the work" (ACUS Recomendation 5).
As noted above the Price-Anderson Amendments Act of 1988 mandated that the Comission conduct a "negotiated rulemaking" on the indemnification of "radiopharmaceutical Itcensees." Therefore, the
1 i general scope of the rulemaking has already been established. The Comission has consulted the convenor on the scope of the issues in the rulemaking and how potentially affected interests should be identified.
The convenor, due to the short statutory time schedule for the rulemakino, will not have the opportunity to solteit. individually, the participation of affected interests, or to discuss the rulemaking issues 3
with the potentially affected interests. The convenor intends to l
establish the scope of issues based on the position statements required I
of any person who wishes to participate in the rulemaking proceeding, i
Because this "negotiated rulemaking" proceeding involves l
artotration, in that the convenor is required to make a binding
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recomendation to the Comission regardless of whether consenses is 1
reached, the Comission has not itself established a negotiating
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1 connittee in order to avoid the exclusion of any affected interest.
Rather, the convener will fom the negotiating comittee based on an t
evaluation of the detailed position statements required of any person who i
desires to participate in the proceeding.
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The Comission has also consulted with the convenor on the forinat f
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j and schedule for the rulemaking proceeding.
l "To ensure that the appropriate interests have been identified and have f
l had the opportunity to be represented in the negotiating group. the l
agency should publish in the Federal Register a notice that it is l
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contemplating developing a rule by negotiation and indicate in the notice l
the issues involved and the participants and interests already involved" I
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(ACU$ Recomendation 7).
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The Cosnission is issuing this notice to alert potentially affected interests of the proceeding, and to invite participation by those
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affected interests. A copy of the notice will be mailed to NRC
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licensees, Agreement States, and other organizations thtt the Cnsmission believes may be interested in participating.
I "The agenc.y should designate a senior official to represent it in the j
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j negotiations 6nd should identify that official in the Federal Register l
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notice"(ACUSRecospendation8).
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i The Connission has designated Mr. Stuart A. Treby Assistant General l
Counsel for Rulemaking and Fuel Cycle Office of the General Counsel, to l
4 serve as the Cosnission's negotiator and to represent it in the s
l proceeding.
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'It may be that, in particular proceedings, certain affected interests i
l will require reimbursement for direct esponses to be able to participate j
at a level that will foster broadly based successful negotiations...and f
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.he agency should consider reimbursing the expenses of cvch participants" j
(ACUSRecommendation9).
I Secause of the arbitration aspects of this rulemaking proceeding, I
the Commission does not believe that it is appropriate to reimburse any of the participants in the proceeding.
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'The goal of tha negotiating group should be to arrive at a consensus on l
I the proposed rule" (ACUS Recommendation 11).
l As noted above, in the proceeding contemplated by Section 19 of the i
l Act, the convenor is required to submit a recommendation on the i
i indemnification issue to the Cernission regardless of whether consensus I
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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 I
any proposed rule that he might recomend to the Comission.
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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 l
judgment of the participants, the likelihood of achieving consensus would l
be significantly erhanced" (ACUS Recomendation 12).
j The meetings in this proceeding will be open to the public.
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Furthermore, members of the public will be given the opportunity to
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l express their opinions at a designated time during each meeting.
In l
addition, the prepared statements of the participants in the proceeding.
i and any minutes of the proceeding, will be placed in the Comission's l
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Public Document Room. 2120 L Street W. Washington D.C. 20036.
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l Schedule i
i Five sessions have been scheduled for the negctiated rulemaking proceeding--
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November 14, 15. 1988.
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t 2.
December 5. 6, 7. 1988.
1 3.
December 19, 20. 1988.
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4 January 11. 12, 1989.
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5.
February 9, 10, 1989.
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All meetings will begin at g:00 a.m. and end at 5:00 p.m. each day, and
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l will be held at the Comission's headquarters. One White Flint North 11555 1
i Rt tkville Pike. Rockville. Maryland, a
The session on November 14 and 15.1988, will be devoted to the oral j
presentation of position statements by the participants and the exchange of 1
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the detailed position statements required for participation in the proceeding.
t The time allotted for each presentation will be detr,rmined by the number of 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 devoted to responses to the position statements. The remaining sessions will be devoted to attempting to develop a consensus on any proposed rule that may be desirable.
In connection with these later sessions, the participants should be prepared to engage in the drafting of proposed rules that they would find acceptable, f
Participation in the rulemaking proceeding t
The Act establishes a broad scope for the proceeding.
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 i
radioisotopes or radiopnamaceuticals for medical purposes." However, any recomendation develcped in the proceeding, either by a consensus of the participants, or by the convenor, may be confined to any subclass of these licensees. The Connission has identified the followiag interests as being f
potentially affected by this proceeding-.
I private practice physicians clinics hospitals i
t nuclear phanracies
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mobile nuclear medical services teletherapy services i
i in vitro blood testing labs medical radioisotope manufacturers radiopharmccoutical manufacturers patient associations Agreement States comercial insurers other Federal agencies such as the Food and Drug Administration transporters of radioisotopes or radiopharmaceuticals to be used for medical purposes environmental interest organizations l
Any person who desires to participate in the rulemaking proceeding must notify the Secretary of the Comission U.S. Nuclear Regulatory Comission, Washington DC 20555, of its intent to participate. Such notification must be postmarked no later than November 7,1988.
In addittoa, such notification I
must be accompanied by a detailed written position statement that addresses the following issues--
l the representative of the person or organizatien who will participate in the proceeding the nature of the person's interest that may be affected by the l
rulemaking the nature and extent of the risk to pubite health and safety posed by the activity of concern whether financial protection for such risk is available to licensees from i
comercial sources L
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11 the position of the person on whether a proposed rule on indemnification i
of radiophamaceutical licensees, or any class thereof, is necessary, and f
a rationale for the position any other facts pertinent to the ind entfication issue A copy of the notification and the written positic.1 statement should also be forwarded to the convenor, Mr. Howard S. Bellman,119 Martin Luther King Jr. Boulevard, Madison, Wisconsin 53703.
Persons with similar interests are encouraged to consolidate their position statements and their participation in the proceeding. The convenor, if necessary for the efficis.nt conduct of the proceeding, has the authority to require the consolidation of participacts tao hAVe Substantially the sm interest that may be affected by the proceeding. T.e conw or ' Iso has the authority, based on his evaluation of whether a person has submitted the detailed infomation required in the written position statement, to detemine who will participate in the proceeding other than as a member of the public.
Dated at Rockville, Maryland this [7 day of h.1988.
For the Nuclear Jegulatory Ceanission.
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SamueliJ.Chilk, Secretary of the Cornissice..