ML20247A786
| ML20247A786 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/1989 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-53FR40233, RULE-PR-140 NUDOCS 8905230274 | |
| Download: ML20247A786 (7) | |
Text
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PROPOSED RULE l
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I (53 FR %2&
w HUCLEAR REGULATORY COMMISSION
'89 E 18 P5 20 10 CFR PART 110 RIN: 3150-AD13 Q
INDE!!NIFICATION OF LICENSEES THAT MANUFACTURE, PRODUCE, POSSESS, OR USE RADI0 PHARMACEUTICALS OR RADI0 ISOTOPES FOR MEDICAL PURPOSES AGENCY:
Nuclear Regulatory Comission.
ACTION:
Termination of rulemaking proceeding.
SUMMARY
- The Nuclear Regulatory Comission is terminating the negotiated rulemaking proceeding on the indemnification of radiophamaceutichl licensees required by Section 19 of the Price-Anderson Amendments Act of 1988. Section 19 required the Comission to determine, through use of a negotiated rulesaking proceeding, whether persons licensed by the Comission or Agreement States for the manufacture, production, possession, or use of radioisotopes or radiopharmaceuticals for medical purposes ("radiophamaceutical licensees")
should be indemnified under the Price-Anderson Act. Section 19 required the Convenor of the proceeding to submit a recommendation to the Commission on whether the Comission should enter into indemnity agreements with radio-pharmaceutical licensees.
The Convenor's report recomendeo that the Comission not extend indemnity under the Price-Anderson Act to any class of radiopharmaceutical licensees.
ADDRESSES: The Convenor's Report and other documents pertaining to this proceeding may be examined at the NRC's Public Document Room, 2120 L Street, N.W., lower level, Washington, D.C.
Single copies of the Convenor's Report 8905230274 890517 PDR b
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may be obtained from Francis X. Cameron, Office of the General Counsel, l
U.S. Nuclear Regulatory Comission, Washington, D.C.
FOR FURTHER INFORMATION CONTACT:
Francis X. Cameron, Office of the General Counsel, U.S. Nuclear Regulatory Comiss'on Washington D.C. 20555, Telephone:
301-492-1623.
SUPPLEMENTARY INFORMATION: On August 20, 1988, the President signed into law the Price-Anderson Amendments Act of 1988, Pub.L. 100-408. Section 19 of the Act requires the Nuclear Regulatory Comission (NRC) to determine whether to enter into indemnity agreements with persons licensed by the Comission or by
. an Agreement State for the manufacture, production, possession, or use of raoicisotopes or radiopharmaceuticals for medical purposes
("radiopharmaceuticallicensees").
For the purpose of making this determination, the NRC was to conduct a " negotiated rulemaking" proceeding.
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 (ACUS) to conduct the
" negotiated rulemaking", Within seven months after enactment (March 20, 1989), the Convenor was to submit a recommendation.to the Comission on whether the Comission should enter into indemnity agreements with radiopharmaceutical licensees.
Section 19 provides that if the Convenor
[7590-013 recomended that the Comission indemnify any of these licensees, the Convenor must also submit to the Comission a draft proposed rule setting forth the terms and conditions of such indemnity agreements and the procedures for their execution.
Further, if the Convenur recommended that indemnity be provided, the Comission is required to publish the recommendations as a notice of proposed rulemaking. However, Section 19 does not contain any explicit provisions for the circumstance where the Convenor recomends that the Comission not extend indemnity under the Price Anderson Act.
The Comission initiated the negotiated rulemaking proceeding on October 14, 1988,with the publication of a notice in the Federal Register inviting potentially affected parties to participate in the rulemaking proceeding and designating Howard S. Bellman as the Convenor for the proceeding (53 FR 40233).
The first session of the negotiated rulemaking proceeding was held on November 14, 1988. The National Association of Nuclear Pharmacies (NANP),
represented by the firm of Baker & Hostetler, and a group of radiopharma-ceutical manufacturers (Mallinkrodt, duPont, Hoffman La Roche), represented by the finn of Ross & Smith, expressed an interest in participating. These groups, as well as the NRC staff, filed the initial position statement required by the Comission of any person or group that desired to participate in the proceeding. These groups were later designated as participants in the proceeding by the Convenor. The first session of the proceeding was devoted
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principally te a discussion of the initial position statements submitted by the participants in the proceeding.
The next session of the proceeding was held on December 5 and 6, 1988, anc was devoted to testimony and cross-examination on the issue of the adequacy of insurance for radiopharmaceutical licensees.
The remaining sessions of the proceeding (December 19 and 20,1988; January 10-and 11, 1989; February 9 and 10, 1989) were devoted to attempts to reach consensus on a draft text of a proposeo rule for the indemnification of radiopharmaceutical licensees. To the extent that consensus was reached on a regulatory text, the Convenor would use that consensus text if he recommenced
-that indemnity be provided to one or more classes of radiopharmaceutical licensees. The participants agreed that the attempts to develop a consensus on a draft text would not prejudice the position of any participant in the croceeding on the ultimate issue of the need for indemnification.
Convenor's Recommendation The Convenor has determined and recotinended that the NRC not extend i
Price-Anderson indemnification to radiopharmaceutical licensees. This recommendation was based on the fact that indemnification would not be l
uniformly extended to the radiopharmaceutical licensees represented in the proceeding because of the varying a:nounts of naturally occurring and l
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accelerator-produced radioactive material ("NARM") in the possession of these l
l licensees. Most, if not all, of the radiophamaceutical licensee facilities
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contain inventories that include both licensed byproduct material and NARM, which is not licensed by the Commission. Therefore, any damage resulting from the release of radioactive material from these facilities may have been caused by NARM -- a radioactive material over which the Commission does not exercise jurisdiction.
It was the NRC negotiator's position during the proceeding that the NRC authority to indemnify radiopharmaceutical licensees reaches only byproduct materials 1or medical purposes and that the NRC "has no licensing or other regulatory jurisdiction over NARM for medical use". Therefore, damage solely caused by releases of NARM cannot be covered by indemnity agreements betwsen licensees and the NRC. As noted by the Convenor--
NANP and the Manufacturers do not contradict the basic conclusion that current law and policy do not extend to NARM.
Rather, they urge that there is an issue of causation that must be resolved when a claim is based upon a release from a facility where NARM have been present. That is, they do not see this matter as an obstacle to the indemnification which they seek for non-NARM releases, except in terms of proof and evidence.
In the process of attempting to achieve consensus on a proposed rule, NANP ered
'90 agrwi to conditions for presuming that damages resulting from a nuclear incident at a given location were caused by byproduct material in situations
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where a mixed inventory of byproduct material ano NARM existed at the location. The conditions were such that when the risk of causation from all medical use radioactive materials at a location was evaluated, the relative risk of causation from the byproduct material equalled or exceeded 95 percent at all relevant times.
It was believed that under such conditions it would be sound as a scientific and legal matter to presume that the byproduct inventory was the cause of any damage. Under this presumption, the nuclear pharmacies represented by NAHP could continue to operate as they are currently cperating and maintain such risk percentages.
However, the manufacturers reported that both their manufacturing facilities f'
and their pharmacies could not operate with such a limitation and asserted that a 51 percent byproduct risk presumption would be required to cover a substantial number of their facilities of both types. As noted by the Convenor, a 51 percent presumption would not meet rigorous scientific standards or the legal concept that a presumption should more-than-likely approximate actuality.
In the Convenor's view, the dispute over the NARM presumption is critical.
Even if one concludes that government indemnification should be provided, given the inadequacy of private alternatives for liability coverage--
it is still the case that indemnification would only be provided to some pharmacies and no manufacturers unless
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7 the NARM presumption is adjusted for the inappropriate purpose of being more inclusive.
Therefore, the extension of indemnity coverage to only certain nuclear pharmacies would not be based on the inability of those finns to obtain commercial liability insurance or because only those firms contributed significantly to the practice of nuclear medicine. The Convenor would not favor coverage for only some pharmacies and no manufacturers, because no broad-i policy based upon national health or the protection of future plaintiffs would be implemented by such coverage.
Based on the Convenor's recommendation not to extend indemnity coverage to radiopharmaceutical licensees, which the commission finds persuasive, the Commission is terminating the Section 19 rulemaking proceeding.
Dated at Rockville, MD this [7 'g-day of MAY,1989 F r the Nuclear Regulatou Commission.
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x, Samuel J. Chit C Secretaryoft(decommission.
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