ML20246D130
| ML20246D130 | |
| Person / Time | |
|---|---|
| Issue date: | 04/28/1989 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-54FR19378, RULE-PRM-35-8 NUDOCS 8905100134 | |
| Download: ML20246D130 (6) | |
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10 CFR PART.'35 4.J'l >,d Docket No. PRM-35-8 Amersham Corporation; Receipt of Petition for Rulemaking AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; notice of receipt.
SUMMARY
- The Commission is publisning for public comment a notice of-receipt of a petition.for rulemaking dated November 14, 1988, .;
which was filed with the Commission by Amersham Corporation. The petition was docketed by the Commission on February 15, 1989, and has been assigned Docket No. PRM-35-8. The petitioner-requests that the Commission amend its regulations concerning tne medical use of byproduct material to include Iridium-192 wire for interstitial treatment of cancer in the provisions of 10 CFR 35.400 that govern the use of sources for brachytherapy.
DATE: Submit comments by June 5, 1989. Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.
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ADDRESSES: All persons who desire to- submit written comments concerning the petition for rulemaking should send their comments to the Secretary of the Commission, U. S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.
Deliver comments to the One White Flint North Building,11555 Rockville Pike, Rockville, Maryland between 7:30 a.m. and 4:15 p.m.,
Federal Workdays.
For a copy of the petition, write the Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. I l
l The petition and copies of comments received may be inspected and copied for a fee at the NRC Public Document Room, 2120 L Street, NW. , Lower Level, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Acting Chief, Rules Review Section, Regulatory Publications Branch, Division of 1
Freedom of Information and Publications Services Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: 301-492-7758 or Toll Free: 800-368-5642.
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SUPPLEMENTARY INFORMATION: The Nuclear Regulatory Commission (NRC) '
has established provisions that regulate the medical use of byproduct material in 10 CFR Part 35. Under these provisions, medical licensees are permitted to use small, radioactive sources to treat cancer. These sources are designed to be implanted directly into a tumor area or applied on the surface of an area to be treated. This procedure is known as brachytherapy. The list of sources approved for use in brachytherapy is set out in 10 CFR 35.400.
The petitioner requests that the NRC amend 10 CFR 35.400 to add Iridium-192 wire for the interstitial treatment of cancer to the list of sources approved for use in brachytherapy. The petitioner manufactures and markets a range of Iridium-192 wire products and accessories designed to facilitate product use.
The source wire consists of an alloy of iridium and platinum which is encased in a pure platinum sheath. The composite is drawn into a wire of various diameters rangiag from 0.3 to 0.6 mm. The inactive i
platinum sheath is 0.1 mm. The wire is irradiated to activate the l I
Iridium-192 nuclide. The wire may then be cut and mounted in holders to specified lengths by the user. In some cases, the petitioner may arrange to supply the wire ready mounted in narrow bore plastic tubing.
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The petitioner does not regard these products as sealed sources because of the unavoidable contamination generated in the source casing during neutron irradiation. However, the petitioner states that the contamination does not represent a serious problem because of the short half life and low energy of the contaminants.
According to the petitioner, about half of the removable contamination showed a half life of 2.5 days and the remaining portion showed a half life of 15 days. No gamma radiation was emitted by the contaminants.
The petitioner has submitted a proposed amendment to the Illinois Department of Nuclear Safety (IDNS) requesting the addition of Iridium-192 wire products, Model Number ICW.100, to Amersham's Medical Source Distribution License. The products covered by Model Number ICW.100 were marketed by Amersham in the United States prior to May 28, 1976, and were included in the Amersham /Searle Clinical Radiation Sources and Accessories Catalog of April 1973. The products covered by this model number were listed with the FDA as medical devices in August 1979.
As noted, the Amersham product consists of a platinum covered platinum-iridium alloy. The difference in hardness between the comparatively sof t platinum outer sheath and the harder alloy core causes the platinum to smear over the end of the wire as it is cut.
I This minimizes contamination and improves the integrity of cut wire.
As a result, Amersham states that it has not encountered any problem of " flaking" or delamination of the Iridium-192 wire. I Amersham also supplies two accessories that aid in the safe handling, cutting, and loading of the Iridium-192 wire. The first accessory, wire loader, code N.4100, is used to cut the 0.3 mm diameter wire by way of a special guillotine and to enclose and fix it in a small diameter nylon tube. The wire is, almost without exception, implanted in patients af ter enclosure in nylon tubing.
The second accessory is pin cutter, code ASN 200. The pin cutter and its associated handling device are used on the 0.6 mm diameter wire fabricatd into the shape of single-pins or " hair pins". These !
are, almost without exception, directly implanted in patients without the use of a nylon tubing. j The petitioner requests this amendment so that each medical licensee that intends to use Iridium-192 wire source for the interstitial treatment of cancer may do so without having to request and obtain a specific amendment to the license authorizing the medical use of
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s byproduct material. As a result, the products manufactured and .
1 marketed by the petitioner would be more easily availabic to a
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greater number of potential users. i
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n ( 1 Dated at Rockville, Maryland, this day of 1989.
F r the Nuclear Regulatory Commission.
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amuel J. Chi ,
Secretary of the Commission.
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