ML19344E707
| ML19344E707 | |
| Person / Time | |
|---|---|
| Issue date: | 08/07/1980 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML19344E706 | List: |
| References | |
| FRN-45FR14589, RULE-PR-40 NUDOCS 8009020546 | |
| Download: ML19344E707 (4) | |
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TITLE 10 ' ENERGY CHAPTER I - NUCLEAR REGULATORY COMMISSION PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL Deletion of Source Material Medicinals from the General License for Small Quantities of Source Material 1
AGENCY:
U.S. Nuclear Regulatory Commission.
ACTION:
Final Rule.
SUMMARY
The Nuclear Regulatory Commission (NRC) c, amending its licensing regulations by deleting the provision for general license authorization of the use of source material
- in humans by physicians, pharmacists and other persons receiving source material in the form of medicinals or drugs.
Thorotrast, cont'aining alpha-emitting thorium-232 dioxide, was the only source material medicinal used in humans.
However, as the radiobiological hazards of alpha-emitting radionuclides became known, the product fell into disuse and production of Thorotrast was discontinued in 1965.
This action will require authorization by means of an NRC specific licerse for internal or external administration of source material, or the radiation therefrom, to human beings.
EFFECTIVE DATE:
SEP 13 UED
" Source material, as defined in Section 40.4(h) of 10 CFR Part 40, means, among other things, uranium or thorium, or any combination thereof, in any physical or chemical form.
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FOR FURTHER INFORMATION CONTACT:
Deborah A. Bozik, Office of Standards Development, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555 (Telephone 301-443-5860).
SUPPLEMENTARY INFORMATION:
Thorotrast, authorized for use by the general license in $40.22, "Small quantities of source material," of 10 CFR Part 40, and used as an X-ray contrast agent, has been the only source material utilized as a medicinal; no other thorium or uranium compounds have been used as source material medicinals.
Thorotrast is the colloidal dioxide of thorium-232 which is an alpha-emitting radionuclide.
As the radiobio-logical hazards of these radionuclides became apparent, the carcinogenic potential of Thorotrast became evident, and, in 1965, the production of Thorotrast was stopped.
Improvements in X-ray machines and imaging techniques have resulted in Thorotrast being replaced with nonradioactive contrast agents.
The Food and Drug Administration (FDA) terminated the approved New Drug Application (NDA) for Thorotrast on June 13, 1977.
NRC and FDA both strive for consistency with respect to each other's regulations.
On March 6,1980, NRC published a proposed rule (45 FR 14589) to amend the general license in 540.22 by deleting the authorization for the following persons to use and transfer small quantities of source material:
(1) Pharmacists using source material. solely for compounding.medicinals; (2) Physicians using source material for medicinal purposes; and (3) Persons receiving possession of source material from pharmacists and physicians in the form of medicinals or drugs.
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LPNFE2J Under the prcpssed rule, the following groups would still retain their. authorization under this general 71 cense to use small quantities of source material for research, developmeni., educational, commercial or operational purposes:
(1) Commercial and industrial firms; (2), Research, educational and medical institutions; and (3) Federal, State and local government agencies.
A new paragraph would be added under the proposed rule to the general license in 540.22 of 10 CFR Part 40 which would prohibit licensees from administering source material, or the radiation therefrom, either internally or externally, to human beings, except where authorized by an NRC specific license.
The public was invited to submit written comments on the proposed rule by May 6, 1980.
Eight comments were received, and all supported i
the proposed amendment.
One commenter qualified his support by inquiring if the people whose authorization is being withdrawn by this amendment have been making other use of source material.
To the best of the Commission's knowledge, no one in the affected groups has been using source material since Thorotract production was discontinued in 1965.
Therefore, the Comm'ission is adopting the final rule in the form identical to the proposed amendment.
Under the Atomic Energy Act of 1954, As amended, the Energy Reorganization Act of 1974, as amended, and sections 552 and 553 of title 5 of the United States Code, the following amendment to Title 10, Chapter I, Code of Federal Regulations, Part 40 is published as a document subject to codification.
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Section 40.22 of 10 CFR Part 40 is amended by revising para-graph (a), and by adding a new paragraph, (c), to read as follows:
9 40.22 Small quantities of source material.
(a) A general license is hereby issued authorizing commercial and industrial firms, research, educational and medical institutions and Federal, State and local government agencies to use and transfer not more than fifteen (15) pounds of source material at any one time for research, development, educational, commercial or operational purposes. A person authorized to use or transfer source material, pursuant to this general license, may not receive moia than a total of 150 pounds of source material in any one calendar year.
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(c) Persons who receive, possess, use or transfer source material pursuant to the general license in paragraph (a) of this section are prohibited from administering source material, or the radiatio,n therefrom, either externally or internally, to human beings except as may be autho-rized by NRC in a specific license.
(Secs. 62, 63, 161b., Pub. Law 83-703, 68 Stat. 932, 933, 948b. (42 U.S.C.
2092, 2093, 220lb.); Sec. 201, as amended, Pub. Law 93-438, 88 St;t. 1242, Pub. Law 94-97, 89 Stat. 413 (42 U.S.C. 5841))
Dated at Mvu Ud this 7
day of WF
, 1980.
For the Nuclear Regulatory Commission.
~ William J. Dircks Acting Executive Director for Operations 4
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