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December 31, 1984 RULEMAKING ISSUE sscv-84-48s I (Notation Vote)
For: The Commissioners From: William J. Dircks Executive Director for Operations
Subject:
PROPOSED REVISION OF 10 CFR PART 35 " MEDICAL USE OF BYPRODUCT MATERIAL" l
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Purpose:
To obtain Commission approval of a notice of proposed rulemaking.
Cateoory: This paper covers a significant policy question conc'erning the licensing and regulation of byproduct materials.
Issue: Consolidation of requirements that apply to the medical use of byproduct materials, and provision for flexibility for licensees in meeting safety requirements.
Summary: The proposed rule codifies the regulations and previously-used licensing policies and practices concerning the medical uses of radioactive materials. The proposed rule has been redrafted in accordance with the directives provided by the Commission in 1983 and is consistent with the Commission's 1984 Policy and Planning Guidance. The central issue is whether a regulatory agency must specifically approve mirar changes in a licensee's day-to-day radiation safety program. NRC Offices and Regions concur with the proposed level of flexibility that would be provided to licensees. Some Agreement State representatives do not. If adopted, resource requirements for both NRC and licensees are expected to be reduced.
Backcround: The phrase " medical use" is used to refer to the intentional irradiation of humans by medical practitioners for diagnosis or treatment of disease. There are about 2200 hospitals and 300 physicians in private practice who are NRC licensees.
In 1983, NRC received 143 applications for new licenses, 647 renewal applications, and 1,772 amendment applications for a total of 2,562 requested licensing actions.
Contact:
Norman L. McElroy 427-4108 hgg92ggo68850906 35 50FR30616 PDR
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'The Commissioners 2 In an earlier Commission Paper (SECY-83-62), the staff recommended a complete revision of Part 35, " Human Uses of Byproduct Material."
The two key features of that paper were:
Consolidation of the medical radiation safety requirements that are now dispersed throughout existing regulations, branch policy positions, standard license conditions, and regulatory guidance, and Allowance for greater flexibility under the license, thereby reducing the number of amendment requests.
After hearing arguments for and against certain aspects of the paper, the Commission directed the staff (Enclosure 2) to revise the proposal, keeping in mind four directives:
"(1) The Commission approves the consolidation of the essential ' safety elements...into a Part 35 rule'."
The staff has received many technical comments from headquarters and regional staff and the Agreement States; many of them have been incorporated in the proposed regulation. In some cases the suggestions could not stand the test of need based on public safety; chose have not been incorporated.
"(2) The Commission has decided to continue the pre-licensing review of physicians' qualifications. . . ."
The Enclosure 1 preamble has been revised to reflect this directive. The Commission should note that NRC would also require pre-licensing review of Radiation
. Safety Officer qualifications (consistent with current practice), and Qualified Teletherapy Calibration Expert qualifications (contrary to current practice, in which the licensee evaluates that individual's qualifications in comparison with the standards in the current Part 35).
"(3) The Commission has decided to continue the pre-licensing review of applicants' operating procedures...."
The operating procedures describe the Radiation Safety Committee charter and by-laws, instrument calibration, package receipt and opening, general laboratory safety measures, area surveys, waste disposal, etc. Under the alternative that the staff recommends (Alternative 2 of Enclosure 10), the staff will continue to review applicants' procedures to determine whether they are sufficient to meet the recuirements of the regulations.
(Consistent with current licensing policy, an applicant could simply certify that it will follow a model proce-dure supplied in a regulatory guide developed by NRC with public comment, or could submit its own procedure
f tr i The Commissioners 3 for staff review.) However, in order to allow each licensee to make changes for improved patient care, safety, or reduced cost, licensees will be free to make minor changes without NRC review or approval as
-long as they continue to meet the safety parameters in the regulations. At a hospital, the Radiation Safety Committee would have to reviev and approve a change before it could be implemented; at private practice facilities, the Radiation Safety Officer and management would have to review and approve changes.
"(4) The staff should clarify how it will implement the proposed requirements regarding license amendments...."
The Enclosure 1 preamble has been clarified to indicate when a license amendment request must be submitted and what information will be needed to support it.
All the headquarters offices, the regions, and the Agreement States concur in this proposal with respect to the changes made to meet directives (1), (2), and (4).
All the headquarters offices and the regions concur in the changes made to meet directive (3). The Agreement States disagree with the approach recommended by the staff. Note that under current licensing policy, licensees must submit an amendment request describing each proposed radiation safety program change. The staff makes a detailed review of each submission before issuing an authorizing amendment or denying the request. The Agreement States believe that-many licensees do not have the expertise needed to make an adequate safety review of minor changes in their radiation safety programs and that the agency would not have the opportunity to circumvent ill-advised changes. Region III would prefer more control by the licensing staff than is provided in the proposal. Some believe that, under the proposed program, inspectors will have to spend an inordinate amount of field time reviewing changes in licensees' procedures manuals. The Agreement States believe they will be pressured by medical associations and their own licensees to adopt the proposed regulatory method. A more complete discussion of these concerns is attached as Enclosure 10.
In preparing the response to directive (3), the staff took guidance from the Comnission's policy (" Policy and Planning Guidance, 1984," NUREG-0885, Issue 3, page 7 item 2, and page 8 item 3) that ". .NRC regulations should allow indi-vidual licensees the flexibility to select the most cost-effective ways to satisfy NRC safety objectives. . Exist-ing regulatory requirements that have a marginal importance to safety should be eliminated. . "
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The Commissioners 4 Furthermore, the staff notes that this proposed provision is similar to the flexibility allowed for operating power reactors.
Regulatory Guide 1.33, " Quality Assurance Program Requirements (Operation)," lists, by title, many management, facility opera-tion, and radiation safety procedures that may be needed depending on the facility configuration. The technical specifications for the reactor facility, which actually comprise part of the operating license but are standardized for the various reactor designs, identify:
(1) essential elements of normal operating procedures; (2) procedures that must be implemented in case o# degraded conditions; and (3) which degraded conditions require shutdown.
Under 10 CFR 50.59, the operating licensee may make changes in the facility and procedures that were described in the safety analysis report without NRC approval except for changes in the technical specifications or changes that might have major safety implications. The licensee is required to make a safety evaluation of each proposed change.
The proposed flexibility provision of Part 35 is similar to the reactor regulatory concept described above because the staff has codified the following provisions in regulations that are similar in character to technical specifications:
(1) essential elements of normal operating procedures (for example, management oversight, survey frequency, equip-ment calibration, and safety precautions);
(2) procedures that must be implemented in case of what are termed degraded conditions (for example, repair and recalibration of equipment that is not working properly);
and (3) conditions that require something akin to shutdown (for example, limits on trace radioactive contaminants in radiopharmaceuticals, removable contamination from sealed sources, and surface contamination in rooms for unrestricted use).
Thus, the licensee would be allowed to make changes in the facility and radiation safety procedures as long as they were consistent with the requirements of the regulations; the licensee would have to make a safety evaluation of each proposed change.
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The Commissioners 5 L
The staff also notes that the proposed regulation and current NMSS internal operating procedures provide for additional administrative oversight and checks and balances:
(1) Licensee management would provide a statement of authority and responsibility to the Radiation Safety Officer and Radiation Safety Committee.
(2) The hospital Radiation Safety Committee, comprised of users, management, and nursing representatives, must review worker doses and incident reports quarterly.
(3) The Radiation Safety Officer must brief licensee manage-ment annually.
(4) The regulation clearly identifies minimum training standards for key personnel and requires supervision of subordinates.
(5) The Medical Licensing Section of NMSS currently reviews
, all notices of violation and makes a statistical analysis to assess trends; the proposed regulation would simplify this procedure.
p (6) NMSS already has in place a mechanism for promptly notifying licensees of isolated incidents that might have generic implications.
I Therefore, the proposal includes licensee and agency oversight.
l Almost all the individuals who have reviewed this proposal agree that.the current Part 35 needs revision because it is difficult to read and does not contain all the requirements necessary for medical radiation safety. Most of them endorse the proposed regulatory text.
l At issue here is whether or not a regulatory agency must approve minor changes in a licensee's day-to-day radiation l safety program. When NRC issues a byproduct materials cita-i tion, it is usually for-doing nothing when something is clearly required, or for doing something that is clearly l . forbidden; citations are seldom issued for failure to exactly follow a certain procedure or to have satisfactory equipment.
- l. This raises the question of whether or not a " paper" analysis
, by NRC of minor operational changes contributes significantly to safety. The essential elements of a medical radiation safety program are well defined and have been codified in the proposed rule. The present review policy is resource intensive, causes backlog due to the bulk of material submitted for review and the number of license amendments needed, and results in a regulatory regime that is different for each licensee.
The Commissioners 6 In light of the required internal review and the checks and balances described above, all the affected NRC Offices and Regions concur with the proposed level of flexibility that would be provided to medical licensees. Not only will this reduce the burden on licensees and licensing staff, but it might lead to better radiation safety and patient care because it will allow licensees to meet changing program needs more rapidly without waiting for a license amendment.
A discussion of the opposition to this approach is included as Enclosure 8.
The Commission should note that because this is a proposed rule for public comment and because it represents a change from the current highly prescriptive regulatory method, the Federal Register Notice specifically calls for public comment on whether the change is appropriate.
Recommendation: The Commission:
- 1. Approve publication of a notice of proposed rulemaking (Enclosure 1) that would consolidate all medical use requirements into 10 CFR Part 35 and would describe a new licensing method.
Certify that this rule, if promulgated, will not have a significant economic impact on small entities. This certification is necessary to satisfy the requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b).
- 2. Note: .
- a. The rulemaking would be published in the Federal Register for 120-day public comment period;
- b. The staff conclusions, set forth in Enclosure 3, provide the analysis called for by the Periodic and Systematic Review of Regulations;
- c. The Director of the Office of Nuclear Material Safety and Safeguards has found, pursuant to the environmental assessment in Enclosure 7, that the proposed action would not have a significant environmental impact. This provides the basis in Enclosure 1 for the Commission's determination under S 51.32 not to prepare an environmental impact statement for the proposed action.
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- d. The Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act;
., , t The Commissioners 7
- e. The proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
This rule will be submitted to the Office of Management and Budget for review and approval of the paperwork requirements.
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- f. A draft regulatory analysis (Enclosure 4) has been )
developed for this proposed rule;
- g. A public announcement (Enclosure 5) will be issued when the proposed rule is filed with the Office of the Federal Register; ;
- h. The appropriate Congressional Committees will be informed (Enclosure 6); and
- i. Copies of the Federal Register notice of p'roposed rulemaking will be distributed to all affected Commission specific licensees and to other interested organizations and individuals.
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(( c ( e L<s William J. Dircks Executive Director for Operations
Enclosures:
- 1. Federal Register Notice of Proposed Rulemaking
- 2. Memo Chilk to Dircks dated June 23, 1983
- 3. Periodic and Systematic Review
- 4. Regulatory Analysis
.5. Draft Public Announcement
- 6. Draft Congressional Letter
~7. Environmental Impact Analysis
- 8. Summary of unresolved comments
! 9. Summary of human use licensee citations issued in 1982
-10. Analysis of alternatives
8 Commissioners' comments should be provided directly to the Office of the Secretary by c.o.b. Tuesday, January 22, 1985.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT Tuesday, January 15, 1985, with an information copy to the Office of the Secretary. -If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissionars OGC OPE OI OCA OIA OPA REGIONAL OFFICES EDO ELD SECY l
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3 8 ENCLOSURE 1
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l NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30, 31, 32, 35, and 40 MEDICAL USE OF BYPRODUCT MATERIAL AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to revise its regulations to modify the process for licensing and regulating the medical use of radioactive byproduct material. The proposed revision would primarily affect hospitals, clinics, and individual physicians.
By clarifying and consolidating all the essential radiation safety requirements that are'now contained in the regulations, license condi-tions, regulatory guides, and staff positions, the proposed regulation provides a single source of requirements related specifically to medical use of byproduct materials. The proposed regulation also provides flexibility for licensees to update their day-to-day radiation safety procedures. The revision of the regulations would provide a more efficient method for regulating the medical uses of byproduct material.
DATE: Comment period expires (insert 120 days after FRN). Comments received after this date will be considered if it is practitel to do so, but assurance of consideration cannot be given except as to comments filed on or before this date.
ADDRESSES: Submit written comments and suggestions to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.
Copies of the preliminary regulatory analysis and the comments received may be examined at the Commission's Public Document Room at 1717 H Street NW., Washington, DC. Single copies of the preliminary regu-latory analysis and environmental impact assessment are available from 1 Enclosure 1
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Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone:
(301)427-4108.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301)427-4108.
SUPPLEMENTARY INFORMATION:
BYPRODUCT MATERIAL IN MEDICINE Use for Patient Care Radioactive materials are used in drugs in the field of nuclear medi-cine. Drugs labeled with radioisotopes are known as radiopharmaceuticals.
In diagnostic nuclear medicine, patients receive these materials by injec-tion, inhalation, or oral administration. Physicians use radiation detec-tio'n equipment to visualize the distribution of a radioactive drug within the patient. Using this technology, it is possible to locate tumors, assess organ function, or monitor the effectiveness of a treatment. In therapeutic nuclear medicine, larger quantities of radiopharmace"ticals are administered to treat hyperactive thyroid conditions and certain forms of cancer. An estimated 15 to 20 million nuclear medicine proce-dures are performed in this country annually.
Sealed radioactive sources that produce high radiation fields are used in radiation therapy to treat cancer. A radioactive source in a teletherapy machine can be adjusted to direct a radiation beam to the part of the patient's body to be treated. An estimated 2 million tele-therapy treatments are performed annually by NRC licensees. Smaller, less radioactive sealed sources are designed to be implanted directly into a tumor area or applied on the surface of an area to be treated.
This proce, dure is known as brachytherapy. NRC licensees perform approx-imately 10,000 brachytherapy treatments annually.
Sealed radioactive sources can also be used in machines that are used for diagnostic purposes. The source provides a beam of radiation that is projected through the patient. A device on the other side of the patient detects the amount or spatial distribution of radiation that 2 Enclosure 1
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goes through the patient. This can provide information about tissues within the patient. This is a relatively new development in the field
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of medicine and the NRC has no estimate of the number of these diagnostic procedures performed annually.
State and Federal Regulation Twenty-seven states, known as Agreement States, have assumed respon-sibility for regulating certain radioactive materials within their respec-tive borders by agreement with the NRC. (This kind of agreement is authorized by the Atomic Energy Act.) They issue licenses for the medi-cal use of byproduct material. In non-Agreement States, the NRC issues licenses to medical institutions (mostly hospitals and clinics) and to individual physicians. These licenses authorize certain diagnostic and therapeutic uses of radioactive materials.
NRC'S REGULATORY PROGRAM Current Licensing Practice The current regulations in 10 CFR Part 35, " Human Uses of Byproduct Material," provide for general and specific licenses for medical use.
The general license in current S 35.31 authorizes physicians to use small quantities of prepackaged, individual dosages of byproduct mate-rials. Physicians simply submit a registration Form NRC-482 to NRC. A validated copy with a registration number is returned to the applicant.
Most medical institutions and physicians who use byproduct material need more byproduct material than can be permitted under the general license program. A specific license, which authorizes a larger inven-tory of byproduct material and a wider variety of uses, may be issued for one or more of six types of medical use, defined as Groups I-VI in the current S 35.100. Each group is comprised of a number of diagnostic or therapeutic procedures that have been grouped together because they require similar physician training and radiation safety precautions for safe use. A separate specific license may also be issued for use of a teletherapy unit. Applications for a specific license are much more detailed than a general license application and actually contain the applicant's step-by-step radiation safety procedures, which are reviewed and approved individually by NRC.
3 Enclosure 1
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The NRC has issued 650 general licenses, and in 1983 received seven-teen new applications. NRC currently has about 2500 specific medical licensees (2200 hospitals and 300 physicians in private practice). In 1983, the NRC received 143 new applications for specific licenses, 647 license renewal applications, and 1,772 license amendment requests for a total of 2,562 licensing actions.
To help licensees design their radiation safety programs, the NRC has published many NUREG reports and regulatory guides that contain radiation safety guidance. These publications address three general
. areas: radiological health and safety, personnel training and exper-ience, and facilities and equipment. Experience has shown that if licens-ees follow the guidance in the publications, the medical use of byproduct material generally poses no hazard to workers and the public.
Problems with Current Practice The General License. The general license program is based on the fact that the quantities and forms of material that are authorized by a general license present a very low health risk. The NRC believes it is no longer efficient to issue medical general licenses. The tests author-ized under S 35.31 have been superseded by newer procedures with greater diagnostic accuracy. These developments have been reflected by a signi-ficant decrease in applications for general ~ licenses. As noted above, although NRC has on file 650 in-vivo general licenses under S 35.31, only seventeen new applications were received by NRC in 1983.
To determine the status of general license use, the staff performed a telephone survey of 10 percent of the current registrants. The survey results indicated that less than 9 percent of all the current registrants still use material under a general liceme; many are now using byproduct material under a specific license. Be a of the low level of use of the general license, the NRC has concludea that it no longer serves a useful role in licensing the medical use of byproduct material.
The Specific License. Because of the potential radiation hazard to workers and the public, the specific license program incorporates three regulatory features: case-by-case review of applications, on-cite inspec-tions, and periodic license renewals.
4 Enclosure 1
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A major problem with the current licensing program is that radiation protection requirements are not located in one document. Requirements are scattered in the regulations, Inspection and Enforcement (IE) orders that modify a license or group of licenses, and in conditions attached to indi-vidual licenses. Suggestions for good practice are contained in NRC regu-latory guides and technical reports (NUREG's). For example, Regulatory Guide 10.8, " Guide for the Preparation of Applications for Medical Programs,'_' and NUREG-0267, " Principles and Practices for Keeping Occupa-tional Radiation Exposure at Medical Institutions As Low As Reasonably Achievable," contain many recommendations that the NRC believes are impor-tant for the safe use of byproduct material. The revision of Part 35 incorporates those recommendations, and also corrects the piecemeal fashion in which the regulations have been amended over the years to address specific problems.
When preparing a specific license application for review under the current licensing program, the applicant must include sufficient informa-tion to' assure NRC reviewers that byproduct material will be used safely.
Applicants include, as an integral part of the application package, copies of their proposed step-by-step radiation safety procedures. In many cases, the procedures are edited versions of procedures described in Regulatory Guide 10.8.
When NRC receives the application, a licensing reviewer evaluates the applicant's training and experience, facility, equipment, and radia-tion safety procedures in detail. If the application is found to be incomplete or inadequate, a " deficiency letter" is sent to the applicant explaining what additional information is needed. Review of the applica-tion is not resumed until a written response from the applicant has been received. Staff studies indicate that about 40 percent of all applicants receive either a deficiency letter or a phone call for additional informa-tion. The need for deficiency letters stems from two sources. Guidance on what is needed to get a license is unclear and scattered in various documents. Application review practice must be conservative because the application and license comprise the basis for regulatory control. Defi-ciency letters are costly for the NRC and the applicant and greatly increase the time needed to complete licensing actions.
5 Enclo.ure 1
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When the application, including any additional submitted information, is approved, the NRC issues a specific license that grants the authority for medical use of byproduct material in accordance with the program described in the application. Requirements in addition to those contained in the regulations are frequently incorporated in the license as condi-tions of use. Since the licensee must comply with conditions specified in the license, the license, rather than the regulations, is frequently used to regulate radiation safety in the day-to-day use of byproduct material.
The specific license is valid for five years. The license must be amended before methods of use or procedures may be added or changed, or before permitting additional physicians to use materials. Amendments to a specific license involve an application, review, and approval process similar to that for new licenses. Renewals are treated in the same manner as new license applications.
This regulatory process was appropriate during the evolution of the use of byproduct material in medicine. Radiation safety problems were not well defined, regulatory requirements had not caught up with develop-ing technology, physician training curricula had not been established, and there were no formal training programs for nuclear medicine technol-ogists. Therefore, it was necessary to regulate by reviewing each indi-vidual radiation safety program to ensure that the applicant had adequate personnel, facilities, and equipment.
PROPOSED REVISION OF THE REGULATORY PROGRAM Overview NRC intends to modify its regulation of the medical use of byproduct material. The Commission plans to revise the regulations to provide a single source of requirements specifically related to medical use of by-product materials, and within the boundaries set by the regulations, allow medical licensees to modify their radiation safety procedures, facilities, and eauipment so they can make prompt use of new safety methods and also meet new needs caused by changes in demand for various patient care services or in patient load. The proposed revision of 10 CFR Part 35 is consistent with the Commission's general policy on medical use of byproduct material issued February 9, 1979 (44 FR 8242).
6 Enclosure 1
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It states "NRC will continue to regulate the medical uses of radioiso-tapes, as necessary, to provide for the radiation safety of workers and the general public."
Codification of Requirements in the Regulations NRC proposes to simplify regulation of medical licensees by incor-porating all medical use requirements in 10 CFR Part 35. These regula-tions would become the primary means of regulating the medical use of byproduct material. General safety requirements for worker instruction, worker safety, noncompliance reports, and materials licensing that are in Parts 19, 20, 21, and 30 will also continue to apply to Part 35 licensees. The current license application process will be unchanged.
The applicant prepares a complete Form NRC-313. That form asks for the following information: the name and mailing address of the applicant; the location of use; a person who can be contacted about the applica-tion; what materials are requested; the purpose (in this case, " medical use"); the training and experience of the authorized users and Radiation Safety Officer; the worker radiation safety training program; facilities and equipment; the radiation safety program; and waste management.
Licensees would not face significant new regulatory burdens because, in most cases, these requirements are currently imposed as license condi-tions. Under the proposed revision, the license would authorize medical use of byproduct materials for specified types of use. A licensee's day-to-day uses would be controlled by the regulations. This would simplify inspections for NRC because inspectors would only need to be familiar with one set of regulations rather than a different set of license condi-tions and radiation safety procedures at each facility.
License Application, Issuance, and Authority and Responsibility New revisions of Regulatory Guide 10.8, " Guide for the Preparation of Applications for Medical Programs," and Draft Regulatory Guide TM 608-4,
" Guide for the Preparation of Licenses in Medical Teletherapy Programs,"
will contain instructions on the type and extent of information that must be submitted based on what byproduct materials the applicant has requested.
They will also contain model procedures that the applicant can use to develop site-specific procedures. (Consistent with current practice, 7 Enclosure 1
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applicants will alternatively be allowed to simply certify that they will follow the model procedure developed by NRC staff with public comment and published in a regulatory guide to meet a certain requirement. This method significantly reduces the amount of time NRC must spend reviewing procedures.) The applicant mails the completed application, with applica-tion fee, to the NRC office identified on the form.
The NRC staff will continue to review the application to determine whether the applicant's radiation safety program is sufficient to meet the requirements of the regulations. After completing the review, if the applicant's program appears incomplete or inadequate, NRC will issue a deficiency letter that describes the apparent shortcomings in the appli-cant's program and requests clarification or correction. If the appli-cant's response to the deficiency letter is satisfactory (or if no defi-ciency letter was needed), the license will be issued.
Licensees will be free to modify their procedures after conducting a required internal review and approval process. At medical institutions, the Radiation Safety Committee would review and approve a modified proce-dure before it could be implemented. At non-institution facilities, the Radiation Safety Officer (RS0) and management would review and approve changes. This will allow each licensee to make prompt use of new safety methods and to adjust radiation safety procedures to meet new needs caused by changes in demand for patient care services or patient load. A list of radiation safety topics that should be considered when reviewing pro-posed changes will be published as an appendix in Regulatory Guide 10.8.
The right to modify procedures does not relieve the licensee from the requirement to comply with the regulations. This regulatory scheme would not incorporate the current requirement that licensees use byproduct mate-rial in accordance with the statements made in the application.
This proposed regulatory program, which gives more discretionary authority, and concomitant responsibility, to the licensee, represents a change in the policy that has guided NRC's regulation of medical licens-ees for several years. The NRC particularly invites comment on whether this change is appropriate at this time, and whether or not it will bene-fit licensees, workers, and the public.
8 Enclosure 1
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l The proposed regulations require specific training and experience for the use of material in each use group. Proposed authorized user physicians and qualified teletherapy calibration experts (identified in current Part 35 as qualified experts) will have to submit summaries of their training and experience. This is currently required for authorized users and Radiation Safety Officers, but would be a new requirement for qualified teletherapy calibration experts, whose credentials are currently reviewed by the licensee. The staff will review those individuals' training and experience against the standards in the regulation before authorizing them to work under the license. (Also consistent with current practice, any individual who does not meet the standards may ask for an exemption from the training and experience requirements. The NRC staff will review the individual's training and experience with the assistance of its Advisory Committee on the Medical Use of Isotopes, and may issue the exemption as a license condition.)
Enforcement Under this regulatory scheme, a licensee will be cited for failure to meet the requirements of the regulations or license conditions (which would list, for example, authorized users, locations of use, authorized methods of use, authorized byproduct material and inventory limits, and other site-specific limitations), failure to have on hand the written procedures required by the regulations, failure to follow the procedures on hand, failure to have the records required by the regulations, or fail-ure to follow technically valid procedures (examples: using an instrument that doesn't work, not determining instrument detection efficiency, not allowing an instrument enough time to respond, or making unsubstantiated assumptions in calculations). Use of material can be authorized either by license or by virtue of working under supervision; use without author-ization would be a violation of the regulations and the Act, which would subject the user to an enforcement action.
Amendments As mentioned above, under the current regulatory scheme, the licensee is required to handle material exactly according to the radiation safety procedures submitted with the application. The NRC frequently receives 9 Enclosure 1
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- requests for permission to modify day-to-day radiation safety procedures.
Because the regulations will now contain sufficient prescriptive and per-formance criteria on which to base enforcement actions, the NRC would allow a licensee to change its radiation safety procedures without pre-paring a formal amendment request, paying an amendment fee, and awaiting NRC approval. This would not relieve the licensee from the regulatory requirement to comply with the regulations in Part 35 or in other parts of 10 CFR Chapter I.
Four types of program changes will still require formal license amendments:
(1) New users. The NRC will review the training and experience of each proposed authorized user, Radiation Safety Officer, and qualified teletherapy calibration expert as described above before listing the individual on a license.
(2) New type of use. A licensee's request to add a type of use (for example, adding radiopharmaceutical therapy to a license that author-izes radiopharmaceuticals for imaging) to an existing license will be handled as a new application. The authorized user's training and experi-ence will be reviewed for adequacy with respect to the new type of use, and procedures that must be submitted in support of the request will be reviewed for completeness and adequacy with respect to the new type of use before the amendment is issued.
(3) New method of use. Two developments may occur but only one type of license amendment will be needed:
(a) If a new radioactive material becomes available, and the radia-tion safety procedures needed for its safe use are identical to the proce-dures already established for an already established and authorized use (for example, a new imaging agent administered by intravenous injection),
no license amendment will be required. Instead, the new material will be added by rulemaking to the list of materials in the appropriate use group specified in the regulations. The NRC will mail to licensees a notice that says those who are authorized to use material in that group may begin using the new material on the effective date of the final rule that adds the new material to the regulations.
10 Enclosure 1
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(b) If a new radioactive material becomes available but its safe use depends on following a new procedure that current licensees have not submitted and NRC has not reviewed, two actions will be taken.
(i) The new material will be added by rulemaking to the appropriate use group in the regulations but authorization to use it will be limited to persons who were licensed after it was added to the use group and who have submitted the new procedure for review in their application packages.
(ii) NRC will mail to current licensees a notice that says they may apply for authorization to use the new material. With that notice, NRC will also supply a model procedure, which would become a new appendix in Regulatory Guide 10.8, for the new material. Those licensees who want to use the new material will have to submit a request for amendment which ii..iudes a proposed procedure that will be reviewed by NRC for complete-ness e.:t adequacy. .
(4) 3% lo, ation of use. Two types of amendment may be needed:
(a) A r ques: to leave one location of use and begin working in a new location, i'.* ex1mple when moving a private practice to a new office or when moving ir.'o a ,ew hospital building, will have to be supported by a complete new acolication package.
(b) Some licensres ceceive packages, prepare radiopharmaceuticals, and package waste at a ,enval facility, but actually use the byproduct material at satellite loctti os. This might be a mobile nuclear medicine service that provides diagrostic services at clients' facilities such as clinics, small hospitals, or :'urs'ng homes, or it may be a licensee that
.has a principal facility a"d o cly"i.g d inics. If the licensee has been approved to offer service at satellice locations, a request to add another satellite location will only have to i h ntify the new location. (Due to the training, space, and equipment commite nts needed for safety during therapy procedures, the NRC will generally not authorize licensees to perform therapies at satellite locations. This type of request will be handled on a case-by-case basis.)
Renewals The NRC license is valid for five years. If a person wants to con-tinue using byproduct material the license must be renewed. The renewal application must completely describe the entire radiation safety program 11 Enclosure 1 i
[7590-01]'
just as a new application does. If a previously submitted radiation safety procedure, facility description, or equipment list still accu-rately reflects that part of the licensee's program, the renewal appli-cant may simply make a clear reference to the previous submission. If the licensee has-changed a procedure, is using different areas of use,
. or is using different equipment, a complete new description of the parti-cular procedure, area of use, or equipment must be submitted. The licensee may also take this opportunity to identify new authorized users or request authorization for new types or methods of use.
Summary of Changes Proposed in the Regulatory Procram In summary, the regulation.will be amended to require that licensees meet standards that are currently imposed by license conditions. The NRC will, continue to review user training and experience. The NRC will review site-specific radiation safety procedures for completeness and adequacy and issue deficiency letters if necessary, but will allow licensees to change procedures that were submitted in support of the application after conducting an internal radiation safety review of each change. However, the right to change procedures does not relieve the licensee from the re-quirement to comply with the regulations. Amendment requests will gener-ally be reviewed just as new applications are reviewed, but they may incor-porate by reference the original application and any previous amendments.
NOTES Word Usage In preparing the proposed revision of Part 35, one goal was to remove language that might be misinterpreted. The following words used in the revision may require clarification.
- 1. Licensee. The person (individual, partnership, corporation, or agency) listed on the license as the " licensee" is responsible for compli-ance with regulations and license conditions. The licensee may effect compliance through full-time or part-time employees, contracts with con-sultants or service organizations, or other business arrangements. The word " licensee" is used throughout the regulation to stress the fact that, no matter which method is used, the licensee is legally responsible in case of non-compliance.
12 Enclosure 1
[7590-01]
- 2. Type of use and group. In the current Part 35 there are six
" groups" of use described in S 35.100. Each group is comprised of a set of medical procedures that require similar training and equipment for radiation safety purposes. The word " group" has not been used in the proposed revision in order to avoid confusion between the old and new Part 35. The revision uses the phrase " type of use" for this concept.
Some types of use are amalgamations of old groups, and some types are new. The six types of use are: (1) uptake, dilution, and excretion --
Subpart D; (2) imaging and localization -- Subpart E; (3) radiopharma-ceutical therapy -- Subpart F; (4) brachytherapy -- Subpart G; (5) sealed sources for diagnosis -- Subpart H; and (6) teletherapy -- Subpart I.
- 3. Method of use and procedure. The word " procedure" is frequently used in supporting documentation for byproduct materials programs. Some-times it refers to a specific set of steps that must be taken to effect an end, for example a procedure for ordering and receiving packages.
Sometimes it is used to indicate a type of medical examination or treat-ment, for example a thyroid uptake study or a cesium implant therapy, without indicating the amount of byproduct material used or the specific steps taken in handling it. The word may also be used to indicate the number of patients cared for over a period of time, for example an aver-age workload of fifteen procedures each day. In order to avoid confu-sion, the phrase " method of use" appears in the proposed revision. Each type of use is comprised of several methods of use. Each method of use should identify, explicitly or by context, the radionuclide, its chemical and physical form, method of administration, and purpose (diagnosis or therapy).
- 4. Dose and dosage. In pharmacy, the word " dose" is used to indi-cate the amount of chemical administered; in radiation biology it is used to indicate the amount of ionizing energy absorbed per unit mass; and in radiation safety it is used as a shorthand term to indicate a worker's exposure to radiation. In order to avoid confusion, the word " dosage" is ,
used in the proposed revision to indicate quantities of radioactivity )
that are measured with the base unit Curie. The word dose is used to I indicate quantities of radiation absorbed dose or dose equivalent that are measured with the base unit rad or rem.
13 Enclosure 1 1
[7590-01]'
- 5. Record and report. A record is a user-retrievable notation or complete document. It may consist of something as small as a check-mark on a form or something as extensive as a survey of a newly installed tele-therapy unit with appended calculations to demonstrate compliance with the limits on exposure in uncontrolled areas. A report is a transfer of
.information which might be made face to face, by telephone, telegram, computer link, or hard copy transmittal.
- 6. Test and check. For many pieces of equipment, drafting commit-tees comprised of industry experts have prepared standards of performance and complete calibration protocols. If a piece of equipment is subjected to the protocol in the calibration laboratory and meets all the standards, then the ability of the equipment to perform as expected in normal field use is assured. In the proposed revision this concept of complete exami-nation is referred to as a " test." During field use it is common prac-tice to subject a piece of equipment to a quick examination to determine whether it is working. This procedure does not examine all parameters of equipment performance. In the proposed revision this concept of per-functory examination is referred to as a " check."
- 7. Location of use, facility, and area of use. The phrase "loca-tion of use" is used to describe the building or buildings (typically identified by a single street address) where byproduct material is used.
The word " facility" connotes a room or contiguous rooms where byproduct material is used, such as a nuclear medicine clinic comprised of an office, an imaging room, and a dosage preparation and waste storage room. The phrase " area of use" connotes the space used by a worker when performing a specific task connected with receiving, handling, or storing byproduct material.
- 8. Chemical form. The current regulation requires that if a radio-pharmaceutical is used for indications other than those described in the package insert, the user must nevertheless follow instructions on chemi-
' cal and physical form, dosage, and route of administration. The proposed revision has deleted the word chemical in its restatement of this require-ment because to change the chemical form would be to create a radiophar-maceutical other than the one received from the authorized distributor.
Deletion of this word in the proposed revision does not authorize Part 35 licensees to manufacture radiopharmaceuticals.
14 Enclosure 1
[7590-01]
l
- 9. Available for use. In many cases the regulation states an equip-ment possession requirement because the piece of equipment is considered by experts to be an integral part of the radiation safety program. In a few cases the need for a piece of equipment is sporadic and normally sche-i duled weeks in advance. For example, a licensee who has a diagnostic sealed source in a device (see S 35.500) usually only needs a survey l instrument when receiving or returning a radioactive source; there is no need to have the instrument on hand every day. The phrase "available for use" is intended to connote that the licensee either may possess equip-ment or contract for measurement services, but is not required to have regular day-to-day possession of the described equipment.
- 10. Dedicated check source. A long-lived radioactive source can be used to check the day-to-day constancy of an instrument. The same source (a " dedicated" source) must be used every day so that the user knows what reading to expect from the instrument. The source may also be used for other purposes.
- 11. Operable. The word " operable" is not used in the proposed regu-lation because every piece of equipment must be operable. If a piece of equipment is not operable or reliable, whether due to old or absent bat-teries, incomplete or improper maintenance,-damage, inappropriate use, or improper use, it cannot be used to meet a regulatory requirement because there is no assurance that it accomplished the task for which it was used.
- 12. Implement. This verb is used with its ordinary definition, which is "to carry cut, accomplish, or ensure fulfillment of."
- 13. Promptly. This word is used with its ordinary definition, which is " performed readily or immediately."
Record Retention The Commission requires that licensees make and retain records as evidence of compliance with regulations and license conditions. A review of records during inspections is the least burdensome way that the Commis-sion may be assured that the licensee has developed and implemented a
[ radiation safety program. However, permanent retention of all required i records, or retention between inspections, would be unreasonable and would run counter to recent guidance to regulatory agencies that was 15 Enclosure 1 l
L - . . - , _ . _ . _ , . . . . _ _ _ _ , _ , __,~.,_-- __._ _._._ _ _ _ - _ . _ _ _
[7590-01]
issued by the Office of Management and Budget. Therefore the Commission has, in the proposed revision, generally adhered to the following policy.
- 1. 'For recurring records that are created on a daily basis, for example end-of-day surveys, and for most non-recurring, sporadic, or periodic records, such as individual patient dosage measurements or survey
, instrument calibrations, the Commission has made a judgment that records retention for two years provides adequate evidence of compliance with requirements.
- 2. In a few cases a record is only created once or the Commission considers the record to be essential evidence of compliance with regula-tions that, if not followed, might cause an immediate discernible impact on a worker or member of the public_(for example, requirements for the f
geometry _ test for a dose calibrator and the teletherapy dosimetry equip-ment calibration, respectively). In those cases the Commission has made I a judgment that retention for the duration of use of the equipment or of the license is necessary.
Effect on Broad Licensees In addition to the more common " group" licenses which the NRC issues
- that authorize byproduct material for uses described in the groups, the NRC has also issued about 100 broad licenses under Part 33 that include
! medical use. They are issued to large medical / academic institutions that j have had several years experience using radioactive materials.
About 50 of the medical use broad licenses that have been issued vest in each institution's Radiation Safety Committee the authority to permit medical practitioners to use byproduct material for both patient care and medical research, to permit individuals to use byproduct material for research in test tubes and animals, and to review the facilities and radiation safety procedures that these individuals will use. Before NRC issues a broad license it reviews the applicant's administrative and safety procedures, the training and experience of the Radiation Safety Officer and of each individual member of the Committee, and the standards and management procedures it will use when reviewing permit requests.
This type of license is needed to allow for the orderly evolution of the medical sciences. The NRC will continue to review Committee member qualifications on a case-by-case basis because the size and individuality 16 Enclosure 1
I
[7590-01]
of each broad license program precludes the preparation of generic pre-scriptive qualifications. These licensees would be required to comply with the proposed prescriptive and performance criteria of Part 35, but would be exempted from the training and experience requirements of
.Subpart J and the authorized materials and authorized use restrictions in proposed SS 35.49, 35.100, 35.200, 35.300, 35.400, and 35.500.
The other 50 medical broad licenses that have been issued are similar to the license described above, except that the Committee only has the authority to permit individuals to use material in test tube and animal i research, and only authorizes medical use in accordance with the groups in current S 35.100. The NRC would continue to review the training and experience of medical practitioners before allowing them to use material for medical use. Because control of medical use in these cases is the same as that exercised over the more common group licensees, the basis j for a determination of compliance will be the same as that described
- . below for group licensees.
Because, whether at a group or broad license facility, teletherapy
- is separately licensed "for treatment of humans" and because the NRC I
reviews qualifications of proposed users and safety procedures, no sig-nificant inconsistencies with current teletherapy programs or new tele-t
- therapy programs are expected.
t J
Transition Policy For General Licensees 1
The general license in current S 35.31 has been eliminated from the proposed regulations. In the future, all medical use will be specifically licensed. Current general licensees, all of whom are physicians, will receive a specific license that will be incorporated into NRC's filing system for keeping track of specific licensees. However, they will be limited to the methods of use described in the current S 35.31, and relieved, by license condition on a pre printed license, from the require-ments that are more burdensome than the current general licensee require-ments. The only action general licensees will need to take is to respond affirmatively to an NRC notice that asks if they want to continue to have an NRC license that is limited to the methods of use authorized by the cur-rent general license.
17 Enclosure 1
[7590-01]
The Commission proposes, under 6 170.11(b), to continue to exempt these licensees from application and renewal fees as long as their programs are limited to the material uses described in current S 35.31.
Under the new specific licensing system, former general licensees that want to make any changes in their programs, amend their licenses, or transfer them to other physicians, will have to apply under the new licensing scheme arid will be subject to all the fees that apply to other specific licensees.
The Commission proposes to waive fees to fornier general licensees for the following reasons. General licensees do not now pay fees. About 90% of the 600 or so general licensees are inactive. Each year NRC '
receives only a very few requests for general licenses under S 35.31.
There would be no NRC review time needed and only a minor NRC administra-tive cost to process these licenses. It would be unfair to charge these licensees the fees listed in 10 CFR Part 170, and it would be more costly for NRC to alter that fee structure than to grant the exemption.
The current Part 35 also grants a general license for in vitro work described in S 31.11 to group licensees without requiring that they submit an in vitro registration form. Under the proposed regulation, applicants would have to specifically request this authorization as a line item on their applications. Part 31 will be amended to continue the in vitro authorization for current medical licensees until their licenses are renewed. In either case, the use of 9 31.11 materials within the inventory limits of that section will only be subject to the requirements of S 31.11.
Transition Policy for Specific Licensees Under the current regulatory program, the license document with the appended application is used to regulate each individual licensee. Because the requirements in the proposed revision were taken from commonly used topical license conditions and regulatory guidance that most licensees have incorporated into their applications, the Commission does not expect any significant inconsistencies between current licensee radiation safety ,
programs and radiation safety programs of applicants that apply after the effective date of the proposed regulations. Therefore, current licensees will normally be cited if they do not comply with the new regulations. '
However, because each current licensee's radiation safety program was 18 Enclosure 1 1
[7590-01]
reviewed individually and license conditions were tailored to meet the licensee's individual needs, there may be an occasional inconsistency between a license condition and the regulation (for example, a license may require survey instrument calibration biennially, but the proposed regulation would require calibration annually). There is no health and safety reason to undo these licenses to effect compliance with the regu-lation. To impose the regulation in addition to or in lieu of the license conditions would not provide for significant additional health and safety. The Commission therefore proposes to resolve possible temporary inconsistencies between license conditions and the regulation by providing in the regulation a transition period between the effective date of the final rule and the expiration date of each license. During this transition period, if there is an inconsistency between a provision in a license (issued prior to the regulation) and the regulation, the proposed regulation states that the license condition would take precedence over the regulation. Because the license conditions were reviewed from the perspective of overall safety and approved by the NRC, the inconsistency would not result in an increased risk to workers or the public.
In addition to the topical license conditions mentioned above (for example, sealed source leak test requirements, special bioassay require-ments, radioactive patient surveys and release limits, or waste disposal restrictions), each specific license has an encompassing license condition that requires each licensee to possess and use licensed material in accord-ance with the statements, representations, and procedures contained in the license application and in letters of clarification. Despite this encompassing condition, licensees would be allowed to make changes in their radiation safety programs; permissible changes would be restricted to those identified in S 35.36, and the licensee would have to conduct the internal review required by that section.
In the case of record retention, the regulation will generally take precedence because, in the past, the Commission has not offered much guid-ance on this topic. Many applicants have either not specified a period of retention or have incorporated a single, all encompassing record reten-tion phrase "until the Commission authorizes their disposal," rather than shouldering the burden of justifying to NRC a shorter period. If a record 19 Enclosure 1
[7590-01)*
is substantively the same as a record described in the proposed regulation and the licensee has not stated a retention period for that specific record, licensees could adopt the retention period stated in the final rulemaking.
However, licensees would still have to comply with any record retention period required by a topical license condition or another Part (for example Part 20) of the regulations. (For example, surveys that provide the basis for occupational dose records or measurements of effluent release are governed by Part 20.)
NRC does not currently review qualified teletherapy calibration expert credentials, and does not identify the Radiation Safety Officer on the license. Under this proposal, NRC would begin to review their credentials and identify both of them just as it does now for authorized users. To add current licensees to this new scheme, licensees would be required to submit their credentials for review and approval when the next amendment or renewal request is required. These individuals would be identified on the next license amendment.
The NRC particularly requests public comment on this transition policy and would like to know if licensees envision problems of interpre-tation or compliance that the staff might not foresee.
DISCUSSION OF PROPOSED REGULATIONS The primary purpose in initiating this revision to the regulations is to simplify the regulatory process by providing licensees with a single source of requirements for the medical use of byproduct material.
Radiation protection standards now contained in several existing regula-tions, Inspection and Enforcement orders that modify a single license or group of licenses, technical reports (NUREGs), standard conditions of licenses, and regulatory guides would be consolidated into a concise set of regulations. The requirements that apply to all licensees appear first, followed by the specific requirements for each of the six basic types of use.
In the proposed regulation, items of general information, general administrative requirements, and general technical requirements are addressed first in Subparts A through C, respectively. Subparts D through I contain the additional technical requirements that apply to licensees for each of the six new types of use. Subpart J lists the 20 Enclosure 1
i
[7590-01]
training and experience requirements, and Subpart K lists the penalties for violations of the regulations.
In order to maintain consistency among the various parts of NRC's regulations, conforming amendments have been made to the affected sec-tions of Parts 30, 31, 32, and 40. These conforming amendments can be fdund immediately after the revised Part 35. A section-by-section discussion of the proposed revision of Part 35 follows.
Title The title of Part 35 has been changed from " Human Uses of Byproduct Material" to " Medical Use of Byproduct Material" to better reflect the scope of the part.
Authority This listing provides notice of the statutory basis for the regula-tions. It also provides notice that the NRC may initiate criminal prose-cution of persons who knowingly and willfully do not comply with the prescriptive requirements issued under sec. 161b or the recordkeeping and reporting requirements issued under sec. 1610.
Subpart A--General Information S 35.1 Purpose and scope.
The regulations in this part apply to all persons licensed by the Commission to intentionally administer byproduct material or the radia-tion from byproduct material to humans, and to individuals working under their supervision.
S 35.2 License required.
This section requires that persons have a license issued by the Commission or an Agreement State before they handle byproduct material for medical use. The Commission uses the specific licensing process to limit the use of byproduct material to persons who have the equipment, facilities, training, and experience needed to ensure its safe use.
Individuals who are working under the supervision of an authorized user do not need a license document, but this does not relieve them of the 21 Enclosure 1
[7590-01]
- requirement to conduct their work in accordance with requirements of the license and the regulations of this chapter. The licensee remains responsible for the noncompliance of such agents or employees, and may be subject to sanctions for their failure to comply.
S 35.8 Information collection requirements: OMB Approval.
This section provides notice that the Office of Management and Budget has reviewed and approved the information collection require-ments contained in this part.
S 35.15 Definitions.
- The term " Agreement State" applies to those states that have er.tered 7 into an agreement with NRC to assume responsibility for regulating the use of byproduct material within their borders.
The word "ALARA" was added to identify the acronym for the phrase "as low as reasonably achievable."
The term " area of use" was added to identify a place in which byproduct materials are received, used, or stored. The term is used in S 35.36 to authorize licensees to use byproduct materials in rooms, suites, or building wings not identified in the application.
The term " authorized user" was added to identify individuals who are identified by name on a license and who are authorized by the Commission or an Agreement State to administer byproduct material, or the radiation therefrom, to humans for medical care, and supervise its use by others.
The term " dentist" was added to identify a group of practitioners licensed by the States who might use byproduct materials in their practice.
The term " medical use" was included to help identify the scope of this part. The word " intentional" was included in the definition to make it clear that occupational and nonoccupational exposures under the regula-tions of Part 20, accidental exposures, and unwanted exposures from other sources of radiation (e.g., nuclear powered cardiac pacemakers, smoke detectors, and radioactive waste) are not considered medical use. The phrase "in the practice of medicine in accordance with a license" was included to make it clear that NRC recognizes that States may have dif-ferent definitions of medical practice or different levels of control and that licensees should not interpret the NRC license as a pre-emption of 22 Enclosure 1
[7590-01]
State medical regulations or an attempt to direct the States' regulation of medical practice.
The word " medical institution" was added to identify organizations in which the radiation safety program depends on the cooperation of indi-viduals from several different departments.
The word "nlanagement" was added to identify the individual respon-sible for defining the licensee's policies and allocating personnel, budget, and space resources.
The word " misadministration" was included to define those instances in which a mistake has been made in the medical use of byproduct material.
The definitions are the same as those in the current S 35.41.
The term " mobile nuclear medicine service" was added to describe the transport of byproduct material for the purpose of offering diagnos-tic nuclear medicine services at addresses other than the principal business address of the licensee.
The word " output" was added to describe the amount of radiation in a teletherapy beam.
The word " physician" was included to identify individuals licensed by the States to practice medicine and therefore eligible to use byproduct material in the practice of medicine.
The word " podiatrist" was added to identify a group of practitioners licensed by the States who might use byproduct materials in their practice.
The term " qualified teletherapy calibration expert" was included to replace the term " qualified expert" which is used in the current S 35.24.
The new term better reflects the training, experience, and responsibil-ities of the individual who is responsible for calibrating a licensee's teletherapy unit.
The term " Radiation Safety Officer" was added to identify the indi-vidual named on a license and who is responsible for managing the licensee's radiation safety program.
The term ":ealed source" was included to identify byproduct material that is specially encapsulated to prevent leakaga or escape during use and storage. It is the same definition as used in S 30.4.
The term " visiting authorized user" was added to identify individuals listed as authorized users on one license who, while working for another licensee on a temporary or occasional basis, use byproduct material under 23 Enclosure 1 b _ -_ _ _ - - - - -
[7590-01]'
the restrictions of the temporary employer's license, which does not iden-tify the visitor as an authorized user. This authorization is based on a frequently used topical license condition.
S 35.16 Application for license, amendment, or renewal.
At an institution, only management may apply for a license; individ-ual physicians would be listed on that license as authorized users. An individual physician may not apply for use within a medical institution (an organization that provides various medical services). This require-ment reflects the need for coordination with other employees who may not be under the administrative control of the authorized user. For use sited outside a medical institution, such as for private practice or mobile service, any person may apply. An application must be filed on Form NRC-313 because it elicits information in an orderly manner that will allow for uniformity in application review procedures.
Teletherapy applications must be submitted separately because the scope and nature of information needed is much different than that needed for the other types of medical use. This requirement does not imply that the applicant should have two separate safety programs.
This section also reflects the Commission's decision to delegate to Regional Administrators some licensing functions which, until recently, were conducted in the headquarters. This program was described in Federal Register notices published May 27, 1982 (47 FR 23138), April 14, 1983 (48 FR 16030) and May 9, 1984 (49 FR 19630).
S 35.17 License amendments.
The Commission requires that the licensee obtain an amendment for any changes in the byproduct material program that might increase the potential for radiation exposure to workers and the general public, or make it difficult for the Commission to cc. duct its inspection program.
The Commission has determined that certain changes are potentially signi-ficant for the following reasons and thus will require an amendment:
(1) The NRC must be assured that the licensee has adequate training and experience and facilities before authorizing a change in the type or method of medical use or amount of byproduct material used. Such a change might also indicate a need for increased inspection frequency.
24 Enclosure 1
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(2) The use of byproduct material at an address not identified on the license would make it impossible for the Commission to make unannounced inspections. The Commission relies on the unannounced inspection to assure day-to-day compliance. For the purpose of this part, the phrase " location of use" refers to a building. (Moving from one room to another within a building would not constitute a change in location of use.)
(3) The Commission must be assured that the training and experience of Radiation Safety Officers, authorized users, and qualified teletherapy calibration experts is sufficient to assure that they are able to under-stand and follow regulations for the safe use of byproduct material.
S 35.18 Notifications.
A notification requirement was added to require the licensee to notify the Commission if an authorized user, Radiation Safety Officer or qualified teletherapy calibration expert is no longer affiliated with the licensee's byproduct material program. Without this notice the NRC would not have assurance that the collective training and experience of the licensee's remaining personnel is adequate to ensure the safe use of byproduct material for all the types of use authorized by the license.
The Commission has made a judgment that notification within 30 days is sufficient because technicians who have worked under the supervision of the authorized user can adequately ensure the safe receipt and proper storage of byproduct material. However, absence of an individual to oversee a byproduct material program may increase the probability of an accumulation of unused byproduct material or unauthorized use of material.
This presents an unacceptable potential hazard.
S 35.28 License issuance.
The Commission has selected a license term of five years. A shorter term would not benefit the public health and safety because past experi-ence indicates that medical programs do not generally change significantly over that period of time. A shorter term may unduly interfere in patient care because the licensee would spend an inordinate amount of time request-ing renewals. A longer term may occasionally result in unintentional abandonment of the license.
25 Enclosure 1
[7590-01] '
i The applicant must use Form NRC-313 to provide for an orderly safety i review of the applicant's program. The Commission will apply certain standards when rcviewing an application so as to ensure that the safety l of workers and the public will not be compromised if the license is granted. "
1 The staff must be assured that the applicant's' proposed equipment and
, facilities are adequate to protect health and minimize danger to life or property (S 30.33(a)(2)), and that the authorized users are qualified by j training and experience to use the material for the purposes listed in the application in such a manner as to protect health and minimize danger to life or property (S 30.33(a)(3)), and that the applicant has established
- procedures adequate to assure the safe use of byproduct material.
Concerning fees, Congress has directed that agency services, such as licensing and inspection, must be self-sustaining to the extent possible.
]! 8 35.29 Specific exemptions.
As part of an application or amendment request, a person may request 1
an exemption from any requirement of this part. The NRC occasionally receives requests for exemptions-from procedural, equipment, or training standards. The Commission may allow the exemption if the applicant can show
, that it will not compromise the health and safety of workers and the public.
Subpart B--General Administrative Requirements
$35.30 ALARA program, i An ALARA program is a management tool needed to assure that all l reasonable efforts are made to assure the safe use of byproduct material.
l (See ' Management Organization and Administration for ALARA' by Kathren, l Health Physics, Vol. 42, No. 2, February 1982, p. 119-131, and ' Radiation
[ Safety in a Nuclear Medicine Department,' by Gandsman et al., Health l Physics, Vol. 38, No. 3, March 1980, p. 399-408.) In an institution many workers from different departments might be occasionally exposed to by-I product material. The Commission has made a judgment that a formal ALARA
- program is the only management tool that can ensure a cooperative effort
, to reduce individual and collective dose and ensure regular safety reviews. ;
I Specific requirements usually considered part of an ALARA program are t'
required by SS 35.31 and 35.32.
26 Enclosure 1 l
k m--v-,----- - n--n.<-~,g.-- ----,n- ---n---, ,e,.n- -n--- - -wn,--- n e r v-n , - ~-nn - ~~-~~.--n.--w-n..,-n---- ns----
[7590-01]
The annual briefing of management by the Radiation Safety Officer on the byproduct material program is intended to assure that licensee management knows what kinds of byproduct material are used in which departments, which workers are involved, its use, the regulatory require-ments that govern its use, and current and potential radiation safety problems. Management needs this information to ensure that its decisions do not inadvertently result in activities contrary to the regulations or license conditions.
Non-institutional licensees, such as one or a few physicians in private practice, are not required to have a formal ALARA program because the safe use of byproduct material does not usually depend on the coopera-tion of individuals from several administratively separate departments.
S 35.31 Radiation Safety Officer.
The Radiation Safety Officer is an individual with special expertise who is needed to coordinate the safe use of byproduct material in accord-ance with the license and the Commission's regulations.
S 35.32 Radiation Safety Committee.
The proposed Part 35 requires institutional licensees to establish a Radiation Safety Committee to oversee the use of byproduct material.
The committee is required because, in an institution, radiation safety for all workers (users and ancillary staff) and the public depends on the cooperation of employees from administratively separate departments.
Without the benefit of committee discussion, authorized users may not be aware of radiation safety problems outside their own department that are caused by their patients, packages, or waste. The Committee's delibera-tions will provide management and authorized users with information that is needed to optimize allocation of resources available for radiation safety. A Committee is not required for licensees that are not medical institutions because such organizations generally do not have the multi-armed, multi-tiered management structure typical of medical institutions.
In non-institutions the authorized user is likely to be part of management and a line supervisor for ancillary workers; therefore a formal committee structure would serve no useful purpose. A similar requirement was pub-lished as a proposed rule on April 9, 1979 (44 FR 21023), and as a final rule on September 13, 1982 (47 FR 40149).
27 Enclosure 1
[7590-01]'
Committee membership must include a physician identified on the institution's license as an authorized user of byproduct material for each type of use permitted by the license, the institution's Radiation Safety Officer, a representative of the institution's management, and a representa-tive of the nursing service.
Institutions that only request a license for diagnostic sealed sources will be exempted from this requirement by license condition because the radiation safety program would not depend on the cooperation of individuals from several different departments. Packages would arrive infrequently, there would be no chance of contaminating an entire room or suite, no radioactive waste, no radioactive patients, and little chance of loss of material.
To assure the safety of workers and the public in light of site-specific exigencies, the Committee must review on the basis of safety (1) the qualifications of each individual to be listed as an authorized user, and (2) each proposed method of use. In its reviews, the Committee should consider compliance with NRC regulations, special physical or chemical containment problems, the amount of byproduct material that will be used, and the relative hazard of the material, all in light of the licensee's facility and staff.
The Committee must review occupational exposures quarterly. A more frequent review would inappropriately emphasize normal and expected statistical variations in exposure data. A less frequent review would not provide for timely notice of unnecessary or unnecessarily high doses.
The quarterly review should be guided by two trigger levels for individ-ual doses. The lower level would be a minimum level below which no action need be taken. Above the minimum level, the source of exposure should be determined and consideration given to methods of reducing the exposure rate. The higher level should trigger immediate intervention by the Radia-tion Safety Officer to reduce the exposure. The committee should review the appropriateness and completeness of the intervention, and should develop a permanent solution to maintain doses at a lower level.
The annual review of the safety program is needed to determine its adequacy in light of the current and projected use of all byproduct mate-rial. In the Commission's judgment, a review at least once each year is adequate to assure that exposures remain ALARA considering the few program 28 Enclosure 1
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adjustments typically made during any single year. More time between reviews might not permit the committee to make timely recommendations for reducing unnecessary worker, public, or patient exposure by, for example, changing space allocation, purchasing new equipment, or changing procedures.
- ' S 35.33 Requirement for authority and statement of responsibilities.
t To ensure that material is used safely, the Radiation Safety Officer and Radiation Safety Committee need a clear statement of their duties from management so that questions about authority, responsibility, and jurisdiction do not keep these individuals from acting.
S 35.34 Visiting authorized user.
, The uninterrupted provision of medical care occasionally requires a visiting authorized user to work for a host licensee when its permanent staff may be unable to do so. This was allowed in the past by a standard license condition. If the licensee had a copy of another licensee's NRC license that listed the visitor as an authorized user, the visitor could work under the license for sixty days each year without requesting a license amendment. The scope of this concept has been expanded to allow NRC licensees to employ Agreement State authorized users. Because the
! visiting authorized user's training and experience has been reviewed for health and safety consideration by a regulatory agency, this short-term authorization will not pose an undue risk to public health and safety.
The purpose of written permission is to assure that the required records have been reviewed and found complete.
When exercising this privilege, host licensees should identify each individual method of use authorized by their license, each individual method of use authorized by the visitor's license, and each individual method of use that the visitor will be allowed to do at the host facility.
Note that in some cases the Agreement States' groups, schedules, or sub-parts do not correspond to those of the NRC. The visitor can only do those procedures authorized by both licenses.
S 35.35 Mobile nuclear medicine service administrative requirements.
Mobile nuclear medicine service has been limited to diagnostic medi-cal use because the inherent hazard of therapeutic amounts of byproduct 29 Enclosure 1
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material makes it unsuitable for use in locations where the licensee might not have clear and direct control over personnel, facilities, or equipment. The Commission will continue, on a case-by-case basis, to authorize provision of low level radiopharmaceutical therapy by mobile nuclear medicine services. These licensees are required to have a letter of permission from the management of each client to assure that the client management is aware of and in agreement with the medical use of byproduct material within the facility.
Mobile service may not be provided to licensed clients because, in case of a spill or dose rates above regulatory limits, the responsibility for corrective action may be clouded.
S 35.36 Radiation safety program changes.
This section allows the licensee to make changes in the radiation safety program that was described in the application if the changes are l within the requirements of the regulation. The purpose of this authori-zation is to allow the licensee to respond to changes in staff levels, available equipment, or patient load that may require reallocation of floor space, or to make changes that may be necessary for patient care, administrative, radiation safety, or economy needs. Before implementing any change, the licensee must make a record of safety matters that were considered when planning the change. The record will be used during unannounced inspections to determine whether the licensee has made changes that are contrary to the regulations, license conditions or orders, and during termination surveys to provide an indication of every area where material was used.
This section does not allow the licensee to use byproduct material at addresses different from those listed on the license because the Commission would not be able to conduct an unannounced inspection.
S 35.37 Records and reports of misadministrations.
The proposed Part 35 retains the misadniinistration definitions and reporting and recordkeeping requirements of the current Part 35. A discussion of these requirements appears at 45 FR 31701, published May 14, 1980.
30 Enclosure 1
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S 35.38 Supervision.
The authorized user is allowed to use byproduct material in the practice of medicine. Frequently, specific tasks may be delegated (under SS 35.2(b) and 35.38) to individuals with less training and experience.
However, it is necessary that a qualified individual instruct them, oversee their work on a frequent basis, and be available to promptly respond in unusual or emergency situations. The regulatioi requires that supervised individuals comply with instructions, procedures, and the regulations.
The NRC has not specified which tasks may be delegated to whom because the practice of medicine is regulated differently in each State and because medical services must also be responsive to each community's particular needs. The NRC particularly requests comment on whether special training elements should be clearly identified for certain tasks that are delegated or whether the general guidance is sufficient.
S 35.49 Suppliers.
In order to authorize only the use of materials reviewed by the -
government for safety and effectiveness considerations, authorized users may use only byproduct material that has been manufactured and distrib-uted under procedures that were reviewed for safety by the NRC, the Food and Drug Administration (FDA), or an Agreement State.
The NRC will continue its current practice of allowing, on a case-by-case basis, re-transfer of radiopharmaceuticals between Part 35 licens-ees if an applicant specifically requests an exemption from this section and shows the exemption is in the public interest.
Subpart C--General Technical Requirements S 35.50 Possession, use, calibration, and check of dose calibrators.
A dose calibrator is needed to ensure that the dosage of material l given is the dosage that was prescribed. It must be tested for accuracy, the ability to exactly measure a specified quantity, and linearity, the ability to exactly measure a range of quantities. The requirements are generally consistent with the recommerdations of the American National Standards Institute. (See ANSI N42.13-1978. Copies may be purchased by contacting Sales Department, American National Standards Institute, l
31 Enclosure 1
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1430 Broadway, New York, NY 10018. In the interest of economy and effi-ciency, the NRC uses voluntary national standards in its regulatory program if they provide adequate assurance of safety.) The activity levels of the accuracy check sources were chosen because a lower activity would invalidate the accuracy test due to expected statistical fluctua-tions, and a higher activity would present an unnecessary source of radia-tion exposure to workers. The radionuclides required reflect the fact that dose calibrators are not as accurate as might be expected for the photon energies commonly used for imaging (see " Joint NCDRH and State Quality Assurance Surveys in Nuclear Medicine," HHS Publication FDA 83-8205). The linearity test should only be done over the range between highest individual dosage measured and 10 microcuries to ensure that the dosage given is the dosage that was prescribed. It is not necessary to test for linearity for all amounts that might be measured, for example the first elution from a fresh generator or a multidose vial, because this would subject the worker to unnecessary radiation dose. Dosages below 10 microcuries cannot be accurately measured on a conventional dose I calibrator becase they are so tiny. Also, these dosages present only a trivial risk to the patient and therefore need not be so accurately measured. The geometry test assures that the shape of the syringe or vial containing the byproduct material does not affect the dosage measure-ment. The daily constancy check assures that the dose calibrator has worked consistently since it was last tested.
Licensees whose level or scope of use does not indicate need for a dose calibrator may request an exemption from this section. The request should be supported by a description of an alternative method that the licensee will use to measure radiopharmaceutical dosages.
S 35.51 Calibration and check of survey instruments.
The 1000 mR/hr limit was chosen because that is the highest radiation exposure rate that is likely to be encountered in the medical environment.
The calibration frequency and the other prescriptive and performance requirements in this section are generally consistent with ANSI N323-1978.
S 35.53 Measurement of radiopharmaceutical dosages.
This section requires that the licensee assay the radioactivity of each radiopharmaceutical dosage before it is administered to a patient 32 Enclosure 1
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( and keep a record of the assay results. This is required to ensure that l the patient receives the intended dosage. The time at which the measure-ment must be made has been purposefully omitted to allow for flexibility in licensee's procedures.
A similar requirement was published as a proposed rule on September 1, 1981 (46 FR 43840). The comment period on the proposed rule expired November 30, 1981. The NRC is incorporating the dosage measurement pro-l posal in this revision. The proposed Part 35 dosage measurement require-l ment differs from the 1981 proposal in its recordkeeping requirement. The Part 35 proposal requires the dosage measurement record to include the patient's name, and identification number if one has been assigned, and prescribed dosage. This information was not required by the 1981 proposal.
S 35.58 Authorization for calibration and reference sources.
These sources are needed to check and test radiation instruments l and to mark images. They represent a small radiation hazard in relation l
to the amount of radioactivity used in patient care. The activity level was chosen to allow licensees to have a range of sources with several energies and half-lives available.
1 S 35.59 Requirements for possession of sealed sources and brachytherapy sources.
The user must follow the manufacturer's instructions because they have been reviewed for safety considerations by the Commission or an Agreement State.
The six-month test interval has been recommended by the National Council on Radiation Protection and Measurements (NCRP)1 in Report No. 57,
" Instrumentation and Monitoring Methods for Radiation Protection." More frequent testing is inconsistent with ALARA considerations because it would cause worker dose when making the test but provides only a slightly greater probability of finding a leaking source. The test procedures
'The National Council on Radiation Protection and Measurements (NCRP) is a nonprofit corporation chartered by Congress in 1964 to draft proposed recommendations on protection against radiation and on radiation measure-ments, quantities, and units, particularly those concerned with radiation protection. Copies of reports may be purchased by contacting NCRP Publi-cations, P.O. Box 30175, Washington, DC 20014.
33 Enclosure 1
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described are intended to maximize the probability of detecting contami-nation from a leaking source. Report No. 57, Section 3.3.5.3 recommends
! a minimum detectable limit of 0.005 microcuries for equipment used to .
1 i measure leak test samples. This level is also consistent with the requirements of other parts of the current regulations (see, for example, l SS 31.5 and 34.25), and is only slightly higher than the minimum detect-able activity exhibited by instrumentation available to licensees. The Commission has made a judgment that this level provides the most conserv-ative detection level technically achievable at a reasonable cost. It i
is noted that this requirement would reduce the current permissible
- amount of detectable contamination from teletherapy sources ten-fold, from 0.05 microcuries to 0.005 microcuries for purpose of consistency.
The Commission has made a judgment that the exempted sources do not
- present a contamination hazard because of the small amount of radioactiv-ity-in the sources, the method in which they are constructed, or the small l
hazard of the byproduct material. To conduct a physical inventory more t
- frequently than quarterly is inconsistent with ALARA exposure goals. To j inventory less frequently may, in case of a misplaced source, allow an l unacceptable radiation exposure to go on for too long without detection.
i The radiation survey assures that sources are safely stored.
1 i
9 35.60 Syringe shields.
Syringes that contain byproduct material can be an external radia-tion source and should therefore be shielded at all times. In some cases j the use of a shield when making an injection could interfere significantly
) with the injection. This would jeopardize patient benefit. In such cases
{ the higher radiation exposure to the hands that is received by the tech-i nician who does not use a syringe shield is warranted. A shield need not be used when the risk of spoiling the injection is greater than the bene-l fit of reduced worker exposure.
! The NRC considered requiring the use of syringe shields when drawing !
individual dosages from multi-dose vials. That requirement is not [
included in this proposed revision because it appears that the increased I
]
- handling required to remove the shield when measuring the dosage may actually increase radiation dose to the hands. However, the NRC is ,
i i
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soliciting comments on whether syringe shields should be used when draw-ing individual dosages.
S 35.61 Vial shields.
A vial radiation shield can significantly reduce the radiation expo-sure to the fingers and hands of an individual handling a vial of by-product material.
S 35.62 Syringe labels, and S 35.63 Vial shield labels.
Some misadministrations have been caused by accidentally transposing vials or syringes. The proper labelling of containers will help to avoid this type of mistake.
l
$ 35.70 Surveys for contamination and ambient radiation exposure rate.
Since radiopharmaceuticals are frequently handled, it is plausible that a syringe or some radioactive waste may be mislaid. This would result in unnecessary radiation exposure to workers and the public. The exposure rate survey will bring this to the attention of workers. The weekly exposure rate survey of waste storage areas will ensure that expo-sure rates in that area will be monitored so that special steps can be taken if greater than average use of radiopharmaceuticals results in higher than average exposure rates in the waste storage area.
The Commission knows that a removable contamination wipe test made several days after spillage of a short-lived radiopharmaceutical will probably not detect any contamination. The periodic contamination survey serves as a check of workers' physical control of radiopharmaceuticals.
If contamination is found, it indicates that controls or safety measures may be inadequate or are not always being used.
S 35.75 Release of patients containing radiopharmaceuticals or permanent implants.
A patient whose body contains byproduct material is a source of l external radiation and can be a source of radioactive contamination. The patient should not be released from the clinic or hospital until the residual radioactivity in the patient is at an acceptable level. The l Commission proposes to allow patient release limits based on residual l
35 Enclosure 1
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activity in the patient or exposure rate at a specified distance from the '
patient at the licensee's option. The 30 millicuries burden limit is based on a recommendation of the NCRP and current licensing practice. The 6 mR/hr at one meter limit is based on the exposure rate from 30 milli-curies of iodine-131, the most commonly used therapeutic radiopharmaceuti-cal; some individuals believe that the exposure rate is more relevant and easier to measure. The Commission believes that either limit provides an adequate measure of safety for the general public, and that further reduc-tions in public exposure are not reasonably achievable considering the cost and potential for detrimental effect from an unnecessarily long hospital confinement.
S 35.80 Mobile nuclear medicine service technical requirements.
The Commission has limited radiopharmaceutical transportation by these licensees to unit dosages and multi-dose vials of prepared radio-pharmaceuticals.
The Commission did not authorize transportation of generators because they are needed by persons who do not have daily access to pre-pared radiopharmaceuticals. That lack of access would be contrary to the geographic proximity required by S 35.38.
The service must remove all radioactive waste generated during the use of byproduct material at a client location of use because the Commis-sion has no assurance that the client is equipped to safely receive and process radioactive waste. Because there is no assurance that the licensee can control access to areas of use while working in a facility that is under another person's administrative control, client facilities should be considered as unrestricted areas, and the licensee must therefore constantly exercise physical control of byproduct material.
Equipment checks are needed to assure the proper function of equip-ment after transport and before byproduct material is handled. A survey is needed to assure that all byproduct material has been removed from the client location of use. The mobile nuclear medicine service must carry a calibrated survey meter to monitor exposure and contamination in case of any accident that may result in a release of byproduct material.
36 Enclosure 1
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i S 35.90 Storage of volatiles and gases.
Some radiopharmaceuticals present an inhalation or immersion source l (e.g., volatile iodine-131 and xenon-133 respectively). The chance of exposure can be reduced by storing these materials in a fume hood or multiple barriers (such as a folded plastic bag within a folded plastic bag).
S 35.92 Decay-in-storage.
For most hospital radiopharmaceutical waste, decay to background levels is essentially complete over a period of days or months. The l waste disposal requirements of S 20.301, directed primarily at longer
- half-lived material, are not necessary for short half-lived radiophar-maceutical waste. Therefore, short half-lived waste can be exempted f,*om the requirements of S 20.301. A decay period of ten half-lives was chosen because it represents a thousand-fold reduction in radioactivity.
This ensures that, in most cases, byproduct material will have decayed l
to levels below those in S 30.71, which are quantities that, under cer-j tain ordinary conditions, are exempt from a requirement for a specific license. The regulation would only allow decay-in-storage for radioactive
- material with a half-life of 65 days or less because storage for the i required ten half-lives would be in excess of 650 days and more appro-priately considered permanent storage. (Consistent with current practice, the Commission will consider, on a case-by-case basis, requests to decay longer-lived material or to decay for fewer half-lives.) Waste must be monitored to assure that long-lived waste was not accidentally mixed with short-lived waste and that no waste has been added to the container since it was sealed. When the waste is monitored, neither the waste nor the survey instrument may have any radiation shielding because it might hide the presence of long-lived byproduct material in the waste. The require- ,
ment to remove or obliterate radiation labels is in S 20.203(f)(4) and is i included here for completeness. Generator columns must be individually monitored because they contained larger amounts of radioactivity and also may have small amounts of long-lived contaminants.
t 1
37 Enclosure 1
[7590-01] ' i Subpart D--Uptake, Dilution, and Excretion S 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies, and S 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies (S 35.200 is also discussed later).
Drugs approved for human use by the FDA have a label or package insert that specifies the FDA-approved use, physical form, route of admin-istration, and dosage range. NRC relies primarily on FDA's determination of a radioactive drug's safety and effectiveness when it is used according to the package insert. By restricting the physician to the FDA-approved l
physical form, route of administration, and dosage range, NRC assures the safety of the public while allowing the physician flexibility regarding the choice of the clinical procedure.
The Commission notes that the FDA is considering a change in its regulations for reviewing the safety of investigational new drugs and new uses of approved drugs (see 48 FR 26720, published June 9, 1983). The Commission may revise its regulations regarding investigational new drugs and new uses of approved drugs after reviewing FDA's final rulemaking.
The FDA also authorizes the Radioactive Drug Research Committee (RDRC) at an institution to review and approve the use of radioactive materials i
for medical use research purposes. The Commission believes that the guide-l lines used by the FDA when reviewing the credentials of the RDRC members, and the guidelines that the FDA requires the RDRC to use when evaluating research proposals, are adequate to assure the safety of workers and the public without unduly restricting medical research. Therefore, the Com-mission will continue to allow, on a case-by-case basis, licensees to l administer radiopharmaceuticals authorized by an RDRC in accordance with FDA regulations. This authorization was not included in the regulation because only a few licensees request it.
The radiopharmaceuticals listed in 5 35.100 were taken from those
- listed in the current SS 35.31 and 35.100(a). Those listed in 9 35.200 j were taken from current SS 35.100(b) and (c). Mercury-203 was not included in the proposed revision because the Commission believes that there are other radiopharmaceuticals available that provide equivalent diagnostic information with much less radiation dose to the patient. l 38 Enclosure 1
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Manufacturers are currently distributing generally licensed radio-pharmaceuticals under a license issued pursuant to S 32.70. If this revision is adopted by the Commission, these manufacturers would have to apply for a license amendment to distribute radiopharmaceuticals pursuant to S 32.72.
S 35.120 Possession of survey instrument.
A low level survey instrument is needed to check areas of use for contamination. Since the total amount of radioactivity.used for uptake, dilution, and excretion studies is relatively small, the Commission does not believe the licensee needs an ionization survey instrument to measure dose rates.
Subpart E--Imaging and Localization S 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.
Xenon-133 as a gas or saline solution has been added to this group.
Manufacturers are currently distributing the product under a license issued pursuant to Part 30. If this revision is adopted by the Commis-sion, these manufacturers would have to apply for a license amendment to distribute xenon pursuant to S 32.72.
Through continuing medical research, new uses may be found for exist-ing approved radiopharmaceuticals. These new uses, which may require a 1 different dosage, route of administration, or physical form, may not appear on the manufacturer's label or package insert instructions. It was such a situation that resulted in a petition filed by Dr. George V. !
l Taplin (Docket No. PRM-35-1) requesting an exemption for Tc-99m pentetate j as an aerosol for lung function studies. A proposed rule was published !
on April 13, 1982 (47 FR 15798). The comment period on this proposed rule j expired June 14, 1982, and 35 comments were received. The NRC adopted
- the rule in final form without change on February 4, 1983 (48 FR 5217);
! the preamble of the final rule also described how to apply for future exemption requests. The NRC is incorporating this regulation into this revision of Part 35 without soliciting public comment because of the 39 Enclosure 1 i
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recentness of the rulemaking and because there are no substantive changes to the rule as adopted.
S 35.204 Permissible molybdenum-99 concentration.
Technetium-99m is produced when molybdenum-99 undergoes radioactive decay. When the technetium is separated from the molybdenum, unwanted molybdenum may appear as a contaminant in the technetium solution. The
, permissible concentration of molybdenum-99 was chosen to be consistent s.with the permissible concentration listed in the United States Pharmacopeia (USP), the nationwide standard for all pharmaceuticals used in the prac-tice of medicine. It is the judgment of the Commission that the USP standard provides an adequate level of safety and to require a different standard would be confusing and unproductive. Since diagnostic dosages of technetium-99m are generally 30 millicuries or less, the maximum permissible level of molybdenum-99 in such a dosage would result in a patient receiving an undesired 4.5 microcuries of molybdenum-99. The molybdenum would be taken up primarily by the liver. The dose to the liver would be about 0.2 rads as a result of the molybdenum concentra-tion. The Commission has made a judgment that, by holding the permis-sible concentration to the required level, the resulting radiation dose is insignificant compared to the radiation dose which would be received by the patient due to the administration of the technetium.
The licensee that elutes the generator must measure and keep a ,
record of the molybdenum concentration. Persons who receive prepared radiopharmaceuticals do not have to make this measurement because the person who prepared it would have made the measurement (see the conforming amendment to S 30.34).
S 35.205 Control of aerosols and gases.
The Commission believes that a system that provides for the collec-tion or controlled dispersal of aerosols and gases is needed to reduce exposure to workers and the public. If control is by dispersal in the atmosphere, licensees should note SS 20.105 and 20.106, which limit the amount of radioactivity in the effluent stream.
Unlike solid and liquid byproduct materials authorized by this part, gases usually cannot be contained or recovered after a spill. To reduce ,
t 40 Enclosure 1 ,
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(
i -
exposure to workers and the public after a spill, exhaust and dispersal in the atmosphere is commonly used. However, because conventional room ventilation rates are seldom sufficient to clear spilled gas in a timely fashion, the licensee must follow special, room-specific safety measures in case of a gas spill. When making the required exhaust calculation, the licensee must assume that the largest single gas container handled in the area is completely spilled, and may use either ambient or emergency air exhaust rates.
S 35.220 Possession of survey instruments.
The licensee needs a low level survey instrument to check for contami-nation and an ionization type instrument to measure dose rates in areas where large amounts of radioactive material are stored.
Subpart F--Radiopharmaceuticals for Therapy S 35.300 Use of radiopharmaceuticals for therapy.
The radiopharmaceuticals listed in S 35.300 were taken from those listed in the current SS 35.100(d) and (e). The drugs have been approved i for medical use by the FDA.
S 35.310 Safety instruction, and S 35.410 Safety instruction.
In the hospital setting, the use of byproduct material presents special training problems which are not addressed in Part 19 because they are unique to the medical environment. For example, visitor control in a hospital cannot be accomplished by physical barriers which might impede the delivery of emergency medical care to patients. After administration, ;
the byproduct material is contained in an ambulatory human.
}
Therefore, the Commission has made a judgment that worker instruction in addition to that required by Part 19 is necessary. (This parallels special instruction required, for example, for radiographers and radio- <
graphers' assistants pursuant to S 34.31 of the Commission's regulations.) I S 35.315 Safety precautions Because of the special contamination hazards of radiopharmaceutical therapy patients, a private room with private sanitary facilities is i
41 Enclosure 1
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needed to protect members of the public, who might be visiting nearby patients, from unnecessary exposure to radiation. The RSO must be notified in case of the patient's death or medical emergency in order to determine whether special contamination control procedures must be implemented.
S 35.320 Possession of survey instruments.
The licensee needs a low level survey instrument to check for con-tamination and an ionization type instrument to measure dose rates in areas where large amou..ts of radioactive material are stored.
Subpart G--Sources for Brachytherapy S 35.400 Use of sources for brachytherapy.
This section identifies brachytherapy sources that may be used for medical use. The list was taken from the current S 35.100(e), which is a list of sources commonly used for patient care.
S 35.404 Release of patients treated with temporary implants.
A responsibility of the Commission is to restrict the movement of byproduct material when the public exposure would be increased. Brachy-therapy sources for temporary implants have high levels of radiation, and remain radioactive for a long peri'od of time. Loss of control of these sources and their release to unrestricted areas may result in potentially lethal radiation exposure to members of the public. The Commission has made a judgment that temporary confinement of the implant patient is necessary to ensure public safety. Section 35.404 requires that the licensee prevent the patient from leaving the hospital or clinic until all temporary implant sources have been removed. The records required by this section may be amalgamated with the records required by S 35.406; there is no need for duplication.
S 35.406 Brachytherapy sources inventory.
Because of the particular hazard of brachytherapy sources due to their high activity and small size, the Commission believes that an inventory procedure that requires a physical count and a radiation sur-vey log entry each time sources are handled will help to ensure that if 42 Enclosure 1
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a source is misplaced its absence will quickly become apparent to the licensee, which can then promptly begin a search for the source.
S 35.415 Safety precautions.
Because of the high exposure rates around implant patients, a pri-vate room is needed to protect members of the public, who might be visit-ing nearby patients, from unnecessary exposure to radiation. The RSO must be notified in case of the patient's death or medical emergency to ensure that control of implant sources is retained.
S 35.420 Possession of survey instrument.
The licensee needs a high level survey instrument to measure exposure rates in storage areas and uncontrolled areas around a patient's room, and to check to be sure all sources have been removed from the patient before release from confinement.
Subpart H--Sealed Sources for Diagnosis S 35.500 Use of sealed sources for diagnosis.
This is a new type of use group established to incorporate the recent development of medical devices that use a sealed source of byproduct mate-rial to create a beam of ionizing radiation. These devices are now avail-able to persons licensed to use materials listed in S 35.100(f). Because the devices represent a lower level of hazard than the other sources in that group, the Commission has determined that these devices should com-prise a new group.
l l
S 35.520 Availability of survey instrument.
The licensee needs a survey instrument to measure the exposure rates around a packaged sealed source that was just received or that is to be l returnnd to the manufacturer, and to survey for contamination in case of an accident that might have compromised the integrity of the sealed source.
However, because a source exchange is an infrequent and scheduled event, and because a hazardous accident would be a very rare occurrence, the Commission believes that it is sufficient, for safety purposes, to require 43 Enclosure 1
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the licensee to make arrangements to borrow or rent an instrument or con-tract with a measurement service when measurements are necessary.
Subpart I--Teletherapy S 35.600 Use of a sealed source in a teletherapy unit.
This is a new type of use group established to deal with a well-established type of use. Safety measures that now apply to all licens-ees within this group have been used over the years and are reflected in these proposed regulations.
S 35.605 Maintenance and repair restrictions, and S 35.645 Five year inspection (S 35.645 is also discussed later).
These sections provide notice that only specially licensed persons may maintain, adjust, or repair teletherapy units because this type of work requires special training and equipment in order to be done safely.
This work is licensed under Part 30 of the Commission's regulations.
S 35.606 Amendments.
Amendments are required for items identified in paragraphs (a) through (e) because any change described in these paragraphs could easily result in an increase in radiation levels in excess of the levels author-ized in S 20.105. The service of a qualified teletherapy calibration expert is an essential element in ensuring the safe use of a teletherapy unit. The Commission has made a judgment that only an individual with special training and experience can determine the operating characteristics of the licensee's teletherapy unit and should therefore be identified on 4
the license.
S 35.610 Safety instructions.
Emergency instructions must be posted to remind individuals of the proper steps to be taken in case of an emergency and to identify indivi-duals to be notified in an emergency. The Commission believes this is also an appropriate place to remind workers that it is important to ensure that only the patient is in the room before turning the unit on.
The reminder is necessary becautee it is possible that when two workers 44 Enclosure 1
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are stationed on one teletherapy unit one worker may inadvertently turn the unit on when the other worker is still in the treatment room, or a worker may turn the unit on to check its operation after a patient or co-worker has entered the treatment room without telling the worker at the control console.
The special instruction for teletherapy workers is needed because this is the one type of medical use of byproduct material in which a worker or member of the public could receive a high, whole body dose in a matter of minutes if the source were not used safely.
S 35.615 Doors, interlocks, and warning systems.
NCRP Report No. 57, " Instrumentation and Monitoring Methods for Radiation Protection," on page 42, states that a survey of a new tele-therapy facility must determine that ". . .All entrances into the irrad-iation room or other high radiation areas are provided with barriers equipped with interlocks that are not dependent on the operation of a single circuit, and that will interrupt radiation production when the barrier is opened." There have been incidents in irradiation facilities in which personnel were unnecessarily exposed to radiation because door interlocks or alarms were intentionally bypassed for convenience. See, for example, cases 19, 21, and 28 in NUREG/BR-0001, " Case Histories of Radiography Events," vol. 1, 1980. If the interlocks and warning systems had not been bypassed, personnel would not have been irradiated. The Commission, however, has made a judgment that the dual warning system of a door interlock and a radiation monitor in the teletherapy room obviates the need for the dual circuit door interlock recommended in the report.
The beam condition indicator light will indicate to workers about to enter the room whether the mit ic turned on or off.
S 35.620 Possession of survey instrument.
The licensee needs a survey instrument on hand as a backup room moni-toring device in case the radiation monitoring device fails.
S 35.621 Radiation monitoring device.
The radiation monitoring device is needed to indicate radiation levels in the teletherapy room if the interlocks or the warning systems fail.
45 Enclosure 1
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Individuals may be unnecessarily exposed following the failure of the source retraction mechanism coupled with a failure of the primary beam condition indicator system. Therefore, S 35.621 requires licensees to install a permanent radiation monitor in each teletherapy room, to check its operation before using the teletherapy unit, and to use a portable survey instrument or personal audible alarm dosimeter if the monitor is inoperable. Similar requirements were published as a proposed rule on April 28, 1982 (47 FR 18131), and were adopted in a final rule published January 18, 1983 (48 FR 2116).
S 35.622 Viewing system.
If a patient moved during a therapy administration, this could result in a radiation dose to healthy tissue and no dose to the treatment area.
Therefore, a viewing system is needed to monitor the orientation of the patient and the teletherapy unit to assure the prescribed application of radiation.
S 35.630 Dosimetry equipment.
Dosimetry equipment is needed to measure radiation output. In order to help assure accuracy the equipment must be calibrated. The equipment requirements are the same as the current SS 35.22 and 35.23. This section also contains the proposed resolution of the petition filed by the Ameri-can Association of Physicists in Medicine, Petition Docket No. PRM 35-2 (see 47 FR 4311, January 29, 1982). Currently, regulations require that primary dosimetry equipment be calibrated every two years. The petitioner requested that this two year requirement be relaxed to four years if, two years after calibration, the primary dosimetry system is intercompared with a system that was calibrated within the past two years, and the results of the intercomparison indicate that the calibration factor used to convert an instrument reading to a dose measurement had not changed by more than two percent. (Intercomparison meetings are occasionally scheduled by several qualified teletherapy calibration experts within a geographic area. Each expert takes a dosimetry system of similar metro-logical quality tc the meeting. Each dosimetry system in turn is exposed to the same radiation dose from a teletherapy unit. The response of each dosimetry system can then be compared to the response of the other systems.
46 Enclosure 1
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If each system measures the same radiation dose in rads, this provides assurance that each system is working properly. Note that when instruments of different metrological quality are exposed to the same radiation dose, it is referred to as a comparison rather than an intercomparison.) This suggestion has been incorporated into these proposed regulations. The petitioner also asked that the licensee be required to make quarterly constancy checks to assure the consistency of operation of the dosimetry system. The Commission did not incorporate this suggestion because it is not aware of any scientific study that shows that such checks, when made with currently available equipment, are capable of detecting small but significant changes in calibration. Therefore, the Commission has no basis to assume that periodic constancy checks would necessarily provide increased assurance of proper operation.
S 35.632 Full calibration measurements.
Full calibrations are needed to ensure that the given dose is the same as the prescribed dose. The required frequency of full calibrations remains unchanged from that of the current Part 35. The test for timer accuracy has been clarified to include on-off error. The accuracy of localization devices that are used to position the teletherapy patient has been added to minimize the risk of unintentionally irradiating healthy tissue. The function of mechanical and electrical interlocks that are used to limit the directions in which the beam can be aimed, and thereby reduce the exposure rate in uncontrolled areas, has also been added. The licensee need no longer perform all measurements with a calibrated dosime-try system. Instead, the calibrated dosimetry system need only be used for one representative measurement, and then a relative exposure rate measurement system can be used to complete the calibration. This would allow for use of computer-controlled dosimetry systems that are capable of making precise relative measurements but are not suitable for making absolute output measurements.
The Commission proposes to allow licensees to use either the cur-rently required calibration procedure or a new procedure that was recently published. The new procedure is generally considered more scientifically rigorous, but the Commission believes that either procedure provides an adequate measure of teletherapy dose rate.
47 Enclosure 1
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The exposure rate from a radioactive source goes down as time pro-gresses due to source radioactive decay. To ensure accurate dose delivery, the regulation requires that licensees mathematically take this into account in calculating patient doses. The regulation requires that the licensee use time periods of not longer than one month when making decay calculations. This will ensure that the actual dose does not differ from the calculated dose by more than one percent due to this decay error.
S 35.633 Periodic spot-checks, and S 35.642 Safety checks for teletherapy facilities.
A monthly spot-check is required by S 35.22 of the current regula-tions to ensure that the teletherapy unit is giving the expected radiation dose. The following changes from current requirements have been made.
Timer accuracy has been clarified to include on off error. The accuracy of localization devices has been added. Error in either may result in incorrect administration of radiation. The qualified teletherapy calibra-tion expert must review the results of the spot-check measurements within fifteen days, and must notify the licensee in writing of the results of the monthly check, to assure the licensee and the Commission that the check results were reviewed by a qualified individual. The Commission has made a judgment that a response period of less than fifteen days would be unreasonably expensive.
A requirement to check certain safety systems in the teletherapy facility has been added. These checks are needed to assure that safety systems required by other sections of the regulations are working pro-perly. They need not be performed by the qualified teletherapy calibra-tion expert. Devices that are not working must be promptly repaired in order to assure safety in the teletherapy facility. In case of failure of the viewing system, the regulation would allow the physician to decide whether treatments should be interrupted. This would not relieve the licensee from the requirement to promptly repair the siewing system.
The regulation would require that the teletherapy unit not be used in case of door interlock failure because that is the mechanism that protects workers and the public from unintentional irradiation. However, the 48 Enclosure 1
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Commission invites comment as to whether additional administrative proce-dures or personal supervision would provide an acceptable balance of worker safety and medical use needs.
S 35.641 Radiation surveys for teletherapy facilities.
The Commission Nas used these maximum and average permissible source leakage radiation levels for several years as license conditions. They are consistent with guidance from the NCRP in its Report No. 33, " Medical X-ray and Gamma-ray Protection for Energies up to 10 MeV-Equipment Design and Use, ' Section 4.2.2. The Commission has made a judgment that they are sufficiently restrictive to keep exposures as low as reasonably achievable. The required location of the collimators during the head leakage survey is a new specification. It is based on the fact that, for individuals who recieve most of their radiation dose from working around a source in the "off" position, the collimators will normally be at the setting used for the last treatment.
S 35.643 Modification of teletherapy unit or room before beginning a ,
treatment program.
The section is needed to require that licensees take prompt action to reduce exposure rates in uncontrolled areas that may be caused by errors in design or construction of the teletherapy facility.
S 35.644 Reports of teletherapy surveys, checks, tests, and measurements.
Given the potential for high exposure to workers and the public from improperly installed teletherapy units, the radiation survey information required by S 35.644 is needed to assure that teletherapy units have been properly installed and are sufficiently shielded to en:>ure compliance with the exposure limits of Part 20.
S 35.645 Five year inspection.
Many licensees replace teletherapy sources at five year intervals.
Requiring a mechanical check at five year intervals helps to assure that the source exposure mechanism is in good working order and will not stick in the exposed position. The mechanic who exchanges sources and inspects units can remove the source, inspect the drawer mechanism, and then 49 Enclosure 1 1
[7590-01] '
install the new source. More frequent checks would require greater time near a very radioactive source. Less frequent checks would not be suffi-cient to assure the continuous proper operation of the exposure mechanism.
The identification information in the record is needed to establish which unit was inspected, when, and by whom. The remaining information is needed so the Commission may determine that the inspection was of suffi-cient depth to assure the health and safety of workers and the public.
Subpart J--Training and Experience Requirements A combination of theoretical and practical training and experience is necessary to assure the safe use of byproduct material. The criteria in this subpart were developed by the staff with the advice of the Advi-sory Committee on the Medical Use of Isotopes (ACMUI). The requirements for the Radiation Safety Officer have not been published before. The requirements for authorized users are similar to those published as an amendment to Appendix A of Regulatory Guide 10.8, " Guide for the Prepara-tion of Applications for Medical Programs," in the Federal Register on December 2, 1982 (47 FR 54376). The requirements for the qualified tele-therapy calibratica expert are similar to those required of a qualified expert pursuant to the current S 35.24.
Consistent with current practice, if individuals do not meet the training and experience standards, the NRC will review their credentials with regard to the materials requested and these standards and make authorizations on a case-by-case basis.
The Commission has received and is reviewing suggested alternative training standards for some methods of use. The review is being handled as a separate project. If any changes in training standards come out of that project, they will be published for public comment and incorporated into this subpart or elsewhere, as appropriate.
SS 35.900(a), 35.910(a), 35.920(a), 35.930(a), 35.940(a), 35.941(a),
35.950(a), 35.960(a), and 35.961(a) concerring certification.
The Commission has made a judgment that in some cases, certification by an appropriate professional board provides proof of adequate training 50 Enclosure 1
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and experience because the criteria which must be met to attain certifi-cation are more stringent than the training and experience required by the Commission.
S 35.900(c) Authorized user as a Radiation Safety Officer.
The training and experience required by the Commission includes safety considerations for the byproduct material that the aathorized user may use. Therefore, authorized users are qualified to oversee the safe use of byproduct material that they are authorized to use pursuant to the conditions of the license.
SS 35.900(b), 35.910(b), 35.920(b), 35.930(b), 35.940(b), 35.941(b),
35.950(b), 35.960(b), and 35.961(b) Training and experience.
The criteria identified in these sections were developed by the staff with the assistance of the ACMUI over the past several years. The Commis-sion has made a judgment that, for each type of use, the training and experience described is necessary to ensure the safe use of byproduct material. The duration of training and experience is usually specified in classroom (not credit) hours. Training may be received as part of a formal program at an accredited university, at a proprietary school, from an equipment or radiopharmaceutical manufacturer, or elsewhere. NRC will carefully review this information before listing an individual on a license. Supervised work experience must be received at an institution under an authorized user preceptor because usually only such an individ-ual is qualified to teach the clinical use of byproduct material, and, if the experience were not received at an institution, the student would be less likely to receive experience with all the methods of use commonly used or all the management problems associated with the safe handling of byproduct material.
SS 35.910(c) and 35.920(c) Integrated programs.
The Accreditation Council for Graduate Medical Education (ACGME) reviews and approves training programs for physicians. Approval of these training programs is based, in part, on adequate radiation safety content. The Commission has made a judgment that individuals who have successfully completed an approved training program have received suffi-cient training and experience to use byproduct material safely.
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SS 35.901 and 35.970 Current Radiation Safety Officers and authorized users.
The staff has reviewed and found acceptable the training and experi-ence of each individual who is currently listed as a Radiation Safety Officer or an authorized user. Further review of the credentials of these individuals is unnecessary.
S 35.971 Physician training exception.
In addition to the ACGME, the American Board of Radiology, the American Board of Osteopathic Radiology, and the American Board of Nuclear Medicine review and approve nuclear medicine training programs for physi-cians. These three boards independently arrived at the conclusion that, while currently acceptable, a three month training program may not allow sufficient time in the future to provide the training and experience needed to develop a satisfactory level of expertise in nuclear medicine, including radiation safety. All three boards and the ACGME have therefore extended their training programs to six months duration for those who begin their training after June 30, 1984. The Commission has made a judgment that, in the meantime, individuals who have successfully completed an approved three month training program have received sufficient training and exper-ience to use byproduct material safely.
S 35.972 Recentness of Training.
Radiation safety regulations and practices may be expected to change with time. The Commission has made a judgment that training received within the five years preceding submittal of an application is sufficiently up-to-date to assure the safe use of byproduct material. If an individal received training more than five years before the application and has not had continuing involvement in the field, training must be repeated.
Subpart K--Enforcement S 35.990 Violations.
This section gives notice that the Commission will initiate legal proceedings if necessary to enforce requirements.
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S 35.999 Resolution of conflicting requirements during transition period.
As discussed before, to allow for an orderly transition from licenses granted under the present regulations to licenses granted under the new regulations, if there is a conflict between the final rule and a licensee's radiation safety program as described in the statements, representations, and procedures submitted in support of the license request, and if the license was issued before the effective date of the final rule and has not been renewed, the requirements and authorizations of the licensee's radiation safety program will take precedence over the final rule. How-ever, if the licensee exercises its right to make a radiation safety program change as authorized under S 35.36, the changed procedure must be in accord with the revised regulation.
Conforming amendment S 31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing.
Many medical use licensees now use byproduct material for in vitro work under the provisions of current SS 31.11 and 35.14(c). The proposed conforming amendment grandfathers them. In the future, new and renewal applicants will have to specifically request permission to use S 31.11 materials as a separate line item on their applications. The use of mate-rials listed in S 31.11 within the inventory limits of that section will only be subject to the requirements of that section; consistent with cur-rent regulations, the use of materials listed in S 31.11 will not be sub-ject to the requirements of Parts 19, 20, 21, and 35 except for the Mock Iodine-125 disposal, loss or theft, and notification clause of S 31.11(f).
DERIVATION TABLE The following derivation table indentifies the origin of each sec-tion of the proposed regulations. Sources of the proposed regulations include 10 CFR Parts 19, 30, and 35, Federal Register Notices (FR), fre-quently used license conditions, licensing staff policy, current regula-
~
tory guides (RG), Office of Inspection and Enforcement bulletins, the United States Pharmacopeia, an'd new text prepared by staff.
s
~ -
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NEW SECTION NUMBER ORIGIN Subpart A--General Information 35.1 Purpose and scope. 35.1 revised 35.2 License required. 35.2 revised 35.8 Reporting, recordkeeping, and new text application requirements:
OMB Approval.
35.15 Definitions.
Agreement State 20.3 ALARA acronym Authorized users term used on licenses Dentist new term Medical institution new term Management new term Medical use 35.3(a) revised Misadministration 35.41 Mobile nuclear medicine service new term Output new term Physician 35.3(b) revised Podiatrist new term Qualified teletherapy new term calibration expert Radiation Safety Officer term used on licenses Sealed source 30.4(r) verbatim Visiting authorized user new term; similar to " visiting authorized user" license condition 35.16 Application for license, 35.4 revised amendment, or renewal.
35.17 License amendments. new text; compare 30.38 35.18 Notifications. new text 35.28 License issuance. new text, compare 30.36 35.29 Specific exemptions, new text; compare 30.11 54 Enclosure 1
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Subpart B--General Administrative Requirements 35.30 ALARA program. new text; see RG 10.8 Appendix 0 revised 35.31 Radiation Safety Officer. RG 10.8 35.32 Radiation Safety Committee. 35.11(b) revised 35.33 Requirements for authority new text and statement of responsibilities.
35.34 Visiting authorized user. license condition 35.35 Mobile nuclear medicine service licensing policy administrative requirements.
35.36 Radiation safety program changes. new text 35.37 Records and reports of 35.42 misadministrations.
35.38 Supervision. expanded from RG 10.8 p. 3 35.49 Suppliers. 35.14 revised Subpart C--General Technical Requirements 35.50 Possession, use, calibration, RG 10.8 Appendix D2 revised, and check of dose calibrators. and new text 35.51 Calibration and check of RG 10.8 Appendix D1 revised, survey instruments. and new text 35.53 Measurement of radio proposed rulemaking 35.15 pharmaceutical dosages. (46 FR 43840; September 1, 1981) 35.58 Authorization for calibration 35.14(d) revised and reference sources.
35.59 Requirements for possession 35.14(e)(1)(i), 35.14(f) of sealed sources. revised 35.60 Syringe shields. Inspection and Enforcement letter April 16, 1979 35.61 Vial shields. Inspection and Enforcement letter April 16, 1979 35.62 Syringe labels. new text 35.63 Vial shield labels. new text 55 Enclosure 1
___- _ - - _ - - _ _ - _ - - _ ~ _ . . , _ _ _ . _. _ _ _ _ _ . _ _ _ . _
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35.70 Surveys for contamination RG 10.8 Appendix I revised and ambient radiation exposure rate.
35.75 Release of patients containing new text radiopharmaceuticals or permanent implants.
35.80 Mobile nuclear medicine service licensing policy technical requirements.
35.90 Storage of volatiles and gases. RG 10.8 Appendix M revised 35.92 Decay-in-storage. license condition Subpart D--Uptake, Dilution, and Excretion 35.100 Use of radiopharmaceuticals, 35.31 and 35.100 (I) revised for uptake, dilution, and excretion studies.
35.120 Possession of survey instrument. RG 10.8 page 5 Supart E--Imaging and Localization 35.200 Use of radiopharmaceuticals, 35.100 (II) and (III) revised generators, and reagent kits for imaging and localization studies.
35.204 Permissible molybdenum-99 US Pharmacopeia concentration.
35.205 Control of aerosols RG 10.8 Appendix M revised and gases.
35.220 Posession of survey instruments. RG 10.8 page 5 Subpart F--Radiopharmaceuticals for Therapy 35.300 Use of radiopharmaceuticals 35.100 (IV) and (V) revised for therapy.
35.310 Safety instruction. 19.12 revised 35.315 Safety precautions. RG 10.8 Appendix K 35.320 Possession of survey instruments. RG 10.8 page 5 56 Enclosure 1
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Subpart G--Sources for Brachytherapy 35.400 Use of sources for 35.100 (VI) revised brachytherapy.
35.404 Release of patients treated 35.14(b)(5)(vii) revised with temporary implants.
35.406 Brachytherapy sources inventory. RG 8.18 page 8 35.410 Safety instruction. 19.12 revised 35.415 Safety precautions. RG 10.8 Appendix L 35.420 Possession of survey instruments. new text Subpart H--Sealed Sources for Diagnosis 35.500 Use of sealed sources for new text diagnosis.
, 35.520 Availabilty of survey instrument. new text Subpart I--Teletherapy 35.600 Use of a sealed source in new text a teletherapy unit.
35.605 Maintenance and repair license condition restrictions.
35.606 Amendments, new text 35.610 Safety instruction. license condition and new text 35.615 Doors, interlocks, license condition and warning systems.
35.620 Possession of survey instrument. new text 35.621 Radiation monitoring 35.25 (48 FR 2115; device. January 18, 1983) 35.622 Viewing system. license condition 35.630 Dosimetry equipment. 35.22, 35.23 revised 35.632 Full calibration 35.21 revised measurements.
35.633 Periodic spot-checks. 35.22 revised and license condition 4
57 Enclosure 1
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35.641 Radiation surveys for license condition teletherapy facilities 35.642 Safety checks for license condition
> teletherapy facilities.
35.643 Modification of teletherapy new text unit or room before beginning a treatment program.
35.644 Reports of teletherapy surveys, license condition checks, tests and measurements.
35.645 Five year inspection, license condition Subpart J--Training and Experience Requirements 35.900 Radiation Safety Officer. new text 35.901 Training for experienced new text Radiation Safety Officer.
35.910 Training for uptake, new text dilution, and excretion studies.
35.920 Training for imaging Revision of Federal Register and localization studies. Notice (47 FR 53476; December 2, 1982) 35.930 Training for therapeutic use Revision of Federal Register of radiopharmaceuticals. Notice (47 FR 53476; December 2, 1982) 35.940 Training for therapeutic Revision of Federal Register use of brachytherapy sources. Notice (47 FR 53476; December 2, 1982) 35.941 Training for ophthalmic Revision of Federal Register use of strontium-90. Notice (47 FR 53476; December 2, 1982) 35.950 Training for use of sealed new text sources for diagnosis.
35.960 Training for teletherapy. Revision of Federal Register Notice (47 FR 53476 December 2, 1982) 58 Enclosure 1
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35.961 Training for qualified 35.24 revised teletherapy calibration expert.
35.970 Training for experienced new text authorized users.
35.971 Physician training in a three new text month program.
35.972 Recentness of training. Revision of Federal Register Notice (47 FR 53476 December 2, 1982)
Subpart K--Enforcement 35.990 Violations. new text 35.999 Resolution of conflicting new text requirements during transition period.
ADMINISTRATIVE STATEMENTS Finding of No Significant Environmental Impact: Availability The Commission is proposing to completely revise the regulations governing the medical use of byproduct material. The Commission has determined under the National Evnironmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that promulgation of this regulation is not a major Federal action significantly affecting the quality of the human environment and therefore an environ-mental impact statement is not required. The radiation levels and release of byproduct material authorized by this proposed revision are consistent with the Commission's other regulations and internationally accepted standards. Most radiation experts agree that levels and releases that are within these regulations and standards will not have a significant effect on the quality of the human environment. The assessment analyzes the possible impact of release of radioactive patients, the transportation of byproduct material for medical use, storage and control of aerosols and gases, waste disposal by decay-in-storage, and dose rates outside teletherapy rooms. The environmental assessment and finding of no sig-nificant impact on which this determination is based are available for 59 Enclosure 1
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- public inspection at the NRC Public Document Room, 1717 H Street NW, Washington, DC. Single copies of the environmental assessment and finding of no significant impact are available from Mr. McElroy (see "For further information contact:" heading).
Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.
Regulatory Analysis The Commission has prepared a draft regulatory analysis on this pro-posed regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The draft analysis is avail-able for inspection in the NRC Public Document Room, 1717 H Street NW, j Washington, DC. Single copies of the analysis may be obtained from Mr. McElroy (see "For further information contact:" heading).
The Commission requests public comment on the draft regulatory analy-sis. Comments on the draft analysis may be submitted as indicated in
, the ADDRESSES heading.
Regulatory Flexibility Certification j Based on the information available at this stage of the rulemaking proceeding, in accordance with Section 605(b) of the Regulatory Flexi-
- bility Act of 1980, the Commission certifies that this proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. The NRC has issued approximately 2500 medical licenses under 10 CFR Part 35. Of these, approximately 2200 are held by
- institutions, and approximately 300 by individual physicians. Most of
] the institutional licensees are community hospitals. The Small Business l Administration size standards, 13 CFR Part 121, (49 FR 5037; February 9, 1984) classify a hospital or physician's office as a small entity if its
! average gross annual receipts do not exceed $3.5 million. Under these size standards, some NRC medical licensees could be considered "small j- entities" for purposes of the Regulatory Flexibility Act.
I 60 Enclosure 1
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The number of medical licensees that would fall into the small entity category does not constitute a substantial number for purposes of the Regulatory Flexibility Act.
The primary objective of the proposed rule is to simplify the medi-cal licensing process by consolidating requirements without lessening the protection necessary for public health and safety. This will be accomp-lished through incorporation of frequently used license conditions into the regulations and the elimination or modification of requirements that are not essential to the protection of public health and safety. These ,
steps will make it easier for a licensee to determine what is required to obtain a license and what is required of licensees. Therefore, there should not be a significant economic impact on these small entities. ,,,
The Commission has prepared a preliminary regulatory analysis for this proposed regulation which contains information concerning the antici-pated economic effect of this regulation on licensees and presents the basis for the Commission's belief that the proposed regulation would not result in significant additional costs to any licensees. It is available for public inspection in the NRC Public Document Room at 1717 H Street NW, Washington, DC. Single copies are available from Mr. McElroy (see "For further information contact:" heading).
Because of the widely differing conditions under which licensees covered by this proposed regulation operate, the Commission specifically seeks public comment from small entities. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the Commission of this in a comment that indicates:
(1) The licensee's size in terms of annual income or revenue, number of employees and, if the licensee is a treatment center, the number of beds and patients treated annually; (2) How the proposed regulation would result in a significant economic burden on the licensee as compared to that on a larger licensee; (3) How the proposed regulations could be modified to take into account the licensee's differing needs or capabilities; (4) The benefits that would be gained or the detriments that would be avoided to the licensee, if the proposed regulations were modified as suggested by the commenter; and 61 Enclosure 1
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(5) How the regulation, as modified, would still adequately protect public health and safety.
List of Subjects in 10 CFR Parts 30, 31, 32, 35, and 40.
Part 30 - Byproduct material, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Penalty, Radiation protection, Reporting and recordkeeping requirements.
Part 31 - Byproduct material, Labeling, Nuclear materials, Packaging and containers, Penalty, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment.
Part 32 - Byproduct materials, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting and recordkeeping requirements.
Part 35 - Byproduct material, Drugs, Health devices, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupa-tional safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
Part 40 - Government contracts, Hazardous materials - transportation, Nuclear materials, Penalty, Reporting and recordkeeping requirements, Source material, Uranium.
Under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553 the NRC is proposing to adopt the following revision of 10 CFR Part 35 and the following amendments to 10 CFR Parts 30, 31, 32, and 40.
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- 1. 10 CFR Part 35 is revised to read as follows:
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL Sec.
Subpart A--General Information 35.1 Purpose and scope.
35.2 License required.
35.8 Information collection requirements: OMB approval.
35.15 Definitions.
35.16 Application for license, amendment, or renewal.
35.17 License amendments.
35.18 Notifications.
35.28 License issuance.
35.29 Specific exemptions.
Subpart B--General Administrative Requirements 35.30 ALARA program.
35.31 Radiation Safety Officer.
35.32 Radiation Safety Committee.
35.33 Requirement for authority and statement of responsibilities.
35.34 Visiting authorized user.
35.35 Mobile nuclear medicine service administrative requirements.
35.36 Radiation safety program changes.
35.37 Records and reports of misadministrations.
35.38 Supervision.
35.49 Suppliers.
Subpart C--General Technical Requirements 35.50 Possession, use, calibration, and check of dose calibrators.
35.51 Calibration and check of survey instruments.
35.53 Measurement of radiopharmaceutical dosages.
35.58 Authorization for calibration and reference sources.
35.59 Requirements for possession of sealed sources and brachytherapy sources.
f 63 Enclosure 1
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- 35.60 Syringe shields. '
35.61 Vial shields.
35.62 Syringe labels.
35.63 Vial shield labels.
35.70 Surveys for contamination and ambient radiation exposure rate.
35.75 Release of patients containing radiopharmaceuticals or permanent implants.
35.80 Mobile nuclear medicine service technical requirements.
35.90 Storage of volatiles and gases.
35.92 Decay-in-storage.
Subpart D--Uptake, Dilution, and Excretion 35.100 Use of radiopharmaceuticals for uptake, dilution, and excretion studies.
35.120 Possession of survey instrument.
Subpart E--Imaging and Localization 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies.
35.204 Permissible molybdenum-99 concentration.
35.205 Control of aerosols and gases.
35.220 Possession of survey instruments.
Subpart F--Radiopharmaceuticals for Therapy 35.300 Use of radiopharmaceuticals for therapy.
35.310 Safety instruction.
35.315 Safety precautions.
35.320 Possession of survey instruments.
Subpart G--Sources for Brachytherapy 35.400 Use of sources for brachytherapy.
35.404 Release of patients treated with temporary implants.
35.403 Brachytherapy sources inventory.
35.410 Safety instruction.
35.415 Safety precautions.
35.420 Possession of survey instrument.
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Subpart H--Sealed Sources for Diagnosis 35.500 Use of sealed sources for diagnosis.
35.520 Availability of survey instrument.
Subpart I--Teletherapy 35.600 Use of a sealed source in a teletherapy unit.
- 35.605 Maintenance and repair restrictions.
35.606 Amendments.
35.610 Safety instruction.
35.615 Doors, interlocks, and warning systems.
35.620 Possession of survey instrument.
35.621 Radiation monitoring device.
35.622 Viewing system.
35.630 Dosimetry equipment.
35.632 Full calibration measurements.
35.633 Periodic spot-checks.
35.641 Radiation surveys for teletherapy facilities.
35.642 Safety checks for teletherapy facilities.
35.643 Modification of teletherapy unit or room before beginning a treatment program.
35.644 Reports of teletherapy surveys, checks, tests, and measurements.
35.645 Five year inspection.
Subpart J--Training and Experience Requirements 35.900 Radiation Safety Officer.
35.901 Training for experienced Radiation Safety Officer.
35.910 Training for uptake, dilution, and excretion studies.
35.920 Training for imaging and localization studies.
35.930 Training for therapeutic use of radiopharmaceuticals.
35.940 Training for therapeutic use of brachytherapy sources.
35.941 Training for ophthalmic use of strontium-90.
35.950 Training for use of sealed sources for diagnosis.
35.960 Training for teletherapy.
35.961 Training for qualified teletherapy calibration expert.
4 65 Enclosure 1 e . - _ .
. . _ , , . , , _ . _ . , - _ ,._~_--_,._y ._____.__y _
_ - , .-__-.., .._._,- , - .-.y -_, _ , , - . - - - ,-
[7590-01]
~
35.970 Training for experienced authorized users.
35.971 Physician training in a three month program.
35.972 Recentness of training.
Subpart K--Enforcement 35.990 Violations.
35.999 Resolution of conflicting requirements during transition period.
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273); SS 35.2, 35.17, 35.30(a) and (b), 35.31(a) and (b), 35.32, 35.33, 35.34(a),35.36(a),35.38,35.49,35.50(a)-(d),35.51(a)-(d),35.53(a) and (b), 35.59(a)-(c), (e)(1), (g) and (h), 35.60, 35.61, 35.62, 35.63, 35.70(a)-(f),35.75,35.80(a)-(e),35.90,35.92(a),35.100(b),35,120, 35.200(b) and (c), 35.204(a) and (b), 35.205, 35.220, 35.310(a), 35.315, 35.320, 35.400, 35.404(a), 35.406(a) and (c), 35.410(a), 35.415, 35.420, 35.500, 35.520, 35.605, 35.606, 35.610(a) and (b), 35.615, 35.620, 35.621(a)-(d), 35.621(f) and (g), 35.622, 35.630(a) and (b), 35.632(a)-(f),
35.633(a)-(i), 35.641(a) and (b), 35.642(a) and (b), 35.643(a) and (b),
35.645(a) and (b), 35.900, 35.910, 35.920, 35.930, 35.940, 35.941, 35.950, 35.960, 35.961, 35.970, and 35.971 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and $$ 35.18, 35.30(c), 35.31(b), 35.32(b),
35.33(b), 35.34(a) and (c), 35.35(b), 35.36(b), 35.37(a)-(d), 35.50(e),
35.51(e), 35.53(c), 35.59(d) and (e)(2), 35.59(g) and (i), 35.70(g), 35.80(f),
35.92(b), 35.204(c), 35.310(b), 35.315(b), 35.404(b), 35.406(b) and (d),
35.410(b),35.415(b),35.610(c),35.621(e),35.630(c),35.632(g),35.633(j),
35.641(c), 35.642(c), 35.643(c), 35.644, and 35.645(c) are issued under sec. 1610, 68 Stat. 950 as amended (42 U.S.C. 2201(o)).
66 Enclosure 1
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i
~
Subpart A -- General Information S 35.1 Purpose and scope.
4 This part prescribes requirements and provisions for tne medical use I
of byproduct material and for issuance of specific licenses authorizing
- the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The require-ments and provisions of this part are in addition to, and not in substi-tution for, others in this chapter. The requirements and provisions of Parts 19, 20, 21, 30, 71, and 170 of this chapter apply to applicants and
, licensees subject to this part unless specifically exempted.
- 6 35.2 License required.
(a) No person shall manufacture, produce, acquire, receive, possess, use, or transfer byproduct material for medical use except in accordance with a specific license issued by the Commission or an Agreement State and as allowed in paragraph (b) of this section.
(b) An individual may receive, possess, use, or transfer byproduct material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in S 35.38, unless pro-i hibited by license condition.
S 35.8 Information collection requirements: OMB approval. e (a) The Commission has submitted the information collection require-ments contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act of 1980 (44 U.S.C.
3501 et seq.). OMB has approved the information collection requirements in this part under control number 3150- .
(b) The approved information collection requirements contained in this part appear in SS 35.16, 35.17, 35.18, 35.30(c), 35.31(b), 35.32(a),
35.33(b),35.34(c),35.35(b),35.36,35.37(a)-(d),35.50(e),35.51(e),
35.53(c), 35.59(d), (e), (g), and (i), 35.70(g), 35.80(f), 35.92(b),
35.204(c),35.310,35.404(b),35.406,35.410(b),35.606,35.610,35.621(e),
35.630(c), 35.632(g), 35.633(e) and (j), 35.641(c), 35.642(c), 35.643(c),
35.644, and 35.645(c).
67 Enclosure 1
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S 35.15 Definitions.
~
" Agreement State" means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic Energy Act of 1954, as amended.
"ALARA" means as low as reasonably achievable.
" Area of use" means a portion of a physical stru::ture that has been set aside for the purpose of receiving, using, or storing byproduct material.
" Authorized user" means a physician, dentist, or podiatrist who is identified as an authorized user on a Commission or Agreement State license that authorizes the medical use of byproduct material.
" Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of l Puerto Rico to practice dentistry on humans.
" Management" means the chief executive officer.
" Medical Institution" means an organization in which several medical l
disciplines are practiced.
l " Medical use" means the intentional internal or external administra-tion of byproduct material, or the radiation therefrom, to human beings in the practice of medicine in accordance with a license issued by a l State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
" Misadministration" means the administration of:
(1) A radiopharmaceutical or radiation from a sealed source other than the one intended; (2) A radiopharmaceutical or radiation to the wrong patient; (3) A radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician; j (4) A diagnostic dosage of a radiopharmaceutical differing from the prescribed dosage by more than 50 percent; (5) A therapeutic dosage of a radiopharmaceutical differing from the prescribed dosage by more than 10 percent; or (6) A therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry result in a calculated total treatment dose differing from the final pre-scribed total treatment dose by more than 10 percent.
68 Enclosure 1
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~
" Mobile nuclear medicine service" means the transportation and medical use of byproduct material.
" Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.
" Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia,
+ or the Com:;.onwealth of Puerto Rico to prescribe drugs in the practice of medicine.
" Podiatrist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry on humans.
" Qualified teletherapy calibration expert" means the individual identified as the qualified teletherapy calibration expert on a Commission license.
" Radiation Safety Officer" means the individual identified as the Radiation Safety Officer on a Commission license.
" Sealed source" means any byproduct material that is encased in a capsule designed to prevent leakage or escape of the byproduct material.
" Visiting authorized user" means an authorized user who is not identified on the license of the host. I l
S 35.16 Application for license, amendment, or renewal.
(a) For use sited in a medical institution, only the institution's management may apply. For use not sited in a medical institution, any person may apply.
(b) An application for a license for medical use of byproduct mate-rial as described in SS 35.100, 35.200, 35.300, 35.400, and 35.500 of this part must be made by filing an original and one copy of Form NRC-313, i
" Application for Materials License." For guidance in completing the form, refer to the instructions in Regulatory Guide 10.8 Revision 2, " Guide for the Preparation of Applications for Medical Programs." A request for a license amendment or renewal may be submitted as an original and one copy in letter format.
(c) An application for a license for medical use of byproduct mate-rial as described in S 35.600 of this part must be inade by filing an 69 Enclosure 1
[7590-01]
original and one copy of Form NRC-313. For guidance in completing the form, refer to the instructions contained in Regulatory Guide 10.- ,
" Guide for the Preparation of Applications for Teletherapy Programs." A request for a license amendment or renewal may be submitted as an origi-nal and one copy in letter format.
(d)' An applicant shall mail the completed request as directed below.
(1) If the applicant is not a Federal agency and is located in Connecticut, the District of Columbia, Delaware, Maine, Massachusetts, New Jersey, Pennsylvania, or Vermont, it shall mail or deliver the com-pleted application form to U.S. Nuclear Regulatory Commission, Region I, Material Licensing, 631 Park Avenue, King of Prussia, Pennsylvania 19406.
(2) If the applicant is not a Federal agency and is located in Virginia, West Virginia', Puerto Rico, or the Virgin Islands, it shall mail or deliver the completed application form to U.S. Nuclear Regulatory Commission, Region II, Material Licensing Section,101 Marietta Street, Suite 2900, Atlanta, Georgia 30323.
(3) If the applicant is not a Federal agency and is located in illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, or Wisconsin, it shall mail or deliver the completed application form to U.S. Nuclear Regulatory Commission, Region III, Material Licensing Section, 799 Roose-velt Road, Glen Ellyn, Illinois 60137.
(4) If the applicant is not a Federal agency and is located in Oklahoma, Montana, South Dakota, or Wyoming, it shall mail or deliver the completed application form to U. S. Nuclear Regulatory Commission, Region IV, Material Licensing Section, 611 Ryan Plaza Drive, Suite 1000, Arlington, Texas 76011.
(5) If the applicant is not a Federal agency and is located in Alaska, Hawaii, or Guam, it shall mail or deliver the completed applica-tion form to U.S. Nuclear Regulatory Commission, Region V, Material Licensing Section, 1450 Maria Lane, Suite 210, Walnut Creek, California 94596.
(e) If the applicant is a Federal agency or if it is located in a State, territory, or possession that is not mentioned in paragraphs (d)(1) through (5) of this section, it shall:
70 Enclosure 1
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(1) Mail the completed application form to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commis-sion, Washington, DC 20555, or (2) Deliver the completed application form to the Commission offices at:
(i) 1717 H Street NW, Washington, DC, or (ii) 7915 Eastern nvenue, Silver Spring, Maryland.
S 35.17 License amendments.
A licensee shall apply for and must receive a license amendment:
, (a) Before it uses byprot'uct material for a method or type of medical use not permitted by the license issued under this part; (b) Before it permits anyone, except a visiting authorized user described in S 35.34, to work as an authorized user under the license; (c) Before it changes Radiation Safety Officers or Qualified Tele-therapy Calibration Experts; (d) Before it receives byproduct material in excess of the amount authorized on the license; and (e) Before it adds to or changes the location or locations of use or mailing address identified on the license.
S 35.18 Notifications.
A licensee shall notify the Commission by letter within thirty days when an authorized user, Radiation Safety Officer, or Qualified Tele-therapy Calibration Expert, permanently discontinues performance of duties under the license. It shall mail the report to the appropriate address identified in S 35.16.
S 35.28 License issuance.
The Commission shall issue a license for the medical use of byproduct material for a term of five years if:
(a) The applicant has filed Form NRC-313 " Application for Materials License" in accordance with the instructions in S 35.16; (b) The applicant has paid any applicable fee as provided in Part 170 of this chapter; 71 Enclosure 1
[7590-01]
(c) The Commission finds the applicant equipped and committed to observe the safety standards established by the Commission for the protection of -the public health and safety; and (d) The applicant meets the requirements of Part 30 of this chapter.
8 35.29 Specific exemptions.
The Commission may, upon application of any interested person or upon its own initiative, grant such exemptions from the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
Subpart B--General Administrative Requirements 6 35.30 ALARA program.
(a) Each medical institution licensee shall implement a program to maintain individual and collective dose equivalents as low as reasonably achievable.
(b) To satisfy the requirement of paragraph (a) of this section:
(1) Management, the Radiation Safety Officer, and all authorized users must participate in the establishment, implementation, and oper-ation of the program as required by the regulations or requested by the Radiatio'1 Safety Committee.
(2) The program must include an annual review by the Radiation Safety Committee of the types and amounts of byproduct material used, occupational dose reports or summaries, and continuing education and training for all personnel who work with or in the vicinity of byproduct ma+arial. The purpose of the review is to ensure that individuals make every reasonabia effort to maintain individual and collective occupational dose as low as reascc. ably achievable, taking into account the state of technology, and the cost of improvements in relation to benefits.
(c) A licensee shall retain a written description of the ALARA program for the duration of the license. The written description must include:
(1) A commitment by management to keep individual and collective occupational dose as low as reasonably achievable; 72 Enclosure 1
[7590-01]
O (2) A requirement that the Radiation Safety Officer brief management '
once each year on the byproduct material program; (3) Personnel exposure investigational levels that, when exceeded, will initiate an investigation by the Radiation Safety Officer of the cause of the exposure; and (4) Personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the Radiation Safety Officer of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence.
S 35.31 Radiation Safety Officer.
(a) A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.
(b) The Radiation Safety Officer shall:
(1) Investigate overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, and disposals, and other devia-tions from approved radiation safety practice and implement corrective actions as necessary; (2) Establish and implement written policy and procedures for:
(i) Authorizing the purchase of byproduct material; (ii) Receiving and opening packages of byproduct material; (iii) Storing byproduct material; (iv) Keeping an inventory record of byproduct material; (v) Using byproduct material safely; (vi) Taking emergency action if control of byproduct material is lost; (vii) Performing periodic radiation surveys; (viii) Performing checks of survey instruments and other safety equipment; (ix) Disposing of byproduct material; (x) Training personnel who work in or frequent areas where byproduct material is used or stored; 73 Enclosure 1
[7590-01]
(xi) Keeping a copy of all records and reports required by the Commission regulations, a copy of these regulations, a copy of each licensing request and license and amendments, and the written policy and procedures required by the regulations.
(3) For medical use not at a medical institution, approve or disapprove radiation safety program changes with the advice and consent of managenent; and (4) For medical use at a medical institution, assist the Radiation Safety Committee in the performance of its duties.
S 35.32 Radiation Safety Committee.
Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material. Management may estab-lish more than one committee to meet these responsibilities.
(a) Each Committee must meet the following administrative requirements:
(1) Membership must consist of at least three individuals and must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, !
and a representative of management who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate.
(2) The Committee must meet a least quarterly.
(3) To establish a quorum and to conduct business, one-half of the Committee's membership must be present, including the Radiation Safety Officer and the management's representative.
(4) The minutes of each Radiation Safety Committee meeting must include:
(i) The date of the meeting; (ii) Members present; (iii) Members absent; (iv) Summary of deliberations and discussions; (v) Recommended actions and the numerical results of all ballots; and (vi) ALARA program reviews described in S 35.30(b)(2)
(5) The Committee must provide each member with a copy of the meeting' minutes, and retain one copy for the duration of the license.
74 Enclosure 1
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(b) To oversee the use of licensed material, the Committee must:
(1) Be responsible for monitoring the institutional program to maintain individual and collective doses as low as reasonably achievable; (2) Review, on the basis of safety and with regard to the training and experience standards in Subpart J of this part, and approve or dis-approve any individual who is to be listed as an authorized user, the Radiation Safety Officer, or Qualified Teletherapy Calibration Expert before submitting a license application or request for amendment or renewal; (3) Review on the basis of safety and approve or disapprove each proposed method of use of byproduct material; (4) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove procedures and radiation safety program changes;
-(5) Review quarterly, with the assistance of the Radiation Safety Officer, occupational radiation exposure records of all personnel working with byproduct material; (6) Review quarterly, with the assistance of the Radiation Safety Officer, all incidents involving byproduct material with respect to cause and subsequent actions taken; (7) Review annually, with the assistance of the Radiation Safety Officer, the byproduct material program; and (8) Establish a table of investigational levels for occupational dose that, when exceeded, will initiate investigations and consider-ations of action by the Radiation Safety Officer.
S 35.33 Requirement for authority and statement of responsibilities.
(a) A licensee shall provide the Radiation Safety Officer, and at a medical institution the Radiation Safety Committee, sufficient author-ity and organizational freedom to:
(1) Identify radiation safety problems; (2) Initiate, recommend, or provide solutions; and (3) Verify implementation of solutions.
(b) A licensee shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Officer, and at a medical institution the Radiation Safety Committee.
75 Enclosure 1
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- S 35.34 Visiting authorized user.
(a) A licensee may permit any visiting authorized user to use licensed material for medical use under the terms of the licensee's I license for sixty days each year if:
(1) The visiting authorized user has the prior written permission of the licensee's management and, if the use occurs on behalf of an -
institution, the institution's Radiation Safety Committee; (2) The licensee has a copy of a Commission or Agreement State license that identifies the visiting authorized user by name as an authorized user for medical use; and (3) Only those procedures for which the visiting authorized user is specifically authorized by a Commission or Agreement State license are
. performed by that individual.
(b) A licensee need not apply for a license amendment in order to permit a visiting authorized user to use licensed material as described in paragraph (a) of this section.
(c) A licensee shall retain copies of the records specified in this section for two years after the visiting authorized user's last use of ,
licensed material unless the visiting authorized user has been listed as an authorized user on the licensee's license.
S 35.35 Mobile nuclear medicine service administrative requirements.
(a) The Commission will only license mobile nuclear medicine service in accordance with Subparts D, E and H of this part and S 31.11 of this chapter to serve clients who do not have a Commission or Agreement State license for the materials listed in those Subparts.
(b) Mobile nuclear medicine service licensees shall retain for the duration of service a letter signed by the management of each location where services are rendered that authorizes use of byproduct material.
S 35.36 Radiation safety program changes.
(a) A licensee may change the radiation safety procedures and equipment that are used to meet regulatory requirements and that were described in the application for license, renewal, or amendment. The licensee may also receive, use, and store licensed material (except 76 Enclosure 1
[7590-01]
teletherapy sources) in areas of use that were not identified in the application for license, renewal, or amendment.
(b) A licensee shall retain for the duration of the license a record of each change. The record must include the effective date of the change, a copy of the old and new radiation safety procedures, equipment descrip-tions, or area floor plans, the reason for the change, a summary of radiation safety matters that were considered before making the change, the signature of the Radiation Safety Officer, and the signatures of the affected authorized users and of management or, in a medical institution, the Radiation Safety Committee's chairman and the management representative.
S 35.37 Records and reports of misadministrations.
(a) When a misadministration involves any therapy procedure, the licensee shall notify by telephone the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. The licensee shall also notify the referring physician of the affected patient and the patient or a responsible relative (or guardian), unless the referring physician agrees to inform the patient or believes, based on medical judgment, that telling the patient or the patient's responsible relative (or guardian) would be harmful to one or the other, respectively. These notifications must be made within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee discovers the misadminis-tration. If the referring physician, patient, or the patient's responsible relative or guardian cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify.them as soon as practicable. The licensee is not required to notify the patient or the patient's responsible relative or guardian without first consulting the referring physician; however, the licensee shall not delay medical care for the patient because of this.
(b) Within 15 days after an initial therapy misadministration report to NRC, the licensee shall report, in writing, to the NRC Regional Office initially telephoned and to the referring physician, and furnish a copy of the report to the patient or the patient's responsible relative (or guardian) if either was previously notified by the licensee under paragraph (a) of this section. The written report must include the I
licensee's name; the referring physician's name; a brief description of I
l l
l l
77 Enclosure 1 l
.- ----- - - - ---mn, . - , . . - - , - . - - - ,,,---------.,...------,-,--,--n,-,-nee-- --~n em----- - --
[7590-01] . .
the event; the effect on the patient; the action taken to prevent recur- ,
rence; whether the licensee informed the patient or the patient's respon-sible relative (or guardian), and if not, why not. The report must not include the patient's name or other information that could lead to identification of the patient.
(c) When a misadministration involves a diagnostic procedure, the licensee shall notify, in writing, the referring physician and the appropriate NRC Regional Office listed in Appendix D of Part 20 of this chapter. Licensee reports of diagnostic misadministrations are due within 10 days after the end of the calendar quarters (defined by March, June, September and December) in which they occur. These written reports must include the licensee's name; the referring physician's name; a description of the event; the effect on the patient; and the action taken to prevent recurrence. The report should not include the patient's name or other information that could lead to identification of the patient.
(d) Each licensee shall retain for ten years a record of each misadministration. The record must contain the names of all individuals involved in the event (including the physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number, a brief description of the event, the effect on the patient, and the action taken to prevent recurrence.
(e) Aside from the notification requirement, nothing in this section shall affect any rights or duties of licensees and physicians in relation to each other, patients, or responsible relatives (or guardians).
S 35.38 Supervision.
A licensee who permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user as allowed by S 35.2(b) shall:
(a)(1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct material; (2) Review the supervised irJividual's use of byproduct material and the records kept to reflect this use; (3) Require the authorized user to be immediately available by telephone to the supervised individual; and 78 Enclosure 1
[7590-01]
~
(4) Require the authorized user to be able to be physically present and available to the supervised individual on one hour's notice. The supervising authorized user need not be present for each use of byproduct material.
(b) Require the supervised individual receiving, possessing, using or transferring byproduct material under S 35.2(b) to:
(1) Follow the instructions of the supervising authorized user; (2) Follow the procedures established by the Radiation Safety Officer; and (3) Comply with the regulations of this part and the license condi-tions with respect to the use of byproduct material.
S 35.49 Suppliers.
A licensee may use for medical use only:
(a) Byproduct material manufactured, labeled, packaged, and distri-buted in accordance with a license issued pursuant to the regulations in Part 30 and SS 32.72, 32.73, or 32.74 of this chapter or the equivalent regulations of an Agreement State; (b) Reagent kits that have been manufactured, labeled, packaged, and distributed in accordance with an approval by the Commission pursuant to S 32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use; and (c) Teletherapy sources manufactured and distributed in accordance with a license issued persuant to Part 30 of this chapter or the equiva-lent regulations of an Agreement State.
Subpart C--General Technical Requirements S 35.50 Possession, use, calibration, and check of dose calibratoes.
(a) A medical use licensee authorized to administer radiopharma- l ceuticals shall have in its possession a dose calibrator and use it to measure the amount of activity administered to each patient. '
(b) A licensee shall:
(1) Check each dosa calibrator for constancy with a dedicated check source at the beginning of each day of use. To satisfy the requirement 7 of this paragraph, the check must be done on a frequently used setting i
79 Enclosure 1
[7590-01] ' '
~
with a sealed source of not less than 10 microcuries of radium-226 or 50 microcuries of any other photon-emitting radionuclide; (2) Test each dose calibrator for accuracy upon installation and at least annually thereafter by assaying at least two sealed sources containing different radionuclides whose activity the manufacturer has determined within 5 percent of its stated activity, whose activity is at least 10 microcuries for radium-226 and 50 microcuries for any other photon-emitting radionuclide, and at least one of which has a principal photon energy between 100 kev and 500 kev; (3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the range of its use between the highest dosage that will be administered and 10 microcuries; and (4) Test each dose calibrator for geometry dependence upon installa-tion over the range of volumes and volume configurations for which it will be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator.
(c) A licensee shall also perform appropriate checks and tests required by this section following adjustment or repair of the dose calibrator.
(d) A licensee shall mathematically correct dosage readings for any geometry or linearity error that exceeds 10 percent if the dosage is greater than 10 microcuries and shall repair or replace the dose cali-brator if the accuracy or constancy error exceeds 10 percent.
(e) A licensee shall retain a record of each check and test required by this section for two years unless directed otherwise. The records required in paragraphs (b)(1) through (b)(4) of this section must include:
(1) For paragraph (b)(1), the model and serial number of the dose calibrator, the identity of the radionuclide contained in the check source, the date of the check, the activity measured, and the initials of the individual who performed the check; (2) For paragraph (b)(2), the model and serial number of the dose calibrator, the model and serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, and the signature of the Radiation Safety Officer; 80 Enclosure 1
t t%
u'
'M
[7590-01]
- P ..
(3) For-pahagraph(b)(3),themodelandserialnumberofthedose calibritor,thecalculatedactiv'ities,themeasuredactivities,thedate
~
<x,e '
of the test, and the signature of the Radiation Safety Officer; and
- .- (4) -For paragraph (b)(4), the model and serial number of the dose t ;- 6 I calibrator, the configuration of the source measured, the activity measured s ~, .
a ^
for each volume measured, the date of the test, and the signature of the
~
l Radiation Safety 0fficer. ~-
t H $ 35.51 Calibration and check of survey instruments. s (a) A licensee shall calibrate the survey instruments used to show 4
compliance with this'part before first use, annually, and following repair; (b) To satisfy,the requirements of paragraph (a) of this section,
~
the licensee shall: ,
x, r 'w.
(1) Calibrate all scale readin'gs up to 1000 milliroentgens per hour /
with a radiation source; (2) Calibrate two readings on each scale that must be calibrated; and (3) Conspicuously note on the instrument the apparent exposure
? rate from a dedicated check source as determined at the time of calibra-
~
tion, and the date of calibration.
(c) . To satisfy the requirements of paragraph (b) of this section, the licensee shall:
-(g) Consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 10 percent;
'and s -
n
] (2) Consider a point as calibrated if the indicated exposure rate differs frota the calculated exposu're rate by not more than 20 percent if-C a correction chart or graph is conspicuously atiached to the instrument.
_, (d) A' licensee shall check each survey instrument for proper opera-1-
[ ] ' tion with the dedicated check source before' and after each use. The
> h iicensee is not required to keep records of these checks.
j
%^ (e) The licensee shall retain a record of each calibration required in p'aragraph (a) of this section for two years. To satisfy the require-ments of this paragraph, the record must include: ( - . 1 l , (1). A description of the calibration procedure; and
~
I s. Q. ' ~. I ( 81 Enclosure 1
-- , - - . - - , - - - - . . -- -,-m ,-..,,,,.,,,n. .._nn,--, _,,,,--.,,,,_,,,,p,,.,.m,,.-- ,,..,,,m- _m.,,n,,,-,.,n.m.,-.e , . . , , , , . - - .
[7590-01] ' (2) A description of the source used and the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, and the signature of the individual who performed the calibration. S 35.53 Measurement of radiopharmaceutical dosages. A licensee shall: (a) Assay before medical use the activity of each radiopharmaceu-tical dosage that contains more than 10 microcuries of a photon-emitting radionuclide; (b) Assay before medical use the activity of each radiopharmaceutical dosage with a desired activity of 10 microcuries or less of a photon-emitting radionuclide to verify that the dosage does not exceed 10 micro-curies; (c) Retain a record of the measurements required by this section for two years. To satisfy this requirement, the record must contain the: (1) Generic name, trade name, or abbreviation of the radiopharma-ceutical, its lot number, and expiration dates and the radionuclide; (2) Patient's name, and identification number if one has been assigned; (3) Prescribed dosage and activity of the dosage at the time of measurement, or a notation that the total activity is less than 10 micr-ocuries;
- (4) Date and time of the measurement; and (5) Initials of the individual who made the measurement.
l S 35.58 Authorization for calibration and reference sources. l Any person authorized by S 35.2 for medical use of byproduct mate-rial may receive, possess, and use the following byproduct material for check, calibration, and reference use: (a) Sealed sources manufactured and distributed by a person licensed pursuant to S 32.74 of this chapter or equivalent Agreement State regula-tions and that do not exceed 6 millicuries each; 82 Enclosure 1 L
[7590-01] (b) Any byproduct material listed in SS 35.100 or 35.200 with a half-life not longer than 100 days in individual amounts not to exceed 15 millicuries; (c) Any byproduct material listed in SS 35.100 or 35.200 with a half life longer than 100 days in individual amounts not to exceed 200 microcuries each; and (d) Technetium-99m in individual amounts not to exceed 50 millicuries. S 35.59 Requirements for possession of sealed sources and brachytherapy sources. (a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to users. (b) A licensee in possession of a sealed source shall: (1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and (2) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement l State and described in the label or brochure that accompanies the source. (c) To satisfy the leak test requirements of this section, the licensee must: (1) Take a wipe sample from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which radioactive contamination might be expected to accumulate or wash the i source in a small volume of detergent solution and treat the entire l volume as the sample; l (2) Take the teletherapy source test sample when the source is in the "off" position; and , (3) Measure the sample so that the leakage test can detect the presence of 0.005 microcuries of radioactive material on the sample. (d) A licensee shall retain leakage test records for two years. The records must contain the model number, and serial number if assigned, of each source tested, the identity of each source radionuclide and its estimated activity, the measured activity of each test sample expressed 83 Enclosure 1
[7590-01]
- in microcuries, a description of the method used to measure each test sample, the date of the test, and the signature of the Radiation Safety 0fficer.
(e) If the leakage test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall: (1) Immediately withdraw the sealed source from use and store it in accordance with the requirements in Parts 20 and 30 of this chapter; and (2) File a report within five days of the leakage test with the appropriate Nuclear Regulatory Commission Regional Office listed in Appendix D of Part 20 of this chapter, with a copy to Director of Inspec-tion and Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, describing the equipment involved, the test results, and the action taken. (f) A licensee need not perform a leakage test on the following sources: (1) Sources containing only byproduct material with a half-life of less than 30 days; (2) Sources containing only byproduct material as a gas; (3) Sources containing 100 microcuries or less of beta or gamma-emitting material or 10 microcuries or less of alpha-emitting material; (4) Sources stored and not being used. The licensee shall, however, test each such source for leakage before any use or transfer unless it has been leakage-tested within six months before the date of use or transfer; and (5) Seeds of iridium-192 encased in nylon ribbon. (g) A licensee in possession of a sealed source or brachytherapy source shall conduct a quarterly physical inventory of all such sources in its possession. The licensee shall retain each inventory record for five years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, and the signature of the Radiation Safety Officer. (h) A licensee in possession of a sealed source or brachytherapy source shall survey with a low range survey meter quarterly all areas 84 Enclosure 1
[7590-01] where such sources are stored. This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices. (i) A licensee shall retain a record of each survey required in paragraph (h) of this section for two years. The record must include the date of the survey, a plan of each area that was surveyed, the measured exposure rate at several points in each area expressed in millirem per hour, the model number and serial number of the survey instrument used to make the survey, and the signature of the Radiation Safety Officer. S 35.60 Syringe shields. (a) A licensee shall keep syringes that contain byproduct iraterial to be administered in a radiation shield. (b) A licensee shall require each individual who prepares a radio-pharmaceutical kit to use a syringe radiation shield and shall require each individual who administers a radiopharmaceutical by injection to use a syringe radiation shield unless the use of the shield is contraindicated for that injection. S 35.61 Vial shields. l A licensee shall require each individual preparing or handling a vial that contains a radiopharmaceutical to keep the vial in a vial radiation shield.
, S 35.62 Syringe labels.
A licensee shall conspicuously label each syringe, or syringe radia-tion shield that contains a syringe with a radiopharmaceutical, with the radiopharmaceutical's abbreviation or with the type of diagnostic study or therapy procedure to be performed. S 35.63 Vial shield labels. , A licensee shall conspicuously label each vial radiation shield that contains a vial of a radiopharmaceutical with the radiopharmaceutical name or its abbreviation. I i 85 Enclosure 1 1
8 0 [7590-01] 4 l S 35.70 Surveys for contamination and ambient radiation exposure rate. (a) A licensee shall survey with a low range survey meter at the l end of each day of use all areas where radiopharmaceuticals are routinely i prepared for use or administered. (b) A licensee shall survey with a low range survey meter at least l once each week all areas where radiopharmaceuticals or radiopharmaceutical l waste is stored. l (c) A licensee shall conduct the surveys required by paragraphs (a) l and (b) of this section so as to be able to measure exposure rates as low l as 0.1 milliroentgen per hour. l (d) A licensee shall establish radiation exposure rate action levels for the surveys required by paragraphs (a) and (b) of this section and i shall require that the individual performing the survey immediately notify l the Radiation Safety Officer if an exposure rate exceeds an action level. l (e) A licensee shall survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored. (f) A licensee shall conduct the surveys required by paragraph (e) of this section so as to be able to detect contamination on each wipe sample of 200 disintegrations per minute. (g) A licensee shall establish removable contamination action levels for the surveys required by paragraph (e) of this section and shall require I that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds the action level. (h) A licensee shall retain a record of each survey for two years. The record must include the date of the survey, a plan of each area sur-veyed, the action level established for each area, the measured exposure rate at several points in each area expressed in millirem per hour or disintegrations per minute, the model number of the instrument used to make the survey or analyze the samples, and the initials of the individual who performed the survey. S 35.75 Release of patients containing radiopharmaceuticals or permanent implants. 1 (a) A licensee may not authorize release from confinement for medical care any patient administered a radiopharmaceutical until either: 1 l 86 Enclosure 1 l i
[7590-01] (1) The exposure rate from the patient is less tnan 6 milliroentgens per hour at a distance of one meter; or (2) The activity in the patient is less than 30 millicuries. (b) A licensee may not authorize release from confinement for medical care of any patient administered a permanent implant until the exposure rate from the patient is less than 6 milliroentgens per hour at a distance of one meter. S 35.80 Mobile nuclear medicine service technical requirements. A licensee providing mobile nuclear medicine service shall: (a) Transport to each location of use only syringes or vials containing prepared radiopharmaceuticals; (b) Bring into each location of use all byproduct material to be used and, before leaving, remove all unused byproduct material and all associated waste; (c) Secure or keep under constant surveillance and immediate control all byproduct material when in transit or at a location of use; (d) Check survey instruments and dose calibrators as described in SS 35.50 and 35.51, and check all other transported equipment for proper function before medical use at each location of use; (e) Carry a calibrated survey meter in each vehicle that is being used to transport byproduct material, and, before leaving a client loca-tion of use, survey all radiopharmaceutical areas of use with a low range survey meter to ensure that all radiopharmaceuticals and all associated waste have been removed; (f) Retain a record of each survey required in paragraph (e) of I this section for two years. The record must include the date of the survey, a plan of each area that was surveyed, the measured exposure rate at several points in each area of use expressed in millirem per hour, the model number of the instrument used to make the survey, and the initials of the individual who performed the survey, 6 35.90 Storage of volatiles and gases. A licensee shall store volatile radiopharmaceuticals and radioactive gases in a fume hood or in a container with two barriers against release. l l l 87 Enclosure 1
[7590-01] . . S 35.92 Decay-in-storage. - (a) A licensee may hold byproduct material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash and is exempt from the requirements of S 20.301 of this chapter if it: (1) Holds byproduct material for decay a minimum of ten half-lives; (2) Monitors byproduct material at the container surface bofore disposal as ordinary trash and determines that its radioactivity cannot be distinguished from the background radiation level with a low range survey meter set on its most sensitive scale and with no interposed shielding; (3) Removes or obliterates all radiation labels; and (4) Separates and monitors each generator column individually with all radiation shielding removed to ensure that it has decayed to background radiation level before disposal. , (b) For paragraph (a) of this section, the licensee shall retain a record of each disposal for two years. The record must include the date of the disposal, the date on which the byproduct material was placed in storage, the model number of the survey instrument used, the background radiation exposure rate, the radiation exposure rate measured at the surface of each waste container, and the name of the individual who performed the disposal. Subpart D--Uptake, Dilution, and Excretion S 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies. (a) A licensee may use the following prepared radiopharmaceuticals for diagnostic studies involving the measurement of uptake, dilution, or excretion: (1) Iodine-131 as sodium iodide, fodinated human serum albumin (IHSA), labeled rose bengal, or sodium todohippurate; (2) Iodine-125 as sodium iodide or iodinated human serum albumin (IHSA); (3) Cobalt-58 as labeled cyanocobalamin; 88 Enclosure 1
[7590-01]
~
(4) Cobalt-60 as labeled cyanocobalamin; (5) Chromium-51 as sodium chromate or labeled human serum albumin; (6) Iron-59 as citrate; (7) Technetium-99m as pertechnetate; (8) Any byproduct material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or excretion for which the Food and Drug Administration (FDA) has accepted a " Notice of Claimed Investigational Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA). (b) A licensee using a radiopharmaceutical listed in paragraph (a) of this section for a clinical procedure other than one specified in the product label or package insert instructions for use shall comply with the product label or package insert instructions regarding physical form, route of administration and dosage range. S 35.120 Possession of survey instrument. l A licensee authorized to use byproduct material for uptake, dilu-l tion, and excretion studies shall have in its possession a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour. l Subpart E--Imaging and Localization S 35.200 Use of radiopharmaceuticals, generators, and reagent kits for l imaging and localization studies. > (a) A licensee may use the following radiopharmaceuticals, genera-tors, and reagent kits for imaging and localization studies: (1) Molybdenum-99/ technetium-99m generators for the elution or ' . extraction of technetium-99m as pertechnetate; , l l (2) Technetium-99m as pertechnotate; (3) Prepared radiopharmaceuticals and reagent kits for the prepara-tion of the following technetium-99m labeled radiopharmaceuticals: (i) Sulfur colloid; h (ii) Pentetate sodium; l (iii) Human serum albumin microspheres; J { 89 Enclosure 1
. _ _ _ _ . - _ _ . _ _ - _ - _ - _ . _ . _ _ . _ _ _ _ - _ _ . a
[7590-01] (iv) Polyphosphate; (v) Macroaggregated human serum albumin; (vi) Etidronate sodium; (vii) Stannous pyrophosphate; (viii) Human serum albumin; (ix) Medronate sodium; ' (x) Gluceptate sodium; (xi) 0xidronate sodium; (xii) Disofenin; and (xiii) Succimer. (4) Iodine-131 as sodium iodide, iodinated human serum albumin, macroaggregated iodinated human serum albumin, colloidal (microaggregated) iodinated human serum albumin, rose bengal, or sodium iodohippurate; (5) Iodine-125 as sodium iodide or fibrinogen; (6) Chromium-51 as human serum albumin; (7) Gold-198 in colloidal form; (8) Mercury-197 as chlormerodrin; (9) Selenium-75 as selenomethionine; (10) Strontium-85 as nitrate; (11) Ytterbium-169 as pentetate sodium; (12) Xenon-133 as a gas or saline solution; (13) Any byproduct material in a diagnostic radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a radio-pharmaceutical containing byproduct material for which the Food and Drug Administration has accepted a " Notice of Claimed Investigational Exemp-tion for a New Drug" (IND) or approved a "New Drug Application" (NDA). (b) A licensee using the radiopharmaceuticals listed in paragraph (a) of this section for clinical procedures other than those specified in the product label or package insert shall comply with the product label or package insert regarding physical form, route of administration, and dosage range. (c) A licensee shall elute generators and prepare reagent kits in accordance with the manufacturer's instructions. (d) The following radiopharmaceuticals, when used for the listed clinical procedures, are not subject to the restrictions in paragraph (b) of this section: 90 Enclosure 1
[7590-01] i I (1) Technetium-99m pentetate as an aerosol for lung function studies. S 35.204 Permissible molybdenum-99 concentration. (a) A licensee may not administer to humans a radiopharmaceutical containing more than 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m. (b) A licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/ technetium-99m generators shall measure the molybdenum-99 concentration in each eluate or extract. (c) A licensee who must measure molybdenum concentration shall retain a record of each measurement for two years. The record must include, for each elution or extraction of technetium-99m, the measured activity of the technetium expressed in millicuries, the measured activity of the molybdenum expressed in microcuries, the ratio of the measures expressed as microcuries of molybdenum per millicurie of technetium, the date of the test, and the initials of the individual who performed the test. S 35.205 Control of aerosols and gases. (a) A licensee who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed by SS 20.103 and 20.106 of this chapter. (b) The system must either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container. (c) A licensee shall only administer radioactive aerosols and gases in rooms that are at negative pressure compared to surrounding rooms. (d) Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a spill to reduce the concentration in the area of use to the occupational limit listed in Appendix B to Part 20 of this chapter. The calculation must be based on the highest activity of gas handled in a single container and the measured available air exhaust rate. (e) A licensee shall post the calculated time at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed. 91 Enclosure 1
[7590-01] (f) A licensee shall check the operation of collection and ventila-tion systems each six months. S 35.220 Possession of survey instruments. A licensee authorized to use byproduct material for imaging and localization studies shall have in its possession a portable low level - radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour and a portable ion chamber radiation survey instrument that has a scale with a full scale deflection of 1 roentgen per hour. Subpart F--Radiopharmaceuticals for Therapy S 35.300 Use of radiopharmaceuticals for therapy. A licensee may use the following prepared radiopharmaceuticals: (a) Iodine-131 as iodide for treatment of hyperthyroidism, cardiac dysfunction, and thyroid carcinoma; (b) Phosphorus-32 as soluble phosphate for treatment of polycythemia vera, leukemia, and bone metastases; (c) Phosphorus-32 as colloidal chromic phosphate for intracavitary treatment of malignant effusions; (d) Gold-198 as colloid for intracavitary treatment of malignant effusions; (e) Any byproduct material in a radiopharmaceutical and for a therapeutic use for which the Food and Drug Administration has accepted a " Notice of Claimed Investigational Exemption for a New Drug" (IND), or approved a "New Drug Application" (NOA). 6 35.310 Safety instruction. (a) A licensee shall provide oral and written radiation safety instruction for all personnel caring for the patient undergoing radio-pharmaceutical therapy. To satisfy this requirement, the instruction must describe the licensee's procedures for: (1) Patient control; (2) Visitor control; 92 Enclosure 1
i , [7590-01] , l (3) Contamination control; (4) Waste control; and (5) Notification of the Radiation Safety Officer in case of the
; patient's death or medical emergency. ;
(b) A licensee shall keep for two years a list of individuals
; receiving instruction required by paragraph (a) of this section, a
( description of the instruction, the date of instruction, and the name of the individual who gave the instruction. S 35.315 Safety precautions. (a) A licensee shall provide each individual hospitalized for - l radiopharmaceutical therapy a private room with a private sanitary facility. j (b) A licensee shall notify the Radiation Safety Officer immediately
; if the patient dies or has a medical emergency.
j (c) A licensee shall post the patient's door with a " Radioactive Materials" sign and note in the patient's chart where and how long visi- 1
; tors may stay in the patient's room. ,
(d) The authorized user and Radiation Safety Officer must specifi-cally authorize visits by individuals under age 18 on a case-by-case basis. ' (e) The licensee shall either monitor material and items removed from the patient's room to determine that their radioactivity cannot be distinguished from the natural backgrnund radiation level with a low range survey meter set on its most sensitive scale and with no interposed shielding, or handle them as radioactive waste. (f) The licensee shall survey the patient's room and private ,
- sanitary facility for removable contamination before assigning another l I
patient to the room. The room must not be reassigned until removable contamination is less than 200 disintegrations per minute per 100 square centimeters. (g) Within three days after administering a therapeutic dosage of l l iodine-131, the licensee shall measure the thyroid burden of each individual q who helped prepare or administer the dosage, and retain for the period required by 9 20.401(c)(1) a record of each thyroid burden measurement, its date, the name of the individual whose thyroid burden was measured, i and the initials of the individual who made the measurements. i i j 93 Enclosure 1
[7590-01] 6 35.320 Possession of survey instrumeny . A licensee authorized to use byproduct material for radiopharma-ceutical therapy shall have in its possession a portable low level radia-tion survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per' hour and a portable ion chamber radiatien survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour. Subpart G--Sources for Brachytherapy 6 35.400 Use of sources for brachytherapy. A licensee shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions: (a) Cesium-137 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer; (b) Cobalt-60 as a sealed source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer; (c) Gold-198.as a sealed source in seeds for interstitial treat-ment of cancer; (d) Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer; (e) Strontium-90 as a sealed source in an applicator for treatment of superficial eye conditions; and (f) Iodine-125 as a sealed source in seeds for interstitial treatment of cancer. S 35.404 Release of patients treated with temporary implants. (a) Immediately after removing the last temporary implant source from a patient, the licensee shall make a radiation survey of the patient to confirm that all sources have been removed. The licensee may not release from confinement for medical care a patient treated by temporary implant until all sources have been removed. (b) A Ifconsee shall retain a record of patient surveys for two years. Each record must include the date of the survey, the name of the patient, the exposure rate from the patient expressed as millirem per 94 Enclosure 1
[7590-01] hour and measured within one meter of the patient, and the initials of the individual who made the survey. S 35.406 Brachytherapy sources inventory. (a) Each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall immediately count the number returned to ensure that all sources taken from the storage area have been returned. (b) A licensee shall make a record of brachytherapy source use which must include: (1) The names of the individuals permitted to handle the sources, (2) The number and activity of sources removed from storage, the room number of use or patient's name, the time and date they were removed i from storage, the number and activity of the sources in storage after the removal, and the initials of the individual who removed the sources from storage; (3) The number and activity of sources returned to storage, the room number of use or patient's name, the time and date they were returned to storage, the number and activity of sources in storage after the return, and the initials of the individual who returned the sources to storage. (c) Immediately after implanting sources in a patient the licensee shall make a radiation surve/ of the patient and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey. (d) A licensee shall retain the records required in paragraphs (b) and (c) of this section for two sears. S 35.410 Safety instruction. l (a) The licensee shall provide oral and written radiation safety instruction to all personnel caring for the patient undergoing implant therapy. To satisfy this requirement, the instruction must describe: (1) Size and appearance of the brachytherapy sources; l 95 Enclosure 1
[7590-01] . i (2) Safe handling and shielding instructions in case of a dislodged source; (3) Procedures for patient control; (4) Procedures for visitor control; and (5) Procedures for notification of the Radiation Safety Officer if the patient dies or has a medical emergency. (b) A licensee shall retain for two years a record of individuals receiving instruction required by paragraph (a) or ?his section, a description of the instruction, the date of inst ov . i, and the name of the individual who gave the instruction.
$ 35.415 Safety precautions.
(a) The licensee shall provide a private room to each individual hospitalized for implant therapy. (b) The licensee shall notify the Radiation Safety Officer imme-diately if the patient dies or has a medical emergency. (c) A licensee shall post the patient's door with a " Radioactive Materials" sign and note in the patient's chart where and how long visi-tors may stay in the patient's room. (d) The authorized user and Radiation Safety Officer must specifically authorize visits by individuals under age 18 on a case-by-case basis. 6 35.420 Possession of survey instrument. A licensee authorized to use byproduct material for implant therapy shall have in its possession a portable ion chamber radiation survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour. Subpart H--Sealed Sources for Diagnosis S 35.500 Use of sealed sources for diagnosis. A licensee shall use the following sealed sources in accordance with the manufacturer's radiation safety and handling instructions: (a) Iodine-125 as a sealed source in a device for bone mineral analysis; 96 Enclosure 1
[7590-01] (b) Americium-241 as a sealed source in a device for bone mineral analysis; and (c) Iodine-125 as a sealed source in a portable device for imaging. S 35.520 Availability of survey instrument. A licensee authorized to use byproduct material as a sealed source for diagnostic purposes shall have available for use a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour or a portable ion chamber radiation survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour. The instrument must have been cali-brated in accordance with 9 35.51 of this part. Subpart I--Teletherapy 6 35.600 Use of a sealed source in a teletherapy unit. > The regulations and provisions of this subpart govern the use of teletherapy units for medical use that contain the following sources. (a) Cobalt-60 as a sealed source; and (b) Cesium-137 as a sealed source. S 35.605 Maintenance and repair restrictions. Only a person specifically licensed by the Commission or an Agree-ment State to perform teletherapy unit maintenance and repair shall install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source or maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels. S 35.606 Amendments. A licensee shall apply for and must receive a Ifcense amendment I before: (a) Making any change in the treatment room shielding; (b) Making any change in the location of the teletherapy unit within the treatment room; 97 Enclosure 1
[7590-01] (c) Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room; (d) Relocating the teletherapy unit; or (e) Allowing an individual not listed on the licensee's license to perform the duties of the qualified teletherapy calibration expert. 5 35.610 Safety instruction. (a) A licensee shall post written instructions at the teletherapy unit console. To satisfy this requirement, these instructions must inform the operator of: (1) The procedure to be followed to ensure that only the patient is in the treatment roon,before turning the primary beam of radiation on to begin a treatment or after a door interlock interruption; (2) The procedure to be followed if: (i) The operator is unable to turn the primary beam of radiation off with controls outside the treatment room or any other abnormal operation occurs; and (ii) The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted if the teletherapy unit or console operates abnormally. (b) A licensee shall provide instruction in the topics identified in paragraph (a) of this section to all individuals who operate a tele-therapy unit. (c) A licensee shall retain for two years a record of individuals receiving instruction required by paragraph (b) of this section, a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.
$ 35.615 Doors, interlocks, and warning systems.
(a) A licensee shall control access to the teletherapy room by a door at each entrance. (b) A licensee shall equip each entrance to the teletherapy room l with an electrical interlock system that will: l (1) Prevent the operator from turning the primary beam of radiation on unless each treatment room entrance door is closed; 98 Enclosure 1 k
[7590-01] (2) Turn the primary beam of radiation off immediately when an entrance door is opened; and (3) Prevent the primary beam of radiation from being turned on following an interlock interruption until all treatment room entrance doors are closed and the beam on-off control is reset at the console. (c) A licensee shall equip each entrance to the teletherapy room with a beam condition indicator light. S 35.620 Possession of survey instrument. A licensee authorized to use byproduct material in a teletherapy unit shall have in its possession either a portable low level radiation survey instrument whose most sensitive scale has a full-scale deflection of not more than 1 milliroentgen per hour or a portable ion chamber radiation survey instrument that has a scale with a full scale deflection of 1 Roentgen per hour. S 35.621 Radiation monitoring device. (a) A licensee shall install in each teletherapy room a permanent radiation monitor capable of continuously monitoring beam status. (b) Each radiation monitor must be capable of providing visible notice of a teletherapy unit malfunction that results in in exposed or partially exposed source. The visible indicator of high radiation levels must be observable by an individual entering the teletherapy room. (c) Each radiation monitor must be equipped with an emergency power supply separate from the power supply to the teletherapy unit. This emergency power supply may be a battery system. (d) Each radiation monitor must be checked for proper operation each day before the teletherapy unit is used for treatment of patients. (e) A licensee shall maintain a record of the check required by paragraph (d) of this section for two years. The record must include the date of the check, notation that the monitor indicates when the source is and is not exposed, and the initials of the individual who performed the check. (f) If a radiation monitor is inoperable for any reason, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor 99 Enclosure 1
[7590-01] for any malfunction of the source exposure mechanism that may result in an exposed or partially exposed source. The instrument or dosimeter must be checked for proper operation at the beginning of each day of use. (g) A licensee shall promptly repair or replace the radiation monitor if it is inoperable. S 35.622 Viewing system. A licensee shall construct or equip each teletherapy room to permit continuous observation of the patient from the teletherapy unit console during irradiation. S 35.630 Dosimetry equipment. (a) A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met. (1) The system must have been calibrated by the National, Bureau of Standards or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or (2) The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty-four months by the Nationa' t'ureau of Standards or by a calibration laboratory accredited by the AAPM. The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating cesium-137 teletherapy units, the licensee shall use a teletherapy unit with a cesium-137 source. 100 Enclosure 1
~
~ .. . - - - - _ _ _ - - . - _- .. .- .. . - . - . - . -__ . _ _ _
f #
, [7590-01]
(b) The licensee shall have available for use a dosimetry system ! for spot-check measurements. To satisfy this requirement, the system may l be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (a) of this section. l (c) The licensee shall retain a record of each calibration, inter-comparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instruments that were l calibrated, intercompared, or compared as required by paragraphs (a) and (b) of this section, the correction factors that were deduced, the names of the individuals who performed the calibration, intercomparison, or ! comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by AAPM. S 35.632 Full calibration measurements. (a) A licensee authorized to use a teletherapy unit for medical use , shall perform full calibration measurements on each teletherapy unit: ! (1) Before the first medical use of the unit; and (2) Before medical use under the following conditions: l (i) Whenever spot-check measurements indicate that the output l differs by more than 5 percent from the output obtained at the last full ( calibration corrected mathematically for radioactive decay; (ii) Following replacement of the source or following reinsta11ation of the teletherapy unit in a new location; i (iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and (3) At intervals not exceeding one year. (b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements must include determination of: (1) The output within 13 percent for the range of field sizes and l j for the distance or range of distances used for medical use; i i l 101 Enclosure 1
[7590-01] . . (2) The coincidence of the radiation field and the field indicated by the light beam localizing device; (3) The uniformity of the radiation field and its dependence on the orientation of the useful beam; (4) Timer accuracy; (5) On-off error; and (6) The accuracy of all distance measuring and localization devices in medical use. (c) A licensee shall use the dosimetry system described in S 35.630(a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (b)(1) of this section may then be made using a dosimetry system that indicates relative dose rates. (d) A licensee shall make full calibration measurements required by paragraph (a) of this section in accordance with either the procedures recommended by the Scientific Committee on Radiation Dosimetry of the American Association of Physicists in Medicine that are described in Physics in Medicine and Biology Vol. 16, No. 3, 1971, pp. 379-396, or by Task Group 21 of the Radiation Therapy Committee of the American Associa-tion of Physicists in Medicine that are described in Medical Physics Vol. 10, No. 6, 1983, pp. 741-771. Both of these references have been approved for incorporation by reference by the Director of the Federal Register. Copies of the documents are available for inspection or may be obtained from the U.S. Nuclear Regulatory Commission, Public Document Room, 1717 H Street NW, Washington, DC 20555. Copies of the documents are also on file at the Office of the Federal Register, 1100 L Street NW, Room 8301, Washington, DC 20408. A notice of any change in the material will be published in the Federal Register. (e) A licensee shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding one month. (f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by a qualified teletherapy calibration expert. 102 Enclosure 1 l
l [7590-01] l (g) A licensee shall retain a record of each calibration for the duration of the license. The record must include the date of the cali-bration, the manufacturer's name, model number, and serial number for ! both the teletherapy unit and the source, the model numbers and serial numbers of the instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the l light beam localizing device, the measured timer accuracy for a typical treatment time, the calculated on-off error, the estimated accuracy of each distance measuring or localization device, and the signature of the ! qualified teletherapy calibration expert, l i l S 35.633 periodic spot-checks. (a) A licensee authorized to use teletherapy units for medical use ; shall perform spot-checks on each teletherapy unit once in each calendar l month. (b) To satisfy the requirement of para 0raph (a) of this section, measurements must include determination of: (1) Timer accuracy; (2) On-off error; (3) The coincidence of the radiation field and the field indicated by the light beam localizing device; (4) The accuracy of all distance measuring and localization devices used for medical use; (5) The output for one typical set of operating conditions; and (6) The difference between the measurement made in paragraph (b)(5) of this section and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay). (c) A licensee shall use the dosimetry system described in S 35.630(b) to make the measurement required in paragraph (b)(5) of this section. (d) A licensee shall perform measurements required by paragraph (a) of this section in accordance with procedures established by the qualified teletherapy calibration expert. That individual need not actually perform the spot-check measurements, t i 103 Enclosure 1 i
[7590-01] * (e) A licensee shall have the qualified teletherapy calibration expert review the results of each spot-check within 15 days. The quali-fled teletherapy calibration expert shall promptly notify the licensee in writing of the results of each spot-check. The licensee shall keep a copy of each written notification for two years. (f) A licensee authorized to use a teletherapy unit for medical use shall perform spot-checks of each teletherapy facility once in each calendar month. (g) To satisfy the requirement of paragraph (f) of this section, checks must assure proper operation of: (1) Electrical interlocks at each teletherapy room entrance; (2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism); (3) Beam condition indicator lights on the teletherapy unit, on the control console, and in the facility; (4) Viewing systems; (5) Treatment room doors from inside and outside the treatment rcom; and (6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off. (h) A licensee shall lock the control console in the off position if any door interlock malfunctions. The licensee may not use the unit until the interlock system is repaired. (i) A licensee shall promptly repair any system identified in paragraph (g) of this section that is not operating properly. (j) A licensee shall retain a record of each spot-check required by paragraphs (a) and (f) of this section for two years. The record must include the date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit and source, the manufac-turer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, the measured timer accuracy, the calculated on-off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the measured timer accuracy for a typical treatment time, the calculated 104 Enclosure 1
[7590-01] i - on-off error, the estimated accuracy of each distance measuring or locali-zation device, the difference between the anticipated output and the measured output, notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot-check. S 35.641 Radiation surveys for teletherapy facilities. (a) Before medical use, after each installation of a teletherapy source, and after making any enan.;e for which an amendment is required by S 35.606(a)-(d),the licensee shall perform radiation surveys to verify that: (1) The maximum and average radiation levels at one meter from the teletherapy source with the source in the off position and the collimators set for a normal treatment field do not exceed 10 milliroentgens per hour and 2 milliroentgens per hour, respectively; and (2) With the teletherapy source in the on position with the largest clinically available treatment field and with a scattering phantom in the primary beam of radiation, that: (i) Radiation quantities in restricted areas adjacent to the treatment room are not likely to cause personnel exposures in excess of the limits specified in S 20.101 of this chapter; and (ii) Radiation quantities in unrestricted areas adjacent to the treatment room do not exceed the limits specified in S 20.105(b) of this chapter. (b) If the results of the surveys required in paragraph (a) of this section indicate any radiation quantity in excess of the respective limit specified in that paragraph, the licensee shall lock the control in the off position and not use the unit: (1) Except as may be necessary to repair, replace, or test the I teletherapy unit shielding or the treatment room shielding; or ! (2) Until the licensee has received a specific exemption pursuant to S 20.501 of this chapter. (c) A licensee shall retain a record of the radiation measurements made following installation of a ;ource for the duration of the license. The record must include the date of the measurements, the reason the l 105 Enclosure 1
[7590-01] . . O survey is required, the manufacturer's name, model number and serial - number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the teletherapy source while in the off position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer. S 35.642 Safety checks for teletherapy facilities. (a) A licensee shall promptly check all systems listed in S 35.633(g) for proper function after each installation of a teletherapy source and after making any change for which an amendment is required by S 35.606(a)-(d). (b) If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system specified in S 35.633(g), the licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system. (c) A licensee shall retain for two years a record of the facility checks following installation of a source. The record must include nota-tions indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, and doors, and the signature of the Radiation Safety Officer. S 35.643 Modification of teletherapy unit or room before beginning a treatment program. If the survey required by 6 35.641 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by S 20.105(b) of this chapter, before beginning the treatment program the licensee shall: (a) Either equip the unit with stops or add additional radiation Ishielding to ensure compliance with 6 20.105(b); 106 Enclosure 1
~
[7590-01] O (b) Perfoim the survey required by S 35.641 again; and (c) Include in the report required by S 35.644 the results of the initial survey, a description of the modification made to comply with paragraph (a) of this section, and thc results of the second survey; or (d) Request and receive a license amendment under S 20.105(a) of this part that authorizes radiation levels in unrestricted areas greater than those permitted by 9 20.105(b). S 35.644 Reports of teletherapy surveys, checks, tests, and measurements. A licensee shall mail an original and a copy of the records required in SS 35.641, 35.642, 35.643, and the output from the teletherapy source expressed as Roentgens per hour at a distance of one meter from the source and determined during the full calibration required in S 35.632, to the appropriate Commission Regional Office listed in S 35.16 of this part within thirty days following completion of the action that initiated the record requirement. S 35.645 Five-year inspection. (a) A licensee shall have each teletherapy unit fully inspected and serviced during teletherapy source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism. (b) This inspection and servicing may only be performed by persons specifically licensed to do so by the Commission or an Agreement State. (c) A licensee shall keep a record of the inspection and servicing for the duration of the license. The record must contain the inspector's name, the inspector's license number, the date of inspection, the manufac-turer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector. (d) Amendments to teletherapy licenses that extended the time interval for the inspection and servicing requirement of paragraph (a) of this section that were in effect on March 4, 1983 remain in effect and are not rescinded by this section. 107 Enclosure 1
[7590-01] , Subpart J--Training and Experience Requirements S 35.900 Radiation Safety Officer. Except as provided in S 35.901, the licensee shall require an indi-vidual fulfilling the responsibilities of the Radiation Safety Officer as provided in S 35.32 to: (a) Be certified by: (1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology in Radiological Physics, Therapeutic Radiological Physics, or Medical Nuclear Physics; or (3) American Board of Nuclear Medicine Science in Nuclear Medicine Science; or (b) Have had 200 hours of classroom and laboratory training and one year of experience as follows: (1) 100 hours of radiation physics and instrumentation; (2) 30 hours of radiation protection; (3) 20 hours of mathematics pertaining to the use and measurement of radioactivity; (4) 20 hours of radiation biology; (5) 30 hours of radiopharmaceutical chemistry; and (6) One year of full time experience in radiation safety at a medical institution under the supervision of the individual identified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or (c) Be an authorized user for those byproduct material uses that come within the Radiat.lon Safety Officer's responsibilities. S 35.901 Training for experienced Radiation Safety Officer. An individual identified as a Radiation Safety Officer on a Commis-sion or Agreement State license on (*** insert effective date of final rule ***) who oversees only the use of byproduct material for which the licensee was authorized on that date need not comply with the training requirements of 6 35.900. 108 Enclosure 1
,s
[7590-01] fa
+ 6 35.910 Trainingforuptake) dilution,andexcretionstudies.
Except as provided in SS 35.970 and 35.971, the licensee shall require the authorized user of a radiopharmaceutical listed in S 35.100(a) to be a physician who: (a) Is certified in: (1) Nuclear medicine by the American Board of Nuclear Medicine; (2) Diagnostic radiology with special competence in nuclear radiology ti4 , by the American Board of Radiology; or m (3) Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or m.
- - (b) Has completed 80 hours of instruction in basic radioisotope handling techniques applicable _to the use of prepared radiopharmaceu-ticals, and 40 hours of supervised clinical experience.
(1) TosatisfythebasicInstructionrequirement,theclassroom s and laboratory instruction must include: (i) 25 hours of radiation physics and instrumentation; (ii) 25 hours of radiation prui.=n.i.iun; (iii) 10 hours of mathematics pertaining to the use and measurement s of radioactivity; (iv) 10 hours of radiation biology; and (v) 10 hours of radiopharmaceuticaf chemistry. (2) To satisfy the requirement'for supervised clinical experience, training must be under the supervision of an authorized user at a medical institution and must include: (i) Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages; (iii) Administering dosages to patients and using syringe radiation l shields-(iv) Collaborating with the authorized user in the interpretation I of radioisetope test /esults; and , i (v) ,Pahientfoliowup;or (c) 'Has successfully completed a 'six-month training program in nuclear medicine as part' of a training program that has been approved by u 1
, 109 Enclosure 1 1
, 1 7
[7590-01] - the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section. S 35.920 Training for imaging and localization studies. Except as provided in S 35.970 or 35.971, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit listed in S 35.200(a) to be a physician who: (a) Is certified in: (1) Nuclear medicine by the American Board of Nuclear Medicine; (2) Diagnostic radiology with special competence in nuclear radiology by the American Board of Radiology; or (3) Diagnostic radiology or radiology within the previous five years by the American Osteopathic Board of Radiology; or (b) Has completed 200 hours of instruction in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuti-cals, generators, and reagent kits, 500 hours of supervised work experi-ence and 500 hours of supervised clinical experience. (1) To satisfy the basic instruction requirement, the classroom and laboratory training must include: (i) 100 hours of radiation physics and instrumentation; (ii) 30 hours of radiation protection; (iii) 20 hours of mathematics pertaining to the use and measurement of radioactivity; (iv) 30 hours of radiopharmaceutical chemistry; and (v) 20 hours of radiation biology. (2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at a medical ! institution and must include: (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters; (iii) Calculating and safely preparing patient dosages; 110 Enclosure 1 1
[7590-01] (iv) Using administrative controls to prevent the misadministration of byproduct material; (v) Using emergency procedures to contain spilled byproduct material safely and using proper decontamination procedures; and (vi) Eluting technetium-99m from generator systems, assaying and testing the eluate fori molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals. (3) To satisfy the requirement for supervised clinical experience, training must be under the supe'rvision of an authorized user at a medical institution and must include: (i) Examining patients and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages; (iii) Administering dosages to patients and using syringe radiation shields; (iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and (v) Patient followup; or (c) Has successfully completed a six-month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in paragraph (b) of this section. S 35.930 Training for therapeutic use of radiopharmaceuticals. Except as provided in S 35.970, the licensee shall require the authorized user of a radiopharmaceutical listed in S 35.300 for therapy to be a physician who: l (a) Is certified in nuclear medicine by the American Board of Nuclear Medicine; or (b) Has completed 80 hours of instruction in basic radioisotope handling techniques applicable to the use of therapeutic radiophar-maceuticals, and has had supervised clinical experience. 111 Enclosure 1
[7590-01] . (1) To satisfy the require:nent for instruction, the classroom and laboratory training must include: (i) 25 hours of radiation physics and instrumentation; (ii) 25 hours of radiation protection; (iii) 10 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) 20 hours of radiation biology; (2) To satisfy the requirement for supervised clinical experience, training must be under the supervision of an authorized user at a medical institution and must include: , (i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; (ii) Use of soluble phosphorus-32 for the treatment of polycythemia vera, leukemia, or bone metastases in 3 individuals; (iii) Use of iodine-131 for treatment of thyroid carcinoma in 3 indivi-duals; and (iv) Use of colloidal chromic phosphorus-32 or of colloidal gold-198 for intracavitary treatment of malignant effusions in 3 individuals. S 35.940 Training for therapeutic use of brachytherapy sources. Except as provided in S 35.970, the licensee shall require the authorized user using a brachytherapy source listed in S 35.400 for therapy to be a physician who: (a) Is certified in: (1) Radiology or therapeutic radiology by the American Board of Radiology; (2) Radiation oncology by the American Osteopathic Board of Radiology; (3) Radiology, with a specialization in radiotherapy, as a British " Fellow of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (b) Is in the active practice of therapeutic radiology, has completed 200 hours of instruction in basic radioisotope handling techniques applicable to the therapeutic use of brachytherapy sources and 500 hours 112 Enclosure 1
[7590-01] of supervised work experience and a minimum of three years of supervised clinical experience. (1) To satisfy the requirement for instruction, tr.c classroom and laboratory training must include: (i) 110 hours of radiation physics and instrumentation; (ii) 40 hours of radiation protection; (iii) 25 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) 25 hours of radiation biology. (2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at an institution and must include: (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Checking survey meters for proper operation; (iii) p ra,na ri na , implanting, and rc=c.ing ccled Ocacas-(iv) Using administrative controls to prevent the misadministration of byproduct material; and (v) Using emergency procedures to control byproduct material. (3) To satisfy the requirement for a period of supervised clinical experience, training must include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accredi-tation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience must include: (i) Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limita-tions or contraindications; (ii) Selecting the proper brachytherapy sources and dose and method of administration; (iii) Calculating the dose; and (iv) Post-administration followup and review of case histories in collaboration with the authorized user. 113 Enclosure 1
[7590-01] , 4 S 35.941 Training for ophthalmic use of strontium-90. Except as provided in S 35.970, the licensee shall require the authorized user using only strontium-90 for ophthalmic radiotherapy to be a physician who: (a) Is certified in radiology or therapeutic radiology by the American Board of Radiology; or (b) Is in the active practice of therapeutic radiology or ophthal-mology, and has completed 24 hours of instruction in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy. (1) To satisfy the requirement for instruction, the classroom and laboratory training must include: (i) 6 hours of radiation physics and instrumentation; (ii) 6 hours of radiation protection; (iii) 4 hours of mathematics p et.aining i.o i.iie use and measurement of radioactivity; and (iv) 8 hours of radiation biology. (2) To satisfy the requirement for a period of supervised clinical training in ophthalmic radiotherapy, training must be under the super-vision of an authorized user at a medical institution and must include the use of strontium-90 for the ophthalmic treatment of five individuals that includes (i) Examination of each individual to be treated; (ii) Calculation of the dose to be administered; (iii) Administration of the dose; and (iv) Followup and review of each individual's case history. S 35.950 Training for use of sealed sources for diagnosis. Except as provided in S 35.970, the licensee shall require the authorized user using a sealed source in a device listed in S 35.500 to be a physician, dentist, or podiatrist who: (a) Is certified in (1) Radiology, diagnostic radiology with special competence in nuclear radiology, or therapeutic radiology by the American Board of Radiology; 114 Enclosure 1
\' [7590-01] (2) Nuclear medicine by the American Board of Nuclear Medicine; or (3) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or (b) Has completed 8 hours of instruction in basic radioisotope handling techniques specifically applicable to the use of the device . To satisfy the requirement for instruction, the training must include: (1) 3 hours of radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation; (2) 3 hours of radiation biology; and (3) 2 hours of radiation protection and training in the use of the device for the purposes authorized by the license. S 35.960 Training for teletherapy. Except as provided in S 35.970, the licensee shall require the authorized user using a sealed source listed in 6 35.600 in a teletherapy unit to be a physician who: (a) Is certified in: (1) Radiology or therapeutic radiology by the American Board of Radiology; (2) Radiation oncology by the American Osteopathic Board of Radio-logy; (3) Radiology, with specialization in radiotherapy, as a British
" Fellow of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (b) Is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radioisotope techniques applicable to the use of a sealed source in a teletherapy unit, 500 hours of supervised work experience, and a minimum of three years of super-vised clinical experience.
(1) To satisfy the requirement for instruction, the classroom and laboratory training must include: (i) 110 hours of radiation physics and instrumentation; (ii) 40 hours of radiation protection; 115 Enclosure 1 I
[7590-01] ' * (iii) 25 hours of mathematics pertaining to the use and measurement of radioactivity; and (iv) 25 hours of radiation biology. (2) To satisfy the requirement for supervised work experience, training must be under the supervision of an authorized user at an institution and must include: (i) Review of the full calibration measurements and periodic spot checks; (ii) Preparing treatment plans and calculating treatment times; (iii) Using administrative controls to prevent misadministrations; (iv) Implementing emergency procedures to be followed in the event of the abnormal operation of a teletherapy unit or console; and (v) Checking and using survey meters.
.. (3) To satisfy the requirement for a period of supervised clinical experience, training must include one year in a formal training program approvGd by the Residency Review Committee for Raaiology of the Acreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience must include:
(i) Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations i or contraindications; (ii) Selecting the proper dose and how it is to be administered; (iii) Calculating the teletherapy doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses as warranted by patients' reaction to radiation; and (iv) Post-administration followup and review of case histories. i 6 35.961 Training for qualified teletherapy calibration expert. ! The licensee shall require the qualified teletherapy calibration t ! expert as to: (a) Be certified by the American Board of Radiology in: 116 Enclosure 1
[7590-01] (1) Therapeutic radiological physics; (2) Roentgen ray and gamma ray physics; (3) X-ray and radium physics; or (4) Radiological physics; or i (b) Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed one year of full time training in therapeutic radiological physics and also one year of full time work experience under the supervision of a qualified tele-therapy calibration expert at a medical institution. To satisfy this requirement, the neophyte qualified teletherapy calibration expert must have performed the tasks listed in SS 35.59, 35.632, 35.633, and 35.641 of this part under the supervision of a qualified teletherapy calibration expert during the year of work experience. S 35.970 Training for experienced authorized users. Physicians, dentists, or podiatrists identified as authorized users for the human use of byproduct material on a Commission or Agreement State license on (*** insert effective date of final rule ***) who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of Subpart J. S 35.971 Physician training in a three month program. A physician who, before July 1, 1984, began a three month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program need not comply with the requirements of SS 35.910 or 35.920. S 35.972 Recentness of training. The training and experience specified in this subpart must have been obtained within the five years preceding the date of application or the individual must have had continuing experience since the required training and experience was completed. 117 Enclosure 1
[7590-01] Subpart K--Enforcement S 35.990 Violations. (a) An injunction or other court order may be obtained to prohibit a violation of any provision of: (1) The Atomic Energy Act of 1954, as amended;
, (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) Any rule, regulation, or order issued under these Acts.
(b) A court order may be obtained for the payment of a civil penalty imposed for violation of: (1) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 under section 234 of the Atomic Energy Act of 1954; (2) Section 206 of the Energy Reorganization Act of 1974; (3) Any rule, regulation, or order issued under these Acts; (4) Any term, condition, or limitation of any license issued under these Acts; or (5) Any violation for which a license may be revoked under section 186 of the Atomic Energy Act of 1954. (c) Any person who willfully violates any provision of the Atomic Energy Act of 1954, as amended, or any rule, regulation, or order issued under the Act may be guilty of a crime and, upon conviction, may be pun-ished by fine or imprisonment or both as provided by law. Regulations issued under the Act include regulations issued under sec. 161, and cited in the authority citation at the beginning of this part for the purposes of sec. 223. S 35.999 Resolution of conflicting requirements during transition period. If the rules in this part conflict with the licensee's radiation safety program as identified in its license, and if that license was approved by the Commission before [*** insert effective date of final rule ***] and has not been renewed, then the requirements in the license will apply. 118 Enclosure 1
, [75C0-01]
The following amendments are also made to existing parts cf the regu-lations in this chapter. The authority for these conforming amendments is: Sec. 161, Pub. L. 83-703, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, Pub. L. 93-438, 88 Stat. 1242, as amended (42 U.S.C. 5841). PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL
- 2. Section 30.4 is amended by revising paragraphs (h) and (1) to read as follows and by adding new paragraphs (y) and (z) as follows:
S 30.4 Definitions. (h) " Medical use" means the intentional internal or external administration of byproduct material, or the radiation therefrom, to human beings in the nractica af medicine in accordance with a licen:c i:: cd by-a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico in the practice of medicine. (1) " Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine; (y) " Dentist" means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry on humans. (z) " Podiatrist" means an individual licensed by a State or Terri-tory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry on humans.
- 3. Section 30.34 is amended by revising paragraph (g) to read as follows:
119 Enclosure 1
[7590-01] ,' S 30.34 Terms and conditions of licenses. (g) A licensee may prepare technetium-99m radiopharmaceuticals only with technetium-99m that contains less than 0.15 microcuries of molyb-denum-99 per millicurie of technetium-99m. The licensee shall perform tests _and maintain the records required by S 35.204. PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL i
- 4. Section 31.11 is amended by revising paragraph (b) to read as follows:
S 31.11 General license for use of byproduct material for certain in vitro clinical or laboratory testing. (b) No person shall receive, acquire, possess, use, or transfer byproduct material pursuant to the general license established by para-graph (a) of this section unless that person: (1) Has filed Form NRC-483, " Registration Certificate - In Vitro Testing with Byproduct Material Under General License," with the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Com-mission, Washington, DC 20555 and received from the Commission a validated copy of Form NRC-483 with a registration number assigned; (2) Has a license that authorizes the medical use of byproduct material and that expires before [*** insert five years after effective date of final rule ***]; or (3) Has a license that authorizes the medical use of byproduct material and also authorizes the use of byproduct material consistent with the requirements of this section. 120 Enclosure 1
[7590-01] .E ' l PART 32 - SPECIFIC DOMESTIC LICENSES TO HANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS ; 4 l 9 32.70 [ Removed] I
- 5. Section 32.70 is removed.
l 6. In S 32.72 the introductory text of paragraph (a) and para-i graph (a)(4)(i) are revised to read as follows: 1 1 6 32.72 Manufacture and distribution of radiopharmaceuticals containing i byproduct material for medical use under aroup licenses. (a) An application for a specific license to manufacture and i distribute radiopharmaceuticals containing byproduct material for use by persons authorized pursuant to Part 35 of this chapter will be approved , if: (4)(1) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay, and the label, or the leaflet or brochure that accompanies each package, contains a statement that the radiopharmaceutical is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed to use byproduct material listed in $$ 35.100, 35.200, or 35.300, as appropriate, or.under an equivalent license of an Agreement State.
- 7. In S 32.73 paragraph (a)(5)(ii) is revised to read as follows:
S 32.73 Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceuticals containing byproduct material. (a) *** (5) *** (ii) A statement that this generator or reagent kit (as appropriate) is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in S 35.200 or under an equivalent license of an Agreement State.
- 8. In S 32.74 the introductory text of paragraph (a) and para-graph (a)(3) are revised to read as follows:
121 Enclosure 1
[7590-01] S 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use. (a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to Part 35 of this chapter for use as a calibration or reference source or for the uses listed in SS 35.400 and 35.500 of this chapter will be approved if: (3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the (name of source or device) is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed to use byproduct material identified in SS 35.58, 35.400, or 35.500, as appropriate, or,under an equivalent license of an Agreement stata PART 40 - DOMESTIC LICENSING 0F SOURCE MATERIAL
- 9. Section 40.4 is amended by revising paragraph (g) to read as follows:
SS 40.4 Definitions. (g) " Physician" means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine; Dated at Washington, D.C. this day of 1984. For the Nuclear Regulatory Commission. Samuel J. Chilk, Secretary of the Commission. 122 Enclosure 1
9
- O Enclosure 2
. . a seg Action: Davis, NMSS g% UNITED STATES Cys: Di rcks y . NUCLEAR REGULATORY COMMISSION Ron 3 .I WASHIN GTON. D.C. 20555 Rehm "g
/ Stello
%,***** / ' June 23, 1983 GCunningham Minogue CFFICE OF THE DeYoung stenETAny i
' ~ ~
Kerr, SP Regions I-V }l I Walker, NMSS MEMORANDUM FOR: William J. Dircks, Executive Director Felton for Operations Philips FROM: Samuel J. Chilk, Secr 4
SUBJECT:
SECY-83-62 (10 CFR PAR 5) This is to advise you that the Commission (with all agreeing) has made the following decisions with respect to the staff's proposed changes to 10 CFR Part 35 (SECY-83-62): (1) The Commission approves the consolidation of the essential 2
, safety elements from regulations, guides and branch pcciticn: into a Part 35 rule.
(2) The Commission has decided to continue the pre-licensing review of physicians' qualifications in processing
. applications for human use of byproduct material in nuclear medicine and instructs the staff to amend the draft Part 35 accordingly.
4 (3) The Commission has decided to continue the pre-licensing review of applicants' operating procedures by NRC licensing staff. The Commission instructs the staff to make the changes as needed to reflect its decision that operating procedures are to be reviewed prior to licensing.
- (4) The staff should clarify how it will implement the proposed requirements regarding license amendments, while ;
continuing to ensure safety in the licensee's operations. (5) The staff should provide the Commission with a proposed Part 35, revised as directed above, by August 30, 1983. (EDO Suspense: August 23,1983) cc: Chairman Palladino Commissioner Gilinsky Commissioner Ahearne Commissioner Roberts Commissioner Asselstine OGC OPE Rec'd Cif. EDO vDatem ;.'.':::9:.h "dbO
!KEll'.
O O e 9 ENCLOSURE 3
i - PERIODIC AND SYSTEMATIC REVIEW - 10 CFR PART 35 i Introduction Task IV G.2 of the TMI Action Plan directed the staff to review all existing regulations for content, quality and clarity. SECY 81-435 and 435A established specific review criteria and created the Regulations Coordinating Committee (RCC) to plan, schedule, and coordinate the review. Under the RCC i charter, one guideline for setting the priority of specific regulations for j review was a Commission or staff initiative for a major revision of an existing rule. The Periodic and Systematic Review of 10 CFR Part 35 is in response to a staff decision that a substantial revision of the medical use licensing requirements of Part 35 was necessary. It should be noted that the re-evaluation of Part 35 does not address the misadministration sections of the current rule (SS 35.41 - 35.44). When these
- provisions were first promulgated, the Commission established a specific time period for their evaluation. Due to this separate time period and the unique nature of the misadministration issue, the proposed revision to Part 35 and this Periodic and Systematic Review do not include this subject within their scope of analysis.
I Analysis . 1. The Need for the Regulation. Under 10 CFR Part 35, the NRC issues licenses to hospitals and physicians for the use of radioactive materials for diagnostic and therapeutic purposes. l The NRC currently has approximately 2500 medical licensees, and 15 to 20 million 4 nuclear medicine procedures are performed in the United States each year. The proposed facilities, personnel, program controls, and equipment used in these ! procedures are carefully reviewed during the licensing process to ensure the , safety of the public, patients, and occupationally exposed workers.
- 2. Direct and Indirect Effects.
The nuclear medicine field has grown substantially over the past three decades, as evidenced by the increase in license applications, renewals, and 1 I 1 Enclosure 3 l _ _ _ _ . - _ _ _ _ _ _ . . . _ . _ - _ ~ . - _ , _ . . _ . _ . _ _ , . _ . . _ _ _ . _
1 l l amendments. In addition to this numerical growth, the scope of use has expanded dramatically over the years. In order to adequately regulate new developments, many safety measures were added as license amendments or recommended in regula-tory guides, rather than being incorporated in the regulations. However, over the past few years nuclear medicine procedures have stabilized, and uniform and comprehensive safety requirements can now be codified in the regulations in order to establish a more coherent regulatory program. The current practice of publishing the licensing requirements and guidance in several different sources has resulted in negative impacts on both the licensees and the NRC staff. The applicant is often uncertain about what must be included in a license application. This results in either an application that provides a substantial amount of extraneous information or in one that does not provide enough of the information necessary to make a licensing decision. This requires additional NRC staff time to review large amounts of unnecessary information or to write deficiency letters that request additional information or clarifica. tion. In either case, there are frequent delays in the licensing process that lead to a backlog in license applications. The existing regulations also severely limit a licensee's flexibility in selecting the most cost-effective method for complying with NRC requirements since even a minor radiation safety program change must be approved by a license amendment. These negative effects of the existing regulatory program have initiated the reevaluation and revision of Part 35.
- 3. Alternative Approaches.
For a detailed analysis of the effects of the proposed revision to Part 35, see the Regulatory Analysis Statement prepared as Enclosure 4 of the package. In developing an earlier staff proposal on the revision of Part 35, SECY-83-62, the staff considered reducing the number of requirements to a few, and simply providing guidance for good practice. Because such a regulatory scheme might not have protected the public health and safety, probably would have left the industry in a state of confusion given the very prescriptive l regulatory scheme used for the past several years, and might have made enforcement actions more difficult, the staff did not consider this to be a reasonable alternative. 2 Enclosure 3
b The staff finally proposed in SECY-83-62 that, because the safety requirements had been codified, applicants simply be allowed to certify that they had met the training and experience standards and would comply with the regulations. In its response to SECY-83-62 (Enclosure 2), the Commission directed the staff to continue pre-licensing review of physician qualifica-tions and operating procedures. The staff also considered that, because the safety requirements had been codified, applicants be required to submit evidence of training and experience and a radiation safety plan that described the licensee's general radiation safety policy and critical safety elements that would be incorporated in site-specific procedures. The staff decided that this alternative was inconsistent with Commission instructions. The alternative recommended by the staff to regulate the medical use of byproduct material includes codification of all generic requirements, and staff pre-licensing review of training and experience and procedures. Consistent with current licensing policy, an applicant could simply certify that it would follow a model procedure developed by NRC staff with public comment and published in a regulatory guide, or it could submit its own procedure for staff review.
- 4. Public Comment.
One important reason for revising Part 35 is to allow public comment on requirements before they are imposed in final form. The existing system of imposing requirements through license conditions does not allow for public comment. Incorporating generic license conditions into the regulations will allow public comment on these requirements before they are finalized. In addition, a few representative licensees, some nuclear medicine professional associations, and Agreement State government personnel were asked to comment during the development of the proposed rule.
- 5. The Regulation Is Written in an Understandable Manner.
The revision of Part 35 has, in part, been prompted by the lack of clarity in the existing rule. The proposed revision is designed to be clear and coherent. 3 Enclosure 3
- 6. Reporting Burdens.
Although the current reporting and recordkeeping activities, and the burdens associated with these requirements, have been cleared by the OMB under the Paperwork Reduction Act, the proposed revision will modify many of the existing requirements. For specific information on the information collection I activities of the proposed revision, see the OMB supporting statement in the rulemaking package.
- 7. Name, Address, and Telephone Number of a Knowledgeable Agency Official.
This information will be included as part of the Federal Register Notice that publishes the proposed rule.
- 8. Plan for Evaluation.
Implementation of the revised licensing system under Part 35 will be con-tinuously monitored to determine whether the regulatory objectives are achieved. The proposed revision is itself the result of an evaluation of the existing rule. The staff does not foresee need for another evaluation before the one required as part of the Regulations Coordinating Committee schedule of prior-ities for review. 4 Enclosure 3
e 9 16 e ENCLOSURE 4
REGULAf0RY ANALYSIS FOR THE PROPOSED REVISION OF PART 35 Table of Contents P_ age Introduction........................................................ 1
- 1. Statement of Prob 1em........................................... 1
- 2. Objectives..................................................... 2
- 3. Alternatives................................................... 2
- 4. Consequences................................................... 3
- 5. Decision Rationale............................................. 4
- 6. Implementation........................ ........................ 4
- 7. Section-by-Section Burden of Proposed Revision of Part 35...... 5
- 8. Total Industry Burden.......................................... 16
- 9. Cost to Workers and the Pub 1ic................................. 20
- 10. Cost to NRC.................................................... 20
- 11. Cost of Alternatives 1 and 3................................... 21 F
i 4 Enclosure 4
Introduction This regulatory analysis was prepared following instructions to Office Directors from the Executive Director for Operations, circulated December 13, 1982. Under those instructions, Part II.A, this proposed rulemaking is not subject to a mandatory regulatory analysis review. However, in the footnote on page 1 of the guidelines, the EDO directed that "... other rulemaking actions not covered by the mandatory review categories ... should also be supported by an analysis based on the guidance provided in Part III.B of the Guidelines but much less detail is required."
- 1. Statement of Problem This proposed rulemaking affects all persons who are licensed by the NRC to irradiate individuals with byproduct material, or its radiation, in the practice of the healing arts. This industry is currently subject to all the general radiation safety materials regulations (Parts 19, 20, 21, and 30),
Part 35, " Human Uses of Byproduct Material," licensing branch policies, a few generic orders, and many generic license conditions. The problem with this regulatory scheme is three-fold: (1) All the regulatory criteria are not published in a single unified text, therefore the applicant or licensee must look in several places to find all the standards that apply to his program; (2) Licensing branch policy and a listing of the applicable generic license conditions are not generally available to the public, therefore the applicant cannot accurately plan for resources needed to meet regulatory burdens until the license is in hand; and (3) Since the requirements are scattered, in order to assure the public health and safety the staff requires that applicants submit for review many detailed procedures that will be followed when the license is issued. Then, they are required by license condition to conduct their programs in accord with the statements made in the application. This proposed rulemaking may be taken at this time because the staff does not believe that dramatic new types of use that would require generic license conditions will evolve in the next decade; rather, the staff believes research will be devoted to refinement of current methods and development of new 1 Enclosure 4
. . ~. _ _. . _ _ _ _ . _ _ . _ . _ . _ _ _ _ _ _ . . . _ _ _ _
materials for which the radiation safety measures are similar to the safety measures for materials currently authorized for use. Even if we do see new technologies that have to be handled on a case-by-case basis, that porfion of any licensee's program designed to provide conventional patient care will benefit from the clarification and codification of regulations. If no action is taken, the staff believes the industry will continue to be confused about whether a specific standard is a requirement or a suggestion. The codification of all regulations in a single document may , result.in fewer enforcement actions because all requirements will be in one text and all licensees will be working under the same set of requiren.ents.
- 2. Objectives ,
The purpose of this proposed rulemaking is to codify, in plain English, dll OddidblOn Safely requirements specific to the medical use of byproduct material. The staff and the industry generally agree that the requirements in the proposed rulemaking are needed to protect the public health and safety.
- 3. Alternatives In developing an earlier staff proposal on the revision of Part 35, l SECY-83-62, the staff considered reducing the number of requirements to a few, and simply providing guidance for good practice. Since such a regulatory scheme might not have protected the public health and safety, probably would have left the industry in a state of confusion given the very prescriptive regulatory scheme used for the past several years, and might have made enforcement actions more difficult, the staff did not consider this to be a reasonable alternative.
The staff finally proposed in SECY-83-62 that, since the safety l requirements had been codified, applicants simply be allowed to certify that they had met the training and experience standards and would comply with the regulations. In its response to SECY-83-62 (Enclosure 2), the Commission directed the staff to continue pre-licensing review of physician I qualifications and operating procedures. i 2 Enclosure 4 L._.
In developing a response to the Commissioners' directive, the staff con-sidered that, because the safety requirements had been codified, applicants be required to submit evidence of training and experience and a radiation safety plan that described the licensee's general radiation safety policy and essential safety elements that would be incorporated in site-specific procedures. The staff decided that this alternative was inconsistent with Commission instructions. The alternative selected by the staff to regulate the medical use of byproduct material, the alternative directed by the Commission, includes codf-fication of all generic requirements, and staff pre-licensing review of train-ing and experience and procedures. Consistent with current licensing policy, an applicant could simply certify that it would follow a model procedure devel-oped by NRC staff with public comment and published in a regulatory guide, or it could submit its own procedure for staff review.
- 4. Consequences Some general comments on the consequences of the proposed action are made below. A detailed burden analysis (expressed in dollars and man-hours) for the recommended alternative follows the narrative portion of this regulatory analy-sis; the cetts and benefits of the other alternatives are also analyzed but not in depth. Based on the analysis, the staff does not believe there will be any significant economic impact on licensees or the NRC.
NRC would have to redirect its training effort because it currently emphasizes review of applicants' procedures at the NRC office rather than an on-site review of work methods at the licensees' facilities. However, the long-term benefit will be a safety inspection based on a uniform, nationwide code of standards. Many Agreement States are in favor of consolidating the various regulatory requirements and support this revision of the regulations. However, the Agree-ment States are concerned about the impact of the proposed licensing policy. Agreement States regulate about 4700 medical licenses. Most States feel that a prelicensing review of radiation safety procedures and changes to the proce-dures is necessary to ensure a proper degree of safety. They believe that to permit the licensees to make changes to approved procedures without second review and approval by the regulatory agency is an unwarranted relaxation of 3 Enclosure 4
regulatory control. (The NRC staff does not agree with this assessment because all the essential elements of a medical radiation safety program have been codified in the proposed regulation.) The States believe that retraining of understaffed offices will be difficult, the number of items of non-compliance will increase, and that inspections will have to be longer and more frequent. Their contention is that they will be under pressure from their own licensees to adopt NRC's revised system of regulating the medical use of byproduct mate-rial, with which they don't agree. The staff does not expect any relief from regulatory burden or significant additional burden for licensees because the requirements in the regulation have, for the most part, been taken from requirements imposed by other means. There may be fewer noncompliance citations because all the generic requirements will be published in one place. The staff does not foresee any impact on other NRC programs or requirements. The stari does not foresee any significant transition problem because, as cur-rently written, each license can stand by itself without reference to the current or proposed Part 35. The staff does not foresee any scheduling, enforceability, policy, institutional, or legal problems.
- 5. Decision Rationale The staff is recommending the proposed revision because it clarifies requirements and grants some authority to licensees to change their procedures, facilities, and equipment for improved patient care, safety, or reduced cost.
The proposed revision is complete and the staff does not foresee any need for wide-ranging revisions, additions, or deletions for at least the next decade.
- 6. Implementation Since they are fairly complete and site-specific, the current licenses will stand alone to provide for public health and safety. As licenses come due for renewal, they can be reviewed and issued under the proposed regulatory method. Since the equipment and procedures specified in the regulation are similar to those required of current licensees, the staff does not foresee any need for significant increase in expenditures of time or money for renewal licensees or new applicants. However, the staff has specifically requested 4 Enclosure 4
1 public comment on the transition policy described in the preamble to the , Notice of Proposed Rulemaking. ihe staff is not aware of any relationship between this part and other existing or proposed requirements that would affect those requirements or cause a need for a reassessment of other actions, systems, or analyses.
- 7. Section-by-Section Burden Analysis of Proposed Revision of Part 35 On the following pages, the cost of complying with each individual section of the proposed regulation is estimated. Then, six hypothetical licensees that are representative of the medical industry are described. For each of the six licensees, the total regulatory burden is estimated by adding
; the burden due to each section with which the licensee would have to comply (not all sections apply to all licensees).
In most cases these are not new I burdens because similar requirements are currently imposed by license condition. Explanation of column descriptors and entries DEFGHIM: Describes which class of licensee must comply; see Subparts D through I in proposed Part 35; M refers to mobile nuclear medicine service; Inst refers to medical institutions. Sec: The subsection where the requirement is stated. R/0: R denotes a requirement; 0 denotes a privilege (with concommitant burdens if the privilege is exercised) contained in proposed Part 35. Freq: Some frequencies are specified in the regulation, and some have been assumed (superscripted "a") for purpose of estimating total cost. Codes: Sy-each 5 years; a-annually; 6m-each 6 months; q quarterly; m-monthly; w-weekly (50 weeks per year); d-daily (250 days per year); 2xd-twice daily.
- Hrs for Records: An estimate of hours spent preparing records, reports, and logs, either by a professional (Pro) or by a technician or
't 5 Enclosure 4
i im D I f n
,/
4 secretary (Tec). Forsrecurring actions, this is the time uneeded to do th0,actidn once. Cost of paper, forms, and filing space ar'e ' insignificant and are not included. Hrs for Work: An estimate of hours spent doing something, other than records generation, that is required of either a professional (Pro) or a technician'or secretary (Tec). For recurring actions, this is the time nseded to do the action once. These estimates are 1 V based on the experience of staff when previously employed by lic6psees. Eqpt & Supplies: An estimate of cost of capital equipment and consumable supplies needed based on catalogue prices from nationwide retailers. Capital equipment is amortized over 5 years. Contract Cost: An~ estimate of the fee charged for a service by an outside contractor. Based on informal surveys. s
$/yr: Dollar cost for compliance each year.
Pro Hrs /yr: Total professional hours consumed each year for compliance. Tec Hrs /yr: Total technical and secretarial hours consumed each year for compliance. N RG, LC, or R: N-a new requirement imposed by the proposed Part 35 RG-a recommended procedure, contained in a regulatory guide,
- that is frequently adopted by applicants LC-a frequently imposed license condition, I&E order, or licensing branch policy R-a current regulation Note: RG, LC, and R imply similar, not identical requirements 6 Enclosure 4
Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, DEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R (Ssveral footnotes follow the Table) 635.2 License Required. DEFGHM R Sy 1901'22 40 R I R Sy 3001'2a 60 R S35.16 Application for license, amendment, or renewal. DEFGHM R Sy 2021 10 4 2 R I R Sy 4021 10 8 2 R S35.17 License amendments. All 0 Sy 2 2 1 401,24 8 0.4 0.2 R S35.18 Notifications. All R Sy 3 0.5 0.5 0.1 0.1 N S35.30 ALARA program. Inst R a 104 10 RG 5 S35.31 RadjationSafetyOfficer. All R m 8 96 RG S35.32 Radiation Safety Committee. Inst R q 2s 82 40 8 R S35.37 Records and reports of misadministrations. DEHM c R Sy s 1 1 0.3 0.3 R S35.50 Possession, use, calibration, and check of dose calibrators. DEFM a R 2000 400 RG DEFM bl R d .02 .02 10 RG DEFM b2 R a .20 .20 500 100 0.4 RG DEFM b3 R q .50 1 6 RG a DEFM b4 R Sy 1 1 0.4 RG S35.53 Measurement of radiopharmaceutical dosages. a DEFM R 15xd .02 .02 150 RG S35.59 Requirements for possession of sealed sources and brachytherapy sources. DEFM bcd R 6m 0.5 0.5 1509 30 1 R G bcd R 6m 1 1 759 15 2 R HI bcd R 6m 0.5 0.5 759 15 1 R All g R qtr 0. 5 0.5 4 R DEFGM hi R qtr 0.5 0.5 4 N
$35.60 Syringe shields.
DEM R 30010 60 RG 7 Enclosure 4
Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, DEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R S35.61 Vial shields. DEM R 50011 100 RG S35.62 Syringe labels. DEM R 8012 80 N S35.70 Surveys for contamination and ambient radiation exposure rate. DEM a R d 0.2 0.4 150 RG DEM b R w 0.1 0.1 10 RG DEM e R w 0.2 0.5 35 RG
$35.75 Release of patients containing radiopharmaceuticals or permanent implants.13 a
F M R m 500 6000 LC S35.80 Mobile nuclear medicine service technical requirements. a M d R 2xd a 0.4 100 LC e R 2xd 0.2 0.2 100 LC 635.92 Decay-in-storage. a DEFM 0 m 0.5 1 18 LC S35.120 Possession of survey instrument. D R 500 5019 150 RG S35.204 Permissible molybdenum-99 concentration. a E R d .02 .04 15 R S35.205 Controls of aerosols and gases. E ab R 200014 400 RG E d R 6m 0.1 0.2 0.6 RG S35.220 Possession of survey instruments. E lo 500 5019 150 RG E hi 1000 5019 250 RG S35.310 Safetyinstruction. F R m 0.1 0.5 3.015 7 36 RG S35.315 Sa{etyprecautions. F a R m 4501s 5400 RG a F c R m a 0.2 2 RG F e R m a
- 1. 0 1.517 12 18 RG g R m 0.2 0.3 6 RG S35.320 Possession of survey instruments.
F lo R 500 5019 150 RG F hi R 1000 5019 250 RG S35.404 Release of patients treated with temporary implants. a G a R m 0.1 0.1 1 1 RG 8 Enclosure 4
O Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, DEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R S35.406 Brachytherapy sources inventory. a G a R m 0.1 1 RG G b R m* 0. 2 2 RG
$35.410 Safety instruction a
G R m 0.1 0.5 3.015 7 36 RG S35.415 Safety precaution a G a R m 45018 5400 G c R m* 0.2 2 RG S35.420 Possession of survey instrument. G R 1000 5019 250 RG S35.520 Availability of survey instrument a H R q 100 400 RG S35.610 Safety instruction a I R y 0.1 0.5 1.018 1 2 RG S35.615 Doors, interlocks, and warning systems. I b R 200 40 LC I c R 100 20 LC
$35.620 Possession of survey instruments.
I hi R 1000 5019 250 RG S35.621 Radiation monitoring device. I a R 750 150 R I d R d 0.02 0.1 30 R 635.622 Viewing system. I R 1000 200 LC S35.630 Dosimetry equipment. I a R 2y 2500 40019 700 R S35.632 Full calibration measurements. I R a 16 16 32 R S35.633 Periodic spot checks. I a R m 0.5 1 18 R I f R m 0.5 1 18 LC 635.641 Radiation sur'veys for teletherapy facilities. a I al R Sy 0.5 1 0.3 LC a I a2 R Sy 8 4 4 12 4 LC 9 Enclosure 4
1
, . l
)
Hrs for Hrs for Pro Tec Records Work Eqpt & Contract Hrs Hrs N, RG, 1 DEFGHIM Sec R/0 Freq Pro Tec Pro Tec Supplies Cost $/yr /yr /yr LC or R l 935.642 Safety checks for teletherapy facilities. a I a R Sy 0.5 1 0.3 N 835.645 Five year inspection. I R -Sy 20002o 400 LC i 10 Enclosure 4
Footnotes 1A fee required by Part 170. 2 Assume one amendment for a new user or use over 5 years. 3 Assume one key individual leaves over 5 years. 4 Preparing the program is part of the application time. This cost assumes six hours to prepare an annual briefing and one hour for the RSO to deliver the briefing to three administrators. 5 Assume eight hours once each month to investigate a deviation from good practice. Developing policy and procedures is part of the application time. Procedure modification is not required and therefore not costed. Helping the Radiation Safety Committee is costed in S 35.32. 6 Typing and distributing minutes. 7 Assume RSO needs three hours to prepare agenda, and five individuals attend a one hour meeting. 8 Assuming 15 procedures per day, 250 days per year, and a frequency of 0.01% (see SECY-82-388 p 2), there will be about one misadministration every three years. 9 Radioactive check sources to convert wipe sample cpm to microcuries. 10 Assume two at $150 each. 11 Assume five at $100 each. 12 Assume 4000 labels per year at $10 per 500. 13 Diagnostic dosages do not require patient confinement for radiation safety purposes. Assume one radiopharmaceutical therapy procedure each month with one additional day of confinement (beyond that needed for patient care) in a private room at $500 each day. Permanent implant administrations generally-do not require patient confinement for radiation safety purposes. 14 Cost of a closed, shielded gas collection system. 15 Assume RSO briefs six nurses for one-half hour. 16 Assume three days in a private room at $500 instead of a semi private room at $350. 17 Assumed time needed to decontaminate room. 1sAssume the RSO briefs two technicians each year. 11 Enclosure 4
l l
- l Footnotes (Continued) 18 Calibration service.
20 Assume two days at $750 each day, plus $500 total per diem and travel. l 21 Draft Regulatory Guide 10.8 for all applications except teletherapy, and a draft Regulatory Guide that is being developed for teletherapy, are available for use by applicants. Except for site-specific information that must be ! submitted, applicants can certify that they will follow the model procedures in the guides, or mark-up the model procedures to meet their site specific needs and submit clean mark-ups for staff review. This burden estimate I assumes that most applicants will use most of the model procedures. 22 Changed on June 20, 1984 to $580. 23 Changed on June 20, 1984 to $580. 1 24 Changed on June 20, 1984 to $120 for all subparts except teletherapy, which is $230. l l l l l 1 l l l l l l 12 Enclosure 4
T~ Sections not costed 35.1 Purpose and scope. 35.8 Reporting, recordkeeping, and application requirements: OMB approval. 35.15 Definitions. 35.28 License issuance. 35.29 Specific exemptions. 35.31 Radiation Safety Officer. Having an RSO is required by the general criteria of S 30.33 which require that the applicant be qualified by training and experience. Development of procedures is costed @ S 35.16. 35.33 Requirement for authority and statement of responsibilities. This is part of the management responsibility to provide a position description for any worker. 35.34 Visiting authorized user. This is an option, not a requirement. The review process may be conducted during the meetings costed at S 35.32. 35.35 Mobile nuclear medicine service administration requirements. 36.36 Radiation safety program changes. 35.37abde Records and reports of misadministrations. Therapy misadministra-tions are very rare (see SECY-83-388 p 2). Investigating and making a record of a misadministration is costed @ S 35.31 as part of a deviation from good practice. 35.38 Supervision. This is part of the management responsibility to supervise employees. 35.49 Suppliers. 35.50cde Dose calibrators do not break down frequently. Records are costed within the prescriptive requirements to test or check the calibrator. 35.51 Calibration and check of survey instruments. The calibration cost is included as a contract cost in the section that requires possession of the instrument. The survey instrument check (d of this section) is included in the time needed to make a survey. 35.58 Authorization for calibration and reference sources. 35.59e Leaking sources are very rare. 35.63 Vial shield labels. Vial shields can be permanently labeled in a few minutes. 35.90 Storage of volatiles and gases. A plastic bag within a plastic bag will meet the requirement of the regulation. 13 Enclosure 4
r 35.100 Use of radiopharmaceuticals for uptake, dilution and excretion studies. 35.200 Use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. 35.205c Control of aerosols and gases. Negative pressure in imaging rooms can be achieved by closing the door, turning off or covering supply vents, and fully opening exhaust vents. 35.300 Use of radiopharmaceuticals for therapy. 35.400 Use of sources for brachytherapy. 35.500 Use of sealed sources for diagnosis. 35.600 Use of a sealed source in a teletherapy unit. 35.605 Maintenance and repair restrictions. 35.606 Amendments. None of the changes which require an amendment request are frequently made. 35.615a Doors, interlocks, and warning systems. Doors are usually installed for compliance with Part 20. 35.643 Modification of teletherapy unit or room before beginning a treatment program. A modification for safety purposes is not usually necessary. 35.644 Reports of teletherapy surveys, checks, tests, and measurements. The licensee need only submit a copy of a record which was costed in another section. The following sections were not costed because they are industry-specific training and experience standards generally required by S 30.33(a)(3). 35.900 Radiation Safety Officer. 35.901 Training for experienced Radiation Safety Officer. 35.910 Training for uptake, dilution, and excretion studies. 35.920 Training for imaging and localization studies. 35.930 Training for therapeutic use of radiopharmaceuticals. 35.940 Training for therapeutic use of brachytherapy sources. 35.941 Training for ophthalmic use of strontium-90. 35.950 Training for use of sealed sources for diagnosis. 35.960 Training for teletherapy. 14 Enclosure 4
35.961 Training for qualified teletherapy calibration expert. 35.970 Training for experienced authorized users. 35.971 Physician training in a three month program. 35.990 Violations. 35.999 Resolution of conflicting requirements during transition period. 9 i l l l I l l i l l i 15 Enclosure 4 L
- 8. Total Industry Burden Because each license authorizes the particular materials requested by the applicant, the exact number of licensees that are accurately described by the
" hypothetical licensee" descriptors is unknown. However, an informal analysis of license files has yielded the indicated estimate of number of licenses affected. For the purpose of estimating total industry burden and increase in the burden caused by this revision, we assume $100 per professional hour, $30 per technician hour, and round to two significant figures.
Case Description and Regulatory Burden per year (see following tally sheets)
- 1. A nuclear medicine diagnostic clinic that is not based in a hospital and conducts 15 procedures each day. Licensee's annual regulatory burden: $1618, 110 professional hours, and 398 technician hours.
Approximate number of licensees: 300. Total industry burden: 300 x (1618 + 110 x 100 + 398 x 30) = $7,400,000 Increase: 300 x (80 + 4.1 x 100 + 0.1 x 30) = $150,000.
- 2. A nuclear medicine diagnostic clinic that is based in a hospital and conducts 15 procedures each day. Licensee's annual regulatory burden: $1618, 160 professional hours, and 406 technician hours.
Approximate number of licensees: 700. Total industry burden: 700 x (1618 + 160 x 100 + 406 x 30) = $21,000,000 Increase: 700 x (80 + 4.1 x 100 + 0.1 x 30) = $350,000.
- 3. A hospital with a nuclear medicine clinic that conducts 15 diagnostic procedures each day and one radiopharmaceutical therapy procedure each month. Licensee's annual regulatory burden: $13,018, 179 profes-sional hours, and 466 technician hours.
Approximate number of licensees: 700. Total industry burden: 700 x (13018 + 179 x 100 + 466 x 30) = $31,000,000 Increase: 700 x (80 + 4.1 x 100 + 0.1 x 30) = $350,000 16 Enclosure 4
- 4. A hospital with a nuclear medicine clinic that conducts 15 diagnostic procedures each day and one brachytherapy procedure each month.
Licensee's annual regulatory burden: $7033, 177 professional hours, and 448 technician hours. Approximate number of licensees: 400. Total industry burden: 400 x (7033 + 177 x 100 + 488 x 30) = $15,000,000 Increase: 400 x (80 + 8.1 x 100 + 0.1 x 30) = $360,000
- 5. A hospital with a nuclear medicine clinic that conducts 15 diagnostic procedures each day and has one cobalt-60 teletherapy unit. Licensee's annual regulatory burden: $3211, 233 professional hours, and 463 tech-nician hours.
Approximate number of licensees: 400. Total industry burden: 400 x (3211 + 233 x 100 + 463 x 30) = $16,000,000 Increase: 400 x (80 + 4.1 x 100 + 0.1 x 30) = $200,000
- 6. A mobile nuclear medicine service that conducts 15 diagnostic proce-dures each day spread between two client locations. Licensees's annual regulatory burden: $1618, 110 professional hours, and 598 technician hours.
Approximate number of licensees: 50. Total industry burden: 50 x (1618 + 110 x 100 + 590 x 30) = $1,500,000 Increase: 50 x (80 + 4.1 x 100 + 0.1 x 30) = $25,000
, The total burden of the revised Part 35 on the medical industry is about $92 million dollars. However, this is not a new impact. Almost all the burden (except for $5 35.18, 35.59h and i, 35.62, and 35.642) is currently imposed by regulation or license condition. The new burden is about $1.4 million dollars.
17 Enclosure 4
r-CASES l 1 2 3 4 5 6
- Pro Tec Pro Tec Pro Tec oro Tec Pro Tec Pro Tec i S:ction $ hrs hrs $ hrs hrs $ hrs hrs $ hrs brs $ hrs hrs $ hrs hrs l
l 35.2 40 40 60 40 L 35.16 4 2 4 2 8 2 4 2 1' 35.17 8 0.4 0.2 8 0.4 0.2 8 0.4 0.2 8 0.4 0.2 l 35.18 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 35.30 10 35.31 96 96 96 [ 35.32 40 8 35.37 0.3 0.3 0.3 0.3 0.3 0.3 , 35.50 500 16.8 500 16.8 500 16.8 i 35.53 150 150 150 35.59bcd 30 1 30 1 15 1 15 1 30 1 l 35.59g 4 4 4 4 l 35.59hi 4 4 4 4 35.60 60 60 60 35.61 100 100 100 35.62 80 80 80 35.70 195 195 195 35.75 6000 35.80 200 l 35.92 18 18 18 ! 35.120* 150 150 150
! 35.204 15 15 15 35.205 400 0.6 400 0.6 400 0.6 35.220* 250 250 250 35.310 7 36
- 35.315 5400 12 24 35.404 1 1 35,406 3 35.410 7 36 35.415 5400 2 35.610 1 2 35.615 60 35.621 150 30 35.622 200 35.630 700 35.632 32 35.633 18 18 35.641 12.3 4 l 35.642 0.3 35.645 400 I
*This expenditure also meets requirements of SS 35.320, 35.420, 35.520, and 35.620.
l 18 Enclosure 4
CASES (Continued) 1 2 3 4 5 6
$ 1618 1618 11400 5415 1593 1618 subtotal P-hrs 110 160 19 17 73 110 T-brs 398 406 60 42 57 598 carryover $ 1618 1618 1618 from P-brs 160 160 160 case 2 T-hrs 406 406 406
$ 1618 1618 13018 7033 3211 1618 TOTAL P-hrs 110 160 179 177 233 110 BURDEN T-brs 398 406 466 448 463 598 Note that the only sections that impose completely new burdens are 35.18, 35.59hi, 35.62, and 35.642. Now we may calculate the new burden caused by this revision (the cost of just those sections).
$ 80 80 0 80 subtotal P-brs 4.1 4.1 4.0 4.1 T-brs 0.1 0.1 0 0.1 carryover $ 80 80 80 from P-hrs 4.1 4.1 4.1 case 2 T-brs 0.1 0.1 0.1 TOTAL $ 80 80 80 80 80 80 NEW P-hrs 4.1 4.1 4.1 8.1 4.1 4.1 BURDEN T-brs 0.1 0.1 0.1 0.1 0.1 0.1 l
l 19 Enclosure 4 l L _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
l 1
- 9. Cost to Workers and the Public Since day-to-day operations will not be significantly affected, the staff does not foresee any increase or decrease in worker or public dose. Nor does the staff foresee any additional cost to the public above that borne by licensees and passed on to the public as overhead. The only government agencies that will be affected are those that provide patient care under an NRC license.
- 10. Cost to NRC NRC staff retraining would be needed to explain the new method of regulat-ing the medical industry. However, there would be no significant changes in day-to-day licensee operations, and no need to learn new medical use or radia-tion safety technology because almost all the requirements in the proposed regulation are already imposed by other means.
About 85 NRC employees (managers, license reviewers, and inspectors) would have to attend a two-day course on the implementation of the revision. The course would be given at headquarters and at each of the five regional offices. The first day of the course would be spent discussing the reasons Part 35 was revised and discussing each section of the regulation. The second day would be spent discussing the licensing and inspection process under the revision. The training would consume 1360 hours (2da x 8 hrs /da x 85 students) of student time, and 176 hours of instructor time. The latter figure is comprised of 80 hours of planning and 96 hours (2da x 8 hrs /da x 6 courses) of teaching. Instructor expenses would be about $1000 for travel and $750 per diem. (10da x $75/da) l If we assume NRC staff time costs $60/hr, the total implementation cost to NRC is about $94,000 ($60 x 1360 + $60 x 176 + $1750). NRC conducts about 1000 medical inspections each year. The inspector must spend about one hour reviewing a license application before he can conduct an inspection because, in many cases citations are based on statements and representations made in the application. The savings to NRC is about 1000 hours, or $60,000 each year. 20 Enclosure 4
- 11. Cost of Alternatives 1 and 3 Alternatives 1 and 3 are fully described in Enclosure 10.
Assumptions for costing Alternatives 1 and 3
- 1. NRC will receive 100 new applications, 600 renewal requests, and 1800 amendment requests each year. Based on current load.
- 2. Approximately 40% of all these requests are returned to the requestor with a deficiency notice that asks for additional information or clarification. Based on current rate.
- 3. Licensee professional time (" pro") costs $100/hr, licensee secretarial and technical time ("tec") costs $30/hr, and NRC professional time costs
$60/hr. Same as used for costing proposed revision.
Cost of Alternative 1 Alternative 1 is the no-action option. The major cost to licensees is the cost of preparing amendment requests that would no longer be necessary under the revision. If we assume one-half of amendment requests are te minor changes in procedures, facilities, and equipment, the industry wil' have to pay $315,000 each year (900 requests x ($120 fee + 2 prohrs @ $100 + 1 techr @ $30)). Licensees will also not be spared the cost of repairing requests that were deficient because of unclear regulatory policy. After subtracting the 900 unnecessary requests, we would receive 1600 licensing actions. If deficiencies were reduced one-half, from 40% to 20%, and if it costs the requestor $230 to respond to a deficiency notice (2 prohrs @ $100 + 1 techt @ $30), a potential savings of $74,000 (1600 x 20% x $230) is lost. Licensees would save the Alternative 2 new burden of about $1.4 million, but the staff would recommend that the Commission adopt those new requirements as a separate action. 21 Enclosure 4
The major cost has to do with NRC also bears costs under Alternative 1. inspections. The NRC currently conducts about 1000 medical inspections each year. The inspector must spend about one hour reviewing a license application before he can conduct an inspection. Because under the proposal all medical inspections would be made against the regulation, that hour could be saved The lost savings to NRC is about 1000 hours or $60,000 under the revision. dollars each year. NRC would also not be spared the cost of generating deficiency notices. If, of the remaining 1600 licensing requests (900 amendments + 100 new appli-cations + 600 renewals), one half of the 40% deficiency rate can be eliminated, and if it takes one hour of professional time to generate a deficiency notice, the lost savings to NRC is about $19,000 (1600 x 20% x $60). NRC would save some of the re-training cost of $94,000, but not all of it because some time would still have to be spent for continuing education for licensing and inspection staff. Cost of Alternative 3 Under Alternative 3 the NRC would revise the regulations and continue to require that the licensee conduct its byproduct material program in accordance with the statements made in the application. As described in the costing of Alternative 1, licensees would lose a potential cost savings of $315,000 needed to generate requests for minor changes in procedures, facilities, and equipment, and $74,000 needed to respond to deficient application notices. Also as described under Alternative 1, NRC would lose a potential savings of about 1000 hours, or $60,000, caused by increased inspection time, and about 320 hours, or $19,000, generating deficiency notices. 22 Enclosure 4
O 1 m ENCLOSURE 5 l l l i J
ORAFTPUBLICANN0VNC$ MENT NRC PROPOSES TO SIMPLIFY MEDICAL LICENSING PROCEDURES The Nuclear Regulatory Commission is proposing to revise its regulations to simplify and make more efficient the regulatory process for the medical uses of radioisotopes. The NRC issues licenses to medical facilities and individual physicians for the use of radioactive materials to diagnose and to treat patients. Specific licenses are issued for one or more of six groups of medical uses organized in ascending order of radiation hazard potential, each containing related diagnostic or therapeutic procedures. A separate license is issued for teletherapy units. Applicants for specific licenses must submit a substan-tial amount of information to show that all radiation safety requirements will be met, including a description of the procedures used in meeting the require-ments. The Commission's radiation safety review covers three general areas: radiological heath and safety procedures; personnel training and experience; and facilities and equipment. Due to the rapid evolution in the medical use of radioisotopes over the last thirty years, current requirements are found throughout the regulations, regulatory guides, standard license conditions and other sources. Therefore, the primary purpose of the proposed revision is to consolidate the requirements. Under the proposal, all requirements would be clarified and published in one place, Part 35 of NRC regulations, which would serve to regulate the day-to-day uses of medical radioisotopes. The revised regulation would give both licensees and NRC staff a clearer basis for licensing, operation, and inspection activities. A draft regulatory guide for medical programs has been prepared. It contains a model procedure acceptable to NRC for meeting each of the medical use requirements. Licensees could use the model procedures for meeting the requirements or could prepare their own procedures. 1 Enclosure 5
If applicants submit their own radiation safety procedures, the NRC staff will continue to review them to assure they are adequate to meet the require-ments of the regulations. However, to permit licensees to make prompt use of new safety methods and to adjust their radioisotope programs to meet new needs caused by changes in demand for patient care services or patient load, licensees would be able to modify their procedures without NRC review provided the regu-lations are met. Modifications would require approval of the licensee's Radia-tion Safety Officer, and at a hospital, its Radiation Safety Committee. Some types of program changes that would still require a formal NRC review and license amendment include new physician user, new medical use, and new loca-tion of use. The proposed revision to Part 35 of NRC regulations is being published for public comment in the Federal Register on . Comments should be submitted within 120 days to the Office of the Secretary, Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch. 2 Enclosure 5
= - - - * - - . - -- - ---a- - .-,_ . .-
9 O ENCLOSURE 6
[ .. l DRAFT CONGRESSIONAL LETTER I i
Dear Mr. Chairman:
i The Nuclear Regulatory Commission is proposing to revise its regulations to p simplify and make more efficient for both licensees and the agency the regula- ] tory process for the medical uses of radioisotopes. . The NRC has licensed about 2200 medical facilities and 300 physicians in private I practice to use radioactive materials to diagnose and to treat patients. The j NRC receives about 100 new applications, 500 renewal requests, and 1800 license 7 amendment requests each year. - 1 4 Due to the rapid evolution in the medical use of radioisotopes over the last 1 thirty years, current requirements are found throughout the regulations, regu-latory guides, standard license conditions and other sources. Therefore, I license applicants must submit a substantial amount of information to show that $ all radiation safety requirements will be met, including a description of the radiation safety management procedures used in meeting the requirements, avail-j able facilities and equipment, and key users' training and experience. The agency reviews the applicant's program before issuing a license. I The primary purpose of the proposed revision is to consolidate the requirements. { Under the proposal, all requirements would be clarified and published in one ) place, Part 35 of NRC regulations. The revised regulation would give both l licensees and NRC staff a clearer basis for licensing, operation, and inspec-l tion activities. i
! The NRC staff will continue to review the applicant's radiation safety procedures
! to determine whether they are adequate to meet the requirements of the regula-l tions. However, to permit licensees to make prompt use of new safety methods and to adjust their radioactive materials programs to meet new needs caused by I i i 1 Enclosure 6
changes in demand for patient care services or patient load, licensees would be able to modify their procedures without NRC review provided the regulations are met. Modifications would require approval of the licensee's Radiation Safety Officer, and at a hopsital, its Radiation Safety Committee. Some types of program changes that would still require a formal NRC review and license amendment include adding new physician users, new medical uses, and new locations of use. The proposed revision to Part 35 of NRC regulations will be published for public comment in the Federal Register. The draft regulation and the draft regulatory guide will be mailed to current licensees and other interested individuals for comment. John G. Davis, Director Office of Nuclear Material Safety and Safeguards cc: 2 Enclosure 6
CONGRESSIONAL ADDRESSEES The Honorable Richard L. Ottinger, Chairman Subcommittee on Energy Conservation and Power-Committee on Energy and Commerce United States House of Representatives Washington, DC 10515 ATTN: Mike Ward 316 House Annex #2 cc: The Honorable Carlos Moorhead ATTN: Chris Warner 2322 RH08 The Honorable Alan Simpson, Chairman Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510 ATTN: Jim Curtiss 6233 0508 cc: The Honorable Gary Hart ATTN: Keith Glaser A728 Immigration Building The Honorable Morris K. Udall, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affairs United States House of Representatives Washington, DC 20515 ATTN: Henry Myers 1327 LH08 cc: The Honorable Manual Lujan 1329 LHOB i i
i O O ENCLOSURE 7
DRAFT ENVIRONMENTAL ASSESSMENT FOR THE PROPOSED REVISION OF 10 CFR PART 35, " MEDICAL USE OF BYPRODUCT MATERIAL"; FINDING OF NO SIGNIFICANT IMPACT.
- 1. Introduction The Nuclear Regulatory Commission (NRC) is proposing to revise its regulations that govern the use of byproduct material for patient diagnosis and therapy. Most of the revision would consist of a clarification and consoli-dation of requirements that are part of the application review process or that are currently imposed on licensees as license conditions or inspection and enforcement orders. The revision would also change the method of applying for a " medical use" license.
Because some of the regulations may have a physical effect on the human environment, the staff has prepared the following Environmental Assessment.
- 2. Need for the Revision; Rejection of the No Action Alternative Guidance in the safe use of byproduct material in patient care is currently scattered among the regulations, orders, license conditions, guides, and technical reports. A document that consolidates the essential elements of the guidance is needed to ensure that each individual who needs the information will receive all the information. The document could be a NUREG Report, a Regulatory Guide, or a revision of the regulations. The NRC chose a revision of the regulations in order to reduce the time needed to issue a license and to ensure uniformity of requirements throughout the NRC-licensed medical industry.
There are currently about 2500 " medical use" licensees. Each year, the NRC receives about 100 new applications, 500 renewal applications, and 1800 amendment 1 Enclosure 7
requests. In order to ensure that the applicant has made a commitment to use byproduct material safely, the staff thoroughly reviews ecch procedure that an applicant proposes to use. Because some of the safety criteria that the NRC considers essential are not in the regulations, the application and license are the primary documents used to establish the licensee's responsibility for the safe use of byproduct material. In order to simplify the licensing process without compromising the safety of workers and the public, the Commission believes it is necessary to have the essential safety criteria in the regula-tions. (Publication of a NUREG report or a Regulatory Guide would provide a consolidated document, but neither has regulatory force.) Therefore, the Commission has determined that, in order to make the P licensing process more efficient and to reduce the amount of time needed to issue a license, amendment, or renewal, the regulations must be revised.
- 3. The Proposed Action and Its Impact
- a. Specific Sections. Most of the proposed revision deals with the safe use of byproduct material in the workplace. The following sections deal with exposure of the public and the environment.
S 35.75 Release of patients containing radiopharmaceuticals or permanent implants. This section requires that the licensee not release a patient until the exposure rate from the patient is less than 6 milliroentgens per hour at a distance of one meter. The Commission notes that a study of the radiation exposure of family members of patients who were administered 8 to 150 milli-curies of I-131 indicated that the median exposure to a family member living with the patient was 19 milliroentgens [A. P. Jacobson, et al., American Journal of Public Health, vol. 68, op 225-230, March 1978]. Currently, accord-ing to a frequently used license condition, the licensee may release a patient who contains less than 30 millicuries of radioactivity. (For I-131, the most hazardous frequently used radiopharmaceutical, this amount of activity would create an exposure rate of about 6 milliroentgens per hour at a distance of one meter from the patient.) The Commission notes that the International Commis-sion on Radiological Protection has, for many years, recommended limits on 2 Enclosure 7
radiation exposure of individuals. "The dose equivalent limits . . . recom-mended by the [ICRP] have been in effect for over 20 years. They have been widely used internationally and have been incorporated into legislation in a number of countries and regions. Furthermore, there is no evidence to indicate that the [ICRP's] recommended system of dose limitation has failed to provide an adequate level of safety . . . The [ICRP's] recoramended whole body dose equivalent of 5 mSv (0.5 rem) in a year, as applied to critical groups, has been found to provide this degree of safety. . ." [ Annals of the ICRP, Pergammon Press, Oxford. ICRP Publication 26, adopted January 17, 1977, para-graphs 77 and 119.] Therefore the Commission has determined that neither the exposure to a family member nor the exposure rate to other individuals or the environment would produce any discernible effect. (See also the discussion of SS 35.90 and 35.205 that follows.) S 35.80 Mobile nuclear medicine service technical requirements. A mobile nuclear medicine service transports and uses byproduct material away from the licensee's base of operation. (The safe transportation of the byproduct mate-rial is regulated by the Department of Transportation.) The licensee will be authorized to transport prepared radiopharmaceuticals, but not radionuclide generators. This will ensure that only byproduct material to be used for patient care will be transported. The regulation requires that the licensee ensure, by radiation survey, that all byproduct material, except that admin-istered to the patient, has been removed from the place of use. Concerning the transportation of by product material, the Commission notes the following information that has been extracted from " Final Environ-mental Statement on the Transportation of Radioactive Material by Air and Other Modes" NUREG-0170 v 1 USNRC Dec. 1977.
"[page iv] Radiation exposure of transport workers and members of the general public along the transportation route occurs from the normal permissible radiation emitted from packages in transport. More than half of the 9800 person-rem exposure resulting from 1975 shipments was received by transport workers associated with the shipments. The remaining 4200 person-rems was divided among approximately ten percent of the U.S. population. None 3 Enclosure 7
of these exposures would produce short-term fatalities. On a statistical basis, expected values for health effects that may result from this exposure are 1.7 genetic effects per year and 1.2 latent cancer fatalities distributed over the 30 years following each year of transporting radioactive material in the United States at 1975 levels (Chapter 4, Section 4.9). More than half of this effect results from the shipment of medical-use radioactive materials where the corresponding benefit is generally accepted (Chapter 1, Table 1-2).
" Transportation accidents involving packages of radioactive material present potential for radiological exposure to transport workers and to members of the general public. The expected values of the annual radiological impact from such potential exposure are very small, estimated to be about one latent cancer fatality and one genetic effect for two hundred years of shipping at 1975 rates (Chapter 5, Section 5.9). More than two-thirds of that impact is attributable to nuclear fuel cycle and other industrial shipments (Chapter 1, Table 1-2). [0nly 13% of the impact is attributed to medical shipments.]. . .
" Examination of the consequences of a major accident and assumed subsequent release of radioactive material indicates that the potential consequences ar6 not severe for most shipments of radioactive material (Chapter 5, Section 5.6). The consequences are limited by one or more parameters: short half-life, nondispersible form, low radiotoxicity. . .
"[page vii] On the basis of the analysis and evaluation set forth in this statement and after weighing the small adverse environmental impact resulting from transportation of radioactive materials and the costs and benefits of the alternatives available for reducing or avoiding the adverse environmental effects, the staff concludes that:
- a. Maximum radiation exposure of individuals from normal transpor-tation is generally within recommended limits for members of the general public (Chapter 3, Section 3.5). There are transportation operations at a few locations where some transport workers receive radiation exposures in excess of the recommended limits established for members of the general public. In most cases, these operations employ radiation safety personnel to establish 4 Enclosure 7
safe procedures and to train and monitor transport workers as though they were radiation workers.
- b. The average radiation dose to the population at risk from normal transportation is a small fraction of the limits recommended for members of the general public from all sources of radiation other than natural and medical sources (Chapter 3, Section 3.5) and is a small fraction of natural background dose (Chapter 3, Section 3.3). . .
"[Page viii] Based on the above conclusions, the NRC staff has determined that the environmental impacts of normal transportation of radioactive material and the risks attendant to accidents involving radioactive material shipments are sufficiently small to allow continued shipments by all modes."
Currently only about 30 of the Commission's 2600 human use licensees are authorized to transport byproduct material for mobile nuclear medicine service. The NRC does not expect any significant increase in mobile service, and there-fore does not expect any significant increase in risk due to transportation. S 35.90 Storage of volatiles and gases, and S 35.205 Control of aerosols and gases. These sections allow the storage of volatile radiopharmaceuticals and gases in a fume hood, and the venting of waste material to the atmosphere. The purpose of these sections is to protect employees from inadvertent release of byproduct material in the workplace. The release of byproduct material to the environment is regulated by Part 20, " Standards for Protection Against Radiation." The Commission notes that the ICRP has calculated the concentration of a radionuclide in an effluent stream taat would cause a member of the population at large to receive an exposure of D.5 rem in one year. " . . .the [ maximum permissible concentration] values for [the population at large] are one-tenth of the occupational values for. . .the 168 hour week." [ Health Physics, v3, June 1960. " Report of Committee II on Permissible Dose for Internal Radiation (1959)", p5] The maximum permissible concentration values in 10 CFR 20 Appendix B for soluble Tc-99m, insoluble Tc-99m, insoluble I-131, and Xe-133 5 Enclosure 7
are equal to one-tenth of the "168 hour week" values referred to in the previous sentence. The appendix B value for soluble I-131 is more restrictive than one-tenth of the "168 hour week" value. (These are the radionuclides most frequently used in human use.) Therefore, allowing releases up to the concentration values of 10 CFR Part 20 Appendix B is not likely to be unsafe to humans. Concerning radiation exposure of the ecosystem, the Commission notes that a National Academy of Sciences-National Research Council committee stated that
" Evidence to date indicates that probably no other living organisms are very much more radiosensitive than man so that if man as an individual is protected, then other organisms as populations would be most unlikely to suffer harm. In fact, it is very difficult if not impossible to detect any effects of radio-nuclides in the environment even at concentrations much higher than the minimum established by regulation agencies." ["The Effects on Populations of Exposure to Low Levels of Ionizing Radiation," Report of the Advisory Committee on the Biological Effects of Ionizing Radiations, National Academy of Sciences-National Research Council, Washington, D.C. 20006 November 1972, p34.] Since it was determined in the preceding paragraph that man as an individual will be protected, we may assume there will not be any detectable effect on other living organisms.
For these reasons, the Commission has determined that, if approved, these sections will not result in any significant impact on the environment. S 35.92 Decay-in-storage. This section allows the licensee to release 1 decayed byproduct material to the environment. Before doing so, the licensee must survey the material to ensure that the radiation from the material cannot be distinguished from natural background radiation levels. Because there would be no detectable radiation emanating from the released material, there will be no discernible effect on the environment. S 35.404 Release of patients treated with temporary implants. This section requires that the licensee determine by source count and radiation survey that all implant sources have been removed from the patient. This will 6 Enclosure 7
ensure that a source and the radiation emanating from it are not unintentionally released to the environment. ' S 35.604 Information to be submitted with application. This section requires that an applicant for a teletherapy license submit information that will allow the staff to make an independent estimate of the environmental exposure due to radiation that penetrates through the teletherapy room walls. This will help to ensure that the applicant will be able to comply with the requirements of S 20.105, which regulates permissible levels of radiation in unrestricted areas. The regulations in that section require that the licensee demonstrate that it is unlikely that any individual in an unrestricted area would receive a dose in excess of 0.5 rem in one year. The Commission has determined that this provides an adequate degree of safety for humans (see the discussion of S 35.75 in this assessment). Occasionally applicants choose to minimize the exposure of individuals by physically restricting access to an area (by a fence, for example) rather than by providing additional radiation shielding. In such a case it is conceivable that, although human exposure would be kept below 0.5 rem in one year, some flora and fauna may be exposed to higher levels of radiation. As noted in the discussion of SS 35.90 and 35.205 in this assessment,
....it is very difficult if not impossible to detect any effects of radio-nuclides in the environment even at concentrations much higher than the minimum established by regulation agencies." Since it is recognized that, for purposes of radiation protection, there is no inherent difference in the effects of internal as contrasted to external radiation exposure (ICRP Publica-tion 26, paragraph 104), that observation may be expanded to govern this discussion of external radiation exposure.
In these cases the higher levels of radiation proposed by applicants are usually not dramatically higher than the 0.5 rem per year limit, and are usually requested by applicants only when the cost of additional radiation shielding would be an unreasonable expense. The Commission notes that the 7 Enclosure 7 I
potential for human benefit due to the availability of radiation therapy far outweighs the conceivable impact on the ecosystem that might be caused by the higher radiation levels. In light of all this the Commission has determined that the benefit to society outweighs any credible impact on the environment.
- b. General. The Commission issues licenses that authorize the intentional irradiation of individuals by licensees. The Commission recognizes that there is a chance that the irradiation of an individual for diagnostic or therapeutic purpose may have deleterious effects. However, in a policy statement that was published February 9, 1979 (44 FR 8242), the Commission gave notice that, while it will regulate the radiation safety of patients where justified by the risk to patients, it will not intrude into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine. For each method of human use authorized by the regulations, the possibility of individual human benefit has been demonstrated by scientific research.
- 4. Summary The Commission has decided that a need exists for a change in the regulations that govern the human use of byproduct material. The change will provide a clear, concise set of regulations for the affected industry. The Commission has determined that there will be no discernible impact on the environment. Therefore, it is not necessary to prepare an environmental impact statement.
8 Enclosure 7
1
, i 9-e ENCLOSURE 8
Summary of Unresolved Comments on Proposed Revision of 10 CFR Part 35 The following comments were made in communications from G. Wayne Kerr, Director, Office of State Programs (SP), dated July 22, 1984, and December 14, 1984; . J. A. Hind, Director, Division of Radiation Safety and Safeguards, Region III (RIII), dated August 3, 1984, and A. B. Davis, Deputy Regional Director, RIII, dated October 29, 1984; and Mary Lou Blazek, (Radiation Control Section, Oregon Department of Human Resources) for the Agreement States (AgS), dated August 16, 1984. Comment: Recently, there have been serious violations that include worker overexposures and unnecessary public exposure. These violations stem from inadequate radiation safety program management, yet you are proposing to decrease regulatory control. SP, RIII, AgS. Response: Of the 26 escalated enforcement actions taken against materials licensees in 1983, only four involved medical licensees; of those four, none involved overexposures to workers or the public. In 1982, there were 1,568 medical inspections. Almost all of the 1,240 citation line items that were issued based on these inspections were for minor safety problems that did not represent a worker or public safety hazard. The serious violations you refer to are very infrequent in the medical industry. Comment: The proposed relaxation in licensing is unwarranted in light of NRC inspection frequency. SP, AgS. Response: A license review cannot be substituted for an inspection. Further-more, because it is conducted at an NRC office and not on site, the licensing program can only assure a commitment to safety and adequate resources; the proposed licensing method provides that assurance. Comment: Revise the regulation, and require licensees to get a license amendment before making any changes in their programs as they described them 1 Enclosure 8
in their applications, or before making any changes that might decrease their - program effectiveness. RIII, AgS. Response: The program you suggest is time consuming for NRC and licensees, and results in a different set of regulatory requirements for each individual licensee. The frequency of escalated enforcement actions suggests either that medical use is relatively safe or that there is good voluntary compliance; in either case, the agency resources needed to make the suggested reviews could be better spent on other problems. Comment: An inspector under pressing time constraints in the field cannot make a proper radiation safety review of program changes. AgS. Response: Watching what the worker does is more important than reading what the worker is supposed to do. If the inspector sees unsafe practices, precipitated either by failure to follow instructions or by following inappropriate instructions, a citation can be issued. Comment: Inspectors will need extensive retraining because they, rather than license reviewers, will be responsible for reviewing operating procedures. RIII. Response: The requirements in the proposed regulation were taken, for the most part from the current Part 35, standard license conditions, and regulatory guides that form the basis of the current regulatory program. There is only a little new technical content. Comment: In the past, health and safety problems associated with program changes proposed by licensees have been circumvented because agency review of the changes was required. Now we will lose this check. RIII. Response: If a licensee was planning to make a change that NRC considers ill-advised, it was probably because most medical radiation safety standards are scattered in the current Part 35, in license conditions, in branch policy state- , 1 ments that are not generally available to the public, and in regulatory guides j that are purported to be for guidance only, but actually serve as de facto l requireinants. The essential elements of these standards have been clearly j 2 Enclosure 8
codified in the proposed regulation. This provides clear public' notice of what NRC considers important in a medical radiation safety program. Comment: Some authorized users do not have the expertise or motivation to make an adequate radiation safety review of proposed changes. RIII. Response: The regulatory guide contains a list of questions that should be considered when reviewing a proposed change. The regulation contains a clear statement of the topics needed in the record that supports a change. If the licensee cannot answer the questions and make the record, it is not authorized to make the change. Comment: Licensing staff will not be able to review inspector concerns during the next amendment request because fewer amendment requests.will be received. RIII. Response: Inspector concerns should be resolved at the time of the inspection. A licensee's amendment request generally should not trigger a new discussion of
- an old topic.
Comment: All medical licensees should be required to make an ALARA commitment. RIII. Response: The commitment, record review, and investigati.onal level requirements, if needed, should apply to all NRC licensees, not just medical licensees. There-fore such requirement might be appropriate in Part 20 or Part 30, but not just Part 35. Comment: Require a license amendment for any room change in order to provide for adequate NRC close-out surveys. RIII. Response: Section 20.201 may be invoked for a licensee's failure to conduct an adequate close-out survey after a room change. Close-out surveys are mentioned in the regulatory guide as a topic to be considered when making room changes. 4 3 Enclosure 8
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Comment: The Radiation Safety Officer, rather than the authorized user, should - be available in case of emergency and to monitor routine operations. RIII. Response: Both emergencies and routine operations may have medical implications outside the expertise of the Radiation Safety Officer. The authorized user is
. the one individual best suited to supervize day-to-day operations and respond to emergencies.
Comment: Require a telephone report in case of high molybdenum concentration in generator eluate. RIII. 1 Response: As you note in your memorandum, your suggestion was triggered by a I recent occurrence. Such an occurrence is very rare. This will be considered
.,tf as a separate matter.
e 4 Enclosure 8
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OF HUMAN USE LICENSEE CITATIONS ISSUED IN 1982 This table is a summary, by category, of all the citations issued to medical use licensees in 1982. The raw data was supplied by the Division of Fuel Facil-ities, Materials and Safeguards, Office of Inspection and Enforcement. It is routinely collected as part of their inspection and enforcement program. The left-most column is the legal basis for the citation. It might be a violation of: (a) section of the regulations or the license, (for example, adding authorized users without NRC approval, or using more material than is allowed by the license; (b) an order or conditioned permission mailed to licensees in response to a generic safety problem (LTR); (c) a standard license condition (SLC); or (d) the license condition that requires the licensee to use material in accord with representations made in the application (APPL), including perhaps the licensee's promise to follow a certain regulatory guide (RG) procedure. The second column shows the legal basis for the citation under the proposed regulation. The third column is a short description of the citation topic, and the fourth column notes the number of citations issued to medical licensees in 1982. There are 2500 medical licensees. In 1982 NRC conducted 1568 medical inspec-tions. Of the 1240 citations issued, 1197 citations would continue to be cita-tions under the proposed regulations. 1 Enclosure 9
In 1982, NRC took escalated enforcement action against two medical licensees; of those, only one involved an overexposure to workers or the public. Almost all of the citations NRC issues to medical licensees are not for items that present an immediate hazard to a worker or the public, but rather are early signs of safety program degradation that are easily corrected. 4 t 2 Enclosure 9
OLD NEW TOPIC NUMBER LICENSE REQUIRED 30.3 30.3 license required 2 30.34c 30.34c use only at location on license 19 35.2 35.2 license required 1 35.14b2 35.200 et al. use only material listed in regs 2 35.14c 35.2 unauthorized user 1 35.14d 35.58 use only calibration sources listed in regs 4 RG10.80 35.58 et al. use proper, authorized calibration sources 10 SLC 35.2, 35.17 license or ame.ndment required 22 APPL 35.17 unauthorized RSO 1 SLC 35.100 et al. use only for authorized purposes 1 APPL 35.38 unauthorized users 1 POSTINGS 19.11a 19.11a post regs 12 19.11b 19.11b post other documents 7 19.11c 19.11c post NRC Form 5 11 19.11d 19.11d post conspicuously 6 TRAIN WORKERS 19.12 19.12 train workers 31 SLC 35.610 practice teletherapy emergency plan 1 WORKER AND PUBLIC DOSE LIMITS 20.101a 20.101a worker dose limits 12 20.102a 20.102a determine prior dose 1 20.103 20.103 limit airborne concentrations 2 20.105b 20.105b 2 mR/hr and 100 mR/wk 23 20.108 20.108 make bioassays 17 20.202 20.202 supply personnel monitors 52 20.207a 20.207a control dose in unrestricted areas 31 20.401a 20.401a keep worker dose records 14 20.405a 20.405a report worker overexposures 2 20.407 20.407 report worker dose summary 3 RG10.8L 20.202 supply personnel monitors 1 EQUIPMENT APPL 35.120 et al. have a survey meter 12 RG10.801 35.51 calibrate survey meters 39 RG10.802 35.50 dose calibrator geometry test 16 RG10.8D2 35.50 dose calibrator accuracy test 28 RG10.802 35.50 dose calibrator linearity test 128 RG10.802 35.50 dose calibrator constancy check 61 RG10.8D2 35.50 use proper dose calibrator test sources 1 3 Enclosure 9
1 OLD NEW TOPIC NUMBER PACKAGE RECEIPT 20.205b 20.205b monitor packages 10 30.51a 30.51a keep records of receipt and disposal 10 30.51c3 30.51c3 keep records 5 years 2 RG10.8G 35.31 establish an ordering procedure 2 MATERIALS CONTROL 20.207b 20.207b watch material in unrestricted areas 9 20.402a 20.402a report loss or theft immediately 1 20.402b 20.402b report loss or theft in 30 days 1 20.403b 20.403b report incidents 1 RG10.8M 35.90, 35.205 store and control gases 1 SAFETY MEASURES 20.203 20.203 use signs and labels 16 20.203f 20.203f use labels for containers 3 RG10.8G NC wear gloves (22) RG10.8G NC monitor hands ( 3) RG10.8G 35.60 use syringe shields 16 RG10.8G NC wear lab coats (4) RG10.8G NC don't eat or drink in lab (14) DOSAGES TO PATIENTS 35.14b4 35.204 measure Mo-99 concentration 16 35.14b6 35.100, 35.200 follow package insert 14 35.43 35.37 report misadministrations 3 RG10.8G 35.53 measure dosages 4 APPL 35.50 use a dose calibrator 5 SURVEYS 20.201a 20.201a make precautionary surveys 37 20.20lb 20.20lb make necessary surveys 151 20.40lb 35.40lb keep survey and monitor records 54 35.14b5ifi 35.404 survey implant patients 1 35.25 35.644 survey new teletherapy units 5 RG10.8I 35.70 make daily surveys 80 RG10.8I 35.70 make weekly surveys 11 RG10.8I 35.70 keep survey records 3 WASTE DISPOSAL 20.301 20.301 authorized methods 21 20.302 20.302 get permission for other methods 1 20.303 20.303 sewerage release limits 1 20.305 20.305 don't incinerate 2 20.401c3 20.401c3 keep disposal records 4 RG10.8J 35.92 decay-in-storage method 2 4 Enclosure 9
~
OLD NEW TOPIC NUMBER SEALED SOURCES 35.14e 35.59e test for leakage 55 35.14e 35.59c record leakage in "microcuries" 5 35.14f 35.59g inventory quarterly 8
. TELETHERAPY CALIBRATIONS AND CHECKS 35.21a 35.632 calibrate if output is off 5% 2 35.21a 35.632a calibrate after source drawer repair 4 35.21b 35.632d calibration procedure 6 35.22 35.633 make spot checks 4 35.22 35.633 check timer accuracy 2 35.22b 35.633b check field / light coincidence 2 35.22b 35.633b compare measured to calculated output 3 35.25a 35.644 keep calibration records 3 TELETHERAPY EQUIPMENT AND PERSONNEL 35.23a 35.630a have dosimetry equipment 1 35.24 35.961 qualified expert training 6 35.25c 35.961 qualified expert training records 1 LTR 35.615 install radiation monitor in treatment room 3 SLC 35.615 use doors and interlocks 1 TRANSPORTATION 71.5a 71.5a follow 00T regulations 11 ADMINISTRATIVE MATTERS RG10.88 35.32a have a radiation safety committee 15 RG10.80 35.30 review worker doses quarterly 2 RG10.80 35.30 review materials program annually 1 Total citations issued in 1982: 1240 Citations not covered (NC) in proposal: 39 Citations covered in proposal: 1201 1
5 Enclosure 9
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( ANALYSIS OF ALTERNATIVES In order to assess the merit of the proposal, the staff developed two alternative statements of regulatory policy and considered the benefits and drawbacks of all three. One alternative is a statement of current policy, and one alternative is based on both current policy and the proposal. The proposal in Enclosure 1 appears here as Alternative 2. Alternative 1: Take no action. Retain the current Part 35 and licensing and inspection methods. The applicant submits evidence of adequate training and experience and a radiation safety program for agency review. The license requires the licensee to conduct its radiation safety program in accord with the statements and representations made in the application. Inspections are conducted against the application, the license, and the regulations. The licensee must receive a license amendment before making any radiation safety program change. Alternative 2: Publish the proposed revision of Part 35 attached as Enclosure 1. The applicant submits evidence of adequate training and experience and a radiation safety program for agency review. Inspections are conducted against the license anc the regulations. The licensee could make minor radiation safety program changes after making an internal safety review. l Alternative 3: i Publish the proposed revision of Part 35, but also require submission of all radiation safety program changes. 1 Enclosure 10
The applicant submits evidence of adequate training and experience and a radiation safety program for agency review. A condition of the license requires the licensee to conduct its radiation safety program in accord with the state-ments and representations made in the application. Inspections are conducted against the application, the license, and the regulations. The licensee must receive a license amendment before making any radiation safety program change. Discussion of Alternative 1: Because the current Part 35 is hard to understand and does not contain all the medical use safety requirements, the NRC would have to continue to review detailed applications and then require that licensees follow the radiation safety procedures that were reviewed and approved by NRC. This alternative does not provide any greater degree of safety than the other alternatives, but is more costly to both NRC and licensees than Alternatives 2 and 3, and denies the industry the benefit of a clear, consolidated codification of the medical use requirements that is offered by both of the other alternatives. It is difficult to maintain standardization under this scheme because the legal basis for controlling a licensee's use of byproduct material is the licensee's application. Because each application is different, the result is a regulatory regime that is different for each licensee. Discussion of Alternative 2: Proponents: Licensure should mean that the agency has found the applicant trained to know safe from unsafe and legal from illegal, and that the applicant is equipped to handle material safely within the scope of use permitted by the license. Licensure connotes that the key users are competent to make minor radiation safety program changes that continue to provide a level of safety consistent with the requirements of the regulations, and to select replacement equipment and to change facilities to the extent consistent with those require-ments. These changes, which might be made for improved patient care, safety, i or reduced cost, would have to be approved by the Radiation Safety Officer and management or, at a hospital, the Radiation Safety Officer and the Radiation 2 Enclosure 10
r ( ' Safety Committee, before being implemented. The licensee would not be authorized to significantly redirect the medical radiation safety program because all the essential elements are clearly codified in the regulation. Independent review of minor changes by a governmental agency will not provide a significant public health and safety benefit but is expensive. Objections: Many licensees are small organizations with a few authorized user physicians, and technicians who have graduated from a two year formal training program or have been trained on the job by an authorized user or co-worker. They might employ a part-time radiation safety consultant who is qualified to review changes for safety problems but who may not be aware of the ramifications implicit in a proposed change because he is not thoroughly familiar with the day-to-day operations. In a private practice license, the authorized user may also be the RSO and management, and therefore would be reviewing his own handiwork for safety considerations. At a hospital the only two individuals on the Radiation Safety Committee who are required to have had radiation safety training are the authorized user and Radiation Safety Officer, who may be the ones proposing the change. Therefore, in either case there would be no independent agent required to review proposed changes. The proposal would place more authority in the hands of licensee management; yet many medical escalated enforcement actions are necessitated by inadequate management control. The agency would not have the opportunity to circumvent ill-advised changes. Effect of Selecting Alternative 2: For the four groups that would be affected, a short textual analysis follows. A more complete regulatory analysis is attached as Enclosure 4. 3 Enclosure 10
NRC The training of licensing and inspection staff would have to be redirected because it now stresses checking the application for completeness and adequacy and then inspecting the licensee for compliance with the application. Under the proposal the inspectors would have to recognize, in the field, technical and management practice.s that do not meet the regulatory standards. The inspector would have to be more thoroughly familiar with the regulation, but would no longer have to be familiar with each licensee's application before conducting an inspection. This would help to ensure uniformity among the regions. However, some NRC inspectors believe an increase in field time will be necessary in order to review procedure changes. Because a major goal was to prepare the statement of consideration, regulation, and regulatory guide in plain English, the staff expects fewer deficient applications and clearer, more succinct inspection reports. Agreement States The Agreement States generally support the consolidation of various regulations and requirements pertaining to the medical use of byproduct material into one docume.1t, and have provided some technical comments on the revised Part 35. The Agreement States strongly object to permitting licensees to change radiation safety procedures without agency review and approval. They believe that they will need to retrain inspectors, that the duration of each inspection will increase, and there may be increased worker doses. Although the Part 35 revision would not be made a matter of compatibility because it deals with l licensing matters, the States believe they will be pressured by their licensees to adopt the NRC system. l Licensees
- The requirements in the proposed regulation were taken from the current regula-tion, licensing policy, frequently used license conditions, and standards recommended in current regulatory guides that are used by many licensees.
4 Enclosure 10 t-
(
- Therefore, the staff does not expect any increase or decrease in worker dose or any significant cost increase. There may be some insignificant savings in amendment fees for those licensees who need to change their procedures.
Because of the consolidated statement of considerations that accompanies the proposed revision, licensees may have a clearer understanding of the regulatory process in general and the need for the requirements. The Public Most man-made non-occupational dose is the result of intentional irradiation of individuals for their own medical benefit under the prescription of a state-licensed physician. Therefore an attempt to reduce public dose would, except in rare circumstances, be a clear and unwarranted intrusion into the practice of medicine. Because the staff does not foresee any significant changes in staff resources needed for day-to-day operations within NRC, the Agreement States, or licensees, the staff does not expect any significant cost or savings for the public. Discussion of Alternative 3: Proponents: The requirement that licensees use material in accordance with the procedures in the application provides assurance that licensees have safe procedures available, and provides a clear basis for enforcement action in cases of noncompliance. If the adequacy or completeness of a procedure is questioned. the license reviewer can consult reference works or co-workers rather than having to make a quick technical judgment during a field inspection. This also allows the license reviewer to exercise a certain amount of flexi-bility to meet each licensee's specific needs. Most Agreement State program directors believe this method of licensing is necessary in order to answer any questions that the applicant or reviewer has, and to resolve any differences of opinion on what is required for compliance. This method may require less extensive training for field inspectors because the inspection is based on compliance with a site-specific step-by-step radiation safety program. 5 Enclosure 10
Objections: Because the licensee is required to use material in accordance with the application and letters written in its supoort, to remain in compliance the licensee may not replace any equipment or service contractor or change any facility described, or change any radiation safety. procedure without requesting a license amendment. A detailed review of applications and amendments does not assure safe use, but rather simply existence of adequate facilities, equipment, and radiation safety procedures. Safe use can only be ensured by the licensee's continued, active commitment to safety. The unannounced inspec-tion provides the best measure of that commitment. The requirement to submit changes in facilities, equipment, and radiation safety procedures for NRC review and approval would be costly to both NRC and licensees, but would not be likely to result in a higher degree of safety than that provided by Alternative 2 and would not provide any stronger or clearer basis for enforce-ment actions. Furthermore, if the licensee made a determination that a change would result in safer or more efficient operations, the agency review and approval requirement would prohibit its prompt adoption. 6 Enclosure 10
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! 2 NUCLEAR REGULATORY COMMISSION k Ngh/c4 l Offica of Public Affairs
'% . . . . . # Washington, D.C. 20555 No. 85-98 FOR IMMEDIATE RELEASE Tel. 301/a92-7715 (Friday, July 19, 1985)
NRC PROPOSES TO SIMPLIFY MEDICAL LICENSING PROCECURES The Nuclear Regulatory Ccmmission is proposing to revise its regulations to simplify ano make more efficient the regulatory process for the medical uses of radioisotopes. The NRC issues licenses to medical facilities and indivicual physicians for the use of racicactive materials to diagnose and to treat patients. Specific licenses are issued for one or more of six groups of medical uses organized in ascending order of radiation hazard potential, each containing related diagnostic or therapeutic procedures. A separate license is issued for teletherapy units. Applicants for specific licenses must submit a substantial amcunt of information to show that all radiation safety requirements will be met, including a description of the procedures used in meeting the requirements. The Commission's radiation safety review covers three general areas: radiological health and safety procedures; personnel training and experience; and facilities and equipment. Due to the rapid evolution in the medical use of radioisotopes over the last thirty years, current requirements are found throughout the regulations, regulatory guides, standard license conditions and other sources. Therefore, the primary purpose of the proposed revision is to consolidate the require-ments. Under the proposal, all requirements would be clarified and published in one place, Part 35 of NPC regulations, which would serve to regulate the day-to-day uses of medical radioisotopes. The revised regulation would give both licensees and NRC staff a clearer basis for licensing, operation, and inspection activities. A draft regulatory guide for medical programs has been prepared. It contains a model procedure acceptable to NRC for meeting each of the medical use requirements. Licensees could use the model procedure for meeting the requirements or could prepare their own procedures. If applicants submit their cwn radiation safety procedures, the NPC staff will continue to review them to detemine whether they are adequate to meet the requiren,ents of the regulations. Mcwever, to permit licersees to make prompt use of new safety methods and to adjust their radioisutope programs to meet new needs caused by changes in demand for patient care services or patient load,
licensees would be able to modify their procedures without NRC review provided the regulations are met. Modifications would recuire approval of the licensee's Radiation Safety Officer, and at a hospital, its Radiation Safety Ccanittee. Some types of program changes which wculd still require a formal NRC review and license amendment include new physician user, rew medical use, and new location of use. The proposed revision to Part 35 of NRC regulations is being published for public coment in the Federal Register on July 19, 1985. Coments should be submitted within 120 days (by November 18) to the Office cf the Secretary, Nuclear Regulatory Commission, Washington, D. C. 20555, Attention: Docketing and Service Branch. d 4 UNITED STATES
- NUCLEAR REGULATORY COMMIS$10N ns57CLAssMAst i Pc57 AGE & Els pana WASHINGTON. o.C. 20566 l Wasp 3C l Pt% Atty a b a ft t 3300
30616 Fed:ral Regist r / Vol. 50. No.144 / Friday, July 26. 1985 / Proposed Rules NUCLEAR REGULATORY $ JP*LEMENTARY INFORMATIOM: phy sicians. These hcenses auttenzes CCMMISSION ByProduc+ Materialin Medicine certam disanastic and therapeune mes of radioactise matenals. Use for Patient Care 10 CFR Parts 30,31,32,35, and 40 Rad;oactive materiais are used in NRC's Regulatory Program dregs in the field of nuclear medicine. Pohcv Regcedmg the Medical Use v! Medical Use of Byproduct Material kn vn as rad;o ar ac cals In diagnostic nuclear medicme. panents In a policy statement pubhshed :n ACENCY: Nuclear Regulatory receive these matenals by infection. Commission. 19 9 M4 FR 8242). the NRC noted that it ichalation. or cral admmistration. regulates the medical use of byproduct Physicians use radiat:on detection rnater:al as necessary to prov:de for the Action: Proposed rule, equipment to visualize the distribution radiat:on safety of workers and the of a radioactive drug within the patient. general public, regulates the radiation
SUMMARY
- The Nuclear Regulatory Using this technology. it is possible to Commission [NRC)is proposing to safety of patients where ;ustified by the locate tumors. assess organ function. or nsk to patients. and mmimizes its rsvise its regulations to modify the monitor the effectiveness of a treatmen intrusion into medical judgments process for licensing and regulating the in therapeut:c nuclear medicine.!arger,t. affecting patients. and into other ureas rnedical use of radioactive byproduct quantities of radiopharmaceuticals are traditiona!!y considered to be the material. The proposed revision would adminstererd to treat hyperactive practice of medicme. The NRC does primarily affect hospitals, climes. and thyroid conditions and certain forms of have the authority to regulate the mdividual physicians. cancer. An estimated 15 to 20 million nuclear medicine procedures are medicial use of byproduct material to By clarifying and consolidating all the protect the health and safety of patients.
essential radiation safety requirements perf rmed in this country annually. but also recognizes that physicians have that are now contained in the Scaled radioactive sources that regulations. license conditions pr duce high radiation fields are used m. the pnmary respcnsibility for the radiat.on therapy to treat cancer. A protectic, of their patients. NRC regulatory guides, and staff po'sitions. regulations are predicated on the the proposed regulation provides a radioactive source in a teletherapy - machine can be adjusted to direct a a3sumption that preperiv trained and smgle source of requirements related adequately aformed physicians will radiation beam to the part of the specifically to medical use of byproduct patient's body to be treated. An make decisians in the best interest of matenals. The proposed regulation also their patients. provides flexibility for licensees to estimated 2 mdlion teletherapy treatments are performed annually by This revision retains NRC.s current update their day-to-day radiation safety NRC licensees. Smaller, less radioactive balance between adequate controls and procedures. The revision of the ao a d sealed sources are designed to be regulations would provide a mere implanted directly into a tumor area or d nts uch re lation efficient method for regulatmg the applied on the surface of an area to be could result in poorer health care msdical uses of byproduct material. treated. This procedure is known as delivery to patients. Insuffic:ent o '.TE:Co ranent period expires brachytherapy. NRC licensees perform regulation could result in the November 18.1985. Comments received approximately T.000 brachytherapy unwarranted or unsafe use of radiation. after this date will be considered ifit is ga ts "^
,adzoactiv sources can also Crent f.icensing Practice oractical to do so but assurance of consideration cannot be g ven except as be used in machines that are used for The current regulations in 10 CFR Part dia:mostic purposes. The source to comments filed on or before this date. 35. "Ifuman Uses of Byproduct provides a beam of radiation that is .
A oRessss:Sabmit wntren comments protected through the patient. A device Material." provide for general and and suegestions to the Secretary of the specific licenses for medical use. on the other side of the patient, detects Commission. U.S. Nuclear Regulatory the amount or spatial distribution of The 8enerallicense in current } 35.31 Commission. Washington. DC 20555. radiation that goes through the patient a t. es ph s ans o" Attention- Docketing and Service This can provide information about
, ,9{ p k ed al Branch. tissues within the patient. This is a dosages of byproduct materials.
Copies of the prelimmary regulatory relatively new development in the field Physicians simp!y submit a registration analysis and the comments received of medicine and the NRC has no Form NRC-482 to MRC. A validated may be examined at the Commission's estimate of the number of these copy w th a registration number is Public Document Room at 171711 Street diagno tic procedures performed returned to the applicant. NW., Washm, gton. DC. Sm, ele cop les of annua 3 g g the preliminary regulatory analysis and State and Federa/Regulaten environmental impact assessment are need more byproduct material than can available from Norman L McE!roy. Twenty-seven states. known, as be permitted under the general license Office of Nuclear Material Safety and A reement States. have assumed program. A specific license. which Safeguard. U.S. Nuclear Regulatory responsibility for regulating certain author:zes a larger inventory of Commission. N, shington. DC 20555. radioactive materiais withm their byprcduct matenal and a w: der vanety Telephone !30114:7-4108. respective borders by agreement with of uses, may be issued for one or more the NRC. (This kind of agreement is of six t3 pes of medical use, defined as FoR FunTHER INFORMAffCN CONTACTt authon=ed by the Atomic Energy Act.) Croups I-VI in the current 135.100. Each Norman L McElroy. Office of Nuclear They issue licenses for the medical use
~ group is compnsed of a number of Matenal Safety and Safeguards. U.S. of byproduct material. In non. diagnostic or therapeutic precedures Nuclear Regulatory Commission. Agreement States. the NRC issues that have been grouped together Wa shington DC 20555. Telephone: (301) licenses to medical institutions (most!y because they require similar physician Jr-4108. hospitals and clinics) and to individual training and radiation safety
Fed;ral Registir / Vol. 50. No.144 / Friday, July 28. 1985 / Proposed Rules 30617 precautions for safe use. A separate features: case.by. case review of specific license may also be issued for approved, the NRC issues a specific apphcanons. on-site inspections, and license that grants the authenty for use of a teletherapy unit. Applications penodic license renewals. for a spectfic license are much more medical use of byproduct mateinal m A major problem with the current detailed than a generallicense accordance with the program desented licensing program is that radiation application and actually contain the in the application. Requirements in protection requirements are not located applicant's step-by. step radiation safety sddition to those contained m the in one document. Requirements are procedures. which are reviewed and reculations are frequently incorporated scattered in the regulattens. Inspection approved indmdually by NRC. n the license as conditions of use Since The NRC has issued 650 general and Enforcement (IE) orders that modify the licensee must comp!y with a license or group oflicenses, and in licenses. and in 1983 received seventeen conditions specified in the hcense, the conditions attached to individual new applications. NRC currently has licenses. Suggestions for good practice license. rather than the regulations is about 2500 specific medical licensees frequently used to regulate radiation are contained in NRC regulatory guides (2'X0 hospitals and 300 physicians in and technical reports (NUREC's) For safety n the day-to. day use of pnyste practice). In 1983. the NRC example. Regulatory Guide 10.8. "Cuide byproduct material. received 143 new applications for for the Preparation of Applications for ne specific license is valid for five specific licenses. 647 license renewal Medical Programs." and NUREG-0267 years. The license must be amended applications, and 1.772 license " Principles a'nd Practices for Keeping before methods of use or procedures
' amendment requests for a total of 2.58: Occupational Radiation Exposure at may be added or changed.,or before licensing actions. MedicalInstitutions As Low As permitting additional physicians to use
, To help !!censees design their Reasonably Achievable." contain many materials. Amendments to a specific radiation safety programs. the NRC has recommendations that the NRC believes license mvolve an application, review.
I published many NUREG reports and are importent for the safe use of and approval process similar to that for f regulatory guides that contain radiation byproduct matenal. The revision of Part new licenses. Renewals are treated in safety guidance. These publications 35 incorporates those recommendations, the same manner as new license
, address three general areas: radiological and also corrects the piecemeal fashion applications.
health and safety, personnel training in which the regulations have been and experience, and facihties and This regulatory process was amended over the years to address appropnate during the evolution of the equipment. Experience has shown that if specific problems. use of byproduct materialin medicine. licensees follow the guidance in the When preparing a specific license publications. the medical use of Radiation safety problems were not well application for review under the current byproduct material generally poses no defined, regulatory requirements had not licensing program. the applicant must hazard to workers and the pt.blic. caught up with developing technology. include sufficient information to assure physician trainmg curricula had not Problems with Current Pmetice NRC reviewers that byproduct material been established, and there were no wdlbe used safely. Applicants me!ude, The CeneralLicense. De general formal training programs for nuclear as an integral part of the application license program is based on the fact that package, copies of their proposed step- medicine technologists. T*nerefore. it the quantities and forms of material that by-step radiation safety procedures. In was necessary to regulate by reviewing are authonzed by a general heense many cases, the procedures are edited each individual radiation safety program present a very low health n sk. The NRC versions of precedures desenbed in to ensure that the applicant had beheves a,t is no longer efficient to issue Regulatory Guide 10.8. adequate personnel, faci ities. and medical general licenses. The tests When NRC receives the application, a '4 " Y * * " I' 7 authonzed under i 35.31 have been hcensing reviewer evaluates the superseded by newer procedures with Proposed Revision of the Regulatory applicant's trair.ing and enefunce. Program greater diagnostic accuracy. These facil ty. equipment. av vatten safety developments have been reflected by a proedures in detad E h oplication is Overview significant decrease in applications for found to be inn ve r 2adequa te, a generallicenses. As noted above. " deficiency W . w - a the NRC int' ends to modify its regula tion although NRC has on file 650 in-vivo of the medical use of byproduct applicant e.41a q e a dditional a material.The Commission plans to general licenses under i 35.31. only information,n needeo. wew of the seventeen new applications were application is not resumed until a revise the regulations to provide a single received by NRC in 1983. wntien response from the applicant has source of requirements specifically
, To determme the status of general been received. Staff studies indicate that related to medical use of byproduct lic.anse use, the staff performed a about 40 percent of all applicants materials, and within the boundaries set telephone survey of to percent of the receive either a deficiency letter or a by the regulations, allow medical current registrants De survey results phone call for additional information. licensees to modify their radiation mdicated thadess than 9 percent of all The need for deficiency letters stems safety procedures, facilities, and the current registrants still use rnaterial from two sources. Guidance on what is g p ,g under a general license; many are now needed to get a license is unclear and of new safew methods and also meet using byproduct material under a scattered in vanous documents. new needs caused by changes in specific license. Because of the low level Application review pract2ce must be demand for various patient care services of use of the generallicense. the NRC conservative bm.ause the application or m patient load. The proposed revision has concluded that it no longer serves a and license compnse the basis for of to CFR Part 35 is consistent with the useful role in Ifeensing the medical use ,
regulatory control. Deficiency letters are Commission s general policy on medical
. ~ of hvproduct material. costly for the NRC and the applicant use of byproduct matenalissued The Specific License. Because of the and greatly increase the time needed to February 9.1979 (44 I R 8242). It states potential radiation hazttd to workers complete licensing actions. "NRC will continue to regulate the and the public, the specific license When the application. including any medical uses of radioisotopes. as program incorporates three regulatory additional submitted information, is necessary, to provide for the radiation
30618 Fedird Registre / Vol. 50. No.1H / Friday July 20, 1985 / Proposed Rules safety of workers and the general public." reduces the amount of time NRC must Officers. but would be a new spend reviewing procedures.) The requirement for qualified teletherapy Codification o/ Requirements in the applicant mails the completed . calibration experts, whose credentials Regulations application, with application fee, to the are currently reviewed by the licensee. NRC proposes to simplify regulation NRC office identified on the form. The staff will review thers individuals' of medical licensees by mcorporating all The NRC staff wdl continue to review training and expenence against the medical use requirements in 10 CFR Pstt the application to determine whether the standards in the regulation before
- 35. These regulations would become the applicant's radiation safety program is authorizing them to work under the pnmary means of regulating the medical sufficient to meet the requirements of license. (Also consistent with current use of byproduct material General the regulations. After completing the practice. any individual who does not safety requirements for worker review. if the applicant's program meet the standards may ask fer an instruction. worker safety
- appears incomplete or inadequate. NRC wil! !ssue a deficiency letter that exemption from the training and expenence requirements. The NRC staff ie ig at are in Parts 19,70,21 and describes the apparent shortcomings in will review the individual's training and 30 will also continue to apply to Part 35 he soplicant s pmgram and requests experience with the assistance ofits licensees. The current license clarificatie or correctim. If the Advisory Committee on the Medical Use application process will be unchanged. applicant,s respmse to the deficjency ofIsotopes, and may issue the The applicant prepares a complete Form leuer is satisfacton (w if no denciency exemption as a license condition.)
letter was needed), the license will be NRC-J13. That form asks for the following . formation: the name and m Issued. Enforcement mailing address of the applicant: the Licensees will be free to modify their location of use: a person who can be procedures after conducting a required
- U ****
internal review and approval process' .cemee be ched Make M med contacted about the application: what At medicalinstitutions, the Radiation ' ' I'9** * **'8 *
- materials are requested,; the purpose (in this case. " medical use ); the training Safety Comnuttee would review and censec m c. w "hst",fw l
and experience of the authorized users approve a modified procedure before it example, authorized users. locations of end Radiation Safety Officer: the worker could be implemented. At non- use, authorized methods of use, radiation safety trainmg program institution facilities the Radiation authonzed byproduct material and
.acilities and equipment: the radiation Safety Officer (RSO) and management invent ry limits, and other site-specific safety program: and waste management. would review and approve changes limitations), failure to have on hand de Licensees would not face significant This will allow each licensee to make written procedures required by the new regulatory burdens because, in prompt use of new safety methods and uguladas, fadure to foHow the most cases, these requirements are to adjust radiation safety procedures to pr cedures on hand, failure to have the currently imposed as license conditions. meet new needs caused by changes in uc rds required by the regulations. or
" P " ' " ' demand for patient care services or fauwe to follow technically valid woul a thon e c1s patient load. A list of radiation safety procedures (examples: Using an f e IIensee day. !use ev w p p se a s e t g e e ec n would be controlled by the regulations, published as an appendix in Regulatory efficiency, not allowing an instrument This would simplify inspections for NRC Guide 10.8. The right to modify enough tune to respond. or making because inspectors would only need to pr cedures does not relieve the licensee unsubstantiated assumptions in ba fanuliar with one set of regulations from the requirement to comply with the calculations). Use of material can be rather than a different set oflicense regulades. This mgulatory scheme authonzed eh h Hceme w h he conditions and radiation safety w uld not incorporate the current of working under supervision: use procedures at each facility, requirement that licensees use without authorization would be a License Application. Issuance, cnd byproduct materialin accordance with violation of the regulations and the Act. -
the statements made in the application. which would subject the user to an Authonty andResponsibility This proposed regulatory program, enforcement action. New revisions of Regulatory Guide which gives more discretionary 10.8. " Guide for the Preparation of authority, and concomitant Amendments Applications for Afedical Programs," responsibility, to the licensee. represents As mentioned above, under the End Draft Regulatory Guide Thf 60s.4 a change in the policy that has guided current regulatory scheme. the licensee
" Guide for the Preparation of Licenses NRC's regulation of medical licensees in hiedical Teletherapy Programs." will is required to handle material exactly for several years. The NRC particularly according to the radiation safety csntain instructions on the type and invites comment on whether this change procedures submitted with the extent of information that must be is appropriate at this time, and whether application. The NRC frequently submitted based on what byproduct or not it will benefit licensees, workers, receives requests for permissicn to mtterials the applicant has requested. and the public. modify day.to-day radiation safety They will also contain model procedures The proposed regulations require procede es. Because the regulations will thit the applicant can use to develop specific training and experience for.the now contam sufficient prescriptive and sit > specific procedures. (Consistent use of material in each use group, performance criteria on which to base with current practice, applicants will Proposed authorized user physicians enforcemer.t actions, the NRC would alternatively be allowed to simply and qualified teletherapy calibration allow a licensee to change its radiation c:rtify that they will failow the model experts (identified in current Part 25 as procedure developed by NRC staff with safety procedures without preparing a qualified experts) will have to submit formal amendment request. paying an public comment and published in a summaries of their training and regulatory guide to meet a certain amendment fee, and awaiting NRC expenence. This is currently required for approval. This would not relieve the requirement. This method significantly authonzed users and Radiation Safety licensee from the regulatory requirement
Fediral Regist:r / Vol. 50. No.144 / Friday. July 23, 1985 / Proposed Rules 30619 to comply with the regulations in Part 35 licensees who want to use the new contmue to review user training and or in other parts of 10 CFR Chapter 1. matenal will have to submit a request experience. The NRC will review site. Four types of program changes will for amendment which includes a specific radiation safety procedures for still require formallicense amendments: proposed procedure that will be completeness and adequacy and issue (1) New users. The NRC will review reviewed by NRC for completeness and deficiency letters ti necessary, but will the training and experitace of each adequacy. allow licensees to change procedures proposed authorized user. Radation (4) New location of use. Two types of that were subantted in support of the Safety Officer, and qualified teletherapy amendment may be needed; appbcation after conductmg an internal , calibration expert as desenbed above (a) A request to leave one location of radiation safety review of each change. before listing the individual on a license. use and begm woning in a new However, the nght to change procedures (2) New type of use. A licensee's location. for example when noving a does not relieve the licensee from the request to add a type of use (for private practice to a new office or when requirement to comply with the example, adding radiopharmaceutical moving into a new hospital bui: ding. wiu regul.iti:ns. Amendment requests will therapy to a license that authorizes have to be supported by a complete new generally be reviewed just as new radiopharmaceuticals for i= aging) to an aoplication package. applications are reviewed. but they may existing license will be handled as a (b) Some licensees receive packages, incorporate by reference the original new application. The authorized user's prepare radiophar=aceuticals, and application and any previous training and experience will be package waste at a central facihty, but amendments. reviewed for adequacy with respect to actually use the byproduct material at the new type of use, and procedures that satellite locations. This might be a Notes must be submitted in support of the mobile nuclear medicine service that g. g ,@, request will be reviewed for provides diagnostic services at clients' completeness and adequacy with facilities such as clinics. small hospitals. In preparing the proposed revision of respect to the new type of use before the or nursing homes, or it may be a licensee Part 35 one goal was to remove amendment is issued. that has a principal facility and outlying languaee that might be misinterpreted. (3) New method of use. Two clinics. If the licensee has been The following words used in the revision developments may occur but only one approved to offer service at satellite may require clarification. type oflicense amendment will be locations, a request to add another 1. Licensee. He person (individual. needed: satellite location will only have to partnership. corporation, or agency) (a)If a new radioactive material , identify the new location. (Due to the listed on the license as the " licensee"is becomes available, and the radiation training. space, and equipment responsible for compliance with safety procedures needed for its safe use commitments needed for safety during regulations and license conditions. The are identical to the procedures already therapy procedures, the NRC will licensee may effect compliance through established for an aiready established generally not authorize licensees to full-time or part-time employees, and authorized use (for example, a new perform therapies at satellite locations. contracts with consultants or service imaging agent administered by This type of request will be handled on organizations. or other business intravenous injection), no license a case-by. case basis.1 arrangements. The word " licensee" is amendment will be required. Instead, genewo/e used throughout the regulation to stress the new material wi!! be added by the fact that. no matter which method is rulemaking to the list of materials in the The NRC license is valid for five used, the licensee is legally responsible appropriate use group specified in the years. If a person wants to continue n case of non.comphance. regulations. The NRC will mail to using byproduct matenal the license
~
must be renewed. ne renewal 2. Me of use and g oup. In the - licensees a notice that says those who application must completely describe current Part 33 there are six , groups, of are authonzed to use materialin that use desenbed in i 33.100. Each group is group may begin using the new material the entire radiation safety program Just as a new application does. If a comprised of a set of medical on the effective date of the final rule previously submitted radiation safety procedures that require s milar trau, u,ng i that adds the new material to the regulations. procedure, facility desenption or and equipment for radiation, safety equipment list still acecrately reflects purposes.De word group has not (b)If a new radioactwe material been used in the p e vision becomes available but its safe use that part of the licensee's program, the depends on following a new procedure renewal applicant may simply make a that current licensees have not clear reference to the previous old and new Part 33. n,.e revision uses submitted and NRC has not reviewed. submission. If the IIcensee has changed the phrase " type of use for this concept. two actions will be taken. a procedure is using different areas of Some types of use are amalgamations of (i) The new material will be added by use, or is using different equipment, a old groups, and some types are new. The rulemaking to the appropriate use group complete new description of the six types of use are:(1) Uptake, dilution. in the regulations but authorization to particular procedure area of use, or and exczetion-Subpart D: (2) imaging use it will be limited to persons who equipment must be submitted. De and localization-Subpart E;(3) were licensed after it was added to the licensee may also take this opportunity radiopharmaceutical therapy-Subpart use group and who have submitted the to identify new authorized users or F: (4) brachytherapy-Sabpart G; (5) new procedure for review in their request authorization for new types or sealed sources for diagnosis-Subpart application packages. H: and (6) teleberapy-Subpart L methods of use. lii) NRC will matl to current licensees 3. Method of use and procedure. The a notice that says they may apply for Summary of C!mnges Proposedin the word " procedure" is frequently used in Regulatory Progenm supporting documentation for by authorization to use the new material. With that notice. NRC will also supply a In summary, the regulation will be product materials programa. Sometimes model procedure, which would become amended to require that licensees meet it refers to a specific set of steps that a new appendix in Regulatory Guide standards that are current}y imposed by must be taken to effect an end, for 10 8. for the new matenal. nose license conditions.The NRC will example a procedure for ordenng and
3b620 Fed:r:1 Registir / Vol. 50. No.1H / Friday. July 20. 1985 / Proposed Rules receiving packages. Sornetimes it is used revision this concept of perfunctory be operable. If a piece of equipment is ' to indicate a type of medical examination is referred to as a " check." not operabie or reliable, whether due to examination or treatment, for example a thyroid uptake study or a cesium 7. Locotion of use. facility, and oreo of old or absent battenes, incomplete or use. The phrase " location of use"is used improper maintenance, damage, implant therapy, without indicating the to descnbe the building or buildings amount of byproduct material used or inapprognate use, or improper uce. it (typically identdied by a single street cannot be used to meet a regulatory the specific steps taken in handling it. address) where byproduct material !s requirement because there is no The word may also be used to indicate used. The word " facility" connotes a assurance that it accomplished the task the number of patients cared for over a room er contiguous rooms where for which it was used. period of time, for example an average byproduct material is used, such as a 12. Implement. This verb is used with
; workload of fifteen procedures each nuclear medictne clinic ccmprised of an its ordinary definition, which is "to day. In order to avoid confusion, the office, an imaging room, and a dosage
' carry out, accomplish, or ensure phrase " method of use" appears in the preparation and waste storage room. fulfillment of." proposed revision. Each type of use is The phrase " area of use" connotes the 13. Promptly. This werd is used with comprised of several methods of use. space used by worker when performing its ordinary definition, which is Each method of use should identify, a specific task connected with receiving. "perfctmed readily or immediately." explicitly or by context, the handling. or storing byproduct material radionuclide, its chemical and physical 8. Chemico/ form. The current A#C## A#'####8 form, method of administration, and regulation requires that if a radio- The Commission requires that purpose (diagnosis or therapy). pharmaceuticalls used for indications ' licensees make and retain records as
- 4. Dose and dosoge. In pharmacy, the other than those described in the evidence of compliance with regulations word " dose"is used to indicate the package msert. the user must and license conditions. A review of amount of chemical administered:In nevertheless follow instructions on records during inspections is the least radiation biology it is used to indicate chemical and physical form. dosage, and burdensome way that the Commission the amount ofiomzing energy absorbed r ute of administration.The preposed may be assured that the licensee has per unit mass; and in radiation safety it revision has deleted the word chemical developed and implemented a radiation is used as a shorthand term to indicate a in its restatement of th:s requirement safety program. However, permanent worker's exposure to radiation. In order because to change the cheinical form retentien of all required records, or to avoid confusion, the word " dosage"is w uld be to create a retention between mspections. would be used in the proposed revision t.s indicate radiopharmaceut. cal other than the one unreasonable and would run counter to quantities of radioactivity that are received fr m the authorized distnbutor. recent guidance to regulatory agencies measured with the base unit Cuiie. The Deletion of this word in the proposed that was issued by the Office of word dose is used to indicate quanities revision does not authorize Part 35 h!anagement and Budget.Therefore the of radiation absorbed dose or dose licensees to manufacture Commission has in the proposed equivalent that are measured with the radiopharmaceuticals. revision generally adhered to the base unit rad or rem. 9. A valloblefor use. In many cases following policy.
- 5. Record and report. A record is a *I" *" " ates an e me possession requirement b@ecause created the Fonecurrmg recops eat are on a daily basis, for example user. retrievable notation or complete document. It may consist of something piece of equipment is considered by end.of. day surveys. and for most non-experts to be an integral part of the recurring sporadic, or periodic records.
as small as a check mark on a form or something as extensive as a sursey of a radianon safety program. In a few cases such as individual patient dosage newly installed teletherapy unit with the need for a piece of equipment is measurements or survey instrument appended calculations to demonstrate sporadic and normally scheduled weeks calibrations. the Commission has made compliance with the limits on exposure in advance. For example, a licensee who a judgment that records retention for has a diagnostic sealed source in a two years provides adequate evidence in uncontrolled areas. A report is a transfer ofinformation which might be device (see 135.500) usually only needs of compliance with requirements. made face to face, by telephone, a survey instrument when receiving or 2. In a few cases a record is only returning a radioactive source: there is tzlegram computer link. or hard copy created once or the Commission transmittal. no need to have the instrument on hand considers the record to be ess'ential every day.The phrase "available for evidence of compliance with regulations
- 8. Test and check. For many pieces of use"is intended to connote that the equipment. drafting comnuttees that if not followed, rnight cause an licensee either may possess equipment immediate discernible impact on a comprised ofindustry experts have or contract for measurement services, prepared standards of performance and worker or m-mber of the public (for but is not required to have regular day- example, reqt rements for the geometry complete calibration protocols. If a piece to-day possession of the desenbed of equipment is subjected to the protocol equipment. test for a dose calibrator and the in the calibration laboratory and meets teletherapy dosimetry equicment
- 10. Dedicated check source. A lorg- calibration. respectively). In those cases all the standards, then the ability of the lived radioactive source can be used to equipment to perform as expected in the Commission has made a judgment check the day.to-day constancy of an that retention for the duration of use of normal field use is assured. In the instrument. The same source (a the equipment or of the license is proposed revision this concept of " dedicated" source) must be used every necessary.
complete examination is referred to as a day so that the user knows what reading
" test." Dunng field use it Is common to expect from the instrument. The Effect on Broadt.icensees practice to subject a piece of equipment source may also be used for other to a quick examination to determine In addition to the more common purposes. " group" licenses which the NRC issues whether it is working. This procedure 11. Operable. The word " operable" is that authorize by product material for does not examine all parameters of not used in the proposed regulation uses desenbed in the groups, the NRC equipment performance. In the proposed because every piece of equipment must has also issued about 100 broad licenses 1
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Fcdml Rrgister / Vol. 50. No.144 / Friday, July 26, 1985 / Proposed Rules 30621 under Part 33 that include medical use. Transition Policyfor GeneralLicensees Trcasition Policy lor Specific Licensees They are issued to large medical / academic institutions that have had The generallicense in current i 35.31 Under the current regulatory program. several years experience using has been eliminated from the proposed the license document with the appended radioactive materials. regulations. In the future, all med2 cal use application is used to regulate each About 50 of the medical use broad will be specifically licensed. Current individual licensee. Because the licenses that have been f asued vest in generallicensees, all of whom are requirements in the proposed revision each institution's Radiation Safety physicians will receive a specific were taken from commonly used topical Committee the authority to permit license that will be incorporated into license conditions and regulatory medical practitioners to use byproduct NRC's filing system for keepmg track of guidance that most licensees have material for both patient care and specific licensees. However, they will be incorporated into their applications, the medical research. to permit individuals limited to the methods of use desenbed Commission does not expect any to use byproduct material for research in in the current i 35.31. and relieved by significant inconsistencies between test tubes and animals, and to review license condition on a pre-printed current licensee radiation safety the facilities and radiation safety license. from the requirements that are programs and radiation safety programs procedures that these individuals will more burdensome than the current of applicants that apply after the use. Before NRC issues a broad license generallicensee requirements. The only effective date of the propsed restulations. It reviews the applicant's administrative action generallicensees will need to Therefore. cunent licensees will and safety procedures. the training and take is to respond affirmatively to an normally be cited if they do not comply expenence of the Radiation Safety NRC notice that asks if they want to with the new regulations. However. Cfficer and of each individual member continue to have an NRClicense that is because each current licensee's of the Committee, and the standards and limited to the methods of use authorized radiation safety program was reviewed management procedures it will use by the current general license. individually and license conditions were when reviewing pernut requests. "Dris The Commis.sion proposes. under tailored to meet the licensee's individual type oflicense is needed to allow for the i 10.11(b). to continue to exempt these needs there may be an occasional orderly evolution of the medical licensees from application and renewal inconsistency between a license sciences. The NRC will continue to fees as long as their programs are condition and tne regulation (for review Committee member limited to the material uses described in nample. a license may require survey qualifications on acase-by-case basis current 135.31. Under the new specific instrument calibration biennially, but because the size and individuality of licensing system. former general the proposed regulation would require each broad licente program precludes licensees that want to make any calibration annually).There is no health the preparation of generic prescriptive changes in their programs. amend their and safety reason to undo these licenses qualifications. These licensees would be licenses, or transfer them to other to effect compliance with the regulation. required to comply with the proposed physicians, will have to apply under the To impose the regulation in addition to prescriptive and performance criteria of new licensing sche'ne and will be , orin lieu of the license conditions would Part 35. but would be exempted from the subject to all the fees that apply to other n t pr vide for significant additional tratrung and experience requirements of specific licensees. an ad saW.He Gnunhskn Subpart I and the authorized materials therefore proposes to resolve possible and authorized use restrictions in The Commission proposes to waive temporary inconsistencies between proposed il 35.49, 35.100. 35J.00. 35.300, fees t f rmer generallicensees for the f Ilowing reasons. Generallicensees do license conditions and the regulation by 35.400. and 35.500. providing in the regulation a transition n t n W pay fees. About 9M of the M0 period between the effective date of the The other 50 medical broad licenses rs general heensees are inactive. final rule and the expiration date of that have been issued are similar to the license desenbed above, except that the Each year NRC receives only a very few each license. Dunng this transition Committee only has the authonty to requests for generallicenses under . period. if there is an inconsistency permit Individuals to use materialin test i 35.31. There would be no NRC review between a provision in a license (issued tube and animal research, and only time needed and only a minor NRC prior to the regulation) and the authorizes medical use in accordance administrative cost to process these regulation, the proposed regulation with the groups in current i 35.100. The licenses. It would be unfair to charge states that the license cond2 tion would NRC would continue to review the these licensees the fees listed in 10 CFR take precedence over the regulation. training and experience of medical Part 170, and it would be more costly for Because the license conditions were practitioners before allowing them to NRC to alter that fee structure than to reviewed frem the perspective of overall use material for medical use. Because grant the exemption. safety and approved by the NRC, the control of medical use in these cases is The current Part 35 also grants a inconsistency would not result in an the same as that exercised over the . generallicense for fri vitro work increased risk to workers or the public. more common group licensees, the basis descnbed in i 31.11 to group licensees In addition to the topicallicense for a determination of compliance will without requiring that they submit an in conditions mentioned above (for be the same as that described below for vitro registration form. Under the example. sealed source leak test group licensees. proposed regulation, applicants would requirements, special bioassay Because, whether at a group or broad have to specifically request this requirements radioactive patient license facility, teletherapy is separately authonzation as a line item on their surveys and release limits, or waste licensed "for treatment of humans" and applications. Part 31 will be amended to disposal restnctions), each specific because the NRC reviews qualifications continue the in vitro authonzation for license has an encompassmg license of proposed users and safety current medical licensees until their condition that requires each licensee to procedures, no significant licenses are renewed. In either case, the possess and use licensed matenalin inconsistencies with current teletherapy use of f 31.11 materials within the accordance with the statements, programs or new teletherapy ;frograms inventory limits of that section will only representations, and procedures are expected. be subject to the requirements of I 31.11. contained in the license application and
30622 Fediril Register / Vol. 50. No.14 / Friday. July PS.1985 / P oposed Rules in letters of clanfication. Despite this guides would be consolidated into a encompassing condit:on. licensees document. but this does not relieve them concise set of regulanons. The of the reqmrement to conduct their work would be allowed to make changes in requirements that apply to alllicensees their radiation safety programs: in accordance with requirements of the appear first. followed by the specific 1. cense and the regulations of this permissible changes would be restncted requirements for each of the six tasic chapter. The licensee remams to those identified in i 35.36. and the t> pes of use. hcensee would have to conduct the responsible for the noncomphance of In the proposed regulation. items of such agents or employees, and may be internal review required by that section. general information. general subject to sanctions for their failure to in the case of record retention, the admimstrative requirements, and regulation will generally take cceply. general technical requirements are precedence because. in the past, the addressed first in Subparts A through C. Se m nJ58 Inbemation calledn Commission has not offered much respecuvely. Subparts D through I reprements: OMB Approval. guidance on this topic. Many applicants contam the additional technical have either not specified a pened of This section provides notice that the requirements that apply to licensees for Office of Management and Budget has retention or have incorporated a smgle, each of the six new types of use. all encompassmg record retention reviewed and approved the information Subpart llists the traming and collection requirements contained in this phrase "unn! the Commission authonzes expenence requirements, and Subpart K part. their disposal." rather than shouldermg lists the penalues for violations of the the burden of justifying to NRC a shorter regulat ons. Sectwn 35.15 Definitions. period. If a record is substantively the in order to maintain consistency ~ same as a record described in the among the various parts of NRC's The term " Agreement State" applies proposed regulation and the licensee regulations. conforming amendments to those states that have entered into an agreement with NRC to assume has not stated a retention period for that have been made to the affected sections specific record. licensees could adopt of Parts 30. 31,32, and 40.These responsibility for regulating the use of the retention period stated in the final byproduct material withm their borders. conforming amendments can be found rulemaking. However. licensees would immediately after the revised Part 35. A The word "ALARA' was added ton still have to comply with any record section-by-section discussion of the dentify the acronym for the phrase "as retecnon period required by a topical proposed revision of Part 35 follows. low as reasonably achievable." license condition or another Part (for The term " area of use" was added to oxample Part 20) of the regulauons. (For Title identify a place in which byproduct example. surveys that provide the basis The title of Part 35 has been chang =d materials are received used. or stored. for occupational dose records or from Human Uses of Byproduct The term is used in 135.36 to authorue measurements of effluent release are Afaterial to Medical Use of Byproduct licensees to use byproduct matenals in governed by Part 20.) Afatenal" to better reflect the scope of buil i as not NRC does not currently review the part. yms, it"'b n app a qualified teletherapy calibration expert "authonzed user" was credentials and does not identify the Authority dded to identify mdividuals who are Radiation Safety Officer on the license. This listing provides notice of the ia.denufied by narne on a license and who Under this proposal. NRC would begin statutory basis for the regulations. It are authonzed by the Commission or an to review their credentials and identify also provides notice that the NRC may Agreement State to administer both of them fust as it does now for initiate enminal prosecution of persons byproduct matenal, or the radiation authonzed users. To ad-! current who knowingly and willfully do not therefrom, to humans for medical care, licensees to this new scheme. !!censees comply with the prescnptive and supervise its use by others. would be required to submit their requirements issued under section 161b The term "dennst" ws added to credentials for review and approval or the recordkeepmg and reporting identify a group of practitioners licensed when the next amendment or renewal requirements issued under section 1810. by the States who might use byproduct request is requtred. These individuals "*"* 'Y**" Sabpart A-Generalinfonnotion would be identified on the next license The term medical use'.'was included amendment. Section 35.1 Purpose and scope. to help identify the scope of this part. The NRC particularly requests public The regulations in this part apply to The word " intentional" was included in comment on this transition policy and all persons licensed by the Commission the definition to make it clear that would like to know if licensees envision to intentior. ally administer byproduct occupatronal and nonoccupational problems of interpretation or material or the radiation from byproduct exposures under the regulations of Part compliance that the staff might not matenal to humans. and to individuals 20. accidental exposures, and unwanted foresee. working under their supervision. exposures from other sources of Discussion of Proposed Regulations Section JJ.2 l.icense required. radiation (e.g.. nuclear powered cardiac pacemakers smoke detectors. and The primary purpose in imtiatmg this This section requires that persons revision to the regulations is to simplify radioactive waste) are not considered have a license issued by the medical use. The phrase "in the practice the regulatory process by providmg Commission or an Agreement State licensees with a smgle source of of medicme in accordance with a before they hand!e byproduct material license" was included to make it clear requirements for the medical use of for medical use. The Commission uses that NRC recognizes that States may byproduct matenal. Radiation the specific licensmg process to limit the have different difimtions of medical protection standards now contained in. use of byproduct matertal to persorts practice or different levels of control several existmg regulations. Inspection who have the equipment. facilities, and that licensees should not interpret and Enforcement orders that modify a trattung, and expenence needed to that NRC license as a pre-emption of single license or group of licenses, ensure its safe use. Individuals who are technical reports INURECst, standard State medical regulations or an attempt working under the supervision of an to direct the States' regulation of conditions of licenses, and regulatory authonzed user co not need a license medical practice.
Fed;r:1 Rzgist:r / Vol. 50. No.144 / Friday, July ZB.1985 / Proposed Rules 30623 The word " medical institution" was Section J5.16 Application for hcense. of this part. the phrase "location of use" added to identify organizations in which cmendmer.t. or rene wel. refers to a building. (Movm; from one the radiation safety program depends on mmt another withm a building would the cooperation of individuals from At an institution, only manaaement may apply for a license: individual n t constitute a charge in iocation of several different departments. physicians would be listed on that usel The word " management" was added license as authonzed users. An (3) The Commission must be assured to identify the individual responsible for individual physician may not apply for that the training and experience of defining the licensee's policies and use within a medicalinstitution (an Radiation Safety Officers. authorized allocatmg personnel. budget, and space organization that provides various users, and quahhed teletherapy resources. medical services) This requirement cahbration experts is sufficient to assure The word " misadministration" was ref:ects the need for coordmation with that they are able to understand and included to define those instances in other employees who may not be under follow regulations for the safe use of which a mistake has been made in the the administrative control of the byproduct material. medical use of byproduct material.The authorized user. For use sited outside a Section 35.16 Notificctions. definitions are the same as those in the medical institution. such as for private practice or mobile service, any person A notification requirement was added . current i 35.41. may apply. An application must be filed to require tne licensee to notify the The term " mobile nuclear medicine Commission if an authorized user. service was added to desenbe the ou Form NRC-313 because it elicits infonnation in an orderly manner that Radiation Safety Officer or qualified transport of oyproduct matenal for the teletherapy calibration expert is no purpose of offenng diagnostic nuclear will a!!ow for uniformity in application review procedures. longer affiliated with the licensee's medicine services at addresses other Teletherapy applications must be byproduct material program. Without than the pnncipal business address of this notice :he NRC would not have submitted separately because the scope the licensee assurance that the collective trainmg and nature ofinformation needed is Ine word " output" was added to much different than that needed for the and expenence of the licensee's describe .the amount of radiation in a other types of medical use. This remaining personnelis adequate to teletherapy beam. requirement does not imply that the ensure the safe use of byproduct The word " physician" was included to applicant should have two separate material for all the types of use identify individuals licensed by the safety programs. authorized by the license. The States to practice medicine and This section also reflects the Commission has made a judgment that therefore eligible to use byproduct Commission's decision to delegate to notification within 30 days is sufficient meterialin the practice of medicine. Regional Administrators some licensing because technicians who have worked functions which. until recently, were under the supervision of the authonzed The word "podiatnst" was added to identify a group of practitioners licensed conducted in the headquarters. This user can adequately ensure the safe pr gram was desenbed in Federal receipt and proper storage of byproduct by the States who might use byproduct material. However, absence of an materials in their practice' Register notices published May 27,1982 (47 FR 23138). April 14.1983 (48 FR individual to oversee a byproduct The term .'cua;ified teletherapy material program may increase the 16030). May 9.1984 (49 FR 19630), and calibration egert' was included to Apnl 15.1985 (50 FR 14092). probability of an accumulation of replace the term " qualified expert' unused byproduct material or which is used in the current i 35.04. The Section J5.17 License amendments. unauthonzed use of matenal.This new term better reflects the traming. The Commission requires that the presents an unacceptable potential experience, and responsibihties of the licensee obtain an amendment for any hazard. individual who is responsible for changes in the byproduct matenal calibrating a licensee's teletherapy unit. Section J5.23 License issuance. program that might increase the The term " Radiation Safety Officer" potential for radiation exposure to The Commission has selected a was added to identify the individual workers and the general public. or make license term of five years. A shorter named on a license and who is it difficult for the Commission to term would not benefit the public health responsible for managing the licensee a conduct its inspection program. The and safety because past experience radiation safety program. Commission has determined that certain indicates that medical programs do not The term " sealed source" was changes are potentially significant for generally change sigmficantly over that included to identify byproduct material the following reasons and thus will penod of time. A shorter term may that is specially encapsulated to prevent require an amendment: unduly mterfere in patient care because (1)The NRC must be assured that the the licensee would spend an mordinate leakage or escape dunng use and amount of time requesting renewals. A storage. It is the same definition as use licensee has adequate traming and expenence and facilities before longer term may occasionally result in in { 30.4. unintentional abendonment of the authonzing a change in the type or The term " visiting authorized user" method of medical use or amount of license. was added to identify individuals listed byproduct material used. Such a change The applicant must use Form NRC-as authonzed users on one license who- might also indicate a need for increased 313 to provide for an orderly safety while working for another licensee on a inspection frequency. review of the applicant's program. The temporary or occasional basis, use (2) The use of byproduct matenal at Commission will apply certam byproduct material under the an address not identified on the license standards when reviewmg an restrictions of the temporary employer's would make it impossible for the application so as to ensure that the license which does not identify the Con. mission to make unannounced safety of workers and the public will not visitor as an authorized user. This inspections. The Commission rehes on be compromised if the license is granted. authonzation is based on a frequently the unannounced inspection to assure The staff must be assured that the used topical license condition. day-to-day compliance. For the purpose apphcant's proposed equipment and
306:4 Federal Register / Vol 53. No.144 / Friday, July 26. 1985 / Proposed Rules facilities are adequate to protect health in this proposed rulemaking the 210:3), and as a final rule on September and mmimize danger to life or property Commission has not required non. () 30.33(a)(2J). and that the author: zed 13.1982 (47 FR 40149). institutional licensees. such as one or a Committee membership must include users are qualified by trauung and few physicians in private practice to expenence to use the material for the a physician identified on the purposes listed in the application in have a formal AIARA program because. institution's license as an authorized for those licensees, the physician user or byproduct matenal for each tvpe such a manner as to protect hesith and authorized user is usually also the ' mminuze danger to hfe or property of use permitted by the licerse, the Radiat:on Safety Officer. management. institution s Radianon Safety Officer. a () 30.33fa)(3)). and that applicant has and the line manager. Wnce. .ny for;ual representative cf the institution's established procedures adequate to ALARA report requiremcP would assure that safe use of byproduct management. and a represe.,tative of the consist of the physician reporting to nurstrig service. matenal himself. However, the Commission Concermng fees. Congress has would appreciate comments as to Institutions that only request a license directed that agency services, such as for diagnostic sealed sources will be whether a#medicallicensees should exempted from this requirement by licensing and inspection, must be self. have a formal ALARA program. If so. sustaining to the extent possible. should smalllicensees conduct an license condition because the radiation Section J529 Specific exemptions. safety pregram would not depend on the internal annual review or should that As part of an application or review be conducted by someone who , is cooperation of individuals from several different departments. packages would amendment request, a person may not associated with the licensee's arrive infrequently, there would be no request an exemption from any pr gram on a day.to-day basis? chance of contaminating an entire room requirement of this part.The NRC Commenters are reminded that the or suite. no radioactive waste no occasionally receives requests for exhonation in to m :0 4c) to make radioactive patients, and little chance of exemptions from procedural, equipment. emy reasonaMe don to maintain loss of material. or traming standards. The Commission radiation exposures and releases of radioactive raaterials ALARA applies t To assure the safety of workers and may allow the exemption if the medicallicensees. the public in light of site. specific applicant can show that it will not exigencies. the Committee must review compromise the health and safety of Section JJ.31 Radiction Safety Officer. on the basis of safety:(1) ne workers and the public. ' qualifications of each Individual to be Subpart B-Ceneral Administrative . The Radiation Safety Officer is an , listed as an authorized user, and (21 g ,, mdividual with special expertise who is each proposed method of use. In its needed to coordinate the safe use of Section Jr0 ALA RA progrum. byproduct matenalin accordance with reviews. the Comnuttee should consider compliance with NRC regulations. An ALARA program is a management the license and the Commission's special physical or chemical tool needed to assure that all reasonable regulations. containment problems, the amount of efforts are made to assure that safe use Section JJ.32 Radiation Sofety byproduct matenal that will be used. of byproduct material. (See Committee' and the relative hazard of the material.
' Management Orgamzation and all in light of the licensee's facality and Administration for ALARA* by Kathren.
The proposed part 35 requires staff. Hec /th Physics. Vol. 42. No. 2. February institutionallicensees to establish a The Committee must review 1982 p.119-131. and ' Radiation Safety Radiation Safety Committee to oversee occupational exposures quarterly. A in a Nuclear Niedicine Department.' by the use of byproduct material. The more frequent review would Gandsman et aL Health Physics. Vol. committee is required because. in an inappropriately emphasize normal and
- 38. No. 3. Nfarch 1980. p. 399-408.) in an institution. radiation safety for c// expected statistical variations in institution many workers from different workers (users and ancillary staff) and exposure data. A less frequent review departments might be occasionally the public depends on the cooperation of would not provide for timely notice of exposed to byproduct matenal. The employees from administratively unnecessary or unnecessanly high Commission has made a judgment that a separate departments. Without the doses.
formal ALARA program is the only benefit of committee discussion. The quarterly review should be guided management tool that can ensure a authonzed users may not be aware of by two trigger levels for individual cooperative effort to miuce individual radiation safety problems outside their doses. The lower level would be a and collective dose and ensure regular own department that are caused by their minimum level below which no action safety reviews. Specific requirements patients, packages, or waste. De need be taken. Above the minimum usually considered part of an ALARA Committee's deliberations will provide level, the source of exposure should be program are required by li 35.31 smd management and authonzed users with determined and consideration given to 35.32. information that is needed to optimize methods of reducmg the exposure rate. The annual briefing of management by allocation of resources avmlable for The higher level should tngger the Radiation Safety Officer on the radiation safety. A Committee is not immediate intervention by the Radiation byproduct material program is intended required for licensees that are not Safety Officer to reduce the exposure. to assure that licensee management medical institutions because such The committee should review the knows what kinds of byproduct material orgaruzations generally do not have the appropriateness and completeness of the are used m which departments. which multi. armed, multi. tiered management intervention and should develop a workers are involved. its use. the structure typical of medicalinsntutions. permanent solution to maintain doses at ' regulatory requirements that govern its In non. institutions the authorized user is a lower level. use, and current and potential radiation likely to be part of management and a The annual review of the safety cafety problems. Management needs this line supervisor for ancillary workers: program is needed to determme its information to ensure that its dectssons therefore a formal committee structure adequacy in light of the current and do not inadvertently result in activities would serve no useful purpose. A proiected use of all b)Treduct material. contrary to the regulanons or license similar requirement was published as a In the Commission's judgment. a review conditions. proposed rule on Apnl 9.1979 (44 FR at least once ear.h year is adequate to
Fed:ral Registzt / Vol. 50. No.144 / Friday. July 28. 1983 / Proposed Rules 306 5 assure that exposures remain ALARA !ccations where the licensee reight not material or different k2nds of matenal considering the few program have clear and direct control over than permitted by the license; and adjustments typically made during any personnel. facilities, or equipment. The before using matenal at locations not single year.More t me between renews Commission wiu continue. on a case-by-might not permit the committee to make listed on the license. These are major case basis, to authorize provision oflow changes in a licensee's radiatior safety timely recommendations for reduc:ng level radiopharmaceutacal therapy by unnecessary worker, public. or pat:ent program for which a license amendment mobile nuclear medicme services. These would still be required (see i 35.17). exposure by. for example, chang:ng licensees are required to have a letter of space allocation. purchasing new per=ussion from the managernent of Under this proposal all other changes equipment. or changing procedures. (such as selecting replacement each client to assure that the chent management as aware of and in equipment re. arranging the nuclear Section JJ.JJ Requirement /or medicine clinic. switching from one authority and statement of - agreement with the medical use of service contractor to another, or 1 bi e s c be provi e to switching to an alternative equipment To ensure that materialis used safely. licensed clients because. in case of a quality assurance procedure) would be the Radiation Safety Officer and spiu or dose rates abose regulatory minor chaages. Radiation Safety Committee need a limits, the responsibility for correeive The Commission would appreciate clear statement of their duties from action rosy be clouded. comments on this maior/ minor dividing management so that questions about Sec#onJa Radio #onsafety line or threshold. Is this dividmg line authonty, responsibility, and clear and complete? Are there cther junsdiction do not keep these program changes. individuals from acting. featuras that should be considered as This section allows the licensee to major changes, or are some of these Section 35.34 Visiting atthorizeduser. e changes in the radiation safety major changes ready not important to program that was desenbed in the The uninterrupted provision of health and safety? la there some other application if the changes are within the medical care occasionally requires a requ:rements of the regulation.The dividing line, either fixed or fleuble, visiting authorized user to work for a purpose of this authonzation is to aUow that would clartfy which changes are host licensee when its permanent staff the licensee to respond to changes in really not important to health and safety may be unable to do so. This was stafflevels. available equipment. or and may therefore be made by the allowed in the past by a standard patient load that may require licensee? Alternatively, should the license condition. If the licensee had a reallocation of floor space. or to make Commission continue to require copy of anotherlicensee's NRClicense changes that may be necessary for licensees to submit all radiation safety that listed the visitor as an authorized patient care, administrative. radiation program changes for agency approval? user. the visitor could work under the safety or economy needs. Before license for sixty days each year without implementing any change, the licensee Section JJ.37 Recordsandreports of ' requesting a license amendment. The must make a record of safety matters misadnunistrations. scope of this concept has been that were considered when planning the %e proposed Part 35 retains the expanded to allow NRC licensees to change. ne record will be used dunng misadmimstration defimtions and employ Agreement State authorized unannounced inspections to determine reporting and recordkeeping users. Because the visiting authonzed whether the licensee has made changes requirements of thecurrent Part 35. A user's training and exnenence has been that are contrary to the regulations. discussion of these requirements reviewed for health a id safety license conditions or orders and dunn8 consideration by a ryulatory agency, appears at 45 FR 3rol. published May termination surveys to provide an ' 3 4, g gga. this short. term authonzation will not indication of every area where matenal pose an undue risk to public health and Although the Commission has not was used. safety. The purpose of wntren The Commission notes that this revised its misadministration reporting permission is to assure that the required change in the current licensing process and recordkeepine requirements. it records have been reviewed and found under which olt radiation safety would like to take this opportunity to complete. program changes must be approved by ask for public comment on these When exercising this privilege. host license amendment. recognizes that. in requirements based on the expenence licensees should identify each mdividual the end. public health and safety is gained since the requirements were first method of use authorized by their based on three features-(1) NRC published in final form five years ago. license, each individua' method of use regulates who may use byproduct For both diagnostic and therapeutic authonzed by the visite 's license. and matenal for medical use bylisting misadministrations are the current each ladividualmethod of use that the authortzed users on the license:(21 NRC requirements adequate to protect the visitor will be allowed to do at the host regulates the degree of hazard. balanced public heelth and safety or should they facility. Note that in some cases the with medicai needs. by only allowmg be made more or less stringent? Should Agreement States' groups. schedules, or certain chemece] and physical forms for the regulations require prompt subparts do not correspond to those of medical use: and (3) NRC regulates notification of the patient who received the NRC. De visitor can only do those where byproduct matenal may be used the misadministration? Do the ~ procedures authorized by both licenses. to auow for unannounced inspecuans of regulations provide the public with a licensee radiation safety programs.nis Secten 1135 Afobile nuclearmedicine proposal would retain those regulatory clear notice of the Commission's role sernce administratire requirements. features by requinng licensees t when there is misadmimstrataon? Should Mobile nuclear medicane servtce has receive a license amendment before the Commission take enforcement action been limited to diagnostic medical use usmg material for new clinical methods against licensees who misadminister by because the inherent hazard of of use not permitted by the license: product matenal or radiahon to therapeutic amounts of byproduct before permitting new authorized users patients?!f so, what tpe of enforcement matenal makes it unsuitable for use in to use material: before receiving more ggg
30tCS Fediril Raist:r / Vol. 50. No.144 / Friday. July 26. 1985 / Proposed Rules Section J5J8 Supervision. economy and efficiency, the NRC uses record of the assay results. This is The authorized user is allowed to use v luntary national standards in its required to ensure that the patient byproduct material in the practice of regulatory pmgram if they provide receives the mtended dosage. The time medicme. Frequently, specific tasis may adequate assurance of safety.)The at which the measurement must be be delegated (under 1135.2f b) and activity levels of the accuracy check made has been purposefully omit *ed to 35.3al to individuals with less training sources were chosen because a lower allow for ilexibility in licensee's and experience. However. it is activity would invalidate the accuracy procedures. necessary that a qualified individual test due to expected statistical Ductuations, and a higher activity would A similar requirement was published mstruct them. osersee their work on a frequent basis, and be available to present an unecessary source of as a proposed rule cn September 1.1981 promptly respond in unusual or radahon exposure to workers. The (46 FR 43840). The comment penod on radionuclides required reflect the fact the proposed rule expired November 30. emergency situations. The regulation requires that supervised individuals 1981. The NRC is incorporating the that dose calibrators are not as accurate dosage measurement proposal in this comply with instructions. procedures, as might be expected for the photon and the regulations. energ es commonly used for imagint revision. The proposed Part 35 dosage The NRC has not specified which (see " joint NCDRH and State Quahty measrrement requirement differs from tasks may be delegated to whom Assurance Surveys in Nuclear the 1981 proposal in its recordkeeping because the practice of medicine is Afedicine." HHS Publication FDA 83- requirement. The Part 35 proposal regulated differently in each State and 8209). The linearity test should only be requires the dosage measurement record done over the range between highest to include the patient's name, and because medical services must also be responsive to each community's individual dosage measured and 10 dentification number if one has been particular needs. The NRC particularly mict curies to ensure that the dosage assigned, and prescribed dosage. This requests comment on whether special given is the dosage that was presenbed. information was not required by the training elements should be clearly it is not necessary to test for lineanty 1981 proposal. identified for certain tasks that are f r all amounts that might be measured. delegated or whether the general Section J558 Authorizationfor f r example the first elution from a fresh cobbmtion and reference sources. guidance is sufficient. gem e a md%se M. kme this would subject the worker t These sources are needed to check SectmnJ549 Supph,ers. unnecessary radiation dose. Dosages and test radiation instruments and to In order to authorize only the use of below to microcuries cannot be g , , gg materials reviewed by the government accurately measured on a conventional radiation hazard in relation to the for safety and effectiveness dose calibrator because they are so tiny. amount of radioactivity used in patient considerations, authorized users may Also, these dosages present only a care. The activity level was chosen to use only byproduct material that has trivial nsk to the patient and therefore allow licenses to have a range of been manufactured and distnbuted need not be so accurately measured. sources with several energies and half. under procedures that were reviewed The geometry test assures that the shape g-for safety by the NRC, the Food and of the syringe or vial containing the Drug Administration (FDA) or an byproduct material does not affect the Section 3559 Requirements for Agreement State, possession ofsealedsources and d sage measurement.The daily constancy check assures that the dose brochythempy sources. The NRC will continue its current practice of allowin8, on a case.bY-case calibrator has worked consistently since The user must follow the basis, re-transfer of it was last tested. manufacturer s instructions because I. censees whose level or scope of use they have been reviewed for safety icensees an a pl nt s ecifical y does not indicate need for a dose considerations by the Commission or an requests an exemption from this section calibrator may request an exemption Agreement ra te. and shows the exemption is in the fr m this section. The request should be public interest. supported by a descnption of an The six month test in*erval has been recommended by the National Council Subport C--Ceneml Technical alternative method that the licensee will on Radiation Protection and Requirements use to measure radiopharmaceutical hieasurements (NCRP)iin Report No. 37 dosages. Section 2350 Possession, use. " Instrumentation and Stonitoring calibmtion, andcheck of dose Section 3151 Calibration andcheck of Afethods for Radiation Protection." % fore frequent testing is inconsistent with survey instruments.
#8I'bmtors. ,
A!. ARA considerations becsuse it The 1000 mR/hr limit was chosen A dose calibrator is needed to ensure because that is the highest radiation would cause worker dose when making that the dosage of material given is the the test but provides only a slightly dosage that was prescnbed. It must be exposure rate that is likely to be encountered in the medical greater probability of funding a leaking tested for accuracy, the ability to source. The test procedures desenbed exactly measure a specified quantity. er.vtronment. The calibration frequency and the other presenptive and are intended to maximize the and lineanty, the ability to exactly performance requirements in this probability of detecting contamination measure a range of quantitles. The from a leaking source. Report No. 57 section are generally consistent with requirements are generally consistent ANSI N3::3-1978. with the recommendations of the 'itie Nanon41 Couned on R4Jianon Pro *echen American National Standards Institute.
- g. y, g ,%,,,,,,,,, ,NCFPI rs a nonpre: At 7
(See ANSI N4? 13-1978). Copies may be h fodMF ofmCC8Mf/ Cold 080888- omranon char + red by Consress en oa4 to eran purchased by contacting Seles creve recommendanone on cemecnon +.nsi This section requires that the licensee ra Department. Amencan National Standards Institute.1430 Broadway, assay the radioactivity of each ,34';aga, ,
'g*gayr'g,";';,,,
,gm,,, ,,,,ernon Co., of corei nm be radiopharmaceutical dosage before it is p,e4 4 ny enr.iaens NCRP Pubkanons. P O.
New York. NY 10018. In the interest of administered to a patient and keep a eos ynts. wasmnron. uc mrnt
Federal Ruister / Vol. 50. No.144 / Friday. July 2S.1983 / Proposed Rules 306?" Section 3.3.5.3 recommends a mmimum individual handhng a vial of byproduct measure of safety for the general pubhc. detectable limit of 0.005 microcuries for matenal. and that further redactions m puolic Sechon J562 Syringe ichels, end up sue am not masonably achievab e a pl s. is le is Iso ns stent jJ56J Violshre!dlabe!s- consideny the cost and potential for with the requirements of other pans of detenmental effect from an the current regulations (see, for Some rn,sadministrations i have been unnecessardy long hospital confinement. example. Il 3L5 and 34.25), and is oniy caused by accidentally transposing vials slight.!y higher than the minimum or syringes. De prope'r labellittg of Serma J5.30 Mobile nuclearmedicine detectable activity exhibited by containers will help to avoid this type uf Jemca technicairequirements. instrumentation available to licensees. mistake. He Commiss.cn has limited at h ?el "O*" #?? *#Y' ? ' ' "' "*" #" "*" o e?the a conservative detection level techmcaUy conta nation and ambient radiction }hese licensees to umt dosage and multi. achievable a ###"## ##'#' ' ' ' noted that th,t radiop a maceu ca is a reasonablewould requirement cost. It is Since radiopharmaceuticals are reduce the current permissible amount frequentjy handled. it is plausible that a b"*" M # ** s>ringe or some radioacave waste may kansp nadon of generators because of detectable contamination from teletherapy sources ten-fold. from 0.05 be nusled.This would result in they are needed by persons who do not unnecessary radiation exposure to have daily access to prepared microcuries to 0.005 microcuries for radiopbarmaceuticals. That lack of purpose of consistency. workers and the public.The exposure The Commission has made a judgment rate survey will bnng this to the access would be contrary to tne that the exempted sources do not attention of workers. The weekly jec{aphic proxmuty required by 3 present a contaminaticn hazard because exposure rate survey of waste storage of the smaU amount of radioactisity in a*eas will ensuft that exposure rates in The service must remove au the sources. the method in which they that area will be monitored so that radioactive waste generated dunng the are constructed. or the small hazard of special steps can be taken if greater use of byproduct material at a client the byptedm;t matsnal.To conduct a than average use of locat on of use because the Commission physicalinventory more frequently than radiopharmaceuticals rasults rn higher has no assurance that the client is quarterly is inconsistent with ALARA than average exposure rates in the equipped to safely receive and process exposure goals.To inventory less waste storage area. radioactive waste. Because there is no frequently may. in case of a misplaced The Commission knows that a assurance that the licensee can control source allow an unacceptable radiation removable contamination wipe test access to areas of use while worxing in exposure to go on for too long without made several days after sptuage of a a fac:lity that is under another person's detection.'Ihe radiation survey assures short-lived radiopharmaceutical wilj admimstrative control, clicct facilities that sources ara tafely stored probably not detect any contammation. should be considered as unrestricted The periodic contamination survey areas. and the licensee must therefore Sectw.n.25.60 Syriageshields. serves u a check of workers' physical constantly exercise physical control of Syringes that contain byproduct control of radiopharmac.euticals. byproduct matenal. material can be an external radiation if contamination is found. It indicates Equipment checks are needed to source and should therefore be shielded that controls er safety measures may be assure the proper function of equipreent at all times. !n some cases the use of a inadequate or are not always being after transport and before byproduct shield when making an iniection could used. material is handled. A aarvey is needed interfere significantly with the miection. to assure that au byproduct material has
# # #8 This would leopar,dize patient benefiL in g f been removed from the client location of such cases the higner radiation exposure use. The mobile nuclear medicme to the hands that is received by the go, gfyg,, service must carry a calibrated survey technician who does not use a syringe A patient whose body contains meter to monitor exposure and shield is warranted. A shield need not byproduct matenalis a source of - contamination in case of any accident be used when the risk of speding the external radiation and can be a source that rney result in a telease of byproduct injection is greater than the benefit of of radioactive contamination.The matenal, reduced worker exposure. patient should not be released fmm the The NRC considered requiring the use climc or hospital until the residual g,cfj,,33g 37,xy, ,7,,7o,jf,, e,j of syTmge sluelds when drawing radioactivity in the patient is at an 88'#*
indiviceal dosages imm multi-dose acceptable level. The Commission Some radiopharmaceuticals present vials. That requirement is not included proposes to allow patient release limits an inhalation or immersion source (e g., in this proposed revision because it based on residual activity in the patient volatile iodine.131 and xenon.133 appears that the increased handling or exposure rate at a specified distance respectively).The chance of exposure required to remove the shield when from the patient at the licensee's option. can be reduced by storing these measu ing the dosage may actuaUy The 30 mdlicurtes burden limit is based materials in a fume hood or multiple increase radiation dose to the hands. on a recommendation of the NCRP and barners (such as a folded plastic brsg However, the NRC is soucitmg current licensing practice.The 6 mRlbr withm a folded plastic baq). comments on wnether synnge shields at one meter !!mit is based on the Section 35S2 Decay-in. storage-should be used when drawingindividual exposure rate from 30 millicunes of dosages. iodme.131. the most commonly used For most hosptial therapeutic radiopharmaceutical; some radiopharmacent2 cal waste, decay to Seefien 35.31 ViolshieMs. Individuals believe that the e'rposure backuround levels is essential'y A vial radiation shield can rate is more relevant and essier to complete over a pened of days or sigmficantly reduce the radiation measure. The Commission believes that months. The waste disoosal exposure to the fingers and hads of an either limit provides an adequate requirements of I 30.301. directed
30628 Federal Register / Vol. 50. No.144 / Friday. July 26. 1985 / P oposed Ru!cs primanty at longer half.hved matenal. are not necessary for short half-lived The Commission notes that the FDA is Sabpart E-/mcy:ng ondlocc/izerion considering a change in its regulations ggef,g, yg;g radiopha rmaceutical wa ste. Therefore, for reviewmg the safety of g,, gf short half-hved waste can be exempted investigational new drugs and new uses radwpharmccauncc!s. genemtars, and from the requirements of 120.301. A recient Ansforimc.ging ondlecci.zation of approved drugs (see 4a FR 26720. decay penod of ten half.hves was stuales, published June 9.1983). The Commission chosen because it represents a Xenon.133 as a ;as or as saline thnusand. fold reduction in radioactivity, rnay revise its regulations regarding This ensures that. in most cases, insestigational new drugs and new uses solutwn has been added to this group. byproduct matenal will have decayed to of approved drugs after reviewing FDA's Manufacturers are currently distnbuting the product under a license issued final rulemaking. levels below those in 13071. which are pursuant to Part 30. If this revision is quant: ties that. under certain ordinary The FDA also authonzes the Radioactive Drug Research Cornmittee adopted by the Commission. these conditions are exempt from a
**" "' * "" ' Y #*
requirement for a specific hcense. The (RDRC) at an institution to review and regulatiort would only allow decay-in- appr ve the use of radioactive materials license amendment to distnbute xenon pursuant to i 32J2. storiae for radioactive material with a f r medical use research purposes. He half. life of 65 days or less because Commission believes that the guidelines Through continuing medical research. storage for the required ten half lives used by the FDA when reviewing the new uses may be found for existmg credentials of the RDRC members, and approved radiopharmaceutica!s. These would be in excess of 650 days and more appropna tely considered the guidelines that the FDA requires the new uses. which may require a different permanent storage. (Consistent with dosage, toute of administration, or RDRC to use when evaluating research current practice the Commission will proposals, are adequate to assure the physical form may not appear on the consider on a case-by. case basis, safety of workers and the public without manufacturer's label or package insert requests to decay longer. lived material unduly restncting medical research. instructions. It was such a situation that or to decay for fewer half. lives.) Waste Therefore, the Commission wdl continue resulted in a petition fi!ed by Dr. George V. Taplin (Docket No. pRM-35-1) must be monitored to assure that long. to allow, on a case.by-case basis, requesting an exemption for Tc-Mm lived waste was not accidentally mixed licensees to administer pentetste as an aerosol for lung funct;on with short. lived waste and that no radiopharmaceuticals authonzed by an studies. A proposed rule was pubhshed waste has been added to the container RDRC in accordance with FDA on Apnl13,1982 (47 FR 15798).The since it was sealed. When the waste is regulations. This authorization was not comment period on this proposed rule monitored. neither the waste nor the included in the regulation because only expired June 14.1982 and 35 comments survey instrument may have any a few licensees request it. were received. The NRC adopted the radiation shielding because it might hide The radiopharmaceuticals listed in rule in final form without change on the presence oflong. lived byproduct February 4.1983 (48 FR 5217): the material in the waste. The requirement 135.100 were taken from those listed in the current il 35.31 and 35.100(a). Those preamble of the final rule also descnbed to remove or obliterate radiation labels how to apply for future exemption listed in i 35.200 were taken from is in i 20203(f](4) and is included hem requats. e RC u mcowadng t.Ms for completeness. Generator columns current i135.100 (b) and (c). Mercury-203 was not included in the proposed regulari n int this revision of Part 35 must be individually monitored because w thout soliciting public comment they contained larger amounts of revision because the Commission behe n that thue am oth" because of the recentness of the radioactivity and also may have small rulemaking and because there are no amounts of long.iived contaminants. radiopharmaceuucals available that provide equivalent diagnostic substantive changes to the rule as Subpart D-Uptab. Dilution, and adopted. information with much less radiation D cretw a dose to the patient. Section 35:04 l'ermissable Section 351m Use of M nufacturers are currentiy molybdenum.99 concentration. radiopharmaceuticals'for uptake. distnbuting generally licensed Technetium-99m is produced when ddution andexcretion studies and radiopharmaceuticals under a license molybdenum.99 undergoes radioactive f J5200 Use of radwphormaceutica/s. Issued pursuant to 132.70. If this decay. When the technetium is generotors, and reagent hits for imaging revision is adopted by the Commission. separated from the molybdenum, and localizatmn studies (J J52M is also these manufacturers would have to unwanted molybdenum may appear as a discussedlater/. apply for a license amendment to contaminant in the technetium solution. distnbute radiopharmaceuticals The permissible concentration of Drugs approved for human use by the pursuant to 132.72. FDA have a label or package insert that molybdenum.99 was chosen to be specifies the FDA approved use. consistent with the permissible Section J5100 Possession ofsurvey physical form. toute of administration. instrument. concentration listed in the United States pharmacopeia (USP). the nationwide and dosage range. NRC relies primanly A low level survey instrument is standard for all pharmaceuticals used in on FDA s determmation of a radioactive the practice of medicine. It is the drug's safety and effectiveness when it , needed to check areas of use for is used accordmg to the package insert. contamination. Since the total amount of judrnent of the Commission that the By restncting the physician to the FDA- radioactivity used for uptake, dilution. USP standard provides an adequate approved physical form. route of and excretion studies is relatively small. administration. and dosage range. NRC ,the Commission does not believe the
# "' '"I ' "
i ' assures the safety of the public while !i censee needs an ionization survey unproductive. Since diagnostic dosages of technetium.99m are generally 30 altowmg th e physician lieubility instrument to measure dose rates. rNarding the choice of the clinical milheuries or less. the maximum procedure, permissible level of molybdenum.99 in such a dosage would result in a patient l l
Fed:ral Rnist:r / Vol. 30. No.144 / Friday. July 26, 1985 / Proposed Rules 30609 receivmg an undesired 4.5 microcunes the current il 35.100 (d) and (e). The their release to unrestricted areas may of moh bdenum-99. The mol)bdenum drugs have been approved for rnedical result in potentially lethal radiation would be taken up pnma tly by the use by the FDA. exposure to members of the public.The liver. The dose to the liver would be Commission has made a judgment that about 0.2 rads as a result of the Section J5310 Sa/ety instmetion. and molybdenum concentration. The f 3&410Safetyinstruction. temporary confinement of the implant In the hospital setting, the use of patient is necessary to ensure public Commission has made a judgment that. safety. Secton 35.404 requires that the by holding the permissible concentration byproduct mater:al p-eyen's special to the required level, the resulting traming probiems whien are not licensee prevent the patient frem leaving radiation dose is insigmficant compared addressed in Part 19 because they are the hospital or clinic until all temporary unique to the medical environment. For impiant sources have been removed. to the radiation dose which would be received by the patient due to the example, visitor controlin a hospital the records required by this section administration of the technetium. cannot be accomplished by physical may be amalgamated with the records The licensee that elutes the generator barners which might impede the required by I 35.406; there is no need for must measure and keep a record of the delivery of emergency medical care to duplication. molybdenum concentration. Persons patients. After admimstration, the byproduct materialis contamed in an Section J5406 Bmchytherapy sources who receive prepared im enery. radiopharmaceuticals do not have to ambulatory human. make this measurement because the Therefore. the Commission has made Because of the particular hazard of person who prepared it would have a judgment that worker instruction in brachytherapy sources due to their high made the measurement (see the addition to tha,t required by Part 19 is activity and small size, the Commission conforming amendment to i 30.34). necessary. (This parallels special believes that an inventory procedure instruction required. for example, for that requires a physical count and a Section 35J05 Contro/of aemsols and radiographers and radiographers' radiation survey log entry each time gases. assistants pursuant to i 34.31 of the sources are handled with help to ensure The Commission believes that a. Commission s regulations.) that if a source is misplaced its absence system that provides for the collection SectionJ5J15 Safetyprecautions. will quickly become apparent to the or controlled dispersal of aerosols and licensee, which can then promotly begin gases is needed to reduce exposure t Decause of the special contamination hazards of radiopharmaceutical therapy a search for the source. workers and the public. If controlis by dispersalin the atmosphere, licensees patients, a private r m with pnvate Section 33415 Safetyprecautions. sanitary facilities is needed to protect should note il 20.105 and 20.106 which Decause of the high exposure rates limit the amount of radioactivity in the members of the public, who might be
- visiting nearby patients, from around implant patients, a pnvate room ryke sol d and ti9uid b unnecessary exposure to radiation. The is needed to protect members of the
.YProduct RSO must be notified in case of the public. who might be visiting nearby materials authorized by this part, gases us a y e o be c nta patient's death or medical emergency in patients, from unnecessary exposure to
,, } rder to determine whether special radiation. The RSO must be notified in da case of the patient's death or medical exposure to workers and the public after $entamination me control procedures must a spill. exhaust and dispersalin the emegency to ensue sat contrd of atmosphere is commonly used. Section 33J20 Possession ofsurvey implant sources is retained.
Ifowever. because conventional room instruments. Section 33420 Possession ofsurvey ventilation rates are seldom sufficient to The licensee needs a low level survey instrument. clear spilled gas in a timely fashion, the instrument to check for contammation licensee must follow special, room
- and an tonization type instrument to The licensee needs a high level survey specific safety measures in case of a gas measure dose rates in areas where large instrument to measure exposure rates m spill. When making the required exhaust amounts of radioactive material are storage areas around a patient's room.
calculation, the licensee must assume stored. and to check to be sure all sources have that the largest single gas container been removed from the pattent before handied in the area is completely Subpart C-Sources for Bmchythercpy release from confinement. spilled. and may use either ambient or Section J34m Use ofsources for emergency air exhuust rates. bicchythempy. Supp ,,, g_gg,y,g Sou,c,, fo, g,,,,,,,, Section J3:20 Possession of survey This section identifies brachytherapy instruments. sources that may be used for medical SectionJ35m Useofsealedsources use. The list was taken from the current for diagnosis The licensee needs a low level survey instrument to check for contamination ! 35.100(e). which is a list of sources This is a new type of use group and an ionization type instrument to e mm nly used for patient care, established to incorporate the recent measure dose rates in areas where large Section 35404 Release o/ patients development of medical devices that use amounts of radioactive matenal are treated with tempomry implants. a sealed source of byproduct matenal to stored. A responsibility of the Commission is create a beam ofionizing radiation. Subpart F-Radiopharmaceuticals for to restrict the movement of byproduct These devices are now ava.lable to Thempy material when the public exposure pusons license to use materials iste would be increased. Brachytherapy in j 35.100(fl. Because the devices Section J3J00 Use of sources for temporary implants have represent a lower level of hazard than radiopharmaceuticals for thempy. high levels of radiation, and remain the other sources in that group, the The radiopharmaceuticals listed in radioactive for a long pened of time. Commission has determmed that these 133.300 were taken from those listed in Loss of control of these sources and devices should compnse a new group.
30630 Fed:ral Raister / Vol. 50. No.144 / Friday, July 26, 1985 / Proposed Rules Section 355:0 A vadability ofsurvey be notifled in an emergency The instrument. Section 35621 Rcdiction momtoring Commission believes this is also an device. The licensee needs a survey apprcpriate place to remind workers instrument to measure the exposure The radiaticn monitonng device is that it is important to ensure that only rates around a packaged sealed source the patient is it: the rooct before turning needed to indicate radiation levels in the teletherapy room if the interlocks or that was lust received or that is to be the umt on. The remmder is necessary returned to the manufacturer, and to the warning systems fail. Individuals because it is possible that when two survey for contamination in case of an may be unnecessanly exposed fo!!owing workers are stationed on one the failure of the source retraction accident that might have compromised teletherapy umt one worker may the intergnty of the sealed source. rnechanism coupled with a failure of the inadvertently turn the unit on when the pnmary beam condition indicator However, because a source exchange is other worker is sullin the treatment an infrequent and scheduled event, and system. Therefore. 1 35.621 requires room. or a worker may turn the unit on licensees to install a permanent because a hazardous accident would be to check its operation after a patient or a very rare occurrence, the Commission radiation monitor in each teletherapy believes that it is sufficient, for safety co-worker has entered the treatment room. to check its operation before using purposes. to require the licensee to room without telling the worker at the the teletherapy unit, and to use portable make arrangements to borrow or rent an control console. survey instrument or personal audible instrument ur contract with a The specialinstruction for teletherapy alarm dosimeter if the monitor is measurement service when workers is needed because this is the inoperable. Similar requirements were measurements are necessary, one type of medical use of byproduct published as a proposed rule on April materialin which a worker or member 23,1982 (47 FR 18131), and were adopted Subport I-Teletherapy I a of the public could receive a high, whole ygha le published January 18,1983 body dose in a matter of minutes if the Section 33600 Use of a sealedsource m a teletherapy umt. source were not used safely. Section 356:2 Viewing system. This is a new type of use group Sectica 35615 Doors, interlocks, and If a patient moved during a therapy established to deal with a well- warning systems. administration, this could result in a established type of use. Safety measures radiation dose to healthy tissue and no that now apply to alllicensees within NCRP Report No. 57, .' Instrumentation dose to the treatment area. Therefere, a this group have been used over the and Monitanng Methods for Radiation viewmg system is needed to monitor the years and are reilected in these Protection." on page 41 states that a orientadon of the patient and the proposed regulations. survey of a new teletherapy facility teletherapy umt to assure the presenbed must determine that . . " All entrances application of radiation. Section 33605 Maintenance andrepair into the irradiation room or other high rest.ictions. andj35645 Five-year e on 33633 Donmdry &pment inspection (f 35645 /s also discussed radiation areas are provided with later). barriers equipped with interlocks that Dosimetry equipment is needed to are not dependent on the operation of a measure radiation output. In order to These sections provide notice that single circuit, and that wfIlinterrupt help assure accuracy the equipment only specially licensed persons may radiation production when the barrier la must be calibrated. The equipment maintain. adjust, or repair teletherapy opened." There have been incidents Irt requirements are the same as the umts because this type of work requires irradiauon facilities in which personnel current il 35. and 35.03. This section special training and equipment in order to be done safely. This work is licensed were unnecessanly exposed to radiation a s c ntains b poposd usoMon of because door interlocks or alarms were
- E# " * . '*"
under Part 30 of the Commission's . Association of Physicists in Medicine. ngu ton intentionally bypassed for convenience. See, for example, cases 19,21. and 28 in petition Docket No. pRM 35-2 (see 47 FR Section 356M Amendments. 4311. january 29,1982). Currently. NUREC/BR-0001. " Case Histories of Radiography Events." vol 1.1980. If the regulations require that primary Amendments are required for items dosimetry equipment be calibrated identified in paragraphs (a) through (e] interlocks and warning systems had not every two years. The petitioner because any change desenbed in these been bypassed, personnel would not requested ' hat this two year requirement paragraphs could easily result in an have been irradiated. The Commission. be relaxed to four years if, two years merease in radiation levels in excess of however has made a judgment that the after calibration. the primary dosimetry the levels authorized in ! .:0.10$. The dual warning system of a doorinterlock system is intercompared with a system service of a qualiGed teletherapy and a radiation monitorin the that was calibrated within the past two calibration expert is an essential teletherapy room obviates the need for years, and the results of the clement in ensurmt the safe use of a the dual circuit door interlock intercomparison indicate that the teletherapy unit. The Commission has recommended in the report. rrade a judgment that only an individudl calibration factor used to convert an The beam condition Indicator light instrument reading to a dose with special training and expenence can willindscate to workers about to enter measurement had not changed by more determme the operating characteristics than two percent. ((ntercomparison the room whether the unit is turned on of the licensee's teletherapy umt and or off, meetings are ocessionally scheduled by should therefore be idenufied on the several qualified teletherapy calibration license. . Section 336:0 Possession ol survey esperts wsthin a geographic area. Each inst: iment. expert takes a dosimetry system of Section 33610 Sofetyinstructions. The licensee needs a survey simdor metrological quality to the Emergency instructions must be posted to remind individuals of the instrument on hand as a backup room rneeting. Each dosimetry system in turn monitonng device in case the radiation is exposed to the same radiation dose proper steps to be taken in case of an from a teletherapy unit. The response of emergency and to identify individuals to monit nng device fails. each dosimetry system can then be
Fedtr:1 R:gister / Vol. 50. No.144 / Friday, July 26. 1985 / Proposed Rules 30631 compared to the response of the other due to source radioactive decay. To source leakage radiation levels for systems. If each system measures the ensure accurate dose delivery. the same radiation dose in rads, this several years as license ccnditions. regula' ion requires that licensees They are consistent with guidance from provides assurance that each system is mathematically take this mto account in working properly. Note that when the NCRP in its Report No. 33. " Medical calculating patient doses. The regulation X-ray and Gamma. ray Protection for instruments of different metrological requires that the licensee use time quality are exposed to the same Energ:es up to 10 MeV. Equipment penods of not lonser than one month Design and Use." Section 4.2.2. The rediation dose,it is referred to as a when makmg decay calculations. This cornparison rather than an Commission has made a judgment that intercomparison.) This suggestion has will ensure that the actual dose does not they are sufficiently restnctive to keep differ from the calculated dose by more expowres as low as reasonably been incorpo ated into these proposed regulations. The petitioner also asked than one percent due to this decay error. achievable.The required location of the that the licensee be required to make Section 3563J Periodic spot-checks. collimators during the head leakage quarterly constancy checks to assure the andf JI642 Safety checks for survey is a new specification. it is based consistency of operation of the telethercpy/ccihtie,~ on the fact that, for individuals who dosimetry system. The Commission did A monthly spot-check is required by receive most of their radiation dose from not incorporate this sus:gestion because working around a source in the "off" i 35.22 of the current regulations to. position, the collimators will normally it is not aware of any scientific study that shows that such checks, when made the ensure that the expected teletherapy radiation dose. unit Theis givinS be at the settmg used for the la st with currently available equipment, are following changes from current treatment. capable of detecting small but requirements have been made. Timer Section J564J Afodification cf significant changes in calibration. accuracy has been clarified to include teletherapy unit orroom before Therefore, the Commission has no basis on-off error. The accuracy of beginning a treatment program. to assume that periodic constancy localization devices has been added. checks would necessarily previde Error m either may result in incorrect The section is needed to require that increased assurance of proper operation. administration of radiation. The licensees take prompt action to reduce exposure rates in uncontrolled areas Section JS6J2 fu// cchbretion qualified teletherapy calibration expert
*"' ' " that may be caused by errors in design measurements. '
heck m a 'ents i ibffe days. r c nstruction of the teletherapy ~ Full calibrations are needed to ensure and must notify the licensee in wnting fac@p that the given dose is the same as the of the results of the monthly check, to Section JiN4 Reports of te/etherapy prescnbed dose. The required frequency assure the licensee and the Commission surveys. checAs, tests and of full calibrations remains unchanged that the check results were reviewed by measurements. from that of the current Part 35. The test a qualified individual. The Commission for timer accuracy has been clarified to has made a judgment that a response Given the pntential for high exposure include on off error. The accuracy of penod ofless than fifteen days would be to workers and the public from localization devices that are used to unreasonably expensive. improperly installed teletherapy units. position the teletherapy patient has A requirement to check certain safety the radiation survey information been added to minimize the nsk of systems in the teletherapy facility has required by I 35.644 is needed to assure unintentional irradiating healthy tissue. been added.These checks are needed to that teletherapy umts have been The function of mechanical and assure that safety systems required by properly installed and are saffic:ently electricat interlocks that are used to other sections of the regulations are shielded to ensure cornpliance with the limit the directions in which the beam working properly. They need not be exposure hmits of Part 20. can be aimed. and thereby reduce the pertormed by the qualified teletherapy exposure rate in uncontrolled areas. has Sechon J5645 five. year inspection. calibration expert. Devices that are not also been added. The licensee need no working must be promptly repaired in Many licensees replace teletherapy longer perform all measurements with a order to assure safety in the teletherapy sources at fis e year intervals. Requinng calibrated dosimetry system. Instead, facility. In case of failure of the viewing a mechanical check at five year the calibrated dosimetry system need system. the regulation would allow the intervals helps to assure that the source only be used for one representative physician to decide whether treatments exposure mechanism is in good working measurement. and then a relative should be interrupted. This would not order and wi!! not stick in the exposed exposure rate measurement system can relieve the licensee from the position. The mechanic who exchanges be used to complete the calibration. This requirement to promptly repair the sources and inspects units can remove would allow for use of computer- viewing system. The regulation would the source. Inspect the drawer o controlled dosimetry systems that are require that the teletherapy unit not be mechanism, and then install the new capable of making precise relative used in case of door interlock failure source. More frequent checks would measurements but are not suitable for because that is the mechanism that require greater time near a very making absolute output measurements. protects workers and the public from radioactive source. I.ess frequent checks The Commission proposes to allow unintentional irradiation. However, the would not be sufficient to assure the licensees to use either the currently Commission invites comment as to continuous proper operation of the required calibration procedure or a new whether additional administrative exposure mechanism. The identification procedure that was recently published. procedures or personal supervision information in the record is needed to The new procedure is generally would provide an acceptable balance of establish which unit was inspected, considered more scientifically rigorous. worker safety and medical use needs. when and by whom.The remammg but the Commission believes that either information is needed so the procedure rovides an adequate Section 35641 Radiation surveys for Commission may determine that the measure ofteletherapy dose rate. teletherapyfacdities. Inspection was of sufficient depth to The exposure rate from a radioactive The Commission has used these assure the health and safety of workers ! source goes down as time progresses maximum and average permissible and the public.
I 30632 Fed:ral Regist:r / Vol. 50. No.144 / Friday. July 26, 1985 / Propcsed Rules Subportl-Training and Experience Requirements Sections 35900(bh 33910(b). 319:0(b). nuclear medicine training programs for 35930(b). 33940f b), 35941(b). 33950(b). physicians. These three boards A combination of theoretical and 31960(bA and35961/b) Training and independently arrived at the conclusion expertence. practical trairung and experience is that, while currently seceptable. a three necessary to assure the safe use of ne criteria identified in these month training program may not a!!aw byproduct material ne criteria in this sections were developed by the staff sufficient time in the future to provide subpart were developed by the staff with the assistance of the AChtUI over the training and experience needed to with the advice of the Advisory the past several years. ne Commission develop a sansfactory level of expertise I Committee on the hiedical Use of has made a judgment that for each type m nuc! ear medicine, including radiation isotopes (AChlUI). The requirements for f use, the trainmg and experience safety. All three boards and the ACChfE the Radiation Safety Officer have not desenbed is necessary to ensure the have therefore extended their training been published before. The safe use of byproduct material.The programs to six months duratiori for requirements for authonzed users are duration of training and experience is those who begin their trairung atter June similar to those published as an usually specified in classroom (not credit) hours. Training may be received 30.1984. The Ccmcussion has made a amendment to Appendix A of judgment that, in the meantime, Regulatory Guide 10.8. 'Cuide for the as part of a formal program at an individuals who have successfully Preparation of Applications for Afed' cal accredited university, at a proprietary completed an approved three month Programs, in the Federal Register on school, from an equipment or radiopharmaceutical manufacturer, or training program have received December 2.1982 (47 FR $4376). The elsewhere. NRC will carefully review sufficient training and experience to use requirements for the qualified byproduct material safely. this information before listing an teletherapy calibration expert are similar to those required of a qualified individual on a license. Supervised work Section 31973 Recentness of TraininS. experience must be received at an expert pursuant to the current i 35.24. Radiation safety regulations and Institution under an authorized user Consistent with current practice. if preceptor because usually only such an practices may be expected to char ge individuals do not meet the training and individualis qualified to teach the with time. The Commission has made a expenence standards, the NRC will clinicaluse of byproduct material and. Judgment that traming received within review their credentials with regard to if the experience were not received at the five years preceding submittal of an the matenals requested and these an institution, the student would be less spplication is sufficiently up-to-date to standards and make authonzations on a likely to receive experience with all the assm the safe use of byproduct case-by-case basis. methods of use commonly used or all mater'al if an individual received The Commission has received and is the management problems associated training more than five years before the reviewing suggested altenative training with the safe handling of byproduct application and has not had continuing material involvement in the field, training must standards for some methods of use. The review is being handled as a separate ' be repeated, Sections 33910(c)and359:0(c) prolect. If any changes in training lategratedprograms. Subpart K-Enforcement standarda come out of that project they will be published for public comment The Accreditation Council for Section 35990 Violations. and incorporated into this subpart or Craduate hfedical Education (ACCH 1E) reviews and approves training programs n.s section gins nouce 4 the elsewhere, as appropnate, forphysicians. Approvalof these Commission willirutiate legal Sections 35900(al. 3391C(a). 33920(a), * "A P '* *'*** i* b* **0*
- P* ** '
33930(a). 3394Dfa),33941(a). 3393C(a).
* "*'* *****N****
- re u te ts. .
35960(a), and33361(a), concermng Commtssson has made a ludgment that
,,4 individuals who have successfullY Section 35999 Resolution of completed an approved trammg program conflicting requirements during The Commission has made a judgment have received sufficient traming and transition penod. .
that in some cases certification by an expenence to use byproduct matenal As discussed before to allow for an 4 appropriate professional board provides safely. orderly transition frorn licenses granted proof of adequate training and under the present regulations to licenses expertence because the enteria which Sections 35901and359m Current Radiation Safety Officen and granted under the new regulations. If must be met to attain certi!! cation are AutAonred users. thm is a cond1ct between the final rule more stringent than the training and and a licensee,s radiation safety esperience required by the Commission. The staff has reviewed and found program as desenbed in the statements. acceptable the training and expenence , Section 35000(c/ Authonzed user as a representations and procedures of each individual who is currently Radiation Safety Officer. listed as a Radiation Safety Officer or submitted in support of the license
' I the request, and if the license was issued The training and expertence required cre before the effecuve date of the f nal rule by the Conurussion includes safety ao es v .
unnecessary, and has not been renewed. the considerauona for the byproduct requirements and authorizations of the matenal that the au;horized user may Section JIJ71 Physician tmining licensee's red!ation safaty program will use. Therefore, authorized users are et -tton. take precedence over the final rule. qualified to oversee the safe use of However, if the licensee exercises its In addition to the ACChtE. the byproduct matenal that they are Amencan Doard of Radiology, the right to make a reaiation safety ptcgram t authorized to use pursuant to the Amencan Board of Osteopathic change as authorized under i 35.38, the conditions of the license. Radiology, and the Amencan Board of changed procedure must be in accord Nuclear hiedicine review and approve with the revised regulacort.
I4deral Rigistir / Vol. 50. No.144 / Friday, July 28, 1985 / Proposed Rules 30633 Conformmg Amendment me. secn. e, %,,
; us, sec,,on u,,,,,, i %
Section 31.11 Generallicense for use sa,enea ,,,, i,,,,,,,,,, of byproduct matenalforcertain in as ===mm aemawwee 3, , , o ,, ,,ec_ _ n4vs see,eme .e - :ao ,oeamnase e vitro clinical or laboratory testing. 3s " *"A" woorwa *= ==t ==* ao to e "*" a=~**"m"'*
- AccormJe 0 r.aeed. 8N*"&
Many medical use licensees now use "j Dg',*, CA 7, ' *,,,,, s,mo.m-se i s.,c. = 3 byproduct material for in vitro work
- e. "'r"*
under the provisions of current {l 31.11 " 33 " " * " * " * * ' * * " * a** "w "#"*"""
".ay'ic,,e * * "
and 35.14(c). The proposed conforming h*" ****"' # ~ 3s sao 4 , e .m, . =n amendment grandfathers them. In the " 3' " * * " " * " " * " " - 'a""'"** """"' future, new and renewal applicants will
"" * "** ""*""** S** - * * * ' "
- e.- e ""e".e,s.'".'. 3,",', ,
have to specifically request pernussion "*'"*
.a m.m i,.t to use 131.11 materials as a separate " h7aann c " **" P '*"'
.e om W 3s a:s u-- are - u m emmam line item on their applications. The use 3s 3s 42.
37,,,,,,,,,, ,,,, of materials listed in 131.11 within the n 3a seen,. coa ta.ww w ac io s n eic see,,wien u- e-a .w inventory limits of that section will only be subject to the requirements of that 3 ., % , 3'iaL as eis coo,s. ,wacia, ena a"=as =-* u 's."are section: consistent with current $#"' ae.,e.e,,,e"*"" " #""'* *"" o regulations, the use of materf als listed in 3s so *one==a. == coere. ao to e emnas c2 n att a.saoa ao==e as 2s as Fa tusan. I 31.11 will not be subject to the ==eanw = wa 3g, " E ss3i u',,',,w,,,_ requirements of Parts 19,20, *1, and 35 ("8 *** w am m. ,,,,,,,, e as si canna ww w=a e ao toa Aceerie of a m oo , nee, .m no um. am es except for the Mock fodine 125 disposal. ***""*"* n s3 ' woe.','e,,,e,e , ,,,e ,,'"o sonne
,,,e,,""e,,,=** e as loss or theft, and notification clause of ormn'mm aoenn. nW Pomos aw<mecu e} um muuW we tenee n is we Fa us4o.
131.11(f)- sawew t isen conmaa 3s se a w e . x imoi,mse 3 648 a=enca =~m
- um mre DeriYOtiE T3bl8 *'" "a*ss*a*em" eros *w""po*ssee. 3s*****
3s 59 r 351meytid). 3s.1aC) *'c"hecas s42 sa'ery for toe >trerne conre mrt i.oa w ea sou,a. -='=--s The fo!!owing denvation table n eo s,rm,e e, es. c ,i 3s 643 wm. er m.e ww identifies the origin of each section of Enwerwe w w, ww a nient eewusen. Acre te, tt's 'eng a toerniere progreat the proposed regulations. Sources of the 3s si vi. er-- iseoeceaa .o 35 844 amoans ce enes-no, trease - esaa. proposed regulations include 10 CFR ** * * * * *** **I
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o,e ia im
- _- - i Parts 19. 30, and 35. Federal Register 3s s2 s mne mee. - m.en a ses F.m., ewenon _ J u=r=e cer-t Notices (FR). frequently used license 35 53 v'* =w === ca.
simo. 3 t.re,, conditions, licensing staff policy, current regulatory guides (RC). Office of "e'on e.e.,e ,.7seen pome = D" ' E'8"" a**a"*'* 3s m a-e-.a sne onic. _ w.=n m tot 3s sot r.~, = . cos c. Inspection and Enforcement bulletins, 3s.is ,n,n,a.sem m a, see.*e - - - . asomma s.,e on . the United States Pharmacopeia, and 5
- new text prepared by staff.
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"*"*3""** == enmee eeweo, es,4weoon emert 08- us pow ==cooms ownede. Me= o'et "uses vu 3s3asm m e as,,ac4,,n
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,,,3m,,reme
,,g sdoen F__ ,_ _- _ . _ ^ $347t ose. 2. i.en.
o,,e,,,,og is.o ,,, ,,, g, e.e ser therer, sueeert u.(nsorceaune son noen as soo vee or .. 36 'oo M and M 2s eso wimwa me *n nosomoa seen, okerm fanii uses on areness scae 6s rieres, ._ _ ==ient 38 seg noenaamn of ermaicoq om sesed schste Jo 49) veteest 38 3'O I4*'W '48RE*3" 4 'I N *88 98"e"$F'fe 8859 Wenemoa w,eeng sureruse user ~,, a14 6'"ao oede it pnd feew
% tone,6,samner
,,,,e is, 3s as sa 39s sesen crecaueone posessessi es n,w ,aoem ioa esos t user ' ecerse enneem 83#"*'"E n 14 AeoncaeDa ior occase. 3&4 eevises Sm:not o.4,e,ese or ens,waeni. ar ===
e,ecr.,,,,e,, Administrative Statements
)$ i' u=====a-'=*=*<="e=* a 400 ves e emme = ere. n ioo m ee we 3 '*****c* "*"=.,wm ' l *so** se. e,,,,, so, finding of No Siemficant Enmenmental n'se u = %. e'm e n,eod
- e. as.ew e.,e w
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- In' pact:Avodabdity 3s a somene woons. no. ssoa**e as'.S* nroe swoo, em,= ( ao a ee osee a The Commission is proposing io e so it e ,. i completely revise the regulanons
30634 Fed .r:1 Raist2r / Vol. 50. No.144 / Friday. July 28, 1985 / Proposed Rules governing the medical use of byproduct in accordance with section 005(b) of the impact should notify the Commission cf material. The Commission has Regulatory Flexibility Act of1980, the determmed under the National this in a comment that indicates: Commission certifies that this proposed (1) The licensee's size in terms of Envirenmental Policy Act of 1969, as rule, if promulgated, will not have a amended, and the Commission's annual incorre or revenue, number of sigmficant economic impact on a employees and if the licensee is a regulations in Subpart A of 10 CFR Part st.bstantial number of small entities. The treatment center, the number of beds 51, that promu!aation of this regulation NRC has issued approximately 2500 is not a major Federal action and patients treated annually: medical licenses under 10 CFR Part 35. (2) How the proposed regulation sigmficantly affecting the quality of the Of these, approximately 2000 are held would result in a significant economic' human environment and therefore an by Institutions. and approximately 300 environmental impact statement is not burden on the licensee as compared to by individual physicians. Most cf the that on a larger licensee: required. The radiation levels and release of byproduct material authorized institutional licensees are commumty (3) How the proposed regulations hospitals. The Small Business by this proposed revision are consistent could be mod: fled to take mto account Ad ninistration size standards.13 CFR the licensee's diffenng needs or with the Commission's other regulations Part 121. (49 FR 5037; February 9.19M)capabihties; and internationally accepted standards. Most radiation experts agree that levels classify a hospital or physician's office (4) The benefits that would be gained as a smaU entity if its average gross or the detriments that would be avoided and releases that are within these annual receipts do not exceed S3.5 regulations and standards will not have to the licensee if the proposed a significant effect on the quality of the million. Under these size standards. regulations were modified as suggested some NRC medicallicensees could be by the Commenter: and human environment. The assessment considered "small entities" for purposes analyzes the possible impact of release (5) How the regulation. as modified, of radioactive patients, the of the Regulatory Flexibility Act. would still adequately protect public transportation of byproduct material for The number of medicallicensees that health and safety, medical use, storage, and control of would fah into the small entity category does not constitute a substanttal number tht of Subjects aerosols and gases, waste disposal by decay.in-storage, and dose rates outside for purposes of the Regulatory to CFR Part JO teletherapy rooms. The environmental Flexibility Act. Byproduct material Covernment assessment and finding of no sigmficant The primary objective of the proposed contracts. Intergovemmental relations, impact on which this deterina' ion is rule is to simplify the medicallicensin3 Isoptes. Nuclear matenals. Penalty. based are available for pubhc :nspection process by consolidating requirements Radiation Protection. Reporting and at the NRC Public Document Fcom.1717 without lessening the protection recordkeeping requirements. 11 Street NW, Washingtan. D.:. Single necessary for public health and safety. copies of the evironme stal assessment This will be accomplished through 10 CFR Part31 and finding of no significant impact are incorporation of frequently used license Byproduct material. Labeling. Nuclear available from Afr.McElroy(See 'For conditions into the regulations and the materials. Packaging and contair.e*s. further information contact: heading). elimination or modification of Penalty, Radiation protection. Reporting requirements that are not' essential to Paperwork Reduction Act Statement and recordkeeping requirements. the protection of public health and Scientific equipment. This proposed rule amends '*I*'Y N " * *'*R' "'U * *k' U ***I Information ccdection requirements that f r a licensee t determine what is 10 CFR Part J: are subject to the Papemark Reduction required to obtain a license and what is Dyproduct materials. Labeling. Act of 1980 d4 U.S.C. 3501 et seg 1. This requ red oflicensees.Therefore there Nuclear materials Penalty. Radiation rule has b9en submitted to the Office of should not be a sigmficant economic protection. Reporting and recordkeeping Manageraent and Dudget for review and impact on thue smau entiun. nqdnments. approvr.1 of the paperwork The Commission has pre ared a . nqsrtants. preliminary regulatory anafysis fcr this 20 CFR Part JJ proposed regulation which contains Byproduct material Drugs. lfealth Regulatory Analysis information concerning the anticipated devices. Health professions. Tae Commission has prepared a draft economic effect of this regulation on Incorporation by reference. Medical rcrulatory analysis on this proposed licensees and presents the basis for the devices. Nuclear materials, regulation. The analysis examines the Commisslorfs belief that the proposed Occupationst safety and health. Penalty, casts and benefits of the alternatives regulation would not result in significant Radiation protection. Reporting and considered by the Commission. The additional costs to any licensees. It is recordkeeping requirements. draft analysis is available for inspection available for public inspection in the la CFR Part 40 in the NRC Public Document Room.1717 NRC Public Document Room at 1717 H H Street NW Washington, DC Single Street NW Washington. DC. Sing!e Covernment contracts. Hazardous Copies of the analysis may be obtained copies are available from Mr. McElroy ma terials-trans porta tion. Nuclear from Mr McElroy (see "For further (see "For further information contact:" materials. Penalty. Rep orting and information contact:" heading). heading). recordkeeping requirements. Source The Commission requests public Decause of the widely differing material tramum. comment on the draft regulatory conditions under which licensee, Under the authenty of the Atomic enalysis. Comments on the draft covered by this proposed regulation Energy Act of 1954. as amended. the analysis may be submitted as indicated operate, the Commission specifically Energy Reorgaruzation Act of 1974. as in the ADDRESSES heading. seeks public comment from small arnended, and 5 U.S C. 353 the NRC is Regulatory Flexibility Certification entities. Any small ennty subiect to this proposing to adopt the following regulatlon which determines that. revision of to CFR Part 35 and the Based on the information available at because of its size. it is likely to bear a fo!!owing amendments to 10 CFR Parts this stage of the rulemaking proceeding, disproportionate adverse economic 30,31,32, and 40.
Federal Registir / Vol. 50. No.144 / Friday, July 26. 1985 / Proposed Rules 30633 1.10 CG Part 35 is revised to read as Subpart F-Radiopharmaceuticals for Authority: Secs. 61.161,181163. Sa Stat. follows: Therapy 935.948,951 954. as amended (42 U.S C. 0111. 35.300 Use of radiopharmaceunca s fcr 001. =31 33): sec. 001. 68 Stat.1:42. as PART 35-MEDICAL tJSE OF therapy. BYPRODUCT MATERIAL amended (42 U.S C. 5all. 35.310 Safety instruction. For the purposes of sec. 03. 68 Stat. 958 as S'C- 35.315 Safe'y precaunons. amended (42 U.S.C. =73): (I 35 2. 35.17. 35.30 35.320 Possession of survey mstruments. (a) and (b). 3131 (a) and (b). 3132. 3133. Subpart A--GeneralInformatson Subpart G-Sources for Brachytherapy 33.34f al. 3136(a). 3138. 35 49. 3150 (a Hd). 311 Purpose and scope. 35.51 (a)-{d). 35.51(a) and (b). 35 59 (a Hc). 312 Ucense required. 35.400 Use of sources for brachytherapy. (e)(11. (g) and (h). 3160. 35.61. 3162. 35.63. 35.404 Release of patients treated wnh 35 8 Information collaction requirements: implants' * * *
- OMB approval.
35.15 Definitions. 31406 temBraoraEytherapy sources mventory ab 3m% m. 35m M and N. 35.410 Safety mstruction. 35m4 (a) and (b) 35205. 35.00,31310(a). 3116 Application for IIcense, amendment. 31415 Safety precauhone. 35.315. 35.300. 31400. 35 404(a). 31406 (a) and or renewal. (c). 31410(a). 35.415. 31420,31500. 35.500, 35.420 Possession of survey instrument. 3117 Ucense amendments. 31605. 35.606. 31610 (a) and (b). 31611 35.16 Nonfications. Subpart H-Sealed Sources for Diagnoels 35.6 0. 31621 (aHd). 35.621 (f) and (g),35.s=. 35.08 Ucense lasuance. 31500 Use of sealed sources for dis gnosis. 3109 Speci$c exemptions. 35.630 (a) and (b). 31632 (aHil. 31633 (aHi). 35.520 Avadabi!ity of survey instrument. 35 641 (a) and (b). 31642 (a) and (b). 31rA3 (a) Subpart B-General Administrative Subpart HTedetherapy Rguimmeh { 59 31600 Use of a sealed source in a 31961. 35.970, and 35.971 are issued under 3130 ALARA program, teletherapy unit. 35 31 Radianon Safety Officer. 31605 hiaintenance and repair restrictions- sec.161b. 68 Stat. N8 as amended (42 U.S.C. 3132 Radiation Safety Commuttee. 35.606 Amendments. 2001(b)): and !! 3516,35.30(c). 3131(b). 3133 RequiremenI for authonty and 35 810 Salery matrucuan. 35.32(b). 35.33(b). 35 34 (a) and (c). 3135(b). statement of responsibihties. 35615 Doors. interlocks, and warmng 35 36(b),3137 (a Hd). 35 50(el. 3151[e),
~
3153(c). 35.59 (d) and (e)(2),35.53 (g) and [it 35 f le nuclear c e servica 316 ossession of survey instrument. 5 80 35 9 35 31@). administrative requirements. 35 621 Radiation monitonng device. - 3136 Radianon safety program changes. 35.622 Viewing system. 35.410(b). 31415(b). 31610(c). 316:1(e). 3137 Recerds and reports of 35.630 Dosimetry equipment. 35 630(c). 35 63:lg1. 35 633fj). 35 641(c1. misadmmistrations. 31632 Full cal.bration measurements. 3164:(c). 35.643(c). 316+4 and 31645(c) are 3138 Supervision. 35.633 Penodic spot-checks. issued under sec.181o. Sa Stat. 950 as 3149 Suppliers. 31641 Radiation surveys for teletherapy amended (42 U.S.C. 2001(o}}. Subpart C-Cenerse Technecal facilities. Requemmeta 35.642 Safety checka for teletherapy Subpart A-GeneralInformation facilities. 3150 Possession. use, eahbration. and check 31643 Modification of teletherapy uma or ! 35.1 Purpose and acope, of dose cahbrators, room before begmning a treatment 3151 Calibration and check of survey program. ' This part presenbes requirements and instruments. provisions for the mer cal use of 31644 Reports of teletherapy surveys, 35.53 Measurement of radiopharmaceutical checks, tests. and meesurements. byproduct material and for issuance of dosages. 35 645 Five. year inspecnon. spectfic licenses authorting the medical 3158 Authonzation for cahbrauon and use of this material.These requirements reference sources. Subpart J-Training and Emperience and provisions provide for the 35.59 Requirements for possession of sealed Rgulmmets protection of the public health and sources and brachytherapy sources. 31000 Radiation Safety Office. safety.The requirements and provisions 3160 Syrmge shields. 31901 Training for expenenced Radaation of this part are in addition to, and not in 35.61 Vial shields. Safety Officer. 35 62 Syrmge labels. substitution for, others in this chapter. 31710 Training for uptake di!udon, and 35 63 Vial shield labels, excretion studies. The requirements and provisions of 3170 Surveys for contamination and 35.900 Training for imaging and localization Parts 19,20. 21,30 71. and 170 of this ambient radiation exposure rate. studies. daw apply M s'pplic. ants and 3175 Release of patients containing 35930 Training for therapeutic use of licensees subject to this part unless radiopharmaceuticals or permanent radiopharmaceuticals. specifically exempted. impiants. 35 040 Trairung for therapeutic use of 3180 bloble nucleet medicine service brachytherapy sources. I m Uoenee muked. techmcal requirements. 35 N1 Trauung for ophthalmic use of (a) No person shall manufacture. 35 90 Storage of volanlea and gases. strontium 00. 3192 Decay-to-etorage. 35.950 Trauung for use of sealed sourtes for produce, acquire, receive, possess, use. or transfer byproduct materf al for Subpert Mptaae, DeWon, and Escreon 35. raiIng for teletherapy, medical use except in accordance with a 31100 Use of radiophartnaceuticals for 35.961 Traimns for quahtled teletherapy specific license issued by the uptake, dilution. and excretion studies. cahbration expert. Commission or an Agreement State and 311:0 Possession of survey instrument. 31970 Training for experienced authonzed as allowed in paragraph (b) of this Suspart Nmeging and moon 3yg;g"Pbysician training in a three month 35.200 Use of radiopharmaceuticals. prograrn. ) individual may receive. generators, and reagent kats for itnaging 31972 Recentness of training. possess use, or transfer bproduct and to:altsation studies. matertalin accordance with the Subpart K-Enforcement regulations in this chapter under the 35 04 Permissible mol)odenum.99 concentration. 35 9'o Violations. supervision of an authorized user as 35.005 Control of aerosols and gsees. 31999 Resolution of conflicting provided in 133.38. unless prohibited by 312:0 Possession of survey instruments. requirements durtng transmon penod. License condition.
30636 Fedtral Registir / Vol. 50. No.144 / Friday. July 26, 1985 / Proposed Rules 6 35.s infomation conection (3) A radiopharmaceutical or requirements: Cue approvat. instructions in Regulatory Guide 10.8 radiation by a route of administration Revision 2 "Cuide for the Preparat:en of (a) The Commission has submitted the other than that intended by the Applicatio;is for 5fedical ProgramsJ' A information collection requirements prescnbing physician; contained in this part to the Office of request for a license amendment or (4) A diagnostic dosage of a h!anagement and Budget (ONfB) for renewal may be submitted as an onginal radiopharmaceutical differing from the and one copy in letter format. approval as required by the Paperwork presenbed dosage by more than 50 Reduction Act of 1980 (44 U.S.C. 3501 et percent: (c) An application for a license for seq.). ONfB has approved'the (5) A therapeutic dosage of a medical use of byproduct material as information collection requirements in radiopharmaceutical diffenng from the described in 135 600 of this part must be this part under control number 3150- presenbed dosage by more than 10 made by filing an orig:nal and one copy percent: or of Form NRC-313. For guidance in (b) The approved information completing the form refer to the (6) A therapeutic radiation dose from collection requirements contamed in this a sealed source such that errors in the instructions contained in Regulatory part appear in 11 35.16.35.17,35.18. source calibration, time of exposure, and Guide 10. " Guide for the Preparation 33.30(c). 33.31[b). 35.32(a). 35.33(b). treatment geometry result in a of Applications for Teletherapy
- 35.34(c). 35.35(b). 35.36. 35.37(al-{d). Programs /* A request for a license calculated total treatment dose differing 1 3150(e). 35.51(el. 35.53(c). 35.59 (d) (e), from the final prescribed total treatment amendment or renewal may be (g). and (1). 35.62. 35.63. 35.70(g). 35.80(f). dose by more than 10 percent. submitted as an original and one copy in 35.92(b). 35.2tM(c). 35.310. 35.315. letter format.
"N!obile nuclear medicine service" 25.404(b). 35.406. 35.410(b) 35.606,35.6t0. means the transportation and medical (d) An apph. cant sha!! mail the 1
35.621(e). 35.630(c) 35.632(g) 35.633 (e), use of byproduct material. , completed request as directed below. and (j). 35.641(ca. 35.642(c). 35.613(c). " Output" means the exposure rate. (1)If the applicant is a Federal agency 35.644, and 35.645(c). dose rate, or a quantity related in a in Region ! or is located in Connecticut. + 5 35.15 Definitions. known manner to these rates from a the District of Columbia. Delaware. teletherapy umt for a specified set of Nfaine. Nfassachusetts, New Jersey,
" Agreement State" means any State exposure conditions.
- 4. Pennsylvania, or Vermont, it shall mail with which the Commission or the " Physician" means a medical doctor Atomic Energy Commission has entered or deliver the completed application l into an effective agreement under or doctor of osteopathy licensed by.a form to U.S. Nuclear Regulatory State or Terntory of the United States. Commission. Region L htaterial subsection 274b of the Atomic Energy Act of 1954, as amended. the District of Columbia. or the Ucensing. 631 Park Avenue. King of Commonwealth of Puerto Rico to Prussia. Pennsylvania 19406.
"ALARA" means as low as prescnbe drugs in the practice of reasonsbly achievable. (2)If the applicant is a Federal agency medicine. In Region 11 or is located in Virginia.
- " Area of use" means a portion of a
).hysical structure that has been set " Podiatrist" means an Individual West Virginia. Puerto Rico, or the Virgin licensed by a State or Territory of the Islands, it shall mail or deliver the aside for the purpose of receiving, using. United States, the District of Columbia, completed application form to U.S.
4 or storing byproduct material. 1
" Authorized use** means a physician, or the Commonwealth of Puerto Rico to Nuclear Regulatory Commission. Region 2 dentist. or podf atrist who is identified as practice podiatry on humans. 11. Staterial Licensing Section.101
" Qualified teletherapy calibration Afarietta Street. Suite 300. Atlanta, an authorized user on a Commission or expert" means the individual identified Agreement State license that authorizes Georgia 30323.
the medical use of byproduct material. as the qualified teletherapy calibration expert on a Commission license. (3) If the applicant is a Federal agency
" Dentist" means an individual in Region III cr is located in Illinois.
" Radiation Safety Officer" rneans the licensed by a State or Terntory of the Indiana. Iowa. htichigan. Minnesota.
United States the Distnct of Columbia. individualidentified as the Radiation Missouri. Ohio, or Wisconsin it shall Safety Officer on a Commission license. or the Commonwealth of Puerto Rico to " Sealed source
- means any byproductapplication mail or deliver practice dentistry on humans. form tothe cornpleted U.S. Nuclear
" Management" means the chief material that is encased in a capsule Regulatory Commission. Region !!!.
executive officer. designed to prevent leakage or escape of hlaterial Licensing Section. 999 the byproduct material.
" Medical lnstitution" means an " Visiting authortzed user" means an Roosevelt Road. Glen Ellyn. Illinois organization in which several medical 60137 disciplines are practiced. authorized user who is not ident: fled on the license of the host. (4)If the applicant is a Federal agency
" Medical use* means the intenational in Region IV or is located in Oklahoma.
intemal or external administration of I 35.1e 4spicadon for Heenee, Montana. South Dakota or Wyoming. It byproduct material. or the radiation amenoment, oe renewat. shall mail or deliver the completed therefrom. to human beings in the (a) For use sited in a medical application form to U.S. Nuclear practice of medicine in accordance with Institution. only the institution's , Regulatory Commission. Region IV, a !! cense issued by a State or Territory management may apply. For use not Matertal L! censing Section. 611 Ryan of the United States, the Distrtet of sited in a medicalinstitution, any person P!aza Drive. Suite 1000. Arlington. Texas Columbia. or the Commonwealth of may apply. ,6011. Pusrto Rico. (b) An app!! cation for a license for (5)If the applicant is a Federal agency "Misadmmistration" means the medical use of byproduct material as in Region V or is located m Alaska, admmistration of: descnbed in 11 35.100.35.200.35.300, Hawaii. or Guam, it shall mail or deliver (1) A radiopharmaceutical or 35.800, and 35.500 of this part rnust be the completed application form to U.S. radiation from a sealed source other made by filing an ongmal and one copy Nuclear Regulatory Comm:ssion. Region than the one intended of Form NRC-J13. " Application for
- 12) A radiopharmaceuticalor V. Matettal Licensmg Screon.1450 Materials License." For guidance m Maria Lane Suite 210. Walnut Creek.
radiation to the wrong patient: completing the form refer to the Califorma 94596 , 4
I Fed:ral Regist:r / Vol. 50. No.144 / Friday. July' 26,1985 / Proposed Rules 3063~ (e)If the applicant is loca ed in a { 35.23 Specific exemptions. { 35.31 Raolation Safety Officer. State, territory, or possession that is not The Commission may, upon (a) A licensee shall appoint a mentioned in paragraphs (d) (1) through application of any interested person or Radiation Safety Officer responsib!e for (5) of this section,it shalb upon its cwn initiative, grant such implementing the radiation safety (1) h1 ail the completed application exemptions from the regulations in this program. The licensee, through the form to the Director. Office of Nuclear part as it determines ara attherized by Radiation Safety Officer. shall ensure hfaterial Safety and Safeguards. U.S. law and will not endanger hfe or that radiation safety activities are be:ng Nuclear Regulatory Commission. property or tne common defense and performed in accordance with approved Washington. DC 20555. or secunty and are othewise in the public procedures and regulatory requirements (2) Deliver the completed application interest. In the daily operation of the licensee's form to the Commission offices at: byproduct material program. (1) 1717 H Street NW., Washington. Subpart B-General Administrative (b) The Radiation Safety Officer shall: DC or Requirements (1) Investigate overexposures. (ii) 7915 Eastern Avenue. Silver {35.30 ALARA program. accidents. spills. losses, thefts. Spring. hfaryland. unauthorized receipts, uses. transfers. (a) Each medical institution licensee and disposals, and other deviations from { 35.17 Ucense amendments. shallimplement a program to maintain approved radiation safety practice and A licensee shall apply for and must receive a license amendment: ul ale ta lo as res bly implement rre tive a tions as e essary: (a) Before it uses byproduct material
- hi bl (b To satisfy the requirement of for a method or type of medical use not paragraph a of this section.-
f permitted by the license issued under ( ) Authoriting the purchase of g.s part., (1) hianagement, the Radiation Safety byproduct material: Officer, and all authorized users must (b) Before it permits anyor s. except a (ii) Receivmg and opening packages of participate in the establishment, byproduct material-visiting authorized user desc ribed in i 35.34, to work as an authcazed user implementation, and operation of the (iii) Storing byproduct material: under the license,- program as required by the regulations (iv) Keeping an inventory record of or requested by the Radiation Safety byproduct material: (c) Before it changes Radiation Safety Committee. Officers or Qualified Teletherapy (v) Using byproduct material safely: (2) The program must include an (vi) Taking emergency action if Calibration Experts; annual review by the Radiation Safety control of byproduct material is lost: (d) Before it receives byproduct Committee of the types and amounts of materialin excess of the amount (vi ) Performing periodic radiation byproduct material used, occupational surveys: authorized on the license: and dose reports or summaries. and (e) Before it adds to or changes the (v i ) Performing checks of survey continuing education and training for all instruments and other safety equipment: location orlocations of use or mailing personnel who work with o~r in the address identified on the license. (ix) Disposing of byproduct material:
- vicinity of byproduct material. The (x) Training personnel who work in or purp se f the review is to ensure that
{35.18 Notifkations. frequent areas where byproduct individuals make every reasonable A licensee shall notify the materialis used or stored: effort to maintain individual and (xi) Keeping a copy of all records and Commission by letter within thirty days collective occupational dose as low as when an authorized user. Radiation reports required by the Commission reasonably achievable. taking into regulations, a copy of these regulatiens. Safety Officer, or Qualified Teletherapy account the state of technology, and the Calibration Expert. permanently a copy of each licensing request and cost ofimprovements in relation to license and amendments, and the discontinues performance of duties benefits. under the license. it shall mail the report written policy and procedures required (c) A licensee shall retain a written by the regulations. to the apprcpriate address identified in description of the ALARA program for ( 35.16. (3) For medical use not at a medical the duration of the license. The written institution, approve or disapprove { 33.28 Ucense issuance. description must include: radiation safety program changes with (1) A commitment by management to the advice and consent of management: The Commission shallissue a license keep individual and collective for the medical use of byproduct and occupational dose as low as reasonably material for a term of five years if: (4) For medical use at a medical achievable: institution, assist the Radiation Safety (a) The applicant has filed Form NRC- (2) A requirement that the Radiation 313 ** Application for hiaterials 1.icense" Comrmttee in the performance ofits Safety Officer brief management once duties. In accordance with the instructions in each year on the byproduct material l 35.16: program: { 35.32 Radiation Safety Committee. (b) The applicant has paid any (3) Personnel exposure investigational Each medical institution licensee shall applicable fee as provided in Part 170 of levels that, when exceeded. will mitiate establish a Radiation Safety Committee this chapter: an investigation by the Radiation Safety to oversee the use of byproduct (c) The Commission finds the Officer of the cause of the exposure: and material. Stanagement may establish applicant equipped and committed to (4) Personnel exposure investigational more than one committee to meet thesa observe the safety standards levels that. when exceeded willinitiate responsibilities. established by the Commission for the a prompt investigation by the Radiation (a) Each Committee must meet the protection of the public hea.th and Safety Officer of the cause of the following admimstrative requirements: safety; and exposure and a consideration of actions (1) Afembership must consist of at (d) The applicant meets the that might be taken to reduce the least three individuals and must include requirements of Part 30 of this chapter. probability or recurrence. an authonzed user of each type of use
306':6 Fed:r:1 R gistir / Vol. 50. No.144 / Friday July 26, 1985 / Proposed Rules permitted by the license, the Radiation (8) Establish a table of invesugarmnal Safety Officer. a representative of the (b) Mobde nuclear medicme service levels for occupational dose that when nursing service, and a representative of licensees shall retain for the duratien cf exceeded. will mittate investigations servtce a letter signed by the management who is neither an and considerations of action by the management of each location where authonzed user nor a Radianon Safety Radiatica Safety Officer. Officer. Other members may be included semces are rendered that authonzes as the licensee deems appropnate. 1 35.33 Regulmment for aumorny and use of byproduct mate al. (2) The Committee must meet a least **""'""**'***- I 35.36 Radiation safety program quarterly. . (a) A licensee shall provide the enanges. (3) To establish a quorum and to Radiation Safety Officer. and at a conduct business.one-half of the (a) Alicensee may change the medicalinstitution the Radiation Safety radiation safety pro'cedures and Committee's membership must be Committee. sufficient authority and present. including the Radiation Safety organizational freedom to: equipment that are used to meet Officer and the management's regulatory requirements and that were (1) Identify radiation safety problems: representarive. (2) Initiate, recommend, or provide descnbed irrihe application for license. (4) The mmutes of each Radiation soluticas: and renewal. or amendment. The licensee Safety Committee meeting must include: (3) Venfy implementation of sehrtions. may also receive. use, and store licensed (i) The date of the meeting: (b) A licensee shall establish in matenal (except teletherapy sources) in (n) Members present: writing the authonties, duties. areas of use that were not identfied in (iii) Members absent: the application for license, renewal or responsibilities, and radiation safet) liv) Summary of deliberations and activities of the Radiation Safety ""dm" discussions: Officer, and at a medical institution the (b) A licensee shall retain for the (v) Recommended actions and the Radiation Safety Committee. duration of the license a record of each numerical results of all ballots: and change. The record must include the (vi) ALARA program reviews j 35.34 wing authertzed user, effective date of the change. a copy of descr: bed in i 35.30(b}(21 (a) A licensee may permit any visiting the and and new radiation safety
- 15) The Ccmmittee must provide each authonzad user to use licensed matenal procedures. equipment descriptions, or trember with a copy of the meeting for medical use under the terms of the ares floor plans, the reason for the rnmutes and re.ain one copy for the licensee's license for sixty days each change. a summary of radiation safety datation of the license. year if: matters that were considered before Ib) To oversee the use oflicensed (1) The visiting authorized user has making the change, the signature of the material, the Committee must: the prior written permission of the Radiation Safety Officer, and the (tl Be responsible for monitoring the licensee's management and,if the use signatures of the affected authonzed institutional program to maintam occurs on behalf of an institution. the users and of mana;;ement or. in a individual and collective doses as low institution's Radiation Safety medical institution. the Radiation Safety as reasonably achievable: Committee: . Committee's chairman and the (2) Review. en the basis of safety and (2)The licensee has a copy of a management representative.
with regard to the training and Commission or Agreement State license experience standards in Subpart J of this that identifies the visiting authorized part. and approve or disapprove any user by name as an authorized user for ((m[7rstYon individual who is to be listed as an medical use: and (a) When a m:,sadmmistration authonzed user, the Radiation Safety (3) Only those procedures for which involves any therapy procedure. the Officer. or Qualified Teletterapy the visiting authorized user is licensee shall notify by telephone the Cahbration Expert before submitting a specifically authonzed by a Commission appropnate NRC Regional Office !!sted license application or request for or Agreement State license are in Appendix D of Part 20 cf this chapter. amendment or renewah performed by that individual. The licenses shall also notdy the (3) Review on the basis of safety and (b) A licensee need not apply for a refuring physician of the affected approve or disapprove each proposed license arnendment in order to permit a patient and the patient or a responsible methed of use of byproduct matenah visiting authorized user to use licensed relative (or guardian), unless the (41 Review on the basis of safety, and material as descnbed in paragraph (a) of refemng physician agrees to inform the approve with the advice and consent of this section. patient or be!! eves, based on medical the Radiation Safety Officer and the (c) A !!censee shall retain copies of judgment. that te!1ing the patient or the management representative, or the records specified in this section for pattent's responsible relative (or disapprove procedures and radsation guardian) would be harmful to one or two years after the visiting authorized safety program changes: the other respectively. These (5) Review quarterly, with the user a last t.se of!! censed material unless the visiting authorized user has notifications must be made within 24 assistance of the Radiation Safety hours after the licensee discovers the been !!sted as an authonzed user on the Officer. occupatiorial radiatten esposure licensee's license. misadmmistration. If the referrmg records of all personnel working with physician, patient, or the patient's bs product materiah I 35.35 Woek nuctest medicce servne responsible relative or guardian cannot
'(6) Review quarterly, with the sommistrettve requirementa.
be reached with:n 24 hours. the licensee
- assistance of the Radiation Safety (a) The Commission will only license shall notify them as soon as practicable.
Officer. allincidents involung mobile nuclear medicine serv ce in The licensee is not re'tutred to notify the byproduct matenal with refpect to accordance with Subparts D. E and H of patient or the patient's responsfoie cause and subsequent actions taken; this part and i 31.11 of this chapter to relauve or guardran without first (7) Review annually. with the serve chents who do not have a consulting the refemng ph)sician: ass: stance of the Radiation Safety Commission or Agreement State license however, the licensee shall not deluy Officer. the byproduct material program; for the matenals listed in these medical care for the pat! int because of and Subparts. this.
Federal Register / Vol. 50. No.144 / Friday. July 26, 1985 / Proposed Rules 30639 (b) Within 15 days after an initial (2) Review the supervised individual's therapy misadministration report to (2) Test each dose calibrator for use of byproduct material and the accuracy upon installation and at lent NRC the licensee shall report, in - records kept to reflect this use: writing, to the NRC Regional Office . annually thereafter by assaying at least (3) Require the authonzed user to be two sealed sources contatmng different initially telephoned and to the refernng immediately available by telephone to radionuclides whose activity the physician, and furnish a copy of the the supervised individual; and report to the patient or the patient's manufacturer has determined withm 5 (4) Require the authorized user to be percent ofits stated activity, whose responsible relative (or guardian) if able to be physically present and activity is at least 10 microcunes for either was previously notified by the available to the supervised individual licensee under paragraph (a) of this radium-::S and 50 microcunes for any on one hour's notice. The supervising other photon emitting radionuclide and section. The wntten report must include authorized user need not be present for the licensee's name: the referring at least one of which has a pnncipal each use of byproduct material. photon energy between 100 kev and 300 physician's name; a brief desenption of (b) Require the supervised individual the evant: the effect on the patient: the kev receiving. possessing. using or (3) Test each dose calibrator for action taken to prevent recurrence: transfernng byproduct material under linearity upon installation and at least whether the licensee informed the 135.2;b) to: patient or the patient's responsible quarterly thereafter over the ram;e of its (1) Follow the instructions of the use between the highest dosage that wtil relative (or guardian), and if not, why supervising authorized usen not. The report must not include the be administered and to microcunes: and (2) Follow the procedores established (4) Test each dose cabbrator for patient's name or other information that by the Radiation Safety Officen and could lead to identification of the geometry dependence upon installation patient. (3) Comply with the regulations of this over the range of volumes and volume part and the license conditions with configurations for which it w 11 be used. (c) When a misadministration involves a diagnostic procedure, the respect to the use of byproduct material. The licensee shall keep a record of this licensee shall notify. in wnting. the $ 35,49 Suppflers. test for the duration of the use of the refer:ing phys-: tan and the appropriate dose calibrator, A licensee may use for medical use NRC Regional Office listed in Appendix only: (c) A licensee shall also perform D of Part 20 of this chapter.1.!censee (a) Byproduct material manufactured. appropnate checks and tests required reports of diagnostic misadministrations labeled. packaged, and distributed in by this section followmg adjustment or are due within 10 days after the end of repair of the dose cabbrator, accordance with a license issued the calendar quarters (defined by pursuant to the regulations in Part 30 (d) Alicensee shallmathematical!y March. June. September and December) ' and 132.72. 32.73, or 3234 of this conect dosane readings for any
,in which they occur. These wntten geometry or iineanty error that exceeds chapter or the equivalent regulations of reports must include the licensee s an Agreement State: 10 percent if the dosage is greater than name: the refernng physician s name; a (b) Reagent kits that have been 10 microcuries and shall repair or desenption of the event: the effect on replace the dose calibrator if the manufactured, labeled, packaged, and the patient: and the action taken to accuracy or constancy error exceeds 10 distnbuted in accordance with an prevent recurrence. The report should approval by the Commission pursuant to percent.
not include the patient's name or other i 32.73 or an Agreement State under (e) A licensee shall retain a reccrd of information that could lead to equivalent regulations for the each check and test required by this identification of the patient. preparation of radiopharmaceuticals for section for two years unless directed (d) Each licensee shall retain for ten medical use; and otherwise. The records required in years a record of each paragraphs (b)(1) through (b)(4) of this (c) Teletherapy sources manufactured misadministration. The record must and distnbuted in accordance with a section must include: contain the names of allindhiduals license issued pursuant to Part 30 of this (1) For aragraph (b)(1). the model invoh ed in the event (including the chapter or the equivalent regulations of and senafnumber of the dose cabbra physician. allied health personnel. the an Agreement State. the identity of the radionuclide patient. and the patient,s referring contained in the check source, the date physican), the patient's social security Subpart C-General Technical gftechc t ea t i tr as ed.and number a bnef description of the event, Requirements , the effect on the patient, and the action performed the check:
i 35.50 Possession. vee, calibration, and (2) For aaragraph (bM:1. the model
"[P de'h'o 5e"r?o ffc tion check ot does caHbrators. and seriaInumber of the dose cabbrator, requirement, nothing in this section shall (a) A medical use licensee authorized the model and serial number of each affect any nghts or duties oflicensees to admimster radiopharmaceuticals source used and the identity of the and physici ans in relation to each other, shall have in its possession a dose radionuclide contained in the source patients, or responsible relatives (or cahbrator and use it to measure the and its activity, the date of the test. tre guardians). amount of activity administered to each results of the test. and the sfgnature of patient. the Radiation Safety Officen 1 35.38 Supervision.
(b) A licensee shall: (3) For paragraph (bH3), the model A licensee who permits the receipt. (1) Check each dose calibrator for and sertal number of the dose cahbritar. possession, use or transfer of byproduct constancy with a dedicsted check the calculated activities. the measured matenal by an individual under the source at the beg:nmng of each day of actmties, the date of the test. and the superviston of an authon:ed user as use.To satisfy the requirement of this mnature of the Radiation Safety allowed by I 35 fb) shall: paragraph, the cl eck must be done on a Officen and I (a)(1) Instruct the supervised frequently used setting with a sealed (4) For paragraph (by4). the model l Individualin the princtples of radiation source of not less than 10 microcunes of safety appropriate to that mdividual's and serial number of the dose cabraw. radium 200 or $0 microcunes of any the configuration of the source use of b) product rnaterial, other photon.emiyting radionuclide: measured, the actmty r"casured for
30640 Fed:ral Raister / Vol. 50. No.144 / Friday. July OS.1985 / Proposed Rules each volume measured, the date of the rad.onuchde to venfy that the dasage test. and the sapature of the Radiation (c) To satisfy the leai test does not exceed 10 microcuries: requirements of this section. the licensee Safety Officer. (c) Retain a record of the must: 5 35.51 caubration and check of eurvey measurements required by this section (1) Take a wtpe sar:ple from the mstruments. f r two Sean.To saus!y this aquirement. the record must contain sea!rd source or from the surfaces of the (a) A licensee shall calibrate the th e. device in wh:ch the sealed source is survey instruments used to show mounted or stored on which radioact:ve compiiance with this part before first (1) Generic name. trade name. or contammation might be expected to use. annually, and following repair, abrevianen of the radiopharmaceut2 cal accumulate or wash the source m a (b) To satqfy the requirements of its lot number. and expiration dates and small volume of detergent solution and paragraph (a of this sect:en. the the radionuclide: treat the ennte volume as the sampie-
!censee sha . (2) Patient's name and Ident:fication (2) Take the teletheraphy source test (1) Calibrate all scale readings up to number if one has been assisned: sample when the source is in the "off" (3) Presenbed dosage and activity of l' mtg ns per hout with a the dosage at the time of measurement.
position: and (3) Measure the sample so that the (2) Calibrate o readings on each " I' ' "" "* *E "#' les ha Or o u-ie scale that must be calibrated: and (3) Conspicuously note on the (4) Date and time of the measurement: OM mche chabas"e genal and " ' *b instrument the apparent exposure rate (d) A licensee shall retain leakage test from a dedicated check source as (5) Initials of the individual who made the measurement. records for twr. years. ne records must determined at the time of calibration. contain the model number. and serial and the date of calibration. I 35.54 Authortzation for caubration and numberif assigned.of each source (c) To satisfy the requirements of reference sources. tested. the identity of each source paragraph (b) of this section. the Any person authorized by I 35.2 for radionuclide and its estimsted activity, licensee shall: med! cal use of byproduct material may the measured activity of each test (1) Cansider a point as calibrated if receive, possess, and use the following sample expressed in microcuries, a the indicated exposure rate differs from byproduct matenal for check, description of the method used to ths calculated exposure rate by not calibration, and reference use: measure each test sample. the date of more than 10 percent: and (a) Sealed sources manufactured and the test. and the si2 nature cf the (2) Consider a point as calibrated il distnbuted by a person !! censed Radiation Safety Officer. the indicated exposure rate differs from pursuant to 132.74 of this chapter or (e)If the leakage test reveals the tha calculated exposure rate by not equivalent Agreement State regulations presence of 0.005 microcurie or more of more than 20 pe cent if a correction and that do not exceed 6 millicunes
- chart or graph is conspicuously attached each: remos able contamination. the licensee shalk to the instrument. (b) Any byproduct materiallisted la (1)Immediately withdraw the sealed (d) A licensee shall check each survey iI 53.100 or 33.200 with a half life not source from use and store it in instrument for proper operation with the longer than 100 days in individual accordance with the requirements in dedicated check source before and after amounts not to exceed 15 mdlicuries: Parts 20 and 30 of this chapten and rach use. The licensee is not required to (c) Any byproduct matenallisted in keep records of these checks. (2) File a report within five days of the 1135.100 or 35.200 w.th a half 4fe longer leakage test with the apprepnate (e) The licenee' shall retain a record than 100 days in individual amounts nct of each calibn P.: required in Nuclear Regulatory Commission to exceed 200 microcunes each: and Fegional Office listed in Appendix D of paragraph (a) oW section for two (d) Technetium-99m in individual years.To ..tisfy the requLonents of this amounts not to exceed 50 rni!!icurics. Part 23 of this chapter, with a copy to paragraph. the record rr.ust include: Director of Irspection and Enforcement.
(1) A descriptior. of the calibration U.S. Nuc!est Regulatory Commission. procedure: and h38 , '",'{'jytn ao ' c Washington DC 20555. describing the (2) A descnption of the source used (a) A !!censee in possession of any equipment involved. the test results. and end the certilled exposure rates from the sealed source or brachytherapy source the action taken. source and the rates indicated by the shall follow the radiation safe and (f) A licensee need not perform a instrument being calibrated. the handling instructions supplied the leakage test on the following sources-correction factors deduced from the manufacturer, and shall maintain the (1) Sources containing only byproduct calibration data. and the signature of the instructions for the duration of source . material with a half life of less than 30 individual who performed t'he use in a legibla form convenient to usere. days- . cahbration. (b) A licensee in possession of a (2) Sources containing only byproduct sealed source shalk matenals as a gas: 1 35.53 Measurement of (1) Test the source for leakage before (3) Sources containmg 100 microcuries rsolopnarmaceutical dosages, its first use utiless the licensee has e or less of beta or gammae mitting A licensee shalh certificate from the supplier indicatmg matenal or 10 microcuries or les; of (e) Assay before medical use the alpha-eoutting matenal; that the source was tested within six activity of each radiopharmaceutical months before transfer to the 1;censee: dos:g, that contains more than to (4) Sources stored and not being used. and . The !!censee shail. however, test each microcurtas of a photen. emitting (:l Test the source for leakage at such source for leakage before any use radionuclide: Intervals not to exceed sta months or at (b) Assay before medical use the or transfer unless at has been leakage. otherintervals approved by the tested witnin six months before the date activity of each radicpharmaceutical Commission or an Agreement State and of use or transfen and dosage with a desired ac.tivity of to described in the labql or brochure that microcunes cr less of a photon.emittmg (5) Saeds ulindium-192 encased ia accompanies the source. nylon ribbon.
Federal Register / Vol. 50. No. tu / Friday July 28,1985 / Proposed Rules 30641 (g) A Iicensee in possession of a 1 35.70 Surveys for contamination and (2) the activity in the patient is less sealed source or brachytherapy source amenent raatation exposure rate. than 30 millicunes. shall conduct a quarterly physical (a) A licensee shall survey with a low inventory of all such sources in its (b) A licensee may not authorize range survey meter at the end of each release from confinement for medical posse each m,ssion. The licensee shall retain day of use all areas where care of any patient admmistered a ventory record for five years. The radiopharmaceuticals are routinely permanent implant until the exposure mventory records must centain the prepared for use or administered. model number of each source, and serial rate from the patient is less than 6 (b) A licensee shall survey with a low mil!iroentgens per hout at a distance of number if one has been assigned, the range survey meter at least once each
~
~ one meter.
identity of each source radionuclide and week all are'as where its estimated activity, the location of radiopharmaceuticals or I 35.80 lese nuclear medicine seMee each source, and the signature of the radiopharmaceutical waste is stored. *""**"*9""'**"'** Radiation Safety Officer. A licensee providing mobile nuclear (c) A licensee shall conduct the th) A licensee in possession of a surveys required by paragraphs (a) and medicine service shall: sealed source or brachytherapy source (a) Transport to each location of use (b) of this section so as to be able to shall survey with a low range survey measure exposure rates gs low as C.1 only synnges or vials sontaining meter quarterly all areas where such mill! roentgen per hour. prepared radiopharmaceuticals sources are stored. This does not apply (d) A licensee shall establis;. radiation (b) Bring into each location of use all to teletherapy sources m teletheraphy exposure rate action leve!s for the byproduct matenal to be used and. units or sealed sources in diagnostic surveys required by paragraphs (a) and before leaving, remove all unused devices. byproduct matenal and all associated (b) of this section and shall require that (i) A licensee shall retain a record of the individual performmg the survey waste: each survey required m paragraph (h) of immediately notify the Radiathn Safet, (c) Secure or keep under constant this section for two years. The record Officer if an exposure rate exceeds an must mclude the date of the survey, a surveillance and immediate control all action level. byproduct material when in transit or at plan of each area that was surveyed, the measured exposure rate at several (e) A licensee shall survey for a location of use: pomts in each area expressed in removable contamination once each (d) Check survey instruments and millitem per hour. the model number week all areas where dose calibrators as desenbed in il 35.50 radiopharmaceuticals are routinely and 35.51, and check ai! other and senal number of the survey prepared for use, admmistered. or transported equipment for proper instrument used to makt the survey. and stored. function before medical use at each the signature of the Radiation Safety icer, (f) A licensee'shall conduct the location of use: surveys required by paragraph (e) of this (e) Carry a calibrated survey meter Lt
. I 35.80 Syrtnge sh*ds. section so as to be able to detect each vehicle that is being used to (a) A licensee shall keep syringes that contamination on each wipe sample of transport byproduct matenal. and, contain byproduct material to be 200 dismtegrations per minute. before leaving a client location of use, admmistered in a radiation shield. (S) A licensee shall establish survey all radiopharmaceutical areas of (b) A licensee shall require each removable contamination action levels use with a low range survey meter to individual who prepares a for the surveys required by paragraph ensure that all radiopharmaceuticals radiopharmaceutical kit to use a synnge (e) f this section and shall require that and all associated waste have been radiation shield and shall require each the individual performing the survey removed; individual who administers a immediately notify the Radiation Safety (f) Retain a record of each survey radiopharmaceutical by injection to use Officer if contammation exceeds the required in paragraph (e) of this section a synnge radiation shield unless the use action level. for two years. The record must include of the shield is contraindicated for that (h) A licensee shall retain a record of the date of the survey, a plan of each injection. each survey for two yeart The record area that was surveyed, the measured must include the date of the survey, a exposure rate at several points in each I 3$.81 Vial shields, area of use expressed in millitem per pl:.n of each area surveyed, the action A licensee shall require each sevel established for each area, the hour, the model number of the individual prepanng or handling a vial messured exposure rate at several instrument used to make the survey, and that contains a radiopharmaceutical to points in each area expressed in the initials of the individual who keep the vial in a vial radiation shield. millirem per hour or disintegrations per performed the survey.
I 35.62 Syringe latsets.
' j 35.90 storege of votaules and gases.
hs henu to k he s vey or A IIcensee shall conspicuously label analyze the samples. and the initials of A licensee shall store volatile each syringe, or syrtnge radiation shield the individual who performed the radiopharmaceuticals and radioactive that contains a synnge with a survey, gases in a furne hood or in a container radiopharmaceutical. with the with two barners against release. radiopharmaceutical's abbreviation or f 3$.75 huw of panents containing with the type of diagnostic study or '***8"*"naceuucala W Pennanent lM2 heaWWagt Implaat8. therapy procedure to be performed. (a) A licensee may hold byproduct (a) A licensee msy not authorize matertal with a physical half life of less
! 35.63 Viel shleid laeeis. release from confinement for medical than 65 days for decay.m. storage before A 'icensee shall conspicuously label care any patient administered a disposal in ord. nary trash and is exempt each vial radiation shield that contains radiopharmaceutical until either- from the requirements of 120.301 of this a vial of a radiopharmaceutical with the (1) The exposure rate from the patient chapter if it:
radiopharmaceutical name or its is less than 6 milliroentgens per hout at (1) Holds byproduct mate *tal for abbrevianon. a distance of one meter: or decay a mmimum of ten half. lives:
l I 30642 Fedsrtl Rsgister / Vol. 50. No.144 / Friday. July 26. 1985 / Proposed Rules l l (2) hfonitors byproduct matenal at the instructions regarding physical form, pharmaceutical containing b>prodt.ct container surface before disposal as route of administration and dosage ordinary trash and determmes that its matenal for which.the Food and Drug range. Administration has accepted a " Notice radioactivity cannot be distinguished from the background radiation level ! 35.1 0 Possession of surveyinstrument, cf Claimed Invest:gational Exe=t ti ,n with a low range survey meter set on its for a N'ew Dr-g* (IND) or approved a A licensee authonzed to use "New Drun Apphcation"(NDA). most sesitive scale and with no byproduct material for uptake, dilutien-interposed shielding: Ib) A ficensee using the and excretion studies shall have in its radiopharmaceuticals listed in (3) Pemoves or obliterates all possession a portable low level radiation labels: and radiation survey instrument whose most paragraph (a) cf this section for cimical (4) Separates and rnonitors each sensitive scale has a full scale dei!ection procedures other than those specified in generator column mdivideally with all the product label or package insert shall of not more than i mi!!! roentgen per comply with the product label or radiation shieldmg removed to ensure hour. that it has decayed to background package insert regarding physical form. radiation level before disposal. Subpart E-tmaging and Localizat!on route of administration,and dosage (b) For paragraph (a) of this section.
,he licensee shall retain a record of each 1 35.200 use of raciopharmaceuticats. (c') A licensee shall elute generators d:sposal for two years.The record must generators, and reagent kits for Imaging and prepare reagent kits in accordance and tocalization stuoies.
include the date of the disposal, the date with the manufacturer's instructions. on which the byproduct material was (a) A licensee may use the following (d) The fo!!owing radio-radiopharmaceuticals. generators. and pharmaceuticals, when used for the su yins ent sed, e 88 a ca a c al proc &n are not studies.. sublect to the restrictions in paragraph background radiation exposure rate, the (1) Molybdenum-99/ technetium-99m (b) of this section: radiation exposure rate measured at the surface of each waste container, and the generators for the elution or extractica (1) Technetium 99m pentetate as an of technetium-99m as pertechnetate; aerosol for lung function studies, name of the individust who performed the disposal (2) Technetium 99m as pertechne' ate: (3) Prepared radiopharmaceuticals 1 35.204 Permissible moryedenum 99 and reagent kits for the preparation of **"*'""'"*"- Subpart 0-Uptake. Dilution, and Excretfore the followmg technetium 99m labeled (a) A licensee may not administer to radiopharmaceuticals: hurr'ans a radiopharmaceutical 1 35.100 Use of redlopharmaceuticals for (i) Sulfur colloid: contaimng more than 0.15 microcurie of uptake, dilution and escretton studies. (ii) Pentetate sodium; molybdenum-99 per millicurie of (a) A licensee may use the following (iii) Human serum albumm technetium-99m. j prepared radiopharmaceuticals for microspheres: (b) A licensee preparing technetium- ! diagncstic studies involvmg the (iv) Polyphosphate: 99tn radiopharmaceuticals from rnessurement of uptake, dilution. or (5) h!acroaggregated hu; nan serum molybdenum-99/ technetium-99m i excretion: albumin: generators shall measure the (1) Iodine 131 as sodium iodide. (vi) Etidronate sodium: molybdenum 99 concentration in each iodinated human serum albumm (!HSA). (vtil Stannous pyrophosphate: eluate or extract. labeled rose bengal. or sodium (viii) Human serum albumin: (c) A licensee who must measure lodohippurate: (fx) N!edronate sodium: molybdenum concentration shall retain (2) lodine 125 as sodium iodide er (x) C!uceptate sodium: a record of each measurement for two icdinated human serum albumm (!HSA): (si) Oxidronate sodium: years. The record must include, for each (3) Cobalt Sa as labeled (xii) Disofenin: and elution or extraction of technettum-99m. cyanocobalamin: (xtii) Succimer. - the measured actnity of the technetium l (4) Cobalt 60 as labeled (4) lodine 131 as sodium iodide. expressed m rnillicuries, the measured cyanocobalamin: iodinated human serum albumin, activity of the moly bdenum espressed in (5) Chromium 51 as sodium chromate macroaggregated lodinated human microcuries. the ratio of the meast s or labeled human serum albumiru serum albumin. colloidal expressed as microcunes of (6) fron 59 as citrate: (microaggregated) todinated human molybdenum per millicurte of l [7) Technetium-99m as pertechnetate: serum albumin, rose bengal, or sodium technetium. the date of the test, and the (8) Any byproduct materialin a todohippurate: initials of the individual who performed I radiopharmaceutical and for a (5) !adine-123 as sodium iodide or the test. diagnostic use involving measurements fibrinogen: l cf uptake, dilutton, or excretion for (6) Chromium 51 as human serum 1352s centrol of aerosols and gases. I which the Food and Drug albumin: (a) A licensee who administers Administration (FDA) has accepted a (?) Cold.198 in colloidal form: radioactive aerosols or gases shall do so
" Notice of Claimed investigational (8) Ntercury 197 as chlormerodnn: with a system that will keep airborne Esemption for a New Drug"(IND) or (9) Selenium 75 as selenomethionme: concentrations withm the limits approved a "New Drug Application * (10) Strontium 45 as nitrate: presenbed by il 20.103 and ;0.106 of i
(NDA). (11) Ytterbium 169 as pentetate this chapter. lb) A licensee usmg a sodium; (b) The sistem must either be directly l radiopharmaceuticallisted in paragraph (12) Xenon.133 as a gas or saline vented to the atmosphere through an air (a) of this section for a clinical solution; exhaust or provide for co!!ection and procedure other than one specified in (13) Any byproduct matenalin a decay or disposal of the aerosol or gas
, the product label or package insert diagnostic radiopharmaceutical or any in a shielded contamer, mstructions for use shall comply with generator or reagent kit for preparation (c) A licensee shail only admmister the product label or package insert and diagnostic use of a radio. radioactive aerosols and gases in rooms
Fedml Raist:r / Vol. 50. No.144 / Friday. July 26,1985 / Proposed Rules 30643 that are at negative pressure compared instruction must desente the licensee's to surrounding rooms. in its possession a portable low level procedures fon radiation survey instrument whose most (d) Before receiving. using, or stormg a (1) Patient control; radioactive gas. the hcensee shall sensitive scale has a full scale def'ection (2) Visitor control: of not more than 1 milliroentgen per calculate the amount of time needed (31 Contamination control; hour and a portable ion chamber after a spill to reduce the concentration (41 Waste control: and radiation survey instrument that has a in the area of use to the occupational [5] Notification of the Radiation limit listed in Appendix B to Part 20 of scale with a full scale dedection of 1 Safety Officer in case of the patient's Roentgen per hour. this chapter. The calculation must be death or medical emergency. based on the highest activity of gas (b) A licensee shall keep for two years Subpart G-Sources for handled in a single container and the a list ofindividuals receiving instruction Brachytherapy measured available air exhaust rate. required by paragraph (a) of this section. (e) A licensee shall post the calculated a' description of the instruction. the date *"***'*' time at the area of use and require that, ofinstruction. and the name of the in case of a gas spi!!. Individuals individual who gave the instruction. A licensee shall use the following evacuate the room until the posted time sources in accordance with the has elapsed' i s.3u safety precauttons. manufacturer's radiation safety and (f) A licensee shall check the (a) A licensee shall provide each handling instructions: operation of collection and ventilation individual hospitahzed for (a) Cesium-137 as a sealed source in systems each six months. radiopharmaceutical therapy a private neecies and applicator ce!!s for topical. room with a private sanitary facdity, interstitial, and intracavitary treatment i 35.220 possession of survey (b) A licensee shall notify the Instrumenta. of cancer: Radiation Safety Officer immediately if (b) Cobalt-60 as a sealed source in A licensee authonzed to use the patient dies or has a medical needles and applicator cells for topical, byproduct material for imaging and emergency. interstitial, and intracavitary treatment localization studies shall have in its (c) A licensee shall post the patient's of cancen possession a portable low level door with a " Radioactive Matenals** radiation survey instrument whose most sign and note in the patient's chart (c) Cold 198 as a sealed source in sensitive scale has a full-scale deflection wcere and,how long visitors may stay m, seeds for interstitial treatment of cancer: of not more than 1 milliroentgen per the patient s room. (d) Iridium 192 as seeds encased in hour and a portable ion chamber (d) The authonzed user and Radiation nylon nbbon for interstitial treatment of radiation survey instrument that has a Safety Officer must specifically cancer' scale with a full-scale deflection of I authorize visits by mdividuals under age g 3trontium-90 as a sealed source in roentgen per hour. 18 on a case-by-case basis. an applicator for treatment of superficial (e) The licensee shall either monitor eFe conditions: and Subpart F-Radiopharmaceut!cala for material and items removed from the (0 todine-125 as a sealed source m. Therapy patient's room to determine that their seeds for. interstitial treatment of cancer. 3 use of radiopnarmaceuticais fo' radioactivity cannot be distinguished 1 35.404 Re#eese of patients treated with froci the natural background radiation temporary impiants. A !!c nsee may use the followinE (a) inedateh siemmoM Ge prepared radiopharmaceuticals: on ts ost sen ii s and wi o interposed shielding, or handle them as "" (a) Iodine-131 as iodide for treet nent radioactive waste. I'" patienf".deEUcensee
"#I I"Esha""' "uake"m##'
a of hyperthyroidism. cardiac dysfunction. (f) The licensee shall survey the 'd "' P and thyroid carcinoma; con 6a i ur sh e en patient's room and private sanitary (b) Phosphorus-3: as soluble facility for removable contamination removed. The licensee may not release phosphate for treatment of polycythemia before assigning another patient to the fmm confinement for medical can a vera. leukemia, and bone metastases: patient treated by temporary implant room. ne room must not be reassigned (c) Phosphorus-32 as colloidal chromic until removable contamination is less until aH wwces have ben remmi phosphate for intracavitary treatment of than 200 disintegrations per minute per (b) A licensee shall retain a record of malignant effusions: 100 square centimeters. patient surveys for two years. Each (d) Cold 198 as colloid for (g) Within three days after record must include the date of the intracavitary treatment of malignant admmistering a therapeutic dosage of 8"Y' the name of the patient, the effusions: lodine 131. the licensee shall measure exposum rate fmrn the patient (e) Any byproduct materialin a the thyroid burden of each individuaj expressed as millitem per hour and radiopharmaceutical and for a who helped prepare or admmister the measured within one meter of the therapeutic use for which the Food and dosage, and retam fcr the period patient and the initials of the individual Drug Administration has accepted a required by 6 :0.401(c)(1) a record of who made the survey. " Notice of Claimed Investigational each thyroid burden measurement,its Exemption for a New Drug" (IND). or 135.40s Bracnytrwrapy sources inventory. date, the name of the individual whose approved a New Drug Application thyroid burden was measured, and the (a) Each time brachytherapy sources (NDA). initials of the individual who made the are returned to an area of storage from meammmects. an area of use. the licensee shall I 35.3 t0 safety instructen. Immediately count the number returned (a) A licensee shall provide oral and 1 35.320 posseuion of survey to ensure that all sources taken from the wntten radiation safety instruction for instruments. storage area have been returned. all personnel canng for the patient A licensee authorized to use (b) A licensee shall make a record of undergoing radiopharmaceutical byproduct matenal for brachytherapy source use which must therapy. To satisfy this requirement, the radiopharmaceutical therapy shall have include:
30G44 Fed;ral Ruistir / Vol. 50. No.144 / Friday. July 26, 1985 / Proposed Rules (1) The names of the individuals authorize visits by individuals under age i 35.606 Amendments. permitted to handle the sources. 18 cn a case by-case basu. (2) The number and activity of sources A licensee shall apply for and must removed from st 135.420 Possession of survey instrument. receive a license amendment before: of use or patient,or3ge. s name, thethe timeroom and number A licensee authorized to use date they were removed from storage, bvproduct material for implant therapy treatment room shielding: the number and activity of the sources shall have in its possession a portable (bl Making any change in the location in storage after the removal, and the f the teletherapy unit within the ion chamber radiation survev instrument imtials of the individual who removed that has a scale with a full scale treatment room; the sources from storage; deflection of 1 Roentgen per hour. (c) Using the teletherapy umt in a (3) The number and activity of sources returned to storage, the room number of manner that could result m increased Subpart H-Sealed Sources for radiation levels in areas cutside the use or patient's name. the time and date Clagnosis teletherapy treatment room: they were returned to storage. the
- number and activity of sources in , , (d) Relocating the teletherapy unit: cr storage after the return and t;te initials clagnosis. (e) Allowing and individual not listed of the individual who returned the on the licensee's license to perform the A licensee shall use the followin8 duties of the qualified te!etherapy sources to storage, sealed sources in accordance with the (c)!mmediately after implanting calibration expert.
manufacturer's radiation safety and sources m a patient the licensee shall handiing instructions: . I 35.6to safety instruction. make a radiation survey of the patient (a) Iodine-105 as a sealed source in a and the area of use to confirm that no (a) A licensee shall post written device for bone mineral analysis: instructions at the teletherapy unit sources have been misplaced. The (b) Americium-241 as a sealed source censole. To satisfy this requirement. licensee shall make a record of each in a devise for bone truneral analysis: survey, these instructions must inform the and operator of: (d) A licensee shall retain the records required m paragraphs (b) and (c) of this (c) lodine-125 as a sealed source in a (1) ne procedure to be followed to section for two years, portable device for imaging. ensure that only the patient is in the I 35.520 Avanaemy of sumy instmment. treatment room before turning the 1 35.410 Safety instruction. pnmary beam of radiation on to begin a (a) The licensee shall provide or al and A licensee authorized to use treatment or after a door interlock wntten radiation safety instruction to all bypt duct material as a sealed source mterruption: personnel caring for the patient for diagnostic purposes shall have (2) The procedure to be followed if: undergoing implant therapy. To satisfy available for use a portable low level (i) The operator is unable to turn the this requirement. the instruction must radiation survey instrument whose most desenbe: sensitive scale has a full-scale deflection pnmary beam of radiation off with
~
(1) Size and appearance of the of not more than 1 milliroentgen per controls outside the treatment room or brachytherapy sources: hour or a portable ion chamber radiation any other abnormal operation cccurs: and (2) Safe handling and shielding survey instrument that has a scale with instructions in case of a dislodged a full scale deflection of 1 Roentgen per (ii) ne names and telephone numbers source: hour. The instrument must have been of the authonzed users and Radiation (3) Procedares for patient control: Safety Officer to be immediately calibrated in accordance with I 35.51 of (4) Procedures for visitor controh and this part. contacted if the teletherapy umt or ($1 Procedures for notification of the console operates abnormally. Radiation Safety Officer if the patient Scopart I--Teletherapy (b) A licensee shall provide dizs or has a medical emergency- instruction in the topics identified in 1 35.600 tJSe of a seeied source in a paragraph (a) of this section to all (b) A licensee shall retain for two, tetetnerapy unit. years a record ofindividuals receivmg individuals who operate a teletherapy instruction required by paraaraph (a) of The regulations and provisions of this unit. this section, a description of the subpart govern the use of teletherapy (c) A licensee shal; retain for two instruction, the date of instruction, and units for medical use that contain the years a record ofIndividuals receiving
" ' the mdividual who gave the following sources. instruction required by paragraph (b) of isu ion' (a) Cobalt-60 as a seated source: and this section, a description of the i 35.415 Safety precautions, (b) Cesium.137 as a sealed source. instruction. the date of instruction. and the name of the mdividual who gave the (a) The licensee shall provide a 1 as. sos Maintenance and repair instructiort.
private room to each individual
- rutnctions.
hositalized for implant thereapy. Only a person specif!cally licensed by h35,th . (b) The licensee shall notify the the Commission or an Agreement State Radiation Safety Officer immediately if to perform teletherapy unit maintenance (a) A licensee shall control access to the patient dies or has a medical and repair shallinstall, relocate or the teletherapy room by a door at each emergency. remove a teletherapy sesled source or a entrance. (c) A licensee shall post the pat!ent's telether1py unit that contains a sealed (b) A licensee shall equip each door with a "Radioact:ye Materials" source or maintain, adjust, or repair the entrance to the teletherapy room with sign and note in the patient's chart source drawer, the shutter or other an electrical mterlock system that with where and how long visitors may stay in mechanism of a teletherapy unit that (1) Prevent the operator from turning the patient's room. could expose the source. reduce the the primary beam of radiation on unless (d) The authonzed user and Radiation shielding around the source. or result in Safety Off'cer must specificalty each treatment room entrance door is mereased radiation beis. closed:
. . I
{ Fed:ral Rxgistir / Vol. 50. No.144 / Friday, July 20. 1985 / Proposed Rules 30G43 (2) Turn the primary beam of radiation (g) A licensee shall promptly repair or offimmediately when an entrance door (c) The licensee shall retain a record replace the radiation momtor if it is of each cahbration. intercompanson. is opened; and inoperable. and ccmpanson for the duration of the (3) Prevent the primary beam of me. For each cahadon. 1 35.622 viewing system. radiation from b6ng turned on following mtercompanson, or companson. the an interlock interruption until all A licensee shall construct or equip recctd must include the date, the model treatment room entrance doors are each teletherapy room to permit l continu us observation of the patient mimbers and serial numbers of the i closed and the beam on off controlis instruments that were cabbrated. t reset at the console, fr m de teletherapy unit console durin3 irradiation. intercompared. or compared as required (c) A licensee sitall equip each by paragraphs (a) and (b) of this section, entrance to the teletherapy room with a l 35.830 Dosimetry equipment. the correction factors that were beam condition indicater light. deduced. the names of the individua,s l (a) A licensee shall have a calibrated who performed the calibration, j 35.620 Possession of survey instrument. dosimetry system available for use. To satisfy this requirement.one of the intercomparison, or comparison, and - A licensee authorized to use following two conditions must be met. ev>dence that the intercomparison byproduct material in a teletherapy unit (1) The system must have been meeting was sanctioned by a calibratio~ shall have in its possession either a calibrated by the National Dureau of laboratory or radiologic physics center portable low level radiation survey Standards or by a calibration laboratory accredited by AAPht. instrument whose most sensitive scale accredited by the Amencan Association has a full-scale deflecticn of not more of physicists in hiedicine (AAPhil. The f 35.632 Full cafit> ration messarements. than 1 milliroentgen per hour or a calibration must have been performed (a) A licensee authonzed te use a portable ion chamber radiation survey within the previous two years and after teletherapy unit for medical use shall instrument that has a scale with a full any servicing that may have affected perform full calibration measurements scale deflection of 1 Roentgen per hour. system cahbration: or . (2) The system must have been " }' 3 g','{,Y g g t dicaluse of the 1 35.621 Radiation monttonng device. umt: and calibrated within the previous four (a) A licensee shallInstallin each years: eighteen to thirty months after (2) Before medical use under the teletherapy room a permanent radiation that calibration, the system must have foHowing conditions: monitor capable of continuously been intercompared at an (i) Whenever monitoring beam status. intercomparison meeting with another measurements dicate m, spot-check that the output (b) Each radiation momtor must be dosimetry system that was calibrated differs b more tha 5e ent from the ele apy nftr aff ct n t tat esu ts e at ns ea f na ry ab m mahmadcah 6 in an exposed or partially exposed a calibration laboratory accredited by ra osct e ecab source. The visible indicator of high the AAPht. The interccmparison (ii) Fo!!owing replacement of the radiation levels must be observable by meeting must be sanctioned by a source or following reinstallation of the an individual entering the teletherapy calibrauon laboratory or radiologic teletherapy unit in a new location: room' physter center accredited by the AAPht. (iii) Following any repair of the (c) Each radiation monitor must be The results of the intercompanson teletherapy unit that includes removal of equipped with an emergency power meeting must have indicated that the the source cr major repair of the supply separate from the power supply ca!ibration factor of the licensee's components associated with the source to the teletherapy unit. This emergency system had not changed by more than 2 exposure assembly; and power supply may be a battery system. percent. The licensee may not use the [3] At intervals not exceeding one intercompar. son result to change the year. (d) Each radiation monitor must be checked for proper operation each day cabbration factor. When intercomparing (b) To satisfy the requirement of before the teletherapy umt is used for dosimetry systems to be used for paragraph (a) of this section, full treatment of patients. nalibrating cobalt-60 teletherapy units, calibration measurements must include the licensee shall use a teletherapy unit determination of: (e) A licensee shall maintain a record with a cobalt-60 source. When (1) The output within c3 percent for of the check requited by paragraph (d) intercomparing dosimetry systems to be the range of field sizes and for the of this section for two years. The record used for calibrating cesium.137 distance or range of distances used for must include the date of the check. teletherapy units, the licensee shall use medical use: notation that the monitor indicates when a teletherapy umt with a cesium-137 (2) The coincidence of the radiation the source is and is not exposed. and the source. imtials of the individual who performed field and the field indicated by the light the check. (b) The licensee shall have available beam localizmg device: for use a dosimetry system for spot. (3) The uniformity of the radiation (f)If a radiation monitor is inoperable check measurements. To satisfy this field and its dependence on the for any reason. the licensee shan require requirement, the system may be crientation of the useful beam: any individual entering the teletherapy compared with a system that has been (4) Timer accuracy: room to use a survey instrument or calibrated in accordance with paragraph audible alarm personal dosimeter to (5) On off error: and (a) of this section. This comparison must (6) The accuracy of all distance monitor for any malfunction of the have been performed within the measuring and localization devices in source exposure mechanism that may previous year and after each servicing medical use. result in an exposed or partially that may have affected system exposed souret. The instrument or (c) A licensee shall use the dosimetry calibration. The spot-check system may system descnced in i 35.630(a) to dostmeter must be checked for proper be the same system used to meet the measure the output for one set of operation at the begmning of each day requirementin paragraph (a) of this of use. exposure conditions. The remaining section. radiation measurements required m
.__. _ . . - - - -- - - - .~- - - - - - .-_--- - - -_
30fA6 Fed;rd Raister / Vol. 50. No.144 / Friday. July 26, 1985 / Propcsed Rules ' paragraph (b)(1) of this section may then perform spot < hecks en each teletherapy th) A licensee shalllock the contrd be made using dosimetry system that umt once in each calendar month. indicates relative dose rates. console in the off pontion if any door (b) To satisfy the requeement of i (d) A licensee shall make full paragraph (a)of this secuon. mterlock malfunctions. The licensee ! calibration measurements required by may not use the umt until the mterlock I measurements must include sys' tem is repaired. paragraph (a) of this section in determination of: ar.cordance with either the procedures (1) Timer accuracy: (i) A hcensee shall prompt!y repair recommended by the Scientific (2) On.off e re" any sistem identified in paregnpri Ig) of Committee on Radiation Desimetry of (3) The comeidence of the ndiaton th:s section that is not operstmg the Amencan Association of Physic:sts field and the field mdicated by the hght pr periy. In Medicine that are described in beam localizmg device: (j) A licensee sha!! retain a record of Physics in Afedicine and Biology Vol. (4) The accuracy of all distance each spot check required by paragraphs to. No. 3.1971, pp. 379-396 or by Task measunng and locali:ation devices used (a) and (f) of this section for two years. Crcup 21 of the Radiation Therapy for rnedical use: The record must include the date of the Committee of the American Association (5) The output for one typical set of spot-check, the manufacturer s names, of Physicista in hfedicine that are operating conditions: and mocei number. and serial number for desenbed in MedicalFhysics Vol 10, (6) The difference between the both the teletherapy unit and source, the No. 6.1983. pp. 741-771. Both of these measurement made in paragraph (b)(5) manufacturer's name, model number references have been approved for of this section and the anticipated and serial number of the instrument incorporation by reference by the output, expressed as a percentage of the - used to measure the output of the Director of the Federal Register. Copies anticipated output (i.e the value te!etherapy unit, the measured timer of the documents are available for obtained at last full calibration accuracy, the calculated on-off error, a intpect:en or may be obtained from the corrected mathematically for physical U.S. Nuclear Regulatory Commission. determination of the coincidence of the decay). radiation field and the field indicated by Public Document Room.1717 H Street (c) A !icensee shall use the dosimetry the light beam localizmg device, the i NW., Washington. DC 20553. Copies of systern decnbed in 133.630(b) to make measured timer accuracy for a typical the documents are also on file at the the rnessurement required in paragraph Office of the Federal Register.1100 L treatment time. the calculated on.off (b)(5) of this section. error, the estimated accuracy of each Street NW Room 8401. Washington. (d) A licensee shall perform distance mensunng or locahzanon DC. A notice of any. change in the measurements required by paragraph (a) device. the d:fference between the metertal will be published in the Federal of this secuan in accordance with anticipated output and the measured Register. procedures established by the qualified (e) A licensee shall correct output, notations indicating the teletherapy calibration expert. That operability of each entrance door mathematically the outputs determined in paragraph (b)(1) of this section for individual need not actually perform the electncal interlock, each electncal or spot-check measurements, mechanical stop. each beam condition physical decay for intervals not (e) A licensee shall have the qualified exceeding one month. indicator light, the viewmg system and teletherapy calibration expert review doors, and the signature of the (f) Full cahbration measurements the results of each spot-check within 15 required by paragraph (a) of this section individual who performed the periodic days. The qualified teletherapy spot-check. and physical decay entrecnons required calibration expert shall promptly notify by paragraph (e) of this section must be the licensee in wnting of the results of f 35.6at Radtauon surveys for towtherapy perforrced by a quulilled teletherapy each spot-check. The licensee shall keep facmttes, cahbration expert. a copy of each wntten notification for
!g) A licensee sha!! retain a record cf (a) Before medical use, af:et each two years. installation of a teletherapy source, and each cahbration for the duration of the (f) A licensee authorized to use a hcense. The record must include the after making any change fcr which as teletherepy omt for medical use shaf!
date of the calibration, the amendment is required by I 35.606(a)- perform spot-checks of each teletherapy (d). the licensee shall perform radiat:on manufacturer's name, model number. facility once in each calendar month, and senal number for both the surveys to venfy that: (g) To satisfy the requirement of telcherapy unit and the source, the paragraph (f) of this section. checks (1) The maximum and average model numbers and serial numbers of must assure proper operation of- radiation levels at one meter from the tha instruments used to calibrate the teletherapy source with the source in the O) Electricalinterlocks at each off position and the collimators set for a telstherapy unit tables that desenbe the teletherapy room entrance: output of the unit over the range of field (:) Electncal or mechanical stops norreal treatment field do not exceed to siz;s and for the range of distances used installed for the purpose of limiting use mdhroentaens per hour and 2 in radiation therapy, a determination of of the pnmary beam of radiation mdliroentgens per hour, respectively: tha coincidence of the radiation field and (restnction of source housing angulation and the field indicated by the light beam or elevation, carnage or stand travel g g.3 g g g ,,gg locallzmg device, the measured timer and operation of the beam en off on position with the largest clinically accuracy for a typical treatment time, mechanism!: available treatment field and with a the calculated on-off error, the estimated (3) Beam condition indicator lights on scattering pnantom in the pnmary beam accuracy of each distance measunng or the teletherapy unit. on the centrol f radiation. that.- localizanon device, and the signature of console, and in the facility; (i) Radiation quantities in restncted th2 quahfied teletherapy calibration (4) Viewmg systems: areas adjacent to the treatment room opert. (5) Treatment room doors from inside are not like!y to cause personnel
! 35.833 Pertocic spot-checas. and outside the treatment room: and exposur-s m excess of the limits (6) Electncally assisted treatment specified in i 20.101 of this chapter: and
[a) A licensee authonzed to use room doors with the teletherapy unit (ii) Radiat:en quantities in telstherapy units for rnedical use shall electncal power turned off, unrestricted areas adjacent to the
~
e ht.b
Federal R: gist:r / Vol. 50. No.144 / Friday, July 26. 1985 / Proposed Rules 30647 treatment room do not exceed the limits 1 35.643 Modification of teletheracy unit requirement of paragraph (a) of this specified in i 20.105(b) of this chapter. or room before beginning a treatment section that were in effect on Atarch 4. (b)If the results of the survey P'09r8m-1983 remain in effect and are not required in paragraph (a) of this section . If the survey required by 1 35.641 rescinded by this section. indicate any radiation quantity in indicates that an individual in an excess of the respective limit specified unnstncted area may be exposed to Subpart J-Train!ng and Experience in that paragraph the licensee sha!! lock h #" F# *" b" #"" the control m the off position and not m tied 2t b c apte use the umt: [*,'g , n he)r, p g,, i 35.000 Radiation Safety Officer. the licensee shall: Except as provided in i 35.901. the [1) Except as may be necessary to (a) Either equip the unit with stops or licensee shall require an individual repair, replace, or test the teletherapy add additional radiation shielding to fulfilling the responsibilities of the umt shielding or the treatment room ensure compliance with 6 0.105(b): Radiation Safety Officer as provided in shielding or (b) Perform the survey required by 133.32 to: (2) Until the licensee has received a i 33.641 again: and (a) De certified by: specific exemption pursuant to i 20.501 (c) Include in the report required by (1) American Board of Health Physics of this chapter. I 35.644 the results of the initial survey. in Comprehensive Health Physics: (c) A licensee shall retain a record of a description of the modification made (2) American Board of Radiology in the radiation measurements made to c mply with paragraph (a) of this Radiological Physics. Therapeutic following installation of a source for the section, and the results of the second Radiological Physics, or Niedical duration of the license.The record must survey: or Nuclear Physics: or include the date of the measurements. (d) Request and receive a license (3) American Board of Nuclear the reason the survey is required. the amendment under i 20.105(a) of this part hiedicine Science in Nuclear hiedicine manufacturer's name. model number that authorizes radiction levels in Science: or unrestncted areas greater than those and serial number of the teletherapy (b) Have had 200 hours of classroom unit. the source, and the instrument used permitted by 120.105(b). and laboratory training and one year of to measure radiation levels, each dose i 35.644 Reports of teietherapy surveys, experience as follows: . rate measured around the teletherapy checks, testa, and measurements. (1)100 hours of radiation physics and source while in the off position and the A licensee shall mail an ongmal and a ,nstrumentation: averan of all measurements, a plan of copy of the records required in (2) 30 hours of radiation protection: the ar'ase surrounding the treatment il 35.641,35.642. 35.643 and the output (3) 20 hours of mathematics pertaining room that were surveyed, the measured from the teletherapy source expressed to the use and measurement of dose rate at several pomts in each area as Roentgens per hour at a distance of radioactivity; expressed in millirem per hour, the one meter from the source and (4) 20 hours of radiation biology: calculated maximum quantity of determined during the full cahbration (5) 30 hours of radiopharmaceutical radiation over a period of one week for required in i 35.632. to the appropriata chemist.y: and each restricted and unrestncted area. Commission Regional Off:ce listed in (6) One year of full time experience in and the signature of the Radiation . 135.18 of this part within thirty days radiation safety at a medical institution Safety Officer' f Ilowing c mpletion of the action that under the supervision of the individual initiated the record requirement. identified as the Radiation Safety
,935.642
,, Safety checks for teletherapy 1 35.645 F1ve-year inspection. Officer on a Commission or Agreement State license that authcnzes the medical
'al A licensee shall have each use of byproduct material: or ia) A licensee shall promptly check all teletherapy unit fully inspected and systems listed in 135.633(g) for proper serviced dunng teletherapy source (c) Be an authorized user for those function after each mstallation of a byproduct matenal uses that come replacement or at intervals not to teletherapy source and after making any exceed five years, whichever comes within the Radiation Safety Officer's change for which an amendment is responsibilities.
first, to assure proper functioning of the ' required by $ 35.606(aHd). source exposure mechanism. 1 35.901 Training for experienced (b)If the results of the checks required (b) This inspection and servicing may Radiation Safety Officer. in paragraph (a) of this section indicate only be performed by persons An individualidentified as a the malfunction of any system specified specifically licensed to do so by the Radiation Safety Officer en a in 135.633fg) the licensee sha!! lock the Commission or an Agreement State. Commission or Agreement State license control console in the cff position and (c) A licensee sha!! keep a record of the inspection and servicmg for the on [ insert efective dote offinalrulel not use the unit except as may be who oversees only the use of byproduct necessary to repair. replace, or rheck duration of the license. The record must material for which the licensee was the malfunctionmg system. contain the inspector's name the authorized on that date need not comply inspect r's license number the date of with the training requirements of (c) A licensee shall retain for two Years a record of the facility checks inspection, the manufacturer s name and 1 35.900. following installation of a source. The model number and senal number for i both the teletherapy unit and source. a 6 35.910 Trairung for urtake, dilution, and record must include notations indicating list of components inspected. a list of C"'""#'*- the operability of each entrance door components serviced and the type of Except as provided in 1135.970 and interlock each electt: cal or mechanical service, s list of components replaced, 35.971, the licensee shall require the stop each beam condition indicator and the signature of the inspector, authonzed user of a light. the viewing system. and doors, and (d) Amendment to teletherapy radiopharmaceutical listed in i 35.100:a) the signature of the Radiation Safety licenses that extended the time interval to be a ;hysician who: Officer. for the inspection and serv cing (a)Is certified in: _ _ l
{G48 Rdtral Registar / Vol. 50. No. M4 / Friday July S.1985 / Proposed Rules (1) Nuclear medicine by the American (2) Diagnostic radiology with special (iv) Co!!aborating with the authon=ed Board of Nuclear Medic =e: competence in nuclear radiology by the user in the interp. etat:on of rad;msotope
- 12) Diagnostic radiology with special American Board of Radiology: or test results: and cmapetence in nuclear radiology by the (3) Diagnostic radiology or radiology (v) Patient followup or A .t:ncan Board of Radiology: or within the previous five years by the [c} Has successfull/ completed a six-(31 Diagnostic radiology or radiology Amer:can Osteopathic Board of month trammg program in nuclear within the previous five years by the Radiology: or medi;:ne that has been approved by the American Osteopathic Board of (b) Has cernpleted 200 l ours of Accreditation Council for Graduate Rad: ology: or instruction in basic radic sotope 5fedical Educat:an and that included (b)Ifas completed 80 hours of hancling techniques applicsble to the classrcom and laboratcry traimng. work instructicn in basic radioisotope use of prepared radiopharmaceuticals. expenence, and supemsed chnical handling techniques applicable to the generators, and reagent kits. 500 hcurs expenence in all the topics iden:tfied in use of prepared radiopharmaceut2cals, of supervised work expenence and 500 paragraph (b) of this sectien.
an.140 hours of supervised clinical hours of supervised chnical exper:ence. N #" * "'" (1) To satisfy the basic instruction i 35.930 Trainmg for tnerspeutre use of , requirement, the classroom and radiopnarmaceuticals. j (1) To satisfy the basic instruction requirement, the classroom and laboratory training must include: Except as provided in { 35.970 the , l.tboratory instruction must include: (1)100 hours of radiation physi::s and licensee shall require the authonzed
, li) 25 hours of radiation physics and instrumentation: user of a radiopharmaceuticallisted in l (i ) 30 hours of radiation protection: 133.300 for therapy to be a physician mstrumentation:
} (iii) 20 hours of mathematics who:
- (ii) 25 hours of radiation protection
- pertaining to the use and measurement (iiil to hours of mathematics (a) Is certified in nuclear medicine by of radioactivity:
pertaining to the use and measurement the American Board of Nuclear I (iv) 30 hours of radiopharmaceutical h!edicine: or of radioactivity: chemistry: and (iv) 10 hours of radiation biology; and (b)lias completed ao hours of l (v) 20 hours of radiation biology. (v) 10 hours of radiopharmaceutical (2) To satisfy the requirement for instniction in basic rad:oisotope chemistry. handling techniques applicable to the supervised work experience, training use of therapeutic radiopharmaceuticals. pl To satisfy the requirement for must be under the supervision of an and has had supemsed climcal supemsed climcal experience, training authoitzed user at a c:edicalinstitution expenence. must be under the supervision of an and must include: (1) To satisfy the requirement for authorized user at a medicalinsti:ution (i) Ordering, receiving. and unpacking instruction, the classroom and f and must include: radioactive materials safely and performing the related radiation laboratory traming must include: (i) Examining patients and reviewing their case histories to determine their su s () suitability for radioisotope diagnosis. ratin8dose dibrows and (i) 25 hours of radiation physics and limitations. or centraindica tions: diagnostic instruments and performing instrumentation: (ii) Selecting the suitable checks for proper operation of survey (ii) 25 hours of radiation protection: radiopharmaceuticals and calculating (iii)10 hours of mathematica and measuring the dosages: *[ Calculating and safely preparing pertaining to the use and measurement (iii) Administenng dosages to patients patient dosages. I radioactivity; and and usmg synnge radiation shields: (iv) Usmg adErmistranve controls to (iv):0 hours of radiation biology; prevent the misademistration of (2) To satisfy the requirement for (iv) Collaborating with the authorized byproduct matenal: user in the interpretation of radioisotope supemsed clinical experience training test results; and (v) Using emergency procedures to must be under the supervision of an contain spilled byproiluct matenal authonzed user at a medicalinstitution (v) Patient followup: or safely and using proper and must include: (c) lias successfully completed a six- decontamination procedures: and (i) Use of iodine.131 for diagnosis of month training program in nuclear (vi) Elutmg technetium.99m from th}roid function and the treatment of medicine as part of a training program generator systems, assaying and testmg hyperthyroidism or cardiac dysfunction that has been approved by the the eluate for molybdenum-99 and in 10 individuals: Accreditation Council for Graduate alumina contamination. and processing (ii) Use of soluble phosphorus.3: for Medical Education and that included the eluate with reagent k2ts to prepare the treatment of polycythemia sera, classroom and laboratory traEting. work technetium 99m labeled leukemia. or bone metastases in 3 experience, and supemsed clinical radiopharmaceuticals. individuals; espenence in all the topics identified in (3) To satisfy the requirement for paragraph (b) of this section. (iii) Use of iodine-131 for treatment of supervised clinical expenence, training thyroid carcinoma in 3 individuals: and for imagmg and must be under the supemsion of an (iv) Use of colloidal chromic (35, s ,, authanzed user at a medicalinstitution phosphorus-3: or of colloidal gold-198 and must include: for intracavitary treatment of malignant Except as provided in 135.970 of li) Exami:ung pat;e.!s and reviewing effusions in 3 mdividuals. 35 971, the licensee shall require the their case histones :o de:errrune their authorized user of a suitability for ramoisotope diagnosis. } 35.940 Trasrung for theraceutic use of radiopharmaceutical. generator, or usenymersey sources. limitations. or contramdications: reagent kit listed in i J5.000(a) to be a (ii) Selecting the suitab!e Except as provided in i 35.970, the physician who: radiopharmaceuticals and calculating hcensee shall require the authonzed (al is certified in: and measunng the dosages: user using a brachytherapy source listed (1) Nuclear medicine by the American (Hi) Admimstenng dosages to p;tients in 135 A00 for therapy to be a physician nutd of Nuc! ear Medicme: and using synnge radiation shields; who:
Federal Register / Vol. 50. No.144 / Friday, July 26, 1985 / Proposed Rules 30649 (a)Is certified in; brachytherapy tastment and any (3) Diagnostic radiology or radiology (1) Radiology or therapeutic radiology limitations or contraindications; by the American Osteopathic Board of by the American Board of Radiology; (ii) Selectmg the proper brachytherapy Radiology:or (2) Radiation oncology by the sources and dose and method of (b) Has completed a hours of American Osteopathic Boart! of administration: instruction in basic radioisotope Radiology: (iii) Calculatmg the dcse: and . handling techniques specifically (3) Radiology, with a specialization in (iv) post. administration followup and applicable to the use of the device. To radiotherapy, as a Bntish " Fellow of the review of case histones in cc!1aboration satisfy the requirement for instruction. Faculty of Radiology" or Fellow of the with the author: zed user. the training must include: Royal College of Radiology": or
$ 35.9e Tra*g for ophthalmic m of (1) 3 hours of radiation physics.
(4) nerapeutic radiology by the mathematics pertaining to the use and Canadian Royal College of Physicians 0 "U"*" measurement of radioactivity, and and Sunfeons: or Except as provided in 135.970. the instrmnentatierr. (b)Is in the active practice of licensee shall require the authorized therapeutic radiology. has completed user usmg only strontium-90 ophthalmic . (:) 3 hours of radiation biolcgy: and radiotherapy to be a physician who: (3): hours of radiation protection and 200 hours of instruction in basic training in the use of the device for the radioisotope handling techniques (a)is certified m radiology or applicable to the therapeutic use of therapeutic radiology by the American purposes authonzed by the license. brachytherapy sources and 500 hours of Board of Radiology: or j 35.960 Traming for teletherapy. supervised work experience and a (b) is in the active practice of Except as provided in 135.970, the minimum of three years of supervised therapeutic radiology or ephthalmology, licensee shall require the authorized clinical experience. and has completed 24 hours of user usmg a sealed source hated in (1) To satisfy the requirement for instruction in basac radioisotope 135.600 in a teletherapy unit to be a instruction. the classroom and handling techniques applicable to the physician who: . laboratory training must include: use of strontium-90 for ophthalmic radiotherapy. and a period of supervised (a) is certified in: , , (i)110 hours of radiation physics and matrumentation: chm, cal training in ophthalmic . (1) Radiology or therapeutic radiolocy (ii) 40 hours of radiation protectioru radiotherapy. by the Amencan Board of Radiology: ~ (iii):5 hours of mathematics (1) To satisfy the requirement for (2) Radiation oncology by the pertaining to the use and measurement instruction, the classroom and American Osteopathic Board of of radioactivity: and laboratory training must include: Radiolcgy: (iv) :5 hours of radiation biology. (3) Radiology, with specialization in
, (i) 6 hours of radiation physics and radiotherapy, as a BMsh Fellow of the (2) To satisfy the requirement for mstrumentation:
supervised work experience, training Faculty of Radiology" or " Fellow of the (ii) 8 hours of radiation protection: must be under the supervision of an (iii) 4 hours of mathematics pertaining Royal College of Radiology": or authorized user at an institution and to the use and measurement of (4) nerapeutic radiology by the must melude: radioactivity: and Canadian Royal College of Physicians (i) Ordenng, receiving. and unpacking and Surgeons: or (iv) 8 hours of radiation biology. radioactive materials safely and (2) To satisfy the requirement for a (b)!s in the active practice of performing the reiated radianen therapeutic radiology, and has pericd of supervised clinical trainmg in completed 200 hours of instruction in surveys: ophthalmic radiotherapy, trammg must (ii) Checking survey meters for proper be under the supervision of an basic radioisotope techniques applicable operatmm . to the use of a sealed source in a authorized user at a medical institution (iii) Prepanag. Irrplanting, and and must include the use of strontium-90 teletherapy unit. 500 hours of supervised removing sealed sources, for the ophthalmic treatment of five work experience, and a minimum of (iv) Using administrative controis to three years of supervised clinical individuals that includes prevent the misadministration of (i) Exarrination of each individual to byproduct material: and be treated:
**E[To (1 sa isfy the requirement for (v) Using emergency procedures to instruction. the classroom and (ii) Calculation of the dose to be laboratory training must include: , control byproduct matenal. administered:
(3) To satisfy the requirement for a (iii) Administration of the dose:and - (1110 hours ofradiation physics and penod of supervised chnical expenence. (iv) Followup and review of each * * " * * *
- trainmg must include one year in a individual's case history. N ""'#' "" " E#**
- formal trainmg program approved by the (iii) 25 hours of mathematics Residency Review Committee for i 35.950 Training for use of ses6ed pertauung to the use and measurement Radiology of the Accreditation Council swees for etagnosis. of radioactivity sad for Graduate Medical Education or the Except as provided in i 35.970 the (iv) 25 hours of radiation biology.
Committee on Postdoctoral Trainmg of licensee shall require the authonzed (2) To satisfy the requirement for the American Osteopathic Association. user using a sealed source in a device supervised work expenence, training and an additional two years of clinical listed in i 35.500 to be a physictan, must be under the supervision of an expenence in therapeuiic radiology dentzst. or podiatnst wno: anthartzed user at an institution and under the supervision of an authonged (alls certified in must include: user at a medical institution. The (1) Radiology, daagnostic radiology (i) Review of the full calibration supervised clinical expenence must with special competence in nuclear measurements and penodic spot checks: inciude: radiology. or therapeutic radiology by (ii) Prepanng treatment plans and (i) Examining individuals and the American Board of Radiciogy; calculating treatment times: reviewmg their case histones to (2] Nuclear medicine by the American (iii) Usmq admuustrative controls to deternune their suitahdity for Board oiNuclear Medicine: or prevent misadmmistrations:
30650 Fed:ral Raist:r / Vol. 50. No.144 / Friday. July 26. 1985 / Proposed Rules (iv) Implementing emergency 1 35.970 Training for expenenced 161. and cited in the authonty citation at procedures to be fellowed in the event authorized users. the begmning of this part for the of the abnormal operation of a Physicians, dentists. or podiatrists purposes of section 223. teletherapy unit or console; and identified as authorized users for the human use of byproduct matenal an a , (v) Checking and usmg survey meters. Commission or Aareement State license requirements cunng transition pened. (3) To satisfy the requirement for a period of supervised c!mical expenence, r, h gg/ gej If the rules in this part cenilict with training must mclude one 3 ear in a who perform only those methods of use the licensee's radiation safety program formal training program approved by the for which they were authorized on that as identified in its license, and if that Residency Review Committee for date need not comply with the train:ng license was approved by the Radiology of the Accreditation Council requirements of Subpart J. Commission before [ insert effectn e date for Graduate Medical Education or the 1 35.971 Physic!an training in a trirse offinalcule) and has not been renewed. month program. then the requirements in $e license will Committee on Postdoctoral Trainmg of apply. the American Osteopathic Association A physician who, before July 1.1984. and an additional two years of clinical began a three month nuclear medicine PART 30-RULE 3 CF GENERAL experience in therapeutic ra.fiology training program approved by the APPLICABILITY TO DOMESTIC under the supervision of an authorized Accreditation Council for Graduate LICENSING OF BYPRODUCT u::er at a medicalinstitution.The Medical Education and has successfully MATERIAL supe ised clinical expenente must co ple d prog a n dn FY inclu e. o 2.The ainthonty citation for Part 30 (i) Examining individuals and 35.920' continues to read as follows: reviewing their case histories to l 35.972 Recentness of training. Authority: Sec. m. as arnended (42 U S C. determine their suitability for ;.201); sec. 201. as arnended i4:U.S.C. 34a1). The training and experience specified teletherapy treatment. and any in this subpart must have been obtained
- 3. Section 30.4 is amended by revisirg limitations or contraindications: within the five years preceding the date pagapu W M W m md u Mm (ii) Selecting the proper dose and how of application or the individual must and by adding new paragraphs (y) and it is to be admmistered; have had continuing experience since (z) as follows:
(iii) Calculating the reletherapy doses the required traming and experience g3o,4 c gin,tions, and collaborating with the authorized was completed. . . . . . user in the review of patients' progress Subpart K-Enf orcement and consideration of tne need to modify [h)" Medical use" means the originally prescnbed doses as j 35.990 Violations. intentional internal or external administration of byproduct material. or warranted by patients' reaction to (a) An injunction or other court order the radiation therefrom. to human beings iadiation: and may be obtained to prohibit a violation in the practice of med: cine in (iv) Post. administration followup and of any provision of: accordance with a license issued by a rcview of case histories. (1) The Atomic Energy Act of 1954. as State or Terntory of the United States. amended: the District of Columbia. or the 135.961 Tramir.g for quahfled teletrierapy (2) Title II of the Energy catitarstton opert. Commonwealth of Puerto Rico in the Reorganizati::n Act of:974 as amended: practice of medicine. The licensee shall require the or . . . . . qualified teletheracy calibra: ion expert . (3) Any rule. regulation or order ;g) .. Physician" means a medical go. issued under these Acts. (b) A coun order may be obtam.ed for doctor or doctor of osteopathy licensed (a) De certified by the American Board by a State or Terntory of the United of Radiology,in: the payment of a cani penalty imposed
" States. the District of Columbia, or the (1) Therapeutic radiological physics:
- 12) Roentgen ray and gamma ray
- 1) ecfo"ns I3. 57. 62. 63. 81.Commonwealth 82.101 of Puerto Rico to presenbe drugs in the practice of
*03.104,107, or 109 under section 234 of physics: the Atomic Energy Act of1954: me cine:
(3) X ray and radium physics: or (2) Section 206 of the Energy (4) Radiological physics: or Reorganization Act of1974: (y) ,, Dentist,, means an individual
, (b) Hold a master.s or doctor.sdegree 0) Any rule regulation. or order licensed by a State or Terntory of the m physics, biophysics. radiological ssurd under these Acts: United States. the District of Columbia.
physics. or health physics. and have (4 Any term condition. or limitation or the Commonwealth of Puerto Rico to of any license issued under these Acts: practice dentistry on humans, completed one year of full time training or in therapeutic radiological physics and (z)"Podiatnst" means an individual (5) Any violation for which a license licensed by a State or Territory of the also one year of full time work may be revoked under section 186 of the United States. the District of Columbia. experience under the supervision of a Atomic Energy Act of 1954. qualified teletherapy calibration expert or the Commonwealth of Puerto Rico to (c) Any person who willfully violates practice podiatrf on humans. at a medicalinstitution. To satisfy this any provision of the Atomic Energy Act requirements. the neophyte quahfied 4. Section 30.34 is amended bv of 19% as amended or any rule. rev: sing paragraph (g) to read a's teletherapy calibration expert must have regulation, or order issued enJer the Act follows: performed the tasks listed m 11 35.59. ~ may .,c guilty of a crime and. upon 35.632. 35 633. and 35 641 of this part conviction. may be punished by fine or i 30.3a Terms and concittens of ricer ses. under the supervision of a qualified imprisonment or both as provided by * * * *
- teletherapy calibration expert dunng the law. Regulations issued under the Act (g) A licensee may prepare year of work expenence. inc!ude regulations issued under section technetium 99m radiopharmaceuticals
Federal Register / Vol. 50. No.144 / Friday. July 26. 1985 / Proposed Rules 30631 only with technetium-99m that contains Authonty: Sec.161, as amended (42 U S C. { 32.74 Manufacture and distribution of less than 0.15 microcuries of molyb- rath sec. 201, as amended (42 U S C. 54811 sources or devices containing byproouct denum-99 per millicurie of technetium. matenal for medical use. 99m. The licensee shall perform tests i 32.70 memoved) (a) An application for a specific and maintain the records required by 8. Section 32.70 is removed. license to manufacture and d:stribute i 35.204. 9. In i 32.72 the introductory text of sources and devices containing paragraph (a) and paragraph (a)(4)(i) are byproduct matenal to persons licensed PART 31-GENERAL DOMESTIC revised to read as Jcilow,: pursuant to Part 35 of this chapter for LICENSES FOR BYPRODUCT use as a cabbration or reference source MATERIAL I 32.72 Manufacture and distribution of or for the uses listed in !! 35.400 and
- 5. The authority citation for Part 31 radiopharmaceuticals containing byproduct 35.500 of this chapter will be approved material for medical use under group it.
continues to read as follows: Ilcenses. ,' . , , . Authority Sec. tel, as amended (42 U.S.C. (a) An application for a specific
=01); sec. 201. as amended (42 U.S.C. 54a1). (3) The label affixed to the source or license to manufacture and distnbute device. or to the permanent storage
- 6. Section 31.11 is amended by radiopharmaceuticals containing container for the soarce or device.
revising paragraph (b) to read as byproduct material for use by persons contains information on tne follows: authorized pursuant to Part 35 of this radionuclide, quantity and date of chapter will be approved if: assay, and a statement that the (name of f 31.11 Generallicense for use of , . . . .
"'" source or device)is licensed by the U.S.
t$ o taborat t tes (4)(i) The label affixed to each Nuclear Regulatory Commission for package of the radiopharmaceutical distnbution to persons licensed to use (b) No person shall receive. acquire, contains information on the byproduct materialidentified m radionuclide, quantity, and date of 1i 35.58. 35.400, or 35.500. as possess, use, or transfer byproduct material pursuant to the general license assay, and the label, or the leaflet or appropriate, or under an equivalent established by paragraph (a) of this br chure that accompanies each license of an Agreement State-section unless that person: package. contains a statement that the , (1) Has filed Form NRC-483. radiopharmaceutical is hcensed by the
..Resistraticn Certificate-In Vitro
~
U.S. Nuclear Regulatory Commission for PART 40-DOMESTIC LICENSING OF Testmg with Byproduct Material Under distnbution to persons licensed to use SOURCE MATERIAL General License." with the Director of byproduct matenallisted in il 35.100. 12. The authonty cuation for Part 40 Nuclear Matenal Safety and Safeguards. 35.200, or 35.300. as appropnate, or continues to read as follows: U.S. Nuclear Regulatory Commission, under an equivalent license of an Agreement State. Authonty:Sec.161. as amended f42 U.S.C. Washington. DC 20555 and received Coll; sec. 201. as amended (42 U.S.C. 54a1). from the Commission a validated copy
- of Form NRC-433 with a registration 13. Section 40.4 is amended by
- 10. In i 32.73 paragraph (a)[5}(ii)is revising paragraph (g) to read as number assigned: revised to read as follows: fojtow,.
(3) Has a heense that authorizes the medical use of byproduct matenal and i 32.73 Manufacture and distribution of generators or reagent us for preparation 1 40.4 Definitions. that expires before [ insert five years , , , , , efterefecrire ccte offinalruleh or 8"*'**ce[ticals
, ,,7 containmg (g)"?hysician" means a medica!
(3) Has a license that authnzes the doctor or doctor of osteopathy licensed medical use of byproduct material and (a) * *
- by a State or Terntory of the Umted also authorizes the use of b3 product (5) * *
- States, the District of Columbia, or the material consistent with the (ii) A staterr.ent that this generator or requirements of this section. Commonwealth of Puerto Rico to reagent kit (as appropnate) is approved prescnbe drugs in the practice of for aistnbution to persons licensed by medicme:
} the U.S. Nuclear Regulatory Commission * * * *
- PART 32-SPECIFIC DOMESTIC to use byproduct material identified in Dated at Washington. D C., this =nd cay LICENSES TO MANUFACTURE OR i 35.200 or under an equivalent license of July 1985.
TRANSFER CERTAIN ITEMS of an A 6teement State. For the Nuclear Regulatory Commission. CONTAINING BYPRODUCT . . . . . Samuel l. Chilk.
- 11. In i 32.74 the introductory text of Secretery o/the Comm ssen.
7.The authonty citation for Part 32 paragraph (a) and paragraph (a)(3) are IFR Doc. 85.-1r03 Filed 7-25-85; 8.45 amj contmues to read as follows: revised to read as follows: erwac cooe isoo of-u I i
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UN11ED STATES NUCLEAR REGULATORY COMMISSION r IN THE MATTER OF: DOCKET NO: COMMISSION MEETING Pod CEC y-8$- $85 r - w . : . LOCATION: PAGES: 1 - 87 WASHINGTON, D. C. DATE: WEDNESDAY, MARCH 20, 1985 I II b
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DISCLAIMER
- ,- This is an unofficial transc'ript of a meeting of the United States Nuclear Regulatory Commission held on March 20, 1985 in the Commission's office at 1717 H Street, N.W., Washington, D. C. The meeting was open to public attendance and observation. This transcript has not been reviewed, corrected, or edited,-
and it may contain inaccuracies. The transcript is intended solely for general informa-tional purposes. 'As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the
- matters discussed. Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs. No pleadin~g or other paper may be filed with the Commission in any proceeding as the result of or addressed to any statement or argument contained herein, except as the Commission may authorize. .
9 9 s s A e 4 i e J t 6
Hinonn'/r&t 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 --- e
** 35 4 DISCUSSION ON PROPOSED REVISION TO PART 4FP*
5 --- 6 PUBLIC MEETING 7- --- 8 Room 1130 ' 1717 H Street, N.W. 9 Washington, D.C. 10 Wednesday, March 20, 1985 11 The Commission met, pursuant to notice, at 10:03 a.m, 12 COMMISSIONERS PRESENT:
,13 NUNZIO PALLADINO, Chairman of the Commission
,- ' JAMES ASSELSTINE, Commissioner. 14 FREDERICK BERNTHAL, Commissioner LANDO ZECH, Commissioner 15 STAFF AND PRESENTERS SEATED AT COMMISSION TABLE: 16 J. HOYLE l 17 B. OLMSTEAD N. McELROY 18 D. MAUSSHARDT W. DIRCKS 19 M. MALSCH J. WARD 20 M.*BLAZEK G. PRICE 21 R. HENKIN J. DEYE 22 AUDIENCE SPEAKER: k-.-' I 23 j L. COBB 24 l 25 l
. . 2 1
PRO _CEEDINGS 2 CHAIRMAN PALLADINO: Good mornin.g, ladies and 3 gentlemen. We have with us today members of the NRC staff, 4 representati'ves from Agreement States, and members of the 5 medical community to discussed proposed revisions to Part 35-6 of the NRC regulation entitled, Medical Use of Byproduct 7 Materials. 8 In June, 1983 the Commission proposed the; con-9 solidation of existing regulations, proposed standardizing 10 regulatory guides and other licensing positions , and directed 11 the continuance of pre-licensing reviews of physicians' 12 qualifications and applicants for operating procedures. 13 The Commission is presently deliberating on the (R) 14 proposed rule that would consolidate all medical use 15 requirements in 10 CER Part 35, l 16 This morning, we will first hear from the NRC 0 17 staff. We have allotted 20 minutes for the staff briefing. 18 This will be followed by a ten-minute presentation by two 19 representatives of Agreement States, and by a ten-minute 20 presentation by three representatives of medical professional 21 associations. 22 In order to facilitate completion of the presen-23 tations, I suggest that to the extent possible, Commissioners 24 hold questions to the end of each segment of the presentation.
%.J 25 Members of each organization will join us in turn at the
3 1 table. We will begin the meeting by having Mr. Dircks, the
) 2 Executive Director for Operations introduce the NRC partici-3 pants. But first, let me thank all of today's participants ,- 4 for taking time from their busy schedules to offer their 5 thoughts on this important subject.
6 Do any of my fellow Commissioners have additional 7 opening remarks to make? 8 COMMISSIONER ZECH: No. 9 COMMISSIONER ASSELSTINE: No. 10 CHAIRMAN PALLADINO: Okay, then I will turn the 11 meeting over to Mr. Dircks. 12 MR. DIRCKS: Well, I don't think we will require.) $E$ 13 all twenty minutes. We had submitted this very c,omprehensive (#)
- 14 paper down here on Decedber 31, 1984 Of course, it is a 15 proposed rule not a final rule. So, we will be getting much 16 more interaction on this as we get comments on it from the 17 public.
18 I thought in view of what we have submitted, we 19 will ha' e a very brief overview statement of what is in 20 there. We thought that we could concentrate only on the one 21 issue that seems to be the issue in question, namely allowing 22 the flexibility for minor changes on the part of the licensees 23 as opposed to pre-approval of minor changes. 24 Don Mausshardt, who is the Deputy Director of the O 25 Office of Nuclear Materials Safeguards is here with Norm
- f 4
1 McElroy who is the Project Manager on this project. 2 I thought, Don, we could move right into it, again 3 emphasizing we are not going to cover in detail this paper. 4 We thought we would just give a very brief overview of it 5 and then move -- spent very little time on that issue so you 6 can hear the other parties. 7 MR. MAUSSHARDT: Thank you, Go ahead, Norm. 8 MR. McELROY: Gen,tlemen, do you have the handout 9 that was prepared? 10 COMMISSIONER ASSELSTINE: Yes. 11 CHAIRMAN PALLADINO: I think so. 12 On page 1, you have MR. McELROY: Okay, fine. f"% 13 an overview of the medical use of materials, the number of ( - 14 licensees we have and the types of use. Most of the materials 15 are used for diagnostic studies; there is also some therapy 16 use of material. 17 On page 2, we do have some problems with our 18 The requirements are scattered current rules and guidance. 19 in several documents because things have been developed to 20 This meet timely problems in as prompt a fashion as possible. 21 results in many unreadable regulations because of cross-22 references in these sentences and not a consolidated 23 organization. Because the requirements are in various 24
,.;7, documents, when an applicant submits an application package ,
u;> 25 in order to establish a legal basis for citations, the
5 1 license says on it you have to use materials the way you k) 2 promised in your application. Therefore, if the licensee wants 3 to make any changes, he has to get a license amendemtn. 4 If we can just rkip over page 3 and go to page 4 5 The problem this results in, is that if a licensee wants to 6 make some changes in procedure -- 7 CHAIRMAN PALLADINO: Which do you call page 4? 8 MR. McELROY: Sample Management Procedure. 9 MR. MAUSSHARDT: It is Appendix B. 10 CHAIRMAN PALLADINO: Thank you. 11 MR. McELROY: If a licensee wants to make some 12 management changes to respond to changes in patient load or g) 13 economy and other business considerations, whether they are 14 minor changes that might say who in the institution is 15 supposed to do a survey or something like that, he has to get I 16 a license amendment. , 17 Now, an example of a management procedure that . l 18 would have to be amended is this Medical Isotope Committee i 19 . procedure. Applicants in their application can say, "I'll l 20 follow Appendix B when I run my Radiation Safety Committee," l l 21 and he is tied down literally to the word to everything that l l 22 you have in front of you. j l
- 23 Now, what we have done in the regulation for this
( 24 management procedure is to pull out the essential elements G 25 that I have underlined here and put them in the regulation.
. _ ____ _ _ _ _______ ___ _ l
- t 6
1 We specify who is on the committee. We specify the committee's
- 2 charge; we specify how frequently they have to meet in the 3 regulation instead of in this application package.
4 In addition to management procedures, there are 5 also some technical procedures that hospitals have to follow, 6 and we have an example on the next page. 7 Here again the applicant can say, "When I do my 8 area survey procedures, I'll follow Appendix I," arl that is 9 all we look at when we review the application. This 10 particular technical procedure says where to survey, how-11 frequently you shcald survey, and when you should take action 12 based on survey results. (7% 13 We again have pulled out the essential elements s 14 that we have underlined here and put them in the regulation, 15 which says how frequently to survey, when to take action, and 16 so on. So, our thesis in summary eis that we have extracted 17 all of the essential hospital radiation safety requirements 18 from the current regulation, the current regulatory guides; 19 some NUREG reports; NCRP guidance, we pulled it all together 20 and put it into the regulation. 21 That now forms the legal basis for regulating each 22 licensee, rather than all of these various documents. Having 23 done that, having given a clear statement of what you have ,,s 24 to do as a licensee, we feel it's appropriate to grant a D 25 certain amount of flexibility to licensees so they can L - ---
7 i 1 respond to developing safety needs, changes in patient load,
#a Ik? 2 other changes within the institution.
3 That is the central issue in this package. That i 4 concludes my remarks, i 5 CHAIRMAN PALLADINO: Any more? 6 COMMISSIONER BERNTHAL: This is just a general 7 question that I wanted to ask -- 8 CHAIRMAN PALLADINO: Were you through with the 9 presentation? 10 MR. McELROY: Yes, sir. 11 CHAIRMAN PALLADINO: Okay. Go ahead, Fred, i 12 COMMISSIONER BERNTHAL: Throughout our regulations -- ,
' peg 13 and as I look almost anywhere in any of this literature --
P 4 14 everything seens to be pegged teward units of micro curies, l 15 milli curies. In other words, the curie, rather than dosages. l. w- 16 In other words, no matter what the isotope, all of our 17 regulations and standards seem to be pegged to the DPMs which 1 18 doesn't really make a lot of sense, it seems to me. 19 I am just wondering if you would comment on that. 20 It seems to me that the requirement for surveillance and 21 generally our regulations should be pegged to biological 22 hazard rather than to this sort of convenient but antiquated (' 23 disintegrations per minute. 24 MR. McELROY: Well, our jurisdiction is limited to
@ 25 radiation. Are you referring to the pharmaceuticals that
8 1 the doctors are using? 2 COMMISSIONER BERNTHAL: Yes, sort of everything. 3 Everywhere I see quantitative requirements and numbers, it 4 refers to, basically to the half-life and quantity of the 5 material involved. That just doesn't seem to me to be a very 6 sensible standard to be regulating against. 7 MR. McELROY: As I said, we have our jurisdiction 8 limited to the radioactivity aspect. As far as the 9 pharmaceuticals go, these doctors, unless they are part of a 10 research project that has been reviewed by the Food and 11 Drug Administration, they are limited to using radio-12 pharmaceuticals that the Food and Drdg Administration has 15 reviewed for safety and effectiveness. (R) 14 COMMISSIONER BERNTHAL: No, I'm sorry, I'm not 15 I quite making myself clear. That indeed is another issue. But 16 specifically on the radio isotopes, there is a vast 17 difference, as you know, between Carbon 14 and Iodine 131 -- 18 MR. McELROY: Yes. 19 COMMISSIONER BERNTHAL: -- and tritium., and a lot 20 of other things -- 21 MR. McELROY: Yes. 22 COMMISSIONER BERNTHAL: -- in terms of a biological
23 hazard, and that is our responsibility. And yet, we regulate, 24 even though there are orders of magnitude dif ferences in 25 the biological hazards of these particular isotopes, we
, - . - - . _ - - . - . . - . - - . - ~ - - - - - . . _ _ - _ - - _ - . _ . - - - - 9 j, i j 1 regulate to DPM, basically. l 2 MR. McELROY: The DPM survey levels that you refer 3 to are applied across the board, and they are about as
- 4 conservative a standard as we have found. Now, I remind you t-5 that many of these radio . pharmaceuticals that the physicians f ;
4-l 6 are using really aren't very hazardous, it is a very low i e - i 7 does to the patient, comparable to all other radiation 1 , . s studies in the hospital, meaning the x-ray studies. t 9 We do have special additional survey requirements f
- 10 that apply when the doctors are using the more hazzardas ,
7
- j. 11 Iodine 131 or the higher activity sealed sources.
l Ut MR. OLMSTEAD: I think I should comment on Part 20, pe 13 which is occupational exposure, which we do regulate. Patient b.g , i i 14 dosage, we don't regulate. That's the doctors' -- ! l , l f 15 , COMMISSIONER BERNTHAL: No, I'm still not -- l' l 16 MR. OLMSTEAD: The material we do regulate. i i-l 17 COMMISSIONER BERNTHAL: I realize that. The things [ i 18 we do regulate , the stuff I'm looking at right here , it's 19 still like laboratories where less than 200 micro curies are t l 20 used will be surveyed monthly. l' 21 Well, 200 micro curies is not 200 micro curies , it
- . 22 depends a lot on what you are using, what the real biological kJ'} 23 And if what you are saying is that we have taken i hazard is.
1 24 the most hazardous of all isotopes and that this standard
- j. 25 applies to them, and that therefore it's appropriately l
l l i-I
10 1 conservative, then I guess I'm prepared to buy that. But I 2 am wondering if it 's really been looked at that carefully. 3 MR. McELROY: That particular standard that you 4 reference has been the one we have been using for guidance 5 to the applicants and licensees for several years, yes. 6 CHAIRMAN PALLADINO: We might want to have ]me 7 of our other speakers -- 8 (Laughter) 9 MR. McELROY: It 's had the benefit of - thought, 10 many years of -- 11 COMMISSIONER BERNTHAL: I found something my first 12 summer on the Commission that has be.en used for many years, WP) 13 and it made about as much sense as a lot of other things do 14 around here. 15 l But, well, okay, I just find that curiosity, I'm 16 surprised. 17 CHAIRMAN PALLADINO: Fred, we might ask our other 18 speakers also to address that question. 19 COMMISSIONER BERNTHAL: Certainly, we can. 20 CHAIRMAN PALLADINO: Could I ask a couple of 21 questions related to the central issue, or at least what 22 has been described as the central issue? 23 I gather the licensees have to make a decision as l 24 to whether the change is a major change or a minor change, 9 25 and I think the implication is that you feel there is no b - . - - . - - - - - - - _ - - --
11 1 Problem in their ability to determine which is major..and which k) 2 is minor. 3 MR. McELROY: We have very clearly listed in the 4 regulation what a major chunge is. It is moving fron one 5 building to another; it is adding a new doctor; it's increasing 6 your inventory possession limit, or picking up a new kind 7 of material, for example, being authorized to do diagnostic 8 work and wanting to get into therapy work. Those are the 9 major changes. And the regulation clearly calls for a 10 license amendment. 11 COMMISSIONER ASSELSTINE: And by implication 12 everything els,e is a minor change. MR. McELROY: Correct, f9) 13 s 14 CHAIRMAN PALLADINO: Now, I gather -- if I read 15 the material correctly -- Region III doesn't support the 16 staff's views. Could you give us some insight as to what 17 their thinking is? 18 COMMISSIONER ASSELSTINE: Is there anybody here front 19 I&E, by the way? M MR. McELROY: Yes. 21 COMMISSIONER ASSELSTINE: It would be interes ting 22 to hear their perspective reflecting the regional view too, 23 Joe. 24 CHAIRMAN PALLADINO: Yes. D 25 MR. McELROY : The Licensing and Inspection staff
12 1 in Region III had some general reservations about the ability 2 of the licensees to make an adequate safety assessment before 3 making a change in its radiation safety program. 4 I perceive that their views are along the lines of 5 those that the Agreement States have, and perhaps the question 6 might be better' addressed to the Agreement State representative s 7 CHAIRMAN PALLADINO: Well, I was interested in 8 what our thinking was internal to the organization first 9 MR. McELROY: I spent a lot of time talking with 10 them, and I think it's just a judgment call. l 11 CHAIRMAN PALLADINO: One of the problems that j l 12 is cited is that when an inspector goes in under the proposed F /) 13 arrangement, that the inspector would have.to spend quite l 14 a bit of time just determining what changes have gone on, and 15 then has to make a judgment as to whether or not they were 16 consistent with our regulations, whereas one of the points 17 made is that that would be better done at headquarters before 18 the fact. 19 The suggestion that licensees are MR. McELROYL 0 going to make changes on a weekly basis, I don't think is 21 valid. You can't run -- CHAIRMAN PALLADINO: I didn't say " weekly basis," 23 but however often. MR. McELROY: We don't perceive licensees' needs 25 to make frequent changes , and when a change is made, the
13 1 regulation clearly calls out for the licensee to set up a O %R' 2 little file of the applicable regulations that direct the 3 change; what he had in place; what he is changing to , and a 4 safety analysis. Now, he would keep that file on hand every 5 time he made a change, for the inspectors to take a look at. 6 CHAIRMAN PALLADINO: But the inspectors would have 7 to look at that and then make a determination, or at least 8 raise the question as to whether or not they complied with 9 the regulation. 10 MR. McELROY: As part of their paperwork audit 11 during the inspection process they would likely look at U those in addition to all of the other things they look at. /*) 13 MR. DIRCKS: I think i5 you look on page 5 -- 14 CHAIRMAN PALLADINO: Of? 15 MR. DIRCKS: -- of the staff documents there is a 16 pretty good small paragraph there that you might refresh
~
17 your memory on. I think it calls out the minor changes in 18 the licensees' day-to-day radiation safety programs. 19 CHAIRMAN PALLADINO: Is this where they talk about 20 the checks and balances? 21 MR. DIRCKS: At issue here is whether or not a 22 regulatory agency must approve minor changes in the licensee's 23 day-to-day radiation safety program. "When NRC issues a 24 byproduct material citation, it is usually for doing nothing 25 when something is clearly required or for doing something
14 1 that is clearly forbidden. Citations are seldom used for 2 failure to exactly follow a certain procedure or to ha.ve 3 satisfactory equipment. This raises the question of whether 4 or not a paper analysis by NRC or minor operational changes 5 contributes significantly to safety." 6 I think this is the issue that you have to focus on, 7 I don't want to get into the position of defending one 8 position or another position. But if we have had a complaint 9 against NRC not only in the materials area but certainly 10 in the other areas that we regulate in, is..that we are a 11 paper factory. 12 We have a tendency to require much paper in this 13 organization -- so much paper that many times we give it a t 14 very cursory review if any review whatsoever. 15 We have the natural story going around that we 16 deliver box loads and carton loads of paper to the various 17 NRC installations. I think what this is trying to do is 18 to call out from the reams of paper that we collect in 19 this organization those very important or major pieces of 20 paper that do require staff analysis and staff approval. 21 I think, if anything, this is equivalent to the 22 50.59 proedddres used under the reactor licensing initiatives t 23 of the agency. But again, it's where and how the Commission 24 wants to focus the staff's attention. I don't think we 25 want to get into the position of having this group saying,
15 1 "Here is a proposal, accept it or reject it." If the 2 Commission feels that the priority of the agency is better 3 focused on approvals of minor changes, that is something the 4 Commission can very well direct the staff to do as a result 5 of its review of other priorities of the agency. 6 This goes back also to the PPG that is cited in 7 the paper and says -- and I'm quoting - "NRC regulations 8 should allow individual licensees the flexibility to select 9 the most cost-effective ways to satisfy NRC safety obj ectiven. 10 Existing regulatory requirement of marginal importance to 11 safety should be eliminated." 12 l And again, here is what the Commission is telling Q 13 the staff and we are perfectly willing to live with whatever ( 14 interpretation the Commission might want to place on that 15 thing. We can certainly go whatever way you want to go. But 16 this is an attempt, after two years we have been looking at 17 this issue, to come back with something that we thought met 18 the Commission's directions. 19 CHAIRMAN PALLADINO: I wasn' t being critical of 20 the Commission. I think it does a tremendous job in this 21 undertaking. But I -- 22 MR. DIRCK3: I'm not acting in a defensive way, 23 I'm just saying we are trying to say, "Here it is," and the 24 issue was certainly out on the table. I think we have gone 25 through the staff. I think Region III has noted something
16 1 where the inspectors spend their time; how they have spent
- I think we noticed that, and the point I was 2 their time.
3 passing up to you here at this point, without trying to 4 encourage you one way or the cther. This is a proposal, 5 certainly the proposed rule that would go out for extensive 6 public comment. 7 And again, we have noted how long it takes these 8 things to get into a final rule , and might note that we have 9 been at this thing for now two years. 10 CHAIRMAN PALLADINO: Well, just having read some 11 of the submittals on the other side, I felt that it was 12 important to ask some of these questions to see how the staf f Q 13 used them. t~' 14 Let me ask'two other questions and then turn it 15 over to my colleagues. 16 One of the other contentions made is that there 17 are many small hospitals that don't have the diverse and 18 extensive staff that the larger hospitals have, and that 19 therefore their Review Boards would not have the background 20 needed to make a good determination on some of these questions. 21 Could you comment on your views with regard to 22 that point? Y M MR. McELROY: TWe'have, as I said before, consolidate d 24 the essential elements and I think everything is spelled out. 25 When making a change, the licensee has to sit down and, Step 1.
, , /
3 17 1 in making a change is what regulations apply -- Part 35 2 regulations, the public dose rate regulations in Part 20, and 3 so on. 4 So, I don't think it takes a high level of 5 technical safety expertise.to make the kinds of changes that 6 we are looking at. It's again, as I said before, more a t 7 business-type of decision. 8 MR. MAUSSHARDT:- Mr. Chairman, in the smaller 8 hospitals too, the frequency of applications is much less 10 and, in a sense, the Committee would be the same people 11 -making the therapeutic appl.ication, whatever was going on 12
. t.here.. ,
O~ 13 CHAIRMAN PALLADINO,: Well, I had in mind in small C/ 14 hospitals because there is a smaller load, that some of these 15 things might be done more infrequently and therefore maybe 16 there is a need for adjustment more frequently. 17 Do you have any' feeling with regard to that particular 18 aspect to small hospitals? 19 MR.-McELROY: With regard to how frequently they 8 would be exercising this right? My best guess would be, not 21 more than perhaps something on the order of once a year or 22 'three time's.in five years. That's approximately the number 23 of license ameridments we get from these hospitals now. We
" have 2,500 licensees. We get about, I think, about 1,500
. . amendment requests.
18 1 CHAIRMAN PALLADINO: Well, I was thinking because of 2 that infrequency, they might have to go back and make re-3 adjustments almost every time they use the procedure. 4 MR. McELROY: The procedures that we are referring 5 to here are in most cases things that are done on a virtually 6 daily basis, that's package receipt. You get packages in 7 just about every day, end-of-day surveys, that kind of thing. 8 CHAIRMAN PALLADINO: Okay, one other area. On 9 page 5 of your paper you do discuss checks and balances. I 10 think it might be worth highlighting a few of those so that 11 we make sure we understand the checks and balances. 12 MR. McELROY: Okay. In order to assure a clear 13 statement of authority, the. regulation does require that 14 the licensee, meaning corporate management, give a clear 15 statement of authority both to the Radiation Safety Officer 16 and the Radiation Safety Committee, so that if a problem 17 does develop they don'.t have to run around trying to 18 establish their authority to act. 19 I think this is a very important safety feature 20 within this document. 21 CHAIRMAN PALLADINO: Is that reviewed by the 22 staff, or is that -- 23 MR. McELROY: The statement of authority? 24 CHAIRMAN PALLADINO: Yes, or does it -- 25 MR. McELROY: I believe in the initial licensing
19 1 process that's one of the things we look at. We have the Ps2/ 2 Radiation Safety Committee within the hospital. Most of the 3 affected workers, both the nuclear workers and the 4 ancillary staff, have representation on that committee. So, 5 we don't have a situation where somebody is off in a corner 6 doing his own thing without any institutional oversight. 7 Some of the problems we have had in the past stem 8 from the f act that the hospital management wasn't clear about 9 the requirement to follow the regulations. So, we have 10 inserted a requirement here that the Radiation Safety Officer 11 go up to the management of fice once a year, close the door, 12 and tell them what is going on -- tell them about current fEj 13 problems as far as staffing or equipment goes, and tell them v ~ 14 if they see any problems coming down the pike in a couple of 15 years for whatever reason. This is -- 16 CHAIRMAN PALLADINO: Is that documented, the 17 fact that that takes place; is that documented? 18 MR. McELROY: We don't have a clear statement of 19 that, no, to document that meeting. We have clearly stated 20 the training standards that apply for the doctors, the 21 Radiation Safety Officer and the teletherapy workers. 22 For the past two years, I have been reviewing all 23 of the citation letters that go to licensees and doing a 24 sort and tally on each line item in each letter. So, if a M new generic problem crops up, I think we have an internal
20 1 sys. tem that will pick up that new problem. (Il
%L# 2 Finally, if something does happen where we do have 3 to get in touch with licensees immediately, we are set up to 4 do that. We can get a letter printed and in the mail to all 5 2,500 licensees on about four hours ' notice. So, we do have 6 a lot of safety features backing up the regulation.
7 CHAIRMAN PALLADINO: All right. Thank you. Let { I 8 me give other Commissioners an opportunity to ask other i 9 questions. { 10 COMMISSIONER ASSELSTINE: I had just a few. Let 11 me focus first on the central issue, Joe, that you were , 1 12 pursuing, and then I want to talk about ALARA a little bit as 13 well. . (@) (' 14 You say that we've got about 2,500 of these 15 licensees ourselves, and your paper, or the viewgraphs 16 show 1,800 amendments per year. l 17 Can you break those down into how many, approximatelt 18 how many are the major amendments and how many would f all 19 intthis minor change category that you have here? 20 MR. MAUSSHARDT: Approximately 50 percent of them 21 would be considered minor amendments. We have taken a look 22 at the savings that would occur in FTE years . Approximately, N 23 it would be two FTE years. 24 COMMISSIONER ASSELSTINE: Yes. 25 MR. MAUSSHARDT : And of course we in this budget
21 I cycle fitured that, assumed that we would be recovering net ?- .
<7 2 savings in th'at program.
3 CHAIRMAN PALLADINO: What fraction were minor? 4 MR. MAUSSHARDT: About half, about 900 of the 1,800. 5 COMMISSIONER ASSELSTINE: Be' fore I ask other 6 questions, let me say first that I think that the package in 7 terms of consolidating the requirements in one place in the 8 regulations, I think, is a good step forward and I think it's 9 a real improvement. I think that's what we wanted to see 10 when we had this meeting the last time, and we wanted to 11 focus your efforts in that direction. 12 I think that's very helpful. Let me ask one questior,
~
r**) , 13 along those lines. (.. 14 You seem to say, Norm, that you have taken these is things out of reg guides and wherever, consolidated them into 16 the regulations, and that perhaps for some reason that 's 17 a justification for providing this additional flexibility 18 for these licensees to make these minor changes. 19 Didn't all that stuff before have to essentially 20 be in the application? Didn't the applicant have to describe 21 those kinds of things in their application and isn't one of 22 the real benefits of this that now you can simply reference ( 23 the regulation, you don't have to load up the application 24 with all this stuff. 25 I don't see that that is in itself, the change in
22 1 approach here, a justification for dropping the review of S' VJ 2 minor changes. I thought you had sort of implied that that 3 was part of the justification for dropping the review 4 requirement for minor changes. 5 MR. McELROY: The justification for making the 6 change in licensing is, I think, the fact that as we sit 7 here today, we have the requirements scattered all around, 8 and even experienced people in the field get tripped up on' 9 occasion because they don't have access to all of the 10 documents. 11 COMMISSIONER ASSELSTINE : Now they are all going to 12 be in one place. f7% . 13 MR. McELORY: In'the regulation, right. L 14 COMMISSIONER ASSELSTINE: Yes. 15 MR. McELROY: And since everybody ha's the same set is of rules to go by, they know what the essential things are 17 in their hospital safety program. They have to make the 18 minor changes. Now we can allow that because we don't have 18 to worry about him breaking something, some requirement that M is hidden in one of various publications. That is the rationa:.e 21 behind the change feature. 22 COMMISSIONER ASSELSTINE: Although didn' t they have to plug all those things into their application before? 23 24 MR. McELROY: They did, and then they had to live 25 with it until they were presumably amending --
23 l 1 COMMISSIONER ASSELSTINE: So, presumably the problem would have been before, whether they picked up everything ! 2 3 and put it in their application that they needed to, not 4 whether once you had those things in the application they knew 5 what they had to do and what they didn't have to do. 6 MR. McELROY: I didn't follow the complete sentence, 7 I'm sorry. 8 COMMISSIONER ASSELSTINE: I guess what I am trying 9 to say is, it seems to me if there was a breakdown in 10 understanding before, it would have been at the stage where 11 you are preparing and submitting your application for a 12 license to start with. If you have to put everything in the f'5 13 application under the old approach, it seems to me once you (- 14 had it in the application and the license was approved, then 15 at that point the licensees all L.'w what they had to do and 16 what they didn't have to do because it was all there in 17 the license. 18 MR. McELROY: That's correct. But then they have 19 to go through the amendment process if -- 20 COMMISSIONER ASSELSTINE: The changes. 21 MR. McELROY: -- there are changes necessary. 22 COMMISSIONER ASSELSTINE: And now they'll have to 23 go through the amendment process if they want to change 1 x' 24 things that are referenced that are in the regulations. s 25 MR. McELROY: Just the addition of the doctors and
24 1 moving the facility. Not so many changes as were necessary b' '47 2 under the current regulatory mechanism. 3 COMMISSIONER ASSELSTINE: Can you give me a sense 4 for, say, out of these 1,800 amendments a year when you do your 5 reviews, how many you find deficiencies in? How many you 6 notified people, " Hey, there is a problem here with what you 7 have proposed to do?" 8 MR. McELROY: A deficiency letter is currently 9 mailed out on about 40 percent. 10 COMMISSIONER ASSELSTINE: So, 40 percent of these 11 1,800 amendments, there is something wrong with them. 12 MR. McELROY: That is correct. ,Q 13 COMMISSIONER ASSELSTINE: Okay. How often do we 14 inspect these licensees? 15 MR. McELROY: They are scheduled for inspection 16 about every three years. We have someone here from IE who 17 can answer further inspection questions. 18 COMMISSIONER ASSELSTINE: Is that an average or 19 do we cover everybody within three years? 20 MR. McELROY: I would have to defer to IE. 21 MR. COBB: My name is Leonard Cobb. I am the 22 chief of the Safeguards Branch. Most of these medical 23 licensees are inspected at a ro'utine frequency of once in 24 three years. There are a few that are once in five years 25 that have minor programs.
25 1 COMMISSIONER ASSELSTINE: All right. So, if you've G 2 got problems with 40 percent of the amendments that are now 3 coming in and you inspect on a frequency of once every three 4 to once every five years, then what you are saying is, you
. 5 could allow a situation to go on where somebody is following 6 a procedure that is wrong and you won't catch it for as long 7 as perhaps three to five years.
8 So, what you will have is , they will be operating 8 for what appears to me to be a fairly extensive period of 10 time and you won't have caught the problem. 11 I mean, it seems to me the crux of the Agreement 12 States' position is, what they are saying is, the present 13 . approach is proactive because what you do is, you catch these 14 problems early on before they are actually put into practice 15 in the hospital or in the doctor's office. 16 MR. DIRCKS: When you say "proactive ," they submit 17 an amendment. It goes into the pipeline. It takes how long 18 to -- 19 MR. McELROY: Turn-around time is approximately 60 20 days. 21 MR. DIRCKS: Sixty days. 22 COMMISSIONER ASSELSTINE: Sixty days is a lot better w. W 23 than five years. 24 MR. McELROY: May I note that the deficiency rate O
- that we have now is not a fair measure of the licensees'
26 1 ability to make a good safety review of a change because 2 the deficiencies are in many cases born of the fact that the 3 requirements are scattered and the guy doesn't know what 4 the rules are. We have branch policy statements that he has i ! 5 to comply with, and unless he has been in the game, he doesn't 6 know about them. 7 COMMISSIONER ASSELSTINE: If all that stuff has 8 to be -- I could understand that as far as the deficiency 8 letters that you send out on the license application. I 10 guess I don't understand that if what you are talking about 11 is deficiency letters that go out on the amendments because, 12 as I understood what you were saying earlier, once you've got On 13 the license, then you know what is require'd of you, it 's in h I 14 the license. It's not scattered everywhere under the 15 present approach, it's in the license. 16 MR. McELROY: It's in the license but the license l 17 reviewer doesn't underline and say, "You are not ever allowed 18 to change this, and you are never allowed to change that." 19 You have a complete program, but you still have no notice as 20 to which are the essential features in the program, which 21 features that the NRC consideres to be essential safety 22 You still have no notice of that.
, elements.
QM 23 MR. MAUSSHARDT: I might add one thing. This 24 program is approximately four years old and what has happened O 25 is, through the years, as you know, new technology has come
27 1 on line, new procedures have been added. I hate to put it in A YC/ 2 this context, but on an ad hoc basis then new requirements 3 were developed -- either in reg guides, in technical 4 publications. -- and adopted by the staff. And what has been 5 troublesome to us is that there are over a dozen references 6 right now that applicants have to go to. And many of them 7 are somewhat confusing and obscure. 8 COMMISSIONER ASSELSTINE: Yes. - 9 MR. MAUSSHARDT: Now, one of the problems we vere 10 confronted with was trying to what I call " consolidate" 11 this in a fairly simple piece of a rule if we could, if we 12 could put it in that context. And one of the frustrations f5h 53 we've got is that we are not going' to fit everything, I know 14 that. In fact, that is one of the problers we have run into. 15 But I think what we have done is, we have taken 16 and tried to make our requirements clear which has been a 17 problem. And I think the 40 percent of the deficiency letters 18 going out every year is because of the unclear nature of 19 the requirements, not because of -- and it's usually omission;
- 3) it's usually, "I didn't know, I didn't understand." We have 21 had to go back and forth.
22 The 60-day turn-around which Norm talked about,
~) 23 that's just a recent event, and that's primarily due to some 24 streamlining and innovative requirements developed within O 25 Fuel Cycle Division which is the licensee management system.
7 f 28 l . i 1 It has not been a common practice. We are trying to expedite 1 2 the management. 3 COMMISSIONER ASSELSTINE: Although that's something 4 that we ought to be able to expect in the future now that 5 you've got the new management system in place. 6 MR. MAUSSHARDT: Yes, yes. But it 's been very 7 frustrating. I mean, to be very honest with you, it 's been a 8 show and tell" game. 9 COMMISSIONER ASSELSTINE: Yes. Although presumably,
.10 if we have achieved what I think we all want to in consolidatir.g 11 the requirements in the regulations, making them clear and {
j L2 understandable, that should also assist you in processing h") 13 these amendment changes as well. , N._ If everybody now fully understands what the 14 15 requirements are and you don't have arguments about what is 16 required and what isn't required, then the minor amendments 17 should become even easier to process, as should the major ones, 18 MR. MAUSSHARDT: I would agree, but it still 19 requires resources and you know, in a time of scarce resources , 20 we felt as a straight-out management initiative that this l 21 would be a savings to the staff, i 1 22 COMMISSIONER ASSELSTINE: I get the sense from G 23 what you are saying that you really don' t think that the 24 problem is with these amendment deficiencies perhaps in the 26 fact that with smaller operations, individual physicians or
I l . . 29 h j 1 the smaller operations, individual physicians or the small
' 2 hospitals, that these people just aren't as prepared or as 3 capable, or as fully trained, for example, as the Johns 4 Hopkins staff. You wouldn't attribute any of the deficiencies 5 to that?
6 MR. MAUSSHARDT: No, I believe they have to meet 7 the same requirements. Now, Norm took a look at the last 8 two years of citations that have gone out. Maybe he could 9 present that. That might, I think, resolve the problem. 10 MR. McELROY: In virtually every citation letter 11 that I have looked at, thereaare a couple of deficiencies 12 you forgot to survey for a week -- the survey meter was out 13 for calibration; your Safety Committee didn't meet. These. 14 are the kinds of citations that we are issuing to the licensees, 15 not things that I personally would characterize as major 16 problems that the inspector just got there in time. But 17 rather, early signs of a need to perhaps remind the corporate 18 management that things have to be run on the straight and 19 narrow. 20 COMMISSIONER ASSELSTINE: But I guess that is sort 21 of the way I would expect it because the focus of the 22 inspection program is, are they complying with current A.) And where I would > 23 requirements and with current procedures. 24 suspect you would get the question about, are there problems 25 in their understanding of these things and in the changes they
30 1 want to make, would come out of the deficiencies in terms 2 of the review of the amendments. The citation process I would 3 not expect to focus on, are they making changes without asking 4 us.
'5 MR. McELROY: Well, if -- I 6 COMMISSIONER ASSELSTINE: Or are they making bad 7 changes?
I 8 MR. McELROY: If there was a lot of unclearness or 9 ignorance out there among the licensees, I think we would i' 10 see a much higher non-compliance rate than we have seen in 11 the inspection reports over the last several years. l 12 COMMISSIONER ASSELSTINE: You mentioned the checks 3 .- f8% 13 and balances . Isn't there a big difference in terms of how l . . 14 effective those checks and balances are, and to what extent 15 they really are checks and balances, and whether you are 16 talking about the large operations as opposed to the individual 17 physicians or the very small hospitals. 18 It seems to me, as I think the Agreement States L 19 point out, in the smaller hospitals typically what you have i 20 are the radiation safety officer and the radiation safety 21 committee being the very people that -- essentially they are 22 all the same people, the same people actually doing the oj" 23 administrations, the very small group. 24 MR. McELROY: Yes. @ 25 COMMISSIONER ASSELSTINE: And typically, your
31 1 checks and balances, to the extent they exist, are within the 2 small handful of people that are directly involved in setting 3 up and running the program. It's not like, say, at a Johns 4 Hopkins where you might have a large number of people to 5 draw from and you truly get the kind of independence you 6 would expect from a checks and balances system. 7 MR. McELROY: When I spoke of the management 8 checks and balances I was referring to the compocition of 8 the ccmmittee. As you know, most of the technical experts 10 on the committee are going to be the users. Well, that is 11 going to be the case in most any institution. 12 But note also that we do require a management f 13 representative who knows about running hospi.tals. He doesn't 14 know about radiation. And we also have a representative of 15 the nursing service who, more than likely, had a little bit 16 of radiation training in nursing school but also is not a 17 day-to-day user but is able to advise the committee on how 18 the use of materials or the patient flow is going to impact 18 on the delivery of nursing care. 20 So, there is more than just the users there to 21 look at what is going on in the program. 22 CHAIRMAN PALLADINO: We might have a chance to %) 23 pick uip some of these questions with the other representatives. 24 COMMISSIONER ASSELSTINE: Yes, okay. 25 CHAIRMAN PALLADINO: Maybe you want to go to --
32 I 1 COMMISSIONER ASSELSTINE: I had just one more on 2 the ALARA thing. 3 I wonder if there is somebody here who could high-4 light Region III's view on the ALARA concern, why they believe 5 that ALARA reviews should be required for the individual 6 physicians. l 1 7 And also, I would like to know what would be a involved in doing an ALARA review of that kind. You know, 9 how burdensome is it? Is it something that can be done 10 fairly simply and easily? 11 MR. McELROY: The regulation requires in hospitals 12 that once a year the Radiation Safety Committee do what we fag 13 have titled the section in the regulation, an ALARA review , (_ ' - 14 of the radiation safety program. 15 The purpose of that review is to have the committee 16 sit down, close the door, look at what is going on with 17 materials, how much material is being used. Has management 18 been responsive to suggestions? What are the worker dose 19 levels within the department, how do they compare to other 20 facilities of a similar size, that kind of thing. 21 We did not require that of private practice doctors 22 because they are the sole line manager there, they are the 23 sole expert who could make that kind of review and it just 24 didn't seem to make a lot of sense to have him sit down and O 25 have a serious conversation once a year. That is why the
33~ 1 formal ALARA review requirement was only placed on a hospital. () 2 We do have the general exhortation in Part 20 that 3 all practices should be continuously reviewed for ALARA 4 considerations, and that would hold in hospitals, private 5 practices, and all other licensees. 6 COMMISSIONER BERNTHAL: Jim, if I could interject 7 a moment. But that implies that the principal difficulty in 8 failing to achieve ALARA is an organizational difficulty. Is 9 that necessarily true -- or would be an organizational 10 difficulty? 11 MR. McELROY: No. Remember, in hospitals we don't 12 have little point sources that you can chain down to the Eg 13 floor. You have patients walking around. There are a lot 14 of nurses walking around and other ancillary personnel. So, 15 there are a lot of non-users affected by the nuclear medicine 16 department, and that's why it is more important to get 17 everybody in at one time to look at the whole program. 18 In a private practice, the doctor is on the license, 19 he has a secertary under his supervision, possibly a nurse 20 under his supervision, and a technician under his supervision. 21 He knows where all the material is; when it comes in; when it 22 goes out. ,' 'h 23 So, there is no need to get all of the various 24 department managers together at one time to make this more O 25 formal review of the complete program because the key user is i
^ 34 1 there on a day-to-day base, watching everything. 1 COMMISSIONER ASSELSTINE: I guess you are saying 3 you don't see a benefit in having that person sit down and 4 think on an annual basis, or however it is, of the kinds of l 5 practices and procedures that I am using, the ones that are 6 best able to result in as low as reasonably achievable levels 7 of exposures and problems, and at least to focus specifically 8 on that issue on a periodic basis? 9 It seems to me that Fred's got a good point, that 10 it is very likely that it is the practices that are being 11 used that may well be the problem areas in some instances, 12 and not the organization itself. Dh 13 . MR'. Mr.ELROY : No, I would respond that'the doctor 14 in the private practice should be doing that on a daily basis. 15 COMMISSIONER BERNTHAL: How do we know he is? . 16 COMMISSIONER ASSELSTINE: We inspect him once every 17 three to five years. 18 ; COMMISSIONER BERNTHAL: No, it just seems to me 19 that a program of ALARA involves procedures and practices, 20 and not necessarily whether this department knows what the 21 other department is doing. 22 COMMISSIONER ASSELSTINE: Yes. [ ^J/ 23 COMMISSIONER BERNTHAL: Somehow the -- l 24 CHAIRMAN PALLADINO: Well, I think they have given @ 25 you their ansvnr. I'm just worried we are going to run out of
4 35 1 time for the others to present. Can we turn to Fred? (% V;/ 2 COMMISSIONER ASSELSTINE: Okay, sure. Do you have 3 any more questions? 4 COMMISSIONER BERNTHAL: I just have one or two 5 small things here I wanted to raise. 6 I gather that other than trying to weave a more 7 coherent document out of what seem to be disparate requirements 8 and scattered requirements, if I understand your summary 9 correctly. One of the, or perhaps "the" major issue here is 10 the question of how in practice you define minor changes 11 versus major changes. 12 You have commented on this, I guess, briefly. But (*) 13 I am still not sure how we intend to hat.41e that sort of 14 thing. Doesn't that leave the door open for a licensee to 15 somewhat set his own definition of what is major and what is 16 minor? 17 MR. McELROY: No. The regulation clearly lists 18 right up front instances in which an amendment is required. 19 It's if you want another doctor to work on the license; if 20 you want more material than is permitted by the current 21 license; if you want to move from one office building to 22 another or if you are building a new hospital or, if you 23 want to get involved in a new type of use. As an example, I 24 mentioned before, you might be authorized to use radio-O M pharmaceuticals for diagnosis and you want to start using
'~
. . 36 1 them for therapy.
2 COMMISSIONER BERNTHAL3 Okay, that 's the easy part . 3 What about these half of the cases that you say are minor; 4 can you give me instances of borderline cases that never-5 theless within our definition could qualify as minor decisions 6 made by licensees? 7 MR. McELROY: Well, for example in order to show 8 that he has completely thought through the daily flow of 9 materials and so on in his original application, the doctor 10 might say, "I'll have the guy who is working in the radio-11 pharmaceutical preparation area do the close-out survey at 12 the end,of the day." As the operation gets larger, he may (gg 13 want to reassign that task. He can't do that without a 14 license amendment. 15 If the traffic flow through the hospital changes, 1G or if a contiguous area is changed to serve some other need 17 id some other department, he might find it advisable to 18 move his waste storage area to a different part of the 19 nuclear medicine suite. He can't do that. 20 COMMISSIONER BERNTHAL: Let me just get to the 21 first point you raised. Suppose that he wants to designate 22 someone else to do his surveys, I presume our regulations
.- 23 then require that any such ' designee be qualified; right?
24 MR. McELROY: He has to be trained under the Part 19 0 25 requirement.
~
37 1 CHAIRMAN PALLADINO: Okay? C? 2 COMMISSIONER BERNTHAL : Well, I have some concern 3 about that, but we'll hear further, I guess , in a moment 4 from the Agreement States. 5 One other question, and it gets back to an issue 6 that -- "the" issue I referred to earlier. What has happened 7 to the question of medical misadministration? 8 I realize this is a peripheral issue somewhat to 9 today's issues. 10 COMMISSIONER ASSELSTINE: But nonetheless 11 significant. 12 COMMISSIONER BERNTHAL: Where are we on that? (~ . kg- 13 MR. McELROY: This document does not deal with that wa 14 issue. We have not made any change in the current requirement 15 to report misadministrations. 16 COMMISSIONER BERNTHAL: And that means that things 17 are as they were since 1980, basically? 18 MR. McELROY: That is correct. 19 COMMISSIONER BERNTHAL: Well, okay. I'll have 20 more to say about that later. I really find that incredible. 21 I guess I'll have to talk to my colleagues about sone aspects 22 of that. 23 COMMISSIONER ZECH: Just a quick couple of comments. 24 First of all, I think that as far as I can see from the work 'u - 25 that is presented to us here, staff has done a commendable
38 1 job trying to consolidate an awful lot of practices, regulations f 4 2 procedures , and so forth. 3 I recognize it is not also that the Agreement
- l. 4 States and others -- there are certain comments that they 5 will have that are perhaps not uniform agreement. But it 6 does seem to me that you have taken a large step forward in 7 trying to bring together some of these very important 8 regulations, requirements, policies.
9 So, I think the effort is certainly commendable. 10 My first comment is on the procedural side, just 11 to the extent that it does seem to me that the rule is indeed 12 giving more authority to the licensee to conduct his buciness, fA , 13 onc.could say, in a more responsibl'e manner, I suppose, and 14 maybe other terms could be used to-describe it. 15 But it does seem to me that he is being given more 16 responsibility. 17 Also, along the same line -- we just touched on 18 it briefly -- it seems to me , though , that your inspector 19 role is a bigger challenge to make sure that that responsibility 20 is being carried out in the proper manner. 21 So, I'm sure you have looked into that, but that's 22 my perception anyway, that it is a bigger challenge and it M"' 23 should be because of the additional responsibility you have 24 given the licensee, b, 26 My second point really deals with the patient, and
v . 39 1 I recognize again thin is not necessarily what you have
) 2 dealt with in the procedural way you have tied all this 3 together. But I just feel that it probably is important to 4 recognize, first of all, that the physicians, as I understand c
5 it, do have the primary responsibility for protection of 6 their patients. 7 However, we do -- NRC does -- have the authority to 8 regulate radiation safety involving patients. Therefore, we 9 get_into NRC regulations aspects of it in which they are 10 predicated on the assumption that properly trained physicians 11 and others are administering radiation treatments, for u example , properly and in the best interest of their pa'tients , g[g 13 But I question a little bit -- again, I know this is not necessarily what you have been involved in here, but 14 15 I can't help but take this opportunity to say, for example, 16 is the patient informed of overdoses? Who does that? Are 17 we sure he is, and shouldn't he always be? 18 Regulations are trying -- as I see it, we are 19 putting regulations together, try to seek a balance between 20 our responsibilities in the controls that we have under our 21 authority, and also we are trying, though, not to interfere 22 with medical judgments. To me that is a very important
- ) 23 balance to try to seek.
24 So, my only comment here on this particular aspect of O 25 it -- and I think it does have some bearing on the rule that
40 l 1 you are putting out, would be that it seems to me that in ! O 2 the statement of considerations to the proposed revision of 3 Part 35, you can summarize in as clear, straight-forward [ 4 language as possible NRC's regulatory role insofar as the l 5 patient is concerned. It seems to me that would be useful. 6 That's all I have, Mr. Chairman. 7 CHAIRMAN PALLADINO: Thank you. Any other comments? 8 COMMISSIONER BERNTHAL: I just want to say, the 9 whole are of medical misadministration especially, and.I l
\
10 think the question of our enforcement responsibility as well, j l 11 Mr. Chairman, is a subject that I think we are long overdue I l I l 12 to, pick up and take a careful look at. )' 13 CHAIRMAN PALLADINO:, Well, I suggest we do that. , 14 in another forum. 15 COMMISSIONER BERNTHAL: Well, I agree, not here. l 16 But I just want to be on the record here as lodgi6g that' 17 request with you, and I would like to ask that my fellow 18 Commissioners be polled and that we do that. 19 COMMISSIONER ASSELSTINE: I think that's a good 20 idea. I agree with that. And I think some of the points 21 that you were raising, Lando, in terms of making sure that 22 the patients are notified. Whether the provisions in the 23 present misadmin'istration rule are strong enough in that 24 regard, I think, is a question that we ought to take a look 25 at. And Fred refreshed my memory about some other in-
41 1 consistencies in the misadministration rule in terms of the' O, n v 2 size of doses that have to be reported, or the wrong patient 3 as opposed to the right patient who just gets the wrong dose. 4 There are some inconsistencies there that don't seem to make 5 too much sense. 6 And I think E' red's point about enforcement on 7 misadministrations is a good one as well. I think we ought 8 to revisit these issues. O COMMISSIONER ZECH: We have a responsibility in 10 this area. 11 COMMISSIONER ASSELSTINE : That's right. And I 12 think it's fair to point out, I think the Agreement States' fA 13 statement does, that with the exception of power. reactors ( 14 this is the area where you have the highest level of exposures . 15 It is a significant area and it is one where unlike in a 16 reactor you are dealing with the public directly, and it is 17 not a situation where you have carefully protected areas, 18 and fences, and those kinds of things. It is a more direct 19 public interface. 20 COMMISSIONER BERNTHAL: It is far, far more 21 significant than power reactors in exposure to the general 22 public. Power reactors are piddly in terms of general public j 23 exposure,-- 24 COMMISSIONER ASSELSTINE : In terms of individual exposure,
.- 42 1 COMMISSIONER BERNTHAL: -- compared to this stuff.
p
\b) 2 COMMISSIONER ASSELSTINE: Yes, that's right.
3 CHAIRMAN PALLADINO: Let me interject, we will 4 address this issue. 5 COMMISSIONER ASSELSTINE: Okay. 6 CHAIRMAN PALLADINO: But at another time. I am not 7 indicating that it is an unimportant issue, I think it is 8 a very important issue. 9 COMMISISONER ASSELSTINE: Good, 10 CHAIRMAN PALLADINO: I concur in many of the 11 comments made. 12 I am' going to suggest now we turn to representatives
- 13 of the Agreement States. We thank the staff for their i
14 presentation and answers to the questions . 15 I want to welcome both of you here. I understand 16 you are Mr. Joseph Ward. 17 MR. WARD: Yes. 18 CHAIRMAN PALLADINO: Chief of the Radiological 19 Section of the California Department of Health. ( 20 MR. WARD: Yes. , l 21 CHAIRMAN PALLADINO: And Mary Lou Blazek, Oregon 22 Radiation Control Section and Chairman of the Ad Hoc Group 23 on Part 35. I 24 I will be delighted for you to proceed. 26 MR. WARD: Thank you. I presume, Mr. Chairman, that
- _ . . _ _ . _ _ _ _ . _ - _ - , . _ - _ _ . ~ . _ , - - - _ _ - _ . - - . _ - _ . . , _ , - _ - _ _.
3 ,. 43 1 you and. the Commissioners have the statement that the 2 Agreement States have prepared. So, I won't trouble you -- 3 CHAIRMAN PALLADINO: Is that the one? l 4 MR. WARD: Yes. The document titled, Statement 5 of the Agreement States on Proposed Amendments to 10'CFR Part 6 35. So, if you agree, I will just paraphrase those in the 7 interest of time. 8 We began, of course, by thanking the Commission for 8 its work in consolidating the appropriate medical regulations 10 in one group. We think that as the staff has suggested, 11 that this will contribute largely to a better understanding 12 of what the obligations of licensure are on the part of the
. 13 medical community and those who have,to regulate under those.
14 But we don't find that we agree that that will is resolve the problem. We think that interpretation will 16 continue to be made and interpretation will have to be made 17 by the regulatory staff, and that we can contribute, you I8 know, significantly to the understanding of those regulations 18 by continuing to participate more fully.
" The alternative that has been suggested as 8I Alternative 3 in the staff analysis would have you adopt c,s 22 Part 35 as reconsolidated, but would continue to permit us W- ;f 23 to participate in the review of these so-called minor 'l 24 procedural requirements with which failure rate we have 26 already had some comment here today. Ar.d the failure rate , I l l
.' . 44 I think, is one that we could contribute to the reduction or Ys 2 prevention of before the fact, proactive, as we suggested.
3 The staff analysis relying on that suggested that 4 the burden on the industry and probably th( burden on the y 5 staff', if I understand the testimony here today, is modest. 6 I would paraphrase by saying, I think it's probably more 7 modest than the burden that will be placed on the inspection 8 staff if they are to do the same thing all over the country 9 as individuals without the opportunities of peer review 10 and agreement on, this is the principle of the activities 11 that the regulatory agencies themselves want to see uniform 12 throughout the country, f, 13 - It was a very modest addition, if you will, some- , 14 thing less than half a percent to the cost of it. We would 16 want to reassert that we think the collective experience of 16 the Agreement States and certainly the NRC staf# in dealing l 17 with problems that arise in the practice of nuclear medicine l 18 is considerable, and that a great number of the licensees f 19 with whom we work w'ill profit by talking to us before the
- 20 l ,-fact about what it is they want to do.
- 21 There are many small institutions in the country, 7s 22 '
people who are quite depenfent on the contribution, if you
. y 23 will, and we think of it as a contribution that regulators c3 24 make in interpreting and making specific for the particular kV M case in point the things that the applicant in this case would
45 I want to do safely. 2 We don't want to belittle the importance of making 3 a decision on what is safe and what is unsafe. It's a very 4 trying question to answer and it is one that is never answered 5 to everyone's satisfaction. Certainly, it is one that has 6 never been answered to the satisf action of the public, at least 7 in most of the issues in which we get involved. 8 So, we want to continue to have a fairly strong 9 program in this area, with the kind of control that has 10 resulted in a great success that is being given as a reason 11 for the abandonment, if you will, of some of the control. I
. 12 think that success speaks for itself. I think the program is
/f} 13 running well. I think that we should contin.ue to run it as 14 we are doing and take credit for that rather than titrate 15 backwards and find out where it is that we can go and how 16 little we can do before problems of significance arise. 17 I think that the cost of going ahead is, we are 18 doing it modest and affordable. Certainly, there are people 19 who are capable of taking care of themselves and we find 20 them in every level of activity. So, again I would say 21 that there are an expected number of failures which we can 22 prevent and control. w/ 23 I think the point was made earlier that this is a 24 substantial area of public exposure to radiation, second O 25 only to x-ray exposure, which is the principal man-made source
o' . 46 1 of radiation in the country. This, at least the last time 2 I read a study, is about 20 percent the size of that and it's 3 a large number. It is not one on'which, I think, we should 4 retreat at all from the successful program that I think we 5 now have. 6 We suggested a couple of alternatives to you. One 7 is to simply adopt Part 35 as written, but continue to review 8 the survey and other so-called minor procedures that we are 9 now reviewing or, wanting that, find some kind of division 10 point that is reasonable in terms of identifying that class 11 of medical licensees to whom our experience base is a 12 substantial contribution, perhaps somewhere in the 200 or fDg 13 300-bed . class and below, and require those people to continue 14 to work through us on their changes. 15 Those are, briefly, my remarks. 16 CHAIRMAN PALLADINO: Ms. Blazek? 17 MS. BLAZEK: I would only like to add that in 18 pyramid to this we made an effort to -- I mean, an unofficial 19 9011 of ten Agreement States , tried to include some 20 large states as well as the Southern States and the East 21 Coast, and the West Coast, 22 In those ten states we have found that 82 percent J 23 of the facilities licensed by those ten Agreement States 24 have 82 percent of those facilities that are licensed are 25 under 300 beds. And I was given information by all ten of
47 1 those Agreement States that that is the cut-off point that 2 they feel they have seen dif ficulty with Radiation Safety 3 Committees not being as functional as they should be to make 4 the kinds of changes that are being suggested, 5 The percentages went as high as 90 percent in the 6 State of Texas. 7 CHAIRMAN PALLADINO: You mean 90 percent in 300 8 and less. 9 MS, BLAZEK: Three-hundred beds, and that seemed to 10 me because I was asked to explain to the Commission by those 11 individuals that I spoke with, that their feeling, strong 12 feeling that just because a facility is greate.r than 300 fag 13 beds is not to say that they have a functional, well-rounded 14 committee; and they wanted that perfectly well understood, 15 But as a general rule the feeling, at least in 16 those ten states that I polled, was that in the hospitals 17 with less than 300 beds they felt that these were the size 18 committees that were not a viable committee. 19 CHAIRMAN PALLADINO: Is there a sharp cut-off at 20 300, or is that just a judgment? 21 MS, BLAZEK: Two-hundred, three-hundred. In the 22 State of Oregon, which is my residence, 76 percent of our ,' i 23 facilities are less than 200 beds; 81 percent are less 24 than 300 beds, 25 CHAIRMAN PALLADINO: No, I meant with regard to
- . 48 1 difficulties with compliance, is there a sharp cut-off at 2 300 beds or 200 beds?
3 MS. BLAZEK: No, I don't think so. 4 CHAIRMAN PALLADINO: Okay. Excuse me, I didn't ' ' 5 mean to interrupt. 6 MS. BLAZEK: The only other statement that I was 7 asked to bring to your attention, there was one particular 8 state that got in contact with me and wanted me to share 9 with you that 42 percent of all the nuclear medicine facilities ; 10 they had inspected in the last 18 months, 42 percent were 11 cited for failure of the Radiation Safety Committee to 12 perform the required review. 13 f7h ,
. So, close to half of their licensees are not 14 doing the review that is already requested and required.
15 CHAIRMAN PALLADINO: Thank you. 16 Let me ask two questions and then I'll go to my 17 colleagues. I'll try to be shorter this time. 18 The staff made a point that the difference betwen 19 major and minor changes is well established in the 20 regulation under this proposed rule. Do you concur in that, 21 do you have some feeling as to whether or not a good 22 judgment can be made by those that are in the practice?
~~
23 MR. WARD: " I 'think -the staff 's position was that 24 there were, I think, some five specific items which they [h 25 declared to be major, and all others were minor.
. 49 1 I think that people familiar with that regulation a
G 2 who will read it and understand it will know what it is 3 they must apply for and what it is they need not. I think 4 that is fairly clear. I think it is the significance of 5 the so-called minor changes themselves that are our point of 6 concern. Many of those will have, in our opinion, a 7 safety implication if not dealt with properly at the 8 beginning. 9 CHAIRMAN PALLADINO: You mean some of those things 10 had fallen -- 11 MR. WARD: The minor things will require the 12 attention and the consultation with the regulatory staff. 13 dHAIRMAN PALLADINO: Do you have an example or 14 two of that? 15 MR. WARD: Mary Lou, you are more familiar with 16 that. 17 MS. BLAZEK: -- procedures would be one.
- 18 CHAIRMAN PALLADINO: What is that?
19 MS. BLAZEK: -- survey procedures. They could 20 make changes and, indeed, the staff has pointed out that 21 the regulations are there. These individuals can be cited, 22 weScan go in and correct the problems because the av 23 regulations are there now. If they come in with an 24 amendment and say, "We want to change our leak-test procedure 25 or we want to change our survey procedure and we are going to
50 I do it thus-and-so," we have an opportunity then to get them
- O 2 on the right track.
3 This way, they can change it and indeed, we can 4 cite them because indeed the regulation is there. But again, 5 it's after the fact. I_ don't consider those minor changes. 6 CHAIRMAN PALLADINO: One other question. What is 7 the impact of our Part 35 rule if it goes out the way it 8 is proposed? What would the impact be on the Agreement 9 States? 10 I gather, from what I read, you are not required 11 to follow it. I should have addressed that to the staff, but 12 I forgot, g 13 MR. WARD: Well, there may be a couple of answ rs k" ' . 14 to that. I think because it is not required, it is probably 15 not too important. It will be required by the pressure of 16 circumstance. Whether we choose to follow it or not, or 17 whether we think it is a good idea or not, we c,ertainly won't 18 trim our resources or redistribute them from licensing to 18 field inspection to accomodate this eventually. 20 So, we don't depart from the Commission lightly. 21 CHAIRMAN PALLADINO: All right, thank you. Let 22 me turn to some of my colleagues. Jim?
,m 23 COMMISSIONER ASSELSTINE: Just a couple of questions .
I'll start with a comment, I thought your statement was very 26 good. It highlighted very clearly what your concerns are
.' . 51 I and the basis for them. I thought it was very helpful.
"9 2 One of the statements that you make on page 3, 3 you say, "It's been the Agreement States' experience that 4 much more than a small minority as the NRC staff implied 5 do not take the time nor.have the inclination to adequately 6 review safety procedures. This is supported by the current 7 level of amendment request deficiency letters." 8 Has your experience -- you have more licensees in 9 totality in all the Agreement States than we do in this 10 area. Has your experience been about the same as what the 11 staff indicated to us in terms of the number of deficiencies 12 and deficiency letters that you sent out on these kinds of M 13 amendments? , k-hink we are sending out a few more 14 MR. WARD: I 15 deficiency letters on amendments than that. I don't have 16 a specific number, Commissioner. 17 COMMISSIONER ASSELSTINE: Okpy. 18 MR. WARD: And I think that the average amendments 19 for medical licenses is about one a year overall. 20 MS. BLAZEK: I think we are very close to that l l 21 figure, perhaps more. 22 Okay, so it's certainly COMMISSIONER ASSELSTINE: 1 23 So, it would be at least 40 percent of these l not less. l 24 l you find problems with. O 25 You mentioned also the dif ference in the burden
.. . 52 I that would be placed on the inspectors. Could you talk a
() 2 little bit more about that? Increasing the difficulty that 3 the inspectors have in terms of looking at these thinga, as 4 well as the other things. that you look at. And also, maybe 5 if you just give me a feel for how long will these inspections 6 run, say, if you are in a small hospital or an individual 7 physician. 8 MR. WARD: We can usually do about one and-a-half 9 a day, one inspection in one of these institutions, in 10 about half a day. 11 COMMISSIONER ASSELSTINE: It's a pretty brief 12 inspection, then.. fI t' 13 MR. WARD: Yes, it is, and necessarily so,
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14 unfortunately. The problem is usually that of having an 15 opportunity to observe. Should we be able to observe people 16 doing work, as experts we might find flaws that we would not 17 otherwise do. But if we go into a small institution, that 18 does a dozen or so procedures a month, I think that's sort 19 of a difficult -- a small institution. It's very likely 20 we will have nothing but records to deal with. So, the 21 opportunities to find faults in survey practices and leak 22 tests, and package acceptance procedures and so on is very 23 limited. And to make pre-arranged inspections on that 24 particular day or afternoon that you are invited or agree to @ 2 go might be misleading. It certainly wouldn't provide the
, 53 1 kind of independent review that we are seeking in the 2 inspection process. Mary Lou?
3 MS. BLAZEK: I think, as Joe indicated, the 4 procedures are**not done every day. So, you are going to have 5 a problem seeing package receipt procedures or leak test 6 procedures, or survey procedures, or all those things unless 7 you ask them specifically to go through the procedure. 8 Simply going to a file to see what safety measures 9 they took before they did it, I'm not convinced that is going 10 to be any help at all.-- the Radiation Safety Officer is 11 also the user, is also a member of the Radiation Safety 12 Committee. 13 CHAIRMAN P'ALLADINO: Could I ask a clarification y. (_. 14 question? How often do the Agreement States, on the average, 15 inspect these licensees? 16 MR. WARD: Our inspection frequency is exactly the 17 same as yours, , 18 CHAIRMAN PALLADINO: So, it's roughly once every 18 three years. 20 MR. WARD: Three to five. 21 MS. BLAZEK: Three to five. And the interesting 22 thing about the five years, we have gone to those of the 23 small licensees who don't have any therapeutic uses of 24 material. So, we are working with a smaller hazard, but 25 then you increase the inspection frequency. Then they've got
54 1 a period of five years where they could really get into b trouble making their own decisions without any guidance. 2 3 CHAIRMAN PALLADINO: But now, if we go along with 4 the procedures that the staff had suggested, would that 5 significantly change the number of deficiencies or change the 6 inspection period? 7 MS. BLAZEK: I'm sorry, I don't understand. 8 MR. WARD: Well, I think if we expect that 40 per-9 cent of those procedures submitted are defective on their
~
10 face, that 40 percent will be undetected until we get there 11 five years later. 12 COMMISSIONER ASSELSTINE: Right. Whereas now'they would find them *- I assume your processing time is similar (3) 13 w 14 to the staff 's? 15 MR. WARD: Yes. 16 COMMISSIONER ASSELSTINE: So, now you would find 17 them within a month or two of when they submitted the 18 proposed change, whereas if you have to go to the staff's 19 approach, it might not be for three to five years. It 20 probably wouldn't be for three to five years until you went 21 out and did the inspection. And given the difficulties in 22 the inspection, you might not even find it -- 23 MR. WARD: It can't be detected. 24 CHAIRMAN PALLADINO: But there may be other O 25 deficiencies that have to be caught by inspection.
55 1 COMMISSIONER ASSELSTINE: Oh, yes. But these are 2 all over and above those. Yes, that's right. 3 COMMISSIONER BERNTHAL: Well, but you just -- let 4 me take the other side of this for a second. You have just 5 said that it's very hard, and I think you are absolutely 6 right, the cold files on the kind of work people have been 7 doing. 8 That would suggest to me that the principal , 9 responsibility that you would have is perhaps in surveys, 10 inspections that look at housekeeping and physical lay-out, 11 and that kind of thing as the best indication that you would 12 have of whether things are likely to be going right or not 13 going right, as the case may be. 14 So, I guess it's not so clear to me that getting 15 paperwork on procedures ^is really g6ing to -- why would that 16 necessarily solve the problems? Paper doesn't tell you 17 very much. 18 MR. WARD: Well, if there is a -- l 19 COMMISSIONER BERNTHAL: You could still do your 20 surveys and inspections. Housekeeping, for example, would 21 tell you a great deal. On things like that, you could 22 certainly do it, that's the most important thing, 23 COMMISSIONER ASSELSTINE: But aren't there two 24 aspects to it? The first part is, do they have a proper 25 procedure in place for doing leak testing or surveys, or
i 56 I whatever. And the second is then, if they have the proper O 2 procedure in place, are they following it; are they following 3 good practices and properly carrying out the procedures. 4 The first part would be caught, presumably, with 5 the amendment review, the change review. The second part 6 won't be caught until the inspection and the question is, 7 how much, how significant are those kinds of deficiencies as 8 opposed to the latter kinds of deficiencies, and how much 9 of an increased risk are you then adding by deferring that 10 first group until the inspection group and adding that as a 11 burden on top of what the inspectors already have to look at. 12 COMMISSIONER BERNTHAL: But it seems like some ("S 13 of the things the staff told us about -- I asked for border-L 14 line cases. I'm not sure whether they gave me borderline 15 cases. But for this half or so of amendments that are 16 currently required maybe the threshold is just too high. 17 Is there some lower class of amendments, or lower 18 threshold that might be 30 percent or 40 percent that you 19 could agree are matters that are not even of such procedural 20 import that they rise to the threshold of being likely to 21 include that 40 percent that you say you find have problems? 22 Maybe the staff's threshold is too high. Have you s 23 thought about that? 24 MR. WARD: I haven't, and I don't know how I would 25 be able to define the real de minimis procedural change. I
57
- O 1 think the thing I would say is that those things that are h 2 quite trivial don't take long to review. And those things 3 that have implications deserve review. So, again I would 4 say on balance it's better to look than not look, 5 CHAIRMAN PALLADINO: More questions?
6 MS. BLAZEK: Could I just add one thing? The 7 staff brought up thatsthe changes in procedures that they 8 perceive are minor changes, Sally Jones is going to do a 9 survey on "X" day. 10 It's been our experience in the Agreement States 11 that we would stop them from saying, " Sally Jones do a 12 procedure." We would say to them, "We want to know that
}
13 the procedure will be done on "X" day or "X" frequency. 14 So, that would not take a change. So, I don' t see that as -- 15 I see that as a minor change that should never have been 16 happening in the first place. 17 What we perceive as a problem or what the staff 18 is calling a minor change that we wouldn't agree with is 19 for instance a leak test procedural change. They come in 20 and they say they are going to have "X" consultant who is i 21 Three days later they qualified to do their leak tests. 22 find out that's going to cost them money. 23 I missed the last part. CHAIRMAN PALLADINO: 24 That that is going to cost money. m MS. BLAZEK: 25 So, maybe the physician decides the technologist should
.. 58 I
have the expertise to do it. He says, "Take care of it." 2 The technologist has a survey instrument that is not capable 3 and they start doing the leak test procedures in-house 4 inadequately. Five years later we find out, well, yes, they 5 have been doing them every six months. 6 But that's the kind of procedural change that we 7 see a problem with, and I don't consider that minor. 8 COMMISSIONER ASSELSTINE: It also seems to me that 9 there is an enforcibility problem here. The thrust of a 10 lot of this, as I understood it, was to ' cry and identify as 11 speifically as we could what is required. Put it all in 12 one place so that everybody knew up front what was required.
- 13 And it seems to me that if now what you are NC) w' 14 saying is, to the licensees , "You can make minor changes l
15 in anything other than the few that are specifically l ! 16 enumerated in the regulation, you can make those and you l l 17 don 't have to come back and get our permission beforehand." 18 Then it seems to me you create theuargument on the part 19 of the licensee up until we do an inspection and find l 20 something that, "Well, wait a minute, you gave us the We made the change. We 21 authority to make the change. 1 22 think it was a perfectly legitimate change and, you know, 23 this is the first opportunity we have had to know that 24 you don't think that it's an appropriate change, and now 25 we start from square one. And whatever exposures have
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o 59 l 1 occurred up until now, you know, that's too bad. That's our O'M 2 authority." 3 Do you see see that kind of a problem in terms of -- 4 MS. BLAZEK: Yes. 5 COMMISSIONER ASSELSTINE: And doesn't it cut against 6 sort of the thrust of what these changes were all supposed 7 to accomplish to start with? 8 MS. BLAZEK: Yes. 9 COMMISSIONER ASSELSTINE: One other question I 10 had -- I wanted to get their views on the ALARA question 11 for individual physicians. 12 Do you all see a benefit in the position taken by 13 one of .our regional offices that individual physicians ought %@) r 14 to be required to do a periodic ALARA review specifically, or 15 do you think it's sufficient just to have the large 16 institutions do that? 17 MR. WARD: I certainly would hope an ALARA could 18 work in every case and would encourage its use by individuals 19 as well as corporations. I think that again this is an area 20 in which the states have traditionally least because of 21 their experience with X-ray been pushy, if I may use that 22 term, in trying to promote thought on things that would ( 23 improve practice in whatever modality was being considered, 24 which is our contribution to their thinking about ALARA, if 25 you will. We would encourage that.
60 1 COMMISSIONER ASSELSTINE: One last quick question. 2 Your recommendation was to draw a cut-off line, say 200 to 3 300-bed hospitals, something like that, and below that they 4 would still have to come back for the changes to the 5 amendments. 6 Was that motivated by at least trying to come up 7 with something that was a compromise with the staff and to 8 what extent is, you know, is your preference that all of 9 these people come back for the changes up front? 10 MR. WARD: Well, -I think we would prefer that all 11 these changes be reviewed as a fall-back position, if you will, or as one that would accomplish much of what we
~
12 (S) 13 intended. We can pick a point. , v 14 COMMISSIONER BERNTHAL: It sounds like .if you are 15 going to pick 200 to 300 beds, that must be the vast 16 majority of the so-called extra paperwork we are talking 17 about here anyway. So, it wouldn't make much sense not to 18 just do it across the board -- 19 COMMISSIONER ASSELSTINE: Yes. 20 COMMISSIONER BERNTHAL: -- if you do it for 21 hospitals smaller than that. 22 COMMISSIONER ASSELSTINE: Yes. That's all I had, 23 Joe. 24 CHAIRMAN PALLADINO: All right. Fred, did you have 25 more?
61 1 COMMISSIONER BERNTHAL: Go ahead. I had another ! 2 thing I was going to ask, but I can't remember what it was.
)
3 COMMISSIONER ZECH: Just a comment. I think your 4 views have been well presented. I think you are talking 5 of practical things as at least I understand what you are 6 trying to say. Although I do feel that there is some merit 7 to inspections, regulations, rules that are to be followed 8 and so I would say that the proposed rule would be something, 9 of course, that you would want to comment on and continua 10 working with the staff on. 11 I would hope that we are both working for the 12 common goal of the protection of the public health and 13 safety, that's what it'is all about. Now, if it regt$ ires more 14 paperwork or more inspections, or whatever, if it's the 15 right thing to do, then we ought to do it. 16 On the other hand, we shouldn 't do something just 17 to create a paperwork mill. So , I think there is a balance 18 there we are trying to seek. I don't know in my own mind 19 now exactly where I would draw the line, but we do need 20 some kind of formality to our procedure and we are certainly -- 21 I think there is room for improvement and I hope that you 22 can continue to work together with our staff and with others 23 to find that balance. 24 COMMISSIONER BERNTHAL: Let me just -- I agree with 9 25 Lando and my thought came back that I wanted to mention
O 62 I earlier. I guess what I would like to see from our staff, 2 if we can see something like this, is a better definition of 3 what these so-called " minor changes" are going to be. If 4 it's half of what we have to look at, I'd like to see a 5 representative cross-section of the kinds of thin 7s that we 6 are talking about here. 7 Maybe there is a class of amendments that can at 8 least eliminate 25 percent of the paperwork if not 50 percent, 9 that is definable in some way that makes sense. I just 10 don't have a very good idea of the sorts of things we are 11 talking about here. And if our staff cares to undertake that 12 task, I would sure like to have a better idea what " minor 6%) la changes" means.
. ~
s.. 14 CHAIRMAN PALLADINO: It might be well to put your 15 question in writing and we can submit it to the staff, and 16 get an answer. 17 COMMISSIONER BERNTHAL: Well, consider it in 18 writing as of -- I guess there is someone writing over there. 19 That's as clear as I can make it. I think SECY can pick up. E CHAIRMAN PALLADINO: Oh , you do a very good job 21 of writing it down, Fred. 22 (Laughter) 23 CHAIRMAN PALLADINO: Well, any more? 24 COMMISSIONER ZECH: No. fn di 25 Well, thank you very much, CHAIRMAN PALLADINO:
63 1 folks. We very much appreciate your coming and sharing your 2 thoughts with us. 3 MR. WARD: Thank you. 4 MS . '.BLAZEK : Thank you. 5 CHAIRMAN PALLADINO: Now we will have representatives-6 of professional associations, and I gather there has been 7 at least one change in the list of participants. So, I am 8 going to ask each of you to identify yourself, and I gather 9 all three of you are going to speak. Is that correct? 10 DR. HENKIN: I assume so. I am Dr. Robert Henkin, 11 representing American College of Nuclear Physicians and the 12 Society of Nuclear Medicine. fD, 13 MR. DYE: Jim Dye with the American Association t 14 of Physicists and Medicine. 15 MR. PRICE: And I'm Gary Price with the American 16 College of Radiology. 17 CHAIRMAN PALLADINO: Which one of you plans to go 18 first? 19 DR. HENKIN: We can take the agenda order, if 20 you want. 21 CHAIRMAN PALLADINO: All right. 22 MR. PRICE: Mr. Chairman, I would just like to make 23 some brief remarks. I'm Assistant Director of Governmental 24 Relations for the American College of Radiology. Mr. Otha 25 Linton who has been actively involved with the Commission for
64 1 a long time wished to be here but did you a favor by not d 2 bringing his flu with him, and stayed in bed instead. 3 (Laughter) 4 MR. PRICE: We appreciate this opportunity to 5 make just some brief comments. And we are pleased that the 6 Commission is considering this revision of Part 35. 7 In testimony at previous hearings, the College-has 8 encouraged this revision so that the applicants for 8 licensure for the medical use of byproduct material could 10 find their task substantially simpler. We believe the 11 Commission shares with the College the goal of making this 12 process as clear and concise, and efficient as possible. p 13 : We sp'ecifically commend the Comniission for t 14 advancing this concept of bringing all the requirements 15 together in one part. We recommend that the Commission -- 16 or rather, we believe that the Commission's responsibilities 17 could be well served by recognizing the emonstrated 18 competence of the licensees to use these isotopes safely 19 and efficiently, and effectively. 20 This, of course, eliminates the duplication of 21 criteria that would be involved, the medical competence 22 found in professionals. 7 ) 23 As you are aware, this proper step towards a 24 reasonable consolication of this process is perhaps -- the 25 time for this is perhaps now, and we hope that you would
65 1 take prompt action. There, of course, may be specifics 2 in the revision with which we would find fault, but it is 3 imperative in our opinion to put it on the public table at 4 this point. And, or course reserving the right to complain 5 about those particulars, w'e do compliment the packaging. 4 6 So, on behalf of the College I would urge your 7 favorable action on Part 35, its submission for public 8 comment and subsequent adoption. 9 CHAIRMAN PALLADINO: Thank you. 10 DR. HENKIN: Mr. Chairman, members of the 11 Commission. I am Robert E. Henkin, a practicing Nuclear 12 Medicine Physician. I am Professor of Radiology at Loyola f.m'/ 13 Stritch School of Medicine and Director of Nuclear Medicine -
~~
14 at the Foster G. McGaw Hospital, a 500-bed teaching and 15 research hospital. 16 I am here today on behalf of the 12,000 members 17 of the American College of Nuclear Physicians and the 18 Society of Nuclear Medicine which represents this country's 19 nuclear medicine community. 20 We would like to express our general support of 21 the proposed rewrite of 10 CFR 35 and would urge that the 22 Commission move this document forward for publication in 23 the Federal Register. 24 The consolidation of radiation safety requirements 25 into one document, which is accomplished in this rewrite,
66 1 provides a more efficient and cost-effective licensing 3 2 2 procedure. We think this is a more sensible approach to 3 regulating the use of byproduct materials on humans, ra ther 4 than the existing arrangement which has requirements 5 scattered amongs regulatory guides, licensing conditions, 6 and staff position pap'ers. 7 We also support the flexibility allowed in the 8 proposed rewrite and the reduction in time associated with 9 licensing and snendments which would result from this 10 revision. 11 More specifically, since the regulation specified 12 the essential elements of a radiation safety program, any (' p.. 13 changes for improved patient care, safety, or cost sav,ings, 14 could be implemented after the Radiation Safety officer or 15 Radiation Safety Committee has approved them without 16 unnecessary or costly licensing review. 17 In this area of cost containment in the delivery 18 of health care services, this effort to consolidate our 19 requirements will be most helpful. More importantly, this
- 2) is not being done at the expense of patient, worker, or~
21 public health and safety. Z2 While we have a number of questions about specifics, 23 let me say in closing, we would like to compliment th'e NRC 24 and its staff for their work on this document and express M the appreciation of the College and Society for the opportunity l
s' ., 67 y 1 to appear before you. i 2 We would hope to respond to a number of the questions 3 that you raised earlier this morning, many of which are very 4 important, and we think we can provide you some information 5 on them. 6 CHAIRMAN PALLADINO: Thank you. 7 MR. DEYE: ~I'm' Jim Deye. I'm with the American 8 Association of Physicists in Medicine. There are about 9 a thousand members of that organization nation wide. I 10 don't have a prepared statement except for a letter that I 11 had written roughly two weeks ago, I guess, three weeks ago. 12 Basically, in that letter what I did was 13 summarize what I feel represents the membership's view 14 that we feel that the package here is, as was stated earlier, 15 is a good package. I think it makes a lot of stride in 16 terms of clarification and simplification that is pulling 17 requirements together into one place. 18 I think it is something that we, practicing in the 19 medical field as expert physicists in that field will find it 20 I know currently, if I go into
.much easier to deal with.
21 an institution and they ask me to say, are we complying with 2 our license I say, "Well, not only show me your license but U I have to see every letter you have ever written to the 24 NRC," and that gets to be a little bit difficult. 25 So, in general we think the package is a good
68 1 package. We do have some technical details that we will 2 address later when it is published in the Federal Register. 3 CHAIRMAN PALLADINO: Let me begin by asking only 4 one question, and this is the one that we have identified as 5 the central question, and ask you to comment on it. 6 The staff proposal identifies major and minor 7 changes, and they would propose that minor changes be made 8 without getting a licensing amendment. Yet, the information 9 that we have been given, both by our staff and by the 10 Agreement States, is that they find that 40 percent of the 11 licensing amendments are deficient and therefore the proposal 12 is, or the counter proposal is not to permit minor changes f' 13 without amendments, b-14 Could you comment on this basic question? 15 MR. DEYE: I'll open that. I'm probably one of the 16 few people in the room who has ever been inspected, number one, 17 and had to file for amendments. I am on the receiving end 18 of this system, if you like. 19 It is very difficult to prepare a license amendment 20 at the present time because of the scattered nature of the 21 regulations. You may feel that you have fulfilled everything 22 NRC wants because of the documents in your hand it looks like 23 you have done that. You send in your requested amendment 24 ,g and it comes back with a deficiency letter saying, "But you
?
25 didn't look at Guide No, this or that." I didn't even own
69 1 guide this or that. I've got to write away and get that guide 2 now. So that a lot of the deficiency letters that occur, 3 occur simply because the current system is real confusing, 4 and that for a -- and we are not a Johns Hopkins, by the 5 way. But for any institution that wants to make license 6 amendments, the current system is very, very awkward. 7 The types of amendments, changing out machines, 8 redesignating people to do jobs, these are management 9 decisions. And as long as they fall within the scope of 10 NRC regs, they should be allowed to be made at the local 11 level. If the reg lays out what it is that has to be done, 12 who does it, or what particular machine is involved in 7 13 doing it, should be the discretion of the people at the site, 14 providing they stay within the regulations. 15 Now, I heard the comment that this is going to 16 increase the inspectors' work because they have to go through 17 all of this. At the present time, the inspector has to la go through every amendment you have made anyway, even if it 's 19 been approved in Washington. They've got to go back through 20 your files, they've got to look at what you wrote; they've 21 got_to look at how you implemented it. So, effectively 22 this isn't any change at all. The inspectors are doing this 23 at the moment. 24 So that they will be looking at something Washington 25 has never seen but the local inspector may not have known
o 70 1 much about what Washington did anyway. We have just been 3 / 2 through a four-day inspection where they went back through u 3 every one of our records again. 4 CHAIRMAN PALLADINO: Do either of the other two 5 have comments?
/
lN C 6 MR. DEYEi'- I second pretty much what he has said, 7 also, as one of the people in the room who has actually been 8 inspected, and say that it seems to me many of the deficiency 9 questions -- in fact, in my case they had to do with phone 10 calls rather then actual letters back to the institution 11 just clearing up some wording, you know, what did you really 12 mean by this, or could you be more specific, send us a follow- ~ 13 up letter being a little bit more specific as.to what that 14 paragraph really meant. And so, I follow up with a letter 15 with the clarifying paragraph. Now, how that got transcribed into the statistics 16 17 here I do n't know because I am not on this end of it, but 18 I have a suspicion it got transcribed in there as a 19 deficiency follow-up, and it was a very minor sort of thing. 20 It was just a matter of semantics really, is what it came 21 down to, to clarify something that was said in the letter. 22 CHAIRMAN PALLADINO: Have any of these deficiencies 23 been of safety significance in your own experience to 24 the extent that , had they not been detected for three years? 25 They were purely MR. DEYE: Not in my institution.
'O 71 1 a matter of -- we were both on the same wave length. I had J 2 fully intended to do what was r..pecu.d, but I had said it 3 in such a way that it was no' clear to the person who was 4 reviewing the license. And so, when I clarified it over 5 the phone, one technical discussion to the other, "Oh, yes, 6 that's certainly exactly the way I meant it." He said, "Well, 7 could you restate it so it is more clear to us." I said, 8 " Fine, and followed up with a letter.
9 CHAIRMAN PALLADINO: So you found none of these 10 that have safety significance in your experien e. 11 MR. DEYE: No. 12 DR. HENKIN: No, we have never had any that have [~ 13 had safety. It's always been a question of whether we had 14 the right guide and used the right key words, 15 COMMISSIONER BERNTHAL: Yes, but aren' t you guys 16 sort of the big guys? I mean, it seems to me one of you 17 said 500 beds. 18 COMMISSIONER ASSELSTINE: Or at least the " middle" 19 guys. 20 COMMISSIONER BERNTHAL: That, I gather, is not the 21 type of organization that the Agreement States have the most 22 concern about. U DR. HENKIN: Let me reply to that because I was 24 sitting here listening to that, and I travel around to a 25 lots of hospitals to teach, that's one of the things that i
72 1 you are expected to do in a university. And most of them s j 2 I go to are small hospitals. We've got a program at our 3 place that has three physicists running the radiation safety 4 program because we've got about 150 users on board. Most 5 of the places I go to have got one user or two users. 6 CHAIRMAN PALLADINO: One -- 7 DR. HENKIN: One user or two users, maybe three 8 users. The complexity of program required at these different 9 levels is very different. We've got one guy who is buying 10 his isotope from a radiopharmacy coming in precalibrated. He 11 checks it, administers it, does some surveys. 12 The requirements, in fact, on the big boys make 13 a great deal of sense. Okay, we have people using bio-14 hazardous material, we have things of that sort going on 15 at the research sections. 16 In the clinical laboratory, our volume is chree 17 to ten times that of some smaller institution. So, again it 18 makes sense to have an in-house expertise and to be able 19 to handle it in-house. But if I go out to a 250-bed hospital 20 where they are doing three procedures or five procedures a 21 day, how much of a level of complexity can I impose on them 22 for a hazard they may be incapable of creating? M COMMISSIONER BERNTHAL : Excuse me just a minute. It 24 almost sounded like when you were saying that the consolidatior t M work that was done by our staff, putting these regulations
+' :l.>
'I e
l
) l- a 73
>i i 1 all into one place, might remove a good deal of the problem N
il 2 in itself, though, in handling these many amendments. Is 3 Shat not the case? 4 J MR. DEYE: I think the amendments will still be 5 generated.. They get generated by internal situations, not 6 by the way the regs read. It just might be easier to write 7 up your amendment request than it had been in the past 8= because you don't have to be running around reading 15 differer t 9 documents to understand to write the request. 10 So, in that sense it might simplify it some. But 11 'the numbers of requests, if one stays with the current 12 system of having to write in every time there is an amendment 13 or a change, will still probably remain the same. L j 14 Actually, it also is a bit foreboding. The smaller
,r .s' 1- institutions tend to, in my experience, become very status 16 quo oriented. In my experience again, limited though it is, 17 but it seems to me they get locked into a certain situation 18 and they are not the ones who run around looking for ways 39 to change procedures. They are happy, business went along 20 fine, and they are not about to rock the boat.
21 It is the medium to So, they stick with it. large-size institutions where situations are very fluid 23 and we must respond to the market or to changing environments 24 in terms of referring physician patterns and that sort of 25 At thing, where anendment requests come up much more of ten. : J O
74 1 least thats my limited experience. The small little zy 2 2 institution, whether it be a private practice physician's 3 office or a small hospital, seems to get locked into a certain 4 way of doing things, and they are perfectly happy as long 5 as they get inspected and approved they say, "Let's not 6 mess with it, we are happy." 7 CHAIRMAN PALLADINO: ' What is the size of the 8 hospital with which you are associated? 9 MR. DEYE: Ours is a 650-bed hospital, it's a 10 fairly large hospital. 11 CHAIRMAN PALLADINO: So, you are both above 200, 12 250 13 MR. DEYE: Also the Association, Fairfax Hospital 14 hssociation, also runs'two other hospitals, Mount Vernon 15 and Commonwealth Doctors'. Both of those are smaller and 16 they fall into this category that I was talking about. If 17 it's running fine, let's not mess with it, let's just leave 18 it be. 19 DR. HENKIN: As a matter of fact, that is one 20 reason people get requests to come and lecture in small 21 hospitals, that the people there are reluctant to introduce 22 new procedures, and the people graduating from the universitiet 23 coming on staff want this, or that, and it's not available. 24 And so they ask somebody from the university to come down and 25 give a medical staff talk on why this is a wonderful procedure
75 1 'and we should be doing it here, in an effort to get off 2 the status quo situation. 3 MR. DEYE: I think, too, there are another two 4 points that popped in my mind when I was listening to the 5 previous discussions which I do think have some merit to them. 6 But one is that the smaller institution certainly becomes 7 aware of what is going on in precedents, who has been fined 8 ,and what have they been fined for. And if they hear that 9 so-and-so, either in their city or nearby, has been fined 10 for change in the procedure and it went on for three or four 11 years and then they got inspected and got fined for it, they 12 become very reticent, administrations become very reticent $' 13 to get themselves in'to that kind of predicament , u 14 Right now, public image of hospitals is obviously
~
15 a very important issue and they are not about to sacrifice 16 some of that over what they consider to be a minor part of 17 the hospital environment. 18 A second part of that -- maybe not a correlary -- 19 but a second part to that that I think has some merit was 20 the statement about whether or not to accept ALARA state-21 ments or require ALARA statements from private practice 22 physician offices. And I think there is some merit to that. 23 I see what the NRC staff is saying, but I also think just 24 getting a commitment to the concept of ALARA and then trying M to follow up on that somehow in a philosophical sort of way
~
76
, g in the inspection and enforcement interviews is not a bad 5
f 2 thing to look at. 3 COMMISSIONER ASSELSTINE: I wouldn 't think that 4 would have to be a burdensome thing. 5 MR. DEYE: No, I wouldn't think so either. Right 6 now, if you are willing to accept the format that was finally 7 agreed to a few years ago, the rubber-stamp management just 8 signs oh it and sends it on in. I think that statement could 9 be modified, of course, for orivate practice institutions. 10 But I don't think it's unreasonable at all from, again, 11 a physicist who kind of travels around and sees small 12 institutions. .
- 13 There is certainly a trend right how, as the 14 Doctor here will attest, of physicians moving into private 15 practice, away from hospital-base situations because of 16 DRGS, et cetera. I think you will see more and more private 17 Practice nuclear medicine facilities where the RSO is a 18 Ph ysician who is an approved user. And I don't think it 19 hurts at all to look towards, you know, an ALARA type
- 3) commitment from that individual.
21 COMMISSIONER BERNTHAL: What's a DRG? 22 ER. DEYE: A diagnostic-related groups. That's
%) another group.
24 DR. HENKINS: That is a different government group 25 we meet with regularly. I would like to support that, partly
77 1 because many of the private offices that are opening are 2 not staffed by people whose primary backgrounds are in 3 radiology or nuclear medicine. They may be in cardiology, 4 oncology, and they have picked up the minimum training 5 standards to open these offices. 6 So, this is a source of concern to the nuclear 7 medicine radiology community that these people run as safe 8 a practice as the institutions do and at least have a 9 commitment to it. 10 COMMISSIONER ASSELSTINE: Let me pick up on the 11 enforcement point that you mentioned. It seems to me that 12 it would be in your interest and to your advantage to know , 13
, at the outset whether the' regulatory body -- whether it is 14 the NRC or whether it is the Agreement States -- has a 15 problem with a particular change that you have in mind.
16 (Commissioner Bernthal leaves meeting.) COMMISSIONER ASSELSTINE: And again, maybe there 18 isn' t such a distinction or differentiation between the 19 larger hospitals that you all are associated with and some 20 of -the smaller ones and private practitioners . But it seems 21 to me it would be in your interest to know up front whether , there are difficulties with the proposed change in procedures 23 that you have in mind, rather than to find that out at some 24 point down the road after there has been an inspection with
)
25 the possibility of enforcement action at that point, given
** 78 1 the sensitivity that you mentioned.
3 J 2 MR. DEYE: Well, one thing that comes up there is 3 that many of the hospitals that would be in that category 4 that may not have their own radiation safety staf f would 5 often have a consultant, and that consultant through his 6 wide contacts with many institutions would know what 7 procedures have been accepted and which ones have not, what 8 procedural changes. That is one aspect. 9 The other aspect is, there is nothing that I can 10 see in the way this is written to preclude the individuals 11 that have that concern to writing to their regional office 12 and say, " Gee, we are thinking about doing this. We thought 13 . about it in thus-and-so context, do you think this would meet ~. 14 with approval?" 15 I think we have conscientious people out there 16 that would do that sort of thing. 17 CHAIRMAN FALLADINO: What fraction of your 18 deficiency is related to procedure? 19 DR. HENKIN: In our particular exp3rience, none 20 have been related to procedure, all have been related to 21 what amount to paperwork violations, failure to post a sign where a sign should have been. At one point, we got cited 23 for not having the location of the license posted which is 24 a requirement, things of that sort. ] But that's the citation
~
25 COMMISSIONER ASSELSTINE:
79 1 th'at focuses on whether your are following procedures rather J 2 than in the deficiencies -- 3 DR. HENKIN: Many of those have been related mostly 4 to the fact ~that operating out of one guide we did something 5 which another guide suggests needs further amplification. I 6 can remember particularly licensing for xenon where there was 7 a lot of confusion about what exactly you had to do and what 8 type of ventilation, and what types 'of measurements had 9 to be made. This went back and forth a number of times 10 because the information simply was not consolidated. 11 COMMISSIONER ASSELSTINE: Isn't at least some of 12 that uncertainEy going to continue, though? I mean, it's 13 hard'to imagine that everything of significance, all of the 14 open questions, have flow been incorporated into the package 15 of the regulations. I mean, I would . expect things would be 16 ~ better, much better than having them scattered among the 17 guides and everything else, but I would be surprised if 18 all of the uncertainty was eliminated. 19 DR. HENKIN: I think it's a question of what 20 price do you want to pay for what level of uncertainty. 21~ COMMISSIONER ASSELSTINE: Yes. 22 DR. HENKIN: If I remember correctly, the Joint 23 Commission on Accreditation of Hospitals requires that 24 the services of a health physicist be available. Therefore, 25 nobody is ever operating completely on their own. They are
80 1 not out there with the doc, making decisions that a health 2 physicist never gets to review; or it's been implied the 3 technologist just making the decisions . 4 There is always a health physicist in the picture 5' some place because to become an accredited hospital, they've 6 got to show that they've got the services of a health 7 physicist available. , l 8 I think these ar'e the things that get referred to 9 the health physicist for analysis. And it 's his decision , if 10 he doesn't know, yes, we have made friendly phone calls to 11 our local NRC office saying, "We are thinking about doing 12 this*or that. How does that sit with you? Have we missed
- f. 13 something in here," and that does work very well.
N , 14 It works pretty well, but then the guy you talk to 15 on the phone may .not be the guy who reviews your amendment 16 request, either, 17 CHAIRMAN PALLADINO: More, Jim? 18 COMMISSIONER ASSELSTINE: I guess maybe it's just 19 a comment rather than a question. But , you know , it seems 20 to me that the big advantage of the pre-review is that you 21 minimize the situations in which -- unlike as you described, 22 everything works well and you check with the proper people -- 23 things may not work well and you end up with a situation 24 where you have some over-exposures that go on for a sub-25 stantial period of time, until theodifficulty gets caught.
81 1 That seems to be the crux of what the Agreement dl 2 States are saying is, you run that risk. 3 DR. HENKIN: Okay, over exposures per se should be 4 picked up by any of the systems. Okay, the in-place ALARA 5 system, any of those should turn those up within a quarter of 6 the time that you institute any new procedure because those 7 people review quarterly under ALARA and that they are going 8 to have an action level specified. And when something pops 9 up, they are going to have to do something about it and 10 look at it. 11 Even an approved procedure may turn out to result 12 in an over exoosure. So that it shouldn't go on for three 13 years or five years, it should go on for 90 days at most L-14 because the ALARA system should pick that up. That's what it 15 is there for. 16 (Commissioner Bernthal rejoins meeting.) 17 CHAIRMAN PALLADINO: Okay, Fred? 18 COMMISSIONER BERNTHAL: I had one minor question. 19 I had raised the issue before of thresholds. Suppose that N we did go with the staff proposal here, but in hearing the 21 concerns of the Agreement States , is there something that 22 can be done here to make the threshold more appropriate, 23 that level where everyone can agree that, yes, these things 24 really are minor but some of the rest of the stuff, the M states feel, ought to be required as amendments .
i 82 1 I just don't know enough about what we are talking 3 d 2 about here to make a judgment. 3 COMMISSIONER ASSELSTINE: How about things like 4 leak test procedures, survey procedures, location of waste 5 storage facilities? 6 MR. DEYE: See, those are now presently not being 7 exempted. They would come under, as I understand my 8 reading of this, requirement that you do go back for approval 9 of that procedure. 10 So, it seems if you lower the threshold, those 11 are already above the threshold and if you lower the o 12 threshold, you still, I guess, have this philosophical 13 problem that there is some category of amendments that do 14 not need to be submitted any more. And it's somewhat the 15 judgment of the user, as I heard the Agreement States' argu-16 ment, to decide whether it's at that threshold or not. 17 I guess your concept raised earlier of maybe a 18 more detailed list would be one way to approach that, take 19 a little bit of that judgmental call out of the user's 20 prerogative as to what really is at the threshold and what 21 is not. 22 COMMISSIONER ASSELSTINE: But the things I 23 mentioned, I don't think are above the threshold. I thought 24 the threshold was, adding another doctor to the license; 25 adding more material than permitted by the license; moving
i 83 1 from one office building to another building or another 2 hospital, and going to a new type of use. 3 So, the kinds of things that I mentioned would 4- seem-to be -- 5 MR. DEYE: I have had all of two weeks to read 6 this monstrous document, but we could ask the staff. I 7 really would have expected the changing leak test procedure. i
. i 8 Now, by " procedure" I mean actual procedure, not the fact 9 that I have gone from a Victoreen instrument to a Nuclear 10 Chicago instrument. And right now you've got all those 11 kinds of prob; ems,.
12 But I mean by an honest-to-God change in procedure, T 13 .I guess I would support the idea that that should come under 14 the category that needs to be looked at. . 15 COMMISSIONER ASSELSTINE: How about survey l 16 procedures? 17 CHAIRMAN PALLADINO: This is something, I think, 18 we ought to ask the staff to look at. 19 COMMISSIONER BERNTHAL: Yes. I just am more 20 convinced than ever, I would like to see a representative 21 cross-section of what we are talking about here, and maybe 22 we can make a better judgment. M MR. DEYE: I think too , though, if this gets out 24 in the Federal Register with that particular request in it, 25 namely that it is open right now where the threshold is going
i I 84 1 to be and inviting back expert testimony from the users h.
- 2 around the country, you might get your best overall view 3 of it.
COMMISSIONER BERNTHAL: Sure, yes. 5 COMMISSIONER ASSELSTIME : Is the big problem with 6 all of this the cost of the amendment process, the cost of 7 having to file for an amendment and the nuisance of doing 8 ' t hat; is that what this is all about? 9 MR. DEYE: Cost, nuisance and time are the three 10 that come to my mind. 11 DR. HENKIN: It's not only that. The ability not 12 to change something for something expotentially better 13 without a time lag. A significant time lag is a problem. 14 If you want to improve a procedure, you can't do it in the 15 current system. 16 COMMISSIONER ASSELSTINE: Although I gather the 17 hime lag is what, two months or less? 18 DR. HENKIN: Well, I find that to be very 19 optimistic, based on our experience at least. 20 COMMISSIONER ASSELSTINE: Are you in an Agreement 21 State? 22 DR. HENKIN: No, we are an NRC state. 23 COMMISSIONER ASSELSTINE: Okay. 24 DR. HENKIN: This may be a very recent event. M (Laughter)
i 85 1 CHAIRMAN PALLADINO: I guess I'm sympathetic to 2 your comment. We sometimes can't even get agreement on the 3 letter responses. , 4 COMMISSIONER ASSELSTINE: The related question 5 would be the Agreement States ' approach, which is to 6 differentiate between hospitals with, say, 200, 300 beds, 7 single practitioners, as opposed to the larger hospitals. 8 Would that work to impose an unfair burden, a further 9 unfair burden on the small operations? 10 DR. HENKIN: I don't think that is realistic 11 because you can't characterize the level of the program 12 based on hospital size. 13 COMMISSIONER ASSELSTINE: So, it's better either 14 all or nothing, one way or the other, 15 DR. HENKIN: Yes. 16 CHAIRMAN PALLADINO: Lando? 17 COMMISSIONER ZECH: I presume what you are saying 18 in the limited time you had to review the proposed rule, that 19 you are telling us with some minor exceptions you think the f 20 rule as it stands is essentially a good one; is that what 21 your conclusion is, for the moment anyway? U MR. DEYE: Definitely, yes. M DR. HENKIN: There are technical questions and 24 some clarifications we would like in these rules. 25 COMMISSIONER ZECH: Right.
86 1 DR. HENKIN: But conceptually, yes. R c/- 2 COMMISSIONER ZECH: Right. Thank you. That is all 3 I have, Mr. Chairman. 4 CHAIRMAN PALLADINO: Let me make a comment with 5 regard to the proposal before us, but maybe first I ought 6 to thank you gentlemen for your participation here today 7 and the input that you have provided. 8 COMMISSIONER ASSELSTINE: Yes, thanks very much, 9 it was very helpful. It is useful to hear from people that 10 are subject to the process. 11 COMMISSIONER ZECHT We all thank you very much. 12 CHAIRMAN PALLADINO: You can stay there for a F'
- 13 minute, I don't think we are going to be that long, i b-14 We have SECY-84-485 before us as a. proposed 15 rulemaking package, and the proposal is that this go out 16 for comment. And it's a notation vote item. I am going to 17 suggest that Commissioners try to address this as a notation 18 vote item and perhaps focus on the things they would like 19 to see modified in terms of asking for comments, rather than 20 trying to settle every aspect of the whole rule at this 21 time.
22 But while it is fresh in our minds, we probably 23 ought to act and I would encourage you to addressing this 24 within the next week to ten days. 25 COMMISSIONER ASSELSTINE: Sure. i i
I 87 1 COMMISSIONER ZECH: Fine, N p/ 2 CHAIRMAN PALLADINO: All right, anything more that 3 we should discuss at this time on this subject? 4 Well, thank you all for a very effective presen-5 tation. 6 COMMISSIONER ASSELSTINE: Thank you. I l 7 CHAIRMAN PALLADINO: We'll stand adjourned, t F (Whcreupon , at 11:55 a .m. , the meeting of the 9 Commission was adjourned.) 10 11 12
- , 13 14 15 16 17 18 19 20 21 22 23 24 2.
CERTIFICATE OF OFFICIAL REPORTER This is to certify that the attached proceedings before the UNITED STATES NUCLEAR REGULATORY COMMISSION in the matter of: . NAME OF PROCEEDING: Discussion of Proposed Revision to Part 35 Public Meeting DOCKET NO.: PLACE: Washington, D.C. DATE: March 20, 1985 , were held as herein appears, and that this is the original transcript thereof for the file of the United States Nuclear Regulatory Commission. (sigt) - bdM8% (TYPED) M. E. Hansen Official Reporter Reporter's Affiliation Ace-Federal t u
' 3/1365 y.
SCHEDULING NOTES VITLE: DISCUSSION OF PROPOSED REVISIONS TO PART 35 , @CHEDULED: 10:00 A.M. , WEDNESDAY, MARCH 20, 1985 @URATION: APPROX l-1/2 HRS AGENDA:
- NRC STAFF - APPROX 20 MIN
- AGREEMENT STATES - APPROX 10 MI.N >
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- JOSEPH WARD, CHIEF -
RADIOLOG.IC HEALTH SECTION CALIFORNIA DEPARTMENT OF HEALTH
- MARY LOU BLAZEK OREGON RADIATION CONTROL SECTION CHAIR OF THE AGREEMENT STATES' PART 35 AD HOC COMMITTEE AND AGREEMENT STATES' REPRESENTATIVE ON NRC'S PART 35 TASK FORCE
- PROFESSIONAL ASSOCIATIONS - APPROX 10 MIN TOTAL
- OTHA W. LINTON ASSOCIATE EXECUTIVE DIRECTOR AMERICAN COLLEGE OF RADIOLOGY
- ROBERT E. HENKIN, M.D., PROFESSOR OF RADIOLOGY LOYOLA STRITCH SCHOOL OF MEDICINE, AND DIRECTOR OF NUCLEAR MEDICINE AT FOSTER G. MCGAw HOSPITAL FOR THE AMERICAN COLLEGE OF NUCLEAR PHYSICIANS AND SOCIETY OF NUCLEAR MEDICINE
- JAMES A. DEYE, PH.D.
FAIRFAX HOSPITAL CHAIRMAN OF THE PROFESSIONAL COUNCIL AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE}}