ML20035A376
| ML20035A376 | |
| Person / Time | |
|---|---|
| Issue date: | 10/23/1991 |
| From: | Heltemes C NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Bernero R, Lieberman J, Norry P NRC OFFICE OF ADMINISTRATION (ADM), NRC OFFICE OF ENFORCEMENT (OE), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20034D215 | List:
|
| References | |
| FRN-57FR56287, RULE-PR-31, RULE-PR-32 AD82-1-003, AD82-1-3, NUDOCS 9303250207 | |
| Download: ML20035A376 (25) | |
Text
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Q ocr n mQ pgg Robert M. Bernero, Director, Office of Nuclear Material MEMORANDUM FOR:
Safety & Safeguards James Lieberman, Director, Office of Enforcement Patricia G. Norry, Director, Office of Administration William C. Parler, General Counsel Harold R. Denton, Director, Office of Governmental and Public Affairs FROM:
C. J. Heltemes, Jr., Deputy Director for Generic Issues and Rulemaking, RES
SUBJECT:
OFFICE REVIEW REQUEST - PROPOSED RULEMAKING CONCERNING THE ACCESSIBLE AIR GAP FOR GENERALLY-LICENSED DEVICES 1.
Title:
Proposed Rulemaking Concerning The Accessible Air Gap for Generally-Licensed Devices.
2.
RES Task Leader:
Donald Hopkins, kegulation Development Branch (492-3784).
3.
Cognizant Individuals:
HMSS - S. Baggett ADM - M. Lesar OGC - M. Rothschild 4.
Requested Action:
Review of and concurrence in the Commission paper.
5.
Requested Completion Date: November 4, 1991.
6.
Background:
This rulemaking is the result of a broad-look Commission Paper in September 1989 (SECY-89-289) on the adequacy of Commission control over generally-licensed devices and a follow-up Commission Paper in May 1990 (SECY-90-175), which identified this accessible air gap issue as one to be resolved in a separate rulemaking action. The Commission agreed with the recommendations of that paper and in Staff Requirements Memorandum dated August 13, 1990, directed that the staff proceed with the rulemaking.
7.
Resources to implement this rulemaking have not been included in the draft FY 1992-1996 FYP. Additional resources would be required for its implementation. A copy of this concurrence package has been forwarded to the Office of the Controller for coordination of resource issues per the EDO memorandum of June 14, 1991.
Origina! Signed By:
C. J. Hehmes, Jr.
C. J. Heltemes, Jr., Deputy Director for Generic Issues and Rulemaking Office of Nuclear Regulatory Research
Enclosure:
Commission Paper cc:
R. Stroggins, OC f
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- SEE PREVIOUS CONCURRENCE V'1 Offc: RDB:DRA:RES RDB:DRA:RES RDB:DRA:RES DD:DR'A:RES}.;D:DRA:Rtk '. D ES Name: *DHopkins:lc +MFleishman *SBahadur FCostanziU MorriP C
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Date: 8/12/91 8/12/91 8/12/91 10/;;/91 10/.m /91 10 96 0FFICIAL RECORD COPY g32g207930309 31 57FR56287 PDR
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The Commissioners From:
James M. Taylor Executive Director for Operations j
Sub.iect:
PROPOSED AMENDMENTS TO 10 CFR PARTS 31 AND 32 CONCERNING THE i
ACCESSIBLE AIR GAP TOR GENERALLY-LICENSED DEVICES
Purpose:
To obtain Commission approval to publish a proposed rule that would revise 10 CFR Parts 31 and 32 to restrict the i
- accessible air gap for generally-licensed devices in order to control radiation exposures of individuals.
Cateaory:
This paper covers a routine matter requiring Commission consideration.
Summary:
The staff seeks to reduce the frequency and likelihood of' unnecessary radiation exposure from generally-licensed i
gauges. The staff proposes that this be accomplished by improving control over certain gauges that have both an accessible air gap end radiation level that exceed specified f
values. Under the provisions of the proposed rule, j
distributors of these devices would be prohibited from
.r transferring them to general licensees, and general licensees
-l would no. longer be permitted to-pos:.ss these devices.
.i Licensees who have such devices at present would be required to obtain a specific license for the device and thus t
establish a radiation safety program which among other things f
could include lock-out procedures-. The general licensee
-j would have the option of having the device physically modified to eliminate the accessible air gap and hence not be required to obtain a specific license. The staff estimates t
that 3.2 FTE would be required each year for 3 years to process the new applications and inspect the new specific j
i CONTACT:
i Donald R. Hopkins, RES
-i 492-3784 l
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V The Commissioners 2
licensees. These resources are not included in the draft FY 1992-1996 FYP.
Backcround:
On February 12, 1959 (24 FR 1089), The Atomic Energy Commission amended its regulations to provide a general license for the use of byproduct material contained in certain luminous, measuring, gauging, and controlling devices. The devices were designed with inherent radiation safety features so that, when installed by the distributor, they could be used by persons with little or ro radiation training, experience, or equipment. This simplified the licensing process so that a case-by-case determination of the i
adequacy of training, experience, and radiation safety program was not necessary.
In May 1990, the staff identified to the Commission (SECY 175) certain applications involving generally-licensed devices that need greater regulatory control.
These devices are gamma gauges that, of necessity, are configured with an air gap large enough that a worker could place his or her body directly in the radiation beam. This would subject workers to unnecessary radiation. The staff proposed to initiate a rule schange to restrict the air gap in generally-licensed devices. The Commission concurred with this recommendation and by SRM dated August 13, 1990 (Enclosure A) directed the staff to proceed with the rulemaking. This rulemaking package, including a Notice of Proposed Rulemaking (Enclosure B), has been developed in response to that SRM.
Discussion:
There are approximately 35,000 general licensees who possess an estimated 600,000 devices containing byproduct material regulated under 10 CFR Parts 31 and 32. From this group there are approximately 52,000 gauges in use by 13,000 general licensees. The staff has identified approximately 3,000 gamma gauges from this group that may need to be better controlled through specific licensing because of inherent radiation levels and large accessible air gaps. These gauges are sometimes mounted so that it is possible for a worker to place his or her body directly in the radiation beam. This occurs because the gauge must have some air gap in order to measure the product as it passes through the radiation beam.
Although a small air gap presents little health and safety concern, a large air gap may subject improperly-trained workers to unnecessary radiation exposure. Hence, the staff is proposing to restrict possession of certain gauges with accessible air gaps to specific licensees only because as a condition of license, specific licensees must have radiation safety programs that will protect individuals from unnecessary exposure to radiation.
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The Commissioners 3
The size of the air gap of concern which would be addressed by this rule change is an " accessible air gap" that is 18 inches or greater between the radiation source and detector which would allow insertion of a 12 inch diameter sphere into the radiation beam. An " accessible air gap" would be defined in 6 32.2, " Definitions," as "an open space between the radiation source and detector of a device that would permit access of a person to the radiation beam of the device without the removal of a barrier." The specification is a reasonable limit to restrict access of a person's torso. An air gap which is longer than 18 inches between the source and detector but is enclosed by a wire mesh enclosure or a chemical tank with a metal lid would not be considered as permitting access of a person to the radiation beam.
The magnitude of the radiation level of concern which would be addressed by this rule change is 125 millirem per hour at 18 inches from the radiation source with any shutter in the open position. This radiation level specification is based on the scenario of a worker receiving less than 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of direct exposure in a calendar quarter at a distance of 18 inches from the radiation source as a result of normal operations and maintenance, resulting in a quarterly exposure of less than 125 millirem.
This corresponds to the dose restriction for general licensees in NRC regulations
[10 CFR 32.51(a)(2)(ii)].
The 18 inch specification corresponds to a guideline (Inspection Manual, Section:
10 CFR Interpretations, p. 20.203-1) set forth for NRC inspectors that a radiation level must extend 18 inches into an accessible area for it to cause whole body radiation doses. While this guideline would allow part of a persons body to be exposed to a higher radiation level than that specified while it is within the 18 inch distance and closer to the source of the radiation, practical considerations dictate that a person would not be situated in the radiation beam next to the radiation source for long periods of time.
A more likely scenario is where a worker is cleaning a vat in which a radiation source and detector are installed on opposite walls, such that the worker is out of the radiation beam most of the time and is in the beam close to the radiation source for only short periods of time.
In order to reduce the frequency and likelihood of unnecessary radiation exposure from these gauges, the staff is recommending the following approach.
First, restrict distribution of such gauges to specific licensees only.
Second, require general licensees who currently possess such gauges to become specific licensees and thus establish radiation safety programs to assure that only individuals who
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U The Commissioners 4
are properly trained are permitted access to those gauges.
These licensees would have the option of having the gauges physically modified to eliminate the " accessible air gap,
and hence not be required to obtain a specific license.
(This physical modification, as with all installation and servicing of the gauge, must be performed by a person authorized to perform such activities by a specific license.)
If no general licensees choose the physical modification approach to solving this problem, the staff would expect approximately 525 applications for new licenses and 225 applications for amendments to existing licenses over a 3-year period.
Resources:
Under the proposed amendments [6 31.5(e)], general licensees who possess gauges with accessible air gaps and radiation levels in excess of specified values, will be required to submit an application for a specific license. The staff estimates that of the 750 general licensees who now possess such gauges, 225 already possess a specific license.
For these licensees, bringing the possession of these gauges under the provisions of their specific licenses would be done by license amendment. The remaining 525 general licensees would be required to apply for a specific license (unless they modify their gauges).
The staff estimates approximately 1.5 FTEs would be needed each year for 3 years to review the applications for new and amended licenses, assuming no licensee chooses to modify his or her gauge. Additionally, inspection resources would be needed for the 525 new licenses issued. The staff estimates that approximately 1.7 FTEs would be needed each year for 3 years to inspect these new licensees. These resources are not included in the draft FY 1992-1996 FYP.
The potential economic impacts on licensees are explored in the regulatory analysis (Enclosure C).
Significant economic impacts on licensees are expected to be rare because of the alternative available. Specifically, licensees may make the air gap of the gauge inaccessible by any number of means such as building an enclosure, locking the area where the air gap exists, or by interlocks where no one can enter the area while the radiation source is in the exposed position.
Specific licensees would be subject to a license application fee of 5500, a renewal fee (each 5 years) of 5500, infrequent inspecticn fees of $1200, and 51500 in annual fees.
Recommendation:
That the Commission:
1.
Approve the Notice of Proposed Rulemaking (Enclosure B) for publication.
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2.
Certify that this rule, if promulgated, will not have-a significant economic impact on a substantial number of small entities, in order to satisfy requirements of the Regulatory Flexibility Act, 5 U.S.C. 605(b). This certification is included in the enclosed Federal Reaister notice.
t 3.
Note:
a.
The rulemaking would be published in the Federal Reaister for a 120-day comment period; b.
Neither an environmental impact statement, an environmental impact assessment, nor. a negative declaration need be made in connection with this rulemaking because it is nonsubstantive and insignificant from the standpoint of environmental impact, and falls within the categorical exclusion of 10 CFR 51.22(c)(3)(iii);
c.
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; d.
The proposed rule contains information collection requirements that are subject to review by OMB. Upon Commission approval, formal request for OMB review and clearance will be initiated; e.
The appropriate congressional committees will be informed (Enclosure D);
f.
A public announcement will be issued (Enclosure E);
g.
Copies of the Federal Reaister notice of proposed rulemaking will be distributed to all NRC distributors of 6 31.5 generally-licensed devices, and to all corresponding general licensees of record; and h.
If the rule changes proposed in SECY-91-275 are made final prior to those proposed in this paper, adjustments to the text will be necessary to merge the two revisions.
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The Commissioners 6
i i
h Coordinat ion:
The Office of Governmental and Public Affairs concurs with
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the contents of this paper. The Office of the General Counsel has no legal objection.
Schedulina:
If scheduled on the Commission agenda, recommend this paper I
be considered at an open meeting. No specific circumstance is known to staff which would require Commission action by any particular date in the near term.
J l
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James M. Taylor Executive Director i
for Operations
Enclosures:
i t
A.
Staff Requirements Memorandum Dated August 13, 1990 B.
Federal Reaister Notice of Proposed Rulemaking C.
Draft Regulatory Analysis D.
Draft Congressional Letter E.
Draft Public Announcement l
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The Commissioners 6
Coordinat ion:
The Office of Governmental and Public Aff airs concurs with the contents of this paper. The Office of the General Counsel has no legal objec. tion.
Schedulino:
If scheduled on the Commission agenda, recommend this paper be considered at an open meeting. No specific circumstance is known to staff which would require Commission action by any particular date in the near term.
James M. Taylor Executive Director for Operations
Enclosures:
A.
Staff Requirements Memorandum Dated August 13, 1990 B.
Federal Recister Notice of Proposed Rulemaking C.
Draft Regulatory Analysis D.
Draft Congressional Letter E.
Draft Public Announcement WParler, OGC JTaylor, ED0 HDenton, GPA RBernero, NMSS JLieberman, OE PNorry, A.DM EBeckjord CHeltemes BMorris FCostanzi SBehadur MFleishman DHopkins
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- SEE PREVIOUS CONCURRENCE
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[7590-01) l NUCLEAR REGULATORY COMMISSION 10 CFR Parts 31 and 32 RIN 3150-AD82 Requirements Concerning the Accessible Air Gap-t for Generally Licensed Devices AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
L
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the safe use of radioactive byproduct material in certain measuring, gauging, and controlling devices. The proposed rule would provide for additional regulatory control over devices with both an accessible air gap and radiation levels that exceed specified values. This action is intended to make it increasingly difficult for individuals to be exposed to the device's radiation beam, thereby reducing the frequency and likelihood of unnecessary radiation exposure. This amendment applies both to persons who distribute these special measuring, gauging, and controlling devices under the
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i NRC general license provisions, and to persons who use the devices under the NRC's' general license.
j i
1 Enclosure B i
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DATES: The comment period expires [120 days following publication in the Federal Register]. Comments received after this date will be considered if it g;
i is practicable to do so, but assurance of consideration cannot be given except for coments received on or before this date.
l ADDRESSES: Mail written comments to: The Secretary, U. S. Nuclear Regulatory l
Commission, Washington, DC 20555, Attention: Docketing and Service Branch.
'l Deliver comments to: One White Flint North, 11555 kockville Pike, Rockville,
[
MD, between 7:30 am and,:15 pm en weekdays. Copies of the draft regulatory l
t analysis, as well as copies of the comments received on the proposed rule, may
.s be examined at the NRC Public Document Room, 2120 L Street NW.
(Lower Level),
l Washington, DC.
l FOR FURTHER INFORMATION CONTACT: Donald Hopkins, Office of Nuclear Regulatory h
Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone l
(301) 492-3784.
t i
SUPPLEMENTARY INFORMATION:
Background
On February 12, 1959 (24 FR 1089), the predecessor to the Nuclear Regulatory Commission (The Atomic Energy Commission) amended its regulations to establish a general license for the use of radioactive byproduct material i
contained in certain luminous, measuring, gauging, and controlling devices.
The general license allowed commercial and industrial firms and research, 2
Enclosure B
a 0
w educational and medical institutions, individuals in the conduct of their business, and federal, State or local government agencies to use specially approved devices, designed for safe use by persons not trained in radiation safety, for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or chemical composition, or for producing light or an ionized atmosphere. This simplified the licensing process so that a case-by-case determination of the adequacy of the licensee's training, experience, and radiation safety progm b the regulatory authority was unnecessary.
The practice of using a device under a general license grew over the years. There are currently some 600,000 devices in use by about 35,000 general licensees. The gauge segment of that group constitutes about 52,000 gauges in use by some 13,000 general licensees. As a result of a recent study of general licensee practices, NRC has identified several types of gauge installations for which there should be improved regulatory control by the NRC. Under the procedures governing the application for and issuance of a specific license, training, experience, and radiation safety program would all be evaluated as to their appropriateness for the types of devices possessed by the specific licensee. Thus, restricting possession of such gauges to specific licensees is a way of obtaining better regulatory control over t!.ese types of gauges.
Discussion The gauges identified as needing improved regulatory control are those which have been installed by the distributor 3 that there is a large air gap 3
Enclosure B
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i f
between the radioactive sealed source and the gauge detector. While some air gap is almost always present in gauging devices for the placement of the i
material being gauged, the identified gauges have a large enough air gap so i
that an untrained or careless worker could place his or her body directly in the radiation beam. Many gauges contain a small enough quantity of
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radioactive material that even with a large accessible air gap, no significant radiation exposures would result. However, for those gauges which have both a l
large air gap and radiation levels that exceed a certain value, thc i4RC 3
intends to prohibit further distribution under the general licease.;ystem and to convert existing installations to the specific license system. The general licensees, of course, would have the option of having the gauges physically.
modified to eliminate the accessible air gap, and thus, not be required to j
become'a specific licensee. The NRC estimates there may be as many as 3000 gauges, used by approximately 750 general licensees, that would be affected by l
this rulemaking.
The size of the air gap of concern which would be addressed by this rule change is an " accessible air gap" that is 18 inches or greater between the i
radiation ource and detector which would allow insertion of a 12 inch diameter sphere into the radiation beam. An " accessible air gap" would be defined in 1 32.2, " Definitions," as "an open space between the radiation source and detector of a device that would permit access of a person to the j
radiation beam of the device without the removal of a barrier." The
-l i
specification is a reasonable limit to restrict access of a person's torso.
An air gap which is 18 inches or longer between the source and detector but ~is enclosed by a wire mesh enclosure or a chemical tank with a metal lid would-not be considered as permitting access of a person to the radiation beam.
l 4
Enclosure B
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i The magnitude of the radiation level of concern which would be addressed by this rule change is 125 millirem per hour at 18 inches from the radiation source with any shutter in the open position. This radiation level l
specification is based on the scenario of a worker receiving less than 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of direct exposure in a calendar quarter at a distance of 18 inches from the radiation source as a result of normal operations and maintenance, resulting l
in a quarterly exposure of less than 125 millirem. This corresponds to the dose restriction for general licensees in NRC regulations. The 18 inch specification corresponds to a guideline (Inspection Manual, Section:
10 CFR Interpretations, p. 20.203-1) set forth for NRC inspectors that a radiation level must extend 18 inches into an accessible area for it to cause whole body radiation doses. While this guideline would allow part of a person's body to i
be exposed to a higher radiation level than that specified while it is within the 18 inch distance and closer to the source of the radiation, practical f
I considerations dictate that a person would not be situated in the radiation j
beam next to the radiation source for long periods of time. A more likely scenario is where a worker is cleaning a vat in which a r&diation source and detector are installed on opposite walls, such that the worker is out of _the radiation beam most of the time and is in the beam close to the radiation i
source for only short periods of time.
)
)
Specifically, the NRC is proposing to modify its regulations 131.5
)
"Certain measuring, gauging or controlling devices" to exclude from the category of generally-licensed devices those types of gauges with both an accessible air gap of 18 inches or greater and a radiation level exceeding 125 millirem per hour at a distance of 18 inches from the source.
5 Enclosure B
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l Of course, there are some general licensees who at present possess such gauges installed in such a way that unnecessary radiation exposure could occur i
if untrained or careless employees inadvertently placed their bodies in the gauges' radiation beams. General licensees who possess such gauges now would be required to obtain a specific license for the gauge and thus establish a radiation safety program to assure that only individuals who are properly j
trained are permitted access to those gauges. Alternatively, these licensees would have the option of having the gauges physically modified to eliminate the " accessible air gap", and hence not be required to obtain a specific license. This physical modification, as with all installation and servicing of the gauge, would need to be performed by a person with a specific license r
that authorizes him or her to perform such activities.
f Invitation to Comment Comments on the criteria defining the type of gauge requiring better NRC control and the implementation of the proposed amendments are encouraged.
r Comments are especially solicited on:
i 1.
The proposed use of both the 18 inch dimension and " allow insertion of a' 12 inch diameter sphere into the radiation beam," as criteria for defining the maximum size of the accessible air gap; 2.
The proposed use of 125 millirem per hour at 18 inches from the source as the level of radiation to which a worker could be exposed before the l
restrictions of this proposed rule are imposed; 3
3.
The need for a grace period between the effective date of the final rule j
and when particular parts of the rule become effective. While it is l
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6 Enclosure B s
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unlikely that distributors would need a grace period'to finish installing a gauge subject to the restrictions of this rule change, it is unclear how long it will take for pres'ent users of that type of gauge to react to the restrictions and take some kind of action, either to have the device physically modified to eliminate the accessible air gap, or to apply for and obtain a specific license; and 4.
The costs that might be expected to physically modify the devices or.to obtain specific licenses.
Environmental Impact: Categorical Exclusion The NRC has determined that the proposed regulations are the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii).
Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statemerit
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The proposed rule amends the information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501'et seq.).
j This proposed rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.
The public reporting burden for this collection of information is estimated to average 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> per initial response by up to 750 general licensees, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and 7
Enclosure B e
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reviewing the collection of information.
Further collections of information at 5 year intervals are estimated to average 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />. Send comments regarding i
this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records Management Branch (MNBB-7714), U.S. Nuclear Regulatory Commission, Washington, DC 20555, and to the Desk Officer, Office of Information and Regulatory Affairs, NE0B-3019, (3150-00016 and 3150-0001), Office of Management and Budget, Washington, DC 20503.
Regulatory Analysis The NRC has prepared a draft regulatory analysis of this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.
Single copies of the draft analysis may be obtained from Donald R. Hopkins, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: 301-492-3784.
6 Regulatory Flexibility Certification Based on information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), the NRC certifies that, if promulgated, this rule will not have a significant economic impact on a substantial number of small entities.
The NRC has adopted size standards that classify a small entity as one whose 8
Enclosure B e
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gross annual receipts do not exceed $3.5 million. The proposed rule affects about 750 persons using 3000_ gauges under this general license. Many of the users would be classified as small entities.
If these users were to adopt the i
regulatory alternative of obtaining a specific license authorizing use of their presently held gauges, the costs, as discussed in the draft regulatory analysis " Proposed Regulations Concerning Certain Generally Licensed Devices" are as follows:
1.
Application preparation $1200 (first year only).
2.
Renewal application preparation $400 (every 5 years thereafter).
3.
Licensing fee $500 (first year and every 5 years thereafter).
4.
Inspection fee $1200 (first year and every 5 years thereafter).
5.
Annual fee $1500 (every year, includes $100 surcharge).
6.
Establishing radiation safety program $7500 (first year only).
7.
Maintaining radiation safety program $2500 (every subsequent year).
Total of $11,900 for first year; $6100 every subsequent fifth year; and $4000 for all other years, for an average annual cost over a 15 year period of
$4807. The 225 licensees who are estimated to already possess a specific license (even though using gauges under a general license) would only have a one-time additional cost of $780 to add the generally-licensed gauges to the specific license. The average cost over a 15 year period is only $52 per year.
While the nearly $5000 per year average costs would be significant for f
i some small entities who must obtain a specific license, the NRC believes that i
the economic impact of the proposed requirements would not be significant for a substantial number of small entities because of the alternative to becoming 9
Enclosure B
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a specific licensee. That alternative is to make the air gap of the gauge inaccessible by any number of means such as building a barrier around the air gap, locking the area where the air gap exists, or by interlocks where no one can enter the area while the radiation source is in the exposed position.
While it is possible that this alternative is impractical in some cases because of the nature of the gauging process, the NRC believes it will be practical in most cases and be subject only to the one-time additional barrier construction costs estimated at $1700 per facility. Over the 15-year period this would average only $113 per year.
The NRC does not have information indicating how many of the potential 525 general licensees may be prevented from adopting the less costly alternatives for technical reasons.
Because of this uncertainty the NRC is seeking comment from small entities (i.e., small businesses, small organizations, and small jurisdictions under the Regulatory Flexibility Act) as to how the regulations will affect them and how the regulations may be tiered or otherwise modified to impose less stringent requirements on small entities while still adequately protecting the public health and safety.
Those small entities which offer comments on how the regulations could be codified to take into account the differing needs of small entities should specifically discuss the following items:
(a) the size of their business and how the proposed regulations would result in a significant economic burden upon them as compared to larger organizations in the same business community.
(b)
How the proposed regulations could be modified to take into account the differing needs or capabilities of small entities.
10 Enclosure B
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i (c)
.The benefits that would accrue, or the detriments that would be avoided, if the proposed regulations were modified as suggested by the commenter.
I (d)
How the proposed regulations, as modified, would more closely equalize
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the impact of HRC regulations or create more equal access to the benefits of Federal programs as opposed to providing special advantages to any individuals or groups.
?
(e)
How the proposed re3ulations, as modified, would still adequately protect the public health and safety.
Backfit Analysis I
The NRC has determined that the backfit rule,10 CFR 50.109, does not.
apply to these proposed rules and therefore a backfit analysis is not required for this proposed rule because these proposed amendments do not. involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects in 10 CFR Parts 31 and 32 i
10 CFR Part 31 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting.
j and recordkeeping requirements, and Scientific equipment.
10 CFR Part 32 - Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements, and Scientific equipment.
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For the reasons set out in the preamble and under the authority of the Atomic i.ergy Act of 1954, as amended, the Energy Reorganization Act of 1974, I
as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 31 and 32:
i Part 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL 1.
The authority citation for Part 31 continues to read as follows:
i AUTHORITY: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842).
j Section 31.6 also issued under sec. 274, 73 Stat. 688 (42 U.S.C. 2021).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
1131.5(c) (1)-(3) and (5)-(9), 31.8(c), 31.10(b), and 31.11(b), (c), and (d) are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b); and il 31.5(c) (4), and (5), and (8), and 31.11(b) and (e) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
2.
In 6 31.5, paragraph (b) is revised and paragraph (e) is added to l
read as follows:
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t 31.5 Certain measurina. cauaina or controllina devices.
(b)
The general license in paragraph (a) of this section:
(1)
Applies only to byproduct material contained in devices which have-been manufactured or initially transferred and labeled in accordance with the specifications contained in a. specific license issued pursuant to i 32.51 of l
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l this chapter or in acct,rdance with the specifications contained in a specific license issued by an Agreement State which authorizes distribution of the I
devices to persons generally licensed by the Agreement State; and (2)
Does not apply after (three years after the effective date of this rule) to byproduct material contained in a device which has been manufactured and installed so that:
(i)
The dose rate in the radiation beam of the device at 18 inches from the radiation source with the device shutter in the open position exceeds 125 millirem per hour; and (ii) There is an accessible air gap, as defined in 5 32.2 of this chapter, of 18 inches or greater between the radiation source and detector l
which would allow insertion of a 12 inch diameter sphere into the radiation beam.
(e)
Any person who, under a general license, possesses byproduct caterial in a device of a type referred to in paragraph (b)(2) of this section:
(1)
Shall submit an application to the Nuclear Regulatory Commission for a specific license authorizing possession of that device, and other activities as appropriate; and (2)
Shall, if the application is submitted not later than (30 days prior to three years from the effective date of this rule) in proper form for a specific license or amendment to a specific license, retain his or her general license until the application has been finally determined by the Commission.
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3.
In 131.6, paragraph (d) is added to read as follows:
5 31.6 General license to install devices cenerally licensed in s 31.5.
(d)
The byproduct material is not contained'in a device of a type referred to in paragraph (b)(2) of 6 31.5 of this chapter.
PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER i
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
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l 4.
The authority citation for Part 32 continues to read as follows:
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);
il 32.13, 32.15(a), (c), and (d), 32.19, 32.25(a) and (b), 32.29(a) and (b),
l 32.54, 32.55(a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are issued under sec.161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b); and il 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52, 32.56, and 32.210 are issued under sec. 1610, 68 stat. 950, as amended (42 U.S.C. 2201(o)).
5.
In 6 32.2, paragraph (c) is addea to read as follows:
I 1 32.2 Definitions.
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(c)
Accessible air aan means an open space between the radiation source and detector of a device that would permit access of a person to the radiation beam of the device without the removal of a barrier.
6.
In 132.51a, paragraph (c) is added to read as follows:
I 32.51a Conditions of licenses.
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(c)
Not transfer a device containing byproduct material to a person
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generally licensed under i 31.5 of this chapter if that device is of a type referred to in paragraph (b)(2) of 5 31.5 of this chapter.
Dated at Rockville, Maryland this day of.
1991.
For the Nuclear Regulatory Commission.
i Samuel J. Chilk, i
Secretary of the Commission.
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