ML20217L912
| ML20217L912 | |
| Person / Time | |
|---|---|
| Issue date: | 07/28/1999 |
| From: | Catherine Haney NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Meyer D NRC OFFICE OF ADMINISTRATION (ADM) |
| Shared Package | |
| ML20217K959 | List: |
| References | |
| FRN-63FR42269, RULE-PR-31 AG06-2-017, NUDOCS 9910270099 | |
| Download: ML20217L912 (3) | |
Text
,
l '
July 28, 1999
." -i
((
MEMORANDUM TO: David L. Meyer, Chief i Nb l ~
Rules and Directives Branch )
Division of Administrative Services Office of Administration .
FROM: Catherine Haney, Acting Chief :
Rulemaking and Guidance Branch !
Division of Industrial and orig. signed by Medical Nuclear Safety, NMSS
SUBJECT:
PUBLICATION OF FINAL RULE: REVISION OF 10 CFR 31.5 TO REQUIRE CERTAIN GENERAL LICENSEES TO PROVIDE REQUESTED INFORMATION On July 1,1999, the Executive Director for Operations approved for publication the final rule on
" Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct ,
Material to Provide Requested Information." As planned, the date and Federal Register cite for l the proposed comprehensive general license rule have been inserted in the appropriate places i in the notice. l Please implement this action by arranging for publication of the attached final rule in the Federal fle_giste_r. The rule is to be effective 60 days after publication.
The original signed Federal Register Notice, fourteen copies, and a diskette are attached. Also attached are the Final Regulatory Analysis for forwarding to the PDR, a Press Release, and the Approval for Publication. A Congressional letter package and the Small Business Regulatory Enforcement Fairness Act forms are attached for transmittal to OCA. An item has been submitted for the Daily Staff Notes.
Attachments: 1. Federal Register Notice,
+ 14 copies + disk
- 2. Final Regulatory Analysis
- 3. Press Release
- 4. Approved for Publication
- 5. Congressional Letters
- 6. Notification for Congressional Review "Small Business Regulatory Enforcement Fairness Act of 1996" Distribution: WITS No. 199800070 RGordon/RF LRiani IMNs/CentralFile DMendiola
' NMSS R/F CGallagher NRC Central File CPoland MBridgers, EDO JMcCausland (0:\MATTSEMGL1F\ ADMIN.MEM)
To recetve 4 copy or tM4 dooment. Indicate in the tes *C" = ewy without attactuumt/ enclosure. '8" = copy with attacMont/ enclosure. *N' = No copy 0FFICE: RGB/IMNS S RGB/IMNS NAME: CMattsen CHaney DATE: 7M /99
/ 7/ b /99 0FFICIAL RECORD COPY 9910270099 991022 PDR PR 31 63FR42269 PDR 9 ff/ ff?@f
. pn stem ph o,
-ni UNITED STATES
.j {y NUCLEAR REGULATORY COMMISSION o WASHINGTON, D.c. 20666 0001 y
kg* Julyi28, 1999-MEMORANDUM TO: ! David L. Meyer, Chief -
Rules and Directives Branch
. Division of Administrative Services Office'of Administration -
FROM: . Catherine Haney, Acting Chief Rulemaking and Guidance Branch Division of industrial and
- Medical Nuclear Safety, NMSS
SUBJECT:
- PUBLICATION OF FINAL RULE: REVISION OF 10 CFR 31.5 TO REQUIRE CERTAIN GENERAL LICENSEES TO PROVIDE REQUESTED INFORMATION
' On July 1,1999,' the Executive Director for Operations approved for publication the final rule on
" Requirements for Those Who Possess Certain industrial Devices Containing Byproduct Material to Provide Requested information." As planned, the date and Federal Register cite for the proposed comprehensive general license rule have been inserted in the appropriate places in the notice.
' Please implement this action by arranging for publication of the attached final rule in the Federal Reaister. The rule is to be effective 60 days after publication.-
The original signed Federal Register Notice, fourteen copies, and a' diskette are attached. Also
' attached are the Final Re'gulatory Analysis for forwarding to th_e PDR, a Press Release, and the Approval for Publication. A Congressional letter package and the Small Business Regulatory -
Enforcement Fairness Act forms are attached for transmittal to OCA; An item has been Laubmitted for the Daily Staff Notes.
Attachments: 1. Federal Register Notice,
+ 14 copies + disk
- 2. Final Regulatory Analysis .
- 3. Press Release
- 4. Approved for Publication
- 5. Congressional Letters
- 6. Notification for Congressional Review "Small Business Regulatory Enforcement Fairness Act of 1996"
- CONTACTS
- Catherine R. Mattsen, NMSS/IMNS (301) 415-6264
_ Jayne M. McCausland, NMSS/IMNS
' (301) 415-6219
l i
l k i i t- j l
l l
l l
ATTACHMENT 1 i 1
Federal Register Notice + 14 copies + disk l
l l
!t l-
p L
l
[7590-01-P]
l l
I NUCLEAR REGULATORY COMMISSION 10 CFR Part 31 RIN 3150 - AG06
~
Requirements for Those Who Possess Certain industrial Devices Containing Byproduct Material to Provide Requested Information i
I AGENCY: Nuclear Regulatory Commission. l 1
ACTION: Final rule. l
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations to add an explicit requirement that generallicensees, who possess certain measuring, gauging, or controlling devices that contain byproduct material, provide the NRC with information i
concerning these devices. The NRC intends to use this provision to request information concerning devices that present a comparatively higher risk of exposure to the public or !
property damage. The final rule is intended to help ensure that devices containing byproduct a
material are maintained and transferred properly and are not inadvertently discarded.
EFFECTIVE DATE: (60 days from date of publication in the Federal Register).
FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of Nuclear Material Safety and Safeguards,' U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001,
.j
e l .-
L _ telephone (301) 415-6264, or'e-mail at CRM@nrc. gov; or Jayne McCausland, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC
- 20555-0001, telephone (301) 415-6219, or e-mail at JMM2@nrc. gov.
SUPPLEMENTARY INFORMATION:
I
' Background
. On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a~generallicense for the use of byproduct material contained in certain -
- measuring, gauging, or controlling devices (10 CFR 30.21(c)). Under current regulations in
- 10 CFR 31.5, certain persons may receive and use a device containing byproduct material under this general license if the device has been manufactured and distributed according to the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license authcrizing distribution of generally licensed devices is issued if a regulatory
, authority determines that the safety features of the device and the instructions for safe operation of that device are adequate and meet regulatory requirements.
The person.or firm who recsives such a device is a general licensee. The general -
licensee is subject to requirements for maintaining labels, following instructions for use, storing
- or disposing of the device properly, and reportin'g transfers and failure of or damage to the
~
l- g device. For some devices, the general licensee must also comply with leak testing'-
i : requirements! The generallicensee is also subject to the terms and conditions in 10 CFR 31.2 l l
concerning general licensefrequirements, transfer of byproduct material, reporting and l I
recordkeeping, and inspection. The general licensee must comply with the safety instructions a
2L I
k
I' L
contained in or referenced on the label of the device and must have the testing or servicing of L
the device performed by an individual who is authorized to manufacture, install, or service these devices.
i A generally licensed device usually consists of radioactive material, contained in a
- sealed source, within a shielded device. The device is designed with inherent radiation safety ,
. features so that it 'can be used by persons with no radiation training or experience. Thus, the
. general license is meant to simplify the lic'ensing process so that a case by-case determination of the adequacy of the radiation training or experience of each user is ad necessary.
There are about 45,000 generallicensees under 10 CFR 31.5. These licensees '
possess about 600,000 devices that contain byproduct material. The NRC has not contacted 1
generallicensees on a regular basis because of the relatively small radiation exposure risk posed by these devices and the very large number of generallicensees. However general licensees are not always aware of applicable regulations and thus are not necessarily complying with all of the applicable requirements. The NRC is particularly concerned about occurrences where generally licensed devices containing radioactive material have not been properly handled or properly disposed of. In some cases, this has resulted in radiation exposure to the public and contamination of property. Although known exposures generally
- have not exceeded the public dose limit, there is a potential for significant exposures. When a source is accidentally melted in a steel mill, considerable contamination of the mill, the steel product, and the wastes from the process, the slag and the baghouse dust, can result.
The NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to assess the effectiveness of the generallicense program. The sampling revealed several areas
-of concern regarding the use of generally licensed devices, in particular, the NRC concluded that many generallicensees are not aware of the appropriate regulations. Also, approximately i 3
15 percent of all generallicensees sampled could not account for all of their generally licensed devices. The NRC concluded that these problems could be remedied by more frequent and timely contact between the generallicensee and the NRC.
On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking concerning the accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement for generallicensees under 10 CFR 31.5 to provide information to the NRC upon request, through which a device registry could be developed. The proposed rule also included requirements in 10 CFR 32.51a and 32.52 for the specific licensees who manufacture or initially transfer generally licensed devices.
Although the public comments received were reviewed and a final rule developed, a final rule 1 was not issued because the resources needed to implement the proposed rule properly were j not available.
The NRC continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. In July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group to evaluate these issues. A final report was completed in July 1996 and published in October 1996 as NUREG-1551," Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."
In considering the recommendations of the working group, the NRC decided, among other things, to again initiate rulemaking to establish an annual registration program of devices generally licensed under 10 CFR 31.5 that would be similar to the program originally proposed in the December 27,1991, proposed rule. However, r :RC decided to do so only for those devices that present a higher risk, compared to other generally licensed devices, of potential exposure to the public and property loss if control of the device were lost. The NRC found the 4
- working group process valuable in identifying criteria for categorizing devices that are more l likely to present a significant risk by exposure of the public or through contamination of property.
On December 2,1998 M3 FR 66492), the Commission again proposed the addition of an explicit requirement to provide information in response to requests made by the NRC. While the rule applies to all 10 CFR 31.5 general licensees, the NRC plans to contact only those general licensees identified by the working group for the purpose of the registration program.
For the most part, general licensees using devices meeting these criteria have a limited number of devices that will require registration.
In that notice (at 63 FR 66493), the NRC also withdrew the December 27,1991, proposed rule. The NRC has reviewed the other provisions contained in the December 27, 1991, proposed rule and the recommendations of the working group and developed additional requirements in a separate proposed rule published July 26,1999 (64 FR 40295). The ,
t recommendations made in NUREG-1551 were considered in developing the separate, more comprehensive proposed rule issued July 26,1999. That proposed rule addresses fees for registration, additional reporting, recordkeeping, and labeling requirements for 10 CFR 32.51 licensees, and compatibility of Agreement State regulations in this area.
On March 9,1999 (64 FR 11508), the Commission established an interim enforcement policy for violations of 10 CFR 31.5 that are discovered and reported by licensees during the initial cycle of the registration program. The iriitial cycle is considered to be the issuance of one l
round of registration requests to all affected generallicensees. This policy supplements the normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will remain in effect through one complete cycle of the registration propram.
I
p Under this interim enforcement policy, enforcement action normally will not be taken for l
violations of 10 CFR 31.5 that are identified by the general licensee, and reported to the NRC if reporting is required, provided that the general licensee --
Takes appropriate corrective action to address the specific violations and prevent recurrence of similar problems; and Has undertaken good faith efforts to respond to NRC notices and provide requested ;
l information. . l This change from the Commission's normal enforcement policy is intended to remove i 1
- the potential for the threat of enforcement action to be a disincentive for the licensee to identify deficiencies.
Under the interim enforcement policy, enforcement action, including issuance of civil j i
penalties and Orders, may be taken where there is --
(1) Failure to take appropriate corrective action to orevent recurrence of similar violations; (2) Failure to respond and provide the information required by regulation; )
. (3) Willful failure to provide complete and accurate information to the NRC; or (4) Other willful violations, such as willfully disposing of generally licensed material in an unauthorized manner.
As noted in the December 2,1998, proposed rule, and discussed further in the j l
separate, more comprehensive proposed rule of July 26,1999, the Commission also plans to increase the civil penalty amounts specified in its Enforcement Policy in NUREG-1600, Rev.1, l for violations involving lost or improperly disposed of sources or devices. This increase will ,
better relate the civil penalty amount to the costs avoided by the failure to properly dispose of
~
the source or device. Due to the diversity of the types of sources and devices, the Commission 6
E is considering the establishment of three levels of base civil penalty for loss or improper ;
disposal. The higher tiers would be for sources that are relatively costly to dispose of.
Discussion I
The Atomic Energy Act of 1954 (AEA), as amended, authorizes the NRC to request appropriate information from its licensees concerning licensed activities. However, the Commission had not included such an explicit provision in the regulations governing 10 CFR 31.5 generallicensees.
This final rule adds an explicit requirement to 10 CFR 31.5 that requires general licensees who possess certain measuring, gauging, and controlling devices to respond in a l
timely way to written requests from the NRC for information concerning products that they have received for use under a general license.
The final rule requires a response to requests within 30 days or such other time as specified in the request. For routine requests for information,30 days should be adequate in a
most instances, and an extension .an be obtained for good cause. If more complicated !
I requests are made or circumstances recognized that may require a longer time, the l l
Commission may provide a longer response time. In the unusual circumstance of a significant safety concern, the Commission could demand information in a shorter time. The NRC will provide a phone number in the request for information in case additional guidance is necessary.
The NRC intends to use this provision primarily to institute an annual registration program for devices using certain quantities of specific radionuclides. The registration program is primarily intended to ensure that generallicensees are aware of and understand the requirements for the possession of devices containing byproduct material. The registration i 7
I
process will allow NRC to account for devices that have been distributed for use under the generallicense. The NRC believes that,if generailicensees are aware of their responsibilities, they will comply with the requirements for proper handling and disposal of generally licensed devices. This should help reduce the potential for incidents that could result in unnecessary I
' radiation exposure to the public as well as contamination of property. )
l The general licensees covered by the registration program will be asked to account for the devices in their possession and to verify, as well as certify, information concerning -- l (1) The identification of devices, such as the manufacturer, model, and serial numbers; (2) The persons knowledgeable of the device and the applicable regulations; (3) The disposition of the devices; and (4) The location of the devices.
An organization which uses generally licensed devices at numerous locations is usually considered a separate generallicensee at each location (except in the case of different facilities at the same complex or campus). In the case of portable devices that are routinely used at multiple sites, there is one general licensee for each primary place of storage, not for each place of use. Thus, an organization may be required to complete more than one registration, if it possess devices subject to registration at multiple locations.
While the final rule applies to all 10 CFR 31.5 general licensees (about 45,000), the ]
NRC will contact only approximately 5100 general licensees, possessing about 20,000 devices, for registration purposes. This category of generallicensees is based on the criteria recommended by the working group for determining which sources should have increased oversight. The proposed rule presented an estimate of 6000 generallicensees, based on the estimates made in the working group report. However, this had not accounted for the f act that, in the interim, Massachusetts had become an Agreement State. Using the same criteria, and 8
)
removing the previously NRC generallicensees in Massachusetts, results in an estimate of 5100. Other States are expected to become Ag eement States in the near future which will '
affect the number of generallicensees under NRC jurisdiction, but not the overall number nationally. The separate, more' comprehensive proposed rule published July 26,1999, indicated that Agreement States will be required to achieve a compatible level of accountability 1 over generally licensed devices. Thus, following Stato implementation of compatible programs in conjunction with that rule, further changes in the number of generally licensed devices within NRC jurisdiction should not adversely affect accountability. .
1 Requests for information will be sent to general licensees who are expected, based on cu ent NRC records, to possess devices containing (as indicated on the label) at least --
370 MBq (10 mci) of cesium-137; 3.7 MBq (0.1 mci) of strontium-90; 37 MBq (1 mci) of cobalt-60; or j
37 MBq (1 mci) of any transuranic (at this time, the only generally licensed devices meeting this criterion contain curium 244 and americium-241).
Most of the devices meeting these criteria are used in commercial and industrial applications measuring thickness; density, or chemical composition in petrochemical and steel manufacturing industries. The requests willinclude the information contained in NRC records concerning the possession of these devices. The licensees will be asked to verify, correct, and ,
add to that information. The NRC records are based on information providod to the NRC by i.
distributors under 10 CFR 32.52(a) and compatible Agreement State regulations and from generallicensees as required by 10 CFR 31.5(c)(8) or (9) regarding transfer of generally l'
licensed devices. If a generallicensee no longer possesses devices meeting the criteria,it will l
l 9
L
be expected to provide information about the disposition of the devices previously possessed. 3 i
Errors in current NRC records concerning these generallicensees could be the result of --
(1) Errors made in the quarterly reports of manufacturers or initial distributors:
(2) General licensees not reporting transfers; or (3) Errors made by NRC or its contractors in recording transfer information.
1 In addition to the 5100 general licensees identified for registration, the NRC may occasionally request information from other general licensees on a case-by-case basis as necessary or appropriate. For example, this might involve investigating the extent that other users have experienced a problem that has been identified with the design of a particular device model. However, significant modifications to the registration program to include a larger class of licensees would be done through rulemaking.
Although the amendment to the regulations imposes some additional costs on !
licensees, the NRC has estimated these costs to be minimal. This cost is the estimated j administrative cost expended by generallicensees to verify the information requested by the NRC regarding licensed devices. The NRC believes that the rule's intended effect of increased compliance by generallicensees with regulatory requirements, and resulting NRC and public )
. confidence in the general license program potentially afforded by these new requirements, outweigh this nominal administrative cost.
Public Comments on the Proposed Rule i
The NRC reviewed the public comments received on the December 2,1998, proposed rule. Seven comment letters were received from: the State of Illinois (an Agreement State),
National Steel Pellet Company, Steel Manufacturers Association (SMA), the Commonwealth of 10
I l .
I L Massachusetts (an Agreement State), the State of New Jersey (a non-Agreement State),
American Iron and Steel Institute (AISI), and one private citizen.
l 1 All commenters supported the proposed rule. One commenter agreed with the NRC that the proposed change would increase accountability and control over generally _ licensed radioactive devices. Another commenter supported the proposed regulation as a step in the ;
right direction,if not completely solving the regulatory problems of the NRC. The steel Ddustry supported the proposed rule as a positive, although small, step toward minimizing the risk associated with improper disposal of spent sources in the scrap supply.
Agreement was expressed by two commenters that the administrative burden on generallicensees to provide the minimal information requested by the NRC is reasonable, as is the 30-day period in which generallicensees have to respond, with extensions granted for good cause.
Several commenters voiced agreement with the interim enforcement policy. One .
1 cornmenter, the State of New Jersey, believes that it is extremely important to remove any l i
incentive for a general licensee to attempt to discard its source rather than comply with the reporting requirement. The commentor stated that when people get rid of their generally licensed devices in a hurry, the State has to go out and find them in mountains of trash or scrap metal.
Two other commenters, the SMA and AISI, stated that they would support any ,
enforcement program that doters improper disposal of radioactive sources. They also endorse the provision allowing generallicensees to report and correct violations without incurring penalties. These commenters believe that this provision would encourage licensees, who are not sure about sources they hold, to remedy the problem rather than improperly dispose of the sources in an attempt to avoid high penalties.
I1
l I !
l A. Current NRC General Licensina Process and Cost Shift. l Comment: in general, the three representatives of the steelindustry expressed similar concerns regarding the current NRC generallicensing process. One commenter, the SMA, stated that the proposed rule did not address the fact that the current regulatory regime has shifted the costs of lax accountability and control onto steel makers, insurers, and the I
taxpayers. This commenter stated that general licensees do not pay for their licenses nor
]
provide information directly to' NRC about the sources they hold. Instead, the cost has fallen on steel producers to detect the sources, on steel producers and taxpayers to arrange for proper j l
disposal, and on steel producers and their insurers to pay the cost when a source is i
inadvertently melted. This commenter believed that generallicensees should be required to J l
shoulder their fair share. )
Similarly,' the AISI pointed out that current NRC regulations have inadvertently and improperly shifted the costs for accountability and control onto hot metal producers, insurers, ;
and taxpayers and that steel producers are being forced to pay the cost of detecting orphaned sources, to arrange for proper disposal, and to pay for the cleanup when a source is inadvertently melted. This commenter also believed that generallicensees should be required to pay their fair share of these costs and stated that improving licensee accountability would also reduce the risk of the illegal release of generally licensed materialinto the public scrap supply. In addition, the AISI noted that the inadvertent melting of orphaned sources by 1
1 domestic steel producers has resulted in decontamination, disposal, and lost production costs ranging between $10 million and $24 million at electric fumace mills and that the cost of a similar incident occurring in a major integrated steel mill could easily exceed $100 million.
l 12 u
l Response: The Commission recognizes the expense to the steel industry when l
generally licensed devices containing radioactive material are not properly disposed of or l
properly handled. The NRC believes that this rulemaking will reduce the probability of lost and improperly disposed of sources, and ultimately the number of incidents of inadvertent meltings.
This would reduce the total expense to the steel industry, insurers, and taxpayers resulting from such incidents. A separate, more comprehensive rulemaking on this subject (proposed on July 26,1999) is expected to further improve accountability for devices and reduce the impact of improperly disposed of sources to the steel indu-stry. In addition, that rule would establish a registration fee to recover the cost of the NRC enhanced oversight program for those general licensees being required to register their devices.
B. Reportina Electronically and Data Verification.
Comment: Two commenters recommended that the NRC provide a means for electronically reporting the information requested by the NRC in order to save time, mailing I
expenses, and paper. They also indicated that the NRC should ensure that its database has an adequate data quality verification system and can easily flag inconsistencies.
One commenter suggested that the electronic filing could be accomplished through a l secure page on the NRC Intemet Web Site and that the NRC could use the employer's tax identification number and a password to secure the information. This commenter also recommended that the NRC database include a data quality verification system to quickly identify and immediately notify licensees of any reporting inconsistencies and that employers could also be required to annually verify the accuracy of the inventory.
Response: The submission of electronic applications and reports is a generic issue that impacts more than the generallicense registration program. The NRC has evaluated the issue 13
II
. j 1
'of permitting licensees to file applications and reports electronically and plans to publish an amendment to the regulations'to allow such submissions. The NRC expects to publish the f Jamendment next year. At that time, the NRC will evaluate how this change will impact !
. implementation of the registration program and future enhancements to the design of the !
J automated system.. However, the NRC currently expects that the initial registration program would require s'ubmission of hard copies of the registration forms.
The NRC is in the process of upgrading its information technology systems to facilitate iprocessing of anriual registrations.~ The upgrades willinclude adequate data verification for
~
distributor, general licensee, and registration information and will include automated readers for processing the large volume of registration forms. The automated readers willidentify changes and inconsistencies with the database, convert changes to electronic form, and incorporate the new data..
C. Control and Accountability.
' Comment: One commenter believed that a great deal of improvement is needed in the
. regulations goveming licensed radioactive devices concerning their location and whether they are being disposed of properly. - This commenter felt that a license should not be given out to
- persons to own'as many. devices as they please; instead a license should be given out per device, thereby limiting the number of devices available and making known the number of de' vices in use.;This commenter felt that radioactive material presents an extreme threat to health and safety even if disposed of properly, Bssponset. The Commission does not believe it is necessary, appropriate, or practical
' toiimit the number of devices going out to general licensees to one per licensee. Tracking the
' number of devices in use and who has them is achievable without such a restriction. Generally ;
L l o' 14 h
licensed devices are designed to be inherently safe and do not present nearly as great a risk to health and safety as the commenter suggests. Given the nature of the generallicense, restrictions on humbers of devices that can be possessed would be difficult to enforce and 1
l would likely lead to difficulties in getting accurate information on devices possessed.
Comment: Another commenter recommended that the NRC not target businesses with specific licenses, pointing out that they are required to --
(1) Have a Radiation Safety Officer:
l (2) Actively perform testing and inspections; and l
(3) Maintain written documentation.
Therefore, specific licensees are almost always aware of the byproduct material regulations applicable to byproduct material managed under a general license as well and are i more likely to adequately account for and handle devices containing byproduct material in accordance with the regulatory requirements. The commenter recommended that the NRC instead target general licensees that do not currently maintain byproduct material under a specific NRC license because these generallicensees are more likely to be unaware of the appropriate regulations and are more likely to inappropriately account for and handle devices containing byproduct material.
Response Specific licensees who also have generally licensed devices are subject to j any regulations applicable to the general license. Therefore, these specific licensees will be subject to registration. Given the approach of this first rule,it would be possible for NRC to simply not make this request for information from those who also hold specific licenses.
However, this would require additional effort to cross reference data on specific licensees with that on general licensees. Specific licensees, while generally more aware of applicable regulations, do have problems with incomplete accountability for devices. The potential 15
im";rovement in accountability should justify the limited administrative effort of providing registration information even in the case of those holding specific licenses.
If the additional rulemaking concerning registration is made final, specific licensees holding generally licensed devices subject to registration may wish to avoid the additional fee.
If so, they would have the option of amending their specific license, if necessary, to include the devices, and'thereby remove the devices from the generallicense status, in this case, labels may have to be changed to be consistent with the device's regulatory status.
Comment: The State of Illinois indicated that a group of general licensees in Illinois possesses devices containing curium-244 in quantities that would require registration under the proposed rule. This commenter recommended that the NRC contact licensees possessing not l only americium 241 but also curium-244, and noted that the statement in the December 2, 1998, proposed rule (63 FR 66493) that americium-241 is the only transuranic radionuclide found in generally licensed devices in quantities exceeding 37 megabecquerels (1 millicurie), is in error, l Resoonse: The Commission agrees. The omission in that statement, of curium-244 as l
. a transuranic element used in generally licensad devices meeting the criteria for registration, was an oversight. Devices containing curium-244 with quantities meeting the criterion for transuranics will be included in the registration requirement Comment: Several commenters stated that the NRC should give serious consideration I
. to the NRC-Agreement State Working Group recommendations as contained in NUREG-1551,
" Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices." Specifically, one commenter stated that there should be a Responsible Individual (RI) and a Backup Responsible Individual (BRI) for each general license.
This commenter stated that, unlike a specific license where there are a Radiation Safety Officer 16
F i l
i and Authorized Users, there may be only one person (RI) who has a real understanding that his or her company possesses a generally licensed device that contains a radioactive source. l When that RI dies, retires, resigns, c- is laid off, there may be no one at the facility with any 1
understanding or appreciation of the significance of the generally licensed device. The l-l commenter stated that the addition of one extra name and phone number to the records should l
l not be too burdensome on the licensee and may help avoid the burden of responding to a radiation incident involving the device.
Two other commenters recommended that the NRC consider the Working Group's
)
j recommended comprehensive measures, including requirements for the NRC to maintain inventory records, to compare and reconcile related discrepancies, and to mandate reporting
.the bankruptcy of a licensee to the NRC. The commenters also recommended State /NRC site inspections and inventories at regular intervals. These commenters felt that serious consideration should be given to each of these measures in order to prevent the continued loss of licensed sources into the scrap stream.
One of these commenters also urged the NRC to move forward with the planned I additional regulations amending or establishing requirements for registration fees, labeling, and I compatibility with Agreement State requirements. The commenter stated that the limited registration program would have minimal impact on the radioactive scrap problem if it is the only amentiaent the NRC proposes.
Response: The more comprehensive measures recommended by the NRC-Agreement State Working Group are being considered in the separate, more comprehensive rule proposed on July 26,1999. Comments on these issues will be considered as part of that rulemaking process, 17 I
L i.
D. Reaistration Proaram.
Comment: One commenter noted that the language of the proposal did not call for a
_ periodic registration program requiring reporting at least annually, Rather, the proposed amendment would merely restate NRC's authority to collect information from licensees. The l
commenter pointed out that the NRC already has this authority under 42 U.S.C. 2095 and in its own regulations at 10 CFR 30.34. This commenter urged the NRC to explicitly call for a l periodic registration program in the amended regulation stating that this would remind general licensees that they have licensed radioactive sources and that there are responsibilities j attached to their licenses, it would also indicate that the Government has knowledge of their sources and the authority to enforce prohibitions on improper disposal.
1 Response: The NRC has proposed explicit provisions for an annual registration requirement in the separate, more comprehensive rule on this subject.
Comment: A commenter suggested that the NRC reconsider one of the provisions in a proposed rule published February 5,1974 (39 FR 4583), that would have required registration of the generally licensed devices before custorners are allowed to receive them. This commenter stated that this would ensure and document that general licensees have received copies of the regulations and that they are aware of their rights and responsibilities.
Response The Commission does not believe preregistration is necessary to ensure and document that generallicensees have received copies of the regulations and that they are
- aware of their rights and responsibilities. However, the Commission has proposed amendments to address the need for customers to receive additional information prior to purchases of generally licensed devices in the separate, more comprehensive rule.
Comment: Another commenter strongly encouraged the NRC to adopt a mandatory registration program for all sources, not merely those that pose the greatest risk to steel mills.
18
f Besponse: The Commission has decided to use the criteria developed by the
) {
NRC/ Agreement State Working Group to determine which sources should be subject to the
\
registration program. These criteria were based on considerations of relative risk and were I limited to radionuclides currently in use in devices considered to present a higher risk of potential exposure, as well as potential for contamination of property.
l E. Fee-Based System.
Comment: One commenter believed that a fee-based system for all general licensees ,
1 would ensure that the NRC recovers the minimal cost to initiate and maintain the reporting program. The commenter stated that such a registration program would enable the NRC to account for all sources that have been distributed. The commenter further suggested that the program could be designed to allow steel companies and the general public to trace the origins of an improperly disposed of source. This would help steel companies in determining liability for the multimillion-dollar clean up costs that the steel companies and their insurers incur when sources are inadvertently molted. It would also provide Federaland State nuclear regulators that handle orphan sources a means to obtain reimbursement resulting in an additional deterrent against improper source disposition.
Another commenter was concerned that, even though a fee-based system for all general licensees would permit the NRC to recover the anticipated cost of initiating and maintaining the reporting program, a fee schedule could slow or prevent implementation of the entire proposal. If this is correct, the commenter recommended that the NRC retain the proposal as published.
l l
19 l
Response: The Commission is not addressing comments on its proposed fee-based I
system as part of this rulemaking process. The separate, more comprehensive rule addresses fees for registration and the comments will be considered in connection with that rulemaking.
F. Reaistration Information Available on the intemet.
Comment: One commenter was opposed to making the registration information available on the Internet because such posting would unnecessarily cause public concern over the presence and use of low level devices. The commenter believes that this information should be available only through the Freedom of Information Act request process.
Fesponset Some of the information submitted in distributor quarterly reports and entered into the generallicense tracking system that is to be used for handling registration information would be considered proprietary.- This database will be designed with security features in order to protect proprietary information. It will not be available on the Internet. The NRC would post information on its website concerning lost or unaccounted for devices. !
l G. Civil Penalty Amounts. l Comment: One commenter agreed with the NRC's intent to increase the civil penalty )
amounts for violations involving lost or improperly disposed of sources or devices. The i
commenter stated that the penalties must be significantly higher than the costs avoided by the j i
~ failure to properly dispose of the source or device. 4 l
A second commenter supported fining general licensees who violate their general !
a licenses by using a schedule that is proportionate to the damage actually caused by the lost source. The commenter used the example of the cost for cleaning a steel mill contaminated by l
melting such a source. This commenter believed that because the NRC's proposed penalty is l 20 t I
E l
not much higher than the current fine of $2500 per loss that has been assessed to licensees, it would not significantly deter illegal behavior. The commenter believes that increasing the current relatively minimal penalty levels to amounts that reflect the real world damage caused by loss of a licensed source will provide general licensees with a substantive economic incentive to dispose of their sources legally.
Resoonse: As discussed in the July 26,1999 (64 FR 40295) proposed rule, the Commission is considering raising civil penalties for violations involving lost or improperly disposed of sources or devices and may use a tiered approach with higher than usual civil penalties for sources that are relatively costly to dispose of. This is to ensure that such civil penalties better relate to the costs avoided by the failure to properly dispose of the source or device. The cost of cleaning a contaminated steel mill would not be an appropriate basis for setting fees.
No comments were made concerning the specific woroing of the croposed amendment.
No change to the rule has been made as a result of these comments.
Agreement State Compatibility Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997 (62 FR 46517), this final rule is classified as Compatibility Category D. Category D means the provisions are not required for purposes of compatibility; however, if adopted by the State, the provisions should not create any conflicts, duplications, or gaps in the regulation of AEA material. Ultimately, an enhanced oversight program is expected to laclude provisions that will require a higher degree of compatibility. This is being considered in the separate, more comprehensive rulemaking that 21 l-
\
-wou!d add more explicit requirements for the registration program and additional provisions
~
concerning accountability of generally licensed devices.
Voluntary Consensus Standards LThe National Technology Transfer and Advancement Act of 1995, Pub. L.104113,
. requires that agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical.L in this final rule, the NRC is amending its regulations to require -
that those who possess certain industrial devices containing byproduct material provide requested information. The amendments are administrative in nature and require certain types of specific entities to provide information concerning specific devices in their possession.
Therefore, this action does not constitute the establishment of a standard that establishes i generally applicable requirements; Environmental Impact: Categorical Exclusion The NRC has determined that this final rule is the type of action described in the
- categorical exclusion in 10 CFR 51.22(c)(3)(iii). Therefore, neither an environmental impact statement n'or an environmental assessment has been prepared for this regulation.
22
Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The information collection requirements in this rule have been approved by the Office of Management and Budget, approval number 3150-0016.
The public reporting burden for this information collection is estimated to average 20 minutes per response, including ths 'ime for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments on any aspect of this information collection, including suggestion for reducing the burden, to the Records Management Branch (T-6 E6), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS1 @NRC. GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, ;
NEOB-10202, (3150-0016), Office of Management and Budget, Washington, DC 20503. '
1 Public Protection Notification l
(
If a means used to impose an information collection does not display a currently valid j OMB control number, the NRC may not conduct or sponsor, and a person is not required to
. respond to, the information collection.
l 23 j i
~
a Regulatory Analysis l l
l The NRC has prepared a regulatovy analysis for this regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The regulatory analysis is available for inspection in the NRC Public Document Room,2120 L Street NW. (Lower Level),
Washington, DC. Single copiles of the analysis may be obtained by calling Jayne McCausland, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6219; or e-mail at JMM2@nrc. gov.
t Regulatory Flexibility Certification l
As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies j that this final rule does not have a significant economic impact on a substantial number of small
. entities. This rule requires generallicensees who have received specific devices to respond to
! requests for information from NRC. The final rule applies to the approximately 45,000 persons t
using prcducts under an NRC generallicense, many of whom may be classified as small j entities. However, the NRC intends to request registration information from only approximately l-5100 of these generallicensees. Registration information to be obtained willinclude
~ identification of the devices, accountability for the devices, the persons knowledgeable of the device and the applicable regulations, and the disposition of the devices. The NRC believes that the economic impact that any generallicensee incurs as a result of supplying this information constitutes a negligible increase in administrative burden. It is estimated that there are approximately 20,000 devices in the possession of the Commission's general licensees which will come under the registration requirement. The average cost to the generallicensee 24
'per device per year is about $4.00. Therefore, the action will not have a significant economic impact on small entities. The final rule is intended to ensure that general licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.
Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this rule, because these amendments do not involve any provisions that impose backfits as defined in ,10 CFR 50.109(a)(1) and, therefore, a backfit analysis is not required.
Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.
List of Subjects in 10 CFR Part 31 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and j containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment.-
25
E
- 1
, k For the reasons set out above and 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. 552 and 553, I
the'NRC is adopting the following amendments to 10 CFR Part 31.
PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL i
- 1. The authority citation for Part 31 continues to read as follows:
AUTHORITY: Secs. 81,161,1183,68 Stat. 935, 948,954, as amended (42 U.S.C.
1 2111,2201,2233); secs. 201, as amended,202,88 Stat.1242, as amended, 1244 (42 U.S.C.
5841,5842).
Section 31.6 also issued under sec. 274,73 Stat. 688 (42 U.S.C. 2021).
2.'Section 31.5 is amended by adding paragraph (c)(11) to read as follows:
$ 31.5 Certain measuring, gauging, or controlling devices."
.) -* * *
- (c).
(11) Shall respond to written requests from the Nuclear Regulatory Commission to provide information relating to the generallicense within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the
' Persons possessing byproduct material in devices under a general license in 10 CFR 31.5 before January 15,1975, may continue to possess, use, or transfer that material in accordance
' with the labeling requirements of 10 CFR 31.5 in effect on January 14,1975. ,
26 I
requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by submitting a letter to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 and provide written justification as to why it cannot comply.
L- Dated at Rockville, Maryland, this : 1st day of July- _ 1999.'
l For the Nuclear Regulatory Commission.
i f-Al A_^ + _
i William D. Travers,k
- l. Executive Director for Operations.
27 s
l
i I
l ATTACHMENT 2 l
Final Regulatory Analysis l
l l
l
FINAL REGULATORY ANALYSIS:
REQUIREMENTS FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE REQUESTED INFORMATION s 1 STATEMENT OF THE PROBLEM l
1.1 BACKGROUND
On February 12,1959 (24 FR 1089), the U.S. Atomic Energy Commission (AEC) {
l amended its regulations to provide a general license to possess and use byproduct materialin certain devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition or for producing light or an ionized atmosphere. The devices must be manufactured in accordance with the specifications contained in a spacific license issupd either by the Commission under 10 CFR Parts 30 and 32, or by an Agreement State. l l
There are approximately 45,000 " general licensees," i.e., persons possessing and using such l l
devices under the general 1icense (10 CFR 31.5). These general licensees possess an - i
. estimated 600,000 devices.
1 A generallicensee under the jurisdiction of the Commission is required to follow safety instructions on device labels, to test or service a device (with some exceptions), or to have the testing or servicing performed by the supplier or other specific licensee authorized to manufacture, install, or service the devices. General licensees may not abandon devices and l
1
must maintain records concerning the testing and servicing of the device. Generallicensees must also report damage to or loss of devices.
The NRC is notified when specific licensees transfer devices containing byproduct material to general licensees through quarterly reports submitted under 10 CFR 32.52(a).
.These reports identify each general licensee by name and address Oncluding, for an
. organization, the name or position of a person who may act as a point of contact between the NRC and the general licensee); the type of device transferred; and the quantity and type of byproduct material contained in the device. Under compatible Agreement State regulations, similar information !s obtainel.> from suppliers in Agretanent States on transfers to NRC general licensees. Further,10 CFR 31.5(c)(8) requires the general licensees to transfer or dispose of the generally licensed devices only to the holder of a specific license under Parts 30 and 32 or to the holder of a specific license issued by an Agreement State. Section 31.5(c)(9) provides a limited exception to this requirement that allows general licensees to transfer the devices to other generallicensees, but only if the device remains in use at a particular location or the device is held in storage in the original shipping container before initial use, in either case, transfers of devices by generallicensees must be reported to the NRC within 30 days of the transfer. A transfer report is not required if a generally licensed device is transferred to a 1
specific licensee in order to obtain a replacement device. The specific licensee making the i l
transfer is required, as part of its specific license, to maintain records of the transfer and to be j accountable for all radioactive material in its possession.
I
.1.2 NRC Study of Conformity with General License Conditions !
The NRC traditionally has had little contact with generallicensees. The NRC staff believes that this is why many general licensees are not aware of their responsibilities under a i
2 ;
i i
I l
I
generallicense and that this results in incidents of mishandling and improper disposition of generally licensed devices. This, in turn, has resulted in radiation exposure to the public and, in some cases, has entailed expensive investigation, cleanup, and disposal activities. In most instances, exposures to the public have not been significant. However, these exposures would not have occurred if the devices were properly handled and disposed of, The Commission conducted a study from 1984 through 1986 (General License Study) to ascertain the extent of compliance with generallicense conditions after it became aware of a .
l few incidents where control over generally licensed devices was lost. The results of the study l were discussed in SECY-87-167, dated July 9,1987, and in SEGY-89-289, dated I
September 14,1989. Although current regulations (10 CFR 30.52) ai:ow for the inspection of licensees possessing byproduct material, the Commission has not inspected general licensees on a regular basis. This is primarily because of the large number of these licensees and the I low risk presented by most of these devices. The Commission's knowledge of whether the general licensees are complying with the regulations for the proper use and disposal of !
generally licensed devices is limited. l l
Because of the broad range of devices covered under 10 CFR 31.5, the General License Study was divided into two parts. The first part covered industrial gauging and l l
measuring devices, such as large-scale level, density, and thickness monitors. There were l then approximately 10,000 Commission licensed devices in this category containing sources ;
with activities in the 0.5 to 1 curie range. The second part of the study covered devices which !
greatly varied in design and use, such as self-luminous signs, analytical instruments such as x-ray fluoresc9nce spectrometers or liquid scintillation spectrometers, and smaller-scale thickness, density, and level gauges. The summary of the results of the study presented below i i
is based on an unpublished NRC report entitled " General License Study Report."
i i
3 ,
[E 1.2.1 Part i Results The Part I study included 228 site surveys of general licensees by the study task force and 132 inspections conducted by NRC regional offices.- Some Agreement States also contributed data to the " General License Study." The information gathered by the study,
. although from a small sample of generallicensees possessing large-scale gauges, clearly established that there is a compliance problem. Among the findings of Part I were the following: ,
i Approximately 16' percent of these generallicensees could not account for all of
{
their gauges.
l
- A majority of these generallicensees either did not notify the NRC of transfers of their gauges or improperly transferred their gauges.
l At least 25 percent of these generallicensees were not performing required leak tests or maintaining leak-test records, or they were not inspecting a gauge's on/off shielding mechanisms or not inspecting them as required.
= Agreement States reported incidents of thickness gauges being found in landfills and, in one case, even in an abandoned paper mill. I l
~ 1.2.2 Part 11 Results Although Part ll of the study covered devices that vary greatly in design and use, the l
range of problems encountered in Part 11 is exemplified by the problem relating to self-luminous exit signs and beta backscatter gauges. Exit signs, which are one of the most common devices
- covered by a general license, contain tritium gas that excites phosphorous-coated glass tubes {
to give off light.' They are used in places where wiring of electrical signs would be difficult or expensive to do. Beta backscatter gauges contain a small sealed scurcs and a radiation 4
l l
detector that measures how much radiation is reflected back from a material sample. The j l
concern about these devices is the accountability of the removable source which is about 1 inch l in diameter. Ninety-eight interviews were conducted of persons who possess these types of 1
devices. The findings of Part 11 are summarized below: 1 Nonconformity with general license conditions was very widespread.
Only.16 percent of the generallicensees for exit signs were aware of the j l
regulatory requirements.
Manufacturers and distributors frequently underreported the number of exit signs sold to generallicensees. Generallicensees (electrical distributors and contractors) reported having about 30 percent more signs than were listed in quarterly reports of the manufacturers.
Three cases involved missing sources from beta backscatter gauges.
Only 45 percent of those surveyed for backscatter gauges were aware of the general license conditions.
Vendor reports did not accurately reflect the number of radioactive sources in the possession of generallicensees. When sources were returned by general licensees to the manufacturer for disposal, the NRC was not always notified.
Therefore, NRC records were not always accurate.
1.3 Subsequent Actions On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking regarding the accountatxlity of generallicensees under 10 CFR 31.5. The NRC proposed a number of provisions, including a requirement for these licensees to provide information at the request of the NRC in order to provide the regulatory basis for the registration 5
of these devices. The proposed rule also would have added requirements in 10 CFR 32.51a and 32.52 for specific licensees who manufacture or initially transfer these devices to the
~
generallicensees. Although the public comments received were reviewed and a final rule developed, that rule was not issued because the resources necessary to implement the proposed rule properly were not available.
The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity, in July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group to evaluate these issues. The working group consisted of both NRC and Agreement State personnel and
- encouraged the involvement of all persons having a stake in the process and its final recommendations. All working group meetings were open to the public. A final report was completed in July of 1996 and published in October of 1996 as NUREG-1551, " Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed l l
Devices." The recommendations of the working group provide a major basis for this rulemaking.
Some of the relevant conclusions of the working group were:
. Lack of adequate oversight by regulatory authorities is a major contributing factor to licensees losing control and accountability over their devices.
- Due to the large population of devices and the low risk associated with the design of many of the devices, an increased oversight program should only be
- l. implemented for certain devices.
. General licensees possessing the identified devices should report annually to their regulatory authority with a listing of their current inventory of devices so as 6
I '
l
to allow the regulator to independently verify that the licensee has maintained accountability and control of the devices.
The NRC has also proposed a more comprehensive rulemaking to more completely ;
1 address issues concerning generally licensed devices. Other recommendations of the working group were considered in that action. {
I 2 OBJECTIVES i
Tne objectives of the amendment to Part 31 are to ensure that certain generallicensees i
are aware of and understand the requirements for possession of generally licensed devices containing byproduct material and to better enable the NRC to verify the location, use, and I
disposition of those devices. The intent is to reduce the possibility of the devices being improperly transferred or inadvertently discarded. This may reduce unnecessary radiation exposure to the public and unnecessary expense involved in retrieving the items, particularly in the scrap metal stream, and avoid the contamination of steel mills, metals, and waste products.
i 3 ALTERNATIVES l 3.1 No action.
This alternative would be to continue the status quo. As costs and benefits are evaluated in terms of changes from the status quo, there are no costs or benefits associated with this alternative. No action, of course, does nothing to address identified concerns.
Often the only communication between a general licensee and the NRC is through the requirement that the NRC be notified when a device containing byproduct material is transferred. Information notices have been sent and inspections have been made but only rarely.
7
As discussed in Section 1.2 of this analysis, general licensees lack awareness of their responsibilities under a generallicense. The NRC staff believes that this lack of awareness is a 1
major contributor to the occurrence of incidents of mishandling and improper disposition of generally licensed devices. This has resulted in radiation exposure to the public and, in some cases, entailed expensive investigation, cleanup, and disposal activities. Therefore, the no action alternative is not appropriate.
3.2 Nonrulemaking alternatives There are a number of ways that toe potential problems of lack of awareness of regulatory requirements on the part of generallicensees could be addressed. Guidanc could ,
l be provided in a number of forms. However, only periodic contact with the generallicensees l I
would be expected to have a significant impact on the level of awareness of requirements. The most appropriate means to remind users of their responsibilities would be to issue information notic's periodically. However, these information notices may not reach all users. Although 10 CFR 32.52 requires that specific licensee distributors report to the NRC or the Agreement State agency the narr e and/or title of the individual who constitutes the point of contact
! between the generr.ilicensee and the NRC or the Agreement State agency, the Genera.
License Study indicated that this individual, who is frequently in the purchasing department, l often did not inform the individual who uses the device of the general license conditions. The study also indicated that personnel turnover frequently eliminated the organization's knowledge of the license conditions. For similar reasons, information notices may not reach the appropriate ' person within the organization of a generallicensee because the contacts provided in the specific licensees' quarterly reports are frequently not the individuals responsible for, or knowledgeable of, the devices after they have been received and are being used.
8
Even when generallicensees are ' aware of their. basic responsibilities concerning the devices, there may be other factors contributing to noncompliance with requirements. For example, the cost of disposal may cause some generallicensees to dispose of devices improperly. It is important that the general licensees understand that the Commission will hold them responsible for these devices. Increased inspection of generallicensees and enforcement of the requirements may improve compliance. However, without a registration Lsystem, increased inspection would be on a random basis and would not be very efficient.
None of these actions would result in a high degree of accountability for these devices.
- A registration system together with followup will be more effective in terms of accountability, ,
and will provide a basis for more efficient use of inspection and enforcement efforts. However, for those devices not subject to a registration requirement, some increased contact such as an occasionalinformation notice may be appropriate.
3.3 Rulemaking to modify reporting requirements This alternative amends 10 CFR 31.5 to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded. The j l
general mechanism to be used is to require general licensees to verify compliance with certain 1 conditions imposed by the general license.
The amendment, a new paragraph (c)(11) in 10 CFR 31.5, requires a general licensee to respond to requests from the NRC for verification of information relating to the general license and the general licensee within 30 days (or other time period specified in the request).
I The licensee can request an extension within the Wma allotted time if he or she is having
. diHiculty in providing the information.
9
The NRC envisions that requests will be made for verification of the information currently on record concerning certain devices containing byproduct material that have been transferred to the generallicensee. The generallicensee will verify, correct, and add to the information, as necessary, and report on the disposition of devices no longer in the organization's possession. This process will offer greater assurance that a generallicensee is informed of its regulatory responsibilities and will provide information from an independent inventory as a mechanism to assist with verifying accountability of devices. The NRC will make periodic (expected to be annual) requests for verification to remind general licensees of their regulatory responsibilities and to reduce the likelihood that devices containing byproduct material are illegally transferred or inadvertently discarded.
The registration conducted under this rulemaking does not completely address the l factors discussed above concerning knowledge of the regulations reaching the appropriate persons. However, a subsequent rulemaking has been proposed which, among other things, l i
addresses changing the suppliers' reporting requirements to provide information regarding a person with responsibility for knowledge of and authority to take actions to comply with the regulations rather than simply a point of contact.
4 CONSEQUENCES 4.1 Benefits of Chosen Alternative l
The revisions are intended to improve understanding of and compliance with the general license requirements, and thereby reduce the likelihood of incidents resulting in unnecessary exposures to the public and contamination of property. These revisions will better enable the NRC to verify the location and disposition of these devices and confirm the efficacy of the 10
b'
' generallicense regulatory program. The primary benefits of this rule can be categorized into
' economic benefits and exposure aversion benefits. . In this case, both of these aspects are very difficult to quantify.- Although ranges of potential exposures have been calculated and ranges of costs from individualincidents have been recorded, the werking group concluded that none of the studies conducted are adequate to quantify an overall net cost of devices that have been improperly disposed of or lost. An admittedly uncertain estimate was made of the current
- economic costs and exposures resulting from improper disposition of both specifically and generally licensed devices meeting the criteria for increased oversight. The degree of effectiveness of a particular process is also uncertain and would depend on the level of effort used in enforcement of the provision.
The estimate of economic costs made by the working group and adjusted here for the
)
number of _ devices covered by this action is based on experience (as reported by the steel industry). Uncertainty in these estimates comes from a number of factors including:
- The number of incidents of meltings reported is small overall. Thus, there is considerable statistical uncertainty in how representative the costs are of future costs
! averted. j
. The likelihood of loss may be different for specifically and generally licensed dsvices and for different categories of devices. However, once a melting has occurred, it usually cannot be determined whether a generally or specifically licensed device was involved.
. The cost of a cleanup depends on the type of steel mill. The experience reported did not include incidents at large integrated steel mills and the resultant costs of such an l
incident are expected to be much greater than those experienced to date, possibly as much as $100 million for a single incident.
I1
The likelihood of meltings depends on the level of effort on the part of metal manufacturers and recyclers in monitoring for radioactive sources in scrap. Monitoring efforts have generally increased over time, particularly at larger mills.
4.1.1 Radiation Exposure Averted Benefit This rule should avert radiation exposure to the public. Although it is reasonable to assume that a member of the public would not deliberately expose himself or herself or q someone else to radiation, in some cases, individuals might not understand that a gamma l gauge is a potential source of radiation. When a gamma gauge is distributed to a general licensee, the gauge must bear durable, legible labels which include a caution that the gauge contains radioactive material. The generallicense in 10 CFR 31.5 requires that the general licensee maintain those labels. However, the cautionary language can become corroded and unreadable or painted over. An individual who finds the gauge without this labeling in an uncontrolled situation would have no reason to suspect that the gauge contains radioactive material.
i If a generally licensed gauge were improperly transferred or disposed of so that it j became available 10 a member of the general public, no significant radiation exposure would i .
i result if the radioactive material sealed source remained in the gauge and the shutter l mechanism remained closed. In addition, temporary exposure to an intact gauge should not cause a significant radiation dose. The gauge would normally include a waming label with a radiation symbol and cautionary words.
l- However, if a gauge with a significant source of activity were to end up in the public l
domain, the labeling were to be destroyed, and a person somehow exposed the source, a l . significant exposure could result. Radiation exposure due to "nproper control could conceivably 12 i
I
result in doses of a few rem to doses that are life threatening. To date, no incidents in the U.S.
have resulted in doses in the upper range, and the likelihood of situations which could result in
. the highest doses is extremely small.
Based on a June 1994 PNL report, " Peer Review of Improper Transfer / Disposal
. Scenarios for Generally Licensed Devices," the WG estimated the average dose received from incidents of lost devices involving cesium-137 (the most common nuclide involved in incidents historically) could be 7 rem (70 mSv) and the maximum dose that might be received could be somewhat over 1000 rem (10 Sv). The PNL study considered gamma gauges containing 20 mci or greater of cesium-137. The analysis was based on the average activity of 883 mci of cesium-137 within this category using data from the General License Data Base on devices registered in the Sealed Source Device Registry during the period 1987-1992. Gamma gauges l
were chosen for'the example analysis as representative of relatively high risk sources amongst generally licensed devices. These were very preliminary estimates. The data has known errors and the average activity per device actually distributed is lower as the registry information gives maximum activities to be used; also average activities used have declined.
Although the potential exists for individuals in the public to receive a very significant exposure, the probability is very low. This final rule will further reduce the probability of inadvertent exposures.
4.1.2 Economic Benefits 1 I l There is a cost savings to industries that might inadvertently come into posse,: < of an j l
' improperly disposed device. The most significant of these is the avoidance of a melting of a source and resulting contamination of a steel mill and its products and wastes.
13
l Based on the known incidents during the penod from 1983 to 1995 involving the nuclides for which registration is to be required, the cost of decontamination and cic 'nup (using
~
' the average cleanup costs) is about $12 million per year. This cost can be considered as a societal cost which map be mitigated or possibly averted in the future if the rule is implemented.
1 If this rule covers 15 to 20 percent of the devices contributing to the melting experience to date (since this rule addresses only' devices in NRC-regulated States and some of the melted devices may have been specifically licensed) and reduces the rate of incidents involving those devices by half, the average annual cleanup costs of $12 M will be reduced by roughly $1 M per j year.
There are other costs, though less significant, associated with lost sources which may be reduced by this rulemaking.
The rulemaking should also reduce the number of orphaned sources. The cost of 4 i
disposalin the case of orphaned sources falls on parties other than the user of the device, such as government agencies, e. g., EPA or DOE, or individuals or organizations who inadvertently come into possession of a device.
The projected savings are not entirely attributable to implementation of the rule, but also to the planned increase in inspection and enforcement efforts.
~ 4.2 Costs of Alternative The amendment to 10 CFR 31.5 results in costs to general licensees and to the Commission. There also are costs to the Commission associated with the rulemaking process.
14
,m -
l 4.2.1 Costs of Rev, tions to 10 CFR 31.5 to General Licensees Registration process:
I The revision requires generallicensees to respond to requests from the NRC to verify l
< information related to their generallicenses. This information can help the NRC confirm that the general licensees still possess and are in control of their generally licensed devices containing byproduct materials and are meeting the general license conditions imposed by the Commission's regulations. The NRC plans to send a request for verification to each general licensee who has received a generally licensed device meeting the criteria developed by the working group and should still be in possession of it according to the Commission's records.
The cost to industry will entail a small annual administrative cost to each of j I
( approximately 5100 general licensees. The General License Study found that the everage time {
- 1 required to locate and verify license conditions for all devices in the possession of a general licensee was approximately 30 minutes. The general licensees included in the registration
! requirement as planned under this rule have fewer devices per licensee on average, so we estimate an average time of 20 minutes per response. Assuming that the cost to industry for
(, staff time is $50/hr, the annual cost of this step is estimated as:
Cost = 1/3 hour / licensee x $50/ hour x 5100 licensees = $85,000 i
This estimate assumes that the general licensees are in comphance with the requirements in I ,
10 CFR 31.5. For some generallicensees, particularly in the first year of responding to the
]
registration request, more effort will be invulved because of their lack of awareness of existing requirements and noncompliance with some of them. The cost of this additional effort is not a direct cost of this rule. l 15
l
)
Miscellaneous one time requests:
In addition to the reg;stration program, there may be an occasional need to request other information from generallicensees under this provision. For example, this might involve investigating the extent that other users have experienced a problem that has been identified l
with the design of a particular device model. However, if significant modifications to the registration program, such as inclusion of a larger class of licensees, were envisioned, the Commission will not do so using this provision but would do so through rulemaking. It is estimated that no more than 100 such requests per year on average will be made. This could I include any of the general licensees under 10 CFR 31.5. As the type of information requested will vary and will not be a routine request as in the registration process, the time to respond will vary and may be longer on average than the routine requests. to the unusual circumstance of a significant safety concern, the Commission could demand information in a shorter time if appropriate.
If the average time for responding is assumed to be 30 minutes:
Cost = 100 licensees x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / licensee x $50/ hour = $2500.
l Extension requests:
The rule provides that if a general licensee cannot respond to the NRC's request within the allowed time limit, general licensees may request an extension of time to respond. For the most part, general licensees using devices for which registration will be requested have a limited number of such devices. Thirty days will usually be provided for routine registration requests. It should be quite rare that an extension beyond the time allowed will be needed.
i Also, few incidents are expected where information might be requested from other licensees. 1 Thus, it is estimated that only about 25 licensees will request an extension each year. The {
l NRC estimates that the extension process will average about 30 minutes. This includes the l l
l 16 I
l i
)
l j l
l time to research the subject, draft the correspondence, and any subsequent communications I
with the NRC. The cost of this effort will be:
Cost = 25 licensees x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / licensee x $50/ hour = $625 4.2.2 Operational Costs of Revisions to 10 CFR 31.5 to NRC Registration process:
The NRC will mail periodic (approximately annual) requests to general licensees to l
1 verify compliance with certain general license requirements for all devices meeting certain 1
criteria in the possession of the generallicensees. It is assumed that the NRC uses the information provided by the specific licensees that is stored in the directory and that each request is computer-generated. When the NRC receives a response from a generallicensee,it l will log the response into the computerized directory or record that verification has been received it is assumed that the staff effort associated with both of these steps costs approximately $3.00 per general licensee (averaging roughly 3 minutes per request, $56/ hour).
Cost = 5100 x $3.00 = $15,300
($56/ hour is assumed because of the administrative / clerical nature of the work.)
This estimate assumes that all generallicensees comply with the requirement. The number of general licensees not responding or responding inadequately is expected to be greatest in the first year (about 5 percent) and decline in subsequent years. The cost of fo!Iowup for noncompliance is discussed below. In addition, a number of generallicensees may have difficulty accounting for the devices they have received. This number is als s expected to be greatest in the first year (adding an estimated 10 percent to those requiring followup), and fewer in subsequent' years. The estimated total of 15 percent of general 17
1 licensees needing followup is based in part on the General License Study and the subsequent J experience of some Agreement States that have initiated enhanced oversight programs. j l
in addition, particularly in the first year or so, there may be calls from general licensees l I
requesting clarifications regarding the registration process as well as other aspects of their responsibilities under 10 CFR 31.5. Assuming 30 percent of all generallicensees receiving a i
request for information call for technical assistance in the first year, and one-third of these require 15 minutes to respond, and the remaining average 1/2 hour of staff time, about 640 hours0.00741 days <br />0.178 hours <br />0.00106 weeks <br />2.4352e-4 months <br /> of additional staff time may result at a cost of approximately $35,800. After the initial j implementation, this is expected to be 128 hours0.00148 days <br />0.0356 hours <br />2.116402e-4 weeks <br />4.8704e-5 months <br /> (510 requests (10 percent) averaging 15 minutes) or roughly $7200.
I Miscellaneous one time requests: l l
For the occasional requests for information from general licensees made on a case-by-case basis under this provision, it is estimated that NRC will make no more than ;
l 100 such requests per year on average. This is primarily expected to be requests sent to a l group of licensees for a particular type of information likely relating to a particular device or l device type, if this involves an average of 30 minutes per request for determining what j i
information is needed, sending out the requests, and reviewing the responses, the cost will be:
Cost = 100 requests x 0.5 hour5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / request x $70/ hour = $3500.
$70/ hour is used as it involves primarily time on the part of a professional reviewer. 0 Extension requests:
i The cost to the NRC of processing requests for extensions is estimated to average i
30 minutes per request. This includes the time to evaluate the request, respond to the general licensee, if necessary, and to log in the action. The cost to the NRC for processing the estimated 25 requests is: j 18 i
Cost = 25 requests x 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / request x $56/hr. = $700.
Followup Costs:
A significant cost for followup af ter the registration process is initiated is expected. The cost to NRC will come primarily from followup in cases where licensees either do not respond or cannot account for devices they have received and reconciliations of discrepancies between current NRC records and the registration information submitted by generallicensees. Most of l
this is not a direct cost of this rule, but a means of enforcing preexisting requirements. In fact, (
1 the registration process allows for inspection and enforcement efforts related to the requirements in 10 CFR 31.5 to be applied more efficiently and effectively (versus inspecting i
these generallicensees randomly). Although the Commission plans to increase inspection and )
1 enforcement actions as part of an overall effort to improve oversight of these generallicensees, i most of the costs of this increased effort are not a direct result of this rulemaking. Most of the effort will be followup related to lost or improperly disposed of sources.
NRC will incur followup costs directly related to this rule when licensees do not respond )
to the request for information or report unaccounted for discrepancies from information in NRC records.
First Year:
In the first year, it is estimated that 5100 general licensees will be contacted and that approximately 5 percent will require followup efforts because of either nonresponse or J l
discrepancies between the information in the NRC records and the reports of the general licensees.
If the followup averages 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> effort at $56/ hour:
Cost = 5100 x 0.05 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr. = $28,560 l l
19
l Second Year:
In the second year, the NRC will request verification from the same 5100 general licensees notified the first year, as well as any new general licensees added to the database meeting the criteria for inclusion, as a result of quarterly transfer reports from the suppliers, in the second year, a followup rate of 2 percent is projected.
- Cost = 5100 x 0.02 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr. = $11,424
~ Third and subsequent years:
- The NRC will continue to request verification from the entire list of general licensees in the database. In the third and subsequent years, the need for followup is estimated at
- 1 percent.
j Cost = 5100 x 0.01 x 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> x $56/hr. = $5,712/ year after the first two years.
l l
I 4.2.3 NRC Development and Implementation Costs )
I NRC development costs are the costs of preparing a regulation before its promulgation and implementation. These costs may include expenditures for research in st:pport of the j
. regulatory action, publishing rulemaking documents, responding to public comments, and issuing a final rule. The General License Study, the working group process, and the additional contractual work, which have been used to support this rulemaking, have already been performed and dealt with a broader range of issues. These costs are considered outside the scope of this analysis. Development costs within the scope of this analysis are the costs of proceeding with this specific action and consist mainly of the costs of the effort of NRC
- professional staff members expended in developing this rule.
NRC implementation costs are those "Iront-end" costs necessary to effectuate the l 1 action.- They may arise from the necessity of developing procedures and guidance to assist l 20 i i
i
)
i l
I licensees in complying with the final action. These costs do not include the cost to the NRC of i
' improving and maintaining a computerized directory of devices. Although the computer ,
database must be updated in order to implement this rule, and this will be done in a way to 1
particularly accommodate a registration process, the database must be updated, in any case, if '
it is to provide a reasonable information base for inspection and enforcement and regulatory ;
actions related to 10 CFR Part 31 generallicensees. Additional costs related to l accommodating the registration process are expected to be a small fraction of the overall costs for the update and are not estimated here.
The total development and implementation costs for this rule and the preparation of associated guidance is estimated as: $189,000 (1 % professional staff year x $126,000).
i 5 DECISION RATIONALE This action is being adopted because it represents a reasonable means for the Commission to fulfill its obligation to protect public health and safety, property, and the environment, it will better ensure that certain generallicensees are aware of those requirements with which they must comply and provide the information on the location, use, and disposition of generally licensed devices needed to confirm the efficacy of the general license regulatory program and the estimates of low risk from these devices. The rationale for this recommendation follows.
. The General License Study conducted by the NRC indicates that there is a significant level of noncompliance with the general license requirements contained in 10 CFR 31.5(c).
! This noncompliance presents a risk of low, but avoidable, exposure of the public to radiation plus a low probability of significant axposure as a consequence of improper handling or disposal of the devices generally licensed. The study revealed that a major reason for 21
l
' )
a noncompliance is that users of the generally licensed devices are unaware that there are regulatory requirements associated with the possession and use of these devices. j j
This regulatory action will establish a reasonable procedure to ensure that general licensees are aware of the provisions awociated with the general license and comply with the applicable regulatory requirements. It is believed that increased awareness and understanding
- of the NRC's requirements on the part of the generallicensees willincrease the likelihood that general licensees will comply with those requirements and thereby reduce the potential for )
l unnecessary radiation exposure to the public and prevent costs to industy from improper handling or disposal of generally licensed devices. Promulgation of this rule should result in improvement in the accountability for devices and should provide confidence that the use of generally licensed devices is being regulated in an appropriate manner.
This regulatory action has resulted in an estimated up-front development and implementation cost to the Commission of $189,000 and will result in annual costs to industry
- and the Commission of $88,125 and $32,412 respectively, with somewhat higher costs in the first few years of implementation. Although the NRC estimates that the overall risk associated with these devices is small and, therefore, any risk reduction realized through improved compliance with the Commission's regulations by general licensees will also be small, there is some probability of signific ?t dose to the public from incidents resulting from loss of device The staff has concluded that the benefit of increased confidence in the efficacy of the general license regulatory program outweighs the nominal cost per device. The benefit to be realized even further overshadows the nominal costs when considered in light of the contribution of this action to the possible avoidance of the substantial cleanup costs that have occurred because of the improper disposition of generally licensed devices in the past. If this rule covers 15 to 20 percent of the devices contributing to the melting experience to date and reduces the rate of 22
- - incidence involving those devices by half, 't he average annual cleanup costs of $12 M will be t
reduced by about $1 M per year because of the implementation of this rule and the increased inspection and enforcement efforts that are also planned.
6 IMPLEMENTATION The regulatory action is not expected to present any significant implementation problems. The computerized directory that will be required has already been implemented by
' the Commission. However, it is outdated and needs improvement or replacernent. This is the I
case if it is to be useful to the program irresp,ective of this rule. General licensees will be sent a '
copy of the final Federal Register notice.
7 EFFECT ON SMALL ENTITIES As was discussed in Section 4.2.1 of this analysis, the action will have some economic impact on generallicensees of devices containing byproduct material. There are up to 45,000 generallicensees under 10 CFR 31.5 of which 5100 will be routinely requested to verify information, some of whom may be "small entities" within the meaning of the Regulatory
- Flexibility Act (Pub. L.'96-534). However, the economic impact on these entities will not be significant.
In Section 4.2.1 of this analysis, it was estimated that the cost of responding to the Commission's verification requests to general licensees will total about $85,000/yr.
It is estimated that there are approximately 20,000 devices in the possession of the Commission's generallicensees which will come under the registration requirement. The average cost to the general licensee per device per year is about $4.00. Therefore, the action will not have a significant economic impact on small entities.
23 l
l I
l l
l l
ATTACHMENT 3 Press Release i I
i
C l-NRC CHANGES REGULATIONS TO REQUIRE INFORMATION FOR DEVICES CONTAINING RADIOACTIVE MATERIAL
. The Nuclear Regulatory Commission is amending its regulations governing the use of radioactive material in certain measuring, gauging and controlling devices to explicitly require licensees who possess the devices to provide information to NRC upon request.
Companies'and individuals are permitted to use the devices under an NRC " general license," which means that they need not have a specific license issued to a named individual L.
or organization with specific license conditions and requirements. A generally licensed device usually consicts of radioactive material contained in a sealed source within a shielded container.
! The device is designed with inherent radiation safety features so that it can be used by persons j l ~ with no radiation training or expenence. The general license is meant to simplify the licensing
!- a process so that a case-by-case determination of the adequacy of radiation training or l experience of each user is not necessary.
! There are about 45,000 genera' licensees under the Commission's general 'icense l
program; they possess about 600,000 devices containing radioactive material. In the past, the
- j. NRC has not contacted these generallicensees on a regular basis because of the relatively l small radiation risk posed by the devices and the very large number of licensees. However, l
thee cave been a number of instances in which generally licensed devices have not been properly handled or properly disposed of, which have occasionally resulted in unnecessary l
radiation exposure to the public and contamination of property.
A three-year sampling of general licensees showed that approximately 15 percent of thos'e surveyed could not account for all of their devices. The NRC believes this situation could be addressed by more frequent and timely contact.
f
p
'.,Y.
2 l l
While the Atomic Energy Ac't gives NRC the authority to request appropriate information l from licensees, Commission regulations (Part 31) had not previously included an explicit
. provision for information from general licensees.
L The NRC plans to use the new requirements for certain general licensees to establish a L ' registration system. This system will cover measuring, gauging and controlling devices with l
l E quantities of certain radioactive materials posing a higher risk to public safety or of property damage if the device were lost than would other generally licensed devices. The majority of the devices meeting these criteria are'used in commercial and industrial applications measuring thickness, density'or chemical composition in industries such as petrochemical and steel ,
- manufacturing. About 5,100 general licensees possessing about 20,000 devices will come under the registration' requirement.
- The revision requires the affected licensees'to respond to NRC requests for information within 30 days,in most cases.
t l
w l
i L.
- c. 1 1
i i
1 l
l l
i 1
1 ATTACHMENT 4 i
Approval for Publication l
L
booroved for Publication The Commission delegated to the EDO (10 CFR 1.31(c)) the authority to develop and promulgate rules as defined in the APA (5 U.S.C. 551(4)) subject to the limitations in NRC Management Directive 9.17, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213,038,039, and 0310.
. The enclosed final rule, " Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information," amends 10 CFR 31.5 to add
. an explicit requirement that general licensees who possess devices containing byproduct material provide the NRC with information concerning products that they have received for uso under a generallicense as requested by the NRC. This provision will be used primarily to institute a registration system for devices using certain quantities of specific radionuclides.
4 This final rule does not constitute a significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7,8, or 9 Subpart C concerning matters of policy. I, therefore, find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
July 1, 1999 d)t zw fe _ -
Date - William D. Trav ers.
Executive Director for Operations.
i
ATTACHMENT 5 Congressional Letters l
l l
l
$, t,Y Ith p 4. _
UNITED STATES ,
~g 12- NUCLEAR REGULATORY COMMISSION o WASHINGTON, D.C. 205554001
. The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, ,
' Private Property and Nuclear Safety.
Committee on Environment and Public Works y United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Final Rulemaking to be published in the Federal Reaister. The U.S. Nuclear Regulatory Commission (NRC)is amending 10 CFR Part 31 to add an explicit requirement that certain general licensees, who possess devices containing byprodt'ct material, respond to NRC requests for information
. concerning devices that they have received for use under a general license. This provision will be used primarily to institute a registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications.
NRC has observed a number of instances in the past where generally licensed devices have
- not been handled or disposed of properly. This amendment will allow NRC to account for devices that have been distributed for use under the general license and thereby reduce the potential for inciderts that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely,-
Dennis K. Rathbun, Director
- Office of Congressional Affairs
Enclosure:
Federal Register Notice
, cc: Senator Bob Graham
F t
epa 4%
4 UNITED STATES
{9 o
" j L NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-) ci
,o
+9 . . . .
The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
. Enclosed for the information of the Subcommittee is a copy of a Notice of Final Rulemaking to be published in the Eederal Beaister. The U.S. Nuclear Regulatory Commission (NRC) is amending 10 CFR Part 31 to add an explicit requirement that certain generallicensees, who
. possess devices containing byproduct material, respond to NRC requests for information concerning devices that they have received for use under a general license. This provision will I be used primarily to institute a registration system for devices using certain quantities of specific I radionuclides that are primarily used in commercial and industrial applications.
NRC has observed a number of instances in the past where generally licensed devices have not been handled or disposed of properly. This amendment will allow NRC to account for devices that have been distributed for use under the general license and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well
. as contamination of property. This change will have no adverse impac* on the health and )
I safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, Dennis K. Rathbun, Director Office of Conyessional Affairs
Enclosure:
Federal Register Notice cc: Senator Bob Graham 4
L
L 1
1
- The Honorable James M. Inhofe, Chairman l 1
. Subcommittee on Clean Air, Wetlands, l Private Property and Nuclear Safety l Committee on Environment and Public Works
( United States Senate l Washington, DC 20510 1
1
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Final Rulemaking to be published in the Federal Reaister. The U.S. Nuclear Regulatory Commission (NRC) is .
amending 10 CFR Part 31 to add an explicit requirement that certain general licensees,who possess devices containing byproduct material, respond to NRC requests for information concerning devices that they have received for use under a general license.- This provision will be used primarily to inst tute a registration system for devices using certain quantities of specific i radionuclides that are primarily used in commercial and industrial applications. I NRC has observed a number of instances in the past where generally licensed devices have not been handled or disposed of properly. This amendment will allow NHC to account for devices that have been distributed for use under the generallicense anJ thereby reduce the potential for incidents that could resylt in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely,
~ Dennis K. Rathbun, Director Office of Congressional Affairs Enclosur Identical letter sent to: The Honorable Joe L. Barton Federal H'6gister Notice Chairman, Subcommittee on Energy and Power cC: Senator Bob Graham DISTRIBUTION: EDO 199800070 NMss 199900199 JDO r/f .
Mbridgers PHolahan CPoland CRMattsen NMss Dir, Off, rif . JMcCausland DACool (o:\MATTsENiGL1F\GL1FCoN]
To recetwe a copy of tNo document, Indicate in the bos 'C' e cepo eMhout attachmert/ enclosure, *8* e copy witti attachment / enclosure, "N* e No cop' r OFFICE RGB\lMNs lC RGBilMNs l D:lMNs l l TECHED li D:N M U oCA NAME CMattsen (W PkHolahan DFg68tvt- EKrsus CPMilo DKRathbun DATE i /JPJ9 9 d$p9 6/Z1/99 b/ h /99 6 /-13'/99 , / /99 OFFICIAL RECORD copy Mi f
l l
L
i i
t ATTACHMENT 6
-t Notification for Con assional Review "Small Business Regulatory Enforcement Fairness Act of 1996" l
I i
4 I
i r
l
r .
o as 24722 U
Submission of Federal Rules Under the Congressional Review Act President of the Senate O Speaker of the llouse of Representatives E GAO Please fill the circles electronically or with black pen or #2 pencil.
- 1. Name of Department or Agency 2. Subdivision or Office U.S. Nuclear Regulatory Commission NMSS/IMNS
- 3. Rule Trtle 10 CFR Part 31 - Final rule to amend 10 CFR 31.5, " Requirements for Those Who Possess Certain Industrial i Devices Containing Byproduct Material to Provide Requested Information"
- 4. Regula*;on Identifier Number (RIN) or Other Unique identifier (if applicable)
]
RIN 3150-AG06
- 5. Major Rule O Non-major Rule 9
- 6. Final Rule G Other O !
I
- 7. With respect to this rule, did your agency solict pubhc comments? Yes G No O N/A O
- 8. Pnonty of Regulation (fillin one) l O Economically Significant; or G Routine and Frequent or Significant; or informational / Administrative /Other Substantive, Nonsignificant (Do not complete the other side of this form if filled in above.)
9 Effective Date (if applicable) 60 days after publication in the Federal Register 1
- 10. Cnncise Summary of Rule (fillin one or both) attached O stated in rule 9 i
Submitted by. (signature)
Name: Dennis K. Rathbun m e: Director Office of Congressional Affairs l
For Congressional Use Only:
Date Received:
Committee of Jurisdiction: _
3/23/99 F-b
y~
O_ k , O 24722 Yes No N/A A. With resr,ect to this rule, did your agency prepare an analysis of costs 9 O O and benefits?
- 8. With respect to this rule, by the final rulemaking stage, did your agency
- 1. certify that the rule would not hsve a significant economic impact on a - 4 O O substantial number of small entities under 5 U.S.C. $ 605(b)?
i
- 2. prepare a final Regulatory Flexibility Analysis under 5 U.S.C. $ 604(a)? O O O
~ C, With respect to this rule, did your agency prepare a written statement under O O O
' $ 202 of the Unfunded Mandates Reform Act of 19957 1
D. With respect to this rule, did your agency prepare an Environmental Assessment O 9 O 1 or an Environmental lmpact Statement under the National Environmental Policy l
Act (NEPA)? !
E. Does this rule contain a collection of information requiring OMB approval e O O ;
under the Paperwork Reduction Act of 1995?
]
l F. Did you discuss any of the following in the preamble to the rule? O O O )
i e E.O.12612 Federalism O O O e E.O.12630, Government Actions and Interference with Constitutionally O O O Protected Property Rights e E.O.12866, Regulatory Planning and Review O- O O e E.O.12875, Enhancing the Intergovernmental Partnership O O O e E.O.12988, CivilJustice Reform O O O e E.O.13045, Protection of Children from Environmental Health Risks . O O O and Safety Risks e Other statutes or executive orders discussed in the preamble concerning the rulemaking process (please specify) a Small Business Regulatory Enforcement Fairness Act i National Technology Transfer and Advancement Act of 1995 {
11 3/23/99 i
k l
O. ^. C.-
\
24722 Submission of Federal Rules Under the Congressional Review Act President of the Senate E Speaker of the Ilouse of Representatives O GAO m _
Please fill the circles electronically or with black pen or #2 pencil.
- 1. Name of Department or Agency 2. Subdivision or Office U.S. Nuclear Regulatory Commission NMSS/IMNS
- 3. Rule Title l 10 CFR Part 31 - Final rule to amend 10 CFR 31.5, " Requirements for Those Who Possess Certain ladustrial l Devices Containing Byproduct Material to Provide Requested Information" l
l l
- 4. Regulation identifier Number (RIN) or Other Unique Identifier (if applicable) i RIN 3150-AG06
- 5. Major Rule O Non-major Rule e l
- 6. Final Rule e Other O
- 7. With respect to this rule, did your agency solict public comments?
Yes e No O N/A O l I
- 8. Prionty ofi egu atson (fillin one) l C Economically Significant; or 9 Routine and Frequent or Significant; or Informational / Administrative /Other Substantive. Nonsignificant (Do not complete the other side of this form
- f filled in above.)
- 9. Effective Date (if applicable) 60 days after publication in the Federal Register 1
- 10. Concise Summary of Rule (fulin one or both) attached O stated in rule e Submitted by: (signature)
Name: Dennis K. Rathbun True: Director, Office of Congressional Affairs l 1
l 1
For Congressional Use Only:
l Date Received-Committee of Junsdiction:
3/23/99 l U u
l
f r#q q
O' O ,g -
L_ )
( .24722 l
t
?'
Yes No N/A-
- . A. With respect to this rule,did your agency prepare an analysis of costs 9 O O and benefits?
B. - With respect to this ru's, by the final rulemaking stage, did your agency
- 1. certify that the rule would not have a significant economic impact on a 9 O O substantial number of small entities under 5 U.S.C. $ 605(b)?
- 2. prepare a final Regulatory Flexibility Analysis under 5 U.S.C. $ 604(a)? O e O C. With respect to this rule, did your agency prepare a written statement under O O O-6 202 of the Unfunded Mandates Reform Act of 1995?
D. _With respect to this rule, did your agency prepare an Environmental Assessment O 9 O or an Environmentallmpact Statement under the National Environmental Policy Act (NEPA)?
. E. Does this rule contain a collection of information requiring OMB approval 9 O O under the Paperwork Reduction Act of 19957 F . Did you discuss any of the following in the preamble to the rule?
O O O e E.O.12612, Federalism O O O e E.O.12630, Government Actions and Interference with Constitutionally O O O Protected Property Rights e E.O.12866, Regulatory Planning and Review O O O e E.O.12875, Enhancing the Intergovernmental Partnership O O O e E.O.12988, Civil Justice Reform .O O O e E.O.13045 Protection of Children from Environmental Health Risks O O O i and Safety Risks l
- e Other statutes or executive orders discussed in the preamble concerning the rulemaking process (please specify) =
Small Business Regulatory Enforcement Fairness Act l National Technology Transfer and Advancement Act of 1995 l 1
I l
i l
i i
i I
3/23/99 i
l' n LJ o J
n o o ^. =. r' 24722 Submission of Federal Rules Under the Congressional Review Act President of the Senate O Speaker of the llouse of Representatives O GAO Please fill the circles electronically or with black pen or #2 pencil
- 1. Name of Department or Agency 2. Subdivision or Office U.S. Nuclear Regulatory Commission ' NMSS/IMNS 3 Rule Title 10 CFR Part 31 - Final rule to amend 10 CFR 31.5, " Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Infonnation" j
- 4. Regulation identifier Number (RIN) or Other Unique identifier (if applicable)
RIN 3150-AG06
- 5. Major Rule O Non-major Rule S .l
- 6. Final Rule 9 Other O
- 7. With respect to this rule, did your agency solict public comments?
Yes 4 No O N/A O
- 8. Pnonty of Regulation (fill in one)
O Economically Significant. or G Routine and Frequent or Significant; or informational / Administrative /Other Substantive. Nonsignificant (Do not complete the other side of this form if filled in above.)
i
- 9. Effective Date (if applicable) 60 days after publication in the Federal Register l
- 10. Concise Summary of Rule (fill in one or both) !
attached O stated in rule e j
I Submitted by: (signature) i Name: Dennis K. Rathbun i m e: Director, Office of Congressional Affairs o
i For Congressional Use Only:
Date Received:
Committee of Jurisdiction:
l 3/23/99
f.- ] , < .m.uma a _
24722 Yes No N/A l l A. With respect to this rule, did your agency prepare an analysis of costs e O O and benefits? )
l ~ B. With respect to this rule, by the final rulemaking stage, did your agency )
j i .. 1
, 1. certify that the rule would not have a significant economic impact on a S O O !
l substantial number of smalt entities under 5 U.S.C. $ 605(b)?
i.
- 2. prepare a final Regulatory Flexibility Analysis under 5 U.S.C. 6 604(a)? O e O
' C. With respect to this rule, did your agency prapare a written statement under . O 9 O
$ 202 of the Unfunded Mandates Reform Act of 19957 D. With respect to this rule, did your agency prepare an Environmental Assessment O O O or an Environmental lmpact Statement under the Nationa! Environmental Policy Act (NEPA)? :
E. ' Does this rule contain a collection ofinformation requiring OMB approval 9 O O !
under the Paperwork Reduction Act of 1995? j F. Did you discuss any of the following in the preamble to the rule? O @ O j l
i e E.O.12612, Federalism O O O l e E.O.12830, Government Actions and Interference with Constitutionally O O O Protected Property Rights e E.O.12866, Regulatory Planning and Review O O O e E.O.12875, Enhancing the Intergover.1 mental Partnership O O O e E.O.12988, CivilJustice Reform O O O k e E.O.13045, Protection of Children from Environmental Health Risks O O O and Safety Risks l i e Other statutes or executive orders discussed in the preamble l concerning the rulemaking process (please specify) . i Small Business Regulatory Entbreement Fairness Act l l . National Technology Transfer and Advancement Act of 1995 l
l 1
e 1
3/23/99 Y
t f~,
b ,
l 1
%* fpf Q MCqT NJMr:ER - '
.'50S2D RULE fE5 Jf [7k~65M-PP
( G.5FR(M9.2)
NUCLEAR REGULATORY COMMISSION 10 CFR Part 31 Cl.
n . .> .
RIN 3150 - AG06 Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested information AGENCY: Nuclear Regulatory Commission.
i l
ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations to add an
~
explicit requirement that general licensees, who possess certain measuring, gauging, or controlling devices that contain byproduct material, provide the NRC with information conceming these devices. The NRC intends to use this provision to request information concerning devices that present a comparatively higher risk of exposure to the public or j l
property damage. The final rule is intended to help ensure that devices containing byproduct l
l material are maintained and transferred properly and are not inadvertently discarded.
I Sefoder- ( / 99#1 EFFECTIVE DATE: (00 deye fium uaie ai puviication in (nu Federal Register).
{
l i
FOR FURTHER INFORMATION CONTACT: Catherine R. Mattson, Office of Nuclear Material l 1
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, l
l l
ff cn q0f036/SV M ~ eMl99
.Ae of P A o /
- a eA
, .' )
g j
. u
- telephone (301) 415-6264, or e-mail at CRM@nrc. gov; or Jayne McCausland, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC l 20555-0001, telephone (301) 415-6219, or e-mail at JMM2 @ nrc. gov.
f i
SUPPLEMENTARY INFORMATION: i
Background
l
(
On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a generallicense for the use of byproduct material contained in certain )
measuring, gauging, or controlling devices (10 CFR 30.21(c)). Under current regulations in 10 CFR 31.5, certain persons may receive and use a device containing byproduct material j under this generallicense if the device has been manufactured and distributed according to the specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license authorizing distribution of generally licensed devices is issued if a regulatory j authority determines that the safety features of the device and the instructions .or safe l 1
operation of that device are adequate and meet regulatory requirements.
The person or firm who recdives such a device is a general licensee. The general licensee is subject to requirements for maintaining labels, following instructions for use, storing or disposing of the device properly, and reporting transfers and failure of or damage to the device. For some devices, the general licensee must also comply with leak testing requirements. The general licensee is also subject to the terms and conditions in 10 CFR 31.2 concerning general license requirements, transfer of byproduct material, reporting and recordkeeping, and inspection. The general licensee must comply with the safety instructions
, 2
l l
L i l- ."
l l contained in or referenced on the label of the device and must have the testing or servicing of the device performed by an individual who is authorized to manufacture, install, or service these devices.
A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded device. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. Thus, the ,
1 general license is meant to simplify the licensing process so that a case by-case determination
]
i
~
of the adequacy of the radiation training or experience of each user is not necessary.
i' Th'ere are about 45,000 general licensees under 10 CFR 31.5. These licensees l
possess about 600,000 devices that contain byproduct material. The NRC has not contacted generallicensees on a regular basis because of the relatively small radiation exposure risk l
posed by these device's and the very large number of generallicensees. However, general licensees are not always aware of applicable regulations and thus are not necessarily l i
i complying with all of the applicable requirements. The NRC is particularly concerned about j 1
occurrences where general y licensed devices containing radioactive material have not been j properly handled or properly disposed of. In some cases, this has resulted in radiation exposure to the public and contamination of property. Although known exposures generally 1 1
Dave not exceeded the public dose limit, there is a potential for significant expo.sures. When a !
source is accidentally melted in a steel mill, con.siderable contamination of the mill, the steel i product, and the wastes from the process, the slag and the baghouse dust, can result.
i The NRC conducted a 3-year sampling (1984 through 1986) of general licensees to assess the effectiveness of the generallicense program. The sampling revealed several areas of concem regarding the use of generally licensed devices. In particular, the NRC concluded ,
! that many generallicensees are not aware of the appropriate regulations. Also, approximately l
l
[ 3 l
15 percent of all generallicensees sampled could not account for all of their generally licensed devices. The NRC concluded that these problems could be remedied by rnore frequent and n
timely contact between the general licensee and the NRC.
On December 27,1991 (56 FR 67011), the NRC published a notice of proposed rulemaking concerning the accountability of generally licensed devices. The proposed rule contained a number of provisions, including a requirement for generallicensees under 10 CFR 31.5 to provide information to the NRC upon request, through which a device registry could_be developed. The proposed rule also included requirements in 10 CFR 32.51a and 32.52 for the specific licensees who manufacture or initially transfer generally licensed devices.
- Although the public comments received were reviewed and a final rule developed, a final rule was not issued because the resources needed to implement the proposed rule properly.were not available.'
The NRC continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. ' in July 1995, the NRC, with
~
assistance from the Organization of Agreement States, formed a working group to evaluate 1
- these issues. A final report was completed in July 1996 and published in October 1996 as NUREG 1551," Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."
In considering the recommendations of the working group, the NRC decided, among other things, to again. initiate rulemaking to establish an annual registration program of devices generally licensed under 10 CFR 31.5 that would be similar to the program originally proposed
- in the December' 27,1991, proposed rule. However, the NRC decided to do so only for those devices that present a higher risk, compared to other generally licensed devices, of potential exposure to the public and property loss if control of the device were lost. The NRC found the 4
g i
'4 l'.
working group process valuable in identifying criteria for categorizing devices that are more likely to present a significant risk by exposure of the public or through contamination of i
property.
' On December 2,1998 (63 FR 66492), the Commission again proposed the addition of l
[: an explicit requirement to provide information in response to requests made by the NRC. While I the rule applies to all 10 CFR 31.5 general licensees, the NRC plans to contact only those l general licensees identified by the working group for the purpose of the registration program.
For the most part, general licensees using devices meeting these criteria have a limited number of devices that will require registration.
In that notice (at 63 FR 66493), the NRC also withdrew the December 27,1991, proposed rule. The NRC has reviewed the other provisions contained in the December 27
- 1991, proposed rule and the recommendations of the working group and developed additional requirements in a separate proposed rule published July 26,1999 (64 FR 40295). The recommendations made in NUREG-1551 were considered in developing the separate, more comprehensive proposed ruIe issued July 26,1999. That proposed rule addresses fees for registration, additional reporting, recordkeeping, and labeling requirements for 10 CFR 32.51 i
licensees, and compatibility of Agreement StaL, regulations in this area. !
On March 9,1999 (64 FR 11508), the Commission established an interim enforcement j policy for violations of 10 CFR 31.5 that are discovered and reported by licensees during the initial cycle of the registration program. The initial' cycle is considered to be the issuance of one l l
round of registration requests to all affected general licensees. This policy supplements the i _ normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will remain in effect through one I ~ complete cycle of the registration program.
l l
5 i
i e
r i
[ ..
L Under this interim enforcement policy, enforcement action normally will not be takeb for violations of 10 CFR 31.5 that are identified by the generallicensee, and reported to the NRC if i
reporting is required, provided that the general licensee --
l Takes appropriate corrective action to address the specific violations and prevent <
t l recurrence of similar problems; and
' Has undertaken good faith efforts to respond to NRC notices and provide requested information.
This change from the Commission's normal enforcement policy is intended to remove the potential for the threat of enforcement action to be a disincentive for the licensee to identify deficiencies.
l I Under the interim enforcement policy, enforcement action, including issuance of civil penalties and Orders, may be taken where there is --
l (1) Failure to take appropriate corrective action to prevent recurrence of similar violations; (2) Failure to responif and provide the information required by regulation; (3) Willful failure to provide complete and accurate information to the NRC; or (4) Other willful violations, such as willfully disposing of generally licensed material in an l
unauthorized manner.
i As noted in the December 2,1998, proposed rule, and discussed further in the separate, rnore comprehensive proposed rule of July 26,1999, the Commission also plans to I
increase the civil penalty amounts specified in its Enforcement Policy in NUREG-1600, Rev.1, :
i
! for violations involving lost or improperly disposed of sources or devices. This increase will better relate the civil penalty amount to the costs avoided by the failure to properly dispose of ;
I the source or device. Due to the dhrersity of the types of sources and devices, the Commission i i
6 l
l
is considering the establishment of three levels of base civil penalty for loss or improper disposal. The higher tiers would be for sources that are relatively costly to dispose of.
(
Discussion l
l The Atomic Energy Act of 1954 (AEA), as amended, authorizes the NRC to request appropriate information from its licensees concerning licensed activities. However, the Commission had not included such an explicit provision in the regulations governing 10 CFR 31.5 general licensees.
This final rule adds an explicit requirement to 10 CFR 31.5 that requires general licensees who possess certain measuring, gauging, and controlling devices to respond in a timely way to written requests from the NRC for information concerning products that they have received for use under a general license.
The final rule requires a response to requests within 30 days or such other time as specified in the request. For routine requests for information,30 days should be adequate in ,
most instances, and an extension can be obtained for good cause. If more complicated requests are made or circumstances recognized that may require a longer time, the Commission may provide a longer response time. In the unusual circumstance of a significant safety concern, the Commission could demand information in a shorter time. The NRC will provide a phone number in the request for information in case additional guidance is necessary.
The NRC intends to use this provision primarily to institute an annual registration program for devices using certain quantities of specific radionuclides. The registration program is primarily intended to ensure that generallicensees are aware of and understand the requirements for the possession of devices containing byproduct material. The registration 7
Y
- I '.
l process will allow NRC to account for devices that have been distributed for use under the generallicense. The NRC believes that,if generallicensees are aware of their responsibilities, they will comply with the requirements for proper handling and disposal of generally licensed devices. This should help reduce the potential for incidents that could result in unnecessary i radiation exposure to the public as well as contamination of property.
The generallicensees covered by the registration program will be asked to account for the devices in their possession and to verify, as well as certify, information concerning -
l (1) The identification of devices, such as the manufacturer, model, and serial numbers; (2) The persons knowledgeable of the device and the applicable regulations; (3) The disposition of the devices; and (4) The location of the devices.
An organization which uses generally licensed devices at numerous locations is usually considered a separate generallicensee at each location (except in the case of different facilities at the same complex or campus). In the case of portable devices that are routinely used at '
multiple sites, there is one general licensee for each primary place of storage, not for each place of use. Thus, an organization may be required to complete more than one registration,if it possess devices subject to registration at multiple locations.
While the final rule applies to all 10 CFR 31.5 general licensees (about 45,000), the NRC will contact only approximately 5100 general licensees, possessing about 20,000 devices, for registration purposes. This category of general licensees is based on the criteria recommended by the working group for determining which sources should have increased oversight. The proposed rule presented an estimate of 6000 generallicensees, based on the l
estimates made in the working group report. However, this had not accounted for the fact that, in the interim, Massachusetts had become an Agreement State. Using the same criteria, and i
. 1 8
I
~.
.. l L removing the previously NRC general licensees in Massachusetts, results in an estimate of ;
5100. Other States are expected to becomo Agreement States in the near future which will l affect the number of generallicensees under NRC jurisdiction, but not the overall number nationally. The separate, more comprehensive proposed rule published July 26,1999, indicated that Agreement States will be required to achieve a compatible level of accountability over generally licensed devices. Thus, following State implementation of compatible programs '
in conjunction with that rule, further changes in the number of generally licensM devices within
. NRC jurisdiction should not adversely affect accountability.
j Requests for information will be sent to general licensees who are expected, based on current NRC records, to possess devices containing (as indicated on the label) at least -
370 MBq (10 mci) of cesium-137; 3.7 MBq (0.1 mci) of strontium-90; 37 MBq (1 mCl) of cobalt 60; or I li 37 MBq (1 mci) of any transuranic (at this time, the only generally licensed devices l
1 meeting this criterion contain curium-244 and americium-241).
j Most of the devices meeting these criteria are used in commercial and industrial !
l applications measuring thickness, density, or chemical composition in petrochemical and steel I l
manufacturing industries. The requests willinclude the information contained in NRC records j conceming the possession of these devices. The licensees will be asked to verify, correct, and )
i add to that information. The NRC records are based on information provided to the NRC by i i '
distributors under 10 CFR 32.52(a) and compatible Agreement State regulations and from generallicensees as required by 10 CFR 31.S(c)(8) or (9) regarding transfer of generally 1
licensed devices, if a general licensee no longer possesses devices meeting the criteria, it will i 1
9 I
be expected to provide information about the disposition of the devices previously possessed.
Errors in current NRC records concerning these generallicensees could be the result of --
(1) Errors made in the quarterly reports of manufacturers or initial distributors; (2) General licensees not reporting transfers; or (3) Errors made by NRC or its contractors in recording transfer information, in addition to the 5100 generallicensees identified for registration, the NRC may occasionally request information from other generallicensees on a case-by-case basis as necessary or appropriate. For example, this might involve investigating the extent that other users have experienced a problem that has been identified with the design of a particular device model. However, significant modifications to the registration program to include a larger class of licensees would be done through rulemaking. .
Although the amendment to the regulations imposes some additional costs on licensees, the NRC has estimated these costs to be minimal. This cost is the estimated administrative cost expended by general licensees to verify the information requested by the NRC regarding licensed devices. The NRC believes that the rule's intended effect of increased compliance by general licensees with regulatory requirements, and resulting NRC and public confidence in the general license program potentially afforded by these new requirements, outweigh this nominal administrative cost.
Public Comments on the Proposed Rule The NRC reviewed the public comments received on the December 2,1998, proposed rule. Seven comment letters were received from; the State of Illinois (an Agreement State),
National Steel Pellet Company, Steel Manufacturers AssociaMon (CMA), the Commonwealth of 10
y-Massachusetts (an Agreement State), the State of New Jersey (a non Agreement State),
l American iron and Steel Institute (AISI), and one private citizen; All commenters supported the proposed rule. One commenter agreed with the NRC i g
- that the proposed change would increase accountability and control over generally licensed !
, radioactive devices.: Another commenter supported the proposed regulation as a step in the
, i
.right direction, if not completely solving the regulatory problems of the NRC. The steelindustry I
supported the proposed . rule as a positive, although small, step toward minimizing the risk associated with improper disposal of spent sources in the scrap supply.
" Agreement was expresseci by two commenters that the administrative burden on general licensees M pre vide the minimal information requested by the NRC is reasonable, as is I the 30-day period in which general licensees have to respond, with extensions granted for good cause.
. Several commenters voiced agreement with the interim enforcement policy. One commenter, the State of New Jersey, b'elieves that'it is extremely important to remove any
~
-incentive for a general licensee to attempt to discard its source rather than comply with the
. reporting requirement. The commenter stated that when people get rid of their generally licensed devices in a hurry, the State has to go out and find tham in mountains of trash or scrap l metal.'
Two other commenters, the SMA and AISI, stated that they would support any .
enforcement program that deters improper disposal of radioactive sources. They also endorse l the provision allowing general licensees to report and correct violations without incurring penalties. These commenters believe that this provision would encourage licensees, who are not sure.about sources they hold, to remedy the problem rather than improperty dispose of the
. sources in an attempt to avoid high penalties.
11
i l'~ l U,
I j1 l
- A. Current NRC General Licensina Process and Cost Shift.
- Comment: In general, the three representatives'of the steelindastry expressed similar concerns regarding the current NRC generallicensing process. One commenter, the SMA, stated that the proposed rule did not address the fact that the current regulatory regime has shifted the costs of lax accountability and control onto steel makers, insurers, and the taxpayers. This commenter stated that general licensees do not pay for their licenses nor provide information directly to NRC about the sources they hold. Instead, the cost has fallen on steel producers to detect the sources, on steel producers and taxpdyers to arrange fer proper disposal,' and on steel producers and their insurers to pay the cost when a source is inadvertently melted. This commenter believed that general licensees should be required to shoulder their fair share.
Similarly, the AISI pointed out that current NRC regulations have inadvertently and improperly shifted the costs for accountability and control onto hot metal producers, insurers, and taxpayers and that steel producers are being forced to pay the cost of detecting orphaned sources, to arrange for proper disposal, and to pay for the cleanup when a source is <
inadvertently melted. This commenter also believed that general licensees should be required
. to pay their fair share of these costs and stated that improving licensee accountability would also reduce the risk of the illegal release of generally licensed material into the public scrap
, supply, in addition, the AISI noted that the inadvertent melting of orphaned sources by L. domestic steel producers has resulted in decontamination, disposal, and lost production costs ranging petween $10 million and $24 million at electric fumace mills and that the cost of a similar ' incident occurring in a major integrated steel mill could easily exceed $100 million.
12 L.
Resoons:9: The Commission recognizes the expense to the steelindustry when generally licensed devices containing radioactive material are f ot properly disposed of or
. properly handled. The NRC believes that this rulemaking will reduce the probability of lost and improperly disposed of sources, and ultimately the number of incir:ents of inadvertent meltings.
1This would reduce the total expense to the steelindustry, insurers, and taxpayers resulting from such incidents. A separate, more comprehensive rulemaking on this subject (proposed on July 26,1999) is expected to further improve accountability for devices and reduce the impact of improperly disposed of sources to the steelindustry, in addition, that rule would establish a registration fee to recover the cost of the NRC enhanced oversight program for those general licensees being required to register their devices.
B. Reoortina Electronically and Data Verification.
_pomment: Two commenters recommended that the ans provide a means for electronically reporting the information requested by the NRC in order to save time, mailing I
expenses, and paper. They also indicated that the NRC should ensure that its database has an
]
adequate data quality verification system and can easily flag inconsistencies.
One commenter suggested that the electronic filing could be accomplished through a secure page on th'e NRC Intemet Web Site and that the NRC could use the employer's tax identification number and a password to secure the information. This commenter also recommended that the NRC database include a data quality verification system to quickly identify a' nd immediately notify licensees of any reporting inconsistencies and that employers could also be required to annually verify the accuracy of the inventory.-
l Response: The submission of electronic applications and reports is a generic issue that l impacts more than the general license registration program. The NRC has evaluated the issue l a
13
of permitting licensees to file applications and reports electronically and plans to publish an amendment to the regulations to allow such submissions. The NRC expects to publish the amendment next year. At that time, the NRC will evaluate how this change willimpact implementation of the registration program and future enhancements to the design of the automated system. However, the NRC currently expects that the initial registration program ,
I would require submission of hard copies of the registration forms.
l The NRC is in the process of upgrading its information technology systems to facilitate I l
processing of annual registrations. The upgrades willinclude adequate data verification for distributor, general licensee, and registration information and will include automated readers for processing the large volume of registration forms. The automated readers willidentify changes and inconsistencies with the database, convert changes to electronic form, and incorporate the new data.'
C. Control and Accountability.
Comment: One com'menter believed that a great deal of improvement is needed in the regulations governing licensed radioactive devices concerning their location and whether they are being disposed of properly. This commenter felt that a license should not be given out to persons to own as many devices as they please; instead a license should be given out per device, thereby limiting the number of devices available and making known the number of devices in use. This commenter felt that radioactive material presents an extreme threat to health and safety even if disposed of properly.
Response The Commission does not believe it is necessary, appropriate, or practical to limit the number of devices going out to general licensees to one per licensee. Tracking the l
number of devices in use and who has them is achievable without such a restriction. Generally 14 L
1
.a licensed devices are designed to be inherently safe and do not present nearly as great a risk to health and safety as the commenter suggests. Given the nature of the generallicense, restrictions on numbcrs of devices that can be possessed would be difficult to enforce and would likely lead to difficultiss in getting accurate information on devices possessed.
l Comment: Another commenter re ommended that the NRC not target businesses with !
specific licenses, pointing out that they are required to --
(1) Have a Radiation Safety Officer; (2) Actively perform testing and inspections; and (3) Maintain written documentation.
Therefore, specific licensees are almost always aware of the byproduct material regulations applicable to byproduct material managed under a general license as well and are more likely to adequately account for and handle devices containing byproduct material in accordance with the regulatory requirements. The commenter recommended that the NRC instead target general licensees that do not currently maintain byproduct material under a specific NRC !icense because these general licensees are more likely to be unaware of the appropriate regulations and are more likely to inappropriately account for and handle devices containing byproduct material.
Response: Specific licensees who also have generally licensed devices are subject to any regulations applicable to the general license. Tharefore, these specific licensees will be subject to registration. Given the approach of this first rule, it would be possible for NRC to simply not make this request for information from those who also hold specific licenses.
However, this would require additional effort to cross reference data on specific licensees with that on general licensees. Specific licensees, while generally more aware of applicable regulations, do have problems with incomplete accountability for devices. The potential 15
p
., n improvement in accountability should justify the limited administrative effort of providing registration information even in the case of those holding specific licenses.
If the additional rulemaking concerning registration is made final, specific licensees -
! holding generally licensed devices suhioct to registration may wish to avoid the additional fee.
If so, they would have the option of un og their specific license, if necessary, to include the devices, and thereby remove the devices from the general license status, in this case, labels p may have to be changed to be consistent with the device's regulatory status.-
Comment: The State of Illinois indicated that a group of general licensees in Illinois possesses devices containing curium-244 in quantities that would require registration under the e
iproposed rule. This commenter recommended that the NRC contact licensees possessing not
. only americium-241 but also curium-244, and noted that the statement in the December 2,
.1998, proposed rule W3 FR 66493) that americium-241 is the only transuranic radionuclide found in generally licensed devices in quantities exceeding 37 megabecquerels (1 millicurie), is in error.
. Resoonse: The Cominission agrees. The omission in that statement, of curium-244 as a transuranic element used in generally licensed devices meeting the criteria for registration, was an oversight. Devices containing curium 244 with quantities meeting the criterion for transuranics will be included in the registration requirement.
Comment:. Several commenters stated that the NRC should give serious consideration i
to the NRC-Agreement State Working Group recommendations as contained in NUREG-1551,
'" Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices." Specifically, one commenter stated that there should be a
' Responsible Indudual (R!) and a Backup Responsible Individual (BRI) for each general license.
L This commenter stated that, unlike a specific license where there are a Radiation Safety Officer .
16 l
l l
t.
and Authorized Users, there 'may be only one person (RI) who has a real understanding that his or her company possesses a generally licensed device that contains a radioactive source.
When that RI dies, retires, resigns, or is laid off, there may be no one at the facility with any understand' ing or appreciation of the significance of the generally licensed device. The commenter stated that the addition of one extra name and ' phone number to the records should not be too burdensome on the .'!censee and may help avoid the burden of responding to a radiation incident involving the device.
Two other commenters recommended that the NRC consider the Working Group's -
- recommended comprehensive measures, including requirements for the NRC to maintain inventory records, to compare and reconcile related discrepancies, and to mandate reporting
. the bankruptcy of a licensee to the NRC. The commenters also recommended State /NRC site
. inspections and inventories at regular intervals. These commenters felt that serious consideration should be given to each of these measures ln order to prevent the continued loss of licensed sources into the scrap stream.
Onc of these commeilters also urged the NRC to move forward with the planned additional regulations amending or establishing requirements for registration fees, labeling, and compatibility with Agreement State requirements. The commenter stated that the limited 1 registration program would have minimal impact on the radioactive scrap problem if it is the only amendment the NRC proposes.
Response: The more comprehensive measures recommended by the NRC-Agreement State Working Group are being considered in the separate, more comprehensive rule proposed l on July 26,' 1999. Comments on these issues will be considered as part of that rulemaking process.,
17-l l
l t
d
~
g .. - ,
p
. D. '
- Reaistration Proaram.
l Comment: One commenter.noted that the language of the proposal did not call for a '
periodic registration program requiring reporting at least annually. Rather, the proposed !
i
. ' amendment would merely restate NRC's authority to collect information from licensees. The commenter pointed out that the NRC already has this authority under 42 U.S.C. 2095 and in its l
own regulations. at 10 CFR 30.34. This commenter urged the NRC to explicitly call for a ,
l-
_periodic registration program in the amended regulation stating that this would remind general
= licensees that they have licensed radioactive sources and that there are responsibilities -
. attached to their licenses. It would also indicate that the Government has knowledge of their
. sources and the authority to enforce prohibitions on improper disposal, i
Response:~ The NRC has proposed explicit provisions for an annual registration requirement in the separate, more compmhensive' rule on this subject.
Comment: A commenter suggested that the NRC reconsider one of the provisions in a
. proposed rule published February 5,1974 (39 FR 4583), that would have required registration of the generally licensed devices before customers are' allowed to receive them. This .
commenter stated that this would ensure and document that generallicensees have received copies of the regulations and that they are aware of their rights and responsibilities.
Resoonse: The Commission does not believe preregistration !s necessary to ensure h
and document that general licensees have received copies of the regulations and that they are aware of their rights and responsibilities. However, the Commission has proposed amendments to address the need for customers to receive additional information prior to
- purchases of generally licensed devices in the separate, more comprehensive rule.
s Comment: Another commenter strongly encouraged the NRC to adopt a mandatory u- registration program for all sources, not merely those that pose the greatest risk to steel mills.
x
- 18
Response: The Commission has decided to use the criteria developed by the NRC/ Agreement State Working Group to determine which sources should be subject to the registration program. These criteria were based on considerations of relative risk and were limited to radionuclides currently in use in devices considered to present a higher risk of potential exposure, as well as potential for contamination of property.
E. Fee-Based System.
Comment: One commenter believed that a fee-based system for all generallicensees would ensure that the NRC recovers the minimal cost to initiate and maintain the reporting program. The commenter stated that such a registration program would enable the NRC to account for all sources that have been distributed. The commenter further suggested that the program could be designed to allow steel companies and the general public to trace the origins of an improperly disposed of source. This would help steel companies in determining liability for the multimillion-dollar clean-up costs that tha steel companies and their insurers incur when sources are inadvertently melted. It would also provide Federal and State nuclear regulators that handle orphan sources a means to obtain reimbursement resulting in an additional deterrent against impropor source disposition.
Another commenter was concerned that, even though a fee-based system for all general licensees would permit the NRC to recover the anticipated cost of initiating and maintaining the reporting program, a fee schedule could slow or prevent implementation of the entire proposal. If this is correct, the commenter recommended that the NRC retain the proposal as published.
19 l
{
, Response The Commission is not addressing comments on its proposed fee-based system as part of this rulemaking process. The separate, more comprehensive rule addresses i
fees for registration and the comments will be considered in connection with that rulemaking. >
)
F. Reaistration Information Available on the internet. I Comme _n_f One commenter was opposed to making the registration information !
(
available on the internet because such posting would unnecessarily cause public concern over the presence and use of low level devices. The commenter believes that this information should be available only through the Freedom of Information Act request process. ,
I Response: Some of the information submitted in distributor quarterly reports and t entered into the general license tracking system that is to be used for handling registration information would be considered proprietary. This database will be designed with security features in order to protect proprietary information. It will not be available on the Intemet. The NRC would post information on its website concerning lost or unaccounted for devices.
G. Civil Penalty Amounts.
Comment: One commenter agreed with the NRC's intent to increase the civil penalty amounts for violations involving lost or improperly disposed of sources or devices. The commenter stated that the penalties must be significantly higher than the costs avoided by the
{
failure to properly dispose of the source or device.
A second commenter supported fining general licensees who violate their general licenses by using a schedule that is proportionate to the damage actually caused by the lost source. The commenter used the example of the cost for cleaning a steel mill contaminated by I
melting such a source. This commenter believed that because the NRC's proposed penalty is 1
20
e l l: ..
L u
not much higher than the current fine of $2500 per loss that has been assessed to licensees,'it l would not significantly deter illegal behavior. The commenter believes that increasing the a
current relatively minimal penalty levels to amounts that reflect the real world damage caused 1
- by loss of a licensed source will provide generallicensees with a substantive economic 1
incentive to dispose of their sources legally, Resoonse: As discussed in the July 26,1999 (64 FR 40295) proposed rule, the Commission is considering raising civil penalties for violations involving lost or improperly
, h disposed of sources or devices and may use a tiered approach with higher than usual civil penalties for sources that are relatively costly to dispose of. This is to ensure that such civil
' penalties better relate to the costs avoided by the failure to properly dispose of the source or -
' device.. The cost of cleaning a contaminated steel mill would not be an appropriate basis for setting fees.
No comments were made concerning the specific wording of the proposed amendment.
No change to the rule has been made as a result of these comments.
Agreement State Compatibility
' Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997 (62 FR 46517), this final rule is classified as Compatibility Category D. - Category D means the provisions are not required for t !
purposes of compatibility; however, if adopted by the State, the provisions should not create ,
any conflicts, duplications,'or gaps in the regulation of AEA material. Ultimately, an enhanced oversight program is ' expected to include provisions that will require a higher degree of compatibility. This is being considered in the separate, mora comprehensive rulemaking that b
21 U
s.
o ;o 4
. . l
.wouid add more explicit requirements for the registration program and additional provisions
-concerning accountability of generally licensed devices.
Voluntary Consensus Standards
.The National Technology Transfer and Advancement Act of 1995, Pub. L.104-113, requires that agencies use technical standards that are developed or adopted by voluntary 1 i
consensus standsrds bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical'. In this final rule, the NRC is smeading its regulations to require that those who possess certain industrial devices containing byproduct material provide J l
requested information. The amendments are administrative in nature and require certain types of specific entities to provide information concerning specific devices in their possession.
Therefore, this action does not constitute the establishment of a standard that establishes
. generally applicable requirements.
, i Environmental Impact: Categorical Exclusion The NRC has determined that this final rule is the type 31 action described in the categorical exclusion in 10 CFP 31.22(c)(3)(iii). Therefore, neither an environmental impact
{
. statement nor an environmental assessment has been prepared for this regulation.
l l
i I
'l 22 L l
!?
... 1 Paperwork Reduction Act Statement l l
This final rule amends information collection requirements that are subject to the
]
- Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The information collection regt ,nents in this rule have been approvbd by the Office of Management and Budget, approval number 3150-0016.
I The public reporting burden for this information collection is estimated to average i
20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the l information collection.' Send comments on any aspect of this information collection, including
. suggestion for reducing the burden, to the Records Management Branch (T-6 E6), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS1 @ NRC. GOV; and to the Desk Officer, Office of information and Regulatory = Affairs, l
NEOB-19202, (3150-0016), Office'of Management and Budget, Washington, DC 20503.
! l l I Public Protection Notification l l- if a means used to impose an information collection does not display a currently valid j OMB' control number, the NRC may not conduct or sponsor, and a person is not required to i
l respond to, the information collection.- )
t ii 4 23
]
i
- .2 l
Regulatory Analysis The NRC has pre' pared a regulatory analysis for this regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The regulatory analysis is
,available for inspection in the NRC Public Document Room,2120 L Street NW. (Lower Level),
Washington, DC. Single copies of the analysis may be obtained by calling Jayne McCausland, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6219; or e-mail at JMM2@nrc. gov.
Regulatory Flexibility Certification l
As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this final rule does not have a significant economic impact on a substantial number of small entities. This rule requires general licensees who have received specific devices to respond to requests for information frorri NRC. The final rule applies to the approximately 45,000 persons using products under an W ' generallicense, many of whom may be classified as small entities. However, the NRC intends to request registration information from only approximately 5100 of these generallicensees. Registration information to be obtained willinclude identification of the devices, accountability for the devices, the persons knowledgeable of the device and the applicable regulations, and the. disposition of the devices. The NRC believes that the economic impact that any general licensee incurs as a result of supplying this information constitutes a negligible increase in administrative burden. It is estimated that there l- are approximately 20,000 devices in the possession of the Commission's general licensees which will come under the registration requirement. The average cost to the general licensee 24 t :
1
- , i
)
l per device per year is about $4,00. Therefore, the action wi.ll not have a significant economic !
impact on small entities. The final rule is intended to ensure that general licensees understand
'and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.
Backfit Analysis l
The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this rule, because these amendments do not involve any provisions that impose backfits as defined in 10 CFR 50.109(a)(1) and, therefore, a backfit analysis is not required.
Small Business Regulatory Enforcement Faimess Act I
in accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.
List of Subjects in 10 CFR Part 31 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment.-
4 25 i
e
{:
s* .
F For the reasons ' set out above and under the authorityo' f the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR Part 31.
' PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL .
I
- 1. The authority citation for Part 31 continues to read as follows:
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.
l 5841,5842).
Section 31.6 also issued under sec. 274,77 Stat. 688 (42 U.S.C. 2021).
- 2. Section 31.51s amended by adding paragraph (c)(11) to read as follows:
9 31.5 Certain measuring, gauging, or contro5.ag devices.8 (c)'
(11) Shall respond to written requests from the Nuclear Regulatory Commission to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the generallicensee cannot provide the 8 Persons pcssessing byproduct material in devices under a general license in 10 CFR 31.5 before January 15,1975, may continue to possess, use, or transfer that material in accordaace with the labeling requirements of 10 CFR 31.5 in effect on January 14,1975.
26
C h; ,- ) j l:.. .
4 e. ,
[ requestad information within the allotted time, it shall, within the'same time period, request a -
I long' er kenod to supply the information by submitting a letter to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC
{
20555-0001 and provide written justification as to why it cannot comply.
. . . 1 l
I Dated at Rockviin., Maryland, this 1st day of July 1999.
l l
l l
For the Nuclear Regulatory Commissicn. !
AJ A*e __
William D. Travers,'
Executive Director for Operations.
I
{
27
b* ll' t gg@
4 Rul:0 cnd R::guttiona 9 6 B N N '- Vol. 64. No.149 Wedneulay. August 4.19%
This section of the FEDERAL REGISTER amended its regulations to provide a posed by these devices and the very contains regulatory docurnents having general general license for the use of byproduct large number of general licensees.
applicability and legal effect, most of which are keyed to and codified in the Code of material contained in certain measuring. However, general licensees are not Federal Regulations, which is published under gauging, or controllitig devices (10 CFR always aware of applicable regulations 50 titles pursuant to 44 U.S C.1510. 30.21(c)). Under current regulations in and thus are not necessarily complying 10 CFR 31.5, certain persons may with all of the applicable requirements.
The Code of Federal Regulations is sold by receive and use a device containing The NRC is particularly concerned the Superintendent of Documents. Pnces of byproduct material under this general about occurrences where generally new books are listed in the first FEDERAL licen.se if the device has been licensed devices containing radioactive l REGISTER issue of each week. manufactured and distributed according material have not been properly
__ to the specifications contained in a handled or properly disposed of. In specific license issued by the NRC or by some cases, this has resulted in NUCLEAR REGULATORY an Agreement State. A specific license COMMISSION radiation exposure to the public and authorizing distribution of generally contamination of property. Although 10 CFR Part 31 licensed devices is issued if a regulatory known exposures generally have not authority determines that the safety exceeded the public dose limit, there is RIN 3150-AG06 features of the device and the a potential for significant exposures.
instructions for safe operation of that When a source is accidentally melted in Requirements for Those Who Possess device are adequate and meet regulatory a steel mill, considerable contamination Certain Industrial Devices Containing requirements. of the mill, the steel product, and the Byproduct Material to Provide The person or firm who receives such wastes from the process, the slag and Requested information a device is a generallicensee. The the baghouse dust, can result.
general licensee is subject to The NRC conducted a 3 year sampling AGENCY: Nuclear Regulatory Commission. tehuirements for maintammg labels, (1984 through 1986) of general licensees fo owing instructions for use, storing or to assess the effectiveness of the general ACTION: Final rule. . disposing of the device properly, and license program. The sampling revealed
SUMMARY
- The NucleERegulatory rep rting transfers and failure of or several areas of concern regarding the Commission (NRC)is amending its damage to the device. For some devices, use of generally licensed devices. In licit the general licensee must also comply particular, the NRC concluded that regulations to add an exflicusees, who with leauesting requirement that genera uirements. The many general licensees are not aware of possess certain measuring, gauging, or general licensee is a so subject to the the appropriate regulations. Also, controlling devices that contain terms and conditions in to CFR 31.2 approximately 15 percent of all general byproduct material, provide the NRC c ncerninggenerallicense licensees sampled could not account for with information concerning these r quirements, transfer of byproduct all of their generally licensed devices.
devices. The NRC intends to use this material, reportmg and recordkeepmg, The NRC concluded that these problems provision to request information and inspection. The general licensee could be remedied by more frequent and concerning devices that nresent a must cmnply with the safety timely contact between the general comparatively higher n.s ( of exposure t instructions contained in or referenced licensee and the NRC.
the public or property damage. The final on the label of the device and must have On December 27,1991 (56 FR 67011),
the testing or servicing of the device the NRC published a notice of proposed rule devices is intended containing to help ensure byproduct matenathat ,performed l by an individual who is rulemaking concerning the authorized to manufacture, install, or accountability of generall licensed are maintained and transferred pro erly and are not inadvertently discar e . service ilmse devices. devices. The proposed ru o contained a EFFECTIVE DATE: October 4,1999, A generally licensed device usually number of prosisions, including a consists of radioactive material, requirement for general licensees under FOR FURTHER INFORMATION CONTACT: contained in a sealed source, within a 10 CFR 31.5 to provide information to Catherine R. Mattsen, Office of Nuclear shielded device. The device is designed the NRC upon request, through which a Material Safety and Safeguards, U.S. with inherent radiation safety features device registry could be developed. The Nuclear Regulatory Commission, so that it can be used by persons with proposed rule also included Washington, DC 20555-0001, telephone no radiation training or experience. requirements in 10 CFR 32.51a and (301) 415-0264, or e-mail at Thus, the general license is meant to 32.52 for the specific licensees who CRM@nrc. gov: or Jayne McCausland, simplify the licensing proce 4 so that a manufacture or initially transfer Office of Nuclear Material Safety and case-by-caso determination of the generally licensed devices. Although the Safeguards, U.S. Nuclear Regulatory adequacy of the radlation training or public comments received were Commission, Washington, DC 20555- experience of each user is not necessary. reviewed and a final rule deve'ioped, a 0001, telephone (301) 415-6219, or e- There are about 45,000 general f*mal rule was not issued because the mail at JMM2@ntc. gov. licensees under 10 CFR 31.5. These resources needed to implement the SUPPLEMENTARY INFORMATION: licensees possess about 600,000 devices proposed rule properly were not Background that contain byproduct material. The available.
NRC has not contacted general licensees The NRC continued to consider the On February 12,1959 (24 FR 1089), on a regular basis because of the issues related to the loss of control of the Atomic Energy Commission (AEC) relatively small radiation exposure risk generally licensed, as well as
42270 Fed:ral Registtr/Vol. 64 No.149/ Wednesday, Au ,ust 4,1999/ Rules and Regulations
,, 'specifically licensed, sources of initial cycle is considered to bo the provision in the regulations governing m) radioactivity. In July 1995, the NRC, issuance of one round of registration to CFR 31.5 general licensees.
with assistance from the Organization of requests to all affected general licensees. This final rule adds an explicit Agreement States, formed a working This policy supplements the normal requirement to 10 CFR 31,5 that requires group to evaluate these issues. A final NRC Enforcement Policy in NUREG- general licensees who possess certain report was completed in July 1996 and 1600, Rev.1. It will remain in effect measuring, gauging, and controlling published in October 1996 as NUREG- .through one cemplete cycle of the devices to respond in a timely way to 1551," Final Report of the NRC- registration program, written requests from the NRC for Agreement State Working Group to Under this interim enforcement infonnation concerning products that Evaluate Control and Accountability of policy, enforcement action normally they have received for use under a
' Licensed Devices." will not be taken for violations of to general license, la considering the recommendations CFR 31.5 that are identified by the . The final rule requires a response to of the working group, the NRC decided, . general licensee, and reported to the requests within 30 days or such other among other things, to again initiate NRC if reporting is required, provided time as specified in the request. For rulemaking to establish an annual that the generallicensee .
routine requests for information,30 registration program of devices Takes appropriate corrective action to days should be adequate in most
- generally licensed under to CFR 31.5 address the specific violations and instances, and an extension can be that would be similar to the program prevent recurrence of similar problems: obtained for good cause. If more originally proposed in the December 27, and complicated requests are made or 1991, proposed rule. However, the NRC Has undertaken good faith efforts to circumstances recognized that may decided to do so only for those devices respond to NRC notices and provide require a longer time, the Commission that present a higher risk, compared to requested information. may provide a longer response time. In other generally licensed devices, of This change from the Commission's the unusual circumstance of a potential exposure to the public and' normal enforcement policy is intended significant safety concern, the property loss if control of the device to remove the potential for the threat of Commission could demand information were lost. The NRC found the working enforcement action to be a disincentive in a shorter timo. The NRC will provide group process valuable in identifying ~ - for the licensee to identify deficiencies. 'a phone number in the request for criteria for categorizing devices that are Under the interim enforcement information in case additional guidance
! more likely to present a significant risk policy, enforcement action, including is necessary.
by exposure of the public or through issuance of civil penalties and Orders. The NRC intends to use this provision contamination of property may be taken where there is - primarily to institute an annual On December 2,1998 (63 FR 66492). (1) Failure to take appropriate registration program for devices using the Commission again proposed the corrective action to prevent recurrence certain quantitles of specific addition of an explicit requirement to of similar violations; radionuclides.The registration program
. provide information in response to (2) Failure to respond and provide the is primarily intended to ensure that requets made by the NRC, While the information required by regulation; general licensees are aware of and rub ,vdes to all 10 CFR 31.5 general (3) Willful fallure to provide complete understand the requirements for the licensees, the NRC plans to contact only and accurate information to the NRC; or possession of devices containing those general licensees identified by the (4) Other willful violations, such as byproduct material. The registration working group for the purpose of the willfully disposing of generally licensed process will allow NRC to account for registration program. For the most part, material in an unauthorized manner, devices that have been distributed for general licensees using devices meeting As noted in the December 2,1998' use under the general license. The NRC these criteria have a limited number of proposed rule, and discussed further in believes that,if generallicensees are devices that will require registration. the separate, more comprehensive aware of their responsibilities, they will in that notico (at 63 FR 66493), the proposed rule of July 26,1999, the comply with the requirements for NRC also withdrew the December 27 Commission also plans to increase the proper handling and disposal of 1991, proposed rule. The NRC has civil penalty amounts specified in its generally licensed devices. This should reviewed the other provisions contained Enforcement Policy in NUREG-1600, help reduce the potential for incidents in the December 27,1991, proposed rule Rev.1, for violations involving lost or that could result in unnecessary and the recommendations of the improperly disposed of sources or radiation exposure to the public as well working group and developed devices. This increase will better relate as contamination of property.
additional requirements in a separato the civil penalty amount to the costs The generallicensees covered by the
. proposed rule published July 26,1999 avoided by the failure to properly registration program will be asked to (64 FR 40295). The recommendations dispose of the source or device.Due to account for the devices in their made in NUREG-1551 were considered . the diversity of the types of sources and possession and to verify, as well as
. In developing the separate, more devices, the Commission is considering certify, information concerning-comprehensive proposed rule issued the establishment of three levels of base (1) The identification of devices, such
- July 26,1999. That proposed rule civil penalty for loss or improper as the manufacturer, model, and serial addresses fees for registrationi disposal. The higher tiers would be for numbers; additional reporting, recordkeeping, and sources that are relatively costly to (2) The persons knowledgeable of the labeling requirements for 10 CFR 32.51 ' dispose of. device and the applicable regulations:
licensees, and compatibility of (3) The disposition of the devices; and L Agreement State regulations in this area. M8C"88I"" (4) The location of the devices.
On March 9,1999 (64 FR 11508), the The Atom!c Energy Act of1954 An organization which uses generally Commission established an interim (AEA), as amended, euthorizes the NRC licensed devices at numerous locations j
' enforcement policy for violations of 10 to request appropriate information from is usually considered a separate general j CFR 31.5 that are discovered and its licensees concerning licensed licensee at each location (except in the reported by licensees during the initial activities. However, the Commission case of different facilities at the same cycle of the registration program. The had not included such an explicit complex or campus). In the case of
Fed:ral Register /Vol. 64, No.149/ Wednesday, August 4,1999/ Rules and Regulations 42271
'1 portable devices that are routinely used provided to the NRC by distributors control over generally licensed at multiple sites, there is one general - under 10 CFR 32.52(a) and compatible radioactive devices. Another commenter licensee for each primary place of Agreement State regulations and from supported the proposed regulation as a storage, not for each place of use. Thus, general licensees as required by 10 CFR step in the right direction, if not an organization may be required to .
31.5(c) (8) or (9) regarding transfer of . completely solving the regulatory complete more than one registration,if generally licensed devices. If a general problems of the NRC. The steel industry it possess devices subject to registration licensee no longer possesses devices supported the proposed rule as a at multiple locations. meeting the criteria, it will be expected positive, although small, step toward While the final rule applies to all to to provide information about the minimizing the risk associated with CFR 31.5 general licensees (about disposition of the devices previously improper disposal of spent sources in 45,000), the NRC will contact only possessed. Errors in current NRC the scrap supply, approximately 5100 generallicensees, records concerning these general Agreement was expressed by two
- possessing about 20,000 devices, for licensees could be the result of- commenters that the administrative registration purposes. This category of (1) Errors made in the quarterly burden on general licensees to provide generallicensees is based on the criteria mports of manufacturers or initiel the minimal information requested by recommended by the working group for distributors; the NRC is reasonable, as is the 30-day determining which sources sbould have (2) Generallicensees not reporting period in which general licensees have
. increased oversight. The proposed rule transfers; or to respond, with e.xtensions granted for ;
presented an estimate of 6000 general (3) Errors made by NRC or its good cause. '
licensees, based on the estimates made contractors in recording transfer Several commenters voiced agreement in the working group report. However, int rmation. with the interdm enforcement policy. j this had not accounted for the fact that, In addition to the 5100 general One commemer, the State of New i in the interim, Massachusetts had licensees identified for registration, the Jersey, believes that it is extremely NRC may occasionally request
)
becomo an Agreement State. Using the important to remove any incentive for a same criteria, and removing the inf rmation from other general licensees general licensee to attempt to discard its previously NRC general licensees in n a case-by case basis as necessary or source rather than comply with the Massachusetts, results in an estimate of appropriate. For example, this might reporting requirement. The commenter 5100. Other States are expected to mv Ivo investigating the extent that stated that when people get rid of their become Agreement States in the near ther users have experienced a problem generallv licensed devices in a hurry, future which wil' affect the number of that has been identified with the design the Sta9 has to go out and find them in generallicensees nder NRC f a particular device model. However, mountains of trash or scrap metal.
jurisdiction, bu' the overall number significant modifications to the Two other commenters, the SMA and nationally. Th, arate, more registration program to include a larger AISI, stated that they would support any comprehensive aposed rule published class oflicensees would he'done enforcement program tha,t deters i July 26,1999, indicated that Agreement through rulemakm, g. Improper disposal of radioactive Although the amendment to the sources. They also endorse the l States compatiblewill lovebe refuired toover of accountability regulations achieve a . imposes some additional provision allowing general licensees to generally licensed devices. Thus, costs a licensees, the NRC has report and correct violat ons without i
following State implementation of estimated these costs to be minimal. incurrin penalties. These commenters This cost is the estimated administrative believe t ist this provismn would t ams in conjunction compatible with that ru fo,obrther changes in cthe st expended by generallicensees to encourage licensees, who are not sure number of generally licensed devices verify the information requested by the about sources they hold, to remedy the within NRC jurisdiction should not NRC regarding hcensed devices. The problem rather than improperly dispose NRC believes that the rule's intended of the sources in an attempt to avoid adversely Roquests foraffect accountability'1 information wil beeffect sentof increased compliance by high penalties.
to general licensees who are expected, generalli ensees with regulatory i
A. Current NIfC CeneralLicensing based on current NRC records, to ref rements, and resulting NRC and Process and Cost Shlff c co
- possess devices containing (as indicated on the label) at least--
g cj sn ya o "f I e Comment:In general, the three representatives of the steelindustry new requirements, outweigh this 370 MBq (10 mCl) of cesium 137: expressed similar concerns regarding 3.7 MDq (0.1 mCl) of strontium-90; nominal admi Amtive cost.
the current NRC generallicensing i 37 MBq (1 mCl) of cobalt-60; or Public Cominu s on the Proposed Rule process. One commenter, the SMA, '
37 MBq (1 mCl) of any transuranic (at The NRC reviewed the public stated that the proposed rule did not this time, the only generally licensed comments received on the December 2, address the fact that the current devices meeting this criterion contain 1998, proposed rule. Seven comment regulatory regime has shifted the costs ,
curium-244 and americium-241). letters were received from: the State of of tax accountability and control onto Most of the devices meeting those Illinois (an Agreement State), National steel makers, insurers, and the criteria are used in commarcial and . Steel Pellet Company, Steel taxpayers. This commenter stated that industrial applications measuring Manufacturers Association (SMA), the general licensees do not pay for their thickness, density, or chemical Commonwealth of Massachusetts (an licenses nor provide information composition in petrochemical and steel Agreement State), the State of New directly to NRC about the sources they manufacturing industries, The requests Jersey (a non Agreement State), hold. Instead, the cost has fallen on steel will include the information contained American Iron and SteelInstitute (AISI). producers to detect the sources, on steel in NRC records concerning the and one private citizen. producers and taxpayers to arrange for possession of these dev(ces, The All commenters supported the proper disposal, and on steel producers
. licensees will be asked to verify, correct, proposed rule. One commenter agreed and their insurers to pay the cost when and add to that information. The NRC with the NRC that the proposed change a source is inadvertently melted. This records are based on information would increase accountability and commentcr believed that general
'a
'42272 Fed:rzl Regist:r/Vol. 64, No.149/ Wednesday, August 4,1999/ Rules and Regulations
$' ' licensees sbould be required to shoulder Internet Web Site and that the NRC devices in use and who has them is their fair share. could use the employer's tax achievable without such a restriction.
Similarly, the AISI pointed out that identification number and a password to Generally licensed devices are designed current NRC regulations have secure the information. This commenter to be inherently safe and do not present inadvertently and improperly shifted also recommended that the NRC nearly as great a risk to health aM wiety the costs for accountability and control database include a data quality as the commenter suggests. Givoc the onto hot metal producers, insurers, and verification system to quickly identify nature of the generallicense, restrictions taxpayers and that steel producers are and immediately notify licensees of any on numbers of devices that can be l being forced to pa possessed would be difficult to enforce orphaned sources,y the for to arrange cost of detecting proper employers reporting could also be incansistencies required to and that likely lead to difficulties in and would disposal, and to pay for the cleanup annually verify the accuracy of the getting accurate information on devices when a source is inadvertently melted. Inventory. possessed. I This commenter also bolleved that Response:The submission of Comment: Another commenter general licensees should be required to electronic applications and reports is a recommended that the NRC not target pay their fair share of these costs and generic issue that impacts more than the businesses with specific licenses, stated that improving licensee general license registration program. pointing out that they are required to-accountability would also reduce the The NRC has evaluated the issue of (1) Have a Radiation Safety Officer; risk of the illegal release of generally permitting licensees to file applications (2) Actively perform testing and licensed material into the public scrap and reports electronically and plans to supply. In addition, the AISI noted that publish an amendment to the insp)ections; and documentation.
(3 Maintain written the inadvertent melting of orphaned regulations to allow such submissions. Therefore, specific licensees are sources by domestic steel producers has The NRC expects to publish the almost always aware of the byproduct resulted in decontamination, disposal, amendment next year. At that time, the materfil regulations applicable to and lost production costs ranging NRC will evaluate how this change will byproduct material managed under a
' between $10 million and $24 million at impact implementation of the general hcense as well and are more electric furnace mills and that the cost registration program and future likely to adequately account for and of a similar incident occurring in a enhancements to the design of the handle devices containing byproduct major integrated steel mill could easily automatsd system. However, the NRC materialin accordance with the exceed $100 million. currently expects tnat the initial regulatory requirements. The Response TheCommission registration program would require commenter recommended that the NRC recognizes the expense to the steel submission of hard copies of the mstead target general licensees that do industry when generally licensed registration forms, not currently maintain byproduct devices containing radioactive material The NRC is in the process af material under a specific NRC license are not properly disposed of or properly upgrading its information technology because these general licensees are more handled. The NRC believes that this systems to facilitate prot.essing of likely to be unaware of the appropriate rulemaking will reduce the probability annual registrations. The upgrades will regulations and are more likely to of lost and improperly disposed of include adequate data verification for inappropriately account for and handle sources, and ultimately the number of distributor, general licensee, and devices containing byproduct material.
incidents of inadvertent meltings. This registration information and will Re8Ponse: Specific licensees who also would reduce the total expense to the include automated readers for have generally licensed devices are steel industry, insurers, and taxpayers processing the large volume of subject to any regulations applicable to resulting from such incidents. A registration forms. The automated the general license. Therefore, these separate, more comprehensive readers will identify changes and 8Pecific licensees will be subject to rulemaking on this subject (proposed on inconsistencies with the database, registration. Civen the approach of this July 26,1999)is expected to further convert changes to electronic form, and first rule, it would be possible for NRC improve accountability for devices and incorporate the new data. to simply not make this request for reduce the impact of improperly information from those who also hold
' disposed of sources to the steel C. Controland Accountability spec fic licenses. However, this would indus . In addition, that rule would Comment:One commenter believed require additional effort to cross establism a registration fee to recover the that a great deal of improvement is reference data on specific licensees with cost of the NRC enhanced oversight needed in the regulations governing that on general licensees. Specific program for those general licensees licensed radioactive devices concerning licensees, while generally more aware of tioing required to register their devices. their location and whether they are applicable regulations, do have being disposed of properly. This problems with incompleto B. Reporting Electrom.cally and Data commenter felt that a license should not accountability for devices. The potential Verification 'be given out to persons to own as many improvement in accountability should Comment:Two commenters devices as they please; instead a license justify the limited administrative effort recommended that the NRC provide a should be given out per device, thereby of providing registration information means for electronically reporting the limiting the number of devices available even in the case of those holding information requested by the NRC in and making known the number of specific licenses.
order to save time, malling expenses, devices in use. This commenter felt that if the additionalrulemaking
' and paper. They also indicated that the radioactive material presents an extreme concerning registration is made final,
! NRC should ensure that its database has threat to health and safety even if specific licensees holding generally l- an' adequate data quality verification disposed of properly. licensed devices subject to registration I system and can easily flag Response: The Commission does not may wish to avoid the additional fee. If I
inconsistencies, believe it is necessary, appropriate, or so, they would have the option of One commenter suggested that the practical to limit the number of devices amending their specific license, if electronic filing could be accomplished going out to general licensees to one per necessary, to include the devices, and through a secure page on the NRC licensee. Tracking the number of thereby remove the devices from the l
~
l L
i ;
Federal Register / Vol. 64, No.149/ Wednesday, August 4,1999/ Rules and Regulations 42273 l l
l general license status. In this case, The commenters also recommended Response:The Commission does not i labels may have to be changed to be State /NRC site inspections and believe preregistration is necessary to l consistent with the device's regulatory inventorien at regular intervals. These ensure and document that general j status. commenters felt that serious licensees have received copies of the !
Comment:The State of Illinois consideration should be given to each of regulations and that they are aware of l indicated that a group of general these measures in order to prevent the their rights and responsibilities.
l licensees in Illinois possesses devices continued loss of licensed sources into However, the Commission has proposed containing curium 244 in quantities that the scrap stream. amendments to address the need for would require registration under the One of these commenters also urged customers to receive additional proposed rule. This commenter the NRC to move forward with the information prior to purchases of recommended that the NRC contact planned additional regulations. generally licensed devices in the licensees possessing not only amending or establishing requirements 80Parate, more comprehensive rule.
americium 241 but also curium-244- for registration fees, labeling, and Comment: Another commenter and noted that the statement in the compatibility with Agreement State strongly encouraged the NRC to adopt a December 2,1998, proposed rule (63 FR requirements. Tho commenter stated mandatory registration program for all 66493) that americium 241 is the only that the limited registration program sources, not merely those that pose the transuranic radionuclide found in would have minimal impact on the greatest risk to steel mills. i generally licensed devices in quantities radioactive scrap problem if it is the N.eSPonse:The Commission has exceeding 37 megabecquerels (1 only amendment the NRC proposes. decided to use the critena developed by millicurie), is in error. the NRC/ Agreement State Working Response:The more comprehensive Response:The Commission agrees. rneasures recommended by the NRC- Group to determme which sources The omisrion in that statement, of should be subject to the registration Agreement State Working' Group are curium 244 as a transuranic element Pmgragn. These criteria were based on used in generally licensed devices being considered in the separate, more meetm, g the enten,a for registration, was comprehensive rule proposed on July 9 ".siderati ns f relative nsk and were 26,1999. Comments on these issues will Imuted to radionuclides currently in use an oversight. Devices containing curium-244 with quantities meetm.g the be considered as part of that higher rulemaking in devices nsk of potential considered exposure, as to p criterion for transuranics will be Process. well as potential for contamination of included in the registration .D. Registmtion Progmm property.
o nt Several commenters stated C mmenL One commenter noted that E. Fee Based System that the NRC should give serious the language of the proposal did not call Comment: One commenter believed consideration to the NRC-Agreement f r a periodic registration program
,, that a fee-based system for all general State Working Group recommendations requinng reporting at least annually. licensees would ensure that the NRC as contained in NUREG--1551 " Final R ther, the proposed amendment would recovers the minimal cost to initiate and Report of the NRC-Agreement State merely restate NRC's authon,ty to collect maintain the reporting program. The Working Group to Evaluate Contro; and inf rmation from licensees. The commenter stated that such a Accountability of Licensed Devices.., c mmenter pointed out that the NRC registration program would enable the Specifically, one commenter stated that already has this authonty under 42 NRC to account for all sources that have there should be a Responsible U.S.C. 2095 and in its own regulations been distributed. The commenter Individual (RJ) and a Backup at 10 CFR 30.34. This commenter urged further suggested that the program could Responsible Individual (DRI) for each the NRC to explicitly call for a periodic be designed to allow steel companies general licence. This commenter stated registration program in the amended and the general public to trace the that, unlike a specific license where mgulation stating that this would
, origins of an improperly disposed of there aie 1 Radiation Safety Officer and remmd general licensees that they have source. This would help steel Authorized Users, there may be only licensed radioactive sources and that companies in determining liability for one person (RI) who has a real there are responsibilities attached to the multimillion-dollar clean up costs understanding that his or her company their licenses. It would also indicate that the steel companies and their possesses a generally licensed device that the Government has knowledge of insurers incur when sources are that contains a radioactive source. When their sources and the au%rity to inadvertently melted. It would also that RI dies, retires, resigns, or is laid eriforce prohibitions on improper provide Federal and State nuclear off, there may be no one at the facility disposal. regulators that handle orphan sources a with any understanding or appreciation Re8Ponse:The NRC has proposed means to obtain reimbursement of the significance of the generally explicit provisions for an annual resulting in an additional deterrent licensed device. The commenter stated registration requirement in the separate, against improper source disposition.
that the addition of one extra name and more comprehensive rule on this Another commenter was concerned phone number to the records should not subject. that, even though a fee-based system for be too burdensome on the licensee and Comment: A commenter suggested all general licensees would permit the may help avoid the burden of that the NRC reconsider one of the NRC to recover the anticipated cost of responding to a radiation incident provisions in a proposed rule published initiating and maintaining the reporting involving the device. February 5,1974 (39 FR 4583), that program, a fee schedule could slow or Two other commenters recommended would have required registration of the prevent implementation of the entire that the NRC consider the Working generally licensed devices before proposal. h this is correct, the Group's recommended comprehensive customers are allowed to receive them. commenter recommended that the NRC i measures, including requirements for This commenter stated that this would retain the proposal as published, the NRC to maintain inventory records, ensure and document that general Response: The Commission is not to compare and reconcile related licensees have received copies of the addressing comments on its proposed discrepancies, and to mandate reporting regulations and that they are aware of foe-based system as part of this the bankruptcy of a licensee to the NRC. their rights and responsibilities, rulemaking process. The separate, more
~ ;
l
. 42274 Fed:r:1 Regi;t:r/Vol. 64, No.149/ Wednesday, August 4,1999/ Rules and Regulations '
y, - comprehensive rule addresses fees for for sources that are relatively costly to Paperwork Reduction Act Statement registration and the comments will be dispose of. This is to ensure that such considered in connection with that civil penalties better relate to the costs This final rule amends information rulemaking. collection requirements that are subject I avoided by the failure to roperly to the Paperwork Reduction Act of 1995 st F. llegistmtion Information Avallable on ~ (44 U.S.C. 3501 et seq.). The information j the Internet c([nin8 c n amh kte el, 11 collection requirements in this rule have would not be an appropriate basis for been approved by the Office of Comment: Org comme'nter was setting fees.
opposed to makmg M registration Management and Budget. approval No comments were made conceming information available on the Internet. 'a umber 3150-0016' the specific wording of the proposed The public reporting burden for this because such postmg would amendment. No change to the rule has unnecessarily cause public concern over been made as a result of thes" information collection is estimated to the presence and use of low level . average 20 minutes per response, comments. including the time for reviewing tlis r fIrr ation s out be val $b o Agreement State Compatibility instructions, searchin existing data only through the Freedom of Under the " Policy Statement on s urces, gathering an mamtaining the Information Act request rocess. Adequacy and Compatibility of data needed, and completing and flesponse:Some of the information Agreement State Programs" approved by reviewing the information collection.
submitted in distributor the Commission on June 30,1997 (62 FR Send comments on any aspect of this reports and entered into bparterly 46517), this final rule is classified as e general inf rmation collectw, n, mcluding license tracking system that is to be Compatibility Category D. Category D suggesti n for reducing the burden, to used for handling registration the Records Management Branch (T-6 means the provisions are not required information would be considered, b E" for purposes of compatibility; however, yg]g" ""[3y t C 20555-proprietary. This database will be if adopted by the State, the provisions 0001, or by internet efectronic mail at designed with secunty features in order should not create any conflicts, BJS1@NRC. GOV; and to the Desk to protect propnetary information. It duplie itions, or gaps in the regulation of Officer, Office ofinformation and will not be available on the Internet. AEA matenal. Ultimately, an enhanced Regulatory Affairs, NEOB-10202, The NRC would post information on its oversight program is expected to (3150-0016), Office at Management and website conce ning lost or unaccounted include provisions that will require a for devices. Budget, Washington, DC 20503.
higher degree of compatibility. This is ;
G. Civil Penalty Amounts being considered in the separate, more Public Protection Notification '
comprehensive rulemaking that would if a means used to impose an Comment:One commenter agreed add more explicit requirements for the with the NRC's intent to increase the information collection does not display registration program and additional a currently valid OMB control number, I civil penalty amounts for violations provisions concerning accountability of the NRC may not conduct or sponsor, invo'vmg lost or improperly disposed of generally licensed devices. and a person is not required to respond sources or devices. The commenter to, the information ecllection.
stated that the penalties must be Voluntary Consensus Standards significantly higher than the costs The National Technology Transfer Regulatory Analysis avoided by the failure to properly and Advancement Act of 1995, Pub. L. The NRC has prepared a regulatory dispose of the source or device. 104-113, requires that agencies use analysis for this regulation. The analysis A second commenter supported fining technical standards that are developed examines the cost and benefits of the generallicensees who violate their or adopted by voluntary consensus alternatives considered by the NRC. The general licenses by using a schedule that standards bodies unless the use of such regulatory analysis is available for is proportionate to the damage actually a standard is inconsistent with inspection in the NRC Public Document caused by the lost source. The applicable law or otherwise impractical. Room 2120 L Street NW. (Lower Level).
commenter used the example of the cost In this final rule, the NRC is amending Washington, DC. Single copies of the for cleaning a steel mill contaminated its regulations to require that those who analysis may be obtained by calling I
by melting such a source. This possess certain industrial devices layne McCausland, U.S. Nuclear commenter believed that because the containing byproduct material provide Regulatory Commission Office of NRC's proposed penalty is not much requested information. The amendments Nuclear Material Safety and Safeguards, higher than the current fine of $2500 per are administrative in nature and require . Washington. DC, 20555-0001; telephone loss that has been assessed to licensees. certain types of specific entities to (301) 415-6219. or e-mail at it would not significantly deter illegal provide information concerning specific JMM2@nrc. gov.
behavior. The commenter believes that devices in their possession. Therefore, increasing the current relatively Regulatory Flexibility Certification this action does not constitute the minimal penalty levels to amounts that establishment of a standard that As required by the Regulatory reflect the real world damage caused by establishes generally applicable Flexibility Act (5 U.S.C. 605(b)), the loss of a licensed source will provide ' requirements. Commission certifies that this final rule generallicensees with a substantive does not have a sigmficant economic economic incentive to dispose of their Environmental 1mpact: Categorical impact on a substantial number of small sources legally, Exclusion -
entities. This rule requires general ,
flesponser As discussed in the July 26, The NRC has determined that this licensees who have received specific 1999 (64 FR 40295) proposed rule, the final rule is the type of action described devices to respond to requests for Commission is considering ral ing civil - in the categorical exclusion in 10 CFR information from NRC. The final rule penalties for violations inv4 og lost or 51.22(c)(3)(iii). Therefore, neither an applies to the approximately 45,000 impropedy disposed of to;ms or environmental impact statement nor an persons using products under an NRC l devices and may use a tiered approach environmental assessment has been generallicense.many of whom may be with higher than usual civil penalties prepared for this regulation. classified as small entities. However, the l
l l
i
p l l_y Frd:rxl Registtr/Vol. 64. No.149/ Wednesday, August 4,1999/ Rules and Regulations 42275 !'
\
NRC Intends to request registration 2233h secs. 201, as amended. 202. 88 stat.
I information from only approximately 1242. as amended. 1244 (42 U.sL sa4 t-material that s below design strength standards may have been utilized on the !
5100 of these general licensees. 5842L '
wing attach fittings on the Model PA- ~
[ Registration information to be obtained Section 31.6 also issued under sec. 46-350P airplanes manufactured since willinclude identification of the 274, 73 S, tat. 688 (42 U.S.C. 2021). Januarv 1995. The actions specified by l devices, accountability for the devices, 2. Section 31.5 is amended by adding this AD are intended to prevent i the persons knowledgeable of the device paragraph (c)(11) to read as follows:
and the applicable regulations, and the structural failure of the wing attach l disposition of the devices. The NRC $3L5 Cedain measudng, gauging, w %p caud h he ud1kau'm of a e ntr tring devices.s substandard mater (ial, which could believes that the economic impact that any general licensee incurs as a result of
- * * *
- result in the wing separating from the supplying this information constitutes a (c) * *
- airplane with consequent loss of j negligible increase in administrative (11) Shall respond to written requests control, burden. It is estimated that there are fr m the Nuclear Regulatory DATES: Effective September 24,1999, Commission to provide information approximately 20.000 devices in the The bossession of the Conunission's relating general to the calendar general days of the license date ofwithin the 30 certam, incorporation by reference of request, censees which will come under the publications listed in the, registration requirement. The average r ther time specified in the request. If regulations is approved by the Director the general licenseo cannot provide the of the Federal Register as of September cost to the general licensee per device per year is about $4.00. Therefore, the mquested infmmadon within the 24,1999.
allotted time,it shall, within that same action will not have a significant time period, request a longer period to A00RESSES: Service information that I' economic impact on small entities. The applies to this AD may be obtained from '
final rule is intended to ensure that supply the information by submitting a The New Piper Aircraft,Inc., Customer general licensees understand and letter to the Director. Office of Nuclear Services,2926 Piper Drive, Vero Beach, comply with regulatory responsibilities Matenal Safety and Safeguards, U.S. Florida 32960. This information may regarding the generally licensed Nuclear Regulatory Commission, also be examined at the Federal i radioactive devices in their possession. Washmgton, DC 20555-0001 and Aviation Administration (FAA), Central i p v de wnuen iusuncadon as to why Region, Office of the Regional Counsel, d Backfit Analysis The NRC has determined that the * *
- Attention: Rules Docket No. 99-CE j backfit rule, to CFR 50.109, does not Dated at Rockville' Maryland, this 1st day apply to this rule, because these of July 1999. X""8"8 W' E88 d Mm m at b .
amendments do not involve any e eral Regists,8@ M 2 For the Nuclear Regulatory Commission.
provisions that impose backfits as wittiam n. Travers, aphol mt. N%,, suite 700, ;
defined in 10 CFR 50.109(a)(1) and, Eucutive Directorfor opemtions.
therefore, a bacKfit analysis is not FOR FURTHER INFORMATION CONTACT: Mr. j required, (FR Doc. 99-19984 Filed 8-3-99:8A5aml a em m4 William O. Herderich. Aerospace i Small Business Regulatory Enforcement Engineer, FAA, Atlanta Aircraft '
Fairness Act Certification Office, One Crown Center, DEPARTMENT OF TRANSPORTATION 1895 Phoenix Boulevard, suite 450, in accordance with the Small Atlanta, Georgia 30349; telephone: (770)
Federal Aviation Administration 703- 6084; facsimile: (770) 703-6097.
irness Ar t o 19 ,ti has determined that this action is not a 14 CFR Part 39 SUPPLEMENTARY INFORMATION:
Ietermi natfo th t ffice of [D cket No.99-CE-01-AD; Amendment 39- Events Leading to the Issuance of This Information and Regulatory Affairs, H244 AD MW AD Office of Management and Budget. RIN 2120-AA64 A proposal to amend part 39 of the l List of Subjects in 10 CFR Part 3t Altworthiness Directives; The New Federal Aviation Regulations (14 CFR d By roduct material, Criminal Piper Aircraft, Inc. Model PA-46-350P part 39) to include an AD that would penafties, Labeling, Nuclear materials, Airplanes apply to certain Piper Model PA Packaging and containers, Radiation .
350P airplanes was published in the protection, Reporting and recordkeeping Admmistration, AGENp FederalDOT. Aviation Federal Register as a notice of proposed requirements, Scientific equipment. rulemaking (NPRM) on March 19,1999 For the reasons set out above and ACTION: Final rule. (64 FR 13530). The NPRM proposed to under the authority of the Atomic "9" "8'" 8 " " ' " * "
Energy Act of 1954, as amended, the
SUMMARY
- This amendment adopts a to the wing forward and att attacf*
Energy Reorganization Act of 1974, as new airworthiness directive (AD) that fittings by incorporating the Wing to j .
amended, and 5 U.S.C. 552 and 553, theA"7c t nc.( iper i el P Fuselage Reinforcement Installation Kit, NRC is adopting the following 6-350P airplanes. This AD requires installing Piper part number 766-656. ,
amendments to 16 CFR Part 31.
reinforcement plates to the wing Acc mP lishment of the proposed action i f rward and aft attach fittings. This AD spe a di ' M d be PART 31-GENERAL DOMESTIC d in a co d LICENSES FOR BYPRODUCT is the result of a report that sheet steel instructions to the above-referenced kit, MATERIAL as referenced in Piper Service Bulletin iPens pms: ng
- 1. The authority citation for Part 31 devices under a genera cense $p>dumna,aam in to cFR si.s No.1027, dated November 19,1998, continues to read ~as follows: b" rare lanuary is, iv7s. may continuc io poness. The NPRM was the result of a report use, or transfor that material in accordance with the that sheet steel material that is below Authority: Secs. 81, lui,183,68 Stat. 035, labeling requirements of to CFR at.s in effect on ;
948. 9s4, as amended (42 U.S.C. 2111,2201, January it 197s. design strength standards may have i