ML23153A052

PR-031 - 63FR66492 - Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information

ML23153A052
Person / Time
Issue date:	12/02/1998
From:	Knapp M NRC/EDO
To:
References
PR-031, 63FR66492
Download: ML23153A052 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 12/02/1 998 TITLE: PR-031 - 63FR66492 - REQUIREMENTS FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE REQUESTED INFORMATION CASE

REFERENCE:

PR-031 63FR66492 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PR-031 (63FR66492)

In the Matter of REQUIREMENTS FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE REQUESTED INFORMATION DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/27 /98 11/19/98 FEDERAL REGISTER NOTICE - PROPOSED RULE

. 01/20/99 01/15/99 COMMENT OF NATIONAL STEEL PELLET COMPANY (JOHN M. GIVEN) ( 1) 01/25/99 01/20/99 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (THOMAS W. ORTCIGER, DIRECTOR) ( 2) 02/16/99 02/05/99 COMMENT OF STEEL MANUFACTURERS ASSOCIATION (THOMAS A. DANJCZEK) ( 3) 02/16/99 02/10/99 COMMENT OF MASSACHUSETTS RADIATION CONTROL PROGRAM (ROBERT M. HALLISEY, DIRECTOR) ( 4) 02/18/99 02/11/99 COMMENT OF NEW JERSEY DEPARTMENT OF ENVIRONMENTAL PROTECTION (JILL LIPOTI, PH.D., ASST. DIRECTOR) ( 5)

. 02/18/99 02/16/99 COMMENT OF AMERICAN IRON AND STEEL INSTITUTE (PETER HERNANDEZ, VICE PRESIDENT) ( 6) 03/01/99 02/17/99 COMMENT OF DIAB ELMASHNI ( 7) 08/02/99 07/01/99 FEDERAL REGISTER NOTICE - FINAL RULE 08/30/99 08/23/99 COMMENT OF CENTRAL EMERGENCY SERVICES (LEN A. MALMQUIST) ( 8) 10/01/99 09/15/99 COMMENT OF NORTHMINSTER PRESBYTERIAN CHURCH (LEANDER P. TORI, JR.) ( 9)

(fJ 140Trenton Road Fairless Hills, PA 19030 215-945-4264 0!

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~ rnz :, 6 fl Paul L. Rhodes, Pastor September IS, 199'J Sccn,tary U. S. Nuclear Regulatory Comm.

Washington, DC 20555-0001 Gentlemen:

This letter is in response to the two notices of rulemaking being proposed by your Commission relative to "Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material, etc" which would require periodic reporting and payment of fees. Proposed rule changes would appear in 10CFR Part 31 RIN 3150 - AG06 and IOCFR Parts 30, 31, 32, 170 and 171, RIN 3150 -AG03.

In the interests of simplifying the administrative burden such rulemaking would impose on the Commission, and to lessen its impact on small, non-commercial users of such devices, we respectfully request that an additional provision be incorporated in both rules that will provide:

l. That it does not apply to non-commercial enterprises, including churches and other religious institutions who employ less than 7 such devices, when such devices are limited exclusively to self-luminous exit signs.

2. Enterprises which meet the requirements of exception 1 above will receive from the Commission annual notices relative to the proper maintenance, transfer and ultimate disposal of such devices, but without requiring the payment of any fee.

In justification for the above, we would like to advise that in the case of Northminster Presbyterian Church, the self-luminous exit signs were specifically required to be installed by our local Fire Marshall. Ours is a small Church with slightly over 100 members, and a very tight budget. Any new governmental fees such as envisioned by the proposed rules would impose a burden upon us. We believe that the proposed exception is reasonable, and respectfully request that you give it serious consideration, advising us of your decision.

For the Session

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Leander P. Tori Jr.

Administration Committee cc:Pastor Paul L. Rhodes gedby

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CENTRAL EMERGENCY SERVICES OC CKE IF fJ Central Kenai Peninsula Fire & EMS Providers I IS 'f'. (;

1 231 SOUTH BINKLEY SOLDOTNA, AK 99669-8084 907-262-4792 e Fax 907-262-5770 *99 AU 30 AC:12 "Prepared for th* Worst, Providing the Best" August 23, 1999 Secretary, U.S. Nuclear Regulatory Commission Attn: Rulemakings and Adjudications Staff Washington D.C. 20555-0001 COMMENTS ON NRC PROPOSED RULES 63 FR 66492 AND 64 FR 40295 Central Emergency Services is a local fire and EMS service provider in the State of Alaska. We have enforcement authority for provisions of the Uniform Fire Code, which requires illuminated exit signs for certain occupancies. In addition ,

we also have requirements for our own properties for illuminated exit signs.

We currently use radioactive powered exit signs in all of our fire stations. The rationale for the use of these devices is that the}' will always work as :hey are not power dependent, and they are easier to maintain in that we do not have to replace burned out bulbs in the exit signs .

• I have reviewed the information that you have mailed to us for comment. You have requested comments in the following areas:

1. Whether the registration should include a provision that would require the general licensee to completed registration by a certain time, whether or not the NRC requests registration. "

No, the commission should not require registration until the NRC requests it. This sort of requirement would increase paperwork for all involved parties that may not be needed until a determination has been made that the information is needed to satisfy a requirement of the regulations."

2. Whether it is appropriate for new devices obt~iri~c;t by registrants to be registered *when the annual re-registration is carried out. "Yes, it makes sense that the logical !il'!l.e to add or subtract devices would be at the annual re-registration. This would provide only one information flow, which will reduce paperwork, SH - l 19 i

~cknowfedged by card __ _......,............

cost of implementation, and the chance for errors and/or loss of materials."

3. Whether the general licensee should assign a backup responsible individual. "No, the requirement is not needed.

General licensee's should be advised of the need to have responsible individual(s), and they should be encouraged to have one, or more, backups available. Most of the licensee's will be responsible."

4. Should information be provided to potential general licensee's earlier? Yes. The consumer should have all information available to them PRIOR to their making a purchase that would make them a party to these regulations. If the purchase of a regulated device is

$200.00, and it costs $420.00 to register it and another $250.00 to dispose of it properly, then the consumer may make the decision to purchase an alternative type of device. The proposed rules will probably force some manufacturers out of business, as the consumers will not purchase their products due to the regulatory requirements and costs of these proposed rules. Unfortunately, some of these products are superior to the alternatives-specifically the use of radioactive powered exit signs vs. electrically powered exit signs." -~

5. The advantages and disac!vantages of a national databa~e of general licensees and their devices. The adyantage ota national database would be that their would be one central Jocation with information on who had devices, and what type:of:devices.

Tt:e disadvantages include: the cost to set up such a database;*the stigma of having your company's name in the database; the potential for receipt of unsolicited comments from readers of the database; and the potential for misuse of the database by outsiders.

6. Are the proposed fees reasonable? No, they are not reasonable.

The intent of having a single fee for a registrant makes sense. But, if the registrant has only one small device and the fee is much more than the device, where is the incentive to use the device? Also, using the exit signs as an example again, does the fee recognize that the consumer purchased the device to improve the safety of a building for the general public?

After reading the material provided, I fail to see the need for the proposed regulations. The material did not document where the problems were, to what extent the problems have impacted the general public, the financial costs of implementing the rules compared to the costs of leaving the rules as they are currently written; and the potential for loss of business due to the costs of compliance with the proposed regulations.

If the intent of the rules changes are to make sure that general licensee*s know the rules, follow labeling requirements, and dispose of their devices properly, then it would make more sense to make sure that all general licensee's know what is expected of them. We did not receive any information from the manufacturer, distributor, or supplier on any of these items regarding the illuminated exit signs that we purchased. Complete instructions, including the regulatory requirements, should be packaged with all devices so that consumers know what is expected of them.

Please provide us with a copy of the adopted regulations when they are completed. We do wish to be compliant with your regulations.

Yours in public safety, ____ _

• ~~

Fire Chief

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205ll6--0001 August 12, 1999 To NRC General Licensees:

Enclosed are two notices of rulemaking which may affect you. The first is a final rule that requires Nuclear Regulatory Commission (NRC) general licensees respond to requests for information that we may make. This rule will be effective October 4, 1999. The second rule was published to solicit public comment before completing a final rule. This rule proposes requirements for a registration process and payment of fees that NRC plans to initiate for licensees who possess certain generally licenced devices. Presently, registration is planned for devices that contain certain types and quantities of radioactive materials.

You are being sent a copy of these rules because our records show that you received a device which is generally licensed under Title 10 of the Code of Federal Regulations. Thus, you may be considered to be an NRC general licensee. The devices containing radioactive material included under a general license are various types of measuring, gauging, and controlling devices, as well as devices for producing light or an ionized atmosphere. Among the most common devices are self-luminous exit signs, gas chromatographs, and other gauges used to measure product level, thickness, density, or chemical composition.

If you wish to comment on the proposed rule, please follow the instructions in the notice. The comment period closes on October 12, 1999.

Sincerely,

~ ' ,,/.~ ~:,tJ John W. N. Hickey, Chief Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosures:

As stated

UNITED STATES FIRST CLASS MAIL NUCLEAR REGULATORY COMMISSION POSTAGE AND FEES PAID USNRC WASHINGTON, DC 20555-0001 PERMIT NO. G-67 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300

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• 99 AUG -2 P12 :Q8 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 AGENCY: Nuclear Regulatory Commission.

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

• 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 material are maintained and transferred properly and are not inadvertently discarded.

~ 1, 199'1 EFFECTIVE DATE: (68 dsys fl 0111 date or pUbllcatlon In tne Fede rel Register).

FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001,

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:

Background

On February 12, 1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a general license 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 I

specific license authorizing 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 receives 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

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

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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 general license is meant.to simplify the licensing process so that a case-by-case determination of the adequacy ~f the radiation training or experience of each user is not necessary.

There areiabout 45,000 general licensees under 10 CFR 31.5. These licensees possess about 600,000 devices that contain byproduct material. The NRC has not contacted general licensees on a regular basis because of the relatively small radiation exposure risk posed by these devices and the very large number of general licensees. However, general licensees are not always aware of applicable regulations and thus are not necessarily complying with all of the applicable requir~ments. 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 ~ 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 general licensees to assess the effectiveness of the general license program. The sampling revealed several areas of concern regarding the use of generally licensed devices. In particular, the NRC concluded that many general licensees are not aware of the appropriate regulations. Also, approximately 3

15 percent of all general licensees sampled could not account for all of their generally licensed devices. The NRG concluded that these problems could be remedied by more frequent and timely contact between the general licensee and the NRG.

On December 27, 1991 (56 FR 67011), the NRG 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, general licensees under

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1o CFR 31.5 to provide Information to the NRG upon request, through which a device registry could be developed .. The proposed rule also included requirements in 10 CFR 32.51a and

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32.52 for th*e 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 NRG continued to consider the issues related to the loss of control of generally licensed, as weJI as specifically llcensed, sources of radioactMty. In July 1995, the NRG, with assistance from the Drganization of Agreement States, formed a working group t~ evaluate these issues. A final report was completed in July 1996 and published In October 1996 as

• NUREG-1551, ."Final Report of the NRG-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices.D In considering the recommendations of the working group, the NRG decided, among other things, to again initiate rulemaking to establish an annual registration program of devices generally llcensed under 10 CFR 31.5 that would be similar to the program originally proposed in the December 27, 1991, proposed rule. However, the NRG 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 NRG found the J

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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 property.

On December 2, 1998 (63 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,*gene~l 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 rule issued July 26, 1999. That proposed rule addresses fees for registration, additional reporting, recordkeeplng, 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 Co!Jlmission 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 initial cycle is considered to be the issuance of one round of registration requests to all affected general licensees. 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 program.

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Under this interim enforcement policy, enforcement action normally will not be taken for 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 Information.

This chan,ge from the Commission's normal enforcement policy is* intended to remove the potential for the threat qf enforcement action to be a disincentive for the licensee to identify deficiencies.

Under the interim enfprcement policy, enforcement action, including Issuance of civil penalties and Orders, may be taken where there is -

(1) Failure to take appropriate corrective action to prevent 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 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, for violations involving lost or improperly disposed of sources or devices. This increase will better relate the cMI penalty amount to the costs avoided by the failure to property dispose of the source or device. Due to the diversity of the types of sources and devices, the Commission 6

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 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 GFR 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 general licensees are aware of and understand the requirements for the possession of devices containing byproduct material. The registration 7

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process will allow NRC to account for devices that have been distributed for use under the general license. The NRC believes that, if general licensees 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 radiation exposure to the public as well as contamination of property.

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 (1) The lde.ntifica~on 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 general licensee 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 Js 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 general licensees, based on the 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 1

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removing the previously NRC general licensees in Massachusetts, results In an estimate of 5100. Other States are expected to become Agreement States in the near future which will affect the number of general licensees 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 g~nerally licensed devices. Thus, following State implementation of compatible programs

• In conjuricti~n with that* rule, further changes in th*e number of generally licensed devices within NRC jurisdiction_ should not adversely affect accountability.

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 ceslum-137; 3.7 MBq (0.1 mCi) of strontium-90; 37 MBq (1 mCi) of cobalt-60; or 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 will Include 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 provided to the NRC by distributors under 10 CFR 32.52(a) and compatible Agreement State regulations and from general licensees as required by 1o CFR 31.5(c)(8) or (9) regarding transfer of generally licensed devices. If a general licensee no longer possesses devices meeting the criteria, it will 9

be expected to provide Information about ttle disposition of the devices previously possessed.

Errors In current NRG records concerning these general licensees 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 NRG or its contractors in recording transfer information.

In additio_n to the 5100 general licensees identified for registration, the NRG 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 NRG has estimated these costs to be minimaJ. This cost is the estimated administrative cost expended by general licensees to verify the information requested ,by the NRG regarding licensed devices. The NRG believes that the rule's intended effect of increased compliance by generaJ licensees with regulatory requirements, and resulting NRG and public

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confidence in the general license program potentially afforded by these new requirements, outweigh this nominaJ administrative cost.

Public Comments on the Proposed Rule The NRG reviewed the public comments received on the December 2, 1998, proposed rule. Seven comm~nt letters were received from: the State of Illinois (an Agreement State),

National Steel Pellet Company, Steel Manufacturers Association (SMA), the CommonweaJth of 10

Massachusetts (an Agreement State), the State of New Jersey (a non-Agreement State),

American Iron and Steel lnstiMe (AISI), and one private citizen.

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 com.pletely solving the regulatory problems of the NRC. The steel industry 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.

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Agreement was expressed by two commenters that the administrative burden on

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general licensees to provide the minimal information requested by the NRC is reasonable, as is the 30-day period in which general licensees have to respond, with ' extensions granted for good cause.

Severahcommenters voiced agreement with the interim enforcement policy. One commenter, the State of New Jersey, believes 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 them in mountains of trash or scrap 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 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.

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A. Current NRC General Licensing Process and Cost Shift.

Comment: In general, the three representatives of the steel industry expressed similar concerns regarding the current NRC general licensing 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 aCCQuntability and control onto steel makers, insurers, and the J

taxpayers. This commenter stated that general licensees do not pay for their licenses nor provide ,inforrnc!,t!.on. directly to NRC about the sources !!1ey hold. Instead, the cost has fallen on steel producers to detect the sources, on steel. producers and taxpayers to arrange*for 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 me1tir:1g of orphaned sources by domestic steel producers has resulted In decontamination, disposal, and lost production costs ranging between $1 O million and $24 million at electric furnace mills and that the cost of a similar Incident occurring in a major integrated steel mill could easily exceed $100 million.

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Response: The Commission recogilizes the expense to the steel industry when generally licensed devices containing radioactive material are not 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 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 disP.05ed of sources to the steel industry. 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. Reporting 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 -

expenses, and paper. They also indicated that the NRC should ensure that. its database has an

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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 the NRC Internet Web Site and that the NRC could use the employer's tax identification number and a password to secure the information. This commenter also J

recommended that the NRC database include a data quality verificatipn 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 general li~nse registration program. The NRC has evaluated the issue 13

of permitting licensees to file applications and reports electronically and plans to publish an amendment to the regulations to allow such submissions. The NRG expects to publish the amendment next year. At that time, the NRG will evaluate how this change will impact implementation of the registration program and future enhancements to the design of the automated system. However, the NRG currently expects that the initial registration program would require submission of hard copies of the registration forms.

The NRG is in the process of upgrading its information technology systems to facilitate

, processing of annual registrations. The upgrades will include adequate data verification for

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distributor, general_ licensee, and registration Information and will include automated readers for processing the large volume of registration forms. The automated readers will identify 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 governing licensed radioactive devices concerning their location and whether they are beipg 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 m_aterial presents an extr~me 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 number of devices in use and who has them is achievable without such a restriction. Generally 14

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 general license, restrictions on numbers of devices that can be possessed would be difficult to enforce and would likely lead to difficulties in getting accurate information on devices possessed.

Comment: Another commenter recommended that the NRG 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 NRG instead target general licensees that do not currently maintain byproduct material under a specific NRG license 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. Therefore, these specific licensees will be subject to registration. Given the approach of this first rule, it would be possible for NRG 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 appllcable regulations, do have problems with incomplete accountability for devices. The potential 15

l 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 subject to registration may\~ish 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 general license 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 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.

R0SDpOSB: The Commission 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 to the NRG-Agreement State Working Group recommendations as contained in NUREG-1551, "Flnal Report of the NRC-Agreem-ent State Working Group to Evaluate Control a*nd Accountability of Licensed Devices." Specifically, one commenter stated that there shoul~ be a Responsible Individual (RI) and a Backup Responsible lndividufll (BRI) for each general license.

This commenter stated that, unlike a specific license where there are a Radiation Safety Officer 16

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 understanding 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 burderisome on the licensee and may help avoid the burden of responding to a radiation Incident lnvoMng 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 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 additional regulations amending or establishing requirements for registration fees, labeling, and 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 amendment the NRC proposes.

Response: The more comprehensive measures recommended by the NRG-Agreement State Working Group are belr:,g considered in the separate, more comprehensive rule proposed on July 26, 1999. Comments on these issues will be considered as part of that rulemaklng process.,

17

D. Registration Program.

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 commenter pointed out that the NRG already has this authority under 42 U.S.C. 2095 and In its own regulations at 10 CFR 30.34. This commenter urged the NRG to explicitly call for a

-periodic registration program in the amended regulation stating that this would remind general licensees that'the-y have licensed radioactive sources and that there are responsibilities attached to their licenses. It would also indicate that the Government has knowledge qf their sources and the authority to enforce prohibitions on improper disposal.

Response: The NRG has proposed explicit provisions for an annual registration requirement in the separate, more comprehensive rule on this subject.

Comment: A commenter suggested that the NRG reconsider one of the provisiofls in a proposed rule published February 5, 1974 (39 FR 4583), that would have required registration l

of the generally licensed devices before customers 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.

Resooose: The Commission does not believe preregistration is necessary to ensure and document that general licensees have received copies of the regulations and that they are aware of their rights and responsibilities. Howe~er, 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 NRG to adopt a mandatory registration program for all sources, not merely those that,pose the greatest risk to steel mills.

18

Response: The Commission has decided to use the criteria developed by the NRG/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 tor all general licensees 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 tor the multimillion-dollar clean-up costs that the steel companies and their Insurers incur when sources are inadvertently melted. It would also provide Federal and spite 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 retaln the proposal as published.

19

Response: The Commission is not addressing comments on its proposed fee-based

$ystem as part of this rulemaklng process. The separate, more comprehensive rule addresses fees for registration and the comments will be considered in connection with that rulemaking.

F. Registration Information Available on the Internet.

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 Ieve.I devices. The commenter believes that this information

-should be available only through_the Freedom of Information Act request process.

Response: Some of the information submitted in distributor quarterly reports and 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 Internet. The NRG would post information on its website concerning lost or unaccounted for devices.

G. CMI* Penalty Amounts.

Comment One commenter agreed with the NRC's intent to increase the civil penalty amounts for violations lnvoMng 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 melting such a source,. This commenter believed that because the NRC's proposed penalty is 20

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 I ,

by loss of a licensed source will provide general licensees with a substantive economic Incentive to dispose of their sources legally.

Response: As discussed in the July 26, 1999 (64 FR 40295) proposed rule, the Commission is considering ralsing civil. penalties tor violations invoMng lost or improperly

_disposed of sou~ 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 cMI penalties better relate to the costs avoided by the failure to property dispose of the source or device. The cost of cleaning a contaminated steel mill would not be an appropriate basis tor 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 0

Under the Pollcy 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 a:re 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 inclu~e provisions that will require a higher degre~ of compatibility. This is being considered In the separate, more comprehensive rulemaking that 21

would 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 consensus standards bodies uni~ the use of such a standard is inconsistent with applicable law or otherwise impractical. In this final rule, the NRC is amending its regulations to require that those who possess certain industrial devices containing byproduct mat~rial 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.

I Therefore, this action does not constitute the estabiishment of a standard that establishes generally applicable requirements.

Environmental Impact Categorical Exclusion The NR(? has determined that this final rule Is the type of action described in the categorical exclusion in 10 CFR 51.22(c)(3)(iil). Therefore, neither an environmental impact statement nor 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 13stimated to average mlnutes per response, Including the time 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 @NRG.GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0016), Office of Management and Budget, Washington, DC 20503.

Public Protection Notification ,

If a means used to impose an information collection does not display a currently valid 0MB control number, the. NRG may not conduct or sponsor, and a person is not required to respond to, the information collection.

23

Regulatory Analysis

\

The NRC has prepared 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 NRG 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 atJMM2@nrc.gov.

Regulatory Flexibility Certification As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this final rule do~s not have a significar:it 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 from NRG. The final rule applies to the approximately 45,000 persons using products under an NRG general license, many of whom may be classified as small -

entities. However, the NRG intends to request registration Information from only approximately 5100 of these general licensees. Registration information to be obtained will include identification of the devices, accountability for the devices, the persons knowledgeable of the device and the applicable regulations, and t;he.disposition of tt:ie 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 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

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 backflt rule, 10 CFR 50.109, does not apply to this l ,

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, Pacfsaging and containers, Radiation protection, Reporting and recordkeeplng requirements, Scientific equipm~nt.

25

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, the NRG is adopting the following amendments to 10 CFR Part 31.

PART.31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

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.

5841, 5842).

Section 31.6 also issued under sec. 274, 73 Stat. 688 (42 U.S.C. 2021 ).

I

2. Section 31.5 is amended by adding paragraph (c)(11) to read as follows:

§ 31.5 Certain measuring, gauging, or controlllng devices.2 (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 general licensee cannot provide the 2

Persons possessing byproduct material in devices under a general license in 1O CRR 31.5 before January 15, 1975, may continue to possess, use, or transfer that material In accordance with the labellng requirements of 10 CFR 31.5 i':} effect on January 14, 1975.

requested lnfonnation within the allotted time, It shall, within that same time period, request a longer period to supply the infonnatlon 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.

Dated at Rockville, Maryland, this 1st dayof _--=J=yl.,_,y.._____ 1999.

For the Nuclear Regulatory Commission.

William D. Travers, Executive Director for Operations.

27

(j)

DOCKET NUMBER PROPOSED RULE p 3! 0 "'KET:

us,Rc Diab Elmashni ( /,3F~ {pt, tf 9 :i.)

1859 Berry Ct.

Fremont, CA 94539 *99 NAR -1 A9 :S 1 Nuclear Regulatory Commission Office of Public Affairs Washington, DC 20555 Re.: No.98-214 NRC Proposed Changes to Regulations for Devices Containing Radioactive Material I feel it is very important to have a tight control on how many licensed radioactive devices there are in use. The problem is that radioactive material posses

• an extreme threat to the public's health and safety, even if it is disposed of properly; because just the capability of causing a health hazard can be seen as a threat. I feel this change in the NRC' s regulation of the licenses of these commercial radioactive devices would force the licensees to be aware of who using their licensed device, how many they have, and how they are being disposed of. This change in regulations should have been proposed and passed years ago. In my eyes, it appears quite ludicrous that there was never an explicit provision demanding that licensees respond to the inquires of the NRC.

There needs be a great deal of improvement upon these regulations to know the whereabouts of these licensed devices and that they are being disposed of properly. Also, a license should not given out to a person to own as many devices as they please. A license should be given out per device, that way the number of devices that are available will be limited and the number of devices in use will be known. As stated earlier this is a public health and safety issue and I would hope that the NRC would not allow an excessive amount of devices to be in use which could in tum pose a great danger to the public.

This proposal will not completely solve the regulatory problems of the NRC when it comes to the regulation of radioactive devices, however, it is a step in the right direction.

Diab Elmashni

~cknowtedged MAR 8 \99 card.,..,_,._,.,_,--..-**=-----

J ~ NI JCLEAR Rt-OULATORY COIM8SK)N RULI~KINl~&ADJI.IDICfflQ*STAFF FACE OFMSECAETARV THECOMIMl9~

1101 17th Street, N.W.

a Suite 1300 American Iron and Steel lnstitutEJOCKETEO Washington, D .C. 20036-4700 J c:

• J

')* .... (202) 452- 7100 Fax(202)463-6573

°99 FEB 18 P2 :55 February 16, 1999 Peter A. Hemandez Vice President 01-Secretary - Employee Relations United States Nuclear Regulatory Commissi~ ='

Washington, DC 20555-0001 DOCKET NUMBER Attn : Rulemaking and Adjudication Staff PROPOSED RULE PR 3/

( ~3 t:Rt,G. 'I 9:1)

Re: Requirements for Those Who Possess Certain Industrial Devices Containing By Product Material to Provide Requested Information, 63 Fed.

Reg., No. 231, pp. 66,492 et seq. December 2, 1998

Dear Madam or Sir:

The American Iron and Steel Institute (AISI) herein submit its comments regarding the United States Nuclear Regulatory Commission (NRC) proposal to require registration by general licensees of certain industrial devices. AISI represents thirty-eight domestic members that account for approximately 70% of the raw steel production in the United States and employ over 125,000 in their steel producing operations.

Al Si 's members recycled over thirty million tons of steel scrap in 1998, most of which ,

was purchased scrap. Due to the precautions taken by our members to monitor purchased scrap using sensitive portal monitors, to date they have not experienced the melting of a large source. However, our members have detected and returned radioactive sources to scrap dealers after notifying appropriate federal and/or state regulatory authorities. The melting of a large source could produce a substantial adverse economic impact and create a health and safety problem for our members, their workers, and the local community. It could also produce similar problems for other hot metal producers, including aluminum, ferrous, and non-ferrous metals.

American Iron and Steel Institute initially alerted the scrap dealers about the existence of a problem nearly twenty years ago and more recently joined with the Steel Manufacturers (SMA) to ask the NRC to promulgate rules that provide tighter accountability and control over all major licensed sources. AISI also actively participated in the NRG-Agreement State Working Group's (Working Group) comprehensive deliberations regarding this matter and reiterated its concerns before the NRC in January 1998. AISI is pleased the NRC is proposing to begin addressing the problem and concurs with the SMA statement that NRC's "proposal is a positive, although small, step toward minimizing the risk associated with improper disposal of spent sources in the scrap supply. "

HB 2 4 1999 Representing

~owteoged by cara . . *. ,,, .

---

Steel Producers in Canada, Mexico and the United States

uvLt:AA REGULATORY COMMISSION RULEMAKINGS & AOJUOICA~ STAFF OFFICE OF THE SECRETARY OF THE COMMISSION

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I.

• Problem with the Current NRC General Licensing Process The NRC became aware of serious problems associated with licensee reporting, control, and accountability pursuant to the Commission's specific and general license programs after the Auburn Steel incident in 1983. As a result, the Commissioners created the NRG-Agreement State Working Group (Working Group) to Evaluate Control and Accountability of Licensed Devices several years ago. As noted above, AISI was active in the Working Group's comprehensive deliberations.

The Final Report of Working Group noted that the current NRC regulatory model provides little economic incentive for general licensees to discard radioactive sources in an appropriate manner. Current rules also make it difficult for NRC to collect information directly from licensees on a timely basis. Consequently, sealed sources have been improperly discarded into recycled scrap destined for aluminum, non-ferrous and ferrous melting operations. The NRC Working Group recognized that transporting or melting of orphan radioactive sources presents a potential significant adverse health risk to the public and to workers in the scrap recycling and metals producing industries.

As noted above, AISI members responded to this potentially serious problem well before 1983 by installing radiation detection systems to monitor all incoming shipments of scrap. These companies paid (and continue to pay) to train their employees to detect and properly handle potentially radioactive scrap. However, as AISI noted in its earlier comments to the NRC, no radiation detection system is failsafe because radioactive sources that are shielded by dense scrap in a truck or railcar can pass undetected through even the most sensitive detectors. And as NRC is aware, the inadvertent melting of orphaned sources by domestic steel producers has resulted in decontamination, disposal, and lost production costs ranging between ten million and twenty-four million dollars at electric furnace mills. The cost of a similar incident

• occurring in a major integrated steel mill could easily exceed $100 million.

II. The December 2, 1998 NRC Proposal On December 2, 1998, the NRC proposed to amend 10 C.F.R. § 31.5 by requiring general licenses to respond to requests from the NRC to provide information relating to their general licenses. In proposing this amendment, NRC said it intends to help ensure that generally licensed sources posing the greatest threat to steel mills and the public are maintained and transferred properly.

The NRC proposes to use its authority under the amended rule to survey approximately 6,000 general licensees that account for approximately 24,000 sources considered to pose the greatest threat to steel mills. NRC estimates the total number of general licensees is approximately 45,000 and would select respondents based on information reported to the Commission by licensed source distributors. Licensees would be required to respond with the information within a thirty-day period but the NRC could , at its discretion, grant an extension to the thirty-day deadline.

2

The NRG plans to ask 6,000 general licensees to verify, correct, and add to the information contained in NRG's records regarding: (1) identification of devices -

including manufacturer, model and serial numbers; (2) persons responsible for compliance with the regulations; (3) disposition of devices; and (4) location of devices.

The NRG also said it plans to establish an interim enforcement policy for violations of this amended rule. The enforcement policy would include a self-reporting component allowing affected facilities to correct deficiencies without incurring any penalties. The NRG would pursue escalated enforcement action, including civil penalties for significant violaUons and for failure to provide the information requested . The enforcement policy would increase the civil penalties to amounts higher than the cost of proper disposal when sources are improperly disposed.

II. AISI Comments AISI members typically have both specific and general licenses and would be subject to the proposed NRG registration requirement. As general licensees, AISI members agree the administrative burden to provide the minimal information and the timeframe NRG proposes are both reasonable. The proposal to grant an extension for good cause is also reasonable. However, AISI recommends NRG also permit licensees to report the required information electronically, for example through a secure page on the NRG Internet web site. {The NRG could use the employer's tax identification number and a password to secure the information.) The NRG database should include a data quality verification system to quickly identify and immediately notify licensees of any reporting inconsistencies. Employers could also be required to annually verify the accuracy of the inventory.

However, we are concerned that this limited registration program would have minimal impact on the radioactive scrap problem if NRG does not follow through with additional regulations amending or establishing requirements for registration fees, labeling, and compatibility with Agreement States requirements. We also note, that the Working Group recommended comprehensive measures, including a requirement for NRG to maintain inventory records, compare and reconcile related discrepancies, mandate reporting the bankruptcy of a licensee to the NRG, and State/NRG site inspections and inventories at regular intervals. NRG must give serious consideration to each of these measures in order to prevent the continued loss of licensed sources in the future.

While a fee-based system for all general licensees would permit the NRG to recover the anticipated modest cost of initiating and maintaining the reporting program, our members are concerned that the institution of such a fee schedule could slow or prevent implementation of the entire proposal. If that is correct, we recommend NRG retain the proposal as published.

3

Current NRC regulations have inadvertently and improperly shifted the costs for accountability and control onto hot metal producers, insurers, and taxpayers. 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.

General licensees should be required to pay their fair share of these costs. Improving licensee accountability would also reduce the risk of the illegal release of generally licensed material into public scrap supply.

We believe general licensees who violate their general licenses should be fined using a schedule that is proportionate to the damage actually caused by the lost source. (For example, the cost for cleaning a steel mill contaminated by melting such a source.)

Because the NRC's proposed penalty is not much higher than the cu rrent fine of $2500 per loss that has been assessed to licensees, it would not significantly deter illegal behavior. 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.

AISI also supports allowing general licensees to report and correct violations without incurring any penalties. This provision would encourage licensees to maintain a careful inventory and to dispose of their sources properly to avoid a substantive penalty.

Ill. Conclusion Unfortunately, NRC staff is behind the schedule established by the Commission in the April 13, 1998 memorandum regarding this matter. We respectfully urge the NRC staff to quickly finalize this rulemaking and to proceed with the additional rulemakings we described above. AISI appreciates the opportunity to submit its comments on the NRC proposal. Please do not hesitate to advise me if you have any questions about these comments. We look forward to continuing to work with NRC and NRC staff on this critical issue.

Sincerely,

~~

Peter Hernandez U cc. AISI Radiation Task Group Mr. Tom Danjczek - Steel Manufacturers Association 4

Ch ristin e Tod d Whitman Department of Environmental Protection

• FEB \ 81.ofei2 ('J~ inn, Jr.

Go vernor Division of Environmental Safety, Health and Analytical Progr ms Commissioner Radiation Protection Programs POBox415 Trenton, New Jersey 08625-0415 Phone: (609) 984-5636 Fax: (609) 633-2210 February 11 , 1999 Secretary DOCKET NUMBER U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 PROPOSED RULE p 3/

( G,3 FR (p(,,4/'f :i)

Attention: Rulemakings and Adjudications Staff

Dear Sir or Madam:

We support your proposed rule entitled "Requirements for Those Who Posses Certain Industrial Devices containing Byproduct material to Provide Requested Information." We have responded to a number of incidents where generally licensed devices were improperly sent to a scrap metal recycling facility, landfill, or incinerator. We have also responded to notifications of lost generally licensed (GL) devices, to try to locate them. We are pleased that NRC is taking this first step in requiring information from the approximately 6000 general licensees that were identified by the working group. We hope that the exercise of responding to the request for information will raise the consciousness level of the licensees, and they will be more cognizant of complying with their GL requirements. We hope that you will keep good statistical records of the responses from these first 6000 licensees as an indicator of the status of licensee compliance for the other 600,000 licensees.

Your interim enforcement policy seems appropriate to encourage general licensees to search their facilities to ensure sources are located, to determine if applicable requirements have been met, and to develop corrective action plans when deficiencies are found. It is extremely important to remove any incentive for a general licensee to attempt to discard their source rather than comply with the reporting requirement. We know what happens when people get rid of their GL devices in a hurry - we have to go out and find them in mountains of trashor scrap metal. It isn't pleasant.

We agree with your intent to increase the civil penalty amounts for violations involving lost or improperly disposed sources or devices. These penalties must be significantly higher than the costs avoided by the failure to properly dispose of the source or device.

NRC should reconsider one of the provisions in the proposal put forth in 39 FR 4583 that required registration of the general licensed device BEFORE customers are allowed to *

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receive them. This would ensure and document that general licensees have received copies of the regulations and that they are aware of the rights and responsibilities of a general licensee.

NRC should follow the recommendations listed in the NUREG-1551 "Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices". Specifically, there should be a responsible individual (RI) and Back-up Responsible Individual (BRI) for each general license. Unlike a specific license, where you have a Radiation Safety Officer and Authorized Users, there may be only one person who has a real understanding that their facility possesses a generally licensed device that contains a radioactive source. When the RI dies, retires,, resigns, or is laid off, there may be no one at the facility with any understanding or appreciation of the significance of the general licensed device. There have been incidents in our state where gauges containing Curie qualities of Cs-13 7 found their way to public auctions and were discovered at demolition sites due to the fact that the RI left the organization and there was no one else with any knowledge of what was being disposed or abandoned. The addition of one extra name and phone number to the records should not be too burdensome on the licensee, and it may help to avoid the burden of responding to a radiation incident involving the device.

We look forward to the future rulemaking addressing fees for registration, additional labeling requirements, and compatibility requirements for Agreement States.

Sincerely, 1/4/j/1

. I Lipoti, Ph.D.

Assistant Director

The Commonwealth of Massachusetts 0 Executive Office of Health and Human Se,n.vn,,oc TlD Department of Public Health Radiation Control Program 174 Portland Street, 5th Floor, Boston , ~ Og~1lt5 P3 :1 6 ARGEO PAUL CELLUCCI (617) 727-6214 (617) 727-2098 - Fax GOVERNOR JANE SWIFT QF:h LIEUTENANT GOVERNOR RL,1 L'

'"'OCKET NUMBER ADJL'.:::- 1 WILLIAM D. O'LEARY SECRETARY r'ROPOSED RULE-r- P_R-3 _/ - -==

HOWARD K. KOH, MD, MPH COMMISSIONER (~3 FR~lrt/~.;i. )

February 10, 1999 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attn: Rulemakings and Adjudications Staff RE: Comments on Proposed Rule:

"Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material To Provide Requested Information" (RIN 3150-AG06)

Dear Secretary:

• The Massachusetts Radiation Control Program has reviewed the above identified proposed rule and agrees with the establishment of a registration program and annual reporting requirements for certain categories of generally licensed devices as described in the proposed rule.

The Massachusetts Radiation Control Program currently implements a registration program for general licensees in which they are required to provide similar information as would be required in the proposed rule.

Sincerely, I *

~~ ~ & ~

Robert M. Hallisey, Director Massachusetts Radiation Control Pro RMH:jed H8 1 8 1999 _

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STEEL MANUFACTURERS ASSOCIATION Suite 907 ni 1730 Rhode Island Avenue, N.W., Washington, D.C.'"-2 Fax: (202) 296-2506 Thomas A. Danjczek . (202) 296-1515 President *99 FEB 16 PJ *e ~ ail: danjczek@steelnet.org 0 .-1 ht _I AO_i!_~

February 5, 1999 DOCKET NUMBER PROPOSED RULE PR 3/

Secretary ( kl 3 FR folotf '1.d)

United States Nuclear Regulatory Commission Washington, DC 20555-0001 Attn: Rulemaking and Adjudications Staff Re: Comments on Proposed Rule: Requirements for Those Who Possess Certain Industrial Devices Containing By Product Material to Provide Requested Information, 63 Fed. Reg. 66,492 (1998)

Dear Sir or Madam:

On behalf of the Steel Manufacturers Association ("SMA"), we submit the following comments regarding the United States Nuclear Regulatory Commission ("NRC") proposal to require registration by general licensees of certain industrial devices. 63 Fed. Reg. 66,492 (1998). We believe that the proposal is a positive, although small, step toward minimizing the risk associated with improper disposal of spent sources in the scrap supply.

I. The SMA The SMA is the primary trade association of electric arc furnace ("EAF") steel producers, often referred to as "minimills," which make new steel products from a feedstock of nearly 100%

iron and steel scrap. The SMA also includes several integrated steel compani~s'.th,a!_m~e steel from a mix of iron ore, coke and scrap, as well as companies engaged in hot and cold r9.l!i~g of steel mill products. The forty-nine United States member companies of the SMA are geographically dispersed across the country and account for almost half of total domestic steel production (see attached list).

According to the SMA, the EAF steel industry last year recycled over forty-five million tons of steel scrap, which would have otherwise been discarded in landfills or littered the .countryside.

SMA members make a valuable contribution to the environment by recycling and remain one of the most competitive and cost efficient segments of the world steel industry. The presence of spent fEB 181891

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United States Nuclear Regulatory Commission February 5, 1999 Page2 radioactive sources in the ferrous scrap supply, however, has produced significant, unanticipated economic consequen~ and health and safety risks to steel workers and the general public.

The SMA has been urging NRC for over the past six years to promulgate rules for tighter accountability and control over generally licensed sources. The SMA undertook this effort for the following reasons: (1) to reduce the costly impact of radioactive scrap on steel mills; (2) to protect worker health and safety; and (3) to protect the health and safety of the general public that may be unknowingly exposed to improperly discarded sources.

n. Statement of the Problem

• 1 A. General License Prowim Under NRC's current regulatory regime for control and accountability of licensed devices, 10 C.F .R ,§ 31, there is little economic incentive to discard generally licensed radioactive sources properly. The regulation provides a general license, automatically and without filing an application, to firms, institutions, and individuals, to acquire, receive, possess, use, or transfer radioactive sources designed and manufactured for detecting, measuring, gauging or controllingthickness, density, level, interface location, radiation, leakage, and chemical composition. The general license saves time for licensees and regulators because they do not have to spend the time and effort to complete and file license applications. Fi.1ial Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices, NUREG-1551, 10 (1996) (hereinafter "Working Group Report").*

This licensing regime renders it difficult for NRC to collect information directly from holders of certain radioactive sources. Consequently,NRC has insufficient control over generally licensed sources, and licensees have minimal accountability. The result is that sealed sources are often improperly discarded in shipment of ferrous scrap destined for steel mills, presenting major risks to human health and safety if inadvertently breached in a scrap shredder or melted in a steel making furnace.

B. Cost to the Steel Industn:

The steel industry has responded to the inadequate control of licensed devices by installing sophisticated detection systems to monitor all incoming shipments of scrap. Most SMA members have installed additional detectors at the charge bucket and baghouse to improve detection, While steel mills usually detect the sources, no system is completely effective in detecting sources buried in the middle of a truck load of scrap. If a steel mill inadvertently melts a radioactive source, it can incur $10 - 24 million dollars in unanticipated costs for decontamination, disposal of cootamioated materials, and lost production time. The cost can bankrupt a small or medium sized minimill.

United States Nuclear Regulatory Commission February 5, 1999 Page 3 SMA member companies have taken the initiative to keep radioactivity out of their mills, and have become the "second net" to catch improperly discarded sources that escape NRC's regulatory regime. Steel companies perform this function at considerable cost, as they must finance the purchase and installation of detection equipment, incur production delays, and pay for worker time and training in detection and handling of radioactive scrap.

The impact of radioactive somces is not only economic. The health and safety risks are evident from the several documented incidents that have occurred in the United States and worldwide where lost sources have been stolen by petty thieves, abandoned in shuttered factories, or hidden under fences and in private homes. There is clearly a public policy interest in holding gene!8.l licensees accountable for the sources they use.

C. Bi:tton

1. Licensing In enacting the Atomic Energy Act ("AEA") the United States Congress established a licensing regime to promote private sector technological developments for peacetime uses while protecting national security interests. 42 U.S.C. § 2011 et seq. SEN. REP. No. 1699, reprinted in 1954 U.S.C.C.A.N. 3456, 3472. Previously, the United States government was the exclusive owner and user of radioactive materials. The AEA allowed private persons, under license, to possess and use nuclear materials, for the first time. Id, at 3456-65. -

The Congress delegated to the forerunner of NRC, the Atomic Energy Agency, the responsibility of developing the licensing regime. 42 U.S.C. §§ 2111, 2134. It is unlikely that the Congress would have foreseen at that time the potential threat to human health and safety from the type of sources found in measuring gauges and hospital equipment, that are so common today. See SEN. REP. 1699 (1954), reprinted in 1954 U.S.C.C.A.N. 3456, 3456-65.

2. NRCDuty The AEA states that "the development, use, and control of atomic energy shall be directed so as to promote world peace, improve the general welfare, increase the standard of living, and strengthen free competition in private enterprise." 42 U.S.C. § 201 l(b). NRC has been aware of the lack of accountability and control in its general license program since 1983, when the first known inadvertent melting of a radioactive source in a steel mill occurred. It is clearly within NRC's authority to amend its licensing regime to minimi z.e the threat that radioactive sources pose to human health and safety, the environmental, and the economic viability of United States steel companies.

_. _Yet, NRC has not responded to the radioactive scrap problem by making even minimal substantive changes to its regulations to improve control and accountability over generally licensed sources.

United States Nuclear Regulatory Commission February 5, 1999 Page4

3. 1974 Proposal NRC proposed a registration program for generally licensed sources in 1974. See 39 Fed.

Reg. 43,531 (1974). NRC retracted that proposal shortly thereafter in response to comments opposing the program. Scrap-based EAF steel production was not a major component of the steel industry at that time, however, and the risks posed by sources in metals recycling industries were generally unknown. Sufficient time has elapsed in the last twenty-five years to warrant reconsideration of the proposal.

m. Summary of the Proposal On December 2, 1998, NRC again proposed to amend 10 C.F .R § 31.5 by requiring general licenses to respond to requests from NRC to provide information relating to their general licenses.

63 Fed. Reg. 66,492 (1998). In proposing this amendment, NRC intends to help ensure that generally licensed sources that pose the most threat to steel mills and the public are maintained and transferred properly. Id.

A. Scope of Survey NRC stated in the proposal that it would use its authority under the amended rule to survey approximately 6,000 general licensees, accounting for approximately 24,000 sources that pose the most threat to steel mills. NRC would base its selection of respondents on information that source distributors have reported to the agency. NRC estimates that the total nIDD:ber of general licensees is approximately 45,000 .

• B. Response Period Licensees that NRC contacts would be required to respond with the information within a thirty-day period. 63 Fed. Reg. at 66,495-96. The amendment would also allow general licensees to obtain an extensions to the thirty-day deadline, which NRC may grant at its discretion. Id.

C. Information Requested NRC plans to ask the 6,000 g~eral licensees to verify, correct, and add to the information in NRC's records regarding: (1) identification of the devices, including manufacturer, model and serial numbers; (2) persons responsible for compliance with the regulations; (3) disposition of the devices; and (4) location of the devices.

United States Nuclear Regulatory Commission February 5, 1999 Page 5 D. Enforcement NRC stated that it plans to establish an interim enforcementpolicy for violations of 10 C.F .R.

§ 31.5.

1. SeH-reportin,:

The enforcement policy would include a self-reporting component which would allow facilities that self report and correct deficiencies to do so without incurring any penalties.

2. Escalated Enforcement NRC's enforcement policy would include escalated enforcement action including civil penalties for significant violations, including failure to provide the information requested.

3. Penalty Increase The enforcement policy would increase the civil penalties for improper "disposal of sources to amounts significantly higher than the cost of proper disposal.

IV. SMA Comments on the Proposal A. The Administrative Burden on General Licensees is Reasonable Many SMA members are general licensees and could thus be subject to the proposed registration requirementthemselves. SMA members agree that the administrative burden on general licensees to provide the minimal information that NRC proposes to request is reasonable. The thirty-day period in which general licensees have to respond, with a extensions granted for good cause, is also reasonable. The SMA recommends that NRC provide the means for electronic reporting of -

information to save time, mailing expenses, and paper. NRC should also ensure that its database has an adequate data quality verification system and can easily flag inconsistencies.

B. The Proposed Amendment Would Not Explicitly Provide for an Annual Remtration Program The language of the proposal does not call for a periodic, e.g. annual or semi-annual, reporting requirement, which the SMA and the Working Group have been encouraging NRC to adopt. Rather, the proposed amendment would merely re-state NRC's authority to collect information from licensees. NRC already has this authorityunder42 U.S.C. § 2095, and in its own regulations, at 10 C.F.R. § 30.34.

United States Nuclear Regulatory Commission February 5, 1999 Page6 We urge NRC to explicitly call for a periodic registration program in the amended regulation.

A registration program requiring reporting on at least an annual frequency 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.

C. The Proposal Lacks Other Components Necessan for Accountability and Control The limited registration program that NRC proposes would have minimal impact on the radioactive scrap problem if it is the only amendment that the NRC proposes. NRC stated in the announcement that it will propose additional regulations amending or establishing requirements for registration fees, labeling, and compatibility with Agreement States requirements at a later date.

NRC is behind the schedule that the Commissioners established in their memorandum to the staff regarding rulemaking for additional amendments. See Staff Requirements Memorandum from AnnetteL. Vietti-Cook,ActingSecretary,NRC (April 13, 1998). The SMA urgestheNRCtomove forward with these additional rulemaking as expeditiously as possible.

Furthermore, the Working Group Report recommended far more comprehensive measures, including a requirement for maintenance of inventory records, comparison and reconciliation of discrepancies, mandatory reporting to NRC in the event of bankruptcy, and physical inventories and inspections at intervals not to exceed twelve months. It is imperative that NRC give more serious consideration to all of these measures. Otherwise, sources will continue to be lost and find their way into the scrap stream.

D. The Reptration Program Should Be More Inclusive The SMA strongly encourages NRC to adopt a mandatory registration program for all sources, not merely those which present the most risk to steel mills. A fee-based system for all general licensees would ensure that NRC recovers the minimal cost to initiate and maintain the reporting program. Such a registration program would enable NRC to account for all sources that have been distributed. The program could be designed to allow steel companies and the general public to trace the origins of an improperly disposed sources. This would help steel companies in determining liability for the multi-million dollar clean-up costs the steel companies and their insurers incur when sources are inadvertently melted. It would provide federal and state nuclear regulators that handle orphan sources a means to obtain reimbursement. The end result would be an additional deterrent against improper source disposition.

United States Nuclear Regulatory Commission February 5, 1999 Page 7 E. The Proposal Does Not Address the Cost Shift The current regulatory regime has shifted the costs of lax accountability and control onto steel makers, insurers, and the taxpayers. Currently, general licensees do not pay for their licenses nor provide information directly to NRC about the sources they hold. The cost has instead fallen on steel producers to detect the sources, on the steel producers and taxpayers to arrange for proper disposal, and on steel producers and their insurers to pay the cost when a source is inadvertently melted. General licensees should be required to shoulder their fair share.

F. Accountability Must Be Upstream Rather than Downstream NRC must impose requirements at the origin of the radioactive scrap problem, where it is most easily and efficiently addressed. General licensees are in the best position to control the disposition of their sources. Better licensee accountability would reduce the risk from the transit of improperly disposed sources and minimiz:e the economic impact of sources released into the scrap supply. Requiring all general licensees to complete a simple form requesting the information that NRC would request in its current proposal, and to update it on an annual basis, imposes a reasonable burden on licensees that is preferable to the risk of radioactive source incidents at steel mills.

G.

• The SMA Supports the Proposed Interim Enforcement Policy The SMA would support any enforcement program that deters improper disposal of radioactive sources. The SMA believes that, in the past, source holders who violated their general licenses were fined amounts significantly less than the cost of proper disposal. Increasing minima)*

penalty levels to amounts significantly higher than the cost of proper disposal will provide general licensees with a new and real incentive to dispose of sources properly. The SMA also endorses the provision allowing general licensees to report and correct violations without incurring penalties.

This provision would encourage licensees who are not sure about what sources they hold to remedy the problem, rather than improperly dispose of their sources in an attempt to avoid high penalties.

V. Conclusion The SMA supports the NRC proposal but emphasizes that NRC has the authority to accomplish much more through the rulemaking process towards mitigating the risk of radioactive sources in the scrap supply. NRC's past inaction and its current proposal for a limited registration program demonstrate that the agency is not adequately fulfilling its mandate under the AEA.

Accordingly, we encourage NRC to implement a more comprehensive registration program. If, however, NRC determines that it must choose between further inaction and the current proposal, we support the current proposal, and urge the agency to propose the additional measures necessary for an effective accountability and control of radioactive sources as soon as possible.

United States Nuclear Regulatory Commission February 5, 1999 Page 8 Please do not hesitate to call us if you have any questions.

~~J Thomas/\. Danjczek cc. Hon. Shirley Ann Jackson, Chairman, NRC Hon. Greta Joy Dicus, Commissioner, NRC Hon. Nils J. Diaz, Commissioner, NRC Hon. Edward McGaffigan, Jr., Commissioner, NRC Hon. Jeffrey S. Merrifield, Commissioner, NRC Joel Lubenau, NRC Simon Friedrich, Office of Industrial Technologies, Department of Energy Peter Hernandez, American Iron & Steel Institute

STEEL MANUFACTURERS ASSOCIATION 49 MEMBER COMPANIES Tel: (202) 296-1615 Fax: (2021 296-2606 A.B. Steel MIii, Inc. Cincinnati, Ohio AmerlSteel Tampa, Florida Arkansas Steel Associates Newport, Arkansas Auburn Steel Company, Inc. Aubum, New York Bayou Steel Corporation LaPlace, Louisiana Beta Steel Corporation Portage, Indiana Bethlehem Lukens Plate Coatesville, Pennsylvania Birmingham Steel Corporation Blnnlngham, Alabama Border Steel, Inc. B Paso, Texas Calumet Steel Company Chicago Heights, Illinois Cascade Steel Rolling MIils, Inc. McMinnville, Oregon Charter Manufacturing Company, Inc. Mequon, Wisconsin Chicago Heights Steel Chicago Heights, Illinois CltlSteel USA Inc. Claymont, Delaware Commercial Metals Steel Group Seguin, Texas Connecticut Steel Corporation Walllngford, Connecticut CSC, Ltd. Warren, Ohio FirstMiss Steel, Inc. Hollsopple, Pennsylvania Gallatin Steel Ghent, Kentucky Geneva Steel Corporation Provo, Utah GS Industries Charlotte, North Carolina lspet Inland Bar Products East Chicago, Indiana IPSCO Steel Inc. Muscatine, Iowa J & L Structural, Inc. Aliquippa, Pennsylvania Jersey Shore Steel Company Jersey Shore, Pennsylvania Kentucky Electric Steel, Inc. Ashland, Kentucky Keystone Steel and Wire Company Peoria, IDinols Koppel Steel Corporation Beaver Falls, Pennsylvania Laclede Steel Company St. Louis, Missouri Lone Star Steel Company Lone Star, Texas Merion Steel Company Marion, Ohio McDonald Steel Corporation McDonald, Ohio North Star Steel Company Minneapolis, Minnesota North Star BHP Steel, Ltd. Delta, Ohio Northwestern Steel and Wire Company Sterling, Illinois Nucor Corporation Charlotte, North Caroline Oregon Steel MIiis, Inc. Portland, Oregon Pennsylvania Steel Technologles Steelton, Pennsylvania Qualitech Pittsboro, Indiana Republic Engineered Steel, lnc./Bar Technologies Inc. Massillon, Ohio Roanoke Bectrlc Steel Corporation Roanoke, Virginia Sheffield Steel Corporation Send Springs, Oklahoma Steel Dynamics, Inc. Butler, Indiana TXI IChaparral Steel} Midlothian, Texas TAMCO Rancho Cucamonga, Calrfomla Tuscaloosa Steel Corporation Tuscaloosa, Alabama USS/KOBE Steel Company Lorain, Ohio W. Silver, Inc. El Paso, Texas Wheeling-Pittsburgh Steel Corporation Wheeling, West Virginia 1750 Rhode Island Avenue, N.W., sutte 907 2/5/98 Washington, D.C. 20038-5101

0 DEPARTMEN ~

1035 OUTER 2 -

George H. Ryan Thomas W. Ortciger 0,

• r' Governor Director rl;__

ADJ/ I_.

, I January 20, 1999 D KE i\lUIVll:JEH Secretary, U.S. Nuclear Regulatory Commission PROPOSED RULE ~ 31 Washington, D.C. 20555-0001 ( r,.3 FR t,t,,c/9 i)

Attn: Rulemakings and Adjudications Staff Re: Proposed Rule, "Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information" (RIN 3150 -

AG06)

Sir or Madam:

The Illinois Department of Nuclear Safety hereby submits the following comment on the above-identified proposed rule. The Department agrees with NRC that the proposed change would increase accountability and control over generally licensed radioactive devices.

When contacting general licensees for the purposes of registration as described at 63 FR 66493, we recommend that NRC contact licensees possessing not only americium-241, but also curium-244. There is a group of general licensees in Illinois that possesses devices containing curium-244 in quantities that would require registration under the proposed rule. The statement at 63 FR 66493 is in error by declaring that americium-241 is the only transuranic radionuclide found in generally licensed devices in quantities exceeding 37 megabecquerels (1 millicurie).

Thank you for the opportunity to comment on this proposed rule. If you have questions, please contact Joe Klinger at 217-785-9930.

Thomas W. Ortc1ge Director cc: James Lynch, State Agreements Officer Ff B 4 1999

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'99 JAN 20 P2 :13 PO Box 217 Keewatin MN 55753--0217 (218) 778-8700 Phone OF: (218) 778-6112 Fax DOCKET NUMBER January 15, 1999 PROPOSED RULE PB 3 /

( l,3FRt,,i,'{t;;i.J Secrctur; U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff RE: Written Comments on the December 2, 1998 Proposed Rulemaking:

Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information

Dear Sir/Madam:

Enclosed please find the original comments of the National Steel Pellet Company on the proposed

• amendment adding a requirement that general licensees who possess certain devices containing byproduct material provide the U.S. Nuclear Regulatory Commission with information concerning these devices. This proposal,was published at 63 Fed. Reg. 66492 on December 2, 1998.

Sincerely, r-1~~1q~ .. <.

John M. Given, Radiation Safety Officer and Manager - Electrical Systems and Millltetiance Enclosure JAM 2 1 1999

\cknowledged by caro * ... .... _

U.S. NUCLEAR REGULATORY COMMlSSION AULEMAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY Of THE OCUMSSJON DoclnemSl!allllta PostRlalk Data , /; 5 / 9 'I Copiel Rallatnd _ _ _1____ __

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Secretary, U.S. Nuclear Regulatory Commission January 15, 1999 Page2 cc: LaTisha R. Ulrich (w/enclosure)

John K. Heintz (w/enclosure)

John J. Moran, Jr., Esquire Chester R. Babst III, Esquire

Comments of the NATIONAL STEEL PELLET COMPANY on the U.S. Nuclear Regulatory Commission's Proposed Rulemaking:

REQUIREMENTS FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE REQUESTED INFORMATION

• 63 Fed. Reg. 66492, December 2, 1998 Submitted on January 15, 1999 via First Class U.S. Mail

COMMENTS OF THE NATIONAL STEEL PELLET COMPANY ON THE PROPOSED RULEMAKING REGARDING REQUIREMENTS FOR THOSE WHO POSSESS CERTAIN INDUSTRIAL DEVICES CONTAINING BYPRODUCT MATERIAL TO PROVIDE REQUESTED INFORMATION I. INTRODUCTION National Steel Pellet Company ("NSPC"), a subsidiary of National Steel Corporation, operates a 5.3 million long ton per year iron ore pellet production facility in Keewatin, Minnesota. NSPC's manufacturing activities involve the use of byproduct material covered by an U.S. Nuclear Regulatory Commission (NRC") general license. If promulgated as proposed at 63 Fed. Reg. 66492 on December 2, 1998 (hereinafter referred to as the "Proposed Rulemaking"), the information request provision would directly impact NSPC. Accordingly, NSPC thanks the NRC for this opportunity to submit comments and requests that the NRC take these comments into account prior to finalizing the Proposed

• Rulemaking.

II. SPECIFIC COMMENTS NSPC does not oppose the regulatory language proposed at 10 C.F.R. § 3 l.5(c)(l 1). However, NSPC is concerned with the NRC's selected methodology for initially targeting licensees for registration. As discussed in the preamble language at 63 Fed. Re~. at 66493, 1st col. :

Initially, the NRC will use the criteria developed by the working group to determine which devices should be registered

• The working group's criteria was provided at 63 Fed. Re~. at 66493, 3rd col. :

Requests for information would be sent to general licensees who are expected, based on current NRC records, to possess devices containing at least 370MBq (]0mCi) ofcesium-137, 3. 7 MBq (0.1 mCi) ofstrontium-90, 37 MBq (1 mCi) ofcobalt-60, or 37 MBq (1 mCi) of any transuranic (at this time, the only generally licensed devices meeting this criterion contain americium-241). The majority 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.

NSPC believes that NRC's resources would be more appropriately spent by targeting general licensees that do not currently maintain byproduct material under a specific NRC license. Specifically, Page 1

NSPC believes that because businesses with device-specific licenses are required to have a Radiation Safety Officer(s) and actively perform specific testing and inspections, as well as maintain written documentation, these businesses are almost always aware of the byproduct material regulations applicable to byproduct material managed under a general license and are more likely to adequately account for and handle devices containing byproduct material in accordance with the regulatory requirements. In contrast, NSPC believes that businesses without specific licenses* are more likely to be unaware of the appropriate regulations and are more likely to inappropriately account for and handle devices containing byproduct material.

In addition, NSPC is concerned that the information obtained through the registration process will be readily available to the public through posting on the internet. Although NSPC does not oppose making the registration information available through the Freedom of Information request process, due to" ... the relatively small radiation exposure risk posed by these devices ..."(~ 63 Fed. Re~. 66492, 3n1 col.), NSPC does oppose posting this information on the internet. NSPC believes that such posting will unnecessarily cause public concern over the presence and use of these low level radiation devices.

III. CONCLUSION Again, NSPC thanks the NRC for this opportunity to submit written comments on the Proposed Rulemaking. Consistent with these comments, NSPC recommends that the NRC reconsider its planned approach for deciding which general licensees should be selected for participation in the contemplated registration process. Further, NSPC requests that the registration information not be placed on the internet. Such information should only be available through a Freedom of Information request process .

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'98 NOV 27 P2 :38 NUCLEAR REGULATORY COMMISSION 10 CFR Part 31 OFH.

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ADJUCI.

RIN 3150 -AG06 Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information

• AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) proposes 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 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 proposed rule is intended to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded.

DATES: Submit comments by ( l a s e ! = . ,:,p1 ~~:!an date) . Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.

ADDRESSES: Send comments by mail to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications Staff.

Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4: 15 pm on Federal workdays.

You may also provide comments via the NRC's interactive rulemaking website through the NRG home page (http://www.nrc.gov). This site provides the availability to upload comments as files (any fomiat), if your web browser supports that function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher (301) 415-5905; e-mail CAG@nrc.gov.

Certain documents related to this rulemaking, including comments received and the regulatory analysis, may be examined at the NRG Public Document Room, 2120 L Street NW.

(Lower Levet), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRG for this rulem&king.

FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001,

• 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.

2

SUPPLEMENTARY INFORMATION:

Background

On February 12, 1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a general license for the use of byproduct material contained in certain measuring, gauging, or controlling devices (10 CFR 30.21 (c)). Under current regulations (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 authorizing 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 general licensee must comply with requirements for labeling, instructions for use, and proper storage or disposition of 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 contained in or referenced on the label of the device and must have the testing or servicing of the device performed by an i,ndividual 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 3

general license is meant to simplify the licensing process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary.

There are about 45,000 general licensees under 10 CFR 31.5 who possess about 600,000 devices that contain byproduct material. In the past, the NRC has not contacted general licensees on a regular basis because of the relatively small radiation exposure risk posed by these devices and the very large number of general licensees.

However, there have been a number of 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.

For example, 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.

Because of these incidents, the NRC conducted a 3-year sampling (1984 through 1986) of general licensees to assess the effectiveness of the general license program and to determine whether there was an accounting problem with generally licensed device users and, if so, what action could be taken. The sampling revealed several areas of concern regarding the use of radioactive material under the general license provisions of 10 CFR 31.5. The NRC concluded that - (1) Many general licensees are not aware of the appropriate regulations, and (2) Generally licensed devices are inadequately handled and accounted for.

Approximately 15 percent of all general licensees 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 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 4

contained a number of provisions, including a requirement for general licensees 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 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 1996 and published in October 1996 as NUREG-1551, "Final Report of the NRG-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."

• In considering these recommendations, the NRC has decided, among other things, to initiate 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 has 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 is lost. Initially, the NRC will use the criteria developed by the working group to determine which devices should be registered.

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This proposed rule presents the proposed addition of an explicit requirement to provide information in response to requests made by the NRC for a second round of comment. While the proposed rule would apply 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.

The NRC is withdrawing the December 27, 1991, proposed rule. The NRC plans to review the other provisions contained in the December 27, 1991, proposed rule and the recommendations of the working group and develop additional requirements in a separate rulemaking.

Discussion 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 has not included such an explicit provision in the regulations governing 10 CFR 31.5 general licensees. Although 10 CFR 2.204, 30.34(e), and 30.61 (a) require information from licensees by order or demand, these provisions are not considered appropriate for the initiation of a routine registration program. In a previous rulemaking, the Commission (then AEC) had proposed the inclusion of a registration requirement for generally licensed

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devices before receipt of devices (February 5, 1974; 39 FR 4583). In response'to comment on that proposal, the Commission decided not to institute a registration requirement as part of the final rulemaking on that action (December 16, 1974; 39 FR 43531). Given this history, establishing a device registration program without a rulemaking process is also considered inappropriate.

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This proposed rule would add an explicit requirement to 10 CFR 31.5 that would require general licensees to respond to written requests from the NRC for information concerning products that they have received for use under a general license in a timely way.

The proposed rule.would require 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 is specifically soliciting comments on this time period. Also, a phone number will be provided 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 general licensees are aware of and understand the requirements for the possession of devices containing byproduct material. The registration process would allow NRC to account for devices that have been distributed for use under the general license. The NRC believes that if general licensees are aware of their responsibilities they would comply with the requirements for proper handling and disposal of generally licensed devices. This would help reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property.

The general licensees covered by the registration program would be asked to account for the devices in their possession and to verify, as well as certify, information concerning:

1. The identification of devices, such as the manufacturer, model and serial numbers;

2. The persons responsible for compliance with the regulations; 7

3. The disposition of the devices; and

4. The location of the devices.

While the proposed rule would apply to all 10 CFR 31.5 general licensees (about 45,000), the NRC would only contact, for purposes of registration, approximately 6000 general licensees, possessing about 24,000 devices. This estimate is based on the criteria recommended by the working group for determining which sources should have increased oversight. Requests for information would be sent to general licensees who are expected, based on current NRC records, to possess devices containing 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 37 MBq (1 mCi) of any transuranic (at this time, the only generally licensed devices meeting this criterion contain americium-241 ). The majority 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 will include 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 provided to NRC by distributors under 10 CFR 32.52(a) and from general licensees as required by 10 CFR 31.5(c)(8) or (9). If a general licensee no longer possesses devices meeting the criteria, it would be expected to provide information about the disposition of the devices previously possessed. Errors 1n current NRC records concerning these general licensees 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 6000 general licensees identified for registration, the NRC may occasionally request information from other general licensees on a case-by-case basis as 8

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 proposed amendment would impose 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 proposed 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.

The NRC is currently considering additional rulemaking concerning the control and accountability of devices generally licensed under 10 CFR 31.5. The recommendations made in NUREG-1551 will be considered at that time. That anticipated rule would address fees for registration, additional labeling requirements for 10 CFR 32.51 licensees, and compatibility of Agreement State regulations in this area. Public comments on this current proposed rule should only address the requirements proposed in this action. Comments concerning possible future rulemaking and the possible imposition of fees will not be addressed in any rule resulting from this proposed action.

Public Comments on the Original Proposed Rule The NRC reviewed the comments received on the December 27, 1991, proposed rule.

There were 26 comment letters received from a variety of sources including private and publicly 9

held corporations, private citizens, citizens groups, the Armed Forces, and State governments.

These comments have been considered to the extent applicable to this more limited proposed rule and will be considered in the development of a subsequent rulemaking concerning the accountability of devices generally licensed under 10 CFR 31.5. A detailed-analysis of the comments received on the December 27, 1991, proposed rule will not be presented in either action as many of the specific comments pertain to specific provisions that have been withdrawn, much time has passed since these comments were made, and additional opportunity for comment is being provided.

Comments received on the December 27, 1991, proposed rule demonstrated that there was considerable opposition to the rule as proposed, some of it specifically concerning a registration requirement. Most of this opposition was related to the breadth of the proposal which would have made the registration program applicable to all of the 10 CFR 31.5 general licensees, accounting for as many as 600,000 devices. Some respondents questioned whether this was justified or cost effective. Some thought the impacts were underestimated, particularly for general licensees possessing many devices, and that the provision would have serious impacts on certain industries. Registration was specifically opposed for devices used by the airline industry, self-luminous signs, static eliminators, and some other devices which present relatively low risks.

The NRC found the 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 property. Therefore, the registration of devices under this proposed rulemaking would be limited to those devices meeting the criteria recommended by the working group. For the most part, general licensees using devices meeting these criteria have a limited number of devices that would require registration. The NRC is exploring IO

approaches to minimize the administrative effort for both general licensees and the NRC in implemE:,nting this requirement.

This proposal includes a provision to request an extension to the time interval to provide a complete response to requests for information, if the general licensee is having difficulty in meeting the time limit. This provision was included in response to comments on the December 27, 1991, proposed rule. Although this difficulty is much less likely to arise within the limited population of general licensees covered by the current proposal, the Commission believes that the additional flexibility is desirable.

Interim Enforcement Policy As had been planned at the time of the 1991 proposed rule, the Commission. intends to establish an interim enforcement policy for violations of 10 CFR 31.5 that licensees discover and report during the initial cycle of the registration program. This policy will supplement the normal NRC Enforcement Policy in NUREG-1600, Rev. 1. It will be issued in the near future and will remain in effect through one complete cycle of the registration program.

Under the current NRC Enforcement Policy, significant violations, such as those l

involving lost sources, may result in escalated enforcement action including civil penalties. The interim policy would provide that enforcement action normally would not be taken for violations identified by a licensee and reported to the NRC if appropriate corrective action is taken. For the period that the interim policy is in effect, it would a_lso apply to general licensees not subject to the registration requirement if they identify and report violations and take appropriate corrective action. This change from the current NRC Enforcement Policy is intended to remove any disincentive to identify deficiencies that might be caused by a concern over potential 11

enforcement action. This action would encourage general licensees to search their facilities to ensure sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective action when deficiencies are found. A Notice of Violation (NOV) without a civil penalty still may be issued if the NRG staff believes that taking this action is justified by the safety significance of the violation or the need to record and document the general licensee's corrective action in the formal manner required in a response to an NOV.

In addition, escalated enforcement action still will be considered for violations involving failure to provide the information requested, failure to take appropriate corrective action, or for willful violations including the submittal of false information. Sanctions in those situations may include significant civil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a general license.

The Commission also intends to increase the civil penalty amounts specified in its current Enforcement Policy in NUREG-1600, Rev. 1, for violations involving lost or improperly disposed sources or devices. This is to ensure that such civil penalties are significantly higher than the costs avoided by the failure to properly dispose of the source or device.

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 proposed 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 include provisions that will require a higher degree of 12

compatibility. This will be considered in a subsequent rulemaking to add more explicit requirements for the registration program and additional provisions concerning accountability of generally licensed devices.

Environmental Impact: Categorical Exclusion The NRC has determined that this proposed rule is the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this regulation.

Paperwork Reduction Act Statement This proposed rule amends information

. collection requirements that are subject to the Paperwork Reduction Act of 1995 {44 U.S.C. 3501 et seq). This rule has been submitted to the Office of Management and Budget for review and approval of the information collection requirements.

The public reporting burden for this informati~m collection is estimated to average 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 information collection. The U.S. Nuclear Regulatory Commission is seeking public comment on the potential impact of the information collections contained in the proposed rule and on the following issues:

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1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?

2. Is the estimate of burden accurate?

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the information collection be minimized, including the use of automated collection techniques?

Send comments on any aspect of this proposed information collection, including suggestions for reducing the burden, to the Records Management Branch (T-6 F33), 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.

Comments to 0MB on the information collections or on the above issue$ should be submitted by (insert date 30 days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date.

Public Protection Notification If an information collection does not display a currently valid 0MB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

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Regulatory Analysis The NRC has prepared a draft regulatory analysis for this proposed regulation. The analysis examines the cost and benefrts of the alternatives considered by the NRC. The comments received on the earlier draft regulatory analysis have been considered to the extent that they apply to this more limited action. 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 As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. This proposed rule would require general licensees who have received specific devices to respond to requests for information from NRC. The proposed rule would apply to the approximately 45,000 persons using products under an NRC general license, many of whom may be classrfied as small entities. However, the NRC intends to request registration information from only approximately 6000 of these general licensees about the identification of the devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the devices. The NRC believes that the economic impact of the proposed requirements on any general licensee would be a negligible increase in administrative burden. The proposed rule is intended to ensure that general 15

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 proposed rule and, therefore, a backfit analysis is not required because these amendments would not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).

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.

For the reasons set out in the preamble 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.

553, the NRC is proposing to adopt the following amendments to 10 CFR Part 31.

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PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

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.

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:

10 CFR 31.5 Certain measuring, gaugl'ng, or controlling devices. 2 (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 general licensee cannot provide the 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 2

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.

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Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 and provide written justification as to why it cannot comply.

Dated at Rockville, Maryland, this ~ a y of j)pvcm b efi 1998.

For the Nuclear Regulatory Commission.

&~£.£-

Malcolm R. Knapp * ;pY Acting Executive Director for Operations.

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