ML20055C246
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l APR 6Ime 37 Note to: Richard E. Cunningham, Director, Division of Industrial and Medical. NMSS R. Lee Spessard, Director, Division of Operational Assessment.
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Frank Congel, Director, Division of Radiation Protection and i
Emergency Preparedness, NRR Stewart A. Treby, Assistant General Counsel for Rulemaking, j
OGC James Lieberman, Director, Office of Enforcement OE From:
Zoltan R. Rosztoczy, Deputy Director, Division of Regulatory Applications. Office of Nuclear Regulatory Research
SUBJECT:
REVISIOh ?0.403 (NOTIFICATION OF INCIDENTS).
On April 17, 1989 we met as a group to discuss a draft Federal Register notice dealing with clarification of the provisions of 20.403 (Notification of Incidents). At this meeting a number of significant suggestions were made that not only improved clarification of the proposed rule, but also changed it's structure.
Based on the input provided, a revised draft of 20.403 has been prepared.
I would appreciate your review of the attached draft and any additional changes you would like to make.
Please send your marked up draft or concurrence to i
Joe Mate, mail stop NL/S Room 129.
I would appreciate receiving your coments by May 5, 1989.
If you have any questions regarding the attached, please call me at 23760.
Distribution:
[2RR NOTE PART 20?
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Offe Namet J ate:cb TDG31o Rosz czy Date: 4/M/89 4/M/89 4/97/89 0FFICIAL RECORD COPY
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ENCLOSURE 1 l
FEDERAL REGISTER NOTICE i
0F PROPOSED RULEMAKING i
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1 Approved For Publication The Comission delegated to the E00 (10 CFR 1.31(a)(3)) the authority to develop and promulgate rules as defined in the APA (5 U.S.C. 551 (4)) subject i
to the limitations in NRC Manual Chapter 0103, Organfration and Functions, i
Office of the Executive Director for Operations, paragraphs 0213. 038, i
and 0310.
The enclosed rule, entitled Notification of Incidents will amend 10 CFR 20.403. These amendments are needed to ensure that significant incidents are promptly reported to NRC so that the agency can evaluate whether feediate action is required to protect the public health and safety.
This proposed rule does not constitute a signific6. t question of policy, nor does it amend regulations contained in 10 CFR hrts 7, 8 or 9 Subpart C concerning matters of policy.
I, therefore, find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
Date YIctor 5tello. Jr.
Executive Director for Operations i
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[7590-01' 1
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NUCLEAR REGULATORY COMISSION 10 CFR Part 20 Notification Of Incidents
. AGENCY: Nuclear Regulatory Comission.
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Comission proposes to amend its regulations to clarify licensee reporting reoutrements regarding the Notification of Non-Reactor Incidents relating to radiation safety. This action is needed to ensure that significant occurrences are promptly reported to NRC so that NRC can evaluate whether imediate action is required to protect the public health and safety.
DATE: The comment period expires
. Coments received after this date will be considered if it is practical to do so, but the Comission is able to ensure consideration only for coments received on or l
before this date.
l ADDRESSES: Mail written comments to Secretary, U.S. Nuclear Regulatory Comissfon Washington, DC 20555, Attention: Docketing Service Branch.
Deliver comments to One White Flint North,11555 Rockville Pike, Rockville, PD, between 7:30 a.m. and 4:15 p.m. on weekdays. Copies of the regulatory analysis, as well as copies of the coments received on the proposed rule, may be examined at the NRC Public Document Room, 2120 L Street NW, Pashington, DC.
FOR FURTHER INFORMATION CONTACT: Joseph J. Mate, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555, telephone (301) 492-3795.
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SUPPLEMENTARY INFORMATION:
Background
Regulations in 10 CFR 20.403 (Notification of Incidents) require that NRC licensees report certain events involving byproduct, source, or special nuclear material that cause or threaten to cause:
the exposure of the whole body to specific levels of radiation, the release of radioactive material in specific concentrations, the loss of use of facilities, or damage to property in excess of a specific dollar amount.
The events are to be reported either imediately or within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> depending on the nature and severity of the event as defined in i 20.403. NRC has become concerned that certain provisions of 6'20.403 need to be clarified because licensees have not been reporting certain signif' cant j
events.
l In one case, a fire destroyed a licensee's building that contained the l
licensee's moisture density gauge.
Damage caused by the fire rendered the gauge unusable, although no radioactive material was released. NRC was not notified of the fire.
NUREG 1198 reports lessons learned from another case where rupture of a
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UF cylinder caused the death of one individual and injured several others.
6 The investigation revealed a prior event at another licensee's site where, under similar circumstances, a cylinder bulged but did not rupture. NRC had not been notified of the prior event. The lessons learned report recommended l
that requirements for reporting events should be reviewed to ensure that all potentially significant events are reported to NRC.
It is important that such events be rept,rted promptly 50 that NRC can evaluate whether prompt action is required to protect the public health and safety.
Discussion The existing reporting requirements in 10 CFR 20.403 are fairly general.
More specific requirements are appropriate to reduce misconceptions by licensees about the types of events that should be reported. The NRC staff has examined the provisions of 9 20.403 and decided that amendments are appropriate 2
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(1) better describe reportable events having significant implications for public health and safety and (2) define "immediate notification." In final fom, this revision will also amend the major revision to Part 20 currently under consideration by the Comission.
The requirements in paragraphs 20.403 (a)(3), (a)(4), (b)(3), and (b)(4) dealing with notification of loss of operation and damage to property are being deleted and separate amendments are being added.
This action is being taken because the staff believes that these amendments more clearly reflect the needs of the NRC to capture valuable safety related data from materials licensee activities. Similar reporting requirements for reactors are already contained in 10 CFR Part 50. The Comission specifically requests comments on the appropriateness of these amendments.
In order to more accurately assess the impact of this proposed rulemaking, the Commission also requests specific comments on the number of reports that licensees expect might be generated yeariy.
Because material licensees are usually not required to monitor operations as closely as do Part 50 licensees, a period of four hours from the discovery of the event has been used to define imediate notification.
NRC places the primary responsibility on the licensee for controlling and using licensed material safely.
Therefore, it is important that NRC receive reports of events or conditions that threaten the health and safety of individuals using licensed material or that prevent the performance of surveys or other safety related duties necessary to maintain control of licensed material. A reporting requirement for these types of safety related events has been specifically included to clarify that such events must be reported.
The bulging of a filled uranium hexafluoride cylinder may cause minimal damage and no injury, but if it threatens a release of licensed material that could injure individuals in the area and prevent response actions necessary to control the material, NRC must be aware of such occurrences so that it can take approppriate action.
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The requirement for licensees to report events where access to an area must be restricted for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> because of contamination is being clarified. This requirement is intended to capture an event which causes accidental contamination to an area which is in excess of the radiological conditions normally present. Accidental contamination events increase radiation exposure and the risk of ingesting radioactive material.
If contamination is not cleaned up in a timely manner, personnel entering the area at a later date may receive unnecessary radiation exposure and risk spreading the contamination to themselves and outside the area.
It is important that NRC receive notification of such events because NRC action may be necessary to ensure that decontamination and cleanup activities are performed in a timely manner.
This requirement is applicable to both the contamination of unrestricted areas where a restriction is imposed, and to occupational areas where additional restrictions are imposed.
For example, a radioactive waste container storage area is nonnally locked and restricted. But a spill contaminating the floor that is not cleaned up immediately would require workers to wear additional anti-contamination clothing and increase the risk of further spreading the contamination during future operations in the area. This l
type of situation would be reportable ur. der the clarified regulation.
l The reporting requirement requiring licensees to report events that prevent or could prevent structures or systems needed to control releases, minimize radiation exposures, or mitigate the consequences of an accident from functioning properly is also being clarified.
Such events must be evaluated to determine where changes and improvements are required.
If the interlock on a shielded irradiator chamber door malfunctions, the door could be opened when a source containing several thousand curies is exposed, resulting in a large radiation dose in a very short time.
NRC action may be necessary to warn other licensees of generic safety problems and to specify additional controls to protect occupational workers and the public.
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The requirement f6e licensees to report events that require medical treatment of a radinctively contaminated individual at a medical facility is being clarified. Such events are highly significant because they:
- 1) indicate safety problems in a Itcensed operation, 2) risk internal contamination through open wounds, and, 3) expose medical personnel to radiation and contamination.
An evaluation must be performed to determine how to prevent any recurrence.
The requirement was worded to avoid any reference to transporting the individual to ensure that events of this type occurring in medical facilities where no transportation is required are not excluded.
To avoid numerous reports of insignificant events such as a medical technician puncturing a hand with a syringe containing a radiopharmaceutical, a note is added to clarify that a notification is not required if first aid for a superficial injury is the only treatment rendered.
Impact The impact of the proposed regulations cannot be precisely determined at this time.
It is anticipated, towever, that the impact on the licensee in general will be minimal since the proposed changes are considered to be primarily of a clarifying nature.
The proposed changes clarify what NRC considers to be information having significant implication for public health and safety reortable under existing regulations including i 30.9(b), 6 40.9(b),
and 6 70.9(b).
l Environmental Impact:
Categorical Exclusion The NRC has detemined that the proposed regulations are the type of action described in the categorical exclusion 10 CFR 51.22 (c)(3)(iii).
Therefore neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
Paper Redrction Act Statement The proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the papert;ork requirements.
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l Public reporting burden for this collection of information is estimated to average two hours per response, including the time for reviewing instructions, searching existing date sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send coments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Records and Reports Management Branch, Division of Information Support Services /IRM, Office of Administration and Resources Management, U.S. Nuclear Regulatory Comission, Washington, DC 20555; and to the Office Of Management and Budget, Paperwork Reduction Project (3150-0014), Washington, DC 20503.
Regulatory Analysis The Comission has prepared a draft regulatory analysis on this proposed regulation.
The analysis examines the costs and benefits of the alternatives considered by the Comission. The draft analysis is available for inspection in the NRC Public Document Room, 2120 L Street NW., Washington, DC.
Single
- copies of the draft analysis may be obtained from Joseph J. Mate, telephone (301-492-3795).
The Comission requests public coment on the draft regulatory analysis.
Comments on the draft analysis may be submitted to the NRC as indicated under the ADDRESSES heading.
Regulatory Flexibility Certification Based upon the information available at this stage of the rulemaking proceeding and in accordance with the Regulatory Flexibility Act, 5 U.S.C.
605(b), the Comission certifies that, if promulgated, this rule will not have a significant economic impact upon a substantial number of small entities.
The proposed rule affects approximately 9,100 licenses monitored by NRC under 10 CFR Parts 30, 40, and 70. The licenses are issued to academic institutions, medical institutions, and industrial entities.
The requirements epecified in this rulemaking are primarily a clarification and redefinition of the requirements currently contained.in 10 CFR Part 20.
No reporting is required 6
by Itcensees unless they have an incident involving licensed material that meets the requirements specified in the proposed amendments. Since the revised reporting requirements are essentially the same as the current reporting requirements, the impact on licensees should,be minimal at best.
Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this proposed rule and therefore that a backfit analysis is not required because these proposed amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109 (a)(1).
Y9 List of Subjects in 10 CFR Part 20 10 CFR PART 20:
Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Penalty, Radiation protection, Reporting and recordkeeping requirements.
Special nuclear material, Source material, and Waste treatment and disposal.
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 20.
PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION.
1.
The authority citation for Part 20 continues to read as follows:
AUTHORITY: Secs. 53, 63, 65, 81, 103, 104, 161, 68 Stat. 930, 933, 935, 936, 937, 948, as amended (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201);
secs, 201, as amended, 202, 206, 88 Stat.1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
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r Section 20.408 also issued under secs. 135, 141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273); il 20.101, 20.102, 20.103(a), (b), and (f), 20.104(a) and (b), 20.105(b), 20.106(a), 20.201, 20.202(a), 20.205, 20.207, 20.301, 20.303, 20.304, and 20.305 are issued under sec.161b, 68 Stat. 940, as amended (42 U.S.C. 2201 (b)); and il 20.102,20.103(e),20.401-20.407,20.408(b),and 20.409 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C.
2201(o)).
2.
In i 20.403 the introductory text of paragraph (a) is revised and paragraphs (a)(3), (a)(4), (b)(3), and (b)(4) are removed, and new an,.1dments are being added, i 20.403 Notification of Incidents.
(a)
Immediate notification.
Each licensee shall notify the NRC within four hours after discovery of any of the following events involving licensed material:
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(3) Any event or condition that poses a threat to the health and safety of L
personnel using licensed material or that prevents the performance of duties or safety systems necessary to maintain and verify control of licensed material (includes fires, toxic gas releases, radioactive releases, etc.).
(b) Twenty-four hour notification.
Each licensee shall notify the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the discovery of any of the following events involving licensed material:
(3) Any contamination event that results in restriction of access to the contaminated area by workers or the public for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
(4) Any event that prevented or could have prevented the fulfillment of the safety function of structures or systems needed to control releases of radio-active material, to prevent exposure to radiation, or to mitigate the ense-quences of an accident.
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(5) Any event that requires medical treatment of a radicactively contaminated individual at a medical facility.
Notification is not required if first aid for a superficial in.iury is the only treatment rendered.
(6) Any fire involving or damaging any device, container, or equipment containing licensed material.
(c) Preparation and submission of reports. Reports filed with the Comission pursuant to this section shall be prepared 50 that the names of individuals who have received exposure to radiation will be stated in a separate part of the y
report.
Reports.made by licensees in response to the requirements of this section must be made as follows:
(1) Licensees shall make reports required by paragrrphs (a) and (b) of this section by telephone to the NRC Operations Center.I To the extent that the information is available at the time of notification, the info;mation provided in such reports shall include:
(1) the caller's name and call back telephone number, (ii) a description of the event, including date and time, s
(iii) the exact location of the event.
(iv) the isotopes, quantities, and chemical / physical form of the licensed material involved, and (v) any personnel radiation exposure data available.
(2) Thirty-day followup written report.
In addition to the notifications required by this Part each licensee who makes a report required by paragraph (a) or (b) of this section shall make a followup report in writing within 30 days of the initial report. These written reports shall be sent to the U.S. Nuclear Regulatory C'ammission, Document Control Desk, Washington, DC 20555, with a copy to the appropriate NRC Regional office listed in Appendix D of 10 CFR Part 20. The reports shall include the following:
1 Commercial telephone number of the NRC Operations Center is (202) 951-0550.
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(i) a description of the event including the probable cause and the manufacturer and model number of any equipment that failed or selfunctioned, (ii) the exact location of the event.
(iii) the isotopes, quantities and chemical / physical form of the licensed material involved.
(iv) date and time of the event, (v) corrective actions taken or planned and the results of any evaluations or assessmssts, and (vi) the extent of exposure of 'ndividuals to radiation or to radioactive materials.
Dated at Rockville, Maryland, this
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, 1989.
For the Nuclear Regulatory Commission.
Victor Stello, Jr.,
Executive Director for Operations.
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