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MEMORANDUM FOR: Eric 5. Beckjord, Director Office of Nuclear Regulatory Research FROM:
Robert M. Bernero Director Office of Nuclear Material Safety and Safeguards q
SUBJECT:
PROPOSED RULEMAKING-- NOTIFICATIONS OF INCIDENTS 10 CFR 20.403 (NMSS89-651)
We have reviewed the proposed rulemaking package you submitted to us on December 14, 1989, and we concur subject to incorporating the additional example and minor editorial changes on the enclosed markup. Please contact Kevin Ramsey of any staff at 492-0534 if you have any questions about our changes.
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/ Robe t M. Bernero, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc: w/ enc 1: T. Murley J. Lieberman E. Jordan y
9007060319 900626 PDR PR 20 55FR19890 PDR
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t ENCLOSURE 1 FEDERAL REGISTER NOTICE OF PROPOSED RULEMAKING l
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1 NUCLEAR REGULATORY COMMISSION i
20 CFR Parts 20, 30, 40, and 70 RIN: 3150 - AC g1 Notifications of Incidents AGENCY: Nuclear Regulatory Commission.
ACTION:. Proposed rule.
SUMMARY
- The Nuclear Regulatory Comission (NRC) proposes to amend its regulations to revise licensee reporting requirements regarding the notifications of inciderts related to radiation safety. This action is needed to ensure that significant occurrences at material licensee facilities are promptly reported to NRC so that the Cosmission can evaluate wheth(ba-
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action is required to protect the public health and safety.
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DATE:..The consent period expires 75 days after publication. Comments received after this date will be considered if it is practicable to do so, but the staff is able to ensure consideration only for connents received on or before this date.
ADDRESSES: Mail written comments to the Secretary, U.S. Nuclear Regulatory Connission, Washington, DC 20555, Attention: Docketing and Service Branch.
Comments may be' delivered to One White Flint North,11555 Rockville Pike, Rockville, MD, between 7:30 a.m. and 4:15 p.m. on weekdays. Copies of the l
- regulatory analysis, as well as copies of the comments received on the prgosed rule, may be examined at the NRC Public Document Room, 2120 L Street NW, Lower Level, Washington, 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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e SUPPLEMENTARY INFORMATION:
Background
i Current regulations require that NRC licensees promptly 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 for a specific duration, or dange to property in en of a specific dollar amount. The events are to be reported either immenacely or within 24 hcurs, depending on the nature and severity cf the event as defined in i 20.403. NRC has become concerned that certain provisions of 5 20.403 need to be revised because Itcensees have not been reporting certain significant events. Two examples of events that were not reported are shown below.
In both cases, the licensee was cited for violations.
In one case, a fire destroyed a material licensee's building that contained the 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. As.a result, a potentially significant event was not promptly evaluated by NRC to determine whether the damaged gauge might present a hazard to public health and safety.
In a second case at a licensee's site, a uranium hexafluoride cylinder bulged but did not rupture. The event was not reported to NRC. Again, this meant that NRC was not able to promptly evaluate the potential hazard associated with the incident. After this incident, a uranium hexafluoride cylinder in a similarsituNiokdi[rktuYe',ciTIingonedeathandseveralinjuries.
Discussion The existing reporting requirements in 10 CFR 20.403 are +at-eneral.
More specific requirements are needed to reduce misunderstanding by licensees ab'out the typer of events that should be reported. The NRC staff has examined the provisions of 5 20.403 and decided that revisions are appropriate to better describe reportable events having significant implications for public health
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U discussed below do not apply to comercial power reactor licensees under 10 CFR Part 50.
g Definition o.f Immediate Notification A period of four hours would be used to define the term "immediate, notification" for saterial licensees.
It is intended that licensees will notify the NRC of incidents as soon as possible, but in no case later than four R
hours after discovery. This is consistent with some of the immediate reporting requirements specified in i 50.72 for pont reactors. Four hours was used because many smaller material licensees do not have the capability to quickly assess and respond to events that reactor licensees possess and because 'the degree of hazard posed by nonreactor events is typically much smaller than the httard posed by reactor events.
Worker Safety-Related Events NRC places the primary responsibility on the licensee for controlling and using licensed material safely. Therefore, it is important that NRC receive reports of hrNN5:gvents or conditions that prevent or threaten to prevent theNr y
control of licensed material. A reporting requirement for these types of safety-related events has been specifically included to clarify that these events must be reported. A similar requirement is currently specified in 10 CFR 50.72(b)(1)(vi) for reactor licensees. An example of an incident that should be reported is the bulging of a filled uranium hexafluoride cylinder.
This incident 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 corrective actions necessary to control the material, NRC must be aware of the situation so that it can respond appropriately.
Prompt notification is required only if events or conditions threaten an imediate disabling injury or threaten to prevent imediate
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and safety.
In final fom, this rule will also amend the major revision to l
Part 20 currently under consideration by the Commission (51 FR 1092).
The requirement's paragraphs (a)(3), (a)(4), (b)(3), and (b)(4) of i 20.403 because the staff believes these criteria *arh5c !$;Nhdk:5Y:gele that deal-with loss of operation and damage to ppperty atgbging vents that pose a hazard to public health and safety or the environment. For I
example, the periodic loss of operation of a facility h::=: ef ::: Or n. :,.1 "
Mis not necessarily related to any potential hazard to the public or environment. The same is true for the cost of repairing damage, which may be high for reasons unrelated to any potential radiation hazard associated with licensed material. The deleted sections are being replaced with new criteria that will be added to Parts 30, 40, and 70. Criteria for nuclear power reactors are already contained in i 50.72 of 10 CFR 50. The staff believes the new requirements to be added to Parts 30, 40, and 70 will be more indicative of potentially significant events affecting the health and safety of the public and the environment.
The intent of these amendments is to require prompt notification to the NRC of events that would require prompt action by the NRC to protect public health and safety.or the environment. Prompt NRC actions may include evaluating the potential hazards and corrective actions being taken, issuing immediate warnings of generic hazards to appropriate organizations, activating the_NRC incident response center, or dispatching a response team to the site of the event.
The NRC specifically requests public comments on (1) the appropriateness of these amendments, (2) the number of reports that licensees expect might be generated yearly, (3) how to minimize reports of events that do not require a prompt NRC response without excluding any events that do require prompt NRC actions, and (4) events that would require prompt NRC actions but are not&_
covered under the proposed amendments, and how to include these events ing notification requ'irements.
The proposed amendments for Parts 30, 40, and 70 are identical. The discussion that follows is, therefore, organized by the type of requirement
. rather than by the part of the regulation where it is found. The amendments
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protective actions necessary to protect the public or the environment. For example, prompt NRC notification is not required if crumbling insulation is exposing licensee personnel to airborne asbestos fibe n.
Although the condition threatens the health of the workers, it does not threaten an innediate disabling injury or threaten to prevent immediate actions necessary to maintain and verify control of licensed material.
Contamination Events A new' requirement would be added for licensees to report contamination events if 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. This requirement is intended to capture an event that causes accidental contamination in excess of the radiological conditions normally present in an area.. If contamination is not cleaned up in a timely.
manner, personnel entering the area may receive unnecessary radiation exposure and may spread the contamination to.themselves, others, or other areas. It is important that NRC receive notification of these events because NRC action my be necessary to ensure that decontamination and cleanup activities are perfomed-in a timely manner. Moreover, if contamination cannot be cleaned up within 24
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pgence For example, a radioactive waste contIiYstorage area is 1 areasg normally locked and restricted. A spill that contaminated the floor and was not cleaned up immediately would require workers to wear additional anti-contamination clothing and would increase the risk of spreading the l
contamination during operations in the area. This type of situation would bi reportable under the revised regulation.
Safetyf..lystem Related Events A new reporting requirement would be added for licensees to report events in which equipment necessary to prevent uncontrolled releases of radioactive
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I protective actions necessary to protect the public or the environment. For example, prompt NRC notification is not required if crun611ng insulation is i
exposing licensee personnel to airborne asbestos fibers. Although the condition threatens the health of the workers, it does not threaten an immediate disabling injury or threaten to prevent immediate actions necessary to maintain and verify control of licensed material.
1 Contamination Events i
A new' requirement would be added for licensees to report contamination events if 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. This requirement is intended to capture an event that causes accidental contamination in excess of the radiological conditions normally. present in an area. If contamination is not cleaned up in a timely manner, personnel entering the area may receive unnecessary radiation exposure and may spread the contamination to themselves' others, or other amas. It is important that NRC receive notification of these events because NRC action may be necessary to ensure that decontamination and cleanup activities are performed in a timely manner. Moreover, if contamination ::.;moc be cleaned up within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the matter may be significant and say require prompt Ngcj-site presence.the resin ** we mfelable to both unrestricted and restricted This recuirement is anpit A.u k k cewbn 4
areasg For example, a radioactive waste container storage area is normally locked and restricted. A spill that contaminated the floor and was not cleaned up immediately would require workers to wear additional anti-contamination clothing and would increase the risk of spreading the contamination during operations in the area. This type of situation would be reportable under the revised regulation.
Safety System Related Events A new reporting requirement would be added for licensees to report events in which equipment necessary to prevent uncontrolled releases of radioactive
material, to prevent overexposure to radiation, or to mitigate the consequences of an accidentnis disabled or fails to function as designed. This notification umacLU requirement eneempasses' procedural errors, equipment failure, and equipment g
damage. Notification is not required for an individual component failure if redundant equipment is available and is able to form t e uired fungtion.
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.These events must be evaluated to detennine anges an aprovements g 6 -
needed. A similar requirement is currently specified in 10 CFR 50.72(b)(2)(iii) for reactor licensees. An example of a reportable event is a malfunctioning interlock on a shielded irradiator chamber door -- the door could be opened while a source containing several thousand curies is exposed, % a resulting in a person receiving a large radiation dose in a very short time.
be necessary to warn other licensees of generic safety problems or to specify additional controls to protect occupational workers and the public.
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-:} mew.ny namema The NRCg,ees est-wanthceiveh,eports of events with little safety significance thak'donit require an NRC response. For example, a radiographer may crank the source out of his radiography camera and then discover that his survey meter is inoperable because the battery.just went dead. Without an Sun nct operable survey meter, the radiographerg'Cverify that the source is safely within the shielded camera after cranking it back. If another operable survey meter is available or a spare battery is available and the camera is i
innediately surveyed to verify the radiation levels, NRC notification of the survey meter failurI[bgrIquiredbytheproposedamendments. However, if redundant equipment is not available, prompt NRC notification is required because prompt NRC action is needed to ensure that appropriate steps are taken to restrict the area and verify the location of the source.
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Personal Injury Events A requirement would be added for licensees to report events that require medical treatment of a radioactively contaminated individual at a medical f acility. These events are highly significant because they may (1) indicate safety problems in a li'ensed operation, (2) risk internal contamination through c
open wounds, and (3) expose medical personnel to radiation and contamination. A
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requirementhNwor.tc$cid:qref:m.:: t:9 transporting the individual to ensure that events of this type occurring in medical fac111 ties 4where no transportation is required are not excluded. To avoid numerous reports of g
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 at a' licensee-maintained medical facility is the only treatment rendered.
Fires and Explosions A new requirement would be added to report all fires and explosions damaging licensed material or any device, container, or equipment containing licensed material.
These events must be evaluated progtly ty ajnimize any spreadofcontaminationandtodeterminetheperformbEce[featu$designedto
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control licensed material. Fires or explosions damaging licensed material are of particular significance because they can cause material in sealed sources to be released, generate airborne radioactive contamination, and generate contaminated runoff from water used to extinguish fires.
Environmental Impact: Categorical Exclusion The NRC has determined that this proposed regulation is the type of action described as a categorical exclusion in 10 CFR 51.22(c)(3)(iii). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
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J Paperwork Reduction Act Statement i
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 proposed rule has been submitted to the Office of Management and Budget for review and approval of the paperwork requirements.
Public reporting burden for this collection of information is estimated to average two hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Information and Records Management Branch (P-530), U.S. Nuclear Regulatory Commission.
Washington, DC 20555; and to the Paperwork Reduction Project (3150-0014),
Office of Management and Budget. Washington,' DC 20503.
Regulatory Analysis The Cosmission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. 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 Commission requests public comments 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 on 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 Commission certifies that, if promulgated, this rule vill not have
.a significant economic impact on a substantial number of small entities. The l
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k propored rule affects approximately 9,100 licensees monitored by NRC under 10 CFR Parts 30, 40, and 70. The licenses are issued to academic institutions, medical institutions, and industrial entities. The proposed rule is being issued in order to reduce misunderstand 1ngs by material licensees and to clarify the types of events that must be reported to NRC. No report would be required of licensees unless there is an incident involving Itcensed saterial that meets the requirements specified in the proposed amendments. Since the revised reporting requirements are esstatially the same as the current reporting requirements, the impact on lit.ensees should be minisal.
Backfit Analysis The NRC has detennined that the backfit rule,10 CFR 50.109, Coes not' apply to this proposed rule and therefore a backfit analysis is not cequired because the amendments that apply to power reactors (deletion of Sections (a)(3), (a)(4), (b)(3), and (b)(4) of 10 CFR 20.403) involve only a relaxation L
of requirements.
(See Memorandum fmm M.G. Malsch, OGC, to Commissioner l
Asselstine, January 23,1986.)
l List of Subjects in 10 CFR Part 20, 30, 40, and 70 10 CFR PART 20 Byproduct material, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging ara containers, Penalty, Radiation protection, Reporting and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and disposal..
10 CFR PART 30
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Byproduct material, Government contracts, Intergovernmental relations, j
i Isotopes, Nuclear materials, Penalty, Radiation protection, Reporting and recordkeeping requirements.
I 10 CFR PART 40 Government contracts, Hazardous materials-transportation, Nuclear materials, Penalty, Reporting and recordkeeping requirements, Source material and Uranium.
i 10 CFR PART 70 4
Hazardous materials-transportation, Nuclear materials, Packaging and containers, Penalty, Radiation protection Reporting and recordkeeping requirements, Scientific equipment, Security measures, Special nuclear material.
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 amendmer.ts to 10 CFR Parts 20, 30, 40, and 70.
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).
Section 20.408 also issued under secs. 135,141, Pub. L.97-425, 96 Stat.
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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. 948, as amended (42 U.S.C. 2201 (b));andil 20.102, 20.103(e), 20.401-20.407, 20.408(b), and 20.409 are issued under sec.161o, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
2.
In 5 20.403, paragraphs (a)(3),(a)(4),(b)(3),and(b)(4)areremoved.
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l PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING 0: BYPRODUCT MATERIAL 3.
The authority citation for Part 30 continues to read as follows:
AUTHORITY: Secs. 81, 82,161,182,183,186, 68 Stat. 935, 948, 953, 954, 955,
- as amended. -sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232,2233,2236,2282); secs.201,asamended. 202, 206, 88 Stat.1242, as amended, 1244,1246 (42 U.S.C. 5841, 5842, 5846).
Section 30.7 also issued under Pub. L.95-601, sec.10, 92 Stat. 2951 (42U.S.C.5851). Section 30.34(b) also issued under sec.184, 68. Stat. 954, asamended(42U.S.C.2234). Section 30.61 also issued under sec.187, 68 Stat. 955 (42 U.S.C. 2237).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
il 30.3, 30.34(b)(c) and (f), and 30.41(a) and (c), and 30.53 are issued under sec.161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and 55 30.6, 30.9, 30.36, 30.51, 30.52, 30.55, and 30.56(b) and (c) are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
4.
A new i 30.50 is added to read as follows:
5 30.50 Notification Requirements.
(a)Immediatenotification. Each licensee shall notify the NRC as soon as possible but in no case later than fotr hours after the discovery of any event involving licensed material that prevents or threatens to prevent immediate actions necessary to maintain and verify control of licensed material (includes fires, explosions, toxic gas releasd D." 4M4f4eetica-is requ4mdanly if-theA event 4nvolves-immed4te bod 44y-hermNr-would-prevent-immediste-protect 4ye '
S ction-neces sa ry-40-pret est-t h e -p u bl i e--oe-the-env4 rena n t.4 (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 /> af ter the discovery of any of the following events involving licensed material:
(1) Any contamination event that restricts 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 />.
'(2) Arty event in which' equipment necessary to prevent uncontrolled releases of radioactive material, or to prevent overexposures to radiation, or to mitigate j
the consequences of an accident, is disabled or fails to function as designed when it is needed. Notificationisnotrequt$d n individual compo'neng s j
ti disabled or fails to function if redundant _ equipment is available and 1s eh g
to perforin the required function.
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l (3) Any event that requires medical treatment of a radioactively contaminated individual at a medical facility. Notification is not required if first aid at i
l a licensee-maintained medical facility for a superficial injury is the'only treatment rendered.
I (4) Any fire or explosion damaging any licensed material.or any device, l
l container, or equipment containing licensed material.
(c) Preparation and submission of reports. Reports filed with the NRC pursuant to this section must have the names of persons who have received exposure to radiation stated in a separate part of the report. Reports made by licensees in response to the requirements of this section must be made l
as follows:-
(1) Licensees shall make reports required by paragraphs (a) and (b) of this section by telephone to the NRC Operatioris Center. To the extent that the information is avaihble at the time of notification, the information provided in these reports w st include:
(1) The caller's name and cal'. back telephone number, (11) A description of the event, including date and time, (iii) The exact location of the event, The commercial telephone number for the NRC Operations Center is (202) 951-0550.
ad (iv) The isotopes, quantities, ar d chemical er physical form of the
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j licensed material involved, and (v) Any personnel radiation exposure data available.
-(2) Thirty-day followup written report. Each licensee who makes a report required by paragraph (a) or (b) of this section shall submit a written followup report within 30 days of the initial report. These written reports sha'11 be ser.t to the U.S. Nuclear Regulatory Comission, 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 must include the following:
(1) A description of the event,Jncludigtp probable cause and the manufacturer and model number,obany equipment that failed or malfunctioned.
(ii) The exact location of the event, y
(iii) The isotopes, quantities, and chemicalpr 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 assessments, and (vi) The extent of exposure of individuals to radiation or to radioactive materials.
he n.s e e s sa Qa 6 so Mc.nof:Sc< d,n
+e <a ' ~<m n A L A 7 L (3) The provisions of i 30.50 do not apply to,commer44aHwer reacto'r-4feensees.- These: licensees-will-continue-to-report-under-fr-50r76 PART 40 - DOMESTIC LICENSING OF SOURCE MATERIAL 5.
The authority citation for Part 40 continues to read as follows:
AtITHORITY: Secs. 62, 63, 64, 65, 81,161,182,183,186, 68 Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs.11e(2), 83, 84, Pub. L.95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 83 Stat. 444, as amended (42 U.S.C.
2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274, Pub. L.86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842,
i 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L.97-415, 96 Stat. 2067 (42 U.S.C.-2022).
Section 40.7 also issued under Pub. L.95-601, sec.10, 92 Stat. 2951 (42 U.S.C.5841)Section40.31(g)alsoissuedundersec.122,68 Stat.939(42 U.S.C.2152). Section 40.46 also issued under sec.184, 68 Stat. 954,,as amended (42 U.S.C. 2234). Section'40.71 also issued under sec.187, 68 Stat.
955(42U.S.C.2237).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
il 40.3, 40.25(d)(1)-(3), 40.35(a)-(d), and (f) 40.41(b) and (c), 40.46, 40.51(a) and (c), and 40.63 are issued under sec.161b, 68 Stat. 948, as
- amended (42 U.S.C. 2201(b)); and $$ 40.5, 40.9, 40.25(c), (d)(3), and (4),
40.26(c)(2), 40.35(e), 40.42, 40.61, 40.62, 40.64, and 40.65 are issued under sec.1610, 68 Stat. 950, as amended (42 U.S.C. 2201(c)).
6.
A new i 40.60 is added to read as follows:
1 40.60 Notification Requirements, (a)Immediatenotification. Each licensee shall notify the NRC as soon as possible but in no case later than four hours after discovery of any event involving licensed material that prevents or threatens to prevent immediate actions necessary to maintain and verify control of licensed yetc.
material (includes fires, explosions, toxic gas releases). fictifi::t* G
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A is req;; ired caly if the ; vent-involves 644te-bodily -harir. er wuid prever.t i=:diate-pretectiv: ::t4orsacessary-to-protect-the-pet 44c6 er-the :nv*ren at ?-
(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 folloving events involving licensed material:
(1) Any contamination event that restricts 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 />.
e
'(2) Any event in which equipment necessary to prevent uncontrolled releases of radioactive material, or to prevent overexposures to radiation, or to mitigate the consequences of an accident, is disabled og[fatis to function when it is needed. Notification is not required nindividualcomponengis disabled or fails to function if redundant equipment is available and is M to perform the required function.
(3) Any event that requires medical treatment of a radioactively contaminated individual at a medical facility. Notification is not required if first aid at l
a licensee-maintained medical facility for a superficial injury is the only treatment rendered.
(4) Arty fire or explosion damaging any licensed material or arty device, container, or equipment containing licensed material.
(c) Preparation and submission of reports. Reports filed with the NRC pursuant to this section must have the names of persons who have received exposure to radiation stated in a separate part of the report. Leports made by licensees in response to the requirements of this section must be made as follows:
(1) Licensees shall make reports required by paragraphs (a) and (b) of this section by telephone to the NRC Operations Center.
To the extent that the infonnation is available at the time of notification, the information provided in these reports must include:
(1) The caller's name and call back telephone number, (ii) A description of the event, including date and time, (iii) The exact location of the event, g
(iv) The isotopes, quantities, and chemica sical fonn of the licensed material involved, and (v) Any personnel radiation exposure data available.
- ihe commercial telephone number for the NRC Operations Center is (202) 951-0550.
i (2) Thirty-day followup written report. Each licensee who makes a report required by paragraph (a) or (b) of this section shall submit a written followup _ report within 30 days of the initial report. These written reports shall be sent to the U.S. Nuclear Regulatory Consission, Document Control Desk, Washington, DC 20555, with a copy to the appropriate NRC Regional office listed in Appendix 0 of.10 CFR Part 20. The reports must include'the following:
(1) A description of the eventginclud g the probable cause and the manufacturer and model number [ any equipment that failed or malfunctioned, (11) The exact location of the event, g
(iii) The isotopes, quantities, and chemical hysical fonn 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 assessments, and (vi) The extent of exposure of individuals to radiation or to.
radioactive materials.
facemees sd rupaan ds m 5 SD'N-The provisions of 9 40.60;uk 4 % nk(wdu ndo not apply to4;;=:r;ie.
(3)
C Mee sees. - Hse licensees 4111mti= to-report ;;r,t.er i 50.7h -
PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR HATERIAL 7.
The authority citation for Part 70 continues to read as follows:
AUTHORITY: Secs. 51, 53, 161, 182, 183, 68, Stat. 929, 930, 948, 953, 954, as atended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2071, 2073, 2201, 2232, 2233,2282); secs.201,asamended, 202, 204, 206, 88 Stat. 1242, as amended, 1244,1245,1246,(42U.S.C.5841,5842,5845,5846).
Sections 70.1(c)and70.20a(b)alsoissuedundersecs. 135,141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C.10155,10161). Section 70.7 also issued under Pub. L.95-601, sec.10, 92 Stat. 2951 (42 U.S.C. 5851). Section 70.21(g) also issued under sec.122, 68 Stat. 939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub. L.93-377, 88 Stat. 475 (42 U.S.C.
v 2077). Sections 70.36 and 70.44 also issued under sec.184, C8 Stat. 954, as amended (42 U.S.C. 2234). Section 70.61 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237). Section 70.62 also issued under sec.108, 68
. Stat. 939, as amended (42 U.S.C. 2138).
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
il 70.3, 70.19(c), 70.21(c), 70.22(a), (b), (d)-(k), 70.24(a) and (b);
i 70.32(a)(3),' (5), (6), (d), and (i), 70.36, 70.39(b) and (c), 70.41(a),
70.42(a) and (c),-70.56, 70.57(b), (c), and (d), 70.58(a)-(g)(3), and (h)-(j) are issued under sec.161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); li 70.7, 70.20a(a) and (d), 70.20b(c) and (e), 70.21(c), 70.24(b), 70.32(a)(6),
70.36,70.5'(c)-(g),70.56,70.57(b)and(d),and70.58 (c),(d),(e),and(g),
1 (a)-(g) (3) and (h)-(j) are issued under sec. 1611, 68 Stat. 949, as amended (42U.S.C.2201(1));andil70.5,70.9,70.20b(d)and(e), 70.38,70.51(b)and (1), 70.52, 70.53, 70.54, 70.55, 70.58(g)(4), (k), and (1), 70.59, and 70.60(b) and(c)areissuedundersec. 1610, 68 Stat. 950, as amended (42 U.S.C.
2201(o)).
8.
A new I 70.50 is added to read as follows:
I 70.50 Notification Requirements.
(a)'Immediatenotification. Each licensee shall notify the NRC as soon as possible but in no case later than four hours after the discovery of any. event involving licensed material that prevents or threatens to prevent inmediate action necessary to maintain and veri y control of licensed material (includes fires, explosions, toxic gas releas'es.'
NetM4 eat 4en4s-required-only if--thd l
event 4 nv olves4mmedi a te-bo di4y-ha rm-or-wou44-preven t4mmedia te-protect 4 ve est4en-necessary to -protect-the-publ4c-or-the-environmentA (b) Twenty-four hour notification. Each licensee shall notify the NRC within l
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 l
material:
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. _ _... ~ _ _ _ _ - - _ _ _
(1) Any contamination event that restricts 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 />.
(2) Any event in which equipment necessary to prevent uncontrolled releases of radioactive material, or to prevent exposure to radiation, or to mitigate the consequences of an accident is disabled or fails to function as designed'when Notification is not requireY nindividualcomponentiy it is needed.
disabled or fails to function if redundant equipment is available and is4a #
to perform the required function.
(3) Any event that requires medical treatment of a radioactively contaminated individual at a medical facility. Notification is not required if first aid at
-a Itcensee-maintained medical facility for a superficial injury is the only treatment rendered.
(4) Any fire or explosion damaging any licensed material or any device.
l container, or equipment containing licensed material.
(c) Preparation and submission of reports. Reports filed with the NRC pursuant to this section must have the names of persons who have received exposure to radiation stated in a separate part of the 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 paragraphs (a) and (b) of this section by telephone to the NRC Operations Center.
To the extent that the information is available at the time of notification, the information provided must include:
- The commercial telephone number for the NRC Operations Center is (202) 951-0550
-l i.
(1) The caller's name and call back telephone number, (ii) A description of the event, including date and time.
(iii) The exact location of the event, g
(iv)' The isotopes, quantities, and chemical hysical form of the licensed material involved, and (v) Arty personnel radiation exposure data available.
3
,'(2) Thirty-dayfollowupwrittenreport. Each licensee who makes a report required by paragraph (a) or (b) of this section shall prepare a written followup report within 30 days of the initial report. These written. reports must be sent to the U.S. Nuclear Regulatory Commission, Document Control Desk, Washington, DC 20555, with a copy to the appropriate NRC Regional office listeo in Appendix D of 10 CFR Part 20. The reports must include the following:
(1) A description of the event,gnelugthe probable cause and the manufacturer and model numbergYanyequipmentthatfailedor malfunctioned, (ii) The exact location of the event, g
(iii) The isotopes, quantities and chemical [, hysical 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 assessments, and (vi) The extent of exposure of individuals to radiation or to radioactive materials.
re aameds m SM2 The provision [ocennees & uf k % t$u$ms of 9 70.50 do not app (3)
He n::::. The:: "censees_w441 : r.tinue te repoet-trader ; 50J2/
Dated at Rockville, Maryland, this day of
,1989.
For the Nuclear Regulatory Comission.
James M. Taylor Executive Director for Operations
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ENCLOSURE 2 DRAFT REGULATORY ANALYSIS e
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STATEMENT Of THE PROBLEN The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to revise licensee reporting requirements regarding the notification of incidents related to radiation safety.
The present regulations in 10 CFR 20.403 (Notifications 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 for a specific duration, or damage to property in excess of a specific ' dollar amount. The events art to be reported either immediately or within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of discovery, depending on the nature and severity of the' event as defined in i 20.403. NRC has become concerned that certain provisions of i 20.403 need to be revised because material licensees have not been reporting significant events that the NRC staff believes should have been reported.
l I-OBJECTIVES l
L The present reporting requirements of 6 20.403 are ( M eneral and more l
specific requirements are believed appropriate to reduce misconceptions by material licensees about the types of events that should be reported. Specific requirements for nuclear power reactors are already contained in 10 CFR Part
- 50. The staff's proposed amendments to 10 CFR Parts 20, 30, 40 and 70 have the following objectives:
(1) to better describe reportable events that have
(
significant implications for public health and safety, and (2) to clarify the 1
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1 term "imediate notification." This action is needed to ensure that significant occurrences are promptly reported to the NRC so that the NRC can evaluate whethe te d: '--c M etio$
r tect the public health and
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A safety.
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COSTS AND BENEFITS OF ALTERNATIVES 1
Since the only alternative to the proposed amendments under consideration is to take no action, the incremental costs and benefits of that alternative are i
zero.
The benefits of these proposed amendments relate to increased public health and safety and decreased risks of occupational exposure. First,.the action will make material licensees more aware of their responsibilities with respect to reporting incidents. _ This amendment should result in material licensees reporting occurrences when required, resulting in a greater likelihood that-
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' licensees and the NRC will take the timely steps to pfeserve the public health 4
and safety, as well as that of employees.
Another potential benefit will be greater assurance that the NRC will receive material licensee reports of an increased beneficial nature relating to public and occupational health and safety. These data will allow the NRC to more readily -identify potential problems that may need remedial action.
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The costs of this action are the operating expenses, which say be incurred l
by both saterial licensees and the NRC, based on the proposed regulatory action and the subsequent change in the number of material licensee reports expected to be generated as a result of the revision. These costs are not easily estimated because it is not clear how great the change will be in'the number of incidents reported. Since this proposed action is Monsidered a nchCu k re remh
&g,Juden cf y h jer d dtt!:.., t re should be 1 ttle additional burden imposed; hence there should not be a large increase in the number of material licensee nports coming to the NRC.
It should be noted that the NRC labor rates presented here differ from those developed under the NRC's license fee recovery program (10 CFR Part 170). For regulatory analysis purposes, labor rates are developed under strict incremental cost principles wherein only variable costs that are directly related to the implementation of the proposed requirement are included. This l.
approach is consistent with guidance set forth in NUREG/CR-3560, "A Handbook L
for Value-Impact Assessment," and general cost-benefit methodology.
Alternatively, NRC labor rates for fee recovery purposes are appropriately.
designed for full cost recovery of the services rendered and as such include l
non-incremental costs (e.g., overhead, administrative, and logistical support costs).
Data obtained from the NRC's Office of Governmental and Public Affairs indicate that there are approximately 9,100 material licensees monitored by NRC under 10 CFR Part '20, as of February 1989. A review of the reports submitted in recent years indicate that about 90 to 95 nonreactor incident reports have been submitted annually. Since NRC has discovered very
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few unreported incidents the incremental change in the number of additional reports d expected to be small. Alternatively, this action may raise the licensees' awareness of their responsibility to report incidents and may initially result in an increase in the nunber of unnecessary reports.
Licensees may feel it necessary to take a cautious approach and report,'
incidents that would not actually need to be reported. The staff believes that, for this analysis, a doubling of the present nua6er of reports, i.e., 90 reports to 180 reports per year, is conservative.
4 In addition to the potential impact on material licensees from an increased number of reports, this proposed action could also have an impact on the NRC Operations Center staff and resources. There is a concern that the increased number of telaphone calls is most likely during the licensees' 8 to 5 workday, placing a dispioportionate peak demand on the Operations Center.
If this turns out to be the case, an additional FTE could be needed for the Operatio.v. Ccster.
The staff estimates the licensee's cost for telephoning the NRC and producing the required two-to three-page letter report to be a few hours of effort.
Hence, a value of $100 per report is assumed to more than adequately capture the licensee's cost. The-annual cost to the industry for the additional 90 reports, at the assumed $100 per report, is $9,000.
Emergency Operations Ct..;er data indicate that the average time for an operator to receive, evaluate, report, and record a material licensee's telephone call is 30 minutes. The Regional Offices indicate that, on 3
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i average, about four hours of staff time is required for follow-up on each report received. Therefore, NRC's annual cost estimate is based on a 30-minute-per-report value for the Operations Center staff, and an a(ditional four hours for the Regional Offices to review the report and act on the incident as necessary. Using $40 75 as the average NRC technical staff hourly rate (See NUREG/CR-4627, Rev.1, ' Generic Cost Estimates,' Abstract 5.2), the annual NRC cost is calculated to be $16,500 for the additional 90 telephone calls and follow up reports per year. Assuming a 30-year time period and a 10 percent real discount rate, the total industry costs become $84,870, while the total NRC costs would be $155,630.
(For a description of the approach used, see Appendix C of NURE6/CR-3568, 'A Handbook for Value-Impact Assessment.')
However, the average total industy cost over the 30-year period is $3.50 per licensee.
Table 1.
Estimated Incremental Impact Based on an Assumed Annual Increase of 90 Reports 30-Year Present Worth Factor, Based on a 10%
Total Costs Industry Costs Annual Costs Real Discount Rate Over 30 Years
($100perreport)
$ 9,000 9.43
$ 85,000 NRC Cost (4.5 hr per report 9$40.75 per br)
$16,500 9.43
$156,000 DECISION RATIONALE This proposed regulatory action is essentially an update and revision of existing rules, and potentially its greatest benefit is " expected regulatory
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and compliance improvements resulting from the proposed action" (NUREG/CR-3536, "A Handbook for Value-Impact Assessment,' p.2.3). Therefore, the attribute that could well be most affected is " regulatory efficienqy,"
which does not lend itself to ariy type of quantification.
L Nonetheless, there is a distinct possibility that hesith and safety benefits can be achieved with little or no significant incrementa? cost to the NRC or its licensees. MRC's awareness and collection of this data could result in additional requirements (based on these reports) that will promote incremental impacts to health and safety. If substantial changes occur in the number of.these reports coming to the NRC, the Operations Center may need to expand its staff and resources.
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