ML20055J009
| ML20055J009 | |
| Person / Time | |
|---|---|
| Issue date: | 11/02/1989 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Carr, Roberts, Rogers NRC COMMISSION (OCM) |
| Shared Package | |
| ML20055H979 | List: |
| References | |
| FRN-53FR8460, FRN-55FR843, RULE-PR-34 AC12-2-05, AC12-2-5, NUDOCS 9007310259 | |
| Download: ML20055J009 (3) | |
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MEMORANDUM FOR: Chairman Carr Commissioner Roberts Commissioner Rogers Commissioner Curtiss L
FROM:
James M. Taylor Acting Executive Director-for Operations
SUBJECT:
AMENDMENTS TO 10 CFR PART 34: SAFETY REQUIREMENTS L
FOR RADIOGRAPHIC EQUIPMENT L
The purpose of this memorandum is to provide. additional information developed by the staff about implementation of the recently approved radiographic equipment rule, and to request that the Connission reconsider the effective date for the final rule.
The Commission directed, in a Staff Requirements Memorandum dated September 18,
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.1989,thatthestaffshouldmodifytherule(transmittedbySECY-89-194)as noted, including. making the effective date for -implementation six months, rather than one year, from publication. The staff, also, wants to implement the rule as quickly.as practicable. However, the licensees and the several companies manufacturing the equipment will require sufficient time to_ properly implement the rule. This is important, because the rulemaking also modifies 10 CFR Part 2 Appendix C, Supplement IV. :This spodification puts licensees on notice that failure to implement the requirements for dosimetry and equipment by the required date may be considered a significant violation'(1.e. - Severity Level !!!).
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.The. staff believes that a-six-month period is too'short to allow orderly adoption of the rule, for,the reaso_ns stated below. We therefore request the Commission to' reconsider its decision to make the rule effective in six months and approve one year as an acceptable interval after rule publication.
1.
Concerns About Radiography Cameras and Associated Equipment with Meeting an 18-Month
- Implementation Date F
o Contacts.with industry representatives have indicated that it-takes at least two years to develop and have an approved new radiography-device ready for marketing. A manufacturer will spend approximately four months designing a new device, and seven months constructing, prototype testing, and field testing _ several device prototypes..
After the testing phase is completed, a manufacturer will spend about.
'The rule as proposed by the staff becomes effective in stages. Two portions become effective six months after publication.- The portion affecting new 4
radiography equipment becomes effective 12 months later or a total of 18 months after publication of the final rule.
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2-l two months oreparing documents for registering / licensing the device and for certifying'the device as~a Type B container. Review by regulatory agencies could take at least six months, and " tooling-up"is for production may require an additional six months afteT approval
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o Of the 16 different radiography-device models currently marketed in the United States, only two are approved es. meeting the new equipment requirements. A third is likely to meet the requirements with l
furthertesting(althoughanapplicationhasnotbeenreceived),and the staff is aware of a fourth model that a manufacturer _is currently
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modifying to meet the requirements. As of this date, the Nuclear RegulatoryCommission(NRC)doesnothaveanypendingrequestsfor 1
_ amending existing radiography-device registration sheets or for adding devices which meet the rule. Although competition among manufacturers is not,a primery NRC concern, we believe an early effective date would be an advantage to some of t5e companies.
- o. NRC's approval and registration process, under Section 32.210, 10 CFR l
Part 32, can routinely take few months, or longer, if there are significant safety questions or information is incomplete.
If the staff believes it necessary to have new devices independently tested by a. third party to provide greater assurance of adequate designs, the approval process could be further delayed. NRC has requested third-party testing for at least one radiography device.
c Most Agreement States have not yet adopted rules with similar requirements. This process usually takes several years'after NRC adopts a rule. Two manufacturers are located in Agreement States.
Tha-staff will need to coordinate with the Agreement States for s w designs under their jurisdictions, to ensure that the device meets the new regulatory requirements for NRC-regulated radiographers.
l This cumpatibility resolution may add additional review time.
If the device is intended to be used as a Type B container for o
transportation, obtaining certification may add six months to the total approval-process time. If supplemental information is needed for certification, additional delays can be expected.
2.
Concerns about Availability of Alarming Ratemeters Based on telephone contacts with six manufacturers / suppliers of o
alarming ratemeters, one indicated that a six-month implementation period would be a significant problem, with respect to supplying large numbers of ratemeters.
o Most currently available devices are more " sophisticated" than the rule requires, and provide features such as integrating dose, variable alarm settings, etc., which may not only be undesirable for radiography applications, but also would add to cost. These extra features may in fact, reduce the safety benefits obtainable from use of alarming rate meters if they are overly complicated and therefore 1
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create implementation problems in the field. Several manufacturers /-
suppliers indicated they may have to modify dosimeters, in order to.
delete certain features, to reduce the costs of the ratemeters,while still meeting requirements of the rule. Development and production of these " modified" dose rate meters have not begun.
I o Manufacturers / suppliers will need time to prepare and distribute Six months may not provide adequate product information brochures.
time for NRC's licensees to obtain information about the various and then dosimeters which are available, make informed decisions, ions.
Some place orders for dosimeters best-suited for their situat companies may wish to obtain~ samples for field testing, before entering into large purchase agreements, Licensees will have to modify their. internal operating and emergency o
procedures on use of the' alarming dosimeters. They will also need to provide training and instruction to'their workers, on both proper use and care of the dosimeters, and the revised operating and emergency procedures, which may take two to four months depending on the number-of workers involved.
The staff will work with the' manufacturers of radiography equipment and alarming dose rate meters to ensure they are aware'of the new NRC require-l In sumary, the staff requests the Connission reconsider the proposed ments.
effective date for the rule in light of the more detailed information presented in this memorandum that was not available earlier.
J The Office of the Geners1 Counsel has no lega0rkin i ki Bbthispaper.
has M.Taylot I
James M. Taylor Acting Executive Director for Operations cc: SECY OGC GPA.
SECY please track.
DISTRIBUTION:
NM55 R/F NRC File Center
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- MLamastra :JGlenn :GSjoblom:RECunningham :GArlotto :RBernero :HT l
DATE :09/27/89* :09/26/89* :9/26/89*:09/27/89*:09/26/89*
- 10/14/89*:10/19/89*:1[/ //89 0FPICIAL RECORD COPY
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ACTION - Beckjord, RES September 18, 1989 Cys:
Taylor-OFFICE OF THt Thompson i
stentTARY Blaha; Lieberman, OE'
/)y Hayes 01-Scroggins, OC DNellis, RES DMeyer, ADM BShelton, IRM MEMORANDUM FOR:
James M. Taylor Murley, NRR _ :
Acting Executive Director for Operations Bernero.-NMSS ;
Jordan, AEOD
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FROM:
Samuel J. Chilk, Secretary
SUBJECT:
STAFF REQUIREMENTS - AFFIRMATION / DISCUSSION AND VOTE, 10:00-A.M., MONDAY,-SEPTEMBER 11,-
1989,. COMMISSIONERS' CONFERENCE ROOM, ONE j
WHITE FLINT. NORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC-ATTENDANCE)
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I.
SECY-89-276 - Motion for Reconsideration Filed by Joseoh J.
Macktal The Commission, by a 4-0 vote, approved an order responding to an August 18, 1989,. motion by Joseph J. Macktal requesting that the Commission reconsider its decision in CLI-89-14 where in it declined to disqualify itself from deciding any future matters involving Mr. Macktal.
The order denied the motion to-reconsider.
(Subsequently, en September 11, 1989, the Secretary signed the Order.)
II.
SECY-89-194 - Amendments to 10 CPR Part'34!
Safety Recuirements for Industrial Radicarachic Eculoment The Commission, by a 4-0 vote, approved amendments to 10 CFR Part 34 which apply.to industrial radiography.
The amendments are intended to reduce radiation exposure to both radiography personnel and the general public from'the use of radiographic l
equipment.
The Commission also modified its enforcement policy to add a specific example to put licensees on notice that the failure to implement the requirements for dosimetry Lnd
'l equipment may be considered a violation of significant regulatory concern, i
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The Commission also agreed to make the rule effective six months after publication and agreed to the attached modifications.
The rule should be modified as noted, reviewed by the Regulatory Publication Branch for conformance with the requirements of the Federal Register and r3 turned for signature and publication.
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(RES)
(SECY Suspenset 10/6/89)
Attachments As stated I
cc Chairman Carr Commissioner Roberts Commissioner Rogers Commissioner Curtiss OGC GPA PDR - Advance DCS - T1-24 i
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