ML20235W268
| ML20235W268 | |
| Person / Time | |
|---|---|
| Issue date: | 02/22/1989 |
| From: | NRC |
| To: | |
| References | |
| FRN-50FR51992, RULE-PR-19, RULE-PR-20, RULE-PR-30, RULE-PR-31, RULE-PR-32, RULE-PR-34, RULE-PR-40, RULE-PR-50, RULE-PR-61, RULE-PR-70 NUDOCS 8903100565 | |
| Download: ML20235W268 (52) | |
Text
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HAND 0UT FOR MEETING BETWEEN NRC STAFF AND STAFF FROM THE NUCLEAR UTILITY MANAGEMENT AND RESOURCES COUNCIL (NUMARC) l l
l l
l I
FEBRUARY 22, 1989 l
l 8903100565 890222 FDR PR
(,
19 50FRS1992 PDC
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l l
l
TABLE OF CONTENTS l'
I I.-
Meeting Notice.
II.
Current, Proposed and Final Rule on Internal Dose
!~
620.204, 620.205.
III.
Staff Response to NUMARC Coments (incl. NUMARC coments).
IV.
Staff Response to ACRS Coments.
V.
Advisory Comittee on Nuclear Waste Coments.
VI.
NCRP 84 and NCRP 91 Positions on Comitted Dose (Reproduced by Permission).
VII.
Federal Guidance.
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HEETING NOTICE
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FOR FURTHER INFORWahoN CONTACT:
warrant Correction.Dese do not involve TSs a*etson of the FEDERAL REGISTER contains notices to the putplec of 988 ' '
Harold T.peterson.fr Office of Nuclear any substantive change.
Propos*d issuance of rWs and Regulatory Research. U.S. Nuclear paTE: Comments due by March 13.1see.
'ghtens. w smiose of em notoes Regulatory Commission. 5650 Nicholson -
ADDRESS: Comments should be O to give interested persons an IAne South [14. Rocgvg;e MD 20652.
.Cavanagh.
addressed to: James )d rinancial Polley opportunsry to pa.tscipate in the Me Telephone: (301 492-3640. Ta csimile: -
Director. Business an rnauno prior to te adopten et Fue Anal (21) 443-7804 or 443-7836. Verification:
Division (MA-422), Procurement and 4
,was.
(302) 492-3607 i
Ass! stance Management. U.S.
i sureautNTAmmoRMAnon:
Department of Energy.1000 * '.
NUCLEAB REGUs.ATORY ne deletion of i 20.205 has been Independence Avenue SW.
COMMISSION previously discussed in public meetings Washington, DC 20585.
of the NRC Advisory Committee on FOR FURTHER INFORMATION COstTACT:
10 CFR Part 20 Reactor Safeguards (ACRS)
Public Meeting To Discuss Subcommittee on Occupational and Edward F. Sharp Bustriers and Requirements Ior Controf of internal Environmental Hesith on Msy 31.1988 Financ!al Policy Diviston (MA-422),
U.S. Department of Energy.1000,.
and before the full ACRS on "une3.
Doses 1988;in the Commission's puIlic Independence Avenue SW.
WashingtoneDC 20585 (202) 586 41st ActNev: Nuclear Regulatory -
meeting on to CFR part 20 on November Christopher Smith. Office of the Comm!ssion.
10.1988; and the NRC Advisory Assistant Cencral Counsel ACTDCN: Notice of public meeting.'
Co:nmittee on NuclearWaste on Procurement and Finanoe (GC-84),
December 21.1980.
sVMWaRM ne prop 0:ed revislon to 10 Persons wishing to make statements U.S. Department of Energy.
CFR Part 20. pubbshed on January 9.
on these issues should notify the contact Wa shington, DC 20585. (202) 586-1528.
1986. (51 TR 1092), contained a section person identified in th!$ document and SUPPuMtwfARY mPORMAnost (l 20.205) that would have allowed submit a written request including the
. I.letroduc6co I
licenses to control the internal dose statement to be presented at lease one from certainlong lived radionuclides on week in advance of the meeting.ne
. De Department of Energy (DOE)is the basis of the dose actually delivered statement should be nolonger than 8 today issuir4 a proposed rule to make s
non. substantive changes to the during the year imm allintakes, both minutes..
Financial Assistance Rules (10 CTR Part i
past and present (annual dose).ne Deted at Rockvh. Maryland, thk oth day 600) to correct errors appearing in it.
l control of all other nuclides was to be of Tabruary seas.
Dere have been three significant 1
bemed upon the dose both present and
. no x.m u.a.
amendmente to the Rulesin spea:
l future, thet would be delivered as a.
j," ""
Chat.ges to the way in which
- M hf[N$"d, clearAegu7alory result ofintakes of radioactive materials coopersUve agreements are bandled (53 during the year (committed dose).na Applicouons. Ofpaof FR 5260. February 22.1988), adoption of NRC staff. during preparation of the AsseamA..
tl e A-102 Common Rule (53 FR 4064.
final rule that would implement the to pR Doc.ai-soas Filed sa s45 am)
March 11.1988), and the establishment l
CFR Part 20 revision, deleted this option. a n ae seas run m.a nis deletion e!!ectively continues the of procedures for dealing with determinations of noncompetitive present practice of requiring that financial assistance and justifications of internal doses to workers from all.
' DEPART 5fENT OF ENERGY restricted eligibility (53 FR 12137. Apr0 todionuclidea would be ocetrolled on 13,19&C).Tb. cl.uges haic not sL!y committed dose equivalents.
e of the se m ary
~ involved polley issues,but,in the case At the request of the Nuclear Utilities of the common rule, a substantial i
Mansgement and Resources Council
- 10 CFR Pa-t t'.A
- J.
reorgen!rationof theFicancial (NUMARC). a meeting between industry Assistance Rules, with renumbering of,
I i
representatives and NRC staff members Financial Aaatstance Rules;Techrdeel varlous sections. Inevitably, errorskove I
'la scheduled to bear industry concerns Corrections appeared in the text, including *
. regardir4 the deletion of the proposed t 20.205 and discuss the impact of the 5.-
A#E"cn Department of Energy.
typographical mistakes, repetitions; and i
fold reduction in the occupational air Acnow: Proposed rule.
. incorrect references..
p suwuARY:ne Department of Energy E. Proposed Changes,to 10 CFR.Pa.rt 800 concentrationlimit forinsoluble (DOE) today proposes amendments to Section 600.2 is being amended by.
uranium on nuclear fuelfabrication I
- facuitles.
' the Financial Ass! stance Rules.10 CFR ' deleting the reference to OMB Circular 1
Meeting to be held'Febru'ary 22. * ' Part 600, to make technical, non.
A-102 in paragraph (f)(i) sind to OMB DATE:
1989. from 1:30-3.30 p.m.
substantive corrections.Because of Circular A-124 in paragraph (f)(lii).
Ac omtss: Meeting t'o be held in room -
three changes to the rules in1988, a
. Circular A-102 was reptseed by the 10-B-11 of the Commission's detailed review of them has taken place Common Rule (adopted by DOE as hea dquarters building at One White and disclosed a number of technical Subpan E of the Financial Assistance Flint North,11555 Rockville Pika, errors (typographical errors repetitions.
Rules) and Circular A-124 was..
e' Rociville.MD 20a52.
locorrect citations, and the like) which. cancelled in March 1987.The remaining
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II. CURRENT, PROPOSED AND FINAL RULE ON INTERNAL DOSE $20,204, $20.205
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III. STAFF RESPONSE TO NUVARC COMMENTS (THCL NUPARC COMENTS)
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NRC STAFF ANALYSIS OF NUl! ARC LETTER OF OCTOBER 20, 1988 011 10 CFR PART 20 General NRC Comment: The NRC staff welcomes the opportunity to work with the industry to develop specific implementation details, including Regulatory Guides for Part 20.
NUMARC Coment: Section 20.205 is of particular importance to the commercial 1
uranium fuel fabrication workers and industry, allowing its licensees the
. option of making direct measurements to determine internal radiation doses to workers on an annual rather than on the 50-year corrrnitted dose basis, hRC Staff Response: The revised Part 20 also allows direct measurements of bocy burden or excretion to 'be used to assess dose.
[Se' $20.204). 'The only s
fundamental differences between the annual dose approach and the comitted dose approach are the dose factors used to convert the body burden to dose and the method of accounting for past and future exposures.
NUf'. ARC Comment:
Accounting for internal doses on an annual basis would provida overall ecuivalent protection at a small f raction of the cost.
_tCC Staff Response: We believe that the year.-by-year accounting of' annual doses is more complex than using the committed dose approach in which a single record is made for the year of exposure and this value m:d not be considered in future years.
Either the annual dose control or the committed dose approach might provide equal protection during employment, but dose to the worker after he leaves employment, woulo be ignored. Control on the basis cf higher dose to worker in terms of annual cose rate.
NUMARC COMMENTS GEL @MM A
NUMARC Coment:
In the presentation before the ACRS, the NRC Staff estimated that the. provisions of the proposed rule controlling internal doses on a 50-year #comitted dose basis would cost the U.S. fuel f abrication industry $75 million.
Industry estimates generally confirm this figure as being representative of the one-time cost to implement the proposed rule, but it does not reflect the additional annual cost which would be considerable.
i
@ C Staff Response: The issue driving the cost is not which method of control is 9 sed, but the impact of the fivefold decrease in the allowable air and concentration for uranium.
Internal exposures in U.S. fuel f abrication plants have always been controlled by controlling air concentrations using limits based upon the 50-year comitted dose equivalent.
The NRC cost estimates are necessarily generic as the cost of actual design modifications for specific facilities could not be estimated.
However, we do not agree that the annual costs are substantially underestimated.
In fact, we beli, eve that the cost of $75 million is an upper bound cost and that further analysis of specific plant conditions on a case-by-case basis should provide lower cost methods of control.
~
l NUKARC Coment: We are concerned that the Staff recomencation does not adequately incorporate the guidance from cognizant international, national, and professional bodies. The issue of how to account for the radiation dose from radionuclides persisting in the body is decidedly complex and not without some controversy. Nevertheless, the National Council on Radiation Protection and Measurements and the ACRS at its June 1988 meeting, recomended that the annual dose accounting be an integral part of the overall radiation worker dose management program. The Staff's latest recommendations not only represent excessive costs to the industry but lack the support of these specific bod'ies.
NRC St6ff Response: The NCRP stated in their report No. 91 that:
The NCRP adopts the committed dose equivalent for radiation protection planning, such as in the desi development of manufacturing processes, gn of facilities and research protocols, etc.;
NUMARC C041ENTS ENCt.05URE 9
I for the demonstration of compliance with those plans; and for use in calculating anr.ual limits of intake (Alls) and derived air c' concentrations (DACs).
The ccmmitted effective dose equivalent may.
also be used to provide an estimate of the. lifetimt risk from a given intake and, in this respect, its use is the same as the effective dose equivalent for external irradiation, with the limitation given above.' However, it does not constitute a sufficient basis in itself for the. evaluation of-the potential health effects of radiation exposures in individuals. Such evaluations.should be based on estimates of actual absorbed dose, derived from the models given in ICRP Publication 30 (ICRP,1979), for.the period of exposure appropriate to the individual case.
For greater accuracy, the acceptable practice is to base these estimates on physiological and exposure information specific to the individual rather than on ICRP models which are for Reference Han (ICRP,1975) [p.19].
Thus, their position is that the use of the consnitted dose equivalent shoulo not be used for estimating health effects, but that it should be used for estimating the lifetime risk fron: c given intake..The NCRP also states that:
To take into consideration the varying time distributions of radiation dose, the ICRP defined the committed dose eauivalent in a
- particular organ or tissue as.the total dose equivalent averaged throughout that organ or tissue in the 50 years after. intake of a radioruclide into the body. The comnitted effective dose equivalent is assumed to be a rieasure o,f_.the, risk.,t, hat. wi.11.. result from that intake.c...[.p.18).
- w..., ::., w - m :
The NUMARC statement does not totally reflect the NCRP position particularly in regard to lifetime risk.
1 NUMARC Comment: The deletion of the previously proposed Section 20.205 represents a major change from the proposed rule and the implementa. tion of the proposed rule.
NRC Staff Response: The proposed rule was never in effect and based upon analysis of the pubite connents, some for and some against the exception in Propos'ed $20.205, the staff has reverted back to the approach that the AEC and NRC have used over the past 30 years to control internal doses. This does not require reproposal.
I O
NUKARC COMMENTS ENCLOSURE 9
4 NUMARC Coment: We further recommend that the proposed five-year implementa, tion date be from the date of publication of the final rule, not from the date of' publication of the proposed rule (January 9,1986) as was stated by' the Staff in a presentation before the ACRS on May 31, 1988. The changes to be implemented by the revised 10CFR20 are extensive and three years have essentially elapsed since the proposed rule was published.
Industry views on the need for a five-year implementation period are reflected in the October 1987 AIF letter and the May 1988 NUMARC letter.
NRC Staff Response: The statement of consideration contains provision for fuel fabrication facilities to request an extension in the implementation date in order to make the necessary modifications to the facility and to their procedures.
~
APPENDIX A TO NUMARC COMMENTS NUMARC 'Coment: Air sampling would'be used under either an annual or comitted dose control approach for day-to-day control of the workplace, and in either case the action levels would be based on 50 year comitted dose calculations.
Allowing t,he optiertof.. annual dose accounting.woule. encourage 1.icenseesrto use --
technology, such as state-of-the-art lung counters, to measure actual lung i
content as a method of demonstrating compliance. Adoption of a strict connitted dose control would significantly diminish the usefulness of lung counting and other in-vivo assay techniques which measure radionuclides retair.ed in the body.
NRC Staff Response: 520.204 of the final rule permits the use of either body burden excretion measurements, or air concentrations to estimate the intake.
j Information from all of these may be used in conjunction with standard models to calculate the 50-year comitted dose.
i i
NUMARC Comment: An annual dose control provides equivalent overall protection of the worker when compared to comitted dose. Annual dose control merely approaches the accounting of future doses in a different manner.
NUMARC COMMENTS ENCLCSURE 9
imC Staff Response: The annual dose control provides equivalent protection as far as ann'ual dose rate while employed but does not consider the dose
~
contributions that are accrued in employment is terminated.
The staff agrees but notes that the annual dose approach allows the dose to be accrued at a faster rate in the early years of exposure and may result in higher lifetime exposures.
NUMARC Coment: Comitted dose discounts or ignores the dose from all int 6kes prior to the current year and accounts for all of the future dose from a year of intake by adding it into the employee's record that year.
Its forward l
projections must be made using conservativit models.
NRC Staff Response: The committed dose approach neither " discounts" nor
" ignores" all intakes prior to the current years. These intakes would have been accounted for in the year on which they occurred. The committed cose approach does account for the future dose frem the present year's intake; the annual dose approach does not account for the future dose.
The revised Part 20 permits actual retention measurements to be used in calculating 't'h'e"c5mmitted'cos$ sB"It1sidif 86t7hd'id7 con'se' Native'models.
~
NUMARC Coment: Annual dose control accounts for all doses from current and previous years' intake but adds future doses as they occur. Annual dose determination is based on actual measurements on a worker such as lung counting Lnd autuwtically accounts fo'r variations among individuals, particle size and solubility, and inaccuracies inherent in air sampling.
NRC Staff Response: The future doses are added only during the period of
~
employment. The residual dose from retirement to death is not accounted for under the annual dose cuntrol but is a part of the overall risk from employment. The revised Part 20 permits use of actual measurements of radionuclides retention or excretion for estiniating intakes.
It also permits ddjustment of DAC or ALI values (with NRC approval) based upon the actut1 NUMARC COMMEhTS ENCLOSURE 9
characteristics of the working environnient.
(Suchasparticle W,and solubility),
NUMARC Comment: Annual dose control would promote real gains in reduc'ed worker exposure as a result of future ALARA efforts since the proof of ALARA efforts would be based on direct measurements on individuals.
Demonstration of ALARA under comitted dose control would encourage licensees to attack and reduce the conservatism in the committed dose determination as the most fruitful method of reduciig the measure of worker doses. Thus, ALARA under annual dose control woula lead to lower amounts of internally deposited radioactivity whereas ALARA under committed dose would tend to promote better air sanspling and dose analysis.
NRC Staff Response: Actual " direct measurements on individuals" are not prohibited by the revised Part 20; measurements of either body burdens or excreta are acceptable alternatives for showing complisace. The NRC staff sees no problen. In using more " realistic estimates of dose." he believe that most licensees may attempt to use "more realistic estimates of dose" regardless of whether doses are evaluated using annual or comitted dose models.
Effort should be directed more; towards prevention. of intake' of long-lived:.. "%. ne J---
radionuclides rather than departed post-intake analysis aised at showing that an overexposure dio not occur.
This philosophy is consistent with the'recent Federal guidance on occupational protection.
(RecommendationNo.4, 52 FR 2831, January 27,1987)
NUMARC COMMENTS EliCLQSURE9
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NUMARC ATTACHMENT B DISCUSSION OF NRC STAFF OBJECTIONS TO ACRS RECOMMENDATION CF ANNUAL DOSE FLEXIBILITY 10/7/88 It is NUMARC's understanding that the NRC staff objections were that the proposed Section 20.205:
- 1. Was criticized by the U.S. Department of Energy.
- 2. Would have been a significant departure from the established NRC policy of controlling the workplace not the worker.
- 3. Would mortgage worker's future employability due to internal doses froci e large intake allowable under an annual dose scheme.
NUMARC Discussion of item 1:
It is true the U.S. DOE criticized Section 20.205, indeed they criticized the NRC's entire dose limitation system. The DOE position, under the Presidential Guidance, is that committed dose would only be usea for design and planning. Any accounting of worker doses actually received should be based only on annual dose. DOE is in the process of updating their guidance to reflect this program.
It appears the NP.C staff misunderstood the sense of the DOE coments.
NRC Staff Rebuttal on item 1: The LOE comments on the proposed 10 CFR Part 20 supported the use of the committed dose equivalent for design and workplace controls and the annual dust approach for worker control., However, the DOE comments did not support the specific exemptions contained in $20.205 as being justified or complete.
NUMARC COMME!!TS ENCLOSURE 9
NUMARC Discussion of item 2:
Proposed Sec' tion 20.205 would have requireo licensees to design new facilities to meet comitteo dose controls and would hdve required licensees to operate all f acilities in such a manner "that any individual is unlikely to have an intake in excess of the ALI value [a comitted dose control]" thus clearly providing for control of the workplace on the basis of comitted dose.
Such controls for day-to-day operations would have to based on air sampling. After establishing workplace controls licensees would have the option of using an additional, separate control system to control the annual dose from present and previous years intakes of insoluble compounds.
i l
flRC Staff Rebuttal:
In essence, the NUfMC comment describes the provisions of the proposed 120.205.
However, this sumary fails to note that existing facilities would not have to comply with the lowered uranium air concentration limits in the revised Part 20, whereas existing facilities are currently requireo' to meet the existing Part 20 concentration limits.
The coment also, fails to note the control using the committed dose approach has been the
)
standard approach for over 30 years.
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HUMARC Discussion of item 3:
As given in Section 20.205 an annual dose system would be effective and practical for the vast majority of the workforce exposed to persistent radionuclides. Item 3 is a criticism based on hypothetical, improbable, or extremely infrequent cases.
Most workers in the commercial uranium fuel fabrication industry today are given lung counts routinely. Reruits how that the great majority of workers have measured lung contents less than 50% of the proposed 3 rem annual internal dose limit. Only a small fraction of workers in other nuclear industries receive external doses in excess of a few rems.
Therefore, it is highly unlikely that workers changing jobs from fuel fabrication to another nuclear industry would receive a conbined dose exceeding 5 rems.
NUMARC COMMENTS ENCLOSURE 9
1 l
Rather than cebate'on the basis of hypothetical examples, the NRC staff originally, drafting Section 20.205 suggested limiting the annual ir,ternal dose componen.t to'3 rems, 60% of the 5 rem annual total dose limit.
It is believed that this small conservatism would limit the combined doses of workers changing sobs between industries for all cases of practical interest.
Further, strict adoption of committed dose controls by the NRC does not make the problem go away. Workers with internal doses, whom DOE intends to manage on an annual dose basis, will, from time to time, change jobs to work for t'RC licensees.
NRC Rebuttal of item 3:
Based upon the distribution of doses as characterized above, the continuance o[ controls based upon the committed dose equivalent should not create a substantial impact. Again, the NRC staff believes that the principal issue is the 5-fold decrease in the uranium air concentration limits, not the remuval of the exception on propose 520.2C5.
The staff notes that the removal of this exemption, combined with the lowering of the airborne c' concentration limits for several radionuclides (notably thorium and uranium), might require extensive modifications to current and future facilities that use these meterials. Licensees that are affected by these changes may request an extension of the implementation tisie in order to make the necessary modifications to comply with the revised limits.
However, the st6f f believes that is reither reasunable nor practical to expect future employers to take special measures tu control radiation dose to wurkers because of previous employer, working under annual organ dost limits, permitted intakes thet would result in future dose rates that are appreciable fractions of the allowable dose limits. Such a practice would not be fair to workers whose future employability may be limited because of the additional restrictions a new employer would hav' to put on their exposure.
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IV. STAFF RESPONSE TO ACRS COMMENTS
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Response to ACRS Comments on 10 CFR 20,
" Standards for Protection Against Radiation" l
The following are the NRC staff responses to comments prepared by the Advisory Committee on Reactor Safeguards on the subject Prrposed Revisions of 10 CFR 20,
" Standards for Protection Against Radiation." These responses will follow the order of the specific comments given in the letter dated June 7,1988 from W.
Kerr, Chairman, ACRS, to Chairman Zech.
The ACRS made two general recommendations that the NRC staff has incorporated i
in the Part 20 Federal Register notice.
The first was to list the issues that were being resolved either by other NRC rulemaking proceedings or that would be resolved at a later date. This list of issues is presented in Section III (pages 15-16) of the Statement of Consideration..
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The second ACRS general recommendation was for a list of Regulatory Guides that the staff was planning to issue to provide further guidance on implementation of the Part 20 rule.
A list of the topics for the most important Regulatory Guides that the staff believes necessary is given in Section IV (page 17) of the statement. Although the ACRS recommendations suggested that schedules for these guides be included, the staff.is presently carrying out,a detailed examination of the Regulatory Guides needed to implement Part 20 so that f
publishing detailed schedules at this time would be premature.
y 1.
Recommendation:
We agree that application of the committed pffective dose equivalent is the proper approach to follow in planning for radiation protection and in controlling exposures from nuclear activities. However, the committed effective dose equivalent does not constitute a sufficient basis in itself for evaluating the potential health effects of radiation exposures in individuals.
Such evaluation should be based on estimates of the actual absorbed dose for the period of exposure appropriate to the
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.s individua1' case.
For this reason, in the case of radionuclides having long effective half-lives, it is recommended that licensees be provided the option of using the annual effective dose equivalent in the determination of compliance with 10 CFR 20.
Response: The NRC staff agrees that the committed effective dose equivalent is the proper approach for planning radiation protection and controlling exposure. This approach is the one upon which the ICRP recommendation is based, and the approach has also been adopted in the Federal Guidance ~for Occupational Exposures signed by the President on January 20, 1986. A second approach, the use of the annual effective dose equivalent, was provided in the proposed rule as a potential alternative to the committed effective dose equivalent for certain long-lived isotopes.
Considerable comment, both pro and con, was received on this proposal. As a result, the staff has decided not to allow use of the annual effective dose equivalent for the following reasnns:
~
The appfoach fs'inco'nh it'ent'with the recommendations of the ICRP d '- m -
a.
upon which th6'reVisfWri"Ts"tiised.
b.
The Federal Guidance, while allowing the use of annual effective dose equivalent, limits its use to situations where control of the l
workplace has been violated.
It was not considered as appropriate for normal operations and routine radiation protection. This position wes reiterated by Allan Richardson, EPA, during the ACRS meeting.
c.
The basic standards contained in 10 CFR Part 20 should be applicable to all licensees. An exception for certain licensees, principally fuel cycle facilities, would be inconsistent with this approach.
d.
Although cited as the reason for high costs to fuel cycle facilities, the committed effective dose equivalent is the approach under which these licensees have been regulated on the past. A more important j
reason for costs to these fuel facilities is the change in the Annuak
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Limit of Intake necessitated by the metabolic models and data developed since the original 10 CFR Part 20 was promulgated 25 years ago.
2.
Recommendation: The proposed regulations exempt " medical research programs" from the given dose limits; in a similar manner, they exempt' excreta from medical patients for release to sanitary sewers. We suggest that an analysis be made of the potential health impacts'of these exemptions. Also of possible benefit would be a survey of related practices in other countries.
Response: The NRC staff currently has underway a contract with PNL to examine dose pathways associated with sanitary sewer sludge. This research should provide information on the potential impacts of sanitary sewer releases. These exemptions are currently part of the regulations, and the NRC staff has not been presented evidence to withdraw the exemption. Comments on the proposed revision tended to support further a
expansion of exemption., t.a o., -. 4, _
3.
Recommendation: Several of the definitions included in the proposed revision appear to be' incomplete or to contain errors. These are:
a.
" Natural background" - this 'should emphasize that the exempted sources do not ir.clude those of natural origin that have been
" technologically enhanced."
1 4
~
b.
"Whole-body" - this definition states that a dose equivalent to the head will be recorded as to the whole body. Consideration should be given to the development of weighting factors for converting partial external body exposures into equivalent whole-body doses.
Response: The NRC staff does not propose to make any changes to the definition of " Natural Background." The ACRS proposal would remove
. " technologically enhanced natural radiation" from the exempted materials.'
Although this might be desirable, most " technologically enhanced radioactive materials" are not within NRC's statutory authority to regulate and should remain excluded.
The definition of whole body remains as previously defined in the regulations. However, an allowance for development and use of externai weighting factors has been added by a change to the definition of
" weighting factor" and a modified discussion in the Statement of Consideration for the final rule.
4.
Recommendation: The revised regulations do not allow any exemptions from the security requirements that cover access to licensed materials.
Quantities of certain radionuclides that represent minimal risk to health-should be exempted form these requirements.
Response: The NRC has had a longstanding policy that control should be maintained over.. radioactive materials not.only.to limit.radiatf or}.._,-....,...
exposures, but also to prevent contamination of the workplace and the environment. Certain quantities and forms of materials are granted exemptions from the requirc::ents of 10 CFR 20, and these materials would therefore not be subject to the security requirements. The staff does not believe that further exemptions are appropriate at this time.
5.
Recommendation: The proposea regulations require that recipients monitor i
for radioactive contamination and external dose rates, all transportation packages labeled as containing radioactive materials. We believe that monitoring for external radiation levels should be required only for those packages t. hat are required to have a warning label for external radiation.
Response: The Part 20 requirement to promptly monitor packages of radioactive material on receipt was added to the regulations in response to two incidents in the mid-1970's; one where spilled material was widely spread because the leakage was not promptly discovered over a weekend, and STAFF RESPONSE TO ACRS COMMENTS ENCLOSURE 10
+
. ~
one where a sealed source was partially unshielded during transport.
These int.idents demonstrated the potential for serious radiological consequence.where packaging became ineffective with no associated transportation accident which would serve as a warning of. danger. With no requirements for carriers to have radiation monitoring capability, the monitoring rule was imposed on licensees who receive packages of radioactive material. The rule was issued and made effective in May 1974 allowed by the issuance of Regulatory Guide 7.3, " Procedures For Picking Up and Receiving Packages of Radioactive Material." That regulatory guide notes that the general survey requirement of Part 20 would require some form of physical survey of each package received by a licensee, prior to being placed in use, for the radiation protection of the user and the ifcensee's facility. The requirements of $ 20.205 have added the requirement that package monitoring be done on an ~ expeditious basis for the protection of the transportation system. Any discovered leakage of radioactive material or radiation in excess of appropriate limits would be promptly reported so that remedial action could be taken with respect to contaminated vehicles and associated baggage and any exposed persons.
The rule in 5 20.205 has provided reasonable assurance that leakage of excessive radiation or radioactive material during transport will be l
discovered and reported on a timely basis. The rule has not, however, resulted in any reports of significance, the few reports received being primarily reports of fuel casks received with excessive uternal contamination due to " weeping" during transport. Based on this record over 14 years, the staff believes 'that the relaxation most needed is with respect to the promptness provisions which now require that personnel be made available over weekends to promptly monitor packages received. The staff does not consider that a relaxation in the type of packages being monitored is either justified or useful. Monitoring of labeled packages is similar to the existing rule but easier tu apply. To monitor only for packages labeled to indicate existing moderate external radiation levels (i.e. The Yellow-III label in DOT regulations, 49 CFR 172.403) would not serve the purpose of this requirement, which is to look at packages which
c 1
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'have the potential for serious consequence due to package failure during transport or as a result of inadequate package preparation for transport.
Thus, the staff believes that the requirement for sonitoring of all labeled packages is appropriate.
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UNITED STATES Roecklein I
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December 30, 1988
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1 The Honorable Lando W. Zech, Jr.
Chairman I
U.S. Nuclear Regulatory Comisrion Washington, D.C. 20555
Dear Chairman Zech:
SUBJECT:
COMMENTS ON THE PROPOSED DELETION OF SECTION 20.205 FROM THE PROPOSED REVISION OF 10 CFk PART 20, " STANDARDS FOR PROTECTION AGAINST RADIATION" (SECY-88-315) i During the fifth meeting of the Advisory Comittee on Nuclear Waste, December 21, 1988, we held additional discussions with the NRC staff on the proposed revision of 10 CFR Part 20, Standards for Protection Against Radiation.
In response to the inquiry from Commissioner Roberts (SRMdatedNovember 28,1988), these discussions were directed primarily to procedures for the control of certain long-lived radionuclides, such as those handled at fuel cycle facilities.
As you know, the proposed rule published in the Federal Register on January 9,1986 contained a new Section 20.205 which addressed the prncedures 'noted~ abo >ie'.
The proposed section recomended a modified procedure that had been drafted in recognition of the difficulties in '
measuring (in a practical manner and with the required accuracy) air concentrations in restricted areas and the amounts of radionuclides in bioassay samples taken from workers whose intakes had been held at or below the permissible annual limits of intake (ALI).
Although the proposed revision would have required licensees to design facilities so that air concentrations averaged over the year in restricted areas would be below the derived air concentration Ifmits and would also have required that suc*n facilities be operateo in a manner that would ensure that any individual would be unlikely to have an intake from occupa-tional exposure in any one year in excess of the ALI value, the modified procedure would have allowed licensees to permit doses to workers in excess of the limits in Section 20.201 as long as the sum of the in-ternal and external effective dose equivalent would not have exceeded 5 rem, and the annual effective dose equivelent from certain.specified internally deposited long-lived radionuclides would not have exceeded 3 rem.
We believe that such a modified procedure is unacceptable.
First, it would not be in accord with what we understand are the recommendations of either the International Comission on Radiological Protection (ICRP Publication 26, 1977) or the National Council on Radiation Protection and Measurements (llCRP Report No. 91,ld not be in conformance with theIn a 1987).
interpretation that such a position wou requirements outlined in the " Radiation Protection Guidance to Federal
V,,;
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The Honorable Lando W. Zech, Jr. December 30, 1988 Agencies for Occupational Exposure,* approved by President Reagan on January 20,1987 Based on our review of this issue we recomend that annual doses arising from the intake of long-lived radionuclides be limited to a dose l
comitment no higher than the annual dose limit of pro >osed Section 20.201. To make an exception for any specific group of radionuclides or Ifeensees would, in our opinion, be inappropriate.
Hence, we concur i.
with the NRC steff's recommendation to delete Section 20.205.
In addition, we recomend that the NRC encourage licensees to follow the guidelines contained. in the Radiation Protection Guidance to Federal-Agencies referred to above; namely, that record keeping include data on both the annual and comitted effective dose equivalent, as well as on thecumulative(lifetime) dose.
We hope these additional coments will be helpful.
Sincerely, 9s A 7d M A Dade W. Moeller Chairman
References:
1.
SECY-88-315 dated November 4, 1988 for The Commissioners from Victor Stello, Jr.,
Subject:
Revision of 10 CFR, Part 20, *Stan-dards for Protection Against Radiation."
2.
Staff Requirements Memo dated November 28,1988 for Victor Stello, Jr., EDO, W. C. Parler, 0GC, and D. W. Moeller, ACNW, regarding Briefing on Final Rule on Standards for Protection Against Ra-diation in Part 20.
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VII. Federal Guidance
~ mv- - - - --
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'r3822 I- =*
Presidential Documents i
4 l p.t u. u.. n n
..r. i.,,..g. es r fi J
' Recommendations Approved by the President Title s--
4 The President Radiation Protection Guidance to Federal Agencies T.
I for Occupational Exposure J
i He commendations concerning Feders! radiation protection guidance for occupational exposure transmitted to me by the Administrator of the Environ-mental Protection Agency in the memorandum published below are approved.
I direct that this memorandum be published in the Federal Register. To promote a cot,rdinated and effective Federal program of worker protection.
the Administrator la directed to keep infonned of Federal agency actions to l
implement this guidance and to 6terpret an.1 clarify these recommendations
]
from time to time, as necessary,in coordinat'en with affected Federal agen-cles. Consistent with existing authority, the Ao;n!Matrator may, when appro-priate consult with the Federal Coordinating Coune9 for Science. Engineering and Technology. He Administrator may also, when appropriate, issue inter-pretstions and clarifications in the Federal Register.
Approved: January 20.1987 g
e 9,. %
Emorandum for the Prealdent FIDERAL RADIATION PROTECTION GUIDANCE FOR OCCUPATIONAL r.
.3-..
EXPOSURE
.........w_.
.r......_.
r ba
%!s memorandum transmits recommendations that would update previous..
guidance to Federal agencies for the protection of workers exposed to ionizing 5
radiation. Dese recommendations were developed cooperatively by the Nu-clear Regulatory Commission, the Occupational Safety and Health Admints-tration. the Mine Safety and Hedth Administration, the Department of De-fense, the Department of Energy, the National Aeronautics and Space Admin-letration, the Department of Commerce, the Department of Transportation, the Department of Health and Human Servicea, and the Environmental Protection Agency. In addition, the National CouncU on Radiauon ncisction ar.d Mcas-urementa (NCRP), the National Academy of Sciences (NAS), the Conference of Radiation Control Program Directors (CRCPD) of the States, and the Health Physics Society were consulted during the development of this guidance.
Executive Order 10831. the Atomic Energy Act, as amended, and Reorganiza-tion Plan No. 3 of 1970 charge the Administrator of the Environmental Protection Agency (EPA) to "... advise the President with respect to radi-ation matters, directly or indirectly affecting health. including guidance for all Federal agencies in the formulation of radiation standards and in the estab-lishment and execution of programs of cooperation with States." His guld-ance has historically taken the form of qualitative and quantitative " Federal Radiation Protection Guidance." De recommendations transmitted here would replace those portions of previous Federal guidance 125 FR 4402),
approved by President Eisenhower on May 13.1960, that apply to the protec-e
3
.....____.n._.
1
)
Federal Register / Vcl. 52. No.17 / Tueaday. January 27, 1987 / Presid:ntial Documents taas
)
q' tion of workers exposed to ionidag radiati:n.%e porti:ns ef that gu; dance' which opply to exposure of the general public would not be changed by these s==m-Ma tions.
Dese recommendations are based on consideration of (1) current scientific andentanding of effects on health from lonidng radiation. (2) recommends.
tions of international and national organizations involved in radiation protec.
sian. [3] proposed " Federal Radiation Protection Guldt.nce fo'r Occupational Exposure" published on January 23.1981 (48 FR 7836) and public comments on that proposed guidance, and (4) the osUcetive experience of the Federal agencies in the control of occupational exposure to ionizing radiation. A -
l summary of the considerations that led to these recommendations is provided below. Pablic commeats on the pnviously proposed guidance and s nsponse to those comments are contained in the document " Federal Radiation Protec.
tion Guidance for Occupational Exposure--Response to Comments" (EPA Single copies of this report are available from the Program 420/1-44-011).
Management Office (ANR-458). Office of Radiation Programs. U.S. Environ-maatal Protection Agency. Washington. D.C. 20680; telephone (202) 47H388.
~
Rockground A review of current radiation protection p! dance for workers began in 1974 with the formation of a Federal interagency committee by EPA. As a resuit of the deliberations of that committee. EPA published an " Advance Notice of Proposed Recommendations and Future Public Hearings" on September 17, 6
23.1981. EPA published " Federal Radiation 1979 (44 FR 83785). On January Protection Guidance for Occupational Exposures; Proposed Recommends-tions. Request for Written Comments, and Public Haarings" (46 FR 7836).
- Houston, Public hearings were held in Washington. D.C. (April 20-23,1981):
Texas (May 1-2,1981); Ch!cago. Illinois (May 5-4,1981), and San Francisco, L
California (May be.1981) (46 FR 15205). De public comment period closed i
July 8,1981 (46 FR 28557). On December 15,1982, representatives of the ten Federal agencies noted above. the CRCPD, and the NCRp convened under the sponsorship of the EPA to review the lasues raised in public comments and to complete development of these recommendations.%e issues were carefully considered during a series of meetings, and the conclusions of the wo group have provided the basis for these recommendations for mvised Fede
- guidance, w _ _..
.a. __
EPA has also sponsored or conduifell'four Ina}orstudieIin support-oLab 3,
aview of occupational radiation protection guidance. First, the Committee ao
- =-
the Biological Effecto of Ionidng Radiations. National Academy of Sciennee--
National Research Council reviewed the scientific data on health ris Jevels of ionizing radiation in a seport transmitted to EPA on July 22'1980:
"7he Effects on Populations of Exposure to Low levels of lontdng Radiation:
T 1980" National Academy Press. Washington, D.C.1980. Second. EPA has published two studies of occupations radiation exposure: " Occupational Erposure to lonizing Radiation in the United Etstes: A Comprehensive Sum-mary for the Year 1975 (EPA 520/4-4H01) and
- Occupational Exposure to h:i$:g Radistion in the United States: A Comprehensive Review for the Year 1980-1985" (EPA 22/1-66-c05).
1980 and Summary of Trends for the Years Third, the Agency sponsored a study to examine the changes in previous!y derived concentration limits for intake of radionuclides from air or w neult from use of up-to<!ste dosimetric and biological transport models.
%ese are presented in Federal Guidance Report No.10. "The Radioactivity Concentration Guides: A New Calculation of Derived Limits for the 1 Radiation Protection Guides Reflecting Updated Models for Dostmetry and 520/1-44-010). Finally, the cost of implementing Biological Transport" (EPA the changes in Federal guidance proposed on January 23.1981 was surveyed and the findings published in the two. volume report: " Analysis of Costs for Compliance with Federal Radiation Protection Guidance for Occupatio Exposure: Volume i--Cost of Compliance"(EPA 520/2-ebOSF1) and " Vo F. Case Study Analysis of the impacts" (EFA 820/2-as-02b2). These EPA e
'3824 Fediral R:gister / Vol. 52. No.17 '/ Tuesday. January 27, 1987 / Presidential Documents reports are available from National Technical information Service. U.S. De-partment of Commerce. 5285 Port Royal Road. Springfield. Virginia 22t61.
ne interagency review of occupational redistion protection has confirmed the need for revising the previous Federal guidance, which was promulgated in -
1960. Since that time knowledge of the effects of ionizing radiation on humans has-Increased substantially. We now have a greatly improved ability to estimate risk of hann due to irradiation of individual organs and tissues. As a result, some of the old numerical guides are now believed to be less and some more protective than formerly. Other risks, specifically those to the unbom.
m now considered to be more significant and were not addressed by the old guidance, nese disparities and omissions should be corrected. Drawing on this improved knowledge, the international Commission on Radiological Pro- -
tection (ICRp) published, in 1977. new recommendations on radiation protec-tion philosophy and limits for occupational exposure.nese recommendations are now in use, in whole or substantial part, in most other countries. We have considered these neommendations, among others, and believe that it is appropriate to adopt the general features of the ICRP approach in radiation protection guidance to Federal agencies for occupational exposure. In two cases, protection of the unborn and the management of long. term exposure to Intemally deposited radioactivity, we have found it advisable to make addle l.
tions.
Here are forr types of possible effects on health from exposure to ionizing radiation. The first of these is cancer. Cancers caused by redistion are not different from those that have been historically observed, whether from known or unknown causes. Although radiogenic cancers have been observed in humans over e range of higher doses, few useful data are available for defining the effect of doses at normal occupational levels of exposure. The second type of effect is the induction of hereditary effects in descendants of exposed persons.ne severity of hereditary effects ranges from inconsequent-tial to fatal. Although such effects have been observed in experimental animals at high doses, they have not been confirmed in studies of humans.
Based on extensive but incomplete scientific evidence,it is prudent to assume that at low levels of exposure the risk of incurring either cancer or hereditary effects is linearly related to the dose received in the relevant tissue. The severity of any such effect is not related to the amount of dose received. Rat is, once a cancer or an hereditary effect has been induced, its severity is independent of the doses. nus, for these two types of effects, it is assumed that there is no completely risk free level of exposure.
1, A
ne third type includes a variety of effects for which the degree of damage (i.e., severity) appears to depend on the amount of dose received and for r
which there is an effective threshold below which clinically observable effects 5
do not occur. An example of such an effect is radiation sickness syndrome.
U which is observed at high doses and is fatal at very high doses. Examples of I
lesser effects include opacification of the lens of the eye erythema of the skin, and temporary impairment of fertility. All of these effects occur at relatively h!gh doets. At the levels of dose contemplated under both the previous Federal guidance and these recommendations, clinically observable examples of this third type of effect are not known to occur.
De fourth type includes effects on children who were exposed in utero. Not only may the unbom be more sensitive than adults to the induction of malformations, cancer, and hereditary effects, but recent studies have drawn renewed attention to the risk of severe mental retardation from exposure of the unbom during certain periods of pregnancy.ne risk ofless severe mental retardation appears to be similarly elevated. Although it is not yet clear to what extent the frequency of retardation is proportional to the amount of dose (the data available at occupational levels of exposure are limited). It is prudent to assume that proportionality exists.
ne risks to health from exposure to low levels of ionizing radiation were reviewed for EPA by the NAS in reports published in 1972 and in 1980.
+
sim nii mi-
Federal Register / W1.' 82, M.17 / Teesday, lannary 27, 1987 1 Presidential DocumInts -
3325 l
Regarding aancer there omiinues to tie divided cpinion en how to interpolate between the absence ofvediation affects at vero dose and the cheerved effects i
of radiation (mostly at high dosu) to estimate the most pmbable effects oflow l
Moses.Some weiesftists brileve that av&11able data best support use of a linear j
model for estimating such effects. 0thers.however, believe that other models,.
which osvally predict somewhat lower risks, provide better estimates.These 1
.f".
efferences of opinion have not been resolved to date by studies of the effects if radiation in humans,the most important of which are those of the Hiroshi.
inn and Nagasaki atom bomb survivors. Studies am now underway to reas-sess radiation done calculations for these survivors and in tum to pmvide tipproved estimates d risk. It wul be at least'several years before these assessments and estimates are completed and it is'not likely that they will conclusively resolve uncertainties in estimating low dose effects. EPA is inonitoring the progress of this work. When it is completed we will initiate
. reviews of the risks ofiowlevels of radiation. in order to pmvide the basis for'
.any indicateo reassessment of this guidance.
in sphe d she above amoestairtties sethaetes of the risks from exposum to low levels of ionizing radiation are reasonably well bounded, and the average
-l worker isbelleved to incur a setatively small risk of harm from radiation. This ettuation has resulta8 from a system af protection which combines limits on i
maximum dose with active application af measuret to =laimi*e doses within 1hese limits.%ese recommendations antinue that approach. Approximately
't.'s million workers were employed in occupations in which they were poten-tia!!y. exposed to radiation in 8980, thelatest year for which we have compre.
'bensive assessments. About half af these workers received no measurable occupational done. In that year the average worker measurably exposed to external radiation received an accrpational dose equivalent of 0.2 rem to the whole body, based on the meadings of individual doelmeters wem on the-surface of the body,We estimate (assuming a linear non-threshold model) the ancreased risk af premature death due to radiation induced cancer for such a idase is appmrimstely 2 to a in 100,000 and that the increased risk of serious 1pespective ertth other occupational hazards,put these estimat hereditary affects is somewhat smaller. To they are compareble to the observed tisk d job related accidental death in the safest industries, whole-sale and retail trades, for which the annual accidental death rete averaged shout 5 per100.000 fram teso to 9964. De U.S. average for all industries was 11 per 300.000 in.1984 and 1185.
These ascomir5tdations are based on the assumption that risks ofinL from estposure so mdiation shodid be considend in relation to the overafbe deriusd imm the activities osasing the exposure. %Is approach is similar to' 4 bat ansed by the Federal Radiation Council (FRC) in developing the 1900 Eederal guidance.ne FRC said then, " Fundamentally, setting basic radiation sprotection standards involvse possing judgment on the extent of the possible health hasard society 4s wming to ecoept in order to realise the known eenefits of radiation
- This leede to &ree basic principles that have governed omdistion pmtection of werkers in recent decades in the United States and in unost ether countries.Mthough the precise formulation of these principles has wwolved ever the years,itheir intent has continued unchanged, ne first is that any activity involving eeeopational apesure should be determined to be woeful enough to society to warrantthe exposure of workers:1.e., that a finding he made that the oetivity is "hmtifted".%is same principle applies to virtually
.any human endeavor,r ichinvolves some risk of injury. De second is that, n
for justified setkities, expoeure of the work force should be as now as wasonablyechien able (commonly designated by the acronym "ALARA") this has most recently been characterized as 'Jeptimization" of radiation protection hy the latemational Co==lacion an Radiological Protection (ICRp). Finally, to
< provide en wpper Gmit on visk to individual workers, " limitation" of the maximum allawed. individual dose is required. %1s is required above and beyond the protection.provided by the.first two principles because their primary objective is to minirnize the total harm from occupational exposure in
/
o e
l 323 Fediral Register / Vcl. 52. No.17 / Tuesday, [anuary 27, 1987 / presidential Documents the entire work force, they do not limit the way that harm is distributed among individual workers.
%e principle that activities causing ocemostional exposure should produce a E
net benefit is important in radiation protection even though the judpnent of net benefit is not easily made.%e 1960 pidance says:"There should not be -
any man made radieuon exposure without the expectation of benefit resulting
.I from such exposure..." And "It is basic that exposure to radiation should result from a real determination of its necessity" Advisory bodies other than the FRC have used language which has essentially the same meaning. In its most recent revision of intemadonal guidance (1977) the ICRp said "... no practice shall be adopted unless its introduction produces a positive net benefit." and in slightly different form the NCRP, in its most acent statement (1975) on this matter, said "... all exposures should be k',pt to a practicable minimum:... this principle involves value Judgments b", sed upon perception realistic numerical estimates of both benefits and riskrcierably in the fon of compensatory benefits commensurate with risks, s from activities involv.
ing radiation and alternative means to the same benefits."
nis principle is set forth in these recommendations in a simple form:"Ibere abould not be any occupational exposure of workers to ionizing radiation without the expectation of an overall benefit from the activity causing the exposure. An obvious difficulty in making this judgment is the difficulty of quantifying in comparable terms costs (including risks) and benefits. Given this situstion, informed value Judgments are necessary and are usually all that
~
is possible. It is perhaps useful to observe, however, that throughout history I
individuals and socleues have made risk-benefit judgments, with their success
[
usually depending upon the amount of accurate information available. Since more is known about radiation now than in previous decades, the prospect is e'
that these judgments can now be better made than before.
%e preceding discussion has implicitly focused on major activities, f.e., those instituting or continuing a general practice involving radiation exposure of workers. This principle also applies to detailed management of facilities and direct supervision of workers. Decisions on whether or not particular heks abould be carried out (such as inspecting control systems or acquiring spec:fic experimental data) require judgments which can, in the aggregate, be as.
significant for radiation protection as those justifying the basicactivitiaalhusi"".-73.Zr, -
tasks support.
--w
- : _ v m.
.A b
%e principle of reduction of exposure to levels that are "as low as reasonably achievable" (AIARA) is typically implemented in two different ways. First, it
)
is applied to the engineering design of facilities ao as to reduce, prospectively..-
i the anticipated exposure of workers. Second,it is applied to actual operations:
that is, work practices are designed and carried out to reduce the exposure of workere. Both of these applications are encompassed by these recommenda.
tions.' ne principle applies both to collecuve exposures of the work force and to annual and cumulative individual exposures, its application may therefore require complex Judgments, particularly when tradeoffs between collective and individual doses are involved. Effective implementation of the A1 ARA principle lavolves most of the many facets of an effective radiation protection program: education of workers concerning the health risks of exposure to radiation: training in regulatory requirements and procedures to control exposure; monitoring, assessment, and reporting of exposure levels and doses; and management and supervision of radiation protection activities, including the choice and implementation of radiation control measures. A l
comprehensive radiation protection program will also include, as appropriate.
'The recommendation that Federot egencies, throush their regulations, operational precedures and other appropriate means, maintain doses ALARA le not intended to express. and therefore should not be interpreted as expressing. a view whether the ALARA sancept abould seestitute e duty of care in tort litisation. Implementation of the A1. ARA concept requires e complex.
subjective betencins of scientific, economic and soclel lectors senerstly resulung to the attain-ment of everese dose levels alsnit,cantly below the memimum permlited by able guldence.
i Faderal Regleur / Vol. 52. No.17 f hesday.1snuary 27. '1987 / Passidential Docmaments M27 i
1 properly ' trained and qualified Tadiation protection personnel; adequately designed.' opersled, and maintained facilities and equipment; and quality essurance smd audit procedures. Another important aspect of such programs is j
maintenance of records of cumulative exposures of workers and implementa-j
~
' Eon ef appropriate ineseums to assure that lifetime exposure of workers
)
vepeatedly exposed near the hudte is minimised.
De types of work and motivity which involve worker exposure to radiation wary greatly and are mimintalered by many different Federal and State agencias under a avide vanety of. legislative authorities. In view of this
. complexity. Faderaltadiation protection guidance can address only the broad prerequisites afan effective ALARA program, and regulatory authorities must ensure that more detailed requirements are identified and carried out. In doing this,such authorities may find it useful to establish or encourage the use of 1 simirdstrative controllevels specifying.for specific categories of workers or) work situations, dose levels below the limiting numerical values recommend-ed in this guidance: 2) reference levels to indicate the need for such actions as J
ancorchag, dovestigotion, and intervention: and 3) local goals for limiting dadividual and collective occupational exposures. Where the enforcement of a general ALARA requirement de act yrsetical under an agency's statutory authorhy,it is sufficient that an esency endorse and encourage AIARA, and i
establish such regulations erhich result from A1 ARA findings ai may be useful and apropriate to aneat the ob}ectives of this guidance.
b
%e numerical radiation protection guidance which has been in effect since 1960 for limiting the maximum alowed dose to an individual worker is based es the concept of limiting the < lose to the most criticallj exposed part of the body. This approach was appropriate, given the limitations of scientific laformation available at that time, and aesulted in a set of five independent emerios! guides for ent=== axposure of a) the whole body, head and trunk, active blood forming a
, gonads,and lens of eye: b thyroid and skin of the whole body; c) b and foreanna, feet and ankles:)d) bone, and e) organa..A consequen:s of this approach when several different parts of the
, body are esposed simultaneouslyis that only the part that receives the highest dost rela tive to its respective guide is decisive for limiting the dose.
Current knowledge permits a more comprehensive approach that takes into account the separate contributions to the total risk from each e ed part of ne body. nese recommendations incorporate-the~ dose?we theysteel"7.-
introduced for this purpose by the ICRpin 1977. Rat system assigns weighting
.fsetors to the various parts of the body for the risks of lethal cancer and I
serious prompt genetic. effects (those in the first two generations); these factors are chosen so tbalthe sum of weighted dose equivalents represents a e
visi the esme as that from a numerically equal dose equivalent to the whole body. De ICRp reoenumeads that the effective (i.e. weighted) dose equivalent r*
lacurredin any year be lindled to 5 eums. Based on the pub!!c response to the almilar propceal pubhahed,hy epa.in 1981 and Federal experisnoe with samparable exposure benfts, the Federal agencies concur. %ese recommenda-2 c..: th=sfcre replcc6 use.1960 whole bouy numerical guides of a rems per enarter and EN-18) rems cumulative dose equivalent (where N is the age of Jhe worker) and enociated critical organ guides with a limiting value of 5 Jems effective dose equivalent Anamed in any year. Supplementary limiting salues are 1also secearnended to provide protection against those health sElacts for which an eIIsotive threshold is believed to exist.
In recommending 3 timiting value of 5 rems in any single year. EPA has had to balance a amnber lof considerations. Public comments confirmed that, for some beneficial setivities,1 occasional doses aproaching this value are not eensonably avoidable. On the 1other hand, continued annual exposures at or meer this irvel over substantial portions of a working lifetime would, we believe, lead to unwsnanted visits. For this reason such continued annual exposures should be svoided, and these recommendations provide such guld-ence..As noted earlier, these. recommendations s!so continue a system of protection which combines limiting values for maximum dose with a require-
(<*
382s Federal Regleter / Vcl. 82. Ib.17 / Tuesday January 27, 1987 / Presidential Documents ment for active application of measures to minimize doses-the AIAb requirement.nis has resulted in steadily decreasing average annual doses to workers value), an(most recently to about one. fiftieth of the recommended limiting d, to date, only a few hundred out of millions of workers have received planned cumulative doses that are a substantial fraction of.the s
maximum previously permitted cumulative dose over an occupational lifetime.
1 epa anticipates that the continued application of the ALARA requirement, combined with new guidance on avoidance of lerse cumulative doses, will result in maintaining risks to all workers at low levels. EPA will continue to review worker doses with a view to initiating recommendations for any further modifications of the dose limitation system that are warranted by future trends in worker exposure.
Certain radionuclides, if inhaled or in irradiate the body for many years. gested, may remain in and continue to Dese recommendations provide that radionuclides should be contained so as to minimke intake, to the extent reasonably achievable. When avoidance of situations that may result in such intake is not practical, the recommendations distinguish between pre expo.
sure and post exposure situations. With respect to the former. Federal agen-cles should base control of prospective internal exposure to radionuclides facility design, monitoring, training, and operating procedares? upon the en tire future dose that may result from any intake (the committe( dose), not just -
upon the dose accured in the year of intake. His is to assure that, prior to exposure to such materials, proper account is taken of the risk due to doses ht future years.
With respect to post. exposure situations, most significant internal exposure to radionuclides occurs at the result of inadvertent intakes. In the case of some long-lived radionuclides, it may also be difficult to measure accurately the..
small quantitles corresponding to the recommended numerical guidance for control of committed doses. In such cases, when workers are inadvertently exposed or it is not otherwise possible to avoid intakes in excess of these recommendations for control of committed dose,it will be necessary to take appropriate corrective action to assura control has been reestablished and to properly,mmge future exposare of the worker. In regard to the latter requirement, povision should be made to pontinue to monitor the annual dose T
received from radionuclides in the body as long as they remain in sufficient _._- --
amount to deliver doses significant compared to the limiting values for annual dose. Dese recommendations extend those of the ICRP because it is appro-priate to maintain active management of workers who exceed the guidance for
~~
committed dose in order that individual differences in retention of such
~
~
materials in the body be monitored, and to assure, whenever possible, ano-formance to the limiting values for annual dose.
nese recommendations also incorporate guidance forlimiting exposure of the unborn as a result of occupational exposure of fenaale workers. It has long been suspected that the embryo and fetus are more sensitive to a eariety of effects of radiation than are adults. Although our knowledge remains incom-p!sts. It has now become clear that the unbom are especially subject to the risk of mental retardation from exposure to radiation at a relatively early phase of fetal development. Ava!!able scientific evidence appears to indicate that this sensitivity is greatest during the period near the end of the first trimester and the beginning of the second trimester of pregnancy, that is, the period from a weeks to about 15 weeks after conception. Accordingly, when a j
woman has declared her pregnancy, this guidance recommends not only that the total exposure of the unbom be more limited than that of adult workers.
but that the monthly rate of exposure be further limited in order to provide additional protection. Due to the incomplete state of knowledge of the transfer
(
of radionuclides from the mother to the unborn (and the resulting uncertainty in dose to the unborn), in those few work situations where intake of radionu-clides could normally be possible it may also be necessary to institute measures to avoid such intakes by pregnant women in order to satisfy these recommendations.
f J
- edesal anglater / v41. st. A w / rendsy. Wy 27. ses7 / Psaldential Documents ants Ibe heshh protection objecces of this guidance f r the unbom should be schieved in accordance with the piovisions of Title VII of the Civil Rights Act of196t as amended, with respect to discrimination in employment practices.*
%e guidance spphes only to ettoetions in which the worker has voluntadly made her prepancy known to her employer. Protection of the unbom may be 4,.
- edieved through such measures es temporary job rotation, worker self.
esleotion.or ese ofprotective equipment.ne guidance recognl es that protec.
Son of tie unbom is e joint responsibility of the employer and worker.
Wackars should be 1sdormed of the risks Javolved and encouraged to voluntar.
% maka pregnancies known as early as possible so that any temporary.
ansagements necessary to modify exposares can be made. Convernly em. -
sloyers should make such.anangements in a manner that =laimI=es the impact on the worker.
De recommended numerical guidance for limiting dose to workers applies to.
6e sum of dose troen extemal end internal sources of radiation. His proce-doe is aconumanded so as to provide a single limit on the total risk from adiation exposum.%enfore, en these asses where both kinds of radiation isources are pesent, decisions about the control of dose from intemal sources shondd not be assh wjthout mpsal monalderation of their implication for dose dem extamalsammes.
[
' Se guldance emphasizes the importance of recordkeeping for annual, com-k'.
signed to evold burdensome re)quirements for crses in whic helgnificant. Currently, regula tory woords are not generally required for doses small compared to regulatory limits for annual extemal and intemal doses.
Under this guidance such regulatory practices would continue to be appropri-ste if doe consideration is gtven to the implications of summing internal and external doses and to recordkeeping needs for assessing cumuladve doses. To de extent ensonable such records abould be established on the basis of bdividual dealmetry rather than on monitoring of exposure conditions.
h summary, many of the important changes from the 1980 guidance are strecturs).%ese include introduction of the concept of risk based weighting af doses to different parts of the body and the use of committed dose as the, 4rimar.y basis for control ofintemal suposure. De numerical values of the j
.guldance for mart =um radiation deses are also modified.Dese changes bdng_~.... u and @ practice. An addition, guidance is provided for protect
~
dhis
~ into general-conformanwwith intimations) recomniendations e
and increased amphaals is placed on eliminating unjustified exposure and on b
larping lustified exposure as low as masonably achievable, both long stand-4 I
Ing tenets of radiation protection. ne guidance emphasizes the importance of hatraction of workers and their supervisors, monitoring and recording of Asass to workers. sad the use of administrative control and reference levels i
der carrying out A1ARAprograms.
n
%ese socorrmendations appg It is sometimes hard to ident to workars exposed to other than normal bachpound raistion on the J.
because everyone as exposed to natural sources of radieuon and many occupational exposures are small. Workers or workplaces subject to this i-st5 dance will be identified by the responsible implementing agencies. Agen.
sies will have to use care in determining when exposure of workers does not ased to be regulated. In making such determinations agencies should consider
'"The Crvil Rishte Act of sest, as amended, supsedes that *It shall be an entswful emplorseent pronuse lar an employer it) ao led er esfuse to hbe er to discharge any ind v6 dual er otherwise to escriminate agemst any individual with respect to ble compensation. serms, sendiuono er prwDeses of employment, because of such ladwidue!'e... ses... er is) to halt eestessle. se steerify his employees or applicante for employment in any way which would deprive er tend to deprive any indwidual of employment opportunlues or otherwloe adversely affect mis status as en employee, because of such indwidual's... een. 7 (42 USE scooe4(e)]. The Presnancy hacruninstion Act of ters defines "because of ses" so seclude because of er en the beels of propiancy. childbirth. or setsted medical conditione l42 USC mone[k)).
3830 Fed:ral Register / Vcl. 52. Nm.17 / Tuesday, January 27, 1987 / Presidential Documents both the collective dose which is likely to be evolded through regulation and the maximum individual doses possible.
Implementation of these recommendations will require changes that can reasonably be achieved only over a period of time.it is expected that Federal agencies willidentify any problem areas and provide adequate flexibility and the necessary transition periods to avoid undue impacts, while at the same time assuring reasonably prompt implementation of this new guidance.
Upon implementing these recommendations, occupational exposure should be reduced. It is not possible to quantify the overall exposure reduction that will be realized because it cannot be predicted how efficiently these recommenda.
tions will be implemented or how much of existing e :posure is unnecessary.
Dese recommendations reduce the maximum whole body dose that workers may receive in any one year by more than hdf (l.a., from a rems per quarter to e
5 rems per year), require that necessary exposure to internal radioactivity be controlled on the bas!s of committed dose, require that internal and extemal doses be considered together rather than separately, and provide increased protection of the unbom. We also expect the strengthened and more explicit recommendations for maintaining occupational exposure "as low as reason-s l
ably achievable" will improve the radiation protection of workers. Finally.
these recommendations would facilitate the practice of radiation protection by introducing a self. consistent system of limits in accordance with that in practice intemationally.
l Recommendations
%e following recommendations are made fer the guidance of Federal agen-cies in their conduct of programs for the protection of workers from ionizing radiation.
- 1. Here should not be any occupational exposure of workers t6 fonizing radiation without the expectation of an overall benefit from the activity causing the exposure. Such activities may be allowed provided exposure of workers is limited in accordance with these recommendations.
L No exposure is acceptable'without regard to the reason'for permitting ite._ _..
[.
and it should be general practice ~ to maintain doses from radiation to levels. m.7 below the limiting values specified in these recommendations. nerefore, it is fundamental to radiation protection that a sustained effort be made to ensure P
that collective doses, as well as annual. committed, and cumulative lifetime individual doses, are maintained as low as reasonably achievable (ALARA),
r economic and social factors being taken into account.
- s. In addition to the above recommendations, radiation doses received as a I-result of occupational exposure should not exceed the limitig relues for assessed dose 1o individual workein specified below. These are given sepe-retely for protection against different types of effects on health and apply to the sum of doses from extemal and intemal sources of radiation. For cancer and genetic effects, the limiting value is specified in terms of a derived quantity called the effective dose equivalent. For other health effects. the limiting values are specified in terms of the dose equivalent a to specific organs or tissues.
.?
'" Dose equivalent"is the product of the absorbed dose. e quality factor which varies with the energy and type of radiation. and other snodifying factors. as defamed by she internatioma,I emion on Radietion 1) nite and Measurernents.
O 9
e l
1
,.. ~
._m._
- - - ~ ~ - - - - - - -
t i
Feder:1 Regist:r / WI. 82. Ns.17 / Tuesday, January 27, 1987 / Presidendal Documents tast Cancer and Genetic Effects. The efrective dose equivalent. Hz. received in any year by an adult worker should not exceed 5 rems (0.05 sievert).* The effecuya dose equivalents defined as:
'1 H
~
E "7 "T '
T J
where w is a weighting factor and Hr is the annual dose equivalent averaged r
ever organ or tissue T. Values of w and their corresponding 8 organs and r
tissues are:
' con.de a.as arents a.ts Red bone marmw a.12 tamgs a.12 Thyroid am none urt en om Remainder, o.so For the case of uniform irradiation of the whole body, where H may be
. assumed the same for each organ or tissue, the effective dose equivalent is equal to the dose equivalent to the whole body.
OtherHealth Effects. In addition to the limitation on effective dose equivalent.
the dose equivalent. Hr. received in any year by an adult worker should not exceed 15 rems (0.15 sievert) to the lens of the eye, and 5 to
[
any other organ, tissue (including the skin), or extremity
- of the bo i
Additional limiting values which appi to the control of dose from intemal exposure to radionuclides in the work lace are specified in Recomniendation
- 4. Continued exposure of a worker at or near the limiting values for dose received in any year over substantial portions of a working lifetime should be avoided.This should normally be accomplished through application of appro-priate radiation protection practices established under Recommendation 2.
- 4. As the primary means for controlling internal exposure to radionuclides.-
agencies should require that radioactive materials be contained, to the extent reasonably achievable, so as to mini nire intake. In controlling internal expo _
- 4 sure consideration should also be given to concomitant external exposure.
~
sure of adult workers to r"adioactive materials in
-The control of necessa e the workplace abould igned, operated, and monitored with sufficient frequency to ensure that, as the roult of intake of radionuclides in a year, the b
following ihnitir4 values for contml of the workplace are satisfied: (a) the anticipated magnitude of the committed effective dose equivalent from such intake plus any annual effective dose equivalent from external exposure will not exceed 5 rems (0.05 sievert), and (b) the anticipated magnitude of the t
committed dose equivalent to ay Organ or tissue from such intake plus any annual dose equivalent from external exposure will not exceed 50 rema f0.5 sieven). Tne committed effective dose equivalent from internal sources of.
radiation. Ham.is defined as:
"E.50 "
"I T.50 '
T s %e imtt of done equivalent in the system of special quantitles fee ionizing redietion currently in use in the United States le the " rem."In the recently edopted international eystem (SI) the unit of dose equivalent is the % vert".One sievert = too reme.
e" Remainder" means the Sve other orsens (such as liver, kidneys, spleen, brain. thymus, adrenals, pancress, stomach, small intestine upper large intestine and lower larse intestine, but excludmg skin. lens of the eye. and satremities) with the highest Aoses. ne weighting facter for each such orsan is 006.
- *T.stremity" means the forearms and bends. or the lower legs and feet.
_m_ _ _ _ _ _ _ _ ____.____ _ _ _ _ _ _ _ _ _. _ _ _ _ _ _
}
3832 Feders! Regist:r / W1. 32. M.17 / Tuesday. Isnuary 17, 1987 / Presidential Documents j
where w, is defined es in Recommendation 3 and the comrnitted dose aquivalent Mean,is the sum of all dose equivalents to organ or tissue T that may accumulate over an individual's anticipated remaining lifetime (taken as 50 years) from radionuclides that are retained in the body. Dese condidons on committed doses should provide the internalexposure to radioactive materials.* primary basis for the control of
.J.
In circumstances where assessment of actual intake for an individual erorker shows the above conditions for control of intake have not been met.
Agencies abould required that appropriate corrective action be taken to assure control has been reestablished and that future exposure lof the worker is appropriately managed. Provision should be made to assess annual dose equivalents due so radionuclides retained in the body from such intake for as Song as they are significant for ensuring conformance with the limiting values specified in Recommendation 3.
- 5. Occupational dose equivalents to individuals under the age of eighteen should be limited to one-tenth of the values specified in Recommendations 3 and 4 for adult workers, i7.xposure of an unbom ch!!d abould be less than that of adult workers.
Mrkers should be infonned of carrtent knowledge of risks to the unbom*
<m radiation and of the responsibility of both employers and workers to
~1.aimi e exposure of the unbom.%e dose equivslent to an unbom as a result of occupational exposure of a woman who has declared that she is pregnant should be maintained es low as reasonably achievable, and in any case i
abould not exceed 0.5 rem (0.005 sievert) during the entire gestation period.
Efforts should be made to avoid substantial variation above the uniform monthly exposure rate that would satisfy this limiting value. De limiting value for the unborn does not create a basis for discrimination, and should be achieved in conformance with the provision of Title VII of the Civil Rights Act of 1964, as amended, re cluding hiring. discharge,garding discrimination in employment practices, i compensation and terms, conditions, or privileges of employment.
F. individuals occupational!!y exposed to radiation and managers of activities involving radiation abould be instructed on the basic risks to health from ionizing radiation and on basic radiadon protection principles.nis should, as a minimum. Include instruction on the somatic (including m ulem) and geneuc.
effects of ionizing radiation, the recommendations set forth in Federal radi-
- ~ -
ation protacuon guidance for occupational exposure and applicable regula-s l'
tons and operating procedures which implement this guidance, the general
[*
Arvels of risk and appropriate radiation protection practices for their work r
situations, and the responsibilities ofindividual worker to avoid and = tat =G exposure. ne degree and type of instruction that is appropriate will depend r
on the potential radiation exposures involved.
- 8. Appropriate monitoring of workers and the work place should be performed and recorde kept to anaute conformance with these recommendations. De types and accuracy of monitoring methods and procedures utilized should be 1periodies11y reviewed to assure that appropriate techniques are being compe-tently applied.
Maintenance of a cumulative record of lifetime occupational does for each worker is encouraged. For doses due to intake of radioactive materials, the committed effective dose equivalent and the quantity of each radionuclides in the body should be assessed and recorded, to the extent practicable. A summary of annual, cumulative. and committed effective dose equivalents should be provided each worker on no less than an annual basis: more 8 When 6ese senditione en intoke of radioactive meterials beve been actiefied. it le act ascesesty to tonese sentributtens from such intakes to annual doses in future years, and, as se aparational procedee, such doses mey tie sosigned to the year of intake for the purpose of an.es. ins eomphenoe with Recommendetron s.
e The term " unborn" is deFmed io emoompees Gie period commencing with sonorption and endens erith tsirth i
1
.(
FodIr:1 Registir / Vel. 52 No.17 / hesday, January 27, 1987 / presidentist Documents asas detailed informatica concerning his or her exposure should be made available upon the worker's request.
- 9. Radiation exposure control measures should be designed, selected, utilized, and maintained to ensure that anticipated and actual doses meet the obiec-1 tives of thin guidance. Establishment of administrative control levels' below-the limiting values for control may be useful and appropriate for achieving this objective. Reference levels' may also be useful to determine the need to take such actions as recordm' E. investigation, and laterventions. $1nce such admin.
~
istrative contro! and reference levels will often involve A1 ARA consider-ations, they may be developed for specific categories of workers or work situations. Agencies should encourage the establishment of measures by which management can assess the effectiveness of ALARA efforts, including. -
where appropriate, local goals for limiting individual and collective occupa-tional doses. Supervision should be provided on a part time, full time, or task-by task basis as ne essary to maintain effective control over the exposure of workers.
- 10. ne numerical vabes recommended berein should not be deliberately exceeded except during emergencies, or under unusual circulastances for which the Federal agency having jurisdiction has carefully coneidered the reasons for doing so in light of these recommendations. If Federal agencies authorize dose equivalents greater than these values for unusual circum-stances, they should make any generic procedures specifying conditions under which such exposures may occur publicly available or make specific instances in which such authorization has been given a matter of public record.
l The following notes are provided to clarify application of the above ecom-mendations:
- 1. Occupational exposure of workers does not include that due to normal background radiation and exposure as a patient of practitioners of the healing arts.
- 2. %e existing Federal guidance (Se FR 576 and 36 FR 13a21) for limiting exposure for underground miners to redon decay products' applies independ-ently of, and is not changed by, these recommendations.
- 3. He values specified by 'the International Commission on Radiological Protection (ICRP) diation, the models for reference persons, and th for quality factors and dosimetric conventions for the various types of ra their dosimetric methods and metabolic models may be used for determing conformance to these recommendations.
l
- 4. " Annual Limits on intake" (ALis) and/or " Deriv'ed Air Concentrations" 8
(DACs) may be used to limit radiation exposure from intake of or immersion l
in radionuclides. He A1J or DAC for a single radionuclides is the maximum intake in a year or average air concentration for a working year, respectively.
for a reference person that, in the absence of any external dose, satisfies the conditions on committed effective dose equivalent and committed dose equiv-e!ent of Recommendation 4. ALis and DACs may be derived imm differsat chemical or physical forms of radioactive materials.
- 8. He numerical values provided b these recommendations do not apply to workers responsible for the management of or response to emergencies.
%ese recommendations would replace those portions of current Federal Radiation Protection Guidance (25 FR 4402) that apply to the protection of workers from ionizing radiation. It is expected that individual Federal agen-cies, on the basis of their knowledge of specific worker exposure situations.
' Administrative control levels are requirements deterudned by a sempetent authorp of abe y
management of an institution or facihty. They are not primary halts. and may therefore be exceeded. upon approvel of competent authority or management. as ettogtione dictate.
- Reference levels are not limits, and may be empressed in terme of any useful perameter. They are need to determine a course of action, such se recordins. envestisation, or intervention. erhen the value of a parameter enceede. or la projected so encoed. the reference level.
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7 I !
3 s34 Federst Register / Vol. 52. No.17 / Tuesday January 27.1987 / Pres!Aantial Docurnents 1
I will use this new guidance as the basis upon which to revise or develop t
detailed standards and regulations to the extent that they have regulatory or I
administrative huisdiction. The Environmental Protection Agency will keep i
informed af Federal agency actions to knplement this guidance, and willissue eny necessary clarifimtions and interpretations required to reflect new infor-mation, so as to promote the coortlination necessary to achieve an effective Federal program of worker protection.
I If you approve the foregoing recommendations for the guidence of Federal agencies in the conduct of their rediation protection activities, I further recommend that this suemorandum be published in the Federal Register.
Ime M. Themes, Admlaistator.Karltonmental Protection 4ency.
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