ML20202G020
| ML20202G020 | |
| Person / Time | |
|---|---|
| Issue date: | 11/25/1974 |
| From: | Roger L NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| References | |
| SECY-R-75-162, SECY-R-75-162-R, NUDOCS 9902040237 | |
| Download: ML20202G020 (64) | |
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3 November 25, 1974
- SECY-R 16 2 l .I '
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POLICY SESSION ITEM "=gygP=
The t.ommissioners 3ce, q,4, n ,
Lt 37/9 Thru: Director of Regulation' 4h wg
Subject:
IMPLEMENTATION OF NCRP RECOMMENDATIONS FOR LOWER RADIATION EXPOSURE LEVELS FOR FERTILE WOMEN */
Category: This paper covers a minor, but controversial policy question which involves relatively low radiation risks, but major and conflicting social questions.
yLsue: The primary issue is how the AEC should respond to the ,
recommendation of the National Council on Radiation I Protection and Measurements (NCRP) set forth in NCRP j Report No. 39, issued January 15, 1971. That recommendation would reduce the maximum permissible dose equivalent to the 1 embryo or fetus by limiting occupational exposure of the i expectant mother to 0. 5 rem. A secondary issue is how the ;
AEC should proceed to inform all female employees who are 1 exposed to radiation in contractor and licensee facilities of the NCRP recommendation and the possible adverse effects of the higher radiation doses on offspring, as recommended by the General Accounting Office in a May 17, 1974 letter to Dr. Ray (Enclosure "A").
Decision
'C riteria: 1. AEC's general practice of adopting the principal i recommendations of the NCRP.
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!, ;j 2. The potential, reduction of exposure to embryos or fetuses is m W small in view of:
(a) The small number of workers who actually
[- l receive exposures in excess of the NCRP's recommendation for fertile women.
c (b) The small fraction (unquantified) of those workers who
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- C-r s (c) The Commission's policy to maintain occupational 2 radiation exposures "as low as practicable. " I O
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- R-75-162 R PDR ]
j */ See SECY-R-74-229 dated June 3,1974 - Implementation of NCRP C.
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i Recommendation for Lower Radiation Exposure Levels for Fertile j Women.
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- i The Commissioners 3. The likelihood that employers, in view of the practical i difficulties involved in implementation of the NCRP i recommendation, may not hire women for jobs where radiation exposure is a possibility, resulting in sex discrimination in employment.
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- 4. Informal staff comments of the Office of General Counsel i of the U.S. Equal Employment Opportunity Commission i (see Enclosure "H") that a regulation requiring adherence to the NCRP recommendation probably would be held to be inconsistent with Title VII of the Civil Rights Act of 1964.
(Title VII applies to employers of 15 or more employees). i The informal views of the O" ice of Legal Counsel, Department of Justice (see Enclosure F") are in concurrence with the position of the EEOC.
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, 5. The need to recognize the inherent responsibility of the individual woman with respect to her offspring.
I Alternatives _: 1. To decide not to implement the NCRP recommendation for lower dose limits for fertile women.
Pro: (a) The practical implications of implementing the NCRP recommendation for fertile. women are not accurately known at this time.
(b) This alternative would avoid discrimination by sex j likely to result from establishing lower limits that i
! apply only to women. l L
(c) This alternative would accord with the informal views of the EEOC and the Department of Justice !
regarding the legality of regulations implementing l the NCRP recommendation under Title VII of 1964 i
Civil Rights Act.
f Con: (a) This alternative would be inconsistent with AEC's general practice of adopting the principal recom-I mendations of the NCRP, ICRP, and FRC.
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l (b) The exposure limits in AEC regulations would continue l
fo be in excess of NCRP recommendations for limiting l exposure to embryos or fetuses.
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- 2. To proceed with the publication of a notice of proposed amend-ment to Part 20 implementing the NCRP recommendation by 1'
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The Commissioners l l
l specifying that during the entire gestation period, the maximum permissible dose equivalent to the fetus from occupational exposure of the expectant mother should not exceed O. 5 rem.
l Pro: (a) This a ternative would be consistent with AEC's l general practice of adopting the principal recommendations of NCRP.
l (b) It would allow for public input to the decision, t
(c) There would be some small reduction in the risk to i fetuses of those women who become pregnant while employed in work involving radiation exposure.
l Con: (a) Lower dose limits for women could lead to dis-crimination against the employment of women.
(b) Implementation would also require additional
- administrative controls that may result in sex l discrimination in employment.
l l (c) Implementation of a rule applicable to fertile or l pregnant women may involve questions concerning
! invasion of privacy, depending upon how the regu-
! lation was implemented.
I l (d) Direct implementation of a rule applicable to all women would make no provision for the woman who
-cannot or does not wish to become pregnant to be employed under dose liinits otherwise applicable to adults.
(e) According to the informal views of EEOC and the Department of Justice this alternative probably would be held to be inconsistent with Title VII of the Civil Rights Act of 1964.
(f) This alternative could be used by licensees who are also
. government contractors as a reason for not making l
good faith efforts" towards affirmative action on equal ,
employment of women under Executive Order 11246.
- 3. To proceed with implementation of the NCRP recommen-dation by the publication of a notice of proposed rule making that would achieve the degree of protection for the embryo or fetus by reducing the permissible dose limits for all i adult workers to 0,5 rem per calendar quarter.
s, The Commissioners Pro: (a) Implementation would avoid possibility of dis-crimination by sex.
I (b) There would be some reduction'in risk to I individual workers for whom radiation ex-posures would be reduced.
(c) It would allow for public input to the decision.
(d) It appears to appeal to organized labor.
Con: (a) Would go beyond any NCRP, ICRP, or FRC recommendation.
(b) In the absence of specific data we believe that such a dose limit is lower than reasonably achievable for some licensees.
(c) Implementation would cost both the nuclear in-dustry and the Government substantial sums of money (rnquantified)in that it would be necessary either to apply design and engineering efforts or employ additional workers in order to accomplish essential work within reduced individual dose limits. The latter could result in a net increase in total man-rems of exposure.
(d) Implementation would greatly aggravate (unquantified) the existing critical shortage of available workers in certain key occupations, e. g. , in nuclear power plants and industrial radiography.
(e) 13ases limits for all workers on a comparatively minor problem.
- 4. To decide not to adopt the dose limit recommended by NCRP for fertile women, but to implement the NCRP recommendation by: (a) publishing a proposed amendment to $19.12,10 CFR Part 19, that would require licensees to include in instructions to workers information about biological risks to embryos or fetuses exposed to ionizing radiation; (b) developing a Regulatory Guide providing i guidance regarding risks to embryos or fetuses from i
i exposure to ionizing radiation considered acceptable for dissemination to employees pursuant to S19.12; (c) publishing a proposed amendment to S20. I (c) 10 CFR Part 20, that would state that licensees should make particular efforts to keep the radiation exposure of an embryo or l
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The Commissioners !
fetus to the very lowest practicable level during the entire gestation period as recommended by the NCRP; and (d).
requesting all licensees to (1) submit data on the number and radiation exposure of women working in their facilities
- in jobs involving radiation exposure during 1973, and (2) advise all of the women so employed of the NCRP recom--
mendation, indicating that the intent of the recommendation is to minimize exposure to, and possible adverse effects on embryos or fetuses.
l Pro: (a) This alternative would be consistent with AEC's general practice of following the principal NCRP l recommendations although AEC would not adopt the recommended dose limits as regulations.
(b) It would avoid much of the potential for discrimination l
by sex and the potential impact on employability of
- women, and would accord with the informal views of EEOC and the Department of Justice regarding the legality of regulations implementing the NCRP recommendation under Title VII of the 1964 Civil Rights Act.
(c) It would avoid much of the potential for invasion l of privacy.
l (d) This alternative could not be used by licensees who are also government contractors as a reason for not making additional " good faith efforts" towards affirmative action on equal opportunity for employment of women under Executive Order 11246.
(e) A woman would have the opportunity to make an informed perscnal choice regarding the application of the NCRP recommendation to her employment and to her offspring.
(f) It implements the second recommendation of GAO, l i. e. , ". . . AEC inform all female employees who may l be exposed to radiation in contractor and licensee i
facilities of NCRP's recommendation and of the
, possible adverse effects on offspring from the higher radiation doses. "
Con: Would not provide specific numerical limits applicable to to women.
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The' Commissioners l
~ Discussion: The' International Commission on Radiological Protection in ICRP l Publication 9, adopted September 17, 1965, also has made !
recommendations regarding exposure of women of reproductive !
capacity which, while different in numerical detail, are similar !
in their intent to minimize dose to the embryo or fetus. -
The subject recommendation of the NCRP Report No. 39 was ,
among the matters considered in an exchange of correspondence - !
with the Environmental Protection Agency (EPA) in 1971 i (Enclosure"D"). While it is customary for AEC to implement ;
NCRP recommendations, no action was taken immediately pending provision of guidance by the EPA to Federal Agencies under the Federal Radiation Council authority transferred to ;
EPA. When EPA guidance was not forthcoming, the Directorate of Regulatory Standards considered five alternative courses of action and recommended (October 1972) publication of a notice of consideration inviting public comment on specific questions ,
of implementation. This proposal, and subsequent efforts to go forward with a notice of proposed rule making to implement the NCRP recommendation (February 1973) or with a re- ,
commendation not to do so (June 1973), failed to achieve i staff concurrence. In September 1973, AEC staff met with !
the NCRP and requested them to reexamine the bases for this !
recommendation, . including the social problems involved in !
implementation of the original recommendation. !
We are informed that on June 5,1974, the Board of Directors ;
of the NCRP, after the requested reexamination, reaffirmed ,
the original NCRP recommendation that the total dose j equivalent to an embryo or fetus as a result of occupational ,
exposure of the expectant mother, should not exceed O. 5 1 during the entire gestation period. The decision of the .
Board of Directors has been submitted to the full Council i for their approval. ;
1 Arguments against Alternative 1 include the historical ;
practice of the AEC to implement NCRP recommendations. ;
L However, it is recognized that the actual reduction of risk to ;
fetuses and the actual cost of implementation of the recommen- l dation are not accurately known. Estimates of that risk re- j duction would depend on, the number of women employed in l
jobs involving radiation exposure, or the fraction of those j
- that become pregnant while so employed; such data currently j t-exist only in licensee files. Data on the results of personnel .i l
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The Commissioners monitoring by four categories of licensees considered to re-present the greatest potential for significant occupational exposure indicate a total of 54,432 individuals were reported to have been monitored in 1973; 26,750 received measurable exposures averaging 0. 75 rem. Of those 26,750 individuals, 23,471 (87.7%) received less than 2 rems. Further, the staff believes that continued implementation of the "as low as practicable" concept implements the intent of the NCRP, and will result in further reduction of the radiation doses, and may make specific implementation of the NCRP recom-mendation of minor effect. On the other hand, consideration of the potential for impact upon employability of women, sex discrimination, invasion of privacy, and added administrative control that may be involved in direct implementation of the NCRP recommendation, and which defy quantification, would favor a decision not to implement the recommendation.
Alternative 2 would implement the NCRP recommendation directly. The position of is set forth in Enclosure ' proponents G". of this alternative The staff has considered and rejected a modification of Alternative 2 that would have provided that a woman, after being informed of the lower dose limit, the reason therefor, and after receiving appropriate information about levels of biological risk to an embryo or fetus exposed to ionizing radiation, could waive application of the lower limit. While the use of a waiver would provide the woman the opportunity to make an informed personal choice regarding application of the lower dose limit, and could eliminate some of the discriminatory aspects of a regulation, it presents legal questions regarding the status of a fetus as a person, and the right of a mother to waive a protective regulation in its favor.
Further, such a waiver could set a precedent for any worker to request a waiver of other applicable radiation limits.
The staff does not have in hand sufficient data to quantify the cost or other impact of reducing the dose limits for all adult workers to 0. 5 rem per quarter (Alternative 3). A large percentage of licensees and contractors would be unaffected. However, some activities would require extensive design and engineering changes or additional workers in order to accomplish essential work within the reduced limit. Action upon this matter could be delayed pending derivation of support-ing data, or such data could be developed during the period provided for public comment on a notice of proposed rule
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.The Commissioners
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The Regulatory staff recommends Alternative 4 on the basis that it provides endorsement of the NCRP recommendation to provide added protection to fetuses, yet does not provide a mechanism for discrimination against women.
! .The alternative actions being considered and the implementation proposed by the Regulatory Staff were discussed with the Atomic Energy Labor Management Advisory Committee on October 31, 4
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-1974. The Committee expressed general opposition to lower limits applicable to women only. The representative of the Oil, Chemical, and Atomic Workers Union stated that he would anticipate labor related problems if a limit such as proposed in Alternative 2 is promulgated. The Advisory Committee did not specifically endorse any one of the four Alternatives.
Recommendation: The Commission:
(a) Approve publication of a notice of proposed amendment to 519.12, 10 CFR Part 19, that would require licensees to include in instructions to workers information about biological risks to embryos or fetuses exposed to ionizing radiation.
(b) Approve publication of a notice of proposed amendment to 520,1 (c), 10 CFR Part 20, that would state that licensee.s should make.particular efforts to keep exposure of an embryo or fetus to the very 1 lowest practicable level during the entire gestation j period as recommended by the National Council -
l-on Radiation Protection and Measurements.
(c) N ote
- 1. The proposed amendment to 10 CFR Parts 19 and 20 set out in Enclosure "B", will be published in the Federal Register, allowing 60 days for public comment:
- 2. If after expiration of the comment period no significant adverse comments or significant questions have been received and no substantial l changes in the text of the rule are indicated, l the Director of Regulation will arrange for
- l. publication of the amendment in final form.
- If significant adverse comments or significant o ;
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- g. 1 The Commissioners questions have been received or if substantial changes in the text of the rule are indicated, the revised amendment will be submitted to the Commission for approval:
- 3. The Joint Committee on Atomic Energy will be informed of this action; ,
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- 4. The General Accounting Office will be informed of this action; i' i
- 5. !
An appropriate public announcement, such as Enclosure "C", will be issued upon filing of the I notice of proposed rule making with the Office of the Federal Register; i
6 Copies of the natice of proposed rule making will be mailed to all AEC licensees by a letter such as Enclosure "E", inviting their comments and request-ing that they advise the women they employ in jobs involving radiation exposure of the NCRP recommen-dation, indicating that the intent of the recommen-dation is to minimize exposure to and possible ad-verse effects on embryos or fetuses. This action would satisfy the second recommendation of the May 17,1974 letter frein GAO. By the same action licensees would be requested to submit data on the j number and radiation exposure of women working in their facilities in jobs involving radiation exposure during 1973 Licensees will also be ad-vised that the Commission considers it essential that the instruction to workers regarding health protection problems include appropriate information about biological risks, including risks to fetuses, from exposure to ionizing radiation at expected levels;
- 7. A Regulatory Guide will be developed that will provide guidance regarding risks to fetuses from exposure to ionizing radiation, considered acceptable for dissemination to employees pursuant to $19,12 The Guide would be made available concurrent with l promulgation of the proposed amendment in effective form.
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1 The Commissioners 8. Pursuant to $51. 5(d)(3) of Part 51 of the Commission's regulations, neither an environmental impact statement nor a negative declaration need be prepared in con-junction with the proposed amendment since the amend-ment is insignificant from the standpoint of environ-mental impact.
Coordination: The Office of the General Cnunsel, Directorates of Licensing and Regulatory Operations, the General Manager, and the Divisions of Biomedical and Environmental Research and Labor Relations concur in the recommendation of this paper. .The Divisions of Operational Safety and Naval Reactors favor Alternative 2 (see Enclosure "G").
The Office of Information Services prepared the draft announcement, Enclosure "C".
Scheduling: For consideration at an early policy session.
Director e egulatory Standards
Contact:
Walter S. Cool Ext: 153-36920
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OFFHQAL USE ONL( '
DISTRIBUTION NO. OF COPIES j Secretary. 12 Chairman Ray- 3' i Commissioner Kriegsman 3 J Commissioner Anders 4 General Manager 1 General Counsel 4 Asst. Gen. Mgr.-Controller 1 Planning 6 Analysis 2
'Information: Services 2 .
Inspection 1 !
Congressional Relations 1 Civil Rights Compliance 1 Asst. Gen. Mgr. for Admin. 1 i Labor Relations 2 Asst.-Gen. Mgr.. for E6D Programs 1 Naval Reactors 2 AGM for Biomed 6 Env Res 4 Safety Programs 1 Biomed 6 Env Research 1 Operrtional Safety 2 i Director of Regulation 1 Deputy Dir. of Regulation 1 l .
l Asst. Dir. of Regulation 1 i
Dir., Off. of Admin.-REG. 3 l Dir., Program Analysis-REG. .
.1 l Dir.,0ff.of Tech. Advisor-REG. 1 .
Dir.of Regulatory Standards '7 Dir.of Regulatory Operations 7-Director of' Licensing 2 ,
Dep.Dir.for Fuels 6 Mats.,L 1 :
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Asst. Gen. Counsel for L6R 1 j i
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- (Y' h.i..'[:."pl WASHINGTON. D.C. 20s4a* k-Y,4 7tE50URCE3 AND CCONOhtsC OEVELOPblEN T DIVISION B-164105 .
The Honorable Dixy Lee Ray Chairman, Atomic Energy Commission
Dear Dr. Ray:
During a survey of certain aspects of the Atomic Energy Comission's (AEC's) radiation standards, we learned of ar. issue which we believe war-rants your attention.
the flational Council on Radiation Protec-tion andIn aMeasurements January 1971 repory, recommended that "the maximum permissible dose ep ivalent to the(tiCRP) fetus from occupational exposure of the expectant mother should not exceed 0.5 rem." AEC's exposure standard in effect -
before the fiCRP report and in effect today sets a maximum exposure of 5 rems a year for all employees of both AEC contractors and licensees.
According to AEC officials and documents, AEC's established policy is to adopt f;CRP recommendations for application to both AEC contractor and licensee operations. However, in this instance, well over 3 years have elapsed since flCRP made its recommendation and AEC still has not adopted it.
Our discussions with AEC officials and a few contractors and licens-ees indicate that, during this period, female workers in AEC contractor and licensee operations may have been receiving radiation doses which, if they were pregnant, might have exposed fetuses to more than the reco:n-mended maximum dose.
On October 10, 1972, the Directorate of Regulatory Standards pro-ga posed five alternative courses of action available to AEC on the f;CRP reccc=endation. These were:
i" %* 1. Take no action
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$ 2. Publish a notice of proposed rulemaking adopting M p- 1 the NCRP reco.Tmendation. Om s-/.u/7/ j
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6 m Tim.4 A L _.
l E W-4 do IA nonprofit corporation chartered by the Congress in 1964 to, among y4F other things, collect, analyze, develop, and disseainate, in the public interest, information and recc mendations about (1) protection cgainst opg radiation and (2) rac1ation measurements, quantities, and units, par-i I
$p ticularly those concerr.ed with radiation protection. !
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.2-tc C6bteclier for appropriate action - ?!ote': Please send to appropriate staff offic l ith a vie.i so preparing an action that can be brought before the Ccomission at an cari !
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- B-164105
- 3. Reduce permissible dose limits for all workers.
- 4. . Issue a guide leaving implementation of the recom- 1 mendation to employers and to the female employees.
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- 5. Publish a notice of consideration inviting public !
comment on an approach to be trken. l l
Hembers of AEC's'. Regulatory staff favored adopting the last alternative.
AEC's Divisions of Naval Reactors, Operational Safety, and Biomedi-cal and Environmental Research, however, favored publishing a notice of proposed rulemaking adopting the NCRP recommendation. According to AEC correspondence, these divisions selected this alternative because-
- l "Unless the AEC intends to depart from arevious policy l or disregard the guidance of the * *
- NCRP] it seems !
inappropriate to solicit comments and suggestions on whether or not AEC should * * * [ adopt the recommendation]." . ~-
l AEC's Division of Labor Relations disagreed with the other AEC divi-sions and pointed out that establishing "more restrictive exposure limits for fertile or pregnant women may well be seen by women's groups as an attempt to establish a discriminatory occupational qualification based on sex, particularly since the . lower limit may be applied by contractors or licensees to all women in order to avoid the delicate problem of ascer- I taining which women are fertile and which are not." However, AEC corres-pondence indicates that the three divisions favoring adoption of the NCRP recommendation were of the view that:
"* *
- the involuntary aspect of the exposure and the radio-sensitivity of the human system during the development in utero took precedence as a consideration over other factors such as those pertaining to female employment."
In September 1973, the directors of several AEC divisions met with tne Chairnan of NCRP to discuss the question of discrimination and to request that NCRP reexamine its recommendation in light of this question.
NCRP is now reexamining the reccanendation.
AEC officials told us they expect that NCRP will reaffirm its recom-
! mendation within several months and that AEC would then decide whether to acoot it. AEC officials aise told us that, if AEC decides to adopt the NCRP reconnendation, it could take up to 12 months to implement it.
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B-164105' Information developed by AEC in 1970 showed that, at contractor facilities alone, several hundred female workers would be affected by. .
adoption of the NCRP recommendation. Also, AEC is attempting to develop statistic's and projections to define the actual risk in terms, of the cancers and leukemias that could result.if NCRP's recommendation is not adopted.-
RECOMMENDATIONS TO THE CHAIRMAN, AEC i
Because a radiation dose exceeding the maximum dose recommended by NCRP may possibly adversely affect the fetus of an exposed pregnant em-ployee, we recommend that, when NCRP finishes reexamining its previous recommendation, AEC expedite its decisicn on the acceptability of any -
such recommendation and its implementation. ,
7 We also recommend that, as an interim measure, AEC inform all fe-male saployees who may be exposed to radiation in contractor and licensee i facilities of NCRP's recommendation and of the possible adverse effects on offspring from the higher radiation doses. We believe that providing such information would be consistent with AEC's responsibility to protect -
l the public from radiation-induced health and safety hazards. Informing i female employees would permit them to exercise their own judgment on this i
issue while AEC is deciding whether to formally adopt NCRP's recommendation.
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We appreciate the courtesy and cooperation extended to our representa-tives during the survey. Because of our continuing interest in the area of radiation exposure standards, we would appreciate being informed of the action you take on our recommendations. .
We are sending copies of this report to the Director, Office of Man-agement and Budget; the Chairman, Joint Committee on Atomic Energy; the Chairmen of the House and Senate Appropriations and Government Operations Committees; and the Chairman of the Health Subcommittee of the Senate Com-mittee on Labor and Public Welfare.
As you know, section 236 of the Legislative Reorganization Act of 1970 requires the head of a Federal agency to submit a written statement on actions taken on our recommendations to the House and Senate Committees on Government Operations not later than 60 days after the date of the report, and to the House ar.d Senate Canmittees on Appropriations with the g e (96 f e
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agency's first request forLappropriations made more than 60 days after' the date of the report. .
Sincerely 'yours,
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. Henry Eschwege
. Director .
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. [10 CFR Parts 19 and 20]
NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS: INSPECTIONS STANDARDS FOR PROTECTION AGAINST RADIATION Implementation of NCRP Recommendations For Lower Radiation Exposure Levels For Fertile Women Notice is hereby given that the Atomic Energy Commission has under consideration amendments to 10 CFR Parts 19 and 20 of its regulations that would incorporate the intent of the recommendation of the National Council on Radiation Protection and Measurements (NCRP) in Report No. 39 that the radiation exposure to an embryo cr fetus be minimized.
Both the International Commission on Radiological Protection (ICRP) and the NCRP have set forth recommendations regarding reduced occupational radiation exposure limits for fertile women.
The most recent recommendation on this matter by the ICRP was in Publication 9, adopted September 17, 1965. Paragraphs 62-65 of that publication recognize that an embryo is especially radiosensitive during critical states of embryogenesis in the early months of pregnancy. The ICRP noted:
"In particular, the possible induction of leukemia and other malignant conditions must be considered. Recent studies in children indicate that exposure of the foetus in utero to doses of a few rads of X-rays can increase the incidence of malignant disease within the subsequent decade. Furthermore, investigation has shown that exposure of foetuses to doses of a few rads of X-rays can give rise to detectable somatic mutations, resulting in the condition of pigmented mosaicism, although this condition does not appear to be hazardous. "
The ICRP recommended that, in circumstances involving abdominal radiation exposure of women of reproductive capacity, such women should be employed only under conditions where the dose to the abdomen is limited l
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Enclosure "B" n
in thn light of questions concerning sex discrimination in employ-
, ment of women, invasion of privacy, and the constitutionality of special limitations applicable to fertile women, the NCRP Board of Directors reaffirmed the original recommendation.
The risk to an individual embryo or fetus can be estimated on the basis of available radiobiological data. Animal studies have shown that about I rem per day to the fetus over a large part of the gestation period is the lowest level of extended irradiation that has altered development. On the basis of available dose-effect data, radiation exposure at levels of those in current radiation protection standards appear unlikely to cause significant effects on development, growth, and fertility of the irradiated offspring.
Two major retrospective epidemiologic studies have suggested l a relationship between diagnostic radiation during pregnancy and the occurrence of excess leukemia and cancer deaths up to age 10 in the offspring. It has been estimated that an in-utero dose of 1-2 rems l increases the chance of leukemia developing in the offspring by a factor of 1.5 over the natural incidence; however, prospective studies l
of smaller populations failed to confirm these results. An increased risk of .l. 5 could mean a risk of 1 in 2,000 of the exposed child l developing leukemia in the first 10 years of life against the risk of approximately 1 in 2,880 with no exposure to man-made radiation.
l Based on this assumption, the 1972 United Nations Scientific Committee l
on the Effects of Atomic Radiation report estimated that not more than 23 " excess" deaths per million children per year per rem over
- a 10 year period would occur from leukemia. The National Academy i
I j Enclosure "B" l
e of Sciences has estimated that an equal number of other cancers may also result from irradiation. Although a considerable difference of opinion exists as to the etiologic role that radiation may play in the production of tumors or leukemia in children, the NCRP has adopted the conservative viewpoint of a positive relationship between fetal irradiation and childhood malignant disease.
Data on the results of personnel monitoring reported to the Commission pursuant to $20. 407,10 CFR Part 20, for calendar year 1973, indicate that 67,862 in:!ividuals were monitored, 29,169 received measurable exposures averaging 0.73 rem for the year, and 3,435 individuals (11. 8% of those receiving measurable exposures) had estimated exposures in excess of 2 rems. (The four categories of licensees are specified in $20. 407(a), and are the categories considered to have the greatest potential for significant occupational exposure. ) Reduction of the dose limits for all radiation workers in order to avoid discrimination against women i l
does not appear practicable. Such a reduction in the dose limits would cost the nuclear industry large sums of money in the application of design and engineering changes and, in some cases, the employment of additional workers in order to accomplish essential work within l
the reduced individual dose limits. The latter could even result in a net increase in total man-rems of exposure. Reduction of the dose limit for 211 workers would aggravate an existing shortage of available manpower in certain key occupations, e. g. , radio-graphers, welders, and pipefitters, that may involve relatively high radiation exposures.
- Enclosure "B" 1
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l In evaluating the potential risk to fetuser, one should take l
into account the fact that women are less than proportionately i
represented in those occupations most likely to involve relatively l high occupational exposures. Also, many women, for one reason or another, are not fertile; and, at any given time, only a small
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l portion of the fertile women ceing exposed are pregnant.
Further, the Atomic Energy Commission implements the l recommendations of the NCRP, ICRP, and Federal Radiation Council (whose responsibilities have been transferred to the Environmental Protection Agency) that radiation doses be maintained as low as practicable. Paragraph 20.1(c),10 CFR Part 20, specifies that an AEC licensee should "make every reasonable effort to maintain radiation exposures, and releases of radioactive material in I effluents to unrestricted areas, as far below the limits specified in this part as practicable. " The Commission believes that its I
implementation of this "as low as practicable" concept reflects practical application of the intent of the NCRP. The Commission also believes that continued implementation of this concept in its licensing and enforcement process and in its operations will result in further reduction in radiation doses, and may make specific adoption of the NCRP recommendation regarding additional limitation I on exposure of fertile women of minor effect.
The Commission recognizes problems in the practical implementation of the ICRP and NCRP recommendations. If a regulation were to be promulgated indicating a difference in l
l radiation protec+ ion standards applicable to fertile or pregnant Enclosure "B"
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- women versus other women, implementation would require a licensee to know which of his female employees are fertile and which pregnant. Many would consider the information that an individual is fertile or pregnant to be a most intimate, private matter.
The Commission recognizes the potential for impact of a change in the radiation dose limits for women on continued employment in certain jobs usually filled by women, such as medical and laboratory technicians and nurses, and on consideration of women for employment in certain jobs involving radiation l exposure that are now usually filled by men.
At the same time, the Commission considers that the evidence of greater radiosensitivity of the embryo and fetus, and the concern expressed by both the ICRP and NCRP over the possible j 1
adverse effects on the human embryo and fetus, should be taken i into account.
The proposed amendment to 10 CFR Part 19 that follows would amend 519.12 to require licensees to include in instruction to workers regarding health protection problems associated with exposure to radiation and radioactive materials, information about biological risks to embryos and fetuses.
The proposed amendment to 10 CFR Part 20 that follows would supplement the wording in $20.1(c), quoted above, with a i
statement of the the purpose of the Commission that licensees I should make particular efforts to keep the radiation exposure of an embryo or fetus to the very lowest practicable level during i
3 Enclosure "B" i
l
.v-
. I*
i the entire gestation period as recommended by the NCRP. It is l l
not proposed to amend the dose limiting. sections of the Commission's ;
regulations to differentiate between women and men. I The Commission is taking other actions in addition to publication of this notice of proposed rule making. All AEC licensees are requested to (1) submit data on the number and radiation !
i exposure of women working in their facilities in jobs involving radiation exposure during 1973; and (2) advise all of the women so i
employed of the NCRP recommendation, indicating that the intent i
of the recommendation is to minimize exposure to, and possible adverse effects on embryos or fetuses. Licensees are also advised that the Commission considers it essential that the instruction to l
workers regarding health protection problems, provided pursuant !
to $19.12,10 CFR Part 19, include appropriate information about risks to fetuses from exposure to ionizing radiation. The instruction should contain information similar to that presented in this notice of proposed rule making. The Commission is developing a Regulatory Guide that will provide guidance regarding risks to fetuses from exposure to ionizing radiation, for dissemination to employees pursuant to $19.12. If, after consideration of all aspects of this matter, including consideration of comments filed in response to this notice of proposed rule making, the Commission decides to pro-mulgate the proposed amendment in effective form, the Regulatory Guide would be made available concurrently.
The Commission believes that, by following good radiation protection procedures in accordance with actions being proposed Enclosure "B"
i or ta' ken, radiation exposures of fertile women and fetuses will be kept well within the numerical dose limits recommended by the l NCRP without undue restriction on activities involving radiation and radioactive material.
Pursuant to the Atomic Energy Act of 1954, as amended, !
and section 553 of title 5 of the United States Code, notice is hereby given that adoption of the following amendments to Title i 10, Chapter I, Code of Federal Regulations, Parts 19 and 20 is contemplated. 'All interested persons who desire to submit written comments or suggestions for consideration in connection with the proposed amendments should send them to the Secretary of the Commission, U.S. Atomic Energy Commission, Washington, D.C. 20545, Attention: Docketing and Service Section by ,
- Copies of the comments on the proposed amendments may be examined at the Commission's Public Document Room at 1717 H Street, N.W. , Washington, D. C. .
- 1. Section 19.12 of 10 CFR Part 19, is amended to read as follows:**
$19.12 Instruction to workers All individuals working in or frequenting any portion of a !
restricted area shall be kept informed of the storage, transfer, or use of radioactive materials or of radiation in such portions of the restricted area; shall be instructed in the health protection l
problems associated with exposure to such radioactive materials i
or radiation, including biological risks to embryos or fetuses, in precautions or procedures to minimize exposure, and in the
- A date will be inserted allowing 60 days for public comment.
- Comparative text. Added material is underlined.
- Enclosure "B" l
l
. j purposes and functions of protective devices employed: shall be l
instructed in, and instructed to observe, to the extent within j the worker's control, the applicable provisions of Commission regulations and licenses for the protection of personnel from exposures to radiation or radioactive materials occurring in such areas: shall be instructed of their responsibility to report promptly to the licensee any condition which may lead to or cause a violation of Commission regulations and licenses or annecessary exposure to radiation or to radioactive material; shall be instructed in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and shall be advised as to the radiation exposure reports which workers may request pursuant to $19.13. The extent of these instructions shall be commensurate with potential radiological health prote ction problems in the restricted area.
- 2. Paragraph 20.1(c) of 10 CFR Part 20, is amended to read as follows:
320.1 Purpose. ,
l
$ o o e
- l (c) In accordance with the recommendations of the Federal Radiation Council, approved by the President, persons engaged in activities under licenses issued by the Atomic Energy Commission i
pursuant to the Atomic Energy Act of 1954, as amended, should, )
in addition to coraplying with the requirements set forth in this l l
part, make every reasonable effort to maintain radiation exposures, and releases of radioactive materials in effluents to unrestricted
-9 Enclosure "B" r
i l
, . .. l
. i areas, as far below the limits specified in this part as practicable. i Such persons should make particular efforts to keep the radiation exposure of an embryo or fetus to the very lowest practicable level l
(
during the entire gestation period as recommended by the National !
Council on Radiation Protection and Measurements. The terms j i
l "as far below the limits specified in this part as practicable" and i "very lowest practicable level" mean[s] as low as is practicably achievable taking into account the state of technology, and the l economics of improvements in relation to benefits to the public health and safety and in relation to the utilization of atomic energy !
in the public interest.
l (Sec.161, Pub. Law 83-703, 68 Stat, 948; (42 U.S.C. 2201))
i Dated at this l l
l day of 197 .
For the Atomic Energy Commission l
1 l Secretary of the Commission !
l l
I i
10 - Enclosure "B" i i
I w w n w- , w ,
r 1
o ENC LOSURE "C "
DRAFT PUBLIC ANNOUNCEMENT AEC IMPLEMENTS NCRP RECOMMENDATION FOR LOWER R ADIATION EXPOSURE LIMITS FOR FERTILE WOMEN The Atomic Energy Commission is taking action to implement recommendations of the National Council on Radiation Protection
- and Measurements (NCRP), and the International Commission on Radiological Protection (ICRP), for lower radiation exposure limits for fertile women. The basis for the recommendations is to minimize possible exposu- e to an embryo or fetus, considered to be more radiosensitive than an adult.
Both the NCRP and ICRP, which provide recommendations regarding radiation exposure, have strongly recommended that steps be taken to assure that the radiation exposure after conception but before a pregnancy is diagnosed, together with accumulated ex-posure during the entire pregnancy, will not result in adverse effects on the unborn child.
NCRP has recommended that during the entire gestation period the maximum permissible exposure to the fetus from occupational exposure of the expectant mother should not exceed 0. 5 rem ---a rem is a measure of human exposure to radiation. NCRP states, further, that this implies that fertile women should be employed only in situations where the annual exposure is unlikely to exceed two or three rems and is acquired at a more or less steady rate.
In such cases, the probability of the exposure to a fetus exceeding I 0.5 rem before a pregnancy is recognized is negligible. Once a pregnancy is known, the actual approximate exposure can be 1
! Enclosure "C"
t reviewed to see if work can be continued within the recommended l r
limit of 0.5 rem during the pregnancy. ,
NCRP noted that the method of application is speculative !
i and needs to be tested for practicality in a wide range of occupational '
f l circumstances, but recommended vigorous efforts to keep exposure l
l of an embryo or fetus to the very lowest practicable level. !
i The AEC's Regulations already provide that every effort !
t l should be made to keep radiation exposures "as low as practicable. " !
(
l Information on radiation exposures reported to the AEC by certain l i
l licensees considered to have the greatest potential for significant :
i occupational exposure, indicate that the average exposure of those j
, found to have received any measurable amount was 0.75 rem during f i
1973; approximately 90"/o of those individuals received less than 2 rems. l The Commission believes that continuing implementation of the "as )
low as practicable" concept will result in further reduction in l
exposures. l The Commission recognizes the potential for impact of a j i
change in the occupational radiation exposure limits on the status ;
of women in occupations commonly filled by women such as l medical and laboratory technicians and nurses and on consideration I
of women for employment in certain jobs commonly filled by men. I i
On the other hand, the Commission considers that the evidence of !
i greater radiosensitivity of the embryo or fetus, and the concern l l
expressed by both the ICRP and NCRP over the possible adverse r
effects on the human embryo and fetus, should be taken into i i l
[ account. i
+
l i -2 Enclosure "C" !
l 1
l l
i I
- f. l
The AEC is proposing several actions to implement the recommendations. It is proposing an amendment to Part 19 of its regulations that would require licensees to include in instructions to workers regarding health protection problems associated with exposure to radiation and radioactive material, information about biological risks to embryos or fetuses. It is proposing an amendment to Part 20 of its Regulations that would l supplement the statement of purpose regarding maintaining !
exposures as low as practicable to state that licensees should make particular efforts to keep the radiation exposure of an embryo or fetus to the very lowest practicable level during the entire gestation period as recommended by the NCRP. It is not proposing to limit, by regulation, exposures to women as compared to men, l
- At the same time, the AEC is requesting all licensees to submit data on the number and exposure of women working in their l
l facilities in jobs involving radiation exposure during 1973.
l Licensees also are being requested to advise all of the women
- so employed of the NCRP recommendation, indicating that the intent of the recommendation is to minimize exposure to, and possible adverse effects on embryos and fetuses. In addition, licensees are being advised that the Commission considers it l
l essential that the instruction to workers regarding health protection problems, under AEC Regulations, include appropriate information about risks to fetuses from exposure to ionizing radiation. The AEC is developing a Regulatory Guide that will 1
Enclosure "C" l
r-provide guidance regarding risks to fetuses from exposure to radiation, considered acceptable for dissemination to employees.
The proposed amendments to Parts 19 and 20 of the Commission's Regulations will be published in the Federal j Register on , 1974.
l Interested persons who desire to submit comments on the l proposal should do so in writing by , 1974.
Comments should be sent to the Secretary of the Commission, U.S. Atomic Energy Commission, Washington, D.C., 20545, Attention: Docketing and Service Section.
1 L
l Enclosure "C" l
l
,. l
- ~
. .. , I i
. .f C
LETTER FROM THE ENVIRONMENTAL PROTECTION AGENCY AND AEC REPLY P y ENVIRONMENTAL PROTECTION AGENCY Washington, D.C. 20460 -
l March 26, 1971 office of the Administrator Honorable Glenn T. Seaborg Chairman U. S. Atomic Energy Commission -
Washington, D. C. 20545
Dear Mr. Chairman:
On December 2, 1970, the Environmental P.rotection Agency assumed the functions of the Federal Radiation Council and the Atomic Energy Commission's responsibility for establishing generally applicable
, standards for the protection of the environment against the effects of releases of radioactive material. These authorities and responsi-bilities were transferred to EPA by Reorganization Plan No. 3 of 1970.
The basic Radiation Protection Guides (RPG) for exposure of individuals and populations used by Federal agencies were recommended by the FRC and approved by the President in May 1960. These guides are under review by our Radiation Office, in consultation with the National Academy of Sciences, the National Council on Radiation Pro-tection and Measurements, and interagency task groups, as a continua-tion of the effort initiated by the FRC. If the results of these studies indicate the need for changes in the RPG's, new guidance will be provided by EPA.
Until these studies are completed, the existing RPG's, as defined by the FRC, supplemented by the recommendations of the NCRP and the ICRP (International Commission on- Radiological Protection), will continue to be used by Federal agencies for radiation protection (by EPA as well as by other agencies). The RPG is defined as the radia-tion dose which should not be exceeded without careful consideration of the reasons for doing so; every effort should be made to encourage l
the maintenance of radiation doses as far below this guide as practi-cable.
Following a ten-year study on its basic radiation protection standards, the NCRP recently issued Report No. 39, " Basic Radiation Protection Criteria;" a copy is enclosed. EPA staff have been re-viewing this report with a view to deciding what, if any, EPA action may be indicated in relation to the review initiated by the FRC.
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l Honorable Glenn T. Seaborg l i
- 1 To assist us in this review, we would appreciate any comments or l suggestions you might have concerning possible acceptance by EPA of some of the recommendations in Report No. 39, and possible effects of ;
implementing such recommendations. We particularly direct your atten- i tion to the following matters covered in the NCRP recommendations: l
\
a) A special occupational exposure Ibnit for fertile women. l i
l b) Limits applicable to people exposed to patients released
]
from hospitals after treatment with radioactive material, j
\
c) A decrease in the dose limit for exposure of individual organs to make them the same as limits applie,d to exposure of the whole body.
Your views will be very helpful to us in developing definitive ERA guidance in these and other areas covered in the NCRP report. {
Sincerely yours, __
, Signed by William D. Ruckelshaus Willian D. Ruckelshaus Administrator Enclosure 1
l i
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,. cnatrman seaborg (e) ~,
Commissioner Raracy ,
Commissioner Johnson '
Commissioner Larson
. R. E. Hollingsworth, CM (2)
~
g 21 N John A. Erlewine, AGMO
! lionorable Willinto D. Ruckelshbus t. DR Administrator gg 6
.... Environpantal Protection Agency
Dear Mr. Ruckelshaus:
In response to your letter of !! arch 26, 1971, the Atomic Energy -
Coranission provides the encioned cor.rnents and suggestions on
~ the use of the recom.2ndations in the National Council on Radia-tion Protection and M2acurerr.muts (UCRP) Report No. 39, "Dasic .
Radiation Protection Criterin." ,
The guidance issued by the Federn1 Radiation Council was general in nature - that is, it involved philosophical cnd nuraarical guidelinen that stated tha objectivas of adequato radiation con-
- trol progrars uithout specifyin3 to an inordinate degree the usys of meeting these objectives. This ficxibility has allotted ths regulatory agencic.s to adapt their standards to the varying cit-untions encountered in different atomic energy endeavors uhilo still maintaining an cdequate degrco of health pr._e:. tion for ,
the uorker and for the public. ,
Ue note in your letter that the Rndiation Protection Guides "(RPG) for cr.posure of individenis and populctions used by Federal agen-cies are under revieu and that until the studice are coupleted, the existing RPG supplemnted by the recour.2ndations of the l'CR1*
nad the ICRP will continue to ba used by Federal agencies for radiation protection. .
liuch of the guidance anr', other inforrution in the NCRP Report No. 39 in intended for tha use of other scientific comittecc Of the NCRP as well ns the industry; not all of the recorenendations are amannbla
.to acceptance as general guides or to issuance by AEC and other agen-
.cios as regulatory stcndards. Tha onclosed staff annlysis in pro-vided to assist you in evaluating the- relative unrits of the various recomnandations of, the UCRP. -
.. I hope tha't these vicws.and the cuelosed staff analysis will be useful to you. Please do not h2citate to advise if the Atomic Enorgy' Com:nission can be of further assiotance.
Sincerely,
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E OS: ADHP7 e OS::
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,* 'j ' STAFF ANALYSIS - AT01HC EMERGY COMMISSION (AEC)
. s NCRP REPORT NO. 39 , i l
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CENERAL COMMENTS ' '
XCRP Rc' port No. 39, " Basic Radiation Protection Criteria," contains I
' backI ;round information, data and analyscs, and basic radiation pro * '
l tcction criteria. The latter criteria nay be divided into threc ;
l categorics: (1) philosophical guides and premises, generally non- 1 l , numerical, (2) numerical dosc-limiting recommandations, and (3) administrative guides.
Philosophical guidos either present the rationale and' value judgments implicit in the derivation of dosc-limiting reconraendations or present concepts that are not readily amenabic to quantification (such as application of radiation to human subjects for research purpose's,
' dose allocation for the population, or Icgitimacy of varying standards,
'for different situations). Nunarical dosc-linitian recomm2ndations, such as those listed in Tabic 6 of the report, c.r u luabic in de .
- riving regulatory standards but are not necessarily ap;w y -inte for l
. . incorporation directly .into.a regulation (for. cxampic, population dose limits or prospective /rctrospective occupational dose linits).
' Admin strative guides, philosophical or numarical, generally provide
- ~ guidai ce on one or more possibic approaches that may be used to im-l plcmer : a basic dose-limiting recommendation; such guides are not always appropriate to incorporation directly into regulations. In
- considiring these various types of criteria, it is necessary to j distin uish betueen,possibic incorporation by EPA of such recommenda-tions r.. basic guidance on radiation protection established for the use of Federal agencies and possible revision of individual Federal agency regulations and standards to reflect the sams NCRP recommenda-tions.
~ . .
. 'It is generally expected that Federal agencies vill operate within the' guidance of existing Radiation Protection Cuides supplemanted by rec onuendations of the NCRP and the ICRP. The application of basic standards of radiation protection by regulatory agencies to specific j situations generally requires some translation of such standards into specific regulatory requirem2nts uhich (1) listit responsibilitics for the exercism of judgn:nt by regulated persons to matters reasonably within their knowledge and co'mpetence, (2) facilitate the determination of compliance with applicabic regulations, and (3) meet the qualita-l tive a(monition that, within specified icvels, exposures to radiation
! be kept as low as practicabic. Such requiremants would not necessarily
, be appropriate foc i :1uston ;ln a system of bas 1c guidance.
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' At the present time, Federal agencies utilize certain recommendations of the NCRP and the ICRP (e.g., so-called maximum permissibic body
- burdens and concentrations) for coma applications 6f existing Federal
, standards. Federal agencies should not necessarily be expacted to adopt NCRP and ICRP recomendations more restrictive than Federal standards.
., s As. discussed in greetcr detail in tha specific coments provided be-low, the NCRP recomendation of a singic dor.c-limi~ for all organs -
purparts to have been based on the desire for numerical simplicity.
In fact, the preface "to Report No. 39 states that, except in the case of fatal exposure, "any numerical changes in the dosc-limiting recomandations in this report re' lect the urge for simplification l
rather than bionadical necessity." The NORP recontr.andation concerning the exposure of fertile uomn workers appears to be cicarly inconsist-ent with current standards for. limiting o cupationn1 exposures to radi-ation. -
Since both rec'ommandations vould appear t'o result in reduced exposures under soma circumstances, the AEC m,y find sonn corresponding revisions to its regulations and standards to be warrante:1 however, EPA might be in a somauhat different position from AEC in this reg .c4 Uhen l EPA has completed its current comprehensive review and evalua ion of I
~
c>:isting standards, it might determine that these standards shoul' bc l
,taadified ui. h respect to concept, specified levels of exposur'c, or l
, both. With this possibility in mind, it may be prematu'e r for EPA to adopt at this time recomandations of tha NCRP which differ from current standards an ' for which there have not been established convincing jus- i tifications .nd which may involve concepts incompatibic with the results !
of EPA's* cur cut program of review and evaluation.
Further, NCRP states that one of the areas of app 1'icatio'n for the cri-l teria in Report No. 39 is to provide a contemporary and more or 1 css
. uniform framework for marc detailed recomendations of the various NCRP Scientific Cormnittees that dcol with spacific aspects of protec-tion. It is our vicu that these more specific recomendations generally fall in the area of administrative guides and should remain under the purview of standards-recomanding groups rather than regulatory bodies.
. In sumNry, differences bettfacn the responsibilitics of the AEC and l those of EPA, as they relate to the recom:ndations of the NCRP, might tanke it appropriate for the AEC to adopt one or trarc' NCRP recomanda- l j , tions which might not be appropriate for incorporation by EPA in its -
basic guidance for radiation protection. Certain other NCRP recomnanda-
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.... 1. OCCUPATIONAL EXPOSURE 07 FERTILE UO;iEN (UITil RESPECT TO FETUS)
In Report No. 39, the NCRP reco.uands that the maximuct parmissibic dose equivalent to the fetus from occupational exposure of the ,
'
- expectant mther should not execed 0.5 rem during the entire par-
- .iod of gestation. This NCRP recostnendation is substantially more restrictive than the ICRP recommendation (Publication 9, paragraphs 62-63) that uhen a pregnancy has been diagnosed, the exposure of
'the fetus during the remainder of.the p:riod of pregnancy should not exceed,1 rem. Conceptually, the lower NCRP valua functions to treat tha unborn child as a mamber of the general public. The,
- AEC staff considers that neither the AEC nor the EPA can adopt guidance less restrictive than that of NCRP uith respect to ex- -
posure of the fetus. . .
NONP states -that this recor.n:endation i;nplies that fertile women should be employed only in situations where the annual dose accu -
" mulation is unif dy to execed two or three roms and is acquired at a mre or less unk m rate. Under such circumstances, the ! ,
p'robability of the dose to a fetus exceeding 0.5 rem before a pregnancy is recognized is consi?cred negligible. A strict con ,
structionist could take the position. that an annual owc limit of -
two or three rcrqs to the whole body, applicabic to fertile wo: nan,
- does not provide adequate assurance 'that forni exposures greater than 0.5 rem will not occur before pregnancy is recognized and action is taken to appropriately limit further ex p ure. The small additional risk does not justify restrictions on the ex-posure of fertile ' woman substantially narc severe than th6sc con-l
. templated by NCRP. However, there are many factors that could necessitate case-by-caso application of such restrictions, in-
- cluaing age, marital status, economic status, m: dical condition,
, , nature of occupational exposure conditions, and so forth. Becausc.
of these factors, it appears that the specific regulations impic-menting control of fetal exposure should be Icft to the discretion of tihe individual Federal agencies. Si~nce. th'is recotznendation may
- ' have substantial implications with respect to the status of woman
' working in the atomic energy industry, the AEC wishes to consider I. the matter further and consult with its Atomic Energy Labor-Manage-
- m2nt Advisory Committee and parhaps other advisory coranittecs re-garding its propar impicmantation. -
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- 2. L11nTS APPLIC.\P,LE TO PEnSONS EXPOSED TO PATIENTS C0ttrAININ':
l RADIOACTIVE IMTERIAL . -
As noted by UCRP, this subject is dealt with in tircatcr detail t
', in NCRP Report No. 37, "Freenutions in the Managem2nt of Patients Whg Have Received Therapeutic Amounts of Radionuclides". Report I
/
- No. 37 provides greater ficxibility than the summary provided in Report No. 39 arid should be used as thn basic reference for guid- ;
ance. However, the. staff does not agree with the NCRP reconman- ~
dation that releases from hospital care of patients containing l .
radioactive materials should be barred on the basis that "no par- ;
l , son under age 45 shall be parmitted to receive a dose in excess
." of 0.5 rem in a year," and "no person over the age of 45 years ;
shall_ be.parmitted to receive a dose in excess of 5 rems in a year." l N. . ,
~
~
As'a practical mitter, the staff considers that the determination of When or whether a patient containing radioactive materials .
should be released from a hospital should depend bpon'more im-portant considerations than uhether or not homa care night res' ult ,
l in cuposures in excess of these reconnunded limits - for excmpic, j the potential exposures that might ensue from losn of a renovable ;
source of rodiation. Further, one may question the ?ogic of a
- j
- set of standarda that would parmit a m-2mber of the pt :icut's fam-D 1y..in order to finance continu2d' hospitalization, t accept em-ploymant~undar condit.Nns permitting exposures up to 0-15 rems ,
in a year, but which would limit to 0.5 or 5 rems-in ,ny one year l the exposure the same person might rcccive in direct are of the
'. patient. It is possibic that under strict applicatio.. of thesc
- i recotuendations a patient may not receive needed th?.repy because i of unavailabic honpital carc due to lack of funds or for other reasons. .
It may be argued that the NCRP recommandations.m2ct this issue,
, in part, by provi. ding exceptions that permit parse ns over 45 years of age to roccive exposures as high as the prospective occupational dose limit of 5 rems per year. NCRP Report No. 37 states "the di- j vir. ion at the age of 45 is suggested by that made in NCRP Report ;
No. 17 (1) which'per'mits uechly doses twice as high for the indi- l
- vidual over 45 as for those under that age". However, the age 45 l l
distinction was climinated in the addendum to Report No.17 (Jan- -
l uary and February,1957). The staff considers that tLa distinction ;
betwzen parsons under and over 45 years of age draua in Report No.
L -
37 (and referenced in Report No. 39) is incompatibic with the gen-eral structure of dose-limiting recommandati.o n s prescatly issued r
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by the PRC, the NCRP, the ICRP a'nd others. On tha basis of thesc*
. considerations, it vould' appear ,prudant for AEC and for EPA to ,
con. sider these reconnandations in Reports No. 37 and 39 as general ,
~
guidance to the madical profession and not to issue them as manda-tory requiremants. .
- 3. DOSE LIMITS b?PLICABLE TO INDIVIlyJAL MDMERS OF THE PUBLIC
~
l .
In Report No. 39, the NCRP recommands that the dose limit for the
. critical organs (whole body) of an individuni not occupationally
. exposed shall bc 0.5 rem in any ona year, in addition to natural
. radiation and madical and dental exposures. NCRP states that
. "there may be cases in which somz organs or tissues may receive '
. doses above the annual limit of 0.5 rem par year," and that any changes from tha old limits are based primarily on the desire for numarical simplicity in the standards and not on an establishad
~
, biom2 dical need. .. .
I
. If implem3nted, this NCRP rdcommendation would, in effect, climinate
. the concept of individuni organ dose. There w id than be one or-gan (uhole body) uhich limits the exposure pf ca .h :~nponent mmber
- without regard to radiation scusitivity or to the critu.:1 impor- :
. tance of the organs. This change mkes NCRP reconuiandations in this area genarally inconsistent with the approaches taken by the FR% .
the ICRP and others in regards to both the setting of individual
~
organ standards and the ' relationship bttueen dose stdndards for
- ~
, occupational exposure and limits for individual members of the pub- "
lic. ' / .
. There may be circumstances wharc the pt aposal to establish a singic ,
. dose lin:it for all portions of the body conycys certain marit, for example, in dealing uith exposures of the public to sources of radi- '
- ation external to the body or when several organs are simultaneously l
- irradiated. internally. However, this 'is off-ret by the NCRP state-m2nt that for various special caser for particular organs or tissues
. and, for . specific nuclides, special" sed committees of the NCRP may reconniend deviations from the impli ed ruic. A preliminary study of the prob 1 cms, that uould be involvec in applying this recomnendation j to, limitation of exposures to individual radionuclides in air, water and' food indicate that such an application would complicate rather j than simplify the limitation of public exposure.. In particular, l . any listing of dosc limits or maximum parmissibic doses connotes
( ,,
som2 maasure, more or 1 css, of equivalent relative risk over the
, lifetimes of the exposed individuals. From thase dose-limiting O
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reconnendations are developed permissibic organ burdens, naximum j
, permissibic concentrations in air and unter, listing of relative :
radiotoxicity, and other secondary. standards and guides. It is ,
i
- "* unfortunate that HCRP did not, 'in presenting its dose-limiting . !
l recomendations, make a cicar delineation.between nu.nsrical values l
based on relative risk and safety margins or those-factors com ' '
I l prising "value judgm nts". ~. . ;
E . . !
l . 'The staff reco.wcends that EPA d2fer, until' it has completed its l l
. review of exis' ting standards, 'any action that uould apply these !
simplifying dose limit' reductions for all organs (including whole
- j. body) cither for m:mbers of the p*ublic or for occupstional ex-posures. If, for exampic, EPA were.to determine that standards of :
radiation protection should. continue to reficct relative risks', it !
might find a limit'for the whole body as high as~for any portion of ~ ,
the body difficult to justify. .
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ENCLOSURE "E" NOTICE TO AEC LICENSEES This notice sets forth several actions being proposed or I
taken by the Atomic Energy Commission to implement the recommen-dation of the National Council on Hadiation Protection and Measurements (NCRP) regarding lower radiation exposures for fertile women. The basis for the recommendation is to minimize dose to, and possible adverse effects on an embryo or fetus, considered to be more radiosensitive than an adult. The NCRP recommendation is set forth and discussed in paragraphs 240 and 241 of NCRP Report No.
39 dated January 15, 1971. The report may be obtained from NCRP Publications, P.O. Box 4867, Washington, D.C. 20007.
The referenced paragraphs are quoted in the enclosed notice of proposed rule making published by the AEC in the Federal Register on .
The proposed amendment to 10 CFR Part 19, set out in the enclosed notice, would amend $19.12 to require that instructions to workers regarding health protection problems associated with exposure to radiation and radioactive materials, include information about biological risks to embryos or fetuses. !
The proposed amendment to 10 CFR Part 20 would supplement i the wording in $20.1(c) which specifies that AEC licensees should "make every reasonable effort to maintain radiation exposures. . . .
as far below the limits specified in this part as practicable." This wording would state as the purpose of the Commission that licensees l
should make particular efforts to keep the radiation exposure of an t
l
- Enclosure "E" 1
I.
7 embryo or fetus to the very lowest practicable level during the entire gestation period as recommended by the NCRP. The Commission believes that its implementation of the "as low as practicable" concept reflects practical application of the intent of the NCRP. The Commission also believes that continued implementation of this concept in its licensing and enforcement process will result in further reduction in radiation exposures, and may make specific adoption of the NCRP recommendation regarding additional limitation on exposure of fertile women of l minor effect. It is not proposed to amend the dose limiting sections of Part 20 of the Commission's regulations to differentiate i between women and men.
In a continuing evaluation of this matter, the Commission i i
! requires data concerning the number and radiation exposure of l
l women employed in jobs involving radiation exposure. Therefore, you are invited to comment on the notice of proposed rule making suggesting alternative implementing action that you consider more l appropriate or acceptable, and requested to:
- 1. Provide this office with the following information:
(a) A statistical summary of the estimated whole body exposures recorded for women working in your facilities during 1973 in jobs involving radiation exposure such that personnel monitoring was provided. A suggested form for the submission of the data is enclosed. If no women I
i were monitored, please inform us of that fact.
l Enchsure "E" i
o i
- l' 1 (b) The namber of such women with estimated whole l
i .
body exposures greater than 0. 5 rem during any calendar quarter in 1973.
2 Advise the women of the NCRP recommendation, indicating that the intent of the recommendation is to minimize exposure to, and possible adverse effects on embryos or fetuses.
We consider it essential that the instruction of female workers.
include appropriate information about risks to embryos or fetuses I i
exposed to ionizing radiation. The instructions should contain information similar to that presented in the enclosed notice of pro- i l
l posed rule making. Particular attention should be given to the I l presentation of precautions and procedures to be followed to minimize exposures and to keep exposures as low as practicable.
The Commission is developing a Regulatory Guide that will provide guidance regarding risks to fetuses from exposure to ionizing
- radiation for dissemination to employees pursuant to S19.12.
If, after consideration of all aspects 'of this matter, including consideration of comments filed in response to the notice of pro-posed rule making, the Commission decides to promulgate the proposed amendment in effective form, the Regulatory Guide would be made available concurrently.
The Commission believe's that, by following good radiation
!- protection procedures in accordance with actions being proposed
! or taken, radiation exposures of fertile women and fetuses will be kept well within the numerical dose limits recommended by the NCRP t
! without undue restriction on activities involving radiation and radioactive material.
I Enclosure "E"
l ~~. ..
.m-_ --
,- > ~
A .t.d d %v:m c>
m i -
.B_.E. 2nns .
. NOV 11974 ,
Marcus A. Rowden .
General Counsel "
Nuclear Regulatory Comission ,
Washington, D. C.. 20545 -
l l
Dear Mr. Rowden:
This is in response to your request for our infomal views on a legal memorandum entitled "An Analysis of !
Constitutional and Other Legal Aspects of Amending 10 CFR j Part 20 to Set Lower Radiattan Exoosure Levels for Fertile i
Wenen," prepared by Stephen H. Greenleigh of your office.
The proposed amendment to 10. CFR 20 (Standards for Protection Against Radiation) would icolecent a 1971 recom-cendation of the National Council on Radiation P: otection l and Measurements that "the cazimum permissible dose equiva-lent to the fetus from occupational exposure of the expect-ant cocher should not exceed 0.5 rem." We understand that ;
i to accomplish the objective of protecting unborn fetuses !
froc the risks of radiation it would be necessa: y for the !
reg..lation to reautre the exclusion frco certain jobs of l l fertile wocen, as distinguished f- om pregnant wecen, because the damage could be done in the first few weeks of l a pregnancy before the pregnancy can be detected.
The. two basic issues here are (1) whether the prcposed 2:end ent would effect an illegal sex discrimination as ber.reen men and wozen in order to protect the fetus, and (2) whether the Govement has any interest in protecting :
l the health of a fetus in the first trinester of pregnancy
.or before the onset of preg.ancy, that would eve n ide a i 4 veran's right to privacy and her right to equal e ploy-rent opportunity.
Enclosure "F" i
L' . l
( ,
j ,
- 2 With respect to the first issue, it is our view that unless the regulation could be drafted so as to apply only
> to pregnant women it would be difficult to show that there-was a rational relationship between the restriction and the protective purpose of the regulation. With respect to -
! the.second issue, we think the Supreme court's decisions L - ' in the abortion cases precludes governmental restrictions l o on the. rights of women for the purpose of protecting the.
t fetus in the first (and. second) trimesters of pregnancy. l l
! As a practical matter, we do not see how such a regulation could be drafted tnat would not be vulnerable to attack under the Fifth- Amendment or that an_ eciployer-could be required to comply with in view of the nondiscrim-
[
. ination as to sex requirements of Title VII of the Civil Rights Act of 1964, as amended (42 U.S.C. 2000e, et sec.).
- It would be better to issue regulations requiring e=ployers to give full explanation of the risks involved in exposure of an unborn fetus to radiation and to advise fe= ale employees who plan to have children to request a traftsfer or to terminate their e= ploy =ent prior to the onset of pregnancy, so that women who may become pregnant can exercise informed judgment s -
We have reviewed the memorandum and also the accom -
panying letter frcm the Equal E. ployment Opportunity -
Commission, and have the following canznents:
(a) The cemorandt=1 (pp. 6-7) suggests that the reg-ulation would not require the exclusion of all wc=en working in radiation exposed positions. It would not apply to non-farcile women. A aajor problem would be in providing a ceaningful definition'of "fartile wcmen." Many wecen of child bearing age are not fertile; many who are fertile are not exposed to risk of pregnancy; scme who are fertile do not. plan to beco=e pregnant or plan to ternisce any pregnancy which occurs; seca do not know whether they are fertile or sterile.
l.
The regulation would presu= ably be drafted so as to ;
i exclude ~from its application such wo=en who will nec beccee i I
l
, Enclosure "F" 4
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pregnant during their employment in radiation exposed !
positions or will not give birth to a child. However, it would be v'irtually impossible to deter =ine which wccen are covered by the regulation and which women are not, withont ;
invading their rights to privacy with respect to their '
I medical condition and sexual and birth control practices.
(b) The memorandum. notes (p. 7) that there may be some doubt as to the interest of the government in an !
unborn child in light of the Supreme Court's holding in Roe v. Wade, 410 U.S. 113 (1973). In that case, the Court held that a woman's right of personal privacy is protected. l by the Due Process Clause and includes the decision of whether or not to have an abortion. It is subject to regulation only if the government shows an overriding and compelling interest. See also Doe v. Bolton, 410 U.S. 179.
In applying this principle, the Court explained A't during the first trimester of pregnancy, the state cay not require that an abortion be performed in a hospital. Afte: ,
approximately the first trimester, the state may regulate 4
the abortion procedur.e -in the interest of protecting -
maternal health. After viability .of the fetus, the scata cay regulate or proscribe acortion in the interest of protecting the potentiality of hu=an life, except where the abortion is necessary to protect the life or health of the pregnant woman.
Thus, during the first tricester of the pregnancy the government may not restrict the right of a pregnant woman to secure an abortion, which destroys the " life" o'f the fetus. We doubt that the.gove_.oent could, consistent with the Due Process Clause, restrice both a vccan's dght to privacy and her employcent opportunities for pu cosas of protecting the health of the unborn fetus, during the fi*st trimester of pregnancy.
(c) The cecorandtra statas (p. 6) that whether the l regulation will stand against a constitutional a::sck en l
sex discrimination grounds will depend en Nh="b - -%
Government can show sore rational pt= pose for the disc _+i-nation." In the event the proposed 2.cual Rights A: enc ent Enclosure "F"
\ '
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- c.
4 . :
l l is ratified (approval of five more states are needed) and l
the regulation is tested under the new a:endment, the l
" rational-. basis" standard for equal protection would not .be . l
! applicable. Moreover, whether the rational basis test could, !
i be met would depend upon how narrowly the regulation were i
' drawn so as to meet the purpose of protecting 'against the !
L risk._
.... ~ .
j, (d) _ With respect to canflict of. the suggested regula- ;
tion with. the requirements of Title. VII of the Civil Rights- l Act of'1964r wefconcur withithe interpretation of the Equal. {
!- Employment Opportunity Connaission,. and note that the memo- t
{. randum (pp.11-13) also agrees that the exclusion of fertile !
l ', . women from certain jobs requiring the exposure to' ram = Man j l
could not be defended under the " bona fide occupadanal s l qualification" exception in the Act.. !
l An additional. question which needs to be considered is -
d l whether the express prohibition against sex discr4+= tion !
in section 401 of the Energy Reorganization Act of 1974. -
- (P.L.93-438, approved .0ctober 11, 1974) would preclude any regulation making a distinction between can and women employees.- That section provides:
Sec. 401. No person shall on the ground of sex be excluded from participation in, be denied a license under, be denied the benefits of, or be subjected to discrimination under any program or activity carried on or receiving Federal assistance under any title of this Acr. This l provision will be enforced th ough agency pro-visions and rules similar to those already
~
established, with respect to racial and other discrimination, under title VI'of the Civil Rights
-Act of 1964. However, this re=edy is not exclu-sive and will not prejudice or cut off any other legal re=edies available to a discri=inatee.
! i S*ncerely, hh/)%Vb i~
i eon 01:an Deputy ss'istant Atto -.ey General j
- _ Office of Legel Cct..sel l 1
~
Enclosure "F" l
.- _. - ~ -- . - _ .- .- - . _ . .-
(
UNITED STATES t
. e . ATOMIC ENERGY COMMISSION WASHINGTON. D.C:. 20545 NOV 15 EE4 John A. Erlewine General Manager
{
i OS AND NR POSITION ON THE REGULATORY STAFF PAPER CONCERNING IMPLEMENTATION OF NCRP RECOMMENDATION FOR LOWER RADIATION EXPOSURE LEVELS FOR FERTILE 1 WOMEN
{
The Directorates of Licensing, Regulatory Operation and Regulatory Standards and the Divisions of Labor Relations and Biomedical and Environmental Research recommend that the AEC not adopt the dose limit recommended by the NCRP for the fetus but rather require licensees to instruct female workers in the biological risk to the fetus of exposure to ionizing radiation and to make particular efforts to keep the exposure of the fetus to the very lowest practicable level during the gestation period. The Divisions of Operational Safety and Naval Reactors oppose this position for the following reasons:
- 1. While there is an appearance of taking a positive action, in reality, the action "... to keep the radiation of an ,
embryo or fetus to the very lowest practicable level ..."
is merely a reiteration of existing policy and practice. ,
1
- 2. It shifts the burden of decision to the licensee and the female employee and thus can be viewed as an abdication of a responsibility assigned to the AEC. It is particularly ;
unfair for the employee to have to make a choice between l safety and continued employment.
OS and NR recommend Alternative #2, to publish a notice of proposed rulemaking which would simply put into effect the NCRP recommendation, "During the entire gestation period, the maximum permissible dose equivalent to the fetus from occupational exposure of the expectant mother should not exceed 0.5 rem." It is our view that the employer l should be accorded the leeway to implement this standard in the way best suited by reason of the nature of the job and the worker popu-lation. Further, we do not agree that the standard should be expressed i
in terms of a percentage of the maximum permissible concentrations j listed in 10 CFR 20.103. These MPC's were derived for purposes of j exposure control, not dose assessment, and to apply them to the latter I
i Enclosure "G"
w ,
- .. '. \
l John A. Erlewine l l
would be incorrect. We would favor REG's intention to hold a public meeting to gather comments from interested persons.
At the request of the AEC the NCRP, through an expert committee, reviewed its original recommendation. While no formal. response has been received, it is our understanding that the consnittee reaffirmed the recommendation as originally stated. The numerous AEC public statements naming the NCRP as ' the source of our basic radiation standards would make repudiation of this recommendation an inconsistent position.
There is a distinct possibility that implementation of the NCRP recommendation would be used as an excuse for practicing discrimination in the hiring of_ women. However, there are existing laws and regula-tions against such practices and positive action programs to counteract j them.
It_is our view that, as a general principle, if a government agency !
must choose between safety and individual rights, the agency's first position should be on the side of safety. If, in the course of public hearings, this safety position is shown to be impracticable or illegal the agency can more easily defer to the alternate position. The opposite route would be difficult and likely to be accompanied by a' serious loss of public confidence.
While the EPA, in its role as _ successor to the FRC, has not acted l officia11y' on this NCRP reconsnendation, it has cited this lowered i standard for fetuses (0.5 rem in 9 months) as the basis for its most recent draft of emergency standards.
In presenting our position we realize that there are legal questions arising from the implementation of the NCRP recoimeendation. While it l is beyond our competence to consnent on these questions, we hope they )
l can be resolved within the framework of Alternative #2. !
1 We have surveyed the contractors and find that there will be virtually no impact'on AEC operations if the NCRP recommendation is implemented.
A susanary of pertinent information is enclosed.
. b Harti B. Biles, Director l
[ Division of Operational Saf'ety -]
l Enclosure-1 As stated i
Enclosure "G"
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- , . ENCLOSURE I l'..w i
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' N#N' MM SIFItXSER 20, 1974 E!5ACZZS C? m c-siCZ3 i
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C3 .I15.'15,1971, TE3 FAUGAI, MCII. Di* RADIAUCN P:tDTECHON AND t
1~.:.L"~2.CZ5% G'.'.'J) 155tD 7.N. 30. 39 "2ASIC RADI), TICS P.'DTECIION -
CI_~~ * ' t , " ~ ~ ~I ~2 IFC G A 720CICCO~J.~ICN T AT ". ..Ti'Z MAXI;TM PEE- -
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l IN SUCH CASES, NCRP CON-A.CQ'.~.. .D AT A *.C7. C2 I2.55 03 CTf PATE.
SI. ~'..:.D T'D.? 7.-172 *,:CC 3 13 A FICI.ICIF Z M.OV.DILITY OF II!Z DOSE TO -
- A , ..t3 EI aING O.51.EX IIICII A PP.I2Wo.' Is RF.COGNI2ED." Tits
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DCT- .~ ~TT25 CT '.,',iT3 AC COS'*?ACIC;'5 A'O LItwdEE OFF1ATIONS. A?.837 i
(CCNTINU 3)
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1
! FRCH MDC2 DIF7ERDiC~;.S 15 TF.I DCSE EQUIVALZ:,7 VAII,IS, T.-21;CRP AICCM- . ,
I tSQLTIC3 'IS THE S122 AS. AN EAG.1E?. RZCO? NIT.'."AIC:1 ISSLC BY. THE Ih'IZR-- l EAnonAL Cc.::IssIcs Cs nDIAnc:: PicnCnos (IcKP) Is nS 2EPCRT FO.
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9,SE77. 17, 1965. TKE F2CCrMESTenC3 IN LO!?. casts WAS PP.DICATED 05 A C0f;C"3 EIP22SSD C.
THE PADICSD:SITIUTT CP TEZ CC}UO DUR-IRC CRITICAL SIA0Z3 C? EGR. ENESIS. m IECIDDX~.E OF IIUK XIA A'..'D .
OIEEZ FALICFAhT DI5?lSIS AN.e u GrILD?.ni EXPOSD TO PADIAMOS IN l i
i I
t,s e -:0 VAS PARTICCIAR! EC?2ASI223 IN TG hm Pl? CAT. PAPA TCW!aD I7 alt:ATI 2G T2E nr.waAL IM?ACr O/ T23 EC2? RECOF N. DATIONS ON AEC l
C?I2ATICES AS IT CO:Ac. ::S EI?CSUR3 TO TEZ n.tJS, PLEASE P.'.07IDZ THE DIV. C'.* O?"?anCSAL Sl?tTT (OS) WIT 3 TEI TOI.InJD:0 UI?CPJ'AIICN I?.0M AEC PRD2 CCCT.ACDES ET C.O.B., CCT.1,1974. TE3 IFIV??ATION 15 l
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EI?ZC! TO S3, C.AZ2 TFA1: G::E ALF 7 E3 IN A2.T Q'JARTIP.,
(4) CCE Td2 DC>A7*, I? A'T. C'i 0???ATIONS SiOULD TSE F2.P ~
l TrCILE VCtZ:f 72C' C;'.'.ATICS Z'I. ?"LI.T D'?II.r2bw.
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MA'tACI23 0F FIELD C7TICZS -b 5?JrD3Z!t 20,1974 ' i s
(5) NCI TEE Cos:s An AW Lm.TLn Fr.cc?u DIsy.U7ncs Ir -
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EZl%T134WS TO A'.L EC44YIIS D AU. W7K PIACIS U::DDL TCtrA JD1ISDICTICS k'223 TD 33 N ATD M 13 >C2I t!AS 0.'fE-FAIJ RD4
- l IR AW qCArtII. Irc. .
l b.: W. Burr,BER .
l Ee Herrick,.IlER .
S. Creenleigh, CGC -
C. Bradshaw, IS )
PEit & 513 - Tl2 U: Dir.,2G -
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s
...L ENCIASURE II . ,
TABLE-I ,
FEMAtE RADIATION WORKERS RECEIVING > 0.5 REM IN ANY QUARTER No. of female radiation Ave, yearly.No of female No. of female radiation- workers receiving y 0.5 radiation workere re-worken. currently cin- rein in any quarter dur- coiving >0.5 rem in any 1.93 1973 quarter (1969-1973)
Field Office playeQ_ -
259 0 5 AL 4 cli 700, 7 (est.) 8 ;
1 0 o ,
c.r m 33 0 41 t
'253 0 o NV 1,515 0 o ,
on 34 0 o UNR 126 5 13 ItL ,
0 <, 1
- AN 451 r
4 13
!;n '193 i
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1 11 -
i n 41 3,583 24 ff TOTALS ,
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ENCthSURE III TAnl.I'. II ,
i: UMBER OF COfffRACTOR RADIATION WORKERS EXPECTED TO RECEIVE AN EXi'OSURE 70.5 REM IN ANY QUARTER ,
No. of workere ex-pected to receive
!!o, of femnic rnd- No. of malo rad- 0.5 rem in any . !
Ir telet Of f tec i nt:f on worhorn _
lation workers gunrter'
}
AL 259 6,142 310 ,.
cn 700 7,556 2,522 -
l 37 o $ .
GJ I LU 33 - 1,3I3 27 i i
t NV 233 3,019 11 OR 1,515 10,340 . 93 rNR 34 2,441 ...
1 ut, 126 2,302 . 1,178 451 . 3,022 132 ,
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193 4,924 100 g sit '
o 18 1.507 87-i
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TOTALS 3,583 43,551 4,476
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i ENCLOSITRI IV 3 .
POSSIBLE IF2ACT OF IF21IFE!GING NCR? RICCF.J..iDATION FOR A RAbIATION LIMIT TO THE FETUS AD REDUCI:4 TEE RADIATION i
LIMIT F01 ALL EF2LOTIES TO 0.5 FIM/ QUARTER
]
I Should the NCRP fertile woman recocoendation be fully icple:ented, ;
86 percent of AIC contractors esti= ate that the icpact on operations ;
would be negligible. Approximately 10 percent of AIC contractors .
estimate that the reco:cendation vould have soce slight icpact on l operations. These contractors cite additional costs, closer con- {
trols, and possible-labor relations proble=s as esti=ated i= pacts.
Each of these ite=s is predicted by about 4 percent of AIC contractors. l Should all ecployees be regulated to no core than one-half ren in any quarter, esticates of the i= pact on operations vary videly.
Several of the university facilities esticate little or no inpact.
Many facilities foresee a serious i= pact, but are unable to provide an estimate of additional equip =ent and operating expenses. Those -
facilities that are able to provide cost estimates foresee addition-al costs of $150,000 to $7,500,000 for capital equip =ent, operating expenses, facility upgrading, and additional personnel. Several
' facilities also esticate disruption of operations due to loss in efficiency.
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2G$US374. 3 i Mr. Stephen H. Greenleigh -
Counse1g Envizcnme#1t and Safaty.
United Stataa Atcuic Energy Cc= mission L Washington, D.C. 20545.
l '
I l . Dear Mr. Greenleigh -
l l 'Ihis is in response to your letter of July 12, 1974, L and our subsequent meeting on July 25, 1974, ..vch of sich requestad- that we review a draf t of the Atc=ric Enargy c =>-
mission's (AEC) legal analysis supporting on'a:andr. ant of 10 C7R Part 20 to set icwer radiation exposura icvelo for fortilo wcman. 'Ihe National Council-on Radiatics ?rotac-des and Measuramants (UCR2) has- roccmmanded that fertile w:=sen j be employad only in - thes.a situaticna whero the c=nual desa i
l accu =ulation of radiation in unlikaly to c::ceed t.a or chree-l vans w.a is ecqeired at c scre = 12r hrr2 91rh ?.3 -
l i .aplementation of UC37's raccrt:aondation by tha AEC could adversely. affect the hiring and centinued c= ploy =act cf w=.an in radicaansitivo occupat:.cas. As cgrc40, tha dellow-- ]
ing are the informal staff cc.~::: ento en ycur draft legal ;
c alysis in support of implementing tho UCn? recu=catics. l 1
As we indicated in cur caeting, it is not clear to us j Wy, in view of the exc ntiennily le.i ric c to the f atus cc=- !
pared with the cavero adversa i:: pace on tha hiri.; csd con-tinued c=picy=ent of wcnen in radiosensitive cecupaticas,
- the A3C chculd implement the NCPA roccrinendations. i~cile you did -inform us of ccngressional pressure to adept their recu. cendatien z.id tha f act that you had in t'.2 gas:. tdopted all previons recc:r.andstiens of the ncn?, chena reesons - ,.-suid pct appear to us sufficient to justify c:.cptica of ZC'?'s cpacific p;cpenal in vic.o of the severo cfverse : picy ent
!. i.cpect on uc=an.
i t.'a would ur:;.3 that ycu Cat 2:mine . (1:) hua ::a..y jchs in
- the . industry, if held by .;cac n, . ot.lu be uf f actai ~y thi
re.;ulot .cas enc (b) t'.a IrJ.=..:ar.cv c: ensc;cro i . e .1. 5 = 5
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to percono in cuch pcaitions. Evontun11y scme sort of l," s
" balancing" test may be applied and this information would l hs necessary to weigh the cc=peting interests.
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Secondly, if in. fact it is your cecision to adept tha l UCnP reccc:mendation than ws strcngly urge you to consider ;
minimi=ing the adverse offect en wcoen.by adopting thoaa Perhaps a regu- l regulaticna with the least adverse impact. '
lation regulring all fertila ucten to undergo pariedic prog:ancy tests would have lesser effect than a regulation absolutely excluding all fortila women frcm jobs where the r:diation levala 'are higher than 2 or 3 rems, Wila t:hore
! . are scme questions of invasica of privacy which may be raised, such tests might be held a justifiabla ccndition of employ-ment under the peculiar working environment with which are j concerned.- Such tests would to secaIfextant help reduce tha already mini:nal r,isk to the fetus. pregnancy is detected,
. the pregnant employee could then be ~ transferred (if the con-curs) to another, safer position.
l The inclusicn of a vaiver clausa, i.o. requiring for- f I l tila wccen to sign a statacent persuant to ACC regulations l cc'enowledging the risks involved in working in areas with I radiation 1svels above 2 or 3 rems, but vaiving such riska )
.in fsver of accepting the jch may also minimize the adversa M l
! i:, pact upon uccen.
Ce question of whether--ths-ri@ +m the f2tus cculd be effectively valved legally by the mother to preclude possible futura lawsuits On by one the the h::cd, child is we subject feel to differing legal conclusions.
that persuasive legal argusants may be used to counter law-
' cuits see'. ting to invalidate the waiver clause while at the sc=e time'we recognize the legal difficultics inhoront Again, when in ;
nttempts to legally waive the rights another.
l usighing tha possibility of such a lawsuit being filed- against
- the rights of females to werk in the nuclear industry, the i..2iver may be a legally vicble option to a regulation which virtually encludes all females frcn wording in certain positient ,
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.within the nuclear incuatry.
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'Iha feregoing cur,gsstions are indicative of the concerna l C has no reasonable l
we hcVe with the ccnclu.iicn thr.t ths ?:: ,
l rv:tilable alternativo to the cc:clusion Da 7CO of fortilo ucman uculd hava a haavy frca l the proacribed ucri: environment. )
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burden to justify the proposed regulation even if the only alternative to'excluaica of fertile ucmen would be a reduction i of radiation levels for every employee which A30 representa- l tives suggest would require a complete and costly retooling l
-of the . nuclear power industry. .
We le' gal analysia you submitted dcncluded that Titla VII i "would not preclude the presulgaticn of a protactivs regulation sotting permissible radistica exposure lovels fcr women s o are fertila" based on the bona fide occupational qualification
/ (B300) exception. 'Ihe BFCQ exception applies to vary narrow and restrictive circumstances, whare sex la inher.e.ntly necessary for the performance of the job, usually for purposes of ,
authenticity or ganiuneness.. Sex cannot be shcwn to be a 1 preroquisita for working in the nuclear industry albeit these may be potential radiation risks to a fetus.
'Ihe other possiblo justification under Title VII for a policy which would have an advarse impact on women is the the judicially created defense of business necessity. Again, hcwevar, the AEC seems precluded frcm reliance on this exceo-tion. Before esteliching, ce business necessity defense, the Aac has the burdan cf showing that the virtual exclusion of waaen from cartsin positions within the nuclear industry -
- is essential to tha safory or efficiancy of its operation.
l l See achinson v. T.orillard Coro., 444 F.2d 791 (4th Cir.
! 1970), cert. di r.issed, 404 U.S. 1005 (1971); Hoad v. Tinkar Zo_113r astring co., 495 F.2d 870 (6th Cir. L'373); and Unit d
('ntes v. Beth1chel., Steel CO o. , 446 F.2d (2nd cir.1971) .
! .;.a c urt stated in ! einso', - : , at 7c 3:
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'Ihe challenged practice must effectively carry out the business purpose it is alleged to serva. And there cust be availablo no l l '
cece n slo .-Itarnatiic policies or practices which uculd better acccmplish tha. business purpose cdienced, cr ecccnolish it equally l well with a lesser differential. . . .(Em- l phasis added.)
A business necassity d 4./.ce c n be unstained only unarc j the challenged policy is noutral c.4 its faca but has a dis- !
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UNITED STATES j , fp ,
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x ATOMIC ENERGY COMMlbSION ,
20545 y,; , jg WASHINGTON. D.C.
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. [w/-S m- l ( , , August HAlltMAN [l 26, 1974 Q
gf l USC(_
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Dr. Ray JULY 15,.1974, SCIENCE TRENDS, RELATING TO THE EXPOSURE OF FEMALE WORKERS TO RADIATION i I find only one major error in Mr. Kranish's account. This i is in the last paragraph. AEC did not tell either its con- l tractors or its licensees to advise female workers of the potential risk, nor did it mention a specific number as a maximum permissible annual. dose. Word of what was being ,
considered very likely leaked to the field, however, and this is what Mr. Kranish may be speaking of. I believe l DuPont-Savannah River had begun putting the 0.5 rem in their regulations and that Dr. Biles called them off on the l basis of the general policy that no contractor would write
! maximum permissible levels lower than the AEC's.
As early as 1958 we, in the Division of Biology and Medicine, began considering what could be done about this regulation of 0.5 rem per year to females coincident with rumors that I the NCRP was considering it dmto the publication of l Alice Stewart's retrospective data on a supposed increased frequency of leukemia in children of mothers who had been exposed to 200 to 500 millirem of x-rays during pregnancy.
Other data, including those from ABCC and by Brian MacMahon, failed to substantiate her claims. However, in the interest of conservatism it was clear that the 0.5 number probably would prevail. Every suggesticn for early detection of pregnancy and removal of the women from the place of exposure proved unworkable. The EEO edict has merely complicated matters.
In short, the problem today is just a little more insoluble than it was when we gave up on it five years ago.
Lester Rogers has a partial solution, in that women shall be
-limited to no more than three rem per year or per quarter. g Under this limit the fetus would receive not more than an I estimated 0.5 rem since the fetus is rather well shielded. y l Also the recorded dose may be varied depending on where she .
wears her film badge or meters, something that cannot be -
i enforced. y c
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Act. 431-8G-11s ,
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