ML20234B554
| ML20234B554 | |
| Person / Time | |
|---|---|
| Issue date: | 08/28/1987 |
| From: | Ryan Alexander NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Morris B NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| References | |
| NUDOCS 8709180462 | |
| Download: ML20234B554 (7) | |
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MEM0RANDUM FOR: Bill M. Morris, Director Division of Regulatory Applications, RES FROM:
Robert E. Alexander, Chief j
Radiation Protection & Health Effects Branch, DRA/RES
SUBJECT:
RADIATION PROTECTION OF THE EMBRY0/ FETUS As we come closer to the time when the staff will recommend to the Comission issuance of the revised 10 CFR Part 20 in final form, it may be helpful to review for you the. controversial question of protecting the embryo / fetus.
In the version of.Part 20 published for public comment (January, 1986), a 0.5 rem limit, effective dose equivalent, was_ proposed.
It would apply only to occupational exposure of a declared pregnant woman. At the time a woman declares her pregnancy.to the licensee, if the embryo has already received a 0.5 rem dose, the licensee would not be considered in violation of the limit.
l The licensee would be in compliance if the woman is not subsequently assigned tasks which result in the embryo / fetus receiving an additional dose exceeding 0.05 rem during the remainder of the pregnancy. The proposed rule also contains the following very important hortatory statement:
" efforts should be made to avoid substantial-variation above a uniform monthly exposure rate which would satisfy 'this limit." Control of the dose rate is important because a i
woman may be unaware that she is pregnant during early weeks of the gestation p(eriod when the embryo is most susceptible to radiation damage.1987) recommends a NCRP Report 91 known.
The need for special action to protect the embryo / fetus is a technical consideration that apparently is non-controversial. However, considerable controversy has arisen'over tho important non-technical considerations of equal employment opportunity and invasion of privacy. Employment opportunities could be adversely affected by the 0.5-rem limit.
If a licensee has two applicants to choose from of equal capability, and if one of them could in the future declare a pregnancy so that her availability for certain assignments would be limited, the selecting official could be influenced by the availability consideration. Availability questions could also affect promotability.
Discrimination on the basis of sex is prohibited by Title VII of the Civil Rights Act of 1964. This act was amended in 1978 to include discrimination on the basis of pregnancy ("... women affected by pregnancy... shall be treated the same for all employment-related purposes... as other persons not so affected but-similar in their ability or inability to work...," Pregnancy Discrimination Actof1978). As. discussed below, the'O.5-rem limit may or may not contradict these acts.
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The question of invasion of privacy arises primarily because of the desire of people other than the mother to protect the embryo / fetus.
Required periodic pregnancy tests and required declarations regarding fertility are two examples of protective measures that could lead to protection during the early stages of pregnancy but would invade the privacy of women. Adding to the difficulties of this aspect of the issue is the consideration that such requirements may be used by licensees for purposes of legal protection. The invasion of privacy issue is avoided in the proposed rule by making it applicable only to women who have on their own volition declared their pregnancies. This way of avoiding 1
the non-technical problem limits the opportunity for people other than the I
mother to protect the embryo / fetus (if the mother so chooses). Thus the dose rate protective measure becomes important not only during the period before the j
woman knows she is pregnant but also afterward in the case of women who choose not to declare their pregnancies. There may be arguments that the proposed dose rate, as an exhortation only, is incompatible with the declared pregnancy j
provision, particularly in view of the new NCRP recommendation for a limit of l
0.05 reni/ month. As discussed subsequently, it appears that the period of greatest embryonic sensitivity to radiation occurs during the 8th to 15th weeks.
The 0.5-rem limit was first recommended by the NCRP in 1971 (NCRP Report 39) and repeated in 1987 (NCRP Report 91). My involvement in the regulatory aspects of the issue began in 1972 when I joined the AEC. We considered these issues in a very thorough manner, eventually arriving at a staff position that is best described as " informed consent." Because of the importance of the non-technical issues and the lack of NRC jurisdiction and expertise in these matters, it was determined that the NRC should take action to assure that women (as well as their fellow workers and supervisors) who work in restricted areas are informed about radiation risks to the embryo and about the NCRP 0.5-rem recommendation. The argument that this position was tantamount to delegating l
the NRC responsibility to licensee employees and other workers was countered by l
reasons of the nature expressed below.
l It is the woman, not the government, who must balance the risk of any income loss arising from work restrictions against the potential radiation risk to an embryo.
For example, if she has a chronically ill child for whom necessary medical care is expensive, the risk to the existing child created by income loss might in her mind be a stronger consideration than the potential radiation risk to a possible embryo / fetus not yet conceived. The position taken at the NRC was that women should be fully informed as to what is known about the l
radiation risk and that decisions regarding radiation exposures within the regulatory dose limits for workers should be t'nen left to the women.
In 1985 the Conmission published for comment a proposed rule which would have modified i
$19.12 of 10 CFR Part 19 to specifically list protection of the embryo / fetus as a requirement for inclusion in each licensee's training curriculum.
But it was determined that the existing language on training requirements in this section, i
as well as the ALARA exhortation in Section 20.1(c) of 10 CFR Part 20, l
l adequately cover the regulation aspects of the problem. The rule was never l
submitted to the Connission in final form.
In 1975 we issued Regulatory Guide l
8.13 on the subject of prenatal radiation exposure. This guide describes the risk in non-technical language and lists alternative actions available to l
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3 workers who might prefer not to accept this risk. Other than proposals for public coment, the NRC/ licensee interface on this issue has rot changed.
Several years ago, during a staff presentation to the Comission, Commissioner Victor Gilinsky raised a question as to whether licensees are specifically j
required to provide the information in Regulatory Guide 8.13 to their workers i
in,conformance with Part 19.
It was a good question..because the informed consent' position does not implement NRC responsibilities unless workers are, in fact, informed. Questions of this type often arise about regulatory guides, and the staff answers are usually the same. Unless a. guide is incorporated
.into a license, licensees are free to comply with the associated NRC regulation
.in ways other than those recomended in the guide. The only stipulation is that the other ways must be as effective for the intended purpose as those given in the guide. The effectiveness of ~1icensee alternatives is judged by -
Region employees.
I have no information regarding the extent to which Regional personnel-inspect against this aspect of Part 19.
(Although I was the Branch. Chief responsible for developing the staff position, informed consent was my second choice. My first choice was to leave this difficult question for the Supreme Court to decide. They are better qualified than a technical agency, such as the NRC, to resolve the conflicting socio-technical aspects of the issue, and it is their job to do so. My preference was, and remains, to adopt the 0.5-rem limit on technical grounds that we understand.
I would expect legal challenges which would ultimately be resolved by Supreme Court decision.
It appears that this outcome may yet
' happen.)
One of the most intriguing facets of this question involves analyses of the Supreme Court's decision regarding abortion'and any impact that decision should' have on' protecting the embryo / fetus against radiation. Specifically, and bluntly, would it be inconsistent for a governmental agency to establish a l
regulation which forces protection of an embryo / fetus (even against the mother's will) from a comparatively low radiation risk while at the same time the Supreme Court allows the mother to arrange termination of the embryo / fetus' life? If.that question does come to the Supreme Court, this problem of logic could prevail, setting aside the special radiation dose limit.
(Hopefully,the declared-pregnancy provision of the rule will defuse this issue.)
In anticipation of this problem, there have been proposals to leave the regulations as they are in this respect and impose the existing dose limits for minors (0.125 rem per quarter) on the embryo. But this interpretational maneuver'would draw the same legal fire.
The impact of the abortion question on our present policy of informed consent is not trivial.
In general, when a woman elects to abort her embryo / fetus, it might be conceded that she does not need information from the government or her employer to make this decision. However, if she is deciding whether to accept a radiation risk for her embryo / fetus, she might consider such information to be essential. The point is that the freedom-to-abort argument can be used to support the informed consent policy only in the case of women who are, in fact, informed, once again indicating the necessity of positive NRC action to ensure appropriate training.
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4 In 1977.the ICRP published new. recommendations on occupational dose limitation including'a special limit for the embryo / fetus,(about twice that oflthe NCRP)-
coupled with a non-numerical dose. rate limitation. At that time the NRC staff was working with.the EPA and other Federal agencies in the preparation of new Presidential guidance.on occupational radiation protection; it was clear.that the guidance would track the new ICRP recommendations closely. However, it was also clear that the agency representatives working ~on the guidance preferred.
Lthe NCRP 0.5-rem limit. The former RES Office Director took the position that the staff should recomend to the Comission, for its proposed major revision of Part 20, the adoption of this anticipated Presidential guidance provision withoutattemptingtojus}ify(Asyouareaware,asofthisdatewehaveexamined it or deal with the non-technical issues in the preamble. This was done.
only a sample of the public coment letters on Part 20.) The President signed
'the guidance on January 20, 1987, including the special 0.5-rem limit for-the embryo of.a declared pregnant: worker.
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To my knowledge, only'one legal analysis of the NRC proposed regulations for arotecting the embryo / fetus has been published.- In the Ecology Law Quarterly,
- Vol.13
- 879,-1987] Neal Smith and Michael Baram have published.an article entitled "The Nuclear Regulatory Comission's Regulation of Radiation. Hazards in the Workplace:
Present Problems and New Approaches to Reproductive Health."
These attorneys, after consulting a large number of references on this topic, conclude that:
"Because the NRC has framed its proposal to protect prenatal health while minimizing the impact on equal employment opportunities, the proposed standards should be positively received."
(emphasisadded) i The conclusion is based on the belief of the authors that risks to the embryo / fetus from occupational radiation pose "...a dilema that Title VII does not adequately address." They believe that Title VII will have to be amended or be construed in the courts as permitting a special dose limit for the embryo / fetus. -They express confidence that the NRC " pregnancy standards will survive judicial review." But it is not anticipated that survival will come easily; the authors expect challenges on two fronts.
First, the agency will be attacked on the basis.of inadequate scientific evidence that does not substantiate the need or stringency of the standard. The courts may then hold the NRC to high standards of scientific proof. Second, the authors state that charges of violating the equal protection clause can be expected. They attempt to clarify this confusing concept as follows:
1 It is my opinion that this attempt to transfer full responsibility to the Presidential guidance,.or to the EPA, cannot succeed. The NRC is not i
legally bound to comply with the guidance.
Radiation protection standards in 10 CFR Part 20 are the responsibility of the NRC alone, regardless of where or by whom they may have been recomended.
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" Reduced to its most fundamental principle, equal protection analysis condemns both the differential treatment of groups that have similar characteristics and '
the similar treatment of groups that have different characteristics."
Men, women who are not pregnant, and pregnant women have many similar characteristics and must therefore be. treated alike. However, pregnant women have a different characteristic, and similar treatment of them is condemned.
The authors tell us, encouragingly, that "...the Supreme Court has generally held that discrimination on the basis of pregnancy is not sex discrimination per se."
This logic is persuasive. The authors conclude that:
" Pregnant workers who are exposed to reproductive health hazards on the job should not be treated differently unless:
(1) sufficient scientific evidence demonstrates that a toxicant poses a significantly greater health risk to the. embryo / fetus from direct exposure than from preconception parental exposure; (2) that it is not feasible to lower all exposures to a level where the risk from direct exposures of the embr.yo/ fetus is acceptable; and (3) an employer's or a regulatory reproductive health program is narrowly tailored to affect only those employees who are, or who intend to become, pregnant. The NRC's proposed response to the reproductive health threat posed by occupational radiation exposure meets these three j
tests."
Looking at our current situation, I can see four weaknesses that need attention:
(1) The 1975 version of Regulatory Guide 8.13 was issued before attention was called to an excess of microcephaly / severe-retardation among atomic bomb survivors who were exposed in utero. Apparently this effect is predominant for exposures that occur between the 8th and 15th weeks of gestation, ut the risk coefficientmaybeashighas4X10"g/ rad.
If so, this risk may exceed that of childhood cancer as discussed in Regulatory Guide 8.13.
A major revision and updating of this guide has been prepared and is now in publicatio_n.
(2) We have not documented objective evidence that J
Regulatory Guide 8.13 is used extensively in licensee training programs.
Because of the time it will take to issue the major revision of Part 20 in final form, and the proposed grace period, the current informed consent policy is likely to remain in effect for about 7 more years. We should therefore determine whether 4
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l action on our part is needed to ensure that workers are actually informed.
A menorandum from the RES Office Director to the Regional Directors is in preparation requesting their views on this matter. Corrective action will be planred as may be indicated by their replies.
(3) The staff has not critically reviewed the data and epidemiological techniques used by the NCRP and ICRP working groups in their assessment of radiation risks to the embryo / fetus, Blind acceptance of such recon:mendations, particularly where assumptions and extrapolations must be used extensively in lieu of adequate data, does not leave the staff in a strong positien to defend its recommendations to the Commission.
It is possible that the uncertainties associated with the assumptions are not commensurate with the :tierity of the proposed regulatory action.
A critical review will be performed by the RPHE Branch.
(4) The proposed 0.5-rem limit for the embryo / fetus refers to the effective dose equivalent quantity. The significance of the use of this quantity is that it requires assessment of the embryonic organ doses from nuclides deposited in the mother's body. The doses must be weighted and added to the dose from external sources. The proposed major revision of Part 20 states that the organ doses for the embryo / fetus may be determined by doubling those of the mother.
Since the placental transfer fraction may be different for every element and/or compound, this regulation is the 1
I most glaring weakness in the proposed Part 20.
The RES budget request for FY88 includes funds for a comprehensive literature search and the development of i
a research agenda as necessary to provide the needed data base.
The FY89 request includes funds for initiating the necessary research.
We have virtually no idea as to how many pregnant women at any time are working in NRC-licensed activities.
It is believed that most of them work in medical institutions; the female work force in the nuclear power industry appears to be growing. Although our risk assessment effort cannot be quantified in this
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respect, the staff is taking the position that the degree of protection I
provided through NRC action should be adequate even if the number is small.
i If the thoroughly researched and well documented article by Smith and Baram is l
right, the denouement of our experience with the 0.5-rem limit for embryo / fetus will be watched intensely by interested parties outside the nuclear I
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establishment. Reproductive hazards in the workplace include teratogens and carcinogens other than radiation. The Equal Employment Opportunity Commission has reported that 20 million jobs may involve exposure to such haza.rds; OSHA has reported that about.835 thousand men and women are affected by its occupational standards for protection against lead alone.
It has also been reported that employers have closed many jobs to women to avoid exposure to such hazards. Smith and Baram point out that "... adoption of the NRC's pregnancy exposure limits may have a wide-ranging impact on employment opportunities for women in countless other industries."
Origid tip7j by Ennert E. Alcur*
Robert E. Alexander, Chief Radiation Protection & Health Effects Branch, DRA/RES
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DISTRIBUTION CIRC /CHRON/RF CKelber HPeterson WShaefer, Reg. III SBJ.
RECunningham JFoulke WFisher, Reg. IV REAlexander FCongel JBuchanan FWenslawski, Reg. IV RPHEB JBecker DCool
'DCS/PDRU ZRostoczy DNussbaumer WCool l
TSpeis LCunningham SYaniv Dross ARoecklein RBellamy, Reg. I EBeckjord WLahs DCollins, Reg. II in n i A 0FF:
RPHEA:@ES NAME RAlbiapd' Y/bh:
e DATE: 1/1}/87 lE ___ __ _____ -.
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