ML20212F240
| ML20212F240 | |
| Person / Time | |
|---|---|
| Issue date: | 07/30/1986 |
| From: | Kline J Atomic Safety and Licensing Board Panel |
| To: | NRC OFFICE OF THE SECRETARY (SECY) |
| References | |
| FRN-50FR51992, FRN-56FR23360, RULE-PR--860730, RULE-PR-19, RULE-PR-20, RULE-PR-30, RULE-PR-31, RULE-PR-32, RULE-PR-34, RULE-PR-40, RULE-PR-50, RULE-PR-61, RULE-PR-70, RULE-PR-70-860730 AA38-2, AA38-2-0990, AA38-2-990, NUDOCS 8608130261 | |
| Download: ML20212F240 (8) | |
Text
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[ [pu% t UNITED STATES ( So ggS/W2) y E'
js NUCLEAR REGULATORY COMMISSION ATOMIC SAFETY AND LICENSING BOARD PANEL 00CMETED USNRC jf
- W ASHIN GTON, D.C. 2055s
'86 Als -1 A10:07 July 30, 1986 -
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- MEMORANDUM FOR: Secretary of the Commission U.S. Nuclear Regulatory Commission FROM: Jerry R. Kline {
Administrative Judge, ASLBP -
SUBJECT:
COMMENTS ON PROPOSED 10 C.F.R. PART E0 % 20.208 I recommend that the Commission reconsider the advisability of ,
setting a special radiation dose limit intended to protect the embryo / fetus, because such limit may cause an unwarranted intrusion on the private rights of women; it may be in conflict with the principles established by the Supreme Court in Roe v. Wade, 410 U.S. 113, 35 L. Ed.
2dat147(1973), and it is not technically supportable under the backfit rule.
In setting a special regulatory dose limit for protection of the fetus the Commission could be in conflict with the Supreme Court decision, in Roe v. Wade which dealt with a woman's right to choose abortion, but which nevertheless set forth principles which may be broadly applicable to NRC's asserted interest in promulgating regulations governing radiation dose to the fetus / embryo in order to protect public health and safety. Specifically, the court found that:
"The right of privacy . . . is broad enough to encompass a woman's decision whether or not to terminate her pregnancy." The court went on to list a number of personal hardships that could be considered and could result if the State imposed a detriment by denying this choice.
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add: . Alexand SS e608130261 e60730 PDR PR PDR J. Becker, 960 19 50FR51992 IfO
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The privacy right is not unqualified however and must be considered against State interests in regulation. At some point the State interest in the health of the mother or in potential human life becomes significantly involved. The court considered these two interests separately.
It is clear however that the court's approach postulated a tension between the individual privacy right to decide the fate of a fetus and the interest of the State in protecting the health of the pregnant woman and in protecting potential life. The State could not by adopting one theory of life override the rights of pregnant women that are at stake.
In resolving this tension, the court found that with respect to the State interest in health of the mother the " compelling" point is approximately at the end of the first trimester. Prior to that time the State does not have a compelling interest in regulation. With respect to the State interest in potential life, the point of compelling interest is at viability of the fetus which occurs at approximately 28 weeks after conception. "If the State is interested in protecting fetal life after viability it may go so far as to proscribe abortion . . . ."
(Emphasis added.)
The NRC in promulgating 9 20.208 asserts no special interest in protecting the health and safety of pregnant women. The generally applicable 5 rem /yr. occupational dose limit together with an ALARA program is presumably adequate for that purpose. Thus, the Federal
3 interest lin promulgating a special dose limit for protection of the fetus which is applicable in the first trimester is not compelling. The NRC could have a compelling interest in protecting fetal life at the point of viability, howeve" that occurs at about 28 weeks which is beyond the period of 10 to 17 weeks (Supplemental Information Section XII) which may be especially critical in fetal development. Thus, the NRC may have no compelling interest in promulgating a regulation for protection of the fetus in the second trimester either. It is not clear from the risk data available whether any compelling Federal interest exists in regulating dose at special limits after the onset of viability.
It appears that regulation of radiation dose, for protection of the life of the fetus or embryo, lies within the privacy right of the pregnant woman at least within the first two trimesters and is not a matter for which the NRC has a compelling Federal interest to regulate under its general mandate to protect the public health and safety.2 l
1 I assume the Federal interest to be analogous to the State interest in this discussion.
2 No definition has been proposed which suggests that the fetus is in any sense a member of the "public." Thus, NRC's extension of regulatory requirements for protection of the fetus under its general mandate to protect public health and safety may be erroneous. Indeed, the Court found that the fetus is not a
" person" entitled to protection of life under the Fourteenth Amendment.
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The court found: "The pregnant woman cannot be isolated in her privacy. She carries an embryo and later a fetus . . . ." Therefore regulation applicable to the fetus alone inevitably regulates the pregnant woman. There may well be instances, however, where a woman in consultation with her physician may decide to accept the small additional risk to the fetus associated with some radiation dose greater than 0.5 rem during the period of pregnancy in consideration of possible consequences related to her job or personal life. In any event even if there is some possibility that an individual might gamble and lose, it is still apparently her choice to make since it seems self evident that a right to choice governing the life of a fetus would easily encompass a right to add incrementally to its risk.
There is of course no warrant for concluding that if the NRC does not set special dose limits for protection of the fetus wholesale harmful doses will ensue. The NRC backfit analysis shows that some 37,000 radiation workers (not including reactor workers) now receive doses in excess of 0.5 rem per year while only 1500 receive doses in excess of 5 rem per year.3 Thus, there is a distribution of doses in the interval between 0.5 rem and 5 rem among radiation workers with a mean dose apparently less than 5 rem. All workers will now receive additional radiation protection under the new ALARA requirements in the 3
Draft Backfit Analysis: Cost of compliance with occupational exposure revision to 10 C.F.R. Part 20, Table 2-2.
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proposed rule. The new mandatory ALARA program applicable to all licensees can reasonably be expected to result in further dose reductions from levels now prevailing.
NRC could assert some interest in regulation in order to prevent the social consequences resulting from birth defects if that interest was adequately supported by scientific data. There is no evidence, however, that fetal doses received in practice under current limits have in fact resulted in excess birth defects. There is therefore no reason -
based on observation to believe that the currently proposed 9 20.208 would result in an actual reduction in the frequency of birth defects.
There is of course a scientific basis for believing that reduced doses to the fetus would achieve reduction in the frequency of birth defects. That belief rests on direct observations of effects at high doses and linear extrapolation to low doses. It is the same basis that guides the generally applicable risk assessments and it shares the same uncertainties. No one has actually observed any effects at low dose levels. The setting of generally applicable standards on that basis may be justifiable since there is apparently no other way to do it, and it i l
is non-discriminatory in its applicability. However, there is good reason to question the wisdom of proliferating fixed standards l applicable to special groups on that basis because the scientific ;
evidence is only inferential and individuals in special groups may well have other interests or rights at stake.
Lauriston Taylor has recently reviewed the historical evolution of radiation standards with particular reference to control of doses to the
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fetus.4 The NCRP recognized as long ago as 1971 that a basis existed for restricting dose to the fetus to 0.5 rem during gestation.
Nevertheless, on consideration of the possible interests of individuals the NCRP declined to "make detailed recommendations concerning modes of practical implementation of the recommended dose limits." Taylor concludes that "the concept of having multiple standards for radiation protection while based on reasonable scientific distinctions between different kinds of individuals at risk is nevertheless bound to lead to confusion, misunderstanding, and even abuse for non-scientific reasons."
Taylor points out that women might not take kindly to the intrusion of special regulation in their private affairs even though there is every reason to believe that women's interest in bearing healthy children is at least as strong as the regulators public interest in promoting that result. As we have seen, the Supreme Court gave strong weight to privacy rights. NRC's interest, however, is based on evidence at the technical margin where it cannot rigorously demonstrate that its proposed regulation would actually produce a health benefit over and above what is actually being achieved in practice and what could be achieved with a newly required ALARA program. Under these circumstances, I conclude that NRC should consider restraining itself from proliferating fixed special dose limits applicable to special 4
Taylor, Lauriston S. 1985. The problems of radiation double standards: exposure of potentially pregnant persons. Health Physics 49 (No. 6) (December): 1043-1052.
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7 classes of individuals where the incremental benefit is only speculative, and the scientific basis is weak.
In connection with this rulemaking, Comissioner Asselstine requested comment on the issue: What more can be done to protect an embryo or fetus from occupational radiation exposures of female workers without unduly restricting the careers or employment of female workers?
In view of the foregoing analysis, it may not be appropriate'at all for NRC to apply fixed, mandatory dose limits to one special class of ,
persons where such limits would inevitably interfere to some extent with ,
their employment or careers.
In consideration of the balance between NRC's perceived interest in further reducing risks to the fetus and the interest of female employees in both career and healthy children, NRC could extend by regulation an enforceable opportunity for a pregnant individual to voluntarily seek more protection frcm radiation than that being afforded by her employer's generally applicable ALARA program. If NRC wished to pursue
! this course, it could do so by deleting the current 5 20.208 in its entirety and replacing it with a section modelled on the following approach.
20.208 Dose to an Embryo / Fetus. , f (a) Licensee shall provide to female employees who work in ,
restricted areas information required by 55 19.12 and 19.13(a) which additionally discloses (1) risks to a developing fetus from radiation doses currently prevailing under the Licensee ALARA program, and (2) a woman's right to request special protection from radiation during pregnancy under this section.
(b) Pregnant employees who work in restricted areas may requ'est temporary working assignments or other special provisi'ns o I that will result in a radiation dose to the fetus which is
- lower than would be permitted under the generally applicable
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l Licensee ALARA program during the term of the pregnancy.
Upon receipt of any request for special radiation protection under this section, Licensees shall perform an additional analysis similar to that required under 5 20.102(a) that takes specific account of radiation risks to the fetus to determine whether actions required to achieve further reduction of projected doses to the individual during pregnancy are reasonably achievable and should be implemented.
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