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Submitted by J. Ross, ECNP
   Commenting on behalf of the organisation
Document 2005 ICRP Recommendation

These comments are filed by the Pennsylvania-based Environmental Coalition on Nuclear Power (ECNP), a citizen’s not-for-profit organization which was founded in 1970. ECNP has participated as a public-interest advocate in numerous local, state, and federal formal proceedings on proposals for reactors and radioactive waste disposal, reactor licensing (including Three Mile Island Units 1 and 2), radiation health issues, and other regulatory proceedings and litigation, plus public education and publications. The director has served on Pennsylvania’s Advisory Committee on Low-Level Radioactive Waste disposal since its inception in 1988.

Comments below on the full draft text may refer to specific sections or be generally applicable to more than a single section and topic. Other comments and expressions of concern may seem less specific to the ICRP’s document; but they are meant to address the recommendations that ICRP is urged to adopt. In our opinion, these ICRP recommendations do need to be revised, with some major alterations in order to provide assistance to regulatory agencies.

We believe that the recommendations we offer would help to assure better (safer) protection for nuclear industry workers, for members of the general public, and for others who may unwittingly be exposed to ionizing radiation doses that will provide them with no benefits but will add to the risk of damage to their health and, perhaps, the length of their lives. The comments are tied to the text, although not every topic is covered.

Within the context of the observations above, at Section 2.1.(13-14) of ICRP-2005 Draft Recommendations, the ICRP’s primary aim must be considered to be flawed. Questions: What is, and who decides what is, “an ‘appropriate’ level of protection”? How does ICRP define “desirable human actions and lifestyles”? On what criteria is “a lifestyle that increases radiation exposures” justified, in comparison with fatalities resultant from radiation exposures? Is a nuclear scientist or health physicist (especially one allied with the industry at issue) an appropriate person ”to make [ethical] value judgments [on] the relative importance” of various risks, or to decide the balance between risks and benefits? Are not these issues for the body political of those who are physically or economically affected by the decisions? The Commission, at 2.2.(18-19), appears to deny or shift much responsibility for such considerations. The public needs to know ICRP’s answers to the questions posed here (and others) in order to evaluate the wisdom of the Commission’s recommendations.

.With respect to exclusion and authorizations of exposures, related to points above, the statement in 2.3.(24) that the concept of exclusion “...will largely be of use in the control of natural sources” is unclear. It is not evident that exclusion is related to natural sources, but instead is applied to materials and wastes that a licensee wishes to be rid of at low or no cost. In what way or ways do exclusions control natural sources?

At 2.3.(26), explanation is also needed for the statement that exempted material “remains subject to the system of protection, although without further regulatory control.” Because all exposures -- “natural” and “artificial” or TENORM -- carry risks of biological damage, it stands to reason that the presence of radioactivity which will add to the exposures unavoidably received from naturally-occurring sources should be the subject of concern to regulators. It is not clear that this is the meaning here. Nor does the discussion of exclusion and exemption indicate that such materials or wastes would in fact remain under any regulatory control. An exempt material or process is one that is no longer subject to the rules and regulations. It has been exempted from them. The same is true of those materials and wastes that have been excluded from regulations. Perhaps the terms are used differently in different countries. Please clarify.

At 2.3.(28), ICRP is suggesting that “[s]ources with activity concentration above exemption levels need not necessarily be subject to the ‘full rigour’ of regulations.” How is “full rigour” defined and applied in this context? This statement requires explanation and justification that are lacking.

We concur, at 2.4.(29-30) that waste disposal and site remediation should be regarded as practices (or activities) that are related to the practice that created them, and that they must be so dealt with. It is not made clear, however, who has responsibility and who pays in circumstances where a licensee has vanished. What entity retains responsibility for institutional control and remediation of a closed or abandoned site over the whole hazardous life of the waste or materials? Our LLRW Advisory Committee wrestled mightily with these specific issues.

As for the summary of health effects caused by ionizing radiation, at 3.2.(38), the ICRP draft states that protection in the low dose range is mainly concerned with radiation-induced cancer and hereditary disease.
But numerous other non-lethal illnesses and disorders, from heart disease to immune system malfunction to mental retardation, and now many others, have been identified and should be taken into consideration.
(BEIR V, 1990) The draft also assumes that the linear no threshold relationship correctly describes the dose-risk relationship. Other studies have suggested that low level exposures may have greater non-lethal adverse consequences than higher ones. If fully verified, this relationship challenges the proposed expansion of exemptions and the recommendation of exclusions for low activity concentrations. It is becoming clear that
low internal doses received repetitively are more hazardous than previously believed by the experts. We hope that the Commission will supply wise counsel to regulators on recognition of low-level adverse impacts.

At 3.3.2 (48), it is concluded that all protection quantities rely on the linear no-threshold dose-response relationship. This seems to contradict other statements and those in 3.3.2(50) with regard to internal emitters. If there is a contradiction on this point, it should be explained.

As for cancer risk, addressed at 4.2.1.(100-105), the recent research findings on low dose-induced DNA damage and the post-irradiation cellular phenomena of induced genomic instability and bystander signaling appear to be rejected by ICRP on the grounds of some remaining unspecified uncertainties about the mechanisms and consequences relative to specifying cancer risk. Our comment is that there then is a question as to what would convince the Committee to exercise the principles of prudence and precaution, rather than moving in the opposite direction of relaxation of protection? What evidence and how much evidence is required for a determination that caution is the wiser course? The roles of low-dose, protracted dose, and greater impacts of internal emitters ought to be fully acknowledged and regulators should be advised to take them all into consideration.

While admitting that the A-Bomb Life Span Study provides additional data on temporal and age-dependent patterns of radiation-related cancer risk among people exposed when very young, the ICRP, at 4.2.1.(103), continues to base its standards decisions on doses to Standard (Reference) Man – not recognizing the evident greater sensitivity of young children. This position seems incompatible with other ICRP thinking and indefensible with respect to providing best protection for those who are most at risk

In addition, in the statement at 4.2.1.(104), the Commission notes that LSS data do differ from other sources, significantly for the lung – but then states that “data on dosimetry and tumor ascertainment” associated with environmental radiation exposures is insufficient to be used for risk estimates – yet states that they may be “a potentially valuable data source in the future.” Since human life spans are at stake, regulatory and advisory agencies should, again, adopt the precautionary approach to protecting public (and worker) health and safety, and do it now. The failure to do so in this instance seems clearly unjustified.

In the discussion of risk of hereditary effects, at 4.2.2.(106-109), the ICRP states that it finds “somewhat contradictory data on induction of mutations in certain repeated DNA sequences... (mini-satellites) in... mouse and human germ cells,“ and that, based on “current knowledge, these repeat sequence mutations are only rarely associated with heritable disease,” and therefore the mutation rate data for mini-satellites are “not considered relevant to estimation of risk of heritable effects from radiation exposure.” Despite that lack of definitive proof of an association, even an initial indication of a potentially significant relationship should cause a prudent advisor to issue a caution, or, at minimum, not reduce the levels of protection.

In 4.2.4.(114-118, w)e find no mention of the ova that are carried from birth by women of reproductive age. What literature and information on both external and internal doses were reviewed concerning the radiation doses delivered to those ova that later become a developing embryo and fetus, also receiving background radiation and possibly other exposures during gestation and thereafter? We regret that far too little attention has been paid to intergenerational consequences, as well. We urge the Commission to give these and related issues a high priority.

As for impacts on a developing embryo and fetus, the Commission recognizes that there is lethal radiation sensitivity prior to implantation, and risks of tissue injury, malformations in utero, and severe mental retardation if exposed at 8-15 weeks post-conception. These injuries may occur at a “few tens of mGy low LET.” Yet the conclusion is that there is “no reason to believe” that there will be “significant risks to health after birth”; that risks of malformation may “be discounted”; that severe mental retardation may have...a true threshold of at least 300 mGy” and therefore absence of risk at low doses; but that, for a full 25-point IQ loss, a “non-threshold dose response cannot be excluded,.although the IQ loss would “be undetectable and therefore of no practical significance.” These numbers and conclusions do not square with the permissible dose levels approved for healthy young adult male members of the general population under normal exposure circumstances. “Several tens of mSv” (several thousands of mrem)” would be exceedingly hefty doses for a developing embryo or fetus compared with the maximum 1 mSv (100 mrem) per annum dose limit for an adult from an operating nuclear reactor. We suggest that the Commission should reconsider these sections of the recommendations pertaining to the very young developing human being. The kinds and severity of the forms of damage described in these paragraphs will result in lifelong impediments for those afflicted, and possibly substantial life shortening.

In genetic susceptibility to cancer, 4.2.5.(119-122) even despite its acknowledgment of increased childhood cancer risk, the Commission concludes that “in utero exposure should not be a specific protection case in....situations where the prolonged dose is well below about 100 mSv (10 rem). To be blunt, any agency or advisory body that can find no reason for concern, or for reducing such high permissible in utero dose levels to the embryo and fetus, given its own admissions that serious damage does occur, should be, at best, ignored, if not accused of irresponsible negligence toward those it is supposed to protect. We strongly recommend that reliance on the ABCC data be reconsidered. To our understanding of the data from those early post-bomb investigations, they were primarily taken from victims whose exposures were primarily from blast and hence represented mostly external exposures. Certainly more research on the impacts of internal emitters on the developing embryo and fetus should be undertaken, but in the interim, any evidences of damage should elicit strong warning of potential detriment.

As for non-cancer diseases post-irradiation, 4.2.6.(123-125) the ICRP, acknowledges that they do exist and “increase in irradiated populations” at dose levels of 1 sV – heart disease, stroke, digestive disorders, and respiratory disease. Nevertheless, this Commission finds the available data are not adequate to require establishment of protective standards. Thus, all health effects, other than lifetime risk of fatal cancer and gross genetic effects in the first generation, will continue to be ignored or denied. The illnesses cited may be very debilitating at the minimum or as much a prelude to death as the cancers. Disregard for all non-cancer diseases and gross genetic defects is unacceptable.

In Section 5., The General System of Protection, the network of exposures is nicely described, although the simplifications adopted are an impediment to full analysis of total doses actually received. This results from the Commission’s decision to continue separation of the doses in the three different classes of exposures. If total dose to an individual is unknown, then risk of adverse effects cannot be accurately calculated. At 5.1.(131), the ICRP states that source-related assessment can trigger actions for a single source so that a whole class of individuals is protected from that source. However, it would seem that it still leaves the affected individual member of that class receiving doses from other sources. How does this simplification improve overall dose assessment and protection? The wording and meaning of the second sentence at 5.2.(132) on dose restrictions “from specified sources in all situations within their scope” is obscure. Please clarify.

At 5.2.(133-134), it appears that the individual is protected only in terms of dose received from only one source within a class of exposure, but not protected from all other exposures emanating from the other classes devised for the sake of simplification. And who, in this context is the “most exposed individual? Standard Man? Or developing embryo or fetus? Later in this paragraph, the Commission discusses dose limit and the inability to determine precisely the total doses received by an individual from all sources. Hence the use of approximations, which may be fairly accurate for occupational exposures but not for members of the general public. For that reason, if no other, the Commission should incorporate an elevated level of conservatism in its dose recommendations for the public, and particularly so for the most susceptible sector.

We take exception with the statement at 5.2.(136) that managements (presumably licensees) may have power and information to set the constraints. The unregulated exercise of such authority by self-interested parties has all too often created opportunities for illegal actions or disregard of safety. At least in our society such permission is decidedly inadvisable. If the ICRP expects regulatory agencies to set constraints lower than its recommended maximum values, one could conclude that the Commissions limits should be more restrictive. The further qualification, “In normal situations only” cited at 5.2.(138) also makes the reader uneasy. When is an exposure limit an actual maximum exposure allowed and when is it not? Other comments have questioned the “complementary” optimization approach. The wording at 5.2.(139) increases the unease: ALARA, supposedly strives for “reasonable achievable” although as it is applied cost factors are allowed to enter into the equation. Thus, the ALARA standard can be bent to meet the complaint of a licensee about the profit-reducing high costs of everything, and convince the regulator to set a monetary ceiling on the amount that must be spent in order to meet the qualification. This exemplifies the concerns expressed about the limited effectiveness and misuses of stakeholder input.

At 5.3.2.(145), is admission that no one source operator is capable of assessing an accurate apportionment of the doses that a member of the critical group may be receiving from other sources and classes. If a maximum dose limit is set for a single individual – not averaged out of a so-called “critical group,” that limit would have to be fractionated among all of the classes. There is no evident mechanism or requirement to do this. As understanding and sympathetic as one may want and try to be, the harsh reality remains that determining exposure limits is neither simple nor straightforward.

With respect to medical doses, we must note that all too many medical personnel are either ill-informed about radiation risks or deceptive in explaining them accurately to patients. The hospital radiation safety officer who introduces hormesis into his or her assurances that radiation is good for you is not providing the patient with accurate information on which to make an informed decision whether or not it will be beneficial to accept an exposure. We recommend that the ICRP recommend that medical personnel encourage patients to keep their own records of receipt of nuclear medicine procedures, including information on the equipment, the film, and how the dose was calculated – just as one keeps a record of vaccinations and the names and doses of prescription medications.

Some experts in this field claim that the largest but least necessary source of irradiation is from medical procedures. If ICRP concurs, it is suggested that the Commission develop strong recommendations to medical practitioners on how to minimize exposures and how to inform the dose recipient of all information and tradeoffs pertinent to wise decision-making.

In chapter 6. on “required levels of protection for individuals, we take exception to ICRP’s adoption of the 100 mSv (10 rem, 10,000 mrem) upper limit for workers or members of the public, especially if annual doses of that magnitude are allowed to be received year after year due to special circumstances of unremediated contamination.

Although the text of the draft fails to mention, at 6.2.(164), the effective dose value of 0.01 mSv ( 1mrem) per year is intended to serve as the threshold dose below which ICRP is recommending exclusion from regulatory control. We very strongly oppose adoption of such a recommendation. It will, almost beyond question, trigger quite massive relase of radioactive materials, radioactive wastes, and mixed radioactive and hazardous wastes, without notification or warning labels or any other means for a member of the public to be able to know, to measure, or interpret the importance of single or multiple doses received. The only conclusion that our organization can come to, after addressing this particular issue since 1978, is the nuclear industry and the military are simply unwilling to expend money on the safest attainable means of isolating the biologically dangerous wastes they willingly generate. The Commission should vehemently oppose, not recommend, the 0.01 mSv (1 mrem)/yr threshold dose.

Further comments on this document are likely to be highly repetitive. They come to a close with a final suggestion: at 6.3.3, on exposure of women: the tern “unborn child” has come to have controversial political significance. A more appropriate term in the context of the statement would be “fetus,” which term is used below in the same paragraph.

The Environmental Coalition on Nuclear Power wishes to express our appreciation to the ICRP for opening this Draft for Consultation last spring to public scrutiny and comment. We sincerely hope that the Commission will benefit from the objections, agreements, and disagreements with its draft recommendations for 2005. We will be pleased to respond to any questions you might have. We want to thank, in particular, Dr. Valentin for his prompt response to questions about how to submit comments. And we hope also that the Commissioners will respond favorably to our various suggestions, which are offered pro bono publico for improvement of radiological protection worldwide.