The following comments on the summary portions of the ICRP draft document “The Scope of Radiological Protection Regulations” are submitted on behalf of the Radiation Committee of the Sierra Club in the United States. We appreciate the opportunity to do so and urge the ICRP to incorporate our recommendations into revised versions of this document, and as relevant, in ICRP’s 2005-.Recommendations, which are now also available for public comment. Introductory Background Comments: Sierra Club, like ICRP, is a non-governmental organization. The Club includes more than 750,000 Americans who have concerns for the quality of the natural and human-modified environments, on which all forms of life depend. Within the web of life are many interdependencies of which, at present, we are still only dimly aware or not at all. Therefore, we have an ethical obligation to consider as carefully as possible the impacts of all decisions we make, especially those that may negatively impact our species and other occupants of the biosphere. In part because ionizing radiation is a significant factor in the genetic evolution of species, the scope of regulation of radioactive materials must include all materials and wastes that are radioactive, in all their various forms and at all levels and duration of their radioactivity. The primary purpose of regulation is to prevent harm to those who may be exposed to such materials. Numerous academic researchers, independent scholars, and governmental bodies, such as the U.S. National Academies of Science and National Research Council, have now concluded that the linear no-threshold hypothesis (LNT) is valid and that there is no “safe” level of radiation exposure. As stated in the ICRP Committee One Task Group 2004 draft report, “Low-dose Extrapolation of Radiation-Related Cancer Risk,” a single track through a cell may be sufficient to initiate injury. The medical dictum for humans remains “First to do no harm.” This said, we believe that the ICRP cannot legitimately recommend that there are radiation exposure situations that need not be subject to regulation and that can be excluded from control by law “because they cannot be controlled by any reasonable means.” The determination of what constitutes a justifiable regulatory requirement that is warranted is left in the hands of regulators – or, worse, of legislators, who may or may not have an understanding of the scope of the hazards, or of the somatic and genetic damage that may result from low dose and additive radiation exposures. Due in part to long latency periods and few or no societal mechanisms for tracking recipients, legislators, in particular, are unlikely to know the consequences of exposures to the public that they or the regulators allow. By regulators arbitrarily dismissing radioactive materials as not requiring regulatory control, the recipients of doses that are additive above unavoidable background levels cannot protect themselves from more doses that increase their total exposures. The opportunity to accept or reject additional exposures is at the very heart of the medical Hippocratic oath. Comments on the Abstract and Executive Summary: The Abstract, in particular, would benefit from careful editing to improve its clarity (as would our comments) and to explain the full intent of the ICRP’s purposes, as is done more fully in the text. It appears that the outcome of adoption of ICRP’s proposals would be global harmonization of reduced radiation protection. ICRP, a private entity, would determine definitions and limits of radiological protection which presumably would be recommended to international bodies, such as the European Union, and to the governing bodies of various treaties and trade agreements that are binding upon their signatories. In turn, ICRP’s standards and exemptions and exclusions would have to be adopted in required conformity to the agreements by national legislative bodies, and thus preempt the ability of sub-national governments and communities to provide greater levels of protection for their citizens. We note that a similar harmonization and compatibility approach to reducing public protection by regulatory internationalization was utilized in 2003 by the International Atomic Energy Agency. The purpose was to govern transnational transport of radioactive materials and wastes. Inter alia, regulatory control and labeling in transit were reduced; terrorist attacks, or diversions of radioactive materials, were not fully addressed; and exemptions and exceptions from regulation continued to be allowed or were expanded. (Adoption of the IAEA-initiated standards has been challenged in U.S. courts.) As an example of our concerns: the Abstract states that “foodstuff” and drinking water with low activity concentrations “are candidates for automatic exemption” from regulatory control. In the United States, food irradiation has been rejected by the public repeatedly in the past twenty years – in part because notification of irradiation was required, and the public had the option to reject. “Non-edible” radioactive materials are also proposed for automatic exemptions in accord with “agreements reached under the aegis of international organizations, as referenced in this report.” Whether such exemptions would be mandatory or optional is not made clear. Among our concerns in the Summary: In Paragraph (a), ICRP states that “a precise definition of ....scope for both legal and practical reasons” is recommended to legislators. Only if there is no requirement that legislators must adopt ICRP’s recommendations could this proposal be acceptable in our democratic society. In Paragraph (b), ICRP uses the undefined term “controlled by any reasonable means” to justify exclusions from control and from legislation. What does “any reasonable means” mean? What are the criteria and judgments that determine “exemption from compliance” with.... regulatory requirements.... ”because those requirements are unwarranted.”? What are the criteria and who determines them and what are the bases? In paragraph (c), we find also the phrase “.. unamenable to control by any reasonable means” but who defines and how? What is “reasonable,” and what “means are not”? What exactly is amenable vs. unamenable – and who decides? The ICRP? A regulator supportive of the nuclear industry? Or the recipient of an unwanted and unnecessary radiation exposure? Re: Paragraph (c): Whatever justifications we find elsewhere in this document, these introductory summations make clear that the ICRP does not put the public’s health and safety first. For if it did, there would be no discussion of exclusion and exemption. The BEIR VII Report, released one year ago this month, in concert with contemporary research and publications in the field of radiation microbiology, plus the excellent review of the status of low-dose research in ICRP’s 2004 Committee One report should settle the issue of the hazard of radiation doses even at low dose levels. The law may call the consequences of radiation injury de minimis, but such injuries are not de minimis to the person who suffers a resultant cancer or birth or other genetic defect in his or future generations. At Paragraph (d), we would suggest that discussion of the categories of dose recipients must include ICRP’s acknowledgment that any radioactive materials or wastes that are excluded or exempted from regulation will, or may, remain available in the environment. ICRP should also state that an additive exposure, perhaps rather small, is nonetheless another uncounted dose. ICRP must explain that there will be a greater probability of many such small but additive and unidentifiable exposures resulting from exemptions and exclusions. ICRP must also explain that these doses will augment the total individual dose received by that individual. Thus: individuals’ total exposures from which they receive no benefit but may be harmed are multiple, additive, cumulative, and synergistic. They will also be interacting with the many other toxics in the environment in ways that may injure recipients, and do so in ways not yet understood. The right to be able to avoid damage to oneself should be the paramount consideration of any organization that claims to protect the health and safety of the public. At Paragraphs (e) and (f), ICRP states that the public’s desire for protection is perceived to be greater for technologically-produced (“artificial”) byproducts than doses from a naturally-occurring source. Although, for example, radon in ambient air may be “naturally-occurring,” the radon levels may be markedly increased due to uranium mining or milling, or higher radon emanations may even result from a gardener’s seasonal soil-turning. Any adverse impacts may be at least somewhat reduced if the decision is made to forego the radon-releasing activity. Comparable decision points exist throughout the entire nuclear production and utilization system. Naturally-occurring sources of exposure should not be categorically excluded or exempted from regulatory control. Tradeoffs that provide economic advantage to the generator/user of a naturally-occurring source should, however, not enter the decision process. It is the protection of health and safety that should trump economic gain. Paragraphs (g), (h) and (i) might be an encouraging recognition of the frivolous, unneeded, and potentially dangerous consequences of exemptions and exclusions, except for the fact that, in general, the members of the public, workers, and medical patients seldom have either equal access to the regulatory decision-makers that is enjoyed by licensees and other generators or users of radioactive materials and deregulated wastes. To our knowledge, seldom, essentially never, are all of the long-term economic and health costs of inadvertent or unregulated radiation exposures to members of the public and others factored into the decisions to exempt and exclude. As for allowing a one or 100 millirem per year dose resultant from exclusion, exemption, or any other failure to regulate, there is no way for the recipient of a dose -- or of doses -- resultant from that lack of regulatory protection to know how many additional similar or dissimilar exposures and millirems or microSieverts he or she may have experienced. The interests of the public are thus ill-served. Re: Paragraph (j): As stated previously, there is no justification for exemption of foodstuffs or drinking water (or water used in the preparation of foods or otherwise ingested). Since the mid-1980's, the public has rejected repeated efforts to sell irradiated foods. The ICRP could serve the public well by investigating the presumably small but additive doses received from processed or prepared foods that are allowed to contain irradiated ingredients. Similar comments apply to Paragraph (k). This proposed allowance of exemption or exclusion or any other form of deregulation has been tried repeatedly in the United States – especially in the guise of “Below Regulatory Concern.” It has been soundly opposed and rejected by more than 31 of the states. Note that the rights of individual states within the Union are important to these subordinate units of government in order to protect their populations from various harms. The argument for retention of those rights remains vital in this nation, despite the federal preemption contained in the U.S. Atomic Energy Act. As for Paragraph (l), there is no clear positive gain for members of the public who, subsequent to first use following exclusion or exemption, would run the risk of encountering an unmarked piece of equipment. Such contaminated equipment would potentially continue to add small but cumulative doses to others for extended periods of time. There is no protection for the public in this form of deregulation of radioactively contaminated equipment. Whether Paragraphs (l) and (m) address “clearance” (which has been opposed by U.S. public interest organizations) or “BRC” or “authorized release,” or some other designation – and whether or not the subsequent exposures emanate from a discharged medical patient or other person or object -- the result will be the same. An individual member of the public is at risk to receive an unwanted, unmonitored, and hence unknown and unknowable additional radiation exposure from which he or she gains no benefit. A recipient may be injured from that deregulated source. Those who claim to regulate the nuclear industry, and other users of radioactive materials, need to take responsibility for maximizing the protection of members of the public, rather than protecting the interests and financial status of the industry. It is troubling that these proposals for the scope of regulation focus primarily on reducing regulatory control to the detriment of the public interest. We look to ICRP to advise on improvement of control, on reducing radiation exposures. Paragraphs (n) and (o) recognize the possibility of a serious radiological accident or terrorist attack. The somewhat convoluted use of “exemption” from requirements for “intervention” raises some questions about how best for the industry and its regulators to address these contrary concepts, in order to best serve the public’s rights to know and to receive the most protective solutions to a regulatory dilemma. But it should be borne in mind that setting a quantitative added dose limit will probably be tantamount to assuring that that dose will be in addition to other exposures during the course of the year. The recipient, again, will be unlikely to know if he or she is receiving only the set additional amount or numerous such doses. Or higher or lower ones. Clearly, clarity is lacking. So is accountability. We would add that there is substantial concern about the dose levels that are now expected to be allowed in the aftermath of a “dirty bomb or other radiological attack, both in the immediate aftermath and for many years beyond as augmented doses substitute for costly cleanup. Paragraph (p) addresses the variable legalities of the ICRP’s position on scope of regulatory authority in potentially affected nations. We are appreciative of sensitivity to national sovereignty and differences in cultures. We want to emphasize, however, that radiation protection is not improved by exempting and excluding radioactive materials or wastes from regulatory control. Nor is the concept of optimization defined and accepted similarly worldwide. The scope of radiation protection encompasses all sources of radiation exposure, and in turn, all radioactive materials. Obviously, there is a need for societal means of controlling rogue nations – those that generate nuclear weapons and engage in reliance on nuclear power and other avoidable uses of the atom, but the goal of this organization, we aver, is should be to contribute to minimization of the damage caused by all exposures to ionizing radiation. In conclusion, the Sierra Club Radiation Committee respectfully recommends that the ICRP withdraw this draft “Scope” document, to be revised so that maximum protection be means of careful (though probably expensive) monitoring and full regulatory control will characterize the entire nuclear industry and other users for the duration of worldwide uses of atomic energy. We urge you not to deregulate. Too much is now known about the mechanisms of radiation injury at low levels to subject our own and future populations to either the somatic or genetic damage that would result otherwise from the proposals for massive deregulation, exemption, exclusion, or other failures to control the radioactive materials and wastes that are generated today. Thank you for accepting public comments on this important topic. We hope ours are of use.