SARI Comment on EPA’s ANPR for 40 CFR 190

On February 4, 2014, the US EPA (Environmental Protection Agency) issued an advanced notice of proposed rulemaking (ANPR) asking for interested stakeholders to review and provide comments and information about 40 CFR 190, Environmental Standards for Uranium Fuel Cycle Facilities. The comment period, originally scheduled to last 120 days, was extended to 180 days. That extended comment period ends on Sunday, August 3.

Earlier today (August 1, 2014), Scientists for Accurate Radiation Information (SARI) submitted the following document in response to that ANPR. It is being republished here to allow wider distribution and commentary about the important information submittal provided by this highly knowledgable group of scientists and radiation health specialists.

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SARI’s Response to EPA’s ANPR Regarding its Standards for Nuclear Power Operations

The Federal Register dated Feb 4, 2014 http://www.gpo.gov/fdsys/pkg/FR-2014-02-04/pdf/2014-02307.pdf published an Advance Notice of Proposed Rulemaking (ANPR) requesting public comment and information on potential approaches to updating the Environmental Protection Agency (EPA)’s ‘‘Environmental Radiation Protection Standards for Nuclear Power Operations’’ (40 CFR part 190). Below is the response from Scientists for Accurate Radiation Information (SARI) to this ANPR:

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These comments are from an international group of professionals called Scientists for Accurate Radiation Information (SARI), http://radiationeffects.org/.

The objective of SARI is to monitor and counter nuclear/radiological misinformation that could adversely impact the world’s ability to effectively respond to nuclear and radiological challenges, to the end point of saving lives. Our group is multidisciplinary and includes expertise in a variety of areas including radiation source characterization, radiation transport, external and internal radiation dosimetry, radiobiological effects (both harmful and beneficial), dose-response modeling, radiation risk and benefit assessment, nuclear medicine, diagnostic radiology, radiation oncology, commercial nuclear power, technology supporting use of nuclear power, isotope production, and nuclear/radiological emergency management.

EPA’s current regulations relating to radiation safety are based on the linear no-threshold (LNT) hypothesis for radiation-induced cancers or the concept that even very low doses of radiation can cause cancers, resulting in the setting of very low radiation dose limits for the public. The first enclosed document entitled “Comment to EPA on its standards for nuclear power operations” discusses the current state of the art in the field of low-dose radiation health effects, and shows that accumulated evidence neither supports the LNT hypothesis for radiation-induced cancers nor the concept that low-dose radiation causes cancers. Hence, regulating radiation dose at low levels would not be protecting health or minimizing danger to life, but would tend to diminish health and endanger life.

The second enclosed document, entitled “Comment to EPA on the Importance of Considering Dose-rate and Dose Fractionation in Setting Dose Limits”, discusses the importance of taking into consideration the period over which radiation exposure occurs, for estimating the health effects of radiation. Illustrative examples of evidence are presented to show that the same cumulative radiation dose can result in excess cancers when received acutely whereas when received over an extended period of time it can be cancer curative. Hence, radiation dose limits, when they are defined without specifying the period of exposure, would not be protecting health or minimizing danger to life.

The above comments and the enclosed documents apply not only to the current ANPR regarding 40 CFR Part 190 but also to the overall framework of radiation safety regulations of EPA. Prompt action is advisable in modifying EPA radiation safety regulations taking these concepts into consideration, so that EPA can truly perform its Congressional mandate to protect health and minimize danger to life.

Thank you for your consideration.

Mohan Doss, Email: mohan.doss@fccc.edu
on behalf of Scientists for Accurate Radiation Information (SARI)

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Comment to EPA on its standards for nuclear power operations

The bases for the existing EPA standards relating to public radiation dose limits are described in the Federal Register notice: http://www.gpo.gov/fdsys/pkg/FR-2014-02-04/pdf/2014-02307.pdf. In the Background section it states (bolding of text is by the authors of the Comment):
Section 161(b) of the Atomic Energy Act of 1954 (AEA) authorized the Atomic Energy Commission (AEC) to ‘‘establish by rule, regulation, or order, such standards and instructions to govern the possession and use of special nuclear material, source material, and byproduct material as the Commission may deem necessary or desirable to promote the common defense and security or to protect health or to minimize danger to life or property[.]’’ 42 U.S.C. 2201(b) (1958).

This authority was transferred to EPA in 1970, as per the subsequent text. Finally, it says:

Relying on this authority, EPA promulgated standards in 1977 to protect the public from exposure to radiation from the uranium fuel cycle at 40 CFR part 190, ‘‘Environmental Radiation Protection Standards for Nuclear Power Operations.’’

Thus the mandate to the EPA by the US Congress is to take actions to protect health or minimize danger to life. EPA’s actions in this area in 1977 were based on the concept that even the smallest exposure to radiation increases the risk of cancer. This concept for predicting cancer risk from radiation, known as the linear no-threshold (LNT) hypothesis, was adopted by the National Academy of Sciences (NAS) in 1956 (Calabrese, 2013). On this basis, complying with EPA’s very small radiation dose limits to the public would protect public health and minimize danger to life. These dose limits also applied to accumulated doses, over time, from low dose-rate exposures.

The primary data used by the NAS for predicting low-dose radiation health effects are the atomic bomb survivor data. For example, the BEIR VII report (NRC, 2006) on p. 141 refers to these data as “the single most important source” for evaluating the cancer risk from low-dose radiation. The conclusion of the report, on p. 323, states: “The committee concludes that the current scientific evidence is consistent with the hypothesis that there is a linear, no-threshold dose-response relationship between exposure to ionizing radiation and the development of cancer in humans.” This conclusion, irrespective of the exposure mode, implies that the smallest radiation dose increases the risk of cancer. Indeed, it supports the very low dose limits set by EPA in 1977 for members of the public.

The atomic bomb survivor data, based on acute radiation exposures, have also been described as the “gold standard” for determining health effects of low-dose radiation by influential scientists (Hall and Brenner, 2008). The reported excess cancers in the low-dose cohorts among the atomic bomb survivors have been used to raise concerns about the radiation dose from CT scans (Brenner and Hall, 2007). Indeed, the atomic bomb survivor data are the most frequently cited source for the current widespread cancer concerns regarding low-dose radiation.

However, the latest update to the atomic bomb survivor data (Ozasa et al., 2012) is qualitatively different from the previous reports (Preston et al., 2003, Preston et al., 2007) in that the new dose response data for cancer mortality has a significant curvature, as indicated by the authors’ statement on p. 234 that “the curvature over the 0–2 Gy range has become stronger over time, going from 0.20 for the period 1950–1985 to 0.81 for 1950–2003, and has become significant with longer observation (Table 7).” The curvature is discussed on p. 238: “The apparent upward curvature appears to be related to relatively lower than expected risks in the dose range 0.3–0.7 Gy (Fig. 4), a finding without a current explanation.”

The LNT hypothesis, used to fit the atomic bomb survivor data, does not explain the reduction of cancers in this low dose range. When a hypothesis does not fit the data, the Scientific Method requires that it be rejected, and so the predictions of excess cancer risk for low doses (Ozasa et al., 2012), based as they are on the LNT hypothesis, cannot be considered valid.

On the other hand, if the reduction of cancers in the lowest dose cohorts is due to the up-regulation of adaptive protection (Feinendegen et al., 2004, Feinendegen et al., 2013), the baseline cancer rates used in the atomic bomb survivor data analysis (Ozasa et al., 2012) would have a negative bias. Correcting the negative bias would result in a dose-response curve consistent with the concept of radiation hormesis (Doss, 2012, Doss, 2013), which would therefore imply that low-dose radiation reduces rather than increases cancer risk. There is, indeed, considerable evidence already for the cancer-preventive effect of low-dose radiation (Kostyuchenko and Krestinina, 1994, Cuttler and Pollycove, 2003, Sakamoto, 2004, Hwang et al., 2006, Tubiana et al., 2011).

The qualitative change in the atomic bomb survivor data—that they no longer provide the evidence for low-dose radiation carcinogenicity—has been recognized de facto by influential scientists in the field, since they do not refer to the latest atomic bomb survivor data (Ozasa et al., 2012) to raise cancer concerns. Rather, they refer to older data (Preston et al., 2007), irrespective of the mode of exposure, as seen in their publications, e.g. (Brix et al., 2013, Miglioretti et al., 2013, Brenner, 2014, Brix and Nekolla, 2014, Cucinotta, 2014, Steward et al., 2014).

We would add that, in a recent debate on the health effects of low-dose radiation (Doss et al., 2014), the proponent of low-dose radiation carcinogenicity, in his opening statement, did not refer to the latest atomic bomb survivor data but cited older data, and that too only indirectly. This contrasts with a previous debate (Little et al., 2009) where the atomic bomb survivor data were given a central role. In the Rebuttal, the proponent again did not cite the newer data but referred to older atomic bomb survivor data to claim absence of threshold or hormetic dose-response.

Thus, the primary data used for low-dose cancer risk assessment in the BEIR VII report (and in other advisory body reports) are no longer a valid justification for the concerns. On the contrary, there is considerable support for using a threshold concept for radiation protection, based on the evidence of threshold or hormetic dose-response for the effect of radiation, both after acute and low dose-rate exposures (Kostyuchenko and Krestinina, 1994, Sakamoto, 2004, Hwang et al., 2006, Tubiana et al., 2011, Doss, 2013, Cuttler, 2014). Hence the EPA’s low dose limits, which are based on the LNT hypothesis, neither protect public health nor minimize danger to life.

A very harmful consequence of any low dose limit is that it reinforces the public perception that low dose radiation is very dangerous, resulting in the “precautionary” actions that contribute to increased deaths. A recent example is Fukushima where many deaths were caused by the emergency evacuation of hospitals and nursing homes and the prolongation of the evacuation for years, mostly due to the low-dose radiation concerns (Ichiseki, 2013, Nomura et al., 2013, Saji, 2013, AJW, 2014). Precautions because of low-dose radiation concerns in diagnostic imaging may also be harming patients: poor quality images due to dose reduction, physicians not ordering diagnostic studies when indicated, patients withholding consent for such imaging studies, etc. (McCollough, 2011, Boutis et al., 2013, Goske et al., 2013, Pandharipande et al., 2013, Brody and Guillerman, 2014).

Since the mandate to EPA is to take actions to protect health or to minimize danger to life, and since the current low dose limits do not protect public health or minimize danger to life based on the above discussion, the EPA’s low dose limits cannot be justified under the present law. These limits have to be raised as high as reasonably safe, in order to satisfy the mandate of the Congress and comply with the laws of the United States.

Whereas EPA may have previously utilized advisory body reports, such as BEIR VII, for guiding its actions, the new atomic bomb survivor data have negated the conclusions of these reports. They can no longer be used as the current state of the art in this field. There is no requirement for the EPA to follow the guidelines of international or national advisory bodies. If it had no scientists but only administrative and management staff, EPA would be excused for ignoring the new atomic bomb survivor data and the low-dose-rate exposure data, and making no changes to its dose limits. However, EPA does have a considerable base of scientific expertise and is able to evaluate the current literature and reach the conclusions that we have.

We strongly urge EPA to fulfill its mandate to protect public health and minimize danger to life by using the latest data and scientific information, and by rejecting old reports whose conclusions are no longer valid.

Sincerely,

Mohan Doss, PhD, Fox Chase Cancer Center, USA (mohan.doss@fccc.edu)
Rod Adams, MS, Publisher, Atomic Insights, USA
Wade Allison, PhD, Oxford University, UK
Lu Cai, MD, PhD, University of Louisville, USA
Mervyn Cohen, MBChB, Indiana University, USA
Leslie E. Corrice, MA, Author – Fukushima: The First Five Days, USA
Jerry Cuttler, DSc, Cuttler & Associates, Canada
Ludwik Dobrzynski, DSc, National Centre for Nuclear Research, Poland
Vincent J Esposito, DSc, University of Pittsburgh, USA
Ludwig E. Feinendegen, MD, Heinrich-Heine University, Germany
Alan Fellman, PhD, Dade Moeller & Associates, Inc., USA
Krzysztof W. Fornalski, PhD, Polish Nuclear Society, Poland.
P.C. Kesavan, PhD, M.S. Swaminathan Research Foundation, India
Jeffrey Mahn, MS, Sandia National Laboratories (Retired), USA
Mark L. Miller, Sandia National Laboratories, USA
Jane M. Orient, MD, Doctors for Disaster Preparedness, USA
Doug Osborn, PhD, Sandia National Laboratories, USA
Charles W. Pennington, MS, MBA, Independent Nuclear Consultant, USA
Jeff Philbin, PhD, Sandia National Laboratories (Retired), USA
Chary Rangacharyulu, PhD, University of Saskatchewan, Canada
Bill Sacks, MD, PhD, FDA’s Center for Devices and Radiological Health (Retired), USA
Bobby R. Scott, PhD, Lovelace Respiratory Research Institute (Retired), USA
Jeffry A. Siegel, MS, MS, PhD, Nuclear Physics Enterprises, USA
Ruth F. Weiner, PhD, Sandia National Laboratories (Retired), USA
James S. Welsh, MS, MD, FACRO, President-elect, American College of Radiation Oncology, USA

Note: The above signatories are members or associate members of Scientists for Accurate Radiation Information, http://radiationeffects.org/. This document represents their professional opinions, and does not necessarily represent the views of their affiliated institutions.

References:

AJW. 2014. Editorial: Plight of Fukushima evacuees deserves serious policy responses. The Asahi Shimbun, Mar 8, 2014. Available: http://ajw.asahi.com/article/views/editorial/AJ201403080030
BOUTIS, K., et al. 2013. Parental knowledge of potential cancer risks from exposure to computed tomography. Pediatrics, 132, 305-11. Available: http://www.ncbi.nlm.nih.gov/pubmed/23837174
BRENNER, D. J. 2014. What we know and what we don’t know about cancer risks associated with radiation doses from radiological imaging. Br J Radiol, 87, 20130629. Available: http://www.ncbi.nlm.nih.gov/pubmed/24198200
BRENNER, D. J. & HALL, E. J. 2007. Computed tomography–an increasing source of radiation exposure. N Engl J Med, 357, 2277-84. Available: http://www.ncbi.nlm.nih.gov/pubmed/18046031
BRIX, G. & NEKOLLA, E. A. 2014. Response to letter by Doss: addition of diagnostic CT scan does not increase the cancer risk in patients undergoing SPECT studies. Eur J Nucl Med Mol Imaging, 41 Suppl 1, 148-9. Available: http://www.ncbi.nlm.nih.gov/pubmed/24595466
BRIX, G., et al. 2013. Radiation risk and protection of patients in clinical SPECT/CT. Eur J Nucl Med Mol Imaging. Available: http://www.ncbi.nlm.nih.gov/pubmed/24052089
BRODY, A. S. & GUILLERMAN, R. P. 2014. Don’t let radiation scare trump patient care: 10 ways you can harm your patients by fear of radiation-induced cancer from diagnostic imaging. Thorax. Available: http://www.ncbi.nlm.nih.gov/pubmed/24764114
CALABRESE, E. J. 2013. How the US National Academy of Sciences misled the world community on cancer risk assessment: new findings challenge historical foundations of the linear dose response. Arch Toxicol. Available: http://www.ncbi.nlm.nih.gov/pubmed/23912675
CUCINOTTA, F. A. 2014. Space radiation risks for astronauts on multiple International Space Station missions. PLoS One, 9, e96099. Available: http://www.ncbi.nlm.nih.gov/pubmed/24759903
CUTTLER, J. M. 2014. Leukemia incidence of 96,000 Hiroshima atomic bomb survivors is compelling evidence that the LNT model is wrong. Archives of Toxicology, Online First. Available: http://rd.springer.com/article/10.1007/s00204-014-1207-9/fulltext.html
CUTTLER, J. M. & POLLYCOVE, M. 2003. Can Cancer Be Treated with Low Doses of Radiation? Journal of American Physicians and Surgeons 8. Available: http://www.jpands.org/vol8no4/cuttler.pdf
DOSS, M. 2012. Evidence supporting radiation hormesis in atomic bomb survivor cancer mortality data. Dose Response, 10, 584-92. Available: http://www.ncbi.nlm.nih.gov/pubmed/23304106
DOSS, M. 2013. Linear No-Threshold Model vs. Radiation Hormesis. Dose Response, 11, 480-497. Available: http://www.ncbi.nlm.nih.gov/pubmed/24298226
DOSS, M., et al. 2014. Point/Counterpoint: Low-dose radiation is beneficial, not harmful. Med Phys, 41, 070601. Available: http://www.ncbi.nlm.nih.gov/pubmed/24989368
FEINENDEGEN, L. E., et al. 2013. Hormesis by Low Dose Radiation Effects: Low-Dose Cancer Risk Modeling Must Recognize Up-Regulation of Protection. In: BAUM, R. P. (ed.) Therapeutic Nuclear Medicine. Springer. Available: http://download.springer.com/static/pdf/898/chp%253A10.1007%252F174_2012_686.pdf?auth66=1406023023_56a2607887c108e2e7f2d4ec5e0995de&ext=.pdf
FEINENDEGEN, L. E., et al. 2004. Responses to low doses of ionizing radiation in biological systems. Nonlinearity Biol Toxicol Med, 2, 143-71. Available: http://www.ncbi.nlm.nih.gov/pubmed/19330141
GOSKE, M. J., et al. 2013. Diagnostic reference ranges for pediatric abdominal CT. Radiology, 268, 208-18. Available: http://www.ncbi.nlm.nih.gov/pubmed/23513245
HALL, E. J. & BRENNER, D. J. 2008. Cancer risks from diagnostic radiology. Br J Radiol, 81, 362-78. Available: http://www.ncbi.nlm.nih.gov/pubmed/18440940
HWANG, S. L., et al. 2006. Cancer risks in a population with prolonged low dose-rate gamma-radiation exposure in radiocontaminated buildings, 1983-2002. Int J Radiat Biol, 82, 849-58. Available: http://www.ncbi.nlm.nih.gov/pubmed/17178625
ICHISEKI, H. 2013. Features of disaster-related deaths after the Great East Japan Earthquake. Lancet, 381, 204. Available: http://www.ncbi.nlm.nih.gov/pubmed/23332962
KOSTYUCHENKO, V. A. & KRESTININA, L. 1994. Long-term irradiation effects in the population evacuated from the east-Urals radioactive trace area. Sci Total Environ, 142, 119-25. Available: http://www.ncbi.nlm.nih.gov/pubmed/8178130
LITTLE, M. P., et al. 2009. Risks associated with low doses and low dose rates of ionizing radiation: why linearity may be (almost) the best we can do. Radiology, 251, 6-12. Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19332841
MCCOLLOUGH, C. H. 2011. Defending the use of medical imaging. Health Phys, 100, 318-21. Available: http://www.ncbi.nlm.nih.gov/pubmed/21595081
MIGLIORETTI, D. L., et al. 2013. The use of computed tomography in pediatrics and the associated radiation exposure and estimated cancer risk. JAMA Pediatr, 167, 700-7. Available: http://www.ncbi.nlm.nih.gov/pubmed/23754213
NOMURA, S., et al. 2013. Mortality risk amongst nursing home residents evacuated after the Fukushima nuclear accident: a retrospective cohort study. PLoS One, 8, e60192. Available: http://www.ncbi.nlm.nih.gov/pubmed/23555921
NRC 2006. Health risks from exposure to low levels of ionizing radiation : BEIR VII Phase 2, National Research Council (U.S.). Committee to Assess Health Risks from Exposure to Low Level of Ionizing Radiation., Washington, D.C., National Academies Press. Available: http://www.nap.edu/openbook.php?isbn=030909156X
OZASA, K., et al. 2012. Studies of the mortality of atomic bomb survivors, report 14, 1950-2003: an overview of cancer and noncancer diseases. Radiat Res, 177, 229-43. Available: http://www.ncbi.nlm.nih.gov/pubmed/22171960
PANDHARIPANDE, P. V., et al. 2013. Journal club: How radiation exposure histories influence physician imaging decisions: a multicenter radiologist survey study. AJR Am J Roentgenol, 200, 1275-83. Available: http://www.ncbi.nlm.nih.gov/pubmed/23701064
PRESTON, D. L., et al. 2007. Solid cancer incidence in atomic bomb survivors: 1958-1998. Radiat Res, 168, 1-64. Available: http://www.ncbi.nlm.nih.gov/pubmed/17722996
PRESTON, D. L., et al. 2003. Studies of mortality of atomic bomb survivors. Report 13: Solid cancer and noncancer disease mortality: 1950-1997. Radiat Res, 160, 381-407. Available: http://www.ncbi.nlm.nih.gov/pubmed/12968934
SAJI, G. 2013. A post accident safety analysis report of the Fukushima Accident – future direction of evacuation: lessons learned. In: Proceedings of the 21st International Conference on Nuclear Engineering. ICONE21. Jul 29 – Aug 2. Chengdu. China. ASME. Available: http://proceedings.asmedigitalcollection.asme.org/proceeding.aspx?articleid=1829180
SAKAMOTO, K. 2004. Radiobiological basis for cancer therapy by total or half-body irradiation. Nonlinearity Biol Toxicol Med, 2, 293-316. Available: http://www.ncbi.nlm.nih.gov/pubmed/19330149
STEWARD, M. J., et al. 2014. Abdominal computed tomography, colonography and radiation exposure: what the surgeon needs to know. Colorectal Disease, 16, 347-352. Available: http://dx.doi.org/10.1111/codi.12451
TUBIANA, M., et al. 2011. A new method of assessing the dose-carcinogenic effect relationship in patients exposed to ionizing radiation. A concise presentation of preliminary data. Health Phys, 100, 296-9. Available: http://www.ncbi.nlm.nih.gov/pubmed/21595074

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Comment to EPA on the Importance of Considering
Dose-rate and Dose Fractionation in Setting Dose Limits

The EPA’s public radiation dose limit is 0.25 mSv per year for nuclear energy related operations. This low limit is based on the linear no-threshold (LNT) hypothesis for predicting the cancer risk from low-dose radiation that was adopted by the National Academy of Sciences (NAS) in 1956. It presumes that even the smallest dose of radiation increases the risk of cancer death. We would like to demonstrate again why such a low dose limit is unreasonable. In doing so, we have selected just a few illustrative examples from a large number of reports of epidemiological, clinical and experimental investigations.

We are aware of the complexity of the mechanisms involved in the biological effects of low dose-rate exposures and repetitive low dose treatments. The studies cited here on humans, who received low dose-rate radiation in the environment or fractionated radiation exposures in therapeutic medicine, reveal the invalidity of modeling the risk of cancer or other health detriment as a linear function of accumulated dose. All of these data contradict the predictions of the LNT hypothesis for assessing risk, the method recommended by national and international radiation protection organizations. This 1956 hypothesis, which suggests keeping exposures as low as reasonably achievable (ALARA) to minimize risk, is still the basis for the EPA policy of setting limits for radiation exposures in order to protect health or minimize danger to life.

No evidence of increased cancer mortality in areas of high background radiation

The natural background radiation level in the USA ranges from about 1 to more than 20 mSv per year (NCRP, 2009). Figure 1 indicates that people who live in areas of higher background radiation do not have an increased risk of cancer mortality (Frigerio et al., 1973). So there is no justification for setting the current public radiation dose limit at 0.25 mSv/year as it would not protect health or minimize danger to life.

Dose-rate and dose-fractionation considerations

The carcinogenicity of a high dose of radiation was established in the study of the atomic bomb survivors. However, they were exposed instantaneously. When organisms are exposed to radiation continuously over an extended period of time, it is well known that they adapt to this stress by up-regulating their protective systems, which prevent, repair or remove cell and tissue damage and maintain organ function and health (Fliedner et al., 2012).

For the case of radiation cancer therapy, though the total dose given to the tumor and incidentally to the surrounding tissues is quite high, being in the range of 20-80 Gy, using dose fractions allows the body’s protective systems to repair (or replace) damaged cells/tissues during the period between the dose fractions. Different from tumor cells, the normal tissues suffer less damage and side effects in comparison to similar doses given acutely in a short time. These real-life experiences contradict the radiation protection LNT methodology of summing radiation doses over prolonged periods to calculate DNA damage and predict cancer risk (Mitchel, 2007).

Another example of the different response obtained, when a recovery time interval is provided between radiation exposures, is the systemic treatment of cancers using low-dose total body irradiation (LD-TBI) (Chaffey et al., 1976, Choi et al., 1979). In these clinical studies, a total whole body dose of 1.5 Gy was delivered in comparatively small fractions over a period of five weeks. This treatment resulted in similar or better success in curing cancer, compared to chemotherapy (see Figures 2 & 3 – Figure 2 shows no statistically significant difference, while Figure 3 shows better success with LD-TBI.) (Chaffey et al., 1976, Pollycove, 2007). The same dose, given instantaneously, is known to increase cancer mortality from the follow-up of the atomic bomb survivors (see Figure 4) (Ozasa et al., 2013). The low-dose treatments exploit not only the capability of normal cells to enhance protection against immediate damage but also the up-regulation of the adaptive protection systems over extended periods of time (Feinendegen et al., 2013).

Thus, dose-rate and dose fractionation are very important considerations in determining the health effects of radiation. Since the risk of losing very important beneficial health effects of dose-rate and dose fractionation are not considered in setting the public dose limits, the present dose limits would not only fail to protect health or minimize danger to life, but would actually endanger health and increase the danger to life.

We urge EPA to consider the effects of dose-rate and dose-fractionation in setting public radiation dose limits.

Sincerely,

Mohan Doss, PhD, Fox Chase Cancer Center, USA (mohan.doss@fccc.edu)
Rod Adams, MS, Publisher, Atomic Insights, USA
Wade Allison, PhD, Oxford University, UK
Meredith Angwin, MS, Carnot Communications, USA
Lu Cai, MD, PhD, University of Louisville, USA
Mervyn Cohen, MBChB, Indiana University, USA
Leslie Corrice, MA, Author, Publisher of The Hiroshima Syndrome, USA
Jerry Cuttler, DSc, Cuttler & Associates, Canada
Ludwik Dobrzynski, DSc, National Centre for Nuclear Research, Poland
Scott Dube, MS, Morton Plant Hospital, USA
Vincent Esposito, DSc, University of Pittsburgh, USA
Alan Fellman, PhD, Dade Moeller & Associates, Inc., USA
Ludwig E. Feinendegen, MD, Heinrich-Heine University, Germany
Krzysztof W. Fornalski, PhD, Polish Nuclear Society, Poland
P.C. Kesavan, PhD, M.S. Swaminathan Research Foundation, India
Patricia Lewis, Free Enterprise Radon Health Mine, USA
Jeffrey Mahn, MS, Sandia National Laboratories (Retired), USA
Mark L. Miller, Sandia National Laboratories, USA
Jane Orient, BA, BS, MD, Doctors for Disaster Preparedness, USA
Charles W. Pennington, MS, MBA, Independent Nuclear Consultant, USA
Jeff Philbin, PhD, Sandia National Laboratories (Retired), USA
Chary Rangacharyulu, PhD, University of Saskatchewan, Canada
Bill Sacks, MD, PhD, FDA’s Center for Devices and Radiological Health (Retired), USA
Charles L. Sanders, PhD, Korea Adv. Inst. of Science and Technology, S. Korea (Retired), USA
Bobby R. Scott, PhD, Lovelace Respiratory Research Institute (Retired), USA
John A. Shanahan, Dr.-Ing., Go Nuclear, Inc., USA
Alexander Vaiserman, PhD, Institute of Gerontology, Ukraine
James S. Welsh, MS, MD, FACRO, President-elect, American College of Radiation Oncology, USA

Note: The above signatories are members or associate members of Scientists for Accurate Radiation Information, http://radiationeffects.org/. This document represents their professional opinions, and does not necessarily represent the views of their affiliated institutions.

References

CHAFFEY, J. T., et al. 1976. Total body irradiation as treatment for lymphosarcoma. Int J Radiat Oncol Biol Phys, 1, 399-405. Available: http://www.ncbi.nlm.nih.gov/pubmed/823140
CHOI, N. C., et al. 1979. Low dose fractionated whole body irradiation in the treatment of advanced non-Hodgkin’s lymphoma. Cancer, 43, 1636-42. Available: http://www.ncbi.nlm.nih.gov/pubmed/582159
FEINENDEGEN, L. E., et al. 2013. Hormesis by Low Dose Radiation Effects: Low-Dose Cancer Risk Modeling Must Recognize Up-Regulation of Protection. In: BAUM, R. P. (ed.) Therapeutic Nuclear Medicine. Springer. Available: http://download.springer.com/static/pdf/898/chp%253A10.1007%252F174_2012_686.pdf?auth66=1406023023_56a2607887c108e2e7f2d4ec5e0995de&ext=.pdf
FLIEDNER, T. M., et al. 2012. Hemopoietic response to low dose-rates of ionizing radiation shows stem cell tolerance and adaptation. Dose Response, 10, 644-63. Available: http://www.ncbi.nlm.nih.gov/pubmed/23304110
FRIGERIO, N. A., et al. 1973. Argonne Radiological Impact Program (ARIP). Part I. Carcinogenic hazard from low-level, low-rate radiation. Argonne National Lab., Ill. . Available: http://www.iaea.org/inis/collection/NCLCollectionStore/_Public/05/119/5119810.pdf
MITCHEL, R. E. 2007. Cancer and low dose responses in vivo: implications for radiation protection. Dose Response, 5, 284-91. Available: http://www.ncbi.nlm.nih.gov/pubmed/18648562
NCRP 2009. NCRP Report No. 160 – Ionizing Radiation Exposure of the Population of the United States (2009), Bethesda, Md., National Council on Radiation Protection and Measurements. Available: http://www.ncrponline.org/Publications/Press_Releases/160press.html
OZASA, K., et al. 2013. ERRATA for Volume 177, number 3 (2012) in the article “Studies of the mortality of atomic bomb survivors, report 14, 1950-2003: an overview of cancer and noncancer diseases”. Radiat Res, 179, e0040-e0041. Available: http://www.rrjournal.org/doi/full/10.1667/RROL05.1
POLLYCOVE, M. 2007. Radiobiological basis of low-dose irradiation in prevention and therapy of cancer. Dose Response, 5, 26-38. Available: http://www.ncbi.nlm.nih.gov/pubmed/18648556

Use of the comments in this document: These comments are being submitted to EPA and will be publicly available at their website. You are encouraged to make copies of these comments or distribute them. During such use, we appreciate identification of the source as Scientists for Accurate Radiation Information (SARI), with a link to the website: http://radiationeffects.org.

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Note: A PDF version of the submitted document can be downloaded here.