PRESIDENT BOICE, members and emeritus members of the Council, colleagues, ladies, and gentlemen. It is very difficult to put into words just how I feel at this moment. First, I never dreamed I would be standing here. But more importantly, I cannot explain in words just how much being the 40th Lauriston Sale Taylor Lecturer means to me. Even though there were significant differences in our ages, I always considered Laurie as a friend and a colleague. I first met him at the Health Physics Society Midyear Meeting in 1972. I was much younger and relatively new to health physics. But, of course, I knew who Dr. Lauriston Taylor was and the role he played in the early days of the National Council on Radiation Protection and Measurements (NCRP) and the profession of health physics. When I entered the breakfast room at the hotel, I spoke to Dr. K.Z. Morgan and his wife Helen. Of course I would, he was my boss at Oak Ridge National Laboratory (ORNL). They were sitting with Dr. Taylor but were about to leave. I was alone and Dr. Taylor asked me to join him. He was such a gracious person, and we had a wonderful conversation, not solely along technical lines. From that day forward, at other meetings including those at NCRP’s headquarters, he always spoke to me, asked about my family, and called me by my first name. As you might guess, it took me a very long time to venture into the realm of calling him other than Dr. Taylor. Suffice it to say that I have followed his lead in my career, always trying to treat my colleagues and my students with the same respect he embodied during his career.
My topic today may seem a strange one to many in the audience; “Radiation Protection and Regulatory Science.” But I suspect that many of you employed by the federal government have your own definition of the term regulatory science. Someone once said that “confession is good for the soul.” I do not intend to confess all my sins but instead to make an admission to begin this presentation. I admit that until about 1 y ago, I did not know about the new field called “regulatory science.” I must also admit that having served on advisory committees to several government agencies for several decades, I have been involved in regulatory science for a very long time. But I am almost certain that I can shield myself by surrounding myself with many colleagues on these committees because we thought we were simply doing “science.”
Nevertheless, I was embarrassed when one of our Ph.D. students at Texas A&M told me he was going to conduct his dissertation research on regulatory science. Unfortunately, I broke my trust as a teacher/advisor when I flippantly responded, “Isn’t that an oxymoron?” His disappointment at my question showed on his face, and I decided I needed to learn all I could about regulatory science. But let’s not get too far into the discussion without considering the past.
It took about 30 y after Wilhelm Konrad Roentgen’s discovery of x rays and Henri Becquerel’s discovery of natural radioactivity for scientists to formulate recommendations on exposure to ionizing radiation. Many scientists established control measures in their own laboratories, but there was no unified approach (Morgan and Turner 1973). We know of the early efforts today because the organizations that resulted from the concerns raised in 1928 at the Second International Congress of Radiology still play a role in radiation protection. The organizations are known today as the International Commission on Radiological Protection (ICRP) and, in the United States, the National Council on Radiation Protection and Measurements (NCRP). Today, as we have annually for many years, we honor Dr. Lauriston Sale Taylor, the U.S. representative to the 1928 Congress, for his dedication and leadership in the early growth of NCRP.
NCRP’s mission is “to support radiation protection by providing independent [emphasis added] scientific analysis, information, and recommendations that represent the consensus of leading scientists” (NCRP 2016). The developments in science and technology, including radiation protection, are occurring so rapidly that NCRP is challenged to provide its advice and guidance at a faster pace than ever before. NCRP’s role has also expanded as the Council considers newer uses and applications of ionizing radiation in research and medicine as well as the response to nuclear or radiological terrorism. In such a technical world, new areas have been established to deal with the nexus of science and regulation, especially in the United States.
Lord Ernest Rutherford supposedly said, “That which is not measurable is not science. That which is not physics is stamp collecting.” I wonder what he would say if he were alive today as now many embrace a new field called “regulatory science.” This term was suggested by Professor Mitsuru Uchiyama in Japan in 1987 (Jasanoff 2011) and was reviewed in literature published in English in 1996. Some have attributed a similar idea to Dr. Alvin Weinberg, for many years Director of ORNL. He actually introduced the term “trans-science,” which he defined as the policy-relevant fields for which scientists have no answers for many of the questions being asked (Weinberg 1972). At the time, he was probably influenced by the heavy involvement of ORNL in developing methods to assess environmental impacts as mandated by the 1969 National Environmental Policy Act. Professor Uchiyama defined regulatory science as “the science of optimizing scientific and technological developments according to objectives geared toward human health” (Uchiyama 1996). In essence, regulatory science is that science generated to answer political questions in terms of human health.
If there are some among you who suffer from lack of knowledge, as I did at that moment, I need to say more. To begin, we must go back to the 1970s and 1980s, when regulatory agencies were being established in the federal government to meet the demands of consumer advocacy and environmental groups. According to Alan Moghissi, the term “regulatory science” was coined during the period when agencies were being forced to make decisions based on incomplete science (Moghissi et al. 2014). Thus, the term “regulatory science” had the objective to address the scientific needs of these regulatory agencies.
So, first I must briefly define the terms related to regulatory science. I don’t know if you caught the fact that the word “terms” was plural not singular, and this fact, in and of itself, contributes to some of the confusion regarding regulatory science. To accomplish this, I must rely on my old friend Alan Moghissi again, who is President of the Institute of Regulatory Science. According to Dr. Moghissi, “Regulatory science has become a well-established branch of applied science.” It was so-named during this period of time with the objective of addressing the scientific needs of regulatory agencies. He offered this definition: “Regulatory science is a scientific discipline consisting of the development and application of scientific methods, tools, approaches, and other relevant processes derived from various scientific disciplines used in regulatory and policy decisions” (Moghissi et al. 2014).
I will not bombard you with other definitions of regulatory science, except to say that regulatory science includes a large number of scientific disciplines. Clearly, regulatory science has applications in many areas and supports regulatory agencies in their decision making. U.S. agencies such as the Food and Drug Administration, the Environmental Protection Agency, the Occupational Safety and Health Administration, the Fish and Wildlife Service, the Marine Fisheries Service, and many others, benefit from the science that for the most part supports their regulations.
However, all that glitters is not always gold. These agencies I just named, and many I did not, usually operate with the “guidance” of external advisory committees. These committees, composed of distinguished scientists, are intended to add legitimacy to the proposed regulations proffered by the regulatory agency. But the fact is, some of these committees are carefully controlled through the use of their charter, the rules and procedures. On some advisory committees, the members are given carefully worded and focused questions to be discussed and answered in writing. Under established operating procedures, the agency is only required to take action on the written replies to these specific questions. Pertinent comments, suggestions for improvement, directions to the agency, etc. from the committee members on related and/or other scientific matters of importance to the issues are only considered at the discretion of the agency leadership. In such cases, those contributing the regulatory science clearly fail to contribute significantly to policy making or are simply ignored. Or, to be blunt, in this case, politics trumps good science.
I find myself agreeing with one of my old tennis partners, Dr. Alvin Weinberg. He proposed a concept called “trans-science,” which referred to policy-relevant fields for which scientists had no answers. He was trying to address situations in which scientists were asked questions they could not answer. As I stated earlier, I believe these thoughts were generated during the period that ORNL began to carry a part of the burden for the preparation of environmental impact statements. He supposedly calculated that it would require eight billion mice to provide the answer to a single, unresolved question regarding radiation exposure. Some of you may remember Lilian and Bill Russell and the “mega-mouse project” at ORNL as an attempt to better understand the genetic effects of radiation.
In his 1958 paper in volume one of Health Physics, Walter Claus provided his view of the profession: “In short, it is just about all things to health physicists whose job is to provide protection against the potential hazards of radiation, while at the same time making it possible for the human race to enjoy all the benefits which may arise from the use of atomic energy” (Claus 1958). Of course, while the wording we use today might be more politically correct, I don’t think there would be much argument with his definition.
We have been studying ionizing radiation for more than 100 y, and in many ways, I believe we know a great deal about the effects of radiation and how to protect ourselves and others from the harmful effects. Certainly there are subtleties that we can investigate in a number of areas, and space travel provides another challenge.
Let me now “cut to the chase.” In contrast to some of my colleagues, I do not believe that regulatory science has a significant role to play in the future of radiation protection. I understand that we are still learning about radiation effects. But I believe we are more in the realm of “trans-science” as defined by Alvin Weinberg; that is, questions for which the answers are not known. There are many things we do not know with certainty. Let me support my view by citing a quote from NCRP Report No. 136 (NCRP 2001): “In conclusion, the weight of evidence, both experimental and theoretical, suggests [emphasis added] that for many of the biological lesions which are precursors to cancer (such as mutations and chromosome aberrations), the possibility of a linear non-threshold dose-response relationship at low doses cannot be excluded.” And here is another statement from the same report: “The existing epidemiological data on the effects of low-level irradiation are inconclusive, however, and, in some cases, contradictory” (NCRP 2001).
But in radiation protection, do we really rely heavily on whether or not a linear no-threshold dose-response relationship is valid in the range of doses usually found in nuclear power plants and other nuclear facilities in the United States?
It seems to me that the current state of radiation protection is no longer a two-pronged profession in which there is focused research to underpin the profession and those that apply the results of this research in the “real world” every day. There is no funding for research in the national laboratories nor in the universities in this country. Our educational programs in radiation protection are small, and many are under threat of closure.
Every time ICRP issues a new report, I don’t know how to react. I have lots of questions. What is the purpose of changing our approach to radiation protection? Why are the limits being lowered again? Are these changes based on science? What are the benefits from these changes? What do those members of the Commission know that we don’t know? Why has NCRP failed to “step-up” and provide a review and suggestions for implementation (or not) of the ICRP recommendations in the United States?
Perhaps I have not moved into the modern world as many of you have done, but I read and interpret these statements in a different manner than many. I am also swayed by the admonitions of ICRP in their reports. I believe it is true that in every ICRP report describing a change in the approaches to radiation protection, we will find a similar statement. ICRP usually has a “qualifying statement” in those documents that recommends changes in our approach to radiation protection. Usually the statement is similar to the one below:
“The Commission wishes to reiterate that its policy is to consider the fundamental principles upon which appropriate radiation protection measures can be based. Because of the differing conditions that apply in various countries, detailed guidance on the application of its recommendations, either in regulations or in codes of practice, should be elaborated by the various international and national bodies that are familiar with their needs [emphasis added]. The Commission recognizes that the individual experts responsible for putting radiation protection into practice need guidance that is sufficiently flexible to allow for national, regional or other variation. For this reason, the Commission’s recommendations are intended to provide an appropriate degree of flexibility. Because of this, the form in which the recommendations are worded will not necessarily be suitable, and may often be inappropriate, for direct assimilation into regulations or codes of practice.” [emphasis added] (International Commission on Radiological Protection, 1977).
To me these sentences define one of the important roles of NCRP. This is a role that the Council has not fulfilled in a very long time. According to my recollection, the last such review of ICRP recommendations was conducted and reported in NCRP Report No. 116 published 31 March 1993.
But perhaps I have been too harsh in my criticism of the Council. Several weeks ago, I was very happy to receive a draft of a new NCRP report titled “Radiation Protection Guidance for the United States (2018).” While the 2018 in the title indicates NCRP guidance in the future, this is an indication of the Council’s activity to uphold their Congressional Charter as well as follow the ICRP call for elaboration by individual countries. I applaud this effort, and I apologize for not completely understanding the charge of Council Committee 1 when it was described at a previous NCRP annual meeting. I look forward to 2018 for many reasons, including the NCRP report.
PROGRESS IN THE UNITED STATES
But I would be remiss if I did not recognize the progress made in the U.S. nuclear-electric-generating stations that impacts radiation protection. Much of the approach is based on common sense and on the application of an old approach—keeping the occupational radiation doses as low as is reasonably achievable (ALARA).
In 1954, the National Committee on Radiation Protection (the precursor to today’s National Council on Radiation Protection and Measurements) stated in Report No. 17 that radiation exposure should be kept “at the lowest practical level.” Similar wording (“as low as possible”) was used in the 1954 Recommendations of the International Commission on Radiological Protection (International Commission on Radiological Protection, 1955). Keeping exposures ALARA (as low as reasonably achievable) became the “watch-word” following the publication of the revision of 10 CFR Part 20 in 1991 (taking effect in 1994) (USNRC 1991). Another important approach is the establishment of a strong nuclear safety culture, and in the commercial nuclear power industry, nuclear safety remains the overriding priority. The nuclear safety culture is defined as:
“The core values and behaviors resulting from a collective commitment by leaders and individuals to emphasize safety over competing goals to ensure protection of people and the environment” (Institute of Nuclear Power Operations, 2004). This new culture recognizes that the same traits apply to radiological safety, industrial safety, environmental safety, and security. And it has had an impact on these other safety concerns, including radiation protection.
The nuclear safety culture has also impacted radiation safety in a number of ways including effectively reducing the occupational exposures in these plants. This nuclear safety culture is basically the heartbeat of the industry in that it drives essentially every activity in each station. This culture includes training, retraining, and “just in time training” before complex evolutions are undertaken. Significant changes have been made in work planning and how lessons learned are fed back into improving the process. Even simple steps that reduce occupational exposures have been implemented. A simple example is the use of low-radiation waiting areas for many work activities. Workers not immediately engaged in a work evolution wait in low-dose-rate areas until their particular expertise is needed. This is such a simple, but effective, idea.
Of course, the secret to this nuclear safety culture is that it permeates the organization from top to bottom. There is a collective responsibility, and no one is exempt from the obligation to ensure safety first. The watch-phrase is, “A nuclear accident anywhere is a nuclear accident everywhere.”
I find it very interesting that the commercial nuclear-electric-generating companies in the United States came together with the Institute of Nuclear Power Operations (INPO) and other organizations to formulate the nuclear safety culture. It is also interesting to me that the individuals formulating the culture, initially in 2004 (INPO 2004) and in a revised and expanded version in 2012 (INPO 2012), used basically what we call “common sense.” In this regard, “as low as is reasonably achievable” represents the common sense approach. There was no argument over the shape of the dose response curve, whether or not there was a threshold, and other things scientists debate. The only understanding was that the sensible approach was to keep occupational radiation exposures as low as possible. Many of the activities were already well established as part of the ALARA program, but these became even more important as part of the nuclear safety culture. The U.S. Nuclear Regulatory Commission (NRC) compiles the occupational radiation exposures from all activities under their purview and reports these in a summary document. The last summary document I could find was for the year 2013. According to this report, the average annual occupational exposure in nuclear-electric-generating stations in the United States was 100 mrem (Table 1). Sorry, the NRC report did not use the International System of Units in order to be in agreement with the other, older summaries in this series (there are at least 35 annual summaries).
Now, I would like to return to quickly discuss the activities of ICRP. I may use a dirty word in the discussion, and I apologize in advance for it. As I said, every time ICRP issues a new report lowering the limits or changing the nomenclature, I don’t know how to respond. First, I doubt that there is really any “amazing, new science” sufficient to justify the changes. We are introduced to new terms, some of which are just “cute.” For example, the new term called “dose constraint.” What is the purpose of the “dose constraint,” and what does ICRP mean when they mention making radiation exposures more equitable? How does one establish the difference between these two when maintenance has to be done on a critical component?
Finally, I cringe because I understand the cost of making changes to regulations and other guidance. There, I said it; I am concerned about the cost—I am concerned about money invested in unnecessary changes in federal and state regulations regarding radiation protection. NCRP Report No. 116 states: “The need to ensure that the total societal detriment from such justifiable activities or practices is maintained ALARA, economic and social factors being taken into account” (NCRP 1993).
Yes, we have to remember that in our country, besides the numerous federal agencies, there are a majority of the states that are Agreement States. I believe the latest number is about 37 Agreement States. Look back at the last time we went through the exercise of changing federal regulations. We seem to forget the cost of new regulations being written and approved though 37 state legislatures and in effect established in all 50 states. We forget the cost to the utilities and other institutions of rewriting their procedures as well as retraining their employees. These are not insignificant impacts, and the question to be answered is who pays for these costs? We all know that the government never pays for anything, so the taxpayers and the rate payers will bear the cost. And finally, there is a question that should have a national answer: Is there a net benefit to this exercise?
I believe our efforts to reduce doses as low as reasonably achievable show that there is absolutely no benefit to be derived from these “new approaches.” I am happy to see that Council Committee 1 will be addressing some of these issues. I wish them well. I hope that this distinguished group of scientists will evaluate the true impact of change on radiation protection but also the economic and social impacts on the future of our nation. I also hope that the regulatory bodies will find a way to implement a very common sense approach to radiation protection in the United States.
Thank you very much.
Claus WD. What is health physics? Health Phys 1:56–61; 1958.
Institute of Nuclear Power Operations. Principles for a strong nuclear safety culture Atlanta, GA; INPO; 2004.
Institute of Nuclear Power Operations. Traits of a healthy nuclear safety culture. Atlanta, GA: INPO; 12‐012, 2012.
International Commission on Radiological Protection. 1954 recommendations of the International Commission on Radiological Protection. Br J Radiol (Suppl 6) 1955. Available at: http://ani.sagepub.com/content/os-1/1/iii.1
. Accessed 9 September 2016.
International Commission on Radiological Protection. Recommendations of the International Commission on Radiological Protection. Thousand Oaks, CA: Sage Publications; ICRP Publication 26; 1977.
Jasanoff S. What is regulatory science? Concept and history in United States and Japan. Clin Eval 39:1–16; 2011.
Moghissi AA, Straja SR, Love BR, Bride DK, Stough RR. Innovation in regulatory science: evolution of a new scientific discipline. Technol Innov 16:155–165; 2014.
Morgan KZ, Turner JE. Principles of radiation protection
. Huntington, NY: Robert E. Krieger Publishing Company; 1973.
National Council on Radiation Protection and Measurements
. Limitation of exposure to ionizing radiation. Bethesda, MD: NCRP; Report No. 116; 1993.
National Council on Radiation Protection and Measurements
. Evaluation of the linear non-threshold dose-response model or ionizing radiation. Bethesda, MD: NCRP; Report No. 136; 2001.
National Council on Radiation Protection and Measurements
. Our mission [online]. Bethesda, MD: NCRP; 2016. Available at http://ncrponline.org/
. Accessed 23 March 2016.
Uchiyama M. Prospect for drug quality: regulatory consideration. Pharm Tech 20:44–52; 1996.
U.S. Nuclear Regulatory Commission. Standards for protection against radiation. Washington, DC: USNRC; 10 CFR Part 20; 1991.
U.S. Nuclear Regulatory Commission. Occupational radiation exposures at NRC-licensed facilities. Washington, DC: USNRC; Forty-sixth annual report, NUREG‐0713, Vol. 35; 2013.
Weinberg AM. Science and trans-science. Minerva 10:209–222; 1972.