SETTING STANDARDS IN THE PRESENCE OF DEVELOPING SCIENTIFIC UNDERSTANDING Frank Barnes University of Colorado at Boulder ABSTRACT. The setting of standards for potential hazards as result of the application of a new technology depends on both the philosophy with respect to risk and the state of knowledge about the circumstances under which the technology can cause damage. Typically biological damage is first observed for high levels of exposure and short times. As our understanding of the technology and its effects on the biology improve, biological effects are observed at lower levels and longer exposure times. For extended low level exposures it also becomes more difficult to demonstrate a hazard that is independent of others influences. This has been true for electric and magnetic fields both at low and radio frequencies. In this paper it is recognized that a set number is needed for both manufactures and system operators to meet if the technology is to serve the public. It is also recommended that the public be presented with tables of relative risks that include levels of exposure and other risks for comparison. Three tables of relative risks are included as a possible starting point. INTRODUCTION. Standards setting bodies for safety are faced with conflicting pressures. One is to protect worker and the public against risks for injury and health problems. Another is to make useful technology available to the public. How these possibly conflicting requirements are met is dependent on many things including how well the hazards are understood by the public, the regulators, the value of the technology, and the public view of the kind of potential damage the technology may do to their health and their degree of control over exposure to it. The philosophy with respect to risk is important. In some circles the only safe exposure to electric and magnetic fields is one that can be proven to have no possible health effects. Since we do not know how to prove that all those experiments that we have not yet done will not show biological effects this is not possible. If we were to satisfy this criteria we would not allow the generation of electricity or man made electromagnetic radiation. The other extreme would be to have no regulations at all and shift the responsibility for safety to the public. In practice neither of these extremes work or are followed. Standards setting committees tend to protect against risks that occur over relatively short time scales and where the hazards may be hard for the public recognize. For example standards exist for insulation to reduce leakage currents below the levels where people feel a shock. However, it is still possible to hit a high voltage distribution line with an aluminum ladder or to create a short in house wiring or an appliance that causes a shock or starts a fire. Additionally long term low level exposures to current that might modify the growth of cells are not taken into account in most thinking about the effects of electric fields in standard setting discussions. In a sense these standards are not being written to protect against low probability events when there are clear advantages to making the technology available including using it to save lives. AN EXAMPLE AT RADIO FREQUENCIES The approach of setting standards for high levels and short time exposures is complicated by the fact that our scientific understanding improves over time as we get a better understanding of its effects on human biology. For radio frequency fields the first biological effects to be observe where associated with heating. This is clearly useful in a microwave oven or for removing a tumor or other therapy. However heating is not desirable for cell phones if they increase you brain temperature to dangerous levels and the standards have been set to avoid this. Other effects such as changes in free radical life times, the release of heat shock proteins, and changes in interleukin concentrations have been observed during the last 20 years for lower levels of exposure and for relatively long exposures. However the present standards do not take these effects into consideration for at least two reasons. First there is not a reproducible trail of data that connects these changes to serious health effects. Second there has not been sufficiently convincing reproducible epidemiological data to over rides the value of the use of radio frequencies for communications in the minds of the regulators and standards committees. Most of the current epidemiological studies for exposures to radio frequencies (RF) fields and the incidence of cancers have either poor exposure data or the studies have been conducted for periods of exposure that are short compared to the predicted latency for the cancer of interest.( (Collatz et al,2005, 1999, Inskip et al 2001, Johansen et al 2001,) ) However, there are some studies that indicate that there is a correlation between cell phone use and the incidence of brain tumors. (Hardell et al 2002, Mashevich et al. 2003, Kundi et al 2004) If there is a cause and effect relationship between exposures to radio frequencies from cell phones, base stations, TV and radio stations these relationships should become clearer over time as more studies are carried out. The results of those studies that show a correlation between RF exposures, cancers and other health effects are likely to show some kind of intensity vs. time curve. Additionally it is likely that there will be a threshold bellow which no effects are observed. Other factors such as background stress, diet, age, environmental factors and personal histories are also likely to be factors as to when a given level and length of exposure leads an adverse health effect. The fact that the body has repair mechanisms and that allergies can develop with repeated exposures will make defining the conditions when a given exposure is harmful or helpful much more difficult than those that are developed for high level short term exposure. From the scientific point of view this means we are going to need a much better understanding of how electric and magnetic fields affect the human biological system. A STRATEGY FOR NOW. In the mean time standards groups and other political bodies need to decide what to do. Manufactures, system operators and installers need to know what they can and cannot do. Additionally because of economies of scale these numbers and the rules should be relatively uniform. In the case of RF base stations they need to be installed so that they can carry the traffic and cover the desired regions. This means that minimum signal strengths need to be available at both the cell phone and at the base station if the system is to work. The current standards are set so that the probability that a person could position themselves near enough to a base station so that the power absorbed would be large enough to cause a temperature rise of 1oC is very small and most situations it would not be measurable. For hand held phones the powers densities are much larger but limited so that the calculated peak temperature rises are less than 2oC. [Li,Q and Gandhi O. 2006] Much of the current debate is over whether or not the allowed exposures should be greatly reduced is based on limited data that there is a correlation between a verity of health problems and proximity to base stations. Additionally there is a debate over whether effects other than the increase in temperature should be used to limit the amount of radiated power. Clearly needed are carefully constructed epidemiological studies that either show the reported health problems are, or are not, related to the exposure to levels, the length of time for the exposures to the radio frequency fields and any other environmental factors. These studies will need both good exposure data and run for periods of time that exceed the latency for the cancers and other possible health problems being studied. It is likely that short-term exposures are unlikely to cause health effects at the same level where long-term repetitive exposures may very well lead to measurable biological changes and health effects in combination with other adverse factors or for individuals with particular histories. There are some indications that exposures to low levels of electric and magnetic fields behave like stress. Stress can be either positive or negative. Stress extended over long terms can cause serious health problems and reduce the body’s ability to respond to other stresses, such as recovering from a wound or infection.( Marucha, P. T., etal.1998). The recommended epidemiological studies would include the collection of data that could show if a combination RF exposure and other stress factors could lead to an increased probability of adverse health effects. Standards setting bodies need to take into account both the results showing biological changes at low levels and the large number of studies that do not show any changes. Additionally they need to take into account the benefits of having wireless communications that are used to save lives and enhance the standard of living for a significant fraction of the public. Given the lack a strong consistent body of data showing that exposures bellow the levels needed to cause temperature rises of a degree or more are a source of reproducible health effects that can be linked to the exposure level, frequency, and length of exposure, it is unlikely that current standard setting bodies will change the exposure standards. Short of developing the kind of data that shows under what circumstances low levels of RF radiation can cause health problems and those that will not, it is recommended that the problem be divided into two parts. The first is as has been done for many years in setting numbers that manufacturers and system operators must meet and the second is that tables of relative risks are distributed to the public. Since we do not live in a risk free world it would seem to be appropriate that estimates of the risk for exposures to the field from power lines, cell phones etc be distributed to the public so that they can make up their own minds as to the levels of risk that they are willing to take. These tables of risk might well have more than one entry for different levels and lengths of exposure. For example the level of risk might well be different for walking under a power line with fields of 5 KV/m once in awhile and for living 10 or more hours a day in the same fields. An advantage of distributing tables of risk is that it allows individuals to better understand what risks that they are taking and to exercise more control over the risks they are willing to take just as we do when we drive a car or work around the home. Secondly it helps remove the myth that we can have the advantages of electric power and wireless communications with no risks. There will be those who cannot control their exposure to levels they would like because these fields are so pervasive. How these cases will be treated will depend to a large degree on both the political process and the public attitude toward the risk. It will also depend on what science and technology is available to gain the desired benefits with at lower risk. The author has included three tables of relative risk that might be used as starting points for developing tables of relative risk that could be used to go with information supplied by cell phone, manufactures, system operators, power companies to customers that are concerned about possible health risks from electric and magnetic fields. Additional material that might be added to these tables includes sunlight, and highenergy radiation. It would be no surprise if different people put somewhat different numbers on different hazards. It would also be relatively easier to change the numbers as new information is learned than it is to change specifications for the manufacture and installation of new equipment or require the removal of equipment that is already in place. Table 1 gives some estimates of the relative risks of getting a disease from a number of sources. Table 2 gives related data for cancers. Table 3 gives another way of putting these risks in perspective. Such tables will not remove the controversy but it should give the public much better information. Table 1. Relative Risk Factors for Disease Factors Factor (Cancer type) Smoking (lung cancer) Benzene, Occupational exposure (leukemia) Asbestos, Occupational exposure (lung cancer) Prenatal X-ray exams (childhood cancer) Hair Dye (leukemia) Powerlines (childhood cancer) Saccharin (bladder cancer) Excessive Alcohol (oral cancer) Coffee (bladder cancer) Relative Risk 10-40 References Wynder and Hoffman 1982 1.5-20 Sandler and Collman 1987 2-6 Fraumeni and Blot 1982 2.4 1.8 Harvey et.al. 1985 Cantor et.al. 1988 Wertheimer and Leeper 1979, Savitz et.al. 1988 IARC 1987 Tuyns 1982 Morrison and Cole 1982 1.5 – 3 1.5-2.6 1.4 -2.3 1.3-2.6 Source: (J. Lee, Bonneville Power Administration) Monson (1980) characterized the significance of relative risk levels as follows: Relative Risk 1.0 – 1.2 1.2 – 1.5 1.5 – 3.0 3.0 – 10.0 Above 10.0 Strength of Association None Weak Moderate Strong Infinite It has been suggested by epidemiologists) that cause and effect associations are only clearly established when relative risks are large (i.e., 5 or more) and when data from epidemiological studies are consistent. Table 2 Relative Risk of Getting Cancer Risk Source (Daily Exposure) Carcinogen 0.3 Coffee (1 cup) Hydrogen peroxide 0.4 Bread and grain products (average US diet) Ethylene Dibromide 0.5 Food with pesticides (average US diet) PCBs, DDE/DDT 8.0 Swimming in a pool (1 hour for a child) Chloroform 9.0 Cooked bacon (100 grams) Dimethylnitrosamine 30 Comfrey herbal tea (1 cup) Symphytine 30 Peanut butter sandwich Aflatoxin 60 Diet cola (12 oz.) Sacchrin 70 Brown mustard (5 grams) Allyl isothiosamine 90 Shrimp (100 grams) Formaldehyde 100 Mushrooms (1 raw) Hydrazines 300 Pain relief pill (300 mg) Phenacetin 400 Bread (2 slices) Formaldehyde 604 Breathing air at home (14 hours) Formaldehyde 2,700 Regular cola (12 oz.) Formaldehyde 2,800 Beer (12 oz.) Ethyl alcohol 4,700 Wine (1 glass) Ethyl alcohol 5,800 Breathing air at work (8 hours) Formaldehyde 16,000 Sleeping pill (60 mg.) Phenobarbital Source:B.N. Ames, R. Magaw, L.S. Gold, 1987, “Ranking Possible Carcinogenic Hazards”; Science,V236, p 271-236. Table 3 hazards. Estimates of the number of days life is shortened as a result of a veriety of Cause Days Cause Days Being unmarried-male 3,500 Drowning 41 Cigarette smoking-male 2,250 Job with radiation exposure 40 Heart disease 2,100 Falls 39 Being unmarried-female 1,600 Accidents to pedestrians 37 Being 30% overweight 1,300 Safest job accidents 30 Being a coal miner 1,100 Fire-burns 27 Cancer 980 Generation of electricity 24 Being 20% overweight 900 Illicit drug use (US average) 18 < 8 grade education 850 Poison (solid, liquid) 17 Cigarette smoking female 800 Suffocation 13 Low Socio-economic status 700 Fire arms accidents 11 Stroke 520 Natural radiation 8 Living in unfavorable state 500 Medical x-rays 6 Army in Viet Nam 400 Poisonous gases 7 Cigar smoking 330 Coffee 6 Dangerous job accidents 300 Oral contraceptives 5 Pipe smoking 220 Bicycle accidents 5 Increasing food intake 100 calories/day 210 All catastrophes combined 3.5 Motor vehicle accident 207 Diet drinks 2 Pneumonia, influenza 141 Reactor accidents-UCS 2 Alcohol (US average) 130 Reactor accidents-RCS 0.002 Accidents in home 95 Radiation from nuclear industry 0.02 Suicide 95 PAP exams -4 Diabetes 95 Smoke detector in home -10 Being murdered (homicide) 90 Air bags in car -50 Legal drug misuse 90 Mobile coronary care unit -125 Average job accident 74 Safety improvement ‘66-’76 -110 th Source: Cohen, Bernard L. 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