The Environmental Protection Agency (EPA) was created by Congress in 1970 to write and enforce regulations designed to protect the environment and, by extension, human health. The Agency for Toxic Substances and Disease Registry (ATSDR), a sister agency of the Centers for Disease Control (CDC), was created by Congress ten years later (1980) as a non-regulatory, public health information agency that would analyze the public health implications of environmental data provided by EPA and others, and would write Public Health Assessments for concerned citizens at contaminated sites. (As a board-certified, PhD toxicologist, I worked at ATSDR for 20 years before retiring on October 30, 2013.)
Although ATSDR has always been a non-regulatory agency, it has always been a compliant stepchild of the EPA, largely because, for most of ATSDR’s history, EPA was the source of both its funding and many of its personnel, especially in upper management. More importantly, both political agencies have always been more responsive to the environmental lobby than to the scientific facts, and the legitimate needs of the American People.
The Word Game:
Even before the manipulation of numbers became commonplace, the manipulation of words was a major tool in keeping the fear alive. Simple words in common usage, like “risk”, “known”, “similar” and “equivalent” were given esoteric meanings that bore little resemblance to their definitions in Webster’s Dictionary and of which the general public was completely unaware.
Thus, unbeknownst to the average citizen, EPA’s so-called quantitative cancer risk assessments have never quantitatively assessed the true risk of potentially carcinogenic exposures. In EPA’s 1986 Risk Assessment Guidelines, the following, uncharacteristically honest, and seldom quoted (except by me) statement was made: “The true risk is unknown and may be as low as zero.” Obviously, if the “true” risk is unknown, then the “risk” that is supposedly quantified in EPA risk assessments cannot be the “true” risk. Throughout my career as an ATSDR toxicologist, I routinely quoted the “zero true risk” statement in all of my toxicological evaluations for health assessments that addressed potential cancer hazards on site. And, it never failed to irritate agency management, and even some of my colleagues.
Originally, EPA classified chemicals as “known”, “probable” or “possible” carcinogens. These classifications were strictly defined. In particular, a substance could be classified as a “known Human Carcinogen” only if sufficient epidemiological evidence existed to establish a cause-and-effect relationship between cancer and exposure to that substance. However, in 1996 (the date of the first draft), EPA rewrote its Cancer Risk Assessment Guidelines (CRAGs) to allow it to classify substances as known human carcinogens in the absence of any epidemiological evidence of a cause-and-effect relationship. The final draft of EPA’s new CRAGs was not actually published until 2005, but, 5 years earlier (2000), dioxin (2, 3, 7, 8-tetradichlorodibenzodioxin) became the first chemical to which the new CRAGs were applied, resulting in that chemical’s re-classification as a “known” human carcinogen.
On November 28, 2006, late in my career as an ATSDR toxicologist, I delivered an in-house lecture entitled “Frank’s Last Word on Dioxin” to a very small audience. I concluded my lecture by predicting that the next “bogus human carcinogen” would be trichloroethylene. Just 5 years later (September 2011), TCE was, indeed, declared by EPA to be a “known” human carcinogen, notwithstanding all of the toxicological&epidemiological data to the contrary. Strictly speaking, my prediction was off by 4 months, because inhaled formaldehyde was also reclassified as a known human carcinogen in June of 2011, in the wake of the “toxic trailers” scare after Hurricane Katrina.
None of these 3 chemicals (dioxin, TCE and formaldehyde) is actually “known” to cause cancer in humans, because there is no epidemiological evidence of a cause-and-effect relationship. Nevertheless, ever since EPA redefined the word “known” to mean whatever the Agency wants it to mean, evidence of a cause-and-effect relationship has become unnecessary.
During the run up to the esoteric re-definition of dioxin as a known human carcinogen, EPA was fond of stating that human cancer patients who had been exposed to dioxin had “similar” concentrations of dioxin in their tissues as did lab rats that developed cancer after chronic treatment with dioxin. However, what they didn’t acknowledge was that their in-house definition of the word “similar” was “within a factor of ten.” By that definition, 10 and 99 aspirin tablets would represent “similar” doses of acetylsalicylic acid. Except that 10 tablets would upset your stomach, while 99 would most likely kill you.
The general public does not know that, when EPA uses non-technical words like “similar”, and “risk” (as in “carcinogenic risk”), and “known” (as in the “known human carcinogen”, dioxin) and “equivalent” (as in “human equivalent concentration”), those terms have been redefined “in house”, without the public’s knowledge, with esoteric meanings that bear little or no resemblance to those same words as they are defined in Webster’s Dictionary. If you think that such shenanigans are not tantamount to lying to the general public, then I have some swamp land in Florida I’d like to sell you.
The Numbers Racket:
The disingenuous, esoteric re-definition of simple words in common usage (e.g., risk, safe, known, similar, and equivalent) has, all by itself, proven surprisingly effective in deceiving the majority of trusting citizens. However, the politicians who created agencies like EPA, ATSDR & NTP, and a more circumspect minority of citizens, demanded more than semantics. They expected, and the agencies provided, a consistent, seemingly scientific, basis for their determinations of safety and hazard. The resulting systems were indeed internally consistent. However, those systems were essentially bureaucratic procedures that had very little to do with the known scientific facts. (Otherwise, they could not have been arbitrarily modified whenever it became necessary to “keep the fear alive”.)
“Funny Numbers”
EPA and ATSDR promulgate dose-specific health guidelines (variously called MRLs, RfDs, and RfCs) which represented “safe” levels of ingestion and inhalation exposure to various chemicals. Both agencies also promulgate media-specific comparison values (variously called EMEGs, and RMEGS) which represented safe” levels of exposure to various chemicals in various environmental media such as air, water, soil, and fish. Health Guidelines are expressed in units of dose (mg/kg b.w./day), while comparison values are expressed as environmental concentrations, e.g., parts per billion (ppb) in air or drinking water and parts per million (ppm) in soil or fish. Dose-specific health guidelines are converted to media-specific comparison values by simply multiplying the former by the quotient of body weight over intake rate. (Rocket science this is not.)
When they were originally created, both federal agencies had legitimate problems to solve. But, EPA quickly became a victim of its own success. As the environment became cleaner, there were fewer and fewer real environmental problems to address. So, they began inventing them, initially by just making their dose-specific health guidelines and media--specific comparison values smaller to create the impression of increased “risk”. Then, they would make the unsubstantiated and over-used claim that chemical X “is now more toxic than previously thought”. But, it was almost never true.
This was an on-going process so that officially “safe” levels of exposure gradually went from conservative, to ultra-conservative, to completely ridiculous. (As a toxicologist at ATSDR between 1993 and 2013, I privately referred to the agency’s MRLs and EMEGs as “funny numbers”.)
The most common health guidelines are EPA’s RfDs (Reference Doses for ingestion exposure) and RfCs (Reference Concentrations for inhalation exposures), and ATSDR’s MRLs (Minimal Risk Levels) for chronic lifetime exposure. They are typically derived by simply dividing a threshold dose for a sensitive effect (i.e., a NOAEL or LOAEL) by safety factors that typically range from 10 – 10,000. (A LOAEL is a Lowest-Observed-Adverse-Effect-Level; a NOAEL is a No-Adverse-Effect-Level.) Using this “safety factor approach”, one can give the impression that a chemical poses a greater risk to human health by simply selecting a less serious (or even non-adverse) LOAEL or NOAEL for the numerator, or by increasing the safety factor used in the denominator, or both. But, there is a limit to how large you can make an arbitrary safety factor without attracting unwelcome attention and looking silly. Consequently, you won’t see any safety factors larger than 10,000. The preferred method for inflating apparent “risk” today is to base EPA’s Reference Dose (RfD) or ATSDR’s Minimum Risk Level (MRL) on what I personally refer to as “bogus LOAELs”. When I retired from ATSDR, many of the agency’s “funny numbers” for celebrity chemicals like dioxins, PCBs, arsenic, lead, trichloroethylene and formaldehyde were based on such bogus LOAELs for non-adverse effects well within normal ranges. Many of these bogus LOAELs were even based on “effects” that were not actually a consequence of the experimental exposure. And, if you remove both the “A” and the “E” from “LOAEL”’ all you have left is an LOL (twitter jargon for “Laugh Out Loud”). (See “The Gipper Speaks Out on Funny Numbers: The Flaw in MRL Development”.)
But, wait, there’s more. Once they were already deriving health guidelines using excessively high safety factors and bogus LOAELs for non-adverse effects within normal ranges, EPA and ATSDR had to come up with newer and more creative ways to further inflate the “risk” that is implied by health guidelines and comparison values.
Currently, that is being accomplished by eliminating altogether LOAELs, NOAELs, and even the concept of Dose. In 2005, ATSDR set an unfortunate precedent by eliminating all 32 pages of tabulated LOAELs and NOAELs from the agency’s Toxicological Profile for Lead. Those doses were replaced by “Internal Lead Doses Associated with Health Effects from Selected Studies” (my italics).
The importance of dose to effect cannot be overestimated. The central tenet of Toxicology is “the dose makes the poison”. Two of the most important determinants of the effect that a substance will have on an organism is (1) the body weight of that organism and (2) the frequency of the exposure. That’s why “Dose” is typically expressed in milligrams of the substance per unit body weight per frequency of exposure, e.g., mg/kg/day. It is an established scientific fact that larger, slower-breathing, longer-lived mammals like humans tend to be more resistant to the adverse effects of a given chemical than are smaller, faster-breathing, shorter-lived mammals like rats. In larger animals (like humans), the final concentration of the potential toxicant at the cellular level is more “dilute”. The slower ventilation rates in larger animals effectively reduce the frequency of exposure. And, finally, longer-lived mammals tend to have more efficient immune systems and other defense mechanisms. (That’s why they live longer.)
The HEC Fraud:
In 1994, however, EPA came up with a new way to evaluate inhalation exposures that took into account neither body weight nor exposure frequency. (See EPA’s October 1994 “Methods for Derivation of Inhalation Reference Concentrations and Application Dosimetry”) Instead, the ratio of the blood: gas partition coefficient of the chemical for the laboratory animal species to the corresponding value in humans ((Hb/g)A / (Hb/g)H) was used to convert a relevant (or not) NOAEL or LOAEL concentration in air into a so-called “Human Equivalent Concentration” or HEC. The biological relevance of such a convoluted process would be suspect, even if sufficient data on chemical-specific blood: gas partition coefficients in animals and humans actually existed. But, only for a few dozen different chemicals do blood: gas partition data actually exist for both rats and humans. More importantly, those blood: gas coefficients that have been determined tend to be smaller in humans than in rats almost 90% of the time. (See Table 8 on page 94 of Gargas et al, Toxicology and Applied Pharmacology, 98, 87-99 (1989).) This would make the resulting HEC larger than the animal NOAEL or LOAEL (in ppm) which, in turn, would suggest that human exposure to a given chemical (as opposed to dose) will almost always have less of an adverse impact than the same exposure would in rats. (Consider, for example, the very different effect that a squirt of RAID would have on a roach versus a human being.)
This is precisely what one would expect in any realistic comparison of the effect of the same inhalation exposure concentration (as opposed to dose) of the same chemical in humans versus much smaller, faster breathing, and shorter-lived animals. But, it is precisely the opposite of the result that EPA wanted. The long-standing policy at EPA and ATSDR has been that humans are more susceptible than laboratory animals are to the adverse effects of a given chemical exposure. (But, of course, policy is not the same thing as science.)
EPA got around this problem by introducing a purely political policy into the new, ostensibly scientific, HEC method. According to that policy, “the value of 1.0 is used for the ratio if (Hb/g)A > (Hb/g)H”. In other words, if the available partition coefficient data in rats versus humans would yield an “HEC” that is larger than the corresponding animal exposure (as one would intuitively expect to be the case the great majority of the time), then no conversion at all actually takes place. Rather, the “HEC” is, by default, set equal to the value in the much smaller, faster breathing, & shorter lived animal. This intentional disregard for the effect of radically different body weights is particularly puzzling when one considers that, as long ago as 1949, it was already known that more than 30 physiological & somatic parameters were proportional to body weight (E.F. Adolph, Science, June 10, 1949, Vol. 109, pp 579-85).
Confused?
If all this is confusing, it was meant to be. Because, when something unintelligible is expressed mathematically and claims to be “scientific”, the tendency is for most people to assume that it is just “over their heads” and accept it uncritically. However, in this instance, as Seven of Nine said in Star Trek Voyager (Season 6, Episode 2), “You are being confused by irrelevant data; Ignore it.” In reality, the sole purpose of EPA’s scientifically bankrupt HEC method for evaluating the “risk” associated with “equivalent” inhalation exposures was to rescue the cherished (but counterintuitive) bureaucratic assumption that humans are more sensitive to the adverse effects of chemical exposure than are experimental animals.
It is an entirely defensible argument that, in order to protect the public health in the face of unresolved uncertainties, it is often necessary that agencies charged with that responsibility should “err on the side of safety”. However, that argument does not justify intentionally erring on the side of the absurd. For, there is with all things a point of diminishing returns. And, when we start basing expensive public policy decisions on the mere possibility that an implausible thing might happen, then we may as well start building airports for UFOs.
“Funny Numbers” are NOT Thresholds of EFFECT: Flint, Michigan
For decades, now, EPA and ATSDR have intentionally and cynically manipulated words and numbers for the express purpose of deceiving the general public and keeping the fear alive. And, it has worked. Because, the general public commonly misinterprets those bureaucratically generated “safe” levels of exposure as legitimately established thresholds of effect, i.e., as strict demarcations between harmless and hazardous levels of exposure. (Valid NOAELs and LOAELs for sensitive effects do approximate such thresholds, but not after they are divided by safety factors of one or more orders of magnitude to yield official exposure guidelines.) Environmental activists encourage this misconception by characterizing exposures above EPA’s and ATSDR’s conservative exposure guidelines and comparison values as “dangerously elevated”, “unsafe”, “poisonous” or variations thereof.
This is precisely how the public was fooled into believing that the incidence of drinking water-related cases of lead poisoning reached crisis proportions at Flint, Michigan after a 2014 switch to a new water source. In fact, however, there were none. As stated in a March 13, 2018 article in The Journal of Pediatrics (Gomez et al., 2018: “Blood-Lead Levels of Children in Flint Michigan: 1006-2016”):
“…changes in GM BLLs in young children in Flint, Michigan, during the Flint River water exposure did not meet the level of an environmental emergency… not a single BLL from a child ≤5 years of age attained a BLL of 45 µg/dL (or greater), the minimum level for which the current CDC guidelines suggest initiation of chelation therapy, during the switch to the Flint River water source. In addition, no child was hospitalized in the area for acute or chronic lead toxicity during this time frame.”
Blood lead levels (BLLs) at Flint (as in the rest of the U.S.) have been declining for decades, now. During the same time, however, CDC, ATSDR and EPA have continually lowered their official “safe” BLL’s (currently at 5 µg/L) to “keep the fear alive”. As usual, this ploy has worked; any BLLs at Flint that exceeded those official “safe” levels were (and continue to be) mischaracterized by the press and environmental groups as “lead poisoning”. Again, as stated in the Journal of Pediatrics (Gomez et al, 2018):
“Between 1960 and 1990, [CDC’s} BLL reference concentration was gradually lowered from 60 µg/dL to 25 µg/dL. In 1991, the CDC lowered the reference concentration to 10 µg/dL and in 2012 to the current value of 5 µg/dL. This reference concentration, originally intended by the CDC as a tool to identify children at greater risk, has been frequently misinterpreted as a definitive threshold of lead toxicity or poisoning.”
Forty years ago, 78% of Americans had BLLs ≥ 10 µg/dL (NHANES II, 1976-1980). Amazing, is it not, how well most of us turned out, in spite of being so severely lead poisoned?
From Effects, to Exposure, to Concern:
If one decides that even lower “funny numbers” are required to “keep the fear alive”, then it becomes necessary to abandon altogether the concept of adverse health effects caused by chemical exposures, and replace it with something more subtle. Thus, toward the end of my career at ATSDR, health effects were seldom even mentioned, as such. The focus on “levels of effect” had been replaced by a focus on exposure, regardless of the presence or absence of exposure-related adverse health effects. Later, even measureable exposure was no longer an absolute requirement. The focus finally shifted from exposure and effects to “levels of concern”. Thusly, did a major U.S. public health agency switch its focus from the Objective to the Subjective. From the perspective of the environmental activists, and the federal agencies that pandered to them, this was a tidal shift in a spectacularly useful direction. For, no longer was it necessary to demonstrate even the remotest possibility that an actual adverse effect was causally associated with a measureable exposure. A sufficiently uninformed and propagandized individual could be deeply “concerned” in the complete absence of either an exposure or an effect.
The Future: Fire or Ice?
For the last 50 years (at least), real science has become increasingly politicized until it no longer provides any brake at all on the effective propagation of even the most ridiculous public health scares. For some time, now, the environmental movement has been able to thrive on political propaganda, alone, without any basis in good science. This occurs at a time when public health scares have graduated from the relatively small stage of chemophobia to the much grander stage of phony global climate disasters. The normal occurrence of and purely natural basis for ozone “holes” and “global warming”, independent of CFC and CO2 levels, have long been understood by apolitical earth scientists. But, the science no longer matters to the general public. Government-sanctioned political propaganda has taken its place. Matters have gotten so bad that most citizens can no longer tell the difference between a real scientist and a salesman with a political agenda.
Climate Change
The “word game”, described earlier in this article, has acquired newer & broader applications. Thus, climate change, an altogether natural process that has been going on for billions of years (i.e., as long as Planet Earth has had oceans and an atmosphere), was officially re-defined in June of 1992 by a United Nations Convention on Climate Change in Rio de Janeiro as “a change of climate which is attributed directly or indirectly to human activity……which is in addition to natural climate variability” (my italics). So, be warned. Should anyone ever ask if you believe in “climate change”, be sure to have them define their terms before you answer. Because, apparently, “climate change” is no longer the same thing as “natural climate variability”. The former term is now secretly modified by an invisible adjective (“anthropogenic”).
A popular belief system has replaced the science of climatology. And, error-prone computer models have replaced established scientific facts. Thus, “true believers” in the purely political belief system known as [anthropogenic] “climate change” are completely unaware of following facts:
(1) Levels of CO2 and other so-called “greenhouse gasses” do NOT control the climate & CANNOT cause catastrophic global warming;
(2) We are all now living in the Pleistocene ICE AGE, albeit just past the peak of the current, relatively balmy, interglacial period which will inevitably give way to the next glacial phase;
(3) The Earth has been cooling for most of the last 55 million years and Antarctica, which froze over 40 million years ago, will remain frozen for millions more, i.e., until the end of the current ice age; and
4) The last time that BOTH average temperatures and CO2 levels were as LOW as they have been in the Pleistocene ice age was 300 MILLION years ago during another ice age, the Permo-Carboniferous.
Science will eventually recover from this sad period of history, just as it eventually recovered from the scientifically bankrupt ideas of T. D. Lysenko in Stalinist Russia. But, between now and then, the politicization of science in much of the civilized world can still do incalculable harm to all the peoples of the Earth.
Comments