Home arrow Air Pollutants arrow Risk Assessment
Main Menu
Home
Take Action!
Search
About Us
In the News
The Crofton Mill
Air Pollutants
Contact Us
Links
Press Centre
Documents and Reports
CACG Newsletter
Letters
Toxic Legacy of Federal Neglect
Pulp Pollution Primer
RWDI Peer Review
Senes Peer Review
Regulations?
Jacques Whitford Study
Air Quality Reports
Paprican Study on Dioxins
Interbeing and Paper
Risk Assessment
Transcripts
Best Technology for P&P:EC
Risk Assessment PDF Print E-mail
An article on risk assessment and how corporations and government decide to take risks with public health, courtesy of Rachel's Environment and Health News.

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
RACHEL'S ENVIRONMENT & HEALTH NEWS #800

http://www.rachel.org         September 16, 2004
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

THE CHEMICAL WARS, Part 3

by Peter Montague

[Continuing: We have been describing the philosophy ofenvironmental regulation in the U.S. Basically, it is a "proveharm" system -- anything goes until someone can "line up thedead bodies" and prove that significant harm is occurring. Whenthat happens, which is rare, then a multi-year, ormulti-decade, battle begins in which underfunded andunderstaffed government regulators bargain with a phalanx ofcorporate lawyers and scientists-for-hire. Eventually theyhammer out a compromise between public health and corporatepurposes. The compromise becomes an enforceable regulation --until one corporation or another decides to mount a challengeand the dance begins anew.

The "prove harm" system rests on three assumptions: (1) Humanscan determine the "assimilative capacity" of every populationof humans and animals and every ecosystem on Earth -- thecapacity to absorb damage without suffering permanent, seriousharm. (2) Once the "assimilative capacity" of a river, or apopulation of humans or birds, has been determined, we will setregulatory controls to keep the harm within "acceptable"limits; and (3) We already know which substances and activitiesare harmful or, in the case of activities we never suspectedwere harmful, we will we warned of possible dangers bytraumatic but sublethal shocks.

Obviously the system really hinges on assumption #1 -- that wecan determine the "assimilative capacity" of an ecosystem, orof a population of polar bears or humans. For this purpose, aspecial technique has been developed called "risk assessment."Risk assessment is the linchpin of the "prove harm" regulatorysystem, and the main intellectual armor of industrialpolluters. But this emperor is wearing no clothes. Let's take alook.]

Of course there's nothing wrong with trying to assess risks. Weall do it every day. But there's an important differencebetween our own personal risk assessments andcorporate/governmental risk assessments.

When we assess risk in our own lives, (a) we examine risks thatwe ourselves are willing to take; (b) we compare our options;and (c) we use all available information; and (d) we weigh notonly the risks we face but also the benefits. For example, wemight ask ourselves, "Can I just dash across this street in themiddle of the block, or, given the shoes I'm wearing and thearthritis in my left knee, should I walk to the corner andcross with the light? Is saving a minute or two worth the riskof being hit by a truck?" We compare risks and benefits, weassess our alternatives, we consider all the availableinformation, and we weigh the risks we ourselves are willing totake.

In contrast, corporate risk assessors almost always (a) assessthe dangers of a single pre-determined option, and (b) assessdangers that they intend to impose on others, usually withouttheir informed consent; and (c) examine only thescientifically-proven evidence, ignoring other kinds ofinformation such as historical precedents, worker knowledge,and community preferences; and (d) ignore the benefits (or lackof them) to those who will be enduring the dangers. Basically,the main use of corporate/governmental risk assessment is toestablish how much damage corporations and governments can getaway with and to label that damage "acceptable."[1]

Typical questions that corporate/governmental risk assessmentsanswer would include, How much dioxin can aluminum smeltersdischarge into the Columbia River basin without thinning theBald Eagle population to extinction? How many trout canfamilies along Lake Michigan eat each month before theirchildren's IQs are diminished 5 points? How much benzene can wemaintain in the air of this factory without killing more than 1in every 10,000 workers? Will this urban trash incinerator killno more than one in each million citizens who breathe itsfumes?

Risk assessment serves corporate purposes because it involveslarge quantities of scientific data, all of it subject tolimitations and uncertainties that can be disputed foreverwithout resolution. Where data are lacking or disputed,assumptions and judgments must be substituted for facts. TheNational Academy of Sciences put it politely when it said,"Risk assessment techniques are highly speculative, and almostall rely on multiple assumptions of fact -- some of which areentirely untestable."[2]  In 1983 the National Academy identifiedat least 50 points during the course of a cancer riskassessment where choices had to be made on the basis ofprofessional judgment, not science.[3] Corporatescientists-for-hire can select and manipulate the data andchoose particular assumptions (often silently), allowing themto reach almost any conclusion they set out to reach yet stillpackage it as "science" even though the conclusion is based onjudgment and is not in any way reproducible.[4]

Risk assessment provides corporations other major benefits aswell. Because risks are expressed mathematically (theprobability of x occurring during y years of exposure tochemical z), troublesome questions of right and wrong cannotarise, and most of the public is left out of the process. Thusrisk assessment gives corporate goals a patina of "soundscience," prevents ethical considerations from muddying thedebate, and keeps the affected citizens locked out of thediscussion.

Risk assessment now guides all environmental management, notmerely the control of chemicals. Before cutting new roads intoa national forest, the government completes a risk assessmentto decide how many roads would decimate the bear population.Ocean fisheries are managed by risk assessment to determine the"maximum sustainable yield" of fish. Risk assessment determinesallowable drug residues in beef, allowable pesticide residuesin food, allowable withdrawals of water from rivers andaquifers, allowable contamination of drinking water, limits onthe discharge of particulates and toxic chemicals fromcoal-fired power plants, auto emission limits, livestockgrazing allotments on arid lands, allowable harvests ofendangered species, fishing and hunting quotas, workplaceexposure limits, radiation limits in medical settings, cleanupstandards for contaminated sites, and on and on.

Risk assessment is so fundamental to the "growth and rapidinnovation" culture that the technique is now taught at mostlarge colleges and universities. There are several scholarlyjournals devoted to it. Many books have been written on thesubject, including several by the National Academy of Sciences.The federal government sponsors research to elaborate andrefine risk assessment techniques, and it trains risk assessorsin places like Mexico and the Ukraine, intending to "harmonize"the response to corporate harms world-wide. Risk assessmentresearch institutes at places like Harvard are generouslyfunded by important corporate risk-makers like Monsanto andDow, and the work of these institutes is injected directly intofederal "risk policy." Professional societies of risk assessorsmeet each year in resort locations to swap war stories andshare their latest techniques. Assessing risks has become amajor industry unto itself. It is no exaggeration to say thatthe modern industrial system with its culture of "rapidinnovation at any cost" could not maintain its present coursewithout risk assessors to run interference.

In the last decade, however, risk assessment has come underwithering criticism from at least a dozen perspectives:

1) Because of genetic makeup, individuals differ markedly intheir susceptibility to poisons. Some people are far moresensitive than others. For example, some people cough andwheeze when they walk down the detergent aisle at the grocerystore; others don't. Furthermore, many people suffer fromchronic conditions (asthma, diabetes, etc.), so riskassessments cannot reasonably assume, as they typically do,that only healthy young adults are exposed.

2) Risk assessors try to account for human variability byapplying a "safety factor" of 10 to their numerical estimate ofrisk. But such a number has little to do with science. Safetyfactors are often little more than guesses. Why not a factor of11 or 17 instead of 10? Even calling it a "safety" factor ismisleading because who can say it offers safety?

3) Risk assessments of chemicals are conducted on singlechemicals, but in the real world we are all exposed to mixturesof chemicals day in and day out. Furthermore, many studies havenow shown that harmless amounts of individual chemicals, incombination, can add up to a harmful dose.[5] The healtheffects of mixtures are far too complex for science to sortout, yet mixtures are what we encounter in our daily lives, sotesting single chemicals is misleading and often beside thepoint. Corporate scientists-for-hire may pretend that, withsufficient testing, the problem of mixtures can be mastered.But when asked where the resources will come from to test allpossible combinations of even 1000 chemicals, they grow silent.There are 41 billion possible combinations of 1000 chemicalstaken in groups of 4. Even if we could test a millioncombinations a year, which we can't, it would take 41,000 yearsto complete such a battery of tests.

4) Some chemicals are only biologically active during a briefperiod of time (a "window of vulnerability") in the developmentof an organism, so toxicity must be tested during those exacttimes.[6,7,8,9,10] Chemicals tested during other times willappear to be less potent or even inert.

5) In the case of some hormone-disrupting chemicals, low dosescan cause greater endocrine disruption than high doses. Morethan 100 studies have now confirmed that this phenomenon isreal.[11] This seems to happen because the hormone system isactive at low doses but becomes overwhelmed and stopsresponding at higher doses. Traditionally, chemicals have beentested at the highest doses that laboratory animals couldtolerate, but now we know that high-dose tests may missimportant toxic effects that only occur at low doses. Many ofthe high-dose tests that have been completed to date (and uponwhich federal regulations are based) are of very limited valuefrom a public health perspective and need to be re-done at muchlower doses.

6) We now know that cells respond differently to chemicals,depending on their prior history of exposure.[12,13] Inaddition, whole organisms (mice, humans) exhibit similarbehavior: response to a chemical is strongly conditioned byprior exposure. For example, a person who smokes a cigarettefor the first time reacts with lightheadedness and perhapsnausea but a habituated smoker develops a craving for cigarettesmoke and feels sick without it. Furthermore, after a heavysmoker quits smoking, he or she will be "sensitized" tosecond-hand smoke thereafter, reacting to it much morepowerfully than a person who has never smoked. Thus individualhistory of exposure to a chemical can dramatically affectresponse. This important phenomenon is not taken into accountin the toxicity tests that underlie chemical risk assessments.

7) It has now been established that cells respond differentlyto pulsed exposures to some chemicals, compared to continuousexposures. Thus a pattern of repeated exposures interrupted byregular intervals of non-exposure elicits a different responsecompared to cells continuously exposed.[14,15] "For example,when animals respond to gonadotropin-releasing hormone, thepulse frequency of stimulation is more important than theaverage level of the hormone."[14]

8) Medical understanding of the role of inflammation in diseaseis now changing substantially. Inflammation is a sign that theimmune system has been incited, and animals (or humans) withinflammation react differently to chemical exposures thananimals without inflammation.[16]

9) We now know that many dose-response relationships are notlinear. Indeed, the shape of dose-response curves is thesubject of an extensive body of contentious literature, yetrisk assessors continue to rely most often on the simplifyingassumption of linearity. This simplifying assumption makes manyrisk assessments possible but it may also make them wrong.

10) Thousands of potentially important biochemical reactionsare ignored during risk assessments. Current federal protocolsfor examining the tissues of experimental animals weredeveloped before the advent of biochemistry and molecularbiology. After animals are dosed and then killed for tissueanalysis, their organs are examined visually for gross damage,but microscopic examination of the organs is not typicallyrequired -- much less the sophisticated analyses made possibleby modern biochemistry and molecular biology. Animal testing isdecades behind current biology, and will likely remain so foreconomic reasons. Thorough examination of dosed animals wouldbe far more expensive than the simple examinations that arestandard today (and which already cost in the range of $20,000to $100,000 per test).

Even when animal tissues are examined under a microscope, notall tissue types are examined. All organs are composed ofvarious types of cells, and each type would need to be examinedto claim that a thorough investigation had been conducted, butthis is not done.

Thus thousands of distinct biochemical mechanisms are notexamined, because no one requires them to be (to keep costsdown). Cognition, behavior, fertility, disease resistance, malereproduction, chronic neurotoxicity, immune alteration andhormone function (critical to hundreds of biochemical systems)are all ignored in typical risk assessments.[17]

In sum, thousands of potential injuries are missed by typicalgross visual (and occasional microscopic) examinations inanimal toxicity tests.

11) The vulnerable period of development is not tested. Withrare exceptions, the period of greatest vulnerability(corresponding to the human period of life from conceptionthrough age 18) is not tested in laboratory animals. Adultanimals are tested. In addition, effects on second and thirdgenerations are not typically looked for.

12) The commercial forms of chemicals tested in the laboratorymay bear little resemblance to chemicals of the same name foundin environmental food chains. Depending on source of exposure,pathway through the food chain, and weathering effects,chemicals measured in humans or other animals can havedistinctly different characteristics from "pure" commercialforms of chemicals, meaning that many risk assessments areconducted on chemical species that are not encountered in thereal world.[18]

It must be obvious that these shortcomings of risk assessmentcannot be remedied because there simply aren't enoughlaboratories and enough money to take into account all thesources of variability listed above.

And if corporations and government agencies cannotsystematically take these biological phenomena into account,they should acknowledge that their risk assessments are hardlymore than window dressing, having little to do withreproducible science, intended mainly to mollify anapprehensive public.

[To be continued.]

============

Reprinted with permission from: Peter Montague, "The ChemicalWars," New Solutions Vol. 14, No. 1 (2003), pgs. 19-41.

[1] Mary O'Brien, Making Better Environmental Decisions; AnAlternative to Risk Assessment (Cambridge, Mass.: MIT Press,2000; ISBN 0-262-65053-3).

[2] Quoted in Anthony B. Miller and others, EnvironmentalEpidemiology, Volume 1: Public Health and Hazardous Wastes(Washington, DC: National Academy of Sciences, 1991), pg. 45.

[3] United States General Accounting Office, Chemical RiskAssessment; Selected Federal Agencies' Procedures, Assumptions,and Policies [GAO-01-810] (Washington, D.C.: United StatesGeneral Accounting Office, August, 2001), pg. 31.

[4] A major study of risk assessment was conducted by 11 Europeangovernments during the period 1988-1990, and published by theCommission of the European Communities under the titleBenchmark Exercise in Major Hazard Analysis in 1991. The 11governments (Netherlands; Greece; Great Britain; Denmark;Italy; Germany; France; Belgium; Spain; Finland; andLuxembourg) established teams of their best scientists andengineers and set them to work on a single problem: analyzingthe accident hazards of a small ammonia storage plant. Privatecompanies like Rohm & Haas, Solvay, Battelle, and Fiatcontributed experts as well. The results were stunning: the 11teams varied in their assessment of the hazards by a factor of25,000. Analyzing the hazards of a single, small plant handlingonly one chemical, these world-class "risk experts" reachedwildly different conclusions. For example, the individual riskat the "refrigerated storage site" was calculated by one groupof experts to be one-in-400, but by another group of experts tobe one-in-10-million. (Figure 3.5, pg. 58 of the Benchmarkstudy.) See Commission of the European Communities, BenchmarkExercise on Major Hazard Analysis. 3 Volumes. (Luxembourg,Luxembourg: Commission of the European Communities, 1991).

[5] David O. Carpenter, Kathleen Arcaro, and David C. Spink,"Understanding the Human Health Effects of Chemical Mixtures,"Environmental Health Perspectives Vol. 110 Supplement 1(February, 2002) pgs. 25-42.

[6] Beverly S. Rubin, Mary K. Murray, David A. Damassa, Joan C.King, and Ana M. Soto, "Perinatal Exposure to Low Doses ofBisphenol A Affects Body Weight, Patterns of Estrous Cyclicity,and Plasma LH Levels," Environmental Health Perspectives Vol.109, No. 7 (July 2001), pgs. 675-680.

[7] K.S. Landreth, "Critical windows in development of therodent immune system," Human and Experimental Toxicology Vol.21, Nos. 9-10 (Sep-Oct, 2002), pgs.493-498;

[8] M.C. Garofolo,  F.J. Seidler, M.M. Cousins, C.A. Tate, D.Oiao, and T.A. Slotkin, "Developmental toxicity of terbutaline:Critical periods for sex-selective effects on macromoleculesand DNA synthesis in rat brain, heart, and liver," BrainResearch Bulletin Vol. 59, No. 4 (Jan. 15, 2003), pgs. 319-329;

[9] T.A. Lindsley and L.J. Rising, "Morphologic and neurotoxiceffects of ethanol vary with timing of exposure in vitro,"Alcohol Vol. 28, No. 3 (Nov., 2002), pgs. 197-203;

[10] M.R. van den Heuvel and R.J. Ellis, "Timing of exposure toa pulp and paper effluent influences the manifestation ofreproductive effects in rainbow trout," EnvironmentalToxicology and Chemistry Vol. 21, No. 11 (Nov., 2002), pgs.2338-2347.

[11] Erik Baatrup and Mette Junge, "Antiandrogenic PesticidesDisrupt Sexual Characteristics in the Adult Male Guppy(Poecilia reticulata)," Environmental Health Perspectives Vol.109, No. 10 (October 2001), pgs. 1063-1070.

[12] Nicholas T. Ingolia and Andrew W. Murray, "HistoryMatters," Science Vol. 297 (Aug. 9, 2002), pgs. 948-949.

[13] Upinder S. Bhalla, P.T. Ram, and R. Iyengar, "MAP KinasePhosphatase As a Locus of Flexibility in a Mitogen-ActivatedProtein Kinase Signaling Network," Science Vol. 297 (Aug. 9,2002), pgs. 1018-1023.

[14] M.S. Berrill, S. Bertram, B. Pauli, D. Coulson, M. Kolohon,and D. Ostrander, "Comparative sensitivity of amphibiantadpoles to single and pulsed exposures of the forest-useinsecticide fenitrothion," Environmental Toxicology andChemistry, Vol. 14, No. 6 (1995), pgs. 1011-1018;

[15] R.B. Naddy, K.A. Johnson, and S.J. Klaine, "Response ofDaphnia magna to pulsed exposures of chlorpyrifos,"Environmental Toxicology and Chemistry Vol. 19, No. 2 (2000),pgs. 423-431.

[16] P.E. Ganey and R.A. Roth, "Concurrent inflammation as adeterminant of susceptibility to toxicity from xenobioticagents," Toxicology Vol. 169, No. 3 (Dec 28, 2001), pgs.195-208.

[17] U.S. Environmental Protection Agency, Health Effects TestGuidelines; OPPTS 870.4100 Chronic Toxicity [EPA 712-C-98-210](Washington, D.C.: U.S. Environmental Protection Agency, 1998.)

18. S.L. Schantz, J.J. Widholm, and D.C. Rice, "Effects of PCBExposure on Neuropsychological Function in Children,"Environmental Health Perspectives Vol. 111, No. 3 (March 2003),pgs. 357-376.

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
RACHEL'S ENVIRONMENT & HEALTH NEWSEnvironmental Research FoundationP.O. Box 160New Brunswick, N.J. 08903Fax (732) 791-4603; E-mail:


< Prev   Next >

This site donated by Charles Buchwald