HAZARDOUS WASTEVolume 1, Number 3, 1984Mary Ann Liebert, Inc., PublishersPp. 363-375

The Interaction of Science, Policy, and the Lawin Agency Use of Risk Assessments for the

Regulation of CarcinogensDON G. SCROGGIN

Beverage & Diamond, P.C.1333 New Hampshire Avenue N.W.

Washington, DC 20036

ABSTRACT

The National Academy of Sciences and Environmental ProtectionAgency ("EPA") Administrator Ruckelshaus have both urged thatrigorous risk assessment be incorporated into federal agency pro-cedures for the regulation of toxics and carcinogens. Ruckelshaushas made considerable efforts to upgrade the quality of scienceused in federal agency rulemakings and to assure that "our scienceanalysis be rigorous and the quality of our data be high." Inspite of these admirable goals, the current state of risk assess-ment and risk management in the federal agencies appears to be a

tangle of inconsistency. Not only do different agencies use dif-ferent standards for acceptable health risks, but regulations tocontrol cancer risk may vary by as much as 1000 times even withinEPA itself. This article discusses the practical problems of in-corporating scientific risk assessments into agency rulemakings andthe complex policy issues involved. The first major analysis ofcurrent agency use of risk assessment has just been completed by ablue-ribbon panel of EPA's Science Advisory Board ("SAB"). Theissues raised in the SAB radionuclides review cut across all en-vironmental laws premised on an assessment of risk and suggestseveral critical procedural steps that should be immediatelyhelpful to all agencies currently struggling with the difficultproblems of incorporating risk assessments into the bases for theirregulations of toxins and carcinogens.

INTRODUCTION

Implementation of virtually all of the environmental lawsregulating toxic or carcinogenic pollutants requires an assessmentof risk to human health or the environment. Thus, methodologies ofrigorous risk assessment, including the analysis of uncertainties,should be an essential step in a decisionmaker's determination ofallowable levels of exposures. For example, the Resource Conserva-

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tion and Recovery Act ("RCRA") requires a determination thathazardous wastes "pose a substantial present or potential hazard tohuman health or the environment . . . ." 1/ Other environmentallaws have similar requirements of determination of the risk ofharm.

The current status, however, of regulatory agencies' use ofhealth risk assessments is confused and inconsistent. The recentexample of the EPA's regulation of radionuclides, discussed indetail below, is a pointed and groundbreaking illustration of thepractical problems that may arise in incorporating risk assessmentsinto agency rulemakings, where regulation is based upon a risk ofharm to man or the environment. The issues raised in the radio-nuclides rulemaking cut across all environmental laws premised onan assessment of risk. The lessons learned from the experiencewith radionuclides suggest several critical procedural steps thatshould be helpful to all agencies currently struggling with thedifficult problem of incorporating risk assessments into the basesfor their regulations.

The specific standards requiring risk assessments vary some-what among the environmental statutes, but these standards allshare the practical problems of implementation discussed in thisarticle. In the implementation of the Comprehensive EnvironmentalResponse, Compensation, and Liability Act 2/ ("CERCLA" or "Super-fund") to clean up hazardous waste sites, a chief issue is thequestion, "How clean is clean?" Superfund requires remedial action"to prevent or minimize the release of hazardous substances so thatthey do not migrate to cause substantial danger to present or fu-ture public health or welfare or the environment." 3/ Does thisrequirement imply that the concentrations of hazardous substancesreleased be no greater than background or only that the publichealth risk posed by releases not create "substantial danger"? Ifthe latter, then it would follow that some level of exposure abovebackground but corresponding to a health risk less than "sub-stantial danger" should be allowed. The difference may determinewhether extra millions of dollars are expended and resourcesdiverted from addressing other health risks.

Other environmental statutes present similar puzzles. TheClean Air Act requires the EPA Administrator to determine that"emissions of [pollutants] into the ambient air will cause, orcontribute to, air pollution which may reasonably be anticipated toendanger public health." 4/ Congress and the courts haveinterpreted these words to mean that EPA must make a determinationthat a significant public health risk exists at levels of emissionsof the pollutant that are actually occurring in the ambient

1/ RCRA, Section 1004(5)(B); 42 U.S.C. § 6903(5)(B). RCRA's mainemphasis has been with contamination of the ground surface,water, or groundwater. Concern regarding air emissions isevidenced by new provisions in Amendments to the RCRA Re-authorization Bill (H.R.757) now before Congress.

2/ 42 U.S.C. §§ 9601 et seq.

3/ CERCLA, § 101(24); 42 U.S.C. § 9601(24).

4/ Clean Air Act, Section 122(a); 42 U.S.C. § 7422(a).

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air. 5/ The Clean Water Act requires that effluent standardsprovide "an ample margin of safety." 6/ The Federal Insecticide,Fungicide and Rodenticide Act ("FIFRA") requires determination ofan "unreasonable risk to man or the environment." 7/ The ToxicSubstances Control Act ("TSCA") requires that the EPA Administratordetermine that the manufacture or use of a chemical "may present anunreasonable risk of injury to health or the environment." 8/ Andthe Safe Drinking Water Act ("SDWA") requires regulation ofpollutants which are "reasonably suspected of increasing the riskof illness." 9/ Some form of risk assessment should be anessential step in making any of these determinations.

In response to these statutory requirements, AdministratorRuckelshaus has made admirable efforts to upgrade the quality ofscience used in federal agency rulemakings and to assure that "ourscience analysis be rigorous and the quality of our data be high."10/ Administrator Ruckelshaus has adopted the National Academy ofSciences' distinction between risk assessment and risk manage-ment: risk assessment is the quantitative determination of themagnitude of health risks and the uncertainties that accompanythem; risk management is the policy judgment of what is an ac-ceptable risk to society. 11/ Ideally, risk assessment should beperformed by scientists and risk management by enlightened policy-makers. The Administrator also has urged that we "make uniform theway in which we manage risk across the federal regulatory agen-cies." 12/ Such consistency is essential if scientific bases ofhealth-based rules are to be legally defensible and politicallyacceptable. Recently he said, "The public interest is not servedby two Federal agencies taking diametrically opposed positions onthe given health risks of a given toxic substance." 13/

5/ Seer e.g.. Industrial Union Dept., AFL-CIO v. AmericanPetroleum Institute et al., 448 U.S. 607 (1980). But seeNatural Resource Defense Council, Inc., "Comments on theProposed Withdrawal of Proposed Standards for Benzene Emis-sions" ("NRDC Benzene Comments"), Washington, D.C. April 13,1984.

6/ Clean Water Act, Section 307(a)(4); 33 U.S.C. § 1317(a)(4).

7/ FIFRA, Section 2(bb); 7 U.S.C. § 136(bb).

8/ TSCA, Section 4(a)(1)(A)(i); 15 U.S.C. § 2603(a)(1)(A)(i) .

9/ SDWA, Section 1412(e)(3)(D); 42 U.S.C. § 300g-l(e)(3) (D) .

10/ "Science Risk in Public Policy," a speech by William D.Ruckelshaus, EPA Administrator, before the National Academy ofSciences, June 22, 1983, ("Ruckelshaus Speech"), p. 11.

11/ Risk Assessment in the Federal Government: Managing theProcess, National Academy of Sciences, Washington, D.C.1983.

12/ Ruckelshaus Speech at 17.

13/ Id.

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CURRENT INCONSISTENCIES INAGENCY USE OF RISK ASSESSMENTS

In spite of these admirable goals and in spite of the pressingneed for adequate risk assessment in the implementation of the en-vironmental laws, the current state of risk assessment and riskmanagement in the federal agencies seems a tangle of inconsistency.14/ Not only do different agencies use different standards foracceptable health risks, but EPA's own risk management work grouprecently found that risk estimates used in regulations to reducecancer risk may vary by as much as 1,000 times even within EPAitself. 15/ For one recent rulemaking for airborne radionuclides,which is discussed in more detail below, EPA determined that an

"adequate margin of safety" for regulation of the same carcinogenicpollutants varied by 25 times from one regulated industry toanother. 16/

The basic question that emerges from these inconsistencies iswhether the government is regulating human exposure to toxic chemi-cals and other cancer-causing agents to protect public health or,rather, is engaged in an exercise to impose regulations merelybecause they are technically and economically achievable. If pro-tecting human health is the goal, then the federal government'scurrent implementation of the environmental laws designed to pro-tect human health appears inconsistent with that objective. Arational approach to this complex problem might be first to make adetermination of what level of health risk from exposure to a pol-lutant is deemed acceptable. Since scientists often disagree onthe interpretation of the scant data available, this first stepwill be a combination of risk assessment and risk management de-cisions and will include value judgments of the decisionmaker.Once that decision is made, the next step would be to requiresources of that pollutant to limit their emissions down to thatlevel of acceptable risk. This is not, however, what is oftendone.

14/ Three recent efforts to address this pervasive problem include(1) the establishment of the Interagency Risk ManagementCouncil, a multi-agency group whose main purpose is toidentify and resolve differences among federal agencies usingrisk assessments. See Environment Reporter, June 22, 1984, at311-312. (2) Rep. Don Ritter has introduced legislation (H.R.4192) calling for the creation of a risk assessment agency toaddress the same problem. (3) The White House Office ofScience and Technology Policy has recently published its pro-posed guidance, "Chemical Carcinogens; Notice of Review of theScience and Its Associated Principles," 49 Fed. Reg. 21594(May 22, 1984).

15/ EPA's risk management work group in its recent final reportfound that actions of different EPA offices resulted in finalhealth risks differing by 1,000. See Inside EPA, 29 June1984, p. 11.

16/ "National Emission Standards for Hazardous Air Pollutants;Standards for Radionuclides," 48 Fed. Reg. 15076 (April 6,1983) ("Radionuclides Rulemaking").

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The Problem of Regulating Pollutants That Cause Cancer at High Doses

There is a broad range of disagreement and controversy amongscientists regarding the risk of human exposure to toxics and car-

cinogens. 17/ Some scientists believe that any exposure, no matterhow small, is unsafe and urge government regulations to limit or

eliminate all exposures. These proponents usually focus theirattention on man-made and industrial substances. Other scientistspoint out that humans are routinely exposed to doses of toxics andcarcinogens thousands of times higher in the normal daily diet thanfrom industrial sources and emphasize the lack of credible epidemi-ological data to indicate any increase in cancer incidence fromindustrial emissions. 18/

Health risk assessments for toxic and carcinogenic pollutantspresent a particularly difficult problem for regulators as well as

for scientists. It is well understood that exposure to high levelsof some of these agents causes cancer, at least in animals.Because it is impossible to determine the effects on humans ofexposure to low doses of such pollutants, most agencies have optedto employ the linear non-threshold theory, which predicts that anyexposure, no matter how small, will result in some harm. Thistheory ignores the possibility of thresholds. We know thresholdsexist for some toxic chemicals, such as fluoride, which at highdoses is a deadly poison, but at low doses we put in our drinkingwater to prevent cavities in our teeth. For carcinogens (includingradiation) it is impossible to confirm or refute the existence ofthresholds, although our growing understanding of the existence ofbiological repair mechanisms in cells suggests that approximatethresholds may exist for some carcinogens. 19/

There are significant scientific problems with using only thelinear non-threshold theory, because it tends to overestimate thecalculated risks. Advocates of the linear non-threshold theoryargue that prudence dictates use of its "conservative" risk esti-mates. Other scientists point out that, since there is no evidenceconfirming or refuting the linear non-threshold theory at the ex-tremely low levels considered for regulation, other dose-responsecurves should also be considered. 20/

17/ The collection of letters to the editor of Science in responseto the widely cited article by Bruce N. Ames , infra, ondietary carcinogens is an excellent example of the currentrange of scientific opinion on this subject. "Cancer andDiet," 224 Science 658 (May 12, 1984).

18/ Id.

19/ For example, repair in cells and tissues can markedly reducethe carcinogenic effect of a particular radiation dose, if thesame dose is delivered over a longer, rather than a shorter,period of time. See, e.g., Marvin Goldman, "Ionizing Radia-tion and Its Risks," 137 Western Journal of Medicine 540(1982).

20/ See, e.g., the discussion of quadratic and linear-quadraticdose-response relationships in the National Academy ofSciences' prominent study of radiation health effects in "TheEffects on Populations of Exposure to Low Levels of IonizingRadiation: 1980" ( "BEIR-III").

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Far more troublesome practical problems and policy questionsof a different kind arise when an agency imposes required state-of-the-art control technologies for carcinogenic and toxic pollutantswithout regard for the actual health risk posed by these pollutantsbefore controls are imposed. The result is that pollutants fromone industry may be totally unregulated, even though the calculatedhealth risk posed by its pollutants may be hundreds of times higherthan that from a regulated industry. Thus, often industries posingthe smaller risk are the ones asked to incur the tremendous cost ofcontrolling pollutants merely because pollutant reductions are pos-sible, not because there is any significant public health problemto be eliminated. 21/ Among other consequences, it is difficult, ifnot impossible, for some industries to plan ahead in their budgetsfor the cost of compliance. Even when these companies' operationspose no significant health risk, they may still be burdened withthe cost of compliance simply because control technologies existand EPA determines that the industry can afford the cost.

Some Environmental Groups Strongly Support Regulation of HazardousPollutants at Any Level of Exposure

There is today significant pressure from some environmentalgroups to regulate human exposure to hazardous pollutants, nomatter how low the level of exposure actually occurring. It hasbeen urged, for example, that a determination of a significanthealth risk need not precede regulation. In recent comments sub-mitted to EPA regarding the Agency's proposed withdrawal of severalbenzene regulations 2 2/ because the health risks were insignifi-cant, one such organization stated:

Presumably a police department would respond withthe same urgency to a tip that a dangerous personhas threatened to shoot randomly into a TimesSquare crowd until he kills one person as it wouldto a tip that the same dangerous person intends tokill a specific individual. Why then should a

public health agency such as EPA respond less tothe "statistical" death than the identified,specific death? 23/

This regulatory approach of reducing exposures to carcinogens with-out first determining whether they pose a significant health riskis supported and used by agencies in some rulemakings. 24/

21/ See, e.g., "National Emission Standards for Hazardous AirPollutants; Standards for Radionuclides," 48 Fed. Reg. 15076(April 6, 1983) ("Radionuclides Rulemaking").

22/ "Proposed Withdrawal of Proposed Standards for BenzeneEmissions from Maleic Anhydride Plants, Ethylbenzene/StyrenePlants, and Benzene Storage Vessels," 49 Fed. Reg. 8386 (March6, 1984).

23/ NRDC Benzene Comments at 13.

24/ See, e.g, the Radionuclides Rulemaking. See also "Proceedingsbefore the Subcommittee on Risk Assessment for Radionuclides,Science Advisory Board, U.S. Environmental Protection Agency,Washington, D.C, March 22, 1984, at 81-88.

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RADIONUCLIDES RULEMAKING: A CASE STUDY

A particularly revealing example of common practical problemsthat develop when risk assessments are not fully incorporated intoproposed regulations is a current EPA rulemaking regarding emis-sions of airborne radioactive particles called radionuclides. 25/The history of this rulemaking illustrates several problems thatmay arise in proposing regulations before using a health riskassessment basis to determine whether or not a significant healthrisk exists. These problems include failures to survey thescientific literature, to consider the range of scientific opinionand controversy, to consider the recommendations of other regula-tory agencies and advisory bodies, and to coordinate regulatoryprocedures with other sections of the same agency. The radio-nuclides proposal is striking, however, in that EPA's ScienceAdvisory Board was convened to review the scientific basis of acurrent rulemaking after the proposed rule was published. Thefinal product of that SAB review will be the first major product ofthe new era of risk assessment/risk management rigor urged by Ad-ministrator Ruckelshaus to be incorporated into all federal agencyrulemakings. Because of the inevitable precedent the SAB review ofradionuclides will set, its membership was carefully limited to themost prominent of scientific experts, 2 6/ and EPA has preserved therecord of the Subcommittee's deliberations in formal transcripts.

That Science Advisory Board review, which is now nearingcompletion, has produced a forum that seldom exists in Agencyrulemakings. Eleven of the world's most eminent scientists infields relating to radiation health effects have gathered to reviewthe scientific basis of EPA's far-reaching proposed rule to regu-late emissions of radionuclides. In that forum, the technicalstaff of EPA has explained the basis of the Agency's rule. Thatexchange has been intense, sometimes highly dramatic/ and hasproduced a record that illustrates the kinds of problems thatemerge when agencies fail to rely upon established risk assessmentmethodologies before proceeding to regulate potentially hazardouspollutants.

History of the Radionuclides Regulation

First, a brief history of the radionuclides rulemaking. In1979, EPA listed radionuclides as a potentially hazardous air pol-lutant, pursuant to Section 112 of the Clean Air Act. In 1981, the

25/ "National Emission Standards for Hazardous Air Pollutants;Standards for Radionuclides," 48 Fed. Reg. 15076 (April 6,1983), EPA Docket No. A-79-11. The author's law firmrepresents FMC Corporation in the airborne radionuclidesrulemaking and the Idaho Mining Association in the relatedlitigation and in the proceedings before the Science AdvisoryBoard. See Sierra Club v. Ruckelshaus, No. C-84-0656-WHO(N.D. CalTTT

26/ The SAB Radionuclides Subcommittee was described by SABExecutive Board Chairman as a "Who's Who" or "Hall of Fame" inthe radiation health field at the public Executive Boardmeeting in Washington on 18-19 July 1984.

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Sierra Club brought suit against EPA for failure to publish pro-posed rules within the 180-day statutory deadline. Pursuant to afederal court order, EPA did propose standards for radionuclides on

April 6, 1983. In February of 1984, the Sierra Club brought suitagain, this time to compel EPA to promulgate final standards, sincethe Agency had again failed to meet the statutory deadline. OnJuly 25, 1984, the federal District Court of the Northern Districtof California ordered EPA to issue final regulations by October 25,1984. 27/ Litigation in this matter is likely to continue.

For the elemental phosphorus industry, EPA proposed to reduceemissions of radionuclides to a level approximately 1% of thenatural background radiation. 28/ Even EPA's own "conservative"calculations predicted that a model elemental phosphorus plantwould produce one excess cancer death every hundred years to themaximally exposed individual. 29/ That maximally exposed individualis someone who stands outside, 24 hours a day, at the edge of theplant for all his life. Since over 400,000 persons each year inthe U.S. die from cancer from other causes, detecting that one

hypothetical excess cancer death in a hundred years is scien-tifically impossible.

On August 22, 1983, EPA received a formal request for SABreview of the radionuclides rules. 30/ That request, submitted byan elemental phosphorus manufacturer, was not acted upon untilafter congressional committees held several hearings, where the EPAAdministrator and his staff were questioned on how the Adminis-trator's views on good scientific procedures could be reconciledwith the record regarding the proposed radionuclides regulation.31/ Finally, on December 6, 1983, Administrator Ruckelshausofficially convened an SAB subcommittee to review EPA's use ofhealth risk assessments for radionuclides.

Further review revealed internal procedural problems in EPA'sdevelopment of the radionuclides rules. 32/ Section 112 is designedto protect the public from significant health risks posed byhazardous air pollutants. The Clean Air Act, as well as othermajor federal environmental statutes, uniformly requires thedetermination of a significant health risk before an agency pro-ceeds with regulations to protect public health. To fulfill this

27/ Sierra Club v. Ruckelshaus et al., No. C-84-0656-WHO(N.D. Cal.).

28/ "National Emission Standards for Hazardous Air Pollutants;Standards for Radionuclides," 48 Fed. Reg. 15076 (April 6,1983) ("Radionuclides Rulemaking").

29/ Id.

30/ Letter and accompanying memorandum from Gary H. Baise, onbehalf of FMC Corporation, to Joseph A. Cannon, U.S. Environ-mental Protection Agency, August 22, 1983.

31/ "EPA Radon and Radionuclide Emission Standards," Hearingbefore the Procurement and Military Nuclear Systems Sub-committee of the Committee on Armed Services, U.S. House ofRepresentatives, 98th Congress, 1st Session, October 6,1983.

32/ See "Intervenor's Memorandum in Opposition to Plaintiff'sMotion for Summary Judgment," Sierra Club v. Ruckelshaus etal., No. C-84-0656-WHO (N.D. Cal.)(filed May 25, 1984).

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statutory requirement, EPA has prepared for many pollutants what iscalled a health assessment document. A health assessment documentsurveys the literature, reviews key studies/ examines emission andexposure data for the pollutant, and forms a basis for determiningwhether current emissions of the particular pollutant at levelsactually occurring in the ambient air pose a significant healthrisk to the general population. That health assessment document isthen independently reviewed by other scientists, including EPA'sown Science Advisory Board. But for radionuclides, EPA prepared nohealth assessment document, and there had been no SAB review.

The Science Advisory Board's review of the scientific riskassessment basis for EPA's proposed radionuclides rulemaking hasrecently been completed 33/ and serves as a useful guide in theappropriate use of health risk assessments in rulemakings to regu-late carcinogenic and toxic pollutants. In its draft report, theSAB Radionuclides Subcommittee concluded that EPA had failed toperform a risk assessment "that provides a scientifically adequatebasis for regulatory decisions on airborne radionuclides ....

[Ejven when the proposed standards and the background document areconsidered together, they are not sufficiently complete nor or-

ganized to serve as a scientifically adequate statement of thehealth risks from radionuclide emissions." 34/ The SAB recommendedthat a standing committee be established to oversee and review allrisk assessments and scientific bases for EPA regulations in theradiation area.

LESSONS LEARNED

Uncertainties Should be ExplicitThe experience with radionuclides provides several useful

lessons regarding both what should be done and what currently isbeing done in regulating health risks posed by hazardous pollu-tants. The first lesson is that policymakers should be more candidwith the public regarding the uncertainties in health risk assess-ments. There is an understandable tendency to try to make quanti-tative health risk assessments appear more certain than they are.Crisp, clean numbers are easier to deal with. It makes any policy-maker uncomfortable to have to say he is proposing a costly rulebecause a complex computer program, understood by only a handful ofpeople in the country, predicts that between zero and 10 excesscancer deaths may occur within the next 100 years and that there issignificant uncertainty as to whether or not any health risk existsat all.

It is understandably difficult for a decisionmaker to admitcandidly that he simply does not know for sure whether or not thereis any health problem/ but that he is nevertheless going to exer-cise his best judgment to impose huge control costs on society. Itis much more acceptable to say, as EPA does with radionuclides/that it is proceeding with regulation because current emissions of

33/ "Report on the Scientific Basis of EPA's Proposed NationalEmission Standards for Hazardous Air Pollutants for Radio-nuclides/" Draft Report/ Subcommittee on Risk Assessment forRadionuclides/ Science Advisory Board/ U.S. EnvironmentalProtection Agency, July 1984.

34/ Id. at 1,2.

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radionuclides from an elemental phosphorus plant will produceexactly one excess death in 100 years. The number one sounds cer-tain and implies much greater certainty than actually exists.Acknowledging the uncertainty in the risk assessment calculationsalso allows for public participation in what is ultimately a policydecision, not just a scientific decision, of whether or not regu-lation is justified.

The Basis of the Agency's Regulatory Approach Should Be Made Clear

A second lesson taught by the experience with radionuclides isthat EPA's fundamental regulatory approach to carcinogens may beunrelated to the question of whether the health risks involved aresignificant or not. In the SAB proceedings, EPA explained that thedriving force behind its regulations is as follows: If any pol-lutant causes cancer at high levels of exposure then the Agencywill use the linear non-threshold theory to assume that any ex-

posure, no matter how small, should be reduced still further. TheAgency will then proceed to regulate that carcinogen, at whateverexposure levels it be found, until in the Agency's view, the in-dustry cannot afford further reductions. The important point hereis that the Agency may impose emission controls before asking thecritical question of whether or not a significant health effectexists at the initial exposure levels sought to be regulated.Agency representatives then explained, again on the record, thatthey do finally look at the calculated health risk assessments, butonly after imposition of state-of-the-art control technologies.

In the radionuclides rulemaking, the Agency never asked oranswered the question of whether current exposures to radionuclidesposed a significant health effect to the public, nor, the SAB dis-covered, did the Agency establish a scientific foundation uponwhich that decision could plausibly be made. This fact was re-vealed in the telling exchange that occurred on the record betweenthe SAB and the EPA staff on March 22, 1984. EPA had a formalbriefing for the Science Advisory Board regarding the materials theAgency had presented to the Administrator to support the proposedregulation. The transcript reads as follows:

CHAIRMAN MCCLELLAN: Is there a [staff position paper]that went to the Administrator as regards this proposedrulemaking, and if so, could we examine that document?

Is there a document that went to the Administrator?EPA: The rule.CHAIRMAN MCCLELLAN: The rule went to the Adminis-trator, not a supporting document?

So there is nothing, that if I were a historian 50years from now and wanted to examine the question ofdecision-making in the Environmental ProtectionAgency —

EPA: You would look at the proposed rule and thepreamble.CHAIRMAN MCCLELLAN: The proposed rule would be it andthere would be nothing else there to stand on. 35/

35/ Proceedings before the Subcommittee on Risk Assessment forRadionuclides, U.S. E.P.A. Science Advisory Board, March 22,1984, Washington, D.C. at 93-95.

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Health Risk Assessments Should Compare Similar Risks

A third lesson is that the calculated health risk assessmentsare meaningless unless they are compared with similar risks. Forexample, scientists have only recently come to understand thathumans receive much larger exposure to carcinogens and toxics inthe normal healthy diet than from industrial pollution. 36/ Thelegal and regulatory implications of this new scientific per-spective have only just begun to be explored. 37/

Even the SAB's panel of eleven eminent health scientists onthe SAB radionuclides subcommittee emphasized that the only way togive numbers such as one in a million any real meaning is to com-

pare the risks posed by any pollutant with other risks to whichsociety is exposed. 38/ Society is not risk free. Moreover,society has determined that some risks are acceptable. In thedecisionmaking process whereby hazardous pollutants are regulated/it is meaningless to proceed without first comparing the calculatedrisks with risks that are known and which society judges to beacceptable.

Scientific Peer Review Is Essential

A fourth lesson is that independent scientific peer review ofthe scientific bases of health-related rules is essential. Openexamination of the uncertainties and of the underlying premises ofany health risk assessment is the most reliable way of assuringthat agencies do not rush to regulation without first examiningwhether or not there is any health problem to be addressed.

Taking the Time for Adequate Risk Assessment Actually Saves Time

The fifth lesson is that taking the time to do the scienceright should actually save time in the long run/ not delay rule-making. The real delays that have occurred in regulating airbornecarcinogens/ for example/ have come from proceeding too quicklywith a questionable scientific basis, not from taking the time todo the scientific basis correctly. A prominent example is arsenic,which EPA currently proposes to regulate under Section 112 of theClean Air Act. In 1978, EPA prepared a health assessment documentwhich was deemed by the SAB's review to be so defective as to needa complete rewrite. Instead of responding to the SAB's criticism,EPA submitted a second draft in 1979, which the SAB panel de-termined to be even less acceptable than the first. In stronglanguage, the SAB criticized the arsenic health assessment documentfor its significant scientific deficiencies and specifically criti-

36/ See, Bruce N. Ames, "Dietary Carcinogens and Anticarcinogens,"221 Science 1256 (23 September 1983). See also "Cancer andDiet," Letters Section, 224 Science 653 (May 12, 1984).

37/ See Don G. Scroggin, "Study May Be Used To ChallengeEnvironmental Regs," 6 Legal Times (No. 22) 15 (October 31,1983).

38/ See/ e.g., Proceedings before the Subcommittee on RiskAssessment for Radionuclides/ EPA Science Advisory Board,January 16, 1984, Washington, D.C. at 141-142.

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cized EPA for allowing political considerations to enter into whatshould be scientific determinations. 39/ A period of four yearsthen followed, during which time the arsenic health assessmentdocument was redrafted still again. Not until 1983 was a new draftsubmitted to the SAB, and not until 1984 were regulations finallyproposed for arsenic. Had the science been done adequately in thefirst place, this six-year delay might have been avoided.

The message is clear. If one sincerely believes that there isa significant health problem posed by extremely low exposures tocarcinogenic and toxic agents, then it is imperative that regu-latory agencies take sufficient time to lay credible scientificfoundations before rushing to propose regulations. It is shakyscience that causes the delays, not taking the time to lay an

adequate scientific basis.Rules witn inadequate scientific bases may be remanded to the

agencies by the courts. Such delays and remands do not serve theinterest of industry, environmentalists, or the Agency itself. Inthe interim, industry is unable to plan its investments so that itcan anticipate what expenditures, if any, will be necessary forcompliance. Also the diversion of the Agency's resources to regu-lating tiny risks and then having to duplicate that work means thatthe government has fewer resources to address other risks, some ofwhich are known with certainty to be significant.

CRITERIA FOR DEVELOPING AN ADEQUATERISK ASSESSMENT BASIS FOR REGULATION

The Clean Air Act itself lays down the basics of how to goabout developing an adequate foundation for a proposed health-basedregulation. For example, Section 122 of the Act requires theAdministrator to "review all available relevant information anddetermine whether or not emissions of radioactive pollutants . . .

will cause, or contribute to, air pollution which may reasonably beanticipated to endanger public health." Section 307(d)(3) requiresthat "[a]ll data, information, and documents ... on which theproposed rule relies shall be included in the docket on the date ofpublication of the proposed rule."

As the SAB proceedings revealed, EPA failed to establish inthe docket or anywhere else a discernible basis for concluding thatambient exposures to carcinogenic radionuclides pose a significanthealth risk. The Agency admitted, in proceedings before the SAB,that it had failed to consider perhaps the most prominent referencein the radiation field, the BEIR-III Study, which it had itself re-

quested from the National Academy of Sciences. Section 117 of theAct requires the Administrator "to the maximum extent practicablewithin the time provided, consult with appropriate advisory commit-tees, independent experts, and Federal departments and agencies."But in hearings before Rep. Stratton last October, 40/ EPA ac-knowledged that it had not even attempted to consult with the most

39/ "Report of the Subcommittee on Arsenic as a Possible HazardousAir Pollutant," Executive Committee of the Science AdvisoryBoard, U.S. Environmental Protection Agency, Washington, D.C,April 18, 1979.

40/ "EPA Radon and Radionuclides Emission Standards," Hearingbefore the Procurement and Military Nuclear Systems Sub-committee of the Committee on Armed Services, U.S. House ofRepresentatives, 98th Congress, 1st Session, October 6, 1983at 74, 490, and 123.

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relevant expert agency/ the National Commission on RadiologicalProtection and Measurements/ upon which governmental agencies haverelied upon for expert advice for the past 55 years.

To fulfill these statutory requirements for developing anadequate basis for a regulation/ the Science Advisory Board andAdministrator Ruckelshaus have clarified further the essentialprocedures for developing an adequate risk assessment basis forregulations to protect public health:

(1) After surveying the scientific literature andevaluating key studies/ collect and analyze allexisting data pertinent to the evaluation of thehealth effects of the pollutant on non-occupa-tionally exposed individuals;

(2) Collect new data on concentrations of the pollu-tant near the point sources and collect estimatesof absorption of the pollutant by exposed indivi-duals;

(3) Require that a statistician sit on every workinggroup in which data collection/analysis will occurto avoid statistical problems;

(4) Discuss measures of dose-response relationshipsrelevant to ambient exposures so that the adversehealth responses are placed in perspective withconcentration levels actually observed in the am-bient air;

(5) Independently evaluate for each pollutant thequestion of a possible threshold for human healtheffects; and

(6) Subject the basis of the proposed rule to scien-tific peer review/ including review by the ScienceAdvisory Board. 41/

CONCLUSION

In sum, taking the time to develop a sound scientific basisfor health-based rules, subjecting that science to independent peerreview within the scientific community/ and acknowledging the un-certainties in the risk assessment calculations will allow agenciesto proceed with the difficult task of trying to regulate toxics andcarcinogens. Allowing sufficient time to do the job right will notonly produce speedier results/ but it should produce more rationalrules in which the more significant risks are addressed first andwhere limited resources of regulatory agencies are not divertedinto unproductive efforts. Rules based on sound science will alsobe better able to withstand legal attacks and should produce a moreefficient, cost-effective system for addressing significant healthproblems and for giving regulated industries more certainty, sothat they can plan ahead for compliance.

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41/ See / e.g., "A Report of the Subcommittee on Arsenic as aPossible Hazardous Air Pollutant/" Executive Committee of theScience Advisory Board/ U.S. Environmental Protection Agency/April 18, 1979, at 13-14; "Health Assessment Document forInorganic Arsenic," EPA, Review Draft, EPA-600/8-83-021A, June1983, and Letter from William D. Ruckelshaus to Rep. John B.Dingell, March 9, 1984.