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Feb. 27, 1991 DRAFT THE RISK ASSESSMENT GUIDELINES AND REVIEW PROCEDURES OF THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

THE RISK ASSESSMENT PROCESS OF THE UNITED STATES ENVIRONMEMAL PROTECTION AGENCY In 1986 the United States Environmental Protection Agency ("EPA") promulgated its Guidelines for Carcinogen Risk Assessment, 51 F.R. 33992 (September 24, 1986) ("EPA Guidelines"). The EPA Guidelines were intended to guide the Agency in the evaluation of suspected carcinogens in line with the policies and procedures established in statutes administered by the EPA. The EPA Guidelines emphasized that (i) assessments will give full consideration to all relevant scientific information, (ii) scientific information will be fully presented in agency risk assessment documents, and (iii) agency scientists will identify the strengths and weaknesses of each assessment by describing uncertainties, assumptions and limitations as well as the scientific basis and rationale for each assessment. The EPA Guidelines further expressly state: The purpose of these guidelines is to promote quality and consistency of carcinogen risk assessment within the EPA and to inform those outside the EPA about its approach to carcinogen risk assessment. (51 F.R. 33993) The EPA Guidelines are to be applied and utilized within the framework already provided by applicable EPA statutes and procedures. By virtue of the EPA's own pronouncements, there are thus two components of the EPA risk assessment process. The first

relates to the uniform and consistent application of the EPA's own Guidelines which govern technical aspects of risk assessment. The second is the uniform, consistent and fair application of EPA procedures for involving and informing the public concerning ongoing risk assessments. If EPA risk assessments are uniformly conducted pursuant to the EPA Guidelines, and the EPA's procedures are fairly and evenly applied, then the risk assessment process will proceed in a direction supportive of the public interest. However, when the EPA initiates or permits gross departures from the EPA Guidelines, and when the EPA mandates or allows the application of disparate procedures for processing risk assessments, the public interest is not served. In this regard, the public and Congress are entitled to ask: What are the policy implications of a non- regulatory agency-authority that in actuality, and in practical effect, "regulates" through the use of a random risk assessment process applied in an ill-defined procedural environment that offers no uniformity, no common denominators of fairness, and no uniform procedural safeguards? Despite the fact that the EPA is currently reviewing its EPA Guidelines, it nonetheless issued in mid-1990 three major documents on health effects in the form of review drafts. These documents which are the focal points of three separate risk assessment processes, are identified as follows: 2

(i) EPA Workshop Review Draft, Health Assessment Document for Diesel Emissions, EPA/600/8-90/057A, July, 1990 (hereinafter "Diesel Emissions Review Draft"); (ii) EPA Workshop Review Draft, Evaluation of the Potential Carcinogenicity of Electromagnetic Fields, EPA/600/6-90/005A, June, 1990 (hereinafter "EMF Review Draft"); and (iii) EPA Review Draft," Health Effects of Passive Smoking: Assessment of Lung Cancer in Adults and Respiratory Disorders in Children, EPA/600/6-90/006A, May, 1990 (hereinafter "ETS Review Draft"). Despite the EPA Guidelines, and despite a statutory framework which mandates fairness, objectivity, openness and uniformity, the three Review Drafts -- issued within 90 days of one another -- are the product of dramatically different approaches by the EPA. This document examines the variances and discrepancies in the EPA risk assessment process and explores the policy implications of regulation by procedural uncertainty and unfettered media campaigns.1 I. BACKGROUND EPA AUTHORITY. ORGANIZATION AND PROCESS 1. For an example of the effect of ill-advised health warnings on the public, See The Wasteful Pursuit of Zero Risk, Forbes, April 30, 1990 (Attachment 2). - 3 -

In order to implement its mandate to conduct research and gather and disseminate information under the various statutes it administers, EPA created the Office of Research and Development ("ORD") under an Assistant Administrator ("AA") who functions as the principal science advisor to the Administrator. ORD is responsible for the development, direction, and conduct of national research, development and demonstration programs in: pollution sources, fate, and health and welfare effects; pollution prevention and control; and environmental sciences and other areas. ORD also participates in the development of EPA policy and provides for the dissemination of scientific and technical knowledge [40 C.F.R. § 1.45]. The Office of Health and Environmental Assessment ("OHEA") is the principal advisor to ORD, and thus to the Administrator, on matters relating to the development of health criteria and health effects assessments and risk estimation. The OHEA is charged by federal regulation [40 C.F.R. § 1.47(e)) with developing recommendations on ORD programs (including the identification and development of alternate program goals) and with serving as an Agency health assessment advocate. In this role, OHEA often takes the lead with respect to EPA position papers concerning health issues and risk assessment. Once a position paper is prepared in OHEA, it is submitted to the EPA Science Advisory ~ ~ "final" draft by Cj Board ("SAB") for ~ 4

review. The SAB was created by Congress in the Environmental Research, Development, and Demonstration Act of 1978, 42 U.S.C. § 4365. The Act directed the EPA Administrator to establish an SAB composed of at least nine independent members who would provide scientific advice to the Administrator. The Act also directed that the SAB review proposed criteria documents and provide advice and comments to the Administrator regarding the scientific and technical bases of proposed criteria, standards, limitations or regulations. The current SAB functions as a staff office, reporting directly to the Administrator of EPA. The SAB is a federal advisory committee, and therefore is subject to provisions of the Federal Advisory Committee Act ("FACA"), 5 U.S.C. § 101 et sea., which includes the Administrative Procedures Act ("APA"), 5 U.S.C. § 500 et sea. The stated purpose of FACA is to control the advisory committee process and to open to public scrutiny the manner in which government agencies obtain advice from private individuals and groups. Public scrutiny is accomplished through public notice, open meetings and the solicitation of public comments which became part of the official record, or "public docket." FACA requires, among other things, that advisory committees be "independent" and "fairly balanced." The purpose of the SAB is to serve as a scientific and engineering peer review panel which conducts its activities in public and solicits public comment. - 5 -

The SAB is organized into an Executive Committee ("EC") and eight (8) standing committees. The EC appoints members to and coordinates scientific reviews by the standing committees. It meets four times per year to act on EPA requests for reviews, hear briefings on pertinent issues and approve final reports prior to transmittal to the Administrator. There are more than sixty (60) members of the SAB, appointed by the EPA Administrator (or Deputy Administrator) for staggered terms of one to four years. According to EPA policy, members should be independent and highly qualified. More than two hundred and fifty (250) additional scientists and engineers serve as consultants to the SAB on various issues where their expertise is relevant. There is also a staff of seventeen (17) full-time EPA employees, including a staff director. The EPA's risk assessment review process is subject to the FACA and the APA. Public scrutiny of the process should be accomplished through "open meetings," which are required by the Sunshine Act, 5 U.S.C. § 5526. The Act requires agencies to conduct their business according to numerous procedures designed to ensure public access to government information. These procedures include advance public notice of all meetings, votes when closing meetings, a written explanation of decisions to close meetings, and - 6 -

maintenance of closed meeting transcripts or minutes that the public can obtain if the transcripts do not contain exempt information. SAB open meetings are announced in the Federal Register several weeks prior to the meeting. The notices typically state the time and place of the meeting, the standing committee which will conduct the meeting, and the purpose of the meeting, solicit written comments and set out guidelines for oral presentations. If, after the review process is complete, the SAB standing committee charged with conducting a review of a draft document approves the draft, it will be forwarded to the EC for its approval. If the EC approves the draft, it is forwarded to the EPA Administrator for action. An SAB approval is advisory only and is not binding on the Administrator. Against the framework of this EPA/SAB overview, some background will be provided on the diesel, EMF and ETS Review Drafts, referenced above, which were published in mid-1990. II. BACKGROUND ON RECENT REVIEW DRAFTS A. BACKGROUND ON DRAFT DIESEL EMISSIONS REVIEW DRAFT The Diesel Emissions Review Draft characterizes cancer and non-cancer health effects of diesel vehicle emissions. N a N C+J C1I X 0) ~ N N 7

The draft covers data published since a previous EPA assessment done in 1983 which appeared in the Journal of Risk Analysis. The new data further support the conclusion of the previous assessment that diesel vehicle emissions can present a cancer hazard to humans. (The prior assessment predated EPA's adoption of a weight of the evidence classification system for carcinogens.) Under the current EPA Guidelines, the draft classifies diesel vehicle emissions as a Group B1, "probable" human carcinogen. The new data consist of epidemiologic studies, animal bioassay results, pharmacokinetic data, and data on mechanisms of action. The draft states that classification as a Group B1 carcinogen is supported by sufficient evidence in animal studies; epidemiologic studies showing a positive association between diesel exhaust exposure and cancer; mutagenicity study results; and the presence of known organic chemical carcinogens adsorbed to diesel exhaust particles. The epidemiologic data are considered "limited," which means that they support a credible scientific argument for a cause and effect relationship, but do not eliminate all possible sources of bias or confounding factors. The scientific work in the Diesel Review Draft was the subject of scientific debate and discussion at a July 18-19 workshop in Research Triangle Park, North Carolina. A notice of this - 8 -

workshop appeared in the Federal Register. Invited participants included experts from universities, government laboratories, the regulated motor vehicle industry, and public interest groups. The Health Effects Institute ("HEI") was to provide the EPA with comments on the document. After the workshop and receipt of HEI comments, EPA planned to revise the documents as needed prior to formal external peer review. The document was targeted to be presented to the EPA SAB for review before being issued by the EPA. This review has not yet been scheduled. B. BACKGROUND ON THE EMF REVIEW DRAFT This review and evaluation of the potential carcino- genicity of electromagnetic fields ('1EMF") was carried out by the OHEA within the ORD at the request of the Office of Air and Radiation ("OAR") at the EPA. The Office of Radiation Programs within OAR is responsible for the radiation protection activities of the Agency. The purpose of the EMF document is to evaluate the likelihood that exposure to nonionizing electromagnetic radiation ("NIEP42") poses a risk or is a risk factor for the development of cancer in humans. Although the entire NIEMR spectrum is of interest, the emphasis of the EPA draft EMF document is.on time- varying electric and magnetic fields in the extremely low frequency (ELF) range [approximately 3 to 3,000 Hertz) and on radiofrequency 9

radiation (approximately 0.003 to 30,000 l4Hz). These two regions of the spectrum are emphasized because they are of regulatory concern to the agency and because the preponderance of information is in these regions. The EPA stated in the review draft that the evaluation of the likelihood of human cancer risk is based on a judgment as to the overall weiaht of evidence that a carcinogenic response is causally related to specific levels or types of exposure (emphasis added). Since the establishment of causality is often difficult, the weight of the evidence approach relies on the combination of empirical observations and inferences grounded in reasonable scientific judgment. Under this approach, the evidence from human studies is considered most important, with lesser importance being attached, respectively, to chronic lifetime animal studies and to ancillary evidence, such as short-term tests of genetic toxicity, mechanistic studies, and evidence of carcinogenicity for chemical analogues to the agent under study. Accordingly, the EMF draft document considers human, animal and supporting evidence in separate chapters. As was the case with diesel emissions, EPA held a preliminary scientific workshop for the purpose of discussing EMF issues. A revised draft was prepared, incorporating the suggestions made by the panel of expert reviewers. This second draft was issued

in October, 1990, and was subsequently reviewed by a subcommittee of the SAB, January 14-16, 1991. The subcommittee plans to meet at least once more before preparing the final report. C. BACKGROUND CONCERNING THE ETS REVIEW DRAFT In the Spring of 1990, OHEA prepared a preliminary draft document dealing with health risks associated with ETS ("ETS Review Draft"). That document, among other things, stated that exposure to ETS caused up to 3,800 lung cancer deaths per year and advocated that ETS be classified as a Group A carcinogen. The document was circulated internally at EPA for review, and it was eventually "leaked" to the press in May, 1990, prior to being released to the public. The EPA also issued a press release and allowed press interviews concerning the draft report's conclusions prior to issuing the draft or making it available to members of the "regulated community" (i.e., those members of industry who would be directly affected if ETS were to become a regulated substance). A separate draft policy guide on workplace smoking ("Policy Guide Draft"), containing statements regarding the risks of ETS, based on the ETS Review Draft's conclusions, was prepared and disseminated by the EPA as a review document at the same time. Both "final" draft ETS documents were released on June 25, 1990 and ultimately assigned by EPA to the Indoor Air Quality

Committee ("IAQC") of the SAB for review. The EC of the SAB selected members of the IAQC who would review the ETS drafts.2 The IAQC held an open meeting on December 4-5, 1990, to review the EPA draft documents. Part of the purpose of the meeting was to formally receive written and oral comments from interested parties on the draft documents to aid the IAQC in its independent review process. However, due to procedural ground rules established by the IAQC Chairman at the beginning of the meeting, there was virtually no substantive debate or discourse between members of the IAQC and the public. At the end of the meeting the draft documents were, in effect, remanded to EPA for additional work. The meeting was conducted as though there was no question about the scientific foundation of the draft report and as if the basic issues in the risk assessment were already resolved.3 2. In doing so, the EC selected at least one highly visible anti- smoking advocate and several others who had previously either participated in the drafting of the report or who had reviewed and commented upon the draft report prior to its release to the public. Coincidentally, no scientists were selected by the EC who had expressed views contrary to the draft report's recommendations. This is true despite the EC's announced purpose of selecting "neutral" scientists for membership in the IAQC. 3. In addition, several scientists with critical views concerning the two draft documents were not afforded any opportunity to speak -- in contrast to the fact that nearly unlimited time was allotted at the meeting for presentation by anti-smoking organizations. - 12 -

Despite the fact that some IAQC members expressed major criticisms of the drafts at the meeting, the Chairman of the IAQC closed the meeting by stating that the panel had reached a "consensus" on the classification of ETS as a human carcinogen. This statement was affirmed by the Chairman of the IAQC to the press at a press conference called by the Chairman immediately after the meeting. As a result, he was quoted extensively in the press the next day. A. THE INABILITY OR UNWILLINGNESS OF THE EPA TO FOLLOW ITS OWN RISK ASSESSMENT GUIDELINES The authors of the ETS Review Draft clearly did not follow the EPA Guidelines for risk assessment procedures. This omission is particularly glaring when contrasted with contemporaneous EPA work in other risk assessments. Although the ETS Review Draft claims to provide a weight of the evidence analysis for ETS as outlined in the EPA Guidelines, the approach taken in the ETS Review Draft is neither comprehensive nor critical.4 4. In its April 1990 review of guideline revisions for assessment of suspected toxicants, the Environmental Health Committee of the SAB writes: "Assessing the comoleteness and aualitv of the database for a specific agent is an important part of the risk assessment process" (p.6). - 13 -

A significant number of relevant, published studies reporting no significant associations between ETS exposures and nonsmoker disease were not considered by the authors of the ETS Review Draft, including: (i) Twenty-five disease; (25) studies on childhood respiratory (ii) Thirty-five (35) studies on ETS exposures in realistic settings; (iii) Relevant toxicological data from animal inhalation studies and short term tests for mutagenicity; and (iv) Published criticisms of various studies. Additionally, the ETS Review Draft fails to provide an exposure assessment, a necessary condition for a risk assessment, according to the EPA Guidelines. The fact that no actual exposure data exist for anv of the epidemiologic studies is not addressed in the Draft.5 Confounders in the association between lung cancer 5. The SAB's ad hoc panel on dioxin (November 1989) criticized a~ Review Draft on Dioxin for just those oversights. The ad hoc ~ Panel urged the authors of the Draft to "distinguish between ~ excellent versus poor experimental data" (p.4). The panel CJ recommended that "the document distinguish between excellent CA versus poor experimental work and thorough studies versus(b (continued...) Q~ ~ ~ - 14 - ~

and ETS exposures were also disregarded. Confounders in the association between childhood respiratory disease and ETS exposures were only partially considered. The ETS Review Draft employed a method of aggregating study results (meta-analysis) which did not adjust for statistical significance, study design or study strength. Significantly, and of concern to the public, the EPA provided a quantitative risk for lung cancer which presumed causation. The ETS Review Draft relies exclusively on one kind of evidence, epidemiologic, to the exclusion of other disciplines; even so, of the 24 epidemiologic studies on spousal considered, 19 were = statistically significant. smoking The ETS Review Draft also ignores the guidance set forth in the Regulatory Program of the United States Government (April 1, 1990 - March 31, 1991) ("Regulatory Program") which provides in part: Current practice gives undue weight to studies that show positive relationships. Resulting risk classifications are thus conservatively 5.(...continued) cursory examination. Not all data should be given the same weight" (p.13). The SAB Report also notes that most of the epidemiological studies evaluated for dioxin "do not provide definitive data" and should be classified as "inconclusive, due in most cases to design limitations such as inadequate power and inadequate exposure assessment" (p.10). The Report concludes that "without good exposure data, the epidemiologic studies are meaningless." - 15 -

biased estimates derived from samples of similarly biased observations. Perhaps the most important current need in regulatory decision making is for carefully prepared and scientifically credible estimates of the likely risks involved. Decision makers at all levels need unbiased and impartial risk information so they can focus their attention on significant problems and avoid being distracted by minutiae. For policymakers and the public to continue to rely on risk assessment in the development of regulatory initiatives, a renewed effort must be made to separate science from policy and provide risk information that is both meaningful and reliable. (p.25) The Regulatory Program clearly states: Unfortunately, epidemiological research suffers from its own set of limitations. For example, retrospective studies often have difficulty correlating morbidity and mortality with exposure to specific substances. Exposure data are commonly lacking, incomplete, imprecise, or affected by systematic recall or selection biases. Furthermore, the risks these studies seek to detect are often very small relative to background, thus making statistically significant effects difficult to observe. When health effects are latent, correlating exposures to illness is even harder. Similarly, the Regulatory Program states: [S]esides these unavoidable methodological limitations, epidemiological studies often suffer from outright bias. Many studies employ scientifically questionable procedures aimed at demonstrative positive relationships between specific substances and human illness. Some researchers used inappropriate statistical - 16 -

r procedures to 'mine' existing databases in search of associations . . .6 No consideration of any of these aspects is apparent in the ETS Review Draft. A summary of scientific comments submitted to the public docket was subsequently drafted by the author of the ETS Review Draft. That summary clearly reveals many of the Review Draft's major weaknesses and deficiencies (see Attachment II). The EPA's simultaneous publication of the Policy Guide Draft and ETS Review Draft is clearly in violation of the principle of separation of risk assessment from risk management. While the Review Draft with its assumption that ETS is a carcinogen is in public review, the Policy Guide Draft has already accepted that assumption and sets out to provide guidelines for "implementing" smoking restrictions and for "strategies" to reduce exposure to smoking. (Policy Guide Draft, p. 2) Thus, the "conceptual distinction" of risk assessment and risk management is inextricably blurred in EPA's dealing with the subject of ETS. The ETS Review Draft is inconsistent with the contemporaneous EMF Review Draft released by the EPA in June 1990. The EMF Draft examined AQ epidemiologic studies and a_ll the available animal studies and short-term tests on the subject. It ~ 6. For a further analysis of the implications of science or O regulatory decision making, S.ee Countina on Science at EPA, N W 1990, and August 10 Science ACS Plenary Focuses on Risk , , Assessment, C&EN, September 3, 1990 (Attachment 3). ClI CO 01 - 17 - kQb W N

reported that the relative risks from the various studies averaged 3.0; the authors concluded that those reported risks were not compelling enough to establish EMF as a GrouR B carcinogen. The ETS Review Draft, on the other hand, looked at only 2A epidemiologic studies which reported half the increase in risk (1.41) noted in the studies on EMF, and also failed to consider pertinent animal and exposure data. The Draft nevertheless concluded that ETS J& a Grouo A ("known human") carcinogen! The unwillingness or inability of EPA to uniformly and objectively follow the EPA Guidelines is dramatically illustrated by a visual comparison of the three draft reports issued by the EPA in 1990, within 90 days of one another. Table 1 which follows is a brief comparison of the EMF and ETS reports as to adherence to the EPA's Guidelines. Table 2 is a comparison of the ETS and Diesel reports. These graphic comparisons clearly confirm that the EPA is not uniformly following the EPA Guidelines and is at best conducting regulation by random procedure. - 18 -

TABLE 1 Diesel Emissions 1. Exposure Measurement "A major difficulty with the epidemiological studies regarding exposure to diesel engine emissions was the meastuement of the actual diesel exhaust exposure. Most studies either compared persons in job categories with pnesumably some exposure to diesel exhaust to either standard populations (presumably no exposure to diesel exhaust) or with men in other job categories from industries with little or no potential for diesel exhaust exposure. A few studies have included measurements of diesel fumes, but there is no standard method for the measuremertt." 2. Strength and Consistency of Association . Animal Studies 4. EPA Draft Recommendadons TABLE 2 "Evidence for the potential carcinogenicity of diesel exhaust in humans is limited; however, a few recent studies have indicated a small but significant increased risk of hmF cancer in occupational exposed workers.' A statistically significant risk of 2.6 was reported for miners and heavy equipment operators. "Studies employing rats and an adequate experi- mental design were nearly allpositive in demon- strating diesel exhaust-inducxd increases in tumorigenicity: ' Group 111: Probable human carcinogen EMF (Electromagnetic Fields) 1. Strength of Association 'The association between cancer occurrence and exposure to either EFL or RF fields is not strong enough to constitute a proven causal relation- ship, largely because the relative risks In the publtshed reports have seldom exceeded 3.0 in both childhood residential exposure and in occupational situations:' 2 Consistency of Association and "The consistently repeated pattern of lymphoma, Statistical Significance 3. Confounding Factors 4. Animal Studies 5. EPA Draft Recommendation leukemia, nervous system cancer and lympheuna in childhood studies and the tuling out of several confounding exposure factors in the Savim et al. (1988) study argue in favor of a causal link between these tumor types in children and exposure to ELF magnetic or electric fields. However, the fact that the odds ratios are small and In many cases not statistically significant Indicates that the association may not be strong and therefore argues against a causal relatlon- Ship " "No other agents (confounding factors) have been identified to explain this association." "Both animal and in vitro studies are needed to discover the relevant exposure factors and their interaction and to gain some understanding of the mechanisms of action." No classification ETS (Environmental Tobacco Smoke) These studies compare individuals with higher ETS exposures to those with lower exposures. All of them have made observations on never-smoking married women. Those married to a smoker are assumed to be at higher exposures than those not married to a smoker. These two groups are referred to as "exposed" and "unexposed." respectively, following the established terminology. 18 out of 23 studies are not statistically significant. The EPA calculated the relative risk for ETS (via mets-analysis) to be 1.28. Animal studies attempting to elicit lung cancer as a result of ETS exposure have failed to demonstrate any significant increase in cancer. Group A Known human carcinogen ETS (Environmental Tobacco Smoke) All studies used in the meta analysis calculation have relative risks less than 3.0. The EPA calculated the relative risk for ETS (via meta- analysis) to be 128. 18 of 23 studies are not statistically significant. A number of independent risk factors (confounding factors) for lung cancer have been identified (occupation, cooking oils & diet).1'hese factors were not addressed in the Draft. Animal studies attempting to elicit lung cancer as a result of ETS exposure have failed. Group A: Known Human Carcinogen 19-20

IV. REVIEW PROCESS Because only the ETS and EMF Review Drafts have undergone SAB review at this time, this section of this analysis will focus on only these two drafts. Several aspects of the SAB review process differed greatly. These comparisons are set forth in the following sections. A. SAB COMMITTEE SELECTION PROCESS The Federal Advisory Committee Act requires that SAB members must (1) be selected by the Administrator (or Deputy Administrator) and (2) be "independent" and "highly qualified." A comparison of the contemporaneous ETS and EMF procedures illustrates that EPA's selection process is random, lacking in uniformity, and in some instances, hidden from the public. M. Questionable procedures were used by the EPA in selecting members of the IAQC for the review of the ETS Draft and Policy Guide Draft. First, the "standing" IAQC of the SAB was augmented by adding "consultants" selected in a very indiscriminate manner. The SAB requested names of candidates from a limited universe: the SAB itself, interested groups, and the EPA program offices that prepared the draft ETS documents. Then, the SAB staff responsible for coordinating the activities of the IAQC selected ~ members in discussions with the IAQC Chairman and the Executive ~ ~ Director of the SAB. Finally, after the names of the IAQC had W ~ ~ ~ ~ - 21 - W ~

been released to the public, the SAB removed and then reinstated a nationally known vocal anti-smoking advocate after objections from members of both interested groups. As reported by the press and in subsequent behind the scenes meetings, the anti-smoking advocate was removed and then reinstated by EPA within a 48-hour period. EPA, however, defended its selection procedures by insisting that it had chosen IAQC members who had not taken an advocacy position on ETS and were unbiased and objective. ME. The procedures used by the SAB to form the NIEMF subcommittee charged to review the EMF Review Draft contrasted with the methods employed in choosing members for the IAQC. The first step in the NIEMF member selection process was a decision to start with a new, impartial group of scientists, rather than to use an existing "standing" SAB committee. EPA thus appeared to be making a good faith effort to have a disinterested group review the controversial science in the EMF Review Draft and also avoided the perception that subcommittee members might have preconceived opinions about the EMF Review Draft due in part to prior ties to EPA documents or programs. Secondly, an announcement for candidates was placed in several journals requesting that individuals respond to EPA if they were interested in serving on the NIEMF Subcommittee. Names of candidates were also solicited from interested groups, the SAB and the EPA program offices. This ~ ~ ~ ~ CA process produced a list of approximately 200 candidates. Finally, ~ ~ W ~ - 22 -

the list of candidates was sent to the Radiation Advisory Committee (an SAB "standing" committee) for its assistance with the final membership selection. B. SAB COMMITTEE COMPOSITION The Federal Advisory Committee Act requires that a SAB be "independent" and "fairly balanced." LU . There was a public outcry that the IAQC was inappropriately influenced when the names of committee members were publicized. Because of the concern about conflict-of-interest, members had to publicly disclose any relationship with the tobacco industry at the Committee meeting; however, they were not required to disclose their connections with anti-smoking groups. Some members did admit financial ties to both the anti-smoking and tobacco industry. Nearly one-half of the IAQC had worked on earlier ETS reports issued by the U.S. Surgeon General and the National Research Council, some as primary authors or senior scientific editors. In fact, these members had publicly supported the conclusion of these reports. One member admitted that he had presented comments to EPA on the ETS Review Draft prior to his involvement with the IAQC. Three of the members had testified, either in court.or before Congressional committees, on behalf of anti-smoking organizations in the U.S. Over one-fourth of the ~ IAQC members admitted having received money from EPA to do specific ,~ AV co «'[ x - 23 - 0 04 W ~

ETS-related work. All of these activities suggest that at least some of the individuals who reviewed the ETS Draft had strongpreconceived opinions on the issue. ME. In sharp contrast, the composition of the NIEMF Subcommittee seems to have been consistent with EPA's own publicly stated goal of obtaining technically sound advice from knowledgeable experts who are free from legal and perceived conflict of interest. At the NIEMF Subcommittee meeting, the Subcommittee members were not specifically asked to disclose their ties to the electric power industry; instead, EPA staff explained in great detail their efforts to select members who were fairly balanced in terms of points of view represented. Nevertheless, some Subcommittee members reported that they had received research funding from the Electric Power Research Institute or from EPA; their statements were not nearly as detailed as those of the IAQC. C. USE OF SCIENTIFIC WORKSHOPS There is no requirement that scientific workshops be held as part of the assessment process, but it is common practice and it adds significantly to the credibility of the process. In addition, in areas in which there is scientific debate, a workshop helps to objectively focus the process to better serve the public interest. - 24 -

~„S. In July 1990 the tobacco industry requested that EPA hold a workshop to provide scientists and the public with a forum to discuss the complex scientific issues concerning ETS. In an October 12, 1990 letter to the industry, EPA asserted that a workshop would not illuminate the "appropriate" path to take in addressing the issue, even though it was the first time EPA was taking a comprehensive look at the ETS data. The rationale for denial of the workshop was that there had been earlier comprehensive reports by the National Research Council (1986) and the U.S. Surgeon General (1986). In its denial letter(s), EPA also stated that even though it was. adding recent data and extending analyses of the same body of data, a thorough review by EPA staff and their choice of outside experts prior to obtaining SAB and public comments would suffice as a sufficient peer review. ZU. An expert review workshop was held on June 28, 1990 in Morrisville, North Carolina. The public was allowed to observe and note the scientific issues as they were being debated. In addition, a second NIEMF subcommittee meeting will occur sometime in March/April 1991, at which the EMF Review Draft will undergo further review by additional scientific committees before revisions are made to the Committee within the White House Office of Science and Technology Policy established for the sole purpose of reviewing this document. The interagency Committee on Interagency Radiation Research and Policy Coordination -25- ("CIRRPC")

will also review the EMF Review Draft and provide EPA with its comments. The public will be advised and invited to these scientific deliberations. D. SUBMISSION OF WRITTEN PUBLIC COMMENTS EPA's established policy is that the public be given an opportunity to comment by submitting written statements to a public docket for all risk assessments prepared by the Agency. The procedures for public comment were not uniformly applied for the ETS and EMF Drafts, and there is no guarantee that the comments will be considered, or even read by the SAB. En. There were over 235 public comments submitted to the public docket during the review of the draft ETS documents. These comments represented over 7000 pages. Summaries of the public comments were prepared by the two EPA program offices that prepared the draft documents. The summary of comments on the ETS Draft (seg Attachment II) underscores major substantive problems with the risk assessment. Yet, on the second day of the SAB open meeting, the Chairman announced that the SAB had reached a consensus about the ETS Draft, even though several SAB members had not reviewed the public record and two members had missed the first meeting day. The "consensus" announced by the Chairman bore no resemblance to the EPA summary or to the comments submitted to the public ~ ~ ~ ~ ~ ~ W ~ - 26 -

record; EPA may effectively ignore the substance of these comments in its deliberations. ME. The public comment period for the EMF Review Draft has not yet been initiated. The EMF Review Draft process began with the expert workshop, then proceeded with SAB review in an "open" public meeting. The "official" public comment period begins after several scientific groups have had the opportunity to review and comment on the draft document. The nineteen "public commentors" that addressed the NIEMF Subcommittee meeting will have their presentations and comments placed in the public docket once the docket is opened. E. ADVANCE NOTICE OF COMMITTEE MEETINGS EPA policy is to provide advance notice to the public of all "open meetings" of the SAB or a subcommittee thereof in order to allow effective public participation. Unfortunately, even a routine matter such as a notice may be handled without uniformity. EM. EPA gave the public two workdays' notice to meet the deadline for letting the agency know whether they were attending and presenting at the IAQC meeting. The notice was published in the Federal Register on November 22, 1990, the day before Thanksgiving. Members of the public were told to respond by - 27 -

November 27 if they wanted time to speak before the IAQC. Between the notice time and the IAQC meeting were eight workdays and four weekend days. Ea. There was at least 30 days' notice of the meeting date of the NIEMF Subcommittee. F. SAB COMMITTEE MEMBERS STATED POSITIONS ON THE SUBJECT The Federal Advisory Committee Act requires that SAB members must be "independent" and the SAB must be "fairly balanced, " in terms of views expressed. Because the SAB is a peer review panel, one could expect its meetings to include discussion among its members and with public commentors; however, this is not always the case. ~S. During the IAQC meeting there was virtually no interchange among committee members during their review of the draft documents. Committee members presented fairly formal reports which had obviously been prepared in advance of the meeting, yet, several members stated that they had not had a chance to review all the public comment on the ETS draft documents. This gave a strong impression that the committee members came to the meeting having already formed conclusions, regardless of any debate or information presented by the public commentors. Additionally, there was limited discussion by the IAQC members with the scientists - 28 -

who presented their findings and views on the draft documents. Some of the members' responses to the Chairman's questioning seemed to be critical of the drafting of the documents rather than an agreement or consensus of the conclusions of the members. =. The NIEMF Subcommittee members reviewing the draft EMF document interacted extensively with the scientists presenting their views at the NIEMF meeting. There was significant interchange of information among the public presenters, the EPA staff authors, and the Subcommittee members. Subcommittee members did not present reports on the EMF document. In general, discussion did not focus on the Subcommittee members' views, but on the pertinent scientific issues relevant to the EMF document. The public was encouraged to ask questions of the presenters and the Subcommittee members. G. SCHEDULING OF SCIENCE ADVISORY BOARD MEETINGS Because there is no set policy with respect to the length or duration of SAB "open meetings," the meetings, in practical import, may become a procedural vehicle for the SAB Chairman to direct the review process. EM. The IAQC met for less than two full days to discuss the complex scientific foundation of the two draft ETS documents. Of the time allotted, four hours were devoted to public comment by twenty-six public commentors. Each public commentor was given -29-

approximately nine minutes.in which to make his pertinent points on the science of the ETS draft documents. No attempt was made to. allocate time according to the needs of the speakers or the scientific content of the comments. Moreover, the IAQC Chairman denied a request by several members of the public to extend the amount of meeting time apportioned to public comment, even though the IAQC meeting ended early. Virtually no opportunity was provided for interaction between IAQC members and the assembled experts. No second phase of meetings was contemplated. ZU. The initial NIEMF Subcommittee meeting was scheduled over a three-day period. Approximately seven hours of public comment was scheduled for nineteen "public commentors." Each presenter was asked prior to the meeting by the NIEMF staff how much time he needed for his presentation. Each presenter was allowed anywhere from 15 minutes to 45 minutes; the average was approximately 22 minutes. In addition, time was granted for each presenter to respond to comments and questions from the Subcommittee and audience. Opportunities were provided for extensive discussion among committee members, the audience and the presenters. A second round of meetings is also contemplated. H. PUBLIC COMMENT DURING COMMITTEE MEETINGS O One of the primary purposes of an "open meeting" is toCN solicit the views of the public and other interested parties. ~ ~ ~ ~ - 30 - W

M. Three scientists with views critical of the two draft ETS documents were denied time by the IAQC chairman to make their prepared statements at the meeting. In general, po accommodations were made for the presenters. The IAQC staff divided the time allowed for public comment into four periods: Period I: Tobacco Industry; Period II: Coalition on Smoking and Health; Period III: General Comments, and Period IV: General Comments. Although the third and fourth periods were labeled "general", anti- smoking advocates were allowed to make their presentations during these time periods while the tobacco industry was restricted to Period I. By the end of the meeting the tobacco industry had used approximately 90 minutes for its presentation while the anti-smoking group's periods totalled approximately 150 minutes. LU . The meeting was planned and organized to allow ample time for scientists and members of the public to speak, with the result that there was more than sufficient time for all qualified scientists who wished to speak. The Chairman adjusted the meeting schedule to accommodate speakers, including re- allocating time allotted for Subcommittee deliberations as additional time for speakers. She also allowed an unscheduled speaker to present a comment.

I. QUESTIONS, DISCUSSION AND SCIENTIFIC DEBATE AT THE SAB MEETING The EPA policy is to conduct "open meetings" so as to maximize interaction between committee members and the public. Presumably, the public interest is served by scientific questioning in such meetings. ~. There was no effort to allow any meaningful scientific discussion and debate at the IAQC meeting even though experts on both sides of the issue were present. One of the presentations not heard pertained to an extremely important scientific question which the IAQC was specifically asked to address by the EPA program offices. The IAQC Chairman denied the request and the presentation was not permitted, even though the scientist was present, and there was ample time on the schedule to permit the presentation to be made. There was limited interchange between the members, the presenters and the public. During the entire meeting there were virtually no questions addressed to the group of eleven highly respected experts that composed the tobacco industry panel. These scientists exemplified expertise in epidemiology, risk assessment, statistics and ETS. ME. There was extensive, straightforward discussion at ~ the NIEMF Subcommittee meeting. The Subcommittee repeatedly asked to the public for their comments during the meeting. The public ~ comments and questions clearly fostered scientific debate of the ~ - 32 -

issues and presented thought-provoking challenges for the Subcommittee members. The Subcommittee Chairman's flexibility with regard to the public's questions and the questions of her own Subcommittee members contributed to the process of allowing full public participation. The frankness of the public discussion also supports the impression that there was room for further work on the issue and that there were no predetermined opinions or consensus of the Subcommittee. V. REPORT PREPARATION: SAB ACTIVITIES FOLLOWING THE PUBLIC MEETING It is EPA policy that the SAB review process be.a "credible" and "objective" process. These requirements should carry over into the report preparation stage. ETS. The December IAQC meeting is the only public/scientific meeting to date on the review of the two ETS draft documents. At the end of the IAQC meeting, the members of the Committee were given specific writing assignments relative to the IAQC report. The decision on writing assignments was made outside of the public eye; when asked for the assignments, IAQC staff said they could not give the public assignment information. The individual reports will be compiled into an overall IAQC report; when complete, the Committee will present the written findings to the SAB Executive Committee. Plans now call for the presentation - 33 -

l of the IAQC findings at the April 1991 meeting of the SAB Executive Committee, whose members will be given the opportunity to review the report, present their opinions, and formally approve the IAQC report prior to transmittal to the Administrator of the EPA. The public has been told that the draft IAQC documents and the Committee deliberations during conference calls will not be available to the public. ME. There were at least four public/scientific meetings to review the public comments on the draft and revised EMF documents. At the conclusion of the January NIEMF meeting, the Chairman reported that the Subcommittee had divided into three groups, whose purpose she characterized as "fact-finding." This decision gave the distinct impression that the Subcommittee would actively seek all pertinent information on EMF topics, and that it was not ready to prepare any conclusive report at this time. The three groups (whose membership was made known by the Chairwoman) were to prepare brief reports, and the Subcommittee would discuss them at the next meeting. Also, there will be telephone conferences between the Subcommittee members as they complete their review. There are regularly scheduled telephone conference calls between the NIEMF staff and the general public wishing to ask questions on the process and review of the draft EMF documents. - 34 -

VI. EPA'S CONTROL OF PRESS COVERAGE AS A REGULATORY_TOOL• The stated EPA press policy is conservative but the Agency has historically been plagued by unauthorized leaks and uncoordinated press releases. EPA's randomly applied press procedures effectively allow EPA to use the press to further its regulatory objectives. M. Three scientists of well-known stature asked the IAQC Chairman for an opportunity to present their views but were denied this request. Despite this, the meeting adjourned ahead of schedule. The Chairman's rush to adjourn the IAQC meeting may have been due in part to the fact that the EPA had called a press conference in the same room where the IAQC was meeting. When the press began arriving for the press conference prior to the adjournment of the meeting, it was obvious that the reporters had been given a specific time for the press conference in order to meet their 5:00 p.m. press deadlines. This attention to press coverage overrode the opportunity for additional scientific discussion. At the press conference the IAQC Chairman reported that the IAQC had reached a "consensus," even though contrary positions were stated throughout the meeting by IAQC members. The IAQC Chairman's statements that a consensus had been reached were particularly surprising because two IAQC members were absent one N O N W C1l ~ ~ ~ X {v - 35 -

of the two days of the committee (during the public comment) and one IAQC member was absent throughout the entire two-day meeting. ZME. The NIEMF Subcommittee meeting also adjourned ahead of schedule; however, it did not appear that there was any reason for this, except that the committee had covered the issues it wished to discuss. At the summary session of the Subcommittee meeting the Chairman once again allowed the public the opportunity to present summary comments. Although reporters were present, she then adjourned the meeting with no press conference, even though EMF is also a highly visible and controversial subject and of at least as much public concern as ETS. VII. POLICY IMPLICATIONS OF EPA'S VARYING STANDARDS FOR CONDUCTING RISK ASSESSMENTS The EPA's review procedures for the draft documents relating to health risks from ETS suggest that EPA began the review process as an advocate. Unlike the process mandated by federal statutes and regulations, which focuses on information gathering, research, and critical analysis, the procedural evidence indicates that, in the case of ETS, the EPA concluded first that ETS was an evil which required regulation and then designed a process which would proceed unfailingly to the preordained conclusion. In the process, EPA circumvented the letter and spirit of its own - 36 -

procedural requirements and may have violated provisions of the Federal Advisory Committee Act and the Administrative Procedures Act. These practical realities are underscored by a comparison of EPA's review process as it has been applied to ETS and EMF, respectively. If the EPA acts at all in these areas it ought to be able to act only in an objective, fair, uniform and procedurally sound manner. Above all, the public interest must be served via open, public processes that remain at all times fair and objective. Otherwise, the public will find that government regulation has made intrusions into areas of private life with no credible foundation. Many of the policy implications of the EPA's actions are reflected in the EPA's risk assessment procedures relating to EMF, Diesel, and ETS. Consider, for example: 1. REGULATION BY RANDOM PROCEDURE. If the EPA publishes three health assessments within a period of 90 days, the public interest demands that the same risk assessment guidelines be applied in the same manner and that the same review procedures be applied to the draft documents. If the EPA does not so conduct itself, what are the implications for industries that may eventually become the focus of an EPA risk assessment driven by a "hidden agenda"? - 37 -

How can an industry or the public possibly be put on notice as to EPA's guidelines and procedures for risk assessment if these change on a case-by-case basis? 2. RISK ASSESSMENTS BEFORE REVISED GUIDELINES. Why is the EPA pushing ahead with three major health assessments when the EPA's own risk assessment guidelines are due to come under review, scrutiny and study with an eye toward possible changes? In addition, the EPA's own Science Advisory Board has indicated that the EPA should refocus its efforts on the greatest risks. The activities of 1990 reveal no attempt at comparative evaluation of risks. Why is EPA launching a comprehensive health risk study when the risk assessment guidelines are under review? The EPA has begun work to assess the health risks of the 189 hazardous air pollutants listed in the new Clean Air Act that may overhaul the agency's entire cancer risk assessment approach. The SAB is taking the lead in developing these health risk profiles and will follow the agency's priorities by studying those chemicals included in source categories established by the agency's maximum achievable control technology standards. The categories are established to address those pollutants assessed by the agency to be most prevalent. The SAB also is awaiting the findings of an ongoing N National Academy of Sciences ("NAS") study on EPA's current air ~ toxics exposure and risk assessment methodology -- used to CJ determine cancer and non-cancer risks. NAS is considering the ~ O;b V1 - 38 -

techniques used for describing and estimating the carcinogenic potency to humans of hazardous air pollutants. EPA sources note that the study's findings may force changes to the EPA guidelines. The SAB report, due to EPA by April 1993, details recommendations for emission control based on scientific advances and new data. The study will begin in March, with oversight by the committee on risk assessment methodology, an EPA-sponsored group set up by the NAS Board on Environmental Studies & Toxicology. The SAB also has asked its Clean Air Scientific Advisory Committee ("CASAC") to conduct a study of residual risks after installation of maximum achievable control technology. The study would use new data on the mechanisms of action of specific compounds -- particularly butadiene, ethylene oxide and formaldehyde, according to a CASAC official. The SAB has asked for a CASAC member to join the Clean Air Act Advisory Committee, providing linkage among the different groups. 3. Why is the EPA conducting a risk assessment at this juncture when the EPA currently has no statutory authority to regulate ETS or any form of indoor air pollution?7 7. Pursuant to Title IV of the Superfund Amendments and Re- Authorization Act of 1986 [codified as a free standing law entitled the Radon Gas and Indoor Air Quality Research Act of 1986, 42 U.S.C. § 7401, note] EPA was required to develop a radon gas and indoor air quality research program which would gather data and information on all aspects of indoor air quality, coordinate federal and other programs relating to improvement of indoor air quality, and assess appropriate (continued...) - 39 -

In contrast, OSHA, which does have authority to regulate health and safety matters in the workplace, will issue a Request for Information on Indoor Air in 1991. In this posture, the public is also entitled to know why the EPA has committed already scarce resources to the preparation of a Workplace Smoking Policy Guide (i) before the risk assessment upon which it is based is even reviewed, much less finalized, and (ii) before OSHA has undertaken regulatory information gathering, much less review in the area. If the EPA does not follow uniform, standardized procedures, documents such as the Workplace Smoking Policy Guide can be generated with impunity by the EPA as a part of "health assessments." 4. The EPA's arbitrary, random application of risk assessment guidelines and review procedures allows the EPA to "regulate" through the media. Inside EPA reported on November 9, 1990 as follows: 7.(...continued) - federal actions to mitigate environmental and health risks associated with indoor air quality problems. The Act requires EPA's program to conduct research relating to the effects of indoor air pollution on human health and to disseminate information to the public [Section 403]. The Act specifically bars EPA from regulating indoor air pollution or from any other activity with respect to indoor air pollution other than research, development, and related reporting, information dissemination and coordination activities [Section 404). -40-

A number of scientists have bluntly criticized EPA's office of radiation programs for exaggerating the risks posed by indoor radon exposure and using scare tactics to frighten the public into conducting radon tests on their houses. The criticisms call into question the agency's risk assessment procedure for radon at a time when the drinking water office is also undergoing a lashing by scientists for its poor radiation risk assessment (Inside Zg$, Nov. 2, p. 4). It also raises questions about the agency's ability to realistically communicate risks despite the professed agency goal of better informing the public about actual environmental threats. EPA sources defended the agency's efforts as a way to overcome public apathy concerning what the agency regards as one of the greatest causes of lung cancer each year. The issue centers on EPA's draft 'Citizens' gt~ Wp to radon: don't let this dangerous intruder invade your home,' scheduled to be issued in final form next year, which contains highly emotional language intended to catch the public's attention about the threat of radon in the home. In a Sept. 20 letter to EPA, Anthony Nero, senior scientist for the indoor environment program at the Lawrence Berkeley Laboratory, castigates the agency's use of emotional 'motivational language' to spur public action on radon as little more than a euphemism for misrepresentation and obfuscation.' Similarly, in a Sept. 24 letter to EPA, Nobel Laureate Rosalyn Yalow, a senior medical investigator at the Veteran Affairs Dept., describes the draft guide as 'a clever example of deceptive advertising and a distortion of scientific fact.' Specifically, Nero takes issue with EPA's statement in its draft that 'this intruder is a problem in 1 out of every 5 homes.' The data which are the basis for EPA's statement are not indicative of exposure, however, and are merely 'screening' measurements, Nero says. Yet EPA improperly has used the data to indicate the size of the radon problem overall and to - 41 -

suggest the number of homes at risk. Rather than 1 in 5 homes 'having a problem,' the best data suggest 1 in 15 have a problem, 'assuming that 4 picocuries/liter (pCi/L) is the reference level of concern,' Nero writes. Rather than continue to misrepresent the issue, EPA has a responsibility to remedy the current prevailing misconceptions on this matter on the part of the media, the public, and policy makers,' Nero adds, pointing out that EPA has largely generated the misconceptions. Yalow echoes those views, and questions whether the 4 pCi/L level is an appropriate level of concern based on recent studies. An agency official says that the 1 in 5 figure was a typographical error; the figure should be 1 in 10, based on a preliminary results of a national survey to confirm the value. The source comments that Yalow doesn't believe radon is a problem at all, except for smokers, a view which the agency rejects as invalid. Nero disputes EPA's claim that about 20,000 lung cancer deaths per year are caused by radon, setting the figure closer to 15,000, the agency source says, commenting that EPA and Nero are in agreement that radon is ' not a trivial risk. ' The source also explains that the thrust of EPA's draft, which was circulated to 600 people for comments, was 'to give people motivation' to test their homes and if a problem is found to remediate it. That can't be done with a bland document, the source says. The State of Connecticut's department of health services, in an Oct. 1 letter to EPA's Region I radon office, also defends the agency's language, noting that the Ad Council, representing advertising professionals, had made persuasive arguments in favor of more emotional versus informational language to convey EPA's message to the public. EPA's 1986 citizens' radon guidance made analogies between 4 pCi/L exposures and smoking ten cigarettes a day, a comparison Nero finds totally inappropriate and describes as a misleading means of terrorizing the public. Although the new draft drops the smoking comparison, it uses an 'equally insidious one' that says having radon in one's home 'is like - 42 -

exposing your family to hundreds of chest x- rays a year.' The comparison 'exaggerates and distorts reality, a tendency that simply has to be stopped in the EPA's radon program,' Nero complains. 'The Scientific community continues to be dumfounded' by EPA's focus on 'average' radon levels, Nero notes, one of several references to broad scientific concern about the program's direction. The agency should be focussing on houses with radon levels much higher than the average, an almost universal consensus among scientists, Nero says. An EPA official, puzzled by the criticism, says the agency is targeting states for 'outreach' where over 100,000 homes are estimated to have a higher than 4 pCi/L radon level. The source believes that some scientific opposition is prompted by radiation scientists' fear that EPA's efforts to arouse public concern over radon could spill over into broader concern about x-rays, nuclear power, and other uses of radiation that such scientists consider beneficial. EPA's guidance will incorporate concerns of those scientists 'where appropriate' but will also draw upon EPA's Science Advisory Board and the National Academy of Sciences, who have provided the risk estimates EPA is relying on in`sounding the alarm over radon, the source says.8 CONCLUSION From the discussion set forth herein, it is clear that the EPA has failed to follow its own risk assessment guidelines in conducting a review of the ETS draft documents. This is so despite evidence which suggests that in performing other risk assessments simultaneously, the EPA apparently followed those guidelines to N the letter. This inconsistency is not explained by any statutory, O N 8. See also Where There's Smoke. There's Politics, Washington C.J ~ Times, July 2, 1990 (Attachment 4). ~ ~ CA

regulatory, policy or other objective standard. It can only be explained by the hypothesis that, in the case of ETS, EPA has a "hidden agenda" which drives the risk assessment process. For the regulated community, this means that government regulation of ETS may be a fact before an effective legal challenge can be initiated even though such regulations may be based upon speculation, extrapolation and just "bad science." There is clearly a strong need for consistency and uniformity in the risk assessment process, if for no other reason than that the process often leads to pervasive, intrusive regulation. EPA, as an Agency, has been unreceptive to these arguments. Aggressive Congressional oversight of the EPA's exercise of its statutory authority to conduct research and gather and disseminate information is clearly called for.9 9. A good recent example of the harm that can be caused the public and the regulated community by EPA risk assessments that "shoot from the hip" is the controversy over radon. Critics contend that the EPA failed to consider pertinent scientific information on radon exposures. One commentator recently noted: However, there is still debate in the scientific literature over the extent of the risk to public health from levels of radon typically found in homes. The EPA appears to dismiss any other study that claims different risk estimates from its own. [Ethier, How Useful is EPA Guide?, Indoor Pollution Law Report 4(6): November 1990.] (Attachment 5). 10353715 - 44 -

1. GLOSSARY 2. The Wasteful Pursuit of Zero Risk, Forbes, April 30, 1990 3., Countina on Science at EPA, Science, August 10, 1990, and ACS Plenary Focuses on Risk Assessment, C&EN, September 3, 1990 4. Where There's Smoke. There's Politics, Washington Times, July 2, 1990 5. Ethier, How Useful is EPA Guide?, Indoor Pollution Law Report 4(6), November 1990