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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