Tobacco Documents Online

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF NORTH CAROLINA WINSTON-SALEM DIVISION ) FLUE-CURED TOBACCO COOPERATIVE ) STABILIZATION CORPORATION, et al., ) ) Plaintiffs, ) ) v. ) Civil Action No. 6:93CV370 ) UNITED STATES ENVIRONMENTAL ) PROTECTION AGENCY, et al., ) ) Def endants . ) ) ) DECLARATION OF LARRY R. GLASS, PH.D. I, LARRY R. GLASS, declare that the following statements are true and correct to the best of my knowledge and belief. 1. I am a professional toxicologist currently employed by Occidental Chemical Corporation. I received my Ph.D. in toxicology from the University of Texas in 1987. Beginning in graduate school and throughout my professional career, I have focused primarily on the subject of risk assessment, by which I mean the evaluation of health effects possibly associated with exposure to chemical agents in the environment. curriculum vitae is attached as Exhibit A. A copy of my ~ c.~ w> ~ ~ - 1 - ~ Ck~

2. From January, 1989 until July, 1990, I was employed by the Environmental Protection Agency (EPA) in Cincinnati, Ohio as a Toxicologist in the Chemical Mixtures Assessment Branch of the Environmental Criteria and Assessment Office (ECAO) of the Office of Health and Environmental Assessment (OHEA) within EPA's Office of Research and Development (ORD). 3. The mission of OHEA is to serve as EPA's focal point for the scientific assessment of the degree of risks imposed by environmental pollutants in varying exposure situations on human health and ecological systems. As an organizational group within OHEA, the Cincinnati office of ECAO (ECAO-CIN) was responsible for reviewing health and hazard assessment documents on air and water pollution and solid and hazardous wastes. 4. In my capacity as ECAO-CIN Toxicologist, I reviewed approximately 25 risk assessment documents developed within EPA. In general, my responsibility was to review, analyze and critique EPA risk assessments in accordance with applicable scientific principles and EPA's guidelines. Following my review of a risk assessment document, I would provide written comments within for the purpose of promoting the scientific quality and consistency of EPA's risk assessments. EPA 5. In April 1990, I was asked to review EPA's draft risk ~ O ~ assessment on environmental tobacco smoke (ETS). The draft risk p~ C5t - 2 - ~ C ~ 00

assessment was then entitled "Lung Cancer Hazards and Other Respiratory Effects Due to Exposure to Environmental Tobacco Smoke." After carefully reviewing the draft risk assessment, I prepared a review memorandum. After review and approval by my superior, it was forwarded on behalf of our office to William H. Farland, Director of OHEA, on April 27, 1990. Copies of my superior's forwarding memorandum, my critique, and the critique of my colleague Richard C. Hertzberg, are attached as Exhibit B. 6. As set out in my critique, and as reflected in my superior's forwarding memorandum, I concluded that the draft ETS risk assessment could not properly be used as the basis to classify ETS as a Group A carcinogen for a number of reasons including the following: (a) Under EPA's guidelines, the epidemiological evidence for establishing a causal association between exposure to ETS and lung cancer was too limited to support the Group A classification. (b) In addition, I was concerned about (i) the use of a controversial and novel approach, called "meta-analysis, overcome the inherent limitations in the available epidemiological data, and (ii) the draft's unsubstantiated generalizations regarding the composition and physicochemical properties of ETS relative to mainstream smoke. to - 3 -

(c) I also identified a number of other problems with the draft risk assessment regarding study design, methodology, and interpretation of results. Because of the problems that I identified, I recommended that EPA follow its guidelines and summarize the data as "limited" and not classify ETS as a Group A carcinogen. Based on my experience in reviewing EPA's risk assessment on Electromagnetic Fields (EMF), and other risk assessments with relatively weak epidemiologic evidence, I did not believe EPA could properly single out ETS for a Group A classification based on much weaker epidemiologic evidence. 7. Because of the problems with the draft risk assessment, ECAO-CIN officially recommended that it was only "Acceptable after major revision." In addition, my superior's forwarding memorandum to William Farland stated that "we [ECAO-CIN] question the use of meta-analysis to support the classification as a weight-of-evidence Group A carcinogen ...." It also expressed "our concern with the classification of ETS as a Group A carcinogen" and concluded by stating that ECAO-CIN was "most interested in discussing our comments" with Dr. Farland in more detail. 8. To my knowledge, no such discussion ever took place. ~ Instead, I was called by Steven Bayard, the ETS Project Manager O ~ - 4 - C3~ Oo ~ ~ O

is Washington. Dr. Bayard had overall responsibility for the ETS risk assessment report and its conclusions. Dr. Bayard did not address my substantive analysis of the ETS draft. Rather, he seemed annoyed and questioned my audacity to challenge EPA's conclusions on ETS. 9. In 1992, my former office within EPA was asked to review another draft of the ETS risk assessment ("Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders," EPA/600/6-90/006B). Copies of the ECAO-CIN review memoranda are attached as Exhibit C. Although the ECAO-CIN reviewers complained about being rushed by Washington, their critique of the 1992 draft ETS risk assessment echoed the concerns I expressed in 1990. For example, in addition to being concerned about the unexplained exclusion of some studies and inclusions of others, the EPA reviewer wrote that: ... the case for a clear causal relationship between lung cancer and ETS is somewhat overstated. With respect to EPA's continued use of "meta-analysis," the EPA reviewer wrote that: This might be better titled REinterpretation of studies based on REanalysis of published data. Meta-analysis is repeatedly alluded to but it is never clearly stated what the purpose and form of this data reanalysis really is. * * * - 5 -

It is unclear what the objective of the analysis is because it is never stated. When transmitting to Washington its views of the 1992 draft ETS risk assessment, the EPA office in Cincinnati again refused to recommend an "Acceptable" rating; and in his March 24, 1992 forwarding memorandum, the Director of ECAO-CIN advised Washington that the final ETS risk assessment should set forth: ... a full discussion of carcinogen category A vs. B, based on the absence of definitive data of [ETS] in humans. Like it or not, EPA should live within its own categorization framework or clearly explain why we chose not to do so. 10. I have reviewed EPA's final risk assessment on ETS, "Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders." The document fails to address, and does not correct, the major concerns that ECAO-CIN and I expressed on the drafts. I do not know whether EPA has any information outside of the document that responds to our concerns. I believe some office within EPA must have some information analyzing the major problems with the risk assessment, including the following examples: (a) Group A versus Group B. EPA's guidelines for risk assessment provide criteria for classifying substances in different carcinogen categories depending on how much human data is available. There is no analysis in the final ETS document as to whether Group A versus Group B, for example, - 6 -

is the proper classification category for ETS despite the fact that this issue was raised on two occasions by ECAO-CIN because of the weak epidemiological data and the limited human evidence of ETS' carcinogenicity. (b) Meta-analysis. The ETS risk assessment does not explain how EPA performed its "meta-analysis" even though the issue was raised on two occasions by ECAO-CIN. (c) Strength of Association. In standard risk assessment practice, a relative risk of under 1.5 is usually not considered evidence of a causal relationship. The final risk assessment does not explain how EPA could consider a relative risk of 1.19 supportive of its Group A classification. (d) Analogy to Mainstream Smoking. EPA relies on an analogy to data on mainstream smoking to build a case for the biological plausibility of concluding that ETS is a lung carcinogen. However, EPA does not explain that "biological plausibility" is not sufficient to classify a substance as a Group A carcinogen. (e) Confidence Interval. In addition, standard scientific practice relies on a statistical confidence level of 95%. In the final ETS risk assessment, EPA does not explain why it lowered the confidence level to 90% compared to the 95% level used in the draft document. - 7 -

11. In sum, the final EPA risk assessment on ETS raises numerous important questions about how EPA could justify a Group A classification under EPA's own guidelines and as a matter of good science. Pursuant to 28 U.S.C. §1746, I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge and belief. Signed this '^ I day of 0, ( y"'e/<, 1994. I:\USERS\ACR\41P\MISC\ETSGLASS . las F4-