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TRANSCRIPT OF PROCEEDINGS IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT ACTION ON SMOKING AND HEALTH, Petitioner, --vs-- U.S. DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, et al., Resspondents. No. 89-1656 Pages 1 thru 20 Washington, D.C. May 6, 1991 MILLER REPORTING COMPANY, INC. 507 C Street. N.E. Washington, D.C. 20002 546-6666

1 T504 IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT ACTION ON SMOKING AND HEALTH, Petitioner, . V. U.S. DEPARTMENT OF LABOR, . OCCUPATIONAL SAFETY AND HEALTH . ADMINISTRATION, et al., . No. 89-1656 Respondents. . Monday, May 6, 1991 Washington, D.C. The above-entitled matter came on for oral argument, pursuant to notice, at 9:30 a.m. BEFORE: j CIRCUIT JUDGES RUTH B. GINSBURG, SILBERMAN and j ~ D.H. GINSBURG ~ APPEARANCES: ~ ~ ATHENA R. TAYLOR-CARROLL de MUELLER, ESQ., ~ 2013 H Street, N.W., Washington, D.C. 20006; on behalf of Petitioner CHARLES F. JAMES, ESQ., Office of the Solicitor, U.S. Department of Labor, 200 Constitution Avenue, N.W., Washington, D.C. 20210; on behalf of the Respondents MRLER REPORTING CO., INC. 507 C Street. N.E. Washington. D.C. 20002 (202) 546-6666

2 Jt i C O N T E N T S ORAL ARGUMENT OF: PAGE Athena R. Taylor-Carroll de Mueller, Esq., on behalf of Petitioner 3j I Charles F. James, Esq., on behalf of Respondents 11 1 ~ ~ Athena R. Taylor-Carroll de Mueller, Esq., on behalf of Petitioner -- Rebuttal 19 I MILLER REPORTING CO.. INC. 507 C Street. N.E. Washington. D.C. 20002 (202) 546•6666

jt 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MILLER REPORTINQ CO., INC. 507 C Scceet. N.E. Wuhiagcon. D.C. 20002 (202) 546-6666 3 P R 0 C E E D I N G S THE CLERK: No. 89-1656, Action on Smoking and ~ Health, Petitioner v. The Occupational Safety and Health ~ Administration, Department of Labor, Secretary of Labor, and I the Honorable Alan C. McMillan, Acting Assistant Secretary ofi I Labor for Occupational Safety and Health. ~ Athena R. Taylor-Carroll de Mueller, Esq., for ~ I petitioner; and Charles F. James, Esq., for respondents. i THE COURT: Ms. Mueller, please proceed. I ORAL ARGUMENT OF ATHENA R. TAYLOR-CARROLL de MUELLER, ESQ., I i ON BEHALF OF PETITIONER MS. MUELLER: May it please the Court: My name is ; ~ Athena Mueller. I am representing Action on Smoking and i ~ Health, and today I am deputizing for John Banzhaf, who has I often appearing before this Court before on mattes relating to smoking and health. This is a petition for review of a determination of the Occupational Safety and Health Administration, in response to a ASH citizen petition asking for an emergency temporary standard to regulate tobacco smoke in the workplace. Alternatively, we would like to have had any other remedy which would alleviated this rather serious condition. i

jt 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MIILER-REPONTiNO CO., INC. 507 C Srreer, N.E. Washingron. D.C. 20002 (202) 546•6666 4 The petition was also filed initialled on the 6th of, i May by the Public Citizens Research Group and also by the Medical Public Health Association, also requesting an emergency temporary standard, and there the agency also refused their petition, but they are not proceeding in this matter. ~ ~ Basically, the core of ASH's case is that the ~ agency has not proceeded on the basis of substantial evidencei in the record considered as a whole. Your Honors, I am not I proposing to reiterate arguments in the briefs, but there arei three points I would particularly like to bring your attentioni . i to. ~ Basically, the ASH case rests on the OSHA statute, section 655(c), regulating with regard to an emergency temporary standard, and there are three elements there: i First, the agency must determine that there is a i toxic substance present in the workplace; secondly, it must be considered whether this is, in fact, a danger to employees; and, thirdly, it must be decided whether a standard is going to be necessary to remedy this position. With your permission, I-would like to consider these points, briefly:

jt 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 M0.lER REPORTING CO.. INC. 507 C Screec. N.E. Washingcon, D.C. 20002 (202) 546•6666 5 First, the question of toxic substance, the record 2~ is replete with examples of research which has considered 3~ --his question, and which has found this very complex subject to contain many, many different types of toxins. There are ~ i 3,000 compounds in tobacco smoke alone, and some of these, ~ ~ such as benzine, carbon monoxide, ethylene oxide, are all ; I toxic in their own right, but when you have them mixed j together, they become an extremely deadly cocktail, if one can say that, which people in the workplace are having to i imbibe constantly. j When they were asked whether this_is a question forj regulation by any government agency -- and I have to perhaps remind Your Honors that there are two recent cases in which I general public knowledge, the Perrier case and the Chilean grape case, in which the Federal Food and Drug Administrationi decided to compound cargoes of grapes and prevent the sale of ~ I h l d h i very muc ess very, conta ne Perrier, when they eac carcinogenic material than is present -- QUESTION: Ms. Mueller, on that point, we are attempting to determine whether it was the will of Congress in a situation like this, an emergency temporary standard be put in place, to put this on the fastest track of anything f.~ . ~

jt 1 2 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MILLER REPORTING CO.. INC. 507 C Srreer. N.E. Wuhingcon. D.C. 20002 (202) 546•6666 6 before OSHA, and in that regard, isn't it appropriate to takei into account the Federal policy acquiesced by Congress every i year to continue to support the production of tobacco? i MS. MUELLER: That is true, Your Honor, but on political questions, of course, which one has to consider of Congress, the people who are espousing this naturally have to consider the will of their constituents, so I think this is a 1°ery much a political question, rather than a health question.i QUESTION: But if we are supposed to be attempting to divine the will of Congress, we have no mandate to right all wrongs, and if Congress has not elected to provide the remedy, then is it'appropriate for us to step in? We have two statutes, the one under which you are proceeding, and then there is this other action going on, and my question to you is, is it appropriate for us to take into account that every year there is an affirmative vote in Congress to continue the support of the production of tobacco? MS. MUELLER: That is so, Your Honor, but I would respectfully suggest the votes of Congress are very often based on information which is far older than that which comes before the Court and that which certainly comes before the scientific advisors of the Federal agencies who are specific-

jt 31 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 7 111 ally charged with safeguarding public health. iI 211 QUESTION: Proceed with your argument. MS. MULLER: Thank you. ~ The second point is whether any employees are I I exposed to tobacco smoke and are suffering in grave danger inl i the workplace. Here the record provides a variety of figures,i but I would submit that these are generally ranges. The Repace range is that 5,000 people per year die as a result of exposure to environmental tobacco smoke. I think one of the other public health associations puts it at 3,000. The Office of Technology Assessment of the U.S. Congress puts it at between 9,000 and 11,000. Now, I may stress that this is just deaths from lung cancer. In addition to that, other evidence which has been put in the record, one paper which has been annexed to Ash's petition, the Judson Wells petition, puts an overall figure of 57,000 people dying per year, 32,000 of these of heart disease. Now, if we look in perspective of other regulatory processes, for example, the EPA, 72 people per year die, according to the Repace evidence in the record, from other environmental causes, that is exposure to contaminants in the M/LLER REPORTING CO.. INC. 507 C Street. N.E. Washingcon. D.C. 20002 (202) 546-6666

jt 31 1 41 ~ 5i 6, 71 I 8 10 11 12 13 14 15 16 17 18 19 20 2.1 22 MILLER REPORTINO CO., INC. 507 C Screet. N.E. Washington. D.C. 20002 (202) 546-6666 8 outside air space. So, I think when we see the contrast between this and the amount of exposure in the indoor air• i i space, we have to think very carefully. Even in respondents'I own study that has been sponsored by them, the Meridian I study, they say that the evidence of breathed in is such thatj we cannot easily disregard it. ~ The third point which I would like to make is in relation to whether a standard can remedy a situation, and Ash, of course, very strongly recommends that it can. We are, Your Honors, I would like to submit here, in a case of first impression. All the other.cases which have come before you, the cases regarding ethyl alcohol, the cases regarding i . I benzine, all involved very important industries, arid the chemical in every case was part of that industrial process. So, the agency had not only to consider the actual poison element, but also the question of the economic aspects of the industry and the general economy of the United States, the jobs of thousands of people. Here we are dealing with a substance that has absolutely no industrial purpose. In fact, it interferes with productivity, it causes illness, it fouls the workplace, aD it raises insurance raises. So, if, in fact, the agency N O OD r ~ rJ r

t J 21 41 I 51 6 71 1 81 i 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MILLER REPORTING CO., INC. 507 C Sveer. N.E. Wuhingcon. D.C. :0002 (202) 546-6666 1I',I decides to issue an emergency temporary standard in this 9 case, it will not be damaging the industry or the economic situation, in any case. It will, in fact, be assisting it considerably. Finally, I would like to say, in concluding, that the original petition was filed in 1987, and it is now 4 years later. We are still having people who are dying as a result of exposure. I will not mention, at least I will not rely, because the respondents did not have it before them at the time they made the decision, the recent studies by the Environmental Protection Agency, but if the Court wishes, I would be very happy to submit a supplementary memorandum on the latest findings by the Science Advisory Committee of the EPA. QUESTION: It is the case that this Court has never required an agency to issue any G, is that -- MS. MUELLER: That is so, yes. And Ash, Your Honor, would be very content for Your Honors to consider the matter and make such recommendations as you consider appro- priate in the circumstance, if necessary, properly leading to a regular notice and comment rulemaking, we would be very OD ~ happy with that situation. O aD ~ T C.7

jt 6 1 7 81 10 11 12 13 141 I 151 16 17 18 19 20 21 22 MILLEA REPORTING CO., INC. 507 C Suce[. N E. Wuhingcon. D.C. 20002 (202) 54G-GGGG 10 QUESTION: The agency is proceeding with some kind of inquiry. They have issued a request for information. MS. MUELLER: Yes, Your Honor is right, they have issued a request for information, which, as you are aware, is the lowest possible ranking of a rulemaking or regulatory proceeding. They have not even decided in recent correspon- dence whether this will even include environmental tobacco smoke. But if it does involve environmental tobacco smoke, it will be considered in the contents of all indoor air contaminants, which, of course, can leave them plenty of room to spend how many years considering c-arpet shops, Chanel No. 5 in the Office of Environment, and we don't know what. THE COURT: Are there questions? Judge Silberman? QUESTION: Yes. Counsel, you do not address the scope of review at all. MS. MUELLER: Scope of review? QUESTION: Our scope of review. MS. MUELLER: Well, under the review section of section 555, the Court, of course, is empowered to consider the question of anyone aggrieved by any standards, and I think it is general authority that where there is a power to i

11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MILLfiR REPORTINO CO.. INC. 507 C Saeet. N.E. Washington. D.C. 20002 (202) 546-6666 consider a question where there has been an aggrieving from the exercise of a power, there is also jurisdiction to consider failure to exercise power. Indeed, Ash has, I believe, in some of the later considerations, submitted that the hazard in this case being a failure to exercise agency action which it should have been i exercised, and that there has, in fact, been an unjustifiablej delay, so we would plead that Your Honors do have power underj the question of agency action unlawfully withheld and ' reasonably delayed, even if you might not even have it under ~ ~ I the emergency temporary standard legislation, which we submit ~ ~ you have. ~ I THE COURT: Do you have further questions, Judge Silberman? QUESTION: No, I do not. MS. MUELLER: Thank you. THE COURT: We will hear from Mr. James. ORAL ARGUMENT OF CHARLES P. JAMES, ESQ., ON BEHALF OF RESPONDENTS MR. JAMES: I am Charles James, for the Secretary of Labor. In this case, OSHA concluded that the evidence was

t J 12 i i I not sufficiently definitive on the level of risk which exists i i in the workplace to justify an emergency standard. OSHA's i i 3 assessment of the record was reasonable and warrants affir- j 4 mance of its decision. i 5 Because of the emergency and temporary nature of i 6 this standard, OSHA must make its assessments of grave dangerl I 7 in assessing under actual prevailing workplace exposure 8 conditions. The evidence submitted by Ash in its petition 9 demonstrates that ambient tobacco smoke is causally related i 10 to cancer and other disease, but that evidence does not .11 provide an appropriate basis for determining the level 12 risk which exists. 13 The principal risk assessments in this area are not 14 definitive, because they rely heavily upon data developed in 15 residential studies, rather than on actual occupational 16 exposures. OSHA has noted that the conditions affecting 17 occupational exposure vary widely, depending upon building 18 size and type, ventilatory exchange rates, occupational 19 density and other factors, and -- 20 QUESTION: Mr. James, what about the point that, on 21 the other side of the balance, there is really noting to 22 balance, because, as distinguished from other cases, there is MILLER REPORTING CO., INC. 507 C 5aeec. N.E. Wuhingcon, D.C. 20002 (202) 546•6666

jt 1 10 11 12 13 14 15 16 17 18 191 191 20 21 22 13 i i no expense, no high cost to industry involved, if smoking were I I 31 its brief, all that would be necessary is putting up a"no , 411 I smoking" sign? So, if you have no cost on one side, shouldn'~ 5) it be less required on the other side? I 6 MR. JAMES: Your Honor, the agency must still make ' i 71 its findings of grave danger, in order to justify any standard i 8i~ in this area, and OSHA has concluded that the data in this 911 case do not warrant a finding that an emergency exists and ~ 2;'I to be banned from the workplace, that is, as Ash put it in I that an emergency standard is appropriate. OSHA is consider-i i ing various control strategies, including possibly a ban on smoking in the workplace, but it is doing that in connection i with its ongoing analysis of regulation of other indoor air i contaminants, as well. I QUESTION: Can you explain why OSHA decided to proceed through this request for information, rather than proceed immediately to the initiation of rulemaking? MR. JAMES: OSHA believes that it may be appropriat~ to regulate ambient tobacco smoke together with other indoor air contaminants, including radon, including the biological agents which are implicated in Legionnaires disease, and other factors. We are not looking at every possible indoor MILLER REPORTING CO., INC. 507 C Scmec. N.E. Washington. D.C. 20002 (202) 546-6666

jt 2 4 5 6 8 9 10 11 12 '13 14 151 161 17 18 19 20 21 22 MIILER REPORTING CO.. INC. 507 C Scceet. N.E. Wuhingcon. D.C. 20002 (202) 546-6666 14 air contaminant that can be imagined. We are focusing on a few that may well present significant risks, as well, and it is appropriate, in OSHA's view, if possible to combine a regulatory activity, to include a number of different substances, rather than just one, that it is sufficient or more appropriate to do that, and that is why we have determined to issue the RFI in this case. QUESTION: Mr. James, what makes a danger grave? MR. JAMES: Well, I think the determination of a grave danger has to be based on a statistical level of risk which exists, I think the first efforts to determine what that risk is, and then to determine, based on policy consider~ ations, essentially, whether OSHA believes that constitutes a~ grave danger. QUESTION: Well, when it gets to that second step, what considerations determine whether it is grave? MR. JAMES: Well, I think the level of risk certainly appears -- if it approaches the benchmark figure of significance that OSHA uses in conventional notice and comment rulemaking, that is one aspect to consider. QUESTION: Please keep your voice up. It is O GD gD 04

jt I I 15 1; difficult to hear you, Mr. James. 2 QUESTION: Can there be any room for doubt on the 3 _~-ecord here that some non-trivial number of people are 4 adversely affected or fatally affected by secondary smoke in 5 the work lac ? p e 6 MR. JAMES: Well, I think it is reasonable to 7 assume that there are effects in the workplace to exposure to 8 ambient tobacco smoke, but this is an emergency measure and 9 OSHA requires a higher degree of definition in the level of 10 and I don't think the data demonstrate risk which exists , I 11 that t ll h a a ere. ~ 12 QUESTION: Has the agency ever I issued an emergency 13 tem orar standa d? p y r 14 MR. JAMES: The agency has atte mpted to issue one. 15 It has never successfully issued one. It has never had it 16 sustained I ~ . 17 QUESTION: Was that because of judicial review? 18 MR. JAMES: Yes, at least three I believe have been 19 d overturne on judici al review. 20 QUESTION: So, three times you have issued a 21 standard and had it overturned on review? . OD 22 MR. JAMES: Yes. ~ N O ~ ,-~ MIILER REPORTINa CO., INC. T CD 507 C Sueet. N.E. Washingcon. D.C. 20002 (202) 546-6666

jt 1 4 5 i 61 1 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MIILER REPORTING CO.. INC. 507 C Street. N.E. Wuhingcon. D.C. 20002 (202) 546-6666 16 QUESTION: And have you ever been required to or reviewed an issue of a standard that the agency had declined to issue? MR. JAMES: No, I don't believe that has ever happened. Again, I would point out that the evidence of reference by Ash in its reply brief, while it does demonstrat~ that ambient tobacco smoke can be a cause of disease, does not purport to estimate or quantify the magnitude of risk in ~ the workplace. I think the Surgeon General's report, on whicH Ash places heavy reliance, is typical of this group of studies,in that it expressly recognizes that the degree of risk due to exposure to ambient tobacco smoke is uncertain, and that additional and more accurate estimates to exposures in the workplace, in the home and in public places is necessary in this arena. That is all I have. I would be happy to take questions. If there are none, we would ask that the Secre- tary's determination be sustained. QUESTION: You are not challenging the authority of this Court to review the decision not to issue an ETS? MR. JAMES: That's correct.

17 21 i QUESTION: Let me ask you the question Judge Silberman asked of Ms. Mueller. What is the standard of review? You concede that the refusal to issue an ETS is 4 reviewable under what standard? 5 MR. JAMES: I believe the determination not to 6 issue an ETS is reviewable under the reasonableness standard 7 or an arbitrary and capricious abuse of discretion standard. 8 I believe the Court has adopted that standa rd of review in 9 two prior cases in which it has affirmed OS HA's refusal to 10 issue an ETS in the ethylene oxide and the cadmium cases, 11 which are cited in our brief. In both of those case, the 12 Court applied a reasonableness standard. 13 QUESTION: How, if at all, does OSHA deal wit h the 14 fact that this particular substance is not banned, and some 15 others are, but indeed continues to be supported b y the 16 covernment? Does that enter into the calculus at all? 17 MR. JAMES: I don't think it has entered into the 18 calculus thus far. It certainly hasn't, in terms of grave 19 danger under the emergency temporary standard. OSHA is N O 20 considering regulating this substance in conjunction with ~ 11 21 others, and if it is appropriate to do that, then issue will ~A 22 issue a standard in that area which may provide for a ban, or MILLER REPORTING CO.. INC. S07 C Srmer. N.E. Washingcon. D.C. 20002 (202) 546-6666

jt 31 1 41 5 6 7 9 10 11 12 13 14 15 16 17 18 19 18 it may provide for regulating it on the basis of a permissible 2111 exposure limit,lor perhaps on some ventilatory exchange rate standard, something that requires a certain number of air changes over a given time or something of that nature. QUESTION: Is there any time line for this request for information? How long does that go on? MR. JAMES: Well, we expect to issue this RFI in, i believe it is early June. It will have a comment period of 120 days. QUESTION: If this is issued in early June, then what would be the next step? MR. JAMES: The next step would be to provide a period for solicitation of comments, and then, after the comments are received, to consider those and make a determin- ation of how to proceed in this area. QUESTION: At what point would there be a decision of whether to issue a notice of proposed rulemaking? MR. JAMES: Do you mean at what point in time, timewise? QUESTION: Yes. 21 22 MILLER REPORTINO CO., INC. 507 C Srrcn. N.E Washington. D.C. 20002 (202) 546-6666 MR. JAMES: I'm not sure. It depends on the scope of the responses to the RFI.

jt 1 2 3 4 51 i 61 1 7 19 THE COURT: Are there further questions of Mr. James? [No response.] If the Court has no further questions, thank you, ; I I Mr. James. Ms. Mueller, you have some time remaining. I ORAL ARGUMENT OF ATHENA R. TAYLOR-CARROLL DE MUELLER, ESQ., 8 ON BEHALF OF PETITIONER -- REBUTTAL i ~ 9 MS. MUELLER: M ay it please the Court: I wou ld ~i 10 like t o refer to one small point that came from Mr. Jam i es' 11 remarks, and that was the question of differing effect, as to' 12 whether there is a contact with a poisonous substance at workl 13 or at home, which seems rather unusual. 141 However, in some of the research materials wh ich I ~ 15 are in the record, the Office of Technology Assessment of the I 16 U.S. Congress found that at least one-third of the deat hs 17 caused by exposure to environmental tobacco smoke was a I 18 result of workplace exposure. h fil d k hi i f 19 or emergency now, As t As you e s pet tion 20 relief , because we felt t hat the situation justified it. We 21 know that the respondents are well-meaning and conscientious 22 public servants, but they operate in quite a different a ~ ~ MILLER REPORTINQ CO., INC. W 507 C Srreec. N.E. Wuhingron. D.C. 20002 (202) 546-6666

jt I ~ 21 4 6 7 9 10 11 12 13 14 15 16 17 18 19 20 21 22 MILLER REPORTING CO., INC. 507 C Street. N.E. Wuhing[oa. D.C. 20002 (202) 546•6666 20 context from Ash. They are very much more isolated from the public feeling, and they don't have the people who come to them who come to Ash, the young parents, the families who have just been told that they have cancer of the lung or beautiful young women, flight attendants who have emphysema, the smokers' disease, who have never smoked in their lives. So, I think this is the thing that gives probably Ash a feeling that this is a matter that needs a more urgent approach than would otherwise be necessary. The other, in relation to the position of Congress and the function of the Department of Labor, the Department of Labor is appointed by Congress to carry out the will of Congress to protect the United States workforce and to insure that every American man and woman should, to the extent possible, have a safe and healthful working environment, and we feel that the respondents need your encouragement to carry out this very important public duty imposed by the Congress. Thank you very much. THE COURT: Thank you, Ms. Mueller. The case is submitted. [Whereupon, at 10:00 a.m., the case in the above- entitled matter was submitted.]