Tobacco Documents Online

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