Document 8RjQa1VZGO5NVK03aj3EXxbRZ

amOiWA nVfl iftai ir----- >:i i In tiff '1i IntteJi Tates (Enprinf Appeals t $nt tffB ^frnnh Cttlrrutt FIRESTONE PLASTICS COMPANY, a Division of THE FIRESTONE TIRE &. RUBBER "CbMPANY, Petitioner-1ntervenor, UNION CARBIDE CORPORATION, ' 1 w Petitioner, UNITED STATES DEPARTMENT OF LABOR and PETER i J. BRENNAN, Secretary, U.S. DEPARTMENT OF LABOR, and JOHN H. STENDER, Assistant Secretary of Labor for Occupational Safety and Health, Respondents. 1i ON PETITIONS FOR REVIEW OF AN ORDER OF THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES J DEPARTMENT OF LABOR S .1 1 BRIEF FOR PETITIONERS-INTERVENOR j Of Counsel: WALTER B. CONNOLLY, JR. 'i 4 JOHN J. CASSIDY, JR. ARTHUR B. SMITH. JR. NELSON E. SCHMIDT 1200 Firestone Parkway Akron, Ohio 44317 216/379-7000 jJi NINA G. STILLMAN VEDDER, PRICE, KAUFMAN, KAMMHOLZ & DAY 800 Third Avenue New York, New York 10017 212/838-5544 Attorney for Petitioner-1ntervenor Firestone Plastics Company, a Division of The Firestone Tire & Rubber Company JOHN W. WHITTLESEY JAMES V. MURRAY 270 Park Avenue s New York, New York 10017 212/551-6797 I Attorneys for Petitioner, Union Carbide Corporation i i Gunthorp-Warren Printing Company, Chicago 346-1717 i \ \ .HnJiwrTwi ji hv,i.,i n|i l i BOR 004484 TABLE OF CONTENTS ------------ PAGE Preliminary Statement .......................................................... 2 Issues Presented for Review.......................................... 2 Statement of the Case.......................................................... 3 Statement of Facts ............................................................... 9 A. Description of Domestic VCM and PVC In dustries, Nature and Extent of Employee Ex posures to VCM in Polymerization of VCM to PVC, and the Clustering of Angiosarcoma Cases Associated with VCM in the United States .... 9 1. The Domestic VCM and PVC Industries .. 9 2. Nature and Extent of Exposures................. 10 B. Scientific Knowledge About the Health Hazards of Exposure to VCM......................................... 11 1. Scientific Data in the Record........................ 11 (a) Animal Experiments and Statistical Extrapolation Therefrom to Posit Effects on Humans............................ 13 (b) The Human Experience--Bio-Statisti cal Surveys of Populations Exposed to VCM................................................. 17 (c) The Human Experience--Clinical and Histological Observations .................. 20 (d) Scientific Opinions Regarding an Ac ceptable VCM Exposure Concentra tion for Humans................................. 23 2. The Assistant Secretary's Findings and Con clusions with Respect to Scientific Knowl edge of the Health Hazards of VCM........... 25 C. Technical Feasibility of the Final Standard .... 27 1. Engineering and Technical Data in the Record .......................................................... 27 2. The Assistant Secretary's Findings and Con clusions with Respect to Technical Feasibility 39 11 D. Utilization of Respiratory Protection Against In halation of VCM.................................................. 42 1. The Record Evidence Pertaining to Respira tors ................................................................. 42 2, The Assistant Secretary's Findings and Con clusions with Respect to Respiratory Protec tion ................................................................. 45 E. Data Concerning the Economic Impact of the New Standard ................. 45 1. Economic Data in the Record..................... 45 (a) Compliance Costs............................... 45 (b) Economic Impact.............................. 49 2. The Findings and Conclusions of the Assist ant Secretary with Respect to Economic Feasibility of the New Standard.................... 52 Argument................................................................................ 53 I. Introduction: The Statutory Scheme for Promul gating an Occupational Safety and Health Standard ............................................................... 53 A. Elements Prescribed by Statute................. 53 B. The Standard for Reviewing Determinations of the Assistant Secretary............................ 54 C. OSHA's Burden of Producing Evidence to Support the Standard Finally Promulgated. 57II, II, The Determinations of the Assistant Secretary Are Not Supported by Substantial Evidence in the Record Considered as a Whole................. 58 A. The Determination with Respect to the Human Health Hazards of Exposure to VCM Improperly Fails to Articulate the Policy Choices Confronting the Assistant Secretary or to Provide Adequate Justifica tion for the Policy Promulgated in the1 Standard ...................................................... 58 BOR 004486 iHlilMfc li frill i Vir'*---' i' !""* iii B. The Assistant Secretary Rejected or Ignored the Uncontroverted Record Evidence Which Established that VCM Exposure Levels Be low 10 PPM Are Not Technically Feasible, That Levels Below 25 PPM TWA Will Take Several Years to Attain and That There Is No Evidence Supporting Technical Feasibility of a 1 PPM TWA-5 PPM Ceil ing Exposure Level................. ................... 64 C. There Was No Substantial Evidence Sup porting the Assistant Secretary's Determina tion to Subject PVC Producers to the Same Standard Applied to Producers of VCM .. 71 D. The Assistant Secretary's Failure to Assess the Economic Feasibility of the New Stand ard Plainly Requires That the New Standard Be Vacated and Remanded........................ 72 E. The Assistant Secretary's Determinations with Respect to Respiratory Protection Are Not Reasonable........................................... 75 1. Improper Failure to Provide Adequate Notice with Respect to Continuous Use of Respirators ..................................... 75 2. The Assistant Secretary Improperly Failed to Assess the Health and Safety Hazards Resulting from the New Stand ard's Requirements for Respiratory Pro tection or the Feasibility Thereof and Provided No Rational Explanation for His Action with Respect Thereto .... 78III. III. Critical Portions of the New Standard Are So Vague, Indefinite, and Incapable of Consistent and Uniform Enforcement That the Standard Contravenes the Act and Due Process of Law.. 81 A. The New Standard Is So Vague and In- s definite as to Be No Standard at All and Therefore Violates the Act........................ 81 t r - w .t^ r in ^ 'rfi-i '%j 1 i ; B. The Vagueness and Indefiniteness of the New Standard Violates Due Process of Law 85 IV. The Assistant Secretary's Denial of the Right to Cross-Examine Certain Witnesses Who Presented Evidence on Crucial Adjudicative Fact Issues After the Public Hearings Were Concluded Violated Due Process and OSHA's Own Rules and Regulations and Fatally Tainted the Determi nations of the Assistant Secretary...................... 87 A. The Assistant Secretary's Action in Deny ing the Right of Cross-Examination Vio lated the Constitutional Right to Due Process of Law............................................ 87 B. The Denial of the Right of Cross-ExaminaI tion Violated OSHA's Own Procedural Regulations.................................................. 88 Conclusion ............................ 90 List of Authorities Cited Cases Associated Industries of New York State, Inc. v. Depart ment of Labor, 487 F.2d 342 (2d Cir. 1973)........................ ....................................................................... 55, 56, 57, 60, 67 Automotive Parts & Accessories Assn. v. Boyd, 407 F.2d 330 (D.C. Cir. 1968) ...................................................... 56 Boyce Motor Lines, Inc. v. United States, 342 U.S. 337 (1952)................................................................................ 86 Champlin Refining Co. v. Corporation Commission of Oklahoma, 286 U.S. 210 (1932) .................................K 86 Chrysler Corporation v. Department of Transportation, 472 F.2d 659 (6th Cir. 1972)............................ .................50, 85 Connally v. General Construction Co., 269 U.S. 385 (1926) 86 '^11* I-' I- w>wpBp;)>DUIJ'ilii , i'i" I li . 41 -- - BOR 004488 p X uriiiYnirwilii t MUIU . I--*-.- ||, , n , IIf V Florida Peach Growers Association, Inc. v. Department of Labor, 489 F.2d 120 (5th Cir. 1974) ... .55, 57, 60, 68, 73 Grayned v. City of Rockford, 408 U.S. 104 (1972)........... 86 Illinois Central R.R. Co. v. Public Utilities Com'n, 245 U.S. 493 (1918) ....................................................................... 86 Industrial Union Department, AFL-CIO v. Hodgson, 499 F.2d 467 (D.C. Cir. 1974) ........................................... ................................ 53, 54, 55, 56, 57, 70, 71, T. 4, 75, 88 International Harvester Company v. Ruckelshaus, 478 F.2d 615 (D.C. Cir. 1973)....................................... 56, 70, 73, 88 Isbrandtsen Co., Inc. v. United States, 96 F.Supp. 883 (S.D.N.Y. 1951) ............................................................... 58 M. Kraus & Bros., Inc. v. United States, 327 U.S. 614 (1945)................................................................................ 86 Lanzetta v. New Jersey, 306 U.S. 451 (1939).................... 86 Mobil Oil Corp. v. Federal Power Commission, 483 F.2d 1238 (D.C. Cir. 1973) ..................................................68, 87 . Northbridge Electronics, Inc. v. United States, 444 F.2d 1124 (U.S. Ct. Clms. 1971)........................................... 68 Papachristou v. City of Jacksonville, 405 U.S. 156 (1972) 86 Portland Cement Association v. Ruckelshaus, 486 F.2d 375 (D.C. Cir. 1973) ......................................................... 85 Reserve Mining Company v. United States, 498 F.2d 1073 (8th Cir.), cert, den........... U.S (1974)....................... 63, 64 Synthetic Organic Chemical Manufacturers Assn. v. Bren nan, -------F.2d--------(3d Cir. 1974)..................... 56, 60, 77 United States v. Cohen Grocery Co., 255 U.S. 81 (1921).. 86 Universal Camera Corp. v. N.L.R.B., 340 U.S. 474 (1951) 55 BOR 004489  *1---- ------- -- '... ,.--. .,, .1..------- -w. Statutes Administrative Procedure Act, 5 U.S.C. . 551, et seq (1970): Section 6(d) ................................................................. 57 Occupational Health and Safety Act of 1970 (84 Stat. 1597, 29 U.S.C. 651, ef seq.): Section 6(b) ............................................................... 2, 5, 6 Section 6(b)(2) ........................................................... 77 Section 6(b)(3).........................................................77, 87 Section 6(b)(5)..................................... ........ 5, 53, 61, 85 Section 6(c) ........................................................ 5 Section 6(e) ................... 53 Section 6(f) .............................................................2, 3, 54 Section 7(b) ................................................................. 53 Section 17(c) ............................................................... 85 Section 22................... 53 National Traffic and Motor Vehicle Safety Act (15 U.S.C. 1381, et seq. (1970)) .................................................. 28 U.S.C. 2112(a) (1970) .............................................. 85 3 Miscellaneous 29CFR 1910.93q et seq. (1971)-36 Fed. Reg. 10503-06 4 29 CFR 1910.93q(b)(5)-39 Fed. Reg. 35896 ............. 83 29 CFR 1910.93q(c)-39 Fed. Reg. 35896 ......................7, 81 29 CFR 1910.93q(d)-39 Fed. Reg. 35896 .................... 7 29 CFR 1910.93q(e)-39 Fed. Reg. 35896 ...................... 84 29 CFR 1910.93q(f)-39 Fed. Reg. 35894 ............. 7 29 CFR 1910.93q(f) (iv)*39 Fed. Reg. 16898 ............... 76 29 CFR 1910.93q(f) (2)-39 Fed. Reg. 35896 ............. `. 81 `WJW ilr rrfLfrgJ^vJ>^ f-*-*** ] 29 CFR 1910.93q(g)(l)-39 Fed. Reg. 35896 ........... 79, 84 i 29 CFR 1910.93q(g)(2)-39 Fed. Reg. 35896 ............. 77 J 29 CFR 1910.93q(g) (6) (ii)-39 Fed. Reg. 35896 .... 85 * 29 CFR 1910.93q(i)-39 Fed. Reg. 35896 ...................... 83 j 29 CFR 1910,93q(k) (3)-39 Fed. Reg. 35896 ............... 83 ? 29 CFR 1911.15(a)(3) (1974) ..................................... 77 l 29 CFR 1911.15(b)(2) (1974) ..................................... 88 I 41 CFR 50-204.50 (1971) .............................................. 4 | 37 Fed. Reg. 3758 (1974) ................................................... 61 * 39 Fed. Reg. 3874 (1974) .................................................. 4,5 39 Fed. Reg. 12342 (1974) ................................................ 5 39 Fed. Reg. 16896 (1974) ................................................ 5 39 Fed. Reg. 18303 (1974) ............................................. 5 39 Fed. Reg. 30844 (1974) .............................................. 6 39 Fed. Reg. 33009 (1974) .............................................. 6 116 Cong. Rec. 37622 (Nov. 17, 1970).......................... 54, 61 116 Cong. Rec. 37614 (Nov. 17, 1970)............................ 61 Department of Health, Education and Welfare, The Health Consequences of Smoking (Public Health Service, 1973) 20 OO4492 VIi)hiriw 'tnl'iin ait inii'i'iKiiirSfYO'WOwt in tfje Rntteii Stales (Enuri nf Appeals 3far tlj* &prmtii (flirrutt FIRESTONE PLASTICS COMPANY, A Division of THE FIRESTONE TIRE & RUBBER COMPANY, Petitioner-Intervenor, and UNION CARBIDE CORPORATION, Petitioner, vs. UNITED STATES DEPARTMENT OF LABOR and PETER J. BRENNAN, Secretary, U.S. DEPARTMENT OF LABOR, and JOHN H. STENDER, Assistant Secretary of Labor for Occupational Safety and Health, Respondents. ON PETITIONS for review of an order of the occupational safety and health administration, united states DEPARTMENT OF LABOR s BRIEF FOR PETIHONERS-INTERVENOR ...... ff- r l.l ----- PRELIMINARY STATEMENT These proceedings are before the Court upon petitions filed pursuant to Section 6(f) of the Occupational Safety and Health Act (29 U.S.C. 655(f) (1970)) challenging the validity of a new occupational safety and health standard promulgated on October 1, 1974 by the Assistant Secretary of Labor for Occu pational Safety and Health, Mr. John H. Stender, and regulat ing exposure to vinyl chloride monomer as reported at 39 Fed. Reg. 35890-35898 (October 4, 1974). ISSUES PRESENTED FOR REVIEW 1. Whether the determinations of the Assistant Secretary in promulgating a new occupational safety and health standard regulating exposure to vinyl chloride monomer pursuant to Section 6(b) of the Occupational Safety and Health Act (29 U.S.C. 655(b) (1970) are supported by substantial evidence in the record considered as a whole. 2. Whether the new standard regulating exposure to vinyl chloride monomer is so vague, indefinite and essentially in capable of consistent and uniform enforcement as to contravene the Act and due process of law. 3. Whether, in promulgating the new occupational safety and health standard regulating exposure to vinyl chloride mono mer, the Assistant Secretary's denial of the right to cross-examine certain witnesses who presented evidence on crucial issues of adjudicative fact after the close of public hearings violated the constitutional right to due process and OSHA's own rules and regulations and fatally tainted the determinations of the Assistant Secretary. 111 'I BOR OO4493 STATEMENT OF THE CASE These proceedings are before the Court upon the petitions of 8 major producers of polyvinyl chloride ("PVC") resins, a vital component of widely used and essential plastics, and The So ciety of the Plastics Industry, Inc. ("SPI"),1 pursuant to Section 6(f) of the Occupational Health and Safety Act of 1970 (84 Stat. 1597, 29 U.S.C. 651, et seq. (1970); hereinafter called the "Act") challenging the validity of a new occupational safety and health standard, promulgated on October 1, 1974 by the Assistant Secretary of Labor for Occupational Safety and Health ("Assistant Secretary"), and regulating exposure to vinyl chlor ide monomer ("VCM"), a gas at room temperature and pres sure, effective January 1, 1975. Until very recently, VMC had long been considered low in toxicity when inhaled by humans, and the primary occupational 1 Two Petitions, those of Hooker Chemicals & Plastics Corp. ("Hooker") in No. 74-2286, and the SPI in No. 74-2284, were filed with this Court on October 1, 1974. Air Products and Chemicals, Inc. ("Air Products") and Tenneco Chemicals, Inc, ("Tenneco") have filed Petitions in the Court of Appeals for the Third Circuit. Thereafter, on October 4, 1974, Firestone Plastics Company, a Division of The Firestone Tire & Rubber Company ("Firestone"), was granted leave to intervene by this Court in Nos. 74-2284 and 74-2286. Subsequently, Union Car bide Corporation ("Union Carbide") filed a Petition in No. 74-2308 with this Court, and Firestone filed a Petition with the Court of Appeals for the Sixth Circuit. The B.F. Goodrich Com pany ("Goodrich") also filed such a Petition with the Second Circuit in No. 74-2345. The Diamond Shamrock Chemical Company, Inc. ("Diamond Shamrock") and the Goodyear Tire and Rubber Company ("Goodyear") have filed Petitions with the Court of Appeals for the Sixth Circuit. Motions to Transfer the Petitions of Firestone, Air Products, Tenneco, Diamond Sham rock and Goodyear to this Court, pursuant to the provisions of 28 U.S.C. 2112(a) (1970), have been filed in the Third and Sixth Circuit Courts of Appeals. BOR 004494 * ; w S 3 3 1 i .1 v. * i : i v 4 hazard associated with it was derived from its flammable and explosive properties. In recognition of this, the original occu pational safety and health standard regulating exposure to VCM, adopting a previously established federal standard and promul gated in accordance with the recommendation of the American Conference of Governmental Hygienists on May 29, 1971, pro vided for a permissible maximum exposure of 500 parts of VCM per million parts of air (hereinafter referred to as "........ ppm")- See 29 CFR 19l0.93q(a), Table G-l (1971); 36 Fed. Reg. 10503-06 (May 29, 1971); 41 CFR 50-204.50 (1971), J.A. 10-13.* The procedure for establishing a new standard regulating ex posure to VCM was initiated on January 30, 1974 (39 Fed. Reg. 3874 (1974)) and concluded some 9 months later on October 1, 1974 when the new standard was issued (39 Fed. Reg. 35890 (1974), J.A. 1-9). Triggering the process was a report by Goodrich to the National Institute for Occupational Safety and Health ("NIOSH", a part of the Department of Health, Education and Welfare), which was transmitted to Occupational Safety and Health Administration ("OSHA") in late January that four of Goodrich's employees who had worked at its Louisville, Kentucky PVC facility had died of a rare liver cancer (angiosarcoma) which may have been occupa tionally related. Acting with unprecedented speed, OSHA conducted a fact finding hearing on possible hazards associated with manufacture and use of VCM and PVC on February 15, 1974 (39 Fed. Reg. 2. References to the record will be made as follows: "J.A. -------" refers to pages of the Joint Appendix; "Ex........ refers to exhibits received by OSHA in connection with these1 pro ceedings, either before, during or after the public hearings, and part of the official record but which were not designated for in clusion in the Joint Appendix; "Tr.......... " refers to pages of the transcript of proceedings conducted before Administrative Law Judge Gordon Myatt in Washington, D.C., from June 25 through June 28, again from July 8 through July 11, and on September 23, 1974, which were not designated for inclusion in the Joint Appendix. , r;1 uJJIWI WV, n*v****.jW**.mm V-> i>"^riUjTTVlTOyJ *a,mm ......... ifrW1 BOR 004495 i Mlfrtll'Ill'llimi - rJJlnl'i ~ ........ 5 'i 5 3874 (1974)). Relying on information received during and i after that hearing, the Assistant Secretary, pursuant to Section i 6(c) of the Act (29 U.S.C. 655(c) (1970)), promulgated 4 on April 5, 1974, an emergency temporary standard ("ETS") *t! regulating human exposure to VCM and providing, inter alia, J that no employee shall be exposed to VCM at a concentration in excess of 50 ppm, unless he or she wears a self-contained breath ing apparatus or air-supplied respirator (39 Fed. Reg. 12342 , (1974), J.A. 18). On May 10, 1974, the Assistant Secretary, pursuant to Sec tion 6(b) of the Act (29 U.S.C. 655(b) (1970)), promul .1 gated a proposed new standard to replace both the original and the ETS (39 Fed. Reg. 16896 (1974), J.A. 21-25). That proposed new standard, with minor modifications not here rele vant, adopted the health standard and a medical surveillance pro gram recommended by NIOSH during March 1974. (J.A. 30- "i 69, 104-105). i The proposed new standard set the permissible exposure of employees at "no detectable level" of VCM as determined by a sampling and monitoring method. Engineering controls and .1 in work practice procedures were required as the primary means for achieving the exposure concentration of "no detectable V- level"; provision of specified types of self-contained respirators with full face pieces to protect employees exposed to detectable levels of VCM was allowed only pending the establishment of engineering controls and work practice procedures. Yet, no assess " ' ment or evaluation of "feasibility" accompanied the proposal, * as required by Section 6(b)(5) of the Act (J.A. 21-25). ! Thereafter, pursuant to Section 6(b) of the Act and to notice * (39 Fed. Reg. 18303 (1974)), hearings on the proposal for a ->! new standard were conducted. There, information and data con sisting of presentations and papers by scientists studying the car- cinogenic effect of VCM and studies on the technological feasi bility and economic impact of the proposal were submitted to i BOR 004496 ---if ir--' *-** 6 OSHA. On the day the hearings concluded,* OSHA announced for the first time that it had contracted with Foster D. Snell, Inc. ("Snell"), an independent consultant, to study the feasi bility of compliance at various VCM exposure concentrations, including the one proposed by the Assistant Secretary. Despite the critical importance of the Snell feasibility study to the standard setting process of Section 6(b), a preliminary draft of the Snell report was not made available until August 26, 1974. Cross-examination of its authors, preparers and de signers was not permitted; interested parties instead were given until September 6, 1974 to submit comments (39 Fed. Reg. 30844 (1974); J.A. 26)). The Snell final report was not available for inspection until September 16, and comments by interested parties pertaining thereto were to be received in Washington on September 25. Cross-examination of Snell per sonnel again was not allowed, despite repeated requests therefor by Firestone (39 Fed. Reg. 33009 (1974), J.A. 27; Ex. 184; J.A. 3756-59).* The Snell final report concluded, inter alia, that the new standard proposed by the Assistant Secretary was not feasible and that the technological capability for industry achievement of exposure concentrations as low as 10-15 ppm on a Time Weighted Average ("TWA") basis coupled with a 15-25 ppm maximum was some years away (J.A. 3433-3687). 3. The record remained open after the close of the hearings until August 23, 1974, for the receipt of post-hearing com ments and other data and information. 4. Firestone also requested that the hearings be reopened to permit cross-examination of Dr. Frank Standaert, M.D. of Georgetown University Medical School, and of Dr. David Wegman, M.D. of Arlington, Massachusetts, who were commissioned by the Assistant Secretary to make recommendations concerning a permissible exposure level shortly before the record wassclosed. See also, Assistant Secretary's letter to Firestone's counsel, dated October 21, 1974, attached hereto as Addendum B, denying the right to cross-examine Drs. Standaert and Wegman. ` 5. TWA exposures are derived by averaging all exposures over any specified period of time, e.g., 8 hours. "liWSWHSGWJ-IIR Wynn, uin.i'ipuim.ii... nimwmwm % BOR 004497 ----- ^-4 y^ f .......................................................... .-^.4^ ^ V,, lM, . .u il* .j.jmj Effective January 1, 1975, the new standard for exposure to VCM applies wherever VCM or PVC is manufactured, re acted, packaged, repackaged, stored, handled or used.6 The permissible exposure limit is set at 1 ppm averaged over any 8-hour period coupled with a maximum of 5 ppm averaged over any period not exceeding 15 minutes (29 CFR 1910.93q(c); 39 Fed. Reg. 35896, J.A. 7). Concluding that OSHA was "presently unable to determine when it will be feasible for most establishments to reduce exposure levels to the permissible level" (39 Fed. Reg. 35894, J.A. 5), the Assistant Secretary, never theless, ordered all employers to implement engineering con trols and work practices capable of reducing exposure to the lowest practicable level and to institute a continuing program of engineering controls and work practice procedures to reduce exposures (29 CFR 1910.93q(f); 39 Fed. Reg. 35893, 35896, J.A. 4, 7). Where engineering controls and practices will not reduce exposures below the permissible limit, those controls and practices must be supplemented by employees wear ing respirators specified in the standard and approved by NIOSH. However, until January 1, 1976, employees whose exposures do not exceed 25 ppm may decline to wear respira tors, although each employer must provide each employee with an appropriate respirator when exposures exceed the permissi ble 1 ppm-5 ppm limit (29 CFR 1910.93q(g); 39 Fed. Reg. 35894, 35896, J.A. 4, 7). Finally, area monitoring or monitor ing of each employee is to be undertaken in each establishment to determine if any employee, without regard to the use of respirators, is exposed to impermissible concentrations of VCM (29 CFR 1910.93q(d); 39 Fed. Reg. 35896, J.A. 7). The substantial evidence issues before the Court are: (1) Whether the Assistant Secretary improperly disregarded the medical and scientific data in the record and, contrary to his 6. The ETS was adopted as a permanent standard for the period October 4, 1974-January 1, 1975 (39 Fed. Reg. 35896 (J.A. 9)). h#>`i**'****.-1 BOR 004498 * * ''*'*' ' H statutory mandate, adopted a safety and health standard solely on the basis of a NIOSH recommendation which itself was predicated on the theory that each employee should be provided with a workplace that is absolutely free of hazard regardless of technical and economic feasibility;. (2) Whether the Assistant Secretary, in promulgating the final standard, improperly dis regarded the uncontroverted evidence which established that the final standard is not technically or economically feasible; (3) Whether the Assistant Secretary failed to consider the sub stantial evidence which established that the full-time wearing of respiratory devices by employees is unsafe, hazardous, and not feasible.S. PJU^'Jill' S. BOR 004499 ,.,,^.4. >*-- . ,, ,..., -, ritiatltu./k ) a 9 STATEMENT OF FACTS i A. Description of Domestic VCM and PVC Industries, Nature and Extent of Employee Exposures to VCM in Polymeriza ? tion of VCM to PVC, and the Clustering of Angiosarcoma * - Cases Associated with VCM in the United States l I. The Domestic VCM and PVC Industries i Vinyl chloride monomer (VCM) (CH2=CHC1, Chemical Abstracts Service Registry No. 76016) is a gas at room tempera ture and pressure, and is derived ultimately from ethylene or j acetylene and ohlorine. Liquid VCM boils at 7F, and at room ) temperature it is a gas exerting 40 pounds pressure per square inch. At extremely high concentrations of gaseous VCM in air (in excess of 40,000 ppm), the gas possesses flammable and ex plosive properties. As a liquid, VCM evaporates instantaneously upon release from a pressurized vessel, and the vapor dis sipates into the air as does any gas. VCM is a vital component in the production of polyvinyl chloride (PVC), a thermal . plastic resin which is the basic element of essential plastic products (J.A. 3495-97). VCM is produced domestically by 9 companies in 14 plants employing approximately 940 workers (J.A. 3484-86). Do mestic production of PVC from VCM occurs in 36 plants owned and operated by 21 companies employing approximately ' 5,600 employees (J.A. 3472-80). VCM first attained com : mercial significance in the 1930's and production of PVC was initiated on a large scale during World War II (J.A. 3300). Polymerization of VCM to PVC is accomplished by either *> of four basic processes: suspension, used in 33 plants and which ^ . accounted for 78 percent of the 1973 PVC output; emulsion, used in 16 plants and which accounted for 13 percent of the 1973 PVC output; and bulk and solution, used in a total of 6 i -i i J BOR 00450Q t A *** nUh.. -.-HtjA I i 10 plants and which together accounted for 9 percent of the 1973 3 PVC output (J.A. 3471). In these four processes, polymerization of VCM to PVC occurs in large reactors and the reaction time for each batch produced is about 6-20 hours, depending on which process is utilized. Reactor cleanliness is vital to the production of work able resins. Dirty reactors or reactors with accumulated resins or "buildup" of .little chunks of PVC which adhere to reactor :' -5 walls result in production of inferior resins. When cleaning is necessary, the reactors are purged with fresh air, employees enter the vessels, and, using chisels and scrapers, chip and ; scrape PVC resin from the reactor walls under local exhaust i ventilation. Cleaning takes about 30 minutes and usually re quires two employees to clean each reactor, one inside, one outside (J.A. 3316-3320). a 2. Nature and Extent of Exposures Historically, employee exposures during polymerization from VCM to PVC were at extremely high concentrations. Although equipment to monitor the levels of VCM in work places have : not been installed until quite recently, VCM concentrations to which employees were exposed during the 1940's and 1950's and even the early 1960's were frequently at or above the level 'j at which VCM's odor could be detected. The level at which VCM's odor can be detected has not been conclusively es ' tablished, but recent tests conducted by Union Carbide show, as confirmed by OSHA's Final Environmental Impact State ment, that employee exposures to VCM were in excess of 1,200 ppm during the 1940's and 1950'$ (J.A. 2441-48, 3289-91). Exposure levels experienced by PVC workers have been dramatically reduced since that time and today .generally approach the level specified in the ETS--50 ppm, although significant excursions above that level continue to occur (J.A. 545-78, 2422-40; Ex. 25E, 27A, 28C, 56, 150, 189L\ 193C, A ! 194(a) (b), 197, App. B). < J V wapium WMPIU jpyu, .w -jpi.if . BOR 004501 Since the initiation of large scale PVC production during World War II, thirteen cases of angiosarcoma among domestic PVC polymerization workers have been confirmed in the record (J.A. 3258). All the confirmed cases involve employees who had been exposed to VCM from 11-36 years (with an average of 21 years exposure) and whose exposures had occurred, at least in part, during those periods of time when VCM concentrations in PVC plants were extremely high (J.A. 3258, 3289-91). \ B. Scientific Knowledge About the Health Hazards of Exposure to VCM 1. Scientific Data in the Record The record contains seven different types of scientific evidence on the hazards associated with VCM exposure: (1) Reports by scientists on observations of histological origins of the angi osarcoma lesion or tumor and clinical observations of humans exposed to VCM,7 8(29) reports of studies and research into the metabolic pathways and pharmacodynamics of VCM; (3) re ports on studies and research into the possible mutagenic-- or transplacental---effect of VCM exposure, (4) reports on ongoing studies of the effects of VCM inhalation by, and ab sorption through the skin of, animals;10 1(15) bio-statistical studies of exposed populations of PVC workers, both living and dead, attempting to catalog, summarize and compile medical observa tions made of such employees and to relate those observations to what might be expected in a population not exposed to VCM;11 (6) reports on statistical theories about extrapolating 7. J.A. 2728-59, 3037-54, 2974-76, 3187-3239, 2887-95, 2864-86, 2838-63, 3241-53, 3254-57, 107-116. 8. J.A. 1129-59, 2930-38, 2927-29, 3128-67. 9. J.A. 2919-26, 3168-86, 3076-99, 3128-67, 3055-56. 10. J.A. 3055-56, 2709-25, 3128-67, 1522-32, 2927-29, 2898-2918. 11. J.A. 391-429, 430-41, 442-61, 665-705, 2650-60, 3750-55, 899-903, 1904-16, 1917-19, 2690-91, 2692-93, 65764, 1309-17, 1032-36, 3100-04. ` fiOR 004502 , ,.i>i ----- sa- .... .abjA*;. /' 4 i * - - -- - 1 1r **^k*:---t>T j>-iV_; ^.i l. Miairt n-riT 12 observed carcinogenic effects in animals for the purpose of reach ing valid conclusions about effects on man and on evaluating observed characteristics in human populations exposed to VCM;12 and (7) comments by scientists asked to evaluate the foregoing.15 More than anything else, the scientific evidence in the record demonstrates conclusively that the quest for certainty in explain ing the relationship between VCM and cancer will require much more time than the nine months that elapsed between the time when VCM was first suspected as a cancer-inducing agent in humans and the issuance of the new standard. Dr. Irving R. Selikoff, of the Mt. Sinai School of Medicine, described the infancy of the state of scientific knowledge on the carcinogenic properties of VCM (J.A. 487-90), and aptly de fined the problem as "the question is, what do you do in the absence of knowledge" (J.A.500). Dr. SelikofFs conclusion was confirmed by all the other scientists involved in these pro ceedings,14 and particularly by Dr. Frank Standaert who evalu ated the scientific record after its close at the request of the Assistant Secretary. His conclusion is, as follows (J.A. 3732, 3735): "The deficit in our knowledge is so great that there is no hope of getting adequate quantitative data in the foresee able future and a full explanation of the hazard is probably 12. J.A. 213-46, 2666-89, 1615-25, 316-47, 361, 977, 480, 1225, 1275, 1432, 1900, 3724-42; Tr. 433, 969-70, 1034, 1767. 13. J.A. 316-47, 359-63, 374-75, 442-61, 486-500, 50314, 616-22, 969-78, 1309-17, 1321-28, 1420-21, 1423-24, 1428-29, 1432-39, 1896-1902, 2690-91, 2311-2421, 3724-42, 3743-49. 14. See, e.g,, Dr. Marcus Key, Director of NIOSH (J.A. 316-47); Dr. William Lloyd of the NIOSH staff (J.A. 352); Dr. M. L. Keplinger, Manager of Bio-Test (J.A. 622); Pro fessor Maltoni (J.A. 3055-56); and Dr. David `Wegman, OSHA Consultant (J.A. 3742-49). P5" !> . MMjqj >IP I |l"l BOR 004503 -^.A-^y,. -yir-J- ^.'-J - --'-...^..v v-- , ^ r ii J air ~ ^ - iwi rr-""-*"*-L^1-1 1* 13 several decades away. Since we do not and cannot know what concentration of vinyl chloride is dangerous for man, it will not be possible to set a standard on a solid basis of fact. The best that can be done is to try as hard as possible to reduce the potential medical risk without incurring un acceptable economic risk. ***** Clearly a standard cannot be set on the basis of factual medical, toxicologic, epidemiologic, or pharmacologic data. Such data do not exist." (Emphasis added) OSHA's Office of Planning, Evaluation and Research sum marized the consensus of informed opinion as follows: "The medical evidence must be considered to be both inadequate and incomplete. It has raised the questions that much be examined and answered. What it does not do, however, is answer them" (J.A. 2991). OSHA's Final Environmental Impact Statement confirmed that assessment (J.A. 3285-93). (a) Animal Experiments and Statistical Extrapolation Therefrom to Posit Effects on Humans. The two important animal studies--those of Professor Cesare Maltoni of Bologna, Italy, and Industrial Bio-Test Laboratories ("Bio-Test")--were not completed when the new standard was issued. Thus, only one of Maltoni's 15 experiments has been concluded, and more are planned (J.A. 3055-56). Bio-Test's exposure experiments were completed during September 1974, but the mice involved will not be sacrificed for observation purposes until February 1975 and the rats and hamsters not until September 1975 (J.A. 125-32, 3076-99, 361-64). A final report is not expected until January 1976 at the earliest and perhaps not even until Sep tember 1976 (J.A. 3074-3186, 364, 2979-3036). However, preliminary yet important observations appear from both of these animal studies.18 First, although VCM has produced tumors, both malignant and non-malignant, including 15. Dr. T. R. Torkelson, Senior Toxicologist, Health and Environmental Research Department, Dow Chemical Company, ("Dow") one of the pioneers in animal experimental studies in- N \ BOR 004504  I ih Ill'll *h~ .......... hi'*. 14 liver angiosarcoma in rats, mice and hamsters, species and intra-species differences in tumor induction are considerable. Tentative and preliminary observations of hamsters have im 1 plicated only VCM exposure concentrations of 500 and 2,500 ppm. Less than 5% of the mice and rats exposed to 50 ppm for four to seven hours a day, five to seven days a week for their lifetimes have developed angiosarcoma. Mice are much more ; susceptible to VCM induced angiosarcoma than are rats. The Sprague-Dawley rat is much more susceptible than the Wistar rat (J.A. 2500-2502, 3724-42, 3055-56, 3081, 3285-87; Ex. j 48C, p. 128; Tr. 1035). i :i Second, a dose-response relationship emerges for rats and mice exposed to VCM with respect to development of malignant and non-malignant tumors. Third, increasing the duration of VCM exposure increases the incidence of tumor induction. Fourth, the period of time required for malignant tumor induc tion (the latency period) in animals is quite prolonged with animals developing tumors late in normal life after exposure which commenced relatively early in life. Fifth, decreasing ex posure concentrations increases the latency period for develop ment of malignancy (J.A. 2709-25, 3055-56, 3286-87). Still awaiting completion are experiments by Maltoni and Bio-Test which will attempt to show effects of heavy exposure for short periods of time, of prolonged exposures to VCM con centrations below 50 ppm, and which will search for precusors of tumors in different animal species, including monkeys (J.A. 2709-25, 3055-56). Also awaiting completion are experiments seeking to determine what, if any, mutagenic effect VCM has on the developing embryo and fetus of laboratory animals. A great deal of the record is devoted to discussion about whether the preliminary and incomplete animal study findings volving VCM has expressed concern about the Bio-Test study design, noting that the starvation of animals and the 7-hour per day exposure has produced stresses that may have contributed to the induction of tumors wholly independent of VCM exposure (J.A. 3074-3186, 362-63). WJl-J *'**1 :W".milieu 14 BOR 004505 7 jte. i itfu. ri i 15 could be applied to show an effect of VCM exposures on hu mans. All scientists, except one, concluded that extrapolating from the results of the animal data to posit an effect on humans was speculative and hazardous. Indeed, Professor Maltoni cautioned the Assistant Secretary in this regard, as follows (J.A. 3055-56): "* * * I feel that at the present time it is a difficult task to determine to what extent data on animals may be extra polated to man." Dr. Marvin Schneiderman, Associate Director for Field Studies and Statistics, National Cancer Institute, stands alone in his willingness to apply bio-statistical models to show a projected \ incidence of liver angiosarcoma in humans based on the experi mental animal data (J.A. 213-46). Dr. Schneiderman's sta tistical theories when applied to these proceedings would, in i effect, require human exposure at a non-detectable level. In this context, these theories support the recommendations of die Ad Hoc Committee on the Evaluation of Low Levels of Environ mental Chemical Carcinogens (J.A. 1615-25), of which Dr. Schneiderman was a member, that humans not be exposed to substances shown to be carcinogenic in at least two species of animals.18 In these proceedings, however, neither NIOSH nor OSHA has accepted Dr. Schneiderman's theories. Dr. Marcus Key, NIOSH's Executive Director refused to support Dr. Schneiderman's statistical approach at the hearing (J.A. 3164 16. This report's basic conclusion, however, impliedly cast doubt on Dr. Schneiderman's approach and endorsed the concept of "socially acceptable risk" as a means for setting exposure ,< levels, as follows (J.A. 1619): j "While science can provide quantitative information regard `J ing maximum risk levels, the task ultimately selecting socially acceptable levels of human risk rests with society and its political leaders. The evaluation of the balance^of benefits and risks, required for such a decision by society, should not be the result of uninformed guesswork but should be reached on the basis of complete and pertinent data, social as well as scientific." Wt.jMW 11^,1 illj, v BOR 004506 <***'- J i i *i i _ jV i J ': ,i r j ] 3 i '' "} v ( dk 16 47, 361). OSHA's Office of Planning, Evaluation and Research emphatically rejected the statistical theories, as follows (J.A. 2991): "* * * the search for immediate answers must not lead to improper conclusions. For this reason, statistical projections such as Schneiderman's must be seen for their limitations. His bio-statistical models for projected incidence of angio sarcoma of the liver in humans at various levels of exposure are premised on a human dose/response ratio analogous to that shown in the unfinished work of Maltoni and Bio-Test. His various extrapolations of the incidence of angiosarcoma of the liver in humans at levels below 50 ppm are based on two unproven hypotheses: (1) that rat reaction to VCM exposure is at least as severe as human reaction, and (2) below 50 ppm the posited risk curve is continuous with the curve above 50 ppm." OSHA's Final Environmental Impact Statement adopted a simi lar position with respect to Dr. Schneiderman's theories, as follows (J.A. 3286): "The results of these studies have only slightly advanced the understanding of the carcinogenicity of vinyl chloride. They highlight the many unknowns that need to be clarified before a definitive extrapolation to humans can be made." The refutation of Dr. Schniederman's approach is not limited to comments by government agencies involved herein or to the testimony and comments of other scientists in these proceedings, including Dr. Selikoff himself (J.A. 480, 496, 977, 1225, 1275, 1432, 2000, 3724-42, 164-68a, 2001-2003; Tr. 433, 969-70, 1037). These statistical theories have been subjected to rigorous scholarly analysis and rejected as unsound and misleading at scientific meetings devoted to this subject (J.A. 2^66-89).17 The animal data and the statistical theories were evaluated by Dr. Standaert, as follows (J.A. 3727-29): 17. Claus, et al.. Chemical Carcinogens in the Environment and the Human Diet: Can a Threshold Be Established. s. HP >JMJi iP DJW i IJIUJI i ,Jf Bor 004507 It ti'i ri-^iTuirl!>- --'* lff..-,>>.J-- -'^V'TitT--'-- - M, ; i 17 'i "With regard to animals [rats and mice], it is clear that 50 ppm, four or seven hours a day, five days a week for a lifetime is a powerful carcinogen but there have been no experiments at lower concentrations and therefore there is no way of knowing whether lower concentrations are also dangerous. * * ** Some scientists have taken numbers from these experiments, and have attempted to project the dose response curve below the observed values. Such projection is speculative, at best. Even at the high end of the curve, the data are scanty and give a poor basis for line fitting. They give no grounds for extrapolating to the unknown. More fundamentally, there is no proven or theoretical reason for extrapolating the curve. ***** Finally, there is no way of projecting from the animal data to man." (Emphasis added) (b) The Human Experience--Bio-Statistical Surveys of Populations Exposed to VCM. Dr. Marvin Kuschner, Dean of School of Medicine and Chairman of The Department of Pathol ogy, State University of New York at Stony Brook, reported that there is really little more to be learned from further animal experimentation (J.A. 1900). As stated at the hearings by Dr. Michael Baden, Associate Chief Medical Examiner of New York City, the human experience is much more relevant (J.A. 2001).18 As previously noted, the record shows a significant clustering of liver angiosarcoma in this country's PVC facilities. A total of 13 cases of liver angiosarcoma have been confirmed among workers exposed to VCM. Seven of those 13 cases are associated with Goodrich's Louisville PVC facility and three are associated with Goodyear's Niagara Falls plant. Those bio-statistical studies of the causes of death and of the physical conditions of em- N 18. Dr. Herman Kraybill, of the National Cancer Institute, .i testified that he had seen no data showing that the liver functions in rats were similar to those in humans (J.A. 275), JUipi* U ^J1,! MU-*'* I ' j *VJfplti1JJIJJ ^ ( ' an.ti.li&iliUi iK' fU iT1 tf- i BOJi 004508  1~ t W i -- * - J f t . 18 ployees exposed to VCM at the Louisville and Niagara Falls PVC facilities showed, as would be expected, increased incidence of death caused by liver angiosarcoma than would otherwise be predicted as well as an increased incidence of other non-malignant changes in physical condition. Similar studies of PVC workers employed in plants where no deaths or only one death attributed to liver angiosarcoma had occurred revealed no sig nificant differences in causes of death or in the physical condition of employees than would be expected.10 More significant, however, are the mortality study performed by Dr. B, B. Holder and the medical surveillance study by Dr. Ralph Cook. Dow employees exposed to VCM at concentrations less than 200 ppm exhibited no liver abnormalities or causes of death different from what would be expected in a non-exposed population (J.A. 1173-1200, 1282-1308). Two epidemiological studies of populations of PVC employees involving more than one PVC facility are also included in the record. In the first, Dr. Carl Dernehl of Union Carbide studied 1,402 employees working at PVC plants where no deaths attri buted to VCM had occurred. Those employees had been sub jected to long term (10-20 years) exposures at VCM concen trations estimated by odor, and verified by a VCM odor detec tion test (J.A. 2441-48), to be well above 250 ppm, and perhaps as high as 2,000 ppm. No cases of angiosarcoma were found, nor were any significant differences discovered in em ployee liver functions than would be expected (J.A. 657-64). More important. Dr. Dernehl compared the incidence of liver angiosarcoma in the plant populations where deaths from that cause had been identified with the populations from plants where no deaths from liver angiosarcoma had been identified, and concluded, as follows (J.A. 663): "The plants in which cases of angiosarcoma have been found have an employment of 1,188 persons. The finding* 19 19. See Studies performed for Diamond Shamrock (J.A. 1309-17); Air Products (J.A. 1032-36); Firestone (J.A. 191719, 2692-93). Biy, .m m. iwr '* WHU1XJJ'!**''** -- -- .-- . ~ . -M .,M ---------- -. . . . . . . . . .. ..-J-C . 1 > J i.: BOR 004509 -i 4| 1 `r f $ 3 i j i 3 l 1 W;i, ; .vwii utiiniiiiM Vl "liBiit i ir "iMrt* 19 of 13 [angiosarcoma] cases results in a ratio of one angio sarcoma for each 91 employees. If these plants are the same as the plants in this survey the incidence of angio sarcoma should be in the same ratio and we should have found 21 cases. The fact that not one case was found cannot be ignored. There are people in the survey group who have the same latent period as those seen in cases of angiosarcoma. This suggests that the difference lies in the degree of exposure which in the survey group is esti mated at more than 250 ppm in early years and about 50 ppm in recent years." The other large population study involved 8,384 persons who had experienced at least one year of exposure to VCM and was performed by Tabershaw-Cooper Associates, Inc. (J.A. 665-706, 2650-60). The trends shown by the data collected in this survey may be summarized, as follows: 1. The overall mortality of the study population (which included 683 persons with 10-20 years VCM ex posure, 104 persons with more than 20 years VCM ex posure, 986 persons first exposed to VCM between 10-20 years ago and 416 persons first exposed more than 20 years ago) was approximately 75% of what would be ex pected in a comparable population of United States males; 2. No cause of death showed a statistically significant excess over what would be expected in a comparable United States male population; 3. Cancers of the liver (primarily angiosarcoma), respiratory system, brain, and cancers of unknown pri mary site, as well as lymphosarcoma, occurred more often than expected in those members of the study population with the greatest exposure, but the excesses were not statistically significant; 4. Other cancers occurred at lower levels than in the general male population, with the exception of cancers of the buccal cavity and pharynx. There was an excess of ^ these cancers which was inversely related to exposure.30 20 20. This study has been criticized by Dr. Joseph Wagoner of the NIOSH staff primarily because it includes employees who have had as little as one year of exposure (J.A. 3750-55). HM*m (c) The Human Experience--Clinical and Histological Ob servations. OSHA's Office of Planning, Evaluation and Research concluded that the results of the bio-statistical studies referred to above are "inconclusive" and "must be viewed with an eye towards [sic] their limitations" because of (1) the complexity and length of time required to do the back-tracking and tracing of 'lives of workers studies, (2) the small samples involved, (3) the long latency period associated with occupational can cers, and (4) the unavailability of accurate data on historical exposures (J.A. 2988, 2990-91). Dr. Kuschner observed that determined efforts to define and identify low-level occupational exposures in which no tumors have occurred in humans and studies of the mechanism of inducing the tumor in humans would be much more productive (J.A. 1900). Clinical studies of carcinogenic processes generally have demonstrated that reducing the levels of exposure to carcinogens results in lengthening the induction time for malignant tumor development,21 to the point where, as Dr, Key recognized in connection with VCM, tumor induction would not occur until well beyond the normal human lifespan (J.A. 54-56, 3286-88). Clinical and histological observations have, moreover, pro vided critical insights into the relationship between VCM ex posure and cancer in humans. Prior to the mid-1960's, an giosarcoma of the liver was not associated with VCM exposure (J.A. 107-116). Acroosteolysis--a clubbing of the bone structure of the extremities--in the hands of workers who cleaned PVC reactors was the only physiological phenomenon associated with VCM exposure, aside from anaesthesia induced by ex tremely high concentrations (J.A. 3187-3239, 3278, 3281-82). A satisfactory curb on the development of acroosteolysis had 21. The Department of Health, Education, and Welfare's study "The Health Consequences of Smoking" (Public health Service 1973) at pp. 67-75 shows, for example, that the risk of cancer development from smoking decreases with a decrease in exposure and that those who stop smoking experience a marked decline in the risk of developing cancer. , ..ill ijUMiffinii BOR 004511 fTfiiMurt .. -.,o..^. .-- ,-----ja jitfa--aift 'r ~tu fiii' iW^W 21 been achieved by requiring workers to wear gloves when cleaning reactors and through improved cleaning methods. The papers of a group of scientists from the University of Bonn22 alerted the scientific community to VCM's potential for a greater impact on humans. Reporting on exhaustive and thorough examinations of 13 PVC workers who had worked as reactor cleaners, these studies showed that long-term exposure to VCM can trigger a complex syndrome in humans--changes in skin, bones, blood vessels, and other organs. In early stages of development, obstruction of connective tissue, particularly blood vessel connective tissue, was observed, and blood cir culation disturbances followed. The complex syndrome identified was characterized by fibrotic transformation--non-malignant tissue scarring--of the lungs, liver, spleen, skin and vascular system (J.A. 2864-86, 3187-3239). This significant work has been carried forward in this country by Dr. Hans Popper, of the Stratton Laboratory for the Study of Liver Diseases of the Mt. Sinai School of Medicine and Dr. Louis Thomas, of the Laboratory of Pathology of the National Cancer Institute. Together they have observed slides of the livers of all cases of VCM induced angiosarcoma in the United States. From these observations. Popper and Thomas have categorized all but one of the highly publicized angiosarcoma cases observed during the Spring of 1974 in Connecticut in dividuals who had not worked in PVC plants as definitely not similar to VCM induced angiosarcoma (J.A. 2973-76). The findings of Drs. Popper and Thomas on the relationship between VCM and cancer have advanced the state of sci entific knowledge considerably. First, they observe that angio sarcoma in PVC workers is the result of a precursor non-malig- 22. Lange, et al., The So-Called Vinyl Chloride Disease: Does It Represent An Occupational Systemic Sclerosis (J.A. 3187-3239); Veltman, et al.. Clinical Manifestations and Course of Vinyl Chloride Disease (J.A. 2864-86); Lange, et al. Further Results In Polyvinyl Chloride Production Workers (J.A. 2887-95). ^ t..s..-.^ ..- -i-1^*- * ir tin BOR 004512 * ..'Jan*,JL-,Mllri------- <Hr7--W 22 nant fibrosis (J.A. 2728-59, 3037-54). Second, the evolution from precursor fibrosis to angiosarcoma is observed to be iden tical to the evolution induced by exposure to inorganic arsenicals (J.A. 2728-59, 3037-54). Drs. Popper and Thomas were unable as of the time the record was closed to isolate histologically the causes of the early stages of fibrosis or to determine whether the fibrosis is generated by VCM itself or by a metabolite of VCM in the body (J.A. 2728-59, 3037-54). A significant study of the metabolic pathways VCM follows in the body, however, has been conducted by Dr. Perry Gehring and his colleagues at Dow (J.A. 1127-67, 2930-38). Dr. Gehring and his group, in a sophisticated series of ex periments, have theorized that the ultimate carcinogen is caused by a chemical formed by the metabolism of VCM in the body and not by VCM itself. They have observed in the bodies of rats that VCM is metabolized by means of three different chem ical pathways; that one of those pathways is the primary means by which VCM is metabolized and then eliminated from the body; and that as VCM is metabolized, the non-protein bound sulfhydryl group, part of the defense mechanism against car cinogens, functions with decreased efficiency. When the primary metabolic pathway is saturated by a high VCM exposure and is incapable of metabolizing all the VCM in the system, the Dow group found that the other two path ways then commence functioning to metabolize the remain ing VCM. Observations have revealed the primary metabolic pathway to be saturated above exposure concentrations of 220 ppm, and that one of the two alternate pathways is saturated above concentrations of 1,000 ppm at which time the third pathway begins to also metabolize VCM. It is hypothesized by Dr. Gehring and his group that metabolism by the two alternate pathways which begin to function only when the primary path way is saturated produces the ultimate carcinogen (J.A. 112767, 2930-38). Their findings that metabolism of VCM by JWfl --W.Winlim'WUi.V.n tmr TWW BOR 004513 - '" r " ft iW W 'frjtfcftl 1 |1I it l i |- - iH iV iff I f` ` f f* f -j r - 1 fc)>? w . to * . . *.*< tV t t u tf n J l-ifrtSrti ,.r >n w~- -^ - H i.t.i. H ill n r n.iH^^ -g.-- .4. ~* *- 23 pathways in the body is saturable have been confirmed by a group of English scientists (J.A. 2927-29).23 Dr. Gehring's work with Rhesus monkeys and with humans has also shown that inhalation of VCM, rather than absorption through the skin, is the means by which detectable concentrations of VCM enter the body (J.A. 2939-43). (d) Scientific Opinions Regarding an Acceptable VCM Ex posure Concentration for Humans. All scientists requested to evaluate the evidence agreed that a dose response relationship with respect to VCM induced angiosarcoma probably existed with respect to humans, but that the threshold level of no effect remained to be determined. For example, Dr. Kuschner con cluded that there was not sufficient knowledge for determining a safe level of VCM exposure for humans but that neither was there sufficient scientific knowledge to conclude that levels at which no detectable ill effects occur do not exist (J.A. 1901). Others concluded that safe threshold levels of VCM exposure could be predicated.24 25 The consensus of informed opinion is that the lower the level of human exposure to VCM, both in terms of intensity and duration, the lower the risk (J.A. 316-47, 354, 487, 500-501, 620-21, 2148, 2003; Tr. 1173). Also, there is clear recogni tion, particularly by Dr. Key of NIOSH (J.A. 361, 54-56), that the period of latency prior to development of angiosarcoma might be extended beyond the life expectancy of humans.2* 23. Green, et at., Pharmacodynamics of Vinyl Chloride In Relation to Its Oncogenicity. 24. Dr. Paul Kotin formerly Director, National Institute of Environmental Health Sciences (J.A, 974, 977), Dr. Gehring (Tr. 970), Dr. Baden (Tr. 1690), Dr. Thomas H. Milby, Adjunct Associate Professor of Occupational Medicine and Environmental Health, University of California (J.A. 189394). 25. Early reports on Professor Maltoni's rats showed that at VCM exposures of 50 ppm the latency experience was equiv alent to 80 human years (J.A. 561). BOR 004514 Mttill miYfAVrtrtrtiii ----- " ---1 1 .i.tdifw rflVi riw ^4|. 24 Finally, it was agreed that the state of scientific knowledge was insufficient to show that there would be any difference in ef fects on humans of VCM exposures at 10, 15 or 25 ppm (J.A. 362-63, 1279-80, 1328, 1439, 1584). The scientists differed on what philosophy to embrace with respect to recommending a level of human exposure as a pru dent occupational safety and health standard given the absence of knowledge about effects of present low level occupational exposure. Relying primarily on the results of the animal studies and the recent reports of 13 human angiosarcoma cases among Amer ican PVC workers, Drs. Selikoff, Schneiderman, Wegman and Standaert, embraced the philosophy that humans not be exposed to VCM, a position consistent with affording employees an ab solutely safe work place free from all risk (J.A. 442-61, 21346, 3724-42, 3743-49). Emphasizing the affirmative evidence produced by scientists at Dow and Union Carbide showing no adverse effects on humans of VCM exposures below 200 ppm and 250 ppm, respectively, Drs. Gehring and Dernehl con cluded that a 50 ppm exposure level for humans would not constitute an unreasonable risk (J.A. 657-64, 1277). Dr. Baden, drawing on his experience with risks of death in society generally, also concluded that a 50 ppm VCM exposure level would provide "appreciably less of a health risk than many other risks to health, industrial and otherwise, that our society has judged acceptable" (J.A. 2690). Finally, Dr. J. Wister Meigs, Associate Clinical Professor, Occupational Medicine, Yale University, also rejected the absolutest philosophy adopted by Dr. Selikoff and others and con cluded that VCM exposure concentrations as high as 40 ppm, with phased reductions to 20 ppm over two years would be scientifically and medically reasonable (J.A. 2409-21). BOR 004515 J 25 2. The Assistant Secretary's Findings and Conclusions with Re spect to Scientific Knowledge of the Health Hazards of VCM The Assistant Secretary determined that VCM is carcinogenic in three animal species and in man. But, the Assistant Secretary was impelled to conclude that "the precise level of exposure which poses a hazard and the question of whether a safe ex posure level exists, cannot be definitively answered on the rec ord" (39 Fed. Reg. 35892, J.A. 3). The Assistant Secretary ignored the fact, established by both Professor Maltoni and Bio-Test, that considerable species and interspecies strain differences have been exhibited with respect to development of angiosarcomas as well as non-malignant tumors in animals. Nevertheless, the Assistant Secretary found that the inducement of angiosarcoma in rats and mice at VCM exposure concentrations of 50 ppm coupled with 13 confirmed human angiosarcoma cases associated with high VCM exposure was sufficient to mandate that human exposures not exceed VCM concentrations of 1 ppm averaged over an 8-hour period and 5 ppm averaged over a 15-minute period. In essence, the Assistant Secretary's determination rests on (1) the statistical theories for extrapolating observed effects in animals to posit an expected human experience propounded by Dr. Schneiderman and constituting a foundation for the policy of the Surgeon General's Ad Hoc Committee on the Evaluation of Low Levels of Environmental Chemical Carcinogens ("Ad Hoc Committee") that humans not be exposed to substances shown to be carcinogenic in at least two species of animals and (2) the philosophy and policy that because a safe VCM exposure level at or below 50 ppm cannot be delineated with complete cer tainty at this time, to assure humans an absolutely safe work place no exposure to VCM is permissible. The Assistant Secre tary did not explain why he adopted these policies which conflicted with the informed viewpoint of many scientists ex pressed at and after the hearings. BOR 004S16 26 Dominating the Assistant Secretary's findings and conclusions with respect to the human experience with VCM exposure is an exposition which fails to articulate the policy choices confronting the Assistant Secretary. First, the Assistant Secretary' ignored the revolutionary im plications of the work of Drs. Popper and Thomas which pro vides a basis for the detection and possible cure of disease be fore it reaches malignancy. The Assistant Secretary also failed to recognize, consistent with studies on the general development of cancer in humans, that the dramatic reduction of human exposures to VCM by industry raises the substantial possibility that induction of malignant tumors will occur, if at all, only after man's normal lifespan. Second, the Assistant Secretary's findings and conclusions essentially ignored, without providing a reasoned justification, the human experience with VCM exposure and are devoted almost entirely to identifying perceived shortcomings in sample size and populations studied in the Dow bio-statistical studies. Although the same type of shortcomings apply with equal force to the bio-statistical studies which tend to support the Assistant - Secretary's position, only the Dow studies are singled out for criticism. Not mentioned are the bio-statistical studies submitted by Air Products, Diamond Shamrock, Firestone and Union $ Carbide which clearly do not support the Assistant Secretary's determination. Also not mentioned are the findings of the Tabershaw-Cooper study which conflict with the Assistant Secretary's determination, although the Assistant Secretary does cite the findings of that study tending to show multiple organ involvement as a result of VCM exposure without noting that those findings were not statistically significant.20 26 26. In this context, there is a finding that approximate!' three-quarters of those employees with the longest exposure to VCM (greater them 20 years since initial exposure) have not yet been located. Yet, the record provides no basis for such finding. Furthermore, Union Carbide reported to the Assistant Sccrc- BOR 004517 ,f r^, ;r r m i w M t o r it o . ^ * i tt,m n^ , ; -, -/uu -f ......is;.'.... -O'A, n,i:Arv^ Third, the Assistant Secretary dismissed the research into the pathways in which VCM is metabolized in the body of a basis for setting the standard on the sole ground that the Maltoni and Bio-Test experiments had shown tumor induction at VCM concentrations of 50 ppm. Not articulated by the Assistant Secretary in this context are the possible shortcomings of the Bio-Test and Maltoni study designs with respect to exposure concentrations and times, stress factors, strain and species dif ferences, which can contribute just as much to tumor induction as VCM concentrations of 50 ppm. Finally, the only recognition by the Assistant Secretary that scientific certainty does not exist in delineating the health hazard of VCM exposure is in the finding dismissing the relevance of the cluster of human angiosarcoma cases in three PVC plants. Yet, no explanation is provided by the Assistant Secretary as to why the absence of scientific knowledge renders the clustering phenomenon not relevant in setting the standard when the state of scientific learning is no more advanced with respect to extrapolating from animal data to posit an effect on humans, a factor relied on almost exclusively in the Assistant Secretary's determination as to the health hazards of VCM. C. Technical Feasibility of the Final Standard 1. Engineering and Technical Data in the Record Substantially all of the engineering reports, technical data and scientific information concerning the engineering aspects of the proposed statement and its technical feasibility were sub mitted by representatives of the VC and PVC industries and by independent engineering consultants engaged by industry to study engineering improvements in plant facilities and to tary that it had located all of the employees who had worked at its Texas City PVC facility since its inception and that there were no liver abnormalities or causes of death different than expected (J.A. 2431). BOR 004518 j' i 5 .1 si - v 5f 3 1 : s > 28 report on feasibility. In addition, many representatives of fab ricators or users of PVC resins presented comments with respect to thr proposed standard, but the scope of their presentations esser.r.-Uly was limited to economic impact reports and their ability to function under no-detectable VCM exposure levels. As noted, during the public hearings in July, OSHA com missioned a consulting engineering firm, Foster D. Snell, Inc., a subsidiary of Booz, Allen & Hamilton, Inc., to conduct an engineering and technical feasibility study and an economic impact analysis of the costs industry would incur in attempting to comply with various VCM exposure levels front 50 ppm to the no-detectable level required by the proposed standard. Ap parently, this study was ordered because neither OSHA nor NIOS11 had conducted a technical feasibility study prior to is suance of the proposed permanent standard (J.A. 1366-67, 363). The temporary emergency standard issued by OSHA on April 5, 1974 required the VC and PVC industries to operate their facilities at a ceiling exposure level of 50 ppm (39 Fed. Reg. 35896, J.A. 7). The VC and PVC industries are generally able to comply with the exposure levels of the temporary stand ard. Nevertheless, there are some job classifications in the PVC sector of the industry which are subject to VCM concentration levels in excess of 50 ppm, thereby frequently necessitating the use of respiratory devices among a limited number of PVC indus try workers. (See e.g., Mr. Walker of Firestone, J.A. 1686-87. 1973). The record indicates, however, that in order for the PVC industry to meet the exposure level limit of the temporary standard on a permanent basis, through engineering control methods, substantial capital improvements and expenditures requiring up to a year and a half to implement and increased annua) operating costs would be required (J.A> 1686, 3550, 3556-57). Even prior to the temporary standard's adoption, the PVC industry generally had commenced to make the capital improvements necessary to effect a reduction of VCM concen- -Jw-" L< 1- u MB i^mi BOR 004519 29 trations to the 50 ppm ceiling level, (See e.g., J.A. 1171, 1693, 1982-83, 230S, 2327-30, 2427-28, 1043-1048, 942-45.) The nature and complexity of the chemical processes involved in producing vinyl chloride and polyvinyl chloride resins were described in some detail by a number of industry and govern ment witnesses. (See e.g., J.A. 1829-30, 3297-31; Ex. 48(c), pp. 1-6). By virtue of the nature of the process, equipment and location of plants which are engaged in the production of VCM, VC producers generally have been able to reduce ex cursions of VCM into ambient plant air to levels much lower than can be achieved in the PVC industry. VCM production facilities essentially are highly automated, continuous closed circuit systems utilizing production equipment which normally is installed in the open without structural enclosure. Although certain areas and job classifications in VC plants may present significant VCM exposure risks, concentration levels at such plants generally are relatively low (J.A. 3507-09). In this regard, the Snell organization reported that average VCM ex posure levels in VC plants are less than 10 ppm in four major job classifications (J.A. 3581-82). Despite the existing low average VCM concentration levels in VC plants, industry representatives presented engineering data and reports indicating that reducing exposure levels to the no-detectable 'eve! fixed by the proposed standard was not feasible because o: process and equipment difficulties inherent in the system and because of the lack of any known engineering technology artain such a level. (See e.g., Mr. Oelfke of Dow, J.A. 10-'--S.) The final Snell report confirmed that it is not feasible "rough engineering controls alone for the VC sector of e mmnmry to reach the no-detectable level of the proposed smmmrr. <J.A. 3584). The mes: emsmsive commentary, engineering data and scientific mi :tmodion submitted for the record with respect to N technical rVmmliry concerned PVC resin plants, facilities, equip ment and ::-mrr.os. all of which addressed themselves to the t 1 BOR 004520 jo- MM r.'iaottaawi 30 question of the technical feasibility of the no-detectable level and various alternative concentration levels. Firestone con ducted in-depth engineering studies with extensive reports in cluding much specific data with respect to design, equipment availability, costs and delivery schedules which- it submitted for the record. Many other companies reported on the results of investigations and studies conducted by them in their respective facilities. VCM exposure varies according to job classification but it appears that workers involved in tank car unloading, reactor cleaning, entry of vessels containing VCM for maintenance and repair work, entry of PVC storage silos, shipping and packaging of the PVC resin, and those who work in process areas are subject to the highest concentration levels because of equipment leakage (J.A. 3316-17). The Snell organization esti mated that average VCM concentrations in PVC plants are less than 50 ppm for four broad job classifications: production, maintenance, laboratory and management and support, which includes plant managers, engineering and clerical staffs. In all instances, however, even in the management and support classi fication, concentration levels average 1 ppm or more (J.A. 3581).27 Considerable evidence was submitted demonstrating that be cause of the nature of the polymerization processes employed in producing the various types of PVC resin, the PVC industry's effort to reduce VCM emissions is confronted with complex engineering and technical problems. Essentially, the inability to achieve low concentration levels stems from limitations in exist ing technology and the state-of-the-engineering art.28 The dif- 27. Industry's monitoring data indicates much higher VCM concentration levels in the PVC sector than is reflected by the Snell report. Most companies, however, confirmed that exposure levels of personnel even in the management and support job classifications, which include clerical staffs, average 1 ppm or more (J.A. 2302-2303 , 2312-18, 2323-26; Ex.`193(c); Ex. 25E; Ex. 27A; Ex. 150; Ex. 189L; Ex. 194(a)). 28. See Snell final report (J.A. 3584). .4,II)L, iiTHLijnnjim BOR 00452X 1 31 ferences between the production of the monomer and PVC which precludes PVC producers from reducing ambient ex posure levels to those effected in the VC industry were sum marized by a Tenneco representative who pointed out that VCM production constitutes a "continuous chemical process carried out within a substantially closed system", whereas pro duction of PVC resin (J.A. 836-37): "* * * requires opening of processing vessels after one or more batches have been polymerized; the removal of water, unreacted monomer and inerts from the polymer after the reaction through a series of stripping, venting, and drying steps, and finally the bagging or bulk loading of a solid material at the end of the process. * * * [Most plants] in the industry have, for safety reasons, been designed so that these various operations are separated from one another by considerable distances. Therefore, the problem of emis sions is not confined to a relatively small and manageable area, but is one that exists throughout an entire multi-acre plant site." One factor that causes considerable difficulty with respect to VCM containment is the extreme volatility of VCM which is a gas at room temperatures and, therefore, must be stored, trans ported and pumped at pressures greater than atmospheric pres sure (Ex. 48(c), App. 138-42). Because of this pressure dif ferential, every piece of equipment in the polymerization process becomes a potential emission source of VCM to the ambient air (J.A. 1562, 934-39). As the record amply demonstrated, there is no technology or equipment available to the PVC in dustry which would enable it to prevent these leaks or occa sional excursions of VCM to the ambient plant air (J.A. 372, 1047-48, 775-76, 940, 1968, 932-34, 944, 568). For example, Mr. Williams of Diamond Shamrock stated that an engineering task force identified over 500 potential sources of VCM exposure in Diamond Shamrock's PVC facilities, conclud ing that the "limitations of the mechanical integrity of the vast number of vessels, agitators and pump seals, and thousand? of BOR 004522 Mlii i^a0mUSdm 32 gaskets, flanges, and valves make it impossible to eliminate or contain all VCM emissions" (J.A. 1330-31). Other PVC procedures and equipment, designated as posing particular emission problems, are pump seals, compressors, valves, lab sampling, reactor heads, opening, flushing and clean ing reactors, cleaning valves, lines, etc., PVC build-up, plugged lines resulting from gasket failure, airing out vessels, sampling unstripped resin, spills from unplugging lines, screening, drains and testing (J.A. 1818-20,. 1831-33, 939). The final Snell report confirmed the evidence presented by industry with respect to the major engineering and technical problems confronting industry's attempt to reduce VCM concentration levels (J.A. 3629-33). Because of the nature of the polymerization process with its attendant technical, engineering and equipment inadequacies, the evidence submitted to OSHA during these proceedings con firmed without contradiction that it is not possible to achieve VCM concentration levels below 10 ppm TWA in the PVC industry now or at any time in the foreseeable future. SPX main tained the position at the public hearings that a graduated ex posure level standard should be adopted by OSHA in order to permit the PVC industry to operate at exposure levels con sistent with present and anticipated technology. The levels and effective dates recommended by SPI were: Effective Date October 5, 1974 October 5, 1975 October 5, 1976 Ceiling (ppm) 40 25 25 TWA Ceiling (ppm) 25 - 10 The SPI recommendations, however, were, in effect, merely targets or goals which some SPI members believed might be achievable provided new technical developments, progress in engineering controls, additions to facilities and equipment in stallations were accomplished amply in advance of the proposed effective dates (J.A. 548; see also, J.A. 552-53, 933, 16041605). This uncertainty was particularly evident with respect to ' rtfriirtH *-,(*<*4*' w '~'vV" the proposed 1976 10 ppm TWA level in light of the serious ; doubt that such a level can ever be technically attainable.28 i Several major PVC producers objected to or qualified their ?< position with respect to the SPI proposal on the ground that the technology does not presently exist assuring ability to achieve the lower SPI recommended levels and because there is no ra tional, factual or scientific basis on which to believe that ade quate technological progress would be made prior to 1976. Thus, Air Products, which operates two PVC plants, stated that the SPI levels below a ceiling of 40 ppm and a TWA of 25 ppm would be "much more difficult and much more speculative as to achievement", and refrained from supporting such lower levels on the ground that it cannot be stated with certainty what will result from technology which is yet to be applied. (See Richard Fleming for Air Products, J.A. 933; see also, John T. Barr for Air Products, J.A. 944.) Similarly, Todd C. Walker of Firestone stated (Tr. 1684-85); "Firestone's engineering studies indicate that it is impossible on the basis of the present state of technology and the en gineering art to predict with any degree of certainty that the reduced levels suggested by SPI can be achieved in existing facilities."30 An engineering consultant to Firestone, Dr. Frederick B. Hig gins, Associate Professor of Environmental Engineering Tech nology and Chairman of the Departments of Environmental Engineering and Civil Engineering Construction Technologies at Temple University, concluded with respect to the possibility of meeting a "10 ppm TWA level" that (J.A. 1939); "A level of 10 ppm on a time-weighted average basis might ultimately be achievable in existing PVC plants through construction of extensive and costly new ventilating collect- ----------------------- ------------------------------------------------------------------------ -----------------------------------..x. 29. One PVC producer called the SPI proposals "good goals" while questioning whether the 1976 levels were technically attainable" (Hooker, Ex. 55, pp. 7-8). 30. See also, Pantasote (J.A. 2704).* >"11 !l; if -a v r^a 'U ti- m ira flr r f tn -.-ft >''< -an.^i A .. -ji3^L=.-- 34 ing and exhausting systems, particularly in high concentra tion areas and through revised handling methods in transfer areas. However, on the basis of present technology, no definite forecasts can be made as to whether this low level can be attained. Whether such a low level is practical or achievable can be determined only after the new equipment and engineering procedures have been installed."31 The final Snell report concurred that there is serious question as to whether a 1,0 ppm TWA level is technically feasible for the PVC industry. Thus, the Snell organization stated as a conclu sion to its study, that there is: "* * * Significant Engineering Uncertainty Or Infeasibility Beyond * * * 15-25 PPM Ceiling and 10-15 TWA for the PVC Industry" (J.A. 3585). See also Exhibit VI-1, included among the conclusions to the Snell report, which noted that VCM exposure levels within the range of 10-15 ppm TWA are subject to high engineering risks or are not feasible (J.A. 3587). The record further indicates that even if the concentration levels recommended for the PVC industry by SPI could feasibly be effectuated through technological developments, it would be impossible for industry to make the necessary engineering design changes, plant modifications and equipment replacements within the times specified in the SPI proposal. Thus, the Snell report concluded that compliance through engineering controls would 31. Dr. Higgins' conclusion with regard to attaining a level below 10 ppm TWA is reiterated throughout the record. The record demonstrates that, from an engineering standpoint, there is no practical difference between a 0-1 ppm and a 10 ppm standard because compliance with any standard below 10 ppm is not technologically feasible, as the quote from Dr. Higgins' study indicates. See also, Goodyear (J.A. 2303) (10 ppm ceiling is a "goal" with "not all technology * * * now in sight" to render that goal a reality); Mr. A. W. Barnes, Chairmaa.of the British Chemical Industries Association's Vinyl Chloride Committee (J.A. 543-44 ("the figure of 10 ppm vinyl chloride * * * is for us a target figure, which we might hope (but cqnnot guaran tee) to achieve * * *. [I]t is highly unlikely that, however much money we spent and whatever we did, we would ever get below about 10 ppm"). QjiMVfUfP iw'iiuhm jjiihhh mum i -- f - r - --- ........i-- BOR 004525 St 4 ; 35 '.i i take two and one-half years merely to achieve a 25-40 ppm ceiling; two and one-half years to achieve a 15-25 ppm ceiling; : n\ and four years to achieve the 10-15 ppm ceiling range which the report concluded was a high engineering risk or not feasible at all (J.A. 3587, 3636). Moreover, the Snell report indicates that major processing changes requiring research and develop ment will take 4 to 7 years (J.A. 3533-34). :. 5 The delays in implementing plant modification and equipment replacements, even if the appropriate technology were available, is partly due to the time required to design, order, receive de livery of and install the new equipment. Many witnesses testified 'i that equipment deliveries could take between two to three years (J.A. 782-83, 943-44; Tr. 1523; see also, J.A. 3627-28). This delivery problem is expected to deteriorate as the entire industry l is simultaneously in need of the same equipment (J.A. 944). -i OSHA's own studies have confirmed this. One of its reports has i stated that (J.A. 3031); 'i "The industries that provide these services and equipment will most certainly not be able to meet this sudden surge ; in demand, thus creating shortages and long lead times. This would be especially critical if deadlines are written into the permanent standard." `I Firestone's engineering studies are in accord with those sponsored by OSHA. Firestone estimated that it will take up | to two years to achieve a 50 ppm ceiling through engineering >1 controls, and three years to achieve a 25 ppm TWA with a 40 ppm ceiling. To attempt to achieve a 10 ppm TWA with a 15 ppm ceiling or lower, will take four to five years (J.A. 17971817). With respect to very low concentration levels, including the no-detectable level, the expert testimony in the record uniformly 4 concluded, without contradiction, that with today's technology accomplishment of such levels is infeasible. This position was 3 stated by industry representatives (J.A. 1048, 755, 746, 1668, * M*3 ' -*1 36 1958, 1987, 2303, 2426-27, 2704, 565, 933, 1331-32, 156062; Ex. 27A; Tr. 1136; Firestone's Pottstown Engineering Study, J.A. 179; Firestone's Perryville Engineering Study, J.A. 1824; Engineering Study Prepared by Frederick B. Higgins, Jr., Ph.D., P. E. Chairman of Environmental Engineering Technology, Temple University, J.A. 1939; Engineering Study conducted by Bowshot, Cooper & O'Donnell for Uniroyal, J.A. 1561-62). Moreover, this position was sustained by Dr. Key of NIOSH (J.A. 368) and by the Snell study (J.A. 3584, 2982). Summarizing the effects of attempting to reach a 0-1 ppm standard, the Firestone engineering study with respect to its Perryville, Maryland PVC plant concluded (J.A. 1824): "We have employed the most advanced engineering tech nologies and system designs presently known or anticipated in our study, but there are so many complex engineering factors involved it cannot be predicted whether any ex posure level below 50 ppm can be reached until after the equipment has been installed and the design changes ac complished. However, in the judgment of our staff, it is technologically impossible to meet the non-detectable ex posure level required by the proposed standard through engineering and technological means regardless of the amount of capital expenditures that might be made to im prove and upgrade our plant." The Snell report confirms the studies conducted on behalf of industry. This Teport concluded that (J.A. 3584): "Achieving `No Detectable' Levels of VCM Principally Through Engineering Means Is Judged Not Feasible With Present Technology Both In The VCM And PVC Sectors." This study went on to explain that based on its "independent assessments of the state-of-the-art of the technology", it was required to conclude "that achieving `no-detectable' (0-1 ppm) W rntjli IWIW-! * J>< !WWPMff BOR 004527 4 in ft I** --inr--*1" *1 i 37 *4 VCM levels in the VCM industry is not feasible principally through engineering means" (J.A. 3584).** \ In accord with industry assessments, this OSHA commissioned i i study concluded that reaching levels even higher than a 0-1 ppm i standard was probably technologically impossible (J.A. 3589): "* * * the technology required for compliance with the lower VCM levels is not yet proven. Consequently, con 1 siderable risks exist as to the efficacy of engineering con trols even for levels other than `no detectable', which is not technologically feasible." j i In light of this absence of sufficient technology, the Snell report determined that the lower a standard was set, the greater a percentage of industry would be placed in danger of being "i! required to shut down. Therefore, with a standard requiring a ceiling of 10 to 15 ppm and a TWA of 5 to 10 ppm, Snell's assessment was that approximately 60% of the industry would J be endangered. At a 1 ppm TWA concentration level, the study determined that 100% of the industry would be endangered of being forced to close (J.A. 3587). Virtually all PVC industry representatives who filed technolog tiy ical feasibility reports or who testified at the public hearings stated that if the no-detectable or a 1 ppm TWA concentration } ,4 level were adopted by OSHA, they would be required to dis Il continue their PVC operations. For example, the Firestone engineering studies concluded that if a 0-1 ppm standard were adopted. Firestone would have to close down its PVC opera- i 32. The reasons stated in support of this conclusion in the Snell report are that: (1) PVC manufacture is a batch opera tion; (2) technology, including state-of-the-art developments, is not available to eliminate VCM leaks and fugitive losses; (3) existing plants have not been designed for total VCM containment; (4) there is no design or operating experience in \ the industry' aimed at maintaining very low VCM levels; and'' (5) no direct technology transfer opportunities are known to enable development of designs for `no detectable' levels in new plants (J.A. 3584-85). 1 a ; i HJ I.MIJI i* 38 tions. This was not a matter of dollars; rather, it was the sheer absence of technological feasibility and the impracticability of requiring continuous respiratory protection for long periods of time (J.A. 1791)." Most PVC companies would, therefore, be directly con. fronted with the alternatives of an imminent shutdown at a 1 ppm TWA level or virtually placing all employees in respirators 100% of the time which industry spokesmen and respiratory experts reported would be, in effect, no alternative at all because continuous wearing of respirators by practically all PVC per sonnel was totally impractical, dangerous and infeasible.34 As was noted by Mr. Hughes of Union Carbide (J.A. 2426): "* * * the proposed standard will require, as a practical matter, all personnel in any restricted area to make 100 percent use of respirators at all times or for a major portion of the work day. Union Carbide holds that it is imprac tical and unsafe for employees to work regularly and rou tinely with respirators such as are required by the proposed standard."85 33. Staff members of the Division of Program Evaluation and Research of OSHA impliedly recognize the real possibility of 100% industry shutdown. In a report filed in these proceed ings, it is stated: "The proposed standard proposes difficult issues for government and industry to consider. First, it is not clear that it is technologically feasible to comply with the proposed standard without a shutdown of the entire vinyl chloride in dustry" (J.A. 2982; see also J.A. 1560-62). 34. J.A. 2425-26, 1331-32, 821, 847, 834, 2705, 551, 724, 1763-64, 1788, 1825, 719, 535, 285, 303; Tr. 1136. 35. See also. Statement of Mr. Arnold of Firestone (J.A. 1788): "Since the entire plant complex is periodically or con tinually exposed to levels above the detectable limit, the standard provides that immediate respiratory protection must be provided for and used by every Employee in the complex. Because of the magnitude of exposure reduction necessary to bring a significant portion of the plant into compliance, use of respirators would be necessary for many BOR 004529 <i< 1l lr---f- iiiitiiitfi'Vfi .1 f i * 39 A number of witnesses took a contrary view with regard to technological feasibility and expressed the opinion that achieving a 0-1 ppm level of exposure was possible through engineering means. These witnesses were either not professionally qualified or V.1 admitted that they had conducted no technological studies. See, e.g., Dr. Key of NIOSH (J.A. 363); Mr. Boyd of OSHA (J.A. 185-86, 1366-67); Mr. Beliczky of the United Rubber Work ers (J.A. 380); Dr. Nicholson (J.A. 480); Dr. Selikoff (J.A. 511-12); Dr, Quigley of the American Chemical Society (J.A. X 1461); Mr. Mazzochi of the Oil, Chemical and Atomic Work ers (J.A. 1541); Mr. Cottine of the Health Research Group (J.A. 1628); Dr. Standaert (J.A. 3736); and Dr. Wegman (J.A. 3741). Mr. Mazzochi testified that his union's position with respect to the feasibility of a 0-1 ppm standard was derived 4l by asking officers of local unions, none of whom were engineers or chemists (J.A. 1542). * 2. The Assistant Secretary's Findings and Conclusions with Respect to Technical Feasibility With regard to technical feasibility, the Assistant Secretary noted in the preamble to the final standard that industry "uni versally claimed that it is unfeasible for the VC and PVC indus tries to remain below 1 ppm consistently, using engineering controls", and that the Snell study on technical feasibility "con cluded that a 1 ppm ceiling is not feasible for the VC and PVC industries with present technology." Referring to the contrary view, the Assistant Secretary states: "Labor union spokesman and the Health Research Group, Inc., however, have suggested that such a level is attainable" (39 Fed. Reg. 35892, J.A. 3). years. Since there would be no unregulated areas in the jjlant, employees would become virtually immobile. Each time any employee found it necessary to move more than fifty (50) feet from his work station he would be requireds to switch to a portable back pack unit. Under these restric tions personal hygiene requirements become almost im possible." .\ \ ""Tag,* ( I I i I i\ i f i i Bor 004530 v Recognizing that there is no actual evidence that any VC or PVC manufacturers have attained a 1 ppm level, and that estimates as to the lowest feasible level attainable necessarily involve subjective judgment, the Assistant Secretary included as a finding that (39 Fed. Reg. 35892, J.A. 3): "We agree that the PVC and VC establishments will not be able to attain a 1 ppm TWA level for all job classifica tions in the near future. We do believe, however, that they will, in time, be able to attain levels of 1 ppm TWA for most job classifications most of the time. It is apparent that reaching such levels may require some new tech nology and work practices. It may also be necessary to utilize technology presently used in other industries." Among his formal conclusions in support of the 1 ppm TWA exposure level, the Assistant Secretary stated, inter alia, that although it is not "clear to what extent exposures can be feasibly reduced", based on the available evidence "we also believe that the VC and PVC establishments will, in time, be able to attain that level through engineering controls" (39 Fed. Reg. 35892, J.A. 3). The final standard requires that where "feasible engineering and work practice controls will reduce exposures below the per missible levels, they must be instituted" (39 Fed. Reg. 35893, J.A. 4). If such controls are unable to reduce exposures be low the permissible level, they must "be supplemented by the use of respirators" (39 Fed. Reg. 35893, J.A. 4). Thereafter, "a continuing program of engineering and work practice con trols must be instituted to reduce exposures to the lowest prac ticable level" (39 Fed. Reg. 35893, J.A. 4). In this regard, the final standard requires that plans for achieving controls by engineering and work practice methods must be drawn up by industry and be made available, upon request, to representa tives of OSHA and NIOSH. Pointing out that no deadlines have been established for full compliance with engineering controls, because OSHA is unable to determine when it will be feasible BOR 004531 ------ ---------- ------- th * 41 for most establishments to reduce exposure levels to the per missible level, the Assistant Secretary stated (39 Fed. Reg. 35893-94, J.A. 4-5): "As noted above, the standard requires all employers to institute feasible engineering controls to the fullest ex tent and to continue to improve and apply engineering controls until full compliance is achieved." With respect to the Assistant Secretary's assumption that the VC and PVC industries will be able, in time, to achieve the 1 ppm TWA concentration level of the Final Standard, there is no reference to any technical or engineering data sup porting such a conclusion nor is there discussion of the reasons or rationale for such a belief. Also, the Assistant Secretary's ob servation that the VC and PVC industries will be able, in time, to attain the permissible exposure levels in most job classifica tions most of the time is not supported by any reference to the record and fails to discuss those job classifications and the con trol means which might be utilized to achieve such a condi tion. No reference is made to the findings of the Snell report which indicate that all job classifications in the VC and PVC sectors, including management and clerical, are exposed to VCM concentration levels in excess of the permissible level. In stating that to meet the 1 ppm TWA exposure level it may be necessary to utilize technology presently used in other industries, the Assistant Secretary failed to explain or discuss what technology might be borrowed from other industries or to discuss the Snell report's conclusion--that there are no technological transfer opportunities known to enable the VC or PVC industries to design plants capable of achieving a 1 ppm concentration level (J.A. 3585). Finally, there is no explanation or discussion by the Assistant Secretary why it was not appropriate to adopt separate industry N standards in view of his express recognition that inter-industry technological differences exist. The rationale for electing to impose the same standard upon three decidedly different indus tries is not stated nor is there any reference to the factors con sidered by the Assistant Secretary in making this policy deter mination. D. Utilization of Respiratory Protection Against Inhalation of VCM 1. The Record Evidence Pertaining to Respirators The Assistant Secretary's proposal for a new standard recom mended the use of four different models of the same type of respirator to protect employees, on a temporary basis, from ex posure to VCM above the no-detectable level (39 Fed. Feg. 16898, J.A. 23). The type of respirator recommended was the self-contained breathing apparatus with a full face piece, oper ating under positive pressure or in a pressure demand mode depending on the model involved. The record on respiratory protection includes evidence with respect to three distinct types of respirators: self-contained breathing apparatus; air line, or air supplied; and air purifying.*8 Mr. Edwin C. Hyatt, a special OSHA consultant on respira tors, concluded with respect to the self-contained breathing ap paratus type of respiratory protection: "At best, any of these de-36 36. A self-contained breathing apparatus contains its air or oxygen source in a tank or tanks carried on the back of the wearer with uncontaminated air supplied to the wearer by the force of his demand therefor (demand mode) or by continuous flow regardless of demand; provides full protection for any concentration of toxic gas or oxygen deficiency; and is usually for emergency use. An air-line or air-supplied respirator has a hose connected to an uncontaminated air source with air or oxygen supplied in demand mode or by continuous flow and is normally employed for specific tasks or for hazardous environ ments. An air purifying respirator removes contahtinants from an atmosphere that contains sufficient oxygen by filtration, ad sorption or by chemical reaction with the contaminant: the filter, adsorbent, or chemicals utilized are contained in a cartridge or canister that is the essential element of the device (J.A. 518-35). BOR 004533 i .11 ,1 J 43 :1j vices are [sic] an instrument of torture" (J.A. 303).*T Every other expert on respiratory protection in this record agreed with that assessment.38 Thus, a self-contained breathing apparatus is of considerable weight and size, dramatically impairs mobility of the wearer, and would, therefore, be totally impractical for use by reactor cleaners who could not wear them when climbing into and out of reactors (J.A. 286, 518-35, 707-19, 732-39, 1068-89, 1712-83). Because such units require recharging from 12 to 16 times per work day, their impact on worker productivity would 1 i be devastating (J.A. 518-35, 709-19,1068-89). Many employees are unable to tolerate the continuous wearing of such units, usually because of claustrophobia or other psychological prob lems (J.A. 286-87, 518-35). \ Similarly, severe safety hazards were associated with air-line respiratory equipment. An air hose can easily cause an employee to trip and fall; kinking of the air line cuts off the air supply; air hoses diminish mobility; a leak in an air hose will allow inhala tion of the toxic material; and an air hose impairs a worker's ability to deal with an emergency because a retracing of steps is required when the air line's length is exhausted (J.A. 707-19, 732-39). In addition, with respect to all types of respiratory protection, the consensus was that respirators are extremely uncomfortable to wear; impair vision; preclude speech; do not evaporate pers piration; cause allergic reactions, drying of the eyes; increase it i 37. Hyatt noted that one of the four models of self-contained breathing apparatus proposed by the Assistant Secretary was not even in existence (J.A. 282). 38. In addition to Mr. Hyatt, the experts on respiratory pro tection are Dr. Joseph F. Tomashefski, M.D.' Head of Pul monary Disease Department Cleveland Clinic (J.A. 518-35); Dr. Robert Soule, an independent industrial hygiene consultant (J.A. 707-19); Dr. Roger Strassburg, Director of Environmental Affairs, Goodrich (J.A. 732-39); Mr. Karl Oelfke, Production .: i Manager, Texas Division, Dow (J.A. 1068-89). wr II ' V* IJ 111 " I f ! t! i 1 i 1 \ t t ( [ ii i f* i BOR 004534 Mtaftiibh 44 fatigue and accidents; cause excessive noise levels and particu larly, if operating in the demand mode, place considerable stress on and exacerbate pulmonary function problems and weak hearts (J.A. 518-35, 707-19, 732-39; Tr. 312-16, 577-78, 382-84). Moreover, face'pieces manufactured in America are available in only one size and shape, which may increase wearer discomfort and the possibility of leaks (J.A. 305). The Snell final report determined that only two of the four models of self-contained breathing apparatus proposed by the Assistant Secretary were commercially available. The supply of the other two models is, according to the report, short, perhaps resulting in a 40-week delay between order and delivery if de mand required only 500 to 700 units, barely enough for the workforce of one of the largest PVC plants (J.A. 3565). The Snell report advised that the cost of the commercially available respiratory equipment was from $515 to $615 for each unit, with maintenance costs averaging $900 per worker per year (J.A. 3565-66). In addition, the Snell final report concluded that the entire workforce in a totally enclosed PVC facility located in the northern United States would be required to wear respiratory protection 100% of the time if the permissible exposure limit was fixed at lppm ceiling and if engineering controls were not available for implementation. The entire workforce of an open air PVC facility in the southern United States would, moreover, be required to wear respirators one quarter of the time if the exposure limit was set at 10 ppm TWA, and available en gineering controls had been implemented (J.A. 3567). All of the experts on respiratory devices agreed with Dr. Tomashefski that "the use of respirators for full-time protec tion in vinyl chloride and polyvinyl chloride production facili ties is unsafe and infeasible" (J.A. 535).89 OSHA's Final En-39 39. Dr. Soule: "it is just not practicable, and indeed it is in many ways unsafe, to operate a chemical production facility when the working force is required to wear respirators of any l,l - 1U.JPHWM-M'WW BOR 004535 >v .j . -3 a 1 t ? 1 i1 ***** SAteiM&ifiMftttu* I 45 vironmental Impact Statement confirmed this assessment as follows (J.A. 3271): "Wearing respirators continuously in itself can constitute an unsafe situation." 2. The Assistant Secretary's Findings and Conclusions with Respect to Respiratory Protection In the new standard, where engineering controls cannot achieve exposures approaching the permissible level, those con trols implemented must be supplemented by the use of respira tors. Until January 1, 1976, however, employees whose expo sures do not exceed 25 ppm may decline to wear respirators, although the employer is still required to supply them to all when exposures exceed the permissible level (29 CFR 1910.93q(g)(1) (1974), J.A. 7). Although the Assistant Secretary's findings recognize that "respirators have many drawbacks" and that he did not con template their use as a final solution (39 Fed. Reg. 35894, J.A. 5), nevertheless, the Assistant Secretary finds that respi rators will be continuously required for some time to come. The Assistant Secretary provided no comment with respect to the safety hazards or feasibility of long-term respiratory use. . Data Concerning the Economic Impact of the New Standard 1. Economic Data in the Record The evidence in the record with respect to the economic feasibility of the new standard falls into two major categories: compliance costs and economic impact. (a) Compliance Costs. The only evidence detailing the cost of engineering controls came from two sources: Firestone and the Snell final report. type on a full-time basis" (J.A. 719); Dr. Strassburg also concluded that full-time use of respirators is "impractical and even hazardous" (J.A. 732). } I \ i k { i \ i | il ij i BOR 004536 -v^.|A,Y^e.. -111^'fiL.-V,lt.-.T sTff,` uM*2&i 46 Firestone commissioned a study by Catalytic, Inc., an inde pendent design engineering and consulting firm, to provide capital cost estimates of specified engineering modifications necessary in an attempt to meet various employee exposure levels in both of its two PVC facilities.40 Catalytic concluded that to consistently achieve a VCM exposure concentration of 50 ppm ceiling at the two PVC facilities would cost $10,138,000. To achieve a VCM exposure concentration of 25 ppm TWA, $20,203,000 would be required. This expenditure would rise to $39,368,000 should Firestone attempt to achieve a VCM ex posure concentration of 10 ppm TWA, with no assurance that such an exposure level could be achieved by technology. More over, despite enormous engineering and process changes esti mated to cost in excess of $55 million, the 0-1 ppm exposure level cannot feasibly be attained. The other major study of compliance costs is the OSHA com missioned Snell final report. Snell concluded that the PVC in dustry would have to spend about $49,400,000 in capital costs to comply with VCM exposure concentrations of 50 ppm ceil ing. These capital costs would rise to $99,100,000 should the industry be required to achieve VCM exposure concentration of 15-25 ppm TWA with a 25-40 ppm ceiling. An attempt to reach VCM exposure concentrations of 10-15 ppm TWA with 15-25 ppm ceiling would require $229,000,000, with no guarantee of technological capability for at least two and one-half years (J.A. 3561). The Snell report offered no cost estimate for a 0-1 standard. Instead, in a footnote, it stated (J.A. 3561): "If the PVC industry expended the capital funds repre sented by the Firestone analysis of attempting to reach the infeasible `no detectable' levels, total capital costs are estimated to be in the order of $856 million * * The Snell final report also offered estimates of the cost of compliance with various exposure levels per thousand pounds 40. See, J.A. 1879-82 for specific breakdown of Catalytic, Inc. computations. ii.JPJ. i UVJ1WIW BOR 004537 47 of PVC resin (J.A. 3350-54). However, the Snell final report made none of its own cost determinations with regard to a VCM exposure concentration of 0-1 ppm and instead, used Firestone data.41 OSHA's Final Environmental Impact Statement has accepted industry estimates as to engineering costs and recognized that such costs necessitate doubling the industry's current capital investment (J.A. 3260-87). The costs of monitoring systems, another element of com pliance costs, for each PVC facility, have been estimated by the Snell final report to be $100,000 in capital outlay and $80,000 in annual expenditures (J.A. 3560-61 ).42 The Snell final report concluded that: "Increasingly strict VCM compliance requirements are expected to result in signif icantly greater price escalations for PVC than for VCM" (J.A. 3555). In OSHA's Final Environmental Impact Statement, price increases are also recognized as inevitable, as follows (J.A. 3345): 41. The Snell final report also includes a case study of a "representative" PVC pilot plant (J.A. 3636). The estimates of engineering and equipment modification costs contained in this study do not confirm Snell's capital and annual cost esti mates for industry generally but, instead, confirm Firestone's estimates. The case study indicates capital expenditures for the pilot plant to be 130% greater than the Snell report capital expenditure estimate for industry generally at a 10 ppm TWA25 ppm ceiling. When the pilot plant case study estimate is multiplied by Firestone's PVC production capacity, it translates into $33,500,000 for direct engineering costs (see, Ex. 199(b), App. A-E), a difference of only $267,100 from Firestone's estimate. The plant case study also included for a 10 ppm TWA25 ppm ceiling level, an estimate of the total direct costs, . ; including productivity losses, of $100.50 per 1000 lbs. When applied to Firestone's PVC production capacity, this translates into $50,750,000. 42. Union Carbide and Firestone alone are actually spend ing $600,000 for monitoring equipment (Ex. 65(a), App. HI; J.A. 1983). Bor 004538 nTi-if-v -`fitw-iTiiii I if* -1 rn --'A " f-'- 48 "In all likelihood, a substantial price increase may be necessary to insure the viability of the industry. Since de mand for PVC is strong and users have become dependent on this material, price increase will likely be accepted." In addition, increases in energy consumption must be con sidered in determinations of compliance costs.43 OSHA's Final Environmental Impact Statement noted that a non-detectablc exposure level "may necessitate increased energy consumption in polymerization plants" (J.A. 3345, 3347-48). Finally, Firestone has estimated that its workforce must be increased by 57% to meet a 50 ppm ceiling level. To comply with an exposure concentration of 25 ppm TWA, 40 ppm ceil ing level, a 63% increase in manpower will be required. A VCM exposure concentration of 10 ppm TWA, 15 ppm ceiling level will bring about a 100% manpower increase (J.A. 1783, 1802, 1808, 1817, 1845-52). The Final Environmental Impact Statement concluded that a standard requiring VCM exposures to be reduced to 1 ppm would not be economically feasible, as follows (J.A. 3344-45): "Engineering changes to reduce emissions * * * will be also substantial, and the capability of achieving 1 ppm may not be technologically and economically feasible for all plants. ** * ** The capital costs in polymer plants are likely to be sub stantial. Plants in this industry are so diverse that some may lose their competitive position, especially smaller firms with older equipment whose operations are already marginal. Previously, the heavy standards for PVC had ensured the continuance of such companies, but compliance with the proposed standard may prove to be an excessive strain. 43. Firestone's Pottstown Plant has estimated that its con sumption of steam will double; oil consumption will increase by .5 to 1.0 million gallons a year; electricity increases will be on the order of 15 to 20 million kilowatt hour? (J.A. 1795). Fire stone's Perryville plant has estimated that oil consumption will increase by 119% and electricity by 37% (J.A. 1867). Bor 004539 L- '* "fffahi^ri'rifh pi** j^tininiiiVii,>-- ~`cy- I frrwii 49 Several employers may find it necessary to close operations, concentrating the industry into fewer companies and caus ing disruptions of several markets."44 (b) Economic Impact. OSHA's Final Environmental Im pact Statement has shown that PVC "* * * finds its way to companies which constitute over 10 percent of the national economy" (J.A. 3350). Because of such domestic permeation, the Statement recognizes that (J.A. 3352): "[A] complete ban, causing a total shutdown of vinyl chloride or PVC plants, would severely disrupt the economy and worsen the employment situation. In all likelihood, a shutdown of VC and PVC plants would reverberate throughout the economy by effecting work stoppages in important sectors of the economy." 1 Arthur D. Little, Inc. ("ADL") conducted an industry im pact analysis to determine the effect on the national economy should the entire PVC industry be required to shut down. The ADL study concluded that a potentially devastating "ripple" or "domino" effect would result from a shutdown of the PVC industry, as follows (J.A. 2593, 2617, 2620): J "Because of the high degree of interdependence among il sectors of the economy and lack of adequate substitute materials, production cutbacks in PVC-related markets would lead to further output reductions in a whole host of materials and service supplying industries. ***** On balance, our analysis indicates that the resulting eco nomic impact to the U.S. economy from an immediate shut down of all PVC resin plants would equal approximately $65-90 billion of lost domestic production, and a reduction in employment of about 1.7-2.2 million. Because of the 44. The Industrial Union Department of the AFL-CIO ("IUD") apparently agrees with this position. It has stated that, "it is a reasonable assumption that if shutdowns are to occur, they will be among PVC plants, probably among those which are old or small" (J.A. 2812). I --------'ll *1 50 magnitude of economic activity and extent of PVC-related products usage in the building and construction and auto motive sectors, these two segments of our economy would receive the greatest share of the total impact. Unavail ability of PVC resin will have production bottleneck effects in these areas in terms of insulated wire and cable, ; flooring, upholstery, and many other materials. ***** "[A]n immediate shutdown of all PVC resin plants in the "U.S. would generate an economic hardship of large magnitude that would create severe economic dislocations <; in many local areas." It further found that the full impact of such a shutdown would be felt disproportionately among regions. Massachusetts, for example, already suffers from a high unemployment rate. Be .< cause of its industrial dependence upon the PVC related shoe ti industry, any disruption in that industry would result in serious economic hardships for Massachusetts and the whole New Eng land area (J.A. 2619).4485 * * \ ; ADL's recognition of the ripple or domino effect from a PVC $ industry shutdown was confirmed by other evidence. General Motors (J.A. 2355-61) conducted its own internal study and concluded that a disruption in its PVC supply could lead to a corresponding disruption of its productive capability (J.A. 2359): "The disruption to our national economy, should polyvinyl chloride products become unavailable or drastically cur45. This data was confirmed by the American Footwear Industries Association (J.A. 1642-64). "If the footwear industry shut down the harshest consequences would be felt in small towns and rural areas. * * * An immediate effect * * * would be felt 41 most acutely in areas such as Maine, Massachusetts, Missouri. New Hampshire, New York, Pennsylvania, Tennessee and Wis consin. In those states there are heavy concentrations of factories producing footwear, and in many instances this production ac counts for a large share of the income of the smaller cities" (J.A. 1647-48). 1 BOR 0454I lift tn ijMlv-*-Dlitl--rf1-! "^'-i-- r:-,;~ v,. r ^. - - 51 tailed, could be incalculable. The impact on our employ ment would be only a small part of the total problem * * *. [I]t is conceivable that a complete shutdown of our U.S. manufacturing operations would be experienced. If this oc curred, as many as 450,000 hourly and salaried GM em ployes could be affected within the United States. The ripple effect could extend to as many as three additional individuals in the automotive-dependent industries for every General Motors employe affected, thus increasing GMrelated layoffs to possibly 1.8 million jobs." The primary reason for this pervasive economic impact is a lack of substitute material for plastic produced from PVC. As analyzed by the Final Environmental Impact Statement (J.A. 3346): "At present, there is no known material or materials which could substitute adequately for all the wide range of PVC uses." This assessment was confirmed by OSHA's Office of Planning, Development and Research and ADL (I.A. 3007, 3014, 2595). In addition, newer and/or open-air PVC plants will be re quired to spend less money, and thereby gain a considerable competitive advantage over older and/or totally enclosed PVC plants, in attempting to comply with exposure concentrations below the ETS (J.A. 184-87, 377, 1322, 1984, 1991, 3584; Ex. 159, p. 20; Tr. 195-96, 1488, 1705). Finally, the adverse effect of a stringent VCM safety and health standard, like the one promulgated by the Assistant Secretary, on America's position in foreign trade and the balance of payments was explained by OSHA's Final Environmental Impact Statement, as follows (J.A. 3347): "The demands for PVC resins are so great that each producing country is hard pressed to meet its own needs and is able to export very little. This situation will probably remain static for the foreseeable future, although an in--' crease in prices caused by the OSHA regulation could alter BOR 004542 \ -``-w- -*1 lt *Zbi* * is 'i 52 this stability. If domestic prices increase substantially, PVC i users may be able to obtain resins from manufacturers in - countries where regulation is less strict. This is not likely ' to occur in the short run because of internal demands in all countries. In the long run, U.S. companies might find 4 it profitable to build plants abroad."46 ) Moreover, such a stringent new standard may permit those PVC \ producers--e.g., Goodrich--which have substantial interests in foreign PVC facilities to gain a competitive advantage over \ those American producers--e.g., Firestone--which have no such `i interests. -; 2. The Findings and Conclusions of the Assistant Secretary with 1 Respect to Economic Feasibility of the New Standard v Despite the assertion of Daniel Boyd, Director of Office of Standards Development, OSHA, that OSHA recognized "eco <: nomic considerations" as well as technological considerations as a factor in the determination of the feasibility of a new standard, the Assistant Secretary made no mention of economic feasibility in his final standard other than to state that the Snell final report had been commissioned to deal with that subject. With regard to the results of that study, or any other economic study, no comment, findings or conclusions were made with respect to the economic feasibility of the new standard regulat ing exposure to VCM. N 46. The fear that foreign producers might force the United States' interests out of the PVC producing and fabricating in dustry appears throughout the record. See, e.g., lJ.A. 1642-64, 1991, 1961-62, 632; Tr. 1838, 1695, 1639, 1242. pimni'-U !. .). aiwpgy BOR 004543 irffhrt^Miri'w n^wwi, 53 ARGUMENT I. INTRODUCTION: THE STATUTORY SCHEME FOR PROMUL GATING AN OCCUPATIONAL SAFETY AND HEALTH STANDARD A. Elements Prescribed by Statute Section 6(b) (5) of the Act (29U.S.C. 655(b)(5) (1970)) (reproduced in full in Addendum A hereto) governs the prom ulgation of occupational safety and health standards dealing with toxic materials or harmful physical agents.47 Section 6(e) (29 U.S.C. 655(e) (1970); Addendum A) requires the Assistant Secretary to provide a statement of reasons for promulgating a standard.48 It is settled beyond question that Section 6(b)(5) of the Act prohibits the promulgation of any standard which cannot be achieved by technology and is not economically feasible. The legislative history of Section 6(b)(5) demonstrates this con clusively,49 and the Court in Industrial Union Department AFL- 47. Section 7(b) of the Act (29 U.S.C. 656(b) (1970)) permits the Assistant Secretary to appoint an advisory committee composed of representatives of employers, of labor, of profes sionals in occupational safety and health, and of the Secretary of Health, Education and Welfare to assist him in standard setting. An advisory committee was not appointed in these pro ceedings. 48. Also relevant to the statutory standard-setting procedure is Section 22 of the Act (29 U.S.C. 671 (1970)) which au thorizes NIOSH to develop occupational safety and health standards for recommendation to the Assistant Secretary. 49. The Congressional intent that occupational safety and health standards be capable of achievement by technology and economically feasible was expressed by then Senator Saxbe's com ment that safety and health standards should not be instituted at* 'I ii.llllllllBUiimi ~'i||ini ii mm i h i ,,JWL *WWW BOR 004544 AitttiTitli.,;, 54 C/0 v. Hodgson, 499 F.2d 467 (D. C. Cir. 1974), endorsed this requirement of the statute, as follows (at pp. 477-78): "* * * [Practical considerations can temper protective re quirements. Congress does not appear to have intended to protect employees by putting their employers out of busi ness--either by requiring protective devices unavailable under existing technology or by making financial viability generally impossible." Finally, the 1UD case also definitively established that the recommendations on an occupational safety and health standard made by NIOSH are not conclusive on the question of what ex posure levels adequately protect health and may be rejected by the Assistant Secretary in setting the standard. (See 499 F.2d at 477.) B. The Standard for Reviewing Determinations of the Assistant Secretary Section 6(f) (29 U.S.C. 655(f) (1970)) provides that the "determinations" of the Assistant Secretary in setting an occu pational safety and health standard "shall be conclusive if sup ported by substantial evidence in the record considered as a whole." the sacrifice of industry's ability to remain productive and com petitive (116 Cong. Rec. 36512, October 13, 1970). Refine ment of Congress' intent in this regard was contained in an amendment offered by Senator Dominick which subsequently was enacted as part of Section 6(b)(5). Senator Dominick's amendment clarified language previously proposed by Senator Javits, expressly rejecting the Daniels bill passed by the House which was interpreted to mandate absolute health and safety in all cases regardless of feasibility (S. Rep. No. 91-1282 at 7, 58, 91st Cong. 2nd Sess. 1970), to more clearly specify that the Secretary must promulgate, ". . . the standard which -most ade quately assures, to the extent feasible, . . .". Senator Dominick stated the purpose of his clarifying the amendment was to in sure that when dealing with toxic agents only those steps which are feasible and practical to provide a safe working atmosphere can be required of the employer (116 Cong. Reg. 37622 Nov 17, 1970). BOR 004545 i *****--* ' ^ntn "*-"n Mf|,--^f^^--^^-->^- - - - ---t"J'*`^---- 1 ? * * 55 * The familiar judicial definition of the "substantial evidence test" was developed in those cases where adjudications by ad ministrative agencies, particularly the NLRB, were challenged pursuant to statutes providing for appellate review thereof and specifying that questions of fact found by the agency shall be oonclusive if "supported by substantial evidence on the record considered as a whole." In Universal Camera Corp, v. NLRB, 340 U.S. 474, 487-88, 490 (1951), Justice Frankfurter, speak ing for the Court majority, reasoned that a reviewing court's assessment of "substantiality" of an agency record must take into account the body of evidence opposed to the agency's view. Appellate review pursuant to the substantial evidence test, however, has also been specified by Congress for agency pro ceedings, as here, which are not solely adjudicative in nature; which, are characterized as "informal rulemaking"; and whioh -is closely resemble legislative hearings. With respect to such proceedings, the appellate court is required to review, pursuant ;; to the substantial evidence test, questions of policy for which no * basis in fact exists, as well as questions of fact applied by the i agency. Both Associated Industries of New York State, Inc. v. Department of Labor, 487 F.2d 342, 348 (2d Cir. 1973), and - Industrial Union Department, AFL-CIO v. Hodgson, 499 F.2d 467 (D.C. Cir. 1974), have unambiguously rejected contentions that policy determinations made by the Assistant Secretary are to be reviewed under a test less stringent than the substantial evidence test.60 The traditional notion of the substantial evidence test that an assessment of a record's substantiality must take into ac count whatever detracts from its weight is the touchstone of a review proceeding involving "determinations" of the Assistant Secretary which include both questions of policy as well as fact. The fundamental principle articulated by the appellate'' courts in review proceedings of this type is that "determina-50 * 50. See also Florida Peach Growers Association, Inc. v. 1 Department of Labor, 489 F.2d 120 (5th Cir. 1974). WP.'.W.u J,J .IWHUfiwwi , | , |, jjijiipu . "W"'*----' 1 BOR 004546 wiT.niifc'-^iir Tfrl 1 > s . 56 tions" of an agency which do not set forth policy choices con flicting with the one adopted by the agency and do not explain the reasons for choosing one policy over another are not supported by substantial evidence in the record considered as a whole. See Industrial Union Department, AFL-ClO v. Hodg son, 499 F.2d at 475-76. J Judge Friendly, in his opinion for this Court in Associated In dustries, quoted with approval Judge McGowan's articulation of the reviewing court's obligation in Automotive Parts c Accessories Assn. v. Boyd, 407 F.2d 330, 338 (D.C. Cir. 1968) to insure that an identification of issues and justification for the policy choice made by the agency has been carried out in a manner calculated to avoid arbitrariness and irrationality. Accord, Synthetic Organic Chemical Manufacturers Assn. v. Brennan,____ F,2d_____ (3d Gir. 1974). To the same effect under statutes with substantial evidence test review provisions V similar to the Act, see International Harvester Company v, Ruckelshaus, 478 F.2d 615, 648 (D.C. Cir. 1973); Chrysler Corporation v. Department of Transportation, 472 F.2d 659 (6th Cir. 1972). Concrete examples of how the substantial evidence test has been applied in reviewing determinations of the Assistant Secretary illustrate the importance of the requirement that the policies contrary to the one chosen by the Assistant Secretary be set forth with a rational explanation of why those policies were rejected. In Associated Industries, this Court vacated an occupational safety and health standard establishing the minimum number of lavatories in industrial establishments because the Assistant Secretary failed to articulate a rational justification for choosing the highest numerical requirement for lavatories contained in any state safety code when a majority of states had opted for smaller minima; industry had objected to the minimum as finally promulgated; and OSHA had failed to produce any KffHPpppfL.II .. ' ip ,1 JIIM JN ( U. BOR 004S47 A`**' `iP*^ - ^[fflirt- yi?ntfifiAi 57 evidence or testimony in opposition to industry's point of view (487 F.2d at 352-53). In the IVD case, the Court, inter alia, remanded that portion of the asbestos exposure standard with respect to a uniform effective date fQr all segments of the asbestos industry because the Assistant Secretary had failed in promulgating the standard to articulate why he had chosen to ignore and, in essence, reject record evidence showing inter-industry and intra-industry dif ferences concerning the time needed by employers to meet the standard. In Florida Peach Growers, the Court vacated an ETS regu lating exposure to pesticides in part because of the Assistant Secretary's failure to articulate the reasons why he rejected the recommendations that an ETS was not justified which were made by a Standards Advisory Committee and Pesticides Sub committee convened by him pursuant to Section 7 and an in 4 ; teragency Task Group on Occupational Exposure to Pesticides. J! C. OSHA's Burden of Producing Evidence to Support the Standard Finally Promulgated It is settled that where, as here, the agency may act only on the record and with opportunity for oral hearing, the obliga tion to produce evidence in support of its position rests with the agency. Section 6 of the Administrative Procedure Act provides, in pertinent part (5 U.S.C. 556(d) (1970)): "The proponent of a rule or order has the burden of proof * * See also McCormick's Handbook of the Law of Evidence, 336 (E.W. Clearly ed. 1972). Both Associated Industries and the IUD cases, discussed above, have clearly established in this context that, particularly when confronted, as here, with overwhelming evidence in opposition to its position, OSHA is obligated, indeed required, to bear the burden of eliciting evidence to support its standard. Thus, in Associated Industries, Judge Friendly stated the critical principle as follows (487 F.2d at 352-53): in- "m BOR 004548 y - ^ i p i 1' - ^ ,r r in * ^ F f f - i -- t f ii" 'r if r n w r iu > i<w r~r T1ti1M V n h ln 1-1T ' , -.^ -.'W -. W -ifr-r 58 'The point is rather that when the Department imposes a standard considerably more stringent than that which apparently has been found satisfactory by many states with a long history of protection to industrial workers, and particularly when it does so over explicit objections grounded on that- history, then it has an obligatidn to pro duce some evidence justifying its action. We can find none in the record here." (Emphasis added) See also Isbrandtsen Co., Inc. v. United States, 96 F.Supp. 883, 892 (S.D.N.Y. 1951). The Assistant Secretary himself has conceded that there is no evidence in the record herein either that the permissible exposure level promulgated is necessary to protect health and safety or that such a standard is technologically feasible. (39 Fed. Reg. 35892, 35893, 35894; J.A. 3, 4, 5). However, in the preamble to the new standard, the Assistant Secretary concluded that industry had not proved that current levels of exposure are safe (39 Fed. Reg. 35892, J.A. 3). This asserted failure by industry to adduce proof that VCM exposure concentrations higher than 1 ppm are safe cannot cure OSHA's failure to fulfill its obligation to adduce evidence that exposure levels above 1 ppm are unsafe. The burden is on OSHA, not on the opponents of its standard. n. THE DETERMINATIONS OF THE ASSISTANT SECRETARY ARE NOT SUPPORTED BY SUBSTANTIAL EVIDENCE IN THE RECORD CONSIDERED AS A WHOLE A. The Determination with Respect to the Human Health Hazards of Exposure to VCM Improperly Fails to Articu late the Policy Choices Confronting the Assistant Secre tary or to Provide Adequate Justification-Tor the Policy Promulgated in the Standard Scientific facts about the health hazards of,human VCM exposure at low level concentrations presently achieved by industry do not exist and clearly do not demonstrate any neces- BOR 004549 ) ir'-" * 4 i i **" ^ ->..n^.; _.Mtf-Le...........'-^- --*'* i 59 sity for the permissible exposure level of 1 ppm averaged over iany eight-hour period with a 5 ppm ceiling averaged over any i 15-minute period promulgated by the Assistant Secretary in the '1 f standard. The Assistant Secretary's special consultant, Dr. Standaert, OSHA's Office of Planning, Development and Re i search," and the Final Environmental Impact Statement unam i biguously advised the Assistant Secretary that there were no ! scientific facts showing exposures of humans to VCM at or below 50 ppm will cause cancer or harm of any kind. Affirma tive evidence produced, particularly by Dow and Union Carbide, > moreover, demonstrates that VCM exposures of 200-250 ppm produced no adverse effect on workmen so exposed. The atmosphere of crisis in which this standard was promul gated cannot obscure the real basis for the Assistant Secretary's determination with respect to the health hazards of VCM. It is solely a policy decision, without foundation in fact. J The first component of the policy choice made by the Assist ant Secretary was the acceptance of the statistical theories of *i Dr. Schneiderman and the position of the Ad Hoc Committee that induction of cancer in two species of animals at low level exposures to any substance can be extrapolated to show an effect t on humans and that, therefore, humans must not be exposed to such a substance. The Assistant Secretary did not even articulate the opposing view, expressed by every other scientist in these . proceedings, including the Assistant Secretary's own special con i sultant Dr. Standaert, NIOSH's Director Dr. Key, and sum s marized by OSHA's Office of Planning, Evaluation and Re - search: With respect to the effects of exposure to VCM, animal data cannot be extrapolated to man and statistical pro jections like Dr. Schneiderman's are invalid and, at best, mis leading in this context. In view of the record evidence in this case which shows that not one scientist, not even Dr. Key of NIOSH, would endorse Dr. Schneiderman's statistical projections from animal data to i s I l < ( f!i \ f 4SS0 >A/L-i+i taa ifr in'Ti i T1iH hrrt llki ,^( ri:,AdhOrii ii \ 'ir -; 60 man and that every other scientist, including Dr. Selikoff, and particularly Professor Maltoni himself, concluded that animal data could not be extrapolated to posit an effect on humans, the Assistant Secretary's policy choice to order a permissible expo sure level so low as to effectively provide that no employee ever be exposed to VCM is not rational. Moreover, the Assistant Secretary's policy choice embracing the automatic extrapolation of animal data to posit an effect on humans cannot be regarded as essentially a legal determination, as was his policy on extrapolation from animal data to humans in the Synthetic case. Unlike the situation in that case, which involved ethyleneimine, a liquid with chemical properties quite different from VCM, all scientists except one here clearly and unambiguously reject automatic extrapolation of animal data on VCM exposure to humans. Even if the Assistant Secretary's policy choice to extrapolate animal data to humans on VCM exposure is viewed as a legal determination in this case, it is clearly erroneous, arbitrary and capricious because of the over whelming record evidence in opposition. The very least that was required of the Assistant Secretary in these circumstances was a rational explanation of his reasons for rejecting the policy that the animal data cannot support an essen tially non-detectable exposure concentration in man. The Assist ant Secretary's failure to explain his reasons for adopting Dr. Schneiderman's approach is akin to Associated Industries and Florida Peach Growers where the Assistant Secretary's determi nations were vacated for failing to articulate a rational justifica tion for choosing among conflicting policies. And here, similar to Florida Peach Growers, the Assistant Secretary's policy deci sion on statistical extrapolation is contrary to the advice pro vided him by his special consultant as well as OSHA's Own Office of Planning, Development and Research and the Final Environ mental Impact Statement. Moreover, in view of the Assistant Secretary's recognition in promulgating the health and safety standard for 14 carcinogens, .11 upflP >*UWIWmp B0* 004S51 61 that levels of safe exposure may well exist with respect to exposure to carcinogenic substances generally (37 Fed. Reg. 3758 (1974)) it was particularly incumbent upon the Assistant Secretary to explain his rejection of that viewpoint in setting the standard in this case, where a number of prominent scientists stated that a safe threshold exposure level for VCM may Well exist The second component of the Assistant Secretary's policy choice is the philosophy expressed by some scientists at the hearing that every employee should be provided with a work* place absolutely free from a health hazard. Aside from the fact, more fully discussed below, that the Act itself does not mandate that each employee be provided with a workplace absolutely free from a health hazard when it is not technologically and economically feasible, the statute itself does not authorize the Assistant Secretary to provide, solely in terms of health matters, a workplace absolutely free of hazard. In its specification of the health purpose to be achieved by a standard, Section 6(b)(5) directs the Assistant Secretary to set a standard which "most adequately assures * * * that no employee will suffer material impairment of health or functional capacity" and to attain, con sistent therewith, the "highest degree of health and safety pro tection". (Emphasis added) Thus, a workplace absolutely free of hazard is not the Assistant Secretary's goal. That the purpose of Section 6(b)(5) is not to assure a work place absolutely free of risk is demonstrated by its legislative history. The present language of the quoted portions of Section 6(b)(5) above was offered by Senator Dominick to replace language that obligated the Secretary to insure, in standard set ting, that no employee suffer any impairment of health or functional capacity. In commenting on the language which his amendment eventually replaced, Senator Dominick stated as follows (116 Cong. Rec. 37622, 37614 (Nov. 17, 1970)): "Unfortunately [the language which his amendment re placed provided] that anyone would be assured that no one M Ji * i WV* 'ii> i. 62 would have a hazard, or at least, * * * would require the 5 Secretary to set standards so stating, and that in the HEW -i standard there would be a requirement to proceed on that basis, so that no one-would, ever have any problem for the rest of his working life. i v *** * * 5 It is unrealistic to attempt, as this section apparently does, to establish a utopia free from any hazards. Absolute safety < is an impossibility and it will only create confusion in the administration of this act for the Congress to set clearly 5i unattainable goals. ***** j The difficulty of the language I am dealing with here and that I am trying to delete is that the Secretary, in establish ing standards, must assure that there will not be any risk at all. 3 ***** Any administrator responsible for enforcing the statute '~4 '] will be faced with an impossible choice [by the language which his amendment replaced]. Either he must forbid : employment in all occupations where there is any risk of 4 injury, even if the technical state of the art could not remove the hazard, or he must ignore the mandate of Con 1 gress and allow the work to continue even though some danger exists." The test proposed by Dr. Baden is consistent with the statute's 5 purpose, confirmed by the legislative history, to assure that no i employee will suffer material impairment of health or functional capacity. He concluded that human VCM exposure at 50 ppm ? provides "appreciably less of a health risk than many other risks to health, industrial and otherwise, that our society has ; judged acceptable" (J.A. 2691). Both Dr. Demehl and Dr. Gehring also concluded that human VCtyl exposure con centrations of 50 ppm would constitute an acceptable risk.51 Assuring employees of a health risk "appreciably less than many 51. Dr. Meigs concluded that exposure concentrations much in excess of the permissible level mandated by the Assistant Secretary would be an acceptable risk. BOR 004553 wti irViiMii^^nfiiT rrtutlitfrl^^ --'------ * it lIM-- 63 other risks to health, industrial and otherwise" is clearly more consistent with the Assistant Secretary's obligation than the philosophy, rejected by the Act but adopted by the Assistant Secretary here, that employees must be provided a workplace absolutely free from risk. , Confronted, as here, with an absence of scientific knowledge with which to delineate the safe levels of exposure to asbestos or to conclude that a safe level of exposure does not exist, the Court of Appeals for the Eighth Circuit in Reserve Mining Co. v. United States, 498 F.2d 1073 (8th Cir.) cert, denied,.....-- U.S.......... (1974), conclusively rejected the absolutest philos ophy, expressed in that case by Dr. Selikoff, that no exposure whatsoever of humans to suspected carcinogens should be allowed. In that case enforcement proceedings under the Refuse Act, the Federal Water Pollution Control Act and the federal common law of public nuisance were invoked to enjoin Reserve from discharging taconite tailings (asbestos-like fibers) into Lake Superior and into the atmosphere surrounding Reserve's plants. Issue was joined in the appellate court on Reserve's motion for stay of the lower court's injunction requiring a plant shutdown where the lower court had been called upon to resolve essentially the same question that was before the Assistant Secre tary in this case: "What do you do in the absence of knowledge?" The state of medical and scientific knowledge about the health hazards of asbestos exposure was, as here, in its early stages and insufficient to base an informed opinion on the nature of the hazard to humans. But, unlike the instant case, where Dr. Baden has assessed the risk to humans to VCM exposure at 50 ppm to be less than other risks society has judged acceptable, a similar assessment of the health risk could not be made on the basis of the known scientific facts in the Reserve Mining case. Yet, the court still rejected Dr. SelikofFs expressed philosophy to resolve all doubts in favor of no human exposure whatsoever and absolute safety, as follows (at p. 1084): ,k i iii. Hl'rfi*"^1 ~ ' -- ' ~'r Ir iWi trft.' >i.mfrtn iniai.K^.iw<iWn>i "'-`i-n|.|r[lljtl fiiitit idM 64 "It cannot be said, other than as a matter of conjecture, that the discharges will result in any higher incidence of disease than that experienced by a general public not simi larly exposed. Although we are sympathetic to the uncertanties facing the residents of the North Shore, we are a court of law, governed by rules of proof, and unknowns . may not be substituted for proof of a demonstrable hazard to the public health." Consequently, the Court concluded that although Reserve would be unlikely to prevail on the merits of its challenge to the lower court's findings that its emissions polluted water and air, it would, on the basis of medical and scientific evidence, prevail in its contention that its emissions in air and water have not been proven to be a substantial health hazard to humans justify ing a plant shutdown. Application of the analysis and rationale of Reserve Mining impels the conclusion here that the Assistant Secretary's deter mination to set a permissible VCM exposure level of 1 ppm averaged over any eight-hour period with a maximum of 5 ppm averaged over any 15-minute period to protect employees from the health hazard of VCM exposure is not supported by sub stantial evidence in the record considered as a whole. This con clusion is even more compelling in view of the Assistant Secre tary's failure to adequately set forth the policy choices con fronting him; to articulate a justification for his choice of policy on statistical extrapolation and absolutism. B. The Assistant Secretary Rejected or Ignored the Uncon troverted Record Evidence Which Established That VCM Exposure Levels Below 10 PPM Are Not Technically Feasible, That Levels Below 25 PPM TWA Will Take Several Years to Attain and That There I No Evidence Supporting Technical Feasibility of a 1 PPM TWA-5 PPM Ceiling Exposure Level A critical issue on this appeal is whether the Assistant Secre tary properly fulfilled the statutory mandate requiring adoption igji,iMiin7ijii ..wipin''.'f.m.j > *" \r9***wTM*- fiO$ 4SSS jj^Miitfr--li aiuJtfcifil m inrfr ` Til'itHnn i nfr i 65 of safety and health standards that are feasible in light of the Assistant Secretary's implicit finding in this case that the final standard as adopted is not technically feasible. The record in these proceedings established without contradic tion that it is technically impossible for the VC and PVC in dustries to attain the 1 ppm TWA permissible exposure levels incorporated in the final standard. Indeed, the Assistant Secre tary found that technology. and engineering capability does not exist to enable either the VC or the PVC industries to achieve a 1 ppm TWA exposure level at any predictable time in the future. In spite of this express recognition, the Assistant Sec retary has imposed upon industry a grossly unrealistic regulation which places every segment of the VC industry in imminent danger of being forced to shut down as is clearly demonstrated by substantial industry evidence and confirmed by the consulting engineers commissioned by OSHA itself to review and report upon the technical feasibility and economic aspects of the proposed standard. Despite repeated acknowledgment that a 1 ppm TWA stand ard technically is not feasible, the Assistant Secretary adopted such an exposure level on the strength of an assumption unsup ported by any articulated reason or by the record evidence. Although agreeing in his formal findings and conclusions that "PVC and VC establishments will not be able to attain a 1 ppm TWA level for all job classifications in the near future" and that it is apparent that "reaching such levels may require some new technology and work practices", the Assistant Secretary makes the startling statement that he believes the industry will, in time, be able to attain such levels (39 Fed. Reg. 35892, J.A. 3). N `jrjtoir-- `itf r^tl^t^rCtii^ -. h --n _A,--^W... i.^ itftl fill Lk^Uh jhfc- -- --" i ifrriitilif^^- Tim 66 If the Assistant Secretary, in arriving at this questionable find ing, had in mind that sometime prior to infinity a 1 ppm TWA level might be attainable, he could well be correct. But, draw ing such a conclusion with reference to the foreseeable future is not only unwarranted but, indeed, irrational and arbitrary .in light of the technical evidence. The 'Snell report and industry engineering studies52 question the feasibility of the PVC in dustry's ability to achieve even a 10 ppm TWA exposure level. The Snell organization concluded that there exist significant engineering uncertainties and high risks of infeasibility in in dustry's attempts to reduce exposure levels merely to a range within 10-15 ppm TWA (J.A. 3585, 3587). Clearly, this range of exposure is substantially above the 1 ppm TWA level required by the final standard and, yet, the uncontroverted evidence establishes that it is doubtful that even they can be attained unless new technology is quickly developed. For these reasons and in light of the statement of Mr. Oelfke of Dow that at lower exposure levels it becomes increasingly more difficult to reduce VCM concentration levels and the Snell report's conclusion to the same effect (J.A. 1095, 3585), the Assistant Secretary's belief that the PVC industry will ultimately attain a 1 ppm TWA level through engineering controls is in credulous. Certainly, if it is questionable in the eyes of OSHA's own engineering experts that an exposure level within the range of 10-15 ppm TWA is attainable, how can it be forecast that a 1 ppm TWA level will be attainable--especially where all the factual and technological data in the record is to the contrary. The substantial evidence in these proceedings confirms that the PVC industry cannot implement engineering controls and 52. Industry's evidence was based on the testimony and technical reports of expert engineers and experienced operating personnel intimately knowledgeable with VC and PVC facilities. Their testimony is not "conjectural or subjective" as suggested by the Assistant Secretary, but is based on accepted objective engineering data. t r.. im. -- I BOR 004557 . . ,4*^**>-*'*'J' 67 work practices to reduce VCM concentrations to a level of 25 ppm TWA in less than two and one-half years to three years, and that the 10-15 ppm TWA range might be attainable in four to five years, providing new technological and engineer ing techniques have been timely effected (Snell Report, J.A. 3587, 3636; Firestone Study, J.A. 1797-1816).55 Clearly, these accepted implementation time requirements manifest that the Assistant Secretary's inferences in the final standard to the effect that the PVC industry is now close to at taining a 1 ppm TWA level are misleading and totally in accurate. Moreover, the Assistant Secretary completely ignored tech nical feasibility factors in setting the permissible concentration levels of the final standard and the Congressional admonition re quiring him to establish occupational safety and health standards which are feasible and which are based on the best available evi dence. Predicating a standard on the basis of an assumption or belief which is totally refuted by the record does not comport with the statutory substantial evidence test and must be labeled an arbitrary and capricious act. (See, Associated Industries, 487 F.2d at 349.) In this case, there is not a scintilla of proof that the exposure levels of the final standard are technically feasible. The record demonstrates that the standard is not only not feasible--even four or five years hence--but that it is an im possibility, totally unrealistic and grossly impractical when judged in light of its effective date--January 1, 1975.5543 53. The SPI recommendation as to accomplishment of the 10 ppm level essentially was a target or goal dependent upon the origination of new technology. See, e.g., Hooker (Ex. 55, pp. 7-8); Air Products (Ex. 23A, p. 7); J.A. 563, 570, 589, 1604-05. 54. The opposite view expressed by the few witnesses (see"' p. 39, supra) who had no technical qualifications and who admittedly conducted no engineering or technical studies is en titled to no weight at all. "Generalized, conclusory, unsupported 1 BOR 004558 ... t-s.'wss ^i iwtfiiriai ... ..... wiiJwiifia'r 68 That the permissible exposure of the final standard was not properly considered in light of its technical feasibility but rather was the result of conjecture and speculation without record sup port, is strongly evidenced by the Assistant Secretary's comments in denying two Firestone motions to reopen the hearings to per mit cross-examination of the Snell personnel. Although OSHA commissioned the Snell organization to prepare a report so that it would have an independent technical and economic feasibility study for its consideration, it essentially disregarded the conclu sions of the report apparently on the questionable theory that the report confirmed the substantial evidence presented by industry with respect to technical infeasibility. In denying Firestone's motion, the Assistant Secretary stated (Addendum B): "Additionally, it is noted that the Snell study was essen tially in agreement with the position taken by industry on the economic and technological feasibility of the proposed standard and-that only limited reliance was placed on the Snell study in the formulation of the final standard." The Assistant Secretary's failure to promulgate a standard on the basis of the best available evidence is magnified by his ad mission that little reliance was placed on the Snell report. At a minimum, the Snell report, which confirms the overwhelm ing record evidence, refutes the Assistant Secretary's belief and substantiates that the Assistant Secretary did not consider the best available evidence with respect to technical feasibility in promulgating the final standard. See, Florida Peach Growers, 489 F.2d at 129. In setting the permissible exposure level at 1 ppm TWA, tech nical burdens have been imposed upon the VC and PVC indus- opinion testimony does not compel respect or demand weiaht, at least in the presence of contrary evidence of an objective nature * * Northbridge Electronics, Inc. v> United States, 444 F.2d 1124, 1129 (U.S. Ct. Clms. 1971). Clearly, such expressions of opinion do not rise to the level of substantial evi dence required by the Act. Mobil Oil Corp. v. Federal Power Commission, 483 F.2d 1238, 1258 (D.C. Cir. 1973). BOR 004559 69 tries which simply are incapable of accomplishment and so unfair that the entire industry is placed in jeopardy. The con centration levels actually are the operative factors which regu late and control substantially all implementation requirements of the final standard. The provisions of the standard with respect to regulated areas, methods of compliance, monitoring, respira tory protection, hazardous operations and reporting requirements are keyed to the permissible concentration level. Consequently, selection of the exposure level directly affects virtually all VC and PVC operations and industry's ability to function. For example, because the exposure level set by the final stand ard may be even more onerous than that reflected in the proposed standard rejected by OSHA for infeasibility, industry admittedly cannot attain through engineering control means at any predict able time a 1 ppm TWA concentration level.*2 Nevertheless, the final standard requires the industry immediately to prepare writ ten plans for a program to reduce levels to the permissible ex posure limit or to the greatest extent feasible solely through engineering and work practice controls and to implement such controls until full compliance is achieved. The Assistant Secre tary, however, failed to discuss how engineering programs can be devised to control exposures to a level that he admits is not technically feasible. In addition, because exposure levels dictate the extent to which personnel will be required to use respirators, virtually all em ployees engaged in the PVC industry, at least, will be required to wear respiratory devices practically 100% of the time. This admittedly hazardous requirement is not practical or feasible but one which when coupled with the equally impractical engineer-55 55. The non-detectable exposure level of the proposed standard was defined to mean an exposure level of from 0.5 ppm to 1.5 ppm. As was demonstrated during the public hear ings, the TWA exposure value selected actually defines the controlling exposure industry will be required to meet in order to be in compliance. Obviously, if the permissible TWA exposure level is exceeded during any part of the day, even if only to the BOR 004560 iW " " fa d w A ^ jlitffijb lC S lfi^ M U h Jt,a*^ ` *** a M frt* * ,to te ``i, `i** * " a ` ,itUtfc; i ' * * ^ ;^ ^ *l -^ M a r r ^ 'r i r - r r r '" iL i r i i ,rf l i i V y^ 1ffclV i 70 mg control methods compel industry to face the real threat of total shutdown. Thus, the Snell organization's assessment that adoption of a 1 ppm TWA level would place 100% of the industry in danger of being forced to close is demonstrably sup ported by the record and manifests the absolute technical infeasi bility of the final standard. The effect of the new standard will result in the very con sequences Congress intended to avoid--putting employers out of business. The comments of the Court in Industrial Union Department, AFL-CIO v, Hodgson, 499 F.2d 467 (D.C. Cir. 1974), with respect to Senator Javits* observations, are indeed applicable here (at p. 478): "Congress does not appear to have intended to protect em ployees by putting their employers out of business--either by requiring protective devices unavailable under existing technology or by making financial viability generally im possible." It is, to be sure, with caution that a court concludes that the law requires a different approach from that taken by an official or agency with technical expertise. But this principle stops short of permitting the agency to regulate by use of a clouded crystal ball. The courts must distinguish between rational prediction and unsupported prophecy. See, International Harvester Co. v. Ruckelshaus, 478 F.2d 615 (D.C. Cir. 1973). In summary, the record evidence demonstrates that the final standard wholly rejects or ignores the record evidence with re spect to technical feasibility. The Assistant Secretary's action in promulgating a standard requiring concentration levels to be kept to a 1 ppm TWA when the evidence established that any permissible 5 ppm ceiling for a 15-minute period, exposures for a substantial part of the remainder of the 8-hour period would have to be at or very close to zero in order to comply with the 1 ppm TWA level. See, Final Environmental Impact' Statement (J.A. 3266); Union Carbide (Ex. 94(b), Appendix); Vittone statement (J.A. 569, 594-96); Firestone written subhiission (J.A. 1782). BOR 004561 w jfrjjft{ifrt jn 71 exposure level below the range of 10-15 ppm is technically not feasible constitutes a gross abuse of administrative discretion and is clearly arbitrary. Moreover, because the Assistant Sec retary has in essence afforded conclusive weight to the NIOSH recommendation with' respect to permissible exposure level, he has also abdicated his responsibility under the Act as well as violated the clear holding of the IUD case. C. There Was No Substantial Evidence Supporting the Assist ant Secretary's Determination to Subject PVC Producers to the Same Standard Applied to Producers o! VCM The standard promulgated by the Assistant Secretary applies both to producers of VCM as well as to those who convert VCM into PYC. Thus, each industry is required by the standard to limit VCM exposures to 1 ppm TWA. Yet, the record unam biguously demonstrates that because of differences between the processes employed by them, it is far more difficult for PVC pro ducers to limit VCM exposures than it is for the VCM producers. VCM is produced in a sealed and largely automated process. The PVC process, however, involves unavoidable worker ex posure to VCM. The Assistant Secretary conceded that the record "reflects broad generic distinctions between the compli ance capabilities of the VC and PVC industries" (39 Fed. Reg. 35893, J.A. 4). Nevertheless, he refused to impose a less stringent standard on PVC manufacturers. Yet, by the Assistant Secretary's own admission, there is no basis for his determination to subject PVC producers to a standard as stringent as that applicable to VCM producers. OSHA has previously been reversed for precisely such a policy decision. In Industrial Union Department, AFL-CIO v. Hodg- "" son, 499 F.2d 467, 480-81 (D.C. Cir. 1974), the Court re manded because the Assistant Secretary did not adequately take into account inter-industry differences. BOR 004562 ^^-1 ` : 1 1 'WWW mi' 72 Here, where the Assistant Secretary has conceded that there are substantial differences between the PVC and VCM indus tries; made no claim that practical administration requires a standard applicable to both; and he has failed to explain the rationale underlying his decision, the substantial record evidence requires that the final standard be invalidated. D. The Assistant Secretary's Failure to Assess the Economic Feasibility of the New Standard Plainly Requires That the New Standard Be Vacated and Remanded As noted above, the Assistant Secretary is required to promulgate a standard that is economically feasible. Industrial Union Department, AFL-CIO v. Hodgson, 499 F.2d 467, 477 (D.C. Cir. 1974). Clearly, the lUD case interpreted economic feasibility to include elements of cost impact in micro-economic terms and elements of impact on the economy as a whole in macro-economic terms. Thus, the Court made it absolutely plain that a standard prohibitively expensive, requiring plant shut downs, and threatening financial viability is not feasible. Neither is a standard feasible which requires changes that only a few leading firms can make or that adversely affects the competitive structure of an industry or the ability of American firms to compete in the international market. (See 499 F.2d at 477-79.) Both the Director of the OSHA office of Standards Development and OSHA's Final Environmental Impact State ment confirmed this position, recognizing that the Act required a standard to be economically feasible in terms of cost impact on an industry and in terms of impact on the economy as a whole. The Assistant Secretary not only completely failed to assess the cost impact of the new standard or its impact on the economy as a whole, but he further failed to provide any justification for de parting from the statute's command. Moreover, the Assistant Sec retary totally ignored the conclusion of the Snell final report that if any standard requiring a VCM exposure concentration below 004563 J,f W .fJ w W 'iHif% u -, -, - - :i,l gi-;.>v, ^ ^ r i ito, . i . . A i ^ t i ^ , ,,. / ^ ^ ,fl,, l ^ |. .M,~lV ,,. ^ T r i - - r i /** niiriV"** ,A i r i'-'- 73 10 ppm were promulgated, 100% of the PVC industry would be endangered. As in Florida Peach Growers, therefore, the Assistant Secretary's failure to explain why he rejected the conclusions of a body specifically requested by him to recom mend a course of action necessitates the vacation and remanding of the new standard. Furthermore, the Assistant Secretary also failed to make a reasoned assessment with respect to the overwhelming record evidence demonstrating the devastating effect a standard em bodying such a stringent exposure concentration could have on the economy as a whole. No explanation is offered as to why the Assistant Secretary ignored or rejected the undisputed evidence that a 1 ppm exposure level would cause domestic employment losses of 1.7 to 2.2 million and domestic production losses of $65 to $90 billion. Moreover, there is no reference to the real probability that the entire VCM market will be severely disrupted. There is no dispute that attempts to achieve low exposure levels will create competitive disadvantages for older and/or totally enclosed PVC plants, the result of which may be an increased share of the PVC market for producers with newer and/or open-air plants. In addition, OSHA's Final Environmental Impact Statement states, "the appearance of the OSHA standard may upset the existing uneasy balance" in an industry "already somewhat unstable" due to the short supply of petrochemical feedstocks (J.A. 3343). It predicts that "several employers may find it necessary to close operations, concentrating the industry into fewer companies and causing disruptions of several markets" (J.A. 3345). The importance of assessing the economic effect on the structure of domestic industry of a standard like that now under consideration, was emphasized in International Harvester Co. v. Ruckelshaus, 478 F.2d 615 (D.C. Cir. 1973). In that case, auto-emission standards were vacated and remanded in part due to the failure of the Administrator adequately to assess both the effect of the emission standard on the structure of the . .. ..................... . ........ ,, - _|| Ilf! II | ................... . IIIIIIIJ....., i;y !v BOR 004564 &amiifranfrya -fa .. i1h-f.. f|,y -T|t,j " ^ .?ij^wi "V ***** riagiii^ySiAifiiiiiiiiBAaitt1*1- 74 automobile industry and the possible effect on that industry's structure should there be a later relaxation or suspension of the standard. Decreased market competition is, however, only the beginning of what the Assistant Secretary has acknowledged "will probably be substantial increases in the price of polyvinyl chloride resins, which will ultimately be passed to consumers" (J.A. 3269). The Snell final report predicted that these price impacts "may be of the same order of magnitude as the price results of the `energy crisis'" (J.A. 3589). These impacts, of course, will be felt in every market which is dependent on PVC resin as a base product. Thus, houses, electrical equipment, furniture, to name a few, will all reflect a near doubling of the price of PVC resin (J.A. 3558). As the Final Environmental Impact State ment has suggested, there are no adequate substitutes for PVC (J.A. 3347). A much more serious result of the new standard may be the migration of PVC production to foreign countries which also was not discussed by the Assistant Secretary. The Final Environ mental Impact Statement recognized the possibility that as domestic prices rise, PVC users may be able to obtain resins manufactured in other countries "where regulation is less strict" or ultimately, "U.S. companies might find it profitable to build plants abroad" (J.A. 3347). Surely it is not conceivable that Congress intended to provide competitive advantages to those PVC producers holding substantial interests in foreign plants. In sum, the Assistant Secretary completely failed to take cognizance of the adverse impact of the new VCM exposure standard on the structure of the PVC industry, on prices in a time of rampant inflation, on the economy generally, and on foreign and domestic competition. That the Assistant"Secretary is obligated to set a standard giving due consideration to all the economic aspects which he has ignored or rejected 4 without reason in this case is demonstrated by Industrial Union Depart ment, AFL-CIO v. Hodgson, 499 F.2d 467 (D.C. Cir. 1974), BOR 004565 75 where the Court recognizes that the feasibility language of the Act requires consideration of such factors. The Court said (at p. 478): "As the effect becomes more widespread within an industry, the problem of economic feasibility becomes more pressing. For example, if the standard requires changes that only a < few leading firms could quickly achieve, delay might be necessary to avoid increasing the concentration of that industry. Similarly, if the competitive structure or posture i of the industry would be otherwise adversely affected-- * perhaps rendered unable to compete with imports or with 5 substitute products--the Secretary could properly consider -1 ~2 that factor. These tentative examples are offered not to illustrate concrete instances of economic unfeasibility but rather to suggest the complex elements that may be relevant to such a determination." The Assistant Secretary's action in promulgating the new standard is an abdication of his responsibility under the Act and is clearly controverted by substantial evidence in the record considered as a whole. Therefore, apart from the Court's conclusions with regard to the Assistant Secretary's determina tions concerning the health hazards of VCM and the tech nological feasibility of industry's achieving the exposure levels mandated by the new standard, this standard must be vacated and remanded for an assessment and analysis of its economic 1 impact. ' 1, E. The Assistant Secretary's Determinations with Respect to Respiratory Protection Are Not Reasonable -i; 1. Improper Failure to Provide Adequate Notice with Respect to Continuous Use of Respirators ** As a result of the unreasonable and infeasible exposure level fixed by the new standard, virtually all employees in VCM \ and PVC facilities will be required to wear respirators practi < cally 100% of the time. However, neither the final standard nor the preamble thereto indicates that the Assistant Secretary con- 'j" i '  . ..<. -: -- "- - --v ^-. - --If-. m. "'-r* *--- 1-Jl^- .-. * .^ ^ ^ - f - - ; . ,,- n .t> - . n il I n n <1 in w M B n a it t w n iw . ` I iim * TrJr W i i% W r i W r t i r ii'-fr^ ~ irti r* t o 76 sidered or assessed the health and safety hazards to employees from being required to wear respirators continuously; whether they physiologically are capable of wearing respirators for such periods; and whether the VCM and PVC industries can feasibly operate under such strict methods of compliance. And, clearly, the Assistant Secretary totally ignored the economic effects of continuous respiratory protection assuming, arguendo, that some facilities will be able to operate at all. The Assistant Secretary's most telling omission, however, is that which relates to his failure to notify interested parties that the final standard would, in effect, although not intended, and as a direct consequence of his setting the permissible exposure level at 1 ppm TWA, elevate respiratory protection which was expressly stated in the proposed standard to be only a temporary measure, to the level of a permanent method of compliance with out an opportunity for interested parties adequately to be heard or present evidence on the issue. Either as a result of a decision by the Assistant Secretary, subsilentio, or as a result of his failure to comprehend the consequences flowing from adoption of a 1 ppm concentration level, based on the Assistant Secretary's unreasoned and unsup ported belief that the industry might attain that level at some indeterminate time in the future, the thrust of the compliance methods of the proposed standard have been changed by impli cation from implementation solely through engineering controls and workpractices (29 CFR 1910.93q(f) (iv), J.A. 23) to accomplishment by continuous respiratory protection. Thus, in effect, the feasibility of compliance and the validity of the standard, now turns on the feasibility of continuous respirator use. The proposed standard, however, did not apprise interested parties that the crucial issue of feasibility would ulti mately depend on the feasibility of continuous respiratory pro tection measures. As a consequence, no party, including OSHA, had an opportunity specifically to address itself comprehensively bor 004567 ru i 'Jin' r'i~' r'iy ~ `i i `)*ri`~-i i'i,rii ;-if 11 r>Hi*WVit>rt i itUiMiWrf-.* 77 to the issue of the multiple consequences and effects that full* time respirator use will have on employees and the industry. Under OSHA's own rules and regulations and the Act, the parties were entitled to be provided with notice and an oppor tunity for hearing on the crucial factual issues underlying the permanent standard.5 The Court of Appeals for the Third Circuit has very recently held in the Synthetic case (slip opinion 10), that in reviewing a standard under Section 6 of the Act, judicial review includes at least "determining whether the Secretary's notice of proposed rule making adequately informed interested persons of the action taken." The proposed standard envisioned that respiratory protection would be necessary only as a temporary measure in specified work situations and in cases of emergency. This characterization of respirator use emerges clearly from the language of the pro posed standard in Section 1910.93q(g) (2) (39 Fed. Reg. 16898, J.A. 23). The provision quoted below is wholly absent from that portion of the permanent standard dealing with respiratory protection: "Respirators shall be used only in cases of emergency and where required by any other provision of this Section. Respirators may not be used in lieu of feasible engineering 3 controls or work practice methods." 56, Sections 6(b)(2)-(3) of the Act require that the Assistant Secretary publish and invite comments on a proposed rule promulgating a standard and provide for an oral public hearing upon request (29 U.S.C. 655(b) (2)-(3)). In its own Rules and Regulations, OSHA has read this section and Section 6(b) of the Act which provides for judicial review, to "provide more than the bare essentials of informal rule making under 5 U.S.C. 553" and requires in particular that the "pre siding officer shall provide an opportunity for cross-examination on crucial issues" (29 CFR 1911.15(a)(3)). ti i } < i t ri \ i i \ '"'"S' miihm m m BOR 004568 78 The Snell final report also interpreted the proposed standard to mean that respirators would be used only as a backup means of compliance (J.A. 3657).67 1S4 '} ; No one would contest the fact that respirators can be used with relative safety for short periods of time or that, despite J hardships, it might be necessary to use them in emergency situa s tions. This was the question noticed for hearing. It is a far different question from that which is now presented. In other words, without providing any party notice or an opportunity for hearing the Assistant Secretary as a result of the exposure level specified in the final standard shifted the crucial issue of feasi bility from one involving the availability of engineering and work practice controls to one hinging upon the continuous use of respirators. This issue was simply not noticed for hearing; it was discussed, at best, tangentially as an adjunct to compliance ; by means of engineering and work practice controls.55 43 2. The Assistant Secretary Improperly Failed to Assess the Health and Safety Hazards Resulting from the New Standard's Require ments for Respiratory Protection or the Feasibility Thereof and Provided No Rational Explanation for His Action with Respect Thereto Clearly, the Assistant Secretary has made a judgmental deter mination on an issue of policy in requiring respiratory protection at all levels above the permissible exposure limit. Either the 57. Mr. Hyatt, OSHA's consultant, testified that such de vices would be "very impractical for routine work" and were used on an extended basis only "where there has been a major accident" (J.A. 285, 299). 58. The extent to which the notice failed to define the relevant issues for hearing is apparent in the fact that the new standard permits the use of several kinds of respirators which-- under the proposed standard--were unacceptable. The most crucial of these is the air-purifying (cartridge or canister) type of respirator which, even now, is still awaiting NIOSH approval (39 Fed. Reg. 35894, J.A. 5). These were explicitly ruled out in the proposed standard as a possible means of compliance (39 Fed. Reg. 16897, J.A. 22). im. sw1 ^^ r n %tr . Ir OR 004569 Assistant Secretary has determined that the wearing of respi rators over long periods of time is less hazardous to the health of PVC and VCM employees than exposure to VCM at concen trations permitted by ETS or he completely ignored the extent to which industry employees would be required to wear respi rators and the percent of time that they would be required to be worn. In either event, the Assistant Secretary's failure to articulate the policy choices before him conflicts with the admonition of those cases which have considered the Secretary's obligation in adopting an occupational safety and health stand ard and required, at the very least, articulation of the policy choices involved and a reasoned explanation for the policy adopted. Thus, the Assistant Secretary did not demonstrate cognizance that virtually all of the employees in the PVC and VCM indus tries would be required to wear respiratory devices for long and continuous periods because of the exposure levels in such plants. As monitoring data in the record reveals, practically every area in VCM and PVC plants are subject to concentration levels of VCM at 1 ppm or above. In addition to the safety hazards unique to each particular respiratory device (as shown above, pp. 42-45), there are safety and health problems associated with the extended use of any respiratory equipment. However, the Assistant Secretary did not indicate that he even considered the extensive--and uncon tradicted--evidence of safety hazards associated with extended respirator use. Nor does his description of respirator use as "inconvenience'' properly describe the substantial--and again largely uncontradicted--evidence that workers would refuse to submit to continuous respirator use. Perhaps the best indication of how difficult it would be to implement a program of continuous respirator use is the fact that the standard itself, while requiring the immediate provision of respirators, permits employees to refuse to wear them up to exposures of 25 ppm until December 31, 1975 (29 CFR 1910.93q(g)(l), J.A. 7). Quite apart from the implication W.BJU..L -lUljlUmi rn 1 -,.iu lUfy.'tpMi > that the Assistant Secretary does not consider a 1 ppm standard to be urgently required, this provision must reflect his concern that this standard is incapable of implementation. If .the Assistant Secretary's burden of establishing feasibility requires only a showing that respirators are theoretically capable of providing effective protection against VCM exposures over long periods of time, then perhaps OSHA has sustained its burden. However, if it requires a showing that respirators can be used in actual working conditions, there is not substantial evidence on the record to support the feasibility of continuous respirator use. Taken together with the admitted infeasibility of engineering and work practice controls, the record leaves room for no con clusion other than that the Assistant Secretary has promulgated a standard which cannot feasibly be implemented. Nowhere in this record was the Assistant Secretary confronted with more fundamental policy choices in terms of his obliga tions under the Act than with respect to respiratory protection. As shown above, the medical and scientific evidence in this record does not demonstrate a health hazard to employees ex posed to concentrations of VCM permitted by the ETS. Yet, the Assistant Secretary not only failed to articulate the health and safety alternatives available to him in setting the permissible ex posure limit in the new standard but also completely ignored his obligation to explain why he chose a policy of essentially con tinuous respiratory protection to achieve compliance with the permissible exposure limit ordered when the overwhelming evi dence demonstrated that hazards from such use of respirators far outweigh the hazards to health from exposures to VCM as high as 50 ppm. The same applies with respect to technological and economic feasibility of the new standard's respirator provisions. The policy choices available to the Assistant Secretary were not articulated and no justification is provided for adopting a policy that the record evidence conclusively demonstrates to be techno logically as well as economically infeasible. w--, , mil W.II I H.H4P I 1) BOR 004571 1 81 In sum, as with each of the critical issues facing the Assistant Secretary in these proceedings, the determination with respect to respiratory protection is clearly not supported by substantial evidence in the record considered as a whole. HI. CRITICAL PORTIONS OF THE NEW STANDARD ARE SO VAGUE, INDEFINITE, AND INCAPABLE OF CONSISTENT AND UNIFORM ENFORCEMENT THAT THE STANDARD CONTRAVENES THE ACT AND DUE PROCESS OF LAW A. The New Standard Is So Vague and Indefinite As to Be No i Standard At All and Therefore Violates the Act The new standard ostensibly establishes "permissible exposure limits" (29 CFR 1910.93q(c), J.A. 7). Yet, doubtless because of the Assistant Secretary's awareness that there is no record evidence that such a level is feasible, he provided that the per missible exposure limit need not be satisfied in all cases, as follows (29 CFR 1910.93q(f) (2), J.A. 7): "Wherever feasible engineering and work practice controls which can be instituted immediately are not sufficient to reduce exposures to at or below the permissible exposure limit, they shall nonetheless be used to reduce exposures to the lowest practicable level, and shall be supplemented by respiratory protection in accordance with paragraph (g) of this section. A program shall be established and imple mented to reduce exposures to at or below the permissible exposure limit, or to the greatest extent feasible, solely by means of engineering and work practice controls, as soon as feasible." (Emphasis added) As a practical matter the standard by which industry must guide its conduct is the requirement that it reduce exposure to the "lowest practicable level" which "feasible engineering and work practice controls" can produce, and that it shall do so as soon as feasible. There is, however, no indication what steps in fact are, or will be, considered "feasible" in limiting the exposure of in dustrial employees to VCM. No objective criteria are provided N 82 for an employer to determine whether measures that would allegedly reduce exposure to VCM are "feasible" or not. Indeed, in the preamble to the new standard the Assistant Secretary recognizes that what is "feasible" is a matter not readily and objectively ascertainable, and that feasibility will vary from plant to plant and from geographic area to geographic area (39 Fed. Reg. 35892, J.A. 3). Even more important, in the absence of any objective criteria, what is feasible may turn on varying interpretations by different OSHA officials, or by OSHA itself on different occasions. Thus, the new standard does not inform employers, employees, OSHA, or the courts how the balance between economic cost, technical feasibility, and work safety is to be struck in any particular case. As a consequence of the foregoing, the new standard provides no basis for an employer to determine whether he is in com pliance with respect to attaining "the lowest practicable level." Unless an employer has reduced VCM exposure to the ulti mate "permissible exposure limit" specified in the regulations, if can have no assurance that it is not in violation of the law, no matter how strenuous its efforts to attain the "lowest practicable level." The absence of objective criteria and norms by which a manu facturer can measure compliance results in a state of uncertainty and confusion as to legal obligations. Must an employer install each new engineering technique as it becomes available, even if it reduces VCM exposure by 1 ppm and even if it requires severe disruption of production during installation? Without objective criteria, no employer is informed as to what conduct will or will not be considered lawful or unlawful. This uncertainty will force manufacturers to spend enormous sums in an effort to reduce exposure to the ultimate "per missible exposure limit" in order to avoid arbitrary and ca pricious enforcement by OSHA. Thus, the new standard in effect abolishes the statutory requirements that health and safety standards be economically and technologically feasible. t i BOR 004S73 J* jj i i -y 83 j Similarly, although a program for the reduction of exposures is also required, the language of the new standard does not specify what the contents of such a program should be. Conse * quently, an employer can only guess as to whether the required program should be based on facts as to the present or fore seeable state of technology or whether the program should speculate as to what hopefully may be accomplished in tech nology at some indefinite time in the future. Because no ob jective criteria are provided, the contents of each employer's program as to the methods and dates for achieving final com pliance will vary. Enforcement, therefore, is solely dependent on the whim and unguided discretion of each particular OSHA compliance officer. Indefiniteness and lack of notice as to prohibited conduct is also the hallmark of the new standard's provisions dealing with emergencies and regulated areas. Section 1910.93q(b) (5) de fines "emergency" to be "any occurrence such as, but not limited to, equipment failure, or operation of a relief device which is likely to, or does, result in massive release of vinyl chloride." Although the new standard nowhere defines the term "massive", it is the pivotal element in determining whether an emergency exists and in triggering other provisions of the standard. Thus, pursuant to Section 1910.93q(i), the employer must provide a written operational plan for implementation during emergencies. Implementation of the emergency plan, therefore, depends upon whether there has been a "massive" release of vinyl chloride. Moreover, each employee exposed to an emer gency is required by Section 1910.93q(k) (3) to be afforded appropriate medical surveillance. Here again, whether such medical surveillance need be given depends on whether there has been a "massive" release of vinyl chloride. Hence, since the term "massive" denotes no specific level of exposure in itself, what constitutes a "massive" release of vinyl chloride is neces sarily vague. Therefore, enforcement of the "emergency" pro visions will be governed by the whim and uncontrolled discretion of a Compliance Officer. J HlP! .-ML! www .1 bor 004574 1. -,------ 84 The same applies with respect to the new standard's require ments for establishing "regulated areas". Section I9l0.93q(e) < requires their establishment where VCM or PVC is manufac tured, reacted, repackaged, stored, handled or used and where VCM concentrations exceed the permissible limit, including even railroad cars, trucks, and other methods of transport. Because the requirement is tied essentially to the occurrence of concen trations exceeding the permissible limit, it is not possible to de termine from the standard whether an area can change back and forth from being a regulated area depending on a fluctuation in exposure concentration or whether an area remains regulated if at any time the permissible limit has been exceeded without regard to the exposure concentration at any particular time. Thus, a railroad car might be a regulated area at all times after being used to transport VCM and it is not at all clear that the Assistant Secretary intended this to be the result. Again, viola tions of the "regulated area" provisions will depend on enforce ment governed by the whim of an OSHA Compliance Officer. The vagueness and indefiniteness of the new standard's pro visions are further evidenced by the discrepancy existing between the Assistant Secretary's explanatory comments in the preamble and the actual provisions as they appear in the new standard. Thus, although the preamble to the standard states that the monitoring requirements of the standard may be accomplished by personal or area monitoring,59 the standard itself is silent as to the type of monitoring to be utilized. While it may be con cluded, therefore, that either personal or area monitoring will be sufficient, the standard implies that some type of continuous area monitoring must be used. In Section 1910.93q(g)(l), employees may decline to wear respirators until December 31, 1975 for those exposures below 25 ppm, measured over any 15minute period. Consequently, in order for the employer to be able to determine when exposures exceed 25 ppm it must imple ment, at the very least, a constant sequential monitoring system having a monitoring cycle not exceeding 15 minutes.1' However, 59 39 Fed! Reg. 35893, J.A. 4. Bor 004575 ;,n^v 85 Section 1910.93q(g) (6) (ii) requires the use of a continuous monitoring and alarm system. It is not ascertainable, therefore, whether the standard actually requires continuous monitoring for an entire affected area or rather requires a system which monitors each point at defined time intervals pursuant to a regu lar cycle (constant sequential monitoring system). The new standard's vagueness and indefiniteness are directly contrary to the requirements of Section 6(b)(5) (29 U.S.C. 655(b)(5)), which requires that: "Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the perform ance desired." In Chrysler Corporation V. Department of Transportation, 472 F.2d 659 (6th Cir. 1972), safety standards under the National Traffic and Motor Vehicle Safety Act (15 U.S.C. 1381, et seq. (1970)) were invalidated for lack of objec tivity under a statutory provision like the one quoted above, as follows (at p. 675): "The importance of objectivity in safety standards cannot be overemphasized. The Act puts the burden upon the manufacturer to assure that his vehicles comply under pain of substantial penalties. * * * Accordingly, such objective criteria are absolutely necessary so that `the question of whether there is compliance with the standard can be answered by objective measurement and without recourse to any subjective determination.' " See also, Portland Cement Association v. Ruckelshaus, 486 F.2d 375 (D.C. Cir. 1973). The same result must follow here. B. The Vagueness and Indefiniteness of the New Standard Violates Due Process of Law Pursuant to Section 17(c) of the Act (29 U.S.C. 666(c) (1970)), criminal penalties may be assessed for employer violations of occupational safety and health standards causing death to any employee. It is well established that a provision. ' *-t*ttitfcvHrt'ni I HiftVrumitf 86 carrying a criminal sanction for its violation, will be voided under the due process clauses of the Fifth or Fourteenth Amend ments if it is so vague and indefinite as to be incapable of consistent and uniform enforcement and of providing adequate notice of conduct deemed unlawful. Champlin Refining Co. v. Corporation Commission of Oklahoma, 286 U.S. 210, 243 (1932); Connally v. General Construction Co., 269 U.S. 385, 391 (1926). See also, United. States v. Cohen Grocery Co., 255 U.S. 81 (1921); LanzettaV. New Jersey, 306 U.S. 451 (1939); Groyned V. City of Rockford, 408 U.S. 104 (1972); Papachristou v. City of Jacksonville, 405 U.S. 156 (1972); Illinois Central R.R. Co. v. Public Utilities Com'n, 245 U.S. 493 (1918). Regulations issued pursuant to a federal statute which provide for criminal penalties must also be explicit, unambiguous and set forth prohibited conduct with sufficient clarity to fairly inform all persons as to what the statute commands. M. Kraus & Bros., Inc. v. United States, 327 U.S. 614 (1945); Boyce Motor Lines, Inc. v. United States, 342 U.S. 337 (1952). All of the specific examples of vagueness and indefiniteness referred to above also render the new standard in violation of the Fifth Amendment's due process clause. For the reasons stated above, the new standard should be voided by this Court because its critical provisions are so vague, indefinite and in capable of consistent and uniform enforcement as to contravene due process of law. Jl B0R 004577 8.7 IV. THE ASSISTANT SECRETARY'S DENIAL OF THE RIGHT TO 3 CROSS-EXAMINE CERTAIN WITNESSES WHO PRE SENTED EVIDENCE ON CRUCIAL ADJUDICATIVE FACT ISSUES AFTER THE PUBLIC HEARINGS WERE CONCLUDED VIOLATED DUE PROCESS AND OSHA'S OWN RULES AND REGULATIONS AND FATALLY TAINTED -> THE DETERMINATIONS OF THE ASSISTANT SECRETARY A. The Assistant Secretary's Action in Denying the Right of Cross-Examination Violated the Constitutional Right to Due Process of Law i The Assistant Secretary of Labor denied Firestone's timely motion to re-open the public hearing to allow cross-examination of the preparers of the OSHA-commissioned economic impact study. The Assistant Secretary also denied Firestone's timely motion to re-open the public hearings to allow cross-examination or deposition of two doctors who were allowed to submit state a ments, comments or conclusions on the merits following the '3* hearings' close. ? * While it may be true that there is no right in the abstract to r a hearing in connection with administrative proceedings, Sec tion 6(b)(3) of the Act (29 U.S.C. 655(b)(3) (1970)) s( expressly provides for public hearings in connection with the promulgation of occupational safety and health standards. In Mobil Oil Corp. v. Federal Power Commission, 483 F.2d 1238, 1260 (D.C. Cir. 1973), the Court condemned the Com mission's administrative proceedings on the grounds that, with respect to evidence admitted on a particular issue, "no one was able to introduce evidence in opposition, criticize the Commis sion's position, or point out flaws by questioning the validity of its sources" (483 F.2d at 1259), and held that informal comments, as in the instant case, on such an issue was not sufficient. N A broad-based claim of right to cross-examination on all matters which came, or could have come, before OSHA in its * :4 i | i (t i t ( vi i IT r BOR 004578 _ 88 deliberations is not advanced here. However, as was recognized in International Harvester Co. v. Ruckelshaus, 478 F.2d 615, 631 (D.C.Cir. 1973), there is a fundamental distinction between: "* * * the assertion of a broad right of cross-examination * * * and a claim of a need for cross-examination of live witnesses on a subject of critical importance which could not be adequately ventilated under the procedures." The latter claim is adduced before this Court The Snell economic impact study directly pertained to an essential element in the OSHA's decision-making process. Industrial Union Dept., 499 F.2d 467. Firestone's economic impact study was properly subjected to the cleansing ablution of cross-examination, as was the study by Arthur D. Little, Inc. Yet neither Firestone nor any other interested party was permitted the same right with respect to the OSHA-commissioned study, despite Firestone's demonstration that- cross-examination was vital to determine whether the Snell study had assessed the full impact of the proposed standard. A similar posture was adopted by the Secre tary with respect to the post-hearing submissions of Drs. Standaert and Wegman. In light of all of the above, the Assistant Secretary's action was clearly improper and served to deny Firestone and other parties essential fairness and justice, as embodied in the very concept of due process and the standard below must be set aside. B, The Denial of the Right of Cross-Examination Violated OSHA's Own Procedural Regulations Section 1911.15(b)(2) of the OSHA Rules of Procedure (29 CFR 1911.15(b)(2) (1974)) provides that the presiding officer "shall provide an opportunity for cross-examination on crucial issues." In the instant case, the Assistant Secretary's arbitrary de parture from OSHA's procedural rules violated administrative WWWWMJ iij.i. j up uc*wvl. WWWiwi.wt~" BOR 004579 89 due process and contaminated the final determinations. For this reason alone, the standard promulgated by the Assistant Secretary should be set aside, and the case remanded for further hearings. In view of the principles set forth in Parts A and B above, it is not enough to assert that the submission of informal written comments on the Snell final report provided adequate opportunity to address the issues as the Assistant Secretary has done in a letter to Firestone's counsel dated October 21, 1974 explaining, post facto, why cross-examination rights had been denied (Addendum B to this Brief). In the first place, because OSHA delayed until the day the hearings closed its commission of the. Snell final report, its authors could not have participated in the hearings even if they had so desired. Second, even if the Snell final report is in "essential" agreement with the industry position, it still deals with crucial issues of adjudicative fact and an opportunity to test those areas of disagreement with industry's position by crossexamination is still required. Third, the cleansing of crossexamination might have convinced the Assistant Secretary to rely fully on the advice and counsel provided by the Snell final report. Similarly, the Assistant Secretary's explanation of his denial of the right to cross-examine Drs. Standaert and Wegman is not sufficient. The Assistant Secretary contends that their func tion was akin to that performed by OSHA employees. But the fact of the matter is that they are not OSHA employees; they are independent consultants just as much as are the authors of the Snell final report. Furthermore, Drs. Standaert and Wegman both did more than comment on the medical and scientific facts in the record. They also commented on the technological feasibility of a 1 ppm exposure concentration (J.A. 3724-49). In the record of these proceedings, every other scientist who reached the same conclusions as did Drs. Wegman and Standaert on a specific exposure concentration N { i l i i i it j ! i i t ti \ i i ii I f i i t r~" T? 90 submitted to cross-examination lor the testing of his competence to address himself to the crucial issues of technological and economic feasibility. The refusal by the Assistant Secretary to allow cross-examination of Drs. Wegman and Standaert with respect to their conclusions on technological and economic feasibility is not only unfair, arbitrary and capricious but a viola tion of the constitutional right of due process of law as well as OSHA's own procedural regulations. 1 CONCLUSION For the foregoing reasons, Firestone and Union Carbide re spectfully request that the occupational safety and health standard regulating exposure to VCM, as promulgated by the Assistant Secretary on October 1, 1974, be vacated by this Court and remanded to the Assistant Secretary for further proceedings. Respectfully submitted, I Of Counsel: WALTER B. CONNOLLY, JR. JOHN J. CASSIDY, JR. ARTHUR B. SMITH, JR. NELSON E. SCHMIDT NINA G. STILLMAN VEDDER, PRICE, KAUFMAN, KAMMHOLZ & DAY 800 Third Avenue New York, New York 10017 212/838-5544 1200 Firestone Parkway Akron, Ohio 44317 216/379-7000 Attorney for Petitioner-lntervenor, Firestone Plastics Company, a Division of The Firestone Tire & Rubber Company JOHN W. WHITTLESEY JAMES V. MURRAY 270 Park Avenue New York, New York 10017 212/551-6797 Attorneys for Petitioner, Union Carbide Corporation Dated: November 12, 1974 MyjgW'BfIKI^Wiir n is.ip uu j. i.i BOR 004581 \ ) iVriim *1 ,3 j A1 ADDENDUM A J Applicable provisions of the Occupational Safety and Health i Act of 1970, 29 U.S.C. 651, et seq. (1970). i 6(b)(5), 29 U.S.C. 655(b)(5) (1970): "(5) The Secretary, in promulgating standards deal -; ing with toxic materials or harmful physical agents I under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure : to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other informa tion as may be appropriate. In addition to the attain ment of the highest degree of health and safety pro tection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. When 1 * y ever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the per formance desired." i 6(e), 29 U.S.C. 655(e) (1970): "(e) Whenever the Secretary promulgates any stand ard, makes any rule, order, or decision, grants any exemption or extension of time, or compromises, mitigates, or settles any penalty assessed under this chapter, he shall include a statement of the reasons for I such action, which shall be published in the Federal Register." ;; 'S .5 "l1 JWTNfl l!LJUV|WN}i U, Jl ft*.) 1 M.V.U45OT r ( r- BOR 004582 ia'*--*--! --mn'itni -im irft'ifcini Mii iif twartiiiMii 4 * A2 1 ? 6(f), 29 U.S.C. 655(f) (1970): i "(f) Any person who may be adversely affected by a standard issued under this section may at any time < prior to the sixtieth day after such standard is promul gated file a petition challenging the validity of such standard with the United States court of appeals for * the circuit wherein such person resides or has his <5 /i principal place of business, for a judicial review of /j such standard. A copy of the petition shall be forth s with transmitted by the clerk of the court to the Secre < tary. The filing of such petition shall not, unless J otherwise ordered by the court, operate as a stay of the standard. The determinations of the Secretary shall be I conclusive if supported by substantial evidence in the record considered as a whole." II i $ V A t N 1 1` i : BOR 004S83 '-rj` J1'*-- r - - f ^ - '^ - ^ ^f^ ilT i^ W i,[i"fi1: -jrfff ft1'llftfr t f f irfr V iliitiii i uoL'.TiW'l'Vl atll/W ~>--~y'' 11 A3 ADDENDUM B U.S. Department of Labor Occupational Safety and Health Administration Washington, D.C. 20210 Office of the Assistant Secretary John J. Cassidy, Jr., Esq. Vedder, Price, Kaufman & Kammholz 39 South La Salle Street Chicago, Illinois 60603 October 21,1974 Dear Mr. Cassidy: This letter is in response to the initial motion and supple mentary motion filed by you on behalf of Firestone Plastics Company. Your initial motion seeks to reopen the hearing on vinyl chloride to permit examination of Foster D. Snell, Inc.; to extend the time for comment on the preliminary economic impact study; and to establish a comment period regarding the final economic impact study. The supplementary motion seeks to reopen the hearing to permit examination of Drs. Standart and Wegman or, in the alternative, to permit depositions to be taken from them; and to allow time for comments on the state ments of Drs. Standart and Wegman. Your first motion, concerning the Foster D. Snell study, is hereby denied for the following reasons. As you know, a full public hearing was held regarding the proposed vinyl chloride standard. All issues, including technological and economic feasi bility. were explored by the participants at the hearing, including vm * * - fa-r-aa^-- . * nr-i BOR 004584 rwfi'rn A4 Firestone Plastics Company. The oral testimony concluded on July 11, 1974, and the record of the hearing was kept open until August 23 for further submissions by participants at the hearing. At the close of the hearing, it was announced that an opportunity to comment on the Snell study would be provided, and that for this purpose comments would be received after August 23. By Federal Register notices published on August 26 and September 13, written comments on the preliminary and final economic impact studies were invited to be submitted by September 25. In view of the extensive opportunity to present evidence and arguments concerning technological and economic feasibility and to comment in writing on the Snell study, we feel that adequate opportunity has been given the public to address this issue. We further are of the view that neither the Occupational Safety and Health Act nor the relevant regulations contained in 29 CFR Part 1911 requires that an opportunity be given to cross-examine those who submit written statements for inclusion in the record and who do not otherwise appear at the hearing. Especially in light of the severe time strictures imposed in these circumstances by section 6(c) of the Occupa tional Safety and Health Act, an opportunity to cross-examine those who prepared the Snell study is not considered necessary to insure full public participation in the rulemaking process. Additionally, it is noted that the Snell study was essentially in agreement with the position taken by industry on the economic and technological feasibility of the proposed standard and that only limited reliance was placed on the Snell study in the formulation of the final standard. Thus, the final standard recognizes the difficulties that will likely be faced by some segments of the vinyl chloride industry in meeting the per missible exposure limits and provides for alternative means of compliance where necessary. Therefore, in any event the failure to permit cross-examination of Snell was not prejudicial to your position. BOR 004585 I-----------n ; ? i A5 i Your second motion, concerning the statements of Drs. Standart and Wegman, is also denied. Drs. Standart and Weg- man were engaged by OSHA, as expert consultants, to review and evaluate the public record developed in this proceeding. Their function was akin to that performed by regular OSHA employees, who review, analyze and evaluate the record evi dence and make recommendations thereon. All participants in the proceeding had a similar opportunity to comment on the "*31 evidence and arguments presented by others. The reports sub mitted by Drs. Standart and Wegman show that they did not >` present new data or information but merely evaluated the avail able information. This is a task which is performed regularly by OSHA employees, without the suggestion being made that > - they are thereby subject to cross-examination as part of the rulemaking proceeding. Accordingly, your request to cross- examine or to depose these consultants is denied. Additionally, the evaluation and conclusions contained in the reports of Drs. Standart and Wegman were merely cumulative. Substantial, and indeed overwhelming support for the health K conclusions reflected in the final standard exists in the record without regard to or reliance on the consultants' reports. There j fore, in any event, the failure to permit examination of the con sultants was not prejudicial. v* Based on the above reasons, and in view of the compelling 1 necessity to publish the final standard on exposure to vinyl ! chloride as expeditiously as possible, your motions are denied. Sincerely, /s/ John Stender John H. Stender Assistant Secretary of Labor V*> Bill HIUU IIJM.I "iUUi-JWJ