Petition for Writ of Certiorari — Firestone Plastics Co. v. United States Department of Labor

Supreme Court brief1975

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| REME COURT. U. @ rtcteD

IN THE

Supreme Court of the United States

OcroBeR TERM 1974

no. €4°1185

FirEstoNE PiLasrics Company, a Division

of THE Firestone Tire & Rupper Company,

UNIon CARBIDE CorPorRATION,

and

THE Society oF THE PLastics INpusrry, INc.

Petitioners,

Unirep States DeparTMeNT oF Lasor, JoHN T.

Dunwop, SecrETaRY, U.S. DEPARTMENT OF LaBoR,

JOHN H. Srenver, Assistant SECRETARY OF LABOR

FOR OCCUPATIONAL SAFETY AND HEALTH, AMERICAN

FEDERATION OF LABOR AND CONGRESS OF INDUSTRIAL

ORGANIZATIONS, and INpUstTRIAL UNION DeEpart-

MENT, AFL-CIO,

Respondents.

PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

March 19, 1975

(CouNSEL ON INSIDE OF CovER)

‘

Press oF Byron S. ADAMS PRINTING, INC.; WASHINGTON, D. C.

ST ee ree

PROT eT ee RT RT Te eT eee sn te a ee ~

)

Of Counsel:

Joun J. Cassipy, Jr.

Nina G. STILLMAN

VEDpDER, Price, KAUFMAN &

KaMMHOLZ

39 South LaSalle Street

Chicago, Illinois 60603

Telephone: 312/346-5544

Leva, Hawes, SyMINGTON,

Martin & OpPpENHEIMER

815 Connecticut Ave., N.W.

Washington, D. C. 20006

Telephone: 202/298-8020

Kewier & HECKMAN

1150 17th Street, N.W.

Washington, D.C. 20036

Telephone; 202/296-2700 *

SPO IE LESTE BERGE IE LER INE LL QE DELI ILE LOLLY NIE MIME CIES LEI IE

Water B. Connouy, Jr.

1200 Firestone Parkway

Akron, Ohio 44317

Telephone: 216/379-7000

Craig MATHEWS

Joun S. Horr

815 Connecticut Avenue, N.W.

Washington, D. C. 20006

Telephone: 202/298-8020

Attorneys for Petitioner

FIRESTONE Puastics CoMPANY,

a Division of THE FIRESTONE

Tire & Rveper CoMPANY

JoHN W. WHITTLESEY

James V. Murray

270 Park Avenue

New York, New York 10017

Telephone : 212/551-6797

lttorneys for Petitioner

Union CarpinE CorRPORATION

JeroME H. HecKMAN

1150 17th Street, N.W.

Washington, D. C. 20036

Telephone: 202/296-2700

Attorney for Petitioner

THE Society oF THE PuLastics

Inpustry, Inc.

EALERTS

| Bieretione cht

TABLE OF CONTENTS

TEER en pe ea rae

JURISDICTION ...... A te ea eee rete

Questions PRESENTED ...............-..-----+--+-

ConsTITUTIONAL, STATUTORY AND REGULATORY PROVISIONS

LSS ORE LEE ETO PEELE ELS

STaTEMENT OF THE CASE .............- FoR Gh a aes Nee

NE SAO Ot le to kins kale 9 Bisa le RN 8

OSHA Proceedings Concerning Vinyl Chloride _.

The Final Standard kee cat ene Wik dnd 6 Vee

The Hearikg ................ ceieyie® etre ere

ae ee eee

2. ‘Technological infeasibility .............

3. Economic infeasibility ..... .....

The Secretary’s Principal Findings and Conclu-

ee ee tee ony in Ge Ch Aen > eo.

1. Medical considerations ...................

2. Infeasibility of compliance ..............

3. Purported justification for the standard... 13

ie A NE i rss ee So key Rea 14

Reasons ror GRANTING THE WRIT ..... tad, Oe nae Te 14

1. The Court Below Improperly Refused to Apply

the ‘‘Substantial Evidence’’ Test Required by

NS or ct rene Gata e ca ss 15

2. The Court Below Improperly Failed Even to

Consider the Extensive Evidence Contrary to

the Secretary’s Determination............... 19

LR ALOR AE POPES EG MIA STE Ge YN ACE A CP ONS Fo

ii Table of Contents Continued

Page

3. The Court Below Improperly Interpreted the

4 Statutory Requirement that the Secretary’s

E Standard Must be ‘‘Feasible’’............... 21

4 | (a) Technology-forcing ..............-..---- 22

3 (b) Differing compliance capabilities of the

3 VCM and PVC industries............... 24

: 4. The Court Below Improperly Allowed the Sec-

retary to Adopt a Standard Which, Because It

; Merely Repeats the Statutory Criterion of

: ‘‘Feasibility,’’ Violates the Legislative Re-

i quirement That the Standard Must Be Stated

: in Objective Terms, and Is Also Unconstitu-

; tiomally Vague ... |)... ...-2---2--e eee reese 25

CoNCLUSION ....... Ae as ans || Sh tat ira ite edna ea 27

sd gy SO al RENE RMN ee COR RRS la

pS Tee pamearent | Sanpete ANE Erm ie 2la

LSS SUT yene |» Pani ilere sk Sener rar ear 63a

TABLE OF AUTHORITIES

CasEs:

Associated Industries of New York State, Inc. v. De-

partment of Labor, 487 F.2d 342 (2d Cir. 1973) .. 16,18

Boutilier v. Immigration and Naturalization Service,

Be Ti Be ED ee rena ee ie weccea seeds 27

Chrysler Corporation v. Department of Transporta-

tion, 472 F.2d 659 (6th Cir. 1972) .... ........ 2, 3, 26

Connally v. General Construction Co., 269 U.S. 385

tener Morr Sree esta Cee 27

a aa ad lat

POSIT PO OOS SOBER EMEA A OGRE ESSE RETIN FLL Ns FE ITI BAIT TE, Pe

mcrete ies So .

aici | SER SP EE ALB ELEN LL ON DYES ISLO AEE BTL SENAY ENG ISIE ee

Table of Authorities Continued iii

Page

Dry Color Manufacturers’ Association, Inc. v. Depart-

ment of Labor, 486 F.2d 98 (3d Cir. 1973) ........ 17

Ethyl Corporation v. EPA (No. 73-2205, D. C. Cir., Jan-

uary 28, 1975) . Be RL eae Hd es 20

Federal Trade Commission v. Colgate-Palmolive Co.,

Oe OE Oe Be Ce aes een ee lee 27

Florida Peach Growers Association, Inc. v. United

States Department of Labor, 489 F.2d 120 (5th Cir.

WOU, os oo a ohn haa Bh hae ees Baers 17

Industrial Union Department, AFL-CIO v. Hodgson,

499 F.2d 467 (D.C. Cir. 1974) .........----- 20, 24, 25

M. Kraus & Bros. v. United States, 327 U. S. 614 (1946) 27

Natural Resources Defense Council, Inc. v. EPA, 489

F.2d 390 (5th Cir. 1974), cert. granted sub nom.,

Train v. Natural Resources Defense Council, Inc.,

42, L.Ed.2d 46 (1974) (No. 73-1742) ............ 23

National Roofing Contractors Association v. Brennan,

495 F.2d 1294 (7th Cir. 1974), cert. denied, 42

Ste FB nen ae 17

Portland Cement Association v. Ruckelshaus, 486 F.2d

375 (D.C. Cir. 1973), cert. denied, 417 U.S. 921

|) SR AKare sr PERC a re PCr. Ree 23, 27

Synthetic Organic Chemical Manufacturers Association

v. Brennan, 503 F.2d 1155 (3d Cir. 1974), petition

for cert. pending (No. 74-789, filed December 21,

MNS ciacioays a inkegeier sen aa etek eee 17, 18

United States v. Mersky, 361 U.S. 431 (1960) ......... 27

Universal Camera Corporation v. N.L.R.B., 340 US.

MMOD ie er ee eek ye oe ens 16, 19

ee |

;

{

;

‘3

iv Table of Authorities Continued

Page

: ConsTITUTION AND StatutTEs:

{ Constitution of the United States, Amendment V 4

Automobile Safety Act, 15 U.S.C. § 1381 et seq... 28

4 Clean Air Act, 42 U.S.C. $1857 et seq... ....... 98

3 Judicial Code:

3 WP SUE) ceca 2

i Occupational Safety and Health Act, 29 U.S.C.

: Ie ye ce tt Ae 5)

MUSE CMM. hs. 5

me ume §@eeCM) (1) ..... «22... ae. 5

Be Uderd. SOBATR)IS) ... oe es ccs, 5

ae USO. $G56(B)(G) ...... 2... cn, 4, 21, 26

} Rue see... 2, 4, 15

REGULATIONS:

29 C.F.R. § 1910.93(a), Table G-1 (1972) ............ 6

29 C.F.R. § 1910.93q:

i 29 C.F.R. § 1910.93q(c) ........................ 7

j 29 C.F.R. § 1910.93q(f)(2) ................. 8, 26

| a0 O.F 3. $ 1011.15(b)(2) ..................0002..,. 5

or I voy Sys e le ek 7

: OrHeR AUTHORITIEs:

S. Rept. No. 91-1282, 91st Cong., 2d Sess. (1970) __.. 21, 23

116 Cong. Rec. 42206 (1970)

1k ae iter ne ee ek oy 16

116 Cong. Rec. 36512 (1970) ................. ...... 23

116 Cong. Ree. 32901-2 (1970) .. ....... 23

ca sh TICLE ROM ES BGS RST, RAI EG ND TNL E AMY OS SE eNOS THERES GALE TIM REL Ge

i ERE PA ae or ee ’ soe “ ia aber, —s

ae pesctve 2 .

3 es ewe SAN DON Ree AY ee at EE aT ee eI

IN THE

Supreme Court of the United States

OcroBeR TERM 1974

No.

Firestone Puastics Company, a Division

of Tue Firestone Tire & RupBeER CoMPANY,

Union CARBIDE CORPORATION,

and

Tue Society oF THE Pxiastics INpustry, INc.

Petitioners,

Unitep States DEPARTMENT OF Lasor, JOHN T.

Duntop, SecreTary, U.S. DEPARTMENT OF Lasor,

Joun H. Srenper, AssisTaNT SECRETARY OF LAaBoR

FOR OCCUPATIONAL SAFETY AND HEALTH, AMERICAN

FEDERATION OF LABOR AND CONGRESS OF INDUSTRIAL

ORGANIZATIONS, and INpustRIAL Union DEPART-

ment, AFL-CIO,

Respondents.

—

PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

Petitioners pray that this Court issue a writ of cer-

tiorari to review the opinion and judgment of the

United States Court of Appeals for the Second Circuit

entered in this case on January 31, 1975.

. RH, .

OHA GT OS A RP EINE OES gt Fey Iw eI TN aah - - :

¥ cst ait SNS pr, EID ES PU SE OI PT ra NE ees hE? Trego

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n> ent Le ee ee ee ae ey Re Ss

OPINION BELOW

The opinion of the United States Court of Appeals

for the Second Circuit is not yet reported. It is set forth

in Appendix A hereto, pp. 1a-19a.

JURISDICTION

The Judgment of the Court of Appeals was entered

January 31, 1975. A copy is included in Appendix A

hereto, at p. 20a. This Court’s jurisdiction is invoked

pursuant to 28 U.S.C. § 1254(1). The jurisdiction of

the Court of Appeals was conferred by 29 U.S.C.

-§ 655(f).

QUESTIONS PRESENTED

1. Whether, despite the requirement of the Occupa-

tional Safety and Health Act that the Secretary’s regu-

latory standards issued pursuant to the Act must be

“‘supported by substantial evidence in the record con-

sidered as a whole,’’ the reviewing court may refuse to

apply this test if the Secretary asserts that his standard

is based on “‘policy judgments’? because the factual

basis is insufficient ; and, regardless of the test applied,

whether the court may refuse even to consider the

evidence opposed to the standard ?

2. Whether, in light of the statutory requirements

that regulatory standards must be ‘‘feasible”’ and must

insofar as practicable be ‘‘expressed in terms of objec-

tive criteria,’ the Secretary may promulgate a stand-

ard that he concedes is infeasible; and whether he can

cure that deficiency by requiring employers to meet the

standard insofar as it is ‘‘feasible’’ for them to'do SO,

without specifying in any manner what actions will

constitute compliance? 7

wen EEA NOOB HOES GI Et ONG AAP RI ORS: Mei BOY PR RIN ROE OBR N NON OEE

IRE a ABO oe ee PRED EET ch LAP cE TIG ILS is

OO MO ieee TET, Fs 6s eR

* * *

Petitioners do not ask this Court to review the evi-

dence of record. Rather, they ask the Court to decide

the appropriate standard for judicial review of the

Secretary’s determination and to decide other impor-

tant questions of statutory construction and Constitu-

tional law raised by the Secretary’s action and its

affirmance by the Court of Appeals.

Petitioners do not question the fact that viny: chlor-

ide is a health hazard at very high concentrations. This

ease does not, however, involve that issue. Rather, it

involves the Secretary’s prohibition of exposures to

vinyl chloride at virtually any level, even though he

recognizes that the data are inadequate to establish a

medical need for such a stringent standard, and even

though he further concedes that the standard is not

technologically achievable.

The Court below refused to review the validity of

the Secretary’s action in accordance with the ‘‘substan-

tial evidence” test specified by Congress in the Occu-

pational Safety and Health Act. Furthermore, the

Court did not consider in any way the extensive evi-

dence of record which shows the Secretary’s standard

to be unnecessary and infeasible. In both respects, the

Court did not adequately exercise its judicial respon-

sibility as required by the statute. It thereby gave the

- Secretary virtually unrestrained license to adopt stand-

eee Oe

ards without sufficient factual basis and without effec-

tive judicial review. These are the errors of which

Petitioners complain.

Petitioners submit that this case presents issues of

exceptional importance. They affect sound judicial

practice, the Secretary’s future administration of a

major federal regulatory program, and the viability of

STGP EBA AS ite NEY bee AN —

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—_— ia

RAPE DRI CEs)

an important domestic industry. Petitioners therefore

ask this Court to grant their petition in order to resolve

these questions.

CONSTITUTIONAL, STATUTORY AND

REGULATORY PROVISIONS INVOLVED

Constitution of the United States:

Amendment V:

**...nor shall any person... be deprived of life, lib-

erty, or property, without due process of law. ...”’

Statutes:

29 U.S.C. § 955(b) (5):

“The Secretary, in promulgating standards deal-

ing with toxic materials or harmful physical agents

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. Devel-

opment of standards under this subsection shall be

based upon research, demonstrations, experiments,

and such other information as may be appropriate,

In addition to the attainment of the highest degree

of health and safety protection 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. Whenever practica-

ble, the standard promulgated shall be expressed in

terms of objective criteria and of the performance

desired.’’

29 U.S.C. § 655(f) :

‘“‘Any person who may be adversely affected by a

standard issued under tuis section may... file a

petition . . . with the United States court of ap-

peals ... for a judicial review of such standard. ...

‘The determinations of the Secretary shall be con-

elusive if supported by substantial evidence in the

record considered as a whole.”’

These and other relevant sections of the Occupational

Safety and Health Act are set forth in full as Appen-

dix C, pp. 63a-98a.

Regulations:

29 C.F.R. § 1911.15(b) (2):

“The presiding officer shall provide an opportunity

for cross-examination on crucial issues.”’

29 C.F.R. § 1910.93q, because of its length, is set forth

in full as Appendix B, pp. 21a-62a.

STATEMENT OF THE CASE

The Act

In 1970, Congress enacted the Occupational Safety

and Health Act, 29 U.S.C. § 651 et seq. The purpose

of the Act is “to assure so far as possible every work-

ing man and woman in the Nation safe and healthful

working conditions and to preserve our human re-

sources.” 29 U.S.C. § 651(b). The Act requires every

employer engaged in interstate commerce to provide

his employees a place of employment which is free ‘rom

‘‘recognized hazards that are causing or are likely to

cause death or serious physical harm.” 29 U.S.C. §

654(a)(1). The employer must also comply with occu-

pational safety and health standards promulgated by

the Secretary of Labor, 29 U.S.C. § 654(a) (2). The

Secretary administers the Act through the Occupa-

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tional Safety and Health Administration of the Depart-

ment of Labor (OSHA).

OSHA Proceedings Concerning Vinyl Chloride

Corporate petitioners manufacture polyvinyl chlor-

ide (PVC) resins by processing the vinyl chloride mo-

nomer (VCM). Petitioner Society of the Plastics In-

dustry includes members who manufacture VCM and

PVC and fabricate a large number of consumer and

industrial products containing vinyl chloride. J.A. 540.

The size and economic importance of the industry are

indicated by the fact that domestic productive capacity

for PVC alone was 5.4 billion pounds in 1974. J.A. 3469,

The OSHA standard at issue relates solely to expo-

sure levels for VCM, since PVC in itself is not alleged

to cause a health problem. |

VCM is a gas at normal room temperature and pres-

sure. It has long been known to pose risks of fire, explo-

sion and toxicity at very high concentrations. Accord-

ingly, in 1971 OSHA promulgated a standard limiting

employee exposure to VOM to 500 parts per one million

parts of air (expressed as 500 ppm).’

In January 1974, The B. F. Goodrich Company re-

ported to the National Institute of Occupational Safety

and Health (‘“‘NIOSH’’) that four of its long-term

employees had died of a rare form of liver cancer

known as angiosarcoma.? NIOSH relayed this infor-

1 References to

the Court below.

* 39 C.F.R. § 1910.93(a), Table G-1 (1972),

*Sinee the initiation of lar

World W

““J.A. ——”’ are to the Joint Appendix filed in

ge-scale PVC production during

ar II, the record shows that there have been 13 cases of

BE Me a SERRA +e

Mir: BTR I! bs

ne re

mation to OSHA. On February 15, 1974, OSHA held a

hearing on the possible hazards of VOM. On April 15,

1974, it promulgated an emergency temporary standard

providing that employers must reduce exposures to 50

ppm. 39 Fed. Reg. 12342.

On May 10, 1974, OSHA proposed a new permanent

standard to reduce VCM exposure to ‘‘no detectable

level.”? 39 Fed. Reg. 16896. Hearings on the proposal

commenced June 25 and concluded on July 11.

The Final Standard

On October 1, 1974, the Secretary promulgated the

new permanent standard, to be effective January 1,

1975. 39 Fed. Reg. 35890 ( October 4, 1974).* The maxi-

mum permissible level was set at 1 ppm TWA over any

eight-hour period, with a ceiling of 5 ppm for any

period not exceeding 15 minutes.’ This criterion is es-

sentially the same as the ‘‘no detectable level’’ standard

suggested in the proposed regulations.” The standard

requires employers immediately to reduce exposures of

all employees to the 1 ppm level. 29 C.F.R. § 1910.93q

(ec), Appendix B, p. 50a. It also provides that if

angiosareoma among domestic PVC workers. J.A. 3258. All involve

employees exposed to VCM during earlier periods of time when

VCM concentrations in PVC plants were far higher than at

present. J.A. 3258, 3289-91.

+The standard was amended in certain details on December 2,

1974, 39 Fed. Reg. 41848 (December 3, 1974).

sTWA (‘‘time weighted average’’) is the sum of the exposure

for any specified period of time divided by that time period.

6 The change in language reflects the fact that, with presently

available monitoring technology, an exposure level of 1 ppm

(+50%) is the lowest that can be detected. Because the two

standards are essentially identical, the description in the text of

the nature of the evidence presented at the hearing applies to the

promulgated standard as well as to the proposed standard.

;

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“feasible engineering and work practice controls

which can be instituted immediately are not sufficient

to reduce exposures . . . [to 1 ppm], they shall never-

theless be used to reduce exposures to the lowest prac-

ticable level, and shall be supplemented by respiratory

protection. . .”” 29 C.F.R. § 1910.93q(f) (2), Appendix

B, p. 52a.

The Hearing

1. Medical testimony

The factual data presented at the OSHA hearing

did not prove a medical need for a standard in the

range selected by the Secretary. On the contrary, a

number of medical witnesses testified specifically that

exposures at much higher levels have no adverse effect

on human health. The Dow Chemical Company pre-

sented the only record evidence relating health and

mortality experience to specific levels of vinyl chloride

exposure. The evidence showed no statistically signifi-

cant deviation in medical experience for employees ex-

posed to vinyl chloride even at levels as high as 200 ppm.

J.A. 1185.

Studies by other researchers showed that malignan-

cies were lower than average for employees exposed to

VCM levels below 200 ppm (J.A. 1744) ; that overall

mortality among employees exposed to VCM was only

79% of the statistical expectation for the general

population (J.A. 665-706); and that no cases of

angiosarcoma were found in a group of more than

1,000 employees exposed to vinyl chloride for ap-

proximately the same number of years as, but at

lower exposures than, the population that produced the

13 eases of angiosarcoma—although, as a statistical

matter, 21 cases should have resulted in the study group

if vinyl chloride were actually a cause of angiosarcoma

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PD da ya EN ee

at the tested levels (50 ppm and above). J.A. 663. These

conclusions were confirmed by three additional studies

of past and present employees. J.A. 1032, 1309, 2669.

In the face of these substantial medical data, OSHA

showed only that VCM is carcinogenic in man at very

high levels of exposure—a proposition not contested by

any party. J.A. 316. OSHA also produced clinical evi-

dence, as did industry itself, that VCM is carcinogenic

in rats and mice at 50 ppm. J.A. 175, 6044. No facts

were presented proving that the carcinogenicity of

VCM can be extrapolated from rats and mice to

humans. Nor were there facts indicating whether VCM

is carcinogenic in rats and mice at any level of ex-

posure lower than 50 ppm.

OSHA’s only “‘evidence’’ allegedly indicating a med-

ical need for the Secretary’s standard was conclusory

testimony that exposures should be reduced below the

detectable level because no level of exposure has been

shown to be safe. None of these witnesses (upon whom

the Court below so heavily relied) produced any factual

support for his view.’

On the contrary, the tenor of their testimony is

reflected in the following examples. The only witness

who based his recommendation on the extrapolation of

7 The record also contained the 1970 report by the Surgeon Gen-

eral’s Ad-Hoe Committee on the Evaluation of Low Levels of

Environmental Chemical Careinogens, which expresses the view

that if a substance causes cancer in two or more animal species this

finding may, by extrapolation, indicate a carcinogenic hazard to

man at any exposure level. The authors of the report were not

subject to cross-examination in the OSHA hearings. The report

contains no reference to vinyl chloride. It thus supplies no factual

data with respect to the question at issue in the hearing and it

provides no factual basis for the Secretary's determination.

test results from rats and mice to man, conceded that

his opinion depended upon a philosophical hypothesis

postulating an invariable ‘continuity of nature.”

J.A. 270. Every other witness rejected the validity of

that extrapolation. J.A. 480, 496, 977, 1225, 1275, 1432,

2000, 2991, 3728, 164-168, 2001-2003, 615, 1224-N-

1224-0, 1323. One of these other witnesses told OSHA

that “‘there is no way of projecting from the animal

data to man.” J.A. 3729. This witness recommended

the Secretary’s standard, yet he frankly admitted that

projecting the known effect of exposure to viny] chlor-

ide at high levels ‘‘is speculative at best... . [The

data] give no grounds for extrapolating to the un-

known. More fundamentally, there is no proven or

theoretical reason for extrapolating the curve.” J.A.

3728-29. And he concluded that “a standard cannot be

set on the basis of factual medical, toxicologic, epide-

miologic, or pharmacologie data. Such data do not

exist.’’ J.A. 3735. As this witness said, ‘‘The Record

contains no reliable information with regard to the

quantity of vinyl chloride that is hazardous to man.”’

J.A. 3727.

2. Technological infeasibility

The record makes clear that the Secretary’s standard

is not technologically feasible. The Secretary himself

so concedes. 39 Fed. Reg. 35892-35894, Appendix B, pp.

32a-33a, 38a-39a. All of the factual evidence demon-

strates that the engineering controls and work practices

necessary to comply with the OSHA standard do not

now exist, and that there is no reason to believe they

can be developed in the foreseeable future. J.A. 560;

754-763 ; 938-948 ; 1096; 1319; 1329-1333 ; 1692-1693.*

* Although several witnesses alleged the contrary, none possessed

engineering or other relevant expertise and none supported his

assertion with facts.

OSHA admitted at the hearing that it possessed no

technological or engineering studies supporting the

standard. J.A. 1366-1367. Presumably for this reason,

the agency announced on the last day of the hearing

that it had contracted with a private consulting firm,

Foster D. Snell, Inc., to conduct a study of the techno-

logical feasibility of the proposed standard and an

analysis of its economic impact. OSHA included the

Snell report in the record after the close of the hearing

and refused to permit cross-examination as required by

Section 1911.15(b) (2) of its own regulations.° Yet even

this report confirms that the OSHA standard is not

feasible and would threaten the continued existence of

the entire industry. J.A. 3584-3589.

3. Economic infeasibility

The record contains considerable evidence that the

proposed standard is not economically feasible. The

Snell report, cited above, concludes that if a 1 ppm

standard were promulgated, the cost of attempted com-

pliance would be so great that the entire PVC industry

in the United States would be ‘“‘endangered.”’ J.A.

3566, 3587. The record contains no evidence that the

standard is economically feasible. :

The Secretary's Principal Findings and Conclusions

The Secretary’s reasons for the final standard appear

in his introduction to the regulations:

lenged in, but not considered by, the Court below. The issue is

encompassed within the questions presented in this petition.

PE MT ee ee

a ee a ye 4.

1. Medical considerations

The Secretary recognizes that there is insufficient

factual evidence that his standard is necessary to pro-

tect employees’ health. 39 Fed. Reg. 35891-35892, Ap-

pendix B, pp. 27a-33a. He nonetheless assumes that,

since vinyl chloride induces cancer in man at very high

exposure levels and in rats and mice at 50 ppm, no safe

level exists. He asserts that, in order to set a specific

exposure level, OSHA need not prove that the level is

required to assure health and safety :

“In our view, the demonstration of cancer indue-

tion in humans at a particular level js nota pre-

requisite to a determination that a substance rep-

resents a cancer hazard at that level.’’ 39 Fed. Reg.

35892, Appendix B, pp. 3la-32a.

2. Infeasibility of compliance

The Secretary also concedes that industry cannot

comply with the 1 ppm standard when it becomes

effective:

“We agree that the PVC and VC establishments

will not be able to attain a 1 ppm TWA level for

all job classifications 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 classifica-

tions most of the time.’’ 39 Fed. Reg. 35892, Appen-

dix B, p. 33a.

* * *

““We recognize that many employers covered by

the standard can not currently achieve compliance

with the permissible exposure limit solely by the

use of feasible engineering and work practice con-

trols.’’ 39 Fed. Reg. 35893, Appendix B, p. 38a.

* * *

“*... [W]Jeare presently unable to determine when

it will be feasible for most establishments to reduce

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exposure levels to the permissible level.’’ 39 Fed.

Reg. 358944, Appendix B, p. 39a.

The Secretary acknowledges that the ‘‘record also re-

flects broad generic distinctions between the compliance

capabilities of the VC and PVC industries.”’ 39 Fed.

Reg. 35893, Appendix B, p. 38a. He nonetheless makes

no allowance for these differences, but applies the

standard identically to both industries.

The Secretary does not discuss the question of eco-

nomic feasibility.

3. Purported justification for the standard

In light of these concessions, the Secretary asserts

that, where the record affords insufficient factual sup-

port, he is nonetheless permitted to adopt regulations

on the theory that they are justified as “‘policy judg-

ments”’:

‘“Where decisions can be based on record evidence,

this has been done. Where, however, factual cer-

tainties are lacking or where the facts alone do not

provide an_ answer, policy judgments have been

made.”’ 39 Fed. Reg. 35892, Appendix B, p. 33a.

On the basis of this rationale, the Secretary con-

cludes:

‘‘ . the precise level of exposure which poses a

hazard and the question of whether a ‘safe’ expo-

sure level exists, cannot be definitely answered on

the record. Nor is it clear to what extent exposures

can be feasibly reduced. We cannot wait until in-

disputable answers to these questions are available,

because lives of employees are at stake. Therefore,

we have had to exercise our best judgment on the

basis of the best available evidence.’’ 39 Fed. Reg.

35892, Appendix B, p. 33a.

The Decision Below

On October 1, 1974, Petitioners Union Carbide and

Society of the Plastics Industry filed timely petitions

for review of the Secretary’s action in the United

States Court of Appeals for the Second Circuit.” After

oral argument, the Court stayed the effectiveness of the

regulations pending its decision on the merits. On Janu-

ary 31, 1975, the Court entered its opinion denying the

petitions.

REASONS FOR GRANTING THE WRIT

The decision below makes inoperative crucial provi-

sions of the Occupational Safety and Health Act. It

gives the Secretary virtually unrestrained license to

promulgate standards that concededly do not comply

with the statutory requirements, and to do so without

meaningful judicial review. It thus presents important

questions of Federal law which should be decided by

this Court. Their significance is emphasized by the fact

that, in numerous respects, the decision below conflicts

with the decisions of other Circuits.

The Occupational Safety and Health Act is a major

Federal regulatory statute which has been in effect

since 1970. It reaches every employer and worker en-

gaged in interstate commerce. It directs OSHA to bal-

ance what is optimal against what is practicable.

OSHA’s role is to assure worker health and safety, but

the Act requires the Secretary to temper his regulations

with considerations of technological reality and eco-

*° Petitioner Firestone filed a motion to intervene in the Second

Cireuit on the same day. On October 7, 1974, it filed a Petition for

Review in the Sixth Circuit. Firestone’s subsequent Motion to

Transfer that Petition to the Second Cireuit was granted on No-

vember 15, 1974.

BTR LE VOLE LLCS Ly Jd

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nomic possibility. Hence the standards must be ‘‘ feasi-

ble’? and must be based on ‘onbstantial evidence in the

record considered as a whole.”’

In this instance, the Secretary has violated these

statutory safeguards. With an admittedly inadequate

evidentiary basis, he has directed employers to pursue

standards which are admittedly infeasible. By allowing

him to do so, the Court below has vitiated the process of

judicial review specified by Congress. |

These issues are central to the proper administration

of the Act. Other Circuits have approached the issues

differently and have reached contrary results. The in-

consistencies produced by the decision below will con-

tinue until this Court provides definitive guidance.

To date, this Court has not reviewed the Act at all.

The decision below demonstrates the need for the Court

now to do so. The questions here presented are of great

legal and practical importance. The Court should ra-

tionalize the administration of the Act, by both the

courts and the Secretary, by resolving the issues on

their merits.

1. The Court Below Improperly Refused to Apply the “Substantial

Evidence” Test Required by the Statute.

99 U.S.C. § 655(f) provides that, upon judicial re-

view, “‘The determination of the Secretary shall be

conclusive if supported by substantial evidence in the

record considered as a whole.’’ * The Court below held

11 The legislative history of the statute demonstrates that Con-

gress meant precisely what it said when it provided that the de-

terminations of the Secretary must be ‘‘‘supported by substantial

evidence in the record considered as a whole.”’

As Congressman Steiger of Wisconsin, chief sponsor of the

statute in the House, said in discussing the bill as reported out of

conference :

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16 ;

“that, this test was “‘almast imanrcsible’’ te epprs —ewrck

therefore did not apply it—because the Secretary’s de-

termination was “essentially legislative” in character.

Appendix A, p. 5a. Although the Court professed to

‘follow Universal Camera Corp. v. N.L.R.B., 340 U.S.

474 (1951), it did not do so. Instead, it chose a different

and lesser test which it did not articulate, except to state

that the courts will only inquire whether the Secretary

has acted in a “‘manner calculated to negate the dangers

_ of arbitrariness and irrationality.” Appendix A, p. 5a.

The Court thus carved out of the statute a major ex-

ception: the substantial evidence test is, not applicable

whenever the agency’s standard under review is based

on a “‘legislative’’ or ‘‘policy’’ determination. The ap-

proach entails the obvious hazard that, as the Secretary

finds less evidence to support the action he desires to

take, he will increasingly assert that his decision is a

matter of “‘policy’’ and hence immune to meaningful

judicial review. Such a result is precisely contrary to

the intent of Congress as expressed in clear statutory

language. The decision of the Court below approaches

an abdication of judicial responsibility.

The case thus poses a critical question as to the role

of the Courts in reviewing determinations under the

Act. Its importance is confirmed by the instances in

“The Secretary's standard will only be sustained by the court

if it is supported by ‘substantial evidence in the record con-

sidered as a whole.’. . ..[T]he court review based upon sub-

stantial evidence provides a sufficient element of fairness to

satisfy me that [the] conference report should be aecepted.’’

116 Cong. Ree. 42206 (1970).

Judge Friendly has explained in Associated Industries of New

York State, Inc. v. Department of Labor, 487 F.2d 342 (2a Cir.

1973), that the substantial evidence test was incorporated in the

statute as an explicit compromise between differing procedural

provisions in the House and Senate bills.

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| which the Circuit Courts have already confronted the

question during the period that Tne dr ‘ac haan. in.

effect. In four such cases, other decisions of the Cir-

cuits directly conflict with the decision below.

In Florida Peach Growers Association, Inc. V.

United States Department of Labor, 489 F. 2d 120 (5th

Cir, 1974), the Fifth Circuit explicitly rejected the

argument that the question on review of an OSHA

standard is whether it is arbitrary and capricious,

rather than the more searching substantial e idence

test. Even though the Fifth Cireuit concluded (as the

Second Circuit did here) that OSHA’s task was **es-

sentially legislative,”’ it eld that the substantial evi-

dence test does apply. Moreover—as discussed in the

next section of this Petition—the court reviewed and

considered the opposing evidence, as the Court below

declined to do. In both respects, the decisions directly

conflict.

Similarly, in Dry Color Manufacturers’ A ssociation,

Inc. v. Department of Labor, 486 F. 2d 98 (3d Cir.

1973), the Third Circuit explicitly ruled that the sub-

stantial evidence test is not limited to factual determi-

nations, but applies to all decisions by OSHA.”

The decision below also conflicts with the decision of

the Seventh Cireuit in National Roofing Contractors

Association v. Brennan, 495 F. 2d 1284 (7th Cir. 1974),

cert. denied, 42 LL. Ed. 2d 801 (1975). Once again the

12°The view of the Third Circuit as to the proper standard of

review is clouded by the fact that a different panel of that court

subsequently held in related litigation that the substantial evidence

test does not apply to any of the Secretary's determinations except

as to factual matters, Synthetic Organic Chemical Manufacturers

Association v. Brennan, 503 F.2d 1155 (3d Cir. 1974). The latter

opinion is the subject of a petition for ceruorari now pending in

this Court (No. 74-789, filed December 21, 1974).

hy ce.

a ee

court held that the substantial evidence test applies to

all of the Secretary’s regulatory determinations under

OSHA and reviewed the evidence opposing the stand-

ard as well as that supporting it.

Finally, the opinion of the Court below is in conflict

with another decision of the Second Circuit itself. In

Associated Industries of New York State v. United

States Department of Labor, 487 F. 2d 342 (2d Cir.

1973), the Second Circuit, per Friendly, J., explicitly

rejected OSHA’s contention that the substantial evi-

dence test does not apply to questions of policy. Having

held that the substantial evidence test does apply, the

Court examined all of the evidence and invalidated

OSHA’s action.”

The conflicts among the Circuits, the conflicts within

the Third and Second Circuits, and the pendency of

another petition for certiorari raising the identical

issue as to the proper standard of review,” all attest to

the importance of the question now presented to this

Court.

Petitioners also point out that, even if this Court

were to conclude that the Fifth and Seventh Circuits—

as well as the Second Circuit itself in Associated Indus-

**In the usual case, a petition for rehearing en bane would be

the appropriate mechanism for resolving such a conflict within a

Cireuit. This case presents an unusual circumstance, however,

which renders that remedy unavailable. No member of the panel

which decided this case sits on the Second Circuit bench. The case

was heard by a retired Justice of this Court, a retired District

Judge, and an active District Judge. Petitioners are informed that

this panel was selected because every member of the Second Cir-

euit recused himself. In those circumstances, a petition for re-

hearing en bane would be futile.

Synthetic Organic Chemical Manufacturers Association v.

Brennan, note 12, supra.

tries and the Third Cireuit in Dry Color Manufactur-

ers—are in error, and that the Act permits the courts to

create an exception to the substantial evidence test in

the case of ‘‘policy”’ or ‘‘legislative’’ decisions, it would

still be necessary to clarify the criteria for determining

which decisions are which. The Secretary and the Court

below evidently believe that every instance in which the

factual record is insufficient gives rise to such a **nol-

iey’’ judgment. Only this Court can provide the requi-

site guidance.

2. The Court Below Improperly Failed Even to Consider the Exten-

sive Evidence Contrary to the Secretary's Determination.

The decision below also presents the separate ques-

tion whether, irrespective of the proper standard for

judical review, the courts may uphold the Secretary’s

action without examining the contrary evidence in the

record. Here the Court below did not consider or even

mention the extensive evidence opposed to the standard.

In effect, the Court held that, because human health is

involved at high levels of exposure, OSHA may set any

standard it pleases even where the factual basis for

doing so is deficient or non-existent.

The Court’s approach directly contravenes the man-

date of Universal Camera Corp. V. N.L.R.B., supra.

That decision requires a reviewing court to determine

whether the evidence relied upon by the agency is ren-

dered insubstantial by contrary evidence or evidence

from which contrary inferences can be drawn. As Mr.

Justice Frankfurter held: ‘*The substantiality of the

evidence must take into account whatever in the record

fairly detracts from its weight,’ 340 U.S. at 488. Al-

though the Court below cites and professes to follow

Universal Camera, it did not make the evidentiary in-

quiry which that decision requires.

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Once again, conflicting decisions in other Circuits

highlight the significance of the question. The cases

cited in the preceding section of this petition, which

hold that the substantial evidence test applies to OSHA

standards, also recognize the courts’ obligation to weigh

the evidence for and against the Secretary’s standard.

Industrial Union Department, AFL-CTO v. Hodgson,

499 F. 2d 467 (D.C. Cir. 1974), is to the same effect.

There the District of Columbia Circuit conducted a

careful review of the evidence, including the evidence

opposed to the standard set by the Secretary. The court

thus recognized that, whatever standard of review ap-

plies, it must examine all of the evidence rather than

looking merely to that which tends to support OSHA’s

action. The Court below did the opposite.

The same conflict exists with Ethyl Corporation v.

EPA (No. 73-2205, D.C. Cir., January 28, 1975), involv-

ing EPA’s authority to regulate fuel additives under

the Clean Air Act. EPA relied specifically on Indus-

trial Union Department, AFL-CIO v. Hodgson, supra,

to argue that where the issue lies ‘‘on the frontiers of

scientific knowledge”’ the agency may act as a matter of

policy even though the facts are deficient. EPA’s argu-

ment in Ethyl was thus identical to the view of the

Court below. Yet the District of Columbia Circuit re-

jected EPA’s approach. The court held that the

““causal connection between the lead emissions and

the harm must be established by relevant scientific and

medical evidence.”’ (Slip Opinion, p. 12, emphasis in

original.) It weighed the evidence on both sides and

invalidated the agency’s action. The decisions cannot

be reconciled.

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3. The Court Below Improperly Interpreted the Statutory Require-

ment that the Secretary's Standard Must be “Feasible.”

29 U.S.C. § 655(b) (5) contains two provisions re-

quiring that the standards promulgated by the Secre-

tary must be ‘‘feasible’’:

“The Secretary .. - 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

_.? Appendix ©, p. 70a (emphasis supplied)

‘‘In addition to the attainment of the highest de-

gree of health and safety protection, other consid-

erations [in promulgating regulatory standards]

shall be the latest available scientific data in the

field, the feasibility of the standards, and experi-

ence gained under ¢1,is and other health and safety

laws.”? Id. (emphasis supplied)

The legislative history confirms that Congress in-

tended the Secretary’s standards to be feasible.”

Despite the clear statutory directive, the Secretary

candidly acknowledges that his VCM standard is not

feasible. 39 Fed. Reg. 35892-35894, Appendix B, pp.

32a-33a, 38a-39a. Important questions are raised by his

admission :

15 As explained by Senator Javits, the author of the amendment

from which these statutory provisions were derived :

‘“As a result of this amendment, the Secretary, in setting

standards, is expressly required to consider feasibility of pro-

posed standards. This is an improvement over the Daniels bill,

which might be interpreted to require absolute health and

safety in all cases, regardless of feasibility, and the Admin-

istration bill, whieh contains no criteria for standards at all.”’

§. Rep. No. 91-1282, 91st Cong., 2d Sess., at 58 (1970).

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(a) Technology-forcing

The Court below upheld the Secretary’s standard,

despite its admitted infeasibility, by holding that the

Secretary may adopt standards “which require im-

provements in existing technologies or which require

the development of new technology”’

and by assuming

(without evidence) that the necessary technology would

eventually be developed. Appendix A, pp. 16a-17a. This

holding presents a series of questions. Is such a ‘‘tech-

nology-forcing’’ approach valid in the face of the statu-

tory language which seems explicitly to require the con-

trary result? Can the feasibility requirement be satis-

fied simply by assuming that the standard will become

feasible at an unspecified future time? Even if OSHA

can act on the assumption that the technology will even-

tually become available, when its advent is not foresee-

able, does not the statutory requirement of feasibility

at least require deferring the effective date of the regu-

lations until the technology can reasonably be expected

to have been developed ?*

*° The Court below relied on its belief that employees can use

respirators until compliance becomes possible. The Court over-

looked the fact that the respirator provisions do not relieve em-

ployers of the continuing obligation to achieve the 1 ppm standard.

In addition, the Court was factually incorrect, While it acknow]-

edged that the self-contained and airhose respirators are ‘‘infeasi-

ble for full-time use, as well as potentially hazardous,’’ it assumed

that the use of other types of respirators is feasible. In doing so,

it ignored the evidence demonstrating that full-time use of any

respirator is infeasible in the VCM and PVC industries. It also

erroneously concluded that full-time use would not be required. The

record shows, however, that full-time use of respirators would be

required for most jobs, including those in offices and cafeterias, as

well as for workers using washrooms, if a 1 ppm standard were

imposed. J.A. 535-E; 564-566 ; 722-722-B; 724; 745; 1332; 1948.

2288-2289.

To support its technology-foreing approach, the

Court below relied on Chrysler Corporation v. Depart-

ment of Transportation, 472 F, 2d 659, 671-672 (6th Cir:

1972), and Natural Resources Defense Council, Inc. v.

EPA, 489 F.2d 390, 411-412 (5th Cir. 1974), cert.

granted sub nom. Train v. Natural Resources Defense

Council, Inc., 42 L. Ed. 2d 46 (1974) (No. 73-1742).

Neither decision is apposite. The statutes involved in*

those cases (the Automobile Safety Act, 15 U.S.C.

§ 1381 et seq., and the Clean Air Act, 42 U.S.C. § 1857 *

et seq.) both contain technology-forcing purposes

which are absent here. The legislative histories make

this clear. In adopting the Clean Air Act and the Auto-

mobile Safety Act Congress expressly rejected ‘*feasi-

bility’? provisions virtually identical to that contained

in 29 U.S.C. § 655(b) (5). See Chrysler Corporation V.

Department of Transportation, supra; Natural Re-

sources Defense Council, Ine. V. EPA, supra; Port-

land Cement Association V. Ruckelshaus, 486 F. 2d 375,

391 (D.C. Cir. 1973), cert. denied, 417 U.S. 921 (1974).

See also, comments of Senator Muskie, Senate sponsor

of the Clean Air Act Amendments, 116 Cong. Ree.

32901-2 (1970). The Court’s reliance on these deci-

sions is therefore misplaced.

In addition, the holding of the Court below, permit-

ting the Secretary to impose a standard that requires

the use of unavailable technology, conflicts with a

recent holding on this point by the District of Colum-

bia Civeuit:

17 Such comments contrast sharply with comments by Senators

Javits, note 15, supra, and Saxbe, 116 Cong. Ree. 36512 (1970),

regarding the feasibility requirement of 29 U.S.C. § 655(b) (5).

2Att>

“*Congress does not appear to have intended to pro-

tect employees by putting their employers out of

business—either by requiring protective devices

unavailable under existing technology or by mak-

ing financial viability generally impossible.”’

Industrial Union Department, AFL-CIO vy. Hodgson,

supra, at 478 (emphasis supplied).

(b) Differing compliance capabilities of the VCM and PVC

industries

The Secretary's standard applies identically to fab-

ricators of vinyl chloride products, manufacturers of

vinyl chloride and manufacturers who convert the vinyl

chloride monomer into polyvinyl chloride. Yet the ree-

ord demonstrates that, because of differences in the

manufacturing processes involved, it is far more diffi-

cult for PVC producers to limit VCM exposure than

it is for VCM producers to do so. The Secretary hiin-

self concedes that the record “reflects broad generic

distinctions between the compliance capabilities of the

VC and PVC industries.”’ 39 Fed. Reg. 35893, Appen-

dix B, p. 38a.

Petitioners believe, and argued below, that the Sec-

retary acted improperly by failing to adjust his com-

pliance standards to accommodate these acknowledged

differences. The Court below did not consider the point.

Yet such an indiscriminate approach, sanctioned by

the Court, appears to be a further violation of the statu-

tory requirement that the standard must be feasible,

and also to raise a significant Constitutional question.

Once again, the position of the Court below conflicts

with Industrial Union Department, AFL-CIO vy.

Hodgson, supra. There, as here, the record revealed

that some industries could implement the Secretary’s

standard more readily than others. Nevertheless,

OSHA issued a single standard to be effective for all

industries on the same date. For this deficiency the

District of Columbia Circuit remanded.

The record contains ample evidence that compliance

with the Secretary’s standard would be economically

impossible. It contains no evidence that the standard

is economically feasible. Neither OSHA nor the Court

below examined the question. Yet, as its legislative

history makes clear, the statutory requirement that the

Secretary’s standard be feasible includes economic

feasibility."* The District of Columbia Circuit has spe-

cifically so held in Industrial Union Department, AFL-

CIO v. Hodgson, supra, at 477-478. Hence the decision

below presents the question whether the Federal courts

may permit the Secretary to ignore this statutory con-

sideration also. Once again a conflict between the Cir-

cuits emphasizes the significance of the question.

4. The Court Below Improperly Allowed the Secretary to Adopt

a Standard Which, Because It Merely Repeats the Statutory

Criterion of “Feasibility.” Violates the Legislative Requirement

That the Standard Must Be Stated in Objective Terms, and Is

Also Unconstitutionally Vague.

Recognizing that achievement of the one ppm level

is not feasible, the Secretary also requires industry to

employ ‘‘feasible”’ engineering methods and work prac-

tices to reduce exposure to the lowest “practicable”

18 See, e.g., remarks of Senator Saxhe, note 17, supra.

level, 29 C.F.R. § 1910.93q(f) (2), Appendix B, p.

02a.” This standard, of course, merely restates the

statutory requirement of “*feasibility.”’ It contains no

guidance, either for industry or for the OSHA regu-

lators themselves, as to what is ‘feasible’ or ‘‘prac-

ticable.’’ In fact, OSHA’s own explanation of its regu-

lations makes clear that it drafted the standard as it

did precisely because it could not determine, even after

a full hearing, what level of exposure is feasible.

In these circumstances, Petitioners argued in the

Court below that the standard is impermissibly vague

under the Fifth Amendment to the Constitution an.

that it also violates the statutory requirement that

“‘wherever practicable, the standard promulgated shall

be expressed in terms of objective criteria and of the

performance desired,’ 29 U.S.C. § 655(b) (5). As in

the case of various others of Petitioners’ arguments,

the Court below did not discuss the point.

Petitioners submit that the issue is important and

should be addressed by this Court. The Secretary’s

standard is clearly contrary to the statutory language

and purpose. The decision of the Court below uphold-

ing the standard conflicts, furthermore, with two recent

decisions in other Circuits, both of which invalidated

agency action for failure to formulate regulations in

objective and ascertainable terms, Chrysler Corpora-

tion v. Department of Transportation, supra, at 678,

* As noted above, the Secretary’s regulations nonetheless retain

the one ppm standard as an unconditional objective. The provi-

sions relating to “‘feasibility’’ supplement, but do not alter, the

obligation to pursue this objective. Industry remains obligated to

work toward an admittedly infeasible goal. The same is true of the

respirator provisions of the regulations, which do not affect the

employers’ obligation to strive to limit exposures to one ppm.

sha Portland Cement Association V. Ruckelshaus,

supra, at 400-401.”

CONCLUSION

The decision below raises important questions of

Federal law, relating to the implementation of a major

Federal regulatory program and the standards which

should govern agency decision-making. The statute in-

volved has already generated considerable litigation

and conflicting decisions by the Courts of Appeals.

These are matters which have not yet been before this

Court, and av to which the Court should now provide

guidance.

20'The Secretary’s standard also violates the Constitutional re-

quirement, which this Court has clearly articulated, that Federal

administrative prescriptions may not be vague—particularly where,

as here, a failure to comply can invoke criminal sanctions. As this

Court has stated :

«an order’s prohibitions ‘should be clear and precise

in order that they may be understood by those against whom

they are directed,’ ... and... ‘t]he severity of possible

penalties prescribed . . . for violations of orders which have

become final underlines the necessity for fashioning orders

which kre, at the outset, sufficiently clear and precise to avoid

raising serious questions as to their meaning and application.’ ”’

Federal Trade Commission v. Colgate-Palmolive Co., 380 U.S. 374,

392 (1965) (footnotes omitted). See also, M. Kraus «& Bros. v.

United States, 327 U.S. 614, 621 (1946) ; Connally v. General Con-

struction Co\, 269 U.S. 385 (1925) ; and United States v. Mersky.

361 U.S. 431 (1960). In the last case this Court emphasized that

‘businessmen must not be left to guess the meaning of regulations.”’

Id. at 441.

Moreover, as Mr. Justice Clark himself recognized when he was

sitting on this Court, the same principle applies even when erim-

inal sanctions are not involved: ‘‘. . . this Court has held the ‘void

for vagueness’ doctrine applicable to civil as well as criminal ac-

tions.’’ Boutilier v. Immigration and Naturalization Service, 387

U.S. 118, 123 (1967).

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For these reasons, the petition for a writ of certiorari

should be granted.

Respectfully submitted,

Watter B. Conno_y, Jr.

1200 Firestone Parkway

Akron, Ohio 44317

Telephone: 216/379-7000

Craiac MaTHEWS

JouHN S. Horr

815 Connecticut Avenue, N.W.

Washington, D. C. 20006

Telephone : 202/298-8020

Attorneys for Petitioner

FIRESTONE Piastics Company,

a Division of THE Firestone

Tire & RuBBeR Company

JOHN W. WHITTLESEY

JAMES V. Murray

270 Park Avenue

New York, New York 10017

Telephone: 212/551-6797

Attorneys for Petitioner

Union CarBipe CorPoraTIon

JEROME H. HeckMAN

1150 17th Street, N.W.

Washington, D. C. 20036

Telephone: 202/296-2700

Attorney for Petitioner

THE Soctety or THE PLAsTics

Inpusrry, Inc.

PEI er OB AEE tO I RS Bi OLLI APO ELI IIDD, LEON LL ICAL 4s OP ECE

Of Counsel:

Joun J. Cassiwy, JR.

Nina G. STILLMAN

VeppErR, Prick, KAUFMAN &

KaMMHOLZ

39 South LaSalle Street

Chicago, Illinois 60603

Telephone: 312/ 346-5544

Leva, Hawes, SYMINGTON,

Martin & OPPENHEIMER

815 Connecticut Avenue, N.W.

Washington, D. C. 20006

Telephone: 202/298-8020

Ketter & HECKMAN

1150 17th Street, N.W.

Washington, D.C. 20036

Telephone: 202/296-2700

March 19, 1975

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APPENDIX

APPENDIX A

Opinion Subject To Be Reviewed

UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

Nos. 505, 603-608, 670, 671

Argued December 13, 1974

September Term, 1974

Decided January 31, 1975

Docket Nos. 74-2284 74-2400

74-2286 74-2491

74-2308 74-2585

74-2345 74-2609

74-2449

Tarp Society OF THE Puastics InpusTRY, Inc., Petitioner

OccupationaL Sarety & HEALTH ADMINISTRATION,

ET AL., Respondents

Hooxer Cnemicats & Piastics CorPORATION,

and

Arr Propucts AND CHEMICALS, INc.,

and

Tenneco CHEMICALS, INc., Petitioners

OccupaTiIoNAL SAFETY AND HEALTH ADMINISTRATION,

eT AL., Respondents

Union Carni..t CoRPORATION, Petitioner

Vv.

Unirep States DEPARTMENT OF LABOR, ET AL., Respondents

POORER SAL ogrgsecagns

PEMELE FG LEE LIN IP LON LLGOL DE MAE LA MY IT EI TRAN

oF RECT GAT TEI I LOE EE BHO PRIN yg Ta tied

? FoR FAR CEPA ROGER STEED RII Y

Tue B. F. Goopricu Company, Petitioner

Peter J. BRENNAN, ET AL., Respondents

Firestone Puastics Company, A Division of the Frrestone

Tire & Rupper Company, Petitioner-Intervenor

Unirep States DeparTMENT oF Laon, ET AL., Respondents

Unrroyat Inc., Petitioner

OccuPATIONAL SAFETY AND HEALTH ADMINISTRATION,

ET AL., Respondents

GeneERAL Dynamic Cuemicat Co., Inc., Petitioner

Vv.

OccvuPATIONAL SAFETY AND HEALTH ADMINISTRATION,

ET AL., Respondents

Tue Diamonp Suamrock Cuemicat Co., Inc., Petitioner

OccuPATIONAL SAFETY AND HEALTH ADMINISTRATION,

ET AL., Respondents

An amicus curiae brief was filed on behalf of Chemical

Fabrics & Film Association

Before: Cuark, Associate Justice,* Bryan, District

Judge,** and Durry, District Judge.***

Petitions for Review of the Vinyl Chloride Regulation, 29

C.F.R. § 1910.93q, of Occupational Safety and Health Stand-

* United States Supreme Court, Retired, sitting by designation.

** United States District Court, Southern District of New York,

Retired, sitting by designation.

*** United States District Court, Southern District of New York,

sitting by designation.

Der ean

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“%

ards for the Vinyl Chloride Industry, promulgated by the

Secretary of Labor, pursuant to 29 U.S.C. § 655. Petitions

are denied.

Allan Topol, Washington, D.C.

(Covington & Burling on the brief)

Jerome H. Heckman, Washington, D.C.

(Keller and Heckman, 1150—17th St., N.W., Wash-

ington, D.C. on the brief)

Walter B. Connolly, Jr., Firestone Tire and Rubber

Company, 1200 Firestone Parkway, Akron, Ohio

44317

John J. Cassidy, Jr., Chicago, Illinois

(Vedder, Price, Kaufman and Kammbholz, 39 South

LaSalle, Chicago, Illinois, on the brief) for Peti-

tioners

Stephen F. Eilperin, Assistant Chief, Appellate Sec-

tion, Civil Division, Department of J ustice, Washing-

ton, D.C.

For Respondents

George H. Cohen, Washington, D.C.

(Bredhoff, Cushman, Gottesman and Cohen, 1000

Connecticut Avenue, N.W., Washington, D.C., on

the brief) for Intervenor Industrial Union De-

partment, AFL-CIO.

Lawrence Gold, Washington, D.C.

% (Woll, Mayer & Gold, 736 Bowen Building 815—15th

\ St., N.W., Washington, D.C. on the brief) for

y | Intervenor AFL-CIO.

Mr. Justice CLARK:

| 4 This is a petition for review of the health and safety

’ 3 regulations for the vinyl chloride industry, 29 C.F.R.

os § 1910.93q, promulgated by the Secretary of Labor on Oc-

tober 4, 1974, pursuant to the Occupational Safety and

ign

Wis.

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Health Act, 29 U.S.C. § 651 et seq. (hereinafter OSHA).

The standard and the Secretary’s statement of reasons

for its imposition are set forth at 39 Fed. Reg. 35890-35898.

In brief, the Secretary has adopted a standard which re-

quires that no worker is to be exposed to concentrations of

vinyl chloride in excess of one part per million (ppm)

averaged over any eight-hour period. 29 C.F.R. § 1910.93q

(e)(1).

Petitioners—manufacturers of vinyl chloride and vinyl

chloride products—make five principal claims: (1) the

available scientific and medical evidence does not establish

that the 1 ppm exposure level adopted by the Secretary is

required by health or safety considerations; (2) that the

Secretary violated the requirements of 29 U.S.C. § 655

(b)(5) by adopting a standard which is technologically

and economically infeasible for the industry to meet; (3)

that the standard is so vague and uncertain in its terms

that enforcement will violate the requirements of due proc-

ess; (4) that there was no substantial evidence in the

record to support the Secretary’s conclusion that those who

fabricate products out of vinyl chloride should be subject

to the same requirements as those who produce vinyl chlo-

ride; and (5) that the Secretary’s sign and labelling re-

quirements unduly and hence unlawfully emphasized the

carcinogenic properties of vinyl chloride. We find these

contentions meritless, and the petitions for review are

accordingly denied.

Score or JupiIciAL REvIEwW

Before proceeding to an examination of the regulations

at issue in this case, it would be wise to reemphasize the

unique nature of the court’s role under OSHA. Although

the statute sets forth general policy objectives and a pro-

cedural framework, the formulations of specific safety and

health policies is left to the Secretary, subject to review in

PARES PEPE OL LIP IE SE AIP ae

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the United States Court of Appeals. Our mandate is

contained in 29 U.S.C. § 655 (f), which states in relevant

part:

The determinations of the Secretary shall be conclu-

sive if supported by substantial evidence in the record

considered as a whole.

Yet the traditional ‘‘cubstantial evidence’’ test is almost

impossible of application where, as here, the Secretary’s

decision-making is essentially legislative in character.

The problems involved in according judicial review in

such circumstances have been wisely discussed by Judge

McGowan in Industrial Union Department, AFL-CIO Vv.

Hodgson, 499 F.2d 467 (D.C. Cir. 1974), who pointed out

that, under OSHA:

[T]here are areas where explicit factual findings are

not possible, and the act of decision is essentially a

prediction based upon pure legislative judgment, as

when a Congressman decides to vote for or against a

particular bill.

* * * *

[P]olicy choices of this sort are not susceptible to

the same type of verification or refutation by reference

to the record as are some factual questions. Con-

sequently, the court’s approach must necessarily be dif-

ferent no matter how the standards of review are

labeled. [499 F.2d at 474-75. ]

In these circumstances, Judge McGowan concluded, the re-

viewing court must recognize that its task defies general-

ized description and go from there to achieve its paramount

objective which ‘sis to see whether the agency, given an

essentially legislative task to perform, has carried it out

‘na manner caleulated to negate the dangers of arbitrari-

ness and irrationality in the formulation of rules for gen-

eral application in the future.’? Automotive Parts dé Ac-

cessories Assn. v. Boyd, 407 F.2d 330, 338 (D.C. Cir. 1968).

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Thus armed with these salutary remarks on our limita-

tions and our obligations, we turn to the challenged reg-

ulations. The examination of the 4,000-page record in this

case has been a prodigious task, aggravated by duplications

of testimony, irrelevant exhibits and letters, almost illegible

reproduction of documents, and a generally blunderbuss ap-

proach in petitioners’ briefs. Given the task, however, we

have performed it and conclude that the standard laid

down by the Secretary is fully supported by the record

and well within the requirements of Universal Camera

Corp. v. NLRB, 340 U.S. 474 (1951), and Assoc. Industries

of New York State, Inc. v. Department of Labor, 487 F.2d

342 (2d Cir. 1973), as well as Industrial Union Department,

AFL-CIO v. Hodgson, supra.

IL.

BacKGROUND

There are three basic components of the vinyl chloride

industry. First, there are the manufacturers of vinyl

chloride itself. A gas at ambient temperatures and pres-

sure, vinyl chloride monomer (VCM) is primarily syn-

thesized by the oxychloiination of ethylene in a handful

of large outdoor production plants which resemble oil re-

fineries. Shell, Dow, and Goodrich are the leading pro-

ducers, accounting for some 50% of the 5.2 billion pounds

annually available in the United States. Because of the

high degree of automation involved in this manufacturing

process, only some 1,500 workers are employed in VCM

production. VCM plants are open-air facilities, primarily

in the South.

Second, there are the manufacturers of polyvinyl chlor-

ide (PVC). Virtually all vinyl chloride is polymerized

into thermoplastic PVC resin which serves as the basis

for a wide variety of useful plastic products. Goodrich

is by far the largest single producer, producing some 20%

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of the country’s 9.4 billion pounds annually, though in

total there are only 21 companies operating the 37 PVC

plants. Historically, PVC production has been a ‘‘batch”’

or non-continuous operation carried out in relatively small

(2,000-6,000 gallon) ‘‘yeactors’? which require frequent

cleaning; the trend, however, :s towards substantially larger

reactors. PVC plants are not open-air facilities and are

generally located in colder climates than VCM plants. They

employ some 5,000 workers.

Third, and finally, there are the fabricators of products

which utilize PVC resins. Innumerable firms throughout

the country, employing thousands of workers, compound

PVC with plasticizers, heat stabilizers, lubricants, light

stabilizers, flame retardants, or impact modifiers to pro-

duce an astounding variety of wares, such as pipes and

conduits for building and eonstruction, flooring, wire and

cable, furniture, phonograph records, and packaging. In

fabrication, residual VCM that has been entrapped in the

PVC resin escapes during the heating process, and in this

way workers in the fabricating industry are also exposed

to vinyl chloride.

It is now clear that the workers in all components of

the vinyl chloride industry are subjected to a serious health

risk from VOM. Although conclusive proof of the car-

cinogenie and, in turn, fatal character of VCM did not

emerge until early in 1974 when the deaths of three workers

in Goodrich’s PVC plant at Louisville were reported,

strong warning signals had appeared long before. As

early as 1949, when the vinyl chloride industry had barely

reached its tenth anniversary, a study conducted among

vinyl chloride workers in the Soviet Union found liver

damage in 15 of 48 workers studied, and in 1958 and 1959,

Dow Chemical scientists elicited liver irregularities in

rats and rabbits at a 100 ppm concentration of VCM.

Although Dow recommended a 50 ppm allowable level in

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1961, the industry adhered to its previous 500 ppm

standard.

We need not outline in detail the morbid ‘Vinyl

Chloride Chronology’’, published by an industry spokes-

man, the Manufacturing Chemists Association (MCA), in

a 1974 press release (Joint Appendix at 134-145) in order

to illustrate the mounting evidence of VCM’s carcin-

ogenicity. Indeed, the record shows what can only be

described as a course of continued procrastination on the

part of the industry to protect the lives of its employees.

In 1967, when the industry had not reached its thirtieth

anniversary, upon receiving recurring reports of the

softening of the finger tips and bone of VCM/PVC workers,

the Manufacturing Chemists Association had the Uni-

versity of Michigan study the causes of this abnormality.

Three years later, in 1970, when it was advised that

research could not pinpoint the cause of the malady but

recommended a VCM/PVC ceiling of 50 ppm VCM, nothing

was done. And in March of the same year, Dr. P. L. Viola

of the Regina Elena Institute for Cancer Research in

Rome, Italy, published a report that 30,000 ppm VCM ex-

posure for four hours per day, five days per week for a

year caused cancer of the skin, lung, and bones of rats,

and a few months later at the Tenth International Cancer

Congress, described observations of malignant tumors in

the ear canals of rats subjected to the same exposure.

Apparently relying on Dr. Viola’s comment at the close of

his abstract that: ‘‘No implications to human pathology

can be extrapolated from the experimental model reported

in the paper,’’ the industry did nothing.

In 1971, MCA began to inquire by letter regarding the

conduct of toxicological studies on laboratory animals

with VCM and in May of 1971 heard a detailed presenta-

tion by Dr. Viola regarding his earlier studies as well as

other studies then unreported. The industry began talk-

ing about raising funds for epidemiological research on

ee SARATOGA S| nse ey he ee oe

VCM carcinogenicity, but 9 until Mareh 30, 1972, did 17

U.S. companies agree to finance such a study. By then,

the first deaths of U.S. workers due to VCM exposure were

being recorded. |

Months were consumed in 1972 by negotiations among the

participating company representatives, and it was not until

February of 1973 that a prctocol was agreed upon and a

research contract for animal exposure studies signed.

Meanwhile, startling rest rom European experiments

were filtering back to the inaastry. By January of 1973

it was discovered that Muropean experiments with rats

had not only found tumors the ear canal (which Dr.

Viola had reported as early as 970), but also of the kidneys

and liver at concentrations as low as 250 ppm VOM, but

not at 50 ppm. This discovery, however, was kept con-

fidential, and it was not even revealed to the National In-

<titute of Occupational Safety and Health (NIOSH) until

July 17, 1973. \

Earlier, on September 27, 1971, a patient of Dr. J. L.

Creech, Jr., plant physician of the B. F. Goodrich Chemical

Company in Louisville, Kentucky, died. The patient

had been employed for 15 years as @ helper and op-

erator in Goodrich’s Louisville PVC plant. When first

hospitalized, a tentative diagnosis was made of a bleed-

ing duodenal ulcer, but upon re-admittance and after

an exploratory laparotomy and \biopsy was carried out,

he was found to have angiossYreoma of the liver, an

exceptionally rare and irreversible cancer which strikes

only 1 person in some 50,000, no more than 20-30

persons a year. Kighteen months later, on March 3, 1973,

another former employee of the Louisville plant died,

and a third died on December 19, 1973, again of angiosar-

coma of the liver. Recognizing the rarity of the tumor and

learning that all three had worked in the Goodrich PVC

plant, Dr. Creech brought the matter to the attention of

Goodrich, and then on January 22, 1974, to the attention of

8 PEL LOUELIIONE MS GELLG

10a

the National Institute of Occupational Safety and Health

(NIOSH).

News of other deaths followed swiftly. On January 29,

1974, Goodrich reported the death of a fourth former

employee from angiosarcoma; a report of the death of a

fifth employee followed on February 15th. Six days

later, Union Carbide advised NIOSH of the death of one of

its PVC workers from liver angiosarcoma. Goodyear Tire

and Rubber Company announced a vinyl chloride worker

fatality from liver angiosarcome [sic] on March 1, 1974,

and reported two more such deaths from the same cause

on March 22nd. Goodrich reported cases of liver angiosar-

' coma in two of its living employees. On April 16, 1974,

Firestone Plastics announced the death of one of its

j employees from the same disease. Finally, on May 10,

1974, the National Cancer Institute diagnosed another

Union Carbide VCM worker as a victim of the same

disease. In all, the deaths of 13 workers in the PVC and

fabricating industries were reported.

TI.

Tue Secretary’s ACTIONS

Two days after Goodrich made its report to NIOSH of

its first three VCM worker deaths, an inspection of its

plant by NIOSH indicated considerable exposure of

workers to VCM, and control procedures as well as pre-

cautionary monitoring were recommended. NIOSH

alerted other federal agencies and after additional inves-

tigation soon concluded that VCM was the suspect agent

for a new occupational cancer. On April 5, 1974, the

Assistant Seeretary of Labor, acting on behalf of the Sec-

retary, held a hearing and promulgated an emergency

temporary standard of 50 ppm TWA’ in lieu of the pre-

a ali i

1Time Weighted Average (TWA) represents a worker’s cumu-

lative exposure to a toxic substance during a 9-hour shift.

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vailing 500 ppm one. At the hearing, industry itself

showed concern, and evidence was presented that both -

VCM and PVC plants could reduce concentrations below

50 ppm TWA. As in the past, Dow Chemical spoke out for

worker safety and urged that judustry exposure be re-

duced to 50 ppm TWA by operational and engineering

changes and that appropriate respiratory protection be

given where such level was not attainable. The Assistant

Secretary concluded that the evidence demonstrated VCM

to be carcinogenic for man. See 39 Fed. Reg. 12342. Mon-

itoring and housekeeping requirements were also imposed,

and a requirement was included that, if the 50 ppm level

was breached, appropriate respirators equipment be

furnished workers. The emergency order was limited to

six months ‘‘during which time the whole question of

possible exposure of humans to VC would be reconsidered

more fully and in the light of more information, including

experiments which are underway at the time.”’

On April 9, 1974, the Industrial Bio-Test Laboratory

notified MCA that its preliminary findings in their animal

exposure study showed that angiosarcoma of the liver was

produced in mice at a level of 50 ppm of vinyl chloride, and

MCA so informed the federal government. On May 10,

1974, the Assistant Secretary again acted. Issuing a notice

of proposed permanent rulemaking, he drew attention to

the MCA study results and noted that: ‘‘the question of a

cafe level of exposure for humans cannot be determined

at this time, and may continue as a matter for scientific

deliberation for many years.’’ 39 Fed, Reg. 16986. In the

interim. he concluded, it was necessary to abandon the 50

ppm emergency temporary standard and to establish it at

as low a level as can be detected using methodologies

sensitive to 1 ppm plus-or-minus 50%, i.e., the so-called

‘‘no-detectable”? level. This level was to be reached

through the ‘‘institution of engineering controls and work

practices as soon as feasible,’’ but respiratory protection

12a

was ds he affnrded wchare the smal ould .nnt atherwise Jhe

achieved.

On May 24, 1974, notice of a hearing on the proposed

standard to be held before an Administrative Law Judge

was given. Eight days of hearings were held during June

and July of 1974, and additional materials were received

from interested parties until September 25th. In addition,

the record of the previous hearing on February 25, 1974,

was ordered to be included.

On October 1, 1974, the final standard was promulgated,

effective January 1, 1975.? See 39 Fed. Reg. 35890. The

' main provisions are as follows:

(1) The standard applies to manufacturers of VCM and.

PVC and to fabricators of PVC, but excludes those merely

handling or using already-fabricated products. 29 C.F.R.

§ 1910.93q(a) (2).

(2) In place of the potentially obscure ‘‘no detectable

level’’ standard, a permissible exposure limit not greater

than 1 ppm averaged over an eight-hour period is set, but

allows for peaks of VCM exposure up to 5 ppm during

periods not exceeding 15 minutes. 29 C.F.R. § 1910.93q(c).

(3) All employers are required to conduct an initial

program of monitoring and measurement of exposure

levels, but need not: continue monitoring if initial levels

are below the so-called ‘‘action level’’ of 0.5 ppm averaged

over the eight-hour work day. 29 C.F.R. § 1910.93q(d).

(4) The standard requires that ‘‘feasible engineering

and work practice controls’’ be employed to reduce ex-

posure below the permissible exposure wherever possible,

or to the lowest practicable level if not possible, supple-

mented by respiratory protection. 29 C.F.R. § 1910.93q

(f) (2).

2 Petitioners’ application for stay of the January Ist deadline

was granted pending our disposition of the matter.

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(5) Where respiratory protection is required under the

standard, suitable equipment, as inaikatéa vyvar chert.in the

standard, shall be provided, and use shall be required of

employees unless the VCM level is below 25 ppm measured

over any 15 minute period, in which case the use of

respiratory equipment is optional with the employee until

January 1, 1976. 29 C.F.R. § 1910.93q(g) (1).

(6) Employees working in certain hazardous operations,

especially those involved in physically cleaning the interiors

of PVC manufacturing reactors, shall be provided pro-

tective garments and respiratory equipment. 29 C.F-R.

§ 1910.93q(h).

(7) A medical surveillance program is required for all

employees exposed to VCM in excess of the action level of

0.5 ppm. 29 C.F.R. § 1910.93q(k).

(8) Finally, in addition to certain record-keeping re-

uirements, all entrances, work-areas, and containers re-

lated to VCM or PVC manufacture and PVC fabrication

are required to be labelled with the warning legend :

‘‘Cancer-Suspect Agent’’. 29 C.F.R. § 1910.93q(1).

IV.

Peritioxers’ CONTENTIONS

(a)

Petitioner’s initial claim is that the available scientific

and medical evidence does not establish that the 1 ppm

exposure level adopted by the Secretary is required by

health or safety considerations. They claim that no proof

exists in the record to justify such a low standard, since

all of the medical witnesses testified that no one can say

whether exposure to VCM at low levels was safe or unsafe.

Further, they point to studies of employee health by Dow

‘ Chemical over a number of years which concluded that

exposure to VCM below 200 ppm did not lead to any

adverse effect.

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We find, however, that the evidence is quite sufficient to

warrant the Secretary’s choice. First, it must be re-

membered that we are dealing here with human lives, and

the record reveals that 11 manufacturing plant workers

and two fabrication plant workers have already died from

the effects of this potent chemical. Moreover, the animal

exposure study, sponsored by MCA, the industry’s own

trade association, identified fatal liver angiosarcoma and

4 other kidney and liver diseases at the 50 ppm level. None

of the physicians or scientists who testified could identify

a safe level of exposure to VCM, nor the precise mechanism

F by which it produces cancer; yet expert after expert rec-

ommended that this ‘‘very virulent’* carcinogen be re-

stricted to the lowest detectable level. Indeed, as one

witness, Dr. Kraybill of the National Cancer Institute,

: testified :

Certainly, there is little margin for safety if a

response can be expected at a level below 50 parts per

million which in truth is now only a fifty-fold safety

factor in terms of the proposed standard. According

to toxicological principles, were this compound a non-

carcinogen, then to establish a tolerance or safe level,

there would have to be a 100 to 1 margin of safety in

terms of a no-effect level, and from the experimental

data on the animals we don’t even know what the

no-effect level is. Obviously, this would put the

allowable level at a small fraction of a given standard

—of the given standard.

As in Industrial Union Department, AFL-CIO v.

Hodgson, supra, the ultimate facts here in dispute are

‘ton the frontiers of scientifie knowledge’’, and, though the

factual finger points, it does not conclude. Under the

command of OSHA, it remains the duty of the Secretary

to act to protect the workingman, and to act even in cir-

cumstances where existing methodology or research is

deficient. The Secretary, in extrapolating the MCA

study’s finding from mouse to man, has chosen to reduce

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the permissible level to the lowest detectable one. We

find no error in this respect.

Failing in this contention, petitioners strongly urge that

the Secretary breached his statutory mandate to insure

that the standard selected is a ‘‘feasible’”’ one.* Relying

on the so-called Snell Report, * petitioners claim that VCM

and PVC manufacturers will never be able to reduce levels

of exposure to 1 ppm through engineering means. They

point to the conclusion reached by the Snell Report that:

The costs of compliance increase rapidly with de-

creasing VCM target levels and represent significant

engineering uncertainty or infeasibility beyond 10

ppm ceiling and 2-5 ppm TWA for the VCM industry

and 15-25 ppm ceiling and 10-15 ppm TWA for the

PVC industry.

According to the report, “ [blased on the industry surveys

and Snell’s independent assessments of the state-of-the-art

of the technology,’’ the standard price of VCM would only

rise from 7.41¢ /lb. at present to 7.69¢/Ib. at a target level

of 2-5 ppm TWA, but would supposedly soar to 12.71¢/lb.

at the ‘‘no detectable”’ level.

In his statement of reasons in support of the standard,

the Assistant Secretary acknowledged the industry con-

tention and the Snell conclusion about the infeasibility of

399 U.S.C. § 655(b) (5) provides in part:

The Secretary * * * shall set the standard which most ade-

quately assures, to the extent feasible, on the basis of the best

available evidence, that no employee will suffer material im-

pairment of health or functional capacity * * *.

4 This report, ‘‘ Economie Impact Studies of the Effects of Pro-

posed OSHA Standards for Vinyl Chloride,’ was prepared in

September of 1974 by Foster D. Snell, Ine., an independent con-

sultant, at the request of the Secretary of Labor and estimates the

cost to the industry of complying with various exposure levels

between 50 ppm and 0-1 ppm. Plant and industry visits were the

principal means of information gathering.

l6a

the 1 ppm level, but noted that: ‘Labor union spokesmen

and the Health Research Group, Inc., however, have sug-

gested that such a level is attainable.’’ The Assistant

Secretary went on to say:

Since there is no actual evidence that any of the VC

or PVC manufacturers have already attained a 1

ppm level or in fact instituted all available engineering

and work practice controls, any estimate as to the

lowest feasible level attainable must necessarily in-

volve subjective judgment. Likewise, the projections

of industry, labor, and others concerning feasibility

are essentially conjectural. Indeed, as Firestone has

suggested, it is not possible to accurately predict the

degree of improvement to be obtained from engineer-

ing changes until such changes are actually imple-

mented.

We agree that the PVC and VC establishments will

not be able to attain a 1 ppm TWA level for all job

classifications in the near future. We do believe, how-

ever, 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 technology and work practices. It

may also be necessary to utilize technology presently

used in other industries. In any event the VC and

PVC industries have already made great strides in

redncing exposure levels. (See testimony of Dow

Chemical Co., TR 973). For example, B. F. Goodrich

testified (TR 1120) that it has reduce [sic] average

exposure levels in several PVC plants from 35-40 ppm

early this year to 12-13 ppm at the time of the hearing.

We are confident that industry will continue to do so.

[39 Fed. Reg. at 35892.]

We cannot agree with petitioners that the standard is

so clearly impossible of attainment. It appears that they

simply need more faith in their own technological poten-

tialities, since the record reveals that, despite similar pre-

dictions of impossibility regarding the emergency 50 ppm

standard, vast improvements were made in a matter of

weeks, and a variety of useful engineering and work prac-

tice controls have yet to be instituted. In the area of

aT eT

‘

17a

safety, we wish to emphasize, the Secretary is not restricted

by the status quo. He may raise standards which require

improvements in existing technologies or which require the

development of new technology, and he is not limited to

issuing standards based solely on devices already fully

developed. Cf. Chrysler Corp. v. Dept. of Transportaticn,

472 F.2d 659, 673 (6th Cir. 1972) ; Natural Resources De-

fense Council, Inc. v. E.P.A., 489 F.2d 390, 401 (5th Cir.

1971) [sic].

There is much testimony in the record, especially in the

Snell Report, indicating that VCM concentration can be

easily pinpointed and largely corrected. For example,

many of the companies engaged in PVC manufacture still

perform the cleaning of batch reactors by opening the

vessel and having the worker physically enter it. In

chipping off the aceretion from the walls of the vessel,

the worker is thus exposed to a high concentration of

VCM. Yet other, less hazardous methods are currently

available and in use, in which the vessels are cleaned by

machinery, emulsions or simply water under high pres-

sure. Other sources of exposure are encountered in filling

tank cars, measuring, testing and repairing pipe joints

or other connections. The Snell Report indicates that

much of this may be alleviated.

But whether it can or not, the Secretary’s compliance

scheme does not rest only on engineering and work prac-

tice controls. He does mandate that the industry use such

technology to the extent feasible, but, more importantly, he

requires that, in addition, respiratory protection be used

if engineering means cannot bring the VCM level down to

the permissible limit.

To be sure, respirators have their drawbacks. These

problems were detailed at the hearings and recognized by

the Assistant Secretary. Self-contained and air-hose type

breathing equipment is bulky, expensive, and infeasible for

full-time use, as well as potentially hazardous in terms of

tripping, restricted mobility, and over-exhaustion of work-

; aon

18a

ers. But the fact remains that they effectively eliminate

exposure to VCM, and they are already being used by some

PVC companies in the cleaning process and at other points

in production with good success.

Like the industry’s claims about the impossibility of

achieving compliance through technological means, peti-

tioners’ claims of dire consequences from the requirement

of respiratory protection are exaggerated. It does not

appear that full-time use of respirators is necessary, and

the Snell Report points this out. Furthermore, lightweight,

inexpensive cartridge or cannister-type respirators, which

can effectively filter out VCM at low levels, are now avail-

able and acceptable. Contrary to petitioners’ assertions, the

Snell Report indicates that a variety of respirators are

reasonably available.

We find that the Seeretary’s directions are clear, definite,

and certain and that they are also entirely feasible, since the

goal of the lowest detectable level can definitely be attained

through the combination of technological means and respi-

rators. Our conclusion in this regard is buttressed by the

fact that only some 6,500 of the workers coming under the

standard—those in the VCM and PVC manufacturing field

—are potentially exposed to high or constant VCM concen-

trations, and only a small percentage of them are actually

subject to excessive concentrations of the chemical during

manufacture. The remaining hundreds of thousands of

workers are in the fabrication field where exposure is

already so low that some of the petitioners claim that the

fabricators should not even be under the standard; these, of

course, have been included because of their work with PVC

resin which in final form contains residual amounts of VOM,

and the record shows that two deaths have in fact occurred

among fabricators.

If, in the future, the monitoring under the standard indi-

cates that the VCM level among fabricators is sufficiently

POR ae PL AN II IIE GN” APG L 2 OW,

19a

low and that the sporadic, unpredictable exposure of these

workers to residual VCM has been controlled, the fabrica-

tors might well be excluded or included in a separate, less

rigorous standard. Certainly if PVC producers were able

to eliminate all residual VCM from the resin before it is

delivered to the fabricator, there would seem to be no rea-

son for their inclusion. But this would be for the Secretary

| to decide on appropriate application or on his own motion,

l 4 and, as the record presently stands, their inclusion is amply

justified.

1 | In any event, compliance is time-phased and, if the peti-

tioners find that they cannot comply for reasons beyond

. their control, OSHA permits the amendment of standards.

See 29 U.S.C. § 655(b)(6)(A). Upon application and suffici-

ent proof of such a situation, we feel certain that the peti-

tioners would obtain relief at the hands of the Secretary.

This is especially true of the ‘‘cancer suspect agent’’ label-

ling requirements which petitioners urge are beyond statu-

tory contemplation. We think that the Secretary is simply

‘‘fighting fire with fire’’ and using the labels to bring the

danger of vinyl chloride forcibly to the attention of the

workers. Cf. Synthetic Organic Chemical Mfrs. Assn. v.

Brennan, 503 ¥.2d 1155 (3d Cir. 1974). They deserve no

less treatment. We have also considered the other argu-

ments of the petitioners and find them untenable.

It is our conclusion that the challenged aspects of the

Secretary’s vinyl chloride standard are supported by sub-

stantial evidence in the record and that the petitions for

review must be denied. Taking into account the delay

occasioned by these petitions, we think that a reasonable

‘‘lead time’’ is appropriate and therefore order that the

Secretary’s regulations, rather than being effective Jan-

uary 1, 1975, shall become effective sixty days after the date

of this order and that the time requirement as to respira-

tory protection contained in 29 C.F.R. § 1910.93q(g)(1) is

re-scheduled accordingly.

ay yn 5

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20a

Judgment Sought To Be Reviewed

UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

At a Stated Term of the United States Court of Appeals,

in and for the Second Cireuit held at the United States

Court House, in the City of New York, on the thirty-first

day of January, one thousand nine hundred and seventy-

five.

Present:

Hon. Tom C. Clark, Associate Justice 74-2284 74-2450

Hon. Frederick vP. Bryan, District Judge 74-2286 74-2491

Hon. Kevin T. Duffy, District Judge 74-2308 74-2585

74-2345 74-2609

74-2449

[Names of Parties deleted in reproduction]

Petitions to review an order of the Occupational Safety

and Health Administration.

These causes came on to be heard on a certified list of

items comprising the record of the Occupational Safety

and Health Administration and was argued by counsel.

On consideration thereof it is hereby ordered, adjudged

and decreed that the petitions for review be and they

hereby are denied in accordance with the opinion of this

court with costs to be taxed against the petitioners.

A. Dante Fvsaro,

Clerk

POP PROL EL LILI LEE NEI ELE LY OLROL ILE YE NTC IF SEO AO Pe at SOE

ww UI = ©

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2la

APPENDIX B

REGULATION INVOLVED

Occupational Safety and Health Standard

The Preamble and Order promulgating the Occupational

Safety and Health Standard for Vinyl Chloride, 29 C.F.R.

§1910.93q (39 Fed. Reg. 35890, October 4, 1974), as

amended (39 Fed. Reg. 41848, December 8, 1974), provide

as follows:

TitLe 29—LasBor

Cuaprer XVII—OccvupationaL SAFETY AND Heattu ApMIN-

ISTRATION, DEPARTMENT OF LaBor

Parr 1910—OccupaTIONAL SAFETY AND HeaLtH STANDARDS

Standard for Exposure to Vinyl Chloride

Pursuant to sections 6(b), 6(¢), and 8(c) of the Occupa-

tional Safety and Health Act of 1970 (84 Stat. 1593, 1596,

1599: 29 U.S.C. 655, 657) Secretary of Labor’s Order No.

12-71 (36 FR 8754) and 29 CFR Part 1911, § 1910.93 of

Part 1910 of Title 29, Code of Federal Regulations is here-

by amended in the manner set forth below, in order to pro-

vide an Occupational Safety and Health standard dealing

with the exposure of employees to vinyl chloride.

I. Background—(1) Vinyl chloride. Vinyl chloride (chlor-

octhene), Chemical Abstracts Service Registry No. 75014,

is a synthetic organie chemical made from ethylene or

acetylene and chlorine by any of several processes. It is

the parent compound of a series of thermoplastic resin

polymers and copolymers which are widely used for con-

tainers, wrapping film, electrical insulation, pipe, conduit,

and a variety of other industrial and consumer products.

Vinyl chloride has been made commercially in this country

since 1939, and present production is in excess of seven

billion pounds per year. The vinyl chloride industry di-

vides into three segments: monomer production, polymer

production, and fabrication. Production of the monomer

22a

is a large-scale continuous process, involving only a few

firms. There are comparatively few employees in this seg-

ment of the industry, because the processes lend them-

selves to automation.

Vinyl chloride (VC) is used primarily in the production

of polyvinyl chloride (PVC), a resin which is produced

through batch processing. The conversion of the VC mon-

omer into a polymer or copolymer is an incomplete proc-

ess, i.e., not all of the monomer is reacted.

PVC is fabricated by a variety of techniques, including

extrusion, injection molding and ecalendering, to form a

finished product that needs no further chemical handling.

The vast majority of employees involved in the VC indus-

try are employed by fabrication firms. Such firms range

in size from those with few employees and simple equip-

ment to large plants involving many employees and con-

siderable capital.

Vinyl chloride (VC), a gas at ambient temperature and

pressure, is a chlorinated hydrocarbon, which heretofore

has been regarded as having moderate liver toxicity. The

initial standard, contained in Table G-1 of 1910.93, estab-

lished a ceiling value of 500 parts of VC per million parts

of air.

(2) The emergency temporary standard. On January 22,

1974, the Occupational Safety and Health Administration

(OSHA) was informed by the National Institute for Occu-

pational Safety and Health (NIOSH) that the B. F. Good-

rich Chemical Company had reported that deaths of sev-

eral of its employees from a rare liver cancer (angiosar-

coma) may have been occupationally related. As a result

of this notification and after consultation with NIOSH,

and a joint inspection of the B. F. Goodrich plant by

OSHA, NIOSH and the Kentucky Department of Labor,

a fact-finding hearing was announced on January 30, 1974

(39 FR 3874) and held on February 15, 1974.

FDP AMES ENT Ma PEE POLE LOE LD LOONIE LE OSA I TIALS BAT ESAS

——

23a

W Information obtained from this hearing, particularly the

a preliminary reports of experiments conducted by Profes-

1- sor Cesare Maltoni of the Instituto di Oncologia, Bologna,

Italy, demonstrated that vinyl chloride induced angiosar-

coma in rats at levels as low as 250 ppm, and in other

r species at higher levels. Experiments performed at lower

a levels of exposure were not completed at that time. Other

; testimony from medical witnesses and NIOSH, and the

a results of autopsies, led to the conclusion that the Good-

rich workers had angiosarcoma of the liver and that VC

g probably was the causal agent in the angiosarcomas ob-

a served.

‘ In post hearing comments, additional angiosarcoma

deaths were reported among workers who had been ex-

; posed to VC in plants operated by Union Carbide Corpo-

i ration, Firestone Plastics Corporation and Goodyear Tire

& Rubber Company.

i On the basis of all information available at that time,

. and the fact that employees were being exposed at levels

. around the experimentally observed effect level of 250 ppm,

: an emergency temporary standard (ETS) was promul-

: gated on April 5, 1974 (39 FR 12341) pursuant to section

6(c) of the Act, as 29 CFR 1910.93q.

, This standard reduced the permissible exposure level

‘ from a ceiling of 500 ppm to a 50 ppm ceiling, and estab-

lished other requirements, including, for example, monitor-

; ing and respiratory protection. It was expressly recog-

nized that this standard limiting exposures to a 50 ppm

; ceiling was a tentative, interim standard, and that the

' whole question of exposure to VC would be considered

more fully in ihe light of additional information, especially

the results of experiments which were known to be under-

way at that time.

a»

L On April 15, 1974, information and data were presented

to representatives of OSHA, NIOSH, and the Environ-

;

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24a

mental Protection Agency by the Industrial Bio-Test Lab-

oratories, Northbrook, Illinois, concerning results of ani-

mal exposure studies with VC. These studies were spon-

sored by the Manufacturing Chemists Association. Al-

though only preliminary in nature at that time, these re-

sults revealed that 2 out of 200 mice exposed to VC con-

centrations of 50 ppm for 7 hours a day, five days a week,

for approximately 7 months, had developed angiosarcoma

of the liver.

(3) The proposed permanent standard. Based on the

demonstrated evidence of VC’s carcinogenicity in three

animal species (rats, mice and hamsters), and the substan-

tial probability that VC had been the causal agent in the

cases of liver angiosarcoma found in workers both here

and abroad, OSHA proposed to revise 1910.93q and pub-

lished a comprehensive proposal (39 FR 16896) on May 10,

1974, to protect employees from hazards of exposure to

VC. The proposal called for limitation of employee ex-

posure to VC to ‘‘no detectable level,’’ as measured by a

sampling and analytical method sensitive to 1 ppm, with

an accuracy of 1 ppm +50 percent. The proposal also

called for the establishment of regulated areas and limited

access to such areas to authorized persons. A requirement

for monitoring of employee exposures was proposed, along

with engineering and work practice controls to be imple-

mented when exposures over the detectable limit were

measured,

Respiratory protection would have been required while

engineering and work practice controls were being imple-

mented or where exposures exceeded the permissible limit

even after feasible engineering controls were instituted.

In addition, the proposed standard included require-

ments for medical surveillance, protective clothing, emer-

gency procedures, training, specific protection during main-

tenance and decontamination operations, transportation

loading and unloading operations and record-keeping.

“4

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25a

(4) Hearing on the proposal. The proposal, as pub-

lished on May 10, 1974, allowed 30 days for interested par-

ties to submit written comments and to request an informal

rulemaking hearing. Informal contacts with OSHA staff

and early responses indicated that the subject was of great

interest and importance to many persons. Because of the

limited time available before expiration of the six month

period provided in section 6(¢)(3) of the Act for promul-

gation of a final standard, it was decided to hold a hearing

as soon as possible. Accordingly, on May 24, 1974, a notice

of a hearing was published (39 FR 18303), setting a hear-

ing date of June 25, 1974. The hearing was conducted

from June 25 through June 28, and again from July 8,

through July 11, before Administrative Law Judge Gor-

don J. Myatt. All participants were given the opportunity

to present testimony and to cross-examine other witnesses.

Persons participating in the hearing were given until

August 23, 1974, to file additional posthearing comments,

including various items of information which were re-

quested during the examination of witnesses.

(5) Economic and technical impact study. During the

hearing, OSHA determined that additional facts would be

needed to determine the practicality of certain aspects of

the proposed standard. Accordingly, OSHA contacted an

independent consultant, Foster D. Snell Corporation, to

conduct studies of the feasibility of compliance at various

exposure levels, including those proposed by OSHA and

others advanced by industry spokesmen. Snell was also

commissioned to collect information regarding the eco-

nomic costs of compliance. This action was announced at

the close of the hearing, and Judge Myatt further an-

nounced that the record would be kept open for a period of

time beyond August 23, to allow interested persons to com-

ment in writing on the study. On August 26, 1974, OSHA

announced that the preliminary study was available and

that comments were to be submitted no later than Septem-

ber 6, 1974 (39 FR 30844). On September 13, 1974, OSHA

OTE POY? wrt 2 ESD bir FIL AIP & OL BN,

26a

invited comments on both the preliminary and the final

study, which was to be received on or before ee 25,

1974 (39, FR 33009).

(6) Environmental impact statements. A notice of in-

tent to file an environmental impact statement assessing

the impact of a proposed standard on occupational ex-

- posure to VC was published in the Feperat Recister on

_ April 24, 1974 (39 FR 14522). The notice invited any

person having information or data on the environmentai

impact to submit it to OSHA by May 17, 1974. On June

12, 1974, a draft environmental impact statement was pre-

pared and circulated to all interested persons. Ten copies

were forwarded to the Council of Environmental Quality

(CEQ), which published a notice of its filing and avail-

ability in the Feperat Rectster on June 25, 1974 (39 FR

22975). -A 45 day period was allowed for the submission

of comments on the draft statement. On September 5,

1974, the final environmental impact statement was pre-

pared and a copy of it and all substantive comments were

sent to appropriate governmental agencies, private organ-

izations, and other interested persons. CEQ published a

notice of availability for the final statement on September

6, 1974 (39 FR 32350). The submission of comment was

invited until September 25, 1974. The final statement and

all significant comments have been carefully considered in

arriving at the final standard on occupational exposure

to VC.

mere

‘ea

(7) The record. The record in this proceeding is one of

the most exhaustive ever, relied upon by OSHA. Ii con-

sists of pre and post-hearing comments and testimony re-

ceived at both factfinding and rulemaking hearings, the

studies and inspections conducted by OSHA personnel, the

environmental impact statements, the economic and tech-

nical impact studies, and all other relevant information.

In all, over 600 written comments have been received, with

more than 200 separate oral and written submissions made

thai peg PFE TITLE NET INE RI LONG LOMEIE SG ODES OES RGN IIE OE RN ETO ET PEN NAAN OMT ET EON NL MBH —

27a

with regard to the two hearings. The record itself exceeds

4,000 pages. Employers, employees, labor unions, public

health groups, independent experts, physicians, research

scientists, and specialists in many fields have been invited

to submit information and have made their views, knowl-

edge and expertise available to OSHA. The entire record

encompassing these submissions was thoroughly reviewed

and evaluated ‘in reaching the determinations set forth

below.

II. Findings regarding carcinogenicity, exposure levels

and feasibility—(1) Carcinogenicity of vinyl chloride. The

carcinogenicity of vinyl chloride for three animal species

(rat, mouse, hamster) has been documented on the record

by the studies of Maltoni and Bio-Test Laboratories.

Moreover, Maltoni’s investigations have demonstrated a

dose-dependent relationship for induction of tumors (i.e.,

more tumors‘oceur at higher exposure levels), including

angiosarcoma of the liver, in rats. The investigations of

Industrial Bio-Test Laboratories have demonstrated a

similar relationship for both rats and mice. These investi-

gators have induced angiosarcoma of the liver in rats and

mice at exposure concentrations of 50 ppm, and in ham-

sters at higher concentrations of exposure, Additional

tumors involving other organs, including the kidneys, lungs,

and skin of exposed animals, were also observed in fre-

quencies much in excess of contro] animals. The incidence

of tumors in mice in the Industrial Bio-Test Laboratories

investigations is particularly pertinent. Of 200 mice (100

males, 100 females) exposed to 50 ppm of vinyl chloride

by inhalation for eleven months, 100 died. Sixty-four ani-

mals ‘died without gross postmortem pathologie examina-

tion being performed. Of the 36 remaining animals for

which a gross postmortem pathologic examination was

performed, 13 (36 percent) were found with liver tumors

(including angiosarcomas) 21 (58 percent) with lung

tumors, 9 (25 percent) with skin tumors, and one with a

kidney tumor.

<——_ PAE DARLGA RAISE: LEGO IIE, PLEA EIEN PATEL UE Py ELI EAO. y —_ - —_

28a

According to the 1970 report by the Surgeon General’s

Ad-Hoc Committee on the Evaluation of Low Levels of

Environmental Chemical Carcinogens, the finding of can-

cer in two or more animal species may be extrapolated to

indicate a carcinogenic hazard to humans. Here, such a

finding was made in three species that were exposed to

VC by inhalation—a route comparable to employee expo-

sure. In addition, there were at least 13 confirmed cases

of angiosarcoma of the liver among employees exposed to

VC, a particularly significant number in view of the ex-

treme rarity of this cancer in the U.S. adult male popula-

tion (testimony of Dr. Marcus Key, Director of NIOSH,

at the rulemaking hearing).

The findings of angiosarcoma of the liver in both experi-

mental animals and exposed employees is compelling evi-

dence that exposure of humans to vinyl chloride induces

this tumor. Industry spokesmen, at the hearing, conceded

that VC is carcinogenic for humans (e.g., testimony of Dr.

McBurney, Rulemaking hearing, 1041). Accordingly, it is

concluded that VC must be regarded as a human carcino-

gen, and the probable causal agent of angiosarcoma of the

liver, and that exposure of employees to VC must be con-

trolled. .

Additional evidence of tumor induction in a variety of

other organs, including lung, kidney, brain and skin, as well

as non-malignant alterations, such as fibrosis and connec-

tive tissue deterioration, indicates additional oncogenic

and toxicologic properties of vinyl chloride, which must

be considered in establishing control regulations. (See

testimony and results of studies by Bio-Test Laboratories,

Tabershaw-Cooper, Maltoni, NIOSH, and Selikoff.)

(2) Exposure limits. Upon finding that exposure of em-

ployees to vinyl chloride may create a carcinogenic hazard,

the amount of exposure which is hazardous must be deter-

mined, The Surgeon General’s Ad Hoc Committee re-

ferred to above concluded that safe exposure levels for

PRE 20

29a

carcinogenic substances cannot be scientifically determined.

This position is supported by the testimony of NIOSH at

the hearing, its recommendations for a standard of no de-

tectable level, and by the testimony of expert witnesses

from the National Cancer Institute.

Several witnesses and persons who submitted comments

have taken a contrary view and have suggested that man

is less sensitive to biologic aberrations induced by vinyl

chloride exposure than experimental animals. Proponents

of this position have argued that if humans were as sensi-

tive as rodents, an ‘‘epidemic’’ of cancer resulting from

VC exposures should have already been discovered among

employees. They also argue that the employees in whom

tumors have been observed are those who have coneider-

able employment experience as polymerization reactor

cleaners. Because it is generally agreed that reactor clean-

ing involved high exposures to vinyl chloride in years past,

it is argued that the lower levels currently found in the

workplace have not induced cancer and are therefore safe.

We reject this argument.

The fact that approximately three-quarters of those em-

ployees with the longest exposure to VC (greater than 20

years since initial exposure) have not yet been located,

makes it impossible to determine the actual number of

affected employees. The cases of liver tumors observed

to date have an average latency period, since initial ex-

posure, of approximately 20 years. If it is assumed that

induction of angiosarcoma is a dose-related phenomenon,

and if employees engaged in cleaning reactors did, in fact,

receive larger doses of vinyl chloride, it would be expected

that such tumors would be observed earlier for this em-

ployee population. For this reason, the significance of

presumed lower doses cannot be accurately assessed until

a longer period of time has passed, as a longer induction

period would be expected.

Initiation of exposure to chemical carcinogens and in-

duction of cancer are not necessarily synchronous events.

30a

Because of the physiologic complexities involved with car-

cinogenesis, induction of tumors does not occur in al] em-

ployees with similar exposure histories. For example,

Dr. Schneiderman of the National Cancer Institute empha-

sized during his testimony that only about a fifth of longer-

term heavy smokers develop lung cancer. Accordingly, the

industry contention that exposure levels have been dra-

matically reduced since the 1940’s is not reliable evidence

that current levels of exposure are safe.

Some industry spokesmen also suggested that the appar-

ent nonrandom distribution of observed cancer in employ-

ees may indicate an exposure threshold for tumor induc-

tion, based on variations in the workplace design or prac-

tice and resultant employee exposures (testimony and ques-

tioning by Tenneco Chemicals, Inc.). It has also been em-

phasized that in only 3 of 8 polymerization plants where

employees have been exposed to VC for more than 20 years

have any employees developed angiosarcoma of the liver.

This argument is very similar to that raised concerning

variability of past employee exposure. Although geo-

graphic and workpractice differences may ultimately be

demonstrated to be factors in distribution of angiosarcoma,

sufficient information is unavailable to exclude from con-

sideration of risk those employees in workplaces for which

cases of angiosarcoma have not been observed.

It has also been suggested that the absence of cancer

in a population of 335 Dow Chemical Company polymeriza-

tion employees monitored over a period of 7 years, indi-

cates that exposure to vinyl chloride at concentrations of

less than 200 ppm is safe. (See Study by Dr. Cook, sub-

mitted at the hearing by Dow Chemical Company.) How-

ever, the group surveyed did not include all workers who

had been exposed, and the missing employees included

many who had the longer term (over 20 years) exposures.

Moreover, the statistically insignificant size of the sample

population decreases the possibility that tumors would be

observed. ;

3la

Dow also presented preliminary data in testimony at

the hearing on the possible metabolic pathways of VC. The

hypothesis presented was that VC may exert its carcino-

genic effect by a metabolite, and that the metabolite is pro-

duced only when VC is metabolized by a secondary

metabolic pathway operating only when enzymes regulat-

ing the primary pathway are saturated, as would be the

result at higher exposures. The preliminary data indicated

the possibility of an additional pathway for metabolism of

VC in rats exposed to concentrations of VC in excess of

220 ppm. However, the occurrence of angiosarcoma in both

rats and mice at VC exposure concentrations of 50 ppm

indicates that if a metabolite of VC is the ultimate car-

cinogen, then it must be generated at lower exposure con-

centrations in these species. Although this research may

be helpful to the thorough understanding of the carcino-

genicity of VC, it appears that it does not yet offer evidence

which can assist in determination of safe exposure concen-

trations for employees, or even that such safe exposures

exist.

A number of witnesses representing employers have

stressed that there is no evidence of cancer, either in em-

ployees or experimental animals, at exposure concentrations

of VC less than 50 ppm. (See e.g., testimony of Firestone,

Tenneco Chemicals.) The conclusion of these witnesses

was that no decision can be made concerning risk of ex-

posure to VC at concentrations less than 50 ppm.

On the other hand, the testimony of most expert wit-

nesses, including some industry biomedical experts, stated

that quantification of a safe exposure concentration is not

possible with the present state of scientific knowledge. (See

e.g., testimony of Selikoff, Firestone, NCI, and NIOSH.)

In our view, the demonstration of cancer induction in

humans at a particular level is not a prerequisite to a de-

termination that a substance represents a cancer hazard for

32a

humans at that level. It would be imprudent to assume

man to be less sensitive to VC exposure than experimental

animals in the absence of conclusive evidence. It would

also be unfounded to assume that animals will not develop

tumors when exposed at concentrations of VC of less than

50 ppm. Should a sufficiently large number of experi-

mental animals be exposed to VC at concentrations of less

than 50 ppm, Schneiderman said that it would be expected

that some would develop VC induced tumors.

(3) Feasibility. There is virtually no dispute that most,

if not all, fabricators are currently capable of reaching

exposure levels of 1 ppm through engineering controls.

These employers employ well over 95 percent of all em-

ployees exposed to VC. Indeed, several fabricators are

already operating at this level (see SPI testimony). How-

ever, industry spokesmen have universally claimed that it

is infeasible for the VC and the PVC industries to remain

below 1 ppm consistently, using engineering controls. In

addition, the Snell study on technical feasibility concluded

that a 1 ppm ceiling is not feasible for the VC and PVC

industries with present technology, but that the VC indus-

try could currently attain lower exposure levels than the

PVC industry. Labor union spokesmen and the Health

Research Group, Inc., however, have suggested that such

a level is attainable.

Since there is no actual evidence that any of the VC or

PVC manufacturers have already attained as 1 ppm level

or in fact instituted all available engineering and work

practice controls, any estimate as to the lowest feasible

level attainable must necessarily involve subjective judg-

ment. Likewise, the projections of industry, labor, and

others concerning feasibility are essentially conjectural.

Indeed, as Firestone has suggested, it is not possible to

accurately predict the degree of improvement to be ob-

tained from engineering changes until such changes are

actually implemented.

33a

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 technology

and work practices. It may also be necessary to utilize

technology presently used in other industries. In any

event, the VC and PVC industries have already made great

strides in reducing exposure levels. (See testimony of Dow

Chemical Co., TR 973). For example, B. F. Goodrich tes-

tified (TR 1120) that it has reduced average exposure levels

in several PVC plants from 35-40 ppm early this year to

12-13 ppm at the time of the hearing. We are confident

that industry will continue to do so.

(4) Conclusions. The conclusions below are based on a

thorough review and evaluation of all the evidence sub-

mitted. Where decisions can be based on record evidence,

this has been done. Where, however, factual certainties

are lacking or where the facts alone do not provide an

answer, policy judgments have been made.

There is little dispute that VC is carcinogenic to man and

we so conclude. However, the precise level of exposure

which poses a hazard and the question of whether a ‘‘safe’’

exposure level exists, cannot be definitively answered on

the record. Nor is it clear to what extent exposures can

be feasibly reduced. We cannot wait until indisputable

answers to these questions are available, because lives of

employees are at stake. Therefore, we have had to exer-

cise our best judgment on the basis of the best available

evidence. These judgments have required a balancing

process, in which the overriding consideration has been the

protection of employees, even those who may have regular

exposures to VC throughout their working lives.

Based on the available evidence and in view of the above

considerations, including feasibility, we believe that em-

—_

34a

ployee exposures to VC must be reduced to a 1 ppm time-

weighted average (TWA). We also believe that PVC and

VC establishments will, in time, be able to attain that level

through engineering controls, and that fabricators can do

so in the immediate future.

In addition to the TWA requirement, we have established

a 5 ppm ceiling (averaged over a 15-minute period) in

order to prevent exposure of employees to unacceptably

high excursions. From an operation standpoint, this ceil-

ing level is realistic because minor excursions up to the

ceiling level are likely to occur on a regular basis.

III. The final standard—(1) Scope and application.

Both the ETS and-the proposal would apply the standard

to the entire VC industry, including manufacturers of VC

and PVC and fabricators, but excluding employers handling

or using fabricated products made from VC.

There is no dispute that a standard is required for the

monomer and polymer industries. However, the Society

of Plastics Industry (SPI) and various fabricators (see

testimony of Goodyear, General Cable, ete.) recommended

that fabricators be excluded from the standard, or that a

separate requirement be established for them because many

of them were already at or below the proposed ceiling

level.

The record evidence establishes that at least some em-

ployees in the fabricating industry are exposed in excess

of the permissible control limits (See NIOSH testimony,

TR 106; Robintech TR 642). In these circumstances, we

believe that it is imprudent to grant a blanket exemption

for all fabricators. Therefore, the final standard is ap-

plicable to the fabrication industry as well as the monomer

and polymer industries. Employers who, in fact, are sub-

stantially below the exposure limit will be subjected to only

minimal burdens by virtue of the ‘‘action level’’ to be dis-

cussed below.

35a

Where employers in the fabricating industry have ex-

posures approaching the permissible limit, they will appro-

priately be subject to the standard, Employers handling

or using fabricated products made of PVC were not in-

cluded in the ETS or the proposal and are excluded from

the final standard. This conclusion is based on the absence

of adequate evidence of exposure to VC in these operations.

The final standard clarifies the exemption by defining a

fabricated product as a product made wholly or partly

from PVC which does not require further processing at

temperatures, and for times, sufficient to cause mass melting

of the PVC. SPI and others (ef. TR. 344) requested that

PVC resins with less than 0.1 percent residual monomer

be exempted from the regulation now, and that the exemp-

tion level be reduced to 0.01 percent in three years. SPI

suggested that the exemption of materials with less than

0.1 percent of 14 carcinogens from 29 CFR 1910.93p (39

FR 3756) was an appropriate precedent. The cases are not

comparable, because no attempt had been made to set air

concentration limits for the 14 carcinogens. The record

did not include information that reliable monitoring and

measuring techniques were available. Moreover, the ex-

emption did not exempt airborne traces of carcinogens.

The administrative cutoff was provided to avoid regula-

tion of materials about which there was no health hazard

information, and which would have broadly extended the

application of the regulation beyond the record. Herein,

no information was presented to show safe concentration

results from the use of resins with specific levels. Indeed,

the proposal to change the level later, when improved tech-

nology would permit such reduction, would seem to indi-

cate that SPI has doubts about the safety of 0.1 percent

residue level. Diamord Shamrock (Exhibit 142) testified

that there is no direct relation. They indicate that the air-

borne concentration is more related to the physical form

of the resin and the ventilation provided. Also, monitor-

ing data from industry (cf. Exhibits 131, 168, 170) and

a MELEE LYLE Ny AE LEVEL EE IEG IE IE LI EGE SLES LOSI LET ILD" PER CNG IE EO gt SCORE U8 4

36a

OSHA (Exhibit 151) indicate that levels in excess of 1 ppm

may be found in fabrication operations. In view of these

facts and of the opportunity for employers to discontinue

many duties upon a showing of no exposures above the

action level, it does not appear that any residue exemption

is either justified or necessary at this time. This course

also agrees with a number of industry proposals (cf. TR

660).

SPI (TR 345), among others, asked that compounded

PVC pellets be exempted from the standard on the grounds

that the pellets had too low a residue to cause harmful or

measurable emissions. While it appears that PVC pellets

would have a lower residue level than virgin PVC, the fact

that the pellets must be heated to a molten mass at the

same temperature as PVC, for further processing, indicates

that a potential for release of the residue still exists. It

appears that the exemption of fabricated products should

be limited to just those items which will not undergo such

mass heating. Further, the opportunity to demonstrate

that exposures are below the action level, and thus, discon-

tinue many duties of the standard, provides a more posi-

tive control and an adequate relief.

(2) Permissible exposure limit. The standard sets an

exposure limit of 1 ppm averaged over any 8 hour period,

and a ceiling of 5 ppm averaged over any period not ex-

ceeding 15 minutes.

As more fully discussed above, this limit is based on an

evaluation of the best available evidence and on a judgment

that the health and safety of employees must be protected

to the fullest extent feasible. In view of the fact that

releases of VC in the VC and PVC manufacturing processes

are variable, the 1 ppm ceiling level provided in the pro-

posal would require maintenance of an average level sig-

nificantly more difficult to attain through feasible engineer-

ing controls. Therefore, the exposure limit prescribed in

the proposal has been rejected.

37a

(3) Action level. The final standard, unlike the ETS

and the proposal, provides for an ‘‘action level”’ of 0.5 ppm

TWA, one-half of the permissible exposure limit. The

purpose of the action level is to minimize the impact of the

standard on the employers who have attained exposure

levels well below the permissible limit. Thus, where the

results of monitoring under paragraphs (d)(1) or (d3(2)

demonstrate that no employee is exposed in excess of 0.5

ppm TWA, employers may, in effect, be exempted from

some provisions of the standard. For example, fabricators

who are below the action level are not required to provide

medical surveillance or to monitor again, unless the em-

ployer has reason to suspect that any employee is exposed

in excess of-the action level. In our judgment, exposures

below the action level do not present a sufficient hazard to

warrant application of the entire standard to the many em-

ployers who are or will be below that level.

(4) Monitoring. The final standard, like the proposal,

requires that individual employee exposure levels be deter-

mined. This may be accomplished by personal or area

monitoring. Some witnesses and persons who submitted

comments did not understand the meaning of the term

“95 percent confidence level’’ in the proposal. Essentially

it means that the employer is required to take a sufficient

number of measurements so that the results obtained are

statistically valid. We have modified the proposal to estab-

lish accuracy range requirements for various measurement

levels. These ranges are narrow enough to ensure that a

determination of compliance can be made, and broad

enough to allow the application of a variety of technologies.

All covered employers are required to conduct initial

monitoring. Where monitoring and measuring results are

at or below the action level, no further monitoring is re-

quired unless the employer has reason to suspect that any

employee is exposed in excess of the action level, or unless

changes have been made in production, process, control,

type of resin, ete.

red

38a

Where the exposure level, without regard to respirators,

exceeds the permissible levels, monitoring must be con-

ducted at least monthly. Where exposures are less than

the permissible levels, but greater than the action level,

monitoring must occur at least quarterly.

(5) Methods of compliance. The standard, like the pro-

posal, requires that employers immediately institute

feasible engineering and work practice controls to reduce

exposures to at or below the permissible exposure limit.

Where feasible engineering and work practice controls

will reduce exposures below the permissible levels, they

must be instituted. Where such controls will not reduce

exposures below the permissible level, they must nonethe-

less be implemented to reduce exposures to the lowest prac-

ticable level, and be supplemented by the use of respirators

to provide the necessary protection. Thereupon, a con-

tinuing program of engineering and work practice controls

must be instituted to reduce exposures to the lowest prac-

ticable level. When exposures are at or below the permis-

sible exposure limits, the program may be discontinued.

In addition, a plan for achieving control by engineering

and work practice methods must be drawn up and be made

available, upon request, to representatives of OSHA and

NIOSH.

We recognize that many employers covered by the stand-

ard can not currently achieve compliance with the permis-

sible exposure limit solely by the use of feasible engineer-

ing and work practice controls. The record also reflects

broad generic distinctions between the compliance capa-

bilities of the VC and PVC industries. Some industry

spokesmen, including SPI (TR. 358-362), recommended

that a schedule of different permissible exposure limits and

compliance dates be established for the VC and PVC seg-

ments of the industry.

Ga . i GAELIC SOG SRN ET MS 5 Re PO RN, cg ram re ere eee Ceara

39a

This view assumes that the ability and the time required

to feasibly reach increasingly lower control levels is similar

within each industry, but differs markedly between indus-

tries. While the record does suggest that such differences

do exist between industries, as noted above, it is clear that

intra-industry differences also exist. Thus, the ability and

time required by each employer to attain lower control

levels may depend upon such factors as the climate in

which the plant is located, the age of equipment, the size

of reactors, or the type of resin manufactured or used.

(Snell study. Firestone testimony, ete.)

Monitoring data also tends to support such intra-industry

variations. (See, e.g. Dow, Firestone, Tenneco.)

As noted above, the standard requires all employers to

institute feasible engineering controls to the fullest extent

and to continue to improve and apply engineering controls

until full compliance is achieved.

We have not established any deadlines for full compli-

ance through engineering controls because we are pres-

ently unable to determine when it will be feasible for most

establishments to reduce exposure levels to the permissible

level.

We also believe that the requirement that each employer

reduce airborne concentrations to the permissible level, or

to the lowest level feasible as soon as practicable will pro-

vide for inter-industry and intra-industry technological dif-

ferences which do exist, and will avoid the setting of sepa-

rate industry standards on the basis of the general situa-

tion and conditions in each industry.

(6) Regulated areas. The proposed standard would have

required that regulated areas be established, that access be

limited to authorized employees, and that daily rosters or

summaries of those entering be kept for at least 20 years,

In objection to these requirements, it was asserted that

such control of access was not necessary from a health

= FERRI TE I NT LITE NS SCRA RAE PT TAAL IOI ETE AOL INET Si OG - a

- ‘ ee me) ae SOM Lar?

40a '

standpoint. Secondly, it was claimed that these controls

would interfere with operations by preventing access of

needed employees or non-employees, such as contractors,

truck drivers, customers and consultants.

The purpose of establishing regulated areas in the pro-

' posal was to limit the risk of exposure to as few employees

as possible. This concern is still paramount, and thus

the limited access feature remains. The final standard

amends the proposal slightly to allow ‘‘authorized | per-

sons’’ to enter regulated areas, This change, it is felt, will

allow operations to continue without undue interference.

The final standard has also increased the length of time

daily rosters must be maintained from 20 to 30 years. This —

change was based largely on epidemiological considera-—

tions. (See NIOSH testimony, tr. 119.)

(7) Respiratory protection. The final standard, like the

proposal, requires the use of respirators where employee

exposures exceed the permissible control level. Industry

representatives made a number of objections fo proposed

requirements for respiratory protection. They stated that

the ‘‘no detectable level’’ would effectively require continu-

ous wearing of respirators in PVC and VC plants, and

that this is not feasible because respirators are cumber-

some, present a safcty hazard, and employees would not use

them.

We would agree that respirators have many drawbacks; |

the proposal did not contemplate them as,a final solution.

The record shows that the PVC industry particularly may

need several years before plant environmental levels can

be reduced so that respirators are necessary only occasion-

ally, However, we cannot agree that respiratory protection

should not be required simply because it is inconvenient,

, may require additional personnel, interferes with produc-

tion, or may require extensive retraining of employees and

restructuring of work practices. We have carefully con-

sidered all the objections, and have concluded that if the

Ore Oe PNET | be ate ee ie ee en a fa ee ee ee =:

fla

environmental level is not controlled to the permissible

exposure limit, then employees must be afforded respira-

tory protection.

While exposures in excess of the permissible level do

constitute a hazard, we believe that it is necessary to miti-

gate some of the problems associated with implementing a

program of respiratory protection while employees are

being fitted and trained in respirator use, and while other

adjustments which may be required are implemented.

Therefore, until January 1, 1976, where exposures are not

in excess of a 25 ppm ceiling, each employer must provide

each employee'with an appropriate respirator. However,

employees whose exposures do not exceed a 25 ppm ceiling,

may decline, to use the respirator, in which ease the em-

ployer is not obligated to require its use. During this

adjustment period, employees will be trained in the uses,

purposes and limitations of respirators, and the hazards

of exposure to vinyl chloride. Moreover, each employee

will be notified in writing if he has been exposed in excess

of the permissible exposure limit.

—s

Where expdsures exceed a 25 ppm ceiling, respiratory

protection is mandatory in light of our judgment that much

greater risks are associated with such exposures.

The provisions in the final standard regarding the selee-

tion and use of respiratory protective devices differ from

those in the proposal. The descriptions of atmosphere-

supplying respirators have been revised to indicate more

clearly the types of devices intended, and the maximum

permissible concentration level for each device. Moreover,

the number of types of atmosphere-supplying devices has

been increased.

At the hearing Mr. Edwin C. Hyatt, an OSHA consult-

ant, made suggestions regarding the use of particular res-

piratory devices. We have concluded that his sug:gestions

are meritorious. Therefore, the provisions for selection of

—_—_

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-_ Koi Sati Sa, ah ows O28. -"*

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42a

atmosphere-supplying devices follow closely the recommen-

dations contained in his testimony. Industrial spokesman

also agreed. (TR with Hyatt’s suggestions. (See e.g. tes-

timony of SPI and B. F. Goodrich) (TR 85 ff) We had

originally omitted air-purifying respirators because none

had been approved by NIOSH for use against VC, prin-

cipally because they lacked indicators to signal the expira-

tion of the service life of the sorbent. Hyatt and other

witnesses discussed in detail the desirability of being able

to use canisters or cartridge air-purifying respirators,

provided a sorbent could be shown to effectively absorb

vinyl chloride with an adequate service life. Recently,

OSHA has received respiratory data from laboratories re-

garding the effectiveness of commercially available canis-

ters and cartridges for vinyl chloride. These evaluations

were conducted separately by NIOSH and by the B. F.

Goodrich Company and submitted to OSHA in post-hearing

comments. The results indicate that certain presently

available canisters and cartridges effectively absorb vinyl

chloride at relatively low concentrations. In discussions of

these findings with NIOSH, it has indicated that it is will-

ing to consider on an expedited basis the approval of air-

purifying respirators for use against VC. Consequently,

we have included three types of air-purifying respirators

in the list of acceptable units, subject to the approval of

such units by NIOSH. The maximum concentration for

which each respirator may be used is based upon our eval-

uation of the data submitted by NIOSH and Goodrich. Be-

cause air-purifying respirators do not indicate sorbent

exhaustion or breakthrough of VC, and because VC has no

inherent warning properties at levels for which these de-

vices are used, strict administrative controls will be re-

quired for their use. Such controls include a program to

assure timely replacement of canisters or cartridges and an

alarm system to alert employees when vinyl chloride con-

centrations exceed the concentrations allowed for the par-

ticular type of respirator in use.

43a

(8) Hazardous operations. This is a new section within

the final standard. It encompasses essentially the pro-

posal’s requirements for maintenance and decontamination

but has restated them in terms of performance language

to allow greater flexibility for employers to deal with such

operations. The intent of the new section is to protect

employees engaged in activities that present a risk of

exposure to vinyl chloride in excess of the permissible

levels. An example would be the cleaning of a filter where

resin containing high residual monomer is trapped.

The proposal’s requirement for full-body, impervious

clothing has been replaced by the direction to use imper-

vious garments suited to the particular situation and prob-

able extent of exposure. Thus, full-body clothing is not

always necessary, and is therefore not required where less

protection is adequate. Since vessel entry falls within the

definition of a hazardous operation, the vessel entry sec-

tion of the proposal has been deleted from the final

standard.

(9) Emergency situations. The definition of emergency

has been recast in terms of an unexpected massive release.

The main objection to the section on emergency situations

in the proposal was that, as the term was defined, many

ordinary leaks or operations resulting in a small release

of vinyl chloride would be considered emergencies. This

was not the intent of the proposal. The final standard has

been clarified to correct this ambiguity. It should be noted

that the written operational plan required by the standard

need not be developed for minor excursions above the per-

missible exposure limit, and that such excursions need not

be reported.

(10) Signs and labels. The thrust of the signs and labels

section is to apprise employees of the cancer and fire haz-

ards. No objections have been raised with respect to in-

forming employees of the fire hazard. However, a number

PRED IOEL

44a

of objections were raised at the hearing and in written

submissions to the requirement that the word ‘‘cancer’’

appear on all signs and labels. The principal argument

advanced against its use was that the term ‘‘cancer’’ or

*‘cancer-suspect agent’’ scares employees and that instead,

the message should contain instructions on how to deal

with the substance (TR. 347). We believe that a diluted

form of warning will not suffice. We appreciate the con-

cern of employers with the reaction of their employees.

But we consider it imperative that a worker be fully in-

formed, and that he realize the possible risks involved in

his occupation. Coupled with the training requirement in

the standard, we believe that the signs and labels required

will adequately inform employees of the hazard. In addi-

tion, such signs will warn unauthorized personnel to keep

out of regulated areas.

The proper application of most protective measures re-

quires an amount of training and indoctrination of em-

ployees that cannot easily be conveyed on a sign or label.

Also, the variety of measures that could be prescribed

would result in an unwieldy or excessively detailed legend.

Consequently, the required message on signs and labels

will not include information on precautions, relevant symp-

toms, ete. The addition of suitable information by the

employer would be permitted, providing it does not detract

in any way from the required statement.

The requirement in the proposal for labeling containers

of vinyl chloride has been amended by deleting the refer-

ence to the possible hazard of violent polymerization. Very

- little information was developed on this hazard during the

standard-setting procedure. It does appear that this haz-

ard is essentially under control and that the fire and

carcinogenic hazards at present are the most significant.

Since labeling or placarding that is in compliance with the

U. S. Department of Transportation regulations (49 CFR

Part 173, Subpart H) already warns of the fire hazard,

— tn el

45a

only a statement concerning the carcinogenic hazard need

be added to the Department of Transportation labels.

(11) Medical surveillance. The principal questions that

have been raised regarding medical surweillance are the

necessity and efficacy of requiring certain specific serum

enzyme determinations (SMA-12 series) and the applica-

tion of medical examination requirements to the fabrica-

tion segments of the industry where employees are exposed

to lower levels of VC. The objection has also been raised

that the specification of tests and procedures interferes

with the application of advances in medical knowledge.

A particular difficulty in considering medical surveil-

lance is that the most commonly discussed lesion, angiosar-

coma of the liver, currently cannot be diagnosed until the

victim is terminal and, usually, within months of death.

Precursor physiologie alterations, which might be revers-

ible have not yet been directly associated with the lesion.

Consequently, there are no specific diagnostic tests which

can be prescribed which will determine presence or absence

of this tumor at an early stage of development. However,

most medical witnesses indicated that the medical tests

proposed are currently the only ones available which are

useful for medical surveillance (TR 121, Exh. 95, TR 589-

591). Consequently the specifie blood tests proposed have

been retained as a minimum requirement to assist the exam-

ining physician in determining fitness of potential em-

ployees for assignment to workplaces involving VC ex-

posure. In addition, alternative medical examinations may

be used where the examining physician determines that they

are at least as good as those specified by the standard.

The Tabershaw-Cooper study and the various animal ex-

periments suggest that VC may produce a wide spectrum’

of malignant and non-malignant disorders. The general

scope of the required medical examination has, therefore,

been broadened to include kidneys, skin, connective tissue,

spleen, and pulmonary system, as well as the liver. No

CRED (ROLL ON OO GS EM AYERS SIGE LAN PME OR CE Ry ILI, nie

PA tert. ve 7

MEL BD LE PL LEAT AE AE GAT Re en ee eee

46a

additional specific procedures or tests are required, but

recommendations have been included in the Appendix to

assist the examining physician. Because of the nonspecific

nature of the required medical tests, it is not appropriate

to prescribe timing, or type of followup tests, or to man-

date withdrawal from exposure based solely on results of

the tests. Instead, the employer is required to obtain a

statement from the examining physician of the employee’s

suitability for continued exposure, when the examining

physician has completed such tests as he considers appro-

priate. The employer is required to withdraw an em-

ployee only when this statement indicates that the em-

ployee may be at added risk from continued VC exposure.

As with monitoring, there appears to be no basis for

complete exemption of the fabrication industry from the

requirement for medical examination. The record does

show fabricating establishments with concentrations of VC

monitored considerably above the action level. In these

instances, medical surveillance of affected employees will

pr vide baseline data for future evaluation of their health,

even if both monitoring and medical surveillance are dis-

continued because improved controls reduce concentrations

below the action level. Where exposures are below the

action level, the medical surveillance requirements do not

generally apply.

(12) Training. A separate provision for employee train-

ing has been added to the final standard rather than includ-

ing it within the section on emergency situations as in the

proposal. The new paragraph provides for training of

employees concerning the carcinogenic hazard of VC, emer-

gency procedures, the need for monitoring and an annual

review of the standard. It also provides for training of

employees concerning the purpose for, proper use of, and

limitations connected with respiratory protection.

(13) Records and reports. The provisions for record-

keeping contained in the final standard require the prepa-

47a

ration and maintenance of essentially the same information

required by the proposal. The major change from the

original proposal is the requirement for maintenance of

monitoring records and daily roster sheets of authorized

persons for 30 years, instead of 20 years. Additionally, the

employer is required to maintain medical records for the

duration of an employee’s employment plus 20 years, or 30

years, whichever is longer. The original proposal called

for only 20 years.

This change has been implemented because the latency

period for induction of angiosarcoma ranges up to 30 years

from initial exposure. Therefore, as a minimum, medical

records must be maintained for at least that long. It should

be noted that spokesmen for both labor and industry rec-

ommended that this change be made.

The reporting requirements are not significantly differ-

ent from those in the original proposal. However, instead

of the requirement for reporting incidents which result in

the release of VC into areas where employees may be ex-

posed, the final standard clarifies our original intent by

stating that only emergencies must be reported. Also the

requirement for filing a detailed, written report within 15

days has been deleted.. It has been concluded that submis-

sion, within 24 hours, of an initial report that includes

facts immediately available, would ordinarily be sufficient.

However, if the OSHA Area Director requests further in-

’ formation relevant to the emergency, the employer will be

required to furnish such information.

(14) Deleted portions of the proposal. The proposal

contained provisions requiring that shower facilities and

change rooms be provided, and that storage or consump-

tion of food be prohibited in regulated areas. We have

deleted these provisions because it is our conclusion they

are no longer necessary. Showering facilities are not

required because protective clothing, where required by the

final standard, should protect employees from skin absorp-

48a

tion by direct contact with VC and because there is no

reliable evidence that VC vapor is absorbed through the

skin. In addition, since we anticipate that most employees

will not be wearing protective clothing and that employees

who wear protective clothing will change such clothing in-

frequently, we are not requiring that change rooms be

provided.

In addition, we feel that there is inadequate evidence

showing that hazardous amounts of VC can be absorbed

through ingestion. For this reason, the requirement pro-

hibiting the storage or consumption of food in regulated

areas has been deleted.

The proposal also contained provisions on maintenance

and decontamination, transportation loading and unload-

ing, and polymer handling operations. These requirements

are not mentioned in the final standard because attention

to these items is implicit in the requirement that each em-

ployer reach the permissible exposure limit or attain the

lowest feasible level.

(15) Effective date. In order to ensure that affected

employers and employees will be informed of the existence

of these provisions and that employers affected are given

an opportunity to familiarize themselves and their em-

ployees with the existence of the new requirements, the

effective date of the amendment to § 1910.93q will be Janu-

ary 1,1975. To provide continued protection for employees

until that date, the provisions currently contained in

§ 1910.93q are hereby promulgated, pursuant to section

6(b), 6(c) and 8(c) of the Occupational Safety and Health

Act, as an occupational safety and health standard effec-

tive October 4, 1974, the amendment to § 1910.93q set out

below will supersede these provisions as of January 1,

1975.

Accordingly, upon consideration of the whole record of

this proceeding. Part 1910 of Title 29, Code of Federal

. m

DOLD ELE IEC AE EL AE at.

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49a

Regulations is amended, effective January 1, 1975, by revi-

sion of § 1910.93q to read as follows:

§ 1910.93q Vinyl chloride.

(a) Scope and application. (1) This section includes re-

quirements for the control of employee exposure to vinyl

chloride (chloroecthene), Chemical Abstracts Service Reg-

istry No. 75014.

(2) This section applies to the manufacture, reaction,

packaging, repackaging, storage, handling or use of vinyl

chloride or polyvinyl chloride, but does not apply to the

handling or use of fabricated products made of polyvinyl

chloride.

(3) This section applies to the transportation of vinyl

chloride or polyvinyl chloride except to the extent that the

Department of Transportation may regulate the hazards

covered by this section.

(b) Definitions. (1) ‘‘ Action level’? means a concen-

tration of vinyl chloride of 0.5 ppm averaged over an

8-hour work day.

(2) ‘‘Assistant Secretary’’ means the Assistant Secre-

tary of Labor for Occupational Safety and Health, U.S.

Department of Labor, or his designee.

(3) ‘‘Authorized person’’ means any person specifically

authorized by the employer whose duties require him to

enter a regulated area or any person entering such an area

as a designated representative of employees for the pur-

pose of exercising an opportunity to observe monitoring

and measuring procedures.

(4) ‘‘Director’’ means the Director, yational Institute

for Occupational Safety and Health, U.K, Department of

Health, Education, and Welfare, or his designee.

(5) ‘‘Emergency’’ means any occurrence such as, but

not limited to, equipment failure, or operation of a relief

50a

device which is likely to, or does, result in massive release

of vinyl chloride.

(6) ‘Fabricated product’? means a product made wholly

or partly from polyvinyl chloride, and which does not re-

quire further processing at temperatures, and for times,

sufficient to cause mass melting of the polyvinyl chloride

resulting in the release of vinyl chloride.

(7) ‘‘Hazardous operation’? means any operation, pro-

cedure, or activity where a release of either vinyl chloride

liquid or gas might be expected as a consequence of the

operation or because of an accident in the operation, which

would result in an employee exposure in excess of the per-

missible exposure limit.

(8) ‘OSHA Area Director’’ means the Director for the

Occupational Safety and Health Administration Area Office -

having jurisdiction over the geographic area in which the

employer’s establishment is located.

(9) ‘*Polyvinyl chloride’? means polyvinyl chloride

homopolymer or copolymer before such is converted to a

fabricated product.

(10) ‘‘Vinyl chloride’’ means vinyl chloride monomer.

(ec) Permissible exposure limit. (1) No employee may

be exposed to vinyl chloride at concentrations greater than

1 ppm averaged over any 8-hour period, and

(2) No employee may be exposed to vinyl chloride at

concentrations greater than 5 ppm averaged over any

period not exceeding 15 minutes.

(3) No employee may be exposed to vinyl chloride by

direct contact with liquid vinyl chloride.

(d) Monitoring. (1) A program of initial monitoring

and measurement shall be undertaken in each establish-

ment to determine if there is an employee exposed, without

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5la

regard to the use of respirators, in excess of the action

level.

(2) Where a determination conducted under paragraph

(d)(1) of this section shows any employee exposures, with-

out regard to the use of respirators in excess of the action

level, a program for determining exposures for each such

employee shall be established. Such a program:

(i) Shall be repeated at least monthly where any em-

ployee is exposed, without regard to the use of respirators,

in excess of the permissible exposure limit.

(ii) Shall be repeated not less than quarterly where any

employee is exposed, without regard to the use of respira-

_tors, in excess of the action level. .

(iii) May be discontinued for any employee only when

at least two consecutive monitoring determinations, made

not less than 5 working days apart, show exposures for

that employee at or below the action level.

(3) Whenever there has been a production, process or

control change which may result in an increase in the re-

lease of vinyl chloride, or the employer has any other

reason to suspect that any employee may be exposed in

excess of the action level, a determination of employee

exposure under paragraph (d)(1) of this section shall be

performed.

(4) The method of monitoring and measurement shall

have an accuracy (with a confidence level of 95 percent) of

not less than plus or minus 50 percent from 0.25 through

0.5 ppm, plus or minus 35 percent from over 0.5 ppm

through 1.0 ppm, and plus or minus 25 percent over 1.0

ppm. (Methods meeting these accuracy requirements are

available in the ‘‘ NIOSH Manual of Analytical Methods’’).

(5) Employees or their designated representatives shall

be afforded reasonable opportun#ty +o observe thé monitor-

ing and measuring required by th?s paragraph.

52a

(e) Regulated area. (1) A regulated area shall be es-

tablished where:

(i) Vinyl chloride or polyvinyl chloride is manufac-

tured, reacted, repackaged, stored, handled or used; and

(ii) Vinyl chloride concentrations are in excess of the

permissible exposure limit.

(2) Access to regulated areas shall be limited to au-

thorized persons. A daily roster shall be made of au-

thorized persons who enter.

(f) Methods of compliance. Employee exposures to vinyl

chloride shall be controlled to at or below the permissible

exposure limit provided in paragraph (c) of this section

by engineering, work practice, and personal protective con-

trols as follows:

(1) Feasible engineering and work practice controls

shall immediately be used to reduce exposures to at or

below the permissible exposure limit.

(2) Wherever feasible engineering and work practice

controls which can be instituted immediately are not suffi-

cient 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 sup-

plemented by respiratory protection in accordance with

paragraph (g) of this section, A program shall be estab-

lished and implemented 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.

(3) Written plans for such a program shall be developed

and furnished upon request for examination and copying to

authorized representatives of the Assistant Secretary and

the Director. Such plans shall be updated at least every

six months.

(g) Respiratory protection. Where respiratory protec-

tion is required under this section:

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53a

(1) The employer shal! provide a respirator which meets

the requirements of this paragraph and shall assure that

the employee uses such respirator, except that until De-

cember 31, 1975, wearing of respirators shall be at the

discretion of each employee for exposures not in excess

of 25 ppm, measured over any 15-minute period. Until

December 31, 1975, each employee who chooses not to wear

an appropriate respirator shall be informed at least quar-

terly of the hazards of vinyl chloride and the purpose,

proper use, and limitations of respiratory devices.

(2) Respirators shall be selected from among those

jointly approved by the Mining Enforcement and Safety

Administration, Department of the Interior, and the

National Institute for Occupational Safety and Health

under the provisions of 30 CFR Part 11.

(3) A respiratory pxotection program meeting the re-

quirements of § 1910.134 shall be established and main-

tained.

(4) Selection of respirators for vinyl chloride shall be

as follows:

Atmospheric concentration of

vinyl chloride Required apparatus

(i) Unknown, or above 3,600 ppm ..Open-cireuit, self-contained breathing ap-

paratus, pressure demand type, with full

facepiece.

(ii) Not over 3,600 ppm ........--. (A) Combination type C supplied air res-

pirator, pressure demand type, with

full or half facepiece, and auxiliary

self-contained air supply; or

(B) Combination type C, supplied air res-

pirator continuous flow type, with

full or half facepiece, and auxiliary

self-contained air supply.

(iii) Not over 1,000 ppm ........---- Type C, supplied air respirator continuous

flow type, with full or half facepicee,

helmet or hood.

(iv) Not over 100 ppm ...........++-- (A) Combination type C supplied air res-

pirator demand type, with full face-

piece, and auxiliary self-contained

air supply; or

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At pheric concentration

vi vinyl chloride ” Required apparatus

(B) Open-eireuit self-contained —

apparat

us with full facepiece; in

demand mode; or

Tuand type, with full haga

(v) Not over 25 ppm .............. (A) A power air-pu yore

veipeoe de nant, "fall hh, ff ;

ids atediies

a ane life of at seat 4 hours for

eoneentrations of vinyl chloride up

to 25 ppm, or

(B) Gas mask, front- or back-mounted

eanister which des a service life

of at least 4 rs for concentra;

tions of vinyl chioride up to 25 ppm.

(vi) Not over 10 ppm ..........+-.- (A) Combination tess Cc Fos igre res-

pirator, deman type, with half

facepiece, oe auxiliary self-con-

tained air supply

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