Respondents Brief — American Textile Mfrs. Institute, Inc. v. Donovan

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Nos. 79-1429 and 79-1583!

IN THE pwn

Supreme Court of the United States” ~~

OCTOBER TERM, 1980

AMERICAN TEXTILE MANUFACTURERS INSTITUTE, INC.,

ET AL.,

y. Petitioners,

RAY MARSHALL, SECRETARY OF LABOR, ET AL.,

Respondents.

NATIONAL COTTON COUNCIL OF AMERICA,

v. Petitioner,

RAY MARSHALL, SECRETARY OF LABOR, ET AL.,

Respondents.

On Writs of Certiorari to the United States Court of Appeals

for the District of Columbia Circuit

BRIEF FOR UNION RESPONDENTS

PEE ROI A GR.

CER |

Se ee

J. ALBERT WOLL

General Counsel, AFL-CIO

815 15th Street, N.W.

Washington, D.C. 20005

ELLIOT BREDHOFF

General Counsel

Industrial Union Department,

AFL-CIO

1000 Connecticut Avenue, N.W.

Washington, D.C. 20036

ARTHUR M. GOLDBERG

General Counsel

Amalgamated Clothing &

Textile Workers Union

15 Union Square

New York, New York 10003

Of Counsel

GEORGE H. COHEN

(Counsel of Record)

ROBERT M. WEINBERG

JEREMIAH A. COLLINS

BREDHOFF, GOTTESMAN, COHEN,

CHANIN, WEINBERG &

PETRAMALO

1000 Connecticut Avenue, N.W.

Washington, D.C. 20036

(202) 833-9340

LAURENCE GOLD

815 16th Street, N.W.

Washington, D.C. 20006

Attorneys for American Feder-

ation of Labor and Congress

of Industrial Organizations,

Industrial Union Department,

AFL-CIO, and Amalgamated

Clothing & Textile Workers

Union, AFL-CIO

WILSON - EPES PRINTING Co., INC.

- 7JE9-O096 - WASHINGTON. D.C. 20001

E> «0

IN THE

Supreme Court of the United States

OCTOBER TERM, 1980

Nos. 79-1429 and 79-1583

AMERICAN TEXTILE MANUFACTURERS INSTITUTE, INC.,

ET AL.,

~ Petitioners,

RAY MARSHALL, SECRETARY OF LABOR, ET AL.,

Respondents.

NATIONAL COTTON COUNCIL OF AMERICA,

et Petitioner,

RAY MARSHALL, SECRETARY OF LABOR, ET AL.,

Respondents.

On Writs of Certiorari to the United States Court of Appeals

for the District of Columbia Circuit

BRIEF FOR UNION RESPONDENTS

COUNTERSTATEMENT OF THE

QUESTIONS PRESENTED

1. Whether a health standard satisfies the require-

ments of the Occupational Safety and Health Act when

the Secretary has properly determined (a) that the stand-

ard substantially reduces a significant risk to worker

health, (b) that the standard is the one that “most ade-

(i)

quately assures” worker protection, and (c) that the

standard is “feasible.”

2. Whether the Occupational Safety and Health Act

authorizes the Secretary to require earnings protection

for workers whose only available safeguard against ex-

posure to excessive levels of a harmful physical agent is

transfer to jobs in low exposure areas.

TABLE OF CONTENTS

COUNTERSTATEMENT OF THE QUESTIONS

IP III nicest ica eigen a.

Il.

IV.

The Technological Feasibility of the Standard..

The Costs of the Standard ..............

SUMMARY OF ARGUMENT 0c cocee eens

ia ee ee RTH te OR SS RTE

II.

THE SECRETARY IN SETTING THE COT-

TON DUST EXPOSURE LIMITS CARRIED

OUT THE MANDATE OF §§ 8(8) AND 6(b)

CP Si SII cteihleciccicleniinnbeec a eda

A. The Governing Statutory Principles .............

B. The Statutory Principles Applied ................

THE ACT AUTHORIZES THE SECRETARY

TO REQUIRE EARNINGS PROTECTION

FOR WORKERS WHO MUST BE TRANS-

FERRED TO AVOID EXCESS EXPOSURE

BE NEE RAPE MOMIIER access nacucnsdedecditilimacdinecsbociden

RPO RR NUT Lissa pditbibaiciiclobebhicsicletcbeatn ica ie wget te

Page

TABLE OF CONTENTS—Cortinued

Page

APPENDIX A: Text of Statutory Provisions In-

VRS ALICE nr SNe REESE EE OS Co nea la

APPENDIX B: A Survey of Statutory Approaches

to the Consideration of Costs and

Benefits in the Promulgation of

Health and Safety Regulations ......... 1b

TABLE OF AUTHORITIES

Cases: Page

Environmental Defense Fund v. EPA, 548 F.2d

998 (D.C. Cir. 1976) ..---.-..--..-.-22..-4--.-.---—----=---- 5b

EPA Vv. National Crushed Stone Assn. (No. 79-770;

Tse. RODD aoc itimennntn 22, 24, 51, 2b

Forestier v. CPSC, 559 F.2d 774 (D.C. Cir. 1977).. 4b

Industrial Union Depart. v. American Petrol. Inst.,

— US. (Nos. 78-911 & 78-1036; July 2,

) |_| RRA MERI ne at abee inner wanuiue / manu Anton 19, 20, 23, 27

Industrial Union Department v. Hodgson, 499

F.2d 467 (D.C. Cir. 1974) .......................---0+-00---- 53

TVA V. Hill, 487 U.S. 153 (1978) .......-...---.-------------- 39

United States v. General Motors Corp., 518 F.2d

420 (D.C. Cir. 1976) .....-----:-..--.--2ve-so---cs-ses-snnnssaeee 3b

United States v. Rutherford, 442 U.S. 544 (1979).. 5b

Weyerhaeuser Corp. V. Costle, 590 F.2d 1011 (D.C.

Cola. TTB) asaaninicsnssici cient 2b

Whirlpool Corp. v. Marshall, 445 U.S. 1 (1980) ..49, 53, 54

Statutes and Regulations:

Child Protection and Toy Safety Act of 1969, as

amended, 15 U.S.C. § 1261 et seq. -...........-...-.------ 4b

PORE C6) ni i eee 4b

Clean Air Act Amendments of 1970, as amended,

42 U.S.C. $7401 Ob 809. ......-..--.-....-00-nie--eccsenene--<- 3b

& 7545 (c) (2) (A) --..--.---.-----cncosecsansessenssasennencensens 3b

§ 7545 (c) (2) (B) -..-<....--.----.---.-ec--esecoeceseneneseseneee= 3b

Clean Water Act Amendments of 1977, 33 U.S.C.

$1251 ef SOG. ......---..--..-.-..-c-cseeeennsnsonnanenncenensnenssacses 2b, 3b

§ 1814 (b) (4) (B) -.w..........-.---.----ccseesenseceecseoneensess 3b

Consumer Product Safety Act of 1972, 15 U.S.C.

§ DOG OF SOG. ............-..-...csnceeenesseecsnersncescsressneases 4b

§ 2058 (c) (1)-GA) -<..----2<--sccsicwace nese enero 4b

S$ DOES (ec) (1) (CO) nn. ne nnnecsnennnnnnnenensesnnense 4b

§ 2058 (c) (2) (A) ..........--.--.-cceeceeecercrscceeecenensessens 4b

TABLE OF AUTHORITIES—Continued

Page

Energy Policy and Conservation Act of 1975, as

amended, 42 U.S.C. § 6201 et seq. _........ 1b

ELISE SRS rn a a a a 1b

EEE RRR 1b

Federal Coal Mine Health and Safety Act of 1969,

Oe Sanee Bee OC OOO 53

I 53

BERR sara nnn ah eee eae 53

TER Ea nO ene 53

SECT A ad eee NSP ae ee 53

SESS CRC SSCA ns cane ee ere a 53

ES RE SIE SSIS ONE RA OP es eee 53

Federal Environmental Pesticide Control Act of

1972, as amended, 7 U.S.C. § 186 e¢ seq. .............. 4b

8 SESSA STEED eT See 4b

I 5b

I i csc te cwccemecnsabcs 5b

5. ARES Ae cata eee ae 5b

a 5b

| ES Ge EE ee ee OE 5b

Federal Food, Drug, and Cosmetic Act of 1938, 21

RNR EMI IG sso. cstecdacdad chocecisseoccecnne cassis 5b

Fe 5b

ai a ge at ot 5b

EIS ROA URE SRG Dir ET 5b

ID OF OI nna ca cccesdecieeccencane OEE O 5b

I iia cae ntiscdecinas sénsgmwmacccecen’ 5b

NR etn OF ae ATE eer er A ae 5b

Federal Water Pollution Control Act Amendments

of 1972, as amended, 33 U.S.C. § 1251 et seg....... 1b

|. RES Cuey ecR eee ee 2b

Se I a 2b

aa SEE eC nL a 2b

2, IRN TT I ek aie ener a Re 3b

I IED sli ecicchnc<schccnineniansasaasocleuinnitintensoees 2b

vil

TABLE OF AUTHORITIES—Continued

Page

Flood Control Act of 1936, 33 U.S.C. § 701 et seq... 1b

Ye) | RP RCE een ote Es Wier RACE ie Ree ce om 1b

National Traffic and Motor Vehicle Safety Act of

1966, as amended, 15 U.S.C. § 1881, et seg......... 8b

Bt) PRUE See ie. Hen a Oe PD 8b

Occupational Safety and Health Act of 1970, 29

as TI I a i passim

TD), We es OCD occa lsccceccecesneccnnsesseseses 25

§3(8), 29 U.S.C. § 652 (8) ......0 passim

§ 6(a), 29 U.S.C. § 655 (a) 2... 8, 25

§ 6(b) (5), 29 U.S.C. § 655 (b) (5) 0. passim

§ 6(b) (6) (A), 29 U.S.C. § 655 (b) (6) (A)... 35

§ 6(b) (7), 29 U.S.C. § 655 (b) (7) 0... 28, 52, 54

§ 6(b) (8), 29 U.S.C. § 655 (b) (8) 20. 25

§ 28, amending 15 U.S.C. § 686(b) (5) -........ 21, 38

The Outer Continental Shelf Lands Act Amend-

ments of 1978, 43 U.S.C. § 1831 et seq. .............. 1b

PU I eisai a tonchiclnicienchien cb tainuicstlabanhacisea cas nasibbioes 1b

Small Business Act, 15 U.S.C. § 688, et seq. .......... 22

IID picks dicathsituhsasspnscgabasialGactcnttietmsindanses 22

Toxic Substances Control Act of 1976, 15 U.S.C.

I a 5b

gE ERR CI Re ro, Bee co a0) OE 5b

IE TUE 2 stcsodticanccictaialesnemnid geniinanaeciesilibandssans 5b

Walsh-Healy Act, 41 U.S.C. § 85 et seq. .........00.0..... 8

RSW PRET IEICE ie A PA Oe TIO 8

Code of Federal Regulations

, ee oe ES LT \ Reena nna 13

29 C.F.R. § 1910.1048 (f) (1) ooo. 51

29 C.F.R. § 1910.1043 (f) (1) (i)... 12

29 C.F.R. § 1910.1048 (f) (1) (ii) -.022 13

29 C.F.R. § 1910.1043 (f) (1) (iii) ee... 18

29 C.F.R. § 1910.1043 (f) (1) (iv) -0 18

viii

TABLE OF AUTHORITIES—Continued

Page

29 C.F.R. § 1910.1043(f) (1) (v) 0. 13

29 C.F.R. § 1910.1048 (f) (2) (v) one. 13, 51

29 C.F.R. § 1910.1048(h) 0. 13

29 C.F.R. § 1910.1048 (i) .......................... 13

29 C.F.R. § 1910.1043(j) .. SY RETA is Pa 13

29 C.F.R. § 1910.1048(k) -.......20..-0..... 13

WN ER es PO Ss 2

Legislative Materials:

Senate Subcomm. on Labor, Comm. on Labor and

Public Welfare, 92d Cong., ist Sess., Legislative

History of the Occupational Safety and Health

Act of 1970 (Comm. Print 1971)... passim

Senate Report No. 89-1801, 89th Cong., 2d Sess.

ET ivseticoiiininiias Nilsson ag cate No 4b

Senate Report No. 91-287, 91st Cong., 1st Sess.

Cf PREIS SEO ARAL ON AONE AEA oie Rae Te 4b

Senate Report No. 91-1282, 91st Cong., 2d Sess.

SII vic hadminiciceismarercnt yen omh ke ums 30, 31, 38, 40, 41

Senate Report No. 92-749, 92d Cong., 2d Sess.

6 NTC Ne REDE Coe ES TE ORE MRT RT SEN 4b

House Report No. 91-1765, 91st Cong., 2d Sess.

S| ERNE ME DNDN ck Rela Meee ee Dh RAY 35

House Report No. 91-2191, 91st Cong., 2d Sess.

ber aD CEG EMRE Ore ER Ue SPY MR Mian bate TN 29

House Report No. 92-1158, 92d Cong., 2d Sess.

be SASSER MESS pO aE aR eed 4b

Miscellaneous:

House Comm. on Interstate and Foreign Com-

merce, Subcomm. on Oversight and Investiga-

tions, Federal Regulation and Regulatory Re-

form, 95th Cong., 1st Sess. 515 (1976) _............ 40

Decision of the Commissioner in the Matter of

Diethylstilbestrol: Withdrawal of Approval of

New Animal Drug Applications, 44 Fed. Reg.

S438 (Sept. Si, 1979) 5b

STATUTORY PROVISIONS INVOLVED

In addition to the sections of the Occupational Safety

and Health Act of 1970, P.L. 91-596, 84 Stat. 1590, 29

U.S.C. § 651 et seg., which are set forth in the Appendix

to the Brief for Petitioners American Textile Manu-

facturers Institute, Inc., et al., other pertinent provi-

sions of that Act are set forth in Appendix A to this

brief.

STATEMENT OF THE CASE

More than 200,000 workers in the American textile

industry inhale cotton dust throughout their regular

working day.’ As a result, thousands of these employees

1 The textile industry has two basic sectors: (a) the manufacture

of yarn and (b) the weaving of yarn into cloth. Approximately

200,000 workers are exposed to cotton dust in yarn manufacturing.

43 Fed. Reg. 27379, col. 2. A substantial additional number is ex-

posed in the weaving sector. See Ex. 6, No. 76 at III-5 (Joint

Appendix filed in this Court (hereinafter “App.”) at 78).

The Secretary of Labor described the process of yarn manu-

facturing as follows:

Cotton lint arrives at the textile mill in hydraulically com-

pressed packaged bales. At the mill the bale covering is re-

moved and the contents are passed through the opening ma-

chinery which exposes it to successive processes of intense

decompression, beating, cleaning, and mixing. During these

operations, dirt and other heavy impurities are removed by

gravity or by centrifugal force through grids or screens. Cotton

from the opening equipment is usually conveyed pneumatically

to the picker room where it is fed evenly to the pickers which

further open and clean the cotton and deliver either a picker

lap, a flat thick batt of randomly oriented fibers, or pneu-

matically conveyed loose cotton lint to the carding machinery.

Carding machines comb the fiber so that it lies straight and

parallel and some cleaning is also effected... . The main

processes in a spinning mill after carding are: drawing to ob-

tain thorough fiber mixing and weight uniformity, roving to

draw the sliver down to one-fourth to one-eighth its original

size and slightly twist it, and spinning to give considerable

fine draft to the soft roving and twist it into yarn. [Yarn

manufacturing p]rocesses subsequent to spinning [i.e., winding,

spooling, twisting and warping], are only amalgamation of yarn

suffer from chronic and acute respiratory diseases. The

occupational health standard under review here is de-

signed to reduce the incidence of these diseases by con-

trolling employee exposure to cotton dust.

I. Health Effects

A. The Chronic Disease

Textile workers are permanently disabled by chronic

obstructive pulmonary disease at more than three times

the rate of comparable populations not exposed to cotton

dust. In the statement of reasons accompanying the

standard, the Secretary of Labor ? concluded that by “con-

servative” estimate, approximately 35,000 present or

former textile workers are currently permanently disabled

by that disease (commonly known as “brown lung”). 43

Fed. Reg. 273538, col. 3; see also A. Bouhuys, et al.,

Epidemiology of Chronic Lung Disease in a Cotton

Mill Community, Ex. 124 at 14 (App. 347).

Chronic obstructive pulmonary disease—which includes

Grade 3 byssinosis, chronic bronchitis and emphysema—

constitutes “the final clinical stage of cotton dust in-

duced respiratory disease” and is irreversible. 43 Fed.

Reg. 27353, col. 1. That disease is characterized by a

units or changes in the form of the package and result in the

production of a yarn in a form suitable for dispatch to the

fabric manufacturing mill.

43 Fed. Reg. 27365, cols. 1-2 (emphasis added). See also id. at

27365-67.

Weaving operations consist of slashing and weaving. In “slash-

ing” sizing is added to the yarn to strengthen it for weaving.

Weaving is the process of interlacing two sets of yarn, one running

lengthwise on a loom, the other crosswise, by means of a shuttle,

to produce a woven fabric which is ready for finishing processes

such as dyeing.

2 The authority of the Secretary of Labor to promulgate occupa-

tional safety and health standards under the Act has been delegated

to the Assistant Secretary for Occupational Safety and Health. 29

C.F.R. § 1910.4. Hereinafter the term “Secretary” shall refer

jointly to the Secretary and the Assistant Secretary.

debilitating permanent narrowing of the bronchial tubes

or airways of the lungs. 41 Fed. Reg. 56500, col. 3:*

In human terms, the affected worker frequently loses

the ability to function normally on or off the | a

[T]he respiratory disease contracted in the textile

mills typically result(s] in premature retirement

often after futile and painful attempts to continue

on the job. [43 Fed. Reg. 27352-27353. ]

The record contains extensive worker testimony docu-

menting that point. The following examples are illus-

trative:

My mother had to leave the mill in [her] early

fifties. Before she left, her breathing got so short

she just couldn’t hold out to work. My step-father

left the mill on account of breathing problems. He

had coughing spells til he couldn’t breath[e], like a

child’s whooping cough. Both my sisters who work

in the mill have breathing problems. My husband

had to give up his job when he was only fifty-four

years old because of the breathing problem.

I had to retire at age fifty with a breathing prob-

lem that has since been diagnosed as byssinosis

caused by breathing cotton dust. [Tr. 2094-2095

(App. 451-452) (testimony of Mrs. Norton). ]

Every time that I [would] go into the mill I [would]

get deathly sick, choking and vomiting[,] losing my

breath. ...

I am only fifty-seven years old and I am retired

and I can’t even go to church because of my breath-

ing. I get short of breath just walking around the

house or dressing or sometimes just watching T.V.

3 The reference is to the preamble to the proposed standard. In

the statement of reasons accompanying the final standard the Sec-

retary incorporated by reference “the basic conclusions advanced

in the proposed regulations” regarding the health effects of cotton

dust. 43 Fed. Reg. 27352, col. 2.

I cough all the time. [Tr. 2096 (App. 452) (testi-

mony of Mrs. McCoy) .]*

“Total disability and even death may follow.” 41 Fed.

Reg. 56500, col. 3; see also id. at 56501, cols. 1-2.

B. The Acute Disease

The process that produces chronic obstructive pulmon-

ary disease in workers exposed to cotton dust generally

commences with acute respiratory ailments and loss of

lung function. 43 Fed. Reg. 27352, cols. 2-3, 27354, col.

2. The acute stages of that disease process have been

classified as byssinosis grades 14, 1, and 2.5 There is no

orderly progression from one grade of the disease to the

next. As Dr. Russell Harley, an American Textile Manu-

facturers Institute (ATMI) witness, testified:

[T]he assumption is often made that the disorder

progresses from 1% to 1 to 2 to 3 and, thus, all

grades reflect the progress of the individual’s dis-

ability. In many instances, however, there is no

progression at all. Sometimes Grade 3 seems to ap-

* See also Tr. 2107 (App. 453) (testimony of Louis Harrell) :

I got a slip from my doctor in Duke saying I had to get out

of the dust if I were to survive. I gave it to [the company j and

that seemed not to make any difference. They just didn’t come

across with anything so I had to quit because I couldn’t lay

down and rest without oxygen in the night. . . . [When] I

walked across to the mill [,] I couldn’t even breathe, I had to

get out of the door so I could breathe and [my doctor] told me

not to go back in there under any circumstances. So that is how

I came to leave.

See also, e.g., Tr. 2152-2154 (App. 456-457) ; Tr. 2187-2188 (App.

457-458).

5 The commonly used Schilling system classifies the acute stages

of byssinosis as follows (41 Fed. Reg. 56500, col. 3):

Grade 12—occasional chest tightness on the first day of the

work week.

Grade 1 —chest tightnezs and/or breathlessness regularly

occurring on the first day of the work week.

Grade 2 —chest tightness and/or breathlessness throughout

the week.

pear de novo or there is a jump from 1 to 3. Among

those who develop permanent disability, Grade 2

very often never occurs. [Ex. 41 at 3 (App. 192).]

As the Secretary found, “the rate at which a worker

progresses to [the chronic] stage, if at all, depends

upon... the susceptibility of the individual.” 43 Fed.

Reg. 27352, col. 3.°

Looking at the adverse health effects in each of the

acute stages of the disease, the Secretary found that

these effects are “significant . . . in themselves and

should be prevented in so far as possible.” Id. at 27354,

col. 2. These effects include shortness of breath, chest

tightening, cowghing and wheezing, and fatigue.’ They

are typically first experienced by a worker upon re-

entering the mill at the beginning of a work week ;

thereafter, with continuing exposure, the effects become

progressively more frequent and more severe. Id. at 27352,

col. 2, 27854, cols. 2-8. Beginning at Grade 1%, the

physical distress suffered by workers with byssinosis re-

flects a significant loss of lung function, which loss is

measurable by objective techniques.® At the higher grades

® The Secretary found that at the acute stages of byssinosis, the

symptoms of the disease “apparently” may be reversed over time by

eliminating further exposure of the affected employee to cotton dust.

43 Fed. Reg. 27354, col. 2. But a reversal of symptoms does not

necessarily mean that all damage has been repaired; upon a return

to exposure it is likely that an employee’s “ability to combat the

disease is less than when [he was] normal to begin with.” Tr. 839-

841 (App. 421-425) (Dr. El Batawi).

7In addition, beginning at Grade %, acute byssinosis is accom-

panied by an increased prevalence of brorchitis. 43 Fed. Reg.

27354, col. 2.

843 Fed. Reg. 27352, cols. 2-3, 27354, col. 2. The most widely

used measurement of pulmonary function is “forced expiratory

volume in one second” (FEV,), i.e., the volume of air which an

individual is able to expel from his lungs in one second by blowing

hard into a measuring device called a spirometer. See A. Bouhuys,

Byssinosis in the United States, Ex. 6-16 at 14-15 (App. 17-18).

As a group, workers with byssinosis, including those in grade 14,

of acute byssinosis, the physical distress® and the meas-

urable loss of lung function increase; by Grade 2, breath-

lessness and fatigue are frequently such that a worker

must seek a change of job. See J. Merchant, et al.,

Dose Response Studies in Cotton Textile Workers, Ex.

6-51 at 8 (App. 48) ; see also pp. 9-10, infra.

C. The Dose-Response Relationship

The Secretary concluded that:

[T]he work by [Dr. James] Merchant et al...

represents the most thorough and objective evalua-

tion of byssinosis prevalence in the United States

textile industry. ... [43 Fed. Reg. 27355, col. 3.]*°

exhibit lower FEV, values (i.e., less ability to breathe out force-

fully) than other workers. 43 Fed. Reg. 27354, col. 2.

® As Dr. Arend Bouhuys, Director of the Yale University Lung

Research Center and “a preeminent authority on pulmonary func-

tion” (43 Fed. Reg. 27358, col. 2), explained:

I think it is important to stress that I and others who have

done similar studies have seen these workers at the end of the

work shift, have noticed their labored breathing .. . so, there

is no doubt in my mind that there is a serious health hazard

here judging from these acute effects” [Tr. 168 (App. 401-

402).]

Those observations were confirmed by Dr. Jeffrey Taylor, Associ-

ate Director of the Appalachian Laboratory for Occupational Safety

and Health (operated by the National Institute for Occupational

- Safety and Health (NIOSH), the research agency created by the

Act within the Department of Health and Human Services, 29

U.S.C. §671). Dr. Taylor stated that the symptoms of acute

byssinosis tend “to become worse during the working day. And in

the evening [the affected worker] finds it difficult to undergo normal

activities, he finds it difficult to walk rapidly home, and tends to do

very little.” Tr. 1025 (App. 434-435).

10 Dr. Merchant is presently the Director of the Appalachian

Laboratory for Occupational Safety and Health (see note 9, supra),

and has been engaged in research regarding the respiratory diseases

of textile workers since 1968. Tr. 1000-1001 (App. 423-424). His

studies of the prevalence of respiratory ailments in the textile in-

dustry comprise some 15 papers, which have been part of the scien-

tific literature since the early 1970’s, 43 Fed. Reg. 27355, col. 3.

And, the Secretary found, “the dose-response data of

Merchant [et al.], supported by numerous other studies

[in the record] ... , is the best available... .” Id.

at 27358, col. 2.1

The Merchant study found a “striking dose-response

relationship[],” ibid., “between the prevalence of byssino-

sis and the concentration of lint-free respirable dust as

measured by a vertical elutriator.” * Id. at 27358, col.

3. The Secretary concluded that this dose-response re-

lationship provides a proper basis to assess the extent

of the health risks presented by different levels of ex-

posure to cotton dust. Jd. at 27358, col. 2 - 27360, col. 3.

The most extensive of these papers is nearly 350 pages long. See

J. Merchant, Epidemiological Studies of Respiratory Disease Among

Cotton Textile Workers, Ex. 38d.

11The Secretary noted that Merchant’s study had been “pub-

lished and subject to peer review for several years without any

major reported challenges to its basic soundness.” 43 Fed. Reg.

27357, col. 3. At the hearing the only witness to question the

validity of Merchant’s methodology was Dr. Moon Suh, a Burling-

ton Industries statistician. After reviewing Suh’s criticisms, the

Secretary found the rebuttal offered by Dr. Merchant and others

“convincing[ ].” Ibid. “Contrary to Dr. Suh’s view, an evaluation

of the methodology of this massive survey of thousands of textile

workers shows the Merchant study to have been based on sound

statistical ground.” [bid.; see generally id. at 27357-27358.

At the hearing, ATMI submitted several surveys conducted

under the auspices of ATMI and certain of its member companies.

These ATMI surveys purported to find lower prevalences of bys-

sinosis than the Merchant study found. None of these surveys

approached the Merchant study in rigor, thoroughness, and extent

of documentation. The Secretary addressed these industry surveys

in detail, 43 Fed. Reg. 27355-27357, and concluded that they cast

no doubt on the findings of the Merchant study.

2 The vertical elutriator is a device which measures the airborne

concentration of lint-free respirable cotton dust—i.e., dust particles

of 15 microns or less in size. Id. at 27355, col. 2. Measurements of

the concentration of “elutriated dust” (which are expressed in

terms of weight-per-volume) correspond most closely with the

observed health effects of exposure to cotton dust. Ibid. Unless other-

wise specified, hereinafter all references to exposure levels shall be to

concentrations of elutriated dust.

The Merchant study found that 26% of workers in

yarn manufacturing operations“ in the cotton textile

industry would contract some form of acute byssinosis if

exposed at a concentration of 500 ug/m of elutriated cot-

ton dust—an exposure level equivalent to that permitted

by the then-current federal government standard * and

the level that petitioner ATMI proposes should be con-

tinued as the standard. 43 Fed. Reg. 27355, col. 3."°° The

study further found that the prevalence of byssinosis

among those workers is reduced to 18% when the ex-

posure level is reduced to 200 ug/m*—the level that

13 Yarn manufacturing includes all operations in the cotton

textile manufacturing process except the weaving operations. See

note 1, supra.

14 At the time of the rulemaking the exposure limit for all opera-

tions was 1000 ug/m® of “total dust.” See 43 Fed. Reg. 27351, col.

1. In yarn manufacturing operations, this is roughly equivalent to

500 mg/m* of elutriated dust. 41 Fed. Reg. 56504, col. 3; see also

note 12, supra. The 1000 ug/m* total dust standard was first

adopted in 1968 by the Secretary pursuant to the Walsh-Healy Act,

41 U.S.C. §35(e), to apply to government contractors. In 1971

that PEL was adopted by the Secretary, without notice and com-

ment, as an OSHA standard pursuant to §6(a) of the Act, 29

U.S.C. § 655 (a), which required as an interim measure the prompt

adoption, without rulemaking procedures, of “established Federal

standard(s].” The 1000 ug/m® total dust standard was originally

selected as a Walsh-Healy standard because it had been recom-

mended as a “Threshold Limit Value” (TLV) by the American

Conference of Governmental Industriai“Hygienists (ACGIH). 438

Fed. Reg. 27351, col. 1. In 1974, however, the ACGIH revised its

TLV for cotton dust, adopting a limit of 200 ug/m* of elutriated

dust. Ibid.

©The Merchant study measured the prevalence of byssinosis

observed at a particular time, in relation to the dust levels present

at that time. ATMI asserts that the study is therefore flawed

because “exposure levels in the past [in the plants studied] .. .

[were] presumably higher.” ATMI Br. at 9. But Merchant testi-

fied that to avoid just that problem he selected for his study mills

at which production processes and machinery, as well as dust con-

trol equipment, had not been changed significantly in recent years,

and at which the dust levels should have been the same as in the

past. Tr. 1042 (App. 438).

the Secretary ultimately adopted as the maximum per-

missible level. And, the prevalence of such disesse is

reduced still further to 7% when the level is reduced to

100 ug/m*—the level that respondent unions urged the

Secretary to adopt. Ibid.

With respect to weaving operations," the study found

that the rate of byssinosis is 5% at the exposure level

then permitted by the government, 1000 ug/m? “total

dust”.'? Ibid. The rate of byssinosis among affected em-

ployees rises to 10% when the exposure level in the

weaving operation is raised to 750 ug/m’® “elutriated

dust”—the level that the Secretary ultimately permitted.

Id. at 27860, col. 3.18

The Merchant study also broke down the data on

prevalence rates by grade of byssinosis. This breakdown

shows that the prevalence of grade 2 byssinosis for yarn

manufacturing operations is 8% at an exposure level

of 500 ug/m’, as compared to 3% at an exposure level

of 200 ug/m’. Ex. 6-51, Tables 2 and 6 (group 5) (App.

31, 44).

The authors of the study emphasized that this data

underestimated the prevalence rates of grade 2 byssinosis

and of chronic obstructive pulmonary disease:

[Workers] with tightness on Monday and other days

(Grade 2) frequently also complain of dyspnea and

fatigue; as a result it is not uncommon to find that

these workers request a change in job location.

16 See note 1, supra.

17 See note 14, supra.

18The dust in weaving rooms is composed primarily of sizing

materials, usually starch or polyvinyl alcohol, rather than cotton.

Id. at 27360, col. 2. This explains why dust in weaving operations

results in a lower prevalence of byssinosis than the same concen-

tration of dust in yarn manufacturing operations. Ibid. The Secre-

tary determined that the previous 1000 ug/m® total dust standard

was “more stringent” than the 750 ug/m® elutriated dust standard |

which the Secretary adopted in the instant standard for weaving

operations. Jd. at 27381, col. 1.

Therefore, those with Grade 2 byssinosis symptoms

are likely to represent a highly selected group which

would very likely result in an underestimation of

risk. Id. at 7-8 (App. 48).

Further, studies of only active workers cannot measure

the prevalence of chronic obstructive pulmonary disease,

because, as the Secretary found, this “disease contracted

in the textile mills typically result[s] in premature re-

tirement often after futile and painful attempts to con-

tinue on the job.” 48 Fed. Reg. 27352, col. 3 - 27353, col.

1; see also pp. 3-4, supra. However, the study of Dr.

Bouhuys, which included former as well as active cotton

textile workers, enabled the Secretary to assess the prev-

alence of chronic obstructive pulmonary disease among

cotton textile workers:

Although some estimates of the prevalence of chronic

disease have been presented in various studies, the

Bouhuys estimate constitutes the only evaluation of

chronic health effects for the entire active and re-

tired textile worker population. [/Jd. at 27353, col.

3-27354, col. 1.]

Bouhuys estimated, as mentioned, that these workers

suffer disablement from chronic respiratory diseases at

three times the rate of comparable populations not ex-

posed to cotton dust and that “approximately 35,000 em-

ployed and retired textile workers are currently dis-

abled” by such diseases. Id. at 27353, col. 3.”

II. The Standard

After reviewing the massive rulemaking record before

him, the Secretary fashioned a standard designed to de-

crease the prevalence of respiratory disease among cot-

19 See also Ex. 6-1 at 8 (App. 14) (Drs. Roach and Schilling) ;

Ex. 124 at 11 (App. 344) (Dr. Bouhuys); Tr. 244-245 (App. 410)

(Dr. Kilburn) ; Ex. 113 at 9 (App. 343) (Dr. Wolfe).

20 As the Secretary stated, Dr. Bouhuys’ estimate was based on a

“conservative” definition of disability—i.e., a level of lung per-

formance that “even for a very old person is a small fraction of the

pulmonary performance of a ‘normal lung’.” /bid.

ton textile workers by reducing the levels of employee

exposure to cotton dust. The primary means the Secre-

tary selected to achieve this objective was reduction of

the permissible level of cotton dust in the air at the

workplace.

The Secretary determined that for all operations other

than weaving the permissible exposure level (PEL)

would be 200 ug/m*. This PEL, the Secretary recog-

nized, will accomplish a significant reduction in the prev-

alence of acute and chronic respiratory diseases among

cotton textile workers. The prevalence of acute byssinosis

would be reduced from 26% to 138%, with the prevalence

of Grade 2 byssinosis reduced from 8% to 3%. There

are approximately 200,000 employees in the industry in

the operations other than weaving, 43 Fed. Reg. 27379,

col. 2. Thus, this PEL would reduce the number of em-

ployees suffering from acute byssinosis at any given

time by at least 26,000; and the number of employees

suffering from Grade 2 byssinosis at any given time

would be reduced by at least 10,000.7% A comparable re-

duction in the prevalence of chronic obstructive pulmon-

ary disease would follow.

The Secretary was aware that with a PEL of 200

ug/m* there would still be a significant prevalence of

cotton dust induced respiratory diseases among exposed

workers—13% of these workers would still suffer acute

byssinosis; 3% would still suffer Grade 2 byssinosis. 43

Fed. Reg. 27359, col. 2. The Secretary, however, de-

termined “that achieving [a PEL of] 100 ug/m*® [as

urged by the unions] is not within the technological

capabilities of the industry.” Id. at 27360, col. 1.

*1 These figures are understated, for the reasons discussed at

pp. 9-10, supra. In addition, they refer only to byssinosis and do

not include other respiratory diseases induced by exposure to cot-

ton dust. See pp. 5-6, supra.

With respect to weaving operations, the Secretary de-

cided to raise the PEL from the then-current standard

to 750 ug/m*.” Jd. at 27381, col. 1. The Secretary re-

fused to adopt a lower PEL because “the evidence in

the record supports the conclusion that engineering dust

controls in weaving may not be feasible even with mas-

sive expenditures by the industry.” Jd. at 27360, col. 2.

The Secretary did not mandate any single method of

achieving compliance with the PELs set in the final

standard. Rather, the Secretary described several meth-

ods of dust control already in common use throughout

the textile industry which could be applied singly or in

combination, at the discretion of the regulated employer.

Id. at 27362-67. The “application [of these methods of

control] should bring the vast majority of cotton work-

places into compliance with tne permissible exposure

[limits] established in this standard.” Jd. at 27363, col. 2.

The Secretary determined, however, that the demand

for control equipment that would result from establish-

ment of the PELs would exceed the supply of such

equipment for a substantial period f time. Accordingly,

the Secretary in the standard gave all regulated em-

ployers four years in which to obtain and install the

necessary control equipment. Jd. at 27385, cols. 2-3. For

this interim period, while employers are not required to

use engineering controls to meet the PELs set by the

standard, the Secretary imposed two stop-gap measures:

(1) employers are required to provide appropriate res-

pirators where exposure levels exceed the applicable PEL

(29 C.F.R. § 1910.1043(f) (1) (i)) ; and (2) in the cir-

cumstance where an employee is exposed to cotton dust

in excess of the PEL, and where a physician determines

that he is physically unable to wear any respirator, the

employer must offer such employee an opportunity to

transfer, without loss of pay or other employment bene-

22 See notes 14, 18, supra.

fits, to an available position having an exposure level

at or below the PEL. 29 C.F.R. § 1910.1048(f) (2) (v).*

While accepting the use of respirators as an interim

means of protection, the Secretary rejected the industry

position that primary reliance be placed on respirators

as a long-term solution to worker exposure to cotton

dust. Based on the record before him, the Secretary

found that “respirators have many disadvantages which

preclude primary reliance or co-reliance on respiratory

protection on an equal basis with engineering and work

practice controls.” 43 Fed. Reg. 27384, col. 3.7

23 The standard also prescribes the use of respirators in certain

limited circumstances after the expiration of the four-year period.

29 C.F.R. § 1910.1043(f) (1) (ii)-(v). In addition to the require-

ments with respect to exposure limits and respirators, the standard

includes provisions regarding such matters as exposure monitoring

(29 C.F.R. § 1910.1043(d)), medical surveillance (id., § 1910.1043

(h)), employee education and training (id., § 1910.1043(i)), warn-

ing signs (id., § 1910.1043(j)), and recordkeeping (id. § 1910.1043

(k)). None of those discrete provisions is challenged in this Court.

*4 In making this finding, the Secretary relied upon the testimony

of Bruce Held, project leader for respirator research at the

Lawrence Livermore Laboratory of the University of California

and former Chairman of the Atomic Energy Commission’s Res-

piratory Advisory Committee. Jbid. Held testified:

Respiratory protective devices have many limitations which

make them undesirable if engineering controls are at all

possible. Among the limitations of respirators are: A, fitting

problems with persons with small faces, such as many women,

with persons with facial hairs, such as beards or long side-

burns, scars or growths which break the face piece to face

seal, and with persons with pronounced wrinkling, a sunken

nose bridge, deeply cleft chin, very narrow nose, a very wide

or very narrow face, or very long or very short face; B, com-

munication problems between workers wearing respirators. Any

respirator will muffle voice communications to varying de-

grees. With many devices, the jaw movement used for speak-

ing can break the face piece to face seal and cause inhalation of

contaminated air; and C, vision problems can be numerous.

Downward vision is obstructed with half or full face masks,

thus increasing tripping or stumbling possibilities. The in-

III. The Technological Feasibility of the Standard

In this Court, the industry petitioners do not challenge

the technological feasibility of the methods of compliance

prescribed by the standard.”

IV. The Costs of the Standard

A. For those textile industry operations already in

compliance with the PELs set by the standard, no dust

control costs are imposed by the standard. At the time

the standard was promulgated, in large portions of the

industry exposure levels were already below the PELs set

by the Secretary. An ATMI survey provided the most

comprehensive set of data produced at the hearing re-

specting existing dust levels in the industry. Of the large

sample of plants included in the survey, nearly 20% of

the opening through roving operations,” and approxi-

mately 75% of the spinning operations, were already at

or below the 200 ug/m* exposure level, while 88% of the

weaving operations were already at or below the 750

ug/m* exposure level. Ex. 176.77

With respect to those operations not already in com-

pliance, there is no dispute as to the cost estimate adopted

by the Secretary for the operations of opening through

roving. Industry attacks the Secretary’s reliance on the

cost estimates prepared by Hovan Hocutt and Arthur

Thomas (Hocutt-Thomas) on the ground that for certain

ability to look straight down can cause a serious injury. Full

face respirators will restrict the wearer to tunnel vision. Per-

sons who must wear prescription glasses must be fitted with

special glasses kits for full face masks.

* * * *

D, fatigue and reduced efficiency, and E, some people, for rea-

sons of health, would not be permitted to wear a respirator.

Tr. 483-485 (App. 412-418). See also pp. 51-55, infra.

25 See ATMI Br. at 8, n.16.

°6 These operations are described at note 1, supra.

27 This exhibit appears at pp. 3490-3560 of the joint appendix

filed in the court of appeals.

operations those figures were meant to reflect the costs

of achieving exposure levels higher than those ultimately

set by the Secretary. (ATMI Br. 12, 16, 25.) That criti-

cism is inapplicable to the Hocutt-Thomas estimate of

$425 million to meet the standard’s PEL in the opening

through roving operations. For Hocutt-Thomas recog-

nized that the controls they envisaged for those opera-

tions would enable employers to reduce exposure levels

to 200 ug/m*.**

Nor does industry complain about the Secretary’s esti-

mate of the costs of satisfying the PEL applicable to

weaving operations. The Secretary raised that PEL over

what it’ previously had been, and in any event the cost

estimate adopted by the Secretary for compliance in

weaving operations is much higher than the estimate put

forward by RTI, whose overall figures (including the

estimate for weaving operations) industry now

embraces.”°

Thus, all that remains in controversy is the Secretary’s

estimate of the cost of compliance in the 25% of the

spinning operations where exposure levels are in excess

of 200 ug/m*. The Hocutt-Thomas study concluded that

the cost of the control equipment necessary to reach 500

ug/m* in spinning operations would be $17.7 million.”

2843 Fed. Reg. 27380, Table 1, note 2. The Hocutt-Thomas esti-

mate for the opening through roving operations is almost identical

to the estimate in the record industry endorses—that stated in the

report of the Research Triangle Institute (RTI). The Hocutt-

Thomas estimate of the cost of control equipment to meet a 200

ug/m* standard in these operations is $425.6 million. See Ex. 60

at 3-6 and Attachment #1 thereto (App. 236-239, 251); Ex. 62,

Attachment II (App. 486). RTI’s estimate is approximately $429.5

million (derived by applying a process-by-process ratio to the data

in Ex. 6, No. 76 at I-15, V-17 (App. 74, 92).

29 See 43 Fed. Reg. 27380, Table 1 (data for yarn processing).

3% See Ex. 60 at 3-6 and Attachment #1 thereto (App. 236-239,

251); Ex. 62, Attachment II (App. 486). ATMI maintains that by

comparing the RTI and the Hocutt-Thomas estimates for the costs

of compliance in spinning operations, the effect of assuming a 500

The Secretary adopted that cost estimate, concluding for

the following reasons that by using the dust control

equipment Hocutt-Thomas prescribed, the 200 ug/m*

PEL could be met in spinning operations without signifi-

cant additional costs:

Hocutt maintained that it would not be feasible

to reduce dust levels in all spinning operations to

levels lower than 500 ug/m*. His position was based

on the difficulty in working with some equipment,

and the configuration or the lack of space needed to

install ventilation equipment. OSHA is aware that

confounding factors exist in some mills which make

installation of ventilation equipment difficult. How-

ever, when more attention has been given to general

principles of ventilation control, this has in many

ug/m* PEL as opposed to a 200 ug/m* PEL may be discerned. ATMI

points to the fact that while the Hocutt-Thomas estimate for

spinning operations based on a 500 ug/m* PEL was $17.7 million,

the RTI estimate for such operations based on a 200 ug/m*? PEL

was $553.3 million. Thus, ATMI concludes, “the Hocutt-Thomas

figures would have to be increased by at least $535 million if it

were to be applied to achieving a [200 ug/m®] limit in spinning...”

ATMI Br. at 26-27, n.53. That conclusion does not follow. RTI

made its own separate cost estimate for spinning at the 500 ug/m?

PEL—approximately $113 million, or over 6 times the Hocutt-

Thomas figure of $17.7 million. (The figure of $113 million is de-

rived by applying a process-by-process ratio to the data in Ex.

6, No. 76 at I-15, V-17 (App. 74, 92)). This disparity is not a

product of the PEL that was assumed. Rather, it is the product of

erroneous factual assumptions underlying the RTI estimate.

In particular, RTI did not have data on the dust levels in the

industry. RTI’s cost calculations therefore assumed that all mills

were operating at the exposure level permitted by the old stand-

ard (1000 ug/m® total dust) and that no mill had installed any of

the equipment RTI recognized as necessary to achieve a lower

level. Ex. 16 at 29, 34-39 (App. 169-171) ; Tr. 617-619 (App. 418-

420). Primarily because RTI ignored the actual conditions in the

industry its study projected a $553 million cost for achieving a

PEL of 200 ug/m? in spinning. This estimate grossly overstated

the cost because, contrary to RTI’s assumption, the record shows

that at the time of the rulemaking, exposure levels in the vast

majority of spinning operations were below the old standard, and

in 75% of such operations, exposure levels were already at or

below 200 ug/m?3

instances sufficed to reduce levels to within those

herein prescribed. Further, when the entire process

is viewed rather than each operation independently,

it becomes clear that reduction in dust levels in be-

ginning operations may affect the levels in final

operations.'*!] Further, in some instances isolation

of spinning from dustier operations could be utilized

along with additional general ventilation improve-

ments to bring levels to within those herein pre-

scribed. In the past, application of the principles

described above have been used successfully to re-

duce dust levels in the workplace, and it is reason-

able to anticipate that this is what will be done now.

[43 Fed. Reg. 27366, col. 3]*

The Secretary determined that for all textile industry

operations, the Hocutt-Thomas estimate of $550 million

was a reasonable approximation of the cost of compliance

with the standard. The Secretary noted, moreover, that

Hocutt-Thomas had made certain assumptions which

tended to overstate that cost. In particular, the Hocutt-

Thomas estimate failed to reflect “the existing trend

toward replacement of conventional [production] ma-

chines with newer equipment which is more productive

31 In this regard the Secretary further stated:

When each operation in the textile process is examined with

_ regard to its relationship to subsequent operations, it is clear

that reducing dust levels in operations from opening to roving

would aid in the reduction of dust levels in areas of final

processing such as spinning. 43 Fed. Reg. 27367, col. 1.

32 For the operations connected with spinning (i.e., winding,

spooling, twisting and warping), the Secretary likewise adopted the

Hocutt-Thomas cost estimate. While Hocutt had maintained that

the PEL for such operations should be set at 500 ug/m?, the Secre-

tary found that dust levels could easily be reduced to 200 ug/m?

using the control methods Hocutt prescribed:

Levels in all these operations are currently very low and are

not expected to present a compliance problem .... OSHA...

concludes that the vast majority of workplaces will be able to

comply with little difficulty.

43 Fed. Reg. 27367, col. 2.

and produces less dust,” and which results in “fewer

machines to be retrofitted or controlled.” 43 Fed. Reg.

27372, col. 3. The record—including a 1974 report that

ATMI submitted to the United States Department of

the Treasury—established that quite apart from the re-

quirements of the cotton dust standard, the industry is in

the process of a large-scale conversion to more modern

production equipment which greatly eases the problem of

dust control while bringing “higher production rates,

labor savings and improved product quality.” ** But the

Hocutt-Thomas estimate took no account of this impor-

tant development; rather, that study calculated the cost

of controlling cotton dust in the context of the particular

machinery which was in place at the time of the study.

Ex. 60 at 3-6 (App. 236-239).

B. RTI evaluated the ability of the industry to finance

compliance with the standard at several different levels

of cost. The highest cost level considered was more than

33 Td. at 27368, cols. 1-2. See also id. at 27366, col. 3—27367, col.

1, 27370, col. 3—27371, col. 1, 27372, col. 83. The new equipment

includes open-end spinning frames, which reduce dust levels in

spinning while also eliminating the need for roving and winding

operations; automatic opening equipment, which takes the place of

manual opening and feeding; and chute-fed cards, which eliminate

the picking operation and reduce dust levels in the carding process.

Ex. 78 at 19 (App. 269). In the 1974 report referred to in the text

ATMI represented that large segments of the industry were rapidly

converting to this equipment, and would continue to do so. /d. at

20-23 (App. 269-273). Treasury agreed that this is the case. /d.

at 24-26 (App. 273-276). The industry’s ongoing conversion to

this modern equipment was also documented by numerous technical

reports, (id. at 28-30 (App. 278-280); Ex. 143, Appendices G, H

(App. 367-371) ), Union experience (Ex. 78 at 26-28, 33-35 (App.

277-278, 284-285) ), expert testimony (Ex. 79A (App. 293-295)),

and annual reports from textile companies to their stockholders

(Ex. 78 at 30-33, and Appendices 15, 16 thereto (App. 281-283,

288-292) ). As a 1977 article stated, the conversion to new equip-

ment is a major reason why “the . . . description of the textile

industry as a ‘sick’ industry does not hold water anymore.” J. Yale,

The Economic Structure of the Textile Industry, Ex. 143, Appendix

F at 24 (App. 348, 350).

twice that which the Secretary found would be the actual

cost of the standard he promulgated. 43 Fed. Reg. 27378,

col. 2. At that high level, “nothing in the RTI study

showed that the cotton [textile] industry as a whole

[would] be seriously threatened. . . .” 43 Fed. Reg.

27378, col. 2. See Tr. 563. For the “much less severe”

cost requirements of the standard actually promulgated,

the Secretary concluded “that although some marginal

employers may shut down rather than comply, the indus-

try as a whole will not be threatened by the capital re-

quirements of the regulation. .. .” 48 Fed. Reg. 27378,

col. 2.%4 :

SUMMARY OF ARGUMENT

A. The Occupational Safety and Health Act (OSHA),

and this Court’s reading of that Act in Industrial Union

Depart. v. American Petrol. Inst., —— U.S. —— (Nos. -

78-911 & 78-1036; July 2, 1980) (the Benzene case),

establish the following proposition: Congress determined

that the elimination or reduction of significant risks to

employee health, through the most protective standards

that are capable of achievement, justifies the substantial

compliance costs that may be entailed.

*4In reaching that conclusion, the Secretary took into consider-

ation the ability of the industry to pass on the costs of the standard

to consumers, and thus to maintain its existing profit levels. RTI

stated that even at a level of costs twice that of the standard, the

costs of compliance could ultimately be passed on to consumers.

Ibid. This conclusion which the Secretary accepted was based on

two factors. First, as Chase Manhattan Bank’s textile industry

specialist testified, even if the price of cotton products were to rise,

synthetic fiber products are not likely to make a significant further

penetration into the market for cotton textile products. Tr. 2559-62

(App. 474-476). As the Secretary noted, the recent increases in

the price of petroleum, from which synthetic fibers are made, make

it even less likely that cotton products will be unable to compete

successfully with synthetics. 43 Fed. Reg. 27370, col. 2. Second,

trade agreements give the domestic textile industry substantia! pro-

tection against competition from imports. Ex. 6, No. 76 at VI-4

(App. 95).

The instant case is governed by §§ 3(8) & 6(b) (5) of

OSHA. The Benzene case establishes that, at the least,

these provisions er the Secretary, where he

makes the

threshold finding that a place of employment is un-

safe—in the sense that significant risks are present

and can be eliminated or lessened by a change in

practices .. . to select ‘the standard’... that is most

protective ... [and that is] consistent with feasi-

bility. [Opinion of Stevens, J., Sl. Op. 32, 33 n. 48;

Opinion of Marshall, J., Sl. Op. 4-7, 30-33].

1. The language of §§ 3(8) & 6(b) (5) does not con-

tain a hint that the Secretary, as a prerequisite to regu-

lation, must, in addition to finding a significant risk to

worker health, place a value upon the elimination or sub-

stantial diminution of that risk and then assess whether

that value is in reasonable balance with the compliance

costs of the regulation. The basic thrust of § 6(b) (5)

is to the contrary: subject to the constraint of feasibility,

the Secretary is directed to promulgate “the” standard

that “most adequately assures” that “no employee will

suffer material impairment. .. .”

2. The legislative history of OSHA shows that Con-

gress meant exactly what the statutory language says.

The first sentence of §6(b) (5) was the product of a

legislative search for a formula that would provide health

standards “as effective as possible,” while precluding the

elimination of risks by eliminating the affected occupation

or industry.

A more general review of the debate preceding OSHA’s

enactment confirms that Congress, understanding per-

fectly that the statute would require American industry

to make large outlays of money, concluded that workers

should not subsidize the production of goods with their

health and that the cost of health and safety protection

at the workplace should be counted as a cost of doing

business reflected in the prices of goods in the market

place. The legislative materials reveal no dissent from

that approach. No legislator espoused the.theory that the

protection of worker health should be compromised on the

basis of a cost-benefit assessment.

Congress was fully aware of the consequences of its

determination. Congress realized, for example, that the

additional costs of doing business that would be required

to comply with OSHA standards might threaten the via-

bility of a great number of small employers. The legis-

lative response was not, however, to dilute the mandate

of § 6(b) (5) (or the other substantive provisions of the

Act) or to exempt small employers from its reach. Rather,

Congress established in § 28 of the Act a program to

provide loans to small businesses to be used to achieve

compliance with the standards promulgated by the

Secretary.

B. It follows from the language of the statute, read in

light of its legislative history and the Benzene opinion,

that the test for determining whether a standard promul-

gated by the Secretary to regulate a toxic material meets

the requirements of OSHA has three parts: first,

whether the “place of employment is unsafe-—in the sense

that significant risks are present and can be eliminated

or lessened by a change in practices.” Opinion of Stevens,

J., Sl. Op. 32. Second, whether, of the possible available

correctives, the Secretary has selected “the standard...

that is most protective.” Jbid. Third, whether that

standard is “feasible.” The standard here meets that

test.

1. The standard would reduce the number of workers

suffering from acute byssinosis at any given time by at

least 26,000; and the number of workers suffering from

Grade 2 byssinosis at any given time would be reduced

by at least 10,000. A comparable reduction in the prev-

alence of chronic obstructive pulmonary disease would

follow.

2. ATMI does not contend that the Secretary failed to

adopt the “most protective” standard. Rather, ATMI’s

contention is that the “alternative” compliance scheme

it proposed in the rulemaking provides cotton textile

workers health protection “not significantly” less than

that afforded by the Secretary’s final standard and at a

much lower cost. The ATMI alternative, however, falls

far short of offering health protection equivalent to the

Secretary’s standard.

3. In this Court, the industry does not dispute the tech-

nological feasibility of the standard. As to economic

feasibility, the Secretary’s estimate that the total cost of

compliance with the standard would be approximately

$550 million is supported by the record. On the basis of

the RTI analysis of the industry’s ability to finance the

cost of compliance with the standard, the Secretary con-

cluded “that although some marginal employers may shut

down rather than comply, the industry as a whole will

not be threatened by the capital requirements of the

regulation.” And Corgress did not intend the potential

economic dislocation of marginal employers to bar the

Secretary from regulating. In the provisions at issue

here, as in the statute considered in EPA v. National

Crushed Stone Assn, —— U.S. —— (No. 79-770; Dec.

2, 1980),

Congress foresaw and accepted the economic hard-

ship, including the closing of some plants, that [reg-

ulation] would cause; and Congress . . . took certain

steps to alleviate this hardship, steps which did not

include allowing a... [relaxation of the appropriate

protective standards]. [Sl. Op. 14.]

II.

In this standard the Secretary provided an interim

protection to workers who are exposed to concentrations

of cotton dust in excess of the permissible level and who

are found by a physician to be unable to wear a respira-

tor: he required cotton mill operators to give such em-

ployees an opportunity to transfer to available lower ex-

posure jobs without suffering a loss of earnings. The

record showed that absent earnings protection the trans-

fer provision integral to the Secretary’s interim scheme

for worker protection would have been frustrated. ATMI

contends that the Secretary was without statutory au-

thority to promulgate this provision. But the Secretary’s

action falls well within the terms of § 6(b) (7) which

authorizes him “[w]here appropriate [to] prescribe suit-

able . . . control procedures to be used in connection

with [occupational health] hazards... .” And it com-

ports with Congress’ determination that compliance costs

should be borne by employers as reasonable and necessary

costs of doing business.

ARGUMENT

I. THE SECRETARY IN SETTING THE COTTON

DUST EXPOSURE LIMITS CARRIED OUT THE

MANDATE OF §§ 3(8) AND 6(b)(5) OF OSHA

A. The Governing Statutory Principles

The’ Occupational Safety and Health Act (OSHA),

and this Court’s reading of that Act in Industrial Union

Depart. v. American Petrol. Inst., —— U.S. —— (Nos.

78-911 & 78-1036; July 2, 1980) (the Benzene case), we

believe, establish the following proposition: Congress de-

termined that the elimination or reduction of significant

risks to employee health, through the most protective

standards that are capable of achievement, justifies the

substantial compliance costs that may be entailed. Peti-

tioners, in contrast, insist that OSHA does not reflect a

Congressional decision on when the costs of a health

standard are justified, but rather, leaves that question to

the Secretary and to the judiciary to “assess[] costs and

risk reduction benefits” and to decide, on a basis not

disclosed, whether “there is a reasonable relationship be-

tween the two.” ATMI Br. 39.

1, Regulation of industrial activity in order to pro-

mote the public interest in health and safety implicates

a variety of complex practical and moral dilemmas. Rec-

ognizing the variousness of the problems, Congress has

not adopted a single approach to such regulation. The

balance struck between health goals and technological and

economic constraints in the legislative programs for puri-

fying the air, cleaning the water, assuring wholesome

supplies of food, providing drugs that serve their in-

tended therapeutic purpose, regulating airplane and

automobile safety and prohibiting dangerous consumer

products, differs from statute to statute, often in basic

concept, always in detail.** Thus, in proceedings chal-

lenging such regulation:

The question . . . is not what a court thinks is gen-

erally appropriate to the regulatory process; it is

what Congress intended for these regulations. [EPA

v. National Crushed Stone Assn., —— U.S. ——

(No. 79-770; Dec. 2, 1980) Sl. Op. 18 (quoting EJ.

du Pont de Nemours v. Train, 430 U.S. 112, 1388)

(elision and emphasis in original) }.

2. In the instant case “these regulations” are governed

by §§ 3(8) & 6(b) (5) of OSHA. The former states:

The term ‘occupational . . . health standard’ means

a standard which requires conditions, or the adop-

tion or use of one or more practices, means, methods,

operations, or processes, reasonably necessary or ap-

propriate to provide .. . healthful employment and

places of employment.

The latter provides in pertinent part:

The Secretary, in promulgating standards dealing

with toxic materials or harmful physical agents un-

der this subsection, shall set the standard which

most adequately assures, to the extent feasible, on

the basis of the best available evidence, that no em-

ployee will suffer material impairment of health or

functional capacity even if such employee has regu-

lar exposure to the hazard dealt with by such stand-

ard for the period of his working life. ...

35 In these different statutes Congress has adopted a variety of

approaches, some of which require a balancing of costs and benefits

and other of which do not. We survey these statutes in Appendix B

to this brief.

The Benzene case establishes that, at the least, these

provisions “direct[]” the Secretary, where he makes the

threshold finding that a place of employment is un-

safe—in the sense that significant risks are present

and can be eliminated or lessened by a change in

practices[—] . . . to select ‘the standard’—that is to

say, one of various possible alternatives that satisfy

the basic definition in §3(8)—that is most pro-

tective ... [and that is] consistent with feasibility.

[Opinion of Stevens, J., Sl. Op. 32, 33 n. 48; Opinion

of Marshall, J., Sl. Op. 4-7, 30-33].

“{B]oth the language and structure of the Act, as well

as its legislative history, indicate that it was intended to

require the elimination, as far as feasible, of significant

risks of harm”. Jd. Opinion of Stevens, J., Sl. Op. 31.%

3. The statutory language and the legislative history

show that Congress intended the Secretary to issue the

most protective standards to correct significant employee

health risks subject only to the following limitation: the

Secretary is not to follow the self-defeating course of as-

sisting employees by eliminating their entire occupation

either through pursuit of the chimera of a risk-free envi-

ronment or by the imposition of economic burdens beyond

36 This conclusion, Justice Stevens noted, is supported also by

both §§6(a) & 6(b) (8). “Section 6(a) requires the Secretary,

when faced with a choice between two national consensus standards,

to choose the more protective standard.” Jd. Sl. Op. 32, n. 47. “See-

tion 6(b) (8), in turn,

requires that, when the Secretary substantially alters an exist-

ing consensus standard, he must explain how the new rule will

‘better effectuate’ the purposes of the Act. . . . [T]his require-

ment .. . must be read to impose upon the Secretary the duty

to find that an existing national consensus standard is not ade-

quate to protect workers from a continuing and significant risk

of harm.” [Jd., Sl. Op. 34.]

See also §2(b) which states OSHA’s overall purpose—viz., “to

assure so far as possible every working man and woman in the

Nation safe and healthful working conditions and to preserve our

human resources.”

the capacity of their industry to bear. Congress under-

stood that its approach would often impose substantial

costs on an industry, costs that might be beyond the

financial capacity of the marginal employers. But Con-

gress’ judgment was that the expenditures made to pro-

tect workers against significant health risks should be

considered reasonable and necessary costs of doing busi-

ness to be reflected in the regulated industry’s prices.

a. The language of §§ 3(8) and 6(b) (5) does not con-

tain a hint that the Secretary, as a prerequisite to regu-

lation, must value the elimination or substantial dimi-

nution of a significant health risk and assess whether

that value is in reasonable balance with the compliance

costs of the regulation. The basic thrust of the first

sentence of § 6(b) (5), which with regard to the regula-

tion of “toxic materials and harmful physical agents”

particularizes the general definition of a “standard” in

§3(8), evinces a dedication to protecting employee

health: the Secretary is directed to promulgate “the”

standard that “most adequately assures” that “no em-

ployee will suffer material impairment .. .”

To be sure, these sections are not without terms of

limitations: the regulation is to be directed to “toxic

materials or harmful physical agents”; the unhealthy

condition that the regulation seeks to prevent must be a

“material impairment’; the regulation “must be reason-

ably necessary and appropriate to provide healthful em-

ployment”; and the goal of worker protection is to be

pursued “to the extent feasible.” But these limitations do

not import an obligation to weigh the benefits of regula-

tion against the costs. At most, they suggest that the

Secretary is required to show that the condition he in-

tends to regulate constitutes a significant threat to health

(regulate “toxic materials or harmful physical agents”

to prevent a “material impairment’), that the proposed

regulation promises to end, or, in substance, to correct,

that unhealthy condition (that it is “reasonably necessary

and appropriate to provide healthful employment”) ,*7 and

that the proposed regulation is “capable of being done,

executed or effected; possible of realization’ ** (is

“feasible” ).

On the face of the statute, then, once the Secretary

determines that a toxic substance in the workplace poses

a significant risk of a material health impairment to

exposed employees, his obligation is to promulgate the

standard which, within the limits of what is possible,

eliminates or substantially reduces that risk—the most

protective standard feasible.

b. The legislative history of OSHA shows that Con-

gress meant exactly what the statutory language says.

(i) The § 6(b)(5) Debate. The first sentence of § 6

(b) (5), as we have seen, specifies the criteria for estab-

387 As Mr. Justice Marshall observed in the Benzene case:

“[RJeasonably necessary or appropriate” clauses are routinely

inserted in regulatory legislation, and in the past such clauses

have uniformly been interpreted as general provisos that regu-

latory actions must bear a reasonable relation to those statu-

tory purposes set forth in the statute’s substantive provisions.

See, e.g., FCC v. National Citizens Committee for Broadcast-

ing, 436 U.S. 775, 796-797 (1978) ; Mourning v. Family Pub-

lications Service, Inc., 411 U.S. 356, 369 (1973); Thorpe v.

Housing Authority of the City of Durham, 393 U.S. 268, 280-

281 (1969). ... This principle, of course, reflects the common

understanding that the determination of whether regulations

are “reasonably necessary” may be made only by reference to

the legislative judgment reflected in the statute; it must not

be based on a court’s own, inevitably subjective view of what

steps should be taken to promote perceived statutory goals.

[Opinion of Marshall, J., Sl. Op. 21-22.]

Against this background, and in light of the fact that, so far as

we have ascertained, there is not a word in the legislative history

expanding on or even referring to the language of that provision,

§ 8(8) cannot support the conclusion that OSHA requires the Sec-

retary to weigh the benefits of regulation against the costs. See

also infra pp. 35-39.

88 Webster’s Third New International Dictionary, 831 (1961)

(defining “feasible’’).

lishing health standards.* The evolution of those criteria

is a development on the theme stated by Senator Dom-

inick, who was the spokesman in the Senate for the

Nixon administration and a principal participant in shap-

ing § 6(b) (5): *

The duty to set standards and produce criteria for

standards implies that the criteria and thé standards

will be as effective as possible; not that they will

produce a perfect environment. No human effort

can produce a perfect environment no matter how

hard we try. [Leg. Hist. 376.]

39 The remainder of that provision states:

Development of standards under this subsection shall be based

upon research, demonstrations, experiments, and such other

information as may be appropriate. In addition to the attain-

ment 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.

It is inherently unlikely that this language, which was adopted

by the Senate Committee, informs a proper understanding of the

first sentence of § 6(b) (5) as amended on the Senate floor to clar-

ify the meaning of the Committee bill. See pp. 31-35, infra. And in

fact, the final two sentences do not alter the substantive criteria for

health standards stated in the first sentence. Those sentences

merely set forth the types of evidence the Secretary is to consider

in carrying out the mandate of the first sentence—types of evidence

which include not only “research, demonstrations, [and] experi-

ments,” but also “such other information as may be appropriate.”

40 Senator Dominick was the sponsor of S. 4404, introduced on

behalf of the Nixon Administration as a substitute for. S. 2198 (the

“Williams bill”) after it became apparent that the latter bill would

be reported out of the Committee on Labor and Public Welfare. See

Legislative History of the Occupational Safety and Health Act of

1970 (Leg. Hist.) 73, 510. (On the Senate floor, the Dominick sub-

stitute was tabled by a vote of 41 to 39 the day before S. 2193 was

passed. Leg. Hist. 448-450). Senator Dominick’s prominent role

in the development of the legislation was noted by his fellow Sena-

tors. For example, Senator Javits observed that Senator Dominick’s

“efforts had a vital impact on the bill in terms of principle and

fairness... .” Leg. Hist. 526. See also Leg. Hist. 527 (remarks of

Senator Williams).

The legislative process in this instance was a search for

a formula that would provide health standards “as effec-

tive as possible,” while precluding the elimination of risks

by eliminating the affected occupation or industry. The

effort was to advance toward the ideal of worker health

and safety while recognizing the limits on our ability

both to maintain an industrial society and to provide a

risk free environment.

House and Senate consideration of OSHA proceeded on

virtually a simultaneous schedule. In the House the Act

began as “the Daniels bill,” H.R. 16785; in the Senate it

was introduced as “the Williams bill,” S. 2193. Neither

bill contained a provision setting the criteria governing

the issuance of toxic substance standards.*! That pro-

vision was added to each measure in committee.*”

The provision governing issuance of health standards

reported by the House Committee on Education and

Labor on July 9, 1970, contained no “feasibility” limi-

tation. The Secretary was to be required to

set the standard which most adequately assures, on

the basis of the best available professional evidence,

that no employee will suffer any impairment of

health or functional capacity, or diminished life ex-

pectancy even if such employee has regular exposure

to the hazard dealt with by such standard for the

period of his working life.**

On October 6, 1970, the Senate Committee on Labor

and Public Welfare reported out virtually the same pro-

vision but with one significant change: the words “and

feasibly” were added so that the Secretary’s mandate was

41 See Leg. Hist. 721, 728-732 (Daniels bill), 1, 6-7 (Williams

bill).

*2 The standard setting criteria added by the two committees

were applicable to all standards (see materials cited at p. 35 and

n.56, infra), but as enacted the first sentence of §6(b)(5) is framed

to apply solely to standards for “toxic materials and harmful physi-

cal agents.”

«8 H.R. Rep. No. 91-2191, supra at 4, Leg. Hist. 834.

to “set the standard which most adequately and feasibly

assures. .. .’** This additional language resulted from

an amendment offered in Committee by Senator Javits,

the ranking Republican and a key figure throughout the

Senate’s deliberation on OSHA.*® Senator Javits ex-

plained that his amendment “was an improvement over

the Daniels bill [because the latter as reported out of

committee in the House] might be interpreted to require

absolute health and safety in all cases, regardless of

feasibility. ...” *®

The Senate Committee report that accompanied S. 2193

made clear the Committee’s understanding of the Javits

44 Leg. Hist. 204, 242.

45 See e.g., Leg. Hist. 1151.

46S. Rep. No. 91-1282, supra at 58 (individual views of Senator

Javits), Leg. Hist. 197 (emphasis added). Senator Javits described

his “feasibility” amendment as an improvement over not only the

Daniels bill, but also “the [original] Administration bill which

contain[ed] no criteria for standards at all.” Ibid. That bill, S.

2788, had been introduced by Senator Javits on August 6, 1969. See

S. Rep. No. 91-1282 at 5, Leg. Hist. 145. Its provisions regarding

the setting of standards appear at Leg. Hist. 31, 36-42.

ATMI states that “Senator Javits, the author of the original Ad-

ministration bill (S. 2788), took the position that OSHA standards

should be ‘feasible’ in the sense of being ‘reasonable’ and ‘practi-

cable’ as well as technologically achievable.” ATMI Br. 32-33. This

misstates Senator Javits’ role and his words. President Nixon’s

message accompanying the bill drafted by his Administration “de-

scribed” the provision calling for a report on “technical feasibility,

reasonableness, and practicality” as a “report on the feasibility of

the proposed standards.” 115 Cong. Rec. 22511, 22517. Thus Sen-

ator Javits did not author S. 2788 or “describe” the report in such

terms at all. Senator Javits merely asked that the President’s

lengthy message be printed in the Congressional Record. 115 Cong.

Rec. 22511. Rather than endorsing the message, Senator Javits

disassociated himself from the Administration’s bill on a variety of

issues, saying that “it may be desirable to go somewhat further than

this bill does in strengthening the hand of the Federal Government

in this area.” 115 Cong. Rec. 22512. When Senator Javits actually

described his feasibility amendment he consistently used only the

word “feasible” and never equated that term with “reasonable” or

“practical.” Leg. Hist. 197, 418.

amendment by paraphrasing the bill’s language in the

following terms:

[S]tandards should be directed at assuring, so far

as possible, that no employee will suffer impaired

health or functional capacity, or diminished life ex-

pectancy, by reason of exposure to the hazard in-

volved, even though such exposure may be over the

period of his entire working life.*7

The “feasibility” language reported by the Committee

was refined on the floor of the Senate as the final matter

considered prior to passing S. 2193. Notwithstanding the

inclusion in the Committee bill of both §3(8) and the

Javits amendment, several Senators—most notably Sena-

tor Dominick—expressed concern that §6(b) (5) could

nevertheless be read to accomplish what Senator Javits had

sought to avoid. Senator Dominick explained:

[Section 6(b) (5)] is inherently confusing and un-

realistic. It could be read to require the Secretary to

ban all occupations in which there remains some

risk of injury, impaired health, or life expectancy.

In the case of all occupations, it will be impossible

to eliminate all risks to safety and health. Thus, the

present criteria could, if literally applied, close every

business in this nation. In addition, in many cases,

the standard which might most “adequately” and

“feasibly” assure the elimination of the danger would

be the prohibition of the occupation itself.*®

In light of that concern, Senator Dominick proposed an

amendment to delete from § 6(b) (5) the entire sentence

setting forth the criteria for the promulgation of stand-

ards.*°

Throughout the floor debate that ensued, Senator Dom-

inick’s remarks were consistently directed at a single

47S. Rep. No. 91-1282, supra at 7, Leg. Hist. 147 (emphasis

added).

48 Leg. Hist. 367; emphasis in original.

#° Amendment No. 1054, Leg. Hist. 8365-366.

concern: that the language proposed by the Committee

could be read as requiring an absolutely risk-free work-

place—a requirement that could be met only by shutting

down entire industries and by eliminating occupations.”

He gave the following example:

How in the world, . . . during a working day of any

one driving a bus . . . can we set standards that will

make sure he will not have any risk to his life for

the rest of his life? It is totally impossible for this

to be put in a bill; and yet it is in the committee

bill.

As part of his argument, Senator Dominick stressed

also that work of any nature necessarily has an impact

on the human body and, ultimately, on life expectancy,

and that seeking to eliminate all such effects would

amount to a ban on ali employment. In this connection,

50 It is unrealistic to attempt, as [§ 6(b)(5)] apparently does, to

establish a utopia free from any hazards. Absolute safety is an

impossibility and it will only create confusion in the adminis-

tration of this act for the Congress to set clearly unattainable

goals.

* ~ * * *

The difficulty of the language I am dealing with here and that

I am trying to delete is the requirement that the Secretary, in

establishing standards, must assure that there will not be any

risk at all.

¥* * * * *

Almost any kind of occupation one can think of has something

which is inherently hazardous simply by the fact that one is

living and breathing and there is no way a criteria [sic] can

be established so that an employee would not be faced with

some risk for the period of his working life.

* ” * * *

Let us take the case of a bus driver. There is no possible way

that a bus driver for the rest of his life could be assured that

he is not going to get regular exposure to these hazards. By

the very nature of driving a bus over the road, no matter how

many safety tires and signals are on the bus, it is a hazardous

occupation.

Leg. Hist. 480-481. See also Leg. Hist. 345-346, 400-401.

51 Leg. Hist. 423.

Senator Dominick stated that “[s]imply being in a work

environment where one is responsible for certain duties

. . . produce[s] in most people impaired health, and it

certainly diminishes life expectancy to some extent.” ©

In the same vein, Senator Saxbe noted that “[w]orking

itself is apt to diminish one’s life expectancy. If one

wants to stay home in bed, he probably will live longer

than by standing at the plant and doing his job.” ™

Senator Dominick summed up his objections to the

Senate Committee version of § 6(b) (5) in the following

terms:

Any administrator responsible for enforcing the

statute will be faced with an impossible choice.

Hither he must forbid employment in all occupa-

tions where there is any risk of injury, even if the

technical state of the art could not remove the haz-

ard, or he must ignore the mandate of Congress. .. .

The confusion inherent in this provision will, in

my opinion, render it no more than a hortatory

admonition to the Secretary to fulfill his responsibili-

ties under the act. [T]here is no point in putting in

criteria which cannot be met.™

No concern of any other nature with regard to § 6(b)

(5) was raised by any Senator. The view that the

Secretary was to require what is “possible,” not what

is perfect, where the latter choice would be to forbid

“employment in [an] occupation where there is any risk

of injury” reflected the consensus of the Senate. When

that became apparent, the chief spokesman on both

sides of the aisle—Senators Williams, Javits and Dom-

inick—translated that consensus into a modification of

the Committee’s version of § 6(b) (5) which was “agree-

able to all.” ©

52 Leg. Hist. 376.

53 Leg. Hist. 337.

54 Leg. Hist. 481.

55 Leg. Hist. 502.

That modification was embodied in a substitute amend-

ment, introduced by Senator Dominick, consisting of the

language of §6(b) (5) as eventually enacted. In the

colloquy immediately preceding passage of that amend-

ment Senators Dominick and Williams confirmed the

amendment’s purpose:

Mr. Dominick:...

What we were trying to do in the bill—unfortun-

ately, we did not have the proper wording or the

proper drafting—was to say that when we are deal-

ing with toxic agents or physical agents, we ought

to take such steps as are feasible and practical to

provide an atmosphere within which a person’s health

or safety would not be affected. Unfortunately, we

had language providing that anyone would be as-

sured that no one would have a hazard, .. . no one

would have any problem for the rest of his working

life.

It was an unrealistic standard. As modified, we

would be approaching the problem by looking at the

problem and setting a standard or criterion which

would not result in harm.

* * * *

It is my understanding, if I may say so, that

what we are doing now is to say that the Secretary

has got to use his best efforts to promulgate the best

mM available standards, and in so doing, that he should

take into account that anyone working in toxic

agents or physical agents which might be harmful

may be subjected to such conditions for the rest of

his working life, so that we can get at something

which might not be toxic now, if he works in it a

short time, but if he works in it the rest of his life

it might be very dangerous; and we want to make

sure that such things are taken into consideration

in establishing standards; is that correct?

Mr. Williams of New Jersey: That is exactly

correct. ... I think it is clear, the objectives have

been stated, and it strengthens the objectives of

standards that will protect against physical impair-

ment and loss of function.

The first sentence of § 6(b) (5) was therefore modi-

fied to apply only to “toxic materials and harmful physi-

cal agents,” rather than to every type of work hazard;

to change the phrase “adequately and feasibly assures”

to “adequately assures, to the extent feasible;” to refer

to “material impairment” rather than to “any impair-

ment;” and to delete the vague concept of “diminished

life expectancy.” As so amended, the Senate passed S.

2193.

The House, meanwhile, passed a substitute bill which

did not contain criteria governing the setting of health

standards.”

In conference, the House receded and accepted § 6(b)

(5) precisely as the Senate had passed it. In receding,

the House insisted on an amendment which became § 6

(b) (6) (A). As described in the Conference Report, that

section provides:

that employers may petition for a temporary vari-

ance from an occupational health or safety stand-

ard if they are unable to comply with a standard

for the following limited reasons: unavailability of

professional or technical personnel or of necessary

materials or equipment or because necessary con-

struction or alteration of facilities cannot be com-

pleted in time. Economic hardship is not to be a

consideration for the qualification for a temporary

extension order.**

(ii) Congressional Consideration of Costs. A more

general review of the debate preceding OSHA’s enactment

confirms the natural implication of the emphasized por-

tion of the Conference Report: Congress, understanding

56 Leg. Hist. 502-503.

57 Leg. Hist. 1092-1118.

58 H.R. Rep. No. 91-1765, 91st Cong., 2d Sess. 35, Leg. Hist. 1188

(emphasis supplied).

perfectly that the statute would require American indus-

try to make large outlays of rnoney, concluded that work-

ers should not subsidize the production of goods with

their health and that the cost of health and safety pro-

tection at the workplace should be counted as a cost of

doing business reflected in the prices of goods in the

market place.

Senator Williams, who introduced the initial Senate

version of the bill and served as floor manager, explained

the economic philosophy of OSHA as follows: “We know

the costs w[ill] be put into consumer goods but that

is the price we should pay for the 80 million workers in

America.” *°

Senator Eagleton, another proponent, added:

The costs that will be incurred by employers in

meeting the standards of health and safety to be

established under this bill are, in my view, reason-

able and necessary costs of doing business. Whether

we, as individuals, are motivated by simple hu-

manity or by simple economics, we can no longer

permit profits to be dependent upon an unsafe or

unhealthy worksite.”

The judgment that the costs of employee health and

safety should be spread through the economy, rather than

be borne by workers, was described by Senator Yar-

borough, a co-sponsor of the Senate bill, in response to

interest group complaints that such legislation would

prove too expensive:

One may well ask too expensive for whom? Is it

too expensive for the company who for lack of proper

safety equipment loses the service of its skilled em-

ployees? Is it too expensive for the employee who

loses his hand or leg or eyesight? Is it too expensive

for the widow trying to raise her children on meager

allowance under workmen’s compensation and social

59 Leg. Hist. 444.

—

security? And what about the man—a good hard-

working man—tied to a wheel chair or hospital bed

for the rest of his life? That is what we are dealing

with when we talk about industrial safety.

We should have uniform standards so that no

one industry would gain an advantage over any

other industry. It would be far cheayer for our

economy. It would save money in workmen’s com-

pensation premiums.

We are talking about people’s lives, not the in-

difference of some cost accountants. We are talking

about assuring the men and women who work in our

plants and factories that they will go home after a

day’s work with their bodies intact. We are talking

about assuring our American workers who work

with deadly chemicals that when they have accumu-

lated a few years seniority they will not have ac-

cumulated lung congestion and poison in their bodies,

or something that will strike them down before they

reach retirement age.

The legislative materials reveal no dissent from the

approach stated by these Senators. No legislator es-

poused the theory that the protection of worker health

should be compromised on the basis of a cost-benefit as-

sessment.

Congress was fully aware of the consequences of its

determination. Congress realized, for example, that the

additional costs of doing business that would be required

to comply with OSHA standards might threaten the via-

bility of a great number of small employers. The legis-

lative response was not, however, to dilute the mandate

61 Leg. Hist. 510. See also, e.g., Leg. Hist. 1030-1031 (remarks

of Representative Dent) :

Although I am very much disturbed over adding new costs to

the operation of our production facilities . . . I would say there

is a greater concern and that must be for the production men

who do the producing—the men who work in the service in-

dustries and the men and women who daily go out and keep

the economy moving and make it safe for all of us to live and

to work and to be able to prosper in it.

| A

of § 6(b) (5) (or the other substantive provisions of the

Act) or to exempt small employers from its reach. To

have done so would have undermined a central premise

of the regulatory scheme:

Although many employers in all industries have dem-

onstrated an exemplary degree of concern for health

and safety in the workplace, their efforts are too

often undercut by those who are not so concerned.

Moreover, the fact is that many employers—par-

ticularly smaller ones—simply cannot make the nec-

essary investment in health and safety, and survive

competitively, unless all are compelled to do so. The

competitive disadvantage of the more conscientious

employer is especially evident where there is a long

period between exposure to a hazard and manifesta-

tion of an illness. In such instances a particular

employer has no economic incentive to invest in cur-

rent precautions, not even in the reduction of work-

men’s compensation costs, because he will seldom have

to pay for the consequences of his own neglect.”

Rather, Congress established in § 28 of the Act a pro-

gram to provide loans to small businesses to be used to

achieve compliance with the standards promulgated by

the Secretary. Senator Dominick stated the intent of § 28:

‘The small business program] permits the Secre-

tary to make loans to small businesses wherever the

standards that are set by the National Government

are so severe as to have caused a real and substan-

tial economic injury. Under those circumstances the

Secretary is entitled, through the Small Business

Administration, to make loans to those businesses to

get them over the hump, because of the need for the

new equipment, or because of new conditions within

the shop, which would permit them to continue in

operation.

I think this is a very significant and important

provision for minimizing economic injury which

62S. Rep. 91-1282, supra, at 4; Leg. Hist. 144.

could occur if the bill resulted in situations which

would have very serious effects on businesses.

4. The Congressional judgment expressed in the statu-

tory scheme just outlined is that the elimination or sub-

stantial reduction of significant worker health risks jus-

tifies the costs of the most protective standard that does

not endanger the productive activity that occasioned those

risks. That judgment constitutes a rational approach to

the problem of assuring that “industrial hygiene re-

Sources are not being squandered or misallocated in a

fashion that produces very little health benefit ace

ATMI Br. 40. Such allocative judgments are precisely

the kind the Constitution delegates to Congress. It is the

legislative branch that is to “decide the order of priori-

ties in a given area.” TVA vy. Hill, 437 U.S. 153, 194.

The Congressional judgment stated in OSHA is indeed,

if that is deemed relevant, eminently sound, given the

state of our knowledge and wisdom. On the other hand,

ATMI’s posit that the Secretary and the judiciary should

“assess[] . . . costs and risk reduction benefits” and de-

termine whether “there is a reasonable relationship be-

tween the two” (Br. 39), quite aside from its deficiency

in leaving the Secretary and the courts at large, creates

only the beguiling illusion of scientific rigor and logical

decisionmaking. In reality such assessment will at best

be accurate only within a wide range. And, of course,

there is no agreement on the mediating principle for

determining the “reasonable relationship” between elimi-

nating or substantially diminishing significant worker

health risks and the compliance costs entailed.“ See,

63 Leg. Hist. 525.

6 These difficulties are enormously increased by ATMI’s em-

beliishment that the Secretary is to consider “the impact that [the

proposed] standard would have on the industry’s ability to address

other, more significant health and safety risks in the future... .”

ATMI Br. 41.

The “logic” of this suggestion requires that the Secretary, before

he can promulgate a standard to protect employees against any

é.g., House Comm. on Interstate and Foreign Commerce,

Subcomm. on Oversight and Investigations, Federal Reg-

ulation and Regulatory Reform, 95th Cong., 1st Sess. 515

(1976) (“[t]he limitations on the usefulness of benefit/

cost analysis in the context of health, safety, and environ-

mental regulatory decision-making are so severe that they

militate against its use altogether’’).

Congress need not, of course, have taken these diffi-

culties into account. Certainly, however, the legislature

was not obliged to ignore them.

B. The Statutory Principles Applied

It follows from the language of the statute, read in

light of its legislative history and the Benzene case, that

the test for determining whether a standard promulgated

by the Secretary to regulate a “toxic material or harm-

ful physical agent” meets the requirements of OSHA has

health hazard, must inventory the other hazards possibly faced by

those employees and then compare the relative costs and benefits

of the proposed standard with the costs and benefits of regulating

each of the other possible hazards. And industry would read the

Act to require the Secretary to embark on that task despite the

recognition by the sponsors that:

In the field of occupational health . . . [there is a] lack of in-

formation and records,....

... [M]aterials long in industrial use are only now being dis-

covered to have toxic effects. ... [T]echnological advances and

new processes in ‘American industry have brought numerous

new hazards to the workplace. ... It is estimated that every

20 minutes a new and potentially toxic chemical is introduced

into industry. New processes and new: sources of energy

present occupational health problems of unprecedented com-

plexity.

Recent scientific knowledge points to hitherto unsuspected

cause-and-effect relationships between occupational exposures

and many of the so-called chronic diseases—cancer, respiratory

ailments, allergies, heart disease, and others.

S. Rep. No. 91-1282, supra at 2-3, Leg. Hist. 142-143. Nevertheless

under industry’s construct, to do anything the Secretary would

have to investigate and evaluate everything.

three parts: First, whether the “place of employment

is unsafe—in the sense that significant risks are present

and can be eliminated or lessened by a change in prac-

tices.” Opinion of Stevens, J., Sl. Op. 32. Second, whether

of the possible available correctives the Secretary has

selected “the standard ... that is most protective.” Ibid.

Third, whether that standard is “feasible.” The stand-

ard here meets that test.

1. Significant Risk. The risk of contracting chronic

or acute respiratory disease from exposure to cotton dust

at the workplace is precisely the type of risk that Con-

gress determined should be eliminated or substantially

diminished through OSHA health standards. The Senate

Report on OSHA states:

In the field of occupational health the view is par-

ticularly bleak. . . . Occupational diseases which

first commanded attention at the beginning of the

Industrial Revolution are still undermining the

health of workers. ... Workers in the dusty trades

still contract various respiratory diseases.

* * * *

Studies of particular industries provide specific

emphasis regarding the magnitude of the problem.

For example, despite repeated warnings over the

years from other countries that their cotton workers

suffered from lung disease, it is only within the past

decade that we have recognized byssinosis as a dis-

tinct occupational disease among workers in Ameri-

can cotton mills. Recent studies now show that this

illness, caused by the dust generated in the process-

ing of cotton, and resulting in continuous shortness

of breath, chronic cough and total disablement, af-

fects substantial percentages of cotton textile workers.

In some states as many as 30% of those in the card-

ing or spinning rooms have been affected, and it has

been estimated that as many as 100,000 active or re-

tired workers currently suffer from his disease.”

% S. Rep. 91-1282, supra at 2-3; Leg. Hist. at 142-143.

The record in this case bears out Congress’ assessment:

Textile workers are permanently disabled by chronic ob-

structive pulmonary disease at more than three times the

rate of comparable populations not exposed to cotton dust.

By “conservative” estimate, approximately 35,000 pres-

ent or former textile workers are currently permanently

disabled by that disease.

The Merchant study credited by the Secretary found

that 26% of the approximately 200,000 workers in yarn

manufacturing operations (52,000 workers) would con-

tract some form of acute byssinosis if exposed at a con-

centration of 500 ug/m* of elutriated cotton dust—an ex-

posure level equivalent to that permitted by the previous

federal government standard.

The Merchant study also broke down the data on prev-

alence rates by grave of byssinosis. This breakdown

shows that the prevalence of Grade 2 byssinosis for yarn

manufacturing operations is 8% (approximately 16,000

workers) at an exposure level of 500 ug/m*. And the

authors of the study emphasized that the data underes-

timated the prevalence rates of Grade 2 byssinosis and of

chronic obstructive pulmonary disease.

Finally, the Merchant study showed that at the PEL

set by the standard the prevalence of byssinosis in yarn

manufacturing would be reduced to 13%, and the prev-

alence of Grade 2 byssinosis would fall to 3%. Thus,

this PEL would reduce the number of workers suffering

from acute byssinosis at any given time by at least

26,000; and the number of workers suffering from Grade

2 byssinosis at any given time would be reduced by at

least 10,000. A comparable reduction in the incidence

of chronic obstructive pulmonary disease would follow.

See supra at 11.

The standard would thus substantially diminish the

significant health risk faced by cotton textile workers.

2. The Most Protective Standard. ATMI does not con-

tend that the Secretary failed to adopt the “most pro-

tective” standard. Rather, the contention is that at the

rulemaking proceeding ATMI and individual cotton tex-

tile companies proposed an “alternative” compliance

scheme, which they claimed would provide cotton textile

workers health protection “not significantly” less than

that afforded by the Secretary’s final standard and at

a much lower cost. ATMI Br. 10-12. ATMI challenges

the Secretary’s decision not to adopt that alternative.

Id. at 48.

If the Secretary were faced with two possible com-

pliance schemes of equivalent efficacy, one of which is

less expensive than the other, both reason and the statute

point toward the lower cost option. That is not the

situation here. The ATMI alternative in fact falls far

short of offering health protection equivalent to that of

the regulatory approach adopted by the Secretary.

Under ATMI’s proposal ® all employers in the cotton

textile industry would be permitted to continue to expose

their workers to levels of cotton dust at least as high

as those permitted under the prior federal standard.”

A worker exposed to those high dust concentrations would

be afforded no health protection of any type until his

employer was satisfied that the individual had already

contracted byssinosis. That determination would be made

on the basis of a medical surveillance program under

which a worker would be considered to have contracted

byssinosis only if it were clear, from both pulmonary

function tests * and the worker’s responses to a company-

administered questionnaire, that such a diagnosis was

required. Ex. 160 at 22-28 (App. 381-383).

* ATMI’s proposal is described in its post-hearing brief to the

agency, Ex. 160 at 14-29 (App. 872-384).

*7 In the operations of opening through spinning, ATMI called

for a PEL of 500 ug/m’, a level equivalent to the prior federal

standard. See note 14, supra. In weaving operations, ATMI urged

that the PEL be raised to 1000 ug/m’, a level substantially higher

than that permitted by the existing standard. See note 18, supra.

88 See note 8, supra.

Each worker so identified would be “issued and re-

quired to wear a respirator, without regard to the [dust]

levels to which he or she may be exposed.” Jd. at 28

(App. 883). After a period of time, further pulmonary

function tests would be administered by the company

and, if the worker continued to exhibit significant loss of

lung function, he would be examined by a physician.

Ibid. Consideration would then be given to the question

whether the affected worker should be transferred to a

job with a lower exposure level. In this regard, ATMI

stated in its submission to the Secretary:

It must be emphasized that such transfer should be

effected only with the employee’s agreement and only

after consideration is given to a multitude of factors,

including age, length of employment in the present

area, and the extent of decline or decrement in lung

function. [bid.

Even after this sequence of events, if a company enter-

tained any doubt whether a worker’s impaired health re-

sulted from exposure to cotton dust, no transfer would

be offered. Jd. at 28-29 (App. 383).

The underlying premise of ATMI’s alternative is that

workers should be afforded no protection from the acute

health effects of byssinosis and that the standard’s sole

health objective should be to reduce the incidence of

chronic obstructive pulmonary disease. But, as the Sec-

retary found, the acute effects of byssinosis are “sig-

nificant . . . in themselves and should be prevented inso-

far as possible.” 43 Fed. Reg. 27354, col. 2. Under

ATMI’s approach, at any given time as many as 26,000

textile workers would suffer acute respiratory ailments

that could have been prevented by reducing exposure

levels as required by the Secretary’s standard. Of that:

number, as many as 10,000 would suffer Grade 2 bys-

sinosis. See supra at 11. No medical surveillance pro-

gram can assure that the disease will be identified prior

to Grade 2. As Dr. Merchant testified, “one could miss

true grade 2 byssinosis with a medical surveillance pro-

gram that is competent, is professional, well run.” Tr.

1137 (App. 439) (emphasis added).® In large part, this

is because there is no orderly progression from one grade

of byssinosis to another. See pp. 4-5, supra.

At least by Grade 2, acute byssinosis constitutes a

“material impairment of health or functional capacity”

within the meaning of § 6(b) (5). And while it is not

necessary to our point, or to the validity of the standard,

we note that the record supports the conclusion that the

lower grades of byssinosis also constitute such an im-

pairment. Indeed, while ATMI disputes this conclusion

* In this regard, the deficiencies in ATMI’s approach are com-

pounded by the fact that detection of byssinosis depends in large

part on the symptoms an employee reports in response to a standard

questionnaire. Experience with this procedure has shown that work-

ers often do not disclose health impairments to their employers

“especially . . . when [they] fear that forced transfer or early

retirement might flow from [such disclosure].” 43 Fed. Reg. 27359,

col. 2. See also Tr. 1039 (App. 436) (Dr. Merchant); Ex. 6, No.

24 at 265 (App. 24) (Dr. Bouhuys).

Further, under ATMI’s proposal, a worker would be afforded

no protection from exposure to cotton dust unless a company doctor

determined that protection was necessary for that individual. But

the record demonstrates that doctors associated with the industry

have been exceedingly reluctant to diagnose workers as suffering

from byssinosis. See e.g., Tr. 2148-50 (App. 455-456) (Willie

Baldwin) ; Statement of Eva Bradshaw (Ex. 54) at 1-2 (App. 208-

210) ; Statement of Elsie Morrison (Ex. 54) at 1-2 (App. 210-212) ;

Statement of William Tyndall (Ex. 54) at 1 (App. 215-216); Ex.

54A at 14 (App. 219) (Carolina Brown Lung Ass’n); Tr. 2143-46

(App. 454-455) (Charles Hassell). Compare Ex. 48 at 3-9 (App.

203-207) (Statement of Dr. M. C. Battagelli) with 48 Fed. Reg.

27353, cols. 1-2. In part, this may be a reflection of the attitude

harbored by some of those doctors that “byssinosis itself, grades

¥%, 1 and 2... really doesn’t constitute much of a disease” [Tr.

1604 (App. 445) (Dr. Russell Harley) ]—an attitude which the

Secretary found to be outmoded and simply wrong on the basis

of the record evidence. The reluctance of company doctors to

diagnose a worker as suffering from cotton dust-induced lung

disease may also reflect the fact that such a diagnosis could sub-

ject a company to workers’ compensation liability. Ex. 82 at 12

(App. 323).

as to Grade 1% byssinosis, its brief is conspicuously silent

on this point with regard to Grade 1 and above. ATMI

Br. 4-5.

Accordingly, because the ATMI alternative tolerates

subjecting large numbers of cotton textile workers, who

would be protected by the Secretary’s standard, to acute

byssinosis, including Grade 2 byssinosis, the proposal is,

at the threshold, significantly less protective than the

standard.

The “industry alternative” is likewise inadequate as

a means of reducing the prevalence of chronic obstructive

pulmonary disease. ATMI promises that its scheme, while

admittedly ignoring the acute stages of byssinosis, would

“protect[] against any risk of disabling or irreversible

lung damage .. .” ATMI Br. 11-12. The facts are to

the contrary. As noted above, there is no orderly progres-

sion from one grade of byssinosis to another. The point

at which the chronic stage is contracted varies from in-

dividual to individual.” Medical surveillance cannot

therefore ensure timely identification of the disease be-

fore the irreversible stage is reached.

Moreover, even if employers were able to identify

workers with byssinosis before those workers have chronic

obstructive pulmonary disease, ATMI’s proposal would

not protect those identified. ATMI posits that workers

who have contracted the acute forms of byssinosis “could

then be protected . . . by selective use of respirators or

transfer to low exposure areas, as medically appropriate

for the individual concerned.” ATMI Br. 11-12. As the

Secretary found, however, respirators cannot serve as

a long-term solution to worker exposure to cotton dust.

Workers wearing respirators must exert additional ef-

fort in order to breathe. Workers already suffering from

reduced breathing capacity—including by definition those

with byssinosis—generally cannot tolerate this added bur-

70 See pp. 4-5, supra.

den. 43 Fed. Reg. 27384, col. 3.7 Yet ATMI’s “solution”

would be to provide respirators precisely to the workers

who cannot use them. Moreover, it is difficult to fit a

respirator properly, and there is no satisfactory method

for determining when a proper fit has been achieved ;

as a result, there can be no assurance that a respirator

is actually working. 43 Fed. Reg. 27384, col. 3.72 Finally,

while respirators provide questionable worker protection,

they create additional hazards “by interfering with vis-

ion, hearing and mobility” and the ability to communi-

cate. 43 Fed. Reg. 27384, col. 3.78

Apart from respirators the only control measure in-

corporated in the ATMI alternative is that mills would

provide opportunities, on a selective basis, for workers

to transfer to low exposure areas when deemed appropri-

ate by their employer. This aspect of ATMI’s proposal

™ See Tr. 1326 (App. 442) (Dr. Baier); Ex. 80a at 6-7 (App.

312-315) (Prof. Burgess); Ex. 82 at 4, 8 (App. 317-318, 321)

(ACTWU); Ex. 54A at 11 (App. 217) (Carolina Brown Lung

Ass’n); Tr. 2182-38 (App. 453) (employee Vernon Sandlin); Tr.

3015-16 (App. 482-483) (employee Frank Davis). Indeed, the

record shows that even for individuals not already impaired, the

physical demands of wearing a respirator are such that workers

cannot use them on a long term basis; even where exposure to the

most dangerous toxic substances is concerned, respirator usage for

more than a few hours at a time is unheard of in American industry.

Tr. 1325-28 (App. 441-444) (Drs. Baier and Schutz); Tr. 2999-

3000, 3010 (App. 481-482) (Prof. Burgess); Tr. 501 (App. 413-

414) (Bruce Held) ; Ex. 80a at 5 (App. 311-312) (Prof. Burgess) .

72 See Ex. 80a at 2-5 (App. 309-311) (Prof. Burgess) ; Ex. 15 at 2

(App. 165) (Bruce Held); Ex. 82 at 3-4, 8 (App. 317, 321)

(ACTWU); Ex. 54A at 11 (App. 217) (Carolina Brown Lung

Ass’n) ; Tr. 3040-41 (App. 484) (Eric Frumin) ; Tr. 1326-27 (App.

443) (Dr. Baier); Tr. 3016 (App. 4838) (employee Frank Davis).

The inability to obtain a proper facial fit is particularly a problem

for female employees, who constitute a significant percentage of

the workforce in the cotton textile industry. Tr. 3040-41 ( App. 484)

(Eric Frumin).

78 See, e.g., Ex. 15 at 2 (App. 165-166) (Bruce Held); Tr. 3018

(App. 483-484) (employee Alvah Mabe).

necessarily rests on the premise that the number of

workers to be transferred would be “manageable.” Ex.

6, No. 57 at 3-5 (App. 58-60) (Dr. Imbus).%* But at the

industry-proposed PEL one out of four textile workers

would have acute byssinosis. The many thousands of em-

ployees who would have to be transferred would not on

industry’s own estimate be “manageable”’.

Even if a sufficient number of transfer opportunities

could be made available, ATMI’s approach is inadequate.

Dr. Merchant testified, on the basis of his knowledge of

both the textile and coal mining industries, that if such

transfers were offered, many workers would be precluded

from accepting the offer by the attendant loss of earnings

or other adverse employment consequences. Tr. 1139-40

(App. 441). Those workers would be required by fi-

nancial compulsion to remain exposed to the unsafe dust

levels that had already impaired their health. On the

other hand, each employee who did transfer to a job with

a lower level of exposure would have to be replaced. Each

replacement, in turn, would be subjected to the high dust

levels that caused his predecessor to contract byssinosis.

Thus in the name of OSHA compliance, ATMI’s program

is likely to result in increasing the number of workers

who contract acute byssinosis.

In short, ATMI’s alternative offers only an illusion

of worker protection,” rather than the reality OSHA

74 ATMI itself recognized the inherent limitations of any trans-

fer program, stating that, at most, ten (10) percent of the em-

ployees in a mill could be transferred. Ex. 60 at 57 (App. 384-385)

(ATMI Comments) ; Tr. 1881-82 (App. 445-446) (Dr. Imbus).

75 ATMI’s chief witness stated that while

[s]ome may feel that a medical surveillance program [including

the use of respirators and transfers] will be an economical

alternative for institution of dust control[,] I cannot subscribe

to [that] position. * * * Medical surveillance programs are not

a substitute for diligent efforts to control dust. [Ex. 6, No. 57

at 2, 11]

ATMI maintains, however, that the effectiveness of its alternative

was “demonstrated” by the surveys submitted by ATMI and sev-

demands. In Whirlpool Corp. v. Marshall, 445 U.S. 1,

11-12 (1980), the Court stated:

The Act, in its preamble, declares that its purpose

and policy is “to assure so far as possible every

working man and woman in the Nation safe and

healthful working conditiors and to preserve our

human resources. . .”

* * we *

To accomplish this basic purpose the legislation’s

remedial orientation is prophylactic in nature.

The Act does not wait for an employee to die or

become injured. It authorizes the promulgation of

health and safety standards and the issuance of

citations in the hope that these will act to prevent

deaths or injuries from ever occurring.

eral member companies regarding the prevalence of byssinosis at

certain mills where various medical surveillance programs including

the use of respirators and transfers had been in effect (ATMI Br.

10-11). As has been noted, the Secretary found that these surveys

were not reliable. See p. 7, note 11, supra. But even if the re-

sults of the surveys were accepted at face value, they would lend

no support to ATMI’s proposal. For dust levels at the mills in ques-

tion were well below the level of 500 ug/m* which ATMI proposes.

For example, the Secretary noted that the survey conducted by

Dr. Hans Weill had been commissioned by ATMI precisely for the

purpose of evaluating the prevalence of byssinosis at “mills with

very low doses.” 43 Fed. Reg. 27355, col. 3. Dr. Weill stated that

the mills he studied “undoubtedly represent the best environmental

dust control in the industry” Ex. 18a at 2 (App. 158). Similarly,

in the mills surveyed by Dr. Harold. Imbus of Burlington Industries,

66% of the exposure levels were below 500 ug/m* (43 Fed. Reg.

27359, col. 2) ; indeed, Dr. Imbus attributed the reduction of bys-

sinosis prevalence in those mills primarily to a reduction of dust

levels. Tr. 1894-97 (App. 447-448). And in the survey of Dr.

W.K.C. Morgan, “some 90-plus percent of the people . . . [were]

esposed at [300 ug/m*] or [200 ug/m?] or even below [200 ug/m3].”

Tr. 1904-09 (App. 448-449). As the Secretary concluded, given

these low dust levels the industry surveys shed no light on what

would be the consequences of the much higher PEL proposed by

ATMI. “It is not surprising . . . that data gathered from a worker

population which has enjoyed conditions approaching those man-

dated .. . by this final standard show a marked improvement in

worker health.” 43 Fed. Reg. 27359, col. 2.

This “overriding purpose of the Act” (id. at 11), makes

it plain that the alternative adopted by the Secretary,

not the ATMI alternative, is the “most protective” stand-

ard—the standard demanded by Congress.

3. Feasibility. In this Court, the industry does not

dispute the technological feasibility of the standard. See

supra at 14. As to economic feasibility, the Secre-

tary’s estimate that the total cost of compliance with the

standard would be approximately $550 million is sup-

ported by the record.** The RTI analysis of the industry’s

ability to finance the cost of compliance with the stand-

ard, on which the Secretary relied, showed that at cost

estimates twice as high as $550 million “the cotton textile

industry as a whole [would not] be seriously threatened.”

See supra at 19. For the “much less severe” actual

cost requirements of the standard, the Secretary con-

cluded “that although some marginal employers may shut

down rather than comply, the industry as a whole will

not be threatened by the capital requirements of the reg-

ulation.” See supra at 19.

As we have seen (supra at 35-39), Congress in enact-

ing OSHA was aware that the cost of compliance with

occupational health standards would threaten the viability

of marginal employers. But Congress determined that the

level of worker protection is not to. be determined by the

lowest common denominator of economic ability to com-

ply. To the contrary, Congress refused to dilute the man-

dated level of worker protection to meet the economic

needs of marginal employers. Instead, the legislative

solution was to establish a loan program to assist small

businesses in achieving compliance with standards promul-

gated by the Secretary. See supra at 38-39.

76 As we have discussed in detail, the only dispute as to the

Secretary’s cost estimate concerns his conclusion that the cost of

compliance in the 25% of the spinning operations where exposure

levels were in excess of 200 ug/m® at the time of the rulemaking

would be $17.7 million. See supra at 15. The Secretary’s conclusion

is amply supported by the record. See supra at 16-18.

In the provisions at issue here, as in the statute con-

sidered in National Crushed Stone, supra,

Congress foresaw and accepted the economic hard-

ship, including the closing of some plants, that [reg-

ulation] would cause; and Congress . . . took cer-

tain steps to alleviate this hardship, steps which did

not include allowing a... [relaxation of the ap-

propriate protective standards]. [Sl. Op. 14.]

Il. THE ACT AUTHORIZES THE SECRETARY TO

REQUIRE EARNINGS PROTECTION FOR WORK-

ERS WHO MUST BE TRANSFERRED TO AVOID

EXCESS EXPOSURE TO COTTON DUST

Due to an anticipated shortage of the dust control

equipment needed to meet the standard’s PELs, the Sec-

retary granted industry a four-year period in which to

put those controls in place. Swpra, p. 12. And the Sec-

retary recognized that there would undoubtedly be some

mills that would not come into compliance with the PELs

even then. To provide at least some measure of protec-

tion, the Secretary mandated the interim use of res-

pirators. 29 C.F.R. § 1910.1048(f) (1). The Secretary rec-

ognized also that certain workers are physically unable

to wear respirators and concluded that their health could

only be protected by affording them an opportunity to

transfer to jobs with lower exposure levels. In this con-

nection, the record showed that if workers were forced

to take a cut in pay in order to transfer, many would

be compelled by economic necessity to decline a transfer

opportunity.. Supra, p. 48. Accordingly, the standard

provides:

Whenever a physician determines that an employee

is unable to wear any form of respirator, .. . the

employee shali be given the opportunity to transfer

to another position which is available or which later

becomes available having a dust level at or below

the PEL. [29 C.F.R. § 1910.1043(f) (2) (v).]

The Secretary further required that:

The employer shall assure that an employee who is

[so] transferred . . . suffers no loss of earnings or

other employment rights or benefits as a result of

the transfer. [Jbid. }

Thus, the costs associated with these transfers, like those

associated with the other control measures prescribed by

the standard (e.g., engineering controls and respirators),

are to be borne by the employer.

ATMI does not challenge the Secretary’s authority to

require employers to provide workers a transfer oppor-

tunity as a means of preventing excessive exposure to a

health hazard.” ATMI does raise, however, the “rela-

tively narrow question” whether the Secretary has “au-

thority to require employers to maintain the earnings...

of employees who are [so] transferred...” (ATMI Br.

52).

ATMI first argues that since the statute does not in

haec verba grant the Secretary authority to impose a

“wage guarantee provision” (ATMI Br. 53), this provi-

sion of the standard should be invalidated. But the chal-

lenged provision falls well within the terms of § 6(b) (7),

which authorizes the Secretary “[w]here appropriate [to]

prescribe suitable . . . control procedures to be used in

connection with [occupational health] hazards. .. .”

Further, as mentioned, § 3(8) defines an “occupational

safety and health standard” in broad terms to include

“the adoption or use of one or more practices, means,

methods, operations or processes, reasonably necessary or

appropriate to provide safe or healthful employment and

places of employment.” Thus Congress chose not to pre-

scribe a list of

specific ‘do’s and don’t’s’ for keeping workplaces

safe and healthful. Industrial safety and health

™7 Indeed, given ATMI’s proposed “alternative” (see pp. 47-48,

supra) which relies significantly on worker transfers, ATMI could

hardly argue that the statute forbids the Secretary to include such

a provision in his compliance program.

problems are as complex and changing as American

industry itself. They cannot be solved by a lengthy

list of prohibitions spelled out in a statute.

Instead, the [Act sets] up a legal structure; that

is, it. . . empower[s] an administrative agency to

issue detailed safety and health regulations. . . .

(Leg. Hist. 297-298 (analysis of Senator Saxbe) .]78

78 ATMI notes (Br. 56) that under the Federal Coal Mine Health

and Safety Act of 1969, 30 U.S.C. § 801-960, Congress guaranteed

miners with pneumoconiosis the option of transferring to lower

exposure levels in the mine without any attendant loss of pay. Ac-

cording to ATMI, the absence of any comparable express provision

in OSHA evidences a legislative intent to foreclose the Secretary

from imposing a similar requirement when fashioning OSHA stand-

ards. ATMI, however, overlooks a basic distinction. In the Coal

Mine Health and Safety Act Congress drafted legislation for a

single industry, prescribing in great detail a comprehensive pro-

gram of control measures mandated to meet the particular health

hazards of coal mining. 30 U.S.C. § 801-878. These provisions

addressed such highly particularized matters as the precise PELS

to be met (id. § 842(b); see also § 843(b)), the specifications of

ventilation equipment to be installed (id. § 863), and the type of

dust measuring device to be used (“the gravametric dust sampler

with four channel horizontal elutriator developed by the Mining

Research Establishment of the National Coal Board, London, Eng-

land,” id. §842(e) (as originally enacted, P.L. 91-173, Title II,

§ 202 (1969) ).

In OSHA, by marked contrast, Congress was legislating with re-

spect to:

every employer whose business affects interstate commerce.

Eschewing any attempt to establish substantive provisions to

control all these various employers, the Act creates a general

framework to govern the development of regulations, and dele-

gates the task of formulating particular health and safety

standards to the Secretary... . [Industrial Union Department

V. Hodgson, 499 F.2d 467, 499 (D.C. Cir. 1974).]

The lesson, if any, to be drawn from the Coal Mine Health and

Safety Act is that in the one statute where Congress directly ad-

dressed the question, it concluded that if worker transfers are to be

relied upon as a means of providing health protection, an income-

protection provision is necessary. See Whirlpool Corp. v. Marshall,

supra, 445 U.S. at 13, n. 18.

Given this statutory framework, ATMI’s argument

proves too much and therefore proves nothing. For §§ 6

(b) (7) & 3(8) do not expressly provide that the Sec-

retary can require employers to bear the cost of res-

pirators, medical surveillance or any other control meth-

ods. Yet, ATMI does not challenge the Secretary’s au-

thority to impose those obligations through this standard.

For it is manifest that Congress expected the costs of

controlling occupational hazards to be placed upon em-

ployers. Congress viewed these as “reasonable and neces-

sary costs of doing business.” Leg. Hist. 1150-51 (Sen.

Eagleton) See generally supra, pp. 35-39. And, so far

as we are able to discern, or ATMI informs us, there is

no distinction between the costs associated with the par-

ticular control measure here involved—viz., worker trans-

fers—and the costs of respirators or any other control

measure.”®

Finally, contrary to ATMI’s assertion (Br. 55), the

Congressional decision not to include a “strike with pay”

provision in the Act is of no relevance to the issue at

hand. This Court explained in Whirlpool, supra, that:

. . . What primarily troubled Congress about the

Daniels’ bill’s ‘strike with pay’ provision was its

requirement that employees be paid their regular

salary after ... refus[ing]to work... . [445 US.

at 17].

79 ATMI also complains that under the standard workers who are

exposed on the job to excessive levels of cotton dust and who cannot

wear respirators must be offered transfers to other jobs in lower

exposure areas “without any demonstration that they are suffering

a work-related health impairment or even that their inability to

wear respirators is related to exposure to cotton dust...” (ATMI

Br. 52). But the purpose of this control measure, like any other, is

preventive: “The Act does not wait for an employee to die or be-

come injured. It authorizes the promulgation of health and safety

standards . . . in the hope that these will act to prevent deaths or

injuries from ever occurring.” Whirlpool Corp. v. Marshall, supra,

445 U.S. at 12.

Senator Williams explained that the bill would have en-

abled workers “to walk off the job with full pay.” Leg.

Hist. 416. See also id. at 1011 (Rep. Randall), 1046

(Rep. Feighan), and 1089 (Rep. Horton).

Here, however, there is no “strike”. Rather, the

transfer provision will come into play only if a doctor

has certified that a worker exposed to cotton dust levels

above the PEL is physically incapable of wearing a

respirator. At that juncture, a transfer to an avail-

able job with lower exposure levels must be offered not

because the worker has “refused to work” but because

the Secretary has determined that, in these circumstances,

transfer constitutes the only remaining means of pro-

tecting the worker’s health. Once the transfer is ef-

fected, the worker is paid for working, not for remaining

away from work.

CONCLUSION

For the foregoing reasons, the judgment of the court

of appeals should be affirmed.

J. ALBERT WOLL

General Counsel, AFL-CIO

815 15th Street, N.W.

Washington, D.C. 20005

ELLIOT BREDHOFF

General Counsel

Industrial Union Department,

AFL-CIO

1000 Connecticut Avenue, N.W.

Washington, D.C. 20036

ARTHUR M. GOLDBERG

General Counsel

Amalgamated Clothing &

Textile Workers Union

15 Union Square

New York, New York 100038

Of Counsel

Respectfully submitted,

GEORGE H. CoHEN*

ROBERT M. WEINBERG

JEREMIAH A. COLLINS

BREDHOFF, GOTTESMAN, COHEN,

CHANIN, WEINBERG &

PETRAMALO

1000 Connecticut Avenue, N.W.

Washington, D.C. 20036

(202) 833-9340

* Counsel of Record

LAURENCE GOLD

815 16th Street, N.W.

Washington, D.C. 20006

Attorneys for American Feder-

ation of Labor and Congress

of Industrial Organizations,

Industrial Union Department,

AFL-CIO, and Amalgamated

Clothing & Textile Workers

Union, AFL-CIO

APPENDIX A

In addition to the sections of the Occupational Safety

and Health Act of 1970, P.L. 91-596, 84 Stat. 1590, 29

U.S.C. § 651 et seq., which are set forth in the Appendix

to Petitioner ATMI’s brief, the following sections of the

Act are also pertinent:

Section 6(b)(6)(A), 29 U.S.C. § 655 (b) (6) (A),

provides in pertinent part:

Any employer may apply to the Secretary for

a temporary order granting a variance from a

standard or any provisions thereof promulgated

under this section.

Section 6(b) (7), 29 U.S.C. § 655(b) (7), provides in

pertinent part:

Any standard promulgated under this sub-

section shall prescribe the use of labels or other

appropriate forms of warning as are necessary

to insure that employees are apprised of all

hazards to which they are exposed, relevant

symptoms and appropriate emergency treatment,

and proper conditions and precautions of safe

use or exposure. Where appropriate, such stand-

ard shall also prescribe suitable protective equip-

ment and control or technological procedures to

be used in connection with such hazards and

shall provide for monitoring or measuring em-

ployee exposure at such locations and intervals,

and in such manner as may be necessary for

the protection of employees.

Section 6(b) (8), 29 U.S.C. § 655 (b) (8) provides:

Whenever a rule promulgated by the Secre-

tary differs substantially from an existing na-

tional consensus standard, the Secretary shall,

at the same time, publish in the Federal Reg-

ister a statement of the reasons why the rule

as adopted will better effectuate the purposes

of this Act than the national consensus standard.

Section 7(b) of the Small Business Act, 15 U.S.C.

§ 686(b) (5), as amended by § 28 of the Occupa-

tional Safety and Health Act, provides in pertinent

part:

The [Small Business] Administration also is

empowered—

* * * ae

to make such loans (either directly or in coop-

eration with banks or other lending institutions

through agreements to participate on an im-

mediate or deferred basis) as the Administra-

tion may determine to be necessary or appro-

priate to assist any small business concern in

effecting additions to or alterations in the equip-

ment, facilities, or methods of operation of such

business in order to comply with the applicable

standards promulgated pursuant to section 6 of

the Occupational Safety and Health Act of 1970

or standards adopted by a State pursuant to a

plan approved under section 18 of the Occupa-

tional Safety and Health Act of 1970, if the

Administration determines that such concern is

likely to suffer substantial economic injury with-

out assistance under this paragraph.

APPENDIX B

A Survey of Statutory Approaches to the

Consideration of Costs and Benefits in the

Promulgation of Health and Safety Regulations

Balancing of costs and benefits is expressly required by

several regulatory statutes. An early example is the

Flood Control Act of 1936, 33 U.S.C. 8 701a: “(T]he

Federal Government should improve or participate in the

improvement of navigable waters . . . for flood-cont:-ol

purposes if the benefits to whomsoever they accrue are in

excess of the estimated costs and if the lives and social

security of people are otherwise adversely affected.” More

recent examples include the Outer Continental Shelf Lands

Act Amendments of 1978, 43 U.S.C. § 1347 (b), which

provide that offshore drilling operations shall use “the

best available and safest technologies which the Secre-

tary determines to be economically feasible, . . . except

where the Secretary determines that the incremental bene-

fits are clearly insufficient to justify the incremental costs

of utilizing such technologies.” (Plainly, in drafting that

statute Congress did not regard the term “economically

feasible” as including the concept of cost-benefit balanc-

ing; rather, additional language was inserted to incor-

porate that concept.) The Energy Policy and Conserva-

tion Act of 1975, as amended, 42 U.S.C. § 6295(c), (d),

provides that in promulgating energy efficiency standards

“the Secretary . . . shall determine that the benefits of

the standard exceed its burdens based, to the greatest ex-

tent practicable, on a weighing of [several specified ]

factors... .”

In several instances, Congress has required some form

of cost-benefit balancing with respect to the promulgation

of certain regulations under a statute, while requiring

other regulations under the same statute to be developed

without regard to any such balancing, albeit with some

consideration of costs. A good example is the Federal

Water Pollution Control Act Amendments of 1972, as

amended, 33 U.S.C. § 1251 et seg.

That statute specifies that in setting effluent limita-

tions to be achieved by 1977, the Environmental Protec-

tion Agency (“EPA’’) is to require the use of the “best

practicable control technology currently available (§ 1311

(b) (1)), and the statute further provides that EPA’s

“assessment of [that] technology shall include considera-

tion of the total cost of application of technology in rela-

tion to the effluent reduction benefits to be achieved from

that application... .” (§ 1814(b) (1) (B)). The latter

requirement entails a “limited cost-benefit analysis’—a

“balancing test between total cost and effluent reduction

benefits [which] is intended to limit the application of

technology only where the additional degree of effluent

reduction is wholly out of proportion to the costs of

achieving such marginal level of reduction. .. .” 118

Cong. Rec. 33696 (1972), discussed in EPA v. National

Crushed Stone Assn., No. 79-770, Sl. Op. 6, n. 10; td.

at 10-12.

On the other hand, the 1972 Amendments provide that

effluent limitations to be attained by 1973* should be

based on “the best available technology economically

achievable” (as amended, § 1311(b) (2) (A)), and under

that provision, while costs are to be considered, “no bal-

ancing test will be required.” 118 Cong. Rec. 33696

(1972). See EPA v. National Crushed Stone Assn.,

supra, Sl. Op. 6, n. 10; Weyerhaeuser Corp. v. Costle,

590 F.2d 1011, 1044-46 (D.C. Cir. 1978).

The amendments also authorize EPA to set more strin-

gent effluent limitations for particular sources of pollu-

tion where the generally mandated levels will not achieve

the required standard of water quality in a particular

setting; but before so doing the Administrator must con-

duct a public hearing to assess the “economic and social”

costs and benefits involved (33 U.S.C. § 1812(b) (1) ), and

the more stringent limitations cannot be applied against

* This deadline has been extended to 1987 by the Clean Water Act

Amendments of 1977. See id., Sl. Op. 5, n. 9.

any person who demonstrates at that hearing that “there

is no reasonable relationship between the economic and

social costs and the benefits to be obtained. .. .” 33

U.S.C. § 1812 (b) (2).

Similarly, the Clean Water Act Amendments of 1977,

33 U.S.C. § 1251 et seg., which established new criteria

for the regulation of “conventional pollutants,” require

that in setting effluent limitations for such substances

EPA shall consider “the reasonableness of the relation-

ship between the costs of attaining a reduction in efflu-

ents and the effluent reduction benefits derived... .” 38

U.S.C. § 1314(b) (4) (B).

Another statute which requires cost-benefit evaluations

for some regulations but not for others is the Clean Air

Act Amendments of 1970, as amended, 42 U.S.C. § 7401

et seq., which were passed the same week as OSHA. In

that statute, the provision which authorizes EPA to pro-

hibit the manufacture or sale of a fuel or fuel additive

that significantly impairs an emission control device

expressly requires EPA to perform “a cost benefit anal-

ysis” (42 U.S.C. § 7545(c) (2) (B)), while the provision

which authorizes the prohibition of a fuel or additive that

would “endanger the public health or welfare” does not

contain such a requirement (42 U.S.C. § 7545 (c) (2)

(A)).

A particular form of cost-benefit balancing has also

been adopted by Congress in the several statutes which

are based on the concept of “unreasonable risk,” each of

which involves the regulation of particular types of

products.

One of the first “unreasonable risk” provisions is con-

tained in the National Traffic and Motor Vehicle Safety

Act of 1966, as amended, 15 U.S.C. § 1391(1). “As the

Senate hearings make clear, the word ‘unreasonable’ was

placed in the bill deliberately, to signify a ‘common-

sense’ balancing of safety benefits and economic cost.”

United States v. General Motors Corp., 518 F.2d 420,

4385 (D.C. Cir. 1975). See S. Rep. Noa 89-1301, 89th

Cong., 2d Sess. 6 (1966).

The year before OSHA was enacted, Congress incor-

porated an “unreasonable risk” requirement in the Child

Protection and Toy Safety Act of 1969, as amended, 15

U.S.C. § 1261(s). The provision was included so as to

require consideration of “such factors as the utility of

the object, the degree of danger it presents, and the

feasibility of designing out that danger.” S. Rep. No.

91-237, 91st Cong., 1st Sess. 7 (1969). See generally

Forester v. CPSC, 559 F.2d 774, 789 (D.C. Cir. 1977).

Two years after OSHA was enacted, Congress adopted

an “unreasonable risk” requirement in two more statutes.

In incorporating that concept in the Consumer Product

Safety Act of 1972,* Congress stated:

Protection against unreasonable risks is central to

many Federal and State safety statutes and the

courts have had broad experience in interpreting the

term’s meaning and application. It is generally ex-

pected that the determination of unreasonable haz-

ard will involve the Commission in balancing the

probability that risk will result in harm and the

gravity of such harm against the effect on the prod-

uct’s utility, cost and availability to the consumer.

H.R. Rep. No. 92-1153, 92d Cong., 2d Sess. 33 (1972).

See also S. Rep. No. 92-749, 92d Cong., 2d Sess. 6, 14-

15 (1972). Similarly, in the Federal Environmental

Pesticide Control Act of 1972, as amended, 7 U.S.C.

§ 186(bb), Congress defined the term “unreasonable ad-

verse effects on the environment” to mean “an unreason-

able risk to man or the environment, taking into account

the economic, social, and environmental costs and bene-

fits of the use of any pesticide.” The EPA may regulate

a pesticide only to the extent that the pesticide entails

such “unreasonable adverse effects.” See 7 U.S.C. §§ 136

* See 15 U.S.C. §§ 2056(a), 2058(c) (1) (A),(C), 2058(c) (2) (A).

a(c)(5)(C), (D), 186a(e) (7), (8), 186a(d), 186d(b).

This explicitly requires a balancing of costs and bene-

fits. See Environmental Defense Fund v. EPA, 548 F.2d

998, 1005 (D.C. Cir. 1976).

Recently, Congress enacted yet another statute based

on the concept of “unreasonable risk” and explicitly re-

quiring a balancing of costs and benefits: the Toxic

Substances Control Act of 1976, 15 U.S.C. § 2605 (a),

(ec) (1).

Finally, the provisions of the Federal Food, Drug, and

Cosmetic Act concerning human and animal drugs, 21

U.S.C. §§ 321(p) (1), 360b, illustrate an altogether dif-

ferent approach to the consideration of costs and benefits.

In determining whether a human drug is “safe” the Food

and Drug Administration (“FDA”) must assess whether

“the expected therapeutic gain [from the drug] justifies

the risk entailed by its use.” United States v. Ruther-

ford, 442 U.S. 544, 555 (1979). That is to say, a drug

is “safe” only if its curative benefits outweigh its side

effects. But while the statute requires a balancing of

therapeutic costs and benefits, it does not contemplate a

balancing of economic costs and benefits. See Decision

of the Commissioner in the Matter of Diethylstilbestrol:

Withdrawal of Approval of New Animal Drug Applica-

tions, 44 Fed. Reg. 54852, 54881-54883 (Sept. 21, 1979).

On the other hand, the provisions of the Food, Drug, and

Cosmetic Act which authorize FDA to set “tolerances”

for certain hazardous substances (e.g., 21 U.S.C. §§ 346,

346a, 348(c) (4) (A), (B)) may contemplate some form

of economic cost-benefit balancing. Id. at 54881-54882.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.