Petition — MARSHALL v. AMERICAN PETROLEUM INSTITUTE (Nos. 78-1036, 78-911)

€8-103¢

No.

p eliep

Iu the Siywenw Cnet uf the WUuited States

OCTOBER TERM, 1978

RAY MARSHALL, SECRETARY OF LABOR

Vv.

AMERICAN PETROLEUM INSTITUTE, ET AL.

»

PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE FIFTH CIRCUIT

WADE H. McCREE, JR.

Solicitor General

FRANK H. EASTERBROOK

Deputy Solicitor General

WILLIAM ALSUP

Assistant to the Solicitor General

Department of Justice

Washington, D.C. 20530

CARIN ANN CLAUSS

Solicitor of Labor

BENJAMIN W. MINTZ

Associate Solicitor

ALLEN H. FELDMAN

DENNIS K. KADE

NANCY L. SOUTHARD

DIANE E. BURKLEY

Attorneys

Department of Labor

Washington, D.C. 20210

Page

A LEILA 1

I dai daiciten-cnisshquainbencnbbhspodessusebadidaiejuise 2

EEE Le ee 2

EE a EE I a 2

ELSES ES ER ODS ae 3

Reasons for granting the petition .................... 11

GS I) OS ESE SO 21

CITATIONS

Cases:

American Iron and Steel Institute v.

OSHA, 577 F.2d 825, petitions for cert.

pending, Nos. 78-911 and 78-919 .......... 12,13

Atlas Roofing Co. v. OSHRC, 4380 U.S.

NUNES SIS TO a 3

Industrial Union Department, AFL-CIO

v. Hodgson, 499 F.2d 467 .....................- 12,13

Society of Plastics v. OSHA, 509 F.2d

1301, cert. denied, 421 U.S. 992 0.0000... 12

Union Electric Co. v. EPA, 427 US.

ARUN DET EY ib Ac 18

Statutes:

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

2058(c)(1)(C) and (D) ..................... 17

Occupational Safety and Health Act of

1970, 29 U.S.C. 651 e€ seg. .................. 3

RESET aa 3,17

a 3, 9, 16

Statutes—Continued: Page

RE ICTY detaidntebechsscciienoempeshacicashanbioii 3

GP ES SENET | Snichserictncsconteienisnqansinls 4,19

TN EI cliscdcctaveocbentincpobecscnted 2,18

BP Seri SEEDED) cecccvccscccasccsasnenraed passim

Br ieee PERO), ccccstonssccsvncntectonies 19

FP I PUD inpscevintnsntccsicenntinsamnpnsian 4

Miscellaneous:

Comment, Implementing the Anticancer

Clauses of the Food, Drug and Cos-

metic Act, 44 U. Chi. L. Rev. 818

(oy PSRERT ERE SB Dirty SEALER Poa ia Es See 18

EPA, A Preliminary Report on Popula-

tion Risk to Ambient Benzene Ex-

NIUE RUD ecticnncdiceaccptabiceienienstesedeecias 15

Executive Order 12044, 438 Fed. Reg.

PI MIND Nel ctelccict rics ile ac 18

Identification, Classification and Regula-

tion of Toxic Substances Posing a Po-

tential Occupational Carcinogenic Risk,

42 Fed. Reg. 54148 (1977) ...............00+ 12

Senate Committee on Labor and Public

Welfare, Legislative History of the Oc-

cupational Safety and Health Act of

197u, 92d Cong., lst Sess. (1971)....16, 19, 20

S. Rep. No. 92-749, 92d Cong., 2d Sess.

COPE ilacnaduicdabslsigdnedaddeld eabbdinituc ib ucctt 17

Iu the Supreme Court of the United States

OCTOBER TERM, 1978

No.

RAY MARSHALL, SECRETARY OF LABOR

v.

AMERICAN PETROLEUM INSTITUTE, ET AL.

PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS FOR

THE FIFTH CIRCUIT

The Solicitor General, on behalf of the Secretary

of Labor,‘ petitions for a writ of certiorari to review

the judgment of the United States Court of Appeals

for the Fifth Circuit in this case.

OPINIONS BELOW

The opinion of the court of appeals (App. la-33a)*

is reported at 581 F.2d 493. The regulation in ques-

1 The petitions for review of the regulation in the court of

appeals named the Occupational Safety and Health Adminis-

tration as the federal party. Because the Secretary of Labor

is ultimately responsible for the promulgation and enforce-

ment of the regulation, we have named him as petitioner here.

*“App.” refers to the separately bound appendix to the

petition in No. 78-911, which seeks review of the same judg-

ment. Because we believe that the Court should grant review

in No. 78-911, which presents essentially the same questions

as the present petition, we will not file a separate response in

that case.

(1)

2

tion and the administrative opinion (App. 34a-252a)

appear at 43 Fed. Reg. 5918-5970.

JURISDICTION

The judgment of the court of appeals (App. 254a-

255a) was entered on October 5, 1978. The juris-

diction of this Court is invoked under 28 U.S.C. 1254

( 1 ) .

QUESTIONS PRESENTED

1. Whether a health and safety standard for a

toxie substance promulgated by the Secretary of Labor

pursuant to 29 U.S.C. 655(b) must satisfy a cost-

benefit test.

2. Whether a health and safety standard that is

supported by substantial evidence based on the best

available scientific knowledge may be set aside be-

cause of the possibility that future scientific studies

will provide better evidence concerning the need for

the standard.

STATUTE INVOLVED

Section 6(b) (5) of the Occupational Safety and

Health Act of 1970, 29 U.S.C. 65546) (5), provides:

The Secretary, in promulgating standards deal-

ing with toxic materials or harmful physical

agents under this subsection, shall set the standard

which most adequately assures, to the extent

feasible, on the basis of the best available evi-

dence, that no employee will suffer material im-

pairment of health or functional capacity even

if such employee has regular exposure to the

hazard dealt with by such standard for the period

3

of his working life. Development of standards

under this subsection shall be based upon re-

search, demonstrations, experiments, and such

other information as may be appropriate. In

addition to the attainment of the highest degree

of health and safety protection for the employee,

other considerations shall be the latest available

scientific data in the field, the feasibility of the

standards, and experience gained under this and

other health and safety laws.

Section 3(8) of the Act, 29 U.S.C. 652(8), pro-

vides:

The term “occupational safety and health stan-

dard” means a standard which requires condi-

tions, or the adoption or use of one or more prac-

tices, means, methods, operations, or processes,

reasonably necessary or appropriate to provide

safe or healthful employment and places of em-

ployment.

STATEMENT

1. The Occupational Safety and Health Act of

1970 (OSHA), 29 U.S.C. 651 et seg., was enacted

“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.” 29

U.S.C. 651. See Atlas Roofing Co. v. OSHRC, 430

U.S. 442, 444-445 (1977). The Act directs the Sec-

retary of Labor to set occupational safety and health

standards to achieve this objective. 29 U.S.C. 655.

The Secretary has determined that benzene poses a

serious health hazard to employees who are exposed

4

to it, and he has issued three standards regulating

the exposure of employees to benzene.°

During the first two years of OSHA’s existence,

the Secretary was required to adopt as his regulation

any “national consensus standard” or “established

Federal standard,” unless he determined that the

promulgation of such a standard would not result in

improved health or safety. 29 U.S.C. 655(a). In 1971

the Secretary adopted an existing “national consensus

standard” establishing limits on occupational exposure

to benzene. The 1971 standard provided that average

exposure over an eight-hour period could not exceed 10

parts of benzene per million parts of air (ppm), and

that short-term exposure could not exceed 50 ppm

(App. 71a). The 1971 standard was designed to con-

trol the long-recognized toxic non-malignant effects of

benzene. The Secretary later received scientific evi-

dence, including a report of the National Institute for

Occupational Safety and Health, that benzene posed

a risk of leukemia. On May 3, 1977, the Secretary

issued an emergency temporary standard for benzene

(see 29 U.S.C. 655(c)). Because of a temporary

restraining order, the emergency standard never be-

came effective (App. 73a-74a).

This case involves the Secretary’s third benzene

standard, which was promulgated after full rulemak-

ing addressed to the leukemia hazard. The Secretary

* Benzene, a highly volatile liquid, is a hydrocarbon with

many industrial uses. Only 11 other chemicals are produced

in greater tonnage in the United States. Production of ben-

zene has been increasing rapidly (App. 69a).

5

published a proposed permanent benzene standard on

May 27, 1977. Public hearings were held; 95 wit-

nesses, representing employers and employees from

the petroleum refining, petrochemical, oil and gas pro-

duction, aviation fueling, coke oven and coke by-

products industries, gave testimony (App. 74a). Com-

ments were received from other industries, public in-

terest groups and government agencies (ibid.). Briefs,

arguments and additional evidence were submitted

(id. at 75a).

The final benzene standard reduces the permissible

exposure level to an average of one ppm over an eight-

hour day and reduces the limit for any 15-minute

period to five ppm. It prohibits dermal and eye con-

tact with certain liquids containing benzene, and it

requires employers to monitor and enforce the ex-

posure levels.‘

The Secretary published a lengthy statement of rea-

sons for adopting the rule (App. 67a-251a). The

Secretary described evidence showing that benzene

4 Although the standard initially prohibited dermal and eye

contact with any liquid containing any benzene, the standard

was amended on June 27, 1978, to exempt all liquids contain-

ing 0.5% or less benzene by volume for an interim period of

three years, after which the exemption covers all liquids con-

taining 0.1% or less benzene by volume (App. 252a). The

standard also requires employers to assure that caution labels

are affixed to containers of products containing benzene and

requires such labels to remain affixed when the products leave

the workplace (App. 47a-48a). The standard requires respira-

tory protection in limited situations (App. 40a), medical sur-

veillance (App. 42a-46a), employee training programs (App.

46a-47a), and retention of records regarding medical surveil-

lance and exposure monitoring (App. 48a-51a).

6

causes leukemia and non-malignant diseases as well.

Blood disorders induced by benzene have caused deaths

(App. 84a-89a) ; some studies reported blood abnor-

malities at levels below 25 ppm, perhaps as low as

10 ppm (id. at 97a). Observing that “prudent public

health policy, and established toxicological principles

necessitates setting the permissible exposure limit

sufficiently below the levels at which adverse effects

have been observed to assure adequate protection,”

and that “[i]t is customary to use a safety factor

of 10-100 or greater depending on the seriousness of

the toxic effects and the nature of the data being

relied upon,” the Secretary stated that a permissible

exposure limit “substantially less than 10 ppm with-

out regard to the issue of leukemia” would be war-

ranted (App. 97a-98a).

Although the evidence that benzene causes leukemia

was basically uncontroverted (App. 122a), industry

representatives presented several “negative studies”—

studies of purportedly exposed workers who did not

contract leukemia—in an attempt to demonstrate that

there was a threshold of exposure (higher than 10

ppm) below which there was no risk of leukemia. The

Secretary concluded that these studies were unper-

suasive, both because epidemiological studies are im-

precise and because these studies, in particular, had

serious deficiencies.’ The majority of the cancer spe-

cialists appearing at the hearing testified that there

5’ Several of the studies, for example, did not separate work-

ers who were not exposed to benzene from those who were

exposed in computing risks from exposure (App. 124a-125a).

7

was no known safe level of exposure to benzene (App.

182a-187a; Tr. 351-363, 775-780, 1053). This testi-

mony was consistent with the 1970 report of the

National Cancer Institute’s Ad Hoc Committee on

the Evaluation of Low Levels of Environmental

Carcinogens.

The Secretary thus concluded that the evidence

established no known safe level for exposure to ben-

zene (App. 124a-125a). He explained that “once the

carcinogenicity of a substance has been established

qualitatively, any exposure must be considered to be

attended by risk” (App. 124a, 132a, 160a, 185-186a).

The evidence, including a study of the technology re-

quired to reduce the level and the expense to do so,

demonstrated that the one ppm standard with a ceil-

ing of five ppm was the lowest feasible level, and the

Secretary therefore adopted it (App. 132a-135a, 185a-

187a).°

The Secretary also concluded that a health risk

was posed by dermal or eye contact with liquids con-

taining more than 0.5% benzene by volume (see note

4, supra). The evidence revealed a scientific con-

sensus—based on test data, benzene’s physical char-

acteristics, and experience with similar chemicals—

that absorption through skin is a potential source

of exposure. In accordance with the agency’s policy

®* The Secretary estimated that the new standard would in-

crease operating costs for all industries during the first year

by between $187 million and $205 million; that the rule would

require recurring annual expenditures of approximately $34

million; and that necessary investment in engineering con-

trols would be approximately $266 million (App. 134a).

8

that, “in dealing with a carcinogen, all potential

routes of exposure (i.e. inhalation, ingestion, and skin

absorption) should be limited to the extent feasible”

(App. 192a), the Secretary therefore required the use

of inexpensive impermeable clothing to prevent skin

and eye contact (App. 193a-194a).

The Secretary rejected the argument that a rule

about toxic substances must be justified by an attempt

to assess the benefi:s of improved health and to weigh

those benefits against the cost of the regulation and

the costs of other “socially acceptable risks” (App.

158a-163a). The Secretary pointed out that the evi-

dence did not permit the drawing of conclusions about

the exact relationship between decreasing levels of

exposure and disease; unless it could be learned ex-

actly how much disease could be avoided by each one

ppm decrease in exposure, it would be impossible to

know the benefits of the particular proposed regula-

tion. The most that could be said with confidence, the

Secretary concluded, is that decreased exposure would

lead to reduced risk, and thus save lives, The reduc-

tion to one ppm exposure is likely, said the Secretary,

to carry with it “appreciable” health benefits. The

Secretary believed that the statute and the state of

scientific knowledge together required adoption of the

lowest feasible level for carcinogenic materials, at

least so long as there is no known safe level. Only

this position, the Secretary stated, could yield “the”

standard that “most adequately assures, to the extent

feasible” that “no” employee would suffer health im-

pairment as a result of employment, as Section 655

(b) (5) requires (App. 159a-162a).

9

2. The court of appeals concluded that substantial

evidence supports the Secretary’s findings that (1)

benzene causes cancer (App. 18a) ; (2) benzene causes

diseases (some of them fatal) other than cancer

(App. 7a); (3) exposure at the 10 ppm level poses

a leukemia risk, and exposure at the one ppm level

poses less leukemia risk (App. 18a). The court

acknowledged that it is not now possible to determine

the ‘exact relationship between exposure and risk

(App. 19a n.25); it did not dispute the Secretary’s

finding that the one ppm standard is economically and

technologically feasible.

The court nevertheless set aside the standard. It

concluded that the Secretary must demonstrate that

the lower exposure level saves enough lives that the

saving bears a “reasonable relationship” to the cost

of implementing the standard (App. 19a-20a). This

statutory requirement, the court held, had not been

met, principally because the Secretary did not calculate

the precise relationship between exposure and risk.

The court fc ind the requirement that the Secretary

establish a “reasonable” relationship between known

costs and known benefits in the section of the Act that

defines a health standard as a rule “reasonably nec-

essary or appropriate” to protect health (29 U.S.C.

§52(8)). A standard could not be “reasonably neces-

sary,” the court concluded, unless it produced known

benefits or savings commensurate with its known

costs.

Recognizing that OSHA calls for the “highest de-

gree of health and safety protection” and establishes

10

that the Secretary must adopt for toxic materials the

standard that “most adequately assures, to the extent

feasible” health protection (29 U.S.C. 655(b) (5)),

the court stated that the Secretary does not have “un-

bridled discretion to adopt standards designed to

create absolutely risk-free workplaces regardless of

cost” (App. 15a). The court pointed out that Sec-

tion 655(b)(5) also requires the standards to be

“feasible” and instructs the Secretary to consider

“the best available evidence * * * research, demon-

strations, experiments.” These provisions suggested

to the court that the statute contains “pragmatic limi-

tations” (App. 16a), including a requirement to

strike a balance between known costs and known

benefits.”

*The Secretary argued that the standard could satisfy a

cost-benefit test, if one were required. The court rejected this

argument because, although the cost was not in dispute, the

benefits were not well known. Conceding that “some” health

benefits would result from the lower standard, the court held

that there is no substantial evidence to support the Secre-

tary’s finding that the benefits may well be “appreciable”

(App. 18a-19a). The court predicted that “valid extrapola-

tions will be possible as more is known about the effects of

past exposure at higher levels ‘App. 19a n.23). The court

stated that when “studies of the effects of human exposure

to benzene at higher concentration levels in the past are suffi-

cient to enable a dose-response curve to be charted that can

reasonably be projected to the lower exposure levels, or when

studies of the effects of animal exposure to benzene are suffi-

cient to make projections of the risks involved with exposure

at low levels, then OSHA will be able to make rough but edu-

cated estimates of the extent of benefits expected from reduc-

ing the permissible exposure level from 10 ppm to 1 ppm.

Until such estimates are possible, OSHA does not have suffi-

11

The court also invalidated the prohibition on dermal

contact with liquids containing benzene. The Secre-

tary had considered conflicting medical opinions on

the question whether benzene could be absorbed

through the skin and thereby pose a risk of disease.

Although the court acknowledged that the Secretary’s

finding that dermal contact with benzene poses a

cancer risk is supported by substantial evidence (App.

25a), the court noted that one physician had testified

that an experiment using radioactive benzene could

be conducted to determine conclusively whether ben-

zene is absorbed through the skin. No such experi-

ment had been conducted, but the testimony led the

court to hold that the Secretary may not proceed in

the absence of such “readily” available evidence, be-

cause the rules must be based on the “best available

evidence.” 29 U.S.C. 655(b) (5).

Because all of the standard’s other requirements

are “tied to” the permissible exposure limit and the

dermal contact prohibition, the court set aside the

entire standard (App. 33a).

REASONS FOR GRANTING THE PETITION

1. The Occupational Safety and Health Act re-

quires the Secretary of Labor to establish, for toxic

substances, standards of occupational exposure that

“most adequately assure[], to the extent feasible, on

cient information to determine that a standard such as the one

under review which it can only say might protect some worker

from a leukemia risk is reasonably necessary” (App. 20a-

21a; footnotes omitted).

12

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 regular

exposure to the hazard dealt with by such standard

for the period of his working life.” 29 U.S.C. 655

(b) (5) (emphasis added). Because of the great dif-

ficulty that has been experienced in determining

whether most substances that cause cancer are “safe”

in any dose, however small, the Secretary has consist-

ently established standards requiring the lowest level

of exposure that can be achieved within bounds of

economic and technological feasibility. The Secretary

has not attempted to establish comparisons between

the costs of the regulation and the measurgable bene-

fits of reduced exposure to benzene and certain other

toxic substances, and he believes that in this case he

cannot establish such a comparison. Three courts of

appeals have sustained the Secretary’s approach. In-

dustrial Union Department, AFL-CIO v. Hodgson, 499

F.2d 467 (D.C. Cir. 1974) (asbestos dust) ; Society

of Plastics v. OSHA, 509 F.2d 1801 (2d Cir.), cert.

denied, 421 U.S. 992 (1975) (vinyl chloride) ; Ameri-

can Iron and Steel Institute v. OSHA, 577 F.2d 825

(3d Cir. 1978), petitions for cert. pending, Nos. 78-

918 and 78-919 (“‘AISI’’) (coke oven emissions). The

Secretary is continuing to apply this policy in ongo-

ing administrative proceedings dealing with other car-

cinogens. See Identification, Classification and Regu-

lation of Toxic Substances Posing a Potential Occupa-

tional Carcinogenic Risk, 42 Fed. Reg. 54148 (1977).

The decision of the court of appeals in the present

case holds that this policy is unlawful. According to

the court, the Secretary must demonstrate measurable

13

benefits to be achieved by reductions in exposure to

cancer-causing substances. If the relationship between

exposure and disease is imperfectly known, so that

the benefits cannot be measured, then the Secretary

cannot order a reduction in exposure. In reaching

this conclusion the court of appeals declined to address

the decisions we have mentioned above, stating that

they were insufficiently analytical (App. 21a).

The decisions do not simply conflict in result. They

employ completely different reasoning. The three

earlier decisions recognize the authority of the Secre-

tary, when the evidence establishes no known safe

level of exposure to a carcinogen, to resolve doubts in

favor of safety. They do not require the Secretary to

establish the “savings” attributable to a reduction in

exposure; the decision in the present case makes such

a computation essential. AJSJ and Industrial Union,

indeed, explicitly reject the proposition that the stat-

ute requires (or even permits) the Secretary to act

on the basis of a cost-benefit comparison.’ They make

8 The industrial parties in AJS] argued that the Secretary

was required to consider all applicable OSHA standards for a

given industry and the cost of each, and then to maximize

the number of lives saved (by all standards) for a given cost.

This test would have required a cost-benefit analysis of every

possible regulation and a comparison of the costs and benefits

of toxic substances regulation against the costs and benefits

of other forms of safety regulation. The court of appeals

responded that the role “economic considerations are to play

in review of the Secretary’s standard” is limited to determin-

ing whether the standard is economically feasible, and that

means only that the standard will not cause “massive disloca-

tion of industry” or “imperil the existence” of the industry.

577 F.2d at 835-836. See also Industrial Union, supra, 499

F.2d at 478-481.

14

it clear that financial considerations may be taken into

account only to the extent necessary to demonstrate

whether a standard is feasible. The present case thus

creates a conflict on a question that potentially affects

the conditions of thousands of workplaces and the

lives of millions of workers. The decision may well

preclude the Secretary from regulating many of the

other carcinogens present in the workplace. The ques-

tion deserves review by this Court.’

® The case would deserve review even if it involved only the

benzene standard. The regulation governs the occupational

exposure of some 629,000 workers to a known cause of cancer

(App. 137a). Benzene is a widely-used hydrocarbon, and it

can be expected that occupational exposure to it will continue

to raise health questions. Although the court of appeals specu-

lated (App. 19a n.23) that scientific evidence soon would per-

mit the Secretary to establish the relationship between ex-

posure to benzene and the incidence of disease, and thus

establish the amount of benefits attributable to a reduction

in exposure, it offered no sufficient basis for that speculation.

The Secretary believes that the court of appeals overesti-

mated the precision available in scientific studies of risk from

exposure to carcinogens. There are a number of obstacles

that make the measurement of benefits difficult. For example,

it is difficult to study the development of cancer in groups

of persons because it is not known how much of a given sub-

stance they may have been exposed to in the past; moreover,

persons may have been exposed to several different causes

of cancer, and it is difficult to isolate the effects of each.

There may be a substantial lag between initial exposure to

a carcinogen and the development of disease; this makes it

difficult to know when any sample of persons has developed

all of the cases of cancer that may fairly be attributable to a

particular substance. In light of these and other difficulties,

the Secretary believes that the best studies available now

or in the immediate future are not sufficiently precise to per-

mit him to learn the effect of incremental reductions in ex-

posure to benzene of the sort at issue. In other words, the

15

2. The court of appeals’ requirement that the Sec-

retary establish a particular relationship between

Secretary believes that it is not possible to conclude, with

any precision, how many cases of cancer could be avoided

by reducing exposure from 10 ppm to five or one ppm. In

the absence of such information, it would not be possible to

comply with the court of appeals’ requirement of detailed

cost-benefit analysis.

The court of »ppeals based its contrary view on three factors.

First, the court observed that a physicist representing indus-

try had testified that a “preliminary risk assessment”? showed

that only two deaths every six years would be averted by the

reduction in exposure to one ppm. But the Secretary asked

the physicist to supply the basis for this conclusion; although

he agreed to do so (Tr. 2752-2753), the Secretary has never

received this substantiation. The Secretary discussed and re-

jected the physicist’s unsupported conclusion (App. 16la).

Second, the court observed that after the close of the record

in this case the EPA released a preliminary report on the

relationship between cancer and benzene. See A Preliminary

Report on Population Risk to Ambient Benzene Exposures

(1978). (This report estimates that exposure of the whole

population to levels even as low as one part per billion for

only 24 hours would cause between 30 and 80 cases of leu-

kemia yearly.) In the Secretary’s view this report also does

not establish that the relationship between exposure and

incidence of leukemia can be constructed with sufficient relia-

bility to be the basis for setting an exposure level under

OSHA. The EPA stated (id. at 14) that its estimates were

devised by “very crude methods” and could be in error by

several orders of magnitude, so that it could confidently con-

clude only that one sort of exposure would cause between

0.3 and 8000 deaths yearly. Such estimates are not suffi-

ciently precise for use in setting occupational health stand-

ards. The court’s third basis was that the Secretary’s

consultant on the feasibility of implementing a one ppm

standard stated that it could “perform a cost-effectiveness

analysis for the benzene standard” (App. 19a n.23). Although

one witness so testified, he did not offer to demonstrate how

16

known benefits and known costs of a toxic substances

standard is incorrect. The statute provides that the

Secretary must select “the” standard that “most ade-

quately” assures, to the extent feasible, that “no em-

ployee” will suffer harm even if he is regularly ex-

posed to the substance “for the period of his working

life.” 29 U.S.C. 655(b) (5). This provision neces-

sarily precludes a decision to sacrifice health consid-

erations to concerns about cost—at least so long as

the cost is “feasible” within the meaning of the sec-

tion. Nothing in the committee reports on the Act

indicates that Congress desired the Secretary to look

at the cost of regulation for any purpose other than

determining the “feasibility” of a standard. See Sen-

ate Committee on Labor and Public Welfare, Legisla-

tive History of the Occupational Safety and Health

Act of 1970, 92d Cong., 1st Sess. 141-203, 831-892,

1154-1198 (1971) (“Leg. Hist.’’).

The court of appeals found its cost-benefit require-

ment in 29 U.S.C. 652(8), which defines a “health

such a study could be done, or how the data could be acquired.

These three factors thus do not support the court of appeals’

confident assertion that it is possible soon to learn the rela-

tionship between exposure and risk. (There is, of course, no

need in this case to consider the utility of risk assessments

for other purposes under other statutes. The general subject

is under study by an interagency committee that is expected

to issue a report in early 1979.)

Moreover, the court also completely overlooked the Secre-

tary’s conclusion that the benzene standard is justified by

public health considerations without regard to cancer (App.

97a). This error might be sufficient, by itself, to call for

reconsideration. We do not press the point further here,

however, because the court, by deciding the case with the

reasoning it employed, has crippled the Secretary’s ability to

deal with substances that cause cancer.

17

standard” as a regulation establishing a practice or

rule that is “reasonably necessary or appropriate” to

protect health. But the court of appeals cited no leg-

islative history suggesting that this general provision

qualifies the Secretary’s duty to promulgate the stan-

dard that “most adequately” assures that “no” person

is harmed by a toxic substance. Section 652(8) re-

quires a standard to be “reasonably necessary or ap-

propriate,” but nothing in the statute indicates that

a standard is not “reasonably necessary or appropri-

ate” in the absence of a particular cost-benefit ratio.

The court gave no reason for its apparent conclusion

that resolving doubts about safety in favor of lower

exposure to carcinogens is not a “reasonably * * *

appropriate” means of health protection.

The court of appeals’ approach also disregards the

structure of the statute. It renders the statutory re-

quirement of “feasibility” in 29 U.S.C. 655(b) (5)

redundant. It also overlooks the fact that the Act

as a whole indicates a preference for safety “so far

as possible.” 29 U.S.C. 651. When Congress de-

sired to qualify such a goal with a requirement that

costs and benefits be considered, it has done so ex-

plicitly.” The absence of such a qualification in OSHA

1% The Consumer Product Safety Act, for example, contains

such a qualification. See 15 U.S.C. 2058(c) (1) (C) and (D).

See also S. Rep. No. 92-749, 92d Cong., 2d Sess. 33 (1972).

The court of appeals’ reliance on cases decided under the Con-

sumer Product Safety Act (see App. 18a-21a) is therefore im-

proper. Where Congress has not precluded an agency from

using cost-benefit considerations to develop rules, the agency

may properly employ such techniques.

We stress that this case presents the issue whether Section

655(b) (5) prohibits the balancing of costs and benefits for

18

is thus telling. Cf. Union Electric Co. v. EPA, 427

U.S. 246 (1976) (structure of Clean Air Act indi-

cates that it contains no requirement that air pollu-

tion regulations be economically or technologically

feasible); Comment, Jmplementing the Anticancer

Clauses of the Food, Drug and Cosmetic Act, 44 U.

Chi. L. Rev. 817 (1977) (discussing other statutes

regulating carcinogens without respect to cost).

The generally applicable provisions of OSHA all

point toward regulation of toxic substances without

respect to cost-benefit ratios. In selecting from among

competing standards in the first two years of the Act’s

implementation, the Secretary was required to “pro-

toxic substances. We do not address balancing in government

decisionmaking generally. The technique of balancing costs

and benefits is an important decisionmaking tool in govern-

ment. For example, the President has required that executive

branch agencies, including OSHA, perform regulatory

analyses for significant regulations, taking into account the

full economic consequences of the proposed actions and al-

ternatives. He has also established a regulatory analysis

review group to examine the regulatory analysis of significant

regulatory proposals of executive branch regulatory agencies,

including OSHA. Executive Order 12044, 43 Fed. Reg. 12661

(1978). OSHA itself does not preclude all consideration of

cost-benefit assessments in the process of setting health stand-

ards for toxic substances. Section 655(b) permits but does

not require the Secretary to modify previously-adopted na-

tional consensus standards and to issue new standards where

none previously existed, although once the Secretary choosesto

do so, Section 655(b) (5) requires the Secretary to adopt the

standard for toxic substances that is most protective of

health, to the extent feasible. In making the determination

whether to issue a new standard at all, the Secretary is free

to weigh the costs and benefits of the new standards, if it is

possible.

19

mulgate the standard which assures the greatest pro-

tection” of the employees. 29 U.S.C. 655(a). And

the provision for the regulation of toxic substances

is all but inflexible in requiring the Secretary to

select “the” standard that “most adequately” ensures

that “no” employee is harmed. An employer may ob-

tain variances from these rules, but the grounds for

obtaining variances do not include financial considera-

tions. 29 U.S.C. 655(b) (6). See also Leg. Hist. 1188,

1201.

Moreover, the requirement of Section 655(b) (5)

that the Secretary act on the basis of the “best avail-

able evidence” may preclude cost-benefit considera-

tions. Here, for example, the Secretary found that—

as is the case for most carcinogens—the best available

evidence does not permit the drawing of conclusions

about the number of lives that can be saved by each

‘incremental reduction in exposure. Without such

evidence it is impossible to determine the relationship

between benefits and costs. But the statute requires

the Secretary to act anyway, on what Congress surely

knew to be imperfect data. Congress told the Secre-

tary to do the best he could with the “best available”

data precisely to prevent the possibility that “the

Secretary be paralyzed by debate surrounding diverse

medical opinions.” Leg. Hist. 848. Congress could

not have meant to impose a cost-benefit requirement

where, as here, the requirement would produce the

very paralysis it sought to avoid.

8. The court of appeals also erred in invalidating

the Secretary’s prohibition on dermal and eye contact

20

with liquids containing more than 0.5% benzene. As

we have discussed above (see pages 7-8), the medical

and scientific evidence was divided about the question

whether benzene is absorbed through the skin. The

Secretary found that absorption could take place, and

the court of appeals acknowledged (App. 25a) that

the decision to prohibit dermal contact on this basis

is supported by substantial evidence. Under these cir-

cumstances, the court’s conclusion that the Secretary

could not act until another physician had completed

another study using radioactive benzene flouts the

requirement that the Secretary act on the basis of the

best “available” evidence. No radioactive benzene

study was “available” at the time of the hearing and,

to this date, no one has supplied to the Secretary the

results of such a test. No one has argued that the

Secretary prevented the parties from performing and

submitting such a test. We submit that the Secretary

was entitled to act on the basis of the “available”

evidence without waiting for the parties to create

more.”

If, as some of the industry parties contended and the

court of appeals assumed, such a test is uncomplicated and

reliable, it is surprising that the industry parties, with so

much money at stake, have not engaged physicians to per-

form the experiment and furnish the results to the Secretary.

The Secretary cannot reasonably be blamed for the parties’

failure to supply him with relevant evidence. Moreover, if

the Secretary were required to wait until the evidence had

been supplied—however long that might take—the power to

control the timing of new regulations would be effectively

transferred from the Secretary to the affected parties, who

would have every incentive to delay.

21

CONCLUSION

The petition for a writ of certiorari should be

granted.”

Respectfully submitted.

WADE H. McCREE, JR.

Solicitor General

FRANK H. EASTERBROOK

Deputy Solicitor General

WILLIAM ALSUP

Assistant to the Solicitor General

CARIN ANN CLAUSS

Solicitor of Labor

BENJAMIN W. MINTZ

Associate Solicitor

ALLEN H. FELDMAN

DENNIS K. KADE

NANCY L. SOUTHARD

DIANE E. BURKLEY

Attorneys

Department of Labor

DECEMBER 1978

2% The Secretary believes that the case should be decided

this Term if that is possible. In order to facilitate prompt

consideration of the case if the Court should grant review, we

are prepared to file a brief on the merits within 21 days after

the Court grants the petition for certiorari. We believe that

it would be appropriate for the Court to establish a briefing

schedule for the other parties that would make the case ayail-

able for oral argument in April.

bg U. S. GOVERNMENT PRINTING OFFICE; 1978 283747 246