Amicus Brief — Industrial Union Dept., AFL-CIO v. American Petroleum Institute

Supreme Court, U. &*

FILED

JUL 30 is7g

EROTIK, JR, CLERN

IN THE gist

Supreme Court of the United States

OCTOBER TERM, 1979

No. 78-911

INDUSTRIAL UNION DEPARTMENT, AFL-CIO,

Petitioner

v.

AMERICAN PETROLEUM INSTITUTE, ET AL.

No. 78-1036

RAY MARSHALL, SECRETARY OF LABOR,

Petitioner

v.

AMERICAN PETROLEUM INSTITUTE, ET AL.

On Writ Of Certiorari To The United States

Court Of Appeals For The Fifth Circuit

BRIEF FOR THE AMICUS CURIAE

CHAMBER OF COMMERCE OF THE UNITED STATES

Of Counsel ROBERT V. ZENER

STEPHEN A. BOKAT Pepper, Hamilton & Scheetz

WILLIAM L. KOVACS 1776 F Street, N.W.

National Chamber Litigation Washington, D.C. 20006

Center

Attorneys for Amicus Curiae

Chamber of Commerce of the

United States

1615 H Street, N.W.

Washington, D.C. 20062

i

TABLE OF CONTENTS

Page

INTEREST OF THE AMICUS CURIAE .. ees

QUESTIONS PRESENTED ........000.0 «65

SUPPLEMENTAL STATEMENT OF THE CASE 5

SUMMARY OF ARGUMENT .................. Eline 7

ARGUMENT ..... AMEE RAPS ton | Cmetar

J. OSHA HAS NO VALID BASIS FOR ITS

REFUSAL TO ASSESS THE EFFECTIVENESS

OF THE BENEZENE STANDARD | eat

1) The existence of uncertainty is not a sufficient

basis for refusal to assess the health benefits

of a regulation . | Mee raatirn 9

2) The conceded impossibility of quantifying the

value of human life is not an adequate basis for

refusing to assess the effectiveness of a health

regulation , tae Te PRIN PERRO

3) The allegedly inequitable distribution of risk

and benefit is an inadequate basis for refusing

to estimate the extent of health benefits ae

Il. THE PRACTICE OF OTHER FEDERAL

AGENCIES DEMONSTRATES THAT THE

BENEFITS OF HEALTH AND SAFETY P.EG-

ULATION CAN BE ASSESSED WITH SUF-

FICIENT CERTAINTY FOR REGULATORY

PURPOSES, AND THAT SUCH ASSESSMENT

IS CONSISTENT WITH THE PURPOSES OF

HEALTH AND ENVIRONMENTAL LAWS

SIMILAR TO THE OSH ACT PMI POs

ii

TABLE OF CONTENTS

Page

Food and Drug Administration ............................ 19

Environmental Protection Agency oo... 22

Consumer Product Safety Commission .............. oc ae

National Highway Traffic Safety Administration

(BREA, once si Ac . 29

CONCLUSION i tis Loan ueaeere Codes re a

CITATIONS

Cases:

Ethyl Corp. v. EPA, 541 F.2d 1 (D.C. Cir.

197TGE}: 035.23 Res: AAS WARM PE LTS aE ree y

H & H Tire Co. v. Department of Transportation,

471 F.2d 3S CT Cat. RGIS cia ce ae 30

STATUTES & REGULATIONS

Atomic Energy Act 42U.S.C. 2011 et seq.

42 U.S.C. 2201(b) ............ sh ahisd dads Measure ADuUnSS ciaat 27

Consumer Product Safety Act 15 U.S.C. 2051 et seq.

1S, USC. BUSTA hee eee ee 28

IS USC. BOtee kala eee

Federal Hazardous Substances Act 15 U.S.C. 1261

et seq.

1S UBL. 1261 CHAP ee ee 28

ili

STATUTES & REGULATIONS

Federal Insecticide, Fungicide & Rodenticide Act iis

7 U.S.C. 121 et seq.

7 U.S.C. 136(bb) , 26

7 USC. 136a(c) (5) 26

7 U.S.C. 136(d)(b) 7 26

Federal Water Pollution Control Act 33 U.S.C. 1251

et seq. Including Amendments Made by Clean

Water Act of 1977

33 U.S.C. 1313 ... : 3 eA eyeredes lt ae

33 U.S.C. 1313(c) (2) Wh bsobte Ss ee oF ORE 24

33 U.S.C. 1314(a) .. Saehtcsacth ts: janeke echt aa

Food, Drug, & Cosmetic Act, 301 et seq.

21 U.S.C. 346 Be pets roux. gsc tue seveedes acess

pO Slats DAT ORS (\ Oe 19

21 U.S.C. 360b | x 20

21 U.S.C. 360(d)(1)(H) i ai D9 ae

yo SP ORME TCO Dt ) ARR re ee |

Motor Vehicle Safety Standards

15 U.S.C. 1381 SS ein fan Ms aad ed crt Oa

15 U.S.C. 1391(2) nant Wee paella) ae

15 U.S.C. 1392(f) os “eee 30

Occupational Safety & Health Act of 1970,

29 U.S.C. 651 et seq.

er Rt ME feces beled fece eles | 9, 16

29 U.S.C. 652(8) WP ky A ee eal Senay Y RT Ye 7, 28

iv

STATUTES & REGULATIONS

29 U.S.C. 655(b) (5)

Page

Ae © Se F

Safe Drinking Water Act, 42 U.S.C. 300f et seq.

42 U.S.C. 300f et seq.

42 U.S.C. 300g-1(a) (2)

Miscellaneous

Booz, Allen & Hamilton, Inc. Preliminary Estimates

of Direct Compliance Cost and Other Economic

Effects of OSHA’s Generic Carcinogen Proposal

Cover on Substance Producing and re: Indus-

tries (Feb. 1978)

Bazelon, Risk And ere. 65 ABAJ 1066

(July 1979)

10 C.F.R.

21 C.F.R.

21 C.F.R.

29 C.F.R.

40 C.F.R.

40 Fed.

41 Fed.

41 Fed.

42 Fed.

42 Fed.

42 Fed.

42 Fed.

Reg.

Reg.

-Reg.

Reg.

Reg.

Reg.

Reg.

20.1(c)

500.89F

500.90a

1910.1000, Table Z-2

190

23420 (May 29, 1975)

; AB,

21402 (May 25, 1976) |

31860 (July 30, 1976)

2858 (Jan. 13, 1977)

18850 (April 8, 1977)

19996 (Apr. 15, 1977)

34289 (July 5, 1977)

28

13

Vv.

STATUTES & REGULATIONS

Page

Miscellaneous

42 Fed. Reg. 54148 (Oct. 4, 1977) y

43 Fed. Reg. 5756 (Feb. 9, 1978) 24

43 Fed. Reg. 11100 (Mar. 16, 1978) 29

44 Fed. Reg. 2678 (Jan. 12, 1979) 26

44 Fed. Reg. 9548 (Feb. 13, 1979) 26, 27

44 Fed. Reg. 9992 (Feb. 15, 1979) 28

44 Fed. Reg. 15926 (Mar. 15, 1979) 25

44 Fed Reg. 17070 (Mar. 20, 1979) 19, 20, 21, 25

44 Fed. Reg. 32736 (June 7, 1979) 26

44 Fed. Reg. 38330 (June 29, 1979) 22

44 Fed. Reg. 39858 (July 6, 1979) . 11, 14

H.R. Rep. No. 93-1185, 93d Cong., 2d Sess. 23

National Cancer Institute, Estimates of the Frac-

tion of Cancer in the United States Related to

Occupational Factors, Sept. 5, 1978 3

Office of Science & Technology Policy, Executive

Office of the President, Characterization, and

Control of Potential Human Carcinogens: A

Framework for Federal INeRRORILe (Feb.

1, 1979) 12

Raspberry; “Those Hamburger Warnings,” Wash-

ington Post, May 19, 1978 ee

Reorganization Plan No. 3 (1970), U.S. Code

Cong. Ad News 6322 27

IN THE

Supreme Court of the United States

OCTOBER TERM, 1979

No. 78-911

INDUSTRIAL UNION DEPARTMENT, AFL-CIO,

Petitioner

v.

AMERICAN PETROLEUM INSTITUTE, ET AL.

No. 78-1036

RAY MARSHALL, SECRETARY OF LABOR,

Petitioner

V.

AMERICAN PETROLEUM INSTITUTE, ET AL.

On Writ Of Certiorari To The United States

Court Of Appeals For The Fifth Circuit

BRIEF FOR THE AMICUS CURIAE

CHAMBER OF COMMERCE OF THE UNITED STATES

INTEREST OF THE AMICUS CURIAE

The Chamber of Commerce of the United States is the

largest business federation in the United States, consisting

of over 3700 State and local chambers of commerce and

trade and professional associations, and a direct business

membership in excess of 81,000 business firms and indi-

viduals.

site aha

The present case is of vital concern to the Chamber’s

members, for four reasons.

First, the position taken by OSHA — that it may issue

standards without any estimate of their effectiveness in

benefiting worker health — will inevitably increase the

already substantial costs imposed on American business

by OSHA regulation. A recent study of OSHA’s policy

for regulation of carcinogens estimated that it will result

in $9 to 88 billion capital costs and $6 to 36 billion annual

costs, depending on how it is applied.'

Second, the Chamber’s members are concerned that the

approach taken by OSHA will ultimately lead to less

effective protection for their employees’ health. At the rate

of expenditure represented by the benzene standard (con-

servatively estimated to be at least $240 million per case

of cancer avoided) it would take an annual expenditure

far in excess of the Gross National Product to solve the

occupational cancer problem — with nothing left over to

address other societal purposes, including other causes of

cancer and other health and safety problems.’

' Booz, Allen & Hamilton, Inc., Preliminary Estimates of Direct

Compliance Costs and Other Economic Effects of OSHA’s Generic

Carcinogen Proposal on Substance Producing and Using Industries

(February, 1978). This study was directed to OSHA’s still pend-

ing proposal for a generic regulation on controlling occupational

carcinogens. 42 Fed. Reg. 54148 (October 4, 1977).

* As discussed in note 5 infra, the testimony that the standard

represents an expenditure of $300 million per cancer avoided,

should be revised to $240 million in light of OSHA’s final cost

estimates.

There are approximately 360,000 cancer deaths annually in this

country, or about 1,000 per day. See OSHA, Identification, Classi-

fication and Regulation of Toxic Substances Posing a Potential

Occupational Carcinogenic Risk, 42 Fed. Reg. 54148, 54150

(October 4, 1977).

Estimates of the portion of the overall cancer rate attributable

to occupational causes range from 1% to a recent HEW estimate

of 20% (attributable in large portion to asbestos). See National

seis Mie

The Chamber believes that more lives can be saved and

serious injury prevented, by OSHA standards which offer

a larger return for the resources expended. Yet unless OSHA

is required to estimate the effectiveness of its standards there

is no assurance that these regulations will ever even ap-

proach the maximum lifesaving potential of the resources

expended.

Third, OSHA’s refusal to consider the effectiveness of

its standards is at variance with the positions taken by the

Food and Drug Administration, the Environmental Pro-

tection Agency, the Consumer Product Safety Commission

and the National Highway Traffic Safety Administration —

all of which regulate the Chamber’s members. If a decision

of this Court were to endorse OSHA’s position, and the

decision were applied to other agencies, there could be

disastrous effects on the level and effectiveness of regulation

across the entire field of federal health and environmental

control.

Finally, the Chamber is concerned that OSHA’s position

will Jead to public disillusionment and eventually loss of

support for any serious effort to alleviate the cancer prob-

lem in this country. OSHA’s position is basically that all

carcinogens must be regulated to the point of maximum

affordable cost, regardless of the enormous degree of varia-

tion in the risks presented, which differ by more than a

millionfold.* However, this philosophy of 1egulation runs

[Footnote 2 cont.].

Cancer Institute, National Institute of Environmental Health Sciences,

National Institute for Occupational Safety and Health, Estimates

of the Fraction of Cancer in the United States Related to Occupa-

tional Factors (September 15, 1978), at p. 1. An estimate of 10%

would involve 100 deaths a day, meaning that at an expenditure rate

of $240 million per case, the total for 12 weeks would use up the

Gross National Product ($2 trillion).

8’ The potency of different carcinogens varies by as much as a

million times; and this difference is magnified by large differences

in the levels of exposure. See respondents’ brief, Addendum C.,

coo a

the danger of depleting not only economic resources, but

also the public support needed for effective anti-cancer

measures. By refusing to distinguish between severe and

remote cancer hazards, OSHA contributes to an already

common public attitude that “everything causes cancer,

so what’s the use.” Indeed, this attitude was eloquently

expressed last year by a popular columnist:

Not just aerosol deodorants and hair sprays, but

the very air we breathe and the water we drink and

the sunshine that warms us have all been identified

as carcinogens. I even remember reading a report

that linked sex with cancer. After a while, the mind

refuses to accept such warnings * * *,

But for most of us it’s not practical to give up meat

or vegetables grown with the aid of fertilizer and

pesticides. We are not going to give up air or water

or sunshine.

What’s more likely — in fact, what is already

happening —— is that we'll give up on the scientists

who tell us these things.

It would help if scientists would tell us which

substances are more dangerous than which others,

or in what levels these dangerous substances can be

treated as benign.

But they won’t tell us these things; they say they

don’t know.

When nearly everything is demonstrated to be

dangerous, we are forced to behave as though noth-

ing is dangerous. We will make our wry little jokes

(calling cigarettes ‘cancer sticks,’ for instance) and

go on as before.

Raspberry, “Those Hamburger Warnings,” Washington

Post, May 19, 1978 (emphasis added).

As we shall demonstrate, Mr. Raspberry’s remarks are

not completely accurate with regard to other federal health

and environmental agencies, which do make an effort to as-

a ere

sess the degree of public health hazard presented by a sus-

pected carcinogen, before regulating. However, OSHA

refuses to follow the other agencies’ practice and now seeks

this Court’s endorsement for its aberrant views.

QUESTION PRESENTED

Whether OSHA must estimate the health benefits

expected to result from its issuance of an occupational

standard.

SUPPLEMENTAL STATEMENT OF THE CASE *

In 1971, OSHA adopted a standard of 10 ppm (parts

per million) for occupational exposure to benzene. 29

C.F.R. §1910.1000 Table Z-2. The present proceeding in-

volves OSHA’s issuance of a regulation lowering the stan-

dard tenfold, to 1 ppm.

OSHA’s proposal to lower the standard was based on

studies indicating benzene had caused an excess incidence

of leukemia among certain groups of workers. These studies

(summarized in the opinion of the Court of Appeals, Pet.

App. 8a, n. 13) involved exposures to benzene of 100 ppm

and above. ©

At the hearing on the proposed standard, the industry

argued 1) that at the levels of exposure represented by the

current standard (10 ppm), there is no demonstrated risk

of leukemia, and 2) that even if a risk exists, at the 10

ppm current level the risk is extremely low. In this con-

nection, one witness (Dr. Richard Wilson of the Harvard

Energy and Environment Policy Center) testified as to the

level of risk, if any, present by occupational exposure to

benzene at 10 ppm. He found it to be comparable to the

* The Supplemental Statement is not a complete statement but

rather sets forth those facts germane to the arguments presented by

the Amicus.

mer Were

risk that each individual in the population runs of dying

in any one year from drowning or from fires and hot sub-

stances. (A 171, 172). Another comparison made by Dr.

Wilson was that two weeks of exposure to benzene at 10

ppm presents a hazard equivalent to one day of air pol-

lution in Boston or Washington, one gallon of chlorinated

drinking water, or one-half bottle of wine. (A 174).

Based on OSHA’s data that about 30,000 workers now

have benzene exposures between 10 ppm and 1 ppm, Dr.

Wilson concluded that the new standard would save at

most one case of leukemia and one other cancer every six

years. (A 176). Based on OSHA’s preliminary cost esti-

mates, Dr. Wilson concluded that the standard would

cost at least $300 million for every life saved (a figure

which should be revised to approximately $240 million

in light of OSHA’s final cost estimates) and might even

cost more lives than it saved (since some construction work

would be required, and generally one life is lost for every

$20 million spent in construction). (A 81).°

In issuing its final standard, OSHA rejected the industry’s

contention that benzene had not been demonstrated to pre-

sent any risk at the level of the current standard. The court

of appeals accepted OSHA’s conclusion on this point, which

is not contested in this Court. (Pet. App. 18a).

OSHA also rejected the industry contention that it should

attempt to estimate the degree of risk presented by exposure

at the currently-required 10 ppm, and in that context assess

whether the standard was “reasonably necessary” or “feas-

5 OSHA’s final cost estimates were $187-205 million first-year

operating costs, $266 million engineering control costs, and $34

million recurring annual costs (Pet. App. 17a). At an interest rate

of 10%, the annual charge for the total first-year costs plus capital

costs ($471 million) would be $47 million. Adding the $34 million

recurring costs produces a total annual cost of $81 million. At the

rate of two lives every six years or one life every three years, this

produces a total of $243 million per life.

a ae

ible” within the meaning of sections 3(8) and 6(b)(5) of

the Occupational Safety and Health Act. 29 U.S.C.

§§652(8), 655(b) (5).

The court of appeals reversed OSHA on this point,

holding that OSHA must “estimate the extent of expected

benefits in order to determine whether those benefits bear

a reasonable relationship to the standard’s demonstrably

high costs.” (Pet. App. 19a).

SUMMARY OF ARGUMENT

We endorse and adopt the discussion in respondents’

brief, demonstrating that OSHA’s summary rejection of

any serious attempt to estimate the health benefits of the

benzene standard violates the requirements of the Occupa-

tional Safety and Health Act. |

OSHA’s position is at odds with the position taken by

the other key federal agencies with responsibility for health,

safety and environmental regulation —- Food and Drug

Administration, Environmental Protection Agency, Con-

sumer Product Safety Commission and National Highway

Traffic Safety Administration. All these agencies have

performed estimations of health benefits in connection with

their regulations, thus demonstrating disagreement with

OSHA’s position that such estimates are too uncertain to

be used for regulatory purposes. Moreover, these other

agencies have frequently performed health risk estimations

under laws that are either similar to the Occupational

Safety and Health Act, or are stricter (in the sense of

requiring regulations that assure “safety” without explicit

statutory authority to consider cost). In light of the other

agencies’ practice, OSHA cannot summarily dismiss the

view that health benefit estimates can and should be

performed.

It is argued that health risk estimations are too uncertain

to “precisely quantify” the benefits of regulation.

ao pee

However, no one has ever claimed that “precise quanti-

fication” could be provided by health risk estimation, or

is necessary for regulatory purposes. The other federal

agencies, when they perform risk estimations, treat them

as approximations, and yet have found such approximations

to be useful tur regulatory purposes. Nothing in the Occupa-

tionai Safety and Health Act requires precise quantification.

Moreover, there are at least two techniques for dealing

with uncertainty. The witnesses in this case, as well as the

other federal agencies, have compensated for the lack of

precision in health risk estimates by utilizing “conservative”

or “pessimistic” assumptions at key points of uncertainty —

i.e., taking high estimates at uncertain points in the analy-

sis — so as to avoid the danger of underestimating risk.

Another technique (which the Chamber believes to be

preferable) is to obtain from the scientists a “most prob-

able” estimate of the level of risk together with a statement

of the range of uncertainty, and then to have the decision

makers apply whatever safety factors appear to be appro-

priate in light of that uncertainty and other relevant factors.

However, OSHA does not even discuss why it rejects these

techniques as ways of dealing with the problem of un-

certainty in health risk estimation. Instead, OSHA simply

says that health risk estimation is uncertain and therefore

cannot be used. This is simply not adequate.

OSHA also contends that “cost benefit criteria” are

inconsistent with the OSH Act. However, this misses the

point. No one in this case has suggested that one must

place a price tag on human life, and then decide whether

an OSHA regulation is “worth it” in terms of that price

tag. Instead, the point is that because the resources avail-

able for occupational safety and health are limited, they

should be spent where they will have the maximum effec-

tiveness in terms of lives saved. In order to determine

whether its standards approximate their maximum life-

saving potential, OSHA must have some rough idea as to

—_ pom

what the health benefit of each standard is. Only in this

manner can OSHA achieve its statutory goal “to assure so

far as possible every working man and woman in the Nation

safe and healthful working conditions.” 29 U.S.C. §651.

Standards which save lives at the rate of only one per

several hundred million dollars spent will clearly not achieve

anything close to the maximum life-saving potential of the

available resources.

ARGUMENT

I. OSHA HAS NO VALID BASIS FOR ITS REFUSAL

TO ASSESS THE EFFECTIVENESS OF THE BENZENE

STANDARD

As respondents’ brief demonstrates, OSHA’s preamble

to the benzene standard, as well as its statements and

actions on other occasions, are so confusing that it is

impossible to determine what the basis is for its rejection

of any serious effort to estimate the health benefits of

the benzene standard.

What is clear is that OSHA misunderstands the nature

and utility of risk estimation when it claims: 1) that

the data are not sufficiently certain to “precisely quantify”

the health benefits of the regulation (Pet. App. 162a); 2)

that “cost-benefit criteria” are inconsistent with the Act

and would involve the impossible task of quantifying the

value of life (Pet. App. 162a, OSHA Br. p. 62, n.52);

and 3) that cost-benefit analysis is inappropriate as a matter

of equity, because the worker bears the risk while the con-

sumer obtains the benefit (OSHA Br. p. 47).

None of these reasons is an adequate basis for OSHA’s

position.

1) The existence of uncertainty is not a sufficient basis for refusal

to assess the health benefits of a regulation.

OSHA’s summary dismissal of the evidence concerning

the miniscule degree of health benefits to be expected from

the benzene regulation as “uncertain” and lacking “preci-

——

sion,” overlooks the fact that there are at least two ways

of dealing with the conceded uncertainties in risk estima-

tions.

In both Dr. Wilson’s testimony, as well as in the numerous

risk assessments performed by EPA and other agencies

(including EPA’s assessment of benzene), the question of

uncertainty is handled by making “pessimistic” or “con-

servative” assumptions — i.e., at points of uncertainty, the

high assessment of risk is made." In particular, EPA’s esti-

mation of benzene risk used a so-called linear model for

extrapolating risk at low exposures from historical high-

exposure data, on the ground that this model “is expected

to give an upper limit to the estimated risk.” (A 15).’

This approach to dealing with uncertainty has been

described and endorsed in the recent report of the Inter-

agency Regulatory Liaison Group (IRLG), a group con-

sisting of the CPSC, EPA, FDA and OSHA. In this report,

® An industry consultant who estimated the health benefits of

the regulation at one case every 15 to 38 years, listed three “con-

servative assumptions” in Wilson’s testimony that accounted for

Wilson’s higher estimation of risk:

a. All leukemias (not just ANLL [acute nonlymphocytic

leukemia, a form specifically associated with high benzene

exposures] ) are benezene related.

b. For every benzene leukemia there would be another can-

cer at another site in the body due to benzene exposure.

c. Benzene exposure of those currently exposed to 1 to 10

ppm benezene would be far less than 1 ppm if a new

standard were introduced.

(Lamm affidavit, A 34).

* The linear model assumes that cancer incidence varies in direct

proportion to exposure. Dr. Wilson also used this model. (A 89).

By contrast, other models assume that at low exposures the cancer

incidence is much less than a linear model would predict. OSHA it-

self appears to have endorsed the linear model in its proposal for

a generic policy for regulation of suspected occupational carcinogens.

42 Fed. Reg. 54148, 54167 (October 4, 1977).

ee yess

the IRLG specifically addresses the question of estimating

the risk of exposure to carcinogens:

Despite the uncertainties, risk estimates can be

and are being made, not only by some regulatory

agencies but by other scientific bodies. Because of

the uncertainties, however, and because of the serious

public health consequences that could ensue if the

estimated risk were understated, it has become com-

mon practice to make cautious and prudent assump-

tions wherever they are needed to conduct a risk

assessment. This approach has a precedent in other

areas of public health protection where similar prob-

lems arise because of gaps in knowledge. [Citation

omitted] Thus current methodologies, which permit

only crude estimates of human risk, are designed to

avoid understatement of the risk.

Scientific Bases for Identifying Potential Carcinogens and

Estimating Their Risks, Report of the Interagency Regula-

tory Liaison Group (IRLG) Work Group on Risk Assess-

ment, Part III, “The Quantitative Estimation of Risk,”

44 Fed. Reg. 39858, 39871 (July 6, 1979) (emphasis

added).

The Office of Science and Technology Policy, in the

Executive Office of the President, has described an alterna-

tive approach to dealing with uncertainty, which the Cham-

ber favors. Under this approach, there would be generated

a scientific estimate of the “most probable” level of risk,

together with a statement of the range of uncertainty in

the estimate. It would then be the function of the decision-

makers to apply whatever safety factors were deemed

appropriate, in light of the uncertainties in the scientific

estimate, the type of health risk involved, the social costs

of regulation, and any other relevant factors." This ap-

* The OSTP Report describes these two techniques for dealing

with the problem of uncertainty:

For each term in the equation, one could then generate a

range of potential values based upon existing data. Which

pean ee

proach is preferable to the “conservative assumption” tech-

nique, because it encourages the scientists to improve their

techniques of estimation rather than freezing the evolving

science of risk estimation into a particular format, and it

brings out into the open policy forum the choices that must

be made regarding the size of the margin of safety to be

built into regulatory decisions — rather than hiding these

choices in an often high technical scientific analysis.°

| [Footnote 8 cont. ]

of these values, however, should be entered into the equation

for an accurate asessment of overall risk? One approach is

to use the high risk estimate for each term in the equation.

This results in the most extreme estimate possible for risk

to humans. Another approach is to use the most likely value

for each term, including confidence intervals which express

the precision of each estimate, This latter approach generates

the risk estimate which has the greatest probability of being

accurate and which also makes clear the uncertainty in-

— volved.

Office of Science and Technology Policy, Executive Office of the

President, Identification, Characterization, and Control of Poten-

tial Human Carcinogens: A Framework for Federal Decision-

Making (February 1, 1979), ati p. 18.

® A recent article by Judge Bazelon, discussing the question of

tisk estimation, stresses the importance of keeping value judgments

out of the scientific component of the decision, so that they may

be explicitly acknowledged and discussed by the policy-makers. This,

we believe, is the most important reason why the “most probable”

risk approach is preferable to the “conservation assumption” tech-

nique:

The growing use of analytic tools such as cost-benefit

analysis magnifies the chance that unrecognized value judg-

ments will creep into apparently objective assessments. Even

the most conscientious effort by experts not to exceed their

sphere of competence may be inadequate to safeguard the

validity of the decision-making process. * * * *

Courts, standing outside both scientific and political de-

bate, can help to make sure that decision-makers articulate

the basis for their decisions. In the scientists’ realm — the

sphere of fact — courts can ask that the data be described,

hypotheses articulated, and, above all, in those areas where

we lack knowledge, that ignorance be confessed. In the politi-

cal realm — the sphere of values —- courts can ask that de-

ion os

Of course, it is not for this Court to choose between

various forms of risk analysis. Rather, the choices must

be made by the various regulatory agencies that deal with

health and safety issues. However, here OSHA has not

even addressed the issues, but instead has summarily stated

that it cannot accept “uncertainty.” This is simply not an

adequate basis for what OSHA has done.

In the area of health and environmental regulation, the

courts have stressed that the government must act at the

“frontiers of knowledge”; that substantial uncertainties are

necessarily involved; but that uncertain data may never-

theless be the basis for action. Ethyl Corp. v. EPA, 541

F.2d 1, 24-29 (D.C. Cir 1976) (en banc), cert. denied

426 U.S. 941 (1976). See also, OSHA’s proposal for a

generic carcinogen policy, 42 Fed. Reg. 54148, 54153

(October 4, 1977), discussing its obligation to regulate

on the basis of uncertain evidence. The OSH Act itself

emphasizes this point, by directing OSHA to set standards

on the basis of the “best available evidence.” 29 U.S.C.

§$655(b) (5). With specific reference to carcinogen risk

assessment, the IRLG report makes the same point by

stating that with present knowledge, assessment of cancer

risk provides “a rough estimate of the magnitude of the

cancer risks which may be useful in setting priorities among

carcinogens and in obtaining a very rough idea of the

[Footnote 9 cont.]

cision-makers explain why they believe that a risk is too

great to run or why a particular trade-off is acceptable.

Perhaps most important, in the nether realm, at the interface

of fact and value, courts can help assure that the value com-

' ponent of decisions is explicitly acknowledged, not hidden

in quasi-scientific jargon.

Bazelon, Risk and Responsibility, 65 A.B.A.J. 1066, 1068 (July,

1979) (emphasis added). The degree of conservativism in a regula-

tory decision is a question in the “political realm” or the “sphere

of values”, as Judge Bazelon puts it. Thus it should be kept out of

the scientific analysis, which should be confined to an estimation

of the most probable risk and the range of uncertainty.

a | ee

magnitude of the public health problem posed by a given

carcinogen.” IRLG Report, 44 Fed. Reg. at 39872.

When a “rough estimate” is that the regulation would

cost $240 million per life saved, the regulation would be

unreasonable even if the estimate were overstated by a

large multiple (and it may be understated '*). OSHA can-

not avoid the problem by summary and irrelevant references

to “uncertainty” and the impossibility of “precise quantifi-

cation.”

2) The conceded impossibility of quantifying the value of human

life is not an‘ adequate basis for refusing to assess the effec-

tiveness of a health regulation.

OSHA’s decision hints that one of its reasons for refusing

to assess the effectiveness of the benzene standard is the

impossibility of quantifying the value of human life. (Pet.

App. 163a). The same suggestions lurks in OSHA’s state-

ment that “cost benefit criteria” are impermissible under

the Act. (Pet App. 162a). The Government’s brief makes

this point more explicitly (at pp. 62-63 n. 52).

In fact, this argument totally misses the point. No one

in this proceeding has suggested that it is possible or even

desirable to place a value on human life. Instead the point

made was that, since resources are limited, the expenditure

of several hundred million on this regulation would in-

evitably mean that several hundred million would not be

available to spend on other health and safety regulations;

and that if several hundred million spent elsewhere would

save more lives, then its expenditure here would mean that

the overall health and safety effort would be less effective

and save fewer lives."

'’ Other estimates are that the regulation will save one life every

15 to 38 years, or one life every 83 years. (A 34, A 35).

'' Dr. Zeckhauser, an economist, testified that much of the cost

of the standard represents resources that would otherwise be avail-

ian EI ci

In other words, it is just because the value of life is

infinite, that it is vitally important to spend our limited

health and safety dollars in those areas where they will

save the most lives. In order to do this, we must have some

rough idea of the life-saving potential of any health or

safety regulation that is proposed.

The point was summarized in the testimony of Dr.

Zeckhauser:

(Wlhen attempting to accomplish some end such

as protecting human health, we should direct eco-

nomic resources where they accomplish the most.

If the expenditure of an additional $1,000,000 would

save five lives on the highway, but the same expen-

diture on plant safety would only save one life, then

if we chose the plant safety expenditure over the

[Footnote 11 cont.]

able for other societal purposes, including protection of health and

safety in other areas:

If a private corporation is in a 50 percent marginal tax

bracket, for example, one half of any reduction in profits

due to expenditures entailed by regulations will be borne

directly by the taxpaying public as a whole. A further frac-

tion would be borne, of course, given reduced taxes on earn-

ings eventually going to shareholders in the form of dividends

or capital gains. Of course, much if not most, of the expen-

diture will not come out of profits. Some will come out of

the wages of workers. More will be passed on in the form

of higher prices, in general the less elastic is the demand for

the product. For example, since the price elasticity for gas-

oline is low, additional costs in gasoline production will be

mostly absorbed through higher prices.

The economic costs we are talking about represent real

resources that could be devoted to other purposes in society.

For example, in computing the economic costs of the benzene

standard, we should recognize that doctors administering

tests for benzene exposure to workers will not be available

to deliver other medical services. The workers and machines

producing monitoring equipment will be taken away from

the production of other equipment that might have been

used either to save lives, or to serve any other purpose of

society.

(A 142).

Btens Ree

highway expenditure, we would in effect be sacri-

ficing lives.

(A 140).

OSHA’s suggestion that it is impossible to quantify the

value of human life is correct, but totally irrelevant. In

fact, OSHA has given no reason why it cannot and should

not attempt to maximize the effectiveness of the occupa-

tional safety and health dollar, and thus best serve the

purpose of the OSH Act “to assure so far as possible every

working man and woman in the Nation safe and healthful

working conditions.” 29 U.S.C. $651."

‘2 Dr. Zeckhauser made it plain that estimating the effectiveness

of a health regulation does not require putting a value on human

life:

I should be explicit. | am not arguing that a cost-benefit

approach be employed in formulating policy on occupational

safety and health. Such an approach would require that a

dollar price tag be attached to a life saved. The value of the

lives saved would then be weighed against the resources

invested to find the program that had the highest net value.

The major objection to this approach is that there is simply

no widely accepted precedure for determining the value of

lives in contexts such as these.

Fortunately, there is an alternative approach, called cost-

effectiveness analysis, that enables us to establish priorities

in programs for saving lives. The guiding principle of cost-

effectiveness analysis is that for whatever level of resource

expenditure we are undertaking, we should attempt to gain

the maximum possible level of effectiveness. * * * * The

criterion for effectiveness in the occupational health area

would be health or lives preserved.

(A 137).

'8 Dr. Zeckhauser conceded in his testimony that OSHA might

disclaim responsibility for consistency with other government health

and safety agencies, in terms of the level at which standards are

considered to be cost-effective. (A 140). However, Dr. Zeck-

hauser pointed out, OSHA should “make every attempt to be con-

sistent across the broad sweep of problems encompassed by occupa-

tional health and safety.” /bid. But without knowing the cost-effec-

tiveness of the benzene standard, OSHA has no way of knowing

whether the resources spent there might be more effectively spent

and save more lives in some other occupational area.

enstell cused

3) The allegedly inequitable distribution of risk and benefit is

an inadequate basis for refusing to estimate the extent of

health benefits.

The Government’s brief (at p. 47, n.38), although not

the OSHA decision, argues that cost-benefit analysis is

inappropriate because in the occupational context the

worker bears all the risk, while the consumer obtains the

benefit (in the form of a lower price). This, the Govern-

ment argues, is unlike the consumer area, where a risky

product (such as a sharp kitchen knife) at least gives the

consumer some benefit along with the risk.

However, this argument is also irrelevant. The purpose

of estimating the extent of health benefits for occupational

regulations is to maximize the number of lives saved by

occupational regulations. It is not a question of balancing

worker risk against consumer benefit. Rather, it is a question

of maximizing worker benefit. Thus the argument of an

inequitable distribution of cost and benefit is simply

irrelevant.

Il. THE PRACTICE OF OTHER FEDERAL AGENCIES

DEMONSTRATES THAT THE BENEFITS OF HEALTH AND

SAFETY REGULATION CAN BE ASSESSED WITH

SUFFICIENT CERTAINTY FOR REGULATORY PURPOSES,

AND THAT SUCH ASSESSMENT IS CONSISTENT WITH THE

PURPOSES OF HEALTH AND ENVIRONMENTAL LAWS

SIMILAR TO THE OSH ACT.

Among the federal health and environmental! regulatory

agencies, OSHA stands alone in refusing to assess the cost-

effectiveness of its regulations. The Food and Drug Admin-

istration, the Environmental Protection Agency, the Con-

sumer Product Safety Commission, and the National

Highway Safety Administration, have all found it useful

to estimate, generally in quantitative terms, the effective-

ness of their regulations. Recognizing the uncertainties in-

volved in these estimates, these agencies have nevertheless

vii! SR Naot

found them to be useful for regulatory purposes. In par-

ticular, these agencies have attacked the problem of un-

certainty by utilizing the “conservative assumption” tech-

nique — that is, resolving uncertainties in the direction

of the higher health risk, so as to avoid understatement of

risk.

The OSH Act requires OSHA to take into consideration

“experience gained under this and other health and safety

laws.” 29 U.S.C. §655(b)(5). There is no evidence that

OSHA has done so. The experience of other federal agencies

shows that health benefit estimations are sufficiently reliable

to be used for regulatory purposes; OSHA cannot dismiss

this experience with the conclusory statement that estimates

of health benefits are “extremely uncertain” and cannot

provide “precise calculations.” (Pet. App. 162a, 163a).

In addition, as we shall demonstrate, the various statutory

authorities under which other federal agencies have esti-

mated the health benefit of their regulations are frequently

similar to the OSH Act (in the sense of requiring regula-

tions to be “feasible” or “practicable”), and in some cases

are even stricter than the OSH Act (such as the Delaney

Clause).

While OSHA argues that its statute is different, because

of Congress’ overriding concern for worker safety and

health, the statutory authorities of the FDA, EPA, CPSC

and NHTSA also exhibit overriding concern for the safety

of the food supply and consumer products, for environ-

mental protection and for traffic safety. Nevertheless, these

other agencies have found that estimating the effectiveness

of their regulations is consistent with Congressional intent.

The experience of other agencies, at the very least, destroys

any claim made by OSHA that its unique view is entitled

to special deference from the courts.

We shall now summarize the practice of the FDA, EPA,

jel OO Li.

CPSC and NHTSA in estimating the health benefits of

their regulations, in each case also summarizing the per-

tinent statutory authorities under which these estimations

have been made and comparing these authorities to the

OSH Act."*

Food and Drug Administration

Despite statutory authority which, unlike the OSH Act,

on its face would appear to contain no room for risk

estimation, the FDA has estimated the magnitude of risk

in connection with its regulatory actions. Indeed, the FDA

has recently proposed to adopt risk estimation as part of

formal Agency policy.

The Delaney Anti-Cancer clause of the Federal Food,

Drug and Cosmetic Act, forbids the FDA from approving

food additives or animal drugs shown to cause cancer in

man or, by appropriate tests, in animals.’* Both the language

and the legislative history of the Delaney Clause demon-

strate that Congress thought that cost could not be a con-

sideration justifying carcinogenic food additives. Moreover,

the FDA regards the Delaney Clause as a “particularization

of the general safety sections of the act.” 44 Fed. Reg.

17070, 17074 (March 20, 1979). Thus the FDA inter-

prets its general obligation to disapprove a food additive if

the data fails to show that use of the additive “will be

safe,” '* as meaning that the additive must be “safe in all

'* The following discussion is not, of course, intended to imply

endorsement of any particular regulatory decision. Rather, the point

is that agencies other than OSHA are making an attempt to estimate

risk by some method or another, while OSHA claims that the at-

tempt cannot and should not be made.

© 21 U.S.C. §§348(c)(3)(a) (food additives), 376(b)(5)(B)

(color additives), and 360b(d)(1)(H) (animal drugs).

16 Federal Foods, Drug and Cosmetic Act §409(c)(3)(A), 21

U.S.C. §348(c)(3) (a).

nian ete

respects — including safe from carcinogenicity.” 44 Fed.

Reg. 17070 at 17074 (March 20, 1979). Cost is not a con-

sideration under these provisions.

Nevertheless, the FDA has found room in this stringent

statutory scheme to accommodate the quantitative estima-

tion of the magnitude of risk posed by carcinogenic chem-

icals. In its proposed regulation of saccharin (which was

aborted by special legislation), the FDA estimated “that

the lifetime ingestion of the amount of saccharin in one diet

beverage per day results in a risk to the individual of some-

where between zero and 4 in 10,000 of developing cancer

of the bladder.” 42 Fed. Reg. at 20001 (April 15, 1977).

The FDA estimated the number of resulting cancers on

the basis of the conservative assumption that “everyone in

the United States drank one [diet] beverage a day.” Ibid.

The FDA explained that it did not regard current scientific

methods as being capable of determining the “exact risk,”

but that “techniques are available for estimating the upper

limits of the risk.” bid.

Recently the FDA has proposed regulations which would

formalize its commitment to quantitative risk estimation.

This proposal arises in the context of the provision of the

Federal Food, Drug and Cosmetic Act regarding animal

drugs. 21 U.S.C. §360b. This provision prohibits approval

of a drug which induces cancer in man or animals, unless

“no residue” of the drug is found in edible portions of the

animal by approved methods of examination. 21 U.S.C.

§$360b(d)(1)(H). FDA’s recent proposal is to approve

those methods of examination which are sensitive enough

to detect drug residues creating no more than a one in a

million lifetime risk of cancer for the consumer. 44 Fed.

Reg. at 17111 (March 20, 1979 (proposing 21 C.F.R.

§$§500.89(f), 500.90(a)). The proposed regulations em-

ploy the technique of conservative assumptions to avoid

understatement of risk in the estimation of whether the

one-in-a-million risk is present. Thus the proposed regula-

a,

tions require “linear extrapolation” on the ground that it

is “least likely to underestimate risk”; *‘ they also assume

that “the maximum concentration of residues potentially

undetected in edible tissues is consumed every day over a

lifetime”; ** and they use various other “conservative pro-

cedures and assumptions” to help compensate for possible

underestimation. 44 Fed. Reg. at 17093 (March 20, 1979).

Another example of FDA action in estimating health

risk is found in its proposal of a temporary tolerance for

polychlorinated biphenyls (PCB’s) in fish. Section 406 of

the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §346,

authorizes the FDA to limit the quantity of environmental

contaminants in food “to such extent as [it] finds necessary

for the protection of public health.” In establishing the level

of contamination to be tolerated, FDA must take into

account “the extent to which the use of such [contaminating]

substance is required or cannot be avoided in the production

of each such article, and the other ways in which the

consumer may be affected * * *.” Jbid. In short, the

statute is much like the OSH Act, in establishing two criteria

for action: 1) health, and 2) feasibility [i.e., the extent to

which contamination “cannot be avoided” ].

In its recent action reducing the tolerance for PCB’s

from 5 to 2 ppm, the FDA estimated “the upper limit on

the lifetime risk of cancer for heavy consumers of fish

most affected by the tolerance” for the three levels suggested

by parties to the proceeding: 5 ppm, 2 ppm and | ppm.

The FDA concluded that the lifetime risk is “9.8 incidences

of cancer per 100,000 of the population, assuming the

tolerance is 5 ppm; 7.2 per 100,000 assuming the tolerance

is 2 ppm; and 4.4 per 100,060 assuming the tolerance is

1 ppm.” 44 Fed. Reg. 38330, 38333 (June 29, 1979).

1744 Fed. Reg. at 17089 (March 20,1979).

18 44 Fed. Reg. at 17092 (March 20, 1979).

a

Because of uncertainties in the data, the FDA stated that

the utility of the risk assessment is “extremely limited” and

that it did not provide a basis for “precise quantification”

of the amount of risk reduction from the reduction in PCB

levels. Nevertheless, the FDA concluded that the risk

assessment was “illustrative of the toxicological rationale

for reducing the tolerance for PCB’s in fish.” Ibid. More-

over, the FDA was able to conclude that for average con-

sumers, the additional health protection in moving from

2 ppm to 1 ppm (as some parties to the proceeding had

urged) would be “slight” and would thus not justify the

significantly greater impact that such a tolerance would

have on food availability (estimated to be approximately

$16 million). 44 Fed Reg. 38330 at 38335, 38333 (June

29, 1979).

In short, under a statute much like the OSH Act, the

FDA concluded that although its “paramount concern” is

“protection of the public health,” it must nevertheless

“ensure that the direct economic consequences of the toler-

ance (in this case, decreased sales and employment in the

commercial fishing industry) will not be disproportionate

to the increased degree of public health protection accom-

plished by the tolerance.” 44 Fed. Reg. 38333, 38334

(June 29, 1979). Pursuant to that responsibility, the FDA

performed a quantitative estimation of the degree of public

health benefit from the various proposed levels of regula-

tion, and while recognizing the uncertainties inherent in

the estimation, nevertheless utilized it in arriving at its final

judgment as to the proper level of regulation.

Environmental Protection Agency

EPA’s practice with respect to suspected carcinogens

is set forth in “Health Risk and Economic Impact Assess-

ments of Suspected Carcinogens: Interim Procedures and

Guidelines,” 41 Fed. Reg. 21402 (May 25, 1976). This

document requires that where EPA proposes to take regula-

—

tory action against a suspected carcinogen, a “risk analysis”

shall be performed, which will estimate “excess lifetime

incidence, or average excess cancer rates * * *.” IJd., at

21405. The document provides that “[t]he uncertainty in

the data and extrapolation techniques should be clearly

indicated.” /bid. In addition, EPA points out that “the risk

estimates should be regarded only as rough indications of

effect.” Jd., at 21404. Nevertheless, EPA’s policy is to

perform these risk estimates where this is consistent with

its statutory authorities.

The EPA experience confirms 1) that risk estimation for

carcinogens, while concededly not a precise science, is

nevertheless sufficiently reliable for regulatory purposes if

used with an appreciation of its limitations, and 2) that

the statutory concepts of “safety” and “feasibility” are con-

sistent with the use of risk estimation as an element in the

regulation of suspected carcinogens.

Under the Safe Drinking Water Act, 42-U:S8.C. §300f

et seq., EPA has authority to set “national interim primary

drinking water regulations.” These regulations are required

to “protect health to the extent feasible, using technology

* * * which the Administrator determines [is] generally

available (taking costs into consideration) * * *.”

§1412(a (2), 42 U.S.C. §$300g-1(a) (2). Like the OSH Act,

the overriding purpose of the Safe Drinking Water Act is

to protect health but with some allowance for feasibility."

EPA has proposed regulations governing the concentra-

tions of trihalomethanes in drinking water, on the basis of

a suspected cancer risk. 43 Fed. Reg. 5756 (Feb. 9, 1978).

These regulations were proposed at a level which EPA de-

termined to be “as low as economically and technologically

feasible.” 43 Fed. Reg. 5763. However, because the pro-

posed regulations would require very substantial expen-

ditures (annual expenditures, including capital charges,

19 H.R. Rep. No. 93-1185, 93rd Cong. 2d Sess. at 9.

sate ee

operation and maintenance, of between $57 and $145 mil-

lion), EPA also estimated the extent of the cancer risk

presented by trihalomethanes in drinking water. EPA con-

cluded that “a statistical extrapolation of the data indicates

that a life-long exposure to those contaminants in drinking

water may account for 200 excess fatalities per year na-

tionwide. * * *. Other studies would indicate even higher

risks.” 43 Fed. Reg. at 5769.

EPA’s estimates were obtained from a report of the

National Academy of Sciences, which “suggested that the

risk could be approximated with available extrapolation

techniques and, applying such techniques, derived risk es-

timates for the identified carcinogens.” 43 Fed. Reg. at

5768. Referring to the Academy’s report, EPA stated that

although “it is not possible to project with accuracy from

risk estimates to absolute numbers of cancers in a human

population”, nevertheless the “approximate impact” of the

standard had been estimated. 43 Fed. Reg. at 5761.

Section 303 of the Clean Water Act, 33 U.S.C. §1313,

requires the States to establish water quality standards

subject to EPA review and approval. Under section 303,

EPA has also performed risk estimates for carcinogens.

Section 303 provides that water quality standards must

“protect the public health or welfare, enhance the quality of

the water and serve the purposes of the Act.” §303(c) (2),

33 U.S.C. §1313(c)(2). EPA is required to establish

“water quality criteria”, which reflect “the kind and extent

of all identifiable effects on health” which may be expected

from the presence of pollutants in the water. Clean Water

Act, §304(a), 33 U.S.C. §1314(a). A standard is then

set for a particular body of water depending on the use

anticipated; if the anticipated use involves human use of

the water (drinking, recreation or eating fish from the

water), then the standard must be set to “protect the public

health” ($303(c (2)), taking into account the “water qual-

ity criteria.”

di OR la)

In a recent notice, EPA has proposed water quality

criteria designed to assist in the process of setting water

quality standards. 44 Fed. Reg. 15926 (March 15, 1979).

In the case of carcinogenic water pollutants, the EPA cri-

teria “estimate ambient water concentrations which * * *

represent various levels of incremental cancer risk.” 44

Fed. Reg. at 15929.

In the case of benzene, EPA stated that “the recom-

mended concentration of benzene in water for maximum

protection of human health is zero.” 44 Fed. Reg. at

15936. However, “{bjecause attaining a zero concentra-

tion level may be infeasible in some cases and in order to

assist the Agency and States in the posible future develop-

ment of water quality regulations,” EPA estimated “the

concentrations of benzene corresponding to several incre-

mental lifetime cancer risk levels.” Ibid. Specifically, EPA

estimated the concentrations of benzene which would pose

a lifetime risk to persons drinking the water and eating fish

taken from the water of one in 100,000, one in one million,

and one in ten million. bid.

The Federal Insecticide, Fungicide and Rodenticide Act

(FIFRA) provides that a pesticide may not be registered

if its use will result in “unreasonable adverse effects on the

environment”, a phrase that is defined as “any unreasonable

risk to man or the environment, taking into account the

economic, social and environmental costs and benefits of

the use of any pesticide.” 7 U.S.C. §§136(bb), 136a(c)

(5), 136d(b).

EPA’s present practice in the pesticide area is illustrated

by its recent actions in the cases of the pesticides amitraz

and chlorobenzilate.

EPA concluded that the use of amitraz on pears and

apples “might pose a very small risk of cancer to certain ex-

posed groups.” 44 Fed. Reg. 2678 (January 12, 1979). It

further concluded that there is “an indication of possible

— 26—\,

significant benefit from the use of amitraz on pears” but

“little or no benefit from its use on apples.” /bid. Accord-

ingly, EPA granted a conditional registration for pears

(on the basis of “substantial benefits and very small risks”)

and denied registration as to apples. 44 Fed. Reg. 32736

(June 7, 1979).

In reaching this decision, EPA estimated the lifetime

risks for individuals consuming amitraz-treated apples and

pears (two chances in a million) and the lifetime cancer

risks for workers applying amitraz to pears and apples

(one in ten thousand for apples, six in one hundred thous-

and to one in ten thousand for pears). 44 Fed. Reg. at

2681.

, Commenting on these risk estimations, EPA stated that

they are “neither scientific certainties nor absolute upper

limits, but are used by the Agency only as rough approxi-

mations of potential health risks.” /bid.

EPA recently decided to cancel the registration of chlo-

robenzilate for uses other than citrus uses in certain states;

as to these citrus uses, registration was allowed subject to

restrictions on handling of the pesticide. 44 Fed. Reg. 9548

(Feb. 13, 1979). In balancing the risks and benefits, EPA

estimated the magnitude of the lifetime cancer risk through

dietary exposure in Florida and in the rest of the United

States (the estimated risk ranges from 0.5 to 7.0 in a mil-

lion). 44 Fed. Reg. at 9556, 9557.

During the proceedings leading to EPA’s decision, an

environmenta! organization had criticized the cancer risk

assessment on the ground that it did not take into account

the heterogeneity of the human population, and possible

synergistic effects of chlorobenzilate with other chemicals

in the environment. EPA’s response was that it would use

the “conservative assumption” technique to avoid under-

estimation resulting from these uncertainties:

Because uncertainties such as synergism and heter-

pee Mam

ogeneity exist, the Agency used the most conservative

model and test results from the most sensitive group

of test animals to extrapolate to humans the cancer

risk associated with chlorobenzilate.

44 Fed. Reg. at 9553.

EPA also has the authority to establish limits on radia-

tion exposures outside the boundaries of nuclear facilities.

Reorganization Plan No. 3, 1970, §2(5). These standards

are authorized by the Atomic Energy Act, which requires

these standards to “protect health or to minimize danger

to life or property.” 42 U.S.C. §2201(b). This language

has been interpreted by the Nuclear Regulatory Commission

and by EPA to require risk-benefit balancing in the estab-

lishment of radiation protection standards. See 10 C.F.R.

§20.1(c) (NRC interpretation); 40 Fed. Reg. 23420,

23421 (May 29, 1975) (EPA interpretation).

In proposing its environmental radiation standards, EPA

calculated the expected health benefits and the costs, esti-

mating “the cost of implementing the proposed standards

for these long-lived radioactive materials to be less than

$100,000 per potential case of cancer, leukemia, or serious

genetic effect averted.” 40 Fed. Reg. at 23422. In the

final regulation, which adopted the protection levels pro-

posed, EPA rejected criticisms that its risk estimates were

either too low or too high. In particular, EPA stated that

“the weight of currently available scientific evidence sup-

ports the continued use of a linear, nonthreshold model for

deriving standards to protect public health.” 42 Fed. Reg.

2858, 2859 (Jan. 13, 1977) (promulgating 40 C.F.R.

Part 190).

Consumer Product Safety Commission

The CPSC operates under a statutory mandate to protect

the consumer from “unreasonable risks of injury” asso-

ciated with consumer products. 15 U.S.C. §2051(b) (1).

Each standard must be “reasonably necessary” to prevent

ee eae

or reduce such risk. 15 U.S.C. §2056(a). This compares

to the OSH Act, which is aimed at “material” impairment

of health and requires that standards be “feasible” and

“reasonably necessary.” 29 U.S.C. §§652(8), 655(b) (5).

The CPSC’s recent standard for walk-behind power lawn

mowers illustrates its use of risk estimation in complying

with its statutory mandate. In this standard, the CPSC

estimates that about 150,000 injuries associated with power

lawn mowers occur each year, about 60,000 of which are

treated in emergency rooms. 44 Fed. Reg. at 9992 (Fed. 15,

1979). The CPSC further breaks down the number of in-

juries expected to be saved by each of the major require-

ments of the standard; estimates the dollar savings exclu-

sive of pain and suffering; estimates the total retail price

increase resulting from the standard ($189 million); and

concludes that the standard is reasonably necessary to re-

duce an unreasonable risk of injury. 44 Fed. Reg. at 9996-7

(Feb. 15, 1979).

The CPSC also has authority under the Federal Hazard-

ous Substances Act to ban “hazardous substances”, defined

as substances which “may cause substantial persona] in-

jury or substantial illness during or as a proximate result

of any customary or reasonably foreseeable handling or use,

including reasonably foreseeable ingestion by children.”

15 U.S.C. §1261(f) (1) (A). In its notice declaring tris —

a chemical used as a flame retardant in children’s sleep-

wear — to be a banned hazardous substance, the CPSC

relied on three risk assessments concerning the potential

of tris to cause cancer. 42 Fed. Reg. 18850, 18851 (April

8, 1977). These estimates were prepared by the Com-

mission’s Bureau of Biomedical Science, by the Environ-

mental Defense Fund, and by researchers at the Depart-

ment of Biochemistry at Berkeley. The Bureau’s high

estimate was 5100 cases per million male children exposed.

The highest estimate (from Berkeley) was 17,000 cases per

lei Ss

million children exposed. /bid. In view of the very high range

of risk estimates, the Commission took emergency action.

National Highway Traffic Safety

Administration (NHTSA)

In its “Five Year Plan for Motor Vehicle Safety and

Fuel Economy Rulemaking”, NHTSA has stated that among

the factors it considers in establishing motor vehicle safety

standards are “anticipated costs to consumers and indus-

try” and “lifesaving potential of a safety standard.” 43 Fed.

Reg. 11100, 11101 (March 16, 1978). An excellent ex-

ample of NHTSA’s practice in this regard is found in its

air bag standard, which sets forth the “Fatalities Prevented

Per Year” and the “Injuries Prevented Per Year” under

each of the various occupant restraint systems under con-

sideration, with cost estimates for the full front air bag

system (one of the options chosen in the final regulation).

42 Fed. Reg. 34289, 34298-99 (July 5, 1977).”°

NHTSA’s statutory mandate is similar to OSHA’s. Like

OSHA, NHTSA’s overriding mission is to protect health

and safety: to “reduce traffic accidents and deaths and in-

juries to persons resulting from traffic accidents.” 15

U.S.C. $1381. However, the standards must be “reasonable,

practicable and appropriate.” 15 U.S.C. §§1392(f),

1391(2). Judge Stevens’ description of NHTSA’s authority

fits almost exactly to OSHA:

Although I recognize that safety is the ‘overriding

consideration in the issuance of standards’ under

this Act, the statute requires respondent to consider

20 A more detailed breakdown of NHTSA’s cost-benefit analysis

of the air bag standard is set forth at 41 Fed. Reg. 31860 (July 30,

197%. Using the highest NHTSA cost estimate, the full front air

cushion system, adopted in the final regulation, is estimated to save

lives at a cost just under $300,000 per life (leaving out of the estimate

any allocation of cost to the substantial number of injuries prevented

by the regulation).

chs elie

whether a proposed standard is ‘reasonable, practic-

able and appropriate’ before it is prescribed.

H & H Tire Company v. Department of Transportation,

471 F.2d 350, 357 (7th Cir. 1972) (Stevens, J., concurr-

ing). But unlike OSHA, NHTSA interprets this mandate

to require it to estimate the health and safety benefits of

its regulations.

CONCLUSION

Because OSHA has refused to estimate the expected

health benefits for the benzene standard, the judgment of the

Court of Appeals setting the standard aside should be af-

firmed.

Respectfully submitted,

Of Counsel: ROBERT V. ZENER

STEPHEN A. BOKAT Pepper, Hamilton & Scheetz

WILLIAM L. KOVACS 1776 F Street, N.W.

National Chamber Litigation Washington, D.C. 20006

_ Center

Attorneys for Amicus Curiae

Chamber of Commerce of the

United States

1615 H Street, N.W.

Washington, D.C. 20062

DATED: July 30, 1979