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

a

“ga Supreme Court, U. a7.

1 FILED

——$—_$__——- 1979

IN THE

Supreme Court of the United States

OCTOBER TERM, 1978

No. 78-911

NDUSTRIAL UNION DEPARTMENT, AFL-CIO,

Petitioner,

Vv.

AMERICAN PETROLEUM INSTITUTE, ETAL.,

Respondents.

No. 78-1036

RAY MARSHALL, SECRETARY OF LABOR,

Petitioner,

v.

AMERICAN PETROLEUM INSTITUTF. ET AL..,

Respondents.

On Petitions For A Writ of Certiorari To The United

States Court OF Appeals For The Fifth Cireuit

JOINT MEMORANDE MEN OPPOSTTION FOR RESPONDENES

a

THE RUBBER MANE RB ACTURERS ASSOCTATIONOING OAT th..

AMERICAN PETROLEUM INSTIPUTEL ET tL.

CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION,

bt Dt PONT DE NEMOURS AND COMPANY. AND

THE INDEPENDENT PE TROLEL VM ASSOCIATION OF AMERICA

(RELATING TO THE DERMAL CONTACEH Isst B)

| Counsel Listed Inside Front Cover|

January 26, 1979

EET ERT NS aE ae an an A TTR TE.

PRESS OF BYRON S. ADAMS. INC, WASHINGTON, D.C

CHARLES F. LETTOW

JOHN C. MURPHY, JR.

Cleary, Gottlieb, Steen & Hamilton

1250 Connecticut Avenue, N.W.

Washington, D.C. 20036

Attorneys For The Rubber

Manufacturers Association, Inc., Et Al.

EDWARD W. WARREN

ARTHUR F. SAMPSON, III

Kirkland & Ellis

1776 K Street, N. W.

Washington, D.C. 20006

Attorneys For The American Petroleum

Institute, Et Al

ROBERT L. ACKERLY

MARILYN LYNG O'CONNELL

Sellers, Connor & Cuneo

1625 K Street, N.W.

Washington, D.C. 20006

Attorneys For Chemical Specialties

Manufacturers Association

ROBERT R. BONCZEK

JOHN F. DICKEY

E.I. du Pont de Nemours &

Company

Wilmington, Delaware 19898

Attorneys For E.1. du Pont de

Nemours & Company

HAROLD B. SCOGGINS, JR.

JAMIE REPLOGLE

Independent Petroleum Association

of America

1101 Sixteenth Street, N. W.

Washington, D. C. 20036

Attorneys For The Independent

Petroleum Association Of America

TABLE OF CONTENTS

Page

Seen MN, Coe eg pial oil eet gears i eee bs 2

hoy ey. AM IE DG ACA Oe eter panel aA ES 3

MUEBTION FRESCO eb ele helen 3

STATUTE AND REGULATION INVOLVED .. 3

1. The Occupational Safety and Health Act

eS ENs Ga mer phar Ara ynaett= ba phy ohe Cop RED 3

2. Permanent Standard for Occupational

Exposure to Benzene................ 5

STATEMENT (0 THE CAGE... eee.

A. The Original Benzene Standard ......

B. The Amendment To The Standard .... 15

C. Judicial Proceedings And The Decision

| SAR pe an I acral as hi tad ae 19

REASONS FOR DENYING THE WRIT ......... 23

I. The Evidentiary Question Stated By

OSHA Is Purely Hypothetical; The

Facts And Record Demonstrate That

There Is No Evidentiary Issue In This

Case Worthy Of This Court’s Consid-

WN ea aie iaekals ebiahns 23

11. OSHA’s Own Failure To Provide Ade-

quate Notice Of Issues In The Rule-

making Inhibited Orderly Development

Coe RU MO iis sah ata tives eal a os 26

III. There Is No Conflict—The Evidentiary

Issue Before The Court Of Appeals Was

And Is A Matter Of First Impression 30

CN 05) Siete er els ene dct aes 31

il

Page

APPENDIX 1, (H. I. Maibach, M.D., Percutaneous

Penetration of Benzene and Benzene Contained

in Solvents Used in the Rubber Industry (January

TAB. TINA CIR tir aie a er Re UL La la

TABLE OF AUTHORITIES

Page

CASES:

Burlington Truck Lines v. United States, 371

ee: Ay TROD SAO te ace suse Be

Citizens To Preserve Overton Park v. Volpe, 401

Ue Me a), | Eman

Dry Color Manufacturers’ Association, Inc. v.

Department of Labor, 486 F.2d 98, 104 n.8

(3d Cir. 1973) ..... Sh Gta pairs rae 22

N.L.R.B. v. Metropolitan Life Insurance Co., 380

U.S. 438, 443-444 (1965)... 22

United States v. Allegheny-Ludlum, 406 U.S. 742,

SUPORTE ABOTED ois ese YP RAeU Vera . 3

STATUTES AND RULES:

Judicial Code, 28 U.S.C. § 1254(1) ...... oa @

Occupational Safety and Health Act of 1970

Re oe ee ae

Section 2(b), 29 U.S.C. § 65l(b) .......... 3,4

Section 3(8), 29 U.S.C. § 652(8) ........ 4,22

Section 6(b), 29 U.S.C. § 655(b) .......... 30

Section 6(b)(5), 29 U.S.C. § 655(b\(5) . 4, 21, 23, 25

Section 20(a), 29 U.S.C. § 669(a) .......... 30

Section 20(a)(1), 29 U.S.C. § 669(a)(1) 5

Section 20(c), 29 U.S.C. § 669(c) ......... 5,30

REGULATIONS:

29 C.F.R. § 1910.1028(b) .... 22.022... 12

29 C.F.R. § 1910.1028(c)(2) .... eye

29 C.F.R. § 1910.1028(h) ....... oo

29 C.F.R. § 1910.1028(k) ............. J 43

29 C.F.R. § 1910.1028(k)(2)-(4)............ 12

ce

iv IN THE

MISCELLANEOUS: Supreme Court of the United States

42 Fed. Rey. 22,515 (May 3, 1977) ...... ) OCTOBER TERM, 1978

42 Fed. Reg. 27,451 (May 27, 1977)... . i)

42 Fed. Reg. 27,452 (May 27, 1977) 9 Ne. SH0081

‘ C ‘ °

42 Fed. Reg. 27,454 (May 27, 1977) .. . i oa

2 Fed. Reg. 27,460 (May 27, 1977) ) 9 me pel

pe ge iy 27,470 (May 27, 1977) |. ae.) _ INDUSTRIAL UNION DEPARTMENT, AFL-CIO,

43 Fed. Reg. 5917-5970 (February 10, " Petitioner,

ete) ie ie eiiy, : AMERICAN PETROLEUM INSTITUTE, ETAL

43 Fed. Reg. 5920 (February 10, 1978) . . 13 Tide ak

: : Respondents.

43 Fed. Reg. 5948-5949 (February 10,

1978) 3 Faossatsh ih ts 1g No. 78-1036

43 Fed. Reg. 5963-5966 (February 10,

1978) Oe eee |

43 Fed. Reg. 12,890-12,891 (Marcn 28, RAY MARSHALL, SECRETARY OF LABOR,

1978) pone» a ae Petitioner,

43 Fed. Reg. 12,891 (March 28, 1978) .... 16 V.

43 Fed. Reg. 13,561-13,563 (March 28, AMERICAN PETROLEUM INSTITUTE, ETAL.

1978) 9 oot, odes ats See ant | Respondents.

43 Fed. Reg. 27,961-27,971 (June 27,

1978) Beare Rtdsetene gine 4 6

43 Fed. Reg. 27,968 iJune 27, 1078)"..)...\° 38 On Petitions For A Writof Certiorari To The United

43 Fed. Reg. 27,970 (June 27, 1978) . . na States Court OF Appeals For The Fifth Cireuit

Statement of March &, 1978 .... eee

JOINT MEMORANDE VEN OPPOSTTION FOR RESPONDENTS

THE RE BBER MANE RACTERERS ASSOCIATION. ING ET th..

AMERICAN PE TROLED WINSTITDUTEO ET Oh.

CHEMICAL SPECIALTIES MANE RACTE RERS ASSOCIATION,

ELD PONT DE NEMOLRS AND COMPANY. AND

THE INDEPENDENT PETROLEDL VM ASSOCIATION OF AMERICA

(RELATING TO THE DERMAL CONDAGCT ISst )

2

Respondents The Rubber Manufacturers Associa-

tion, Inc., and six member companies,' the American

Petroleum Institute, et al.,? Chemical Specialties Man-

ufacturers Association, E.1. duPont de Nemours and

Company, and The Independent Petroleum Associa-

tion of America oppose the issuance of a writ of cer-

tiorari to review the judgment of the United States

Court of Appeals for the Fifth Circuit entered in this

case on October 5, 1978."

OPINION BELOW

The opinion of the court of appeals is reported at

581 F.2d 493. (App. la-33a.)' Judge Clark wrote the

opinion for a panel of the court comprised of Judges

Coleman, Clark and Tjoflat.

''The six companies are The Armstrong Rubber Company, The

Firestone Tire & Rubber Company, The General Tire & Rubber

Company, The B.F. Goodrich Company, The Goodyear Tire &

Rubber Company, and Uniroyal, Inc.

‘The petroleum industry respondents included in the group

with the American Petroleum Institute are named in the concur-

rently-filed companion Joint Memorandum In Opposition, at 2

nl.

‘This memorandum focuses on the second question presented

for review in No. 78-1036.

See the companion Joint Memorandum in Opposition for re-

spondents’ discussion in opposition to issuance of a writ of cer-

tiorari based upon the question posed in No. 78-911 and upon the

first question presented in No. 78-1036. These similar questions

focus upon the airborne exposure limit but bear upon each of the

provisions in the benzene standard.

‘“ App.” refers to a separately bound Appendix to the Petition

in No. 78-911.

nan

JURISDICTION

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

255a) was entered on October 5, 1978. Petitioner Sec-

retary of Labor has delegated his responsibility for

administering the Occupational Safety and Health

Act of 1970, 29 U.S.C. § 651 et seq. (the ‘‘Act”’), to

the Assistant Secretary of Labor for Occupational

Safety and Health (“Occupational Safety and Health

Administration” or “OSHA”’). The jurisdiction of this

court is invoked under 28 U.S.C. § 1254(1).

QUESTION PRESENTED®

1. Whether OSHA, in incorporating in the benzene

standard a ban on dermal contact with liquids con-

taining even small or trace amounts of benzene, was

entitled to rely solely on outdated and inconclusive

data while failing to obtain readily available evidence

based upon “research, demonstrations, [and] experi-

ments” as required by 29 U.S.C. § 655(b)(5).

STATUTE AND REGULATION INVOLVED

1. The Occupational Safety and Health Act of

1970,

Section 2(b) of the Act, 29 U.S.C. § 651(b), provides

in part:

(b) The Congress declares it to be its purpose

and policy, through the exercise of its powers to

‘As noted supra at 2 1.3, OSHA has set forth two questions

which it believes are presented by this case, and this response

addresses only the second of those questions. Because OSHA's

statement of the second question is inadequate, it has been re-

stated.

4

regulate commerce among the several States and

with foreign nations and to provide for the gen-

eral welfare, 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 ....

Section 3(8) of the Act, 29 U.S.C. § 652(8), provides:

(8) The term “occupational safety and health

standard” means a standard which requires con-

ditions, or the adoption or use of one or more

practices, means, methods, operations, or proc-

esses, reasonably necessary or appropriate to

provide safe or healthful employment and places

of employment.

Section 6(b)(5) of the Act, 29 U.S.C. § 655(b)(5), pro-

vides:

(5) The Secretary, in promulgating standards

dealing with toxic materials or harmful physical

agents under this subsection, shall set the stand-

ard 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 haz-

ard dealt with by such standard for the period of

his working life. Development of standards under

this subsection shall be based upon research,

demonstrations, experiments, and such other in-

formation 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 sci-

5

entific data in the field, the feasibility of the

standards, and experience gained under this and

other health and safety laws. Whenever practic-

able, the standard promulgated shall be ex-

pressed in terms of objective criteria and the

performance desired.

Section 20(a)(1) of the Act, 29 U.S.C. § 669(a)(1),

provides in part:

(al) The Secretary of Health, Education, and

Welfare, after consultation with the Secretary fof

Labor] and with other appropriate Federal de-

partments or agencies, shall conduct (directly or

by grants or contracts) research, experiments,

and demonstrations relating to occupational

safety and health. . ..

Section 20(c) of the Act, 29 U.S.C. § 669(c), provides:

(c) The Secretary is authorized to enter into

contracts, agreements, or other arrangements

with appropriate public agencies or private or-

ganizations for the purpose of conducting studies

relating to his responsibilities under this Act. In

carrying out his responsibilities under this sub-

section, the Secretary shall cooperate with the

Secretary of Health, Education, and Welfare in

order to avoid any duplication of efforts under

this section.

2. Permanent Standard for Occupational Exposure to

Benzene. The benzene standard (App. 34a-66a) and the

accompanying preambular statement (App. 67a-251a)

as originally issued by OSHA are found at 43 Fed.

Reg. 5917-5970. The amendment to the benzene

6

standard (App. 252a) and the accompanying pream-

ble® were published at 43 Fed. Reg. 27,961-27,971.

STATEMENT OF THE CASE

This case presents questions concerning two sepa-

rate and essentially unrelated provisions of OSHA's

Permanent Standard for Occupational Exposure to

Benzene (the ‘“‘benzene standard”’). The first of these

provisions regulates airborne exposure to benzene and

requires employers to assure that no employee is ex-

posed to an airborne concentration of benzene in ex-

cess of 1 part benzene per million parts of air (1 ppm)

as an 8-hour time-weighted average. The second of the

provisions operates independently of the airborne ex-

posure limit and bans dermal contact with benzene or

substances containing even small amounts of ben-

zene.’ (29 C.F.R. § 1910.1028(c)(2); App. at 36a.)

Respondents Rubber Manufacturers Association

and six individual rubber companies (collectively

‘rubber companies’’), supported by and joined in this

brief by other industry respondents,* are affected pri-

* The preamble to the amendment has not been reprinted as

part of the Appendix to the Petition in No. 78-911.

'A related provision of the standard requires employees to

wear protective clothing and equipment where dermal or eye

contact may occur. 29 C.F.R. § 1910.1028(h); App. at 42a. As

described more fully below, the extent of the ban on dermal

contact has varied since the issuance of the permanent benzene

standard. The standard as originally adopted by OSHA prohib-

ited all dermal contact with any liquid containing any amount of

benzene. In the first five months following adoption of the stand-

ard, OSHA twice modified the ban on dermal contact.

* See supra at 2 n.3.

ene

STi sete os -

7

marily by the second of the two major provisions of

the benzene standard—the ban on dermal contact.

Rubber companies manufacture tires and a range of

other products’ from natural and synthetic rubber. In

doing so, they use petroleum solvents, cements and

other materials which contain benzene in small or

trace amounts (less than 1.0 percent). Rubber com-

pany production operations require dermal contact

with these solvents, cements and other materials.'°

The record evidence relating to the dermal contact

provisions of the standard is largely independent of

the record evidence bearing on the airborne portions.

In carrying out its review, the court of appeals made

a separate analysis of the record for each of these two

key provisions. Accordingly, the statement of the case

which follows discusses the procedural posture of OS-

HA’s rulemaking and the record evidence insofar as

they relate particularly to the dermal contact issue.'!

* These other products include such diverse items as tubes,

hoses, v-belts, conveyor belts, tennis balls, adhesives, cements,

tennis shoes, shoe products, and health and hospital products.

See, e.g., Comment of Rubber Manufacturers Association (May

12, 1978), Amend. Ex. 46-59, at 3-4. (For an explanation of the

form of citation to the original record, see infra n. 11.)

Td.

'' The original record has been transferred to this Court from

the United States Court of Appeals for the Fifth Circuit. Refer-

ences in this memorandum to the record will be to the original

record. Where available, accompanying citations to the Appendix

to the Petition in No. 78-911 will also be supplied.

References in this memorandum to the transcript of the hearings

held by OSHA in 1977 will be to ‘Tr.’’ References to the other

documentary portions of the rulemaking proceedings on the orig-

inal standard will follow the form set out in OSHA's certification

of the administrative record to the court of appeals.

8

The statement of the case especially as it concerns

the airborne issues is set out in the other joint mem-

orandum being filed concurrently by the same re-

spondents.

A. The Original Benzene Standard

Benzene is a substance to which most of us in the

United States are exposed every day. It is found

throughout our society, e.g., in ambient air and in

minute quantities in water supplies throughout the

country.'? Notably, benzene is present in gasoline, es-

pecially unleaded gasoline, at levels ranging up to 2-3

percent. Benzene also is a useful building-block inter-

mediate chemical in its own right. It is present in

trace quantities in all petroleum-based products, in-

cluding essentially all plastics, synthetic fibers, petro-

leum-based fuels, cleaning fluids, solvents, deter-

Hearings were also held by OSHA in May 1978 on a proposed

amendment to the standard. See infra at 15-19. References to

those subsequent hearings will be to ‘‘Amend. Tr.’’ References

to the documentary portions of the further administrative record

will similarly follow the form used in OSHA's certification of

this further record to the court of appeals, except that OSHA's

designations will be preceded by ‘‘Amend.”’ as in ‘Amend. Ex.

0-00."

'* Indeed, OSHA itself found that ‘Benzene has been detected

in foods such as roasted peanuts, soybeans, chicken, meat, cod-

fish, tomatoes, pineapples, strawberries and cheddar cheese.”

OSHA, Final Environmental Impact Statement on a Standard

for Occupational Exposure to Benzene (January 1978), Ex. 223,

at 8-9. See also Amend. Tr. 129-130; Testimony of Dr. Herman

Kraybill (National Cancer Institute), Ex. 84.B-18, App. A at 2-3,

Tr. 1176, 1192-1194; Testimony of Edward Baier (National In-

stitute for Occupational Safety and Health), Ex. 84.A at 7, Tr.

749-750, 1131.

NW sont a els a

9

gents, pesticides, and a vast range of other chemical

products.

On May 3, 1977, OSHA issued an Emergency Tem-

porary Standard (““ETS’’) for Occupational Exposure

to Benzene. (42 Fed. Reg. 22,515.) The ETS exempted

from its coverage mixtures containing 1.0 percent

benzene or less. Respecting dermal contact, the effect

of that exemption was to permit employees to have

dermal contact with mixtures containing 1.0 percent

benzene or less."*

Thereafter on May 27, 1977, OSHA issued a Notice

of Proposed Rulemaking for a permanent standard

for benzene. (42 Fed. Reg. 27,451.) The proposed

standard, like the ETS, contained a volume percent-

age exclusion, exempting from the standard’s cover-

age work operations where ‘‘the only exposure to ben-

zene is from liquid mixtures containing 1% (0.1% after

one year from the effective date of this standard) or

less of benzene by volume, or the vapors released from

these liquids.”’ (/d. at 27,460.) The preamble to OS-

HA's proposed permanent standard identified a ‘‘ma-

jor’’ issue in the rulemaking proceeding to be ‘“‘wheth-

er the final standard should exempt certain specified

operations from its coverage.” (/d. at 27,452.) On this

issue OSHA proposed:

[A] step-down procedure exempting those work-

places in which employee exposure to benzene

occurs only from liquids containing benzene of

1% or less with a reduction of that percentage to

0.1% benzene after 1 year. (/d. at 27,454.)

' As noted in OSHA's Petition at 4, the ETS was challenged

in judicial review proceedings, stayed, and never brought into

effect.

10

Comments submitted by the Rubber Manufactur-

ers Association and individual rubber companies pro-

tested the proposal to lower the liquid volume exclu-

sion from 1.0 percent to 0.1 percent a year after ic-

suance of the standard. Those comments questioned

the availability to rubber companies of solvents con-

taining only 0.1 percent of benzene.'* The Rubber

Manufacturers Association also offered a proposed

definition of ‘liquid benzene’ that would have avoid-

ed the problems now presented by the dermal contact

sections.'* OSHA’s proposed ‘‘step-down”’ procedure

underscored its focus upon a percentage exclusion,

however, and parties submitting comments on the

proposed standard understandably shared that focus.

Submitted comments generally assumed that some

percentage exclusion, not lower than 0.1 percent,

would be adopted in the final regulation. '*

‘4B. F. Goodrich Comments (June 27, 1977), Ex - 3; Rub-

ber Manufacturers Association Comments (June 27, 1977), Ex.

6-59, at 1, 3; Firestone Comments (June 27, 1977), Ex. 6-48.

'’ Rubber Manufacturers Association Comments (June 27,

1977), Ex. 6-59, at 1, 3.

'6 Statement of Tyler (SOHIO), Tr. at 1815-1818; Rubber Man-

ufacturers Association Comments (June 27, 1977), Ex. 6-59; Fire-

stone Comments (June 27, 1977), Ex. 6-48; Du Pont Comments

(June 27, 1977), Ex. 6-46.

The reasonableness of this assumption as to the intended scope

of the standard is confirmed by OSHA’s own actions during its

informal hearings on the rulemaking proposal. For example, OS-

HA’s economic consultant, Arthur D. Little, Inc., was explicitly

directed by OSHA to carry out a study of the standard’s feasi-

bility on the assumption that the standard would include the 1.0

percent exclusion. Tr. at 507-509. Because OSHA had directed

its own consultant to ignore small or trace levels of benzene in

mixtures, there was no reason to believe that OSHA was even

interested in mixtures containing amounts of benzene below the

proposed exclusion level.

. otte com eal

1]

During OSHA's informal hearing on the proposed

benzene standard, limited evidence was introduced on

the dermal contact issue. In proposing the standard,

OSHA had candidly admitted that ‘‘studies indicate

benzene is not readily absorbed through intact skin.”’

(42 Fed. Reg. at 27,470.) No significant contrary evi-

dence regarding skin absorption was presented during

the rulemaking proceeding. Dr. Howard Maibach,'’

the only witness participating in the rulemaking who

reviewed in detail the state of scientific knowledge

regarding skin absorption of benzene, concluded that

“the overwhelming majority of the observations sug-

gest that benzene does not penetrate the skin.’’'* (Tr.

at 2465.)

During the rulemaking proceeding, Dr. Maibach re-

peatedly testified that modern analytic techniques

can produce conclusive answers regarding whether

benzene is absorbed through skin and the rate of any

absorption; whether absorption is affected by multiple

exposures; and whether any absorption is harmless or

less harmful than inhalation of benzene. (Tr. at 2465-

2468.) The necessary tests could have been completed

in six to twelve weeks. (Tr. at 2487.)

'’ Professor of Dermatology, University of California Medical

Center.

'* The single reference in the record suggesting that benzene

can be absorbed through the skin was made by Dr. Douglas

Smith of the National Institute for Occupational Safety and

Health. Without discussing the relevant scientific literature, cit-

ing any direct data, or in any other manner suggesting the basis

for his opinion, Dr. Smith remarked:

Apparently it [benzene] is not absorbed through the skin at

the same rate as toluene and xylene but it nonetheless can

be absorbed. (Tr. at 860.)

12

Nearly six months after the close of that hearing

OSHA published the permanent benzene standard. In

contrast to both the ETS and the proposed standard,

the permanent standard provided no exclusion what-

soever for mixtures containing trace amounts of ben-

zene. The permanent standard banned all dermal con-

tact with liquid mixtures containing any amount of

-benzene (29 C.F.R. § 1910.1028(c)(2)),'* and required

employees to wear protective clothing and equipment

where dermal exposure might occur (29 C.F.R.

§ 1910.1028(h)). It also required employers to affix

“Cancer Hazard”’ labels on all containers of all prod-

ucts containing any amount of benzene (29 C.F.R.

§ 1910.1028(k)).

In announcing the permanent standard, OSHA of-

fered no explanation for its last-minute and unexpect-

ed elimination of the exclusion for liquid mixtures

with 1.0 percent or less benzene. OSHA imposed the

draconian prohibition against dermal contact even

though in the preamble announcing the permanent

'’ As noted supra at 8 n.12, benzene is present in minute quan-

tities in water supplies throughout the country, as well as in

everyday foods and elsewhere throughout our society. Conse-

quently, as initially promulgated OSHA's standard would have

produced absurd results. It would have imposed a ban on drink-

ing water in workplaces in the United States and would have

required that all workplace drinking fountains bear a ‘‘readily

visible and legible’’ label stating: “CAUTION - CONTAINS

BENZENE - CANCER HAZARD". 29 C.F.R. § 1910.1028(b),

(c)(2), and (k)(2)-(4), as originally issued, 43 Fed. Reg. at 5963-

5966; App. 34a-48a. See also the opinion of the court of appeals,

581 F.2d at 500; App. 12a. Solid materials would also have been

affected. For example, the same label would have been required

to be affixed to all cans of tennis balls made in the United States,

but not to cans of tennis balls manufactured abroad.

ed ee eae ee)

13

standard, it acknowledged that “‘[iJnhalation is the

primary route of entry of benzene in man.” (43 Fed.

Reg. at 5920; App. 78a.) OSHA further conceded that

it did not know whether benzene is absorbed through

intact skin:

The record evidence on the effect of liquid benzene

on the eyes or the skin is extremely limited. No

scientific data as to the effects of benzene on the

eyes was presented during the rulemaking pro-

ceeding. The few studies of skin effects on animals

and humans are not definitive as to the extent of

benzene that is absorbed through the intact skin

or as to the comparative rate of absorption

through damaged skin. (/d. at 5948-5949; App.

193a (citations omitted) .)”°

Rubber companies filed a request with OSHA for a

stay of the dermal contact provisions and certain oth-

er sections of the standard.*' That request focused

particularly on the fact that it was not feasible for

rubber companies to continue their manufacturing op-

erations in compliance with the ban on dermal con-

tact. Manufacturing operations for tires, tennis balls,

v-belts, conveyor belts, hoses and other products nec-

*OSHA’s Petition incorrectly suggests that OSHA banned

dermal contact only with liquids containing more than 0.5 per-

cent benzene. Compare OSHA's Petition at 7 with id. at 5 n.4.

To the contrary, on the basis of this limited ‘‘evidence’’", OSHA

initially imposed a tetal ban on dermal contact with liquids con-

taining any amount of benzene.

* Other industry respondents filed motions with OSHA for a

stay of the effectiveness of the entire standard.

14

essarily involve dermal contact with solvents contain-

ing small amounts of benzene (less than 1.0 percent).”

The manufacture of tires, for example, involves the

use of petroleum solvents as tackifying agents essen-

tial to the tire building process. (Amend. Tr. 87-89,

160-167, 185-186.) Layers of materials (‘‘plies’’)

swabbed with solvent are manually built up to con-

struct tires. (/d.) To achieve the precision of attach-

ment and adhesion critical for tire uniformity and

compliance with government standards, full use and

dexterity of the workers’ hands is required. (/d.) Skin-

tight, impervious gloves cannot be used; they would

dissolve or become tacky upon contact with petroleum

solvents and actually lead to greater hazards and ex-

posure. (Amend. Tr. 78, 89, 133.) Hand creams or

‘‘barrier creams”’ also are not a feasible option to pre-

vent dermal contact with petroleum solvents.

(Amend. Tr. 133, 168-169.)

—

- “rs are no suitable substitutes in tire building

and -:her rubber company operations for petroleum

solve: s which contain small amounts of benzene as

a contaminant. (Amend. Tr. 115-116.) Despite repeat-

ed requests by rubber companies, it is not possible to

obtain from suppliers solvents which do not contain

trace amounts of benzene. (Amend. Tr. 87, 153, 168,

186-187, 208-209, 213.) While the benzene content of

such solvents has declined in recent years, it remains

well above 0.1 percent and in some instances exceeds

0.7-0.8 percent. (Amend. Tr. 131, 151-153, 175-178,

** See Request for Stay on Behalf of Rubber Companies (March

3, 1978), Amend. Ex. 27-III-E-1 and E-2; Rubber Manufacturers

Association Comments dated May 12, 1978, Amend. Ex. 46-59,

at 3-9; Amend. Tr. 78-82, 87-89, 132-133, 160-167, 212.

15

196-197.) Very substantial quantities of solvents, ex-

ceeding 110 million gallons annually, are purchased

by rubber companies throughout the United States

from a number of suppliers. Moreover, the benzene

content of solvents varies among suppliers, among

different plants of the same supplier, and even among

different shipments from the same plant of the same

supplier. (Amend. Tr. 117-118, 175-178, 200-201, 207-

209.)

In response to the various requests for stay, on

March 8, 1978 OSHA informed rubber companies and

other industry respondents that it would grant a stay

of the standard as to “work operations where the sole

exposure to benzene is from mixtures containing 0.1

percent or less benzene.” (OSHA, Statement of March

8, 1978, 42.)

B. The Amendment To The Standard

Thereafter on March 28, 1978, OSHA published a

notice of its limited stay of the standard’ and of a

rulemaking proceeding to amend the standard. (43

‘ed. Reg. 12,890-12,891.)** That notice proposed an

3 The entire benzene standard had previously been stayed by

the court of appeals.

** OSHA further modified the scope of the standard by means

of a “‘correction’’ document published March 31, 1978. 43 Fed.

Reg. 13,561-13,563. Among other changes, OSHA “corrected”

the preamble to the standard so as to exclude from the standard

solids containing benzene (other than pure solid benzene, which

generally exists only in scientific laboratories). One effect of this

“correction’’ was to exclude cans of tennis balls and boxes of

tennis shoes from the requirement that they be labeled as a

“CANCER HAZARD". See supra, at i2 n.19.

16

amendment to exclude from the standard liquid mix-

tures containing 0.1 percent or less of benzene. The

announcement sought to limit the points at issue to

nine specific questions, and interested persons were

instructed to address the proposed percentage exclu-

sion only as it related to ‘airborne concentrations’’ of

benzene. (/d. at 12,891.) Notwithstanding OSHA’s

lack of evidence as to whether dermal contact with

liquid mixtures containing small amounts of benzene

constituted a health hazard, OSHA sought no evi-

dence on that issue.

Moreover, OSHA refused to consider such evidence

in connection with the rulemaking even after the rub-

ber companies expressly warranted to the Agency

that Dr. Maibach was conducting a study of issues

relating to dermal exposure to benzene. In short, OS-

HA actually rejected the rubber companies’ proffer of

such highly relevant, and even crucial, evidence.

During the new rulemaking proceeding, the rubber

companies informed OSHA explicitly that Dr. Mai-

bach had been commissioned to conduct the absorp-

tion test. (Amend. Tr. 70.) Dr. Maibach’s own descrip-

tion of his testing program was received into evidence

at the hearing. (Amend. Tr. 71-73.)”° Nevertheless,

Grover Wrenn, OSHA's Director of Health Standards

Programs, flatly stated at the hearing that OSHA

would not await the results of such a study even

though these results could be made available to it

within 180 days. (Amend. Tr. 20.)”® Mr. Wrenn further

*® Dr. Maibach was unable to appear in person because of his

teaching schedule. Amend. Tr. 71.

* OSHA's Petition states that “it is surprising that industry

parties, with so much money at stake, have not engaged physi-

cians to perform the experiment and furnish the results to the

ok a 5

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17

testified that OSHA did not have any independent

plans to obtain data to determine whether a hazard

existed from dermal exposure to mixtures containing

small amounts of benzene. (Amend. Tr. 18.)?’

In late afternoon on the day before oral argument

in the court of appeals, OSHA announced the amend-

ments to its benzene standard. (581 F.2d at 496 n.4;

App. 2a n.4.) OSHA exempted liquid mixtures con-

taining 0.5 percent or less benzene from the provisions

of the standard for three years, and thereafter mix-

Secretary.’’ OSHA's Petition at 20 n.11. That statement is in-

correct. As stated in the text, OSHA was informed of Dr. Mai-

bach’s study at the hearing on the proposed amendment to the

standard. Moreover, the opinion of the court below specifically

refers to Dr. Maibach’s study. 581 F.2d at 508 n.27; App. 27a

n.27.

Dr. Maibach has now in fact completed his fundamental study

of the absorption of benzene with rhesus monkeys. A report of

Dr. Maibach’s study was submitted by rubber companies to

OSHA on January 22, 1979. It is reprinted infra, as Appendix 1

to this Joint Memorandum. In important part, Dr. Maibach’s

study found that only minute amounts of pure benzene or ben-

zene contained in rubber solvents were absorbed through the

skin. Dr. Maibach’s report states that in a topical application of

rubber solvent containing a small amount of benzene, the ‘‘actual

penetration was 0.0805 + 0.0119% of the benzene portion

(0.36%) of the applied dose, or 0.00029% benzene in relationship

to the solvent applied.” Jnfra Appendix 1 at 9a.

*’ During the rulemaking proceeding rubber companies strong-

ly urged OSHA to provide in the standard for an ‘action level”

that wouid permit dermal contact with liquids containing small

amounts of benzene, similar in concept to the “action level’’ now

in the standard for airborne exposures to low levels of benzene.

Amend. Tr. 67-68, 76, 95, 98-99, 132-134, 136-137, 159, 170, 188-

191, 212-215. This suggested solution was similarly ignored by

OSHA. See, e.g., Testimony of Mr. Wrenn, Aniend. Tr. 62-63.

18

tures containing 0.1 percent or less benzene.”* In doing

so, OSHA recognized that the dermal contact provi-

sions of the benzene standard posed a “‘real prob-

lem’’** for rubber companies:

[W]ith respect to dermal contact, avoidance of

skin exposure is feasible for workers in most in-

dustrial sectors simply by the use of suitable

protective clothing, such as impermeable gloves.

OSHA recognizes that in tire-building, the record

evidence shows that at present there are no suit-

able methods available to prevent skin contact

with solvents containing a small amount of ben-

zene. (43 Fed. Reg. at 27,968 (emphasis added).)

OSHA nonetheless chose not to modify the dermal

contact provisions, but rather to rely on an across-

the-board percentage exclusion providing a modicum

of temporary relief for three years.*® For the longer

term, OSHA speculated as to the possibility of in-

creased production of solvents containing less than

0.1 percent benzene and other unspecified technolog-

** OSHA also exempted certain previously-packaged mixtures

from the standard’s labeling provisions.

*® OSHA's Supplemental Memorandum in Opposition to Stay

(April 12, 1978), at 67.

* Rubber companies can in most cases obtain solvents at or

less than the 0.5 percent level for use in their Eastern, Southern —

and Midwestern tire and other manufacturing plants. Even for

these plants, the companies often are close to or at the 0.5 percent

level without any margin for deviation. Amend. Tr. 117, 131,

166-168. For West Coast plants, however, the 0.5 percent level

could not be met, since in some instances suppliers could only

meet a limit of 0.7 percent benzene in suitable solvents. Amend.

Tr. 176.

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19

ical developments, without citing any factual basis

and in the face of substantial evidence to the contrary.

(43 Fed. Reg. at 27,970.) OSHA cited no new health

evidence in support of the amendment.

C. Judicial Proceedings And The Decision Below

On March 10, 1978, the American Petroleum Insti-

tute, et al., and the Rubber Manufacturers Associa-

tion, et al., filed motions for stay of the benzene stand-

ard with the court of appeals.*' They were soon joined

by other producers and users of benzene who also

sought a stay. On March 13, 1978, argument was had

before Judge Morgan of the court on the stay motions.

Later that day, Judge Morgan issued a temporary

stay of the standard pending a usin before a full

panel of the court of appeals.

The issues concerning the stay were then fully

briefed by the parties on an expedited basis. Numer-

ous factual affidavits were submitted. A hearing on

the stay was had on April 18, 1978 before a three-

judge panel of the court of appeals. After the hearing,

the court issued an order continuing in effect the tem-

porary stay issued on March 13, 1978, “pending dis-

position of the petitions for review filed in these cas-

s.’’ In the same order the court of appeals established

an expedited schedule for briefing the cases and it

provided for accelerated oral argument.

* Various parties filed petitions for review of the benzene

standard which were considered on a consolidated basis by the

court of appeals. 581 F.2d at 4°5n.1; App. lan.1.

20

Argument to the court of appeals in the consolidat-

ed cases was had on June 22, 1978. Since the amend-

ment to the standard had been issued literally on the

eve of oral argument, at the close of the argument the

court of appeals directed the parties to file supple-

mental briefs, again on an expedited basis, directed to

the effect of OSHA’s amendments on the litigation.

Thereafter on October 5, 1978, the court of appeals

issued its decision granting the petitions for review of

the benzene standard, setting aside the airborne per-

missible exposure limit and the dermal contact pro-

visions, and also vacating the remaining provisions of

the standard.

Specifically, the court of appeals vacated the der-

mal contact provisions on two separate and alterna-

tive grounds.” Rejecting OSHA's claim that its de-

cision to prohibit dermal contact with liquid mixtures

containing small amounts of benzene was supported

by ‘‘substantial evidence’’,** the court stated that:

OSHA's decision to regulate on the basis of

dated, inconclusive data when modern experi-

%2 It did not reach the issue of feasibility of the dermal contact

provision, the third asserted ground for setting the provisions

aside. See infra, at 23.

*’ Petitioner incorrectly asserts that the court of appeals found

OSHA's adoption of the dermal contact provisions to be sup-

ported by ‘‘substantial evidence’. OSHA's Petition at 11, 20. To

the contrary, the court, after reviewing the ‘‘dated, inconclusive

data”’ relied upon by OSHA, stated that ““OSHA’'s finding that

dermal contact with benzene poses a cancer risk could pass mus-

ter’ if that had been the only evidence in the record. 581 F.2d at

507; App. 25a (emphasis added). The court then considered Dr.

Maibach’s testimony describing available and reliable experi-

mental techniques which could resolve within a relatively short

Pv Few a

21

mental methods can quickly and efficiently pro-

vide reliable information contravenes the direc-

tive from Congress to promulgate standards on

the basis of the ‘‘best available evidence,” ‘‘re-

search, demonstrations, experiments, and such

other information as may be appropriate,’ and

“the latest available scientific data in the field.”

29 U.S.C.A. § 655(b)(5). This is not a case where

there is testimony that additional research could

be attempted, but might not shed new light on

a subject. (581 F.2d at 507; App. 26a-27a.)

In reaching that conclusion, the court reviewed in

detail not only the limited data considered by OSHA

but also Dr. Maibach’s ‘‘unrefuted testimony”’ as to

the reliability and accuracy of straightforward exper-

imental techniques relating to benzene absorption.”

On the basis of that detailed factual review, the court

held that:

OSHA's choice to rely on old and inconclusive

evidence that there is a possibilty of absorption

term the issue of whether human skin absorbs benzene, and

found that Dr. Maibach's “additional evidence removejd] the

support for OSHA's actions.” /d.

Indeed, at a prior point in its opinion, where the court summed

up its ruling on the dermal contact provisions, the court stated:

The record therefore fails to support the finding that ben-

zene is absorbed through the skin. Since entry to the body

by dermal contact was not established, the record will not

support a finding that the prohibition of all dermal contact

with benzene . . . [is reasonably necessary]. 581 F.2d at 506;

App. 23a-24a.

“ The court also referred expressly to the fact that the new

test results were ‘‘so readily available’. 581 F.2d at 508; App.

27a.

22

of benzene through the skin which might cause

cancer is in clear disregard of the Congressional

directive as to the kinds of evidence OSHA is

required to consider. Therefore, the provision of

the standard prohibiting dermal contact with liq-

uid benzene cannot stand on the present record.

(581 F.2d at 508; App. 27a.)

The court of appeals also vacated the dermal con-

tact provision on the ground that it was not ‘‘reason-

ably necessary”’ as required by Section 3(8) of the Act,

29 U.S.C. § 652(8). OSHA had sought in the court of

appeals to justify the dermal contact prohibition as

an adjunct to the permissible airborne exposure limit

and on the basis of a concern for dermatitis. Both

contentions were rejected. The court’s analysis of the

record led it to conclude that the argument on der-

matitis ‘‘appearl[ed] to be a post hoc rationalization

for the dermal contact prohibition since it was not a

significant part of OSHA's reasoning process that led

to [that] provision.”’ (581 F.2d at 505; App. 22a.) Be-

cause review of the standard ‘‘must be of the reason-

ing process of the agency at the time it promulgated

the standard based on the record before it’’ (581 F.2d

at 506; App. 23a),*° the court refused to give weight

to the newly proffered argument on dermatitis. And

* As authority for this principle, the court cited Dry Color

Mfrs.’ Ass'n, Inc. v. Department of Labor, 486 F.2d 98, 104 n.8

(3d Cir. 1973), which in turn cites and relies on this Court's

decisions in Citizens To Preserve Overton Park yv. Volpe, 401

U.S. 402, 419 (1971); N.L.R.B. v. Metropolitan Life Ins. Co., 380

U.S. 438, 443-444 (1965); and Burlington Truck Lines v. United

States, 371 U.S. 156, 168-169 (1962), along with United States v.

Allegheny-Ludlum Steel, 406 U.S. 742, 756-757 (1972).

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23

noting that the record did not support OSHA's find-

ing that benzene is absorbed through the skin, the

court determined that:

[T]he record will not support a finding that the

prohibition of all dermal contact with benzene

will result in quantifiable benefits in terms of a

reduced risk of leukemia justifying the costs of

the provision. Thus reasonable necessity is lack-

ing here too. (/d.; App. 23a-24a.)

The court of appeals did not reach the issue of

whether OSHA's ban on dermal contact was ‘‘feasi-

ble’ within the meaning of Section 6(b)(5) of the Act,

29 U.S.C. § 655(b)(5), stating that ‘‘the amendment to

the standard on June 21, 1978, significantly affect[ed]

the feasibility issue. . ..’’ Ud.; App. 23a.)

REASONS FOR DENYING THE WRIT

I. The Evidentiary Question Stated By OSHA Is

Purely Hypothetical; The Facts And Record

Demonstrate That There Is No Evidentiary

Issue In This Case Worthy Of This Court's

Consideration

The second question OSHA seeks to pose is not

presented by the case. As OSHA characterizes the

decision of the court of appeals and the record, the

court first concluded that the dermal contact provi-

sions of the benzene standard were supported by sub-

stantial evidence in the record. (OSHA's Petition at

2, 11, 20.) QSHA then asserts that the court of ap-

peals set aside the dermal contact provisions ‘‘because

of the possibility that future scientific studies will

provide better evidence concerning the need for the

24

standard.” (/d. at 2.) Because OSHA’s factual prem-

ises are not correct, this Court is faced not with the

question OSHA would like to present but rather with

a very different issue.

The court of appeals actually rejected as insubstan-

tial the ‘‘old, inconclusive evidence”’ which formed the

predicate for OSHA’s decision to regulate dermal con-

tact as it did. (581 F.2d at 508; App. 27a; see also 581

F.2d at 506; App. 24a.)** The court did so in light of

all the evidence in the record. This included the old

data of inconclusive nature and manifest unreliability,

plus Dr. Maibach’s testimony that a test using radio-

active benzene could rapidly and conclusively estab-

lish whether, or to what extent, benzene is absorbed

through human skin. The court of appeals knew that

Dr. Maibach was in fact then carrying forward such

a study. (581 F.2d at 508 n.27; App. 27a n.27.)*" And

*% Only one study suggested that benzene was absorbed

through human skin. The description of that study, set out in

the decision of the court of appeals, shows its inconclusive and

questionable nature:

Between 1946 and 1961, experiments were conducted to

determine whether human skin absorbed benzene. Although

the first several of these studies conducted in the late 1940's

and mid-1950’s had negative results, one study published in

1961 found that some absorption had occurred and conclud-

ed that ‘‘the absorption of benzene throughout the skin

must not be neglected.”’ The record reveals problems in the

interpretation of all of these studies, however. In particular,

the 1961 study reporting positive results used a technique

compressing benzene-soaked cotton against the skin with a

glass plate for prolonged periods, that is recognized today

as an efficient way to drive molecules into the skin. 581 F.2d

at 506; App. 24a.

“ During the May 1978 hearings on the proposed amendment

to the standard, OSHA had been supplied with the test protocol

being used by Dr. Maibach, and the approximate schedule for

the study. Amend. Tr. 70-73.

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25

the ruling of the court of appeals was also based on

its determination, reflecting the record, that the ‘‘fac-

tual information [being provided by Dr. Maibach’s

study] is so readily available.”’ (581 F.2d at 508; App.

27a.)**

Given the actual state of the record, which is very

far from what OSHA would have this Court believe,

the court of appeals reached the eminently sensible

result. Moreover, OSHA cannot argue here, as it does

respecting the first question presented by its Petition,

that the statute bars the Agency from itself being

sensible.*® Section 6(b)(5) of the Act, 29 U.S.C.

§ 655(b)(5), directs OSHA in promulgating standards

dealing with toxic materials to consider the ‘‘best

available evidence’, to develop standards ‘‘based

upon research, demonstrations, experiments, and

such other information as may be appropriate,’ and

to consider ‘‘the latest available scientific data in the

field.’’ The decision of the court of appeals faithfully

follows and implements these statutory provisions.

Especial note should be taken that the factual rep-

resentations in OSHA's Petition at 20 and in footnote

“The fundamental information, involving absorption tests of

radioactive benzene with rhesus monkeys, is now actually in

OSHA's hands. See supra, at 16 n.26, and infra Appendix 1.

** As to the first question, pertaining to the ‘‘reasonable neces-

sity” for OSHA’s standard, OSHA argues that Section 6(b)(5) of

the Act “prohibits’’ the Agency from evaluating cost-benefit

considerations or making a risk analysis. OSHA’s Petition at 17

n.10. Neither Section 3(8) nor Section 6(b)(5) of the Act impose

such a restriction. See the companion Joint Memorandum In

Opposition, filed concurrently with this memorandum.

26

11 (bearing on Dr. Maibach’s study) are inexplicable,

in light of the record.*

This is a record-dependent case, as one would ex-

pect, because the second question presented by OS-

HA’s Petition pertains to the evidentiary portions of

the standard-setting provisions of the Act. This Court

should analyze the record before deciding whether or

not to grant OSHA’s Petition. Such analysis will

show that the question OSHA has stated is not ac-

tually presented by the facts. On the facts, Dr. Mai-

bach’s test protocol is not a tentative or experimental

procedure which possibly could provide evidence bear-

ing on a crucial point. Rather, the experimental meth-

ods involving radioactively-tagged benzene are sim-

ple, direct and produce conclusive results. They can

‘so readily’’ provide, and now actually have provided,

fundamental evidence on the absorption point. In the

circumstances, this Court should deny the Petition.

Hl. OSHA’s Own Failure To Provide Adequate

Notice Of Issues In The Rulemaking Inhib-

ited Orderly Development Of The Record

As described in the statement of the case, supra, at

9-10, OSHA failed during the proceedings on the pro-

posed standard to give adequate notice that it was

considering covering by the standard any material

with any benzene content whatsoever. OSHA’s ETS

* This Court will have the full record available to it during its

consideration of the petitions for a writ of certiorari.

27

and proposed standard both had a ‘percentage exclu-

sion’, exempting from coverage materials with less

than a specified percentage benzene content. (See su-

pra, at 9.) When OSHA issued a standard covering

any material with any benzene content, its action

came as a total surprise, at least to respondents. In

the absence of any express notice, it was not reason-

able for them or for anybody else to have conceived

that even OSHA would establish a benzene standard

with the effect, among other things, of banning skin

contact with tapwater in workplaces.*!

Because the rubber companies had relied on the

proposed percentage exclusion as limiting their con-

cern with the proposed standard (see supra, at 10),

they had not then sought to have Dr. Maibach or

anyone else carry out a skin-absorption study using

radioactive benzene. When the final standard issued

without any percentage exclusion, they promptly

sought both administrative relief and a judicial stay.

(See 581 F.2d at 500 n.19; App. 12a n.19.) They also

began work with Dr. Maibach to carry out an absorp-

tion study. OSHA subsequently granted a stay as to:

work operations involving mixtures of 0.1 percent or

less benzene, and initiated a rulemaking proceeding

to determine whether this or another percentage ex-

‘' As noted, benzene is a widely-occurring, natural organic ma-

terial. See supra, at 8-9. The presence of benzene in potable water

supplies in the United States has been reported by, among oth-

ers, the National Academy of Sciences. And as the court of

appeals observed, ‘‘the permanent standard prohibited all dermal

contact with liquids containing any amount of benzene and it

imposed the labeling requirements on all such liquids."’ 581 F.2d

at 500; App. 12a.

28

clusion should be made a permanent part of the stand-

ard. (43 Fed. Reg. 12,890-12,891.) It was during these

subsequent proceedings on the proposed amendment

that the rubber companies presented detailed evi-

dence relating to the infeasibility of tire manufactur-

ing and other operations. As described supra at 15-

17, in the subsequent proceedings the rubber compa-

nies also presented Dr. Maibach’s protocol and sched-

ule for his absorption tests using radioactive benzene.

The subsequent proceedings on the amendment ac-

cordingly were, and are, very important to the rubber

companies. OSHA's decisions on the percentage-ex-

clusion issue provide the impetus for and the empha-

sis on Dr. Maibach’s work. The court of appeals point-

edly observed ‘the major effect of the amendment is

on the arguments regarding the feasibility of the der-

mal contact and labeling provisions.” (581 F.2d at

501; App. 12a.) Most importantly here, the develop-

ment of the factual record in this case can only be

explained in light of OSHA’s actions on the percent-

age-exclusion issue. This point was strongly made in

the court of appeals, and in reaching its decision the

court took cognizance of the problem caused by the

lack of notice. (/d.)*

* One of the consequences is that the court of appeals took

note of, but did not decide, the claims of the rubber companies

that the dermai concact provisions were infeasible notwithstand-

ing the amendment. Thus also, even if this Court were to grant

the petition for writ of certiorari as to both questions and render

a decision on the merits in OSHA's favor, it would still be nec-

essary to remand the case to the court of appeals for considera-

tion of the rubber companies’ feasibility claim.

-

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29

OSHA's Petition is technically correct in stating

that ‘“‘No one has argued that [OSHA] prevented the

parties from performing and submitting such a test

[as Dr. Maibach’s study].’”” (OSHA’s Petition at 20.)

Yet while OSHA did not ‘“‘prevent”’ the parties from

carrying out an absorption study, neither did it inform

the parties that the percentage exclusion would be

eliminated from the final standard, and that the ban

on dermal contact and thus the question of absorption

would be of such concern.“

In sum, OSHA's own actions and especially its fail-

ure to provide notice to affected parties have inhibited

the orderly development of the record. This lack of

notice has led directly to the circumstance that the

fundamental Maibach study has only recently been

completed, approximately eleven months after the

original benzene standard was promulgated. More

particularly, in part because notice was lacking, the

question OSHA would pose to this Court on petition

for writ of certiorari is not fairly presented by the

facts. The writ should be denied.

On the merits, OSHA should not be allowed to force

regulated parties to bear the results of its own dere-

lictions in imposing regulations absent evidentiary

support. The court of appeals correctly observed that

in the circumstances OSHA itself had to shoulder the

responsibility for coming forward vith the absorption

information:

When such factual information is so readily avail-

abie, 29 U.S.C. § 655(b) (5) requires OSHA to ac-

* In its Petition, OSHA almost ignores the fact that a major

amendment to its standard was made. Compare OSHA's Petition

at 7, with id. at 5 n.4. It understandably would not care to

emphasize the reasons why an amendment was deemed neces-

sary.

30

quire that information before promulgating reg-

ulations which would require an established in-

dustry to change long-followed work processes

that are not demonstrably unsafe. (581 F.2d at

508; App. 27a (emphasis added).)**

Il. There Is No Conflict—The Evidentiary Issue

Before The Court Of Appeals Was And Is A

Matter Of First Impression

OSHA cites no conflict of decisions on the eviden-

tiary issue. To respondents’ knowledge there is none.

The court of appeals dealt with the matter as one of

first impression.

“This aspect of the case seems particularly troublesome be-

cause OSHA apparently considers that it has power in effect to

force parties ‘‘to supply [it] with relevant evidence’’ (OSHA's

Petition at 20 n.11), by threatening to act to regulate unless

evidence is forthcoming. Respondents do not concede that OSHA

has been given such power by Congress in Section 6(b) of the

Act, 29 U.S.C. § 655(b).

OSHA itself can obtain technical data if it desires to do so.

OSHA may request that the National Institute for Occupational

Safety and Health carry out technical studies (see Section 20(a)

of the Act, 29 U.S.C. § 669(a)), or OSHA may enter into contracts

with private parties to have such studies carried out. See Section

20(c) of the Act, 29 U.S.C. § 669(c).

31

CONCLUSION

For the foregoing reasons, the petitions for a writ

of certiorari should be denied.

Respectfully submitted,

CHARLES F. LETTOW

JOHN C. MURPHY, JR.

Cleary, Gottlieb, Steen & Hamilton

1250 Connecticut Avenue, N.W.

Washington, D.C. 20036

Attorneys For The Rubber

Manufacturers Association, Inc., Et AL

EDWARD W. WARREN

ARTHUR F. SAMPSON, III

Kirkland & Ellis

1776 K Street, N. W.

Washington, D.C. 20006

Attorneys For The American Petroleum

Institute, Et Al

ROBERT L. ACKERLY

MARILYN LYNG O'CONNELL

Sellers, Connor & Cuneo

1625 K Street, N.W.

Washington, D.C. 20006

Attorneys For Chemical Specialties

Manufacturers Association

ROBERT R. BONCZEK

JOHN F. DICKEY

E.1. du Pont de Nemours &

Company

Wilmington, Delaware 19898

Attorneys For E.I. du Pont de

Nemours & Company

HAROLD B. SCOGGINS, JR.

JAMIE REPLOGLE

Independent Petroleum Association

of America

1101 Sixteenth Street, N. W.

Washington, D. C. 20036

Attorneys For The Independent

January 26, 1979 Petroleum Association Of America

APPENDIX 1

|

la

PERCUTANEOUS PENETRATION OF BENZENE

AND BENZENE CONTAINED IN SOLVENTS

USED IN THE RUBBER INDUSTRY

by

Howard Ll. Maibach, M.D.

Professor of Dermatology

University of California Medical Center

January 19, 1979

Za

TABLE OF CONTENTS

Page

I. INTRODIC TH) fiero eee 4a

i. PROPOR 3a ee 4a

Hl.. RESULTS 6 oo ee ee 5a

A. Parenteral Administration of Benzene . 5a

B. Percutaneous Penetration of Benzene:

Topical. Exposure »\.0.00).0. a 6a

C. Percutaneous Penetration of Benzene:

From a Rubber Solvent ............. 8a

Iv. CONCLUGIONS ©... es Cs nee ees 9a

APPENDICNS. 30.0 oo eee [omitted]

APPENDIX A—DETAILED PROTOCOL

APPENDIX B—DATA REGARDING PARENTERAL

ADMINISTRATION OF BENZENE

APPENDIX C—DATA REGARDING

PERCUTANEOUS PENETRATION

OF BENZENE: TOPICAL EXPOSURE

APPENDIX D—DATA REGARDING

PERCUTANEOUS PENETRATION

OF BENZENE: TOPICAL EXPOSURE

(AMENDED RESULTS)

APPENDIX E—CHARACTERISTICS OF THE

RUBBER SOLVENT USED

APPENDIX F—DATA REGARDING

PERCUTANEOUS PENETRATION

OF BENZENE: FROM A RUBBER

SOLVENT

APPENDIX G—CALCULATION OF PERMITTED

AIRBORNE EXPOSURE TO

BENZENE AT 1 PPM

3a

APPENDIX H—

H-1: Feldmann, R.J. & Maibach, H.1., ‘‘ Absorption of

Some Organic Compounds Through the Skin in

Man’, J. Invest. Derm. 54:399-404, 1970.

H-2: Wester, R.C. & Maibach, H.1.. ‘‘Rhesus Monkey

as an Animal Model for Percutaneous

Absorption”’, pp. 133-137, in Maibach, H.1. (ed.)

Animal Models in Dermatology, Churchill

Livingstone, Edinburgh, 1975.

H-3: Wester, R.C., Noonan, P.K. & Maibach, H.1.,

‘Frequency of Application on Percutaneous

Absorption of Hydrocortisone’, Arch. Dermatol.

113:620-622, 1977.

H-4: Wester, R.C., Noonan, P.K. & Maibach, H.L.,

‘Variations in Percutaneous Absorption of

Testosterone in the Rhesus Monkey Due to

Anatomic Site of Application and Frequency of

Application”’’, Draft Publication in Preparation.

4a

I. INTRODUCTION

This report describes skin absorption of: 1) full strength

benzene; and 2) benzene which is present in trace amounts

in solvents used in the the rubber manufacturing industry.

The purpose of the study was to determine the extent of

benzene percutaneous penetration (if any) using full

strength benzene and rubber solvent containing small

amounts of benzene. The study was conducted as de-

scribed in the detailed protocol (Appendix A).*

Hi. PROTOCOL

Purpose

To determine the extent of benzene percutaneous pene-

tration (if any) and the kinetics thereof.

Method

The experimental details are those described by Feld-

mann, R.J. & Maibach, H.I., as published in ‘‘Absorption

of Some Organic Compounds Through the Skin in Man”,

J. Invest. Derm. 54:399-404, 1970 (Appendix H-1).

Parenteral

C'* benzene will be injected parenterally into the rhesus

monkey, at a dose less than 1 mg. Urine and feces will be

collected for appropriate assay of C'‘ to ascertain the com-

pleteness of excretion (and the kinetics thereof). Should

this demonstrate that benzene (and its metabolites) are

largely excreted and not stored, the cutaneous experiments

will be started.

panies of the Rubber Manufacturers Association.

* Funding for the study was provided by certain member com-

~~ sms

5a

Cutaneous

C'* benzene will be applied to the forearm of the rhesus

and urine and feces collected. The specimens are handled

in a metabolic fashion with aliquots examined at least daily

for kinetic analysis. The initial skin dose will be approxi-

mately 4 micrograms/cm’.

Solvent

Similar experiments will be performed with the benzene

content at a level believed comparable to that found in

typical rubber solvents. In this instance the dose calcula-

tions include that of the solvent and benzene.

General

1. Animals are already trained to sit in metabolic chairs.

2. Animals are tended to several times daily by staff.

3. All radioactivity counting methods have been exten-

sively used for similar experiments in man.

4. Computer programs for handling the data are oper-

ational.

5. Three animals will be utilized in each experiment.

lil. RESULTS

A. Parenteral Administration of Benzene

Purpose

To determine the excretion of a parenteral dose of (C-14)

benzene. This will be used in percutaneous penetration

experiments, as a parenteral recovery control.

Procedure

The dose was given to three rhesus monkeys restrained

in metabolic chairs in a carefully controlled environmental

6a

room. The dose given was 0.785 microcuries dissolved in

propylene glycol. The dose was injected in the thigh of the

monkeys.

Urine samples were pooled at 4, 8, 12 and 24 hours, and

then at 24-hour intervals for the remaining four days. Two

mililiter aliquots of the urine samples were dissolved in

triton-toluene-PPO cocktail and counted. The efficiency

was determined using a (C-14) toluene internal standard of

1 X 10° dpm. Additional details are in the detailed protocol

attached as Appendix A.

Results

The average excretion was 41.02 + 9.41% of the injected

dose with individual values of 47.04, 45.84 and 30.18%.

The last value of 30.18% should be considered only ap-

proximate because of the loss of some of the urine in the

first sample. The true excretion is most probably in the

area of 46% of the injected dose. Analytical data reflecting

these results is set forth in Appendix B. This parenteral

excretion data is to be utilized in preparing the correction

figure for topical experiments, i.e., to correct for incom-

plete urinary excretion. No significant counts were found

in the feces.

B. Percutaneous Pentration of Benzene: Topical

Exposure

Purpose

To determine the percutaneous penetration of benzene

after a small quantity was placed on the skin and allowed

to evaporate.

Procedure

Three healthy rhesus monkeys were isolated in meta-

bolic chairs with a device to isolate one forearm. The mon-

Ta

keys were sedated with Ketamine® during the procedure,

and their forearm hair was removed with a clipper.

The monkeys were transferred outside the building to

minimize inhalation and to preserve the controlled atmos-

phere of the laboratory. Fifty microliters (43.95 mg) of

benzene with an activity of 4.33 microcuries was applied

to a 1 inch by 2 inch (12.9 cm’) area and allowed to dry.

The treated arm was kept isolated for four hours.

Urine samples were pooled at 6, 12 and 24 hours and

then daily for the remainder of the experiment. The feces

were removed and discarded daily. The urine was analyzed

by direct scintillation counting in triton-toluene-PPO, and

an internal standard was added for an efficiency determi-

nation of each sample.

Results

Based upon initial analyses, the amount of label re-

covered was 0.101, 0.051 and 0.113% of the applied dose

with an average of 0.088 + 0.033% in 120 hours. The

excretion of a parenteral dose was 41.0% and using this

correction factor the actual penetration would be 0.2153

+ 0.0805%. Data is set forth in Appendix C.

However, the urine’s radioactivity was measured by di-

rect counting in triton-toluene-PPO cocktail; this method

has an inherent drawback impairing accuracy when the

counts in a sample are close to background levels. The

potassium concentration in the urine varies, and the po-

tassium has a significant number of beta emitting isotopes.

A reanalysis was therefore performed using the chromic

acid oxidation method. The samples were oxidized using

chromic acid, and the '*CO, evolved was captured and

counted by liquid scintillation. This is a more accurate

method.

8a

The excretion determined by this analysis are 0.0436%,

0.0500% and 0.118% of the applied benzene dose with an

average of 0.0705% + 0.0412%. Using the correction fac-

tor of 2.44 determined in the parenteral study of benzene,

the actual penetration was 0.172 + 0.100%. Data is set

forth in Appendix D.

C. Percutaneous Penetration of Benzene: From a

Rubber Solvent

Purpose

To determine the percutaneous penetration of carbon 14

benzene as a component of a rubber solvent containing

0.36% benzene. This solvent was supplied by the Rubber

Manufacturers Association and its characteristics are de-

scribed in Appendix E.

Procedure

Three rhesus monkeys were placed in metabolic chairs,

and had their forearms shaved three days prior to the

penetration experiment. A solvent mixture of the rubber

solvent with 0.36% benzene containing 18.7 microcuries

per 50 microliter dose was prepared. The 50 microliter dose

was applied over an area of 2 in’ (2 X 1 in.) and allowed to

evaporate.

To prevent inhalation of the C-14 benzene the monkeys

wore gas masks during the application and evaporation

period. The application was done in the open air to preserve

the controlled atmosphere of the facility they were housed

in.

Urine was collected at 4, 8, 12 and 24 hours on the first

day and than 24-hour intervals to 120 hours. The feces

were removed and discarded daily.

The urine was analyzed using the wet ashing method;

chromic acid was used to oxidize the organic components

9a

in a five mililiter aliquot of urine and the '*CO, was cap-

tured in an organic base. The '‘CO, was counted via scin-

tillation counting in a toluene-PPO cocktail.

Results

The '*C-benzene and metabolites detected in the urine

were at 0.0274%, and 0.036% and 0.0353% of the applied

dose with an average of 0.0330 + 0.0049%. Using the

parenteral correction factor of 2.44 the actual penetration

was 0.0805 + 0.0119% of the benzene portion (0.36%) of

the applied dose, or 0.00029% benzene in relationship to

the solvent applied. Data is set forth in Appendix F.

IV. CONCLUSIONS

Full strength C-14 benzene was injected into rhesus

monkeys and its presence was identified quantitatively

and kinetically through analysis of the urine and the feces

(see section III-A). Radioactive benzene was applied to the

forearm of the monkeys to quantitate absorption. Using

the correction factor of 2.44 determined in the parenteral

study, the actual penetration was 0.172 + 0.100% of the

100% benzene administered (see section III-B). Carbon-14

benzene as a component of a rubber solvent containing

0.36% benzene was applied topically to the forearm of the

monkeys. Using the parenteral correction factor of 2.44,

the actual penetration was 0.0805 + 0.0119°%o of the ben-

zene portion (0.36%) of the applied dose, or 0.00029% ben-

zene in relationship to the solvent applied (see section III-

C). The 0.172% and 0.0805% penetration figures suggest

that when similar amounts of benzene are presented in

diluted and concentrated forms, proportionally less ben-

zene may be absorbed in the diluted torm.

The rhesus monkey was selected for these experiments

because it has been shown to be a reasonable model for

percutaneous absorption where relevance to man is

10a

sought.' While percutaneous penetration is a complex proc-

ess, it appears from data derived from research with com-

pounds other than benzene that absorption in the rhesus

monkey bears a marked similarity to absorption in man.

The above relates to single exposures. In accordance

with my earlier understanding with the rubber companies

sponsoring this project, we will proceed with experiments

to determine the effect on percutaneous penetration of

multi-dose exposures to benzene or to rubber solvents con-

taining small amounts of benzene. We do not know wheth-

er these experiments will show increased penetration, as

previous studies indicate that percutaneous penetration is

not necessarily increased by multiple exposures.’

Further experiments are necessary in order to draw con-

clusions as to the comparative amount of benzene ab-

sorbed through the respiratory and dermal routes in the

rubber manufacturing industry. However, this study

makes possible a preliminary judgment as to comparative

absorption in humans based upon certain assumptions

stated below.

The maximum permissible airborne exposure for ben-

zene in the permanent benzene standard of the Occupa-

tional Safety and Health Administration is 1 part per mil-

lion (ppm). A computation provided by the Rubber Man-

' Wester, R.C. & Maibach, H.I., ‘* Rhesus Monkey as an Animal

Model for Percutaneous Absorption’, pp. 133-137, in Maibach,

H.1. (ed.) Animal Models in Dermatology, Churchill Livingstone,

Edinburgh, 1975 (Appendix H-2).

? Wester, R.C., Noonan, P.K. & Maibach, H.I., ‘Frequency of

Application on Percutaneous Absorption of Hydrocortisone’,

Arch. Dermatol. 113:620-622, 1977 (Appendix H-3); Wester, R.C.,

Noonan, P.K. & Maibach, H.lI., ‘Variations in Percutaneous Ab-

sorption of Testosterone in the Rhesus Monkey Due to Anatomic

Site of Application and Frequency of Application’, Draft Pub-

lication in Preparation (Appendix H-4).

lla

ufacturers Association (Appendix G) indicates a maximum

permitted exposure of 28.8 mg benzene over an eight-hour

period for a worker doing moderately heavy work.

The third phase of the study described in this report

involved a single topical application of rubber solvent con-

taining 0.36% benzene to the forearm of the rhesus mon-

key. The actual penetration was 0.0805 + 0.0119% of the

benzene portion (0.36%) of the applied dose, or 0.00029%

benzene in relationship to the solvent applied. To make a

preliminary judgment as to comparative absorption of ben-

zene in man, it is necessary to assume that penetration

through the portions of the hand exposed to rubber solvent

containing 0.36% benzene is the same as penetration

through the forearm of the monkey, that percutaneous

penetration of the benzene in rubber solvent is not sub-

stantially increased by multiple exposures and ‘that the

extent of dermal contact does not exceed the equivalent of

full palmar contact. If these assumptions are correct, a

preliminary judgment is that the amount of benzene ab-

sorbed percutaneously from contact with rubber solvent

containing 0.36% benzene is a small fraction of the amount

of benzene permitted to be inhaled at 1 ppm. Further stud-

ies to document or disprove these assumptions are

planned.

[The appendices to this report (appendices A-H) are not

reproduced here. Those appendices are included in a copy

of the report on file with the Clerk. |