Petition — OIL, CHEMICAL & ATOMIC WORKERS UNION v. DUNLOP (No. 74-1443)

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MAY 16 13} )

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IN THE

Supreme Court of the United States

OCTOBER TERM 1974

No. WA- 144 3

OIL, CHEMICAL AND ATOMIC WORKERS

INTERNATIONAL UNION, AFL-CIO,

and

HEALTH RESEARCH GROUP,

Petitioners,

Vv.

JOHN T. DUNLOP, Secretary,

United States Department of Labor

and

JOHN H. STENDER, Assistant Secretary,

Occupational Safety and Health Administration

United States Department of Labor

Respondents.

PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

ALAN B. MORRISON

BERTRAM ROBERT COTTINE

Suite 700

2000 P Street, N.W.

Washington, D.C. 20036

(202) 785-3704

Attorneys for the Petitioners

REO 6 eR RE TCO

ABS DUPLICATORS, INC.—1732 Eye Street, N.W.—Waeshington, 0.C.—298-6637

(i)

TABLE OF CONTENTS

OPINION BELOW .

JURISDICTION .

QUESTION PRESENTED

STATUTE INVOLVED

STATEMENT OF THE CASE .

A. Administrative Proceedings

B. The Decision of the Court of Appeals .

REASONS FOR GRANTING THE WRIT .

A. The Decision Below Violates The Duty

of Appellate Courts to Review Questions

of Law and Thus Seriously Compromises

the Basic Protections Afforded Workers

by the Act

B. This Court Should Settle a Critical

Question Regarding Judicial Review of

Occupational Safety and Health Standards

SS eT ee

Conflict . ' ‘or

C. This Court Should Settle A Critical

Question of Statutory Construction

Involved In the Administration and

Enforcement of the Act .

CONCLUSION

APPENDIX A

Opinion of the Court of Appeals .

(ii)

APPENDIX B

Statement of Reasons and Representative

Carcinogen Standard Issued by Secretary

APPENDIX C

Sections 6(b\(5) & 6(b\(7) of the

Occupational Safety and Health Act..

APPENDIX D

Judgment of the Court of Appeals

TABLE OF AUTHORITIES

Cases:

American Ship Building Co. v. N.L.R.B.,

380 U.S. 300 (1965) . .

American Smelting & Refining Co. v.

Occupational Safety & Health Review Comm'n,

501 F.2d 504 (8th Cir. 1974) .

Associated Industries of New York State v.

U.S. Dep't of Labor,

487 F.2d 342 (2d Cir. 1974) .

Brennan v. Occupational Safety & Health

Review Comm'n,

491 F.2d 1340 (2d Cir. 1974).

Citizens to Preserve Overton Park v. Volpe,

401 U.S. 402 (1971) . ; ;

Dry Color Mfrs. Ass'n v. Dep't of Labor,

486 F.2d 98 (3d Cir. 1973).

Escoe v. Zerbst,

295 U.S. 490 (1935) .

Florida Peach Growers Ass'n v. U.S.

Dep't of Labor,

489 F.2d 120 (Sth Cir. 1974) .

45a

15, 19

6, 19

(iii)

FMC v. Seatrain Lines, Inc.,

411 U.S. 726 (1973) .

FTC v. Texaco, Inc.,

393 U.S. 223 (1968) .

Industrial Union Dep't, AFL-CIO v. Hodgson,

499 F.2d 467 (D.C. Cir. 1974) .

Marbury v. Madison,

S U.S. (1 Cranch) 137 (1803) .

Morton vy. Ruiz,

415 U.S. 199 (1974) .

National Broadcasting Co. v. United States,

319 U.S. 190 (1943) . oe a

National Roofing Contractors Ass'n v. Brennan,

495 F.2d 1294 (7th Cir. 1974)

cert. denied, ah

95 S$. Ct. 775 (1975) .

N.L.R.B. v. Brown,

380 U.S. 278 (1965) . 3

Oil, Chemical & Atomic Workers Int'l Union

v. Brennan,

Civil Action No. 730-73

(D.D.C., filed April 17, 1973) .

Synthetic Organic Chem. Mfrs. Ass'n v. Brennan,

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

cert. denied, US. ;

95 S. Ct. 1396 (1975)

Train v. Campaign Clean Water, Inc.,

US. , 95 S. Ct. 847 (1975) .

Train v. City of New York,

U.S. , 9S St. Ct. 839 (1975)

United States v. American Trucking Ass'n,

310 U.S. 534 (1940) . ve.

10, 19

(iv)

Volkswagenwerk Aktiengesellschaft v. FMC,

390 U.S. 261 (1968) . ". a

Statutes and Other Legislative Authorities:

28 U.S.C. 81254(1) .

Occupational Safety and Health Act of 1970,

84 Stat. 1590, 29 U.S.C. 8651 ef seq. .

Section 2(b), 29 U.S.C. 8651(b)

Section 6(a), 29 U.S.C. 8655(a)

Section 6(b), 29 U.S.C. 6655(b) . .

Section 6(b\(1), 29 U.S.C. 8655(bX(1)

Section 6(b\(5), 29 U.S.C. §655(b\(5)

Section 6(b(7), 29 U.S.C. §655(b\(7)

Section 6(c), 29 U.S.C. 8655(c)

Section 6(c1), 29 U.S.C. 8655(cK1)

Section 6(c\3), 29 U.S.C. 8655(cX3)

Section 6(e), 29 U.S.C. 8655(e)

Section 6(f), 29 U.S.C. 8655(f)

Section 7(b), 29 U.S.C. 8656(b) . .

Section &(c\(1), 29 U.S.C. &57(cX1)

Section 9, 29 U.S.C. 8658

Section 10, 29 U.S.C. 6659 .

Section 22, 29 U.S.C.871.. .

Section 22(a), 29 U.S.C. 8671(a) .

Section 22(b), 29 U.S.C. 8671(b) .

S. Rep. No. 91-1282, 91st Cong., 2d Sess. (1970) .

H.R. Rep. No. 91-1291, 91st Cong, 2d Sess.

(1970) . iv ede

H.R. Rep. No. 91-1795, 91st Cong. 2d Sess.

(1970) . at ,

S. 2193, 91st Cong., 2d Sess. 66(b) (1970)

. 2, 3, 5, 6, 8, 9,

11, 12, 13, 14

2, 3, 5, 6, 12,

13, 14, 21

(v)

H.R. 16785, 91st Cong., 2d Sess. 66 (1970) .

Senate Comm. on Labor & Public Welfare,

Legislative History of the Occupational

Safety & Health Act of 1970, 92d Se

Ist Sess (1971) . 7

Walsh-Healy Public Contracts Act,

38 U.S.C, 435, 38 .

Regulations & Notices:

29 C.F.R. $1910.93,

Tables G-1, G-2 & G-3 (1974) .

29 C.F.R. §1910.93a(b), (f) (1974) .

29 C.F.R. §1910.93e-, 39 Fed. Reg. 3756

(January 29, 1974). F ,

29 C.F.R. §1910.93q(b), (c), 39 Fed. Res

12342 (April 15, 1974) . ip

29 C.F.R. §1910.93q(c), (d), 39 Fed. Reg.

35890 (October 4, 1974) ° «

36 Fed. Reg. 10466, 10503-10506

(May 29, 1971) .

37 Fed. Reg. 13285 (July 6, 1972) .

38 Fed. Reg. 10929 (May 3, 1973) .

38 Fed. Reg. 10930 (May 3, 1973) .

38 Fed. Reg. 4037, 4038-4039

(February 9, 1973).

38 Fed. Reg. 24377 (September 7, 1973) .

39 Fed. Reg. 3874 (January 30, 1974) .

39 Fed. Reg. 31644 (August 30, 1974)

14, 17

18, 21

(vi)

39 Fed. Reg. 44792 (December 27, 1974)

39 Fed. Reg. 33843 (June 20, 1974)

40 Fed. Reg. 3392 (January 21, 1975)

40 Fed. Reg. 4019 (January 27, 1975). .

40 Fed. Reg. 4930 (February 3, 1975).

40 Fed. Reg. 7960 (February 24,1975) . .. .

40 Fed. Reg. 11890 (March 14, 1975) .

40 Fed. Reg. 13231 (March 25,1975)... .

40 Fed. Reg. 17654 (April 21, 1975) .

40 Fed. Reg. 20201 (May 8, 1975) .

Other Authorities:

3 CCH Employment Safety & Health Guide

49545 (1975)

Nat'l Inst. for Occupational Safety & Health,

U.S. Dep't of Health, Educ. & Welfare,

The Toxic Substances List-1974 Edition vii

Nat'l Inst. for Occupational Safety & Health,

U.S. Dep't of Health, Educ. & Welfare,

Criteria for Recommended Standards on

Occupational Exposure (1972-1975) .

Occupational Safety & Héalth Administration,

U.S. Dep't of Labor, Supplement to Final

Environmental Impact Statement on Proposed

Regulation: Handling of Certain ee

(filed December 3, 1973)

U.S. Dep't of Health, Education & Welfare,

Nat'l Inst. for Occupational Safety & Health,

Interagency Agreement #NIOSH-IA-74-35 (1974).

IN THE

Supreme Court of the Anited States

OCTOBER TERM 1974

No.

OIL, CHEMICAL AND ATOMIC WORKERS

INTERNATIONAL UNION, AFL-CIO,

and

HEALTH RESEARCH GROUP,

Petitioners,

JOHN T. DUNLOP, Secretary,

United States Department of Labor

and

JOHN H. STENDER, Assistant Secretary,

Occupational Safety and Health Administration,

United States Department of Labor

Respondents.

PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

The Oil, Chemical and Atomic Workers International

Union, AFL-CIO, and the Health Research Group hereby

respectfully petition for a writ of certiorari to review the

judgment of the United States Court of Appeals for the

Third Circuit in this case.

OPINION BELOW

The opinion of the United States Court of Appeals for

the Third Circuit (Appendix A, infra, pp. la-13a) is re-

ported at 506 F.2d 385. That opinion reviewed the valid-

ity of the issuarice by the Secretary of Labor (the

"Secretary'’) of occupational health standards regulating

fourteen cancer-causing chemicals. The statement of reasons

applicable to all fourteen standards and a representative

carcinogen standard issued by the Secretary, 29 C.F.R.

§1910.93c-p, 39 Fed. Reg. 3756 (January 29, 1974), are

set out in Appendix B, infra, pp. 14a-42a.

JURISDICTION

The judgment of the Court of Appeals was entered on

December 17, 1974. (Appendix D, infra, p. 45a) The time

for filing a petition for writ of certiorari was extended until

May 16, 1975 by an order entered on March 6, 1975. The

jurisdiction of this Court is invoked under 28 U.S.C. §1254(1).

Original jurisdiction was invoked in the Court of Appeals un-

der 29 U.S.C. 8655(f).

QUESTION PRESENTED

Did the Court of Appeals err in testing the validity of

the Secretary's omission of two vital protections from occu-

pational health standards involving fourteen cancer-causing

chemicals by asking only whether the Secretary's decision

was a reasonable judgment rather than by measuring the

decision against the statutory provisions which mandate

these vital protections?

STATUTE INVOLVED

Sections 6(b)(5) and 6(b)(7) of the Occupational Safety

and Health Act of 1970, 84 Stat. 1594, 1595-1596, 29

U.S.C. $8655(b)(5), 655(b)(7), are set out in Appendix C,

infra, pp. 43a-44a.

STATEMENT OF THE CASE

Convinced that the human toll from workplace hazards

must be effectively controlled, Congress enacted the Occu-

pational Safety and Healih Act, 29 U.S.C. $8651 ef seq.

(1970). Section 6(b)(5) of the Act specifically mandated

the Secretary to set health and safety standards which

". . . most adequately assure that no employee will suffer

material impairment of health or functional capacity even

if such employee has regular exposure . . . for the period

of his working life . . . ."" 29 U.S.C. 8655(b)(5).!_ To

guarantee this protection, Congress concluded that there

were certain safeguards which were essential to worker

health and safety. One of these protections was the re-

quirement of a specific limit on the level of the toxic

material in the work environment, generally referred to as

a "performance standard", Jd. Such a standard enables

the Secretary to objectively measure an employer's per-

formance in eliminating the workplace hazard. In addi-

tion, Congress required that the standards include a system

to detect and measure worker exposure to the hazard so

that regular checks would be made of the workplace to

measure performance against the promises made (''moni-

toring") 29 U.S.C. 8655(b\(7). This petition seeks review

| The Secretary delegated his functions under the Act to the

Assistant Secretary of Labor for Occupational Safety and Health,

Secretary's Order #12-71. Both of these officials were respondents

in the Court of Appeals and are respondents in this Court.

of (a) the failure of the Secretary to include in the stand-

ards regulating fourteen cancer-producing chemicals (‘‘car-

cinogens") any performance standard whatsoever and his

indefinite deferral of any monitoring requirement, and (b)

the failure of the Court of Appeals to require the Secre-

tary to amend the standards by providing for these two

elements.

A. Administrative Proceedings

The governmental inquiry into the deaths and serious

health hazards confronting workers exposed to these

fourteen carcinogens began in May 1972 when the Secretary

requested the National Institute for Occupational Safety and

Health ("NIOSH")? to investigate the cancer hazard. NIOSH

transmitted fact sheets on these carcinogens to the Secretary

in July 1972 and its investigation culminated in a NIOSH re-

quest for whatever additional information the public might

have. 37 Fed. Reg. 13285 (July 6, 1972). Since continued

human exposure to these chemicals presented a grave

danger, and since the Secretary took no action to regu-

late them, the Oil, Chemical and Atomic Workers Union

("OCAW") and the Health Research Group, requested the

Secretary to issue an emergency temporary standard under

section 6(c) of the Act, 29 U.S.C. 8655(c). Their petition

documented the cancer hazard and proposed a standard

which included a performance standard and monitoring

among other important protections.? Inspite of the urgency

of the matter, no standard was promulgated until after the

2NIOSH is organized within the Department of Health, Educa-

tion and Welfare, 29 U.S.C. 8671.

3The Secretary noticed receipt of the petition and published the

text of the standard suggested by the petitioners for public com-

ment, 38 Fed. Reg. 4037, 4038-4039 (February 9, 1973).

_ petitioners filed a mandamus action to compel the Secre-

tary to act on their request for an emergency temporary

standard. On May 3, 1973, the Secretary finally issued

an emergency standard to deal "’. . . with the exposure of

employees to certain listed substances that are known to

cause cancer." 38 Fed. Reg. 10929. Specifically, the

Secretary found that: ". . . (1) the 14 carcinogens listed

in the emergency temporary standard are toxic and phys-

ically harmful; (2) that exposure to any of the 14 sub-

stances poses a grave danger to employees; (3) that em-

ployees are presently being exposed to the substances;

and (4) that the emergency temporary standard set forth

below is necessary to protect employees from such expos-

ure." Jd.

Although the emergency standard required employers

using these chemicals to institute certain work practices,

it did not place a definite limit on worker exposure to

the carcinogens by setting a performance standard. In

omitting any limit on worker exposure above fixed levels,

the Secretary violated the statutory mandate that ".. .

[w]henever practicable, the standard promulgated shall

be expressed in terms of objective criteria and of the

performance desired.'' 29 U.S.C. 8655(b)(5). Moreover,

the Secretary did not even require employers to measure

worker exposure to these carcinogens, ignoring completely

section 6(b)(7) which directs the inclusion of ". . . moni-

toring or measuring employee exposure . . . as may be

necessary for the protection of employees . . ."’ in these

standards. 29 U.S.C. §655(b)(7). Instead, the Secretary

merely required employers to report ". . . the type of

4 Oil, Chemical & Atomic Workers Int'l Union v. Brennan, Civil

Action No. 730-73 (D.D.C., filed April 17, 1973).

monitoring system [if any] that has been instituted . . ."

38 Fed. Reg. 10930 (May 3, 1973), a tactic he also em-

ployed with regard to the medical surveillance requirement.°

In fact, his statutorily required statement of reasons® never

mentioned any of the mandated protections contained in

the Act, let alone explained their omission from the

emergency standard.

Petitions for review were filed in the Third Circuit by

industry representatives, who challenged the inclusion of

two chemicals — El and DCB — on the list of carcino-

gens,’ and by petitioners here, who challenged the ade-

quacy of the protection afforded by the standard in the

face of the Secretary's finding that the chemicals posed a

grave danger to worker health. Although petitioners

urged consideration of the Secretary's failure to follow

the statutory mandates of sections 6(b)(5) and 6(b){7),

the Court of Appeals addressed itself exclusively to the

industry claim that two of the chemicals were improperly

found to be carcinogens, Dry Color Mfrs. Ass'n v. Dep't

of Labor, 486 F.2d 98 (3d Cir. 1973). The Court set

aside those findings because of an inadequate statement

of reasons, but declined to address the issues of moni-

toring, medical surveillance, and a performance standard

argued by petitioners. /d. at 108.

5 Section 6(b\7) of the Act, 29 U.S.C. §655(bX(7), requires the

inclusion of ". . . medical examinations and other tests . . . to most

effectively determine whether the health of such [exposed] employ-

ees is adversely affected... ."

6 Section 6(e), 29 U.S.C. 655(e).

7 EI is the acronym for ethyleneimine and DCB the acronym for

3,3 -dichlorobenzidene.

The Act requires the Secretary to replace an emergency

temporary standard with a permanent standard within six

months. 29 U.S.C. 8655(c)(3). In order to obtain expert

advice on this new standard, the Secretary convened an

advisory committee under section 6(b)(1), 29 U.S.C. 8

655(b)(1).8 But the advisory committee refused to ratify

the inadequacies of the emergency standard with the Sec-

retary's deviations from the requirements of the Act.

Instead, it recommended a performance standard of "no

measurable exposure or contact" to the cancer-producing

chemicals. 38 Fed. Reg. 24377 (September 7, 1973). The

committee also stressed the need for monitoring to detect

the presence of these carcinogens in the workplace, and ad-

vised the Secretary to include sufficient medical surveillance

to determine the adverse effects of continued human expo- _

sure to each of these carcinogens. /d.

The permanent standard, which was not promulgated

until January 29, 1974, almost three months after the

statutory deadline, was premised on the conclusion that

". . . a safe level of human exposure to any of the 14

carcinogens cannot be established by. the application of

present knowledge ... ."' (App. B, p. 20a). However,

the Secretary failed to implement this finding by requir-

ing a performance standard, monitoring, ard adequate

medical surveillance which are mandated by the Act. On

the performance standard issue, the Secretary restricted

his consideration to the "no detectable level" standard

proposed by petitioners and later recommended by the

advisory committee (/d. at 20a-2la). He never addressed

his general obligation to set a performance standard,

8 The advisory committee met for eighteen days and considered

evidence from government agencies and other experts, including

extensive presentations from industry.

whether at the zero level or some other level — a failure

which is exemplified by the absence of any discussion of

the section 6(b)\(5) preference, if not a requirement, for

performance standards.

Having failed to establish a definite limit on worker

exposure, the Secretary further eroded worker protection

by omitting any requirement that employers monitor the

workplace to detect the amount of the carcinogen to

which workers are exposed. In a brief two sentences

the Secretary dismissed his statutory responsibility to

prescribe monitoring, and merely referred the develop-

ment of a monitoring requirement to NIOSH, an agency

over which he has no control, 29 U.S.C. 8671(a), 671(b),

and imposed no time limits on the receipt of NIOSH's

work.?

Finally, having failed to insure adequate control of

worker exposure by refusing to set a performance standard,

and having refused to provide monitoring to determine the

extent of worker exposure, the Secretary issued totally

inadequate requirements for medical surveillance. Instead

of prescribing specific tests to detect particular forms of

cancer caused by different carcinogens, the Secretary left

the selection of the techniques entirely to the employers.

In spite of the Secretary's admission that specific medical

surveillance was necessitated by the long latency period

9 In tum, NIOSH signed an interagency agreement on May 20,

1974, with the former Atomic Energy Commission to develop

monitoring techniques. This agreement is not scheduled for com-

pletion until September 30, 1976 — a full two and a half years

after the issuance of the permanent standards. U.S. Dep't of Health,

Education & Welfare, Nat'l Inst. for Occupational Safety & Health,

Interagency Agreement #NIOSH-IA-74-35 at 7 (1974).

, 9

between a worker's first exposure to the carcinogen and

the first appearance of cancer (App. B, p. 20a), the ad-

visory committee recommendations were ignored entirely.

Once again, the statement of reasons reflects no concern

for the statutory obligation to specify the contents of

the required medical examinations and diagnostic tests.

In sum, while the finding by the Secretary that the

fourteen chemicals presented grave dangers of inducing

cancer suggested the need for stringent measures to pro-

tect the workers, the Secretary's standards fell far short

of the minimum requirement under the Act that the

standards ". . . most adequately assure that no employee

will suffer material impairment of health . . ." as a result

of exposure to these carcinogens. Section 6(b)(5), 29

U.S.C. 8655(b)(5).

B. The Decision of the Court of Appeals

Once again petitions for review were filed in the Third

Circuit by the employers who used chemicals found to be

carcinogens. This time, however, there were challenges

not only to EI and DCB, but also to CCME and MOCA.'°

Petitioners once again filed for review under section 6(f)

of the Act, 29 U.S.C. 8655(f), raising substantially the

same objections to the permanent standard that they had

presented to the Third Circuit on the emergency standard

and to the Secretary and the advisory committee during

the proceedings on the permanent standard. At the re-

quest of the employers who utilized El, that petition for

10 CMME is the acronym for methyl chloromethyl ether and MocA®

is the registered trade mark for 4,4 “methylene bis (2-chloroaniline).

review was severed from the remainder of the case, and

an expedited schedule was ordered. Before the argument

was held on the remaining cases, the Court of Appeals

affirmed the determination of the Secretary that El was

a carcinogen, but reversed the part of the standard relat-

ing to its use in laboratories and remanded that matter

for further proceedings. Synthetic Organic Chemical Mfrs.

Ass'n v. Brennan, 503 F.2d 1155 (3d Cir. 1974), cert.

denied, _ U.S. _, 95 S.Ct. 1396 (1975).

Thereafter, on December 17, 1974, 2 different panel

of the Third Circuit affirmed the Secretary's determina-

tion that the other three chemicals whose carcinogenicity

was being contested also presented a significant risk of

cancer to humans exposed to them. (App. A, pp. 3a-5a).

However, the Court concluded that the Secretary had

not followed the statutory procedures and timetable for

utilization of advisory committees and hence the standard

dealing with MOCA — the only chemical as to which the ob-

jection was raised — was ". . . remanded to the Secretary for

compliance with the statutory mandate." (App. A, p. Sa).

The Court then turned to its review of the portions of

the standards which petitioners claimed to be insufficient

to protect exposed workers and to be in violation of various

provisions of the Act. Initially it considered the Secretary's

failure to prescribe a performance standard. Like the Sec-

retary, it made the fundamental error of restricting its ex-

amination to whether a particular performance standard —

one requiring ''no measurable exposure'' — was appropriate,

rather than deciding whether the Secretary erred in omit-

ting any performance standard, be it at zero tolerance or

some other level of exposure. Having so limited the

issue, and without reference to the contrary recommenda-

tion of the advisory committee, the Court concluded that

the Secretary's decision was "'. . . a reasonable exercise

of judgment in the policy-making sphere."' (App. A, p.

10a). In its brief discussion of the question, section

6(b)(5), which directs the Secretary to utilize a perform-

ance standard, was neither cited nor discussed by the

Court.!!

The next deficiency in the standard was also brushed

aside by the Court quite quickly. Although the standard

lacked any monitoring to detect worker exposure to these

carcinogens, the Court sustained the Secretary's decision

to request another agency to develop methods for deter-

mining amounts of carcinogens in the workplace (App.

A, p. lla). Unable to find any explanation for this buck-

passing in the statement of reasons, the Court explained

it by restating what the Secretary had done: ".. . in

effect the Secretary has deferred implementation of moni-

toring requirements pending further development of

methods for doing so... .'' (/d. at 12a). The Court

ignored entirely the monitoring recommendations of the

advisory committee,!? the Secretary's own compilation of

available monitoring techniques,'? and the broad statutory

11 The Act also directs the Secretary to consider ". . . experi-

ence gained under this and other health and safety laws... ."

29 U.S.C. §655(b)(5). Performance standards known as "threshold

limit values" had previously been set for all toxic substances regu-

lated by the Secretary, 29 C.F.R. 81910.93, Tables G-1, G2 &

G-3, 1910.93¢ (1974). Neither the Secretary nor the Court explained

why this experience did not support the use of a performance stand-

ard in regulating these fourteen carcinogens.

12 38 Fed. Reg. 24377 (September 7, 1973).

13 Occupational Safety and Health Administration, U.S. Dep't

of Labor, Supplement to Final Environmental Impact Statement

on Proposed Regulation: Handling of Certain Carcinogens 63-66

& Tables I-III (filed December 3, 1973).

authorization to act on the basis of the "best available

evidence" and the "latest available scientific data in the

field," 29 U.S.C. 8655(b)(5). And, most importantly, the

Court again failed to consider the governing statutory

mandate to provide ". . . monitoring or measuring ex-

posure at such locations and intervals, and in such manner

as may be necessary for the protection of employees... ."

29 U.S.C. §655(b)(7).

Finally, the Court confronted the inadequate medical

surveillance required by the standard. This time, how-

ever, the Court was not satisfied with the Secretary's

failure '"". . . to explain the lack of specific requirements

making the medical examinations effective . . ." (App. A,

p. 13a), and this dissatisfaction led it to compare the

standard to the advisory committee recommendations.

(/d. at 12a). It also noted but did not comment or rely

on the requirement of section 6(b)(7), which directs the

Secretary ". . . to prescribe the type and frequency

of medical examinations . . . to most effectively deter-

mine whether the health of such employees is adversely

affected by such exposure." (/d.) Based on this analy-

sis, it found the standard to be inadequate. The Court re-

manded because ''[t]he Secretary gave no reasons for

ignoring this recommendation of the advisory committee,

nor did he indicate, as he did in connection with moni-

toring devices, that further information was needed."" (/d.)

But even in this action, reversing the Secretary's determina-

tions concerning medical surveillance, the Court of Appeals

fell into the same error as on the other two points: it

judged the standard by whether the Secretary's action

appeared reasonable and not by whether it was within

the statutory guidelines set forth in sections 6(b)(5) and

6(b)(7) of the Act.

REASONS FOR GRANTING THE WRIT

A. The Decision Below Violates the Duty of

Appellate Courts to Review Questions of Law

and Thus Seriously Compromises the Basic

Protections Afforded Workers by the Act.

The failure of past efforts to eliminate serious work-

place hazards prompted Congress to pass the Occupational

Safety and Health Act of 1970. In it Congress sought to

eradicate a nation-wide epidemic which caused 14,500

deaths and disabled 2.5 million workers each year. S.

Rep. No. 91-1282, 9ist Cong., 2d Sess. 2 (1970) (here-

after "Senate Report"). The objective of the Act is

". . . to reduce the number and severity of work-related

injuries and illnesses, which despite current efforts of

employers and government, are resulting in ever-increas-

ing human misery and economic loss," Senate Report at

1. It intended to do this by providing every working man and

woman a safe and healthful workplace. 29 U.S.C. §651(b).

Congress was also keenly aware of the 390,000 new

cases of occupational disease each year. Senate Repoit

at 2. The problems resulting from past inaction in regu-

lating health hazards are compounded by the fact that

". . . every 20 minutes a new and potentially toxic chemi-

cal is introduced into industry .. ."" /d. Furthermore,

Congress found that over 65% of industrial workers were

exposed to harmful physical agents or toxic materials.

H.R. Rep. No. 91-1291, 91st Cong., 2d Sess. 15 (1970).

Among these were the lung carcinogen asbestos and the

bladder carcinogen beta-naphtylamine, Senate Report at

3-4, the latter being one of the fourteen carcinogens in-

volved in these standards.

This serious public health problem could have been

tackled by simply delegating broad rulemaking authority

to the Secretary as Congress had done in the past. £.g.,

Walsh-Healy Public Contracts Act, 38 U.S.C. $35, 38.

The House bill would have copied this former approach

and would have left the Secretary unlimited discretion in

regulating workplace hazards. H.R. 16785, 91st Cong.,

2d Sess. 86 (1970) (engrossed bill).“* However, the Senate

insisted that the Secretary be directed to promulgate

standards for toxic materials which ". . . most adequately

assure . . . that no employee will suffer material impair-

ment of health or functional capacity even if such em-

ployee has regular exposure to the hazard . . . for the

period of his working life . . ." S. 2193, 91st Cong,

2d Sess. $6(b) (1970). In addition, the Senate did not

leave the Secretary free to formulate the contents of a

standard without Congressional guidelines. The non-im-

pairment rule was strengthened by directions to include

specific provisions in each standard. Thus, section 6(b)(5)

and 6(b\(7) required a performance standard, monitoring,

and medical surveillance, as well as appropriate protective

equipment, labels, and warnings. In each case the Senate's

detailed directions were adopted in preference to the

House bill which contained no comparable, specific pro-

visions except for labels and warnings. H.R. Rep. No.

91-1795, 91st Cong., 2d Sess. 35 (1970). The result

was a statute which contained not only a general ad-

monition to the Secretary to protect the health of workers,

14 senate Comm. on Labor & Public Welfare, Legislative History

of the Occupational Safety & Health Act of 1970, 924 Cong., *3t

Sess. 1094-1095 (1971).

but the equivalent of a check list of techniques which he

was to utilize in most, if not all, the cases. '5

Instead of reviewing the Secretary's action in terms of

the controlling statutory mandates, the Court of Appeals

merely looked to the statement of reasons. It then con-

cluded that the Secretary's omission of a performance

standard was a "’. . . reasonable exercise of his judgment

in the policy-making sphere” (App. A, p. 10a), and that

the omission of a monitoring provision was a "pragmatic

decision" (/d. at 12a). In neglecting to measure these

standards in terms of their statutory framework, the court

below significantly failed to perform the function assigned

to it by Congress.

This Court has consistently maintained that the final

authority to interpret Congressional enactments is vested

in the judiciary, United States v. American Trucking Ass'n,

310 U.S. 534 (1940); Marbury v. Madison, 5 U.S. (1

Cranch) 137 (1803), even in those instances in which

Congress has delegated legislative or adjudicatory func-

tions to an administrative agency, FTC v. Texaco, Inc.,

393 U.S. 223 (1968); National Broadcasting Co. v. United

States, 319 U.S. 190 (1943). This is particularly true

15 Each of these provisions contains such phrases as "whenever

practicable’’ or ‘where appropriate" thus indicating that all of these

standards, which cover safety hazards such as physical agents

as well as these chemical carcinogens, need not contain all these

provisions in every case. Nonetheless, a fair reading of these

requirements indicates that inclusion is the general iule. In this

case, the Secretary did not even explain his reasons for omitting

these provisions. Yet, the Secretary is obligated to state the

significant issues which have been faced and then articulate the

rationale underlying their resolution, Associated Industries of New

York State v. U.S. Dep't of Labor, 487 F.2d 342, 353-354 (2d

Cir. 1974). .

where statutory limitations are involved, eg., FMC Sea-

train Lines, Inc., 411 U.S. 726 (1973), or where admin-

istrative action has been mandated by the statute, Train

v. City of New York, ____ US. ____, 95 S.Ct. 839

(1975); Train v. Campaign Clean Water, Inc., U.S.

, 95 S.Ct. 847 (1975). Where there is an n administra-

tive tive interpretation of statutory authority, the courts are

"not obliged to stand aside and rubber stamp their

affirmance of administrative decisions that they deem

inconsistent with a statutory mandate or that frustrate

the Congressional policy underlying a statute . . " NL.R.B.

y. Brown, 380 U.S. 278, 291 (1965); Volkswagenwerk

Aktiengesellschaft v. FMC, 390 U.S. 261, 272 (1968);

FMC vy. Seatrain Line, Inc., supra, at 746. Moreover,

"(t}he deference owed to an expert tribunal cannot be

allowed to slip into judicial inertia . . ." American Ship

Building Co. v. N.L.R.B., 380 U.S. 300, 388 (1965).

The reviewing court has an affirmative obligation to

review administrative action regardless of the Secretary's

failure, as in this case, to analyze his obligations in terms

of the statutory mandate. The Court must delineate the

scope of the Secretary's authority and discretion, and

identify the range of choices left to the administrator by

Congress. Citizens to Preserve Overton Park v. Volpe,

401 U.S. 402, 415-416 (1971). Where there is little

choice left to the administrator, the Court must carefully re-

view compliance with the statutory requirements. Id.

Judicial review thus necessitates a determination that the

administrator's action conforms with the statutory man-

dates, Train v. City of New York, supra, and is consistent

with the Congressional purpose, Morton v. Ruiz, 415 US.

199 (1974). Finally, the reviewing court must interpret

the statute as mandatory when to do otherwise would

seriously impair the interests to be protected, Escoe v.

Zerbst, 295 U.S. 490, 494 (1935).

Although section 6(b) dictates a limited range of

choices for monitoring and a performance standard, the

Court of Appeals has obliterated those limitations by fail-

ing to examine the statute at all. Instead, by concentrat-

ing its exclusive attention on the statement of reasons, it

has abdicated the role assigned by Congress in reviewing

the legal issues arising from the Secretary's interpretation,

or more accurately, his non-interpretation, of the Act.

The gravity of the abidcation of the Third Circuit is

compounded here because these chemicals pose a cancer

hazard to workers, and, as the Secretary himself acknowl-

edged, there is no known safe level of exposure to these

carcinogens (App. B, p. 20a).

The refusal of the Court of Appeals to at least insist

on an explanation from the Secretary for not including

these provisions is even less understandable in view of

the wide spread practice of including performance require-

ments and monitoring in other standards issued under the

Act, as the Secretary's own advisory committee recom-

mended. For instance, the Secretary adopted as "‘estab-

lished federal standards'’ under section 6(a) of the Act,

29 U.S.C. 8655(a), nearly 400 performance standards for

a variety of toxic substances that had originally been

issued under the Walsh-Healy Act. 29 C.F.R. $1910.93,

Tables G-1, G-2, & G-3 (1974). And in the first carcino-

gen standard promulgated under section 6(b), the Secre-

tary included not only a performance standard, but also

extensive monitoring provisions. 29 C.F.R. §1910.93a(b),

(f) (1974) (asbestos). !®

16 Subsequent to the issuance of the standards at issue here,

the Secretary promulgated both emergency and permanent standards

(continued)

Because the court below failed to discharge its duty to

review these standards in light of the requirements im-

posed by Congress, this Court should grant the writ

and direct the Court of Appeals and the Secretary to con-

sider the propriety of the standards under the tests estab-

lished by the Act. In this way the health of the 10,-

000 employees affected by these chemicals will be protected

in the manner provided by Congress, and the courts of

appeals will be given specific guidance on the performance

of their functions under the Act.!”

B. This Court Should Settle A Critical Question

Regarding Judicial Review of Occupational Safety

and Health Standards On Which the Circuits

Appear to Be in Conflict.

Three other circuits have been called upon to review

the Secretary's actions in terms of the statutory require-

ments, and each has directly compared the action to the

terms of the Act. In Florida Peach Growers Ass'n v. U.S.

Dep't of Labor, 489 F.2d 120 (Sth Cir. 1974), the Court

enforced the section 6(c)(1) requirement that a "grave

16 (continued)

for vinyl chloride which contain performance standards and a moni-

toring requirement. 29 C.F.R. §1910.93q(b), (c), 39 Fed. Reg.

12342 (April 15, 1974); 29 C.F.R. §1910.93q(c), (4), 39 Fed. Reg.

35890 (October 4, 1974).

17 The petition for certiorari denied by this Court with re-

spect to the determination that El was a carcinogen sought to

question the approach of the Court of Appeals in applying the

substantial evidence test to factual findings under section 6(f),

29 U.S.C. $655(f). Thus, that petition (No. 74-789) presented a very

different type of issue from the one presented here.

danger" must support the issuance of an emergency tem-

porary standard and required the Secretary to satisfy this

statutory prerequisite. In another case involving the safety

net standard, the Seventh Circuit directly applied the commit-

tee membership requirements of section 7(b) to the con-

struction advisory committee even though it considered

the petitioners’ claims "frivolous.'’ National Roofing Con-

tractors Ass'n v. Brennan, 495 F.2d 1294 (1974), cert.

denied, _ US. __, 95 S.Ct. 775 (1975). Signifi-

cant issues were raised regarding the adequacy of the as-

bestos standard in another case, and the District of Colum-

bia Circuit analyzed each in terms of the controlling

statutory language. IJndustrial Union Dep't, AFL-CIO

v. Hodgson, 499 F.2d 467 (1974). And where it found

that the Secretary failed to meet the requirements of

section 8(c)(1) for the retention of monitoring records,

that Court. remanded the recordkeeping provisions to the

Secretary. Jd. at 485, 487-488. The Court also emphasized

that the reviewing court must closely examine the Secretary's

action in relation to the relevant concerns of the Act, id. at

488, and that it must determine whether the agency had per-

formed in accordance with Congressional purposes. /d. at

475. Finally in Associated Industries of New York State

v. U.S. Dep't of Labor, 487 F.2d 342, 353-354 (2d Cir.

1973), Judge Friendly followed the same basic approach

in reviewing the lavatories standard.

Although the Third Circuit in two earlier decisions,

and in the part of this decision dealing with the timing of

the proposed permanent standard on MOCA (App. A, pp. Sa-

9a), reversed decisions of the Secretary, it did so on procedural

18 Dry Color Mfrs. Ass'n v. Dep't of Labor, supra; Synthetic

Organic Chemical Mfrs. Ass'n v. Brennan, supra.

matters that could be readily cured upon remand. How-

ever, when the Court came to the substantive mandates

for worker protection, it ignored both the controlling

statutory mandates and its past precedents enforcing

procedural mandates. Indeed, even its reversal on the

issue of medical surveillance was based almost entirely

on the irrationality of the Secretary's action and not on

the dictates of the Act.

C. This Court Should Settle A Critical Question of

Statutory Construction Involved In the Adminis-

tration and Enforcement of the Act.

Worker protections meeting the basic statutory mandates

will be a central issue in setting all future health standards

under the Act. The fourteen standards involved in this

petition are the forerunners of hundreds of other standards

which will be necessary to control workplace hazards. The

most recent NIOSH Toxic Substances List includes 13,000

chemicals which have demonstrated toxic effects,!9 and new

chemicals are constantly being introduced into the market-

place. Senate Report at 2.

Formal recommendations for 20 new standards ("‘criteria

documents") have been transmitted to the Secretary from

NIOSH and are awaiting standard-setting action, with an

estimated 18.5 million workers who must confront these

serious health hazards.” Another 31 criteria documents

19 Nat'l Inst. for Occupational Safety & Health, U.S. Dep't of

Health, Educ. & Welfare, The Toxic Substances List — 1974 Edition

20 Nat'l Inst. for Occupational Safety & Health, U.S. Dep't of

Health, Educ. & Welfare, Criteria for Recommended Standards on

Occupational Exposure to Ammonia, Inorganic Arsenic, Benzene,

(continued)

are expected before the end of fiscal year 1976,27! and

NIOSH has recently begun an inquiry into the dangers of

29 other chemical substances.2* However, planned govern-

ment projects will not be the only source of new standards in

the future, as evidenced by the unexpected disclosure of

new hazards for both vinyl chloride® and arsenic.”

Every new standard will necessarily involve the statutory

requirements for a performance standard, monitoring, medi-

cal surveillance, and the other mandates of section 6(b)(7).

rurthermore, in the next two years almost 400 "established

federal standards" promulgated in 1971 will be supple-

mented with the monitoring, medical surveillance, and other

requirements under section 6(b)(7) that they now lack.”

20 (continued)

Beryllium, Carbon Monoxide, Chloroform, Chromic Acid, Coke

Oven Emissions, Cotton Dust, Crystalline Silica, Hot Environments,

Inorganic Lead, Inorganic Mercury, Noise, Sulfur Dioxide, Sulfuric

Acid, Toluene. Toluene Diisocyanate, Trichloroethylene, & Ultra-

violent Radiation (1972-1975).

21 3 CCH Employment Safety & Health Guide 49545 (1975).

22 39 Fed. Reg. 44792 (December 27, 1974); 40 Fed. Reg. 7960

(February 24, 1975); 40 Fed. Reg. 13231 (March 25, 1975).

23 39 Fed. Reg. 3874 (January 30, 1974) (fact-finding hearing);

39 Fed. Reg. 12342 (April 15, 1974) (emergency temporary stand-

ard).

24 39 Fed. Reg. 31644 (August 30, 1974) (fact-finding hearing);

40 Fed. Reg. 3392 (January 21, 1975) (proposed permanent.

standard).

25 36 Fed. Reg. 10466, 10503-10506 (May 29, 1971).

26 Notices of proposed rulemaking appear at 39 Fed. Reg.

33843 (June 20, 1974); 40 Fed. Reg. 4019 (January 27, 1975);

40 Fed. Reg. 4930 (February 3, 1975); 40 Fed. Reg. 11890 (March

14, 1975); 40 Fed. Reg. 17654 (April 21, 1975); 40 Fed. Reg.

20201 (May 8, 1975).

The issues raised in this petition regarding judicial review

and the worker protections required by the Act, will

have universal application to this enormous standard-set-

ting activity. Resolution of these statutory issues by this

Court will assist the Secretary in meeting his statutory

obligations and guide the courts of appeals in reviewing

these standards.

Finally, occupational health and safety standards are

the primary enforcement method under the Act, Brennan

v. Occupational Safety & Health Review Comm'n, 491

F.2d 1340, 1343 (2d Cir. 1974). Where a standard lacks

protective provisions such as monitoring or medical sur-

veillance, compulsory enforcement of these protections

under sections 9 and 10 of the Act will be extremely

difficult. See generally, American Smelting & Refining

Co. v. Occupational Safety & Health Review Comm'n,

501 F.2d 504 (8th Cir. 1974). Even employer efforts

at voluntary compliance are seriously compromised when

the standard lacks any specific guidance on worker pro-

tections.

The cancer hazard posed by these fourteen chemicals

immediately affects ten thousand workers. However, the

necessary protection of the 57 million workers covered

by the Act is directly dependent on the promulgation and

enforcement of standards which afford the complete pro-

tection mandated by Congress. This Court, by reviewing.

the decision below and directing the Secretary and the

courts of appeals to comply with the Act, can signifi-

cantly advance the effectiveness of the worker protection

provided by Congress and give badly needed guidance to all

concerned and thereby avoid unnecessary litigation.

CONCLUSION

For the foregoing reasons, the petition for a writ of

certiorari should be granted.

Respectfully submitted,

ALAN B. MORRISON

BERTRAM ROBERT COTTINE

Suite 700

2000 P Street, N.W.

Washington, D.C, 20036

(202) 785-3704

Attorneys for the Petitioners

May 16, 1975

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APPENDIX A

UNITED STATES COURT OF APPEALS

For toe Turmp Circuit

No. 74-1129

No. 74-1149

No. 74-1268

SYNTHETIC ORGANIC CHEMICAL MANUFAC-

TURERS ASSOCIATION, ET AL.,

Petitioners in No. 74-1129

PETER J. BRENNAN, SECRETARY,

DEPARTMENT OF LABOR, ET AL.,

) Respondents.

OIL, CHEMICAL & ATOMIC WORKERS

INTERNATIONAL UNION, AFL-CIO, ET AL.,

Petitioners in No. 74-1149

PETER J. BRENNAN, SECRETARY,

DEPARTMENT OF LABOR, ET AL.,

Respondents.

POLYURETHANE MANUFACTURERS

ASSOCIATION,

Petitioner in No. 74-1268

DEPARTMENT OF LABOR, ET AL.,

Respondents

Ow Perrrion ror Review or AcTION oF THE

Assistant SEcRETARY oF LABOR FOR

OccuPaTIONAL SaFETY AND HEALTH

Argued October 21, 1974

Before Hastie, Grssons and Weis, Circuit Judges.

Or CounsgEL:

Cleary, Gottlieb, Steen

& Hamilton

1250 Connecticut Avenue,

N.W.

Washington, D.C. 20036

Or CounsgL:

William J. Kilberg, Esq.

Solicitor of Labor

Benjamin W. Mintz, Esq.

Associate Solicitor for

Occupational Safety &

Health

Michael H. Levin, Esq.

Counsel for Appellate

Litigation

Steven F. Witt, Esq.

Robert C. Barnard, Esq.

Donald L. Morgan, Esq.

Charles F. Lettow, Esq.

Eric Schwartz, Esq.

Washington, D.C. 20036

Attorneys for Petitioners

in No. 74-1129

Bertram Robert Cottine,

Esq.

Alan B. Morrison, Esq.

Suite 700

2000 P Street, N.W.

Washington, D.C. 20036

Attorneys for Petitioners

in No. 74-1149

Arvid A. Sather, Esq.

25 West Main Street

Madison, WI 53703

Attorney for Petitioner in

No. 74-1268

Carla A. Hills, Esq.

Assistant Attorney General

Stephen F. Eilperin, Esq.

Michael H. Stein, Esq.

Department of Justice

Washington, D.C. 20530

Attorneys for Respondents

OPINION OF THE COURT

(Filed December 17, 1974)

Weis, Circuit Judge.

The important subject of OSHA’s regulations on the

usage of a group of chemicals labeled as carcinogens oc-

cupies us once again. Although most of the standards are

sustained, those as to laboratory practices and medical

examinations of employees must be remanded. We also

find validity in the objections by one of the appellants that

the Secretary of Labor erred in not publishing a proposed

regulation after receiving the report from his advisory

committee.

These are companion cases to Synthetic Organic

Chemicals Manufacturers Association v. Brennan, — F.2d

— (No. 74-1129 3d Cir. Aug. 26, 1974), consisting of ap-

peals from occupational health standards promulgated by

the Secretary of Labor. These permanent regulations were

issued on January 29, 1974, regulating, inter alia, the ex-

posure of employees to fourteen chemicals found to be

carcinogenic. 29 C.F.R. §1910.93ce-p.

Appeals to this court were filed on behalf of employers

who utilized four of the chemicals—EI, CMME, DCB and

MOCA. Another appeal was filed by the Oil Chemical and

Atomic Workers Union from the standards applicable to

all fouiveen substances. The appeal as it pertained to

Ethyleneimine (EI) was severed, and we held in the prior

opinion that the Secretary had made sustainable determina-

tions as to the chemical’s carcinogenicity and proper stand-

ards for industrial usage. We concluded, however, that

proper notice had not been given before promulgating

regulations for the use of EI in the laboratory and re-

mwanded on that point. Our conclusions as to the legal

issues presented by the earlier case likewise apply to the

appeals now under consideration and we need not repeat

what was said in our prior opinion.

The contentions made here with respect to 3, 3’-di-

chlorobenzidine (DCB) by employers who utilize it are

similar to those raised in connection with El—that is, the

data derived from tests revealing carcinogenicity in ani-

mals were not properly extrapolated to human suscepti-

bility. Nothing in the record permits a differentiation here

from our earlier decision on El, and we do not make one.

While the scientific data varies, of course, the same legal

principle applies and, accordingly, the petitioners’ conten-

tion must fail.

The thrust of the opposition to the standard regulating

chloromethyl methyl ether (CMME) is aimed at certain

studies relied upon by the Secretary. The employers con-

test the validity of the Van Duuren studies’ by questioning

whether pure CMME was tested or whether, as usually oc-

curs, the substance was contaminated to form bis chloro-

methyl ether (BCME).? Again, the issue is the same as

that in the EI appeal, and again in this case the Secretary’s

determination finds adequate support in the record.

Polyurethane Manufacturers Association (PMA), the

employers’ association concerned with the use of 4,4’

methylene bis (2-chloroaniline) (MOCA) ® in various manu-

facturing processes, presses the same arguments as to

carcinogenicity that are advanced for DCB and CMME. Of

necessity, the same criteria of review is applied to this

chemical as the others in question. The Secretary’s deter-

1. Van Duuren studied the properties of BCME and CMME and, in 1968,

experments employing both skin applications. and subcutaneous inject His

presence certain

suub coatmemenes anten Geax CH ead TROT Connell in animal

subjects. anf yr S&S

used through I.R. and GLC analysis, showing no BCME content.

2. BCME is a potent chemical which industry concedes is carcinogenic.

Be cqpee Gag ot Ce eet Ge peceaee & pale Cs © Oe Cae

mercially feasible. In industrial usages. it rapidly decomposes in air and

now

3. "h. MOCA io the wade anme wilted by duPont, stthough te chemical

Seanase of no singliany, bet © cheuld be und We use the MOCA trade name

mination is supported by the record and therefore must be

sustained.

PMA, however, raises one additional contention not

presented in the other appeals. It challenges the pro-

cedures followed by the Secretary in promulgating the

permanent standards for the industrial use of MOCA. This

contention has merit and requires that the case be re-

manded to the Secretary for compliance with the statutory

mandate.

MOCA was subject to the same emergency standard

that was issued by the Secretary for the other thirteen

chemicals on May 3, 1973 although PMA apparently did not

become aware that MOCA was to be included in the group

until the emergency standard was published. Thereafter,

the Secretary instituted procedures to enact a permanent

standard. According to 29 U.S.C. § 655(c) (2) and (3), once

an emergency temporary standard is enacted, it is effective

until superseded by a permanent standard fashioned in ac-

cordance with the procedures prescribed in §655(b). The

emergency standard serves as a proposed rule for that

proceeding and the permanent standard must be enacted

within six months. The legislative history emphasizes that

‘*upon publication of such an emergency temporary stand-

ard, the Secretary must begin a regular standard setting

procedure.’’ 1970 United States Code Congressional and

Administrative News, P. 5184.

We now turn to the requirements of §655(b). That

section provides that the Secretary may request the recom-

mendations of an advisory committee to which he may

submit his own proposals as well as pertinent factual and

research data. The committee then submits its recom-

mendations to the Secretary within a specified time. Para-

graph (2) provides that the Secretary shall publish a pro-

posed rule and that interested parties be given the

opportunity to submit written data, comments or objections

to the proposal within thirty days. If an advisory com-

mittee has been appointed, the Secretary is to publish the

proposed rule within sixty days after the submission of the

committee’s recommendations. Paragraph (3) provides

that, if objections are filed to the proposed rule and a hear-

ing is requested, notice of the hearing shall be given within

thirty days of the last date for filing objections.

With these guidelines in mind, it is appropriate to re-

view the chronology of the proceedings here:

May 3, 1973 —The emergency temporary stand-

| ard was issued.

June 19, 1973 —The Secretary announced the for-

mation of an advisory committee.

July 16, 1973 —The Assistant Secretary of Labor

published a notice of ‘‘Com-

mencement of rule-making pro-

ceeding,’’ stating that the emer-

gency standard of May 3, 1973

was proposed to be made per-

manent.

July 27, 1973 —The Assistant Secretary pub-

lished a revision of the emergency

temporary standard.

August 16, 1973 —An amended notice of proposed

rule making was published to re-

flect the revision.

August 27, 1973 —The advisory committee sub-

mitted its recommendation to the

Secretary.

September 7, 1973 —The committee’s recommenda-

tions were published.

September 11-14, 1973 * —Public hearings were held. Addi-

tional comments were received

until September 28, 1973.

sublished pursuant to. §455(b) (2)

with an allowance of thirty days to file comments. —_

—eEao rr rr lesser ee ee lll eee

January 29, 1974 —The permanent standard was

published as to MOCA, with sep-

arate regulations for the thirteen

other substances.

The procedures followed here did not comply with

§ 655(b). The proposed rule was published before the ad-

visory committee had submitted its report. Consequently,

the parties were not given adequate time to submit com-

ments or to prepare for the hearing after the committee’s

work was completed. Had § 655(b) been observed, under

the most expeditious of circumstances, the hearing could

not have been held earlier than thirty days after the ad-

visory committee had submitted its report te the Secretary.’

The Secretary contends that this timetable does not

apply when an emergency standard has been issued since

§ 655(c)(3) states that the emergency standard shall serve

as a proposed rule for the paragraph (b) proceeding. If no

advisory committee is appointed, paragraphs (b) and

(c)(3) are consistent but when an advisory committee does

function, there is a conflict between the two statutory provi-

sions. It is our conclusion that paragraph (b) must prevail.

As we said in Dry Color Manufacturers’ Association v. De-

partment of Labor, 486 F.2d 98, 104-105 n.9a (3d Cir. 1973) :

‘‘The courts should not permit temporary emergency

standards to be used as a technique for avoiding the

procedural safeguards of public comment and hearings

required by subsection 6(b). Especially where the

effects of a substance are in sharp dispute, the promul-

gation of standards under subsection 6(b) is preferable

since the procedure for permanent standards is spe-

cifically designed to bring out the relevant facts.’’

While that comment was made in another context, its under-

lying philosophy is pertinent.

If we were to hold that paragraph (b) does not apply,

then the purpose of convening an advisory committee would

be subverted. A rule which the committee was to assist in

formulating would have already been published and the

committee’s function would be reduced to merely preparing

comments to a proposal. This is not compliance with the

statutory mandate that the committee shall submit its

recommendations ‘‘regarding the rule to be promulgated.”’

Congress did not intend a mere post facto role for the

advisory committee because it provided that a proposed

rule must be published within sixty days after submission

of the committee’s recommendation. § 655(b) (2).

We are not critical of the Secretary’s decision to utilize

an advisory committee in this instance. To the contrary, in

view of the complexity of the problems, that procedure is

highly desirable. See 1 Davis, Administrative Law

Treatise § 6.03. However, the value of notice and comment

from interested parties in a hearing for rule making was not

realized in this case. As an example, the advisory com-

mittee was instructed that only one set of standards would

be promulgated for all fourteen chemicals, despite the sub-

stantial differences in their properties and their industrial

and laboratory uses.* After the public hearings had been

concluded, however, the Secretary issued separate stand-

ards for each chemical.’ Had the proposed rule recited the

separate standards, the presentation of pertinent objec-

tions, comments and data would have made the public

hearings far more valuable to all concerned.* Since the

6. Some of the committee members objected to this directive and the

Secretary recognized that there was some merit to their pease publishin

a revision of the emergency temporary standard on July 27, 1973. 38 F

Reg. 20074 (1973). However, this revision did little to solve the problem and

the instructions to the committee remained unchanged.

7. Much of the language, however, in the separate standards is merely

duplication of that governing all of the other chemicals.

8. PMA, for example, says that the revision of July 27, 1973 permitted it

to utilize open vessel processes. However, the report of the advisory com-

procedural requirements of the statute were not observed,

the standards relating to MOCA must be remanded to the

Secretary for appropriate action to correct the defects.

The Oil Chemica] and Atomic Workers Union (OCAW)

and the Health Research Group have appealed from the

standards established for each of the fourteen chemicals.

These petitioners assert that the standards are deficient

because :

1. they fail to include a performance standard man-

dating no measurable exposure to any of the chem-

ical substances ;

2. the Secretary erred in declining to require a permit

system as a regulatory device ;

3. no monitoring requirements were included in the

final regulation ; and

4. no specific tests were set forth as part of the require-

ments for medical examinations.

The first contention, suggesting that a no measurable

exposure standard be used, presents the same difficulty in

review as that discussed in the EI case. There, we pointed

out that by extrapolating the testing on animal species to

establish carcinogenicity in man, the Secretary was exer-

cising a policy judgment rather than a purely factual

determination.

Here, the Secretary stated that, while a safe level of

exposure cannot be established by application of present

8. (Cont’d.)

mittee, whose recommendations had to be geared to cover all fourteen chemicals,

permitted only closed wessel operation. The permanent standards ibited

open vessel operation. The Secretary contends that the revised definition of

“closed vessels” formulated by the advisory committee and ultimately adopted

in the permanent standard does permit certain open vessel operations involving

MOCA. PMA questions this and asserts that had it been given the oppor-

a to meet the issues at a public hearing after being advised of the specific

s later adopted, it would have been able to develop the data to show

that the unique properties of MOCA would permit safe operation in open

vessels. We do not resolve that factual dispute here and merely point to it

as an example of where compliance with the terms of the statute might have

provided a regulation and standard more acceptable to all concerned.

10a

knowledge, there is respectable opinion that such levels do

exist and that a total ban on manufacture is the only com-

plete guarantee of no possible exposure.’ He recited that

the intent of the standards is to reduce exposure of workers

to the maximum extent practicable with continued use. The

standards applicable to certain of the substances do provide

that mixtures containing less than one percent of the chem-

ical would be exempt from regulation and in the other six

the level is set at 0.1 percent.

As was aptly stated in Industrial Union Department v.

Hodgson, 499 F.2d 467, 474 (D.C. Cir. 1974):

‘*. . . some of the questions involved in the promul-

gation of these standards are on the frontiers of

scientific knowledge, and consequently as to them in-

sufficient data is presently available to make a fully

informed factual determination. Decision making must

in that circumstance depend to a greater extent upon

policy judgments and less upon purely factual anal-

ysis.”’

And in discussing the requirements of feasibility noted in

§ 655(b)(5),’° the court said:

‘‘Congress does not appear to have intended to protect

employees by putting their employers out of business—

either by requiring protective devices unavailable

under existing technology or by making financial viabil-

ity generally impossible.’’

We conclude that the action of the Secretary in setting

exposure standards is a reasonable exercise of his judg-

ment in the policy making sphere.

9. 39 Fed. Reg. 846 (1974).

10. This section in part provides, “The Secre .. . Shall set the standard

which most adequately assures, to the extent feasible, on the basis of the best

—— evidence, t no employee will suffer material impairment of

lla

While the advisory committee recommendation favored

a permit system," the Secretary stated that a decision had

been made not to adopt such a system. He wrote:

‘*The investigations and evaluations of thousands of

work situations involving a carcinogen, and the com-

pletion of procedures, possibly including hearings, for

the granting of permits, would require many years and

the diversion of substantial resources, even if available,

from other serious occupational safety and health

considerations.’’ ”

Though there is much to be said for recently expressed

concern about undue judicial deference to administrative

expertise, this is an appropriate situation for such respect.

The OSHA program is a vast one, but to interested parties

one particular facet of its operation may understandably

appear to be the most critical. The Secretary, however,

who has the responsibility for allocation of the not un-

limited resources entrusted for OSHA’s operation, may

differ. The court should defer to his opinion of what is a

practical program which can be administered with some

degree of speed and efficiency. We find no error in the

Secretary’s choice between methods of enforcement.

No provision for specific techniques of environmental

monitoring are contained in the standards and OCAW ob-

jects to this omission. But in our view the Secretary has

satisfactorily met this objection by requesting NIOSH ™ to

develop, on a priority basis, methods for determining

amounts of carcinogens in the work place. In effect the

11. An employer would be required to apply to the agency for a permit

before being allowed to use the chemical. The permit would presumably not

issue until there was a showing of compliance with appropriate standards.

This type of regulation should contrasted with the one put into effect,

that is, permitting — but depending for enforcement upon inspections and

sanctions for non-compliance.

12. 39 Fed. Reg. 846 (1974).

13. The National Institute for Occupational Safety and Health (NIOSH)

was established within the Department of Health, Education and Welfare by

29 U.S.C. §671.

12a

Secretary has deferred implementation of monitoring re-

quirements pending further scientific development of

methods for doing so. Such a decision is a pragmatic one

which will not be disturbed by the court.

Finally, OCAW attacks the provisions for medical ex-

aminations because they do not prescribe specific medical

protocols and diagnostic tests to be given employees who

work with the chemicals. The advisory committee sug-

gested that employers should provide a comprehensive

history and physical examination consisting of diagnostic

tests and periodicity specific to the carcinogen and in no

less detail than guidelines set forth by the Secretary of

Labor after consultation with the Secretary of Health, Edu-

cation and Welfare.

During the rule-making process, evidence was sub-

mitted which established that the various carcinogens acted

on different bodily organs and that particular tests were

required for specific chemicals. This evidence was another

instance of the problems engendered by considering all of

the substances as a group rather than on an individual

basis.

The Secretary gave no reasons for ignoring this recom-

mendation of the advisory committee, nor did he indicate,

as he did in connection with monitoring devices, that fur-

ther information was needed.

29 U.S.C. § 655(b)(7) provides, inter alia:

‘In addition, where appropriate, any such standard

shall prescribe the type and frequency of medical ex-

aminations or other tests which shall be made available,

by the employer or at his cost, to employees exposed to

such hazards in order to most effectively determine

whether the health of such employees is adversely af-

fected by such exposure.’’

In contrast to the standards adopted here, certain diagnos-

tic tests are required by the regulations pertaining to

asbestos workers, see 29 C.F.R. § 1910.93a(j)(2) & (3), and

l3a

some specificity is evident in the medical examination re-

quirements for employees who are exposed to viny] chloride,

39 Fed. Reg. 35897 (1974).

At oral argument, counsel for the Secretary posited

that the existing broad standards could be interpreted to

require any specific diagnostic tests which might be neces-

sary. But this approach introduces an element of un-

certainty not satisfactory to either employee or employer.

It is important that the worker be assured of the benefits

of medical procedures that are presently available and that

industry be advised of what is expected of it. The regu-

lations can be drafted with ample flexibility to take ad-

vantage of expanding medical knowledge in the field.

Specific provisions need not discourage improvement or

innovation in this critical area.

The failure of the Secretary to explain the lack of

specific requirements making the medical examinations ef-

fective requires that we remand this aspect of the standards

applicable to all of the chemicals.

In summary then, the regulations applicable to 4,4’

methylene bis (2-chloroaniline) (MOCA) will be remanded

for the publication of a proposed standard, to be followed

by the required procedures for allowance of comments and

hearing. The regulations pertaining to laboratory usage

of all the chemicals involved in these appeals are remanded

so that appropriate notice may be issued to interested par-

ties and opportunity provided for comment and hearing.

The portion of the standards applicable to all of the chem-

icals referring to medical examinations will be remanded

for further proceedings.

A True Copy:

Teste:

Clerk of the United States Court of Appeals

for the Third Circuit.

(A.O.—U. S. Courts, International Printing Co., Phila., Pa.)

l4a

APPENDIX B

STATEMENT OF REASONS AND A REPRESENTATIVE

CARCINOGEN STANDARD ISSUED BY SECRETARY OF

LABOR JANUARY 29, 1974

The Statement of Reasons and Standards on Carcinogens

issued by the Secretary of Labor, 29 C.F.R. 8 1910.93c-p,

39 Fed. Reg. 3756 (January 29, 1974), are reprinted below.

A representative standard has been selected, 29 C.F.R.

§ 1910.93/, since all fourteen standards are identical for

the purposes of this petition.

Titte 29—Lasor

Cuapter XVII—OccupationaL Sarety aNp HEALTH

ADMINISTRATION, DEPARTMENT OF LABOR

Part 1910—OccuPaTIONAL SAFETY AND HEALTH

STANDARDS

Carcinogens

Pursuant to section 6(b) and (c) of the Williams-

Steiger Occupational Safety and Health Act of 1970

(29 U.S.C. 655) and Secretary of Labor’s Order No.

12-71 (36 FR 8754), Part 1910 of Title 29, Code of

Federal Regulations, is hereby amended in the manner

set forth below, in order to provide standards dealing

with the exposure of employees to certain substances

that are known to cause cancer.

Background. On May 22, 1972, the Deputy Assistant

Secretary of Labor for Occupational Safety and Health

requested information from the Director of the Na-

tional Institute for Occupational Safety and Health

(NIOSH) on nine substances alleged to be carcinogens.

As part of his effort to gain the best available scientific

data, the Director published on July 6, 1972, at 37 FR

13285, a request for information concerning 15 sub-

stances. The data, arguments, and conclusions re-

ceived by NIOSH were made available to the Occupa-

tional Safety and Health Administration.

On January 4, 1973, a petition for an emergency

temporary standard from the Oil, Chemical, and At-

15a

omic Workers Union (OCAW) and Health Research

Group (HRG) was received by the Department of La-

bor. The petition contained relevant information on

the danger of exposure to 10 carcinogens, and sug-

gested regulations to prevent worker exposure to the

substances.

On February 9, 1973, a notice was published in the

FeperaL Recister (38 FR 4037) of the receipt of the

petition for issuance of an emergency temporary stand-

ard, and information was requested from interested

persons on the issues involved. In response to the

notice, more than 50 written comments were received.

An emergency temporary standard on carcinogens

was promulgated on May 3, 1973, at 38 FR 10929. The

standard concerned work practices and controls de-

signed to protect employees from exposure to 14 car-

cinogenic substances.

A standard advisory committee on carcinogens was

appointed and began its meetings on June 25, 1973.

The members of the committee represented employers,

employees, Federal and state agencies and profes-

sionals. The committee terminated its meetings on

August 24, 1973, and submitted to the Assistant Sec-

retary of Labor for Occupational Safety and Health

its recommendations for a standard on certain carcin-

ogens on August 27, 1973. The recommendations were

published in the Feperat Recister on September 7,

1973 (38 FR 24375).

This rulemaking proceeding was commenced under

section 6(b) and (c) of the Act, with the emergency

temporary standard serving as a proposal as required

by section 6(c)(3) of the Act. Notice of the proceed-

ing was published in the Feperat Recister on July 16,

1973 (38 FR 18900). On July 27, 1973, a revision of the

emergency temporary standard was published at 38

-FR 20074, and an amended notice of rulemaking pro-

l6a

ceeding was published at 38 FR 22141, on August 16,

1973.

The notices invited interested persons to submit,

prior to September 5, written comments, data and

arguments concerning the proposals, and also pro-

vided for the presentation of oral testimony at a public

hearing scheduled for September 11-14, 1973. Numer-

ous written comments were received and about 36

parties testified at the hearing. The record of the

hearing was initially held open until September 28,

for additional comments. After the close and certi-

fication of the record by the administrative law judge,

additional comments mailed on or before September

28 were received. On October 2 the judge reopened

the record for the limited purpose of including these

additional comments. On October 15, the judge closed

the proceeding and forwarded the certified record to

the Assistant Secretary of Labor for Occupational

Safety and Health for final decision.

A final environmental impact statement on the pro-

posed standard on carcinogens was filed with the

Council on Environmental Quality on October 2, 1973,

and copies were distributed to appropriate agencies.

In a letter dated November 2, 1973, the Council pointed

out alleged deficiencies in the statement filed. Pursuant

to that letter, a supplement to the statement was sent

to the Council on November 29, 1973, with a request

for a waiver of the full, 30-day review period. By

letter dated December 10, 1973, the Council advised

that the request had been denied. Notice of the filing

of the supplement was published by the Council on

December 14, 1973 (38 FR 34488).

The following are the major issues raised in the

record of this proceeding:

(1) Selection of carcinogens. Some participants in

this proceeding have demanded to know the criteria

17a

for the selection of the 14 substances for regulation.

As the written submission of Uniroyal Chemical notes,

thirteen compounds derive from Appendix A to the

1972 TLV pamphlet published by the American Confer-

ence of Government Industrial Hygienists (ACGIH).

Alpha-Naphthylamine, which is not in the appendix, has

been added because it has frequently been found, in

industrial experience and in epidemiologic studies, to-

gether with beta-naphthylamine, and because experi-

mental animal studies demonstrate its independent car-

cinogenicity, Dimethyl sulfate, which is in the appendix,

is not included in the standards because it was con-

cluded after consideration of the relevant literature

that the documentation of its carcinogenicity was inade-

quate. The substances listed by ACGIH (except one)

were selected in order to take advantage of the work

and judgment of that group. Also, ten of the fourteen

substances were proposed to the Occupational Safety

and Health Administration (OSHA) for regulation by

OCAW and HRG in their petition.

(2) Documentation of carcinogenicity. The Na-

tional Institute for Occupational Safety and Health

(NIOSH), as official scientific advisor to OSHA, sub-

mitted to OSHA fourteen hazard review documents;

one for each of the substances included in the stand-

ards. Each hazard review document contains a sum-

mary and evaluation of information and data obtained

by NIOSH, including experimental animal and ep-

idemiologic data. All but one of the substances are

considered by ACGIH to be carcinogenic in man and/

or animals.

In promulgating these standards, OSHA has relied

extensively but not exclusively, on the hazard review

documents prepared by NIOSH. Some of the sub-

stances are recognized as human carcinogens by some

. employers participating in this proceeding. For in-

18a

stance, although Young Aniline Works apparently

takes issue with the studies which demonstrated Ben-

zidine to be a human carcinogen, the Benzidine Task

Force of the Synthetic Organic Chemical Manufac-

turers Association does not oppose OSHA considering

benzidine as carcinogenic to humans.

The essence of the NIOSH hazard review documents

follows.

Ethyleneimine. The carcinogenic potential of ethy-

leneimine (EI) has been confirmed by a study con-

ducted by Walpole in 1954 involving rats and one spon-

sored by the National Cancer Institute involving mice.

In the first study, animals developed injection site

sarcomas which the investigators attributed to the

direct action of Ethyleneimine, and in the second study

80 percent of the animals developed tumors, including

more than one-half with hepatomas (which the inves-

tigators stated had ‘‘malignant potentiality’’) and al-

most three-quarters with pulmonary tumors. Although

high doses of EI were administered, the investigators

stated there was no way to predict whether man would

be more or less susceptible to tumor induction by EI.

The case for the carcinogenicity of EI, then, rests

on the extrapolation to humans of the findings in two

separate, controlled animal studies. This position is

compatible with that of NIOSH concerning the prior

demonstration of carcinogenicity in at least two animal

studies.

A major question of occupational carcinogenesis

relates to the extrapolation of results of animal experi-

mentation to humans. The basis of numerous objec.

tions to the proposals is that, even assuming the

validity of animal experiments, such do not furnish

sufficient evidence that the substances involved are

carcinogenic to humans. Extrapolation of results

19a

obtained by animal experimentation is alleged to be

vitiated by several considerations: (a) That certain

cancers are specific only to some species; (b) that the

conditions of animal experiments are out of proportion

to, and not consistent with, conditions prevailing in

industrial exposure; and (c) that no cancers have yet

been detected in humans exposed to the substances. For

those substances whose metabolism is understood, and

is similar in both animals and man, the fact that they

induce cancers in animals warrants the expectation that

they will induce cancers in men. This applies to the

substances which cause urinary bladder cancers in

animals acting, not directly, but indirectly through

the mediation of metabolites formed both in experi-

mental animals and in exposed workers. This is also

true of those substances which apparently require no

metabolic alteration but attack a particular biologic

system (e.g., respiratory tract, alimentary canal)

which is similar in both animals and humans.

The objections raise the much broader issue of

human exposure to a chemical which is only known

to have caused cancers in experimental animals.

It is important to note that some opponents of the

regulation of such chemicals do not advocate treating

them as if they were harmless with respect to car-

cinogenic potential. Several employers, for instance

insist that such substances must be treated with ‘‘care’’

or ‘‘respect,’’ while also insisting that they call for

significantly less protection than those substances

known to be human carcinogens.

We think it improper to afford less protection to

workers when exposed to substances found to be car-

cinogenic only in experimental animals. Once the car-

cinogenicity of a substance has been demonstrated in

animal experiments, the practical regulatory alterna-

tives are to consider them either non-carcinogenic or

20a

carcinogenic to humans, until evidence to the contrary

is produced. The first alternative would logically re-

quire, not relaxed controls on exposure, but exclu-

sion from regulation. The other alternative logically

leads to the treatment of a substance as if it was known

to be carcinogenic in man.

We agree with the Director of NIOSH, and the

report to the Ad Hoe Committee on the Evaluation

of Low Levels of Environmental Chemical Carcin-

ogens to the Surgeon General, U.S. Public Health

Service, April 22, 1970, that the second alternative is

the responsible and correct one. This decision accords

with the work practices of some who object to the

proposed regulation. For example, although the

Pharmaceutical Manufacturers Association argues for

the exclusion of research laboratories from the stand-

ard, it states as its ground the fact that employees in

Pharmaceutical research are taught to work with all

chemicals under the assumption that they are

dangerous, unless it is specifically known that they

are not.

(3) The petition, zero tolerance, and permit system.

The petition of Oil, Chemical and Atomic Workers

Union (OCAW) and Health Research Group (HRG)

for an emergency temporary standard on ten sub-

stances proceeds on the assumption that any exposure

to any amount of a carcinogenic substance must be

prevented. Accordingly, it proposes a standard of

zero tolerance permitting no exposure whatsoever.

This objective would be accomplished by means of a

permit system and frequent monitoring and reporting.

We agree with the Ad Hoc Committee on the Evalua-

tion of Low Levels of Environmental Chemical Car-

cinogens that a safe level of human exposure to any of

the 14 carcinogens cannot be established by application

of present knowledge. But we are not prepared to

2la

draw from this state of knowledge the conclusion that

such levels do not exist. First, it is the professional

opinion of many knowledgeable people that as yet

undetermined safe levels of exposure possibly do exist.

Also, a conclusion that safe levels do not exist seems

questionable in view of other studies, some in the area

of carcinogenicity which demonstrated that below a

certain amount of a single or cumulative dosage, no

detectable harm is caused, or if harm is caused, the

extent of such harm will be of no practicable impor-

tance because the latency period prior to manifestation

of harmful effects will be of greater duration than the

normal lifespan of man. Secondly, no possible ex-

posure to the carcinogens under any circumstances

could only be guaranteed by a total ban on the man-

ufacture, use (even for cancer research), and trans-

portation of the substances. As long as the sub-

stances are used, exposure to some amounts may occur

because of breakdown of equipment or human error.

Accordingly, the intent of the standards is to reduce

exposure of workers to any of the listed substances

to the maximum extent practicable consistent with

continued use.

Numerous objections have challenged the authority

for, and the administrative feasibility of, the permit

system proposed on July 16, 1973 (38 FR 18902). It

is argued, for instance, that the Act requires the

promulgation of general standards, in accordance with

the procedures prescribed in section 6 of the Act,

while the proposed permits would be tailored to par-

ticular users, and would be issued by a different

procedure.

Another objection argues that a permit system, to

be effective, would require authority to stop an opera-

tion involving a carcinogen by administrative action,

in contravention of the statutory scheme which con-

22a

templates judicial determinations resulting in the ces-

sation of an operation.

With regard to feasibility, it is pointed out that a

multitude of permits would be required, and that,

therefore, the implementation of a permit system would

require substantial resources and several years.

It has been made clear that there are numerous

uses and processes involving carcinogens. It appears,

for instance, that there are 800 to 1800 users of 4,4’-

methylene bis(2-chloroaniline) alone. The investiga-

tions and evaluations of thousands of work situations

involving a carcinogen, and the completion of the

procedures, possibly including hearings, for the grant-

ing of the permits, would require many years and the

diversion of substantial resources, even if available,

from other serious occupational safety and health

problems.

After considering the administrative and legal

aspects of a permit system, as against those of general

standards enforced by the use of the current enforce-

ment tools of the Act, the decision has been made not

to adopt a permit system.

The requirement in the adopted standards for em-

ployers to report the uses of carcinogens and the

nature of operations involved, together with incidents

of releases of carcinogens, will permit significant ad-

ministrative surveillance.

(4) Mixtures. The proposal for this rulemaking

proceeding, like the Emergency Temporary Standard,

excludes from the scope of the standard mixtures con-

taining less than specified percentages of the 14 listed

substances. The specific figure as a cutoff point de-

rives from the regulations of the Commonwealth of

Pennsylvania and England, which also regulate ex-

posure to carcinogens, and apparently have faced

23a

the same administrative difficulties confronting OSHA.

It is recognized that some of the carcinogens may be

used in minute amounts with other substances, or may

appear as unintended, undesired byproducts or contam-

inants of processes. Some of the substances are used

in minute amounts in cancer research laboratories, and

for medical purposes. The College of American Path-

ologists, for instance, points out that for years path-

ology laboratories and physicians have used benzidine

and/or benzidine dihydrochloride for diagnostic pur-

poses. The American Home Products Corporation

calls attention to the use of beta-Propiolactone for the

sterilization of vaccines and tissue grafts. Koppers,

Inc., requests an exemption in some form for materials,

such as coal tar and coal tar products, that contain trace

amounts of some carcinogens as by-products or con-

tamination of processes essential to our industrial

society. It states that the application of the proposed

standard to crude mixtures, such as coal tar and coal

tar products, without any exemption, would have the

effect of closing down large segments of industry, such

as steelmaking, wood preserving, roofing, aluminum

reduction, and possibly even power plants.

The adopted standards retain the proposed ex-

clusion of solid or liquid mixtures containing less than

1 percent, by weight or volume, of eight of the carcino-

gens. Solid or liquid mixtures containing 4-Amino-

diphenyl, Benzidine (and its salts), 4-Nitrobiphenyl,

beta-Naphthylamine, bis-Chloromethyl ether and

Methyl chloromethyl ether are excluded only if they

contain less than 0.1 percent of those substances. Fi-

nally, an exclusion is provided in the destructive distil-

lation of carbonaceous materials, for alpha-Naphthyla-

mine and beta-Naphthylamine, which may occur in such

processes.

The overall purpose of all the exclusions is to avoid

substantial obstruction, if not stoppage, of the use of

iin anal

24a

many processes and products which are considered

useful in industy and even in cancer research, and

about which the record contains very little informa-

tion. We do not know how many such products and

processes there are, nor the availability of substitutes

for all of the carcinogens involved, nor the effect of

the other components of a mixture on the carcinogenic

potentiality of the small amounts of the carcinogen

involved. The exclusionary percentage for mixtures

containing 4-Aminodiphenyl, Benzidine, 4-Nitrobi-

phenyl, beta-Naphthylamine, bis-CLioromethyl ether

and Methyl chloromethyl] ether has been lowered from

1 percent to 0.1 percent because these substances are

known to be potent human carcinogens.

The exclusion for the destructive distillation of car-

bonaceous materials is for the purpose of avoiding the

extreme consequences to the segments of the industry

using vigorous thermal processes at a time when a

separate standard-setting proceeding on coke oven

emissions will afford the opportunity for a more in-

depth consideration of this whole area (see 38 FR

26207). The exclusion of the mixtures rests, not on a

finding that the mixtures are non-carcinogenic, but

rather on a decision not to regulate them at this time,

on the basis of the record of this proceeding.

(5) Number of Standards Needed. Another objec-

tion to the proposals is that the standard ‘*lumps

together’? many different substances with different

chemicals and physical properties, different physical

states, different biological properties and different

uses. There is merit in this objection. Accordingly,

14 standards are adopted, one for each substance listed

in the proposal of July 16, 1973.

These standards recognize and provide for different

uses and operations involving the regulated carci-

nogens. Ethylencimine and beta-Propiolactone are

25a

immediately corrosive, and provisions are made in the

standards for these materials for deluge showers and

eye wash fountains, located near places where ex-

posures might be expected. Principally volatile ma-

terials will not be present long enough for routine

washing or showering to have effect as a protective

measure. Thus, a requirement to wash on each exit,

and shower at the end of the’ day, would not offer any

significant protection to employees working in areas

where the volatile materials, Methyl chloromethyl

ether, bis-Chloromethyl ether, Ethyleneimine and beta-

Propiolactone, are present in a closed system or closed

system transfer operation. Trace amounts that might be

adsorbed onto exposed skin vaporize long before the

employee would routinely wash or shower. Wash re-

quirements are retained for these materials in isolated

system operations because the closed confinement of

glovebox gloves would inhibit vaporization if a leak

should occur.

Special provisions are made for premix operations

involving 4,4 Methylene-bis (2-chloroaniline) and

liquid prepolymer. These premix solutions, frozen or

otherwise, are packaged in such a manner and used only

after the 4,4’-Methylene-bis(2-chloroaniline) and the

prepolymer have started to react. No dust hazard

exists and a vapor hazard is unlikely. For this reason,

the standard requires only protective clothing such as

smocks, coveralls, or long-sleeved shirts and pants,

and gloves. This, we believe, will afford adequate

protection for these workers.

On the other hand, some of the differences pointed

out do not require different treatment. There are

basically two strategies of control, regardless of the

physical state of a carcinogen. One is to isolate the

carcinogen and the other is to isolate the areas of

possible exposure. In cases of isolated systems, the

26a

physical state of the carcinogen may be disregarded for

practical purposes. When a system is isolated and

fully closed so that the substances cannot escape into

the work environment, it does not matter if the sub

stance in it is a solid, liquid, or gas. An isolated

system achieved by engineering controls is the pre-

ferred approach and the basic approach adopted in

the standards. That is, the preferred method of con-

trol is engineering control, such as by closed systems,

mechanical seals, remote controls, and local exhaust

ventilation. This approach most effectively isolates

employees from potential contamination.

This is the reason for the ban on open vessel opera-

tions. Because of consideration of feasibility, special

provisions are made for laboratory hoods and transfer

point operations, and additional work practice require-

ments are made applicable to them.

When protection is afforded by means of personal

protective equipment, it is thought best to require body

coverage, regardless of the physical state of the

substance and its path of travel into the body. The

reason for such personal protection is that even if a

substance is considered to do harm only when ingested

or inhaled, it is prudent to provide protective garments

to be discarded after use, so that a worker may not

accidentally inhale or ingest contaminants adhering

to his clothing or body. This precaution is reasonable,

especially since the standards do not require full im-

pervious air-supplied suits. OSHA agrees with the

many comments that a full impervious air-supplied

suit is cumbersome, while impervious garments with

air-supplied hoods are adequate and more comfortable

to the workers when used in accordance with the work

practice provisions of these standards.

(6) Research laboratories. Numerous objections have

been made to the proposal for identical treatment of

27a

industrial use and laboratory use of the carcinogens.

There are essentially three objections: (a) That

laboratories use very small amounts of the substances ;

(b) that work is done by, or under the direction of,

highly trained personnel; and (c) that, in the absence

of an exemption or other special consideration, the

standard as proposed would obstruct, and possibly

even prevent much research including cancer research.

These objections are well-taken and special pro-

visions are matte applicable to laboratory activities.

The provisions are derived from the Minimum Safety

Guidelines for Research in Cancer (Part 1, For Re-

search Involving Chemical Carcinogens), prepared in

draft form by the Cancer Research Safety Committee

of the National Cancer Institute. In addition, it is

to be noted that the exclusion provisions for certain

mixtures may, by themselves, make a whole standard

inapplicable.

Personnel engaged in animal support activities must

necessarily handle animals exposed in connection with

experiments involving one or more of the carcinogens.

Such support activities include the feeding of animals,

cleaning of cages and the animal room, and caring for

the animals, including weighing operations. Such

close animal contact involves potential exposure both

to a carcinogen and to metabolites of the carcinogen

and therefore requires the more stringent controls for

such personnel provided in the standards.

(7) Signs and labels. The controversy with regard

to signs and labels centers on whether the word

‘‘eancer’’ should be used. We believe that a diluted

form of warning will uot suffice. We appreciate the

concern of employers with the reactions of their em-

ployees and the users of their products. But we con-

sider of paramount importance that a worker should

be fully apprised and realize the possible risks in-

28a

volved in his occupation. The use of the word

‘‘guspect’? in the phrase ‘‘Cancer-Suspect’’ follows

the revised Emergency Temporary Standard issued

July 27, 1973. Coupled with the information and

training requirement in the standard, it appears to

provide the necessary warning to employees.

(8) Information and training. Employers are

responsible for providing indoctrination and training

to their employees on the nature of the carcinogenic

hazards in the establishment, and the precautions to

be used when working with or in the presence of the

carcinogens. Information on the training and educa-

tion to be provided to employees is specified in each

of the standards for a carcinogenic agent.

(9) Monitoring. No provisions for specific tech-

niques or instruments for environmental monitoring

are contained in the standards adopted. OSHA has

requested NIOSH to develop, on a priority basis,

methods for determining qualitative and quantitative

amounts of the carcinogens in the workplace.

(10) Medical surveillance. Medical surveillance by

a physician is required in the standards prior to assign-

ment, at yearly intervals thereafter and whenever

known or possible exposure to a carcinogen has oc-

curred. Medical surveillance is considered necessary

because of the long latency period inherent in oc

cupational carcinogenesis, since initiation of exposure

and induction of cancer are not synchronous events.

(11) Reports and records. The standards require

reports concerning the use of carcinogens, the number

of employees in regulated areas, and incidents result-

ing in the release of a carcinogen in an area where

employees may be potentially exposed. The stand-

ards also require records of medical examinations of

employees. The reports and records are considered

29a

necessary in order to monitor the effectiveness of the

standards in protecting employees against occupa-

tional cancer and in order to obtain information, on a

continuing basis, concerning the hazards found in the

use of the carcinogens.

Accordingly, upon consideration of the whole record

of this proceeding, 29 CFR Part 1910 is amended by

revising §1910.93c and by adding new §§ 1910.93d

through 1910.93p, reading as follows:

§ 1910.931 Ethyleneimine.

(a) Scope and application. (1) This section ap-

plies to any area in which Ethyleneimine, Chemical

Abstracts Service Registry Number 151564 is manu-

factured, processed, repackaged, released, handled, or

stored, but shall not apply to transshipment in sealed

containers, except for the labeling requirements under

paragraphs (e)(2), (3), and (4) of this section.

(2) This section shall not apply to solid or liquid

mixtures containing less than 1.0 percent by weight

or volume of Ethyleneimine.

(b) Definitions. For the purposes of this section:

(1) ‘* Absolute filter’’ is one capable of retaining 99.97

percent of a mono disperse aerosol of 0.3 »m particles.

(2) ‘‘Authorized employee’? means an employee

whose duties require him to be in the regulated area

and who has been specifically assigned by the employer.

(3) ‘‘Clean change room’’ means a room where

employees pnt on clean clothing and/or protective

equipment in an environment free of Ethyleneimine.

The clean change room shall be contiguous to and

have an entry from a shower room, where the shower

room facilities are otherwise required in this section.

- (4) ‘*Closed system’’ means an operation involving

Ethyleneimine where containment prevents the release

30a

of Ethyleneimine into regulated areas, non-regulated

areas, or the external environment.

(5) ‘*Decontamination’’ means the inactivation of

Ethyleneimine or its safe disposal.

(6) ‘Director’? means the Director, National In-

stitute for Occupational Safety and Health, or any

person directed by him or the Secretary of Health,

Education, and Welfare to act for the Director.

(7) ‘‘Disposal’’ means the safe removal of Ethyle-

neimine from the work environment.

(8) ‘‘Emergency’’ means an unforeseen circumstance

or set of circumstances resulting in the release of Ethyl-

eneimine which may result in exposure to or contact

with Ethyleneimine.

(9) ‘‘External environment’’ means any environ-

ment external to regulated and nonregulated areas.

(10) ‘‘Isolated system’’ means a fully enclosed

structure other than the vessel of containment of

Ethyleneimine, which is impervious to the passage of

Ethyleneimine, and which would prevent the entry of

Ethyleneimine into regulated areas, nonregulated

areas, or the external environment, should leakage or

spillage from the vessel of containment occur.

(11) ‘‘Laboratory type hood’’ is a device enclosed on

three sides and the top and bottom, designed and main-

tained so as to draw air inward at an average linear

face velocity of 150 feet per minute with a minimum

of 125 feet per minute; designed, constructed, and

maintained in such a way that an operation involving

Ethyleneimine within the hood does not require the

insertion of any portion of any employees’ body other

than his hands and arms.

(12) ‘‘Nonregulated area’’ means any area under

the control of the employer where entry and exit is

neither restricted nor controlled.

3la

(13) ‘‘Open-vessel system’’ means an operation in-

volving Ethyleneimine in an open vessel, which is not

in an isolated system, a laboratory type hood, nor in

any other system affording equivalent protection

against the entry of Ethyleneimine into regulated

areas, nonregulated areas, or the external environ-

ment.

(14) ‘‘Protective clothing’’ means clothing designed

to protect an employee against contact with or ex-

posure to Ethyleneimine.

(15) ‘‘Regulated area’’ means an area where entry

and exit is restricted and controlled.

mine. A regulated area shall be established by an

employer where Ethyleneimine is manufactured, proc-

essed, used, repackaged, released, handled or stored.

All such areas shall be controlled in accordance with

the requirements for the following category or cate-

gories describing the operation involved: (1) Isolated

systems. Employees working with Ethyleneimine

within an isolated system, such as a ‘‘glove box’’ shall

wash their hands and arms upon completion of the

assigned task and before engaging in other activities

not associated with the isolated system.

(2) Closed system operation. Within regulated

areas where Ethyleneimine is stored in sealed con-

tainers or contained in a closed system, including

piping systems, with any sample ports or openings

closed while Ethylencimine is contained within:

Acvess shall be retricted to authorized employees only.

(3) Open vessel system operations. Open vessel

system operations as defined in paragraph (b) (13) o

this section are prohibited. .

(4) Transfer from a closed system, charging or dis-

charging point operations, or otherwise opening a

32a

closed system. In operations involving ‘‘laboratory

type hoods,’’ or in locations where Ethyleneimine is

contained in an otherwise ‘‘closed system,’’ but is

transferred, charged, or discharged into other norm-

ally closed containers, the provisions of this subpara-

graph shall apply. (i) Access shall be restricted to

authorized employees only;

(ii) Each operation shall be provided with continuous

local exhaust ventilation so that air movement is

always from ordinary work areas to the operation.

Exhaust air shall not be discharged to regulated areas,

nonregulated areas or the external environment unless

decontaminated. Clean makeup air shall be introduced

in sufficient volume to maintain the correct operation

of the local exhaust system.

(iii) Employees shall be provided with, and required

to wear, clean, full body protective clothing (smocks,

coveralls, or long-sleeved shirt and pants), and gloves

prior to entering the regulated area.

(iv) Employees engaged in Ethyleneimine handling

operations shall be provided with and required to wear

and use a fullface, supplied air respirator, of the con-

tinuous flow or pressure-demand type, in accordance

with § 1910.134.

(v) Prior to each exit from a regulated area,

employees shall be required to remove and leave pro-

tective clothing and equipment at the point of exit

and at the last exit of the day, to place used clothing

and equipment in impervious containers at the point

of exit for purposes of decontamination or disposal.

The contents of such impervious containers shall be

identified, as required under paragraphs (e)(2), (3),

and (4) of this section.

(vi) Drinking fountains are prohibited in the reg-

ulated area.

33a

(5) Maintenance and decontamination activities.

In cleanup of leaks or spills, maintenance or repair

operations on contaminated systems or equipment,

where direct contact with Ethyleneimine could result,

each authorized employee entering that area shall:

(i) Be provided with and required to wear clean,

impervious garments, including gloves, boots and con-

tinuous-air supplied hood in accordance ‘ with

§ 1910.134.

(ii) Be decontaminated before removing the pro-

tective garments and hood;

(iii) Be required to shower upon removing the pro-

tective garments and hood. ,

(6) Laboratory activities. The requirements of this

subparagraph shall apply to research and quality

control activities involving the use of Ethyleneimine.

(i) Mechanical pipetting aids shall be used for all

pipetting procedures.

(ii) Experiments, procedures and equipment which

could produce aerosols shall be confined to laboratory-

type hoods or glove boxes.

(iii) Surfaces on which Ethyleneimine is handled

shall be protected from contamination.

(iv) Contaminated wastes and animal carcasses

shall be collected in impervious containers which are

closed and decontaminated prior to removal from the

work area. Such wastes and carcasses shall be in-

cinerated in such a manner that no carcinogenic

products are released.

(v) All other forms of Ethyleneimine shall be in-

activated prior to disposal.

(vi) Laboratory vacuum systems shall be protected

with high-efficiency scrubbers.

34a

(vii) Employees engaged in animal support activ-

ities shall be (a) provided with, and required to wear, a

complete protective clothing change, clean each day,

including coveralls or pants and shirt, foot covers, head

covers, gloves, and appropriate respiratory protective

equipment or devices ; and

(b) Prior to each exit from a regulated area,

employees shall be required to remove and leave pro-

tective clothing and equipment at the point of exit and

at the last exit of the day, to place used clothing and

equipment in impervious containers at the point of exit

for purposes of decontamination or disposal. The con-

tents of such impervious containers shall be identified

as required under paragraphs (e)(2), (3), and (4) of

this section.

(viii) Employees, other than those engaged only in

animal support activities, each day shall be (a) pro-

vided with and required to wear a clean change of

appropriate laboratory clothing, such as a solid front

gown, surgical scrub suit, or fully buttoned laboratory

coat.

(b) Prior to each exit from a regulated area,

employees shall be required to remove and leave pro-

tective clothing and equipment at the point of exit and

at the last exit of the day, to place used clothing and

equipment in impervious containers at the point of exit

for purposes of decontamination or disposal. The con-

tainers shall be identified as required under paragraphs

‘e)(2), (3), and (4) of this section.

neck upon each exit from the reulated area close to the

point of exit, and before engaying in other activities.

(ix) Air pressure in laboratory areas and animal

rooms where Ethyleneimine is handled and bioassay

35a

studies are performed shall be negative in relation to

the pressure in surrounding areas. Exhaust air shall

not be discharged to regulated areas, nonregulated

areas or the external environment unless decontam-

inated.

(x) There shall be no connection between regulated

areas and any other areas through the ventilation sys-

tem.

(xi) A current inventory of Ethylenemine shall be

maintained.

(xii) Ventilated apparatus, such as laboratory type

hoods, shall be tested at least semi-annually or immedi-

ately after ventilation modification or maintenance

operations, by personnel fully qualified to certify cor-

rect containment and operation.

(d) General regulated area requirements—(1) Em-

ployee identification. A daily roster of employees en-

tering regulated areas shall be established and main-

tained. The rosters or a summary of the rosters, shall

be retained for a period of 20 years. The rosters and/

or summaries shall be provided upon request to autho-

rized representatives of the Assistant Secretary and

the Director. In the event that the employer ceases

business without a successor, rosters shall be forwarded

by registered mail to the Director.

(2) Emergencies. In an emergency, immediate

measures including, but not limited to, the requirements

of subdivisions (i), (ii), (iii), (iv), and (v) of this sub-

paragraph shall. be implemented. (i) The potentially

affected area shall be evacuated as soon as the emer-

gency has been determined.

(ii) Hazardous conditions created by the emergency

shall be eliminated and the potentially affected area

shall be decontaminated prior to the resumption of

normal operations.

36a

(iii) Special medical surveillance by a physician

shall be instituted within 24 hours for employees

present in the potentially affected area at the time of

the emergency. A report of the medical surveillance

and any treatment shall be included in the incident re-

port, in accordance with paragraph (f)(2) of this sec-

tion.

(iv) Where an employee has a known contact with

Ethyleneimine, such employee shall be required to

shower as soon as possible, unless contraindicated by

physical injuries.

(v) An incident report on the emergency shall be

reported as provided in paragraph (f)(2) of this sec-

tion.

(vi) Emergency deluge showers and eyewash foun-

tains supplied with running potable water shall be

located near, within sight of, and on the same level

with locations where a direct exposure of Ethylen-

eimine would be most likely as a result of equipment

failure, or improper work practice.

(3) Hygiene facilities and practices, (i) Storage or

consumption of food, storage or use of containers of

beverages, storage or application of cosmetics, smoking,

storage of smoking materials, tobacco products or other

products for chewing, or the chewing of such products,

are prohibited in regulated areas.

(ii) Where employees wear protective clothing and

equipment clean change rooms shall be provided, in

accordance with § 1910.141(e), for the number of such

employees required to change clothes.

(iii) Where toilets are in regulated areas, such toilets

shall be in a separate room.

(iv) Where employees are required by this section

to wash, washing facilities shall be provided in accord-

ance with § 1910.141(d)(1) and (2) (ii) through (vii).

37a

(v) Where employees are required by this section to

shower, shower facilities shall be provided in accord-

ance with § 1910.141(d) (3).

(4) Contamination control. (i) Regulated areas,

except for outdoor systems, shall be maintained under

pressure negative with respect to nonregulated areas.

Local exhaust ventilation may be used to satisfy this

requirement. Clean makeup air in equal volume shall

replace air removed. —

(ii) Any equipment, material, or other item taken

into or removed from a regulated area shall be done so

in a manner that does not cause contamination in non-

regulated areas or the external environment.

(iii) Decontamination procedures shall be estab-

lished and implemented to remove Ethyleneimine from

the surfaces of materials, equipment and the decon-

tamination facility.

(e) Signs, information and training—(1) Signs. (i)

Entrances to regulated areas shall be posted with signs

bearing the legend:

Cancer-Suspect AGENT

AUTHORIZED PERSONNEL ONLY

(ii) Entrances to regulated areas containing opera-

tions covered in paragraph (c)(5) of this section shall

be posted with signs bearing the legend:

Cancer-Susrect Acent Exposep 1x THis AREA IMPERVIOUS

Suir Inc.uprxe Groves, Boots, anp Arr-Suppiiep Hoop

Requrrep at Aut Times, AvTHoRIZED PersonNEL ONLY

(iii) Appropriate signs and instructions shall be

posted at the entrance to, and exit from, regulated

areas, informing employees of the procedures that must

be followed in entering and leaving a regulated area.

(2) Container contents identification. (1) Contain-

ers of Ethyleneimine and containers required under

38a

paragraphs (c)(4)(v) and (c)(6)(vii) (6), and (c) (6)

(viii)(b) of this section which are accessible only to,

and handled only by, authorized employees, or by other

employevs trained in accordance with subparagraph (5)

of this paragraph, may have contents identification

limited to a generic or proprietary name, or other

proprietary identification, of the carcinogen and per-

cent.

(ii) Containers of Ethyleneimine and containers re-

quired under paragraphs (c)(4)(v), (¢)(6)(vii)(d),

and (c)(6)(viii)(b) of this section which are accessible

to, or handled by employees other than authorized

employees or employees trained in accordance with sub-

paragraph 5 of this paragraph shall have contents iden-

tification which includes the full chemical name and

Chemical Abstracts Service Registry number as listed

in paragraph (a) (1) of this section.

(iii) Containers shall have the warning words ‘‘CAN-

CER-SUSPECT AGENT”’ displayed immediately

under or adjacent to the contents identification.

(iv) Containers which have Ethyleneimine contents

with corrosive or irritating properties shall have label

statements warning of such hazards, noting, if appro-

priate, particularly sensitive or affected portions of

the body.

(3) Lettering. Lettering on signs and instructions

required by subparagraph (1) of this paragraph shall

be a minimum letter height of 2 inches. Labels on con-

tainers required under this section shall not be less than

Ym the size of the largest lettering on the package, and

not less than 8 point type in any instance: Provided,

That no such required lettering need be more than 1

inch in height.

(4) Prohibited statements. No statement shall

appear on or near any required sign, label, or instruc-

tion which contradicts or detracts from the effect of

any required warning, information or instruction.

39a

(5) Training and indoctrination. (i) Each employee

prior to being authorized to enter a regulated area,

shall receive a training and indoctrination program

including, but not necessarily limited to: (a) The

nature of the carcinogenic hazards of Ethyleneimine,

including local and systemic toxicity ;

(b) The specific nature of the operation involving

Ethyleneimine which could result in exposure ;

surveillance program, including as appropriate,

methods of self-examination ;

(d) The purpose for and application of decontamina-

tion practices and purposes ;

(e) The purpose for and significance of emergency

practices and procedures ;

(f) The employee’s specific role in emergency pro-

cedures ;

(g) Specific information to aid the employee in rec-

ognition and evaluation of conditions and situations

which may result in the release of Ethyleneimine ;

(h) The purpose for and application of specific first

aid procedures and practices ;

(i) A review of this section at the employee’s first

training and indoctrination program and annually

thereafter.

(ii) Specific emergency procedures shall be pre-

scribed, and’ posted, and employees shall be familiar-

ized with their terms, and rehearsed in their applica-

tion.

(iii) All materials relating to the program shall be

provided upon request to authorized representatives

of the Assistant Secretary and the Director.

40a

(f) Reports—(1) Operations. Not later than March

1, 1974, the information required in subdivisions (i),

(ii), (iii), and (iv) of this subparagraph shall be re-

ported in writing to the nearest OSHA Area Director.

Any changes in such information shall be similarly re-

ported in writing within 15 calendar days of such

change. (i) A brief description and in-plant location of

the area(s) regulated and the address of each regulated

area ;

(ii) The name(s) and other identifying information

as to the presence of Ethyleneimine in each regulated

area;

(iii) The number of employees in each regulated

area, during normal operations including maintenance

activities and

(iv) The manner in which Ethyleneimine is present

in each regulated area; e.g. whether it is manufactured,

processed, used, repackaged, released, stored, or other-

wise handled.

(2) Incidents. Incidents which result in the release

of Ethyleneimine into any area where employees may

be potentially exposed shall be reported in accordance

with this subparagraph. (i) A report of the occurrence

of the incident and the facts obtainable at that time in-

cluding a report on any medical treatment of affected

employees shall be made within 24 hours to the nearest

OSHA Area Director.

(ii) A written report shall be filed with the nearest

OSHA Area Director within 15 calendar days therafter

and shall include: (a) A specification of the amount

of material released, the amount of time involved, and

an explanation of the procedure used in determining

this figure ;

(b) A description of the area involved, and the extent

of known and possible employee exposure and area

contamination, and

4la

employees, and any medical surveillance program

implemented ; and

(d) An analysis of the circumstances of the incident,

and measures taken or to be taken, with specific com-

pletion dates, to avoid further similar releases.

(g) Medical surveillance. At no cost to the em-

ployee, a program of medical surveillance shall be

established and impiemented for employees considered

for assignment to enter regulated areas, and for

authorized employees. (1) Examination. (i) Before an

employee is assigned to enter a regulated area, a pre-

assignment physical examination by a physician shall

be provided. The examination shall include the per-

sonal history of the employee, family and occupational

background, including genetic and environmental fac-

tors.

(ii) Authorized employees shall be provided periodic

physical examinations, not less often than annually,

following the preassignment examination.

(iii) In all physical examinations, the examining

physician shall consider whether there exist conditions

of increased risk, including reduced immunological

competence, those undergoing treatment with steroids

or cytotoxic agents, pregnancy and cigarette smoking.

(2) Records. (1) Employers of employees examined

pursuant to this paragraph shall cause to be maintained

complete and accurate records of all such medical exam-

inations. Records shall be maintained for the duration

of the employee’s employment. Upon termination of

the employee’s employment, including retirement or

death, or in the event that the employer ceases business

without a successor, records, or notarized true copies

thereof, shall be forwarded by registered mail to the

Director. all

42a

(ii) Records required by this paragraph shall be pro-

vided upon request to authorized representatives of

the Assistant Secretary or the Director; and upon re-

quest of an employee or former employee, to a phy-

sician designated by the employee or to a new employer.

(iii) Any physician who conducts a medical examina-

tion required by this paragraph shall furnish to the

employer a statement of the employee’s suitability for

employment in the specific exposure.

43a

APPENDIX C

STATUTE INVOLVED

Occupational Safety and Health Act

of 1970, 29 U.S.C. 8655(b)

(5) The Secretary, in promulgating standards

dealing with toxic materials or harmful physical

agents under this subsection, shall set the standard

which most adequately assures, to the extent feasible,

on the basis of the best available evidence, that no

employee will suffer material impairment of health or

functional capacity even if such employee has regular

exposure to the hazard dealt with by such standard for

the period of his working life. Development of

standards under this subsection shall be based upon

research, demonstrations, experiments, and such other

information as may be appropriate. In addition to

the attainment of the highest degree of health and

safety protection for the employee, other considera-

tions shall be the latest available scientific data in the

field, the feasibility of the standards, and experience

gained under this and other health and safety laws.

Whenever practicable, the standard promulgated shall

be expressed in terms of objective criteria and of the

performance desired.

(7) Any standard promulgated under this subsection

shall prescribe the use of labels or other appropriate

forms of warning as are necessary to insure that

employees are apprised of all hazards to which they are

exposed, relevant symptoms and appropriate emer-

gency treatment, and proper conditions and precau-

tions of safe use or exposure. Where appropriate,

44a

such standard shall also prescribe suitable protective

equipment and control or technological procedures to

be used in connection with such hazards and shall

provide for monitoring or measuring employee ex-

posure at such locations and intervals, and in such

manner as may be necessary for the protection of

employees. In addition, where appropriate, any such

standard shall prescribe the type and frequency of

medical examinations or other tests which shall be

made available, by the employer or at his cost, to

employees exposed to such hazards in order to most

effectively determine whether the health of such em-

ployees is adversely affected by such exposure. In

the event such medical examinations are in the nature

of research, as determined by the Secretary of Health,

Education, and Welfare, such examinations may’ be

furnished at the expense of the Secretary of Health,

Education, and Welfare. The results of such exami-

nations or tests shall be furnished only to the Secre-

tary or the Secretary of Health, Education, and Wel-

fare, and, at the request of the employee, to his

physician. The Secretary, in consultation with the

Secretary of Health, Education, and Welfare, may by

rule promulgated pursuant to section 553 of title 5,

United States Code, make appropriate modifications

in the foregoing requirements relating to the use of

labels or other forms of warning, monitoring or meas-

uring, and medical examinations, as may be warranted

by experience, information, or medical or technological

developments acquired subsequent to the promulga-

tion of the relevant standard.

* * >

45a

APPENDIX D

UNITED STATES COURT OF APPEALS FOR

FOR THE THIRD CIRCUIT

No. 741129

No. 741149

No. 74-1268

SYNTHETIC ORGANIC CHEMICAL MANUFACTURERS

ASSOCIATION, et al.,

Petitioners in No. 74-1129

PETER J. BRENNAN, Secretary, Department

of Labor, and JOHN H. STENDER, Assistant

Secretary of Labor for Occupational Safety

and Health,

Respondents

OIL, CHEMICAL & ATOMIC WORKERS INTERNATIONAL

UNION, AFL-CIO and

HEALTH RESEARCH GROUP,

Petitioners in No. 741149

PETER J. BRENNAN, Secretary United States

Department of Labor, ef al.,

Respondents

POLYURETHANE MANUFACTURERS ASSOCIATION,

Petitioner in No. 74-1268

DEPARTMENT OF LABOR,

PETER J. BRENNAN, Secretary

Department of Labor, etc., et ai.,

Respondents

ON PETITION FOR REVIEW OF ACTION OF THE

ASSISTANT SECRETARY OF LABOR FOR

OCCUPATIONAL SAFETY AND HEALTH

Present: HASTIE, GIBBONS and WEIS, Circuit Judges

46a

JUDGMENT

These causes came on to be heard on the record from

the Assistant Secretary of Labor for Occupational Safety

and Health, and were argued by counsel.

On consideration whereof, it is now here ordered and ad-

judged by this Court that the proceedings be, and the same

are hereby remanded insofar as the standards relating to

medical examinations, applicable to all chemicals, are con-

cerned; and it is further here ordered and adjudged by

the Court that the regulations applicable to 4,4' methylene

bis (2-chloroaniline) (MOCA) be, and the same are hereby

vacated, and the cause be, and the same is hereby remanded

for the publication of a proposed standard, to be followed

by the required procedures for allowance of comments

and hearing; and it is further here ordered and adjudged

by this Court that to the extent that the standards in ques-

tion relate to research laboratories, the said standards be,

and the same are hereby vacated, and the cause be, and

the same is hereby remanded to OSHA for further pro-

ceedings, all in accordance with the opinion of this Court.

ATTEST:

/s/ Thomas P. Quinn

Clerk

December 17, 1974

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.