Appendix — Synthetic Organic Chemical Manufacturers Ass'n v. Brennan

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APPENDIX A

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

No. 74-1129

SyNTHETIC ORGANIC CHEMICAL MANUFACTURERS AssociaT

1075 Central Park Avenue

Scarsdale, New York 10583

Dry Coton MANUFACTURERS AssociaTION, INo,

061 Franklin Avenue

Nutley, New Jersey 07110

American Dye Manuractvrers Institute, Inc.

74 Trinity Place

New York, New York 10006

AMERICAN Cyanamip Company

Bound Brook, New Jersey 08805

InmMont CorPoRATION

1255 Broad Street

Clifton, New Jersey 07016

Union Carsine CorPorRATION

270 Park Avenue

New York, New York 10017

CELANESE CORPORATION

522 Fifth Avenue

New York, New York 10036

ALLIED CHEMICAL CoRPORATION

Post Office Box 1219 R

Morristown, New Jersey 07960

Dow Cuemicat U.S.A.

2020 Abbott Road Central

Midland, Michigan 48640

AEROJET-GENERAL CORPORATION

Post Office Box 702

Elmonte, California 91734

Prister CHEMICAL, I Nc.

Ridgefield, New Jersey 07656

Crompton & KNowLes CorPoRATION

Route 208

Fair Lawn, New Jersey 07410,

Petitioners,

Vv.

Peter J. BRENNAN, Seeretary, Department of Labor, and

Joun H. Stenper, Assistant Seeretary of Labor for Occu-

pational Safety and Health,

Respondents.

Ow Petition ror Review or Action OF THE ASSISTANT

SECRETARY OF LABOR FOR OCCUPATIONAL SAFETY

AND HEALTH

Argued June 13, 1974

Before Statey, Gispons and Weis, Circuit Judges.

Robert C. Barnard

Charles F. Lettow

Donald L. Morgan

Cleary, Gottlieb, Steen & Hamilton

Washington, D.C.

Attorneys for Petitioners

Stephen F. Eilperin

Department of Justice

Michael H. Levin

Department of Labor

Michael H. Stein

: Washington, D.C.

Attorneys for Respondent

ss |

act gereaerene,

OPINION OF THE COURT

(Filed August 26, 1974)

By Sratey, Circuit Judge.

This case is before the court upon petition to review an

order of the Assistant Secretary of Labor for Occupational

Safety and Health, published on January 29, 1974, 39 Fed.

Reg. 3756, issuing permanent occupational health stand-

ards which regulate, inter alia, employee exposure to solid

or iiquid mixtures containing one percent or more of

cthyleneimine (‘‘EI’’). See 29 C.F.R. §1910.93lc.1 This

court has jurisdiction to review and set aside these stand-

ards pursuant to §6(f) of the Occupational Safety and

Health Act of 1970, 29 U.S.C. § 655(f) (‘‘ Act’’).

The standards in question are part of a group of per-

manent standards simultaneously issued pursuant of § 6(b)

of the Act. 29 U.S.C. §655(b). They were derived from

similar emergency temporary standards issued on May 3,

1973, 38 Fed. Reg. 10929. This court has previously vacated

and remanded to the Occupational Safety and Health Ad-

ministration (*‘‘OSHA’’) the temporary standards in so

far as they applied to EI and one other chemical. Dry

Color Manufacturers’ Association, Inc. v. Department of

Labor, 486 F.2d 98 (C.A. 3, 1973). We must now consider

the permanent standards relating to EI.

On review the petitioners request that the court set

aside OSHA’s standards applicable to EI. They challenge

the validity of the standards on three principal grounds.

They maintain that there is not substantial evidence to

show that EI is carcinogenic; that the record does not sup-

port the particular EI standards; and that the Secretary

1 We are presently considering only the EI standards. The pe-

tition as originally filed requested review of the standards for

other substances as well as those relating to EI. This court, how-

ever, ordered a separate consideration of the EI standards and

stayed them pending this determination of the merits of the case.

failed to make sufficient findings of fact or to provide suf-

ficient statements of reasons for the standards,

We deal first with the petitioners’ last contention. Sub-

section 6(e) of the Act provides:

‘“‘Whenever the Seeretary promulgates any stand-

ard, ... he shall include a statement of the reasons

for such action, which shall be published in the Federal

As this court has previously stated, to satisfy subsection

G(e) the statement of reasons should indicate which data

in the record is being relied upon, why that data shows

the substances regulated are harmful, and why~the par-

ticular standards were chosen. Dry Color Manufacturers’

Assn., Ine. v. Department of Labor, 486 F.2d at 106. In

that case a temporary emergency standard for the control

of EI was invalidated by this court because the Secretary,

in promulgating it, had not provided an adequate statement

of reasons.

In the instant case, the statement of reasons offered by

OSHA, published January 29, 1974, 39 Fed. Reg. 3756,

consisted in part of the finding that El was potentially

carcinogenic to humans. In addition, according to OSHA,

the case for El’s carcinogenicity rested on the extrapola-

tion to humans of the findings of two animal studies. The

Seeretary justifies such an extrapolation on the basis of

the April 22, 1970 Report of the Ad Hoe Committee on the

Evaluation of Low Levels of Environmental Chemical

Carcinogens to the Surgeon General. We have earefully

examined the statements as well as those relating to the

adopted standards themselves and conclude that they sat-

isfy the requisites of subsection 6(e). We turn now to a

consideration of the evidence in the reeord.

Subsection 6(f) directs courts reviewing a standard

that ‘‘[t]he determinations of the Secretary shall be con-

elusive if supported by substantial evidence in the record

considered as a whole.’’ 29 U.S.C. § 655(f). See Industrial

Union Department, AFL-CIO v. Hodgson, — I°.2d — (C.A.

D.C. 1974) ; Associated Industries of New York State, Ine.

yv. United States Department of Labor, 487 F.2d 342 (CLA.

2, 1973). We find it extraordinarily difficult to apply this

standard in this case. Section 6(a) of the Act directs the

Seeretary of Labor to promulgate by rule an oecupational

safety or health ‘standard which assures the greatest pro-

tection of the safety or health of the affected employees.”’

29 U.S.C, $655(a). Section 6(b)(5) of the Act, 29 U.S.C,

£ 655(b)(5) directs that

“The Seeretary, in promulgating standards dealing

with toxie materials or harmful physical agents .. .

shall set the standard which most adequately assures,

to the extent feasible, on the hasis of the best available

evidence, that no employee will suffer material impair-

ment of health or functional capacity even if such em-

ployee has regular exposure to the hazard dealt with

by such standard for the period of his working life.”’

Because the Dry Color case turned on noncompliance with

¢6(e), it did not present us with an occasion to discuss the

standard for review of informal rule making by the Seere-

tary under the Act. However, the instant case requires

that we do so.

It is made clear in ¢6(b) that §6(a) standards may be

adopted by notice and comment rule making analogous to

that provided for by ¢4 of the Administrative Procedure

Act, 5 U.S.C. $553. Yet the quoted language of § 6(f)

appears to limit judicial review to the scope of review which

ordinarily applies to administrative determinations result-

ing from formal adjudications. See 5 U.S.C, ¢ 706(2)(F).

Compounding the confusion, § 10 of the Act, 29 U.S.C. § 659,

provides for adjudications, § 11, 29 U.S.C. § 660, provides

for judicial review of adjudications, and the wording of the

standard for review of adjudieatory findings set forth in

¢11(a) is virtually the same as that for review of informal

rule making set forth in §6(f). See Brennan v. Occupa-

tional Safety & Health Review Commission ( Hanovia

Lamp), No. 73-1131 (C.A. 3, filed—1974). Tt is clear that

ROGER LM PMSF

dhe ang SU UTA RN

application of the substantial evidence test to informal

rule making was a deliberate legislative compromise be-

tween the House and Senate versions of the bill which be-

came law. See the legislative history in Judge Friendly’s

opinion in Associated Industries of New York State, Ine. v.

United States Department of Labor, 487 F.2d 342, 348-49

(C.A. 2, 1973).

How a reviewing court applies the substantial evidence

test in reviewing quasi-legislative informal rule making is

an intriguing problem which is just beginning to generate

what will prove to be, we suspect, an extensive literature.

In Associated Industries of New York State, Inc. v. United

States Department of Labor, supra, Judge Friendly sug-

gests that the difference between the substantial evidence

test and the more traditional abuse of discretion test in the

context of informal rule making may be largely semantic.

487 F.2d at 349-50. In Florida Peach Growers Association,

Inc. v. United States Department of Labor, 489 F.2d 120,

129 (C.A. 5, 1974), Judge Roney writes:

‘(I]t seems clear that even with the required substan-

tial evidence test, our review basically must determine

whether the Secretary carried out his essentially legis-

lative task in a manner reasonable under the state of

the record before him.’’

In Industrial Union Department, AFL-CIO v. Hodgson, —

F.2d — (C.A. D.C. 1974), Judge MeGowan distinguished

those rule making issues which were susceptible of resolu-

tion on a factual record, as to which the court would review

for substantial evidence and those issues which by their

nature were not capable of such resolution but represented

policy judgments. As to the latter, Judge McGowan sug-

gested that the Seeretary’s policy judgment would be

affirmed if he indicated that factual certainty was not pos-

sible and identified rationally the controlling considerations.

But cf. Environmental Defense Fund, Inc. v. Environ-

mental Protection Agency, 489 F.2d 1247 (C.A. D.C. 1973)

and International Harvester Co. v. Ruckelshaus, 478 F.2d

615 (C.A. D.C. 1973).

This case is a good illustration of the difficulty of at-

tempting to measure a legislative policy decision against a

factual yardstick. OSILA’s position with respect to EI is

bottomed on an extrapolation from data gathered in two

animal studies. The first is a study carried out in 1954 by

Walpole which concluded that EI may be regarded as car-

cinogenie in rats and mice.*_ The Innes study, the second

upon which OSHA relied, concluded that mice under ex-

perimental exposure to EI developed tumors with ‘‘malig-

nant potentiality.’’* The extrapolation from the data

gathered in these rodent experiments to humans is justified

by the Report of the Ad Iloe Committee on the Evaluation

of Low Levels of Environmental Chemical Careinogens to

the Surgeon General. This report states:

‘Any substance which is shown conclusively to

cause tumors in animals should be considered carcino-

genic and therefore a potential cancer hazard for man.’’

If the issue to be reviewed were merely whether EI

was carcinogenic in rats and mice, we believe that we could

point to the Walpole and Innes studies and safely conclude

that the Seeretary’s determination of animal carcinoge-

nicity was supported by substantial evidence. But the extra-

polation of that determination from animals to humans is

not really a factual matter. The Seeretary’s $6(e) state-

ment puts it thus:

‘‘Extrapolation of results obtained by animal experi-

mentation-is alleged to be vitiated by several considera-

tions: (a) That certain cancers are specific only to

2 Walpole, Roberts, Rose, Hendry, and Homer, Cytotoxic Agents:

IV. The Carcinogenic Actions of Some Monofunctional Ethylenei-

mine Derivatives, ).Brit. J. Pharmacol. 306 (1954).

% Innes, et al., Bioassay of Pesticides and Industrial Chemicals

for Tumorigenicity in Mice: A Preliminary Note, 42 J. Nat’l.

Cancer Inst. 1101 (1969).

some species; (b) that the conditions of animal experi-

ments 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.

“‘The objections raise the much broader issue of

human exposure to a chemical which is only known to

have caused cancers in experimental animals.

a * *

‘*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

carcinogenic to humans, until evidence to the contrary

is produced. The first alternative would logically re-

quire, not relaxed controls on exposure, but exclusion

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 of the Ad Hoc Committee on the Evaluation of

Low Levels of Environmental Chemical Carcinogens

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

April 22, 1970 that the second alternative is the re-

sponsible and correct one.’’ (Appendix at 845-46.)

It seems to us that what the Secretary has done in extra-

polating from animal studies to humans is to make a legal

rather than a factual determination. He has said in effect

that if carcinogenicity in two animal species is established,

as a matter of law §§ 6(a) and 6(b) (5) require that they be

treated as carcinogenic in man. This is in the nature of a

recommendation for prudent legislative action.

This raises the problem of our role under §6(f) in

reviewing the Secretary’s nonfactual policy decisions. The

deliberate congressional choice of the substantial evidence

standard for review might be interpreted to exclude us

from review of any but factual determinations and to re-

quire that we afford absolute deference to the Secretary’s

interpretation of the statute. However, no court that has

considered the scope of judicial review has so read § 6(f).

By one formulation or another each seems to have found

room under § 6(f) for judicial review for consistency be-

tween the Secretary’s rule and the statutory language and

purpose. See Industrial Union Department, AFL-CIO v.

Hodgson, supra; cf. Florida Peach Growers Association,

Ine. v. United States Department of Labor, supra; Dry

Color Manufacturers’ Assn., Inc. v. Department of Labor,

supra; Associated Industries of New York State, Ine. v.

United States Department of Labor, supra. Undoubtedly,

this approach is sound, for the last sentence of § 6(f) can-

not be read in a vacuum. Meaning must be given to all of

6. The last sentence of § 6(f) must be read together with

the requirement in §6(e) that the Secretary ‘*inelude a

statement of the reasons for such action which shail be

published in the Federal Register.’’ He is not directed to

file findings of fact. His reasons for action may include

policy determinations as well as factual findings. The re-

quirement that he state reasons strongly suggests that

those reasons, whether policy judgments or factual findings,

may be subjected to judicial review. Moreover, there are

different legal criteria for the adoption of emergency tem-

porary standards than for the adoption of permanent

standards, but §6(f) provides for judicial review of both.

Section 6(c)(1) authorizes adoption of emergency tempo-

rary standards when the Secretary ‘‘determines (A) that

employees are exposed to grave danger from exposure to

substances or agents determined to be toxie or physically

harmful or from new hazards, and (B) that such emergency

standard is necessary to protect employees from such

danger.’”’ 29 U.S.C. §655(c)(1). Permanent standards

must assure ‘‘ the greatest protection of the safety or health

of the affected employees,’’ 29 U.S.C. § 655(a), and, with

respect to toxic substances, must ‘‘most adequately as-

sure[s], to the extent feasible, on the basis of the best avail-

rer)

10a

able evidence, that no employee will suffer material impair-

ment of health or functional capacity even if such employee

has regular exposure to the hazard dealt with by

such standard for the period of his working life.’’ 29

U.S.C. § 655(b)(5). The very difference in the legal cri-

teria suggests that the court in reviewing pursuant to

§6(f) must at a minimum determine if the Secretary ap-

plied the correct ones, and certainly, as we neld in Dry

Color Manufacturers’ Assn., Inc. v. Department of Labor, :

supra, judicial review under § 6(f) encompasses our evalua-

tion of the procedural requirements of § 6 even though our

interpretation differs from that of the Secretary.

It seems, then, that judicial review of a §6 standard

properly includes at least the following:

(1) determining whether the Secretary’s notice of pro-

posed rule making adequately informed interested

persons of the action taken;

(2) determining whether the Secretary’s promulgation

adequately sets forth reasons for his action;

(3) determining whether the statement of reasons re-

flects consideration of factors relevant under the

statute;

(4) determining whether presently available alterna-

tives were at least considered; and

(5) if the Seeretary’s determination is based in whole

or in part on factual matters subject to evidentiary

development, whether substantial evidence in the

record as a whole supports the determination.

In the context of this case, all five steps are involved.

We note that there was a lack of notice regarding

OSHA’s plans to make special provisions regarding EI’s

use in research laboratories. The Secretary’s notice did

not advise that the agency planned to make special pro-

visions regarding EI use in laboratories. Because of this,

lla

we hold that to the extent that the standards in question

relate to research laboratories, they will be vacated and

remanded to OSHA. Further, as we concluded above, the

statements of reasons reflect considerations relevant under

$$ 6(a) and 6(b)(5) and are therefore sufficient under sub-

section 6(e). Lastly, we hold that there does exist sub-

stantial evidence in the record as a whole to support the

Secretary’s finding that EI is carcinogenic in rats and mice

and in the absence of evidence of carcinogenicity in humans,

the Secretary properly weighed the only available alter-

natives. We, therefore, reject the petitioners’ challenge to

the EJ standards except in so far as they relate to labora-

tories as outlined above. - ;

The cause will be remanded to OSHA with directions to

proceed in er with this opinion.

12a

APPENDIX B

Statute Involved

Occupational Safety and Health Act. Section 6 of the

Occupational Safety and Health Act (29 U.S.C. § 655

(1970)) provides as follows: ;

(a) Without regard to chapter 5 of title 5, United

States Code, or to the other subsections of this section,

the Secretary shall, as soon as practicable during the

period beginning with the effective date of this Act

and ending two years after such date, by rule promul-

gate as an occupational safety or health standard any

national consensus standard, and any established

Federal standard, unless he détermines that the

promulgation of such a standard would not result in

improved safety or health for specifically designated

employees. In the event: of conflict among any such

standards, the Secretary shall promulgate the standard

which assures the greatest protection of the safety

or health of the affected employees.

(b) The Secretary may by rule promulgate,

modify, or revoke any occupational safety or health

standard in the following manner:

(1) Whenever the Secretary, upon the basis of

information submitted to him in writing by an in-

terested person, a representative of any organization

of employers or employees, a nationally recognized

standards-producing organization, the Secretary of

Health, Education, and Welfare, the National Institute

for Occupational Safety and Health, or a State or

political subdivision, or on the basis of information

developed by the Secretary or otherwise available to

him, determines that a rule should be promulgated in

order to serve the objectives of this Act, the Seeretary

may request the recommendations of an advisory com-

mittee appointed under section 7 of this Act. The

Sak SRN

13a

Secretary shall provide such an advisory committee

with any proposals of his own or of the Secretary of

Health, Education, and Welfare, together with all

pertinent factual information developed by the Sec-

retary or the Secretary of Health, Education. and

Welfare, or otherwise available, including the results

of research, demonstrations, and experiments. An

advisory committee shall submit to the Secretary its

recommendations regarding the rule to be promulgated

within ninety days from the date of its appointment

or within such longer or shorter period as may be

prescribed by the Secretary, but in no event for a

period which is longer than two hundred and seventy

days.

(2) The Seeretary shall publish a proposed rule

promulgating, modifying, or revoking an occupational

safety or health standard in the Federal Register and

shall afford interested persons a period of thirty days

after publication to submit written data or comments.

Where an advisory committee is appointed and the

Seerctary determines that a rule should be issued, he

shall publish the proposed rule within sixty days after

the submission of the advisory committee’s recom-

mendations or the expiration of the period prescribed

by the Secretary for such submission.

(3) On or before the last day of the period pro-

vided for the submission of written data or comments

under paragraph (2), any interested person may file

with the Secretary written objections to the proposed

rule, stating the grounds therefor and requesting a

public hearing on such objections. Within thirty

days after the last day for filing such objections, the

Secretary shall publish in the Federal Register a

notice specifying the occupational safety or health

standard to which objections have been filed and a

hearing requested, and specifying a time and place

for such hearing.

l4a

(4) Within sixty days after the expiration of the

period provided for the submission of written data or

comments under paragraph (2), or within sixty days

after the completion of any hearing held under para-

graph (3), the Secretary shall issue a rule pro-

mulgating, modifying, or revoking an occupational

safety or health standard or make a determination that

a rule should not be issued. Such a rule may contain

a provision delaying its effective date for such period

(not in excess of ninety days) as the Secretary deter-

mines may be necessary to insure that affected em-

ployers and employees will be informed of the exist-

ence of the standard and of its terms and that em-

ployers affected are given an opportunity to familiarize

themselves and their employees with the existence

of the requirements of the standard.

(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 scientifie 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.

lida

(6)(A) Any employer may apply to the Secretary

for a temporary order granting a variance from a

standard or any provision thereof promulgated under

this section. Such temporary order shall be granted

only if the employer files an application which meets

the requirements of clause (B) and establishes that (i)

he is unable to comply with a standard by its effective

date because of unavailability of professional or

technical personnel or of materials and equipment

needed to come into compliance with the standard or

because necessary construction or alteration of

facilities cannot be completed by the effective date,

(ii) he is taking all available steps to safeguard his

employees against the hazards covered by the standard,

and (iii) he has an effective program for coming into

compliance with the standard as quickly as practicable.

Any temporary order issued under this paragraph

shall prescribe the practices, means, methods, opera-

tions, and processes which the employer must adopt

and use while the order is in effect and state in detail

his program for coming into compliance with the

standard. Such a temporary order may be granted

only after notice to employees and an opportunity for

a hearing: Provided, That the Secretary may issue

one interim order to be effective until a decision is

made on the basis of the hearing. No temporary order

may be in effect for longer than the period needed by

the employer to achieve compliance with the standard

or one year, whichever is shorter, except that such an

order may be renewed not more than twice (I) so

long as the requirements of this paragraph are met and

(II) if an application for renewal is filed at least 90

days prior to the expiration date of the order. No

interim renewal of an order may remain in effect for

longer than 180 days.

16a

(B) An application for a temporary order under

this paragraph (6) shall contain:

(i) a specification of the standard or portion

thereof from which the employer seeks a variance,

(ii) a representation by the employer, sup-

ported by representations from qualified persons

having firsthand knowledge of the facts rep-

resented, that he is unable to comply with the

standard or portion thereof and a detailed state-

ment of the reasons therefor,

‘

(iii) a statement of the steps he has taken and

will take (with specific dates) to protect employees

against the hazard covered by the standard,

(iv) a statement of when he expects to be able to

comply with the standard and what steps he has

taken and what steps he will take (with dates

specified) to come into compliance with the stand-

ard, and

(v) a certification that he has informed his

employees of the application by giving a copy

thereof to their authorized representative, posting

a statement giving a summary of the application

and specifying where a copy may be examined

at the place or places where notices to employees

are normally posted, and by other appropriate

means.

A description of how employees have been informed

shall be contained in the certification. The informa-

tion to employees shall also inform them of their right

to petition the Secretary for a hearing.

from any standard or portion thereof whenever he

determines, or the Secretary of Health, Education, and

Welfare certifies, that such variance is necessary to

17a

permit an employer to participate in an experiment

approved by him or the Secretary of Health, Educa-

tion, and Welfare designed to demonstrate or validate

new and improved techniques to safeguard the health

or safety of workers.

(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,

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 Seeretary of Health,

‘ducation, and Welfare, such examinations may be

furnished at the expense of the Secretary of Health,

Edueation, and Welfare. The results of such exami-

nations or tests shall be furnished only to the Seere-

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

Fal we AK dy

18a

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.

(8) Whenever a rule promulgated by the Secretary

differs substantially from an existing national con-

sensus standard, the Secretary shall, at the same time,

publish in the Federal Register a statement of the

reasons Why the rule as adopted will better effectuate

the purposes of this Act than the national consensus

standard.

(c)(1) The Seeretary shall provide, without regard

to the requirements of chapter 5, title 5, United States

Code, for an emergency temporary standard to take

immediate effect upon publication in the Federal Reg-

ister if he determines (A) that employees are exposed

to grave danger from exposure to substances or agents

determined to be toxie or physically harmful or from

new hazards, and (B) that such emergency standard

is necessary to protect employees from such danger.

(2) Such standard shall be effective until super-

seded by a standard promulgated in accordance with

the procedures prescribed in paragraph (3) of this

subsection.

(3) Upon publication of such standard in the Fed-

eral Register the Secretary shall commence a_pro-

ceeding in accordance with section 6(b) of this Act,

and the standard as published shall also serve as a

proposed rule for the proceeding. The Seeretary shall

promulgate a standard under this paragraph no later

than six months after publication of the emergency

standard as provided in paragraph (2) of this sub-

section.

19a

(d) Any affected employer may apply to the See-

retary for a rule or order for a variance from a

standard promulgated under this section. Affected

employees shall be given notice of each such applica-

tion and an opportunity to participate in a hearing.

The Secretary shall issue such rule or order if he

determines on the record, after opportunity for an

inspection where appropriate and a hearing, that the

proponent of the variance has demonstrated by a

preponderance of the evidence that the conditions,

practices, means, methods, operations, or processes

used or proposed to be used by an employer will

provide employment and places of employment to his

employees which are as safe and healthful as those

which would prevail if he complied with the standard.

The rule or order so issued shall prescribe the condi-

tions the employer must maintain, and the practices,

means, methods, operations, and processes which he

must adopt and utilize to the extent they differ from

the standard in question. Such a rule or order may be

modified or revoked upon application by an employer,

employees, or by the Seeretary on his own motion, in

the manner prescribed for its issuance under this sub-

section at any time after six months from its issuance.

(e) Whenever the Secretary promulgates any stand-

ard, makes any rule, order, or decision, grants any

exemption or extension of time, or compromises,

mitigates, or settles any penalty assessed under this

Act, he shall include a statement of the reasons for

such action, which shall be published in the Federal

(f) Any person who may be adversely affected by

a standard issued under this section may at any time

prior to the sixtieth day after such standard is pro-

mulgated file a petition challenging the validity of

such standard with the United States court of appeals

;

Bx». BiLihd.'}

20a

for the circuit wherein such person resides or has his

principal place of business, for a judicial review of

such standard. <A copy of the petition shall be forth-

with transmitted by the clerk of the court to the See-

retary. The filing of such petition shall not, unless

otherwise ordered by the court, operate as a stay of

the standard. The determinations of the Secretary

shall be conclusive if supported by substantial evi-

dence in the record considered as a whole.

(g) In determining the priority for establishing

standards under this section, the Seeretary shall give

due regard to the urgency of the need for mandatory

safety and health standards for particular industries,

trades, crafts, occupations, businesses, workplaces or

work environments. The Secretary shall also give

due regard to the recommendations of the Secretary

of Health, Education, and Welfare regarding the need

for mandatory standards in determining the priority

for establishing such standards.

2la

APPENDIX C

‘Regulation Involved

Occupational Safety and Health Standard. The Pre-

amble and Order promulgating the Occupational Safety

and Health Standard for Ethyleneimine, 29 C.F.R. § 1910.-

931 (39 Fed. Reg. 3756, Jan. 29, 1974), provide as follows:

Trr_te 29—Lapor

Cuarten XViT—OccvpationaL Sarety axp HEALTH

Apuuixistratios, Department or Lapor

Part 1910—OccupaTionaL Sarety AND HEALTH

STANDARDS

Carcinogens

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

Steiger Occzpational Safety and NMealth Act of 1970

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

12-71 (26 FR S754), 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 vart 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-

ecived hy NIOSH were made available to the Oceupa-

tional Safety and Health Administration. ,

On January 4, 1975, a petition for an emergency

temporary standard from the Oil, Chemical, and At-

22a

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 mectings 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 carein-

ogens on August 27, 1973. The recommendations were

published in the Fepera 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(¢)(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 28

FR 20074, and an amended notice of rulemaking pro-

23a

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

OL PEELING LE OF AA =

de veal wld ty dead Rae Ay a

24a

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 ecar-

cinogenicity, Dimethyl] sulfate, which is in the appendix,

is not included in the standards because it was con-

eluded after consideration of the relevant literature

that the documentation of its carcinogenicity was inade-

quate. The substances listed hy 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-

idemiologie 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 NIOSIL Some of the sub-

stances are recognized as human carcinogens by some

employers participating in this proceeding. For in-

25a

stance, although Young Aniline Works apparent!»

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.

* * * * * ted 7 * +

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 ET.

The ease for the carcinogenicity of El, 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

Ee LGA 0 aD OT IE 4a me”

26a

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 anima!s 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-

cinogenie 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 ear-

cinogenic only in experimental animals. Once the ear-

cinogenicity Of a substance has been demonstrated in

animal experiments, the practical regulatory alterna-

tives are to consider them either non-carcinogenie or

27a

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 Carein-

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 assuniption 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 (IIRG)

for an emergency temporary standard on ten sub-

stances proceeds on the assumption that any exposure

to any amount of a carcinogenic subsiance 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 Hoe 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

(peewee daeetiiie

28a

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-

29a

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-chloreaniline) 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 enforee-

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

;

er ee te

30a

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 diagnostie 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 thie

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 pereent, by weight or volume, of eight of the carcino-

gens. Solid or liquid mixtures containing 4-Amino-

diphenyl, Benzidine (and its saltx), 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

31a

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-Chioromethyl 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 ear-

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 objee-

tion to the proposals is that the standard ‘‘lumps

together’? many different substances with different

chemicals and phy-ical 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

POU At “

32a

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-Chloromethy! ether, Ethylencimine 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

33a

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 disearded 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. OSHLA 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

De IRR CR FOS

Feral

aan da

Sa ee et

34a

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 (¢) 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 made applicable to laboratory activities.

The provisions are derived from the Minimum Safety

Ciuidelines 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 not suffice. We appreciate the

concern of employers wiih 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-

35a

volved in his occupation. The use of the word

‘suspect’? 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 iroining. Employers are

respousible for providing ixidoctrination 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 cach

of the standards for a carcinogenic agent.

(9) Monitoring. No provisions for specifie 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 surveillanee 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

e. 7

“

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 $1910.93e¢ 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 um 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 put on clean clothing and/or protective

equipment in an enviroument 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

37a

of Ethylencimine 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 fect per minute; designed, constructed, and

maintained in such a way that an operation involving

Ethylencimine 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.

}

38a

(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 Ethylencimine 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 eate-

gories describing the operation involved: (1) Isolated

systems. Employees working with Ethylenecimine

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 Ethylenecimine is stored in sealed con-

tainers or contained in a closed system, including

piping systems, with any sample ports or openings

closed while FEthyleneimine is contained within:

Access shall be retricted to authorized employees only.

(3) Open vessel system operations. Open vessel

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

this section are prohibited.

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

charging point operations, or otherwise opening a

39a

closed system. In operations involving ‘*laboratory

type hoods,’’ or in locations ‘where Ethyleneimine is

contained in an otherwise ‘‘closed systém,’’ 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. é

(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 ¢ 1910.154.

(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.

(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 Kthyleneimine.

(i) Mechanical pipetting aids shall be used for all

pipetting procedures.

(ii) Experiments, sensiiines 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 Ethylenci imine shall be in-

activated prior to disposal.

(vi) Laboratory vacuum systems shall be protected

with high-efficiency scrubbers.

4la

(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 pcint 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

apprepriate laboratory clothing, such as a solid front

gown, surgical scrub suit, or fully buttoned laboratory

coat.

(b) Prior to eack 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 regulated area close to the

point of exit, and before engaging in other activities,

(ix) Air pressure in laboratory areas and animal

rooms where Ethylencimine is handled and bioassay

;

42a

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 eurrent 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 shal] 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.

le OE ADL LTE

43a

(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

Ethylenecimine, 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 see-

tion.

(vi) Emergeney 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).

44a

(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.

j SNS EAENER IT He a

(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 trainmg—(1) Signs. (i)

Entrances to regulated areas shall be posted with signs

bearing the legend:

Caxcer-Suspect AGEnxt

AvutTnorizep PeErRsOoNNEL 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:

Caxcer-Susvect AGENT Exposep 1x Tuts Area Impervious

Suit Incitvptne Groves, Boots, axp Air-Supriiep Hoop

Requirep at Att Times, AvtHorizep Personne Ox iy

(iii) Appropriate signs and instructions shall be

posted at the entrance to, and exit from, regulated

areas, informing employees of the procedures that must

he followed in entering and leaving a regulated area.

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

ers of Ethyleneimine and containers required under

45a

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

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

and handled only by, authorized employees, or by other

employees trained in accordance with subparagraph (5)

of this paragraph, may have contents identification

limited to a generie or proprietary name, or other

proprictary identification, of the carcinogen and per-

cent.

(ii) Containers of Ethyleneimine and containers re-

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

and (¢)(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

14, 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 instrue-

tion which contradicts or detracts from the effect of

any required warning, information or instruction.

ete Wd. iON

AA EAE MTB

46a

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

prior to being authorized to enter a regulated area,

shall receive a training and indoctrination program

ineluding, 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 employce’s specific role in emergency pro-

cedures ;

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

ognition and evaluation of conditions and situations

which may result in the release of Ethyleneimine ;

(h) The purpose for and application of specifie first

aid procedures and practices ;

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

training and indoctrination program and annually

thereafter.

(ii) Specifie emergency procedures shall be pre-

scribed, and posted, and employ °s 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.

pe -4

He =

;

47a

(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. Yncidents which result in the release

of Ethyleneimine into any area where employees may

he 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

ne va inanais MES.

employees, and any medical surveillance program

implemented ; and

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

and measurcs 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 impicmented 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 oceupationai

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.

49a

(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.

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.