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

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Appendix
- **Published:** January 1, 1975
- **Citation:** 420 U.S. 973

## Text

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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

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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 |
OO

act gereaerene,

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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.

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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
Register.’? 29 U.S.C. § 655(e).

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

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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

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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)

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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).

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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

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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)

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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,

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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.

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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

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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.

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(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.

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(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.

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(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,

:
4
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(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.

(C) The Secretary is authorized to grant a variance
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.

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(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
Register.

(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

|
a
;

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

;
4
2
3
4
4

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

of

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.

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(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.

(c) Requirements for areas containing Ethylenei-
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.

(c) Required to shower after the last exit of the day.

(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.

(c) Required to wash hand, forearms, face and
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

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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.

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(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.

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(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.

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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 ;

(c) The purpose for and application of the medical
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.

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(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

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(c) A report of any medical treatment of affected
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.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385608_0559%3A2. Public record. Not legal advice.
