Appendix — Industrial Union Dept., AFL-CIO v. American Petroleum Institute
Supreme Court brief1980
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AMERICAN PerroLetM INSTITUTE, CHieMICAL SPECIALTIES MANUFAC-
ELLIOT BREDHOFF
(ieneral Counsel Weinbere
Industrial Union Deprt..
1000 Connecticut Aveutte, N.W.,
Washington, D.C, 20036 Attorneys for Petitioner
IN THE
Supreme Court of the Unie GRawED
QOcTober Tero, 197
TE
ae pif OFFICE UF THE CLERK
INpustRIAL PN1oN Dr sping xt, AFL-( ‘Kip Ae 4K Rn Ws
dl
TURERS ASSOCIATION, MANUFACTURING CHEMISTS ASSOCIATION,
NATIONAL PETROLEUM REFINERS ASSOCIATION, AMERICAN
Perrovin« INcorporatep, ATLANTIC RicuriseLp COMPANY, ~
CITIFS Servick COMPANY, CONTINENTAL Olu COMPANY, DELTA
Ou Company, Exxon Corporation, Guir Om CoMPANy,
MARATHON Or Company, PHILLIps PETROLEUM COMPANY,
SHELL Oi COMPANY, SoutH HAMpron Om Company, STAND-
ARD Ol. COMPANY (INDIANA), STANDARD O1L COMPANY OF OHIO,
“ux Om ComMPANY OF PENNSYLVANIA, SUN OiL COMPANY OF
Deva ware, Texaco INc.. UNton Ott COMPANY or CALIFORNIA
Recoper Mancuracturerss Association, INc.. Firestone Tire &
Rusper CoMPany, GENERAL Tire & Rupber Company, B. F.
GOODRICH COMPANY, GOODYEAR Tire & RuBBER Co.PANY
E. I. pt Pont pe NEMOURS AND COMPANY
ARMSTRONG RuBpBER COMPANY AND Uniroyal, COMPANY
INDEPENDENT PETROLEUM ASSOCIATION OF AMERICA
AMERICAN IRON AND Stern. INstituTe, BETHLENEM SreeL CoRPoRA-
TION, CycLops CORPORATION, JONES AND LAUGHLIN STEEL Cor-
PORATION, NATIONAL STEEL CorpPoRATION, Repceuic STEEL
CORPORATION, SHENANGO INCORPORATED, UNITED Strates STEEL
CORPORATION
AND
OcCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
APPENDIX TO THE
PETITION FOR A WRIT OF CERTIORARI TO THE
UNITED STATES COURT OF APPEALS FOR THE
FIFTH CIRCUIT
ee
etiponacEe IH. COHEN
Of Counsel : e—eoneRrT M. WEINBERG
JereMian A. COLLINS
Brechoff. Gottesman. Cohen &
1000 Connecticut Avenue, N.W.
AFL-CIO Washington. D.C. 20036
33 ie
TABLE OF CONTENTS
Page
Opinion of the Court of Appeals ..............ccccceeeeeees la
Standard for Occupational Exposure to Benzene .... 34a
Statement of Reasons of the Secretary of Labor .... 66a
Amendment of the Standard for Occupational
Nee i. cccsnsenseoqesoosepare 252a
Order of the Court of Appeals ..............csscssesseseseeees 2538a
Judgment of the Court of Appeals «ccc 2d54a
YC ap
4
APPENDIX A
THE AMERICAN PrerroLeum INSTITUTE ET AL. Petitioners
b] ,
THE MANUFACTURING CHEMISTS ASSOCIATION AND THE CHEMI-
«|
CAL SPECIALTIES MANUFACTURERS Association, Intervenors,
v.
OccupaTIONAL Sarety anp HEautu ADMINISTRATION ET AL.,
Respondents,
INpustriaL Union Departm ENT, AFL-CIO, Intervenor.
Nos. 78-1253, 78-1257, 78-1486, 78-1676, 78-1677,
78-1707 and 78-1745,
United States Court of Appeals, Fifth Circuit.
Oct. 5, 1978.
On Petitions for Review of an Order of the Occupational
Safety and Health Administration.
Before Cotemay, Ciark, and Tsoriat, Circuit Judges.
Crarves Ciark, Circuit J udge:
This case presents consolidated petitions for review! of
* The petitioning or intervening producers of benzene and ben-
zene-containing products are the American Petroleum Institute on
behalf of itself and member companies; the American Iron and
Steel Institute\on behalf of itself and member companies ; the Inde-
pendent Petroleum se Sree of America on behalf of itself and
member companies; and the Manufacturing Chemists Association
on behalf of itself and methber companies. The petitioning or inter-
vening users of benzene and benzene-containing products are the
Rubber Manufacturers Association on behalf of itself and member
companies; the Armstrong Rubber Company and Uniroyal, Inc.;
E. I. du Pont de Nemours and Company ; and the Chemical Special-
ties Manufacturers Association on behalf of itself and member com-
panies. The grouping of the petitioners into the producer or user
category was made in order to coordinate the briefing and arguing
of this case, and this opinion will continue to refer to those cate-
gories.
2a
a new health standard limiting occupational exposure to
henzene? promulgated by the Occupational Safety and
Health Administration of the Department of Labor
(OSHA), pursuant to the Occupational Safety and Health
Act, 299 ULS.CLA, § 651 ef seg. (1975) (the Act). The basis
for the standard is OSH.A’s determination that benzene is
a carcinogen for which there is no known safe level of
exposure. Briefly, the standard requires employers to assure
that no employee is exposed to an airborne concentration of
benzene in excess of one part benzene per million parts of
air (1 ppm) averaged over an eight-hour day,* it requires
employers to assure that no employee is exposed to dermal
contact with liquid benzene,t and it requires employers to
assure that caution labels are aflixed to all containers of
products containing benzene and that the labels remain
wlixed when the product leaves the employer's workplace.®
In addition, the standard imposes numerous compliance re-
quirements for ‘feach place of employment where benzene is
produced, reacted, released, packaged, repackaged, stored,
‘The standard, to be codified at 29 C.F.R. § 1910,1028, and
OSTLA’s statement of reasons in support of the standard are pub-
lished at 43 Fed. Reg. 5918-70 (1978).
* The ceiling limit is 5 ppm as averaged over any fifteen minute
period.
#OSILA promulgated an amended standard the day before oral
argument of this ease which exempted from the scope of the stand-
ard all work operations where the only exposure to liquid benzene
or its vapors is from liquid mixtures containing 0.5 pereent (0.1
percent after June 27, 1981) or less of benzene by volume, 43 Fed.
Rew, 27,962-71 (1978). The original standard’s absolute prohibition
of dermal contact with any liquid containing any amount of benzene
is therefore no longer in existence. The effect of this amendment on
the issues in this case will be discussed infra.
® Not only does the scope of the amended standard affect the label-
ine requirement, but the amended standard also exempts from the
labeling requirement liquid mixtures containing 5.0 percent or less
benzene by volume which were packaged before June 27, 1978.
3a
transported, handled, or used,’? with certain exceptions.
These requirements include initial and continual exposure
monitoring, engineering and work practice controls to re-
duce and maintain exposure below the permissible level,
respiratory protection to prevent excessive exposure in
limited situations, protective clothing and equipment to pre-
vent dermal contact with liquid benzene, initial and con-
tinual medical surveillance, employee training programs,
and retention of records regarding exposure monitoring
and medical surveillance.
The petitioning producers and users of benzene and ben-
zene-containing products principally attack the reduction
of the permissible exposure limit to 1 ppm, the prohibition
of dermal contact with liquids containing benzene, and the
labeling requirements for such liquids. The petitioners also
attack several of the ancillary provisions of the standard
including its broad scope, the monitoring and medical nt
veillance requirements, and the specification of mandatory
engineering and work practice controls.
I,
The Act authorizes the Secretary of Labor? to promul-
gate occupational safety and health standards. 29 U.S.CLA.
§ 650, An ‘occupational safety and health standard’? is de-
fined as ‘a standard which requires conditions, or the adop-
tion or use of one or more practices, means, methods, opera-
tions, or processes, reasonably necessary or appropriate to
provide safe or healthful employment and places of employ-
ment’? 29 U.S.C.A. §652(8). In promulgating standards
* Presently the permissible exposure limit for benzene is 10 ppm
29 C.F.R. § 1910.1000 Table Z-2 (1977). This standard has been a
existence since 1971.
™This authority has been delegated to the Assistant Secretary of
Labor for Occupational Safety and Health, the chief executive
officer of OSITA. References to the Secretary and OSHA are used
interchangeably in this opinion.
4a
dealing with toxic materials, such as benzene, the Secretary
is required to
set the standard which most adequately assures, to the
extent feasible, on the basis of the best available evi-
dence, 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. De-
velopment of standards under this subsection shall be
hased upon research, demonstrations, experiments, and
such other information as may be appropriate. In addi-
tion to the attainment of the highest degree of health
and safety protection for the employee, other considera-
tions shall be the latest available scientific data in the
field, the feasibility of the standards, and experience
gained under this and other health and safety laws.
Whenever practicable, the staidard promulgated shall
be expressed in terms of objective criteria and of the
performance desired.
29 ULS.CLA. § 655(b) (5). When necessary or appropriate,
standards may prescribe labels or other forms of warning,
protective equipment, control or technological procedures,
exposure monitoring, and medical examinations, 29 U.S.C.A.
§ 655(b) (7).
Judicial review of occupational safety and health stand-
ards is authorized by 29 U.S.C.LA. § 655(f), and on re-
view ‘* [t]he determinations of the Secretary shall be con-
clusive if supported by substantial evidence in the record
considered as a whole.’* Several courts, including this one,
have pointed out the problems involved in attempting to
apply the traditional substantial evidence test in assessing
OSHA standards resulting from informal rulemaking, F.¢.,
Associated Industries of New York State, Inc. v. United
States Department of Labor, 487 F.2d 342, 347-50 (2d Cir.
1973); Florida Peach Growers Association, Inc. v. United
States Department of Labor, 489 °.2d 120, 127-29 (Sth Cir.
oa
1974); Industrial Union Department, AFL-CIO vy. Hodg-
son, 162 U.SApp.D.C. 331, 336-340, 499 F.2d 467, 472-76
(1974); Synthetic Organic Chemical Manufacturers Asso-
ciation Vv. Brennan, 503 F.2d 1155, 1158-60 (38d Cir. 1974).
The problem centers not on how to apply the test to factual
findings subject to evidentiary development, but rather on
how to review legislative-like policy judgments. With re-
spect to the former, the substantial evidence standard pro-
vided in the statute clearly is applicable. See, e.g., Indus-
trial Union De partment, AIL-C1O vy. Hodgson, supra, 499
M2d at 474: American lron & Stecl Institute, et al. v. OSHA,
O77 F.2d go5, No, 76-2358 et al. (3d Cir., filed March 28,
1978). Policy choices, though not so susceptible to verifica-
tion or refutation by the record, must be scrutinized never-
theless. See Associated Industries of New York, Inc.
United States Department of Labor, supra, 487 F.2d at 348.
Although the courts have differed in their articulation of
the standard of review of these policy judgments, they have
required the Secretary’s action to be consistent with the
statutory language and purpose. Synthetic Organic Chem-
ical Manufacturers Association vy, Brennan, supra, 503 F.2d
at 1159, As this court stated in assessing an emergency
temporary standard in Florida Peach Growers, ‘it seems
clear that even with the required substantial ey idenee test,
our review basically must determine whether the Secretary
carried out his essentially legislative task in a manner
reasonable under the state of the record before him.’? 489
K.2d at 129. This includes, of course, a review of whether
the Secretary exercised his decisionmaking power within
the limits imposed by Congress.
I.
Benzene is a ubiquitous hydrocarbon compound (CeHe)
that is manufactured for a wide variety of industrial uses.
* Although benzene does oecur naturally in small quantities (a
few parts per billion) in certain substances, including the ambient
Ou
The petro-chemical and petroleum refining industries are
responsible for 94 percent of the total domestic production
of benzene, and the steel industry produces the remaiming
G percent primarily as a by-product of the coking process.
The primary use of benzene is as a feedstock in the manu-
facture of other organic chemicals; it is also uses? in the
manufacture of detergents, pesticides, solvents, and paint,
and as a solvent and reactant in chemical laboratories. In-
dustries currently using benzene include the chemical, print-
ing, lithograph, rubber cements, rubber fabricating,” paint,
varnish, stain removers, adhesives, and petroleum indas-
tries. Among the products that contain benzene are motor
fuels such as gasoline, which contain up to 2 percent benzene.
Benzene has been recognized since 1900 as a toxie sub-
stance capable of producing acute and chronic nomnalig-
nant effects in humans. When benzene vapors are inhaled,
the benzene diffuses rapidly through the lungs and is quick-
ly absorbed into the blood. Acute circulatory failure result-
ing in death within minutes often accompanies exposure to
benzene concentrations as high as 20,000 ppm. Other acute
effects of exposure to milder, though still high (250-500
ppm), concentrations of benzene include vertigo, nervous
excitation, headache, nausea, and breathlessness. When
exposure is stopped, rapid recovery from these symptoms
usually occurs.
air, it is produced in substantial quantities by the petroleum and
steel industries. The production of benzene is rapidly expanding,
and at present only eleven other chemicals and only one other
hydrocarbon are produced in greater tonnage in the United States,
Nee 43 Fed. Reg. 5918.
* According to the rubber companies, the manufacture of tires
requires the use of petroleum solvents which generally contain small
amounts of benzene,
7a
The most common nonmalignant effects of chronic ex-
posure to low’ benzene concentration levels are a non-
functioning bone marrow and deficiencies in the formed
elements of the blood." The degree of severity of such
disorders ranges froim mild and transient episodes to se-
vere and fatal effects. Chromosomal aberrations have also
been associated with chronic benzene exposure, and derma-
titis or other dermal infections can he caused by direct bod-
ily contact with liquid benzene.
As a result of its toxicity, benzene’s history has been
one of regulation. In 1946, the American Conference of
Governmental Industrial Hygienists recommended a thresh-
old limit value for benzene exposure of 100 ppm. This value
was reduced to 50 ppm in 1947, to 35 ppm in 1948, to 25
ppm in 1963, and to 10 ppm in 1974. The American National
Standards Institute adopted a threshold limit value of 10
ppm in 1969, which OSHA adopted in 1971 without rule-
inaking under the authority of 29 U.S.C.A. § 665(a)." This
standard, codified at 29 CLE.R. § 1910.1000 Table Z-2 (1977)
' These toxic effects were documented at exposure levels above
25-40 ppm, and a few studies showed nonmalignant blood abnor-
malities at levels below 25 ppm. 43 Fed. Ree, 5924-25,
"A decline in the red blood cell count (anemia) results in a
decreased capacity of the blood to carry oxygen to various parts
of the body and is characterized by fatigue. A decline in the white
blood cell count (leukopenia) reduces the capacity of the body to
defend against disease and is characterized by reeurrent infections.
A decline in the platelet count (thrombocytopenia) results in an
impaired clotting of the blood and is characterized by bleeding
tendencies.
29 U.S.C.A. § 655(a) directed the Secretary, within two years
after the effective date of the Act and without rulemaking, to prom-
ulgate as an occupational safety or health standard any national
consensus standard that he determined would result in improved
safety or health for employees, The purpose of this power was to
make the Act effective immediately, and the power expired on
April 28, 1973.
Sa
and still in effect, was based on the nonmalignant toxic
effects of benzene exposure and not on any possible leu-
kemia hazard.
Widely scattered through the benzene literature are stud-
ies suggesting a link between benzene exposure and leu-
kemia, a usually fatal cancer of the blood-forming organs.
During the 1970’s several additional studies reported a
statistically significant increased risk of leukemia among
workers occupationally exposed to high levels of benzene
and concluded benzene was a leukemogen.” As a result of
18 One such study was reported in 1975 by Dr. Enrico Vigliani.
In 1963, Dr. Vigliani participated in a study of workers exposed
to resins, inks, varnishes, and glues containing various amounts of
benzene, and found a risk of leukemia among these workers twenty
times greater than that for the general population, Toluene was
substituted for benzene in 1964 in one of the industries studied,
and the 1975 study showed no new cases of leukemia among workers
in that industry.
A second study was reported in 1972 by Dr. Muzaffer Aksoy, a
hematologist who testified at the rulemaking hearing. In this study
Dr. Aksoy reported four leukemia deaths among Turkish shoe-
makers resulting from their exposure to benzene concentrations in
excess of 150 ppm for periods ranging from six to fourteen years,
and at the hearing he estimated that the incidence of leukemia
among the population he studied was twice what would have been
expected for the population as a whole, Dr. Aksoy also noted a
decline in leukemia cases after ‘other solvents were substituted for
benzene. ey
The study most heavily relied upon by OSILA was one reported
by Dr. Peter Infante of the National Institute for Occupational
Safety and Health, a body created to conduct research and recom-
mend occupational safety and health standards. See 29 U.S.C.A.
$$ 669-71. Dr. Infante studied workers exposed to benzene in the
production of Pliofilm at Goodyear’s Akron and St. Mary’s plants
between 1940 and 1949 and found among them a five-fold increased
risk of dying of leukemia when compared to two control groups.
No specific exposure level during the period covered by the study
was established, but testimony at the hearing indicated that ex-
EN etestrdiree ss —.*
this new evidence, OSTLA began procedures which culminat-
ed with the present proposal, among other things, to reduce
the permissible exposure level frour 10 ppm to 1 ppm.
In January 1977 OSHA issued voluntary Guidelines for
Control of Occupational Mxposure to Benzene recommend.
ing exposure not to exceed an eight-hour time-weighted
average of | ppm. An Emergency Temporary Standard for
Occupationak Mxposure to Benzene also providing for a
reduction in the permissible exposure limit to 1 ppm™ was
issued in May 1977, but this standard never went into effect
because of judicial challenges. The proposed permanent
benzene standard, which was based on OSHA’s determina-
tion that the available scientific evidence established that
employee exposure to benzene presents a leukemia hazard
and that exposure therefore should be limited to the lowest
feasible level, was published on May 27, 1977. This pro-
posal provided for a reduction in the permissible exposure
limit from 10 ppm to 1 ppin and established requirements
relating to dermal and eye contact,!® exposure monitoring,
inedical surveillance, methods of compliance, labeling, and
recordkeeping. Public hearings were held July 19 through
August 10, 1977, at which 95 witnesses testified. In addition,
numerous exhibits and documents were submitted to OSHA
as part of the rulemaking record. The resulting permanent
benzene standard was promulgated on February 3 and pub-
. on February 10, 1978, with a March 3, 1978 effective
date.
posure was probably around 100 ppm during most of the period
studied with occasional exposure levels as high as several hundred
parts per million.
™ Both the Guidelines and the Emergency Temporary Standard
exempted work operations where the only exposure to benzene was
from liquids containing 1 percent or less of benzene hy volume.
'® The proposed permanent statement also exempted work opera-
tions where the only exposure to benzene was from liquid mixtures
containing 1 percent (0.1 percent after one year from the effective
date of the standards) or less of benzene by volume.
1Oa
ITI.
The American Petroleum Lustitute on behalf of itself and
iwember companies filed petitions for review of the standard
in this court on February 2 and February 3, 1978. The Amer
ican tron and Steel Institute, the Independent Petroleum
Association of America, the Manufacturing Chemists Asso
ciation, the Rubber Manufacturers Association, the Arm
strong Rubber Company and Uniroyal, Ine., BH. Edu Pont
de Nemours and Company, and the Chemical Specialties
Manufacturers Association subsequently either intervened
on behalf of the American Vetroleum Institute or filed
original petitions for review in other circuits that were
transferred to this eirevit and consolidated with the Amer
iern Petroleum Institute case, In addition, the Industrial
Union Department, AFPL-CLO, intervened on behalf of
OSHA in support of the standard, '*
he petitioners filed motions for a stay of the standard
pending review on Mareh 10, 1978, and on March 13 a judge
of this court issued a temporary stay of the standard pend
ing a hearing before a three-judge panel. The issues con
cerning the stay were fully briefed by the parties on an
expedited basis, and after hearing oral argument a panel
of the eourton April 18, 1978, ordered a stay of the standard
to be continued pending disposition of the petitions for
review"?
The principal argument of the petitioning producers of
benzene and benzene-containing products is that substantial
evidence and the best available evidence do not show that
the reduction of the permissible exposure limit trom 10
Although we speak generally in this opinion about the conten-
tious of the petitioners and the contentions of OSILA, the Industrial
Union Department was an active participant in this ease and
offered sonsiderable support to OSHA's position,
Phe issuance of a stay pending judicial review is authorized
by 29 ULS.CLA. § 655(f).
———— —
lla
ppm to | ppm is reasonably necessary or appropriate to
provide safe or healthful ermiployment and places of em-
ployment. These petitioners also attack several of the an-
cillary provisions of the standard, including its broad seope,
the monitoring and medical surveillance requirements, and
the specification of mandatory, primary means of compli-
ance, as not being supported by substantial evidence that
they are reasonably necessary or appropriate to provide
safe or healthful employment. The attack of the petitioning
users of benzene and benzene-containing products is two-
fold: (i) They contend that substantial evidence and the
best available evidence do not show that the dermal contact
prohibition is reasonably necessary or appropriate to pro-
vide safe or healthful employment, and that the dermal
contact prohibition is not feasible; and (ii) they contend
that substantial evidence does not show the labeling re-
quirement to be reasonably necessary or appropriate to
provide safe or healthful employment, that the labeling
requirement is not feasible, and that the labeling require-
ment is beyond OSILA’s jurisdiction. OSHA, in addition to
arguing that substantial evidence, the best available -evi-
dence, feasibility considerations, and its statutory mandate
to protect workers justify the standard in its entirety, con-
tends that Congress imposed on it no substantive require-
ihent to promulgate only standards that are reasonably
necessary or appropriate to provide safe or healthful em-
ployment and places of employment,
On June 21, 1978, the day before oral argument, OSHA
~ promulgated an amended standard to exempt from the
scope of the benzene standard work operations where the
mly exposure to benzene is from liquid mixtures contain-
ihe 0.5 percent (0.1 percent after June 28, 1981) or less of
nzene by volume, and to exempt from the labeling require-
ments liquid mixtures containing 5.0 percent or less benzene
by volume which were packaged before June 27, 1978. 43
Med. Reg. 27,971 (1978). Although the proposed emergency
12a
temporary standard and the proposed permanent standard
had exempted work operations where exposure to benzene
resulted only from liquid mixtures containing | percent or
less of benzene by volume,'® the permanent standard that
Was promulgated contained no such exemption, As a result,
the permanent standard prohibited all dermal contact with
liquids containing any amount of benzene and it imposed
the labeling requirements on all such liquids. Several in.
dustry groups pétitioned OSILA for a stay of the dermal
contact prohibition and labeling requirements as they ap
plied to liquids containing small amounts: of benzene.
OSHA subsequently granted a stay as to work operations
where the sole exposure to benzene was from mixtures con
taining 0.1 percent or less of benzene and instituted a new
rulemaking proceeding which resulted in the June 21, 1978
amendment,
The court called for supplemental briefing to address the
effect of this amendment on the issues already briefed and
argued, This briefing has been completed, and it appears
that the major effect of the amendment is on the arguments
regarding the feasibility of the dermal contact and labeling
provisions. Since the considerations associated with the
feasibility of those provisions have been significantly
changed by the amendments, we do not address the merits
of the feasibility arguinents in this opinion.
As noted above, the exemption in the proposed permanent
standard fell to O11 percent after the first vear.
These petitioners, who generally were among the user petition-
ers in this case, sought relief on the grounds that OSTLA failed to
provide adequate notice that the final standard might contain no
exemption for work operations where the only benzene exposure
was from liquid mixtures containing small amounts of benzene, that
the dermal contact prohibition was not based on the best available
evidence, and that the dermal contact prohibition was not feasible.
With respect to feasibility, the rubber industry contended that
the manufacture of tires was impossible without some dermal con-
tact with solvent containing trace amounts of benzene.
I3a
IV.
OSHA justifies the reduction of the permissible exposure
limit for benzene from 10 ppm to | ppm by coupling two
factual findings, which it contends are supported by sub-
stantial evidence in the record, with a regulatory. policy
Which OSTILA contends is required by its mandate to protect
workers, The factual findings are that benzene causes leu-
kena and that there presently exists no known safe level
for benzene exposure, The regulatory policy is to limit em
ployee exposure to carcinogens to the lowest feasible level.
The producer petitioners, in addition to attacking the
factual finding that no known safe level for benzene ex-
posure exists,” contend that OSITA has failed to meet a
burden which the Act imposes of determining that the
reduction of the permissible exposure limit from 10> ppm
tol ppmiis ‘reasonably necessary’’ to provide a safe work-
place. In support of the latter contention, these petitioners
point to this cireuit’s recent decision in Aqua Slide ‘N’ Dive
Corp Vv. Cousumer Product Safety Commission, 569 2d
831 (oth Cir. 1978), and assert that OSHA failed to assess
benefits expected to be achieved by the standard in light
of the expected costs of compliance, The petitioners argue
that by defining an “occupational safety and health stan-
dard” as one requiring conditions ** reasonably necessary’
to provide safe or healthful places of employment, 29 U.S.
CLA. §652(8), Congress recognized that safety and health
resources are not unlimited and required OSHA somewhere
in its decisionmaking process to (1) attempt to determine
the extent to which its standards will benefit workers, and
*’'This argument is based on the fact that all studies associating
benzene and leukemia involve high benzene concentration levels,
that a substantial body of the scientifie community subscribes to
the theory that safe threshold levels exist for exposure to carei-
nogens, and that empirical evidence shows that low-level exposure
to benzene does not cause leukemia,
l4a
(2) decide whether the projected benefits justify the costs
of compliance with the standard. Only if all standards are
subjected to such assessment, argue the petitioners, can
OSHA assure maximum benefit from the finite amount
industry can expend on safety and health and thus carry
out Congress’ overriding policy ‘‘to assure so far as pos-
sible every working man and woman in the Nation safe and
healthful working conditions.”’ 29 U.S.C.A. §651(b). Since
OSHA has not made a valid determination that reducing.
the permissible exposure level of benzene from 10 ppm to
1 ppm is reasonably necessary to protect workers from a
risk of leukemia, the producers ask us to set that part of
the standard aside.”
OSHA denies that the ‘reasonably necessary’’ language
imposes any substantive obligation on it in promulgating
standards. OSHA would distinguish Aqua Slide, which
dealt with the Consumer Product Safety Act, on the basis
that the ‘‘reasonably necessary’’ language in that Act
appeared as a part of the sections which dealt with the
agency’s process of setting standards, 15 U.S.C.A. §§ 2056
(a), 2058(c)(2(A), whereas the ‘‘reasonably necessary’’
counterpart in the act it administers appears only in the
section which defines the type of standard it may promul-
gate.
In authorizing the Consumer Product Safety Com-
mission to promulgate safety standards, Congress provided
that ‘‘[a]ny requirement of such a standard shall be rea-
sonably necessary to prevent or reduce an unreasonable
risk of injury associated with such product.’’? 15 U.S.C.A.
§ 2056(a). It also required the Consumer Product Safety
Commission to make a specific finding that its rules were
‘‘reasonably necessary to eliminate or reduce an unreason-
able risk of injury.’”? 15 U.S.C.A. § 2058(e)(2)(A). Rather
“1 As a corollary, they ask us to set aside all other provisions de-
signed to effectuate the 1 ppm permissible exposure limit.
la
than following this format, the Occupational Safety and
Health Act de‘ines the occupational safety and health stan-
dard it authorizes as one “which requires conditions, or
the adoption or use of one or more practices, means, meth-
ods, operations, or processes, reasonably necessary or ap-
propriate to provide safe or healthful employment and
places of employment.’* 29 U.S.C.A. §652(8). We decline
to construe the precisely similar requirements of these two
Acts differently or to read words out of the OSHA legisla-
tion. The Act imposes on OSHA the obligation to enact
only standards that are reasonably necessary or appro-
priate to provide safe or healthful workplaces. If a stan-
dard does not fit in this definition, it is not one that OSHA
is authorized to enact.
OSHA next argues that even if the conditions required
by occupational safety and health standards must be rea-
sonably necessary to provide sate or healthful places of
employment, the Act still imposes on OSHA no obligation
to undertake a cost-benefit analysis with respect to the
standards it promulgates. OSHA argues that 29 U.S.C.A
§ 655(b) (5) defines when conditions imposed by a standard
dealing with toxic materials are reasonably necessary. It
urges that the emphasis of that section on making of a
standard *‘which most adequately assures . . . that no
employee will suffer material impairment of health>.
[from] regular exposure . . . for the period of his working
life,’’ overcomes any requirement to make a cost-benefit
analysis. Nevertheless, OSHA contends that it did under-
take economic analyses of both costs and benefits associated
with the standard as required by Aqua Slide, and that after
assessing those analyses it promulgated the standard.
Although 29 U.S.C.A. § 655(b)(5) requires the goal
of attaining the highest dices of health and safety protee-
tion for the employee, it does not give OSHA the unbridled
diseretion to adopt standards designed to create absolutely
risk-free workplaces regardless of cost. To the contrar vy;
léa
that section requires standards to be feasible, and it con-
tains a number of pragmatic limitations in the form of
specific kinds of information OSHA must consider in enact-
ing standards dealing with toxic materials. Those include
‘‘the best available evidence,’’ ‘‘research, demonstrations,
experiments, and such other information as may be appro-
priate,’’ ‘‘the latest available scientific data in the field,”’
and ‘‘experience gained under this and other health and
safety laws.’’ Moreover, in standards dealing with toxic
materials, just as with all other occupational safety and
health standards, the conditions and other requirements
imposed by the standard must be ‘‘ reasonably necessary or
appropriate to provide safe or healthful employment and
places of employment.’’ 29 U.S.C.A. § 652(8).
Since the purpose of the Act to protect workers from
dangerous conditions of employment is parallel to the pur-
pose of the Consumer Product Safety Act to protect con-
sumers from dangerous products, we must be guided by
Aqua Slide in determining whether OSHA has met its
burden of showing that the benzene standard is reasonably
necessary to protect workers from a leukemia hazard.
There we said:
In evaluating the ‘‘ reasonable necessity’’ for a stan-
dard, the Commission has a duty to take a hard look,
not only at the nature and severity of the risk, but also
at the potential the standard has for reducing the se-
verity or frequency of the injury, and the effect the
standard would have on the utility, cost or availability
of the product.
569 F.2d at 844; see also D. D. Bean & Sous vy. Consumer
Product Safety Commission, 574 F.2d 643 (1st Cir. 1978).
Before it regulates, the agency must show that a hazard
exists and that its regulation will reduce the risk from the
hazard, for ‘‘no [occupational safety and health] standard
would be expected to impose added costs or inconvenience
... unless there is reasonable assurance that the frequency
l7a
or severity of injuries or illnesses will be reduced.’’ 569
F.2d at 839. More importantly for today’s ease, Aqua Slide
also requires the agency to assess the expected benefits in
light of the burdens to be imposed by the standard. Al-
though the agency does not have to conduct an elaborate
cost-benefit analysis, 569 F.2d at 840, it does have to deter-
mine whether the benefits expected from the standard bear
a reasonable relationship to the costs imposed by the stan-
dard. 569 F.2d at 842,
The only way to tell whether the relationship between
the henetits and costs of the benzene standard is reasonable
is to estimate the extent of the expected benefits and costs.
See 569 I".2d at 843. OSHA did this with respect to costs by
engaging a consulting firm to assess the expected compli-
ance costs and economic feasibility of the proposed stan-
dard, 43 Fed.Reg. 5934-39, Based on this study and other
evidence, OSITA estimated compliance costs for all affected
industries to be $187—205 million first year operating costs,
$266 million engineering control costs, and $34 million re-
curring annual costs.27 OSHA determined these costs to be
feasible since they would not threaten the financial welfare
of the affected firms or the general economy. However,
OSHA disclaimed any obligation to balance these costs
against expected benefits. 43 Fed.liog. 5940-41, Rather than
attempting to measure the extent to which the leukemia
hazard of benzene exposure would be reduced by lowering
the permissible exposure limit from 10 ppm to 1 ppm,
OSHA merely assumed that benefits from the reduction
‘may be appreciable.’ [t based this assumption on a find-
ing that benzene was unsafe at any level and its conclusion
*? Although the petitioners du not seriously challenge OSHA’s
estimate of costs in this suit, they refer to the promulgation of this
standard as a $1 billion decision.
Neither OSHA’s estimate nor the petitioners’ estimate takes
into account the effects of the amendment, which narrows the scope
of the standard.
18a
that exposures to lower levels of toxic inaterials would be
safer than exposure to higher levels.
OSHA’s fall-back position attempts to justify its stan-
dard as being reasonably necessary within the meaning of
Aqua Slide. It contends the standard promises appreciable
benefits ata cost which industry can absorb, This justifica-
tion is deficient in one crucial way: substantial evidence
does not support OSHA's conclusion that benefits are likely
to be appreciable. Without an estimate of benefits supported
by substantial evidence, OSHA is unable to justify a finding
that the benefits to be realized from the standard bear a
reasonable relationship to its one-half billion dollar price
tag.
OSHA’s assumption that the standard is likely to result
in benefits is not unsupported. The divided opinion in the
scientific community over the existence or not of safe thresh-
old levels of exposure to carcinogens provides substantial
evidence which would support the finding that exposure to
henzene at the present level of 10 ppm poses some leukemia
risk. The general agreement in the scientific community that
exposure to carcinogens at low levels is safer than exposure
at higher levels permits the further factual deduction that
reducing the permissible exposure limit from 10 ppm to 1
ppm will result in some benefit. This finding and deduction,
however, does not yield the conclusion that measurable
henefits will result, and OSHA is unable to point to any
studies or projections supporting such a finding. As we
noted in Aqua Slide, mere rationality is not equivalent to
substantial evidence that conditions required by standards
are reasonably necessary. 569 F.2d at 841. The lack of sub-
stantial evidence of discernible benefits is highlighted when
one considers that OSHA is unable to point to any empirical
evidence documenting a leukemia risk at 10 ppm even
though that has been the permissible exposure limit since
1971. OSHA’s assertion that benefits from reducing the
permissible exposure limit from 10 ppm to 1 ppm are likely
19a
to be appreciable, an assumption based only on inferences
drawn from studies involving much higher exposure levels
rather than on studies involving these levels or sound sta-
tistical projections from the high-level studies, does not
satisfy the reasonably necessary requirement limiting
OSHA’s action. Aqua Slide requires OSHA to estimate the
extent of expected benefits in order to determine whether
those benefits bear a reasonable relationship to the stan-
dard’s demonstrably high costs.
We are not persuaded by OSHA’s argument that this
standard should be upheld since the lack of knowledge con-
cerning the effects of exposure to benzene at low levels
makes an estimate of benefits expected from reducing the
permissible exposure level impossible.** The statute re-
quires all conditions imposed by a standard to be reasonably
necessary to provide safe or healthful employment, and it
requires decisions to be based on ‘‘the best available evi-
dence,’’ ‘‘research, demonstrations, experiments, and such
other information as may be appropriate,’’ ‘‘the latest
*8 Although OSHA asserts that risk quantification at low expo-
sure levels and therefore estimates of expected benefits from the
standard cannot presently be made, OSHA has provided us with a
Preliminary Report on Population Risk to Ambient Benzene Ex-
posures, recently released by the Environmental Protection Agency,
which attempts to extrapolate from the results of the Infante
study a determination of the risk of leukemia to the general popula-
tion at the exposure level of 1 part per billion. In addition, the
petitioners introduced at the rulemaking proceeding a preliminary
risk assessment for occupational exposure to benzene at 10 ppm and
1 ppm based on the studies at higher exposure levels relied on by
OSILA. Finally, OSHA’s economie consultant testified that it could
perform a cost-effectiveness analysis for the benzene standard; an
analysis which would have included some kind of risk quantifica-
tion, Although OSHA’s assertion that present knowledge is insuffi-
cient to construct a valid dose-response curve for benzene may be
correct, the record reflects that preliminary assessments are now
being made and that valid extrapolations will be possible as more
is known about the effects of past exposure at higher levels.
20a
scientific data in the field,’’ and ‘‘experience gained under
this and other health and safety laws.’’ By requiring the
consideration of such kinds of information, Congress pro-
vided that OSHA regulate on the basis of knowledge rather
than on the unknown. But see Society of Plastics Industry,
Inc. vy. OSHA, 509 F.2d 1301, 1308 (2d Cir. 1975). Until
OSHA can provide substantial evidence that the benefits
to be achieved by reducing the permissible exposure limit
from 10 ppm to 1 ppm bear a reasonable relationship to the
costs imposed by the reduction, it cannot show that the
standard is reasonably necessary to provide safe or health-
ful workplaces.
This does not mean that OSHA must wait until deaths
occur as a result of exposure at levels below 10 ppm before
it may validly promulgate a standard reducing the permis-
sible exposure limit. See Florida Peach Growers Assocta-
tion, Inc. v. United States Department of Labor, 489 F.2d
120 132 (Sth Cir. 1974). Nevertheless, OSHA must have
some factual basis for an estimate of expected benefits be-
fore it can determine that a one-half billion dollar standard
is reasonably necessary. For example, when studies of the
effects of human exposure to benzene at higher concentra-
tion levels in the past are sufficient to enable a dose-response
curve to be charted that can reasonably be projected to
the lower exposure levels, or when studies of the effects of
animal exposure to benzene* are sufficient to make projec-
—————"
“4A dose-response curve shows the re ‘tween different
exposure | hose ex-
ment of leukemia in animals exposed to benzene, those attempts#
the most part have been unsuccessful. Those studies do not even
establish that benzene exposure causes leukemia, much less the
degree of risk associated with various exposure levels. See 43 Fed.
Ree. 5930-31, 5932.
2la
tions of the risks involved with exposure at low levels, then
OSHA will be able to make rough but educated estimates of
the extent of benefits expected from reducing the permis-
sible exposure level from 10 ppm to 1 ppm. Until such esti-
mates are possible, OSHA does not have sufficient informa-
tion to determine that a standard such as the one under
review which it can only say might protect some worker
from a leukemia risk is reasonably necessary.
We will not attempt to reconcile our decision with the
‘ases from other circuits which uphold other standards,
regulating exposure to carcinogens. See Industrial Union
Department, APL-C1O vy. Hodgson, 162 U.S.App.D.C. 331,
499 F.2d 467 (1974) (asbestos dust standard); Society of
Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir.
1975) (vinyl chloride standard); American Iron & Steel
Institute et al. v. OSHA, 577 F.2d 825, No. 76-2358 et al.
(3d Cir., filed March 28, 1978) (coke oven emission stan-
dard). Those opinions did not address what Congress meant
by requiring the conditions imposed by standards to be
reasonably necessary to provide safe or healthful places of
employment. In this circuit, under our Aqua Slide decision,
substantial evidence must support a finding that those con-
ditions are reasonably necessary, a showing that OSHA
has not made, In addition, those cases were decided on their
own records. Without critical analysis of what was estab-
lished in those proceedings, we hold in today’s case that
Congress intended for OSHA to regulate on the basis of
more knowledge and fewer assumptions than this record
reflects.
OSH A’s failure to provide an estimate of expected bene-
fits for reducing the permissi)le exposure limit, supported
by substantial evidence, makes it impossible to assess the
reasonableness of the relationship between expected costs
and henelits. This failure means that the required support
is lacking to show reasonable necessity for the standard
promulgated. Consequently, the reduction of the permissible
22a
exposure limit from LO ppm to 1 ppm and all other parts
of the standard geared to the 1 ppm level must be set aside.
V,
OSHA's prohibition of dermal contact with benzene ts
based on “OSHA's policy that, in dealing with a carcinogen,
all potential routes of exposure (7.¢., inhalation, ingestion,
and skin absorption) be limited to the extent feasible’? 43
Mod. Reg. 5948, OSELA, while acknowledging that the record
evidence on the effect of benzene on the skin is ‘Sextremely
limited’? and that the few studies in the area ‘fare not
definitive as te the extent of benzene that is absorbed
through the intact skin or as to the @@mparative rate of
absorption through damaged skin,’’) 43 Med. Reg, 5948-49,
nevertheless decided to prohibit dermal contact with liquids
containing benzene, In arriving at this decision OSTLA re
lied on animal studies and one human study suggesting
that benzene is absorbed through intact skin, on the assump
tion that benzene would more readily be absorbed through
damaged skin than undamaged skin, and on the belief that
substances containing benzene are readily absorbed through
the skin and act as vehicies for absorption of benzene.
OSHA now seeks in part to justify this prohibition as
an adjunet to the permissible exposure limit for airborne
concentrations of benzene and because of a concern for der-
matitis. To the extent that the dermal contact prohibition is
an adjunct of the permissible exposure limit, it would have
to be set aside along with the permissible exposure limit,
The concern for dermatitis, on the other hand, appears to
be a post hoe rationalization for the dermal contact prohibi-
tion since it was not a significant part of OSILA’s reasoning
process that led to this provision.** The requirements of
6 At one point in the statement of reasons for the benzene stand.
ard OSILA did state that ‘‘[o]ne purpose of the protective clothing
and equipment requirement is to protect employees from dermatitis
and burns.’’ 43 Bed. Reg. 5953. The reason for this standard as a
Bou
this standard were based on the possible leukemia hazard
associated with exposure to benzene, 43 Fed. Reg. 5918, 5948,
and our review must be of the reasoning process of the
ageney at the time it promulgated the standard based on the
record before it, Dry Color Manufacturers’ Association, Ine.
Vv. Department of Labor, 486 2d 98, 104 n8& (3d Cir. 1973).
The user petitioners contend that substantial evidence
and the best available evidence do not support a finding
that the dermal contact provisions are reasonably necessary
to provide safe or heaithful employment, and in addition
they contend that the dermal contact prohibition is not
feasible since it is impossible for certain industries to oper-
ate without some dermal contact with liquids containing
small amounts of benzene, Since the amendment to the stan
dard on dune 21, 1978, significantly affeets the feasibility
issue, we will not address that issue in this opinion. We
agree with the users, however, that OSHA has not shown
the dermal contact prohibition to be reasonably necessary
to protect workers from contracting benzene-related leu-
kemia since readily available evidence of the kind Congress
required OSILA to consider was neglected, The record there:
fore fails to support the finding that benzene és absorbed
through the skin, Since entry to the body by dermal contact
was not established, the record will not support a finding
whole, however, and the primary reason for the absolute prohibition
of dermal contact with benzene (to which the protective clothing
and equipment provision is tied), is to protect workers from a
suspected carcinogen, It is within the context of OSITA’s poliey
of reducing exposure to carcinogens to the lowest feasible level that
we must review the dermal contact prohibition.
Dermal diseases can pose significant hazards in the workplace,
and regulatory action following proceedings specifically focusing
on such hazards may be appropriate. OSHLA recently announced the
formation of a standards advisory committee on cutaneous hazards
“identify the occupational exposures in industry which pose a
hazard to the skin and/or the use of the skin as a portal of entry.’’
Is Med. Reg. 10,647-48 (1978).
to
JAa
that the prohibition of all dermal contact with benzene will
result in quantifiable benefits in terms of a reduced risk of
leukemia justifying the costs of the provision. Thus reason-
able necessity is lacking here too.
Studies of whether benzene is absorbed by the skin of
animals, conducted in the first half of this century, are re
ferred to in this record during the course of expert testi
mony and as background material in later studies ef wheth-
er benzene ean be absorbed by human skin. Though these
studies reached different conclusions, their relevance with
respect to the issue of absorption of benzene by human skin
has been questioned since there are important differences
between the permeability of the skins of animals and hu-
mans. The studies concluding that benzene penetrates skin
of certain animals have also been criticized since the possi-
bility of benzene inhalation was not excluded and since there
Wis no guarantee that the skin remained intact through the
course of the experiment.
Between 1946 and 1961, experiments were conducted to
determine whether human skin absorbed benzene. Although
the first several of these studies conducted in the late 1940's
and mid-1950's had negative results, one study published in
1961 found that some absorption had occurred and conelud-
ed that ‘‘the absorption of benzene threughout the skin
must not be neglected.’’ The record reveals problems in the
interpretation of all of these studies, however. In particular,
the 1961 study reporting positive results used a technique,
compressing benzene-soaked cotton against the skin with a
glass plate for prolonged periods, that ix recognized today
as an efficient way to drive molecules into the skin.
The oral testimony on the issue of skin absorption of
henzene is very limited. Representatives of the National
Institute of Occupational Safety and Health testified that
they were of the opinion that benzene can be absorbed
through the skin, and that absorption is more likely when
the skin is damaged or when the benzene is contained in a
2a
solvent which itself is absorbed, Except for a passing refer-
ence to what appears to be the 1961 positive study, these
witnesses did not attempt to support. their opinions by
reference to empirical data.
The one expert dermatologist who testified in depth on
the issue of skin absorption of benzene, Dr. Howard Mai-
bach of the University of California Medical Center, after
summarizing and discussing critically the studies that have
been conducted to date, concluded that ‘in 1977 it is ex.
tremely difficult, if not impossible, to balance all of the in-
formation that is available. Admittedly, the overwhelming
majority of the observations suggest that benzene does not
penetrate the skin. One observation suggests that it does.’
Dr. Maibach testified that he did not know whether benzene
is absorbed through the skin; that he did not know whether
benzene would be more readily absorbed through damaged
skin than intact skin, although the assumption, unsupported
by any data, is that it would be; and that he did not know
whether benzene would be absorbed more readily if it is in
another solvent.
Were this the extent of the reeord on the issue of skin
absorption, OSHA’s finding that dermal contact with ben-
zene poses a cancer risk could pass muster. When available
evidence of equivalent quality is conflicting, a finding in
accordance with one view or the other should be considered
to be supported by substantial evidence. See Universal
Camera Corp. v. NLRB, 340 U.S. 474, 488, 71 S.Ct. 456, 465,
99 L.Ed. 456 (1951). This reeord speaks further on the issue
of skin absorption, however, and in light of OSHA’s statu-
tory command this additional evidence removes the support
for OSHA’s actions.
Dr. Maibach, following his conclusion that the studies
conducted to date were not definitive on the issue of whether
human skin absorbed benzene, stated:
Today we have a much simpler and much more direet
way of answering this . . . because now radioactive
26a
benzene is available, and one simply would apply radio-
active benzene, some Carbon 14 benzene, to the skin of
the arm of an appropriate animal that has permeability
characteristics similar to the people in this room...
and then would simply look for the radioactivity ex-
creted into the urine, the feces and the breath.
This is a simple technique. It has been done for over
100 organie compounds in the last decade, measuring
the amount of transport to the skin, and it would then
tell us definitively, without argument, and efficiently,
just how much of any benzene penetrates the skin.
Dr. Maibach testified that this experimental technique can
answer a number of questions other than whether any ben-
zene penetrates the skin, including demonstrating any dif-
ferences in existence and extent of absorption of various
parts of the body which may be exposed; whether benzene
applied to the skin has the same toxie potential as benzene
inhaled; whether multiple exposures result in correspond-
ingly greater absorption than a single exposure; whether
it is possible for one to protect himself by wearing protee-
tive clothing; whether and to what extent the amount of
henzene absorbed through the skin is dependent upon ben-
zene concentration; whether, because of its volatility, ben-
zene splashed onto the skin evaporates more rapidly or goes
through the skin more rapidly; and whether benzene is
absorbed more readily if it is in another solvent. Dr. Mai-
hach testified that the experiment would be relatively short
term in length (six to twelve weeks), that the techniques
are straightforward and reliable, and that the experiment
could be done by anybody having the analytie facilities
available. This testimony about the availability and relia-
bility of modern experimental techniques is unrefuted in
the record.
OSHA’s decision to regulate on the basis of dated, incon-
elusive data when modern experimental methods can quickly
and efficiently provide reliable information contravenes the
directive from Congress to promulgate standards on the
basis of the ‘‘best available evidence,’’ ‘‘ research, demon-
27a
strations, experiments, and such other information as may
be appropriate,’’ and ‘‘the latest available scientific data in
the field.’ 29 U.S.CLA, §655(b) (5). This is not a case where
there is testimony that additional sophisticated research
could be attempted, but might not shed new light on a
subject. To the contrary, unrefuted testimony reveals the
existence of simple experimental techniques, tried and
proved effective for over 100 organie compounds, that ean
provide accurate information on the factual issues OSHA
admits are unresolved by the past studies.27 When such
factual information is so readily available, 29 U.S.CLA.
G50(0D)(5) requires OSHA to aequire that information
before promulgating regulations which would require an
established industry to change long-followed work processes
that are not demonstrably unsafe.
In light of unrefuted testimony on the ready availability
of conclusive evidence on the subject, OSHA’s choice to rely
on old and inconclusive evidence that there is a possibility
of absorption of benzene through the skin which might cause
cancer is in clear disregard of the congressional directive
as to the kinds of evidence OSHA is required to consider.
Therefore, the provision of the standard prohibiting dermal
contaet with liquid benzene cannot stand on the present
record,
VI.
The reduction of the permissible exposure limit and
the prohibition of dermal contact are the provisions of the
benzene standard to which all the standard’s other require
inents are tied. Since neither of these provisions can be
upheld on the present record, it follows that the standard
as a whole must be set aside.
Although we vacate the labeling provision in conjunction
with the rest of the standard, this or some similar require-
“7 Tn their brief the petitioners represent that Dr. Maibach is now
conducting one such study.
28a
inent is sure to be considered by OSHA on remand. There.
fore, we address the user petitioners’ jurisdictional attack
on one aspect of that provision. The labeling provision gen-
erally requires the employer to assure that caution labels
are aflixed to all containers of benzene and benzene-contain
ing products. In the aspect of the provision under attack,
OSHA further requires each employer to ‘tassure that the
caution labels remain affixed when the benzene or products
containing benzene are sold, distributed or otherwise leave
the employer’s workplace.’’
By requiring caution labels to remain affixed when ben-
zene products leave an employer’s workplace, OSHA. in-
tended to assure that all employees along the produet’s
distribution chain are apprised of the hazardous nature of
benzene exposure. 43 Fed.Reg. 5960. It relied on the au-
thority given to it by 29 U.S.CLA. §655(b)(7) to require
the use of warning labels in standards, and it coneluded
that this authority was not limited to requiring an employer
to warn his own employees of the hazardous products he
manufactures. Since the manufacturer of a product contain-
ing a toxic substance (and subsequent employers who have
heen informed of the hazard) is in the best position to know
of the hazard and warn others down the distribution chain,
OSHA concluded that the protective purposes of the Aet
would best be served by requiring the manufacturers to
refrain from taking steps designed to withhold information
concerning the dangers of the products from downstream
workers.
The petitioners contend that the Act gives OSHA the
jurisdiction to regulate workplaces, not products. They ar-
gue that OSHA here is claiming the authority to regulate
finished products leaving the workplace, an authority that
would transform what was intended to be a federal work-
place safety code into a federal product safety code. The
petitioners contend that Congress intended to place the
responsibility for proteeting each employee on his or her
etna ae ae A Ne
29a
own employer, an allocation of responsibility that has
proved workable in all but unusual circumstances such as
the multiemployer construction worksite; and that, since
all employers would be required to assure that benzene-
containing products in their own workplaces are labeled,
and the usual allocation of responsibility for labeling would
be workable and effective.
Cases involving multiemployer construction worksites
have recognized a duty on an employer to comply with
OSHA standards in order to protect the employees of an-
other employer. See Brennan vy. Occupational Safety &
Health Review Commission and Underhill Construction
Corp., 013 F.2d 1082 (2d Cir. 1975) (Underhill): Marshall v.
Knutson Construction Co., 566 F.2d 596 (8th Cir. 1977);
Beatty Equipment Leasing, Inc. v. Secretary of Labor, 577
B.2d 534 (9th Cir. 1978). These cases involved citations for
violations of 29 U.S.CLA, § 654(a), which imposes two duties
on employers:
Mach employer—
(1) shall furnish to each of his employees employment
and a place of employment which are free from recog-
nized hazards that are causing or are likely to cause
death or serious physical harm to his employees;
(2) shall comply with occupational safety and health
standards promulgated under this chapter.
In holding that the § 654(a)(2) duty could be violated even
though the cited employer’s employees were not shown to
have been exposed to the hazard created by the violation,
the Underhill court emphasized that the §654(a)(2) duty,
unlike the §654(a)(1) duty, was ‘fin no way limited to situ-
ations where a violation of a standard is linked to exposure
of his employees to the hazard.’’ 513 F.2d at 1038 (emphasis
in original). In reaching its conclusion, the court relied on
the broad remedial purpose of the Act and on the fact that
the cited employer had created the hazard and maintained
30a
the area where it was located. In agreeing with this analysis,
the Beatty court stated:
[This interpretation of the statute] facilitates the
broad remedial purpose of the Act which Congress
declared is ‘‘to assure so far as possible every working
man and woman in the Nation safe and healthful work-
ing conditions.’’ 29 U.S.C.A. § 651, As this court has
stated, ‘‘Congress clearly intended to require employ-
ers to eliminate all foreseeable and preventable haz-
ards.’’ [citation omitted] We agree with the Commis-
sion that this policy can best be effectuated by placing
the responsibility for hazards on those who create them.
577 F.2d at 537. The duty on one employer to comply with
OSHA standards for the benefit of employees of another
employer, however, has only been expressly recognized in
the multiemployer construction worksite context.
In deciding whether an OSHA standard can require an
employer to assure that a warning label remains affixed
when a benzene-containing product leaves his workplace in
order to protect downstream employees, we too must keep
in mind the Act’s overall purpose ‘‘to assure so far as
possible every working man and woman in the Nation safe
and healthful working conditions.’’ 29 U.S.C.A. §651(b).
In this light the provision of the statute requiring OSHA to
prescribe labeling of hazards is broad in scope:
Any standard promulgated under this subsection
shall prescribe the use of labels or other appropriate
forms of warning as are necessary to insure that em-
ployees are apprised of all hazards to which they are
exposed...
29 U.S.C.A. § 655(b)(7). Unlike some sections of the Act,
this provision does not expressly limit the employer’s obli-
gation of informing employees of hazardous conditions to
the employer’s own employees.
The ability of downstream employers to protect their
own employees is also an appropriate consideration in de-
sla
termining where the duty to warn should lie. Cf. Anning-
Johnson Co, v. Occupational Safety and Health Review
Commission, 516 I*.2d 1081, 1086-91 (7th Cir. 1975). This
record reveals that the presence of benzene in a workplace
is often a hidden hazard. Some industries refer to benzene
under code or trade names, and many products containing
benzene are sold only under trade names with no listing of
contents. Under such circumstances it is apparent that the
manufacturer of a benzene-containing product is in a far
better position to warn downstream employees in opera-
tions using the benzene-containing product of the benzene
hazard than is a downstream employer.
Considering the purpose of the Act to protect every work-
ing person in the nation, the express and broad statutory
authorization for OSHA to prescribe warning labels in
standards, and the fact that the presence of benzene in a
product is often a concealed hazard, we agree with OSHA
that it has the authority to prohibit an employer from re-
moving the warning labels from containers of benzene and
benzene products when those containers leave his workplace.
This is not a situation where OSHA is imposing a heavy
regulatory burden on an employer solely for the benefit of
the employees of another. Rather, the regulation says no
more than that an upstream employer may not take affirma-
tive steps to withdraw from downstream employees a pro-
tection that he must furnish to his own employees. The
obvious reluctance of the maker of a product to intimate
or suggest to his consumers that his product is less than
totally desirable is understandable. Such a consideration
may even be shown to have such deleterious effect on sales
that it affects the reasonable necessity for this feature of
the regulation. See Aqua Slide, 569 F.2d at 840-48. In such
a case, OSHA may choose to eliminate the requirement
altogether. It may also choose to moderate the label’s de-
scription to more precisely describe the nature or extent of
the hazard.
oe
Don
Placing the responsibility to warn downstream employees
of concealed hazards on those upstream employers who
create the hazards and know of the hazards is consistent
with the remedial purpose of the Act and is within OSHA’s
broad authority to prescribe warning labels. If on remand
OSHA decides to promulgate a new benzene standard which
includes warning labels, OSHA may require an employer
in the chain of distribution of those products to assure that
such warning labels remain affixed when the product leaves
the employer’s workplace. provided, of course, the labeling
requirement as a whole is shown to be reasonably necessary
to provide safe workplaces.
The user petitioners also contend that OSHA’s authority
to require labeling of products containing benzene has been
preempted under 29 U.S.C.A. § 653(b)(1)* by the Con-
sumer Product Safety Commission, which has promulgated
regulations under the Federal Hazardous Substances Act,
15 U.S.C.A. § 1261 et seq.,”” requiring the labeling of prod-
ucts containing benzene. See 16 C.F.R. § 1500.14(a) (3), (b)
(3) (1977). We reject this argument. The preemption provi-
sion was intended to avoid the ‘‘duplication that would re-
sult where another federal agency was also providing for
the occupational safety of a class of workers.’’ Organized
Migrants in Community Action, Inc. v. Brennan, 172 U.S.
App.D.C. 147, 153, 520 F.2d 1161, 1167 (1975). It applies
only when the preempting regulation is ‘‘directed at a work-
ing condition,’’ Southern Pacific Transportation Co. v.
Usery, 539 F.2d 386, 391 (Sth Cir. 1976), which the promul-
2829 U.S.C.A. § 653)b) (1) states:
Nothing in this chapter shall apply to working conditions of
employees with respect to which other Federal agencies . . .
exercise statutory authority to prescribe or enforce standards
or regulations affecting occupational safety or health.
29 The Consumer Product Safety Commission has authority to
promulgate regulations under the Federal Hazardous Substances
Act by virtue of 15 U.S.C.A. § 2079.
30a
gating agency has authority to regulate. The Consumer
Product Safety Commission’s regulation is not designed to
protect a class of workers and it is not directed at the
working conditions of employees, Although an existing re-
quirement for labeling under another act may affect the
reasonable necessity for an OSHA requirement, 29 U.S.C.A.
§653(b)(1) does not prohibit OSHA from requiring con-
tainers of benzene products to bear the warning labels au-
thorized by 29 U.S.C.A. § 655(b) (7).
Conclusion
The petitions for review are granted. The reduction of the
airborne permissible exposure limit from 10 ppm to 1 ppm
is set aside since the present record does not show that such
a reduction is reasonably necessary to provide safe or
healthful employment. The dermal contact prohibition is set
aside since this provision was not based on the best avail-
able scientific data in the field. The remaining provisions of
the standard are also vacated since they are ancillary to the
permissible exposure limit reduction and the dermal contact
prohibition.
dda
APPENDIX B
Part 1910 of Title 29 of the Code of Federal Regulations
is hereby amended as follows:
1. A new paragraph (c) is added to § 1910.19, to read as
follows:
§ 1910.19 Special provisions for air contammants.
(c) Section 1910.1028 shall apply to the exposure of every
employee to benezene in every employment and place of
employment covered by §§ 1910.12, 1910.13, 1910.14, 1910.15,
or § 1910.16, in lieu of any different standard on exposure
to benzene which would otherwise be applicable by virtue
of any of those sections.
§ 1910.20 [Revoked]
2. Section 1910.20 is revoked.
§ 1910.1000 [Amended]
3. Table Z-2 of §1910.1000 is amended by adding a foot-
note following the words ‘‘ Benzene (Z37.40-1969),’’ and by
adding the following below Table Z-2:
4. Section 1910.1028 is revised to read as follows:
§ 1910.1028 Benzene.
(a) Scope and application. (1) This section applies to
each place of employment where benzene is produced, re-
acted, released, packaged, repackaged, stored, transported,
handled, or used.
(2) This section does not apply to:
(i) The storage, transportation, distribution, dispensing,
sale or use as fuel of gasoline, motor fuels, or other fuels
subsequent to discharge from bulk terminals; or
' Occupational exposures to benzene are subject to the require-
ments of § 1910.1028 except as specifically exempted by § 1910.-
1028(a) (2). Exposures exempted by § 1910.1028(a)(2) are cov-
ered by this § 1910.1000.
ONT ast SI
35a
(ii) The storage, transportation, distribution or sale of
benzene in intact containers sealed in such a manner as to
contain benzene vapors or liquid, except for the require-
ments of paragraph (k) (2), (3), (4), and (5), and para-
graph (j) of this section.
(b) Definitions. ** Action level’? means an airborne con-
centration of benzene of 0.5 ppm, averaged over an 8-hour
work day.
‘Assistant Secretary’? means the Assistant Secretary
of Labor for Occupational Safety and Health, U.S. Depart-
ment of Labor, or designee.
‘“‘Authorized person’’ means any person required by his
duties to enter a regulated area and authorized to do so by
his employer, by this section or by the Occupational Safety
and Health Act of 1970. ‘‘Authorized person’”’ includes a
representative of employees who is designated to observe
monitoring and measuring procedures under paragraph
(m) of this section. :
‘“‘Benzene”’ (Cells) (CAS Registry No. 00071432) means
solid, liquefied or gaseous benzene. [t includes mixtures of
~ tds.containing benzene and the vapors released by these
liquids.
~~,
‘‘Bulk terminal’? means a facility which is used for the
storage and distrbution of gasoline, motor fuels or other
fuels and which receives its petroleum products by pipeline,
barge or marine tanker.
‘*Director’’ means the Director of the National Institute
for Occupational Safety and Health, U.S. Department of
Health, Mducation, and Welfare, or designee.
‘‘Mmergency’’ means any occurrence such as, but not
limited to, equipment failure, rupture of containers, or fail-
ure of control equipment which may, or does, result in a
massive release of benzene,
36a
‘‘OSHA Area Office’ means the office of the Occupational
Safety and Health Administration having jurisdiction over
the geographic area where the affected workplace is located.
(ec) Permissible exposure limits—(1)Inhalation—(i)
Time-weighted average limit (TWA). The employer shall
assure that no employee is exposed to an airborne concen-
tration of benzene in excess of 1 part benzene per million
parts of air (1 ppm) as an 8-hour time-weighted average.
(ii) Ceiling limit, The employer shall assure that no
employee is exposed to an airborne concentration of ben-
zene in excess of 5 ppm as averaged over any 15 minute
period.
(2) Dermal and eye exposure limil. The employer shall
assure that no employee is exposed to eye contact with
liquid benzene; or to skin contact with liquid benzene, unless
the employer can establish that the skin contact is an iso-
lated instance.
(d) Regulated areas. (1) the employer shall establish,
within each place of employment, regulated areas where
benzene concentrations are in excess of the permissible air-
borne exposure limit.
(2) The employer shall limit access to regulated areas to
authorized persons.
(3) Notification of regulated areas. Within 30 days fol-
lowing the establishment of a regulated area, the employer
shall report the following information to the OSHA Area
Office :
(i) The address of each establishment which has one or
more regulated areas ;
(ii) The loeations, within the establishment, of each regu-
lated area;
(iii) A brief description of each process or operation
which results in employee exposure to benzene in regulated
areas; and
37a
(iv) The number of employees engaged in each process or
operation within each regulated area which results in ex-
posure to benzene, and an estimate of the frequency and
degree of exposure within each regulated area.
(e) Exposure monitoring and measurements.—(1) Gen-
eral. (i) Determinations of airborne exposure levels shall
he made from air samples that are representative of each
employee’s exposure to benzene over an eight (8) hour
period.
(1i) For the purposes of this section, employee exposure
is that exposure which could oceur if the employee were not
using a respirator.
(2) Initial monitoring. (i) Hach employer, whe has a place
of employment where benzene is produced, reacted, re-
leased, packaged, repackaged, stored, transported, handled
or used shall monitor each of these workplaces and work
operations to accurately determine the airborne concentra-
tions of benzene to which employees may be exposed.
(ii) The initial monitoring required under paragraph
(e)(2)(i) of this section shall be conducted and the results
obtained within 30 days of the effective date of this section.
Where the employer has monitored after January 4, 1977
and the monitoring satisfies the accuracy requirements of
paragraph (e)(6) of the section, the employer may rely on
such earlier monitoring to satisfy the requirements of para-
graph (e)(2) (i) of this section, unless there has been a pro-
duction, process, personnel or control change which may
have resulted in new or additional exposures to benzene or
the employer has any other reason to suspect a change
which may have resulted in new or additional exposures to
benzene; and provided that the employer maintains a record
of the monitoring in accordance with paragraph (1) (1) and
notifies each employee in accordance with paragraph (e) (5).
(3) Irequency.—(i) Measurements below the action level.
If the measurements conducted under paragraph (e) (2) (i)
38a
of this section reveal employee exposure to be below the
action level, the measurements need not be repeated, except
as otherwise provided in paragraph (e) (+4) of this section.
(ii) Measurements above the action level. If the measure-
ments reveal employee exposure to be in excess of the
action level, but below the permissible exposure limit, the
employer shall repeat the monitoring at least quarterly.
The employer shall continue these quarterly measurements
until at least two consecutive measurements, taken at least
seven (7) days apart, are below the action level, and there-
after the employer may discontinue monitoring, except as
provided in paragraph (e)(4) of this section.
(iii) Measurements above the permissible exposure limit.
If the measurements reveal employee exposure to be in
excess of the permissible exposure limits, the employer shall
repeat the measurements at least monthly. The employer
shall continue these monthly measurements until at least
two consecutive measurements, taken at least seven (7)
days apart, are below the permissible exposure limits, and
thereafter the employer shall monitor at least quarterly.
(4) Additional monitoring. Whenever there has been a
production, process, personnel or control change which may
result in new or additional exposure to benzene or whenever
the employer has any other reason to suspect a change
which may result in new or additional exposures to benzene,
such as spills, leaks, ruptures, or breakdowns, the employer
shall repeat the monitoring which is required by paragraph
(e)(2)(i) of this section.
(5) Employee notification. (i) Within 5 working days
after the receipt of the measurement results, the employer
shall notify each employee in writing of the exposure meas-
urements which represent that employee’s exposures.
(ii) Where the results indicate that the employee’s ex-
posure exceeds the permissible exposure limits, the notifi-
ee
39a
‘ation shall also include the corrective action being taken
or to be taken by the employer to reduce exposure to or
below the permissible exposure limit.
(6) Accuracy of measurement. The employer shall use a
method of measurement which has an accuracy, to a confi-
dence level of 95 percent, of not less than plus or minus 25
percent for concentrations of benzene greater than or equal
to 1 ppm.
(f) Methods of compliance—(1) Priority of compliance
methods, The employer shall institute engineering and work
practice controls to reduce and maintain employee expo-
sures to benzene at or below the permissible exposure limits,
except to the extent that the employer establishes that these
controls are not feasible. Where feasible engineering and
work practice controls are not sufficient to reduce employee
exposure to or below the permissible exposure limits, the
employer shall nonetheless use them to reduce exposures to
the lowest level achievable by these controls, and shall sup-
plement them by the use of respiratory protection.
(2) Compliance program. (i) The employer shall estab-
lish and implement a written program to reduce exposures
to or below the permissible exposure limits solely by means
of engineering and work practice controls required by para-
graph (f)(1) of this section.
(ii) The written program shall include a schedule for de-
velopment and implementation of the engineering and work
practice controls. These plans shall be revised at least every
six months to reflect the current status of the program.
(iii) Written plans for th+se compliance programs shall
be submitted, upon request, to the Assistant Secretary and
the Director, and shall be available at the worksite for ex-
amination and copying by the Assistant Secretary, the Di-
rector, and the employees or their authorized representa-
tives.
40a
(iv) The employer shall institute and maintain at least
the controls described in his most recent written compliance
program,
(g) Respiratory protection—(1) General. Where res-
piratory protection is required under this section, the em-
ployer shall select, provide and assure the use of respira-
tors. Respirators shall be used in the following cireum-
stances:
(i) During the time period necessary to install or imple-
ment feasible engineering and work practice controls;
(ii) During maintenance and repair activities in which
enginering and work practice controls are not feasible ;
(iii) In work situations where feasible engineering and
work practice controls are not vet sufficient to reduce ex-
posure to or below the permissible exposure limits; or
(iv) In emergencies.
(2) Respirator selection. (i) Where respiratory protec-
tion is required under this section, the employer shall select
and provide, at no cost to the employee, the appropriate
respirator from Table 1 below and shall assure that the
employee uses the respirator provided.
(ii) The employer shall select respirators from among
those approved by the National Institute for Occupational
Safety and Health under the program of 30 CFR Part 11.
(3) Respirator program. The employer shall institute a
respiratory protection program in a accordance with
§ 1910.134(b), (d), (e) and (f).
(4) Respirator use. (i) Where air purifying respirators
(cartridge, canister, or gas mask) are used, the employer
shall, except as provided in paragraph (g)(4) (ii) of this
section, replace the air-purifying canisters or cartridges
prior to the expiration of their service life or the end of
shift in which they are first used, whichever occurs first.
4la
(ii) Where a cartridge or canister of an air purifying
respirator has an end of service life indicator certified by
NIOSH for benzene, the employer may permit its use. until
such time as the indicator shows the end of service life.
(iii) The employer shall assure that the respirator issued
to the employee exhibits minimum facepiece leakage and
that the respirator is properly fitted,
(iv) The employer shall allow each employee who wears
a respirator to wash his or her face and respirator facepiece
to prevent skin irritation association with respirator use.
Tasie l.—Respiratory protection for benzene
Airborne concentration of
benzene or condition of
use
Respirator type
_(@) Less thanorequalto (2) Any chemical cartridge res-
10 p/m. pirator with organic vapor
cartridge; or
(2) Any supplied air respi-
rator.
(b) Less thanorequalto (2) Any chemical cartridge res-
50 p/m. | pirator with organie vapor
cartridge and full face-
piece ;
(2) Any supplied air respirator
with full facepiece ;
(3) Any organic vapor gas
mask ; or
(4) Any self-contained breath-
ing apparatus with full
facepiece.
(c) Lessthanorequalto (2) Supplied air respirator
1,000 p/m. with half mask in positive
pressure mode.
42a
(d) Lessthanorequalto (2) Supplied air respirator
2,000 p/m. with full facepiece, helmet,
or hood, in positive pres-
sure mode.
(e) Lessthanorequalto (1) Supplied air respirator and
10,000 p/m. auxiliary self-contained
facepiece in positive pres-
sure mode; or
(2) Open circuit self-contained
breathing apparatus with
full facepiece in positive
pressure mode.
i Brera (1) Any organic vapor gas
mask ; or
(2) Any self-contained breath-
ing apparatus with full
facepiece.
(h) Protective clothing and equipment. Where eye or
dermal exposure may occur, the employer shall provide, at
no cost to the employee, and assure that the employee wears
impermeable protective clothing and equipment to protect
the area of the body which may come in contact with liquid
benzene. Hye and face protection shall meet the require-
ments of § 1910.133 of this Part.
(i) Medical Surveillance—(1) General. (i) The employer
shall make available a medical surveillance program for
employes who are or may be exposed to benzene at or above
the action level and employees who are subjected to an
emergency. ”
(ii) The employer shall assure that all medical examina-
tions and procedures are performed by or under the super-
vision of a licensed physician, and provided without cost
to the employee.
(2) Initial examinations. (1) Within thirty days of the
effective date of this section, or before the time of initial
assignment, the employer shall provide each employee who
4 oa
is or may be exposed to benzene at or above the action level
with a medical examination, including at least the following
elements;
(a) A history which includes past work exposure to ben-
zene or any other hematologic toxins; a family history of
blood dyscrasias including hematological neoplasms; a his-
tory of blood dyserasias including genetically related heimo-
globin alterations, bleeding abnormalities, abnormal fune-
tion of formed blood elements; a history of renal or liver
dysfunction; a history of drugs routinely taken, alcoholic
intake and systemic infections; a history of exposure to
marrow toxins outside of the current work situation, in-
cluding volatile cleaning agents and insecticides;
(b) Laboratory tests, including a complete blood count
with red cell count, white cell count with differential,
platelet count, hematocrit, hemoglobin and red cell indices
(MCV, MCH, MCHC), serum bilirubin and reticulocyte
count; and
(c) Additional tests where, in the opinion of the examin-
ing physician, alterations in the components of the blood
are related to benzene exposure.
(ii) No medical examination is required to satisfy the
requirements of paragraph (i)(2)(i) of this section if ade-
quate records show that the employee has been examined in
accordance with the procedures of paragraph (i)(2)(i) of
this section within the previous six months.
(3) Information provided to the physician. The employer
shall provide the following information to the examining
physician for each examination under this section:
(1) A copy of this regulation and its appendixes ;
(ii) A description of the affected employee’s duties as
they relate to the employee’s exposure; —
(iii) The employee’s representative exposure level or an-
ticipated exposure level;
44a
(iv) A description of any personal protective equipment
used or to be used; and
(v) Information from previous medical examinations of
the affected employee which is not readily available to the
examining physician.
(4) Physician's written opinions. (i) For each examina-
tion under this section, the employer shall obtain and pro-
vide the employee with a copy of the examining physician’s
written opinion containing the following:
(a) The results of the medical examination and tests;
(b) The physician's opinion concerning whether the em-
plovee has any detected medical conditions which would
place the employee's health at increased visk of material im-
pairment from exposure to benzene:
(c) The physician's recommended limitations upon the
employee’s exposure to benzene or upon the employee's use
of protective clothing or equipment and respirators.
(ii) The written opinion obtained by the employer shall
not reveal specific findings or diagnoses unrelated to occu-
pational exposures.
(5) Periodic examinations (i) The employer shall pro-
vide each employee covered under paragraph (i)(1)(1) of
this section with a medical examination at least semi-
annually following the initial examination. These periodic
examinations shall include at least the following elements:
(a) A brief history regarding any new exposure to poten-
tial marrow toxins, changes in drug and alcohol intake and
the appearance of physical symptoms relating to blood
disorders ;
(b) A complete blood count with red cell count, white
cell count with differential, platelet count, hemoglobin,
hematocrit and red cell indices (MAICV, MCH, MCHC); and
a
ee
45a
(c) Additional tests where in the opinion of the examin-
ing physician, alterations in the components of the blood
are related to benzene exposure.
(ii) Where the employee develops signs and symptoms
commonly associated with toxie exposure to benzene, the
employer shall provide the einplovee with a medical exami-
nation which shall include those elements considered ap-
propriate by the examining physician.
(6) Emergency situations. If the employee is exposed to
henzene in an emergency situation, the employer shall pro-
vide the employee with a urinary phenol test at the end of
the employee's shift. The urine specific gravity shall he
corrected to 1.024. If the result of the urinary phenol test
is below 75 mg/ml, no further testing is required. If the
result of the urinary phenol test is equal to or greater than
7) mg/ml, the employer shall provide the employee with a
complete blood count including a red cell count, white cell
count with differential, and platelet count as soon as prac-
ticable, and shall provide these same counts one month later.
(7) Special examinations. (i) Where the results of any
tests required by this section reveal that any of the follow-
ing conditions exist, the employer shall have the test results
of the employee evaluated by a hematologist:
(a) The red cell count, hemoglobin or platelet count
varies more than 15 percent above or below the employee’s
most recent values ;
(b) The red cell count is below 4.4 million or above 6.3
million per min*, (for males), or below 4.2 million or above
5.5 million per mm® (for females) ;
(c) The hemoglobin is below 14 grams percent or above
18 grams percent (for males) or below 12 grams percent
or above 16 grams percent (for females) ;
(7) The white cell count is below 4,200 or above 10,000;
(46a
’
(e) The thrombocyte count is below 140x10° cells per mm*
or above 440x10° cells per mnt
(ii) In addition to the information required to be pro-
vided to the physician under paragraph (i)(3) of this see-
tion, the employer shall provide the hematologist with the
medical record required to be maintained by paragraph
(1)(2) of this section.
(iii). The hematologist’s evaluation shall inelude a deter-
mination as to the need for additional tests, and the em-
ployer shall assure that these tests are provided.
(j) Employee information and training—(1) Training
program, (i) The employer shall institute a training pro-
gram for all employees assigned to workplaces where ben-
zene is produced, reacted, released, packaged, repackaged,
stored, transported, handled or uged and shall assure that
each employee assigned to these workplaces is informed of
the following: ;
(a) The information contained in Appendices A and B
of this section; |
(b) The quantity, location, manner of use, release, or
storage of benzene and the specific nature of operations
which could result in exposure above the permissible ex-
posure limits as well as necessary protective steps;
(c) The purpose, proper use, and limitations of personal
protective equipment and clothing required by paragraph
(h) of this section and of respiratory devices required by
paragraph (g) of this section and § 1910.134(b), (d), (e)
and (f);
(d) The purpose and a description of the medical sur-
veillance program required by paragraph (i) of this section
and the information contained in Appendix C of this see-
tion; and
(ce) The contents of this standard.
i
A OT ai
47a
(ii) The training program required under paragraph
(j)(1) (i) of this section shall be provided within 90 days
of the effective date of this section or at the time of initial
assignment to workplaces where benzene is produced, re-
acted, released, packaged, repackaged, stored, transported,
handled or used, and at least annually thereafter.
(2) Access to training materials. (i) The employer shall
make a copy of this standard and its Appendices readily
available to all affected employees.
(ii) The employer shall provide, upon request, all ma-
terials relating to the employee information and training
program to the Assistant Secretary and the Director.
(k) Segns and labels. (1) The employer shall post signs
in regulated areas bearing the following legend:
DANGER
BENZENE
CANCER HAZARD
FLAMMABLE—NO SMOKING
AUTHORIZED PERSONNEL ONLY
RESPIRATOR REQUIRED
(2) The employer shall assure that caution labels are
affixed to all containers of benzene and of products con-
taining any amount of benzene, except:
(i) Pipelines, and
(ii) Transport vessels or vehicles carrying benzene or
benzene products in sealed intact containers.
(3) The employer shall assure that the caution labels
remain affixed when the benzene or products containing ben-
zene are sold, distributed or otherwise leave the employer’s
workplace.
48a
(4) The caution labels required by paragraph (k)(2) of
this section shall be readily visible and legible. The labels
shall bear the following legend:
CAUTION
CONTAINS BENZENE
CANCER HAZARD
(5) The employer shall assure that no statement which
contradicts or detracts from the information reavired bv
paragraphs (k)(1) and (kj(4) of this section appears on
or near any required sign or label.
(1) Recordkeeping —(1) Exposure measurements. (i) The
employer shall establish and maintain an accurate record
of all measurements required by paragraph (e) of this
section,
(ii) This record shall include:
(a) The dates, number, duration, and results of each of
the samples taken, including a description of the procedure
used to determine representative employee exposures;
(b) A description of the sampling and analytical meth-
ods used ;
(c) Type of respiratory protective devices worn, if any;
and
(d) Name, social security number, and job classification
of the employee monitored and all other employees whose
exposure the measurement is intended to represent.
(iii) The employer shall maintain this record for at least
40 years or the duration of employment plus 20 years,
whichever is longer.
(2) Medical surveillance. (i) The employer shall establish
and maintain an accurate record for each employee subject
eon
ee eee
49a
to medical surveillance required by paragraph (i) of this
section.
(ii) This record shall include:
(a) The name, and social security number of the em-
ployee;
(b) .\ copy of the physicians’ written opinions, including
results of medical examinations and all tests, opinions and
recommendations ;
ted The peripheral Velewel Stuer slides of the initial test,
the most recent test, and any test demonstrating hemato-
logical abnormalities related to benzene exposure;
(d) Any employee medical complaints related to exposure
to benzene;
(ec) A copy of this standard and its appendices, except
that the employer may keep one copy of the standard and
its appendices for all employees provided that he references
the standard and its appendices in the medical surveillance
record of each employee;
(/) A copy of the information provided to the physician
as required by paragraphs (i)(3) (ii) through (i)(3)(v) of
this section; and
(g) A copy of the employee’s medical and work history
related to exposure to benzene or any other hematologic
toxins.
(iii) The employer shall maintain this record for at least
+0 years or for the duration of employment plus 20 years,
whichever is longer.
(3) Availability. (i) The employer shall assure that all
records required to be maintained by this section shall be
made available upon request to the Assistant Secretary and
the Director for examination and copying.
50a
(ii) The employer shall assure that employee exposure
meusurement records as required by this section be made
available for examination and copying to affected employ-
ees or their designated representatives.
(iii) The employer shall assure that former employees
and the former employees’ designated representatives have
access to such records as will indicate the former employee’s
own exposure to benzene.
(iv) The employer shall assure that employee medical
records required to be maintained by this section be made
available upon request for examination and copying to a
physician or other individual designated by the affected
employee or former employee.
(4) Transfer of records. (i) When the employer ceases
to do business, the successor employer shall receive and
retain all records required to be maintained by paragraph
(1) of this section for the prescribed period.
(ii) When the employer ceases to do business and there
is no successor employer to receive and retain the records
for the prescribed period, the employer shall transmit these
records by mail to the Director.
(iii) At the expiration of the retention period for the
records required to be maintained under paragraph (1) of
this section, the employer shall transmit these records by
mail to the Director.
(m) Observation of monitoring.—(1) Employee observa-
tion. The employer shall provide affected employees, or
their designated representatives, an opportunity to observe
any measuring or monitoring of employee exposure to ben-
zene conducted pursuant to paragraph (e) of this section.
(2) Observation procedures. (i) When observation of the
measuring or monitoring of employee exposure to benzene
requires entry into areas where the use of protective cloth-
ing and equipment or respirators is required, the employer
fo
Pah ITU
o
Dla
shall provide the observer with personal protective clothing
and equipment or respirators required to be worn by em-
ployees working in the area, assure the use of such clothing
and equipment or respirators, and require the observer to
comply with all other applicable safety and health proce-
dures.
(ii) Without interfering with the measurement, observers
shall be entitled to:
(a) Receive an explanation of the measurement proce-
dures;
(b) Observe all steps related to the measurement of air-
borne concentrations of benzene performed at the place of
exposure; and
(c) Record the results obtained.
(n) Appendices. The information contained in the appen-
dices is not intended, by itself, to create any additional obli-
gations not otherwise imposed or to detract from any
existing obligations.
APPENDIX A_
SuBsTANCE Sarety Data SHEET. RENZENE
I. SUBSTANCE IDENTIFICATION
A. Substance. Benzene.
B. Permissible Exposure: Except as to the use as fuels of
gasoline, motor fuels and other fuels subsequent to dis-
charge from bulk terminals.
1. Airborne. 1 part of benzene vapor per million parts of
air (1 ppm); time-weighted average (TWA) for an 8-hour
workday for a 40-hour week, with a 15 minute ceiling con-
centration of 5 ppm.
2. Dermal. Eye contact and skin contact ‘with liquid ben-
zene shall be prohibited.
j2a
C. Appearance and odor, Benzene is a clear, colorless
liquid with a pleasant, sweet odor. The odor of benzene does
not provide adequate warning of its hazard.
II, REALTH HAZARD DATA
A. Ways in which the benzene affects your health, Ben-
zene can affect your health if you inhale it, or if it comes in
contact with your skin or eyes. Benzene is also harmful if
you happen to swallow it.
B. Effects of overerposure. 1. Short-term (acute) over-
exposure: If you are overexposed to high concentrations of
benzene, well avove the levels where its odors are first
recognizable, you may feel breathless, irritxble, euphoric,
or giddy; you may experience irritation in eyes, nose, and
respiratory tract. You may develop a headache, feel dizzy,
nauseous, or experience unsteadiness in walking. Severe
exposures may lead to convulsions.
2. Long-term (chronic) exposure. Repeated or prolonged
exposure to benzene, even at relatively low concentrations,
_ may result in various blood disorders, ranging from anemia
to leukemia, an irreversible, fatal disease. Many blood dis-
orders associated with benzene exposure may occur without
physical symptoms.
III. PROTECTIVE CLOTHING AND EQUIPMENT
A. Respirators. Respirators are required for those opera-
tions in which engineering controls or work practice con-
trols are not feasible to reduce exposure to the permissible
level. If respirators are worn, they must have a National
Institute for Occupational Safety and Health (NIOSH)
seal of approval, and cartridges or canisters must be re-
placed before the end of their service life, or the end of the
shift, whichever occurs first. If you experience difficulty
breathing while wearing a respirator, tell your employer.
53a
B. Protective Clothing. You must wear impervious pro-
tective clothing (such as boots, gloves, sleeves, aprons, etc.)
over any parts of your body that could be exposed to liquid
benzene.
C. Eye and Face Protection. You must wear splash proof
safety goggles if it is possible that benzene may get into
your eyes. In addition, you must wear a face shield if your
face could be splashed with benzene liquid.
IV. EMERGENCY AND FIRST AID PROCEDURES
A. Eye and face exposure. If benzene is splashed in your
eyes, wash it out immediately with large amounts of water.
Call a doctor as soon as possible.
B. Skin exposure, If benzene is spilled on your clothing
or skin, remove the contaminated clothing and wash the
exposed skin with large amounts of water and soap imme-
diately. Wash contaminated clothing before you wear it
again.
C. Breathing. If you or any other person breathes in large
amounts of benzene, get the exposed person to fresh air at
once. Apply artificial respiration if breathing has stopped.
Call for medical assistance or a doctor as soon as possible.
D. Swallowing. If benzene has been swallowed and the
patient is conscious, do not induce vomiting. Call for medical
assistance or a doctor immediately.
V. MEDICAL REQUIREMENTS
lf you are exposed to benzene at a concentration at or
above 0.5 ppm on an 8-hour time-weighted average, your
employer is required to provide a medical history and lab-
oratory tests within 30 days of the effective date of this
standard and semiannually thereafter if you are continu-
ally exposed at or above 0.5 ppm. These tests shall be pro-
vided without cost to you. In addition, if you are accidental-
ly exposed to benzene (either by ingestion, inhalation, or
4a
skin/eve contact) under conditions known or suspected to
be toxic exposure to benzene, your employer is required to
make special tests available to you.
VI. OBSERVATION OF MONITORING
Your employer is required to perform measurements that
are representative of your exposure to benzene and you or
vour designated representative are entitled to observe the
mon. toring procedure. You are entitled to receive an ex-
planation of the measurement procedure, observe the steps
taken in the measurement procedure, and to record the
results obtained. When the monitoring procedure is taking
place in an area where respirators or personal protective
clothing and equipment are required to be worn, you or
your representative must also be provided with, and must
wear the protective clothing and equipment.
VII. ACCESS TO RECORDS
You or your representative are entitled to see the records
of measurements of your exposure to benzene upon request
to your employer. Your medical examination records can
he furnished to your physician or designated representative
upon request to your employer.
VIII. PRECAUTIONS FOR SAFE USE, HANDLING AND STORAGE
Benzene liquid is highly flammable. It should be stored in
tightly closed containers in a cool, well ventilated area.
Benzene vapor may form explosive mixtures in air, All
sources of ignition must be controlled. Use nonsparking
tools when opening or closing benzene containers. Ground
or bond metal benzene containers. Fire extinquishers, where
provided, must be readily available. Know where they are
located and how to operate them. Smoking is prohibited in
areas where benzene is used or stored. Ask your supervisor
where benzene is used in your work area and for additional
plant safety rules.
5da
APPENDIX B
Susstance TECHNICAL GUIDELINES, BENZENE
I. PHYSICAL AND CHEMICAL DATA
A. Substance identification.
1. Synonyms: Benzol, benzole, coal naptha, cyclohexa-
triene, phene, phenyl hydride, pyrobenzol. (Benzine, petro-
leum benzine, and benzine do not contain benzene.)
2. Formula: CeHe (CAS Registry Number : 000071432).
B. Physical data.
1. Boiling Point (760 mm Hg) ; 80.1C (176F)
2. Specific Gravity (water = 1) : 0.879
3. Vapor Density (air = 1): 2.7
4. Melting Point: 5.5C (42F)
). Vapor Pressure at 20C (68F) : 75 mm Hg
6. Solubility in Water: .06%
7. Evaporation Rate (ether = 1): 2.8
—_
8. Appearance and Odor: Clear, colorless liquid with a dis-
tinctive sweet odor.
II. FIRE, EXPLOSION, AND REACTIVITY HAZARD DATA
A. Fire.
1. Flash Point (closed cup): —11C (12F)
2. Autoignition Temperature: 580C (1076F)
3. Flammable Limits in Air, % by Volume: Lower 1.3%,
Upper: 7.5%
4, Extinguishing Media: Carbon dioxide, dry chemical, or
foam.
®. Special Fire-Fighting Procedures: Do not use solid
stream of water, since stream will scatter and spread fire.
56a
Water spray can be used to keep fire exposed containers
cool.
6G. Unusual fire and explosion hazards: Benzene is a flam-
mable liquid. Its vapors can form explosive mixtures. All
ignition sources must be controlled when benzene is used,
handled, or stored. Where liquid or vapor may be released.
such areas shall be considered as hazardous locations. Ben-
zene vapors are heavier than air; thus the vapors may travel
along the ground and be ignited by open flames or sparks at
locations remote from the site at which benzene is handled.
7. Benzene is classified as a 1 B flammable liquid for the
purpose of conforming to the requirements of 29 CFR
1910,.106. A concentration exceeding 3250 ppm is considered
a potential fire explosion hazard. Locations where benzene
may be present in quantities suflicient to produce explosive
or ignitable mixtures are considered Class I Group D for
the purposes of conforming to the requirement of 29 CFR
1910.309.
B. Reactivity.
1. Conditions contributing to instability: Heat.
2. Incompatibility: Heat and oxidizing materials.
3. Hazardous decomposition products: ‘Toxic gases and
vapors (such as carbon monoxide).
II, SPILL AND LEAK PROCEDURES
A. Steps to be taken if the material is released or spilled.
As much benzene as possible should be absorbed with suit-
able materials, such as dry sand or earth. That remaining
must be flushed with large amounts of water. Do not flush
benzene into a conlined space, such as a sewer, because of
explosion danger. Remove all ignition sources. Ventilate
enclosed places.
57a
B. Waste disposal method. Disposal methods must con-
form to other jurisdictional regulations. If allowed, benzene
may be disposed of: (a) Absorbing it in dry sand or earth
and disposing in a sanitary land fill; (b) if small quantities,
by removing it to a safe location from buildings or other
combustible sources, pouring it in dry sand or earth and
cautiously igniting it: (¢) if large quantities, by atomizing
it in a suitable combustion chamber.
IV. MONITORING AND MEASUREMENT PROCEDURES
A, Normal monitoring program, Measurements taken
from the purpose of determining employee exposure are
best taken so that the representative average 8-hour ex-
posure may be determined from a single 8-hour sample or
two (2) 4-hour samples. Short-time interval samples (or
grab samples) may also be used to determine average ex-
posure level if a minimum of five measurements are taken
in a random manner over the 8-hour work shift. Random
sampling means that any portion of the work shift has the
same chance of being sampled as any other. The arithmetic
average of all such random samples taken on one work shift
is an estimate of an employee's average level of exposure
for that work shift. Air samples should be taken in the
employee’s breathing zone (air that would nearly represent
that inhaled by the employee). Sampling must be performed
by gas absorption tubes or alternative methods meeting the
requirements of the standard with subsequent chemical an-
alysis, by gas chromatography. Methods meeting the pre-
scribed accuracy and precision and requirements are avail-
able in the ‘*NIOSH manual of Analytical Methods.’’
V. MISCELLANEOUS PRECAUTIONS
A. High exposures to benzene can occur when transfer-
ring the liquid from one container to another. Such opera-
tions should be well ventilated and good work practices
must be established to avoid spills.
58a
B. Use non-sparking tools to open benzene containers
which are effectively grounded and bonded prior to opening
and pouring.
C. Employers ust advise employees of all plant areas
and operations where exposure to benzene could occur.
Common operations in which high exposures to benzene
may be encountered are: the primary production and utili-
zation of benzene, and transfer of benzene.
APPENDIX C
MeEpIcaL SURVEILLANCE GUIDELINES FoR BENZENE
I, ROUTE OF ENTRY
Inhalation; possible skin absorption.
II. TOXICOLOGY
Benzene is primarily an inhalation hazard. Systemic ab-
sorption may cause depression of the hematopoietic system
and leukemia. Inhalation of high concentrations can affect
the central nervous system function. Aspiration of small
amounts of liquid benzene immediately causes pulmonary
edema and hemorrhage of pulmonary tissue. The extent of
absorption through the skin is unknown. However, absorp-
tion may be accelerated in the case of injured skin, and
benzene may be more readily absorbed if it is present in a
mixture or as a contaminant in solvents which are readily
absorbed. Defatting action of benzene may produce primary
irritation upon:repeated or prolonged contact with the skin.
High concentrations are irritating to the mucuous mem-
branes of the eyes, nose, and respiratory tract.
Ill. SIGNS AND SYMPTOMS
It is not clear to what extent benzene is absorbed through
the skin, however, direct contact may cause erythema or
blistering. Repeated or prolonged contact may result in
‘
ab
59a
drying, sealing dermatitis, or precipitate development of
secondary skin infections, Local effects of benzene vapor or
liquid on the eye are slight. Only at very high concentra-
tions is there any smarting sensation in the eye. Inhalation
of high concentrations of benzene may have an initial stim-
ulatory effect on the central nervous system characterized
by exhiliration, nervous excitation, and/or giddiness, fol-
lowed by a period of depression, drowsiness, fatigue, or
vertigo. There nay be sensation of tightness in the chest
accompanied by breathlessness and ultimately the victim
may lose consciousness. Convulsions and tremors occur fre-
quently, and death may follow from respiratory paralysis
or circulatory collapse in a few minutes to several hours
following severe exposures.
The insidious effect on the blood-forming system of pro-
longed exposure to small quantities of benzene vapor is of
extreme importance. The hematopoietic system is the chief
target for benzene’s toxic effects which are manifested by
alterations in the levels of formed elements in the peripheral
blood. These effects have been noted to occur at concentra-
tions of benzene which may not cause irritation of mucous
membranes, or any unpleasant sensory effects. Early signs
and symptoms of benzene morbidity are varied and often
not overtly apparent and not specific for benzene exposure.
Subjective complaints of headache, dizziness, and loss of
appetite may precede or follow clinical symptomology.
Bleeding from the nose, gums, or mucous membranes and
the development of purpuric spots may occur as the condi-
tion progresses. Rapid pulse and low blood pressure in addi-
tion to a physical appearance of anemia may accompany a
subjective complaint of shortness of breath. Clinical evi-
dence of leukopenia, anemia, and thrombocytopenia, singly
or in combination, have been frequently reported.
Bone marrow may appear normal, aplastic, or hyper-
plastic and may not in all situations correlate with periph-
eral blood forming tissues. There are great variations in
60a
the susceptibility to benzene morbidity which prohibits the
identification of ‘‘typical’’ blood picture. The onset of
effects of prolonged benzene exposure may be significantly
delayed after the actual exposure has ceased.
IV. TREATMENT OF ACUTE TOXIC EFFECTS
Remove from exposure immediately, give oxygen or arti-
ficial resuscitation if indicated. Flush eyes and wash con-
taminated skin. Symptoms of non-specific nervous distur-
bances may persist following severe exposures. Recovery
from mild exposures is usually rapid and complete.
V. SURVEILLANCE AND PREVENTIVE CONSIDERATIONS
A, GENERAL
The principal effects of benzene exposure forming the
basis for this regulation are alterations of the hematopoietic
system as reflected by changes in the peripheral blood and
leukemia. Consequently, the medical surveillance protocol
is designed to observe on a regular basis, blood indices for
early signs of these effects.
Tests must be performed frequently enough to discover
individuals who may be unusually sensitive and likely. to
develop marrow abnormalities, to monitor those who ex-
perience accidental overexposure and to provide early de-
tection of delayed evidence of toxicity.
All workers who are or will be exposed to 0.5 parts per
million (ppm) or greater benzene as an eight-hour time-
weighted average are to be given the opportunity for a
medical examination. Initial examinations are to be pro-
vided within 30 days of the effective date of this standard
or at the time of initial assignment and interval examina-
tions semiannually thereafter. There are special provisions
for medical tests in the event of hematological abnormalities
or for emergency situations.
6la
F. HEMATOLOGY GUIDELINES
The following information excerpted from the analysis
of Dr. Jandl, Chief of Hematology, Harvard School of
Medicine, may be useful to physicians in conducting the
medical surveillance program.
‘‘A minimum battery of tests is to be performed by
strictly standardized methods in the circumstances de-
scribed above.
1. Red cell, white cell, and platelet counts must be per-
formed using an automated (Coulter) counter. The normal
range for the red cell count is approximately 4.4 to 6.0
million cells/mm*, the values for women being about 0.4
million cells lower than for men. A decline from a normal
to a subnormal value, or a rise to a supra-normal value, are
indicative of potential toxicity, particularly should there
be a decline. The normal total white blood count is approxi-
mately 6,200 plus or minus 2,000/mm!. For cigarette smok-
ers and white count will be higher, the upper range of
‘*normal’’ being approximately 1,000 cells higher than 8,200.
Either a decline from normal to subnormal or a rise from
normal to supra-normal, should be regarded as a potential
indication of benzene toxicity. The normal platelet count is
250,000 with a range of 140,000 to (at most) 400,000/mm°.
A decline to below 140,000 or a rise to above 400,000 should
be regarded as possible evidence of benzene toxicity.
The reticulocyte count is performed by technical assis-
tants using a cover-slip smear (see below). In my opinion,
the preferred technique for this purpose is the so-called
‘*dry-method’’ employing brilliant cresyl blue (BCB) for
staining the filaments of reticulum within red cell, and
counter-staining with Wright’s stain. The extreme range
of normal for reticulocytes is 0.4 to 1.5 percent of the red
cells, the usual range being 0.5 to 1.2 percent of the red cells,
but the typical value is in the range of 0.8 to 1.0 percent.
There is an advantage of using the BCB reticulocyte stain-
62a
ing technique (followed by counter-staining with Wright’s
stain) in that visible evidence (i.e., the stained, mounted
reticulocyte smears) may be stored, and if kept filed in the
dark may later be retrieved for reexamination and compari-
sons. A decline in reticulocytes to levels of less than 0.4
percent is to be regarded as possible evidence (unless an-
other specific cause is found) of benzene toxicity requiring
accelerated surveillance. An increase in reticulocyte levels
to above 1.5 percent may also be consistent with (but is not
as characteristic of) benzene toxicity.
2. The single most important routine surveillance test is
an expert technician's careful examination of the peripheral
blood smear. As with the reticulocyte count, the smear
should be with fresh uncoagulated blood obtained from a
needle tip following venipuncture or from a drop of earlobe
hlood (capillary blood). If necessary, the smear may under
certain limited conditions be made from a blood sample
anticoagulated with EDTA (but never with oxalate or hep-
arin). When the smear is to be prepared from a specimen
of venous blood which has been collected by a commercial
Vacutainer® type tube containing neutral EDTA, the
smear should be made as soon as possible after the venesee-
tion. A delay of up to 12 hours is permissible between the
drawing of the blood specimen into EDTA and the prepara-
tion of the smear if the blood is stored at refrigerator (not
freezing) temperature. As with the reticulocyte prepara-
tions, the smear should be made on cover slips only. Under
no circumstances should peripheral blood (or bone marrow
aspirate) intended for examination be smeared on micro-
scope slides, a technique which produces artifacts in blood
cells and distorts the white cell differential count by severe-
ly maldistributing them. Dry blood smears should be stained
with Wright’s stain which should be filtered at least weekly
to remove precipated dye (saturated completely by methy-
lene blue-eosinate derivates).
63a
3. The minimum mandatory observations to be made
from the smear and a discussion of their significance now
follows. The observations are four:
a. The differential white blood cell count.
b, Description of abnormalities in the appearance of red
cells,
e. Deseription of any abnormalities in the platelets.
d. A careful search must be made by the technician
throughout the better areas of every blood smear for imma-
ture white cells such as band forms (in more than normal
proportion), any number of metamyeloeytes, myelocytes.
Any nucleated or multinucleated red blood cells should be
reported. Very large ‘‘giant’’ platelets of fragments of
megakaryocytes must be recognized. Should only a single
one of these abnormalities be found, it should be reported.
An increase in the proportion of band forms among the
neutrophilic granulocytes is an abnormality deserving spe-
cial mention for it represents a very early change which
should be considered as an early warning of benzene toxicity
in the absence of other causative factors (most commonly
infection). Likewise, the appearance of metamyeloevtes in
the absence of other probable cause is to be considered a
possible indication of benzene-induced injury.
An upward trend in the number of basophils, which nor-
mally do not exceed about 2.0 percent of the total white cells,
is to be regarded as possible evidence of benzene toxicity.
A rise in the eosinophil count is less specific but also may
be suspicious of toxicity if it rises above 6.0 percent of the
tota) wiute count.
The normal range of monocytes is from 2.0 to 8.0 percent
of the total white count an average of about 5.0 percent.
About 20 percent of individuals reported to have mild but
persisting abnormalities caused by exposure to benzene
show a persisting monocytosis which is sometimes striking.
64a
The findings of a monocyte count which persists at more
than 10 to 12 percent of the normal white cell count (when
the total count is normal) or persistance of an absolute
monocyte count in excess 800/mm®* should be regarded as
a possible sign of benzene-induced injury.
A less frequent but more serious indication of benzene-
induced injury to the bone marrow is the findings in the
peripheral blood of the so-called **pseudo’’ (or aequired)
Pelger-Huet anomaly. In this anomaly many, or sometimes
the majority, of the neutrophilic granulocytes possess two
round nuclear segments—less often one or three round seg-
ments—rather than three normally elongated segments.
When this anomaly is not hereditary, it is often but not
invariably predictive of subsequent leukemia. However,
only about two percent of patients who ultimately develop
acute myelogenous leukemia show the acquired Pelger-Huet
anomaly.
An uncommon but ominous sign, one which cannot be
detected from the smear, but can be suspected easily by a
**sucrose water test’’ or peripheral blood, is transient pa-
roxysial nocturnalhemoglobinuria (PNH), which inay first
oceur insidiously during a period of established aplastic
anemia and maybe followed within one to a few vears by
the appearance of rapidly fatal acute myelogenous leu-
kemia. Clinical detection of PHH, which occurs in perhaps
only one er two percent of those destined to have acute
myelogenous leukemia, may be difficult; if the presumptive
‘*sucrose water test’’ for it is positive, the technician may
perform the somewhat more definitive Ham test, also known
us the acid-serum hemolysis test.
e. Individuals documented to have developed acute myelo-
genous leukemia years alter initial exposure to benzene,
have (see above) progressed through preliminary phases
of hematologic abnormality. In many instances pancyto-
penia(i.e., a lowering in the counts of all circulating blood
cells of bone marrow origin—but not to the extent implied
—
65a
by the term ‘‘aplastic anemia’’) preceded leukemia for
many years. Seldom does relative scarcity of a single type
blood cell (or of platelets) represent a harbinger of im-
minent acute leukemia. However, the finding of two or more
cytopenias, or of pancytopenia, must be regarded as highly
suspicious of more advance although still reversible, ben-
zene toxicity. When ‘‘pancytopenia’’ develops and becomes
associated with the appearance of immature cells (myelo-
cytes, myeloblasts, erythorblasts, etc.), with abnormal cells
(pseudo Pelger-Huet anomaly, atypical nuclear hetero-
chromatin, ete.), or with inappropriate elevations of mono-
eytes, basophils, or eosinsophils, the findings must be re-
garded as evidence of benzene overexposure unless proved
otherwise. These and other aggregates of alterations are
frequently termed ‘‘preleukemia,’’ a term whose meaning
is good when used retrospectively, but less good when used
prospectively where it has only inferential value. Many
severely aplastic patients manifested the ominous finding
of 5-10 percent myeloblasts in the marrow, occasional myelo-
blasts and myeloeytes in the blood and 20-30% monocytes:
these represented the beginning of recovery rather ‘than
the early stage of overt AML. Thus, a considerable propor-
tion of **preleukemias’’ in benzene poisioning fail to pro-
gress to leukemia. Indeed, some have been observed to
revert to normal after withdrawal of the afflicted person
from toxic exposure. Nonetheless, the chance that ‘‘pre-
leukemic’’ (changes in general) will evolve to leukemia is
considerable: at least 20 to 40 percent of persons (only a
few of whom were benzene-exposed) with these blood chang-
es develop acute myelogenous leukemia. Certain tests may
substantiate the person’s prospects for progression or re-
gression. One such test would be an examination of patient’s
bone marrow. But the decision to perform a bone marrow
aspiration or needle biopsy is one that should be made by
the hematologist. The findings to be sought there would be:
hypoplasia or aplasia; an excess of inmimature forms: vacu-
vlation in erythroblasts and myeloeytes—a phenomenon
66a
induced by many toxins apart from benzene, including chlo-
ramphenicol and alcohol; and by infections.
The findings of basophilic stippling in circulating red
blood cells (usually found in 1 to 5% of red cell during
marrow injury), and detection in the bone marrow of what
are termed ‘‘ringed sideroblasts’’ must be taken seriously,
as they have been noted in recent vears to be frequent
premonitory signs of subsequent acute leukemia.
In several recent reports dealing with relatively few
patients, peroxidase-staining of circulating or marrow neu-
trophil granules, employing benzidine dihydrochloride, has
revealed as a ‘‘preleukemic’’ finding the disappearance of,
or dimunition in, perosidase in a sizable proportion of the
granulocytes. Granulocyte granules are normally strongly
peroxidase positive. A steady decline in leukocyte alkaline
phosphatase is also suggestive of early acute leukemia.
Exposure to benzene commonly causes an early rise in
serum iron, often but-not always associated with a fall in
the reticulocyte count. Thus serial measurements of serum
iron levels provide a means of determining whether or not
there is a trend representing sustained suppress of erythro-
poiesis.
Measurement of serum iron, determination of peroxidase
and of alkaline phosphatase activity in peripheral granulo-
cytes can be performed by technical assistants.
(Sees. 4, 6, 8, 84 Stat. 1593 (29 U.S.C. 653, 655, 657) ; See-
retary of Labor’s Order 8-76 (41 FR 25059) ; 29 CFR part
1911.)
[FR Doc. 78-3417 Filed 2-5-78; 1:12 pm]
Ora
APPFIIDIX C
TITLE 29—LABOR
CHAPTER XVII
OccupaTionaL Sarety AND HeattH ADMINISTRATION,
DEPARTMENT OF LABOR
PART 1910
OccuPATIONAL SAFETY AND HEattH STANDARDS
OccuPATIONAL Exposure to BENZENE
AGENCY: The-Occupational Safety and Health Admin-
istration, Department of Labor.
ACTION: Permanent standard for the regulation of
benzene.
SUMMARY: This standard is based on a determination
by the Occupational Safety and Health Administration
(OSHA) that the available scientific evidence establishes
that employee exposure to benzene presents a cancer haz-
ard—specifically, the hazard of developing leukemia. There-
fore, in accordance with OSHA’s regulatory approach to
the control of employee exposure to carcinogens, this stan-
dard limits employee exposure to benzene to the lowest
feasible level, in this case 1 part benzene per million parts
of air (1 ppm) as an 8 hour. time—weighted average con-
centration, with a ceiling level of 5 ppm for any 15 minute
period during the 8 hour day. The standard also prescribes
limits on eye and skin contact with benzene.
The standard provides for the measurement of employee
exposure, engineering controls, work practices, personal
protective clothing and equipment, signs and labels, em-
ployee training, medical surveillance and recordkeeping.
EFFECTIVE DATE: March 13, 1978.
68a
FOR FURTHER INFORMATION CONTACT:
Mr. Gail Brinkerhoff, Office of Compliance Programs,
OSHA, Third Street and Constitution Avenue N.W.,
Room N3112, Washington, D.C. 20210, telephone 202-
523-8034.
SUPPLEMENTARY INFORMATION: This permanent
Occupational Safety and Health standard is issued pursu-
ant to sections 6(b), 6(¢) and 8(c) of the Occupational
Safety and Health Act of 1970 (the Act) (84 Stat. 1593,
1596, 1599; 29 U.S.C. 655, 657), the Secretary of Labor’s
Order No. 8-76 (41 FR 25059) and 29 CFR Part 1911. The
new standard on occupational exposure to benzene which
appears at 29 CFR 1910.1028, applies to all employment in
all industries covered by the Act. For reasons set out below,
the standard does not apply to the distribution or use of
gasoline and other fuels, used as fuels, subsequent to dis-
charge from bulk terminals. Moreover, the standard applies
labelling and training requirements only to sealed, intact
containers of benzene.
This document also amends Table z-2 of 29 CFR 1910.1000
hy adding a footnote which provides that benzene exposures
not covered by the new § 1910.1028 are still covered by the
exposure level and other requirements of §1910,1000. Pur-
suant to section 4(b)(2) of the Act, OSHA has determined
that this standard is more effective than corresponding stan-
dards now applicable to the maritime and construction in-
dustries and currently contained in Subpart B of Part 1910,
and Parts 1915, 1916, 1917, 1918 and 1926 of Title 29, Code
of Federal Regulations. Therefore, those corresponding
standards are superseded by the new standards in §1910.
1028. A new paragraph (c) is added to § 1910.19 to clarify
the applicability of this new benzene standard to the con-
<truction and maritime industries.
69a
lL. BackGRoUND
Benzene (CeHe) is a clear, colorless, non-corrosive, highly
flammable liquid with a strong, rather pleasant odor. Ben-
zene’s low boiling point and high vapor pressure cause it
to evaporate rapidly under ordinary atmospheric condi-
tions, giving off vapors nearly three times heavier than air.
Benzene is produced primarily by the petrochemical and
petroleum refining industries by a process called catalytic
reformation, which converts certain lower octane hydro-
carbons into higher octane aromatics. These two industries
are responsible for 94 percent of the total U.S. production
of benzene. Recovery through catalytic reformation, includ-
ing the benzene formed from the hydroalkylation of toluene,
accounts for almost 80 percent of the total quantity pro-
duced. Recovery of coal-derived benzene, primarily as a
by-product of the coking process in steel mills, was once
the major source of benzene. Today, however, it accounts
for only 6 percent of the total U.S. production.
The production of benzene is rapidly expanding with ap-
proximately 11 billion pounds produced in 1976. Only eleven
other chemicals and only one other hydrocarbon (ethylene)
are produced in greater tonnage in the U.S. Approximately
86 percent of this benzene is used chiefly as an intermediate
in the production of other organic chemicals, including
styrene, phenol, and cyclohexane, The remaining amount is
used primarily in the manufacture of detergents, pesticides,
solvents and paint removers. Benzene is also present as a
component of motor fuels, averaging less than 2 percent in
gasoline.
The first major industrial use of benzene, however, was
as a solvent in the rubber industry just preceding World
War L. During World War I, benzene production was stiin-
ulated greatly by the demand for and resulting production
of toluene in the manufacture of explosives. The large quan-
tities of benzene which were produced, resulted in its more
70a
widespread use as a starting point for the manufacture of
various organic compounds. This situation led to greatly
increased uses of benzene as a solvent in the artificial leath-
er, rubber goods, and rotogravure industries.
Industries and processes currently using benzene include
the chemical, printing, lithograph, rubber cements, rubber
fabricating, paint, varnish, stain removers, adhesives, and
petroleum industries. Benzene is also used extensively in
chemical laboratories as a solvent and as a reactant in
numerous chemical applications. Where benzene is pro-
duced and used in large amounts it is generally used in
enclosed systems, although exposures can occur during
liquid transfer operations, from equipment leakage and
carryover losses, and in maintenance operations.
Il. History or ReGuLatrion
Benzene has been recognized as a toxic substance capable
of causing acute or chronie effects since 1900, In 1927, on
the basis of extensive examination of exposed workmen and
animal inhalation data, Winslow recommended an exposure
limit of 100 ppm for benzene (Mx. 156-3, Annex D).? In
1934, partially as a result of the fact that benzene tonicity
in the shoe leather industries was a serious problem in that
state, the Massachusetts Department of Labor and Indus-
tries established a Division of Occupational Hygiene (Ix.
156-3, p. 2). Relying on reports by Bowditch, Hunter, Mal-
' The exhibit numbers used in this document refer to the certified
exhibit list of the benzene rulemaking proceeding. The first number
designates the particular exhibit on that list. Where the exhibit
contains more than one item, the second number references the
particular item of the exhibit. The designation **PC’’ refers to post-
hearing comments in Exhibit 217. The designation ‘*Tr’’ refers to
the transcript of the benzene hearing and indicates the pages of that
transcript which are referenced.
All references in this document are intended to provide examples
of record support for the information stated.
71a
lory and Elkins of cases of benzene poisoning occurring at
concentrations below LOO ppm, the Massachusetts Division
of Occupational Hygiene reduced the maximum acceptable
limit (MAC) to 75 ppm (Hx. 156-3, pp. 6-7). In the 1940's,
as a result of blood abnormalities and one death among
leather workers exposed to benzene concentrations ranging
from 40 to 80 ppm, Massachusetts lowered the permissable
limit of benzene exposure to 35 ppm (Elkins Ix. p. 7).
The American Conference of Governmental industrial
Hygienists (ACGIH) recommended in 1946 a threshold
limit value (TLY) for benzene exposure of 100 ppm. This
TLY was reduced in 1947 to 50 ppm. In 1948, following
Massachusetts’ lead, ACGLH adopted a TLV of 35 ppm.
In 1963, a TLV of 25 ppm was proposed by the ACGLIL.
The effects of benzene noted by ACGTH at this time were
blood changes, aplastic anemia and other blood dyscrasias.
No mention was made of any association of leukemia with
benzene exposure (fox. 191). It was not until 1974 that the
ACGIH adopted the TLV of 10 ppm which had sometime
earlier been recommended by the American National Stan-
dards Institute (lx. 156-3, p. 7).
The present OSHA standard for benzene (29 CFR Part
1910.1000, Table Z-2) was adopted in 1971 from the Z 37.4—
1969 consensus standard of the American National Stan-
dards Institute (ANSI). The OSHA standard was adopted
without rulemaking under the authority of section 6(a) of
the Act. It prescribes, as the ANSI standard, an 8-hour
TWA of 10 ppm with an acceptable ceiling concentration of
25 ppm and, in addition, allows excursions above the ceiling
to a maximum peak concentration not to exceed 50 ppm
for more than 10 minutes in any 8-hour work period. Neither
the ANST standard nor the resultant OSHA standard was
based on the possible leukemogenie effects of exposure to
henzene,
In 1974, pursuant to section 22(d) of the Act, the Director
of NIOSH submitted to the Secretary of Labor a criteria
72a
document concerning occupational exposure to benzene
which stated that ‘‘the possibility that benzene can induce
leukemia cannot be dismissed.’’ (lx. 382A, p. 1). However,
NIOSH recommended retention of the existing permissible
exposure limit to 10 ppm and ceiling concentration of 25
ppm as measured over a 10 minute period. This recommen-
dation was not based on benzene’s potential leukemia haz-
ard.
Ina letter to the Secretary of Labor, dated April 23, 1976,
the United Rubber, Cork, Linoleum, and Plastic Workers
of America urged that an emergency temporary standard
regulating occupational exposure to benzene be issued (Ex.
2-42). This request was denied on May 18, 1976 by then
Secretary of Labor, William J. Usery (x. 2-45).
Also in 1976, the National Academy of Sciences under
contract with the United States Environmental Protection
Agency, reviewed the literature concerning health effects
of benzene exposure (Ex. 2-4). The Academy concluded
that benzene must be considered a suspect leukemogen.
In August 1976, NIOSH submitted to OSHA an updated
criteria document which revised its earlier assessment of
1974 (Ex. 2-6). On the basis of a review of old studies and
new data, NIOSH concluded in that document that benzene
was a leukemogen. This report further pointed out that
‘‘it is apparent from the literature that benzene leukemia
continues to be reported.’* NIOSH, therefore, recommend-
ed that since no safe level for benzene exposure could be
established that, ‘‘no worker be exposed to benzene in
excess of 1 ppm in air.’’ Following publication of the up-
dated criteria document, the Director of NIOSH recom-
mended to the Assistant Secretary of Labor, by letter dated
October 27, 1976, that OSHA publish an emergency tem-
porary standard for benzene establishing the exposure level
at 1 ppm (Ex, 2-6).
73a
Based on the information supplied by NIOSH, OSHA
issued on January 14, 1977, volwmtary ‘‘Guidelines for Con-
trol of Occupational Exposure to Benzene,’’ recommending
that exposure to benzene in air not exceed an 8-hour time-
weighted average to 1 ppm in any 8-hour shift of a 40-hour
week (Ex, 2-44).
In January 1977, NIOSH informed OSHA that work-
place environments had been found in St. Mary’s and
Akron, Ohio where a sufficient number of employees had
heen exposed to benzene for a number of vears to facilitate
an epidemiological study of health risks (lx. 2-45). The
worksite was a manufacturing plant owned by Goodyear
Tire and Rubber Company which utilized benzene at various
stages in the production of pliofilm. The preliminary con-
clusions of the epidemiological study, which NIOSH con-
ducted of the pliofilm workers, were transmitted to OSHA
on April 15, 1977. In his letter of April 15, 1977, transmit-
ting this report, the Director of NIOSH again urged that
an emergency standard be issued (Ex. 2-7).
On May 3, 1977, the Assistant Secretary for OSHA is-
sued an Emergency Temporary Standard for Occupational
Exposure to Benzene (42 FR 22516), pursuant to sections
6(c¢) and 8(c) of the Act, Secretary of Labor’s Order No.
8-76, and 29 CFR Part 1911. A correction document was
published on May 10, 1977 (41 FR 23601), and an amend-
ment to the emergency temporary standard as published
on May 24, 1977 (42 CFR 26429). The evidence and findings
supporting issuance of the emergency temporary standard
and its amendment and a discussion of its provisions are
set forth in the aforementioned Federal Register publica-
tions. The emergency temporary standard was to have been
effective on May 21, 1977. However, as a result of challenges
to that standard, filed both in the Court of Appeals for the
District of Columbia (udustrial Union, AFL-CIO v. Bing-
ham, No. 77-1395) and in the Court of Appeals for the Fifth
Circuit (API v. OSHA, No. 77-1516), a temporary restrain-
74a
ing order was issued by the Fifth Circuit on May 20, L977,
and the standard never officially went into effect.
On May 27, 1977, OSHA published a proposed permanent
standard to control occupational exposure to benzene (42
FR 27452). The emergency temporary standard and its
preamble, which the new proposal supplemented, were in-
corporated in that proposal. The /ederal Register docu-
ment setting forth the proposal also contained a notice of
hearing scheduling an informal public hearing to be held
pursuant to section 6(b)(3) of the Act, and requesting the
submission of written comments, data, views and arguments
on all the issues raised by the proposed permanent standard
and the emergency temporary standard. Subsequently, on
June 24, 1977 (42 FR 32263), OSHA excluded from the
scope of the benzene hearing and from the final permanent
standard those activities related to the storage, transporta-
tion, distribution, dispensing and sale of gasoline as a fuel
subsequent to its discharge from bulk terminals. OSHA
explained in that notice its intention to assess the regula-
tory action to be taken to protect workers involved in these
activities after conclusion of the deliberations of a joint
EPA-NIOSH-OSHA Task Force.
The public hearings on the benzene proposal were held
July 19 through August 10, 1977. A total of 95 individuals
appeared at these hearings as witnesses. Among the wit-
nesses were employers and emplover associations from a
variety of industries: petroleum refining, petrochemical,
oil and gas production, aviation fueling; and coke ovens
and coke by-products. In addition, representatives of the
affected workforce, including a number of employees who
have been exposed to benzene, unions, government agencies,
public interest groups and other interested parties ap-
peared. Furthermore, comments were received from repre-
sentatives of other industries, such as analytical and re-
search laboratories, paint manufacturing, construction,
maritime, and rubber manufacturing and from users of
Ta
pure benzene as well as users of benzene contaminated
solvents. Public participation was representative of a large
segment of the benzene users. The verbatim transcript of
the hearings, as well as the humerous comments, exhibits
and briefs submitted to OSHA before, during and after
the hearings, are part of this rulemaking record, along with
other relevant documents. The hearing record was origin-
ally scheduled to close on August 20, 1977 but, at the request
of industry participants, the record was kept open until
September 2, 1977 for the submission of additional evidence
and until September 27, 1977 for the submission of briefs,
summaries and arguments.
In conjunction with the development of the proposed
standard, OSHA prepared a draft environmental impact
statement. The draft environmental statement was pub-
lished in the Federal Register (42 FR 27455). On June 17,
1977, the Council on Environmental Quality published a
notice of availability of the benzene draft environmental
impact statement (Ex, 7). In addition to the 45-day com-
ment period specified in 29 CFR 1999.4(¢), the environ-
mental impact of the proposed standard was also an issue
for the benzene hearing as provided by 29 CFR 1999.4(h)
and the notice of proposed rulemaking (42 FR 27452). A
notice of availability of the final environmental impact
statement for benzene was published on February 3, 1978
by EPA (43 FR 4674).
In addition to the draft environmental impact statement,
OSHA prepared an economic and inflationary impact as-
sessment of the proposed standard evaluating factors rele-
vant under section 6(b) of the Act (29 U.S.C. 655(b) (5),
Secretary of Labor’s Order 15-75 (40 FR 54484) and Ex-
ecutive Orders Nos. 11821 (39 FR 41501) and 11949 (42
KR 1017). The notice of the proposed standard indicated
that the economic impact of this proposal was to be con-
sidered at the hearing (42 FR 27452) and certified that the
economic and inflationary impact of the proposed standard
ToOa
has been carefully evaluated in accordance with Executive
Orders 11821 and 11949.
This permanent benzene standard is based on a careful
consideration of the entire record in this proceeding, in-
cluding materials relied on in the emergency temporary
standard, materials referenced in the proposal, and the
record of the informal rulemaking hearing including the
transcript, exhibits and pre-hearing and post-hearing writ-
ten comments. Copies of the official list of hearing exhibits,
comments, and notices of intent to appear at the hearing
can be obtained from the Docket Office, Docket H-059, Room
$6212, U.S. Department of Labor, 3rd Street and Constitu-
tion Avenue N.W., Washington, D.C. 20210.
Ill. Pertinent Lecoau AuTHORITY
The primary purpose of the Act is to assure, so far as
possible, safe and healthful working conditions for every
working man and woman. One means prescribed by Con-
gress to achieve this goal is the authority vested in the
Secretary of Labor to set mandatory safety and health
standards.
Occupational safety and health standards provide notice
of the requisite conduct or exposure level and provide a
basis for assuring the existence of sate and healthful work-
places. The act provides that:
The Secretary, in promulgating standards dealing
with toxic materials or harmful physical agents under
this subsection, shall set the standard which most ade-
quately 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, demon-
xtrations, experiments, and such other information as
may be appropriate. In addition to the attainment of
77a
the highest degree of health and safety protection for
the employee, other considerations shall be the latest
available scientific data in the field, and feasibility of
the standards, and experience gained under this and
other health and safety laws. (Section 6(b)(5).)
Sections 2(b)(5) and (6), (20), (21), (22), and (24) of
the Act reflect Congress’ recognition that conclusive med-
ical or scientific evidence including causative factors, epl-
demiological studies or dose-response data may not exist
for many toxic materials or harmful physical agents. Never-
theless, standards cannot be postponed because definitive
medical or scientific evidence is not currently available.
Indeed, standards need only be based on the best available
evidence. The legislative history makes it clear that ‘‘it is
not intended that the Secretary be paralyzed by debate
surrounding diverse medical opinion.’’ House Committee
on Hdueation and Labor, Report No. 91-1291, 91st Cong.,
2d Session, p. 18 (1970). This Congressional judgment is
supported by the courts which have reviewed standards
promulgated under the Act. In sustaining the standard for
occupational exposure to vinyl chloride (29 CFR 1910.1017),
the U.S. Court of Appeals for the Second Cireuit stated
that ‘tit remains the duty of the Secretary to act to protect
the working man, and to act even in circumstances where
existing methodology or research is deficient.’’ ‘Society
of the Plastics Industry Inc. v. Occupational Safety and
Health Administration,’’ 509 F.2d 1301 (CLA. 2 1975). cert.
den. 99S. Ct. 1998, 4 L.d.2d 482 (1975). A similar rationale
was applied by the U.S. Court of Appeals for the District
of Columbia Circuit in reviewing the standard for oceupa-
tional exposure to asbestos (29 CFR 1910.1001). The Court
stated that:
Some of the questions involved in the promulgation
of these standards are on the frontiers of scientific
knowledge, and consequently as to them insufficient
data is presently available to make a fully informed
factual determination, Decision-making must in that
78a
circumstance depend to a greater extent upon policy
judgments and Jess upon purely factual judgments.
‘Industrial Union Department, AlL-CIO vy. Hodgson,”
499 F.2d 467, 474 (C.A.D.C. 1974).
In setting standards, the Secretary is expressly required
to consider the feasibility of the proposed standards. Senate
Committee on Labor and Public Welfare, S. Rep. No, 9t-
1282, 91st Cong., 2d Sess., p. 58 (1970). Nevertheless, con-
siderations of technological feasibility are not limited to
devices already developed and in use. Standards may re-
quire improvements in existing technologies or require the
development of new technology. “‘Society of the Plastic
Industry, Inc. v. Occupational Safety and Health Adminis-
tration,’ supra at 1309.
Where appropriate, the standards are required to include
provisions for labels or other forms of warning to apprise
employees of hazards, suitable protective equipment, con-
trol procedures, monitoring and measuring of employee
exposure, employee access to the results of monitoring, and
appropriate medical examination (section 6(b)(7)). Stan-
dards may also prescribe recordkeeping requirements
where necessary or appropriate for enforcement of the Act
or for developing information regarding occupational acci-
dents and illnesses (section 8(¢)). The permanent standard
for benzene was developed on the basis of the above legal
considerations.
TV. Heactu EBrrecrs
A. GENERAL
Inhalation is the primary route of entry of benzene in
man. Benzene diffuses rapidly through the lungs and is
quickly absorbed into the blood. The rate of absorption is
ereatest during the first five minutes and thereatter de-
clines significantly. Benzene saturation of the circulating
blood may reach as high as 70-80 percent saturation level
within the first 30 minutes. However, relatively complete
79a
saturation of the blood may not be attained for two to
three days.
The benzene absorbed by the circulating blood is dis-
tributed throughout the body where, because of its liposo-
lubility, it tends to accumulate in various body organs in
proportion to their fat content.
Upon removal from benzene exposure, the concentration
of benzene in the expired breath follows an exponential
decay curve, reflecting removal of benzene from various
body compartments. Mlimination via this route for rela-
tively high concentrations has been estimated to range from
12 to 50 percent of the total amount of benzene absorbed in
humans.
Most of the absorbed benzene remaining ultimately is
metabolized by enzymes contained in the liver to derivatives
which are more water soluble thereby facilitating their re-
moval by the kidneys. A first intermediate in the biotrans-
formation of benzene is believed to be benzene epoxide, a
highly reactive chemical. This is one of several candidates—
others: Hydroquinone and catechol (Snyder Tr. 3229),
suggested as the active agent responsible for benzene’s
hematotoxic effects. Phenol, and to a lesser extent, hydro-
quinone, pyrocatechol, and phenyl-mercapturie acid are
the primary metabolites of benzene found in urine.
B. ACUTE EFFECTS
lixposures to high concentrations of benzene produce an
almost immediate effect upon the central nervous syste.
Benzene concentrations near 20,000 ppm are fatal within
minutes, with death occurriig from acute circulatory fail-
ure or coma, with or without convulsions. Milder exposures
produce a period of nervous excitation, euphoria, headache
and nausea, followed by a period of depression which can
result in cardiovascular collapse and/or unconsciousness.
The occurrence of nonspecific nervous disturbances as an
80a
after-effect of acute exposures is dependent on duration of
unconsciousness and/or severity of circulatory failure.
Breathlessness, nervous irritability, and unsteadiness in
walking have been observed to persist for a period of sev-
eray weeks. Inhalation of still lower concentrations (250-
500 ppm) yields signs and symptoms of mild poisoning,
characterized by vertigo, drowsiness, headache, and nausea.
Rapid recovery from these syniptoms usually oceurs fol-
lowing cessation of exposure.
These effects due to acute exposures to high concentra-
tions of benzene have been recognized for many years and
are well documented in classic toxicological textbooks and
literature.
Direct contact with the liquid may cause erythema and
blistering. Prolonged or repeated skin contact, even with
small quantities of benzene, has been associated with the
development of dry, scaly dermatitis, or with secondary
dermal infections.
C, CHRONIC EFFECTS
1. Background, The primary focus of this regulation is to
minimize worker risk resulting from chronic exposure to
low levels of benzene. These effects of benzene exposure in
man have been recognized for approximately 80 years. As
benzene attacks the hematopoietic (blood-forming) systems
and especially the bone marrow, its toxicity is manifested
primarily by alterations in the level of the formed elements
in the circulating blood (red cells, white cells, and platelets).
The degree of severity ranges from mild and transient epi-
sodes to severe and fatal disorders. The mechanism by
which benzene produces its toxic effects, although under
investigation, is still unknown. (Goldstein, fx. 43.B, p. 132).
The adverse hematopoietic effects of benzene, including
leukemia, have been documented in a variety of industries
and occupations and include the rubber, shoe, rotogravure,
painting, chemical processing, can manufacturing indus-
8la
tries and more recently, the manufacture of natural rubber
cast film. These studies range from single case reports,
through cross-sectional studies to retrospective studies of
morbidity-mortality among a defined cohort of workers in-
dustrially exposed to benzene, An important distinction
among these investigations is that the cross-sectional meth-
od detects cases of mild benzene-induced hematotoxic effects
in current employees who do not demonstrate signs of overt
toxicity, whereas the retrospective method detects overt
and fatal toxic effects subsequent to termination of employ-
ment.
OSHA is aware of the varying quality of the individually
reported studies. Based on a review of the entire set of
studies, taken as a whole, the accumulated evidence is con-
clusive that benzene exposure is causally related to the
induction of leukemia (a cancer of the blood-forming sys-
tem), various cytopenias (decreased levels of a formed
element in the circulating blood), aplastic anemia (a non-
functioning bone marrow) and to development of chromo-
somal aberrations.
The evidence supportive of this conclusion is derived
from: (a) A high degree of association of blood dyscrasias
with benzene exposure; (b) the apparent lack of a similar
association with other known volatile chemicals in the same
workplace; (c) outbreaks of hematotoxicity temporarily
related to the introduction of benzene to an industry and
conversely, a reduction in blood-related disease when other
solvents are substituted for benzene; and (d) the experi-
mental demonstration of marrow toxicity in animals solely
exposed to benzene (Goldstein, Ex. 43B, p. 133).
The following studies are representative, although by no
means all inclusive, of the published literature on the
chronic effects of benzene exposure. These investigations
do, however, illustrate the diversity and variability of the
effects which dominate published reports. There are also
several recent reviews and summaries concerning the hema-
82a
tological effects resulting from benzene exposure (See:
Vigliani and Forni, Ex. 2-15; National Research Council,
Ex. 2-4; NIOSH, Ex. 2-3, 2-5; NYU report; Ix. 43.B and
ORC/Jandl, P.C. 34; Snyder and Kocsis, Mx. 2.B-288, and
the International Workshop on the Toxicology of Benzene
(‘‘International Workshop’’) (x. 18).
2. Non-Malignant Blood Disorders.
a. Human studies. The most common effect resulting from
chronic exposure to benzene is a decrease in the levels of
erythrocytes (red blood cells), leukocytes (white blood
cells) and thrombocytes (platelets) in the circulating blood.
In simplified terms, a decline in red cells is termed anemia,
a decrease in the level of white cells is leukopenia and a
decline in the platelet count is called thrombocytopenia.
Persons found to have depressed blood cell counts may or
may not depending, in part on the severity of the decline,
display overt physical symptoms. Anemia results in a de-
creased capacity of the blood to transport oxygen to various
parts of the body, and persons so diagnosed may appear
pale and weak and fatigue easily. However, the non-specific
symptoms may develop gradually and not require medical
attention until there are significant declines in red cell
counts and blood hemoglobins. Chronie anemia may also
result in physical adjustments by the cardiovascular system
and exacerbate difficulties in those with coexisting disease
such as coronary insufficiency or chronic obstructive bron-
chopulmonary disease (Wintrobe, x. 2A-107, p. 532).
Since white cells provide a defense against many diseases,
persons with leukopenia are prone to recurrent infections.
Goldstein has written that ‘‘ Infections are a dreaded com-
plication of bone marrow toxicity and not uncommonly as-
sociated with a cause of death in benzene-induced pancyto-
penia’’? (Ex. 43B, p. 144). Thrombocytopenia results in an
2In the NYU review of *‘A Critical Evaluation of Benzene
‘Toxicity’, Goldstein uses the term pancytopenia-in a general sense,
Soa
impaired clotting of the blood, end persons with this dis-
order may exhibit bleeding tendencies, such as easy brus-
ing’, nosebleeds, and hemorrhage.
-ancytopenia and aplastic anemia are more serious con-
ditions in which all 3 formed elements are depressed. These
non-cancerous diseases may, in and of themselves, be fatal.
An additional concern is that some or all of these disorders
induced by benzene, may, if allowed to continue, either pro-
gress to or represent a preleukemia stage which may even-
tually evolve into a frank leukemia.
Among the early studies describing benzene toxicity was
that of Selling (fx. 2-12). He observed a significant de-
pression in the levels of cireulating blood cells in workers
employed where benzene was used as a solvent for rubber.
Because of the depressed condition seen in the marrow of
defined as a decrease in the level of circulatory erythrocytes, granu-
locytes, and platelets. His rationale is that there is excellent evi-
dence which suggests that all of these cell lines originate from a
common precursor stem cell (Exhibit 43B, p. 135). While noting
that aplastic anemia is, in a pure sense, an absence or a decrease
in identifiable granulocyte, erythrocyte, and platelet precursors
within the marrow itself, Goldstein finds that it is useful to include
aplastic anemia or hypoplastic anemia under the category of pancy-
topenia. This is because in some human cases of pancytopenia in-
duced by benzene and in some animal experiments, a hyperplasia
of the bone marrow is observed; also there exists the possibility that
sampling errors may affect attempts to quantitate bone marrow
precursor cells, since only a small fraction of the marrow is observed
by aspiration techniques.
Ilowever, Jandl feels that aplastic anemia is not a sufficiently
explicit term to describe failure of ‘‘marrow to provide an ade-
quate popwation of dividing blood cells for the 3 series of formed
elements,’’ and observes that the terminology ‘‘aplastic anemia’’
has been applied to states of chronic or non-acute marrow suppres-
sion, Whether or not anemia was the most striking feature (ORC/
Jandl PC 34, p. 88, Add. 3(i)). Other terms used synonymously
have been ‘“‘hypoplastic anemia, bone marrow failure, refractory
Sta
his patients and the results of extensive animal experiments
(where he was able to produce both destructive and ‘‘regen-
erative’’ effects by subcutaneous injection of benzene),
Selling suggested that the cause of the cytopenias observed
in the workc4+s was due to an aplasia of the marrow.
An important early milestone of the benzene literature
was the 1922 report by Hamilton entitled ‘*The Growing
Menace of Benzene (Benzol) Poisioning in American In-
dustry’’ (Ex. 159.C).
The document attempted to alert the medical community
to the dangers associated with chronic benzene poisoning
which was less well known than acute toxicity. This was
followed several years later by the reports of the National
Safety Council (NSC) which reported the prevalence of
known cases by chronic benzene poisoning. These results
are summarized by Jandl as follows:
The magnitude of toxicity—primarily consisting of
lowered blood cell counts—was shockingly high. Over
half of the workers exposed for a year or more had
abnormalities or cytopenias of the blood cells, a great
aneinia and aregenerative anemia.’’ Based on the degree of severity
exhibited, Jandl recognizes 2 phases of marrow failure:
‘*fB]y convention, a diminution in the level of all blood cells
produced in the marrow accompanied by evidence that bone marrow
cellularity is deficient, but from which recovery occurs, usually,
termed ‘pancytopenia.’ And by convention, a more sustained, more
severe, more likely fatal suppression of the marrow is termed
‘aplastic anemia.’ ’’ (P.C. 26B, p. 83, Add. 3(i)).
OSHA recognizes the usefulness and the technical reasons for
Jandl’s establishment of quantitative diagnostic criteria for various
non-malignant blood disorders and his ‘‘reassignment’’ of diagnoses
contained in the literature according to this classification scheme.
However, for convenience sake, the terais ‘‘pancytopenia’’ and
‘aplastic anemia’’ are used interchan
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