Regl. 2480, art. 2.93
Polyols
Cite as Reglamento Núm. 2480, Art. 2.93
town exposures. The information sup-
.18
.30
.36
plied by the various companies during
'0.94 markup and AN pass-on costs.
the course of the rulemaking has indi-
2ECI estimates from report.
cated that downstream operations do
ECI estimates incorporating SPI cost data.
not, for the most part, represent a significant source of potential for AN ex-
The table makes clear that based
strate that the compliance cost to
posure. Therefore, the omission of COVupon the cost estimates developed by
reach the 2-ppm level in a "typical
erage by ECI of downstream impacts is
ECI, the price impacts of the proposed
plant" would only represent 11 pernot expected to affect the overall cost
AN standard of 2-ppm are all less than
cent of the total capital of a new typiesitmates for the affected industries.
3.1 percent, even when the SPI cost
cal ABS plant (Ex. 148). It is clear that
data is incorporated.
to the extent that the SPI figures are
VIII. BENEFITS
As was noted in the earlier discusoverstated, the projected impacts of
sion of costs, SPI recalculated the
the standard will also be overstated,
The legislative history and language
costs of compliance from the ECI data
particularly as to SPI's dire projection
of the Occupational Safety and Health
using a smaller "typical plant" (deterfor the ABS pipe industry.
Act, as distinguished from some other
mined on the basis of a "survey" of its
Nonengineering costs. The major
environmental health and safety legismembers), and adding a 10-percent
thrust of the economic impact assesslation, clearly indicate that Congress
"return on investment" (ROI) figured
ment was directed at evaluating the
has already arrived at a judgment conon an aftertax basis. Even assuming
impacts and costs of engineering concerning the balancing of cost and
for the moment that the smaller
trols to reach the permissible exposure
benefit, with the result that worker
"typical plant" was more accurate
limits. However, the other elements of
safety and health are to be heavily fathan that determined by ECI, we have
the proposal, such as medical examivored over the economic burdens of
serious difficulties in accepting the adnations, respiratory protection procompliance. Specifically, section
ditional amount included for ROI,
grams, and monitoring have also been
6(b)(5) of the Act provides:
both in concept and in amount. As Dr.
examined. OSHA has determined,
Beale made clear at the hearing, ROI
both from the ECI report and on the
The Secretary, in promulgating standards
was considered in the cost figures debasis of the companies' submissions to
dealing with toxic materials or harmful
veloped by ECI in their report. Therephysical agents under this subsection, shall
the record, that virtually all of the afset the standard which most adequately asfore, the very inclusion by SPI of an
fected employers have both the facilisures, to the extent feasible, on the basis of
additional element of ROI represents
ties and the resources necessary to imthe best available evidence, that no employdouble-counting. In addition, the use
plement these other provisions. Most
ee will suffer material impairment of health
of 10 percent after taxes is not a
of the affected companies have had
or functional capacity even if such employproper application in this context.
medical surveillance programs for
ee has regular exposure to the hazard dealt
To the extent, then, that the SPI esmany years, and should have no diffiwith by such standard for the period of his
working life. Development of standards
timates include a double amount of
culty in providing the medical examiunder this subsection shall be based upon
return on investment, one can connations called for by the final standresearch, demonstrations, experiments, and
clude that the resulting cost estimates,
ard. In addition, OSHA had detersuch other information as may be appropritogether with the projected impacts
mined at the time of the ETS that
ate. In addition to the attainment of the
on prices of ABS/SAN products and
there were then sufficient respirators,
highests degree of health and safety protecmaterials, are considerably overstated.
sampling pumps, and other materials
tion for the employee, other considerations
Even if the overstated SPI cost figavailable for compliance. Since the
shall be the latest available scientific data
ures for compliance capital were acin the field, the feasibility of the standards,
scope of the final standard is, if anyand experience gained under this and other
cepted, their own estimates demonthing, narrower than that of the ETS,
health and safety laws.
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45790
RULES AND REGULATIONS
Thus, while feasibility is an appro-
Parties to this proceeding have atweaknesses of both the assumptions
priate consideration, the Secretary is
tempted to use the du Pont epidemiand the results of such assessments.
directed to set standards which attain
ological data to indicate both the mag-
Miller relied upon the du Pont epi-
"the highest degree of health and
nitude of the risk and the hypothetidemiological study as his source for
safety protection for the employee
cal "cost per worker protected" under
data on cancer risk for employees exthe alternative sets of permissible exposed to AN. His first assumption was
This does not mean, however, that a
posure limits in the proposal (Ex. 92;
that the du Pont cohort was exposed
systematic evaluation of costs and
146). Where the health effectiveness
to 20 ppm. This assumption, which is
benefits is not to be encouraged within
of alternative approaches is extremely
the touchstone of his later use of the
the limits of the estimation techuncertain and likely to vary from situ-
"linear model," is severely flawed. It
niques. In considering the issue of feaation to situation, OSHA believes it is
must first be noted that the du Pont
sibility in this rulemaking, as in
appropriate to adopt the compliance
Company itself has been unable to
others, OSHA has carefully evaluated
strategy which provides the greatest
provide significant data on the expothe cost of compliance which may be
certainty of worker protection within
sure of its cohort. Miller's 20 ppm asincurred by the affected employers
bounds of feasibility, even if the apsumption was based not on informaand their ability to comply. Additionproach carries with it greater economtion from du Pont, but, rather, on
ally, OSHA believes that a standard
ic burdens for the affected employers.
what another company (Monsanto)
for a substance which has been found
The issue of whether traditional
blindly estimated the cohort's expoto pose a cancer risk to workers, in
"risk assessments" should be persures to be. Using the 20 ppm figure as
this case acrylonitrile, must assure
formed has been discussed at great
a starting point for an evaluation of
maximum benefit (i.e., prevention of
length in this proceeding. Perhaps the
risk, therefore, is highly questionable.
serious illness or death) constrained
most accurate discussion of the uncer-
The 20 ppm assumption is also unonly by the limits of feasibility.
tainties surrounding the regulation of
supported by the data on AN expo-
Acrylonitrile has been found to
acrylonitrile was presented by Dr.
sures which is available in the record.
cause cancer in laboratory animals,
Henry Beale, testifying for ECI, in re-
Industry officials have frequently reand has been linked with excess incisponse to a question concerning
ferred to the high acute toxicity of AN
dence of cancer in employees. No ade-
OSHA's policy determinations:
in describing the reasons for their
quate scientific basic exists, however,
early activity in instituting control
to determine a quantitative dose-re-
If you recall (Dr. Cueto's) testimony. most
measures in AN manufacturing and
of it was centered around the issue of detersponse relationship at the lower levels
polymerization operations. Indeed, exmining that acrylonitrile was a carcinogen;
of AN exposures necessary to reduce
posures have generally been well
that is, simply establishing it.
the risk as much as is feasible. The un-
He alluded to the possibility also of develbelow the previous 20 ppm standard
certainty in both the actual magnitude
oping risk factors, dose/response relationfor many years. Twenty ppm is not far
of expected cancers and in the theory
ships and so forth. These, in terms of the
below the level at which acute toxic
of extrapolation from existing data to
materials that I have seen, have not been
effects are noted. The companies have
the exposure level set in this standard
developed for acrylonitrile.
always recognized that AN is a danger-
Now, I would draw a distinction between,
places the estimation of benefits on
ous chemical, even before evidence of
in a slightly technical sense, the term "risk"
"the frontiers of scientific knowledge."
its carcinogenicity became available. If
and the term "uncertainty." Risk is a situa-
While the actual estimation of the
tion of known probabilities. It is like if you
a person could detect AN by odor (benumber of cancers to be prevented is
were a bridge player and you were a good
tween 13 and 19 ppm), that was a sign
highly uncertain, the evidence indibridge player. You may be able to get a
to leave the exposure area. Because
cates that the number is likely to be
count on a suit that is out against you and
AN exposure is, in this range, selfappreciable. A dose-response relationknow after playing nine rounds that it
limiting, it is most unlikely that embreaks four to one. And you have to finesse
ship, that is, a lower incidence of
ployees were exposed to TWA's as
for the queen. You know the odds are four
excess cancer at lower levels of expohigh as 20 ppm. (Vistron's assertion
to one which person to finesse. Okay? That
sure, is likely to exist at lower as well
that the industry standard in the
is risk.
as higher levels of exposures to AN.
If you do not have information, you just
early 1950's was 50 ppm is unsupport-
Therefore, reduction in exposure to
don't know what the probabilities are, you
ed and, in any event, does not serve as
lower levels is accompanied by a reare operating under uncertainty. And to use
evidence of the actual exposures at
duced risk, even though a precise
the bridge player analogy, getting a count
that time). Therefore, Miller's use of
quantitative relationship cannot be eson a suit is a fairly sophisticated operation.
20 ppm as an established exposure for
A bridge player who is just a beginner would
tablished.
the du Pont cohort is highly questionguess, and he might even not finesse for the
In general, widespread employee exable on this ground, as well.
queen.
posure to acrylonitrile did not begin
That is uncertainty. The situation which
The impacts of the 20 ppm assumpuntil the 1950's. In view of the latency
prevails in terms of acrylonitrile is a situation on Miller's risk estimates become
period usually associated with the intion of uncertainty. We do not know what
apparent when one reviews the "linear
duction of cancer, significant reducthe risk situation is. That sort of precludes
model" which was used in the assesstions in mortality and morbidity may
any additional attempts at quantifying furment. As Miller acknowledged on questher benefits
(Tr. 421-422) (emphasis
not be seen in the AN industry for
tioning, if the actual exposures from
added).
many years after this standard is efthe du Pont study were, in fact, 10
fective. However, unless exposures are
OSHA's experience with assessments
rather than 20 ppm, the line between
reduced now, OSHA believes that emof the impacts of health regulations
the starting point and the origin
ployees exposed to AN will be at inhas demonstrated to us the futility of
would change in slope. He stated:
creased risk of cancer for many years
applying traditional cost-benefit anal-
(T)he reduction in risk per unit reduction
to come.
ysis and methodology to the workin exposure would be twice that I have as-
In light of the uncertainties connectplace health context. The basic assumed. So it would mean that the cost figed with risk determination and exsumptions of such approaches are
ures per one reduction and by one chance in
trapolation from animal studies and
always subject to serious questioning,
one thousand would be cut in half (Tr.
human epidemiology, OSHA believes
and the change in one variable can
1278-79).
that it is required by the statutory
result in major changes in the overall
This acknowledgment by Miller is
mandate to adopt a highly protective
assessment. The analysis performed
highly significant, particularly as it reposture in considering the evidence for
by Dr. James Miller for Vistron demlates to the basic conclusions of his
health benefits.
onstrates clearly the limitations and
study. Even using his 20 ppm assump-
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45791
tion, Miller did conclude that a case
In summary, then, OSHA is promulmately 5,130 exposed employees incould be made for a 2 ppm standard
gating this final standard in light of
volved in AN monomer production,
(Tr. 1270). If, as noted above, a more
the specific mandate provided by secprocessing, and use will be directly afreasonable 10 ppm assumption was
tion 6(b)(5) of the Act: to provide the
fected by the standard. The nature of
substituted, a case would be estabgreatest protection for employees,
this effect has been discussed in detail
lished for an even lower standard,
with consideration being given to the
above. The general physical or natural
purely on health grounds.
latest available scientific data, feasibilenvironment external to the work.
Taking Miller's study as it stands, we
ity, and experience under the Act.
place will not be significantly affected
also believe that such an assessment
IX. ENVIRONMENTAL IMPACT
by the proposed action, in that emignores the element of externalities.
The costs of illness and death due to
ASSESSMENT
ployers' efforts to comply with. the
standard will not significantly alter
occupational exposures to carcinogens
In the preamble to the proposed
current levels of environmental emisare only partially absorbed at present
standard (43 FR 2608), OSHA stated
sions from the affected industries.
by the industries involved. Employees
that it had made a tentative determi-
The following paragraphs outline
and former employees must presently
nation that the AN standard would
the major AN industry segments
suffer most of the costs and losses rehave no significant environmental
which will be affected by the standard,
sulting from occupationally induced
impact, and that preparation of an enin somewhat less detail than the discancer. The standard for AN will
vironmental impact statement (EIS)
cussions of technology and feasibility
reduce mortality and morbidity among
was not required. At that time, we soelsewhere in this preamble. Each segworkers, thus relieving them of these
licited comments and data on this dement will be reviewed as to the major
costs. In essence, then, the affected
termination and information relevant
sources of employee exposure to AN,
companies are being called upon to into the issue of whether significant enternalize the types of costs which they
ways in which such exposures may be
vironmental impacts could be anticihad previously been able to externalcontrolled, and how control of: expopated. Written comments were reize. To the extent that the costs of illsures may impact the general environceived from several participants in the
ment.
ness and death related to workplace
rulemaking proceeding in response to
exposures would have been incurred,
AN Monomer Production. Employee
the proposal (1-5).
the costs of protecting employees from
exposures to AN in the monomer pro-
The basic argument presented by all
occupational diseases do not represent
duction segment of the industry occur
of the comments was that OSHA had
new costs to be borne, but, rather, suberred in not preparing an EIS, because
as a result of product sampling activistitute costs. Further, the costs of enties, process leaks, accidental spills,
environmental impacts would occur as
gineering controls may, in many cases,
a result of the proposed regulation.
storage and transport of AN monomer,
be expected to cover more than one
and fugitive emissions. Methods which
The companies referred to general
generation of employees in a given
areas of impact, such as increased
will be used by employers to reduce
worksite.
water usage, increased production of
employee exposures include the fol-
The "linear model" is a useful tool
waste water, increased air emissions,
lowing: more complete enclosure of
only in those situations where one can
and changes in solid waste disposal.
systems to prevent release on AN into
demonstrate a true dose-response rela-
However, no specific examples or data
employee work areas, the use of extionship for an exposed population.
haust or dilution ventilation in areas
quantifying the extent of these poten-
This requires, by definition, a showing
tial impacts were provided to support
where leaks cannot be eliminated or
of a known effect/no effect level. For
the contention that significant imwhere system enclosure is impractical,
AN, we have no data to indicate at
pacts would occur.
use of improved seals and gaskets to
what point this level is reached. In
In making the initial determination
control employee exposures both
this regard, if the cancers in the du
that the proposal would result in no
during normal operations and product
Pont study are traced directly to AN
significant environmental impacts,
sampling, and immediate washdown of
exposure, it is impossible to determine
OSHA relied on the information avail-
AN spills to prevent the generation of
at what level of exposure these canable at the time, which indicated that
persistent high concentrations of AN
cers were actually induced. We cannot
the standard would have little, if any,
vapor in the workplace.
rule out the possibility that employees
impact on the current levels of air and
Most, if not all, of these control
with higher exposures did not, in fact,
water pollution, and minor impact on
methods are already in use to some
have their cancers induced by lower
waste disposal practices.
extent in the AN monomer production
concentrations of AN.
Since the proposal was published, we
facilities operating in the United
In the case of the acrylonitrile
have reevaluated our determination
State. The standard will result simply
standard, the evidence in the record
not to prepare an EIS. Although we
in more agressive control of employee
overwhelmingly demonstrates that the
still maintain that the impact on the
exposures than has been the estabcosts of compliance with a 2 ppm
environment as a result of this standlished practice to date. The control
standard will not be overly burdenard will be insignificant and that an
methods will not result in an increase
some to industry. Having determined
EIS is not required, we are endeavorin the amount of AN released to the
that the benefits of the standard are
ing to present a discussion of the areas
ambient air, and, in fact, may reduce
likely to be appreciable, OSHA is not
which could potentially be affected to
the current levels of emissions someobligated to carry out further exerany noticeable degree. The control
what. Such a reduction would result
cises towards more precise calculations
methods which will be used to limit
from* the improved control. of., leaks
of benefits which would not signifiemployee exposure to acrylonitrile are
and other fugitive emission, sources
cantly clarify the ultimate decision.
more completely discussed in the secwhich presently expose employees and
OSHA has, in the past, attempted to
tion dealing with technological feasiwhich inevitably reach the extenal enobtain a more detailed quantification
bility of the standard. The following is
vironment. This reduction. of expoof benefits to be attained under proan assessment of the environmental
sures may be highly significant insofar
posed standards. Previous efforts in
impact potential of the standard for
as the health of employees is conthis direction as an aid to decisionoccupational exposure to AN.
cerned, although the total amount of
making have not been fruitful (41 FR
1. The proposed action was designed
AN involved would be very small on an
46742), and have provided little, if any,
to control occupational exposure to
absolute scale. The total reduction in
assistance in setting final health
acrylonitrile. Only the workplace envipounds of AN released to the environstandards.
ronment of 43 plants and the approximent would be expected, therefore, to
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45792
RULES AND REGULATIONS
be insignificant in terms of overall enturing sector are exposed to AN pritute a major decrease in the total
vironmental impact.
marily from latexes containing residuamount of AN released into the envi-
Washdowns of spills into process
al and unreacted AN monomer which
ronment.
sewers to prevent employee exposure
are transported throughout the manu-
Nitrile elastomer production. Emto AN is already a common practice.
facturing process. The highest potenployee exposures occur throughout
Thus, no significant increase in the
tial exposures occur around the floccuthe entire processing operation for niamount of water used for this purpose
lation tanks, but other major exposure
trile elastomer manufacture, including
is anticipated.
areas include the filtering, washing,
the polymerization, coagulation, and
In addition, washing down of liquid
and drying processes. As with acrylic
washing/drying operations. Further,
AN serves to remove AN which would
fiber production, exposures may also
exposures can occur at AN monomer
otherwise vaporize into the air. Thus,
occur when AN monomer is transstorage and transfer points. Emissions
whereas there might be an increase in
ferred to or from storage tanks and reto the general environment presently
the amount of AN into process waste
action vessels. Methods which will be
arise from these same emission
water, there would also be a correused to control employee exposures insources.
sponding decrease in emissions into
clude additional enclosure of processes
Methods which will be used by emthe air.
or operations, ventilation of storage
ployers to control employee exposures
Treatment or disposal of contamiand process areas, washdown of spills,
include the same procedures to be emnated waste water is already being acand control of leaks to prevent expoployed in the ABS/SAN industry, as
complished by one of two methods
sure to fugitive emissions. Further, adnoted above. Similarly, the nitrile elas-
(biodegradation or deep-well injection)
ditional stripping of monomer from intomer sector has also implemented
at all five AN monomer production fatermediate polymer materials may be
controls to some extent, as have the
cilities. The OSHA standard for connecessary.
other industry sectors. Some stripping
trol of employee exposure will not
The only control method which has
is already being performed, and furaffect the waste water treatment
the potential for increasing the total
ther stripping is limited by the same
methods currently practiced by the inamount of AN released into the envifactors present in the ABS/SAN industry, nor will it result in higher
ronment is stripping. The additional
dustry.
levels of AN in the environment.
amounts of monomer that can be
The controls envisioned for nitrile
Acrylic Fiber Production. Exposure
stripped from the intermediate polyelastomer production are not expected
of employees in acrylic fiber producmers are greatly limited by two facto result in any significant environtion occurs when the monomer is
tors, however. First, some stripping is
mental impacts.
being transferred from storage tanks
already being carried on by ABS/SAN
2. At the time that the proposal was
to the reactors, during the extrusion
producers; thus, the remaining
published, it was thought that much
of the fibers, and during the stretchamounts of residual AN are relatively
additional stripping might be feasible
ing, washing. and drying phases of the
small. Second, extensive stripping,
for employers in achieving exposure
fiber production process. The latter
beyond what is presently being done,
limits below 2 ppm. As we have noted
operations result in continuous release
can result in degration of the final
in our discussion of technological feaof residual monomer to the ambient
product, as noted in the discussion of
sibility, we have since determined that
air and into process water, as well as
technological feasibility elsewhere in
the type of stripping necessary in the
into employee work areas.
this preamble. Where additional strip-
ABS/SAN and nitrile elastomer indus-
Methods which will be used by emping may be feasible, the amount of
tries to reach a 1 ppm exposure limit
ployers to control worker exposure to
AN released from the ABS/SAN matecannot presently be considered feasi-
AN include eliminating and controlrials is expected to be significant only
ble. The reasons for this determinaling fugitive emissions at tank farm,
from an employee exposure standtion were twofold. First, the materials
loading, storage, and reaction areas;
point (i.e. employee exposures will be
to be stripped have a tendency to coventilation of monomer storage, samreduced), and will not result in large
agulate prematurely, and can severely
pling, and fiber production areas; and
quantities of AN being released into
clog the process machinery when furenclosure of extrusion, stretching,
the general human environment.
ther stripping is attempted. Second,
washing, and drying operations. As
Stripping is usually performed at an
stripping which extends much further
with the monomer production indusearly stage in the polymerization proc-
-than present practices can result in
try, spills and leaks of AN would be
ess. The reason that a company strips
severe degradation of the product.
washed with water into process sewers
its polymer products is to assure that
Comments have been received confor treatment and disposal.
residual monomer is not released to
cerning the increased use of stripping,
None of the exposure control methexpose employees during later stages
stating that such stripping would reods cited above will result in an inin the process. It can be assumed,
lease more AN. into the ambient air
crease in the release of AN into the
therefore, that much of the monomer
and water, creating an adverse envienvironment. It should be noted that
which is driven off by stripping would
ronmental impact. In addition to the
the amounts of residual AN present in
otherwise have been released by the
reasons expressed with regard to the
the fibers and released during processpolymer at some point during manuindividual industry sectors, we believe
ing are very small. Thus, although
facturing. To this extent, stripping
that there are two other bases for our
these small amounts are important
does not increase the total amount of
determiniation that there will be no
from the standpoint of employee pro-
AN released into the environment, but
adverse environmental impact from
tection, controls will not involve rerather, removes at an early stage constripping. First, the amounts of residumoval of vast quantities of AN from
centrations of AN which would have
al AN contained in resins and elasthe general environment. Further, the
been released in any event.
tomers are usually less than 1 percent
industry has chemical sewers already
None of the control methods is exby weight. Thus, any amount which
installed for the disposal of process
pected to result in an increase in the
can be stripped would be, quantitativewastes and spilled materials, and,
amount of AN released to the general
ly, very small, and, therefore, environtherefore, the washdown practices
environment from the ABS/SAN
mentally insignificant. In addition, of
used for control of exposures should
sector. Conversely, although the
the small amount released, it is asnot affect waste water disposal pracamounts of AN to be controlled by the
sumed that at least some of it would
tices already in effect.
additional engineering methods may
have been released at some later stage
ABS/SAN resin production. Employbe significant from the standpoint of
of the process if not for the stripping.
ees in the ABS/SAN resin manufacemployee health, they do not consti-
Second, it is likely that employers
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45793
would make efforts to recover and reimpact on this problem. It is true that
It is not anticipated that the incycle the stripped AN monomer if the
EPA has conducted extensive studies
crease in energy consumption as a
amounts were sufficient to make recyof air and water emissions from AN
result of this standard will result in
cling feasible.
production facilities (6,7,8). These
significant environmental impacts.
3. Several commenters have stated
studies were prompted by the fact
Conclusions Examination of the enthat the proposed standard's requirethat AN is one of the highest volume
vironmental impact potential of the
ments for waste disposal would result
organic intermediates produced in this
proposed standard for control of occuin a complicated change to current
country. Because of the size of the
pational exposure to AN indicate that
waste disposal practices, and, thus, an
production operations involved and
the effects of the proposal on the genadverse environmental impact. No supthe known toxicity of AN, EPA has
eral human environment will not be
porting data on this subject were probeen examining the extent of pollutsignificant, and preparation of an envivided in support of this position, howant release into the environment from
ronmental impact statement is not reever.
AN monomer manufacturing facilities.
quired.
OSHA does not believe that the pro-
Findings published by EPA and re-
REFERENCES: ENVIRONMENTAL IMPACT
posed standard, if implemented as
ferred to in the preamble to the prowritten, would significantly increase
1. Ex. 11:(27).
posal have indicated that a number of
the amount of solid waste for disposal
2. Ex 160.
hazardous air and water pollutants are
by AN affected employers, nor would
3. Exs. 11:(18); 155.
emitted from AN manufacturing, such
4. Ex. 11:(13).
ultimate disposal of AN-contaminated
as carbon monoxide, hydrocarbons, ni-
5. Exs. 11:(22); 71.
waste be significantly affected. The
trogen oxides, and sulfur oxides, but
6. Horn, D. A. and T. W. Hughes. Source
sole purpose behind the proposed rethat the actual amounts of AN emit-
Assessment: Acrylonitrile Manufacture (Air
quirement to inclose AN wastes was to
ted (the only substance to be regulat-
Emissions). Monsanto Research Corp. EPAeliminate uncontrolled employee con-
600/2-76-032. Environmental Protection
ed under the OSHA proposal) are relatact with AN. Provided that employees
Agency. March 1977. 98 pp.
tively small. EPA is attempting to decharged with further handling of
7. Schwartz, W. A., F. B. Higgins, Jr., J. A.
velop standards and control methods
Lee, R. Newirth, and J. W. Pervier. Engiwaste materials were properly protectto limit overall exposures to the high
neering and cost Study of Air Pollution
ed, the standard included no specific
volume pollutants contained in the AN
Control for the Petrochemical Industry,
requirements for methods of disposal
industry emissions.
Vol. 2: Acrylonitrile Manufacture. Houdry
once the waste materials were pack-
Division, Air Products and Chemicals, Inc.,
aged.
As an example, EPA has found that
EPA-450/3-73-006-b, Environmental Pro-
As noted elsewhere in this preamble,
uncontrolled ground level concentratection Agency, February 1975.
we have revised the waste disposal
tions from AN manufacturing reach
8. Lowenbach, W. and J. Schlesinger.
provisions for the final standard retheir highest levels in the product
Acrylonitrile Manufacture: Pollutant Prestorage areas (tank farms). The highdiction and Abatement. Mitre Technical
moving the requirements for placing
est uncontrolled emissions of AN re-
Report MTR-7752, prepared under Contract
AN and PAN waste in closed contain-
No. 68-01-3188 with the Environmental Proers. The reasons for this change are
corded in these areas were less than
tection Agency, February 1978.
not based upon any adverse environ-
0.1 ppm in 24 hours. This level was demental impact, but rest upon two basic
termined using the assumption that
SUMMARY AND EXPLANATION OF THE
determinations as to the risk of emall sources were continuous when, in
STANDARD
ployee exposure posed by these matefact, the actual emissions from storage
The following sections discuss the
rials. "PAN scrap," in and of itself,
tank areas are intermittent and probindividual requirements of the AN
does not constitute a source of AN exably lower than the 0.1 ppm level. All
standard. The sections include an
posure unless it contains sufficient reother point sources of AN emissions
analysis of the record evidence and
sidual AN. In addition, packaging of
are considerably lower than those
the policy considerations underlying
materials containing AN can result in
from the storage area.
the decisions as to the various provi-
a high concentration of AN within the
5. The use of engineering methods
sions of the standard. As discussed in
container, thus posing a greater potensuch as exhaust or dilution ventilation
the PEL section above, the final standtial for exposure of employees hanwill require the increased use of
ard sets a permissible exposure limit
dling the packages for disposal or furenergy in certain segments of the AN
for acrylonitrile of 2 ppm as an 8-hour
ther treatment. The waste disposal
industry. Projected energy increases
TWA, with a ceiling limit of 10 ppm as
provisions as revised require deconwere estimated by Enviro Control,
measured over any 15-minute period
tamination by water washdown, venti-
Inc., in the technology assessment and
during the workshift. Engineering conlation, or other means, before disposal.
economic impact statement it pretrols and work practices are required
The revised provisions incorporate
pared for OSHA in February 1978. Acwhere necessary to reach the PEL, and
continued use of established methods
cording to this document, annual
written compliance plans must be deof handling and treating waste materienergy increase (in terms of barrels of
veloped. Engineering controls must be
als, while minimizing the risk of AN
No. 6 fuel oil) would be approximately:
in place by November 2, 1980, or 2
exposure among employees and other
131, 323 for the 2 ppm alternative
years from the effective date of the
persons handling the materials. Be-
PEL, 222, 150 for the 1 ppm alternastandard. Other portions of the standcause established methods currently
tive and 312, 591 for the 0.2 ppm alterard including those on respirators,
in use are to be continued, the waste
native PEL.
protective clothing, hygiene facilities,
disposal section of the final standard
It was argued by industry represenexposure monitoring, and the exempdoes not result in any increased retatives that the figures for the 1 ppm
tion provisions have been revised and
lease of AN into the environment.
and 0.2 ppm levels were underestimatclarified as described in detail below.
4. One area of concern to some comed, because compliance by means of di-
The language of the standard and
menters involved the fact that the Enlution ventilation would require more
the order of the various provisions is
vironmental Protection Agency (EPA)
than 40 changes of room air per hour
consistent with the drafting in other
was studying emissions from the AN
and the Enviro figures did not account
recent OSHA health standards, such
monomer production industry. It was
for this. Enviro stated that it felt that
as the benzene final standard (43 FR
contended that this indicated a comachievement of compliance by such
5913) and the arsenic final standard
munity health problem with AN, and
methods would be impractical and un-
(43 FR 19584). OSHA believes that a
that OSHA was remiss in not preparworkable so it did not estimate the
similar style should be followed from
ing an EIS to discuss the proposal's
costs associated with such.
standard to standard in order to lead
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45794
RULES AND REGULATIONS
to uniformity of interpretation of simlease monomer into the headspace at
Action level. The proposal contained
ilar provisions. Section 6(b)(5) of the
the top of their storage vessels. When
alternative action levels of 1 ppm, 0.5
Act states that health standards shall
the vessels are opened, the monomer
ppm, and 0.1 ppm, corresponding to
also be based on "experience gained
escapes, with the potential of exposing
the three alternative PEL's of 2, 1 and
under this and other health and safety
employees to AN. OSHA recognizes
0.2 ppm, respectively. The action level
laws."
that this can and will occur. However,
triggers the monitoring and medical
Scope and application: Paragraph
the resultant low level exposures are
surveillance requirements of the pro-
(a). This standard applies generally to
transient and do not represent a sigposal. The final standard sets an
all occupational exposures to acryloninificant source of exposure. (It should
action level of 1 ppm, in accordance
trile (AN). Some of the industry secbe noted that other materials not
with the 2 ppm PEL.
tors where significant exposures to AN
listed in paragraph (a)(2)(i) may ex-
The record contains little negative
may occur are in the manufacturing of
hibit this phenomenon as well. If the
comment on the action level concept.
AN monomer, the production of acrylmaterials would otherwise qualify for
Most comments received were directed
ic/modacrylic fibers, and in the polyexemption under the performance criat the various PEL's, and addressed
merization of AN with other monteria in (a)(2)(ii) for TWA exposures,
the action level primarily from the
omers to produce resins, elastomers,
the headspace release will not affect
measurement and monitoring standand other materials. It should be
their exemption.)
point (Exs. 92; 11:(14)).
noted, however, that not all work-
Paragraph (a)(2)(ii) carries forward,
In the absence of a demonstrated
places where AN may be found will be
with minor modifications, the persafe level of exposure for a carcinogen,
subject to the AN standard. OSHA has
OSHA has consistently required that
formance criteria provided in paradetermined that the standard should
graph (a)(2)(i) of the proposal. The
employee exposure be limited to the
be focused towards those workplaces
maximum extent feasible by the use of
criteria are applicable to all materials
in which there is the greatest potenmade from and/or containing AN.
engineering controls and work practial for AN exposure. This would intices. OSHA believes that it is also ap-
This clarifies a problem area from the
volve primarily the manufacturers of
propriate to begin some protective ac-
ETS and proposal, which referred only
AN, the manufacturers of acrylic and
tions under the standard prior to exto "products fabricated from PAN."
modacrylic fibers, and producers of
ceeding the PEL. The action level
OSHA's interpretation of the ETS has
ABS and SAN resins, nitrile elasserves such a purpose. Another purbeen that PAN itself and other materitomers, polymer polyols, and other AN
pose of the action level is to help to reals made from AN should be allowed
based polymers and materials. In a
lieve the burden on employers by proan exemption if they meet the perlimited number of cases, downstream
viding a cut off point for many of the
formance criteria for AN release.
processing, handling, and use of cerrequired compliance activities under
The criteria for exemption under
tain materials made from or containthe standard.
paragraph (a)(2)(ii) involve the providing AN will be covered by the stand-
From a pure health viewpoint, it
ing of and reasonable reliance on obard.
would not be unreasonable to require
The exemption provisions of the
jective data showing the following:
some action to be taken wherever emthat the material is not capable of refinal standard contain both a listing of
ployees may. be exposed to a carcinomaterials which are exempted, and
leasing AN resulting in airborne congen. However, this approach would be
two performance bases upon which
centrations exceeding 1 ppm (as an 8-
unduly burdensone both to the affectmaterials not specifically listed can be
hour TWA) under the expected condied employers and to the Agency.
exempted. The exemptions as drafted
tions of processing, handling and use
Nonetheless, the standard necessarily
differ markedly in several respects
which will cause the greatest possible
will encompass some employers whose
from those in the proposal. A detailed
release. OSHA anticipates that the
employees are exposed below the PEL.
discussion of the changes that have
manufacturer of the material will be
We expect that the exemption provibeen made and the rationale for these
in the best position to test his prodsions will greatly limit this group of
changes are contained elsewhere in
ucts and supply the necessary objecemployers. Where they are covered,
the preamble to this standard.
tive data.
such employers are required to per-
The first exemption provision, para-
The "1 ppm release" referred to in
form initial monitoring to determine
graph (a)(2)(i), lists a number of "finthe exemption as proposed meant an
the extent of their employees' AN exished polymers" which are to be
8-hour time-weighted average under
posures. If, on the basis of the initial
exempted from the AN standard. This
expected conditions involving the
monitoring results, an employee's exlisting reflects the data received in the
greatest possible release of AN. The
posure is below the action level; the
record which shows the minimal po-
Agency has interpreted the ETS in
employer may discontinue monitoring
tential for AN exposure to employees
this manner, and is revising the final
and all other compliance activities for
during further processing, use and
standard to refer explicitly to an 8-
that employee except for training and
handling of these materials. The term
hour TWA.
labeling. The action level concept thus
"finished polymers" is not defined in
The third exemption provision, paraprovides an objective means for an emthe standard. This is because it is not
graph (a)(2)(iii), exempts the hanployer to determine what further acpossible to state as a general matter
dling, use, and processing of solid mations are required for compliance with
the area of the manufacturing at
terials made from and/or containing
the standard.
which each polymer listed becomes
AN if they are not heated above 170°
The statistical basis for determining
"finished." In most cases, this involves
F. This is changed from the proposal
the action level has been discussed in
a drying step, after which the polyto set a temperature limit instead of
connection with several proposed
mers are packaged and/or stored. At
the term "heating or melting." This
OSHA standards (see, for example,
this point, the polymers are no longer
provision is included primarily to
"Proposed Standard for Trichloroethbeing "manufactured." Further hancover future products made from AN,
ylene" (Oct. 20, 1975, 40 FR 49032)).
dling, including shipping, processing
since most solid materials are already
In brief, although all measurements
and use, of the finished polymers, is
exempted by the listing in paragraph
on a given day may fall below the perexempt from the standard.
(a)(2)(i). The term "solid materials" is
missible exposure limit, some possibil-
As is the case with most polymers,
meant to clarify that the exemption
ity exists that on unmeasured days,
which contain some amounts of resid-
(paragraph (a)(2)(iii)) does not apply
the employee's actual exposure may
ual monomer, some of the AN based
to liquid AN, as defined in the standexceed the permissible limit. Indeed,
polymers on the exempted list may reard.
as various parties have noted, the ex-
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45795
posures in the AN industry can vary
ees from exposure to AN monomer.
vals, and in such manner, as may be
widely from day to day. Where expo-
There is nothing to indicate that ponecessary for the protection of emsure measurements are above one-half
lyacrylonitrile itself is harmful, other
ployees.
of the permissible exposure limit, i.e.,
than through its release of residual
There are various reasons which
the action level, the employer cannot
quantities of AN. In addition, the defimake it appropriate for employers to
reasonably be confident that his emnition of "PAN", as proposed, led to
measure employee exposure to AN.
ployees may not be overexposed.
some confusion under the ETS.
First, exposure monitoring informs
(Leidel, N.A. et al., "Exposure Mea-
Whereas the proposed standard was to
the employer as to whether he is
surement Action Level and Occupaapply only to PAN as limited in the
meeting his legal obligation to keep
tional Environmental Variability,"
definition (not to all generic polyacryemployee exposures below the permis-
DHEW, PHS, DCD, NIOSH, DLCK
lonitrile materials), some persons
sible exposure limit. Second, exposure
(August 1975)). Therefore, requiring
thought that references to "PAN"
monitoring evaluates the effectiveness
periodic employee exposure measurethroughout the proposed standard
of the installation of engineering and
ments to begin at the action level promeant all polyacrylonitrile materials,
work practice controls and informs the
vides the employer with a reasonable
regardless of potential for AN release
employer as to whether additional
degree of confidence in the results of
and exposure.
controls need to be instituted. Third,
his measurement program.
The standard has been revised to
exposure monitoring is necessary in
Definitions: Paragraph (b). For the
read solely in terms of "AN" and
order to determine whether respirapurposes of the final standard, "decon-
"liquid AN." As noted in the discussion
tory protection is required at all, and
tamination" means treatment of liquid
of the scope of the standard, the proif so, which respirator is to be selected.
AN waste, protective clothing, work
cessing, use and handling of most
Fourth, section 8(c)(3) of the Act (29
surfaces, and other areas, usually by
"PAN" materials have been expressly
means of ventilation or water wash-
U.S.C. 657) requires employers to
exempted from the standard. The perdowns, to assure that the materials or
notify promptly any employee who
formance exemption has also been
surfaces no longer release AN above 1
has been or is being exposed to toxic
modified accordingly, to allow materippm. Unlike the exemption provisions,
als made from or containing AN to be
materials or harmful physical agents
the decontamination provisions deal
exempted if they meet the conditions
at levels which exceed those prewith actual release of AN from a leak,
set forth in paragraph (a)(2)(ii). The
scribed by an applicable occupational
spill, or other source of liquid AN,
use of the phrase "products fabricated
safety or health standard, and to
rather than with the potential for refrom PAN," as contained in the proinform such employee of the correclease from a material during processposed exemption was too restrictive,
tive action being taken. Exposure
ing. Testing to assure nonrelease from
since it did not, on its face, appear to
monitoring is necessary in order to de-
a decontaminated area, therefore, may
allow PAN itself or other materials
termine whether employees are being
be performed by an area sample, promade from or containing AN to qualiexposed to AN at levels exceeding that
vided that the probe is placed at least
fy for exemption.
prescribed by this standard and thereas close as any employee would get to
A new definition for "liquid AN" has
fore must be notified as required by
the point of AN release.
been added to the final standard. This
the Act. Finally, the results of expo-
The term "emergency", as used in
definition is intended to assure that
sure monitoring are part of the inforthe proposal, covered any release of
all intermediate products of the polymation which must be supplied to the
AN above the ceiling limit. The
merization process are covered by the
physician.
breadth of this definition would have
standard. The definition also provides
The need to conduct exposure monirequired the employer to implement
a differentiation between intermediate
toring was generally accepted by parthe emergency procedures and notify
latexes and other liquid polymer interticipants in the rulemaking proceedthe OSHA area office whenever the
mediates created in ABS/SAN and niing. A major point of contention cenoeiling was exceeded. As was noted by
trile rubber manufacturing, and final
tered on the available methods of samseveral commentators, such a requireproduct latexes. Whereas final prodpling and analysis, as discussed below.
ment would apply to many situations
uct latexes may present an AN inhala-
In addition, several employers noted
which could not truly be deemed as
tion problem in some cases, there is
that they already conducted monitor-
"emergencies" (Exs. 92; 149). In addinothing to indicate that they also pose
ing on a more frequent basis than the
tion, we recognize that this would tend
a significant potential for skin expomonthly and quarterly periods includto lessen the employee's awareness of
sure to AN. The skin and eye contact
ed in the proposal (Exs. 11:(25);
true emergency conditions if and when
provisions, along with the concomitant
11:(27)). They contended, however,
they did occur.
protective clothing and equipment
that the standard should only require
"Emergency" has been redefined, as
provisions, have therefore been draftemployee notification of the required
in the vinyl chloride standard, to refer
ed in terms of "liquid AN" monomer
qurterly or monthly monitoring. The
to a "massive release" of AN. The emand polymer intermediates.
wording of the proposal, in their view,
ployer is best able to determine if an
Exposure monitoring and measurewould have required the employer to
emergency exists in his facilities. His
ment: Paragraph (e). The standard renotify the employee of any additional
central obligation under the standard,
quires each employer who has a place
monitoring results that he might have
which is to limit employees' exposures
of employment where there is expoas a result of more frequent monitorto AN, is, therefore, supplemented by
sure to AN as the result of the eming. It was argued that to require notithe requirement to take further action
ployer's activities (except where
fication of extra monitoring results
when emergency situations arise.
exempted under paragraph (a)(2)) to
would discourage employers from con-
The proposal defined "polyacrylonimonitor his employees' exposure to
ducting more frequent monitoring
trile," or "PAN" for the purposes of
AN, and to determine an employee's
than that required by the standard.
the standard, as homopolymers or coexposure over an 8-hour period with-
Section 8(c)(3) of the Act (29 U.S.C.
polymers made from AN except for
out regard to the use of respiratory
657) requires employers to notify
materials exempted under paragraph
protection. Section 6(b)(7) of the Act
promptly all employees exposed above
(a)(2).
(29 U.S.C. 655) mandates that any
the PEL. The final standard imple-
This proposed definition of "PAN"
standard promulgated under section
ments section 8(c)(3) by requiring an
has been deleted from the final stand-
6(b) shall, where appropriate, provide
employer to notify each employee in
ard for several reasons. The standard
for monitoring or measuring employee
writing of the employee's measurewas and is intended to protect employexposure at such locations and interment within 5 working days after the
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45796
RULES AND REGULATIONS
receipt of the results of any required
to the ETS, OSHA was most conand precision requirements set forth
measurements.
cerned about this situation, particulartherein. The testing that OSHA has
OSHA recognizes that the standard
ly in light of the industry recommenperformed, supplemented by the
is intended to set only minimum monidations at that time that the standard
NIOSH data, serves to demonstrate
toring requirements for employers. It
be set as low as 2 ppm. Therefore, testthat there is at least one method availis reasonable, then, that the standard
ing was performed at the OSHA Anaable which meets those requirements.
should only require the notification to
lytical Laboratory in Salt Lake City,
We are fully aware that there are
employees when monitoring required
Utah, to determine whether NIOSH
many other methods in use throughby the standard is carried out. Addimethod S-156, which was the method
out industry to sample for AN, as well
tional actions by the employer in monused under the existing 20 ppm standas methods which are in varying
itoring exposures, while certainly enard, could also be used in sampling
stages of development. Such methods
couraged by OSHA, are not required
lower concentrations (see appendix D).
include the use of porous polymer
by the standard, and direct notifica-
The test results clearly showed that
tubes instead of charcoal tubes for coltion need not be given to employees.
S-156 could be used for sampling and
lecting the sample, gas bags, badge-
The standard requires that measureanalysis below 1 ppm with sufficient
type dosimeters, and the use of portaments be made by monitoring which is
accuracy (Exs. 18; 18A). Testing was
ble and fixed-point sampling devices
representative of each employee's experformed in the presence of high huand systems, Considerable data has
posure to AN over and 8-hour period
midity (85 percent) and other monbeen submitted to the record by many
without regard to respiratory protecomers, such as styrene and butadiene,
companies concerning their experience
tion. Exposure measurements for each
to determine whether these elements
with these methods. By demonstrating
individual employee would, certainly,
had any detrimental effect on the
the availability and effectiveness of S-
be an indication of that employee's exsampling and analysis. The effects of
156 as modified, we do not intend to
posure. However, this may be unnecesthese factors was negligible. The Dishort-circuit any of the efforts by
sarily burdensome in some instances.
rector of the OSHA Laboratory, Floyd
these companies to develop their own
Monitoring which can be shown to be
Madsen, appeared at the rulemaking
monitoring procedures, some of which
representative of an employee's expohearing and was questioned at length
may prove to be even more accurate.
sure would provide the necessary inby industry representatives concerning
Industry representatives have
formation and in many instances
his testing procedures and results. In
argued that it is essential for a method
would require fewer samples. This is
addition, representatives of SPI were
to be "field validated" in order to be
particularly true in manufacturing of
permitted to visit the Laboratory after
used for compliance with the AN
AN and other 24-hour continuous
the hearing. in order to talk with Mr.
standard (Exs. 75; 83). Yet it should be
processes.
Madsen further concerning sampling
noted that such representatives have
The proposal required monitoring
and analysis, in response to a direct realso stated that the range of field conmonthly for employees exposed above
quest at the hearing by both SPI and
ditions that may be encountered in
the permissible exposure limit and
Vistron. Although such a visit did,
the AN industry is so wide and variquarterly for employees exposed beindeed, go beyond what is required of
able that it would be necessary to
tween the action level and the PEL. As
the Agency during informal rulemak-
"field validate" a method in each indinoted above, many employers have ining. OSHA determined that it was, in
vidual workplace in order to show that
dicated that they perform monitoring
this limited circumstance, an appropriit was, indeed, a workable method
on a more frequent basis. It is evident
ate gesture toward developing a comacross the board (Tr. 933). It is evident
that the higher the frequency of meaplete record on the sampling issue.
that no single analytical method will
surement, the higher the accuracy of
Laboratory testing has also been
work in every imaginable workplace
the employee's exposure profile. The
performed by NIOSH at their laborasituation, either for AN or for most
companies involved with the manufactories in Cincinnati, also involving
any other organic vapor. In addition,
turing and polymerizing of AN indicatmethod S-156. Data submitted to the
it is also clear that whatever method
ed little, if any, disagreement with the
record by Dr. Judd Posner of NIOSH
an employer may choose to use to
monitoring frequency in the proposal.
also demonstrated that AN could be
monitor for AN, he must validate it
OSHA has carried forward these prosampled and analysed below 1 ppm
for use in his particular plant. The
visions to the final standard. We bewith accuracy (Exs. 43; 66). Since this
need for such individual validation was
lieve that in the industries affected by
data was submitted during the course
espoused by industry representatives
this standard, monthly and quarterly
of the hearing, Dr. Posner invited in-
(Tr. 933).
monitoring will reflect employee expoterested persons at the hearing to
The method of "field validation"
sure with sufficient accuracy to assure
submit questions to him in writing, to
proposed by Dr. Ward of Monsanto
that suitable precautions will be taken
which he would reply during the postpresents an interesting approach
as needed to protect employees from
hearing comment period. It is imporwhich shows promise (Ex. 136). Howexposure to AN.
tant to note that no such questions
ever, there is nothing to indicate that
Industry representatives have conwere received. A complete write-up of
a method is or has been in use in the
centrated much of their criticism on
the analytical method and sampling
past to "field validate" sampling methwhat they have contended to be the
technique used by NIOSH is available
ods for AN or other organic vapors. In
lack of a method of sampling and analin the record (see appendix D). In esaddition, Dr. Posner of NIOSH has
ysis for AN in the range of 1 ppm and
sence, it sets forth the same method
submitted an analysis of Dr. Ward's
below which will meet the accuracy
utilized by the OSHA Laboratory,
validation method which points up
and precision requirements set forth
with the major exceptions being the
that it, too, is not without pitfalls in
in the proposed standard. This issue
use of a different desorbing solvent
its implementation (Ex. 140). There is
was brought to the surface by the
and the use of flame ionization withno single accepted method of "field
original NIOSH recommendations in
out the nitrogen phosphorus detector.
validating" a sampling method to
September 1977 (Ex. 65). In those rec-
OSHA does not require that any one
obtain data which will support its use
ommendations, NIOSH stated that
specific method of sampling and analunder all workplace conditions.
OSHA should issue a 4 ppm standard,
ysis be used for compliance with the
A detailed exposition of the range of
based upon what they characterized as
monitoring provisions of the standard.
available methods of sampling and
the limitations of existing sampling
This provision is set forth in performanalysis for AN was contained in the
and analytical methods for AN. As we
ance language, and permits the use of
written comments submitted by Monpointed out at length in the preamble
any method which meets the accuracy
santo (Ex. 11:(27)). Table A contains a
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45797
listing of five methods which were
recovery (with methanol or carbon dieither validated by Monsanto (field
sulfide) falls below 75 percent by deand/or laboratory validation) or, in
veloping a "working curve," in lieu of
the case of the gasbags, showed a dethe NIOSH protocol. They emphatection limit below 1 ppm. The field
sized that appropriate validation techvalidation was, presumedly, carried
niques are necessary for the use of all
out under the protocol submitted by
monitoring procedures in the work-
Ward (Ex. 136). Although Monsanto
place setting, whether charcoal tubes
reported difficulty in using NIOSH
or other means of sampling are used.
method S-156, it is clear that they
They have chosen to rely upon alterhave been able to develop or apply
native systems, such as porous polyother methods of sampling and analymer adsorption/thermal desorption,
sis to their many and varied opersince they consider them to be less
ations.
subject to the types of variables associ-
Monsanto, in their written comated with charcoal-based systems.
ments, discussed the various problems
As was noted by Madsen in his testithat they had experienced with
mony at the hearing, Monsanto con-
NIOSH method S-156 (Ex. 11:(27)).
curs that the use of a nitrogen-specific
They noted that the only charcoal lot
gas chromatographic (GC) detector
which had shown satisfactory results
has the potential of enhancing the dewas lot 107. This point was noted by
tection limit of all of the methods
Madsen in his testimony (Tr. 132). In
listed in the table by a factor of 10
dealing with the problems of sample
(Ex. 11:(27)). It is also important to
"breakthrough" reported by various
note that other methods which incompanies, including Borg-Warner
volve gas chromatographic analysis,
(Ex. 83), Monsanto noted that some
have this same potential.
companies are using two larger char-
Monsanto has also reported using
coal tubes, containing up to 1,000 mg.,
both the Century OVA 128 and Cenin series, to replace the 150-mg. tubes
tury flare tubes at levels well below 1
generally used. They have concluded,
ppm, noting only that "the methods
however, that there is no evidence of
are claimed to be selective." Century
any effect of humidity or temperature
Systems testified independently that
at low AN burden.
their instrumentation was capable of
Monsanto noted that charcoal tube
measuring AN at concentrations well
methods can be used for AN at concenbelow 1 ppm as an 8-hour TWA (Tr.
trations below 2 ppm even where AN
873-874).
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45798
RULES AND REGULATIONS
TABLE B: ADDITIONAL METHODS OF MONITORING AND ANALYSIS
FOR AN BELOW 1 PPM
(Adapted from Monsanto comments (Exhibit (27)))
Method
Adsorption/Desorption/ Validation:
Analysis
concentration, detection
limits
1. Monsanto
Poropak-N
field validated down to
PoropaK-N
(porous Thermal GC
0.1 ppm; detection limit
polymer)
approaching 0.02 ppm for
a 3-liter air sample.
2. Modified
1 to 2%
field validated at
NIOSH
Charcoal Acetone in/GC
levels above 0.08 ppm
P&CAM 127
CSâ‚‚
within ± 2 std. devs.
for a TWA6.
3. NIOSH
laboratory and field
P&CAM 127
Charcoal/CS2/GC
validated at and above
0.2 ppm for a TWAS;
Reported loss of AN when
desorbed sample is
stored over time.
4. Passive Dosimetry Abcor R Acetone / GC laboratory validated 0.94
Gasbadge/in CSâ‚‚/
ppm; field tested at
0.8-3.8 ppm by reference
to method no. 2 above.
5. Gas sample bags
Gas bag/GC
Detection limit of
ca a 2.5 CC. gas sample.
Reported memory effects
at low AN levels.
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45799
Monsanto was confident that "the
The monitoring defined by the
is certainly one approach toward decharcoal tube or passive dosimeter
OSHA Laboratory involves the use of
termining representativeness of expomethods could be practiced by downcharcoal tubes and personal sampling
sure measurements. There are other
stream processors with some guidance
pumps, with subsequent analysis by
approaches which would be suitable,
from trained professional" (Ex.
gas chromatograph with nitrogen
as well. The employer has the burden
11:(27)). The record reflects that the
phosphorus detector. Laboratory valiof showing, by whatever means at his
employers covered by this standard
dation data indicates that this method
disposal, that his measurements are
possess considerably more technical
can be used with sufficient accuracy
representative of each employee's excapability in this area than downand precision down to the 0.5-ppm
posure to AN.
stream employers would be expected
level and below. Floyd Madsen was
The rulemaking record, along with
to have. The broadening of the exempquestioned extensively at the hearing
experience under the ETS, indicate
tion provisions will limit the scope of
as to his findings by industry reprethat most affected employers have
the standard to those companies best
sentatives (Tr. 117-159). In addition,
successfully implemented a monitorable to provide an effective monitoring
several industry personnel visited
ing method which gives satisfactory
program which will produce meaning-
Madsen at the Laboratory during the
ful results.
results in their operations, at concenposthearing comment period (Ex. 142).
trations in the 1- to 2-ppm range. How-
Companies such as Goodyear, Dow
Neither the questioning at the hearing
Badische, and Dow Chemical have
ever, OSHA cannot ignore the difficulnor the laboratory visit have raised
submitted details of the sampling and
ties that various companies have reany significant questions as to Madanalytical methods that they have
ported in demonstrating the required
sen's findings.
found valid for use in their respective
accuracy and precision specified in
The primary differences between
operation (Exs. 138; 11:(17); 11:(25)).
both the ETS and proposal at a (95
the NIOSH and OSHA variations on
Still others have installed continuous
percent confidence level, ±25 percent
S-156 are the method of desorption
monitoring systems which provide
at or above 2 ppm, and ±35 percent
(NIOSH does not use ultrasonic agitaarea measurements of airborne AN
below 2 ppm) (Exs. 83; 159). We have
tion of the sample), the desorbing solconcentrations (Exs. 11:(10); 11:(8)).
determined that these criteria should
vent (NIOSH use 1 percent acetone in
As the record makes clear, there are
carbon disulfide, whereas OSHA uses
be made more flexible, in order to
a number of adequate methods availamethanol), and the analytical equipassist employers who have encounble for sampling and analysis of AN
ment (NIOSH uses flame ionization,
tered unique sampling problems.
concentrations at and below 1 ppm.
whereas OSHA adds a nitrogen-phos-
Therefore, the final standard permits
OSHA recognizes that one method
phorus detector).
the use of methods with accuracy and
may not work under all workplace con-
Method S-156 and variations thereprecision at a 95-percent confidence
ditions due to such variables as temon have been adopted and accepted for
level, of ±35 percent at or above 2
perature, humidity, and other unique
general use in field monitoring at the
ppm, and ±50 percent below 1 and 2
factors. Regardless of the method se-
1- to 2-ppm level by several major comppm. The difference (35 percent VS. 50
lected, an employer must validate the
panies that manufacture and/or use
percent) reflects a recognition that acmethod that he intends to use under
AN in their facilities. Workplace concuracy of monitoring decreases below
the conditions present in the particuditions and other factors vary widely
2 ppm.
lar workplace to assure himself that it
among these companies (cf. Ex. 2:(22);
The accuracy and precision requirewill be sufficiently accurate. It is for
11:(14); 138; Tr. 1196-1199).
ments are intended to provide the emthis reason that the monitoring accu-
The standard requires that the meaployer with a degree of confidence in
racy and precision required by the
surements be made by monitoring
his sampling results. As noted earlier,
standard are stated in performance
which is representative of each emmonitoring is not carried out for its
terms. The OSHA and NIOSH methployee's exposure to AN over an 8-
own sake, but for the purposes of deods of monitoring employee exposures
hour period without regard to the use
termining what is required for compliare included as an appendix to the
of respiratory protection. Exposure
ance in a given operation. OSHA anfinal standard as a means of assisting
measurements for each individual emticipates that the wide range of availathe employer in the selection of an apployee would, of course, be an indicable methods, combined with more
propriate method for his workplace.
tion of that employee's exposure.
flexible criteria for the method em-
It was also contended that because
However, this may be unnecessarily
ployed, will enable employers to perneither the OSHA nor the NIOSH
burdensome in some instances. Moniform their required monitoring withvariations of method S-156 had been
toring which is truly representative of
out serious difficulties.
"field validated" under all workplace
an employee's exposure would provide
The employee exposure measureinsults and exposure conditions, they
the necessary information and in
ments are to be made without regard
could not serve as reference methods.
many instances would involve fewer
to the use of respiratory protection.
This assertion totally misconstrues the
samples.
One commentator took issue with this
true purpose of a so-called "reference
In their testimony, the NIOSH panel
provision, contending that the sammethod." The applicability of any
expressed concern that OSHA did not
pling does not reflect the actual expo-
"reference method" was described
specify a means of determining if an
sure of the employee who is being promost accurately at the hearing by Dr.
exposure measurement was "repretected by a respirator (Ex. 149).
Ward:
sentative" of an employee's exposure.
Whereas this statement may be true,
There is always a need for a reference
They believed that this presented a
it overlooks the fact that exposure
method. However, the reference method
potential for actually reducing the
monitoring is not a single-purpose accannot serve under all applications. It can
protection afforded to workers extivity. It is necessary to know employserve under laboratory conditions and it has
posed to AN. OSHA believes that the
ee exposure levels without the use of
merit in that respect (Tr. 791).
standard should require the desired
respiratory protection in order to
OSHA and NIOSH have both perperformance, i.e., a showing of repreevaluate the effectiveness of the reformed laboratory testing of their
sentativeness, rather than specifying
quired engineering and work practice
variations of NIOSH method S-156
one method for determining it. We
controls, and to determine whether
and have found the method to be a
recognize, however, that NIOSH has
additional controls must be instituted.
suitable reference method for use in
published a document outlining a sam-
In addition, monitoring is necessary to
the range of concentrations covered by
pling strategy which is directed at this
determine which, if any, respirator
the standard (Exs. 18; 18A; 43; 66).
problem (Ex. 14:(157)). That strategy
must be used by the employee.
PEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45800
RULES AND REGULATIONS
As noted by numerous participants
those operations where exposures
The alarm system required by parain this rulemaking proceeding, expowould be well below the permissible
graph (i) of the standard will detect
sure conditions vary throughout the
exposure limit.
AN concentrations which exceed the
day in many operations. At least one
The standard requires that whenceiling limit. When an alarm is soundsample is to be taken during each shift
ever there has been a production,
ed, the employer will have to take
in order to assure that exposure meaprocess, or control change which may
action to locate the source of the resurements represent exposures of emresult in new or additional exposures
lease which is causing the high levels
ployees on all shifts. Employees workto AN, or whenever the employer has
of AN, and will then have to deconing in the same area doing different
reason to suspect an increase in emtaminate the leak or spill area. In this
jobs may have different exposures.
ployee exposure, the employer shall
regard, the weekly survey, as pro-
Therefore, the standard requires samrepeat the required monitoring and
posed, would be redundant.
pling for each job classification, as
measurements for those employees af-
OSHA has determined, however,
well. The proposed standard did not
fected by such change or increase.
that some form of leak detection procontain detailed procedures in this
The redetermination procedure is
gram should be required by the standregard. However, in order to assure acnecessary to assure that the most
ard. The details of such a program,
curate representative monitoring of
recent monitoring results accurately
however, should be left to the employemployee exposures, OSHA has deterrepresent the existing exposure condier, who is already under the obligation
mined that the variability of expotions. This is necessary so that the emto control employee exposures to
sures warrants such procedures.
ployer may take appropriate actions
within the permissible exposure limits.
The standard requires that the inisuch as instituting additional engi-
The leak detection program in the
tial monitoring be conducted, and the
neering controls and providing approfinal standard has been placed in the
results thereof obtained, as of the efpriate respiratory protection.
housekeeping section of the standard,
fective date of the standard. OSHA be-
The final standard also provides
paragraph (k).
lieves that this provides more than
that employers may discontinue peri-
Regulated areas and notification:
enough time for employers to comodic monitoring for those employees
Paragraphs (d) and (f). The final
plete the sampling and obtain the refor whom two consecutive measurestandard requires the employer to essults. Moreover, the standard permits
ments, taken at least 7 days apart,
tablish regulated areas wherever AN
employers who have monitored under
show exposures to be below the action
exposures exceed the PEL, and to
the ETS, or since January 17, 1978, to
level. Where employee exposure mealimit access to these areas to authorutilize these measurements for pursurements fall below the permissible
ized persons. This requirement will
poses of complying with the initial
exposure limits but are at or above the
help to limit exposure to AN by premonitoring requirements of the final
action level, the employer may alter
venting persons who are not authorstandard. Employers who have already
the monitoring schedule for those emized from entering areas with AN exmonitored their employees' exposures
ployees from monthly to quarterly
posures above 2 ppm. It will also assist
within this period will, therefore, not
after two consecutive measurements
in designating areas where precautionhave to conduct initial monitoring
taken at least 7 days apart indicate
ary signs are to be posted, while also
unless, because of a process, control,
the reduction in levels.
designating areas where employees
or personnel change, they are required
Section 8(c)(3) of the act (29 U.S.C.
will be subject to monthly exposure
to redetermine exposures.
657) requires employers to promptly
monitoring pursuant to paragraph (e).
The final standard requires measurenotify an employee who is exposed in
Employees in regulated areas willl be
ment every 3 months for employees
excess of the permissible exposure
prohibited from smoking and eating in
exposed between the action level and
limit. The standard requires the emthese areas, and may be covered by
the TWA limit, and monthly for) employer to notify each employee in writprotective clothing and equipment and
ployees exposed above the TWA limit.
ing of that employee's measurement
hygiene requirements under other sec-
The higher the measurement frewithin 5 working days after the retions of the standard.
quency, the higher the accuracy of the
ceipt of the results of any measure-
The limitation on eating, smoking,
employee exposure profile. The selecments required under paragraph (e).
and applying cosmetics in regulated
tion of an appropriate interval be-
Notification in writing need not be an
areas is necessary to prevent unnecestween monitoring efforts is judgmenindividual letter to the employee, but
sary exposure to AN. Potential routes
tal. OSHA has determined that requirmay be a notice prominently displayed
of exposure to AN are ingestion, skin
ing monthly and quarterly monitoring
on a bulletin board or similar workabsorption, and inhalation. All' of
for AN exposures will reflect employee
place location.
these routes must be limited by OSHA
exposure with sufficient accuracy to
OSHA has determined that the proin order to protect employees from the
assure that suitable precautions will
posed paragraph (e)(7), requiring a
carcinogenic hazard posed by AN exbe taken as needed.
weekly survey of operations involving
posure.
Periodic measurement is appropriate
liquid AN, should be deleted from the
Paragraph (d) of this standard rewhen exposures are in the 1-2 ppm
monitoring provisions of the final
quires the employer to notify the
range because of the possibility that
standard. The data in the record indi-
OSHA Area Office within 30 days of
minor changes in process, materials, or
cates that the purposes of the weekly
the establishment of regulated areas
weather conditions may raise exposure
survey (i.e., detection of leaks and
in his workplace. This requirement is
to above the TWA limit, and to comspills of liquid AN) can be achieved
more limited than was proposed, in
pensate for the possibility that such
through a less elaborate and detailed
order to concentrate on exposure conmeasurements are falsely low.
leak detection program.
ditions above the PEL. It enables the
Periodic monitoring and measure-
The unpredictable nature of fugitive
Agency to be aware of facilities where
ment are not required when initial
emissions from valves, pumps, and the
substantial exposure to AN exists.
measurements are below 1 ppm. It is
like, makes it unlikely that a survey
Methods of compliance: Paragraph
unlikely, when exposures are at this
performed on a weekly basis will
(g). The final standard requires that
level, that minor fluctuations in procdetect all, or even most, of the leaks
by November 2, 1980, engineering coness, materials, or weather or measureand spills that occur in liquid AN opertrols and work practices be used to
ment accuracy would result in false
ations. Further, such a weekly survey
control employee exposure to acryloninegative readings below the TWA
would add little to the exposure monitrile, except to the extent that the emlimit. It would not be appropriate to
toring required by the standard, in deployer can show that they are not fearequire periodic measurements in
termining employee exposure to AN.
sible. If all feasible engineering and
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45801
work practice controls do not succeed
except in circumstances where there is
CFR 1910.1000(e) and with good indusin reducing exposure below the perno feasible alternative to more subtrial hygiene practice.
missible exposure limit, they must be
stantial reliance on respiratory protec-
Many comments cited problems assoimplemented and supplemented by
tion.
ciated with respirators (Exs. 92;
respiratory protection. OSHA's experi-
Even in situations in which engineer-
11(27)). Respirators are to be considence has been that engineering coning controls will not succeed in reducered secondary to the objective of
trols must be coupled with suitable
ing exposure levels below the TWA
limiting emissions at the source.
work practices to maximize their effeclimit, it is still appropriate to require
Proper facial fit is essential, but due to
tiveness. Respiratory protection may
all feasible engineering controls to be
variations in individual factal dimenbe used only during the time period
installed, even though they would
sions, as well as facial hair, scars, or
necessary to install engineering conhave to be supplemented by the use of
growths, it is difficult to maintain. Fatrols, where engineering controls may
respirators. The engineering controls,
tigue and reduced efficiency may
be inappropriate, such as during some
by minimizing the amounts of AN in
occur more rapidly among workers
maintenance operations, or in those
the workplace environment, will also
wearing respirators due to increased
cases when both engineering controls
minimize the potential for overexpobreathing resistance, heat stress, and
and work practices do not succeed in
sure to AN resulting from poorly fitreduced vision. Additional problems
reducing exposures below the permisting respirators, and will usually
include the entanglement of hoses of
sible exposure limit. Respirators are
reduce the number of employees who
air-supplied respirators, as well as limalso to be used in emergencies.
will need to wear respirators at all.
ited mobility resulting from hose
This compliance strategy has been
The standard places the burden on
length and bulkiness of the apparatus.
consistently OSHA's policy and has
the employer for proving or disproving
(Ex. 19).
been followed in prior standards and
feasibility. The employer is in the best
It is clear, and generally agreed to
proposed standards. This policy is
position to gather evidence on feasibilby the affected employers, that respibased upon the view that the most efity in a particular workplace. He is
rators cannot generally be considered
fective means of controlling employee
exposure is to contain emissions of
most familiar with his own production
as the primary means of employee
processes and engineering modificahealth protection. It is also recognized
toxic substances at their source
tions which can be made. Further, it is
by OSHA that there will be certain opthrough the use of mechanical means
erations in which the use of respiracombined with work practices. This is
the policy of the OSHA Act that emfar more effective than reliance on the
ployers be required to take steps to intors will be necessary to protect emhighly variable human behavior so
vestigate the feasibility of controls
ployees from exposure to AN. This
aspect was recognized in the preamble
critical to the successful use of respiraand install them as necessary.
to the proposal.
tors. As discussed below, respirators
In addition to the obligation to insti-
OSHA has concluded that if the perhave many disadvantages which pretute engineering and work practice
missible exposure limit is exceeded,
clude primary reliance or coreliance
controls, except to the extent that
employees must use respirators. This
on respiratory protection on an equal
such controls are not feasible, the
is necessary in order to provide the
basis with engineering and work pracfinal standard also requires that each
maximum amount of protection availtice controls. Furthermore, the burden
employer establish and implement a
able in situations where engineering
of reducing employee exposure should
plan for reducing exposures to within
controls and work practices do not sucmore properly rest on the employer in
the permissible exposure limits solely
ceed in reducing exposures below perwhose establishment toxic substances
by engineering and work practice conmissible levels.
are released, rather than placing the
trols. These written plans must be fur-
The affected employers have indiburden of respirator use on the exnished upon request for examination
cated that they have endeavored to
posed employee.
and copying to representatives of the
determine, under the ETS, those job
The Council on Wage and Price Sta-
Assistant Secretary and the Director.
positions for which respirator use will
bility suggested a control strategy in-
These plans must be reviewed and upbe necessary for a large part of the
volving principal reliance on respiradated periodically to reflect the curworkshift, under a 2 ppm standard.
tory protection, to reduce the cost of
rent status of exposure control. The
This achievement places the employcompliance (Ex. 27). However, the afwritten plan is an essential part of the
ers in a position to develop a detailed
fected companies themselves readily
compliance program, since it will enrespirator program directed primarily
acknowledge the many difficulties incourage employers to implement the
at these employees. Items which
herent in reliance upon respiratory
necessary technology for reducing emmight be considered for such a deprotective devices (Exs. 11:(27); 92).
ployee exposures. It also provides the
tailed program include making availa-
These difficulties were also discussed
information to allow OSHA, the emble a greater variety of respirators
by respirator expert Darell Bevis (Ex.
ployers, and employees to examine the
from which employees can choose,
19). Because of the difficulties in obcontrol methods chosen and the
having a technician fully trained in
taining and maintaining a proper fit
extent to which these planned conrespirator use and selection, and orgaand seal of the respirator facepiece, it
trols are being implemented in the
nizing the work so that part of the day
is difficult to know whether the respiworkplace.
can be spent in clean rooms or control
rators actually provide adequate pro-
Respirators: Paragraph (h). The
rooms where the exposure limits are
tection. Respirators, by interfering
standard requires that respirators be
not exceeded. The nature of the work
with vision, hearing, and mobility, can
used only during the time period necin many monomer and polymer manucause safety problems. Some employessary to install or implement feasible
facturing facilities, much of which is
ees cannot wear respirators because of
engineering and work practice conhighly automated, lends itself to this
breathing difficulties. Finally, it is not
trols, in operations in which such contype of program. The employer should
appropriate to place the burden of
trols are not appropriate, such as ceralso investigate the possibility for rescompliance principally on the employtain maintenance operations, in work
pirators with microphones, should
ee, as would be the case if respiratory
operations in which such controls are
communication on the job prove to be
protection were the principal means of
not feasible or are not yet sufficient to
a problem.
reducing employee exposure. Therereduce exposure to the permissible
Respiratory protection also has a
fore, OSHA retains in the standard
limits, or in emergencies. These rerole during maintenance operations as
the policy of principal reliance on enstrictions on the use of respirators are
well as during emergency situations.
gineering controls and work practices,
consistent with the requirements of 29
We realize that respirators may be
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45802
RULES AND REGULATIONS
needed in these types of operations,
breathes. This may result in workplace
ing proper protection to the employee.
even over the long run. The standard
air entering the facepiece through
Whereas the qualitative fit test is subis designed to control AN workplace
gaps and leaks in the facepiece seal,
jective, relying upon the employee's
emissions at the source, and, thus, to
instead of passing through the sorbent
sense of smell, the quantitative fit test
minimize the need for general use of
material. Obtaining a proper fit on
uses instrumentation inside the facerespirators by employees.
each employee may require the empiece to determine the integrity of the
In the proposal, OSHA included a
ployer to provide two or three differseal. One type of quantitative fit test
proposed table of respirators for use
ent mask styles.
involves using a simple hood, sodium
with AN. The primary basis for the se-
The employee must be properly
chloride vapor, and automated instrulection and evaluation of respirators in
trained to wear the respirator, to know
mentation. At least one such device is
this table (Table I) was the NIOSHwhy the respirator is needed, and to
commercially available at less than
OSHA respirator decision logic. The
understand the limitations of the res-
$10,000. These tests can be performed
protection factors supplied in the
pirator. An understanding of the
rapidly (10 to 20 minutes) and are relatable were based on qualitative fit testhazard involved is necessary to enable
tively easy to perform. Since the
ing, which involves only the facepiecethe employee to take steps for his or
standard will apply almost exclusively
to-face seal. (Ex. 19). In addition to
her own protection. The respiratory
to monomer and polymer producers, it
the Table, several other requirements
protection program implemented by
is reasonable to assume that these
for respirator usage were included in
the employer must conform to that set
the proposal, concerning approval of
large companies can obtain the equipforth in 29 CFR 1910.134. This proviment for such testing.
respirators, replacement of cartridges
sion contains basic requirements for
and/or canisters, and cleaning of respi-
OSHA requested views, arguments,
proper selection, use, cleaning, and
and other comments on the issue of
rators.
maintenance of respirators.
A number of changes have been
quantitative fit testing in the course of
Under § 1910.134, the employer must
made from the proposed provisions,
this rulemaking proceeding. The use
check to see that the employees' respibased primarily upon the recommenrators fit properly and that leakage is
of such testing has been endorsed by
dations of Darell Bevis, an acknowlthe Z88.2 subcommittee of ANSI as
at a minimum. A rapid simple fit test
edged expert in the field of respiratory
can be performed at the start of each
noted by Bevis in his testimony (Ex.
protection. These changes will be disshift by each employee wearing a neg-
19). The equipment has been develcussed below.
ative-pressure respirator. This test can
oped which makes quantitiative fit
The proposal specified that where
be either a positive pressure test, in
testing relatively easy to carry out,
air-purifying respirators were to be
which the exhalation valve is closed
and it is universally recognized that it
used, they would have to be approved
and in which the wearer exhales into
provides greater assurance of proper
by NIOSH specifically for use with
the facepiece to produce a positive
protection. We believe, therefore, that
AN. NIOSH has since informed OSHA
pressure, or a negative pressure test,
it is appropriate for employers with
that they will not grant such approval
in which the inlet is closed and the
significant numbers of employees
because of AN's poor warning qualiwearer inhales so that the facepiece
wearing negative pressure on respiraties. Since AN cannot be detected by
collapses slightly. Employees must be
tors to be required to provide quantiodor until concentrations reach the
trained to perform this test.
tative fit testing for those employees.
13-19 ppm range, it is not possible for
The standard requires a qualitative
Under the ETS, employers were rethe respirator wearer to detect leakage
fittest at the time of initial fitting and
quired to implement any practicable
or breakthrough within the facepiece
semiannually thereafter. Isoamyl acecombination of engineering, work
until he is clearly overexposed. Under
tate can be used to qualitatively test
practices, and respiratory protective
the respirator decision logic, the use of
facepiece fit. If the employee can
devices to lower their employees' AN
air-purifying respirators should not be
smell the isoamyl acetate while wearexposures below a 2 ppm TWA. Much
permitted for AN, because of this
ing the respirator, it can be concluded
of the compliance activity under the
factor. However, OSHA has deterthat the particular respirator will not
ETS involved the implementation of
mined that air-purifying respirators,
provide suitable protection for that
respiratory protection programs.
when used in a rigidly controlled proemployee.
Therefore, there should be no need for
gram of proper fitting and frequent
The proposal contained no specific
a "transition period" for the implesorbent replacement, should be perrequirement for periodic fit testing.
mentation of respirator programs
mitted for protection against low con-
However, as noted below, the issue was
under the final standard. The standcentrations of AN, as prescribed in
raised by OSHA in the proposal as to
ard requires that the employees ex-
Table I of the standard. When the
whether the more sophisticated quanposed above the PEL as of the effecprotection factors in the respirator
titative fit test should be generally retive date of the standard must be protable are followed, organic vapor carquired. We have concluded that the
vided with and must wear appropriate
tridges and canisters can provide properiodic qualitative fit test can serve
respirators in accordance with the setection for employees.
as a preliminary screening for all reslection criteria in Table I.
Therefore, OSHA has revised its propirator users, to determine whether an
The proposal provided for the reposal to permit organic vapor caremployee's face-to-face piece seal is
placement of "filters" if an employee
tridges and canisters to be used for
sufficient to permit the use of respirareported breathing resistance. This
AN. These sorbent containers must be
tors designated in Table 1.
provision has been deleted from the
approved by NIOSH for use with or-
The standard also requires that each
final standard. As was noted at the
ganic vapors. We must not however,
employer with 10 or more employees
hearing, organic vapor cartridges do
that there are numerous factors which
who must wear negative pressure resnot use "filters," which are generally
affect the performance of air-purifypirators must provide quantitative fit
used for protection against particulate
ing respirators, including the sorbent
testing for those employees at the
hazards (Ex. 19). The vapor hazard asmaterial itself and the fit of the facetime of initial fitting and semiannualsociated with AN in the workplace
piece on the wearer. Other important
ly thereafter. In a quantitative fit test,
should not present any breathing refactors include wearer acceptance and
the level of leakage and degree of prosistance difficulties, since there is no
training.
tection are specifically measured by
problem of clogged filters in this situa-
Proper fit of the respirator is critisensitive instruments. These tests are
tion. Therefore, the requirement is not
cal. A negative pressure is created
more accurate and provide greater asappropriate for a regulation on AN exwithin the facepiece when the wearer
surance that the respirator is providposure.
FEDERAL REGISTER, VOL 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45803
Perhaps the most controversial ele-
On questioning, he elaborated on
The alarm system will, in most cases,
ment of the proposed respirator secthe practice of labeling used cartridges
involve the installation of a continution involved the frequency of replaceas an alternative to replacement each
ous monitoring system which will
ment of cartridges or canisters. It was
shift:
detect AN concentrations at the ceilcontended by many in industry that
the daily replacement of cartridges or
It's my firm opinion that when using soring limits to activate the alarm. Such
bent-type cartridges and canisters (,) the
monitoring systems have already been
canisters was wasteful, particularly if
most conservative approach must be taken
installed by some companies and are
they were only used briefly during the
I never recommend-in fact, I'm a crubeing used for generating area moniworkshift. A system of labeling of carsader against-reuse of sorbent type cartoring data in addition to detecting
tridges, it was argued, would assure
tridges and canisters because I don't feel
ceiling concentrations of AN (Exs.
that cartridges and canisters were rethat they can safely be reused (Tr. 191).
11:(10); 87).
placed before the expiration of their
We agree that in the limited use of
The need for an alarm system has
service life (Ex. 92). OSHA does not
the sorbent-type air purifying respirabeen recognized by many of the affectagree with these contentions. As noted
tors, the most conservative approach
ed companies (Exs. 11:(10); 11:(14);
earlier, the very use of organic vapor
must be taken in order to assure the
11:(27)).
cartridges and canisters for AN, which
most protection from that device.
Protective clothing and equipment:
does not have good warning proper-
As noted in the proposal, the wear-
Paragraph (j). The standard requires
ties, runs totally counter to the respiing of a respirator can result in facial
the employer to provide and assure
rator decision logic and to good indusirritation at the face seal surface. To
that employees use protective clothing
trial hygiene practice. However, OSHA
prevent this irritation and to minimize
and equipment wherever there is pohas determined that it is necessary to
the discomfort of respirator use, the
tential for exposure to liquid AN. This
allow their use under a limited set of
proposal would have permitted emprovision is considerably narrower in
circumstances, provided that that use
ployees to periodically "wash" their
scope than that in the proposal. It reis very narrowly restricted. The lack of
faces and respirator facepieces. This
flects the determination that solid
end-of-service-life indicators for organprovision has been modified in the
PAN and other finished polymers do
ic vapor cartridges used with AN
final standard. It was noted at the
not represent significant sources of
masks it is necessary for OSHA to rehearing that an employee who
AN exposure. The new provisions require the replacement of the sorbent
"washed" his respirator facepiece
quire appropriate protective clothing
at the completion of each shift (Ex.
might also wet the sorbent cartridge
and equipment only for "liquid AN,"
11:(16)).
or canister, possibly rendering it inefas defined in the standard, including
It should be noted, in addition, that
fective or less effective. The employpolymer intermediates produced
even changing the sorbent container
ee's role, it was argued, was to make
during the polymerization process.
each shift may not assure protection.
sure that he wore the facepiece prop-
The protective clothing provisions of
Testing data submitted by a respirator
erly (Tr. 193-4). We believe that the
the proposal elicited much comment
manufacturer and by NIOSH indicate
standard should reflect these conand testimony from interested perthat some organic vapor cartridges
cerns. The provision in the final standsons. The detailed requirements for
used for AN may not last for 8 hours,
ard has, therefore, been clarified to
providing, maintaining, and replacing
and that they may last for only 4
allow washing of the face, but only a
protective clothing and equipment
hours under humid conditions (Ex.
were criticized as not being sufficientwiping of the facepiece-to-face seal of
11:(12L); 11:(13L); 11:(14L)). This findly performance-oriented Some comthe respirator itself. Cleaning of the
ing is particularly important in the
ments noted that impermeable clothactive elements of the respirator
context of this standard, since there
ing was provided to the employee to
should be in the hands of a trained
are numerous monomer and polymer
protect him from skin contact with
person as part of a respirator program.
production facilities which operate
AN. Thus, when such AN-impermeable
OSHA believes that if an employee
under conditions of high humidity. It
clothing became wet with AN, there
receives training as to the purpose of
is clear that where the service life of a
was no need for the employee to
his respirator and the proper method
cartridge or canister is less than 8
remove the clothing immediately, as
of wearing it, he will be less likely to
hours, that cartridge or canister may
the proposal would have required, bedo anything which will limit the prohave to be replaced again at some time
cause there would be no skin exposure.
tectiveness of the respirator program.
during the workshift. The standard
Dow Badische recommended that the
Emergency situations: Paragraph (i).
allows for such a situation by requirstandard provide separate require-
The emergency provisions are substaning the employer to replace cartridges
ments for the handling of impermetially unchanged from those of the
or canisters before the end of their
able clothing, such as rubber gloves
proposal. However, the revised definiand suits, as opposed to coveralls and
service life or at the completion of
tion of the term "emergency" limits
other permeable clothing (Ex. 149).
each shift, whichever comes first. The
the types and number of situations for
employer has the obligation to ascer-
We have determined that these sugwhich a written plan will be required.
gestions have merit, and the final
tain the service life of the cartridges
OSHA has determined that not all instandard incorporates appropriate
and canisters to be used in his workstances of release of AN above the ceilchanges. Where it is likely that imperplace, in order to assure that they are
ing limit should be viewed as emergenmeable clothing has contacted liquid
replaced as required by the standard.
cies. Only the "massive release" of AN
AN such clothing must be washed
On the issue of frequency of replaceis termed an emergency under the
down with water before being removed
ment of the cartridges Bevis stated:
final standard.
by the employee. The employee may
I am in full support of the change of the
It should be noted that the standard
then remove the clothing in the
cartridge after each shift has ended, whethstill requires the installation of an
change room and proceed to shower.
er it has been, used for 15 minutes or
8
alarm system, to be activated by re-
The clothing must then be placed in a
hours, since it is virtually impossible to
leases of AN above the ceiling. Alregulated area and decontaminated.
assure how much air has been drawn
though not an "emergency" per se as
through that cartridge or canister or to de-
A more complicated situation arises
termine the specific minutes or hours of
defined in the standard, the exceeding
if an employee wearing AN-permeable
life. The activated charcoal sorbents in the
of the ceiling limit does necessitate
clothing becomes wet with liquid AN.
organic vapor cartridges will sorb not only
the taking of protective action to
Understandably, this should only
organic vapors but also moisture, shortening
assure that employees are not overexoccur in accidental spills and emergentheir service life (Ex. 19).
posed.
cies. In this situation, the employee
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45804
RULES AND REGULATIONS
shall remove the wetted clothing and
been sharply criticized as redundant
monitoring systems and portable deshower immediately. The clothing
with the permissible exposure limits,
tection units will be used both for deshall then be placed in a regulated
since the presence of even small
tecting sources of AN and for deterarea and decontaminated in the same
amounts of liquid AN on a work surmining whether an area has been demanner as impermeable clothing.
face would result in exposures above
contaminated.
Clothing and equipment worn for
the PEL (Exs. 148; 11:(13)). Other par-
The proposal required that AN and
protection from liquid AN must, of neties contended that the term "accumu-
PAN waste materials be placed in a
cessity, be impermeable to AN. The
lations" needed to be defined more
closed container, labeled, and disposed
proposal would have required replaceprecisely. The use of wipe tests and
of. The employer was required to
ment of such clothing on at least a
bulk liquid samples, it was argued,
inform those persons handling the maweekly basis. We have noted, however,
could lead to citations for the detecterials of the AN content and the hazthat the actual need to provide retion of "accumulations" of "nanogram
ards of exposure to AN. These proviplacement varies greatly with the conquantities" of AN (Ex. 160).
sions drew strong comment from interditions of use. We believe that the em-
Other provisions of the housekeepested parties. It was contended that
ployer should be required to replace
ing section were found by some parties
the enclosure of these materials conprotective clothing and equipment as
to be unnecessary and not in accordstituted a fire and explosion hazard,
necessary to assure its protectiveness.
ance with OSHA's intention to use
since AN might be concentrated
Whereas this does not specify a given
performance language wherever pracwithin the containers. It was also
interval, it does require frequent inticable (Ex. 148). Vistron determined
argued that the downstream handler
spection of clothing to make sure that
that the housekeeping section restrictof the materials would face a serious
it remains impermeable.
ed the use of water flushing to wash
exposure potential when the container
The washing down of impermeable
down work surfaces. Such washing
was opened (Ex. 149).
suits, gloves, and the like before rewould take advantage of the solubility
The record clearly reflects that the
moval is intended to minimize the poof AN in water, as well as its capacity
provisions in the proposal which dealt
tential of skin contact with AN. The
for biodegradation by bacteria (Exs.
with waste disposal are not supported
washdown should be sufficient to
92; 146).
by the record and are inappropriate
assure that the clothing will not re-
In light of these comments, and in
for the proper handling of AN. Therelease AN. The employee shall, noneorder to provide a more performance
fore, these provisions have been retheless, shower at the end of the workoriented standard, OSHA has detervised accordingly. Waste materials
shift.
mined that there is no need for a decontaining or contaminated with
The provision for decontamination
tailed housekeeping section in the
liquid AN are to be placed in a regulatof wetted protective clothing and
final AN standard. Where there may
ed area. The materials may then be
equipment helps to resolve a major
be skin or eye contact with liquid AN,
treated in one of two ways: They may
area of difficulty surrounding both
the employer is already required to
either be placed under ventilation, or
the ETS and the proposal. The proprovide impermeable protective clothwashed with water into the plant's
posal required protective clothing to
ing and equipment to his employees.
process waste water system. When the
be placed in a closed container after
The detailed requirements as proposed
materials no longer release AN in airuse. This presented a problem of possiwould appear to add little, if any, proborne concentrations above the action
ble skin contact with and inhalation
tection to that provided by the permislevel, they may then be disposed of in
exposure to AN by persons opening
sible exposure limits. They would also
the normal manner (clearly, if the mathese containers, as well as by persons
have limited the use of water washterial is incapable of releasing AN
who had to handle the clothing for
downs of work surfaces, which the
above the action level, there would be
disposal or laundering. In addition, the
final standard expressly requires in
no need for the employer to carry out
closing of the containers posed a pocertain circumstances, as a means of
this washing or ventilation step on
tential for fire or explosion due to the
controlling the potential for AN expothat material). The purpose of this
volatility of the AN within the consures. Recommended housekeeping acnew provision is threefold: First, it retainers. The final standard deals with
tivities are contained in appendixes A
duces the number of employees with
these problems by ventilating and
& B.
potential for exposure to AN; second,
washing down the contaminated cloth-
The final standard requires the emit provides a means of dispensing with
ing and equipment to remove their poployer to assure that surfaces are
the detailed disposal and labeling retential to release AN above 1 ppm.
maintained free of visible accumulaquirements contained in the proposal;
Many maintenance operations, partions of liquid AN. In addition, the emand, third, it provides a way for the
ticularly those involving reactor cleanployer must decontaminate (as defined
employer to assure that the material
ing, involve the potential of skin conin paragraph (b)) areas where spills
will not expose downstream handlers.
tact with liquid AN. The impermeable
are detected.
As with protective "clothing, many
clothing requirements, along with res-
The housekeeping provisions have
waste materials will not release AN
piratory protection requirements, are
also been revised from the proposal to
above 1 ppm, even without the types
essential to the protection of employinclude a lead detection program for
of treatment provided for in paraees engaged in these operations.
operations involving liquid AN. OSHA
graph (1). It is clear that the standard
Housekeeping and waste disposal:
has determined that it is appropriate
does not require such treatment in
Paragraphs (k) and (Z). The proposal
to require direct action by the employthis case.
contained detailed housekeeping reer to detect leaks and spills of liquid
The discussion of the revised exempquirements for AN and PAN. As noted
AN which may result in employee extion provisions of the standard makes
above, the final standard removes all
posure. The details and frequency of
clear that solid polymeric materials
references to PAN, since the new defisuch a program are not specified in
are not considered to be a significant
nition of "liquid AN" will cover any
the standard, because of the wide varisource of AN exposure. Therefore, the
polymers and polymer intermediates
ation of workplace conditions and AN
disposal of PAN scrap or debris, other
deemed to carry a significant skin exsources among the affected employers.
than for those materials defined under
posure potential.
However, the housekeeping provisions
"liquid AN," does not require the spe-
Paragraph (k)(1) of the proposal respecify that the employer must deconcial treatment prescribed under paraquired the employer to maintain work
taminate those areas in which leaks
graph (1). The deletion of the term
surfaces free of "accumulations" of
and spills are found. OSHA anticipates
"PAN" has been made in this para-
AN and PAN. This paragraph has
that the use of real-time continuous
graph, accordingly.
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45805
Hygiene facilities and practices:
tered, positive pressure air supply in
trile (Exs. 128; 149). The purpose of
Paragraph (m). The proposal referlunchrooms (Ex. 156). Second, the
these requirements is to make an inienced § 1910.141 and its existing restandard already prohibits eating,
tial medical assessment of each emquirements for hygiene facilities and
drinking, and smoking in regulated
ployee and to establish a baseline
practices in all workplaces. In addiareas. Employees are not permitted to
health condition against which future
tion, the change room and shower fahave food, beverages, or smoking prodchanges in an employee's health may
cility provisions, § 1910.141 (e) and (d)
ucts in areas above the permissible exbe compared.
(3), respectively, were specifically inposure limits. Third, the final stand-
The medical surveillance provisions
corporated into the standard. OSHA
ard retains the requirement for emof the standard contain specific testbelieves that these provisions are parployees exposed above the TWA to
ing requirements, with concentration
ticularly important where there is powash before eating. Airborne concenon the peripheral and central nervous
tential for contact with liquid AN, and
trations above the PEL imply the consystems, respiratory system and gaswhere protective equipment and clothcurrent possibility of skin contact with
trointestinal system. Based upon the
ing may be required.
AN. Even though the standard condata from the du Pont and MCA stud-
The proposed shower provisions
tains a separate requirement for emies of exposure to AN, these vital sites
would have required all employees
ployees who contact liquid AN to
must be considered to be possible
"exposed to liquid AN and PAN" to
shower afterwards, OSHA believes
target sites for AN-induced cancer.
shower at the end of the work shift.
that this additional precautionary
However, due to the lack of site-
This requirement has drawn considermeasure is appropriate in light of the
specificity associated with AN-induced
able comment from affected employnature of the AN exposure hazard.
cancer, all systems must be examined
ers. The term "exposure" caused con-
Medical surveillance: Paragraph (n).
thoroughly (Exs. 42; 89; 92; 160).
siderable confusion, since it was un-
The final standard, like the ETS and
OSHA believes that these provisions
clear what constituted exposure to AN
the Proposal, requires that each emwill enable the examining physician to
in these circumstances (Ex. 149). It
ployer institute a medical surveillance
detect and hopefully make possible
was suggested that the term be
program for all employees who are or
early treatment for any cancers which
changed to "contact or suspected conwill be exposed to AN at or above the
may develop due to past exposures to
tact." In addition, it was argued that
action level. OSHA finds that a medi-
AN.
skin contact with PAN did not constical surveillance program is both neces-
The standard requires fecal occult
tute a significant risk of AN exposure
sary and appropriate to most effectiveblood testing for workers over 40 years
(Exs. 11:(14); 148).
ly determine whether the health of
of age. This is a nontraumatic, nonin-
Several parties contended that the
employees exposed to AN is adversely
vasive procedure for the early detecrequirement for a shower at the end of
affected by such exposure, and to detion of gastrointestinal disease which
a shift would not provide sufficient
velop information on occupational illis available and commonly used mediprotection for an employee who has
nesses. The authority to include such
cally as a screening technique. OSHA
had skin contact with liquid AN. Such
a provision in this standard is set forth
has therefore deleted the provision reemployee should be required to
in section 6(b)(7) of the Act.
quiring the routine proctosigmoidoshower immediately after such con-
The standard requires that the
scopic examination of workers exposed
tact, it was argued, because of the
medical surveillance program provide
to AN. However, should the results of
rapid absorption of AN through the
each covered employee with an opporthe fecal occult blood testing (as well
skin (Exs. 11:(14); 149).
tunity for medical examination. All exas other medical tests or examination)
OSHA has determined that the
aminations and procedures are reindicate that, in the judgment of the
shower provisions should be revised to
quired to be performed by or under
examining physician, further testing is
reflect the comments and data rethe supervision of a licensed physician,
necessary, such additional testing
ceived. The term "PAN", as has been
and provided without cost to the emwould then be performed (cf. Exs.
noted elsewhere, is being deleted from
ployee. While the physician will usual-
14:(37); 42; TR. 704; 708; 710).
this and other provisions of the standly be selected by the employer, the
The standard requires that the emard. The list included in the definition
standard does not so mandate, leaving
ployer provide the physician with cerof "liquid AN" includes those materithe employer free to institute alternatain information. This includes the
als containing or made from AN which
tive procedures such as joint selection
following: (1) A copy of the regulation;
would be most likely to present a sigwith employee or selection by the em-
(2) a description of the affected emnificant risk of skin exposure to AN.
ployee. Clearly a medical examination
ployee's duties as they relate to the
The final standard contains a reis most appropriately conducted by a
employee's exposure; (3) the results of
quirement for employees who have
licensed physician. However, certain
the employee's exposure monitoring;
had or are suspected of having had
parts of the required medical surveil-
(4) the employee's anticipated exposkin contact with liquid AN to shower
lance program do not necessarily resure level; (5) whether any personal
immediately after the contact is disquire a physician's specific expertise
protective equipment has been or will
covered. In addition, employees reand may be conducted by another
be used; and (6) information from prequired to wear protective clothing to
person under the supervision of the
vious medical examinations of the afprevent skin contact with liquid AN
physician (Ex. 141). As mandated by
fected employee which is not otherare required to shower at the end of
section 6(b)(7) of the Act, the medical
wise readily available to the physician.
the shift. These requirements recogexaminations and procedures required
The purpose of making this informanize the nature of the skin exposure
by OSHA standards must be provided
tion available to the physician is to aid
hazard, and effectively limit the need
at no cost to the employee.
in the evaluation of the employee's
for showers to those employees who
The standard requires that the
health in relation to his assigned
may have contacted liquid AN.
medical examination include a work
duties and fitness to wear personal
The lunchroom provisions of the
history, a medical history and a physiprotective equipment when required.
proposal have also come under close
cal examination of the affected em-
The employer is required to obtain a
scrutiny. OSHA has determined that
ployees. The content of the examinawritten opinion from the examining
lunchroom provisions are not required
tion is based upon recommendations
physician containing the following inin the final standard for several reafrom NIOSH (Exs. 42; (41) and upon
formation: (1) The results of the medisons. First, because the airborne
procedures presently followed by sevcal tests performed; (2) the physician's
hazard involves vapor rather than pareral companies in their clinical evaluaopinion as to whether the employee
ticulate, there is not a need for a filtion of employees exposed to acrylonihas any detected medical conditions
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45806
RULES AND REGULATIONS
which would place the employee at in-
It has been suggested that provision
must, at the minimum, apprise the emcreased risk of material impairment of
be made for medical surveillance to inployee of the specific hazards associathealth from exposure to AN; (3) any
clude those employees who have a hised with his or her work environment.
recommended limitations upon the
tory of AN exposure but are no longer
For this reason, the employer is reemployee's exposure to AN or upon
actively working with AN (Ex. 11:(2)).
quired to inform each employee exthe use of protective clothing and
No such provision has been included in
posed to AN of the nature of the relatequipment, such as respirators; and (4)
the standard, as OSHA has detered health problems, the necessity for
a statement that the employee has
mined that the inclusion of past emexposure control, and the medical and
been informed by the physician of the
ployees in a medical surveillance proindustrial hygiene programs. Such an
test results of the medical examinagram would be unnecessarily burdeneducational program will go far in astion and of any medical conditions
some and administratively infeasible.
suring that employees know the facts
which require further examination or
It would be extremely difficult, if not
about AN and its proper handling.
treatment. This written opinion must
impossible, to determine which em-
The content of the training program
not reveal specific findings or diagployees may have been exposed to AN
is intended to apprise the employees
noses which are unrelated to occupaand for how long, and to locate many
of several factors: (1) The hazards to
tional exposure. A copy of the written
such employees so as to inform them
which they are exposed; (2) the action
opinion must be provided to the afof the medical surveillance program.
they can take to protect themselves,
fected employee by the employer.
In addition, where the employee has
including avoiding exposure, using res-
Commentors have objected to the reworked for more than one employer, it
piratory protection and taking medical
quirements for the physician's written
would be difficult to determine which
examinations; (3) their role in reducopinion as unnecessary and burdenemployer should bear the cost of such
ing exposures; and (4) the contents of
some (Exs. 11: (25) Ex. 148; 160). They
medical surveillance.
this standard. Section 6(b)(7) of the
believe the requirements should be
Medical removal protection. Medical
Act makes it clear that these are aplimited to situations where the findremoval protection was raised as an
propriate goals of an employee trainings are adverse (Exs. 73; 153).
issue in the AN proposal. This requireing program, and the standard, there-
These views are unacceptable to
ment would maintain the rate of pay,
fore, includes such provisions.
OSHA. Since the employer has the ulseniority and other rights of an em-
The employer is also required to protimate responsibility to assure the proployee who is transferred or removed
vide, upon request, all materials relattection of the worker's health, where
from his job to protect him from maing to the training program to the Asthe worker's health has not been adterial impairment of health, as a result
sistant Secretary and the Director.
versely affected, transmittal of the
of an increased health risk from expo-
This is intended to provide an objecdoctor's opinion serves to inform both
sure to AN.
tive check of compliance with the repatient and employer and provides
OSHA's primary goal is to assure
quirements of the standard.
documentary evidence that the prethat no employee suffers material im-
OSHA recognizes that AN may be
scribed tests were performed and evalpairment of health or functional caone of many chemicals to which an
uated. The requirement that the empacity. The Agency does not favor
employee may be exposed simultaployee be provided with a copy of the
transfer or removal as an alternative
neously in the workplace. The educaphysician's written opinion will assure
to controlling the level of a toxic subtion and training requirements in this
that the employee is informed of the
stance in the workplace environment.
standard contain those elements
results of the medical examination
Moreover, once full compliance with
which OSHA believes to be basic. The
and may take any necessary or approthe permissible exposure limits is
format of the training and informapriate action. This is consistent with
achieved by engineering controls and
tion program is not rigid. An employer
those provisions of the Act which eswork practices, the need to transfer or
may, if he chooses, incorporate the retablish and implement the employee's
remove employees from exposure to
quired information for AN into a total
right to know about occupational haz-
AN should arise infrequently.
program of training and education
ards and their effects. The purpose of
Limited evidence on this issue was
which is to be provided to his employrequiring that specific findings or direceived during this proceeding. OSHA
ees (Ex. 11:(14)).
agnoses unrelated to occupational exhas conducted extensive hearings on
Signs and labels: Paragraph (p). The
posure not be included in the written
medical removal protection in connecrequirement of the standard regarding
opinion is to encourage employees to
tion with the development of a standthe posting of warning signs and affixsubmit to medical examination by reard for occupational exposure to lead.
ing caution labels remains primarily
moving the fear that employers may
The final lead standard, including resthe same as that in the proposal. The
find out information about their physolution of the question of medical rebroadening of the exemption proviical condition that has no relation to
moval protection, is expected to issue
sions of the standard will result in a
their occupational exposures.
shortly. Once the lead standard is
minimum of products and materials
It has been suggested that physical
issued, OSHA will consider the extent
which will be required to be labeled. In
examinations are not necessary for
to which the conclusions reached
addition, the wording of the signs for
people under 40 and in good health
therein on medical removal protection
regulated areas has been slightly
(Ex. 160). This is contrary to the
are appropriate for acrylonitrile, and
changed. These requirements are conintent of medical surveillance. Workwill propose the inclusion of any apsistent with section 6(b)(7) of the Act,
ers under 40 may already have been
propriate provisions in the AN standwhich prescribes the use of labels or
exposed to AN for 15 to 20 years. Since
ard.
other appropriate forms of warning to
the carcinogenic response may vary
Employee information and training:
apprise employees of the hazards to
widely depending to a great extent on
Paragraph (o). The standard requires
which they are exposed.
individual susceptibilities the long lathe employer to provide a training
Signs. The standard requires the
tency periods associated with carcinoprogram for employees exposed to AN.
posting of warning signs in regulated
gens may also vary greatly among
OSHA believes that an information
areas. These signs are intended to supthose exposed to cancer-causing suband training program is essential for
plement the training which employees
stances. In addition medical surveilthe protection of employees, because
are required to receive under the
lance is intended to aid in the early dean employee can do much to protect
standard. Even trained employees will
tection of cancer and other chronic efhimself if aware of the nature of the
need to be reminded of the locations
fects so as to facilitate treatment of
hazards in the workplace. To be effecof regulated areas and the dangers of
these conditions.
tive, an employee education system
entering those areas. In addition,
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45807
other workers, such as employees of
Only those materials which pose a sigthe final standard makes it clear that
independent maintenance contractors
nificant potential for exposing emthese specific products do not have to
who are authorized to enter particular
ployees to AN are required to be
be labeled. Other than liquid AN
regulated areas, need to be warned of
labled under the standard.
itself, OSHA does not anticipate that
the hazard and reminded to use pro-
The standard requires that the
many products containing and/or
tective equipment. OSHA believes that
labels remain affixed when the AN
made for AN will require labeling
both signs and training are necessary
and AN-based materials leave the emunder the final standard. This reflects
to adequately apprise employees of
ployer's workplace. Some comments
the recognition that most AN-based
the hazards of acrylonitrile exposure.
questioned OSHA's jurisdiction to
materials in downstream workplaces
The standard specifies the wording
impose such a requirement (Exs. 156;
do not have a significant potential to
of the warning signs for regulated
11:(14); 146). The purpose of this reexpose employees to AN during proareas, in order to assure that the
quirement is to assure that all employcessing use, and handling.
proper warning is given to employees.
ees, not only those of a particular em-
Recordkeeping: Paragraph (q). Sec-
Some participants in the rulemaking
ployer, are apprised of the hazardous
tion 8(c)(3) of the Act provides for the
have suggested that the word
nature of acrylonitrile exposure. It is
promulgation of regulations requiring
"Cancer" on the signs be replaced by
OSHA's view that informing employemployers to maintain accurate rec-
"Cancer-Suspect Agent", or "Toxic
ees of the hazards to which they are
ords of employee exposures to poten-
Substance" (Exs. 146; 149). OSHA does
exposed is an important element in retially toxic or harmful physical agents
not believe that the use of the term
ducing occupational disease and
which are required to be monitored or
"Cancer Hazard" overstates the
injury, and one of the significant purmeasured.
hazard. The reference to cancer proposes of the Occupational Safety and
The standard provides that records
vides the necessary warning as to the
Health Act. Section 6(b)(7) of the Act,
must be kept to identify the employee
hazard associated with exposure to
which explicitly provides for regulaand to accurately reflect the employacrylonitrile.
tions which require the use of labels
ee's exposure. Specifically, it must in-
It has been further suggested that
or other appropriate forms of warning,
clude the following information: (a)
the word "Danger" be replaced by the
is broadly drawn. This section does not
The names, social security numbers,
word "Caution". OSHA feels that the
limit the employer's obligation of inand job classifications of the employword "Danger" is appropriate in light
forming employees of hazardous conees monitored; (b) the dates, number,
of the evidence of carcinogenicity of
ditions to the employer's own employduration, and results of each of the
acrylonitrile. Furthermore, the word
ees. When an employer manufactursamples taken, including a description
"Danger" is used to attract the atteners, formulates, or sells a product conof the representative sampling procetion of workers, to alert them to the
taining a toxic substance, that employdure and equipment used to determine
fact that they are in a hazardous area,
er is exposing not only his own ememployee exposure where applicable;
i.e., an area where the permissible exployees, but also the employees of
(c) the type of respiratory protective
posure limit is exceeded, and to emother employers involved in handling,
devices if any, worn by the employee;
phasize the importance of the message
transporting, or using the product.
and (d) a description of the sampling
to follow. The use of the word
The extent of the obligation to inform
and analytical methods used, and evi-
"Danger" is consistent with recent
should be commensurate with the
dence of their accuracy.
OSHA health standards dealing with
extent of the exposure. This is espe-
The standard also requires that the
carcinogens.
cially true where the manufacturer,
employer keep an accurate medical
The signs have been changed from
formulater, or seller will, in many
record for each employee who is subthe proposal to read "Respirators May
cases, be the only employer capable,
ject to medical surveillance. Section
Be Required," instead of "Respirators
through his knowledge of the product,
8(c) of the Act authorizes the promul-
Required." The reason for this inof providing the information necessary
gation of regulations requiring any
volves the difference between the air
for protection of employees. A narrowemployer to keep such records regardconcentrations in the regulated area
er reading of the statutory authority
ing the employer's activities relating
and an employee's TWA exposure.
would defeat the protective purposes
to the Act as are necessary or appro-
There are many areas in which AN
of the Act by effectively preventing
priate for the enforcement of the Act
concentrations exceed 2 ppm, but
the downstream employee from obor for developing information regardwhere the employee's TWA exposures
taining adequate information as to the
ing the causes and prevention of occuwill not exceed the permissible limits.
hazard. Furthermore, the use of the
pational illnesses. OSHA believes that
Such an employee would not be relabels required by the standard will
medical records (like exposure moniquired to wear a respirator, even
alert other employers who utilize or
toring records) are necessary and apthough the proposed sign would have
handle the product and who would not
propriate to both the enforcement of
indicated otherwise. The final standotherwise know of the presence of
the standard and the development of
ard has been revised to provide a more
acrylonitrile in their workplace, of
information regarding the causes and
appropriate warning to employees entheir obligation to comply with the
prevention of illness.
tering the regulated area.
standard. OSHA, therefore, feels that
As explained above, it is necessary to
Labels. The standard requires the
this requirement is necessary and aprelate employees' medical conditions
use of warning lablels on all containers
propriate to effectuate the purposes of
with their exposures in order to develof liquid AN and materials made from
the Act.
op information regarding cause and
and/or containing AN which are not
The standard prescribes the legend
prevention. Medical records are necesexempted from the standard under
that must be included on the label.
sary and appropriate for this purpose.
paragraph (a)(2). This requirement
This is to assure that employees are
In addition, medical records are necesimposes upon the employer the obligaalerted to the fact they they are hansary for the proper evaluation of an
tion to assure that all such containers
dling acrylonitrile and to the hazards
employee's health. For all of these
within his workplace are at all times
involved.
reasons, medical records have been reproperly labeled, in order that his em-
The issue of labeling was of great
quired in the final standard.
ployees be apprised of the hazard.
concern as proposed, because' the
The standard requires that employ-
The revision of the exemption provinumber of products which potentially
ees or their designated representatives
sions in the final standard will greatly
might have required lablels was subbe provided access to examine and
relieve the burden of labeling of matestantial. The listing of exempted polycopy records of required monitoring.
rials made from and/or containing AN.
mer products in paragraph (a)(2)(i) of
The purpose of this provision is to
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
45808
RULES AND REGULATIONS
assure employees that their exposure
quiring these employers to implement
should be construed as establishing a
is being properly monitored and that
the provisions of the standard. In admandatory requirement not otherwise
they are working in a safe and healthdition, the standard permits monitorimposed by the standards, or as deful environment. Section 8(c)(3) of the
ing results and medical examinations
tracting from an obligation which the
Act explicitly provides "employees or
obtained under the ETS to serve as
standard does impose.
their representatives with an opportuinitial monitoring and initial medical
The information contained in appennity to observe and to have
surveillance under the final standard.
dices A and B is designed to aid the
access to the records thereof."
Employers are required to reduce
employer is complying with require-
The final standard requires that ememployee exposures to the permissible
ments of the standard. The informaployee medical records be made availaexposure limits solely by means of feation in appendix C primarily provides
ble upon request for examination and
sible engineering controls and work
information needed by the physician
copying by the affected employee or
practices within 2 years of the effecto evaluate the results of the medical
former employee, or a physician desigtive date of the standard, or November
examination. It should be noted that
nated by the affected employee or
2, 1980. The record reflects a wide
paragraph (o) specifically requires
former employee. The purpose of this
range of present exposure situations
that the information contained in approvision is to protect the employee's
and capabilities of engineering develpendices A and B be provided to emhealth by authorizing his designated
opment. Some companies have reportployees as part of their information
physician to have access to medical
ed that most of their opreations are aland training program.
records which may be useful in the diready below 2 ppm (Exs. 11:(14);
A new appendix D has been added to
agnosis of illness.
11:(10); 2:(21)). One producer expects
the final standard. This appendix
The standard requires employers reto have engineering controls in place
gives the details of NIOSH method S-
lying upon objective data for exempshortly (Ex. 92). One major company
156, together with the NIOSH and
tion under paragraph (a)(2)(ii) to
has predicted that the completion
OSHA variations on that method, for
maintain records of that data and of
schedule for engineering projects to
use in monitoring employee exposures
the basis for their reliance on that
reach 2 ppm may take 2 to 3 years (Ex.
to acrylonitrile. Other methods of
data. These records shall be main-
11:(27)). Other companies which have
sampling and analysis are available in
tained for the duration of the employdeveloped plans for engineering conthe record of the rulemaking, and may
er's reliance on that data for exemptrols to reach 2 ppm have indicated
be obtained from the OSHA Docket
tion.
that they will need leadtime, but have
Office.
Observation of monitoring: Paranot established any timetable for im-
The contents of the appendices have
graph (r). Section 8(c)(3) of the Act replementation (Tr. 1016-1017; 978).
been revised to reflect changes from
quires that employers provide employ-
An SPI witness estimated that projthe proposal. In addition, efforts have
ees and their representatives with the
ect definition for engineering solutions
been made to clarify those sections in
opportunity to observe monitoring of
to reach 2 ppm/10 ppm would take
the appendices as proposed which
employee exposures to toxic subabout 6 months, and that implementawere either inconsistent or unclear in
stances or harmful physical agents. In
tion of those solutions would take up
relation to the standard.
accordance with this section, the
to 24 additional months (Ex. 74).
AUTHORITY
standard contains provisions for such
OSHA has determined that a 2-year
observation of monitoring of acryloniperiod for installation of engineering
This document was prepared under
trile exposures. To assure that the
controls is reasonable for the AN inthe direction of Eula Bingham, Assistright to observe is meaningful, observdustry as a whole. Although some emant Secretary of Labor for Occupaers are entitled to receive an explanaployers will be able to complete impletional Safety and Health, U.S. Departtion of the measurement procedure, to
mentation of controls well within the
ment of Labor, Third Street and Conobserve all steps related to the mea-
2-year time frame, OSHA believes that
stitution Avenue NW., Washington,
surement procedure, and to record the
certain sectors of the industry, primar-
D.C. 20210.
results obtained.
ily resin and elastomer manufacturing,
Accordingly, pursuant to sections
The observer, whether an employee
may require the full 2 years to comply.
4(b)(2), 6(b), 6(c), and 8(c) of the Occuor a designated representative, must
While employers are not required to
pational Safety and Health Act of
be provided with, and is required to
complete installation of engineering
1970 (84 Stat. 1592, 1593, 1596, 1599; 29
use, any personal protective equipcontrols until November 2, 1980, they
U.S.C. 653, 655, 657), the specific statment required to be worn by employare required to develop a compliance
utes referred to in section 4(b)(2), Secees working in the area that is being
program which provides for compleretary of Labor's Order No. 8-76 (41
monitored, and must comply with all
tion of controls by that date, and to
FR 25059), and 29 CFR part 1911, part
other applicable safety and health
follow the schedule set out in the pro-
1910 of title 29, Code of Federal Reguprocedures.
gram. Failure to develop an adequate
lations, is hereby amended by deleting
Effective date: Paragraph (s). The efprogram, or failure to implement the
the emergency temporary standard for
fective date of the standard is Novemprogressive steps set out in the prooccupational exposure to acrylonitrile
ber 2, 1978, thirty days from publicagram to achieve compliance by Novemat § 1910.1045 and adding a new pertion. OSHA has determined that the
ber 2, 1980, will subject the employer
manent standard for occupational excircumstances of this rulemaking
to citation.
posure to acrylonitrile as $ 1910.1045,
make it unnecessary to allow a longer
Training programs are to be impleand by deleting the reference to acryperiod of time. Under the ETS, emmented within 60 days of the effective
lonitrile from table Z-1 of $ 1910.1000.
ployers were required to perform
date of the standard. OSHA believes
In addition, pursuant to section 4(b)(2)
many of the activities, such as initial
that this should provide sufficient
of the act, OSHA has determined that
monitoring, respiratory protection,
lead time, particularly in light of the
this new standard in $ 1910.1045 is
and engineering control plans, which
training requirements of the ETS.
more effective than the corresponding
are to be required under the final
standards now in subpart B of part
APPENDICES
standard. Since the scope of the final
1910, and in parts 1915, 1916, 1917,
standard is narrower than that of the
Four appendices have been included
1918, and 1926 of title 29, Code of Fed-
ETS, it is anticipated that all employin this permanent standard. These aperal Regulations. Therefore, these corers covered by the final standard were
pendices have been included primarily
responding standards are superseded
also subject to the ETS. There should
for purposes of information. None of
by this new § 1910.1045. This determibe, therefore, no need for delay in rethe statements contained therein
nation, and the application of the new
FEDERAL REGISTER, VOL. 43, NO. 192-TUESDAY, OCTOBER 3, 1978
RULES AND REGULATIONS
45809
standard to the maritime and con-
(i) ABS resins, SAN resins, nitrile
having jurisdiction over the geographstruction industries, are implemented
barrier resins, solid nitrile elastomers,
ic area where the affected workplace is
by revising paragraph (c) to § 1910.19.
and acrylic and modacrylic fibers,
located.
In conjunction with the publication
when these listed materials are in the
(c) Permissible exposure limits. (1)
of the emergency temporary standard
form of finished polymers, and prod-
Inhalation. (i) Time weighted average
(43 FR 2586; Jan. 17, 1978), pursuant
ucts fabricated from such finished
limit (TWA). The employer shall
to sections 4(b)(2), 6(c), and 8(c) of the
polymers;
assure that no employee is exposed to
Act (84 Stat. 1592; 1996; 1599; 29
(ii) Materials made from and/or conan airborne concentration of acryloni-
U.S.C. 653, 655, 657), title 29 of the
taining AN for which objective data is
trile in excess of two (2) parts acrylon-
Code of Federal Regulations was
reasonably relied upon to demonstrate
itrile per million parts of air (2 ppm)
amended by adding a new paragraph
that the material is not capable of reas an eight (8)-hour time-weighted
(c) to § 1910.19, and by deleting the
leasing AN in airborne concentrations
average.
reference to acrylonitrile from table
in excess of 1 ppm as an eight (8)-hour
(ii) Ceiling limit. The employer shall
Z-1 of $ 1910.1000. The authority for
time-weighted average, under the exassure that no employee is exposed to
these amendments pursuant to section
pected conditions of processing, use,
an airborne concentration of acryloni-
6(c) of the act has expired. These
and handling which will cause the
trile in excess of ten (10) ppm as averamendments are to be carried forward
greatest possible release; and
aged over any fifteen (15)-minute
in accordance with the promulgation
(iii) Solid materials made from and/
period during the working day.
of the new permanent standard, as
or containing AN which will not be
(2) Dermal and eye exposure. The
noted above, pursuant to sections
heated above 170° F during handling,
employer shall assure that no employ-
4(b)(2), 6(b), 6(c), and 8(c) of the act
use, or processing.
ee is exposed to skin contact or eye
(84 Stat. 1592, 1593, 1596, 1599; 29
(3) An employer relying upon excontact with liquid AN.
U.S.C. 653, 655, 657).
emption under paragraph (a)(2)(ii)
(d) Notification of regulated areas
Signed at Washington, D.C., this 22d
shall maintain records of the objective
and emergencies. (1) Regulated areas.
day of September 1978. These amenddata supporting that exemption, and
Within thirty (30) days following the
ments are effective on November 2,
of the basis of the employer's reliance
establishment of a regulated area pur-
1978
on the data, as provided in paragraph
suant to paragraph (f) of this section,
(q) of this section.
EULA BINGHAM,
(b) Definitions. "Acrylonitrile" or
the employer shall report the follow-
Assistant Secretary of Labor.
"AN" means acrylonitrile monomer,
ing information to the OSHA Area
Office:
Part 1910 of title 29 of the Code of
chemical formula CH,=CHCN.
Federal Regulations is hereby amend-
"Action level" means a concentra-
(i) The address and location of each
establishment which has one or more
ed as follows:
tion of AN of 1 ppm as an eight (8)-
hour time-weighted average.
regulated areas;
1. Paragraph (c) of 1910.19 is re-
"Assistant Secretary" means the As-
(ii) The locations, within the estabvised to read as follows:
sistant Secretary of Labor for Occupalishment, of each regulated area;