DEPARTMENT OF LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, HAZARDS IDENTIFICATION; NOTICE OF PROPOSED RULEMAKING AND PUBLIC HEARINGS

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• Document Creation Date: December 22, 2016
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• Publication Date: January 16, 1981
• Content Type: REPORT

STAT
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Friday
January 16, 1981
Part X1
Department .w . r
Occupational Safety and, Health
Administration
Hazards IndentiticaNon; No ico of
Proposed Ruiemaking and Public:
Hearings
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Federal Register / Vol. 46, No. 11 / Friday, January 16. 1981 / Proposed Rules
DEPARTMENT OF LABOR
Cccupatio; ai Safety and Health
Administration
29 CFR Part 1910
Hazards Identification; Notice of Public
Rulemaking and Public Hearings
AGENCY: Occupational Safety and
Health Administration, Labor.,
AC ION: Notice of proposed rulemaking; .
notice of public hearings.
SUMMARY: The proposed standard
requires employers to identify the
hazardous chemicals in their
workplaces. and to inform their
employees of the identity and nature of
the employees' hazardous exposures.
OSI4A has determined that this
standard is necessary because most
employees are not aware of the
presence of hazardous chemicals in their
workplaces. or of the health effects
exposure to these hazards may produce.
Furthermore, many employers are also
unaware of the complete chemical
identities and hazards of the chemicals
in their workplaces. The proposed
standard vrould alleviate these problems
through specific hazard identification
and evaluation procedures, labeling
requirements. and records preservation.
Public hearings are beiiag scheduled to
permit interested parties the opportunity
to orally present information and data
related to the issues raised by this
proposed rule.
DATES. Comments must be received on
or before April 18,1981.
Notices of intention to appear at the
public hearings must be received on or
before May 1, 1981.
The hearings are scheduled as
follows:
Date Hearing Will Begin and City
1. May 26,1981, Washington, D.C.
2. July 7, 1981, Houston, Texas
3. July 21,1931, Chicago, Illinois
4. August 11, 1981, Philadelphia,
Pennsylvania
5. September 1, 1981, San Francisco,
CaliforrLia.
ADDnE ,S:'Cororncnts should be
submitted. in quardruplicate, to the
Docket Officer, Docket 11-022. U.S.
Department of Labor, Occupational
Safety and Health Admini: traion. 200
Constitution Avenue, N.W. .Room 5-
6212, WasHrgton, D.C. 20210; (202) 523-
7894.
Notices of intention to appear should
be submitted to Mr. Tom Hall. Division
of Consumer Affairs, Room N3635, U.S.
Department of Labor, Occupational
Safety and I Icalth Administration, 200
Constitution Avenue, N.W., Washington,
D.C. 20210. [phone].
Addresses for the hearing locations
will be published in the Federal Register
at a later date.
Written comments received and
notices of intention to appear will be
available for inspection and copying in
the Docket Office, Room 58212 at the
above address.
FOR FURTHER INFORMATION CONTACT:
Proposal
Mr. fames Foster. Room N3641, Office
of Public Affairs, Occupational Safety
and Health Administration, U.S.
Department of Labor. 200 Constitution
Avenue, N.W., Washington, D.C., 20210;
[phone].
Hearings
Mr. Tom Hall, Division of Consumer
Affairs, Room N-3635, U.S. Department
of Labor, Occupational Safety and
Health Administration, 200 Constitution
Avenue, N.W., Washington, D.C. 20210.
[phone].
SUPPLEMENTARY INFORMATION: The
following is a table of contents for this
section of the preamble:
1. Need fora Hazards Identification Standard
II. Background to the Hazards Identification
Standard
A. Introduction
B. Survey-Estimates of Potential
Workplace Hazardous Exposures
C. Previous Recognition of the Need for
Labeling
1. Occupational Safety and Health
Administration Standards.
2. National Institute for Occupational
Safety and Health (NIOSH) Criteria
Document.
3. Report of the OSHA Standards
Advisory Committee.
4. American National Standards
Institute (ANSI) Standard.
D. Selected Labeling Regulations Which
are Currently in Effect
1. Occupational Safety and Health
Administration (OSHA).
2. Fair Packaging and Labeling Act.
3. Environmental Protection Agency
(EPA).
4. Food and Drug Administration
(FDA).
5. Department of Transportation
(DOT).
6. Consumer Product Safety
Coinmiseion (CPSC).
State Reg elations.
8. European Economic Community
(EEC).
E. History of OSHA's Proposed Labeling
Standard
III. Summary, of the Proposed Standard
IV. Major Issues for the Rulemaking
A. Issues of Scope and Type of Standard
1. The generic approach to a hazard
identification standard.
2. Employers covered by the
standard.
3. Duty to disclose specific chemical
identity and impact on trade
secrets.
B. Scientific Issues
1. Hazards covered by the standard
(general issues).
a. Universal vs. hazard labeling.
b. General or workplace-specific
hazard determinations.
c. Impurities, Intermediates, By-
products.
2. Hazards covered by the standard
(definitional issues).
a. General.
b. Physical Hazards.
c. Health Hazards.
d. Specific definitional issues.
e. Regulation of physical hazards by
other agencies.
f. Regulation of health hazards by
other agencies.
3. Hazard Determination Process.
a. Description.
b. Performance vs. specification
standard for the hazard
determination process and
evaluation scheme.
c. Literature search.
d. Use of TDB, standard reference
works and NIOSI I documents.
e. Search files.
f. Concentration of constituent
substances and mixtures hazard
determination.
4. Evaluation procedure.
a. In general.
b. Adequate and well-controlled
study.
c. Case studies use.
d. Statistical significance.
e. Expert opinions.
C. Regulatory Issues
1. "Performance" vs. "specification"
requirements.
2. Content-and format of labels and
placards.
3. Disclosure of chemical identity in
labels shipped in commerce.
4. Exclusion of small containers.
5. Access to records and documents
required by the standard.
6. Worker access to safety data
sheets.
7. Material safety data sheets.
8. Substance-employee identification
lists.
9. The need for generic training
requirements.
10. Impact on small business.
11. Miscellaneous issues.
D. References
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V. Legal Authority
The thing we are asking for is a .
labeling, a chemical labeling of what
really is contained in that lubricant or
that coolant. And I tl~ink we can take it
from*there. We are not asking for a hell
of a lot. But if the men don't know what
they are being exposed to on a daily
basis, there is nothing they can do-about
it until years later. And then it is too
darn late.
(Mr. Victor Horvath, International Assn
of Machinists. Tr. 1378, OSHA Docket
Hi12)
t * ? f 1
caused diseases, illnesses, and deaths and is
a major impediment to preventing there.
Dr. Thom, s Mancuso, an occupational
medicine practitioner for thirty years,
addressed the problem of inadequate
chemical substance identification at
Congressional hearings held in 1976 on
control of toxic substances in the
workplace (25). Dr. Mancuso stated:
? ? the doctor In practice, if he is to
make a medical diagnosis, needs information
about the work environment and the specific
work exposures, the specific chemicals to
which his worker patient was exposed prior
VI. Regulatory Analysis, Environmental
Impact, and Regulatory Flexibility
Requirements
VII. Public Participation
Vlll. Authority and Signature
1. Need for a Hazards Identification
Standard
Approximately 25 million American
workers are currently exposed on the
job to chemical or physical hazards. As
many as 40 to 50 million Americans (23
percent of the entire U.S. population)
may have been exposed to one or more
of the hazardous chemicals presently.
regulated by OSHA at some point during
their lifetime (1).? Yet, as indicated in
the NIOSII National Occupational
Hazards Survey (C1011-IS) discussed
below, workers are generally unaware
of the presence of hazardous chemicals
in the workplace and of the very real
potential that exposure to such
chemicals may injure their health.
Furthermore, some workers complain
that even where they receive
information about hazardous chemicals,
it is often inaccurate or incomplete.
Thus, workers and their
representatives have consistently
emphasized in previous O&4-1A
rulemakings the need f:: r Q2%3A,tai
promulgate a stand::rd ur chemical.
substance identification. 'rhe fuliewirtr
testimony presented during the OSHA
rulemalcing herrings on "Access to
Employee Exposure and Medical
Records," OSHA Docket H-112. is
evidence of workers' concerns about a
labeling regulation (2S).
(A)pproximately 150 new chemicals
come into that plant every day, many of
them with just trade names, many with
just a code number. As I have been
investigating, every company uses a
different code number * * '
Many times our people are exposed
for a month, six weel. s or two months
before we find out (the chemical
identity) * * ? than, after we have it
evaluated. (the company) will remove it;
but the damage is a! Cady done.
(her. John Mroczkowski, United
Steelworkers, Tr. 1183--1100, OSHA
Docket 11-112.)
(\')mv our employees ;,re rather %vell-
scl:ooled craftsmen. They can recognize
hazards~if they k:ow what the hazard is.
Our-ba;ic: Froblenm is on a daily
exposure we have to work with
coolants, lubricants, and the vapors that
result from the use therein
tiurnencai references are to the Refercaces listed
M this preamble, infra.
W)e must reiterate the importance of to the illness. Basically, this lack of
ate,., * * * ..aft .............. r.a...r information constitutes the fundamental
of very efficient labeling data we are
absolutely in the dark about many
chemicals that are used in our shop.
(h?Mr. Michael Gaffney. United
Autoworkers, Tr. 1325. OSHA Docket
H-112)
Without adequate chemical substance
identification, millions of workers with
routine exposures to hazardous
chemical substances are unaware of the
hazards posed by these substances; and
are thus incapable of protecting
themselves or ensuring that their
employers provide adequate protection.
The need for self-protection is no trivial
rnrittcr. Workers are exposed to
haz,wdous c,;f:niicals both iin the
tvorhplace aril the general environment,
making thr.*rt tare greatc st involuntary
consumers of hazardous chemicals in
the nation. Ali(]. in many cases, exposure
in the workplace is far greater than what
occurs in the general environment.
Consequently, to leave workers ignorant
of the hazards they face, without the
ability to protect themselves, would be
incompatible with OSHA's duty w:c'er
the Occupational Safety and Health Act
of 197Q, 29 U.S.C. C51 at seq., to assure
every working man and woman in the
nation, so far es possible, safe and
healthful working conditions.
This lack of an adequate system for
the identification and labeling of
haaaw1ous sub. tances in the work-place
has been, and continues to be. a
ccntributirg factor in the occurrence of
occ r.;tion;iI r`. C 3e. As the C:i.'Ti~,.e"
. at:e
on Government Operations. U.S. Clouse
of Representatives concluded in its
report, Chemical Da;,~-ers in the
11 o.-%ploce (Th:ir?ty-forth Report. 19-6)
(2!:):
Identifyih g and controlling toxic
substances in the workplace is becoming
progressively mitre difficult as more
chemicals, chemical processes, and chemical
products are used in industry. Tens of
thousands of trade-name products. whose
chemical contents are not disclosed, are used
daily. Lack of knowledge about expoaure
hampers the identification of occupationally
obstacle to the recognition of causality of an
occupational illness and appropriate steps
and approaches must be evolved to overcome
this fundamental problem.
Dr. Mancuso also indicated that thc:e
is a nation-wide lack of recognition of
occupationally-related illness, disease,
and death by the worker and his family,
by the doctor, by the industry and by the
government. lie further stated:
This sterns in general from the fact that for
decades the workers, the doctors and society
have been predominantly crient ......... -. ........_N
Organic peroYide._..>..>_...- 173.151 (QS -..._.~. N NC ...........................>_ ,. (2)S.__.._............ NC
Pressure-genera6ng....... .-- NC......... ,_....._._.._.. 1500.3(c) (7)O) (bb ...-._?._........ _
. GO.
Wateroactive_.._..----?--- NPS (see NC...... ................... >. _....... ....... ......... NC ................... (d) M.
ram..T?hle solid).
--_
Compressed gas...................... 173.30e(a) similar.... 1500.3(c) (7)(i) (O)M 162.10 (ili)M....... (2)S............
NoTs.-Reference is OSHA Standard; S = Same coverage; M = OSHA more incluui',a; L - CSF4', less inc:~ t..e
NRS - Not regulated so2erately; NC - No Category.
f. Regulation of Health Hazards By
Other Agencies. Table 10 provides a
comparison of the efforts of Federal
agencies, ANSI and EEC to define health
effects for the purposes of labeling
regulations. All the o gal izat ns ii:sti'd
define and regulate all or most of the
first four health hazards listed (highly
toxic, irritant, sensitizer). Manufacturers
and importers thus should be able to
utilize their organizational ev~perience in
complying with the OSI IA s';jncl..iid,
though they must still perform the
required OSHA hazard determination
process. 0s" IA t .-,t ! in comments which would lead to a
harmonization of definitions among the
various agencies i,lvol ved. OSHA
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faces. OSHA further believes, on the
basis of its accumulated expertise in the
development of health standards, that
the current consensus among -
occupational physicians, industrial
hygienists, toxicologists and other
health personnel is that workers face
hazards in all the health effects
categories defined. Moreover, the
agency does not believe that the
technical problems involved with
defining or identifying carcinogens or
reproductive toxins are inherently more
difficult than those involved with . _
sensitizers and irritants, two health
effects which have been extensively
regulated. The Agency would benefit
from an exchange of ideas in this area
between government, academic, labor
and industry witnesses in the course of
extensive rulemaking proceedings.
manufacturer or importer need only
evaluate material contained either in the
National Library of Medicine's
Toxicology Data Bank (TDB) or in a
representative selection of standard
reference works or relevant NIOSH
documents (See App. A paragraph
(b)(1)). In addition, the manufacturer or
importer may use any other relevant
data (paragraph (b)(1)(ii)). The
manufacturer or importer is not required
to undertake a literature search
(paragraph (c)). The evaluation is to be
based upon sound scientific judgment
(paragraph (b)(3)) and the formal
evaluation scheme described in
Appendix B is not required.
OSHA believes that an abbreviated
hazard determination process for
Category A hazards is adequate to
determine whether the substance
possesses the physical properties
s
ifi
e
d i
th
p
c
e
n
e Category A definitions.
Table 1O.--C0rer +ieon of Scope of Coverage of Health Hazards by U.S. Regulato7Agenciee European The data sources required are sufficient
Economic Communrhj and American National Standards lnsttute because the physical properties are
based unnn ratanrinrAio-A -h-;-A ,..,
expects to participate in international
efforts aimed at harmonization in this
area.
Regulatory experience with the
remaining health.effects that OSHA
proposes to cover in this labeling
standard is substantially more limited
(see table 10). However, OSHA does not
believe that lack of substantial
regulatory experience by other
organizations concerning carcinogens,
reproductive toxins, and the categories
Involving endangerment to human life
and other adverse health effects should
preclude OSHA s regulatory effort
concerning these health effects. OSHA
believes that the validity of the scope of
hazards coverd in this standard should
be judged solely on whether the scope of
hazards regulated corresponds to the
scope. of hazards which -the worker
6
definitiona(Category a) 29 - -- -.' - -1 " ,.. 1-1 - ^1O1 eec rore3l r
CFR CFR Z128.1-1976 EEC Article 2
Highly bxiq-..>..-_...>...... Poisons "B" 1500.3(b). (6). (c) (1) 162.10 (h) (1) (2)M...... _...........
173.343S mear. Simi!sr (But see (Category lS.
"
Endangered
Life," "Other
Adverse Health
Effects" below).
............_....... NC....... >................... 1500.3(1) (5), (c) (2) 162.10(h) (1)
Similar. (Ca.eyary II).
173.381 Different>... 500.3(b)(8), (c) (4)S. 162.10(h) (1)
5onsrtizer> _ _?.._> _ NC_ _ >._>>..>>__ 1500.3(1) (a), (c)
(5)M.
(Catogorie3
fl-M Similar.
(f) Similar,
qualitatve
definition.
(2)M.>._.>.......:.. (g), (h)
qualitative
definition.
(2)%L.._ ............... a) Similar.
NC.........>...... ,->..... NO._..... ..................... 162.11(8) (3) (ii) NO........ _........... .. (1) Similar.
(A) Similar imprecise
Rebuttable definition.
Presumption
agr.inst
Reproductive toxin..._ _.:_.. NC.. _... ........ registration.
>....>.>.... NC .............................. Same reference NO....... ...... _...... (m). (n)
as carcinogen. Undefined.
Endangered worker fifeY..._. 173.326 Poison "A" 1500.3 (e) (1) n ....... 162.1(2) (3) (1 NC ...................... NRS (see highly
Sirmlar. M Rebuttable
toxic and
presumption toxic).
against
Other adverse health effects... NRS(see highly NC .............................. 162.1(a) (3) (l) NC..... _.............. NRS (see toxic).
tox)? - (B) M
Rebuttable
presumption
against
registration.
NOTI -Reference is OSHA Standard S--Same coverage; M=OSHA more inclusive; L=-OSHA less inclusive; NRS'Not
regulated separetey; NC= No oetegory.
3. Hazard determination process. a.
Description. The hazard determination
process is described in Appendix A of
the proposed standard. (References in
this section of the preamble are.to
Appendix A). A manufacturer or
importer must utilize this process in
determining whether a substance is
hazardous. However, the extent to
which the process is. applicable varies
depending upon whether a substance is
being evaluated as- a Category A
(physical) hazard or Category B (acute
or chronic health) hazard.
To determine whether a substance
poses a Category A hazard, the
chemical tests which ordinarily
demonstrate rather small variations in
results, if performed as specified.
Analogously, there is no need for an
extensive evaluation scheme since there
is widespread professional agreement
on the interpretation of such test results.
In contrast; the hazard determination
process for Category B ha2.ai ds for
substances is more extensive, both in
the scientific sources which are required
to be consulted and the evaluation
scheme to be applied. In addition to the
sources required to be consulted for
Category A hazard determinations, the
manufacturer or importer is required to
undertake a literature search using
specified computerized data files, to
obtain copies of the scientific studies so
identified, and to evaluate such material
using the scheme set out in Appendix B
of the proposed standard (paragraph
(c)). IN addition, a manufacturer's or
importer's in-house health effects
studies must be evaluated by the
Appendix B scheme (paragraph
(c)(1)(ii)). A manufacturer or importer
need not evaluate search material or in-
house health effects data for a particular
health hazard, if he or she has elected to
label the substance for the hazard based
upon the TDB, standard reference works
or NIOSH documents (paragraph (c)(1)).
Category B substance hazard
determinations are necessarily more
extensive than those required for
Category A hazards because health
effects studies involving animals or
humans yield substantially more
variable results than do purely physical
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or chemical determinations and the
interpretation of such results calls for
more professional judgment. The
Category B hazard determination
process will ensure that the results of
substantially all relevant scientific .
studies involving a substance are
considered. Moreover, the Appendix B .
evaluation scheme should ensure .
uniform judgment outcomes based upon
what the Agency believes is a sound
scientific approach.
The present hazard determination
process would not normally apply
directly to mixtures. Mixtures are
deemed to represent the same hazards
posed by their constituent substances,
with some qualifictitions (paragraph (i)
of the standard). A similar assua ption
has been used by the European
Economic Community in its directives
(regulations) governing the labeling of
preparations (mixtures) (73/ 173/EEC,
77/728/EEC, 78/631/EEC). If a
manufacturer or importer is dissatisfied
with the results of a hazard
determination based upon its
constituent substances, he is free to test
the mixture. Of course, if a mixture has
been evaluated for a particular hazard,
then the manitfacturer or importer must
use his or her sound scientific judgment
to determine whether a Category A
hazard is present (paragraph (b)(3)) or
the Appendix B evaluation scheme to
determine whether a Category B hazard
is present (see, in particular, paragraph'
(c)(5) in Appendix B). The proposed
standard would not, however, require
that a manufacturer or importer perform
a literature search for mixture hazard
determinations because OSHA believes
that the yield from such searches would
not justify the required expenditures of
time and money. This belief is based
upon a professional judgment that the
scientific literature reflects a strong
preference of epidemiologists and
toxicologists for analyzing the properties
of substances, rather than mixtures,
Thus, in view of the complexity -
inherent in Category B hazard
determinations, the proposed standard
provides assistance in the forri of
explicit directions to the manufacturers
or importers. 'ihe standard describes the
hazard determination process
(Appendix A), details the materials
(including the output of a required
literature search) that must be used for
the determination (Appendix A) and
provides an evaluative scheme for such
materials (AppendixB). The Agency
believes that the explicit directions for
compliance just described will reduce
the ambiguities inherent in a less
detailed standard, will facilitate
compliance and result in many fewer
enforcement actions. Moreover,
specification of the Category B hazard
determinations process is required to
obtain uniformity of labeling;
b. Performance vs. specification
standard for the hazard determination
process and evaluation scheme. Some
industry sources have objected to the
approach taken in the proposal. They
advocate a "performance" standard
under which manufacturers or importers
of a chemical would be freeto
determine the existence of a defined
hazard by whatever procedures they
consider appropriate.
These industry sources claim that
there are alternatives to the hazard
determination (Appendix A) and
-evaluative procedures (Appendix B)
OSHA has chosen which are just as
reliable. They also claim that these are
presently in use, and that it therefore
makes no sense to require firms to shift
to the procedure OSIIA prefers.
However, those making these claims
have not, to date, actually described the
procedures which fright function
adequately as-alternatives to the
procedures of the proposed standard.
Nor have these sources informed OSHA
of the hazard determination and data
evaluation procedures presently
employed by any particular firm.
Consequently, OSHA presently has no
information which would substantiate
the claim that a performance standard is
appropriate.
OSF1-A believes that it is appropriate
and necessary to establish the quantity
and quality of scientific evidence.
required in the hazards determination
process. A performance standard would
simply not guarantee that any firm
would utilize an appropriate alternative
to the hazard determination and
evaluation procedures of the proposed
standard. Under a performance
standard, every firm would be free to
utilize any procedure, or no procedure at
all, to determine hazards.
Moreover, the enforcement
mechanisms at OSHA's command are
simply inadequate to protect against the
very real possibility that under a
performance standard a substantial
number of firms might utilize procedures
which are scientifically deficient or
inconsistent to identify the hazards of
workplace chemicals. There are
thousands of chemicals which are
manufactured in, or imported into, this
country. Yet, OSHA has at its disposal
only approximately 1500 inspectors,
whose duties encompass enforcement of
all requirements imposed by OSHA in
the workplace. Obviously, in terms of
total numbers and the considerable
responsibilities already incumbent upon
these inspectors, this inspection force
would be utterly inadequate to ensure
that each manufacturer and importer
subject to the standard employed a
reliable procedure to determine hazards.
OSHA is willing to consider
reasonable alternatives to its proposed
evaluation procedures. OSHA is also
willing to offer the choice of a number of
scientifically sound procedures, if they
exist. Accordingly, OSHA solicits
comments on these issues. Following
comment, should OSHA choose to move
to a performance standard, the agency
may adopt Appendices A and B as
recommended rather than mandatory
procedures.
c. Literature Search. 1.OSITA has
made a concerted effort in the course of
revising earlier drafts to ensure that the
search requirement is technically
feasible. As a consequence of extensive
discussion, and based upon sound
science policy grounds, the Agency has
decided not to include a search
requirement for mixtures (paragraph
(a)(2) of Appendix A), to permit
manufacturers and/or importers to
undertake hazard determinations jointly
to the extent permitted by law
(paragraph (a)(3) of Appendix A), and to
extend compliance times for small
manufacturers and importers (paragraph
(ii)(1)(ii) of the standard). The delay in
compliance dates for small
manufacturers and importers will permit
them to rely on hazard determinations
of larger manufacturers or trade groups
(paragraph (ii)(1)(ii).of the standard) by
obtaining copies of their labels from a
national label repository (subsection (w)
of the standard).
The mandated literature search for
Category B hazard determinations
(paragraph (b)(2)(ii)(C) of Appendix A)
appears well within the current search
capability of existing computerized
information services.
The following analysis, based upon
material submitted in compliance with
the Toxic Substances Control Act
Inventory requirements (40 CFR Part
710), indicates that the present standard
will impose a one (1) tiitie increase in
search requests of some 250,000.
Table 11.--TSOSCAI Substances (33)
Maxi-
mum
of
per-
Number
aver.
Number of
ceg1 of
of
sub-
are
num-
Estimated
como?nas
sta'ces
bor of
number
repcrcrq a
b
CAI
b
reported
com-
of
su
stance
iven-
ttxy
tapproxi-
L~ ,s
c
searches
mate)
,r .
n
trc a
s .b-
stance
-4............ .............?. 90 49.500 2.5 123,750
5--9 ............................. 6,3 3.405 7 24,255
-10 (x-30) ............. 37 2.035 3U 61,050
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The estimate has been adjusted
upward from that in the table to provide
for search requests involving the other
substances not on TOSCAI which must
be evaluated (paragraph (d) of the
standard). Taken to? cthl!r, such other
substances contribute a comparatively
small number to the total. The Agency
wishes to stress that this is a "worst
case" estimate in that the estimate has
not been reduced to reflect the probable
.impact of joint evaluations or reliance.
on the national label repository in lieu of
a search (paragraph (w) of the standard
and paragraph (a)(3) of Appendix A).
On the supply side, OSHA
understands that the recent expansion
of the computer facilities for
NIEDI.ARStRr? only one of the' available
computerized information services, has
substantially increased search capacity.
The August, 1980, search load of some
60,000 search,-_e appears to represent
less than half of the system's monthly
capacity (Phone communication. NLivl,
1980). -
Thus, the Agency concludes that the
literature search requirement is
technically feasible. OSHA invites
comments on the related issues of
whether searches may be delayed in
various regions because o a dearth of
trained information system users and
whether some manufacturers or
importers lack access through inter-
library loan programs to duplicates of
the scientific material identified in the
search.
While OSHA believes that the
expansion of existing commercial
information services will prevent any
serious compliance problems in this
area, the Agency ency intends to explore
additional mechanisms for complying
with the search requirement. Among the
additional mechanisms under
consideration are permitting reliance on
duplicate copies of current searches
(thus avoiding the actual search) with
payment as appropriate and exploring
creation cf a central duplicating service
for search materials. The Agency may,
in addition, extend c: misiian e .tatc:s if
rulemaking comments so indicate.
d. Use of TDB, st, ndard refererce
works and NL05II &YcL,,n_-,nts. OSHA
beiievas tirat'1 f:B (z;a ` c (1) and
(c)(1) of Append;. A!
document
arid c),1) of
sta:Jard reference Aunts (~ +,r ,,;:.r lrs
(b)(1)(i)(A) and (c)(1) of Appendix A) are
essential elements of the hazard
determination process. All these
materials have been subject to scientific
peer review and thus represent
unusually reliable sources of scientific
inforrr_ation. OSHA invites comments on
tvhethc r al'. _reati a data sources should
be can;' derail.
The A jency does not. however,
believe it would be productive in the
rulemaking to urge consideration of a
particular text not on the list of standard
reference books, "Source Used to
Prepared Toxicology Data Bank.
Records" (paragrahs (b)[1} and (c)(1) of
Appendix A). Additional texts can
already be used in determining whether
a,Category A hazard is present under
paragraph (b)(1)(ti) of Appendix A. In
the case of Category B hazard
determinations, unrestricted expansion
of the standard reference book list
beyond that determined by the TDB
expert scientist group would certainly
cloud the compliance responsibility of
the manufacturer or importer without
necessarily improving the hazard -
determination process. OSHA believes
that a current standard reference book
list, developed by an expert committee,
represents the most reliable list for the
limited purposes for which it is
intended, i.e., positive hazard
determinations in the case of Category B
hazards are ultimately dependent on
evaluation of scientific studies and not
on reference bock content, unless the
manufacturer or importer chooses to
rely on the-standard reference book (see
paragraph (b)(2)(iii)). The standard
provides for modification of the list.
e. Search files.The Agency also
invites comments on the particular data
files required for the literature search
(paragraph (c)(1)(ii) of Appendix A) and
whether equivalent alternative data files
are available. CANCERLIT is required
because it is a unique source of
information on the National Cancer
Institute's carcinogen bioassay program.
OSHA specifically invites comment on
the extent of duplication resulting from
the use of the three remaining data files:
MEDLINEE4R1, TOXLI NE? ? and RTECS.
The Agency requires : U three d-:tu
files be usad because it is current
scientific practices to include all three in
routine searches. Comments are also
invited on the need for any additional.
data filas.The Agency is aware of only
the Excerpts Medica information file as
a possible alternative but invites
comment on this issue.
f. Concentration of Constituent
Substances and Mixtures Hazard
Determination. The proposed standard
sets threshold limits for concentrations
of hazardous substances in mixtures,
abc-. which, exc=?pt in certain c?: fined
circumstances. such ;costa nc:- ,. rims the
mixt:..es V wi-: ai' uc.
regul}`.ed by tl.e standard For ::or-
cariac tens, the threshold vr~'u- is
least 1.0 (by weight) of a mixture. For
carcinogens, the threshold value is at
least 0.1% (by weight) of a mixture (see
paragraph (i)(2) of the standard),
OSHA believes that the uniform
thresholds it has chosen are appropriate,
and that the use of a uniform threshold
is integral to the generic approach to
regulation which the hazard
identification standard embodies.
Elimination of any threshold would
greatly burden the hazard determination
process and likely render it infeasible.
On the other hand, adoption of a system
which required the establishment of an
individual threshold value for each
substance, case by case, would in
OSHA's view render the standard
impossible to administer and enforce.
There may, however, be acceptable
formulas, taking account of the variables
of potency and concentration, which can
be applied reliably to determine whether
constituent substances and the mixtures
in which they appear should be
regulated as hazards (see EEC directives
for labeling mixtures 73/173/EEC, 77/ _
728/EEC and 78/631 JE.EC). OSHA
invites comments on this possibility.and
other issues germane to the threshold
percentage exclusion question.
4. Evaluation Procedure. a. lit
General The proposal mandates that a
substance or mixture be classified as a
Category B hazard, if the proprietary in-
hoase studies or the studies identified in
the literature search satisfy the
following criteria:
1. The study is either "adequate and
well-controlled" (paragraphs (a)(1) and
(b)(1),(2) of Appendix Ill or represents
an acceptable "case report" (paragraphs
(a)(2) and (b)(3) of Appendix B); and
2. The study establishes a
"statistically signifirant" (paragraph
(a)(G) of Apperuax a) reL: t:onsf,`t)
between exposure to the substance and
the subsequent occurrence of a covered
hazard or "strongly suggests" such a
relationship [paragraph (b)(3) of
Appendix B); and
3. The relevant study conclusion is
accepted by any subgroup of qualified
experts [pare ;-:,.};~ (,,)).
OSHA believes that this hazard
determination process and its
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evaluation procedure represents the against the certainty that workers would
sequence and content of any inquiry experience prolonged exposures to
that a reasonable and prudent modern hazardous chemicals if confirmation
scientist would undertake to determine were required. NIOSH indicated the
whether a chemical is a Category B following periods required to complete a
hazard_The evaluation procedure does second study, assuming it is begun after
not consider anecdotal material because the first study becomes available:
the Agency does not believe that such
"data" warrant a positive hazard
determination under this standard. Nor
does the evaluation procedure consider
expert opinion evidence based upon
structure-function or stereo isomer
relationships. Although the Agency
believes that such opinion evidence may
be too problematic to warrant labeling,
it invites comments on this point.
b. Adequate and Well-controlled
Study. The definition of an "adequate
and well-controlled" study is based
upon the Epidemiology Work Group's
"Draft I.R.1-G. Guideline for
Documentation of Epidemiclogie
Studies" (34). The definition has been
modified to meet the proposed
standard's need to define a minimal set
of criteria for evaluating studies that
have already been performed.
Consequently, while OSHA recognizes
that some of the elements that have
been dropped from the present
definition would have enhanced the
utility of some of the scientific studies
that will be evaluated under this
standard, their omission should not
preclude consideration of such studies.
'I he Agency invites comments on
whether additional study elements
should be required..
In addition, an alternative route of
identifying an "adequate and well-
controlled study" was provided to
ensure that past studies which have
achieved general professional
acceptance would be considered in the
evaluation. The Agency believes that
publication of a study in a "peer review"
journal (paragraphs (a)(1)(vii) and (a)(4)
Table12r -Comp!etion Times for Various
Types of Ep/demiologic Studies
Average
Sine to
comple-
tion
Table 13.- Historical Utility of Case
Reports-Selected Examples--Con; Hued
case repurrs ur uccuupaa[wrwr exposures wnten nave been
supported by epidemiological studies
Ctxomaim
.c'-
Arsenic
eenzene
IV. Hazardous Substances first ident3. d from case rrF
of ocaipaticnsi exposure which have not besn ad iranV.,:
by ep:demlologicsl studies
DMAPN (dimethylaminoproplonitrile)
Sodium Hydroxide
V. Substances first identified as hazardous by case repo';
which were later discredited by ep,d,!miotogicat and r
animal studies
Aniline
1. Retrospective cohort mortality studies....._
1319
Fibrous Glass
Hair Spray
2_ Health hazard
.83
3 Case-control s0xies
a
Table 14.--An Assessment of the Appropri.
' Ten in period 1978 60.
ateness of the Use of Case Reports for the
Source: Personal communication from Mr. Richard Lenten,. Determination of a Hazard
NIOSH, 1980.
Of course, this table seriously
underestimates the actual duration of
continued exposure. The capacity of the
scientific community to undertake major
epidemiologic studies is limited.
Therefore, considerable time may elapse
before a confirming study may even be
begun. In view of the extraordinary
shortage of trained epidemiologists and
toxicologists,.delays In undertaking
studies will likely be substantial.
c. Case Studies Use. The proposed
standard requires reliance on well-
documented case studies (paragraphs
(a) (2) and (b) (3) of Appendix B). OSHA
believes that such studies should serve
as a basis for-a positive hazard
determination, e.g., vinyl chloride
monomer exposure and resultant
hemangiosarcoma. In response to a
request from OSHA, NIOSH
investigated two relevant issues: 1) the
historical utility of case reports and 2)
the current utility of case reports that
would be generated from the required
literature search. OSHA invites
comments on the issue of reliance on
tsrlenlific credibility as to warrant the case reports for Category B hazard
standard's requirement that it-be determinations. The following are
r:r,nnideied in the evaulation process, summary tables:
'iur;h studies must still demonstrate
":.tatistical significance"'and be Tebie 13.- Histor:C3l Utility of Case
,tr:i:epted by a subgroup of experts to Reports-Selected Examples
v,;truant a positive hazard
rlr,Ii r ninaLion,
I lie Agency requests comments on its
410-irrrnlinaticn that a single adequate
"'ill well-controlled study shall trigger a
),unitive hazard determination. In
coming to this conclusion, OSHA
wr?i}thed the possibility that there would
lot, same false positive hazard
Ill-tr'rntination under this approach, i.e.,
Jrrrtritlve studies later invalidated,
It. Scbstances first identified by case reports in occupational
settings which are now widely accepted as hazardous to
health
Hyrogen S,Ifide
Melhyi Alcohol
Carbon Disulfide
Nittogeri Oxides
Asbestos
Benzene
It. Hazardous substances catod to attention following use
reports of occupational exposure but for which preliminary
anima( data existed
? vary! Chloride
eis (chloromethyl) ether
DBCP (ditxomoch!oropropane)
Number of case reports
published
Case reports reviewed (5%
sample) ........................................ 10 (100%) 14 (100%)
Causal relationship sufficiently
established .................................. 8(00%) 11 (79%)
Report ed situation amenable to
labeling ......................................... 7 (70%) 10(71%)
Reported situation possibly cov-
trod by the standard pro-
posed by OSHA ......................... 8 (80%) 7 (50%)
First indication of the hazard........ 3 (3016) 4(29%)
Based Only on the Case Reports Which Were the First
Indication of the Hazard
Causal relationship sufficiently
established .................................. 3 (100%) 3(75%)
Reported situation amenable to
labeling ......................................... 2 (c6`.) 3 (75%)
Reported stluation possibly cov- -
erod by the standard pro-
posed by, OSHA .......... ...:........... 2(66%) 3 (75%)
May poalbty indicato labeling
is appropnate .............................. 2(66%) 1 (25%)
Source: Personal communication from Mr. Richard Lemen,
NIOSH, 1550.
The Agency believes that these data
clearly support the necessity for
including case reports as one basis for a
positive hazard determination,
especially in view of the probable
difficulty in mounting epidemiologic
studies to confirm the case reports. The
Agency invites comments on the
advisability of its decision-to require
utilization of case reports.
d. Statistical Significance. The
significance level has been set at 0.10
rather than the customary 0.05 level
(paragraph (a)(6) of Appendix B). While
th increnused Type I error results, by
definition, in an increase in false
positive hazard determinations, there
will be a corresonding decrease in false
negative determinations. While the
Agency believes that this is an
appropriate strategy for a preventive
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health standard. it recognizes that the
significance level chosen is non-
traditional and invites testimony
addressed to this issue.
Testimony is also invited on the
related question of whether the criteria
which govern the use of inccr_aistent
data are adai30ble (paragraph (c) of
Appendix B). For example, the power
(0.83) of data to detect a hazard of a
specified magnitude (25% increase in
risk) is consistent with that of the
Cancer Policy (29 CFR 1990.144 (a),
1980). However the magnitude of the
risk that must be detectable by the
negative study has been decreased from
50% to 2S%. The Agency believes that,
given data or studies that indicate a
potential hazard. the worker should be
informed of the potential hazard unless
extremely reliable negative data are
available.
e. Expert Opinions. The final element
of the data eva. cation scheme requires
that a substance or. mixture be classified
as a hazard if a subgroup of experts
accepts the conclusion of statistical
significance for results in an adequate
and well-contrulled study (paragraph
(b)(1) of Appendix B) or accept the
cause-effect relationship demonstrated
in case report(r !. This acceptance may
be manifested in a variety of ways and a
rebuttable assurr?p ion of such
acceptance is esta''iished when at least
one qualified independent expert has
endorsed the results (paragraph (d) of
Appendix B).
The Agency understands that this
position regarding the role of experts is -
different from t '"at which prevails in the
course of adju iication. However, as a
matter of policy. OSHA believes that
labeling a substance or mixture as a
hazard should of require support from
the majority of experts. Such or, ad hoc
choice of consultants does not guarantee
that the entire spectrum of professional
opinion is adequately represented.
Fat ter, the Agency believes that a
substance or mixture should be
classified as a hazard if evidence of the
specified quality is available, two or
more experts (in"uding the author)
cer.c :r in the cc,--tr usion that a-', a?zard is
present, and strong evidence to the
contrary is not available at the time of
hazard determination (paragraph (d) of
Appendix B). The Agency invites
comments on this approach.
C. Regulatory Issues
1. 'Performance" vs. 's: per-fiend, i"
reguir erren:s.. As previously state(; in
the discussion of hazard evaluation
procedures, OS1tA believes that
employers should be required to follow
specified procedures where established
scientific principles are applicable.
OSHA is not opposed, however, in
appropriate technical areas, to setting
goals ("perfor lance" standards) and
allowing employers to reach those goals
by whatever means they consider
practicable. For instance, the proposal
sets performance stanc:rds for labeling
piping systems (paraot 2 (r)) and
labeling cont.numis op :r,.,;ons
(paragraph (t)(3)). OSHA will consider
performance standards in other areas
where it can be shown that specifying
particular procedures is unnecessary,
and invites comment on this issue.
2. Content and format of labels and
placards. The proposed standard would
require chemical identification and
hazard warning information on labels
and placards for hazardous chemicals. _
This is because OSHA believes that
labeling is the most immediate and
reliable way of communicating hazard
related information to workers.
Some indusrty representatives have
expressed concerns about this
requirement. they believe that it will be
difficult to include all required
information-in readable form on normal
size,labels. There have also been
suggestions from both industry and
representatives cf workers that the
hazard warnings set out in Appendix C
are either too comprehensive or not
comprehensive enough. OSHA invites
comments upon all aspects of the label
format requirements of the proposed
standard. OSIIA also invites alternative
proposals for labeling format.
As previsouly stated, the requirement
for disclosure of chemical identity is
closely related to the trade secrets issue.
Some industry representatives have
suggested that confidentiality for trade
secrets might he enhanced if chemcial
identity of hazardous materials were
maintained in reference books stored
centrally and made available to workers
upon request. In this way, employers
could keep track of those receiving
potential trade secret information and
require confidentiality agreements from
those to whom trade secret information
is disclosed.
Advocates for workers have opposed
this alternative to labeling on several
grounds. First, it is cumbersome. The
worker must make a request to see
information he or she wishes to check.
Second, the worker must leave the work
area in. order to check such information.
Third, the employer knows which
empie ees are making requests
concerning the identity of hazardous
materials, and unions fear this may lead
to reprisal and harassment. OSIIA
invites comment on whether possible
enhancement of confidentiality afforded
by a reference book system outweighs
the drawbacks of removing a -
requirement for workplace labeling.
3. Disclosure of chemical identity in
labels shipped in commerce. A closely
related issue involves the inclusion of
CAS numbers on labels being shipped
downstream to industrial users. The
.proposed standard requires that labels
indicating the cher.iical 1:'e ti:y
CAS number) of hazardous cih ::i;ois be
placed on containers before being
shipped downstream to workplaces
where such substances and mixtures
will be used (paragraph (o)). Industry
representatives have stated that this
requirement will only compound the
trade secrets problem because the
identity of hazardous trade secret
chemicals will be open to scrutiny, not
only in workplaces, but in commerce to
other employers who may be
competitors. Worker representatives
have countered that without a
requirement that labels he in place
when containers reach a downstream
workplace, there is no certainty that
containers of hazardous materials in
downstream workplaces will be
speedily and accurately labeled.
The proposed policy to require
labeling before hazardous materials are
shipped is grounded on several
preliminary conclusions. OSHA has
concluded that once manufacturers and
importers are required to disclose the
chemical identity of hazardous
substances to both their own employees
and the employees of downstream users,
the incremental damage to
confidentiality caused by requiring
chemical identification to app,:cr on
labels in commerce is relatively
inconsequential. OSHA has also
concluded, in the absence of evidence to
the contrary, that there is a substantial
possiblity for tardy and inaccurate
labeling if labels are not required to be
in place upon arrival at a downstream
workplace. OSHA invites comments on
these points.
4. Exclusion of small containers. The
proposed standard-provides for certain
exemptions from labeling requirements
applicable to containers of Ira;:rirdous
mat-pins in tine worl.viace its
(u)(i), (g)(12)). Of particular concern
may be the exemption for containers of
5 gallons (19 liters) or less in volume
which are used to transfer hazardous
materials from or: container ?,
in a particular it-ark area. OSi ?.
requests comments concerning the sizes
and purposes of containers which
should be exempted from labeling
requirements.
5. Access to records and d:,cunients
required by the study, -rd. The proposed
standard would provide access to a
number of types of records and -
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documents by workers, their designated documents are granted should otherwise
representatives, their unions, and OSHA be expanded or limited; and
and NIOSH (paragraphs (cc) and (dd)). Suggestions for any alternative access
In addition., the standard requires and record keeping mechanisms which
manufacturers and importers to would reduce the burden on industry, or
maintain separate files containing the make access to information by workers
materials relevant to the hazard easier or more efficent.
evaluation for each substance and 6. Worker access to safety data
mixture they produce or import sheets. The proposed standard would
(paragraph (m)). The material in these provide material safety data sheets (if
files is to be made available on request they exist).to workers upon request.
to employees and former employees in There is no requirement that an
work areas where the substance or employer affirmatively make copies
mixture is or was present (paragraph available to each worker in the
(dd)). In the event a firm goes out of workplace. This provision is intended to
business, the standard provides for the minimize the administrative burden
transfer of documents and records to upon employers of providing copies in
NIOSH (paragraph (ee)). every work area.
OSHA believes that maintenance of Representatives of workers have
the specified documents and records is objected to such a provision, chiming
essential to the ability of workers to that to require workers to request these
protect themselves from workplace documents will leave workers open to
hazards for several reasons. First, these employer harassment and
documents and records may provide discrimination. These representatives
important information relevant to would prefer that copies of relevant
chemical hazards which is not required material safety data sheets be posted in
to be on labels. Second, access to the each work area. They also suggest that
materials upon which a manufacturer or additional copies be made available in
importer bases hazard evaluations work area locations where they can be
provides workers and their picked up without a specific request.
- representatives the means to verify the Finally, these representatives have
determination made. Likewise, these stated that worker health and safety
materials provide OSHA with the ready requires that these documents be
documentation intrinsic to efficient available for immediate inspection on
enforcement of the standard. the job where necessary.
The benefits of the access and record OSHA dues not have before it specific
keeping provisions of the standard must evidence that would justify the
be weighed against the burdens these allegation that workers who request
provisions will impose upon importers, documents will be harassed or
? manufacturers, and industrial users. discriminated against. Nor does OSHA
Information presently available to have before it evidence of the need for
OSHA indicates that in some material safety, data sheets to be
workplaces at least some of the material immediately available on the job. OSHA
covered by the access and record invites comments on these issues.
keeping provisions of the standard is 7. Material safety data sheets. The
presently made available. Whether filing proposed standard requires that, where
systems similar to those proposed by the available, copies of material safety data
standard are in general use is less clear. sheets (MSDS) for hazardous substances
Comments on a number of issues and mixtures be given to workers and
would be helpful to OSHA in making a their representatives upon request
jugrnent as to the adequacy of its (paragraph (cc)). The proposed standard
proposals concerning access and does not, however, require that.
recordkeeping. These include: manufacturers and importers of
The nature of the burden these hazardous substances and mixtures
provisions will place upon industry, produce an IrISDS for each hazardous
with particular reference to existing substance and mixture. Nor does the
industry practices in the access and proposed standard define the content of
recordkeeping areas-,. any I-4SDS a manufacturer or importer
The use to which information to which decides to produce (see the definition of
access is provided by the proposed an MSDS in-paragraph (g}(7.S}).
standard will be put by workers and OSHA chose to impose neither of
their representatives; these requirements because. under the
Whether employers who use proposed regulation, the MSDS is not
chemicals should be entitled to inspect the primary vehicle for communicating
the records and documents of essential hazard related information to
manufacturers and importers pertaining workers. On this assumption, to have
to those chemicals; imposed.such requirements would have
Whether the classes of persons and put a large and unjustifiable burden
groups to whom access to records and upon industry.
OSHA invites comments on whether
the MSDS should play a more prominent
role than presently contemplated in the
information system proposed under the
hazard identification standard. If so,
OSHA also Invites comment on whether
a MSDS should be produced under some
defined format for every hazardous
substance and mixture to be used in the
workplace.
B. Substance-employee identification
lists. In developing this proposal, OSHA
very seriously considered requiring
manufacturers and industrial users to
develop substance-employee
identification lists for each work area.
Such lists would provide a cross-
reference between the hazardous
chemicals present in a given work area
and the identities of the employees
working in the area.
The purpose of such a listing
requirement would be to give workers
an overall picture of the hazardous
chemicals present in the areas in which
they work, and which might, therefore,
adversely affect their health. If required
to be preserved for extended periods of
time, e.g., 30 years, these lists would
also provide an accurate record of
potential chemical exposures affecting a
worker over time, although the lists
would not establish quantitative levels
of exposure. This information, in turn.
could provide epidemiologists valuable
assistance in tracking down potential
sources of occupational disease.
The costs and administrative burden
connected with the creation and long
term preservation of substarn;er
identification lists would not be
insubstantial. Yet, as the Regulatory
Analysis of the proposed standard
shows, a requirement for such lists may
well yield results which dramatically
increase the benefits of the hazard
identification in terms of improved
worker health and safety over time.
OSHA did not include a requirement
for the development and preservation of
substance-employee identification lists
because while they potentially would
establish a record of basic evid'rice
essential to determining the effects or
hazardous chemicals with prcciior, ti:::
extent of the burden they would impose
upon manufacturers and industrial users
is not yet clear. In pa rt`icular, OSHA is
uncertain abo,:t t'.;. b., development
and maintcmn cc Sf :. 1:.!tl;:.l
place upon dow?;istrecr:, r .i s of
cheniice'.s, such as automooile
manufacturer, whose operations tend to
be labor-intensive and to use thousands
of chemicals. This type of industrial
structure would obviously compound the
difficulty of tracking and croes-
referencing chemicals and employees,
but to what degree is unknown. On the
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a ~ ~a+r,~,~e~^ - -- ~r~es~w
other hand, these employers, as well as
others, may now have in place systems
for keeping track of chemicals and
employees which might be adapted to
the same use as substance-employee
identification lists, or might at least
reduce the burden of putting substance-
employee. identification lists in place.
Accordingly, to determine whether a
requirement for substance-employee
identification lists should be
incorporated in the final standard,
OSHA invites comment upon the uses to
which workers, their representatives,
governmental agencies, and mash;
researchers would put the information-::
provided by substance-employee
identification lists. OSHA also invites
cost and effort which implementation of
the standard would impose such firms is
less than that upon smaller firms-which
have no such procedures in place.
The proposed standard attempts to
minimize the differential burden upon
large and small firms by establishing a
repository for hazard warning
information and by delaying the dates
5. The Occupational Safety and
Health Act, Pub..L.-91--596, 91st
Congress, S. 2193, December 29, 1970.
0. Report of.tha Standards Advisory
Committee on Hazardous Materials
Labeling to the Assistant Secretary of
Labor of Occupational Safety and
Health, U.S. Department of Labor,.
submitted June 6, 1975.
a I comments upon the burden which
,d
_f
compilation of such lists would impose
upon industry, with particular reference
to the extent industry presently
compiles and maintains similar
information.
9. The need forgeneiic training
requirements. The proposed standard
does not include any requirement that
workers be trained to use the hazard
identification information
communicated to them. This is not
because OSHA believes that training is
unimportant to the overall effort to make
is workplaces healthful and safe. It is
because OSHA sees the communication
of hazard-related information and
worker training as distinct tasks which
are not necessarily interdependent for.
a ( the provision of meaningful benefits.
Thus, although the usefulness of hazard
related information would undoubtedly
be enhanced by appropriate training,
such information is extremely helpful to
workers in and of itself. Moreover,
toy I OSHA is aware that some employers
already provide employees with
adequate training in hazard
identification.
Furthermore, OSHA believes there is
_:t a major advantage in creating a
of comprehensive communication and
's training system in several stages. This
procedure minimizes the burdens upon
industry by spreading cost and effort
over time, while still providing
the substantial benefits to workers with the
,ae promulgation of each cor,ponent of the
sers overall system. OSHA believes this to
is be a sound approach, and comment on
:_ient this view is invited.
10. Impact on small business. OSHA
recognizes that the proposed standard
may impesa greater burd.>ns on s :._,Il
1 to ( business than i co: s or. 1(_;,e firms, For
ands example, as mentioned, some lore
chemical manufacturers have indicated
d the that they already follow chemical
4the
evaluation procedures similar in scope
to those proposed in the stantl::rd.
Conse
uently the burden in additional
q
by which small manufacturers and 7. A Recommendad
importers must complete evaluation of Standard ' ' * An Identification
chemicals they produce or import System for Occupational Hazardous
(paragraphs (w) and (ii)). The repository Materials, DHEW (NIOSH) Publication
for hazard warning-information will No. 75-126,1974.
contaiazall infwmuation relevant to the B. American National Standard for the
results of the hazard evaluation for any Precautionary Labeling of Hazardous
cht'.rnicaL This information will be Industrial Chemicals, American
available to manufacturers and National Standards Institute, ANSI
importers. Delaying the compliance 2129.1-1976.
dates for small manufacturers and 9. H.P. 750-Legislative Document 958,
importers will allow them to utilize the State of Maine.
hazard evaluations made by large 10. Title 8, Article 112, State of
manufacturers or importers for California.
chemicals they also produce or import. 11. Public Act No. 80-257 and 80-130,
There may be other provisions which State of Connecticut.
would ease the burden upon small 12. Act 51, Public Acts of 1980, State
business without sacrificing the . . of Michigan.
comprehensiveness and accuracy on 13.7103-D. State of New York.
which the hazard identification standard 14. General Occupational Health
relies to help protect worker health. Regulations 22-015, State of Oregon.
OSHA invites-comments and
suggestions regarding these.
11. Miscellaneous issues. Finally,
there are several specific issues upon
15. Chapter 149, Commonwealth of
Massachusetts.
16. Chapter 296-64 WAC, State of
Washington.
which comment in response to publicly 17. N.J.A.C. 12:130, State of New
released preliminary drafts has been _ Jersey.
!:uarse,?but which may be controversial. 18. Toxic Substances Control Act,
Accordingly, OSHA seeks comment on Pub. L. 94-469, October 11, 1976.
the following: 19. Environmental Protection Agency,
Is the partial exemption from Pesticide Programs, 40 CFR Part 162.
regulation which OSHA has allowed for 20. Environmental Protection Agency,
research chemicals in paragraph (f) Pesticide Programs, Registration,
appropriate? Reregistration and Classification
Are the special enforcement Procedures (40 FR 28242, July 3, 1975).
provisions OSHA has developed in 21. Environmental Protection Agency,
paragraph (hh) adequate? Registration of Pesticides in the United
Should the compliance dates mandate States Proposed Guidelines (43 FR
by paragraph (ii) be either shortened or 2069e, July 10, 1678).
legthened? 22. Department of Transportation,
Are there measures to assure the Hazardous Materials Transportation, 49
communication of updated hazard CFR Part 172.
related information preferable to those 23. Consumer Product Safety
proposed in paragraphs (z)-(aa)? Commission, Feder.-1 Hazardous
Substance Act Regulations, 16 CFR Part
D. Selected References
1r
~OJ.
1. National Occupational Hazards 24. Food and Drug Admiaist.aticri,
Survey, DHEW (NIOSH) Publication No. Food for Human Consumption, 21 CFR
78-114, December, 1977. Part 100; Drugs, 21 CFR Part 2C0;
2. An Interim Report to the Congress Cosmetics, 21 CFR Part 700.
on Occupational Diseases, submitted by 25. Committee on Government
the U.S. Department of Labor, Operations, House of Representatives,
December, 1979. Transcript of Hearin;s Le'ore a
A. OSHA Safety and Health Standards Subcommittee on Control of Toxic
for General Industry, 29 CRR Part 19.10. Substances in the Workplace, May 11,
OSHA 2206, revised, November 7, 1978. 12, and 18, 1976.
4. Toxic Substances Control Act 26. Committee on Government
Chemical Substances Inventory, and Ope:-atimis, blouse of l' o tit es,
Suppletnerlts, U.S. Environmental ilurty i ourth Ropo t, C.hi ar.;c 1
Protection Agency. - in the Workplace, 1976.
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27. Committee on Government
Operations, House of Representatives,
Tenth Report, Failure to Meet
Commitments Made in the Occupational
Safety and Health Act, 1977.
28. Transcripts of OSHA Hearings on
"Access to Employee Exposure an&a
Medical Records". Docket No. H-112.
29. Fair Packaging and Labeling Act,
Pub. L. 84-755, s2, Nov. 3, 1966, 80 Stat.
1298.
30. European Economic Community
Labeling Requirements, Directive 67/
548/EEC, August 18, 1967,. as amended
by Directive 79/831/EEC, Senteniber 18,
1979; Directive 73/173/EEC, June 4, 1973;
Directive 77/ 728/ EEC, Novenber 7,
1977; and Directive 78/631/EEC. . June 26,.,
1978. '
31. Bureau of Labor-Statistics,
Occupational Injuries atzd.illnusses iii
the United States by Industry, 1977.
32. Pilot Study for Development of an
Occupational Disease Surveillance
Method, DHEW-NIOSH 75-162, 1975.
33. Draft I.R.L.G. Guideline for
Documentation of Epidemiologic
Studies, Interagency Regulatory Liaison
Group, November, 1979.
34. Creech and Johnson,
Angiosarcoma of the Liver in the
Manufacture of Polyvinyl Chloride, 16 J.
Occ. Med. 150 (1974).
V. Legal Authority
This notice of proposed rulemaking in
being published in conformity with the
requirements of section 6(b)(2) of the
Occupational Safety and Health Act, 29
U.S.G. 655(b)(2), for publishing a
proposed rule promulgating an
occupational safety and health standard
in the Federal Register, and section 4(b)
of the Administrative Procedure Act, 5
U.S.C. 553(b) regarding the publication
of notices of proposed rulemaldngs in
the Federal Register.
Authority for issuance of this
standard is found in sections 6(b) and
8(g)(2) of the Act, 29 U.S.C. 65E!b) and
657(g)(2). Section 6(b) governs the
issuance of an occupational safety and
health standard, which is defined in
section 3(8) of the Act, 29 U.S.G. 652(8),
as:
[A) standard which requires conditions, or
the adoption or use of one or more practices,
means, methods, operations, or processes,
reasonably necessary or appropriate to
provide safe or healthful employment and
places of employment.
The proposal contemplates the
issuance of a generic standard for the
determination and communication of
workplace hazards. This will require the
adoption and use of one or more
practices (e.g. labeling and access to
records) which the secretary has reason
to believe are reasonably necessary and
appropriate to provide employees with
safe and healthful employment and
places of employment. The issuance of a
generic stan~ard is a necessary and
effective means to carry out the
purposes of the Act and to set priorities
under the Act whenever the Secretary
identifies common occupational health
or safety problems which warrant
common solutions (see the Cancer
Policy standard, 45 FR 5002 et seq., and
the access to exposure to exposure and
medical records standard, 45 FR 35212 et
seq.). .
In particular, the proposed standard is
a generic implementation of sections
6(b)(7) and 6(b)(5) of the Act, 29U.S.C.
655 (b)(7) and (b)(5). Section 6(b)(7)
pertinently states that:
Any standard promulgated under this
sabsectionshall prescribe the use of labels or
other appropriate forms of warning as are
necessary to insure that employees are
apprised of"alI hazards to which they are
exposed, relevant symptoms and appropriate
emergency treatment, and proper conditions
and precautions of safe use or exposure
Section 6(b)(5) authorizes the
Secretary, in promulgating standards
dealing with toxic materials or harmful
physical agents:
* ? * to set the standard which most
adequately assures, to the extent feasible, on
the basis of the best available evidence, that
no employee will suffer material impairment
of health or functional capacity even if such
employee has regular exposure to the hazard
dealt with by such standard for the period of
his working life* * *.
The philosophy of this proposal is to
require the identification and disclosure
of a hazard to employees as soon as the
scientific literature reliably indicates
such a conclusion, even though the
evidence or OSH-IA's priorities may not
yet warrant comprehensive regulation of
the hazardous chemical. This is
consistent with the Supreme Court's
statement in Industrial Union Dep't
(IUD) v. American Petroleum Institute
(API), 100 S.G.T. 2844, at 2872, fn. 66 that
Congress had an "information-gathering
function" in mind when it enacted
section 6(b)(7), and that requirements of
this nature may be imposed at lower
levels than can currently bo set for the
regulation of a toxic.substance on the
basis of a finding of significant risk. This
is so because it is necessary to "keep a
constant check.on the validity of the
assumption made in developing the
permissible exposure limit, giving it a
sound evider-tiary basis. for decreasing
the limit if it was initially set too high,"
id. at 2872, or, a fortiori, not at all.
The Secretary's authority to issue this
proposed standard is further supported
by the general rulemaking authority
granted in section 8(g)(2) of the Act. This
section empowers the Secretary "to
prescribe such rules and regulations as
he may deem necessary to carry out
[his] responsibilities under the Act." The
authority thus granted to the Secretary
is as broad as the purposes of the Act,
which include: .
. Encouraging employers and employees in
their efforts to reduce the number of
occupational safety and health hazards at
their places of employment, and to stimulate
employers and employees to institute new
and to perfect existing programs for providing
safe and healthful working conditions (29
U.S.C. 651 (b)(1)).
Building upon advances already made
through employee and employer initiative for
providing safe and healthful working
conditions (29 U.S.C. 651(b)(4)).
Exploring ways to discover latent diseases,
establishing causal connections between
diseases and work in environmental
conditions * ' * (29 U.S.C. 851(b)(6))
Encouraging joint labor-management
efforts to reduce injuries and diseases arising
out of employment (29 U.S.C. 651(b)(13)).
OSHA believes that this proposal,
when issued in final form, will
significantly advance these statutory
goals.
In addition, Section 6(c)(1) of the Act,
29 U.S.C. 657(c)(1), authorizes the
Secretary to issue regulations requiring
employers to, "make, keep and preserve,
and make available to the Secretary
* * * such records regarding his
activities relating to this Act as the
Secretary * * ? Y4deema1/2 necessary or
appropriate for the enforcement of this
Act or for developing information
regarding the-causes and prevention of
occupational accidents and illnesses."
This proposal directs its major
obligations toward those employers who
are in the best position to develop
information concerning chemical
hazards or who are the primary users of
chemicals in'industry.-To this end,
"manufacturers" and "industrial users"
are limited, by definition, to employers
in Division D (Manufacturing), Major
Groups 20-39, of the SIC Manual. In
issuing standards, the Secretary moy,
under his section 6(g), 29 U.S.C. 655(g),
.priority-setting discretion apply the
standard only to certr=in seenv its of
business, thus "[gi virigj due regard to the
urgency of the need for mandatory
safety and health standards for
particular industries, trades, crafts,
occupations, businesses, workplaces or
work environments."
The system of hazard identification
and communication established by this
proposal is also designed to impose the
duty of hazard evaluation primarily on
the manufacturers and imparters who
distribute hazardous chemicals in
commerce. It would require the
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,,.;u?d related information
,,,,t,.yees involved in the
, tunnicali but also to the
wm the chemicals are
iwrefit of the employees
.This approach is
?,A.+ t ISHA used in its
.,I and which was
%antpart by the Court
i !terican Petroleum
t, 581 F. 2d 493 (5th Cir.
s?acated on other
?,i other grounds sub nom.
;; rr Dep't., AFL-CIO v.
vk'um Institute, 100 S. ct.
,he Court stated (Id at 510):
-e n'+punsibility to warn.
., a rpluyees of concealed hazards
-r+m emplo wlsa?E:i'tuiha,
k.:aw of the hazard is consistent
purpose of the Act and is,
:,A's broad authority to prescribe
C : rt was also influenced by the
t the upstream employer's own
ees were exposed to the same
r.Ss and had to be warned via label3
wont. The responsibility to warn
..,s:Team employees placed on
facturers by this proposal is not
tually different than in benzene.
t)enzene, their own employees are
?.[%t as much exposed to the
:';cats which they must evaluate for
trds and provide warning for
t, n-dingly. OSHA recognizes,
never, that importers may be in a
:?went position than manufacturers
a;:c, if they are not themselves.
r.ufacturers, they may not have
r..,pioyees exposed in any significant
w.+y to the chemicals they ship and may
t:,ive difficulty getting information
r. :corning the identities and hazards of
the chemicals they import from
o%erseas' suppliers. Nevertheless, the
;v-oposal treats importers like
canufacturers because it appears
cecessary that chemical identification
end hazard warnings be developed at
the earliest possible point in the chain of
d;stribution after a chemical enters the
Customs Territory of the United States
to avoid a significant regulatory gap. Cf.
?Iourning v. Family Publications
Services, 411 U.S. 356 (1973). OSHA
specifically invites comment on how
best to regulate hazardous imported
chemicals so that employees may be
informed of their chemical identity and
warned of their hazards.
VI. Regulatory Analysis, Environmental
Impact and Regulatory Flexibility
Requirements
This proposal has been developed in
conformity with pertinent laws,
regulations, and executive orders. In
particular, pursuant to Executive Order
12044 and the implementing Secretary's
Order (44 FR 5370; January 28, 1979)
OSHA has developed a Regulatory
Analysis that extensively considers the
expected benefits and economic Impacts
of the proposed standard, together with
regulatory alternatives considered by
the Agency. This document is available
to the public from the following address:
Docket Officer; Docket Na-M..O22, Room
S-8212, U.S. Department of Labor, 200
Constitution Avenue,_N.W., Washington,
D.C. 20210, Tel: [phone].
The Regulatory Analysis also serves
as the Agency's draft Environmental
Impact Statement (EIS) and Regulatory
ElexihilityAnalysis. Under, tthe National
1?41vironntental Policy Act, 42 U.S.C. 4321
v87saq., as inte ed by 40 CFR Part,
3900 et seq. (Council on Environmental
Quality) and 29 CFR Part 11
(Department of Labor), (45 FR 51187 et
seq.; August 1, 1980) OSHA is required
to prepare a draft EIS if it determines
that a proposed action will have
significant environmental effects.
Because OSHA has identified
significant, albeit beneficial, effects
external to the workplace resulting from
this proposed standard, the Regulatory
Analysis has accordingly been written
so that It may simultaneously function
as the draft EIS. The consolidation of
documents in this manner Is explicity
permitted by 40 CFR 1506.4 and 29 CFR
11.12(d). In addition to assuring that the
substantive subject matter required of a
draft EIS has been addressed, OSHA
has also undertaken to comply with the
notice and filing requirements set forth
in the NEPA regulations, 40 CFR 1508.6
and 1506.9 and 29 CFR 11.12(d).
In like manner, the Regulatory
Analysis also contains an analysis of
the proposed standard's impact on small
businesses, as required by the
Regulatory Flexibility Act of 1980, Pub.
L. 98-353. As detailed in the Regulatory
Analysis and in the preamble above,
OSHA has not only considered the
effects on small businesses, but also has
taken steps designed to lessen the
compliance burden on manufacturers
and importers with 250 or fewer
employees. The decision at this time to
limit the scope of the proposed standard
primarily to employers engaged in
manufacturing (Division D, SIC Major
Groups 20-39)-thereby excluding
construction and other non-
manufacturing industries from its
scope-may also be seen in part as an
attempt to minimize the impact of the
proposed standard on small businesses.
To the extent necessary, OSHA will
issue a final EIS and Regulatory
Flexibility Analysis at the time of the
final standard. It will also make final
determinations regarding the technical
And economic feasibility of the '
standard. To assist it In this task, the
Agency specifically invites comments on
any issue relating to the benefits, costs
and other economic impacts,
environmental consequences, and
impacts on small business of the
proposed standard.
VII. Public Participation
- Interested persons are invited to
submit written data, views, and
arguments-on this proposed standard,
These comments must be received on or
before April 18,1981, and submitted in
quadruplicate to the. Docket Officer,
Docket H-OZ2,. U.S. Department of
Labor, Occupational Safety and Health
Administration, 200 Constitution
Avenue, N.W., Room S-0212,
Washington, D.C., 202,10; [phone].
Written submissions must clearly
identify the provisions of the proposal
which are addressed, and the position
taken on each issue.
OSHA is scheduling public hearings in
several locations to permit interested
persons an opportunity to submit oral
testimony concerning the issues raised
by the proposed standard, including the
economic and environmental impacts.
The dates and cities for these hearings
are as follows:
Date Hearing Will Begin in City
1. May 20, 1981, Washington. D.C.
2. July 7,1981, Houston, 'T'exas.
3. July 21, 1981, Chicago, Illinois.
4. August 11, 1981, Philadelphia,
Pennsylvania.
5. September 1, 1981, San Francisco,
California.
The addresses for the location of the
hearing in each city will be announced
in the Federal Register at a later date.
Notices of Intention to Appear
All persons wishing to participate in
the public hearings must file a notice of
intention to appear, in quadruplicate, on
or before May 1, 1981, addressed to Asir.
Tom Ifall, OSHA Division of Consumer
Affairs, Docket No. 11-022, Room N3035.
U.S. Department of Labor, 200
Constitution Avenue, N.W., Washington,
D.C. 20210; [phone].
The notices of intention to appear
must contain the following information:
(1) The name, address and telephone
number of each person to appear;
(2) The capacity in which the person
will appear;
(3) The approximate amount of time
requested for.the presentation;
(4) The specific Issues that will be
addressed;
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(5) A detailed statement of the
position that will be taken on each issue
addressed; and -
(6) Whether the party intends to
submit documentary evidence and if so,
a brief summary of that evidence.
Filing of Testimony and Evidence Before
Hearing
Any party requesting more than 15
minutes for a presentation at the
hearing, or submitting documentary
evidence, must provide in. advance the
complete text of the testimony or
documentary evidence to be presented.
These texts shall be submitted in
quadruplicate to the OSHA Division of
Consumer Affairs, at the above address,
and must be submitted. by May 8, 1981.
These submissions will be available
for inspection and copying at the OSHA
Docket Office, Room S-6212, at the
above address.
Each submission received will be
reviewed to ascertain if the amount of
time requested in the notice of intention
to appear is appropriate. In those
instances where the information
contained in the submission does not
justify the amount of time requested, a
more appropriate time allocation will be
made and the participant will be
notified of the change. Any party who
has not substantially complied with this
requirement maybe limited to a 15-
minute presentation, and may be
requested to return for questioning at a
later time.
Conduct of Hearings
The hearings will begin at 9:30 a.m.
with resolution of any procedural
matters relating to the proceeding. The
hearings will be conducted in
accordance with 29 CFR Part 1911,
allowing full development of the record
and permitting all parties to exercise
their rights of participation.
The hearing will be presided over by
an Administrative Law Judge who will
have all the powers necessary or
appropriate to conduct a full and fair
informal hearing as provided in 29 CFR
Part 1911. Following the close of the
hearing or of any post hearin co;nrnont
period, the presiding Adminisirative
Law judge will certify the record to the
Assistant Secretary of Labor for
Occupati'~r.al Safety and Health.
All written and oral submissions, as-
well as other information gathered by
the Agency, will be considered in any
action taken. The record of this
rulemaking, including written comments
and materials submitted in response to
this notice and notices of intention to
appear at the public hearings, will be.
available for inspection and copying in
the Docket Office, Room S--6212, at the
above address, between the hours of
8:15 a.m. and 4:45 p.m.
VIII. Authority and Signature
This .document was prepared under
the direction of Eula Bingham, Assistant
Secretary of Labor for Occupational
Safety and Health, U.S. Department of
Labor, 200 Constitution Avenue, MV.,
Washington, D.C. 20210.
(Secs. 6(b), 8(c), and 8(g). Pub. L 91-596.84
Stat.1593,15,09, IU'0; 29 U.S.C. 655, 857; 29
CFR Part 1911; Secretary of Labor's Order No.
8--,-6 (41 FR 25059))
Signed at Washington, D.C. this 13th day of
January. 1981.
Eula Bingham,
Assistant Secretary of Labor.
1. General
(a) Overview.
(b) Purpose.
II. Scope and Application
(c) Employers covered by the standard.
(d) Substances covered by the standard.
(e) Mixtures covered by the standard.
(f) Coverage of research materials.
(g) Coverage of non-hazardous substances
and mixtures.
(h) Substances not covered by the
standard.
111. Evaulation and Communication of
Hazards-Duties of Manufacturers and
Importers -
(i) Evaluation of substances and mixtures
for hazards.
O) Categories of hazards.
(k) Determination of Category A hazards.
(I) Determination of Category 13 hazards.
(m) Maintenance of hazard evaluation files.
(n) Deletion'from hazard evaluation files of
trade secret information.
(o) Information to accompany shipments.
IV. Workplace Requirements
(p) Responsibility to determine hazards--
industrial users and suppliers.
(q) Workplace labels for hazardous
substances and mixtures.
(r) Workplace labels or placards-piping
systems.
(s) Hazard warning labels of other
agencies.
(t) Label and placard display requirements.
(u) Exceptions from workplace labeling and
placarding req~:irements.
(v) Lab.:" ^ of other employers.
(w) Label ref,!rcnce service.
V. Updating Hazard Information and Hazard
Determinations
(x) Duty to update-importers and
manufacturers.
(y) Duty to update-industrial users.
(z) Communication of updated hazard
determinations and information.
(aa) Duties upon receipt of updated
information.
VI. Recordkeeping and Access-Requirements
(bb) Records preservation.
(cc) Access to records.
(dd) Access to hazard evaluation files.
(ee) Transfer of records.
(ff) Duty of a manufacturer or industrial
user to inform employees of right of access.
VII. Definitions
(gg) Definitions.
VIII. Miscellaneous
(hh) Enforcement.
(ii) Compliance dates.
(jj) Appendices.
(kk) Effective dates.
I. General
(a) Overview.
Paragraphs (a) and (b) of this
standard do not themselves impose
requirements on employers but are
intended to set forth the general purpose
of this standard and to summarize (with
appropriate cross-references) the major
provisions of the standard which
implement that purpose.
This standard establishes a system
designed to communicate to workers
and employers essential information
concerning the hazards of workplace
chemicals. Chemicals are classified
under the standard as either substances
(paragraph (gg)(40)) or mixtures
(paragraph (gg)(30)). Employers covered
by the standard generally fall into four
categories: manufacturers (paragraph
(c)(1)(i)), Importers (paragraph (c)(1)(ii)),
suppliers (paragraph (c)(1)(iii)), and
industrial users (paragraph (c)(1)(iv)).
Manufacturers and industrial users
covered by this standard are those
whose establishments are covered by
Division D (Manufacturing), Major
groups 20-39, in the most recent revision
of the Standard Industrial Classification
Manual; Executive Office of the
President-Office of Management and
Budget. In addition, other employers (i.e.
those which fall under other SIC
categories) are required to leave labels
on containers they receive unless or
until the container is put up fur retail
sale (paragraph (v)).
This standard requires (1) the
evaluation of substances and mixtures
to deter miner whether they are
hazardous according to the criteria
specified in the standard (paragraph (i)-
(1); Appendices A and B) and (2) certain
regulatory actions to he taken with
respect to those substances and
mixtures which are determined to be
hazardous. The responsibility for hazard
evaluation is placed on the
manufacturers or importers of a
substance or mixture because they are
in the best position to make such an
evaluation. The standard identifies 17
different kinds of hazards which must
be evaluated (paragraph (g,,)(22)). The
evaluation procedures of the standard
require manufacturers or importers to
make use of information available in
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win records and to search relevant
,.:Ur; literature for evidence of those
-11,10i t,.uy (paragraphs (k)-(1)).
,,hces-A and B of the standard
ti the accepted scientific principles
t, ,u it. to be followed when
,uqg the evidence indicating a
!du hazard. The evaluation
...tures of the standard, however, do
pdre manufacturers and importers
t.,rm any tests to determine the
?liiusness of a substance or
his 4 .
6, it substance or mixture is
,.t iotined by a manufacturer or
-I ter to be hazardous under the
the standard requires each
n,t,icturer and industrial user to:
t.utml every container of every
n,luus substance in the workplace
the precise chemical identity of its
t,?rrts, and with appropriate hazard
.:,ruirngs, (paragraph (q.and Appendix
t.) label every container of a mixture
N,:th the precise chemical identities of
c".e constituent chemicals which are or
May be hazardous, and with appropriate
`.azard warnings. (paragraph (q) and
Appendix C);
(3) Provide employees with any
available material safety data sheets
,-oncerning the dangers posed by
hazardous substances and mixtures in
the workplace (paragraph (cc)); and
(4) Update the information provided to
employees as new information about
hazards becomes available (paragraphs
(x)-0a)).
To provide the information which
industrial users need to protect their
employees, the standard requires
manufacturers and importers to:
(1) Maintain files (i.e. references,
studies, reports or other documents used
in the hazards evaluation procedure) on
all substances and mixtures they
manufacture or import (paragraph (m));
.(2) Assure that the appropriate
chemical identity and hazard warning
labels are affixed to containers that are
being shipped to industrial users and the
suppliers of industrial users (paragraph
(o)); and
(3).Prcvide with the first shipment to
an industrial user or supplier of an
industrial user one copy of any safety
data sheet which the manufacturer or
importer has developed concerning the
hazards posed by the substance or
mixture being shipped (paragraph
(o)(6)). The standard, however, does not
require safety data sheets to be
developed or published if they do not
otherwise exist
To assure that industrial users receive
the chemical identification and hazard
warning information developed by the
manufacturer or importer, the standard
requires suppliers to forward this
information which they receive from
manufaciurers or importers with their
shipments of hazardous substances and
mixtures to industrial users and to other
suppliers of industrial users (paragraph
(o)(5)). The standard permits industrial
users, for the purposes of complying
with their labeling and placarding
duties, to rely on the hazard-related
information which they receive from
manufacturers, importers or suppliers.
(paragraph (p)). .
The standard requires that material
safety data sheets and files containing
hazard determination references and
documents must be preserved for
specified periods of time. (paragraph
(bb)). Access to these records is
generally provided to employees -
(including former employees), their
designated representatives (including
uniors with collective bargaining rights
in the workplace), OSHA and NIOSH
(the National Institute for Occupational
Safety and Health, Department of
Health and Human Services).
(paragraphs (cc) and (dd)). The standard
provides for the transfer of these records.
when an employer subject to its
recordkeeping provisions goes out of
business (paragraph (ee)). The standard
also requires each manufacturer and
importer to send to OSHA, after
completing a hazard determination on a
substance or mixture, either a notice
stating that the substance or mixture has
not been found to meet the criteria for a
hazard or a copy of the. appropriate
hazard warning for the substance or
mixture. This information will be kept in
a central repository and made available
to other employees on request
(paragraph (w)). The compliance dates
of the standard have been extended by
three months for manufacturers and
importers with less than 250 employees
so that they may take advantage of the
hazard evaluations on file with OSHA
(paragraph (ii).)
(b) Purpose.
The system of hazards evaluation and
communication established by this
standard will., by making information
about workplace hazards generally
avaiilable to workers, their _
representatives, OSHA and NIOSH,
yield direct and indirect improvements
in occupational health. Container labels
will give workers immediate access to
thc: idurt;ti-a an-! een,:ers of the
hazardous substances and mixtures
with which they work directly. Material
safety data sheets will provide workers
and their representatives with detailed
information about the properties and
handling of hazardous substances and
mixtures, supplementing the information
on hazard warning labels. Hazard
evaluation files will provide the
documentation to enable workers and
their representatives to make their own
hazard determinations and to check the
employer's determinations.
II. Scope and application
(c) Employers covered by the
standard.
_ (1) This standard applies to any
employer who:
(i) Is engaged inthe manufacturing or
processing of a substance or mixture for
distribution in commerce and whose
business is covered by Division D
(Manufacturing), Major Groups 20-39, in
the most recent revision of the Standard
Industrial Classification Manual,
Executive Office of the President-
Office of Management and Budget
(hereafter "manufacturer"); or -
(ii) Imports a substance or mixture
into the Customs Territory of the Ui7ited
States (i.e., the 50 States, Puerto Rico,
and the District of Columbia), and is the
first person who, knowing the substance
or mixture will be imported, controls the
identity and total amount of the
substance or mixture to be imported
(hereafter "importer"); or
(iii) Receives a substance or mixture
regulated by this standard and
distributes such substance or mixture to
an industrial user or another supplier of
an industrial user in unaltered form,
whether or not in its original container
(hereafter "supplier"); or
(iv) Uses a substance or mixture-
received from a manufacturer, importer,
or supplier, and whose business is
covered by Division D (Manufacturing),
Major Groups 20-39, in the most recent
revision of the Standard Industrial
Classification Manual, Executive Office
of the President- Office'of Management
and Budget (hereafter "industrial user").
(2) This standard applies to employers
who are neither manufacturers,
importers, suppliers, or industrial users
only to the extent set forth in paragraph
M.
(d) Substances covered by the
standard
(1) Any substance covered by this
standard must be evaluated in
accordance with paragraphs (i)-(1) and
Appendices A and B.
(2) This standard applies to any
substance which is:
(i) Listed in the Toxic Substances
Control Act Chemical Substance
Inventory, including UVCBs; or
(ii) A pesticide; or
(iii) A food additive, a prior
s