harmonization on the classification of chemical substances between
the EU and the US. A high degree of harmonization is desirable so
that manufacturers do not need different SDSs that satisfy the
requirements of different countries.

In the final rule, OSHA has continued to remain as consistent as
possible with the provisions of the GHS. In general, OSHA has not
changed the language of GHS provisions unless necessary to conform with
the regulatory requirements of the HCS. Country-specific deviations are
very limited, and are intended to ensure that the protections of the
current rule are maintained in the final rule. This is consistent with
the principle of the GHS developers that no country should have to
reduce protections in order to harmonize. OSHA does not believe that
any of the deviations in the final rule conflict in a substantive way
with the GHS itself.
    Many commenters to the ANPR also suggested that OSHA should
coordinate implementation of the GHS with other Federal agencies. These
included primarily EPA, DOT, and CPSC (See, e.g., Document ID
0048, 0050, 0053, 0076, 0104, 0111, 0123, 0134, 0154, 0162,
and 0170). For example, the Soap and Detergent Association (Document ID
0170) stated:

    SDA urges OSHA to coordinate implementation of revisions to the
HCS related to the GHS with the Environmental Protection Agency
(EPA), Department of Transportation (DOT), and the Consumer Product
Safety Commission (CPSC), which all have announced their intentions
to implement GHS provisions in their regulations. Workplace hazard
communication occurs in a stage of the overall life cycle of
chemicals and finished products. Coordination and synchronization of
implementation timing could greatly improve the efficiency of
implementation of the GHS by industry.

Others mentioned coordinating implementation with the Mine Safety and
Health Administration (MSHA) (Document ID 0049, 0101, and
0111).
    Similar comments were received in responses to the NPRM (See, e.g.,
Document ID 0344, 0345, 0350, 0351, 0375, 0376, 0403, and
0411). OSHA agrees with these commenters that the U.S. government
agencies should continue to coordinate their activities with regard to
implementation of the GHS. In terms of adopting the GHS provisions, DOT
has substantially aligned the criteria for physical hazards in their
regulations with those of the GHS under the HM-215I rulemaking (71 FR
78596, Dec. 29, 2006). DOT and OSHA arguably have the greatest
interface in covered chemical products, and thus adoption of this final
rule will result in greater consistency between these two agencies. EPA
and CPSC have not initiated rulemaking on the GHS. However, as will be
discussed later in this preamble, EPA and OSHA have worked together to
develop a common position on coverage of pesticides and chemicals
covered by the hazard communication requirements of the Toxic
Substances Control Act's (TSCA's) significant new use rules. Clearly,
there is no way to coordinate timelines for adoption given that OSHA is
at the final rule stage, and neither EPA nor CPSC has started a
rulemaking process. As rulemaking develops in these Agencies,
discussions will continue to take place in the interagency committee on
this subject. With regard to MSHA, Department of Labor rulemaking
activities are coordinated through Department officials, and MSHA has
been apprised of OSHA's activities in order to determine what action
may be appropriate for them to pursue in this area.
    A number of commenters to the ANPR also argued that OSHA should
coordinate implementation with major U.S. trading partners (See, e.g.,
Document ID 0042, 0048, 0101, 0116, 0128, 0141, 0155, and
0170). Similarly, several argued that countries should limit
modifications to the GHS that are country-specific, and that the UN
process should be used to control such changes (Document ID
0018, 0042,

0134, 0154, 0163, 0164, and 0171). For example, the American Petroleum
Institute (API) addressed these issues as follows (Document ID
0171):

    API strongly recommends that OSHA ensure that timing and
coordination of GHS implementation schedules are in line with those
of other countries, allowing sufficient time for companies to
organize and accomplish necessary work. In order to achieve
international harmonization of hazard communication materials and to
avoid undue burden on companies, OSHA must stay engaged with all
other actors to encourage even and consistent implementation of GHS
by individual countries. Further, API recommends that OSHA work
closely with other government agencies and countries to ensure
alignment to the UN endorsed version of the GHS. As the
implementation of the GHS by countries deviates from the UN version
of GHS, the perceived benefits of harmonization substantially
decrease.

Similar comments were received by participants in the rulemaking after
the NPRM was published. For example, 3M indicated (Document ID
0405):

    3M agrees that the potential benefits identified in the proposed
NPRM may be achieved through global implementation of GHS. However,
3M emphasizes that the potential benefits of GHS will depend on
countries around the world aligning as closely as possible with the
GHS. The potential benefits of GHS will be substantially undercut by
country-specific differences or additions that would require
companies to have multiple SDSs and labels for the same product.

Michele Sullivan, an independent consultant, recognized OSHA's approach
as being appropriate, and argued for coordination among trading
partners (Document ID 0382):

    Consistent implementation among the major trading partners of
the world is crucial to realize the benefits of the GHS system. For
this reason, the alignment, insofar as possible, of all national and
regional GHS systems with the UN GHS system is critical. In
addition, any national or regional GHS implementation effort must
retain enough flexibility to continually adapt the system as
necessary to harmonize as closely as possible with the UN GHS
system.

    OSHA agrees with these commenters that coordination among trading
partners would enhance harmonization and facilitate implementation. The
Agency remains active in the UN process, participating in the Sub-
committee of Experts on the GHS (UNSCEGHS), as well as the United
Nations Institute for Training and Research (UNITAR) Programme Advisory
Group. There is increased emphasis in the Sub-committee on
implementation issues as well as coordination. OSHA is leading a
correspondence group of interested members established by the Sub-
committee that is reviewing practical classification and hazard
communication issues, and proposing modifications to the Sub-committee
to clarify such provisions when identified. There are also other
correspondence groups that are addressing implementation issues as they
are raised to the Sub-committee. OSHA tries to participate in all of
this work in the Sub-committee to help ensure that any U.S.-identified
issues are raised and addressed. Essentially all of the countries
involved in implementation participate in the Sub-committee, so this is
OSHA's best opportunity to coordinate with them.
    The Agency has also had bilateral discussions with Canada, as well
as the European Union (EU), on issues related to implementation. These
discussions continue periodically to address mutual issues of concern.
    Canada has not yet proposed modifications to their system to
achieve harmonization, but they are planning to in the near future. The
EU has adopted the GHS, and according to a press release on January 4,
2011, from the European Chemicals Agency (ECHA), recently reached a
significant implementation milestone for its Classification, Labelling
and Packaging (CLP) regulation. (http://echa.europa.eu/news/pr/201101/pr_11_01_clp_deadline_20110104_en.asp):

    By 3 January 2011, ECHA received 3,114,835 notifications of
24,529 substances for the Classification and Labelling Inventory. By
this deadline, industry had to notify the classification and
labelling of all chemical substances that are hazardous or subject
to registration under the REACH regulation and placed on the EU
market. * * *
    The Classification, Labelling and Packaging regulation relates
to chemical substances and mixtures. It introduces into the EU the
criteria of the United Nations' Globally Harmonised System for
classifying and labelling chemicals. One of the aims of the CLP
regulation is to improve the protection of human health and the
environment by providing criteria for defining when a substance or
mixture displays properties that lead to its classification as
hazardous.
    CLP applies to manufacturers, importers, users or distributors
of chemical substances or mixtures. They must classify, label and
package any substance or mixture, regardless of its annual tonnage,
in accordance with the Regulation.
    The largest number of the notifications, over 800,000, came from
Germany. Over 500,000 notifications were submitted from the United
Kingdom and nearly 300,000 from France. All together over 6,600
companies notified at least one substance.

    Canada and the EU are two of the major trading partners for the
U.S. When OSHA prepared the NPRM, it examined the CLP to coordinate
where possible on approaches to implementation. However, the primary
principles followed by OSHA in developing this proposal were to ensure
that the modifications maintain or enhance the protections of the
current standard, and that the modifications are consistent with the
negotiated provisions of the GHS.
    One of the issues of concern regarding implementation by some other
countries has been deviation from the GHS itself. Because GHS is
intended to be globally implemented, efforts by countries to deviate in
a collective manner from the GHS, rather than maintaining consistency,
defeats the purpose and, consequently, lessens the benefits of the GHS.
OSHA will continue to seek opportunities to ensure coordination of
implementation and promote harmonization, both internationally and
bilaterally.
    It should also be noted that the GHS is a living document, and the
UN actively reviews it and considers possible changes based on
implementation experiences and other information. These changes are
made on a two-year cycle, referred to as a biennium. The OSHA proposal
and the final rule are based on Revision 3 of the GHS. Revision 3 was
adopted by the UN Committee and Sub-Committee of Experts on the GHS in
December 2008, and is available as a publication and on the UN Web
site. In December 2010, the UN Committee and Sub-committee of Experts
on the GHS adopted additional changes that will be issued as Revision
4.
    It is expected that as the UNSCEGHS fulfills its mandate to ensure
that the GHS is up-to-date and relevant, further changes will be
adopted on a biennium basis. If the change(s) is substantive and
controversial, OSHA will have to engage in notice-and-comment
rulemaking in order to amend the HCS. However, for non-substantive or
clarification changes, other rulemaking options are available that can
be utilized to implement the changes more quickly than the full notice-
and-comment rulemaking process.
    Two possible means are the Standards' Improvement Process (SIPs) or
a Direct Final Rule (DFR). Each of these options gives the public
notice and opportunity to comment, but has the advantage of a faster
process. Either method could be used to ensure that the HCS remains
current with the GHS.
    A number of NPRM participants commented that OSHA should establish
a stakeholder process for input into U.S. government positions on
issues raised at

the UN (See, e.g., Document ID 0376, 0377, 0381, 0382, and
0411). OSHA is always open to receiving suggestions from stakeholders
regarding issues raised in the UN process. The working papers are made
publicly available on the UN Web site some 12 weeks before meetings.
Public meetings are scheduled to receive input in some situations, and
stakeholders may also contact the primary OSHA delegate directly to
discuss any of the issues raised. Stakeholders can participate in the
Sub-committee discussions directly as well through organizations that
have recognized status in the Sub-committee. As already noted, changes
to the OSHA HCS as a result of modifications to the GHS in the future
will be subject to a public rulemaking process where all stakeholders
have the opportunity to participate.
    In the NPRM (74 FR 50288, Sept. 30, 2009), OSHA noted that one
advantage of adopting a system with harmonized hazard statements is
that it would facilitate the use of ``control banding'' in the U.S.
Control banding is an approach to selecting control measures for
workplace chemical exposures. Basically, the employer can, with the use
of information readily available in the workplace, use the approach to
determine the appropriate control measures for a chemical. The
harmonized hazard statements are key to assessing the hazards, and the
degree of severity of the hazards. In combination with data about
physical and chemical characteristics, quantities used, and the types
of processing, the employer can access recommended control measures. It
is particularly helpful in situations with common operations (e.g.,
bagging operations), and chemicals with well-known hazards that are not
severe (e.g., it would not generally be applied to a carcinogen--the
control banding guidance would inform the employer that professional
assistance must be acquired to address such a hazard). Control banding
has been used successfully by small and medium-sized businesses that
don't have extensive health and safety expertise in these types of
situations.
    There is considerable international interest in this approach, and
there have been a number of research studies conducted to refine the
approach and determine its applicability. Both OSHA and NIOSH have
taken part in activities to further investigate its utility in the U.S.
NIOSH has extensive information available on its Web site at http://www.cdc.gov/niosh/topics/ctrlbanding/. As they indicated in their
comments (Document ID 0412):

    The use of control banding to provide guidance for chemical
safety and health approaches in U.S. workplaces cannot be
accomplished until harmonized hazard statements are readily
available. Adoption of the GHS and its phrases would open up the
possibility that control banding guidance can be used in the United
States to help small- and medium-sized employers select and
implement appropriate control measures [NIOSH 2009].

The American Society of Safety Engineers (Document ID 0336) is
also a strong proponent of control banding. However, their position was
that OSHA should have included control banding in the NPRM, and thus in
the HCS:

    * * * ASSE believes OSHA should update the HCS to incorporate
elements of control banding. Assuming that most elements of GHS will
be adopted and a national database for safety data sheets (SDSs) and
chemical classifications will be established to support the
transition to GHS from current practice, building a system that
would allow guided review of materials and processes such as control
banding would be a relatively small additional step. We encourage
OSHA to take that step now and avoid revisiting this issue when it
becomes unavoidable as control banding grows in use internationally
as well among leading employers in this nation.

While OSHA agrees with ASSE that control banding may be a very useful
approach to controlling workplace exposures to chemicals, it does not
agree that this rulemaking is the appropriate place to address this
issue. As noted by both OSHA and NIOSH, adoption of the GHS will
facilitate the use of control banding in the U.S. by making harmonized
hazard statements readily available on labels and SDSs. This will allow
the adaptation of the approach in a way that could not be readily
accomplished with the current performance orientation of the HCS.
However, it is generally viewed as a guidance approach where it is
currently used, and not a mandatory requirement. Furthermore, control
banding continues to be refined in terms of application, and is not
harmonized. Adoption of it in the HCS would also not be consistent with
the principles OSHA has followed in devising the NPRM, i.e., to limit
changes to those required to align with the GHS, and to be as
consistent as possible with the GHS provisions. Therefore, while OSHA
believes the utility of control banding should continue to be assessed
and evaluated in the U.S., it is premature to consider the approach as
a mandatory requirement and part of the revised HCS.
    Outreach/compliance assistance. The ANPR included a series of
questions to solicit input from the public on what outreach or
compliance assistance materials would be appropriate and useful. OSHA
received many comments in response to these questions, with a number of
creative and interesting suggestions for outreach products. The Agency
will use this input to develop an outreach plan and prepare materials
for distribution when the rulemaking is completed. In addition, and as
suggested by a number of ANPR commenters (See, e.g., Document ID
0018, 0025, 0047, 0065, 0081, 0104, and 0154), OSHA will
continue working with interested parties to examine projects that could
be completed by them, or in coordination with them, that could be
targeted to specific industries or interest groups.
    OSHA solicited additional ideas for outreach or compliance
assistance in the NPRM, and many commenters provided such information
(See, e.g., Document ID 0332, 0344, 0356, 0370, 0382, 0405,
0408, 0410, and 0414). There was a wide range of suggestions, including
training programs, workshops, web resources, and enforcement tools
addressing different aspects of the modified standard. OSHA has already
developed some compliance assistance products--or updated products
available for the existing standard--and will be developing and
distributing these and others as resources are made available. There
are also tools being developed internationally that will be available
for employers undertaking compliance, such as training materials in
preparation by the United Nations Institute for Training and Research
(UNITAR). OSHA has provided support to this activity, and expects these
materials will be made available on its Web site when completed. OSHA
encourages trade associations, professional societies, and others to
develop materials that are specific to certain interest groups or
industries, thus providing a more focused compliance assistance
approach than can be done by OSHA at the national level.
    The final standard. The following is a description of the
provisions of the final standard, along with a discussion of what was
proposed and the information provided by rulemaking participants. As
noted above (and supported by rulemaking participants), OSHA's approach
has been to confine changes to the standard to those required to align
it with the GHS. Therefore, provisions that do not require changes for
that purpose have been left the way they are in the current HCS. While
participants supported this approach in general, suggestions were made
that involved changes to the current text in areas unaffected by the
GHS. Since OSHA did not propose to

open these parts of the rule in the proposed rulemaking, and the
analyses did not involve such changes, the Agency will not be adopting
them in the final rule.
    Similarly, as OSHA indicated in the NPRM, the Agency's approach was
also to be as consistent as possible with the GHS itself. Editing was
limited to what was required to make the provisions mandatory in the
context of OSHA rulemaking, and using the regulatory language required
for that purpose. Additionally, as described in the NPRM, OSHA did not
propose adopting language from the GHS that was strictly provided for
guidance purposes (such as the decision logics in the chapters in the
GHS that describe the physical and health hazard criteria). There is no
question that other changes could be made to the language to make it
more readable, or to state it in American English. However, introducing
different terminology also introduces the possibility that readers will
believe that OSHA means something different than the GHS because we
have used different language. Since this is not the intent, the Agency
has avoided doing this.
    Nevertheless, many such editorial changes were suggested. While
OSHA has reviewed all of them, and adopted a few that seemed
appropriate or necessary, in general the Agency did not engage in
extensive editing of agreed text for fear of changing the meaning, or
giving the impression that the meaning has changed. In particular, Dow
Chemical submitted extensive suggested edits in both its initial
comments on the NPRM and in post-hearing comments (Document ID
0353 and 0526). Most of these issues were not raised by any
other participants. Given the large number of such editorial
suggestions from Dow, OSHA does not discuss each one in this preamble,
but simply notes where changes have been made to the text. OSHA,
however, gave each of Dow's suggestions full consideration.
    (a) Purpose. The HCS includes a paragraph that states the purpose
of the rule. This stated purpose is two-fold. First, the paragraph
indicates that the standard addresses assessment of the hazards of
workplace chemicals, and the transmittal of that information to
employers and employees. It also describes the contents of a
comprehensive hazard communication program as being container labeling
and other forms of warning, material safety data sheets, and employee
training.
    The second part of the paragraph addresses the preemption of State
or local laws by this Federal standard. It indicates that OSHA is
addressing comprehensively the issues described, and thus the standard
preempts States, and political subdivisions of States, from addressing
these issues except under the authority of a Federally-approved State
plan under Section 18 of the OSH Act. While Section 18 applies to every
occupational safety and health standard that OSHA promulgates, the HCS
raises particular issues because of the nature of the provisions. It
requires chemical manufacturers and importers to evaluate the hazards
of the chemicals they produce or import, and to prepare labels and
safety data sheets based on those evaluations to transmit hazard
information and appropriate precautionary advice to users downstream.
This is a unique but highly appropriate approach for an OSHA standard,
as it recognizes that chemical manufacturers and importers are in the
best position to assess the hazards of their products and develop
appropriate information for labels and SDSs.
    There is a national, indeed international, marketplace for
industrial chemicals, and thus chemical manufacturers and importers
affect commerce within the meaning of the OSH Act and therefore fall
under OSHA's jurisdiction. If a State, or a political subdivision of a
State, were to establish different requirements for labels and safety
data sheets, such requirements would have an impact on chemical
manufacturers and importers that are not located in that State. This is
a burden that the HCS eliminates by establishing national requirements.
    The proposed revisions to the HCS had essentially the same
purposes, and thus the NPRM included only minor modifications to this
paragraph. OSHA proposed to modify paragraph (a)(1) to change the
language regarding the assessment of hazards to indicate that the
hazards will be ``classified'' rather than simply assessed or
evaluated. This is consistent with the approach in the GHS. In
addition, OSHA proposed to modify this paragraph to clearly indicate
that the standard is intended to be consistent with the GHS, Revision
3. That change is a reflection of the purpose of this rulemaking to
harmonize the existing requirements with the provisions of the GHS,
which is the international instrument that includes globally harmonized
provisions on hazard communication. In addition, in this paragraph and
succeeding paragraphs of the revised rule, the term ``material safety
data sheet'' was modified to ``safety data sheet'' to reflect the
terminology of the GHS.
    The only modifications proposed to paragraph (a)(2) also addressed
terminology, using ``classifying'' instead of ``evaluating'', and
``safety data sheet'' instead of ``material safety data sheet''.
    There were a few comments that were related to the Purpose
paragraph provisions. One comment suggested that the standard should be
limited to a purpose of international communication so as not to
trigger hazard assessments under other OSHA standards that address
respiratory protection, personal protective equipment, or process
safety management (Document ID 0049). There were several other
comments that indicated that new assessments would have to be done for
these standards (Document ID 0111, 0134, 0164, and 0178).
Arguments were made that this would lead to extensive additional costs
for new engineering controls, respirators, or other personal protective
equipment.
    As discussed above, there is no identified link to these other
standards in the stated purpose of the HCS either currently or with the
proposed modifications in the NPRM. While the current HCS and this
final standard require the provision of information on recommended
control measures, including respiratory protection, personal protective
equipment, and engineering controls, there is no requirement for
employers to implement the recommended controls. An employer should use
all available information when designing an appropriate protective
program, but a recommendation on a safety data sheet by itself would
not trigger the need to implement new controls.
    Furthermore, these comments seem to imply that there will be major
changes in the classification of the hazards of chemicals as a result
of implementation of the GHS provisions. Both the HCS and the GHS are
based on identifying and communicating the inherent hazards of
chemicals. Thus the biggest change for most chemicals under the final
rule will be in categorizing the chemical's hazards. Under the current
standard, for example, a chemical either is, or is not, a carcinogen.
Under the revised HCS, if a chemical is a carcinogen, it would be
categorized as a Category 1 or a Category 2 carcinogen. Such a change
would provide additional information for the downstream user, but would
not generally result in a need to change engineering controls or
respiratory protection.
    It is possible that a chemical may be classified under the final
rule as having a hazard it did not have before, but OSHA believes that
this is not likely to happen frequently given the broad coverage of the
current rule. Furthermore, the physical and chemical characteristics of
the chemical--which

affect the types of protection required--would not be changed as a
result of this proposal. OSHA believes that these revisions would
result in few, if any, changes in protective measures required under
other OSHA standards.
    Several commenters to the ANPR noted what they believed to be the
continued need to address the preemption of State standards (See, e.g.,
Document ID 0036, 0048, 0056, 0080, 0123, 0135, and 0178). In
addition, commenters also noted that the impact of GHS adoption on
State and local laws should be considered in the process (for example,
California Proposition 65), and that differences between such laws and
the revised HCS should be discouraged (Document ID 0015, 0038,
0042, and 0072).
    It was also indicated that changes in State laws should be
coordinated with the Federal changes to facilitate implementation
(Document ID 0146). See Section VIII and IX of this preamble
for a comprehensive discussion regarding Federalism and State plans.
    There were a number of comments received in response to the NPRM
that addressed the Purpose paragraph provisions. For example, the
Styrene Information and Research Center (Document ID 0361)
indicated that OSHA should revise paragraph (a)(1) to say that it is
intended to be consistent with the GHS ``with some exceptions,'' since
there are some deviations from the GHS. OSHA does not agree with this
suggestion. The language proposed, and in the final rule, is accurate--
it is consistent with the provisions of the GHS. The GHS is not a model
regulation, and it is not intended that countries will adopt the actual
text of the GHS. Furthermore, there is allowance for flexibility and
differences where necessary to accommodate a country's specific needs.
There was nothing in the NPRM that was inconsistent with the GHS, and
neither is the final rule inconsistent.
    Dow Chemical (Document ID 0353), argued that paragraph
(a)(2) should state that OSHA is preempting personal injury suits
alleging that labels provided inadequate warnings. The Industrial
Minerals Association-North America (Document ID 0394)
indicates that the new rule must make clear that it preempts state law
tort claims alleging failure to warn. OSHA declines these invitations.
As recently explained in the Solicitor of Labor's letter to Stephen
Wodka, dated October 18, 2011, in general the HCS does not preempt
state tort failure to warn lawsuits, and OSHA does not intend to change
that position in the final rule. Indeed, the OSH Act's ``savings
clause'' explicitly preserves, rather than preempts, State tort law.
OSH Act Sec.  4(b)(4), 29 U.S.C. 653(b)(4); Lindsey v. Caterpiller,
Inc., 480 F.3d 202, 209 (3d Cir. 2007); Pedraza v. Shell Oil Co., 942
F.2d 48, 53-54 (1st Cir. 1991). While a limited preemption might be
possible to the extent a state tort rule directly conflicted with the
requirements of the standard, no commenter has provided any evidence of
such a conflict. For example, the record contains no evidence that a
manufacturer might be held liable under a State's tort law rules for
complying with the GHS. However, to eliminate any confusion about the
standard's preemptive effect, and to be consistent with the President's
May 20, 2009 Memorandum on Preemption, OSHA has made two small changes
to (a)(2) in the final rule, changing the words ``legal requirements''
to ``legislative or regulatory enactments'' in the provision's first
sentence and eliminating the words ``through any court or agency'' in
the last sentence.
    Similarly, DuPont (Document ID 0329) says OSHA should
convince States to voluntarily rescind their ``right-to-know'' laws, or
make them consistent with the HCS final rule. And the National Paint
and Coatings Association (NPCA) (Document ID 0328) believes
that OSHA should not allow States to promulgate a standard that is
different from the Federal rule. As indicated in paragraph (a)(2),
States with OSHA-approved State Plans will have to adopt standards that
are at least as effective as this final rule. (See, generally, 62 FR
31159, Jun. 6, 1997.) Those standards will be reviewed by Federal OSHA.
Other States are preempted from covering these areas with regard to
workplace protections. OSHA has no authority with regard to provisions
that are intended to address non-workplace situations.
    Therefore, OSHA has concluded that the changes it proposed to
Paragraph (a) are appropriate, and those changes are being incorporated
into the final rule. No other revisions are being made.
    (b) Scope and application. The HCS is a generic standard that has
very broad provisions in terms of chemicals addressed and workplaces
covered. It also interfaces with a number of requirements of other
Federal agencies that address labeling of chemical hazards. Paragraph
(b) thus includes all of the practical modifications the Agency has
developed to ensure that employers and employees understand how the
standard is to be applied, and to accommodate various circumstances
that potentially affect the application of the standard.
    The provisions of paragraph (b)(2) in the HCS address the overall
scope of the standard as applying to ``any chemical which is known to
be present in the workplace in such a manner that employees may be
exposed under normal conditions of use or in a foreseeable emergency.''
This provision addresses many questions that are raised about the
application of the standard.
    In general, OSHA does not expect significant changes in the
chemicals covered by the HCS under the final rule as compared to the
current standard. The scope of hazards covered by the GHS is very
similar to what is covered by the current HCS. Additional chemicals may
be considered to be acutely toxic due to the proposed adoption of
Category 4 in acute toxicity, which would expand the criteria for
inclusion from the current definition (See the discussion under
``Hazard classification''). However, these chemicals are already
covered under the voluntary national industry consensus standard on
precautionary labeling of industrial chemicals that many manufacturers
follow in their labeling programs (ANSI Z400.1/Z129.1-2010, Hazardous
Chemicals--Hazard Evaluation and Safety Data Sheet and Precautionary
Labeling Preparation), as well as being covered in the requirements
that apply to chemicals shipped to the EU. Thus many manufacturers are
already classifying and labeling these chemicals as acute toxins. The
final rule is also likely to cover fewer mixtures as acute toxins than
the current rule given the hazard classification approach in the GHS
that uses a calculation based on proportionality to determine whether a
mixture is covered, rather than the strict percentage cut-off of 1% in
the current HCS. Other definitions of health hazards would maintain the
current broad HCS scope.
    In addition to the overall scope statement, the final rule, like
the current rule, provides for limited coverage in workplace situations
that have special circumstances, including laboratories (paragraph
(b)(3)) and work operations where employees only handle chemicals in
closed containers (paragraph (b)(4)).
    OSHA also addresses the interface with other Federal agency
requirements by either exempting the products covered from additional
OSHA labeling (such as pesticides required to be labeled by the EPA)
(paragraph (b)(5)), or completely exempting the product (such as
hazardous waste regulated by EPA) (paragraph (b)(6)). These
accommodations help to ensure that

Federal requirements do not conflict or duplicate each other.
    Under the GHS, such provisions are left under the purview of the
``competent authority.'' In developing the GHS, it was recognized that
countries' regulatory authorities would need to have the discretion to
address such national circumstances in ways that are suited to the
regulatory perspective of the country. Thus authorities such as OSHA
are free to make determinations about scope and application issues
while still being harmonized with the primary provisions of the GHS.
    OSHA reviewed the current provisions of paragraph (b), and
determined that no significant changes were required to be consistent
with the GHS. Several minor changes to revise terminology were retained
from the proposal (i.e., adopting the terms ``classifying'' and
``safety data sheets''), but OSHA is not modifying any of the remaining
provisions of paragraph (b). The Agency is also deleting Appendix E of
the current HCS, which was guidance for application of the standard,
and thus is deleting the reference to it in paragraph (b)(1). The Sheet
Metal and Air Conditioning Contractors National Association (SMACNA)
(Document ID 0415) suggested in response to the NPRM that OSHA
update Appendix E and continue to include it in the standard. OSHA will
update Appendix E, and make it available as a compliance assistance
product. It was always available as a pamphlet in any event, and has
been very useful in helping small employers who are users of chemicals
comply with the standard. And as noted above, new outreach and
compliance assistance materials are being prepared as well.
    Several commenters to the ANPR indicated that OSHA should adopt
exemptions included by the European Union in its requirements.
Specifically, these exemptions address non-isolated intermediates,
chemicals involved in research and development, and waste (Document ID
0049, 0134, and 0164). In response to the NPRM, the Society of
the Plastics Industry (SPI) (Document ID 0392) continued to
argue that the EU exemptions should be adopted. All of these situations
are already addressed in paragraph (b), and OSHA does not agree that it
is appropriate or necessary to change them.
    In terms of non-isolated intermediates, the overall scope provision
in paragraph (b)(2) adequately addresses this situation. This was
described in the preamble to the 1983 final rule (48 FR 53335, Nov. 25,
1983):

    That is, the term ``known'' means the employer need not analyze
intermediate process streams, for example, to determine the presence
or quantity of trace contaminants. However, where the employer knows
of such contaminants, and they are hazardous, then they fall under
the provisions of the standard.

    With regard to chemicals involved in research and development,
paragraph (b)(3) limits coverage in laboratories, and partially
addresses this situation. Where there is no knowledge of the hazards of
such chemicals, the HCS does not apply at all since there is no
requirement to generate new hazard information. Where information is
available, it must be provided to exposed employees, consistent with
paragraph (b)(3) when it is in a laboratory situation. Therefore, it
appears to OSHA that this situation is also adequately addressed under
the current provisions. Hazardous waste as regulated by EPA is already
exempted under paragraphs (b)(6)(i) and (ii).
    The North American Metals Council (NAMC) (Document ID
0377) argued in response to the NPRM that OSHA should use the
EU approach to exempt metals in their massive form, alloys, and other
preparations that do not present a hazard. Provisions already exist in
the current HCS, and are included in the final rule, that address these
issues (See, e.g., definition of article (paragraph (c)), special
labeling provisions for solid metals (paragraph (f)(4))).
    There were commenters who suggested that OSHA maintain current
exemptions or limitations in the revised GHS, including the consumer
product exemption (Document ID 0064), guidance on byproducts
(Document ID 0064), the relative roles of manufacturers and
employers (Document ID 0064), and the article exemption
(Document ID 0160). OSHA agrees and all of these
accommodations remain the same in the revised rule. The Agency is not
changing those parts of the HCS that are not affected by the GHS.
    There were also a few comments regarding the scope of the revised
rule in terms of provisions of the GHS that affect the environment or
transportation (See, e.g., Document ID 0072 and 0179). OSHA
does not have the authority to require information in these areas since
they are not directed to the protection of employees under its
jurisdiction. However, OSHA does not prohibit this type of information
on labels or safety data sheets, and is aware that it is often included
on labels and safety data sheets currently developed to comply with the
HCS. OSHA expects that chemical manufacturers will continue to
voluntarily include such data on their labels and safety data sheets to
meet the requests of their domestic and international customers.
Commenters to the NPRM continued to state that OSHA should allow
environmental information although it is not required (Document ID
0344 and 0381). OSHA maintains the position proposed that
manufacturers are free to provide additional information on labels and
safety data sheets to address environmental concerns, as well as
aspects of concern in other areas such as transportation. (74 FR 50387,
Sept. 30, 2009)
    Few comments were received on this paragraph in the NPRM. Dow
Chemical (Document ID 0353) suggested that paragraph
(b)(5)(iv) be updated to reflect the changed name of the Bureau of
Alcohol, Tobacco, Firearms, and Explosives (the word ``Explosives'' has
been added to their name). This has been done. In addition, two
typographical errors in (b)(6)(ii) have been corrected.
    The North American Insulation Manufacturers Association (NAIMA)
(Document ID 0411) states that OSHA has given unwarranted
exemption by ceding authority for products regulated by other agencies.
In particular, NAIMA is concerned about coverage by CPSC, and indicates
that CPSC addresses the fire hazards of cellulose insulation, but not
the health hazards, in its label requirements. NAIMA argues that OSHA
should not allow consumer product labels to supersede OSHA
requirements.
    OSHA considered this issue at length in previous amendments to the
HCS (53 FR 29822, 29834-38, Aug. 8, 1988; 59 FR 6126, 6150-52, Feb. 9,
1994; See also 52 FR 31852, 31862-63, Aug. 24, 1987). After noting that
CPSC labels often do not contain all hazard information relevant to
worker exposures, OSHA concluded that:

    OSHA nevertheless decided to permit the CPSC labels to suffice
so as not to disrupt the extensive labeling conducted in accordance
with those rules. OSHA believed that this could be justified on the
basis that some information is provided on the labels that would be
useful to workers, and that the requirement for MSDSs would provide
what information is necessary to supplement the labels. 48 FR 53289.
This additional information is critical to ensuring that training
can be properly conducted, and that adequate protective measures are
used in the workplace.

(53 FR 29834, Aug. 8, 1988; See also 59 FR 6151, Feb. 9, 1994.) Thus,
under the current HCS, SDSs and employee training are required where
employee exposure to a consumer product exceeds

the range that ``could reasonably be experienced by consumers when used
for the purpose intended.'' 29 CFR 1910.1200(b)(6)(ix). OSHA sees no
need to revisit this issue now, and in any event it is outside the
scope of this rulemaking, which is aimed at the changes necessary to
bring the HCS in conformity with the GHS.
    A few comments were received in response to the ANPR regarding EPA
labels for pesticides, noting that signal words in these labels would
change if GHS is adopted (Document ID 0178), and noting that
the requirements for these labels are dictated by the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), which also
controls the SDS content (Document ID 0108). A commenter also
argued that FIFRA pesticide labels are more useful because they are
risk-based rather than hazard-based (Document ID 0108). These
concerns were not related to the proposal which maintained the
exemption for additional labels on containers that are labeled in
accordance with EPA requirements. If EPA decides to adopt the GHS, then
labels for pesticides would be consistent with OSHA labels on other
types of products. With regard to SDSs, these are required by the HCS,
not FIFRA, and therefore such SDSs must be consistent with GHS
provisions as adopted in this final standard.
    A number of additional comments, and oral testimony, were received
in response to the NPRM from representatives of the pesticide industry
regarding potential conflicts between OSHA and EPA requirements (See,
e.g., Document ID 0352, 0385, 0387, and 0468). OSHA does not
require additional labels on pesticides that require labels under EPA
requirements. However, OSHA does have SDS requirements that must still
be applied, and have been applied since the HCS first went into effect.
Pesticide industry representatives believe that the SDS requirements as
aligned with the GHS would conflict with the EPA-approved labels
because they may have different information on them for OSHA than what
is included in the pesticide label. For example, EPA has three signal
words for pesticides (danger, caution, and warning), while OSHA will
have the two specified by the GHS (danger and warning). There are also
other differences. For example, chronic health effects are rarely
addressed on pesticide labels as the risk mitigation measures are
intended to minimize the possibility of their occurrence. However, OSHA
would require such effects to be included when appropriate. The
commenters also argue that EPA ``labels'' include any information
related to the product, and thus SDSs would be preempted by the EPA
labeling requirements. Therefore, they argue that pesticides should be
exempted from the HCS. For example, the American Chemistry Council's
Biocides Panel says the reasons for exempting pesticides are as follows
(Document ID 0385):

    The principal reasons for this are: (i) Requiring GHS compliant
SDS's but not pesticide labels will result in significant confusion
in workplaces in which pesticides are used; (ii) imposing GHS-based
SDS's would be inconsistent with EPA's interpretation of FIFRA,
which includes all material that may be shipped with a pesticide,
including SDS's, as part of its definition of labeling; and (iii)
applying GHS to pesticide SDS's will not provide any additional
substantive information, as EPA's evaluation of pesticides before
approving them for sale includes all aspects of potential
occupational exposures.

    OSHA considered exempting pesticides from the final rule. However,
exempting pesticides would reduce protections for those workers under
OSHA's jurisdiction. For example, OSHA's jurisdiction extends to
employees in pesticide manufacture and formulation. While EPA approves
the label on the final product shipped out of these facilities, and
that label includes information needed when the products are used by
applicators, EPA does not have hazard communication requirements for
the protection of workers in production facilities. Such protection is
covered by OSHA, and OSHA requires labels on containers that are not
subject to EPA labeling, as well as SDSs and training. The workplace
exposures of these workers are of great concern. The chemicals are
generally designed to be biologically active, and the exposures can be
quite different than they would be for applicators, for example, who
may use them only on an intermittent basis.
    In testimony during the public hearing, representatives from the
ACC Biocides Panel and CropLife America, Inc., agreed that EPA does not
cover workers in pesticide manufacturing or formulating facilities (See
Document ID 0495 Tr. 248-250). An exemption from the HCS would
provide reduced protection for these workers.
    As a result of receiving these comments, and the concerns about
removing current protections from the final rule, OSHA considered
several options. OSHA considered allowing the SDS preparer to use the
EPA classification in section 2 of the SDS to ensure consistency with
the FIFRA label. However, in doing this the SDS would then be
inconsistent with other chemicals in the production of pesticides. In
the pesticide manufacturing workplace the pesticide chemical ``active''
ingredients would bear a FIFRA label but would have an OSHA SDS,
however other chemicals in the workplace such the ``inactive''
ingredients or cleaning products might still be considered hazardous
under the HCS would contain an OSHA label and an OSHA SDS. An added
complication is that an identical chemical (for example, chlorine)
could potentially be in a pesticide manufacturing workplace where in
one situation it could contain a FIFRA label and another it could bear
an OSHA style label depending on its end use (e.g., a disinfectant).
Adding a different SDS would create additional confusion not only for
the worker handling the chemicals but also the personnel in charge of
chemical management as well. Therefore, OSHA and EPA met to discuss
what would be an appropriate resolution. First, with regard to the
argument that SDSs are part of labels, and therefore preempted, EPA has
long had an interpretation that they will not apply their review
requirements to SDSs (US EPA Pesticide Registration Notices 92-04).
Based on our discussions, OSHA does not anticipate that this policy
will change. Secondly, EPA has indicated that they are committed to
working with OSHA to develop an approach that will provide both
appropriate protection for employees, as well as the environment,
through workable guidance for the pesticide industry. OSHA anticipates
that EPA will provide guidance to their regulated community (such as
through a Pesticide Registration Notice) on how to develop an OSHA GHS-
compliant SDS that will not be in conflict with the pesticide label.
Therefore, pesticides will continue to be covered in the same manner as
has been done under the HCS since its inception, and the exemption
requested by pesticides industry rulemaking participants for such
products is not granted.
    Although the OSHA ICR (OMB Control No. 1218-0072) that is currently
pending review and approval by OMB addresses the information collection
activities associated with preparing the entire SDS as prescribed by
the OSHA final rule, the approach OSHA anticipates will be provided in
the EPA guidance for pesticide registrants was not considered by OSHA
at the proposed rule stage. While OSHA preliminarily believes it has
taken sufficient time in its paperwork estimate to cover compliance
with the anticipated EPA guidance, the public has not had the
opportunity to comment

on the paperwork burdens created by that guidance. As such, EPA and
OSHA are collaborating on a subsequent revision to OSHA's ICR to ensure
that it addresses the activities in the EPA guidance. EPA intends to
solicit public comment on an ICR revision that addresses the
information collection activities and related burden estimates
associated with the EPA guidance as part of its release of that
guidance. After public comments are considered by both agencies, OSHA
intends to ask OMB to revise its ICR approval, identified under OMB
Control No. 1218-0072, to capture the information collection activities
and burden adjustments, if any, related to EPA's guidance.
    (c) Definitions. This paragraph in the HCS includes the terminology
used with the corresponding definitions. Comprehension of the
appropriate definitions is critical to understanding the provisions of
the standard. In some cases, terms are defined somewhat differently
than when used in other contexts, so familiarity with the standard's
definitions is important.
    In the proposed revisions, OSHA retained as many definitions as
possible from the current HCS. Changes were proposed only when there
was a new term used that needed to be defined, or there is a different
definition in the GHS, and consistency with the international
definition was needed for harmonization purposes. As with the preceding
paragraphs, minor modifications were proposed to ensure terminology is
appropriate--primarily the use of terms related to classification and
safety data sheets. These modifications were retained in the final
rule. There were relatively few comments submitted on the proposed
revisions to the definitions, other than those referring to the new
definition OSHA proposed to address ``unclassified hazards'' and the
definition for ``pictogram'' that references a red border frame.
    One important difference between the HCS and GHS in terminology
involves the use of the term ``chemical.'' The HCS has used this term
since it was originally promulgated, and defines it to include
elements, chemical compounds, and mixtures of elements and/or
compounds. It has been a convenient way to describe the coverage of the
rule. The GHS, like some other international standards, uses the terms
``substance'' and ``mixture''. OSHA has decided to retain a definition
of ``chemical'' in the revised standard, which minimizes the number of
terminology changes that have to be made to the regulatory text, as
well as providing a shorthand way to define the scope to include both
individual substances and mixtures of substances. This term is used in
the body of the regulatory text of the final standard, similar to its
use in the current HCS. However, the modifications also include
definitions for ``substance'' as well as ``mixture'' to align with the
GHS, and both of these terms are used as well. In particular, in the
appendixes that are adopting GHS language, the separate terms
``substance'' and ``mixture'' are used consistent with the GHS.
    ``Substance'' means ``chemical elements and their compounds in the
natural state or obtained by any production process, including any
additive necessary to preserve the stability of the product and any
impurities deriving from the process used, but excluding any solvent
which may be separated without affecting the stability of the substance
or changing its composition.'' Dow Chemical (Document ID 0353)
objected to this definition, and suggested that it should be ``chemical
elements and compounds in their natural state or obtained by any
production process.'' OSHA has concluded that it is appropriate to
maintain the GHS language for this definition to help to ensure
consistent application, and thus the revised rule includes the
definition of substance that was proposed.
    A ``mixture'' is defined as a ``combination or a solution composed
of two or more substances in which they do not react.'' This is
consistent with the GHS definition--and while slightly different than
the definition in the current HCS, means the same thing. Dow Chemical
(Document ID 0353) suggested that OSHA maintain part of its
current definition in order to avoid inadvertently changing the scope
of coverage by adding ``if the combination is not, in whole or in part,
the result of a chemical reaction.'' OSHA does not believe that the
scope is changed by the GHS definition, and has retained the GHS-
consistent language that was proposed.
    OSHA also proposed to maintain the term ``hazardous chemical'' in
this revised standard as used in the current standard (a chemical which
is a physical or health hazard), except to add the term ``classified''
to indicate how it is determined that it is a physical or health
hazard. OSHA also proposed to include unclassified hazards in this
definition, but, as will be described below, has chosen a different
approach in the final rule. Instead, the definition of ``hazardous
chemical'' in this final rule is ``any chemical which is classified as
a physical hazard or a health hazard, a simple asphyxiant, combustible
dust, pyrophoric gas, or hazard not otherwise classified.'' The term is
used throughout the standard to indicate that the classification
process is completed, and the chemical manufacturer has determined that
the chemical poses a hazard. Most of the substantive requirements of
the rule apply to hazardous chemicals.
    Dow Chemical (Document ID 0353) indicated that OSHA should
drop the use of the word ``substance'' altogether, and instead use the
word ``chemical.'' As noted in the definition of ``chemical,'' however,
it is to be used when a reference is to both substances and mixtures.
Where a provision or statement refers only to a substance, or only to a
mixture, those terms are used in lieu of ``chemical'' or ``hazardous
chemical.'' These individual designations are used most commonly in the
appendixes, particularly in the classification criteria. OSHA has
maintained consistency in the criteria with the GHS insofar as is
possible with regard to this terminology.
    Another proposed modification to the definitions paragraph was to
move the specific physical hazard definitions to an appendix. In the
current HCS, health hazard definitions are addressed specifically in
Appendix A, but the physical hazard definitions were included in
paragraph (c). In the final standard, health hazard definitions
continue to be addressed in Appendix A, but a new Appendix B addresses
physical hazards. Both of these appendixes are discussed below under
the summary and explanation of paragraph (d) ``Hazard Classification.''
    As noted in Section III above, the physical hazard definitions in
the GHS are drawn from the United Nations' Recommendations on the
Transport of Dangerous Goods. Since DOT has already adopted this
international approach, the GHS definitions are substantially
harmonized with the U.S. requirements for labeling of dangerous goods
in transport. All chemicals that are shipped in the U.S. have already
been classified according to DOT's physical hazard definitions. This
will reduce the burdens associated with classifying physical hazards
under the revised HCS. The primary differences involve exceptions that
make the definitions more applicable to workplace situations (for
example, coverage of flammable liquids that are currently defined as
combustible under the HCS). Modifying the HCS to align with the GHS
thus serves the purpose of harmonizing many of these definitions
domestically, and results in shippers only having to classify their
chemicals once for most physical hazards.

    OSHA also has updated the definition of the term ``classification''
to reflect the additional hazards in this final rule (simple
asphyxiant, combustible dust, and pyrophoric gas). The definition for
classification will now read: ``Classification means to identify the
relevant data regarding the hazards of a chemical; review those data to
ascertain the hazards associated with the chemical; and decide whether
the chemical will be classified as hazardous according to the
definition of hazardous chemical in this section. In addition,
classification for health and physical hazards include the
determination of the degree of hazard, where appropriate, by comparing
the data with the criteria for health and physical hazards,'' Dow
Chemical (Document ID 0353) suggested that the language be
changed to read ``for health hazards and for physical hazards.'' OSHA
does not find this to be a necessary revision, and has adopted the
definition as proposed. This definition is very similar to the process
of hazard determination that is currently in the HCS, with the
exception of determining the degree of hazard where appropriate. This
reflects the GHS approach of having categories for each class of
hazard. Under the current HCS, there are some definitions that have
categories in a hazard class (e.g., acute toxicity, flammability), but
other definitions are simply one category (e.g., carcinogenicity). The
additional breakdown in the GHS of classes into categories that reflect
different severities or levels of effect will provide both employers
and employees with more precise information to understand the hazards,
to consider when evaluating workplace conditions to determine the risks
in the workplace, and to respond to exposure incidents.
    OSHA has also retained in the final rule the proposed definitions
for ``hazard class'' and ``hazard category'' to further explain the
approach of breaking down the hazardous effects into levels of
severity. A ``hazard class'' is defined as ``the nature of the physical
or health hazards, e.g., flammable solid, carcinogen, oral acute
toxicity.'' The definition of ``hazard category'' is ``the division of
criteria within each hazard class, e.g., oral acute toxicity and
flammable liquids include four hazard categories. These categories
compare hazard severity within a hazard class and should not be taken
as a comparison of hazard categories generally.'' Both of these
definitions are taken from the GHS. Dow Chemical (Document ID
0353) suggested that the last sentence of the definition of
``hazard category'' should be deleted or moved to Appendix A because it
is ``non-definitional information.'' Given that it is included in the
GHS definition, OSHA has adopted it in the final standard.
    OSHA has retained the proposed definition of ``health hazard'' to
reflect the specific hazards defined in the GHS. While the overall
scope of what is covered is essentially the same as the current HCS,
the hazards may be identified slightly differently. For example, the
current HCS covers reproductive toxicity as a target organ effect, and
includes all aspects of the effect under that hazard. The GHS has a
separate definition for germ cell mutagenicity, which is considered
part of reproductive toxicity in the current HCS. The definition of
``health hazard'' was thus proposed to be ``a chemical which is
classified as posing one of the following hazardous effects: acute
toxicity (any route of exposure); skin corrosion or irritation; serious
eye damage or eye irritation; respiratory or skin sensitization; germ
cell mutagenicity; carcinogenicity; reproductive toxicity; specific
target organ toxicity (single or repeated exposure); or aspiration
hazard. The criteria for determining whether a chemical is classified
as a health hazard are detailed in Appendix A to Sec.  1910.1200--
Health Hazard Criteria.''
    Both the American Chemistry Council (ACC) (Document ID
0393) and Dow Chemical (Document ID 0353) suggested
that OSHA modify the phrase ``any route of exposure,'' which refers to
``acute toxicity.'' ACC suggested it list the three specific routes of
exposure in the criteria, and Dow suggested that it include
``relevant'' to modify routes of exposures. OSHA does not believe
either of these changes is necessary. The definition already uses the
term ``classified'' to refer to each of the health hazards listed, and
the acute toxicity criteria include three routes of exposure for
classification. Dow further suggested that ``serious eye damage'' be
modified to say ``by chemical action.'' Again, the classification
process is for chemicals, and the definition already indicates that it
is covered as a health hazard when classified. Similarly, Dow suggested
that ``aspiration hazard'' be modified to say ``aspiration toxicity
hazard.'' The proposed language is consistent with the GHS, and OSHA is
maintaining it for harmonization purposes in the final standard.
    A revised definition of ``physical hazard'' was proposed to reflect
the physical hazards covered in the GHS. While these are similar to the
coverage of the HCS, they are in some cases described differently. The
definition proposed for ``physical hazard'' is ``a chemical that is
classified as posing one of the following hazardous effects: Explosive;
flammable (gases, aerosols, liquids, or solids); oxidizer (liquid,
solid or gas); self-reactive; pyrophoric (liquid or solid); self-
heating; organic peroxide; corrosive to metal; gas under pressure; or
in contact with water, emits flammable gas. See Appendix B to Sec.
1910.1200--Physical Hazard Criteria.'' This definition has been adopted
in the final standard with one change. OSHA did not include pyrophoric
gas in the definition in the proposal. There is no definition for
pyrophoric gas in the GHS, which is covered under the current HCS, and
OSHA inadvertently left it out in the proposed standard when the
generic definition for pyrophorics was removed. This omission was
pointed out by commenters (e.g., Document ID 0382 and 0530).
OSHA is therefore returning the pyrophoric gas definition from the
current rule to paragraph (c), and making it specific to just gases
since the current rule covers all physical states. Thus, pyrophoric gas
is defined as ``a chemical in a gaseous state that will ignite
spontaneously in air at a temperature of 130 degrees F (54.4 degrees C)
or below.'' Label elements are provided in C.4.30. The signal word will
be danger; the pictogram is the flame; and the hazard statement is
``Catches fire spontaneously if exposed to air.''
    Procter & Gamble (Document ID 0381) noted that the
definition for ``flashpoint'' was missing from the NPRM and suggested
that it should be put back into the rule. However, the meaning of the
term ``flashpoint'' is already addressed in the criteria for
``flammable liquid'' in Appendix B by specifying the test methods to
determine it. OSHA has also included a definition for flashpoint in the
criteria chapter, rather than in the definitions paragraph.
    The definition of ``label'' in the GHS is slightly different than
what is currently in the HCS, and OSHA proposed to modify the HCS to be
consistent with the GHS. The proposed definition of ``label,'' which
has been retained in the final rule, is ``an appropriate group of
written, printed or graphic information elements concerning a hazardous
chemical that is affixed to, printed on, or attached to the immediate
container of a hazardous chemical, or to the outside packaging.'' The
GHS label is more specific than what is required in the current HCS,
and includes certain core information that must be presented. Thus, a
definition for ``label elements'' was also proposed and adopted in the
final rule as ``the specified pictogram, hazard statement,

signal word, and precautionary statement for each hazard class and
category.'' ACC (Document ID 0393) noted that this definition
is different from what is in the GHS. OSHA modified the definition by
making it plural to reflect the way it is used in this section to refer
to the OSHA-required label elements for each GHS label. The GHS
definition in this case defines the singular term ``label element'' as
``one type of information that has been harmonized for use in a label,
e.g., pictogram, signal word.'' OSHA has listed all of the label
elements, including precautionary statements since they are mandatory
under the revised rule. OSHA believes its definition is consistent with
the GHS but more appropriate for the revised rule, and has adopted it
in this final standard.
    ``Safety data sheet (SDS)'' is defined in both the NPRM and the
final rule as ``written or printed material concerning a hazardous
chemical which is prepared in accordance with paragraph (g) of this
section.''
    Definitions for terms that describe information required to be
provided on labels were also proposed to be added to the HCS and are
included in the final rule. These terms include ``hazard statement,''
``pictogram,'' ``precautionary statement,'' ``product identifier,'' and
``signal word.'' These new definitions will help to clarify the
specific requirements for labels under the revised HCS, and are
consistent with similar definitions in the GHS.
    ``Hazard statement'' is ``a statement assigned to a hazard class
and category that describes the nature of the hazards of a chemical,
including, where appropriate, the degree of hazard.'' This is
essentially what is defined as a hazard warning under the current rule.
An example of a hazard statement under the GHS is: ``Causes serious eye
damage.'' These statements have been codified, meaning that numbers
have been assigned to them. They are available in all of the official
languages of the United Nations, and thus translation will not be a
problem when shipping to countries using those languages. Having
standardized statements is expected to facilitate translation into
other languages as well. The definition for ``hazard statement'' is
being adopted as proposed.
    There were a few comments about specific hazard statements, such as
an objection from the National Propane Gas Association (Document ID
0400) indicating the statement for flammable gas is ambiguous,
and lacks substantiation and scientific credence. They object to
labeling propane as ``extremely flammable,'' which is the required
statement for Category 1 for flammability hazards. This objection was
also raised in a comment to the ANPR (Document ID 0068). OSHA
responded in the NPRM that it would not be making chemical-specific
changes to hazard statements (74 FR 50399, Sept. 30, 2009). The point
of having harmonized statements is that all chemicals with the same
degree of hazard have the same statement. OSHA also indicated that some
in the industry already use the ``extremely flammable'' terminology.
NPGA responded that not everyone is familiar with it, or uses it. That
is why OSHA is establishing a standardized approach, so everyone in an
industry with a common product like propane uses the same language to
convey the hazard. This consistency will help people understand what
the hazards are, and simplify the process of conveying them since
everyone will use the same approach. As noted previously, examples of
where the hazard statement ``extremely flammable'' are currently being
used for propane are readily found (e.g., Document ID 0554).
Therefore, OSHA does not agree with NPGA that the hazard statement is
inappropriate or should be modified.
    A few commenters suggested that where hazard statements include two
hazards, separating them should be permitted when data indicate that
only one is applicable to the product involved (for example, it causes
infertility but not developmental hazards) (Document ID 0344,
0376, 0377, 0381, 0382, and 0393). OSHA agrees that such separation
should be permitted. The following provision has been added to Appendix
C.2.2.2: ``If the chemical manufacturer, importer, or responsible party
can demonstrate that all or part of the hazard statement is
inappropriate to a specific substance or mixture, the corresponding
statement may be omitted from the label.''
    Additionally, OSHA permits chemical manufacturers and importers to
combine hazard statements where the information is related and the
combination can shorten the text required on the label. Appendix
C.2.2.1 states: ``Hazard statements may be combined where appropriate
to reduce the information on the label and improve readability, as long
as all of the hazards are conveyed as required.'' OSHA also allows
additional hazard statements under supplementary information, as long
as they are accurate and do not conflict with the required statements.
``Pictogram'' is defined as a ``composition that may include a symbol
plus other graphic elements, such as a border, background pattern, or
color, that is intended to convey specific information about the
hazards of a chemical.'' This definition covers both pictograms in the
transport sector, and those in other sectors covered by the GHS. The
pictograms are required as part of the core information provided on a
label to describe the hazards of a chemical. ACC (Document ID
0393) and Procter & Gamble (Document ID 0381) noted
that the proposed definition of pictogram, which was retained in the
final rule, is slightly different than what is in the GHS: ``a
graphical composition that may include a symbol plus other graphic
elements, such as a border, background pattern, or color, that is
intended to convey specific information.'' OSHA added ``about the
hazards of a chemical'' because that is the only type of information
that will be conveyed by the pictograms in the HCS. The definition is
being adopted as proposed.
    The workplace pictograms proposed were a black symbol on a white
background with a red diamond border frame. Some ANPR commenters noted
that the frame should be permitted to be black for domestic shipments
as allowed under the GHS (See, e.g., Document ID 0032 and
0163). However, as described in Section IV of the proposed preamble,
there are clear safety and health benefits associated with the use of
the red frame in terms of recognition and comprehensibility. Thus OSHA
proposed to allow only the red frame to be used, whether the shipment
is domestic or international.
    Many of the rulemaking participants recognized the communication
benefits of the red border, and supported the proposed requirement for
a red border frame for all shipments (See, e.g., Document ID
0313, 0324, 0330, 0335, 0336, 0339, 0341, 0365, 0383, 0408,
0410, 0412, and 0456). For example, Product Safety Solutions (Document
ID 0313) stated:

    OSHA requests comment on whether pictogram borders should be
required to be in red or should be allowed to be printed in black.
While the use of a red border may increase the cost of printing some
labels, the use of color to draw attention to a potential hazard is
a useful tool and is likely to enhance the communication of safety
information. As products may also be exported to other countries,
the use of the red border would be consistent with the establishment
of a globally recognized hazard symbol. Imported products likewise,
would have to contain the red symbol border and this would have to
be made abundantly clear to Customs Agents and others responsible
for monitoring the importation of chemical products.

    However, others argued that black frames should be permitted on
domestic shipments, and that the use of red borders is too costly and
burdensome in terms of printing costs in particular (See, e.g.,
Document ID 0328, 0338, 0344, 0352, 0370, 0376, 0389, 0399,
0405, and 0411). For example, ISSA (Document ID 0399) claims:

    If OSHA were to require only the red frame for pictograms, it
would require those formulators that presently print single color
labels to utilize different systems for producing labels of this
nature, requiring a substantial capital investment which in turn
will add greatly to the cost of transitioning to the revised HCS.
OSHA must keep in mind, that small and medium sized formulators
handle hundreds of products, each of which in turn are sold under
multiple private labels. Thus a change in color requirements for
labels generally will literally require a formulator to revise
hundreds, if not thousands, of individual labels.
    Further, we believe the use of a black frame will not present a
threat to worker health and safety. ISSA disagrees with OSHA's
conclusion that a red frame would significantly enhance the
communicative value of the label. In citing studies, OSHA does not
take into account that the use of the new labels will be the subject
of intensive employee training that will more than mitigate the use
of a black frame over a red frame.

    In the NPRM regulatory analyses, OSHA did not assess the specific
costs associated with red versus black borders, but has done so in the
analyses for the final rule. See Section VI. As noted by proponents of
the black border option for domestic shipments, the costs of a red
border are greater. However, OSHA's analysis shows that they are
economically feasible. In addition, OSHA believes that it is likely
additional, cheaper printing options will be developed to comply with
this requirement in the final rule. The EU requires red frames for
pictograms: ``Hazard pictograms shall be in the shape of a square set
at a point. They shall have a black symbol on a white background with a
red frame sufficiently wide to be clearly visible.'' (http://europa.eu/legislation_summaries/internal_market/single_market_for_goods/chemical_products/ev0013_en.htm) Application of this requirement in
the twenty-seven (27) EU member states is expected to lead to new
printing options for compliance.
    OSHA believes that the increased comprehension that will be
provided by the red border frame is compelling. The red color will
clearly delineate the hazard symbols from the other information on the
label, and the prominence will lead to increased attention and
recognition of the hazards. The transport labels and placards that have
been in use for many years have multiple colors in their pictograms,
and yet compliance has been achieved. Plus most product labels have
various colors related to their logos, brands, etc., so clearly it can
be done.
    There are also some logistical issues that would make compliance
more difficult with two different colored frames. First, it is unlikely
that it would always be known whether a product would be exported at
the point of labeling it at the end of the manufacturing process. Many
containers are simply shipped to distributors, and the original
manufacturer does not know where they will be sent after that--thus
raising the question of whether a manufacturer or importer would know
when to apply a black versus a red frame. In addition, workers exposed
to chemicals purchased from different sources might have different
frames, requiring additional training to avoid potential confusion. The
final rule remains as proposed, and requires pictograms to have a red
frame, with a black symbol on a white background, for all shipped
chemicals regardless of destination.
    Several commenters (Document ID 0318, 0382, and 0393) also
raised issues regarding whether pre-printed labels with blank red
frames could be used. The manufacturer would simply add the symbols to
the frames when printing the required label information. If a
manufacturer or importer took this approach, a particular label might
have one or more empty red diamonds in addition to any required
pictograms. OSHA does not believe that this would be appropriate. Blank
frames would still attract attention, but workers could be confused
about what they mean and whether something is missing from the
information. While blank frames could be marked to indicate they are
intentionally left blank, they will still contribute to clutter on the
label and distract from the primary messages (See, e.g., Document ID
0284). Blank frames are not considered acceptable by DOT. (See
49 CFR 172.401, Prohibited labeling; PHMSA Interpretation 02-0088).
OSHA does not believe this is a good alternative for compliance either,
and the final rule prohibits blank frames on the label (Appendix
C.2.3.1).
    Under the GHS, a symbol is generally assigned to each hazard class
and category. There are nine agreed symbols under the GHS to convey the
health, physical and environmental hazards. Eight of these symbols were
proposed for adoption in this rulemaking, the exception being the
environmental symbol. Six of these symbols have been used for many
years in the international transport requirements, so some employers
and employees will already be familiar with them.
    The symbols in the proposed rule are adopted in the final rule. Dow
Chemical (Document ID 0353) noted that the pictograms are not
entirely self-evident. While this may be true, the rule requires
training workers so they will know what the symbols mean and how to
respond.
    It should be noted that in the NPRM, the pictogram for C.4.17
(oxidizing gases) was published with a ``flame'' symbol, rather than
the ``flame over circle'' symbol that was appropriate, and was
described. OSHA has corrected this error in the final rule, and has
inserted the appropriate ``flame over circle'' symbol in Appendix
C.4.17 for oxidizing gases.
    The ``precautionary statement'' is ``a phrase that describes
recommended measures that should be taken to minimize or prevent
adverse effects resulting from exposure to a hazardous chemical, or
improper storage or handling.'' The precautionary statements specified
in Appendix C will be required on containers under the final rule. An
example of a precautionary statement is: ``Wear protective gloves.''
The precautionary statements in the GHS are assigned to certain hazard
classes and categories.
    Precautionary statements are not required under the current HCS,
although many chemical manufacturers include them on their labels for
safe handling and use. These statements are codified under the GHS,
meaning that numbers have been assigned to them. The precautionary
statements in the GHS are not harmonized like the hazard statements
are, and the regulatory authority is free to use the statements in the
GHS annex or to use alternative statements when adopting the current
version of the GHS. Using the GHS statements has the advantage of
adopting statements that have undergone expert review by the UN Sub-
committee, are assigned to the appropriate hazard class and category,
and have been translated into six languages. Work continues on them in
the Sub-committee to combine or edit the precautionary statements to
reduce repetition and the complexity of the label. The precautionary
statements may be considered harmonized in the future.
    Other countries are already using them (e.g., in Europe). Since
OSHA did not previously require the use of precautionary statements,
and had no such recommended statements to provide, the Agency decided
to use those in the GHS as the mandatory

requirements. This will make it easier for compliance since chemical
manufacturers and importers will not need to develop, maintain, and
translate precautionary statements on their own. It will also help
employees since they will be seeing the same language on labels
regardless of the supplier of the chemical. Such standardization
improves comprehension, and thus the effectiveness of the information
transmitted under the standard.
    While the definition of precautionary statement itself did not seem
to raise questions with rulemaking participants, there were a number of
comments on the proposal to make the GHS precautionary statements
mandatory. Many commenters agreed with OSHA that the statements should
be on the label, and should be mandatory (Document ID 0328,
0329, 0335, 0336, 0347, 0352, 0365, 0370, 0372, 0377, 0379, 0389, 0402,
0408, 0410, 0412, and 0456). Commenters mentioned increased
comprehensibility, as well as available translations, as some of the
reasons why they support this approach. It was also noted by a number
of commenters that OSHA should permit additional precautionary
statements to cover situations without an available statement in
Appendix C (Document ID 0313, 0324, 0327, 0329, 0335, 0352,
0365, 0370, 0376, and 0402). Others supported making them mandatory
when they are harmonized in the GHS (Document ID 0351 and
0405). And at least one participant argued that precautionary
statements should not appear on labels, just SDSs (Document ID
0338).
    Other commenters did not support the mandatory approach, and
thought that manufacturers should be able to continue to use their own
precautionary statements (Document ID 0321, 0330, 0344, 0353,
0363, 0376, 0381, 0382, 0393, and 0399). It was also suggested that the
UN needs to provide further guidance on when precautionary statements
can be combined or omitted (Document ID 0328, 0370, and 0376),
or that the number of phrases appearing on a label should be limited
(Document ID 0329 and 0405).
    In the final standard, OSHA has maintained the proposed provision
to require the precautionary statements in the GHS to be used on
labels. As noted previously, the use of prescribed precautionary
statements is consistent with the other label elements, and provides
the significant benefits of improved communication of information
through increased comprehensibility and familiarity. In terms of
flexibility, chemical manufacturers and importers are free to put
additional precautionary statements on the label from other sources in
the supplementary information area. As long as the information provided
is accurate, and does not conflict with the required information, this
is permitted.
    OSHA will also permit the statements to be combined as appropriate,
and states in Appendix C.2.4.6: ``Precautionary statements may be
combined or consolidated to save label space and improve readability.
For example, ``Keep away from heat, sparks and open flame,'' ``Store in
a well-ventilated place,'' and ``Keep cool'' can be combined to read
``Keep away from heat, sparks and open flame and store in a cool, well-
ventilated place.''
    In addition, where there are concerns, supported by evidence, about
the applicability of a statement to a particular product, the chemical
manufacturer or importer may revise the statements as appropriate for
the situation. Appendix C.2.4.8 states: ``If the chemical manufacturer,
importer, or responsible party can demonstrate that a precautionary
statement is inappropriate to a specific substance or mixture, the
precautionary statement may be omitted from the label.''
    Thus, the final rule adopts the precautionary statements, which are
taken from the GHS. However, it allows the use of additional statements
where necessary, as long as they are accurate, do not conflict, and are
placed in supplementary information. Additionally, chemical
manufacturers and importers can use their judgment to combine related
statements to shorten the amount of information on a label, as well as
omit any statements that can be demonstrated to be inapplicable to the
particular chemical involved. OSHA believes this approach maximizes the
comprehensibility of the precautionary statements, as well as
simplifies compliance for employers. Nevertheless, there are allowances
for unique situations, and thus assurances that the information will be
accurate.
    It was suggested that the precautionary statements should be
written in plain language (Document ID 0321). There were some
specific changes to particular statements that were suggested (such as
a statement regarding fighting fires near explosives, Document ID
0353). OSHA is not going to modify any of the statements as
published in the GHS in terms of technical information. These have been
reviewed by many experts. Changes should only be made to them through
the UN Sub-committee process at this point, as they are close to being
harmonized.
    However, OSHA has made a few minor changes to precautionary
statements in this final rule to address clarity and related issues.
These changes were adopted by the Sub-committee of Experts on the GHS
at its December 2010 meeting, and are expected to be included in
Revision 4 of the GHS. Most changes simply amend the precautionary
statement to clarify its meaning by making the statement more concise,
or stating it in plain language. Others either provide added
flexibility in applying the precautionary statement, or provide
instructions for the classifier on the conditions relating to use of
the precautionary statement. Examples of each type are presented below.
    Examples of precautionary statements for physical hazards that were
clarified in the final rule are presented below:

------------------------------------------------------------------------
                                             Precautionary statement in
 Precautionary statement in proposed rule            final rule
------------------------------------------------------------------------
Keep away from any possible contact with    Do not allow contact with
 water.                                      water.
In case of fire: Use * * * for extinction.  In case of fire: Use * * *
                                             to extinguish.
------------------------------------------------------------------------

    An example of a precautionary statement providing instructions for
the classifier on the conditions relating to use of the precautionary
statement is provided below for the health hazard class Skin corrosion/
irritation, Category 1A to 1C (for the illustration, the instructions
for use are provided in italics). In this example, note that the
precautionary statement was clarified and the conditions relating to
use of the precautionary statement were added.

------------------------------------------------------------------------
                                             Precautionary statement in
 Precautionary statement in proposed rule            final rule
------------------------------------------------------------------------
Immediately call a poison center/or doctor/ Immediately call a poison
 physician.                                  center/doctor/ * * *
                                            Chemical manufacturer,
                                             importer, or distributor to
                                             specify the appropriate
                                             source of emergency medical
                                             advice.
------------------------------------------------------------------------

    The final example of the precautionary statement changes is
provided below for instructions for the classifier on the conditions
relating to use of the precautionary statement. In certain situations,
text in a precautionary statement may not be appropriate. To address
this issue, a new paragraph C.2.4.5 has been added to explain the use
of text provided in square brackets ([ ]). Paragraph C.2.4.5 states:
``Where square brackets ([ ]) appear around text in a precautionary

statement, this indicates that the text in square brackets is not
appropriate in every case and should be used only in certain
circumstances. In these cases, conditions for use explaining when the
text should be used are provided. For example, one precautionary
statement states: ``[In case of inadequate ventilation] wear
respiratory protection.'' This statement is given with the condition
for use: ``text in square brackets may be used if additional
information is provided with the chemical at the point of use that
explains what type of ventilation would be adequate for safe use.''
This means that, if additional information is provided with the
chemical explaining what type of ventilation would be adequate for safe
use, the text in square brackets should be used and the statement would
read: ``In case of inadequate ventilation, wear respiratory
protection.'' However, if the chemical is supplied without such
ventilation information, the text in square brackets should not be
used, and the precautionary statement should read: ``Wear respiratory
protection.''
    OSHA has included these non-substantive, minor changes approved by
the UN Sub-committee, because they make the statements more readable,
allow added flexibility, and are consistent with the latest version of
the GHS.
    Container labels will also be required to include a ``product
identifier.'' The proposed definition for this term, which was retained
in the final rule with a clarifying change (discussed below), was ``the
name or number used for a hazardous chemical on a label and in the SDS.
It provides a unique means by which the user can identify the chemical.
The product identifier used shall permit cross references to be made
among the required list of hazardous chemicals, the label, and the
SDS.'' In other words, the product identifier is essentially the same
as the ``identity'' under the current HCS. The GHS allows competent
authorities for workplace requirements to choose not to require
specific chemical identities of ingredients to be listed on the label,
as long as they are on the SDS. This is the approach OSHA currently
uses in the HCS, and it has been effective. OSHA will continue to
require chemical identities only on SDSs, and has proposed a definition
for ``product identifier'' that is consistent with the current
definition for ``identity'' (which has been deleted from the final
rule) to maintain this approach. ACC (Document ID 0393) and
Procter & Gamble (Document ID 0381) suggested that OSHA should
clarify what the ``required list of hazardous chemicals'' refers to in
the definition. This terminology has been in the HCS since the original
standard was published in 1983, and refers to the only list of
chemicals required by the HCS, which is in the written hazard
communication program. Therefore, OSHA has modified the language in the
final rule to read: ``among the list of hazardous chemicals required in
the written hazard communication program, the label and the SDS.''
    Another new concept in the NPRM for HCS labels is inclusion of a
``signal word'' to bring attention to the hazardous effects, as well as
to contribute to the recognition of the severity of the hazard. Signal
words have been used for many years in the United States on consumer
and pesticide labels. The proposed definition is ``a word used to
indicate the relative level of severity of hazard and alert the reader
to a potential hazard on the label. The signal words used in this
section are `danger' and `warning.' `Danger' is used for the more
severe hazards, while `warning' is used for the less severe.'' OSHA
received no objections to the proposed definition of ``signal word''
and it is being carried through to the final rule.
    OSHA proposed to add a definition to the HCS for ``unclassified''
hazards. As has been noted, the current HCS is performance-oriented,
and takes a very broad approach to defining hazards covered by the
rule. The GHS is similarly broad in approach, but includes very
specific definitions of criteria to apply when determining whether a
chemical poses a physical or health hazard. This specification approach
has significant benefits associated with it, including providing more
guidance to help ensure a consistent approach to determining hazards.
It also allows more information to be developed that provides an
indication of the severity of effect.
    OSHA proposed to add a definition to the HCS for ``unclassified''
hazards. As has been noted, the current HCS is performance-oriented,
and takes a very broad approach to defining hazards covered by the
rule. The GHS is similarly broad in approach, but includes very
specific definitions of criteria to apply when determining whether a
chemical poses a physical or health hazard. This specification approach
has significant benefits associated with it, including providing more
guidance to help ensure a consistent approach to determining hazards.
It also allows more information to be developed that provides an
indication of the severity of effect.
    In the ANPR, OSHA asked for comment on whether the GHS criteria are
sufficient to cover the hazards present in the workplace. While the
Agency believed the scope of coverage is similar between the two
approaches, OSHA wanted to be sure that the new approach is as
comprehensive as the existing standard. In the NPRM (74 FR 50390, Sept.
30, 2009), OSHA noted two hazards of concern--combustible dust and
simple asphyxiants. Both of these are mentioned in the GHS in the SDS
annex as examples of hazards not classified that should be addressed on
the SDS.
    It is possible that there are other hazards that may not yet be
specifically defined. Rulemaking participants have mentioned several
(e.g., static accumulators) (Document ID 0382 and 0402). The
addition of the definition for unclassified hazards was intended to
address these situations. Where a classifier has identified evidence of
a hazard, but the evidence does not meet the currently specified
criteria for hazards covered by the rule, the definition for
unclassified hazards captures those effects to ensure that the final
rule is appropriately protective, and covers all of the hazards covered
by the current rule. During the negotiations for the GHS, U.S. industry
representatives often raised the issue of ensuring that they could
provide additional hazard information in order to satisfy product
liability laws in the U.S. This was the rationale for allowing such
information to be included on labels under supplementary information,
and on SDSs under Section 2. OSHA believed that addition of the
proposed definition of ``unclassified hazards,'' and specific
recognition of the need to provide information when such effects arise,
would help U.S. industry address its product liability concerns as well
as protect exposed workers (74 FR 50390, Sept. 30, 2009).
    OSHA proposed to require the chemicals posing unclassified hazards
to be treated as hazardous chemicals under the rule. The Agency
anticipated that this information would appear in Section 2 of the SDS
(Hazard Identification)--the GHS already identifies this as the
appropriate place in its guidance on the contents of SDSs (A<IP_ADDRESS>,
Other hazards which do not result in classification), and proposed
Appendix D included the requirement to list unclassified hazards. In
terms of labeling, there are no specified label elements in the GHS for
chemicals that pose unclassified hazards. OSHA proposed to require that
the label for such hazards must name the chemical, and describe the
hazardous effects

under supplementary information on the label, as well as provide any
appropriate precautionary information. OSHA also expected that such
hazards would be addressed in worker training programs.
    It is important to understand that the Agency anticipated that
there would be relatively few situations where there would be
scientific evidence or data indicating an effect that is not currently
classified, and merely wanted to ensure that this information is
captured and conveyed to employers and employees. OSHA also indicated
that it would be appropriate to establish a feedback mechanism, where
classifiers could inform OSHA of situations where the current criteria
are insufficient, and the Agency can then suggest to the United Nations
that appropriate criteria be developed and added to the GHS. This is
consistent with the overall approach to hazard classification in the
GHS that OSHA proposed to adopt--that specific criteria be provided to
help ensure that classification is appropriate, and information
transmittal is consistent from company to company. Therefore, the use
of the definition of unclassified hazard was to be a temporary
situation for these hazards, ensuring information is provided until
such time as the criteria are added to the rule.
    There were many comments received regarding the NPRM definition and
concept of ``unclassified hazards.'' A number of participants agreed
with OSHA that there is a need to cover some hazardous effects that
have not yet been spelled out in the GHS with criteria (Document ID
0313, 0327, 0347, 0363, 0365, 0366, 0367, 0410, and 0412).
Others suggested that it was an appropriate interim step, while working
with the UN to get criteria added to the GHS (Document ID
0329, 0330, 0335, 0339, 0352, 0370, 0376, 0383, 0405, and
0414). Some argued that these hazardous effects should have specific
criteria so employers would know with certainty what is covered
(Document ID 0327, 0361, 0366, 0377, and 0392).
    With regard to the actual definition, some thought it was too broad
and ambiguous (Document ID 0344, 0379, 0381, and 0399). The
U.S. Chamber of Commerce (Document ID 0397) argued that the
definition should be withdrawn, or substantially revised, and that OSHA
was exceeding its authority. There were other commenters who thought
the effects should be called ``hazards not otherwise classified'' or
``additional hazards'' rather than ``unclassified hazards.'' See, e.g.,
Document ID 0328, 0344, 0363, 0370, 0376, 0393, and 0405. It
was also suggested that the approach should only cover those hazards
currently covered by the HCS (Document ID 0338).
    OSHA has considered all of these comments, and the need to provide
sufficient protection for exposed employees, in devising an approach
for the final rule. First, OSHA agrees with commenters that using the
term ``hazards not otherwise classified'' is a better designation.
Secondly, OSHA has revised the language to clarify the intent and
address what was perceived as ambiguity. The definition in the final
rule, which replaces and amends the proposed definition of
``unclassified hazard,'' now reads: ```Hazard not otherwise classified
(HNOC) means an adverse physical or health effect identified through
evaluation of scientific evidence during the classification process
that does not meet the specified criteria for the physical or health
hazard classes addressed in this section. This does not extend coverage
to adverse physical and health effects for which there is a hazard
class addressed in this section, but the effect either falls below the
cut-off value/concentration limit of the hazard class or is under a GHS
hazard category that has not been adopted by OSHA (e.g., acute toxicity
Category 5).''
    Additionally, and importantly, OSHA has deleted proposed paragraph
(f)(2), which specified information to include on labels for the HNOC
chemicals. Given that there are no harmonized label elements available
for these effects, it appears that this could be confusing to both the
label preparers and the users of the chemicals. However, provision of
an SDS for HNOC chemicals is required under the final rule, and
information regarding their hazards is to be included in Section 2.
    The U.S. Chamber of Commerce objected to the inclusion of
``unclassified hazards'' in the final rule because, in its view, the
proposed definition is ``broad,'' ``expansive,'' and will ``impose new
requirements on employers without undertaking all of the steps in a
full OSHA rulemaking'' (Document ID 0397). OSHA appreciates
the concerns and has carefully considered (and in some respects
revised) the provision with those concerns in mind. OSHA does not
intend to impose new requirements, or to bypass rulemaking, but
includes the definition to continue the longstanding requirements that
such hazards be disclosed. As finalized and clarified, the relevant
provision does not expand on those requirements or add new burdens; on
the contrary, it preserves requirements in the current rule. The
following discussion is designed to clarify these points.
    As noted above, the final rule retains the proposed requirement,
using the term ``hazard not otherwise classified'' (HNOC) instead of
unclassified hazard. In essence, this definition requires classifiers
who find ``scientific evidence'' that a chemical can cause death,
illness, or injury to workers in a way not currently covered by the GHS
classification criteria to disclose that fact on the SDS. This is meant
to be a modest and narrow requirement. It is triggered only when the
classifier has objective, scientific evidence of the hazard. OSHA
believes that there are likely to be few such hazards outside those
covered by the specific criteria in the final rule, which are the
product of over thirty years of international experience in hazard
communication.
    It is important to understand that the HNOC definition essentially
preserves (and does not expand) the scope of the current rule, which is
not as tightly bound to specific criteria as the GHS. The HNOC
definition should be interpreted and understood with this preservative
goal in mind. For example, under the current rule, ``health hazard''
means a chemical for which there is at least one statistically
significant scientific study showing that ``acute or chronic health
effects may occur to exposed employees.'' Indeed, while mandatory
Appendix A of the current standard lists criteria for specific health
effects, it also notes that these criteria are not intended to be an
exclusive categorization scheme, but rather any available scientific
data on the chemical must be evaluated to determine whether the
chemical presents a health hazard. Likewise, though the current
definition of physical hazard is tied to a specific list of effects,
some of these can also be quite broad. For example, under the current
rule, ``flammable solid'' includes a material ``which can be ignited
readily and when ignited burns so vigorously and persistently as to
create serious hazard.''
    The essential point is that the HNOC definition is designed so as
to prevent the final rule from being less protective than the current
standard by picking up any hazards that might fall within the
definitions of the current rule, but might fall outside the GHS hazard
classes. As discussed above, it is OSHA's intent that the HNOC
classification would be an interim measure, used until harmonized
criteria for a hazard can be adopted at the UN Sub-committee level, and
subsequently incorporated into the HCS through rulemaking.
    If the provision is understood in light of the foregoing points,
this rulemaking is all the OSH Act and the Administrative Procedures
Act (APA)

requires of OSHA before adopting the HNOC requirement. By preserving
the requirements equivalent to those in the current rule, all the final
rule does is to require chemical manufacturers and importers with
reliable information that exposure to their chemical can cause illness,
injury or death to an employee to disclose that fact on an SDS. OSHA
has the authority to regulate hazard communication on a general level;
indeed it must if it is to provide comprehensive worker protection in
this area. See National Ass'n of Manuf. v. OSHA, 485 F.3d 1201, 1204
(D.C. Cir. 2007); Associated Bldrs & Contrs. Inc. v. Brock, 862 F.2d
63, 68 (3d Cir. 1988). Stakeholders have had a chance to comment on the
HNOC requirement, and this rulemaking proceeding satisfies OSHA's
statutory obligations.
    With regard to the three hazards specifically mentioned during the
rulemaking (pyrophoric gases, simply asphyxiants, and combustible
dust), OSHA is handling them as follows in the final rule.
    OSHA inadvertently removed the definition of pyrophoric gases from
the proposal when it removed the generic definition for pyrophorics.
The American Chemistry Council (ACC) correctly pointed out that
excluding the pyrophoric gases, even though there is no corresponding
definition in GHS, would mean that they would not be labeled or
classified appropriately (Document ID 0393). OSHA agrees and
has included the definition of pyrophoric gas in the current HCS in
this final rule. Pyrophoric gases must therefore be addressed both on
container labels and SDSs, and in worker training programs. Therefore,
OSHA has retained the definition for pyrophoric gases from the current
HCS and has added pyrophoric gases to the definition of ``hazardous
chemical''. Label elements are provided in C.4.30. The signal word will
be danger; the pictogram is the flame; and the hazard statement is
``Catches fire spontaneously if exposed to air.''
    For the two examples of effects not addressed in the GHS that were
raised in the proposal (simple asphyxiants and combustible dust), OSHA
is addressing them specifically in the final rule rather than covering
them under the HNOC definition. Using comments in the record, and
commonly applied voluntary industry consensus standards, the Agency has
designated chemicals with these properties under the definition of
``hazardous chemical.'' The chemicals posing such effects must
therefore be both labeled where appropriate, and addressed on SDSs and
in training. In addition, OSHA has added C.4.30 to Appendix C to
provide the label elements for OSHA defined hazards.
    With regard to simple asphyxiants, OSHA had indicated in Issue
8 (74 FR 50282, Sept. 30, 2009) that it believed it might be
more appropriate to simply add a definition of this effect to the final
rule rather than covering it under the ``unclassified hazard''
approach. A definition was proposed as follows:

    ``Simple asphyxiants'' are substances that displace oxygen in
the ambient atmosphere, and can thus cause oxygen deprivation in
exposed workers that leads to unconsciousness and death. They are of
particular concern in confined spaces. Examples of asphyxiants
include: nitrogen, helium, argon, propane, neon, carbon dioxide, and
methane.

    OSHA also solicited comments on proposed specific label elements.
No symbol would be required, but the signal word ``warning'' would be
used, with the hazard statement ``may be harmful if inhaled.'' In
addition, a precautionary statement such as the following would be
required: ``May displace oxygen in breathing air and lead to
suffocation and death, particularly in confined spaces.''
    A number of commenters agreed with the definition and the approach
(Document ID 0339, 0347, 0351, 0365, 0366, 0370, 0405, 0408,
and 0456). Others had specific comments on what was proposed, such as
arguing for simplification of the language (Document ID 0414);
proposing to replace the definition with the NFPA 704 definition of
``simple asphyxiant'' (Document ID 0330); suggesting a
reference to ``suffocation'' (Document ID 0329 and 0335), or
indicating that the hazard statement is really a precautionary measure,
or vice versa (Document ID 0376, 0382, 0393, and 0405).
Procter & Gamble suggested it should not be covered since it is not an
inherent toxicity (Document ID 0381).
    OSHA disagrees with Procter & Gamble's argument. Chemicals with
certain properties can displace oxygen and cause asphyxiation. Not
every chemical has those properties, so the asphyxiation hazard is
inherent and chemical-dependent. Moreover, OSHA has provided
longstanding interpretations that indicate simple asphyxiants are
covered under the current HCS (e.g., OSHA interpretation, March 4,
1993) and therefore industries working with these substances have
provided labels and SDSs on simple asphyxiants in accordance with HCS
requirements.
    OSHA believes that coverage of simple asphyxiants is very important
to the HCS. Such substances result in fatalities in the workplace,
particularly in confined spaces, and need to be warned about
effectively. The definition has been revised based on the comments
received, and included in paragraph (c): `` `Simple asphyxiant means a
substance or mixture that displaces oxygen in the ambient atmosphere,
and can thus cause oxygen deprivation in those who are exposed, leading
to unconsciousness and death.'' Label elements are provided for simple
asphyxiants in Appendix C.4.30. Simple asphyxiants will require the
signal word ``warning'' and the hazard statement ``may displace oxygen
and cause rapid suffocation.'' In addition, OSHA has added ``simple
asphyxiant'' to the definition of ``hazardous chemical.'' Thus all of
the provisions of the rule that apply to hazardous chemicals will apply
to simple asphyxiants as well.
    OSHA will continue to work with the UN to add this hazard to the
GHS. (The U.S. has raised this issue in the UN Sub-committee, but it
has not yet been resolved. Some of the Sub-committee members share the
view that it should not be covered since, according to them, it is not
an inherent hazard.) We will evaluate the need for additional
rulemaking to change the definition and label elements if the UN
incorporates simple asphyxiants into the GHS.
    For combustible dust, OSHA has also already provided considerable
guidance on the nature and definition of combustible dust in a variety
of materials, including OSHA's Hazard Communication Guidance for
Combustible Dusts, OSHA (3371-08 2009), and its Combustible Dust
National Emphasis Program Directive CPL 03-00-008. As described in the
preamble to the NPRM (74 FR 50395, Sept. 30, 2009), this was an issue
that many ANPR commenters had provided information on, and is clearly a
concern in the workplace. There have been a number of workplace
incidents involving combustible dust, and the U.S. Chemical Safety and
Health Investigation Board highlighted the need to address this
specifically in the HCS (Document ID 0110):

    The CSB therefore recommends that OSHA amend the HCS to
explicitly address the fire and explosion hazards of combustible
dusts, and those materials that could reasonably be expected to
produce combustible dusts, among the substances covered by the
standard, and also that the Agency require inclusion of dust fires
and explosions among the physical hazards that must be addressed in
Material Safety Data Sheets. The CSB also requests that OSHA
advocate similar changes to the GHS through appropriate
international mechanisms.

    OSHA has introduced this issue to the UN Sub-committee as well, and
is leading a correspondence group on it. However, one of the problems
in pursuing this approach is that some countries' systems are limited
to supply chain requirements, and do not cover hazard communication
issues that arise in the workplace as a result of processing. OSHA's
rule does cover such workplace hazards, and requires the provision of
information to downstream customers when known processing approaches
will result in a hazard. Therefore, discussions continue, but the Sub-
committee will not resolve this for at least two years.
    In light of the important nature of the issue, a number of public
comments, and the need to provide clarity sooner than the UN Sub-
committee will complete its work, OSHA is including combustible dust in
the definition of ``hazardous chemical'' in this final rule. We have
noted that many commenters agreed that there was a need to provide
hazard communication on combustible dust, as has been required by OSHA
under the current rule. But there were also suggestions that criteria
and greater clarity were needed in order to avoid confusion. A few
commenters argued that OSHA should not cover combustible dust since it
is not an intrinsic hazard of a product (See, e.g., Document
ID0393). However, OSHA believes that similar to the situation
with simple asphyxiants, all dusts in the workplace are not
combustible, and processing of them does not always result in
combustible atmospheres. Consistent with Executive Order 13563 and its
emphasis on reducing uncertainty, OSHA agrees with commenters noted
above that employers need certainty to properly cover it.
    It is true that a separate rulemaking is ongoing on this topic in
OSHA, and some commenters suggested that the combustible dust issue
should therefore not be addressed in this rulemaking. Such an approach
would, however, eliminate safeguards that have long been in place
(since 1983). Similar to the situation with simple asphyxiants, OSHA
has provided longstanding interpretations that indicate combustible
dusts are covered under the current HCS (e.g., OSHA interpretation,
January 16, 1986). Specifically, under OSHA's existing Hazard
Communication Standard, combustible dust is addressed under the broad
definition as both a flammable solid and an explosive hazard.
Therefore, not addressing combustible dust in this rulemaking would
fail to meet the requirements--which are central to the existing
standard--that chemical manufacturers and importers provide information
on hazardous chemicals.
    While OSHA is currently in the preliminary stages of developing a
proposed rule to address combustible dust, the new standard is not
expected to be completed for some time. It is also important to note
that there is a clear distinction between coverage under the HCS, and
potential provisions promulgated under a specific rulemaking for
combustible dust. The rulemaking on combustible dust is a much broader
approach to the issue, and will likely establish methods to control and
address such dusts in the workplace. The HCS is an information
transmittal standard. Provision of information to downstream employers
is critical now, as it can alert them to the need to have a protective
program. This is a fundamental purpose of the HCS--to provide employers
and employees with information about hazards so they can take steps to
protect their employees and themselves. A failure to continue to
address the combustible dust issue in the HCS at this time would
eliminate current protections. Therefore, the Agency is clarifying its
position that it will continue to regard combustible dust as a serious
hazard for which chemical manufacturers and importers must provide
information to downstream employers.
    The Agency is not adding a definition for combustible dust to the
final rule given ongoing activities in the specific rulemaking, as well
as in the UN Sub-committee. However, guidance is being provided through
existing documents, including the Combustible Dust National Emphasis
Program Directive CPL 03-00-008. This directive includes an operative
definition, as well as provides information about current
responsibilities in this area. In addition, there are a number of
voluntary industry consensus standards (particularly those of the NFPA)
that address combustible dust, and were noted by commenters as
providing further guidance in this area. (See, e.g., Document ID
0379 and 0530). Chemical manufacturers and importers must be
aware of the hazards of their products, both in the shipped form, and
under normal conditions of use or foreseeable emergencies in downstream
workplaces, in order to comply with the HCS. Information about these
hazards is required to be transmitted through labels and SDSs as
specified in the standard. The protection of workers in downstream
workplaces depends on the provision of accurate information to their
employers.
    Label elements are also provided for combustible dust in C.4.30
requiring, when appropriate, the signal word ``warning'' and the hazard
statement ``May form combustible dust concentrations in air'' (similar
to ANSI Z400.1/Z129.1--2010 statements).
    Concerns were raised by commenters that labels with a signal word
and hazard statement may not be appropriate in some situations, because
the combustible dust is created through processing downstream, and the
product may not present a hazard in its shipped form. (See, e.g.,
Document ID 0050 and 0353.) Dow (Document ID 0353)
pointed out: ``Over-warning would dilute the message.''
    OSHA has already addressed a similar situation under paragraph
(f)(4) of the final standard, which addresses solid metal, solid wood,
plastic, and shipments of whole grain that present no hazard in
shipping, but which are used in such a way in downstream operations
that employees can be exposed to hazards. In this situation, the
downstream employer needs label information about the hazards to
protect employees, but OSHA determined that such label information does
not need to accompany the product. Therefore, paragraph (f)(4) allows
the chemical manufacturer or importer to transmit the label to the
customer at the time of the initial shipment, but the label does not
need to be included with subsequent shipments unless it changes. This
provides the needed information to the downstream users on the
potential hazards in the workplace, while acknowledging that the solid
metal or other materials do not present the same hazards that are
produced when these materials are processed under normal conditions of
use.
    Many products that are a combustible dust hazard when processed are
similar in nature, and therefore paragraph (f)(4) would apply. A
shipment of grain, for example, does not present a combustible dust
hazard in the shipped form. But when processed downstream in a plant,
such hazards are a concern, and the employer needs the label
information to properly address the hazard in the workplace. Since this
is a normal condition of use for the grain, the chemical manufacturer
or importer must provide the information at the time of the initial
shipment, and in the future if there is new information regarding the
hazards or protective measures. An SDS must always be provided.
    In other situations where the material is shipped in a dust form
that is potentially combustible without further processing, the
chemical manufacturer or importer must have appropriate labels on the
containers when shipped under the requirements of paragraph (f)(1). If
the chemical manufacturer

labels the product for combustible dust, the label must use the
required labeling elements in C.4.30.
    Combustible dust has been added to the definition for hazardous
chemical, and thus all of the provisions of the standard as amended by
the final rule that apply to hazardous chemicals will also apply to
combustible dusts, including safety data sheets and worker training.
Employers with workplaces where combustible dusts are generated must
comply with the workplace labeling requirements in paragraph (f)(6).
    As with simple asphyxiants, OSHA will continue to encourage the UN
Sub-committee to deal with combustible dusts and develop criteria to be
adopted by countries such as ours where workplace exposures are a key
part of the hazard communication system.

(d) Hazard Classification

    Hazard determination under the current standard. Under the current
HCS, chemical manufacturers and importers are required to evaluate the
scientific data available regarding each chemical they produce or
import, and determine whether the chemical is hazardous within the
meaning of the standard. This requires a thorough search of the
scientific literature on both the health and physical hazards that the
chemical may pose. The identified information must be evaluated within
the parameters established in the standard to determine whether the
chemical is considered to pose a hazard. Paragraph (d), Hazard
determination, provides the regulatory approach for evaluation. This
approach is to be implemented using the definitions provided in
paragraph (c) as well as in Appendix A, which provides further
elaboration on the nature and breadth of health hazards covered.
Appendix B provides additional requirements for identifying and
evaluating data regarding hazards. Both of these appendixes are
mandatory.
    In order to ensure the broadest dissemination of information, and
to reduce the number of situations where conflicting determinations may
be made for the same chemical by different suppliers, the current HCS
considers one study, conducted according to established scientific
principles and producing a statistically significant result consistent
with the definitions of hazard in the standard, to be sufficient for a
finding of health hazard under the rule. See 29 CFR 1910.1200(d)(2) and
Appendix B. This approach was the broadest among those systems that
were used as the basis for the development of the GHS.
    Most of the definitions under the current HCS simply lead to a
conclusion that the chemical involved poses that hazard or it does not.
For example, a chemical might be found to be a carcinogen under the
rule based on one study indicating that it poses a carcinogenic effect.
The current standard does not generally address the degree of severity
of the hazardous effect in most of the definitions--so a chemical is
either a carcinogen, or it is not. However, while a one-study
determination leads to providing information about that hazardous
effect on a safety data sheet, it may not lead to a hazard warning on a
label. The current HCS requires such warnings to be ``appropriate,''
and there are situations where the data do not support warning about
the hazard on the label because of other negative studies or
information. See 29 CFR 1910.1200 (f)(1)(ii). Thus, there is
consideration of the weight of evidence when deciding what to include
on a label. Chemical manufacturers and importers may also review the
weight of evidence in preparing SDSs, and are permitted to discuss
negative evidence and other constraints when reporting the information.
Under the current standard, OSHA expects the hazard evaluation process
to go beyond simply identifying one study, and include a complete
evaluation of all of the information available when determining what
information to transmit to users of the chemical.
    This hazard evaluation process is consistent with product
stewardship processes that have evolved in the chemical industry. (See,
e.g., the Responsible Care[supreg] program implemented by chemical
manufacturers.) Under such processes, chemical manufacturers develop
and maintain thorough knowledge of their chemicals. This knowledge is
critical to the safe handling and use of the chemicals in their own
facilities, as well as in their customers' facilities. It is also
critical to handling product liability concerns for their materials.
    The current HCS requires chemical manufacturers to remain vigilant
regarding new information about their chemicals, and to add significant
new information about hazards or protective measures to their hazard
communication documents within three months of learning about them. See
29 CFR 1910.1200(f)(11), (g)(5). This has always been seen by OSHA as a
more rigorous, but essential, requirement than some other countries'
provisions, which only require these documents to be reviewed every few
years. It should be noted that OSHA has not been enforcing the current
requirement to change labels within three months of getting new
information. This stay on enforcement began some years ago when the
standard was first promulgated, and involved concerns about existing
stockpiles of chemicals and other related information. The stay does
not apply to safety data sheets. OSHA proposed to reinstate the
requirement and lift the stay, making the updating period consistent
with that required for safety data sheets (See the discussion below on
labels).
    At the time the HCS was promulgated, the standard's provisions and
approach were quite novel, and there were concerns that chemical
manufacturers and importers would need more guidance regarding what
chemicals to consider hazardous. Thus OSHA included provisions in the
hazard determination paragraph that established certain chemicals as
being hazardous. Chemical manufacturers and importers still had to
complete a hazard evaluation and determination of what hazards were
posed, but for these designated chemicals, there was no decision to be
made as to whether they were hazardous or not. These chemicals were
considered to be a ``floor'' of chemicals covered by the rule, and
included those for which OSHA has permissible exposure limits in 29 CFR
Part 1910, as well as those for which the American Conference of
Governmental Industrial Hygienists (ACGIH) has recommended Threshold
Limit Values (TLVs). In addition, given that carcinogenicity was the
most controversial and difficult health effect to address, OSHA
indicated that, at a minimum, chemicals found to be carcinogenic in the
National Toxicology Program's biennial Report on Carcinogens (RoC), or
in monographs published by the International Agency for Research on
Cancer, were to be considered to be carcinogens in addition to those
regulated by OSHA as carcinogens.
    The current HCS also includes provisions regarding hazard
determinations for mixtures. 29 CFR 1910.1200(d)(5). Where such
mixtures have been tested to determine their hazardous effects, the
data on the mixture as a whole are used. Where testing has not been
done, OSHA promulgated an approach based on the percentage of a
hazardous chemical in a mixture to determine if the mixture is
hazardous. Therefore, if a mixture contains one percent (by weight or
volume) or more of a chemical determined to present a health hazard,
the mixture is assumed to have the same effect. The one exception is

carcinogens--a mixture is considered to be carcinogenic if it contains
0.1% or more of a chemical found to be carcinogenic.
    In all cases, a mixture will still be considered to be hazardous if
there is evidence that it poses a health risk when the hazardous