OSHA Issues Comprehensive Proposed Revisions
to Hazard Communication Regulations
October 14, 2009
Introduction
On September 30, the Occupational Health and Safety Administration (OSHA) published the first
major proposed rulemaking of the Obama administration--the long-awaited comprehensive changes to
the Hazard Communication Standard, 29 C.F.R. 1910.1200; 1915.1200, 1917.28, 1918.90; and
1926.59 (HCS). The stated aim of the rulemaking is to help promote consistency in the identification,
classification, and labeling of chemicals around the world.
While there is general agreement that the adoption of international standards is an important step in the
right direction, chemical manufacturers, chemical importers, and downstream users of hazardous
chemicals need to pay particular attention the proposed regulatory changes because they (1) may force
a reevaluation and reclassification of the level of danger posed by dangerous chemicals, and (2) may
dictate, often in minute detail, the content of container labels and other materials as they move
downstream. Moreover, the new rule would result in significant changes to the procedures by which a
chemical is determined to be hazardous by eliminating (1) the current "floor" of chemicals considered
to be hazardous and (2) the toxicological study basis for finding that a chemical is hazardous, and by
adding an "unclassified" hazard category. Other significant changes employers should pay attention to
include training costs and expenses associated with the new rules, and their potential adverse impact on
small entities and employers.
We expect the comment period, which expires on December 29, to be an active one, and encourage
companies and organizations to consider submitting comments to address any issues that are
significant to their businesses.
History of the HCS
The HCS was promulgated in 1983 to ensure, among other things, that chemical manufacturers and
importers evaluate and control chemical hazards as the materials move to downstream users. The HCS
requires chemical manufacturers and importers to do the following:
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? Determine if any of the chemicals they produce are dangerous chemicals by reviewing
available scientific evidence concerning the physical and health hazards associated with the
chemicals
? Develop for every chemical found to be dangerous a container label and Material Safety
Data Sheet (MSDS) to provide information about those hazards to all downstream users of
the chemical
In addition, all employers with employees exposed to the hazardous chemicals (including
manufacturers, importers, and downstream employers) must develop a hazard communication
program, and ensure that employees have access to container labels, MSDSs, and training on
hazardous substances in their workplace.
The HCS applies, however, only within the United States. Other countries developed similar standards,
labels, and MSDSs that were not uniform, creating a major compliance burden for businesses operating
internationally. For that reason, in 1992, the United Nations (UN) Conference on Environment and
Development called for the development of a globally harmonized chemical classification and labeling
system. Later that year, the UN adopted the Globally Harmonized System of Classification and
Labeling of Chemicals (GHS), with a 2008 goal for implementation.
The proposed regulatory changes to the HCS incorporate many of the GHS's requirements, bringing
the U.S. standard more in line with the international community. It is important to note, however, that
the GHS has not been adopted "wholesale." OSHA added regulations, for example, to address
previously unclassified dangers--such as combustible dust--while at the same time declining to adopt
other GHS classifications of danger.
New Terms and Definitions
Definition of "Chemical"
OSHA declines in its proposal to remove the terminology "chemical" to match the GHS, which instead
uses the terms "substance" and "mixture." The HCS will continue to define "chemical" to include
elements, chemical compounds, and mixtures of elements and/or compounds. Although the proposal
makes small changes to the terms "substance" and "mixture" to acknowledge the GHS's use of those
terms, OSHA explains that those technical revisions do not alter the meaning of those terms.
"Floor" of Chemicals/Universal One Study Rule
The current HCS includes established procedures by which employers and other entities can currently
evaluate and determine under a performance-oriented system whether or not the chemical in question
is hazardous, including (1) relying on an established "floor" of chemicals determined to be hazardous
based on referenced lists, or (2) a finding that the chemical is hazardous being triggered by the
existence of one toxicological study concluding a possible adverse health effect. The proposal departs
from this established practice in several important respects. The proposal eliminates both the
recognized "floor" of chemicals already determined to be hazardous, as well as the ability of the
existence of one study to trigger a hazard finding. These procedures are replaced by specific and
detailed criteria for every health hazard in an effort to provide a guide for the evaluation of relevant
data to determine classification. The proposal is a significant change from the existing mechanisms and
could result in changes to the present hazard classification of common chemicals.
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"Unclassified" Hazards
The current HCS defines specific harms, such as toxicity or combustibility, and regulates each harm
according to its specific traits. The proposed regulations continue in that tradition--with one important
exception. The proposed regulations recognize that the regulations themselves cannot define every
type of hazard, and that there will be situations in which the classifier has identified evidence of a
hazard, but the evidence does not meet the currently specified criteria for hazards covered by the rule.
OSHA, therefore, added to the regulations coverage for "unclassified" hazards--and requires within
the proposal that organizations treat chemicals exhibiting those "unclassified" dangers as hazardous
chemicals under the rule. This significantly broadens the existing HCS--and expands coverage beyond
international standards. OSHA specifically cites both combustible dust and simple asphyxiates as
examples of chemicals with "unclassified" hazards (although elsewhere in the regulations, OSHA also
states that current HCS regulations do cover combustible dust).
Moving from Hazard Determination to Severity Classification
Under the existing HCS, chemical manufacturers and importers are required to evaluate the scientific
data available regarding the chemicals they produce or import, and to determine whether they are
hazardous within the meaning of the standard. That inquiry, however, yields only a determination that
a chemical is or is not hazardous.
The proposed rule adds a second layer to the inquiry, requiring chemical manufacturers and importers
to not only identify a hazard, but to also classify the severity of that hazard. This inquiry must be made
with reference to two appendices to the HCS--Appendix A for Health Hazards and Appendix B for
Physical Hazards--that delineate, in specific detail, the different classes of hazard in a particular range.
For example, carcinogenic chemicals would have the following classifications:
? Category 1: Known or presumed human carcinogen.
? Category 1A: Known to have carcinogenic potential for humans. Classification in this
category is largely based on human evidence.
? Category 1B: Presumed to have carcinogenic potential for humans. Classification in this
category is largely based on animal evidence.
? Category 2: Suspected human carcinogen.
The proposal also reemphasizes that the classification procedures must be followed for mixtures as
well as individual chemicals. The Appendices provide classification criteria for mixtures.
Other Classification Proposals
In addition, the proposed rule also does the following:
? Allows employers to continue to rely on supplier information when making hazard
determinations.
? Reemphasizes that the evaluator must take into account the "full range" of scientific
evidence concerning potential hazards.
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? Continues the existing rule that there is no requirement to test a chemical to classify its
hazard. The proposal states directly that "[t]he GHS does not require testing, and neither
does the HCS. Both are based on available data. This has always been the case for the HCS,
and is now explicitly addressed in the revised text to ensure it is understood by all
stakeholders."
Label Requirements
HCS labels provide workers with a brief, visual hazard summary at the worksite where the chemical is
used. Current regulations require that the label include the identity of the chemical, the specific
physical and health hazards, including target organ effects, and the name and address of the
manufacturer, importer, or other responsible party. There is no required standard format or design for
the labels.
To increase the effectiveness of these labels, OSHA is proposing a new requirement that labels include
four standardized elements--a signal word, a hazard statement, a pictogram, and precautionary
statements--that the agency believes better convey critically important information chemical hazards.
Appendix C of the proposal specifies the information needed for each hazard class and category.
Signal Words
Current HCS regulations are silent as to the use of signal words that typically appear at the top of a
label to alert the user to a hazard and to indicate a particular level of hazard, such as "DANGER" or
"CAUTION." OSHA proposes to require signal words, but limit labels to the use of only one of two
words: "DANGER," to indicate more severe hazards, and "WARNING," to indicate a less serious
hazard.
Pictograms
Current HCS regulations do not require that container labels contain any "pictograms," i.e., graphic
representation of hazard levels. Under the proposal, labels would be required to have one or more of
eight different, standard pictograms that consist of different black symbols on white backgrounds
within a red frame square, as follows:
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Hazard and Precautionary Statement
The HCS currently includes a simple requirement for "appropriate warning labels" on dangerous
chemicals. The proposed rule would require specific hazard statements on labels, based on the hazard
classification of the chemical. These statements are specifically identified in the appendix, and include
simple statements such as "Toxic in contact with skin" or "Fatal if swallowed," or "Harmful if
inhaled."
Labels on Unclassified Hazards
As described above, the proposal includes coverage for "unclassified" hazards. OSHA's proposal
acknowledges, however, that there are no harmonized labeling elements available for unclassified
hazards (citing by way of example combustible dust and simple asphyxiates). Accordingly, the
proposal requires that (1) hazard information must appear on the MSDS and (2) the responsible party
must determine what is appropriate for the label.
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Material Safety Data Sheets
The current HCS requires chemical manufacturers and importers to develop an MSDS for each
hazardous chemical they produce or import. MSDSs must include the identity of the chemical used on
the label, the chemical and common names of hazardous ingredients, the primary route of entry,
exposure limits, generally applicable precautions, emergency and first aid procedures, the date of the
preparation of the MSDS, and the name, address, and telephone number of the party preparing the
MSDS. There is no format requirement, nor is the information required to be presented in any
particular order, although a number of organizations have developed a voluntary form to meet GHS
requirements.
OSHA's proposal would require the MSDS to be prepared in a standard 16-paragraph format (of which
four paragraphs are optional), similar to those now in voluntary use. The sections include (with
optional sections in italics):
? Section 1: Identification
? Section 2: Hazard(s) Identification
? Section 3: Composition/Information on Ingredients
? Section 4: First-Aid Measures
? Section 5: Fire-Fighting Measures
? Section 6: Accidental Release Measures
? Section 7: Handling and Storage
? Section 8: Exposure Controls/Personal Protection
? Section 9: Physical and Chemical Properties
? Section 10: Stability and Reactivity
? Section 11: Toxicological Information
? Section 12: Ecological Information
? Section 13: Disposal Consideration
? Section 14: Transport Information
? Section 15: Regulatory Information
? Section 16: Other Information(including date of last revision)
It is important to note that OSHA declined to address concerns that MSDSs contain inaccurate or
incomplete information.
Training
The proposed rule includes relatively minor revisions to the current HCS training requirement,
intended to ensure that employers train employees to read and recognize the new label and MSDS
requirements. Training would be required within two years after the adoption of the final rule.
Combustible Dust
Despite significant lobbying, OSHA declined in its proposal to add a specific definition for
"combustible dust," explaining that "[i]t has been the longstanding position of the Agency that the
hazard determination covers dusts known to be subject to deflagration and subsequent explosion."
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OSHA concludes that combustible dust would be covered by the new proposal under the added
definition of "unclassified hazards" (see above).
Effective Date
OSHA is proposing to require implementation of the revisions to HCS within three years after the rule
is complete.
Conclusion
The proposed regulatory changes will have an important impact on chemical manufacturers and
importers, and will force a far-reaching reclassification of hazardous chemicals. Changes for chemical
end-users would be more limited, but will require, at a minimum, that employers integrate the new
changes into their hazard communication program, assuring that employees understand the pictograms
and other information proposed to be required on labels and in MSDSs.
We welcome the opportunity to discuss these proposed changes with you, and we encourage
employers to consider submitting comments to address any issues that are significant to their
operations. If there is sufficient client interest, we plan to assemble a coalition of client companies and
submit comments on these proposed regulations by the end of the comment period. Please contact
Howard Radzely or Jonathan Snare if your organization is interested in participating.
If you have any questions regarding the information contained in this LawFlash, please contact any of
the following Morgan Lewis attorneys:
Washington, D.C.
Howard M. Radzely 202.739.5996 hradzely@morganlewis.com
Jonathan L. Snare 202.739.5446 jsnare@morganlewis.com
Chicago
Nina G. Stillman 312.324.1150 nstillman@morganlewis.com
Philadelphia
Thomas Benjamin Huggett 215.963.5191 tbhuggett@morganlewis.com
Dennis J. Morikawa 215.963.5513 dmorikawa@morganlewis.com
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