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Global Harmonization System: Impact On OSHA


Global Harmonization System: Impact On OSHA s Hazard Communication Standard Adele L. Abrams, Esq., CMSP Law Office of Adele L. Abrams P.C. – PowerPoint PPT presentation

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Title: Global Harmonization System: Impact On OSHA

Global Harmonization SystemImpact On OSHAs
Hazard Communication Standard
  • Adele L. Abrams, Esq., CMSP
  • Law Office of Adele L. Abrams P.C.
  • 301-595-3520

  • OSHA is at final rule stage to release revision
    to 29 CFR 1910.1200 (Hazard Communication
  • Proposed rule published in 9/30/2009 Fed. Reg.
  • Goal is to integrate components of the UN
    projects Global Harmonization Standard (GHS)
    into HazCom
  • Rule cleared OMB/OIRA 3/12 after extended review
  • Rule would modify MSDS requirements, labeling,
    classifications, and require retraining of all
  • Significant opposition to standard from some
    business groups due to
  • Inclusion of unclassified hazards
  • Challenges to economic impact estimates (costs of
    training, revised labels and MSDSs etc.)

Global Harmonization Project
  • Goal of establishing globally harmonized system
    for hazard communication established in 1992 at
    Rio Earth Summit.
  • Mandate A globally harmonized hazard
    classification and compatible labelling system,
    including national safety data sheets and easily
    understandable symbols, should be available, if
    feasible, by the year 2000.

Global Harmonization Project
  • Organization for Economic Cooperation and
    Development (OECD) coordinated the development of
    environmental and health hazard classification
  • UN Committee of Experts on Transport of Dangerous
    Goods (UN COE) developed criteria for physical
    hazards (explosives, flammables, reactives).
  • International Labour Organization (ILO) served as
    Secretariat for overall coordination.

Global Harmonization SystemBased on Existing
  • Requirements of systems in the US for workplace,
    consumers and pesticides
  • Requirements of Canada for workplace, consumers
    and pesticides
  • European Union directives for classification and
    labelling of substances and preparations
  • United Nations Recommendations on Transport of
    Dangerous Goods

Global Harmonization Project
  • Rationale for U.S. adoption of GHS
  • American companies are major importers of
    chemicals as well as exporters, and missing or
    incomplete information on chemicals we import may
    lead to reduced protections for workers and
  • Large number of varying requirements around the
    world create potential barriers to trade in
    chemicals, particularly for small businesses.
  • A harmonized and consistent approach has benefits
    both in terms of protection and trade.

GHS General Principles
  • The Globally Harmonized System (GHS) is not in
    itself a regulation or a model regulation. It is
    a framework from which competent authorities may
    select the appropriate harmonized classification
    communication elements.
  • Competent authorities will decide how to apply
    the various elements of the GHS within their
    systems based on their needs and the target
  • OSHA has to adopt through conventional rulemaking
    (governed by APA) before it can include
    components in mandatory HazCom standard
  • Current OSHA agenda now calls for final rule 4/12
  • MSHA has not yet placed HazCom revision (30 CFR
    Part 47) on its agenda
  • The GHS includes the following basic elements
  • harmonized criteria for classifying substances
    and mixtures according to their health,
    environmental and physical hazards and
  • harmonized hazard communication elements,
    including requirements for labeling and material
    safety data sheets.

OSHA Rulemaking Current Rule
  • HazCom has been in effect for over 25 years
    founddation for building a chemical health and
    safety program in workplace
  • Addresses needs of employers/employees to obtain
    information about chemicals, and worker
    right-to-know about hazards
  • Requires chemical manufacturers and importers to
    evaluate hazards and provide info to customers
    through labels, data sheets and worker training
  • Also addresses trade secret protection
  • Requires all chemicals to be evaluated and
    incorporates wide range of hazardous effects to
    be addressed.
  • OSHA claims HazCom has resulted in 40 decrease
    in injuries/illnesses due to chemical exposures

OSHA Proposed Rule
  • Current standard is performance oriented and
    does not specify formats for labels or data
    sheets GHS would change that by specifying
    warnings and format
  • Method of communication and information
    transmitted now varies GHS would make more
  • GHS system is based on international negotiations
    and OSHA plans to learn from implementation
    experience of other nations
  • New rule CANNOT reduce level of protections
    afforded under current HazCom standard (29 CFR

OSHA Proposed Rule
  • GHS/HazCom still covers all chemicals and wide
    range of hazards, requires downstream flow of
    information, and communication of information on
    labels and data sheets, along with worker
  • Sections that remain about the same as the
    current HazCom rule are scope/application,
    written program, training requirements, and trade
    secret protections
  • Modified parts apply to manufacturers/importers
    (hazard classification and preparation of labels
    and SDS) and employers (receiving revised labels
    and SDSs in new format, integrating into
    workplace, and training workers on new approach)
  • Specification oriented nature of GHS requires
    additional text in warnings
  • Detailed info on classification criteria, label
    elements and SDSs are included in mandatory
    appendices to standard, not in regulatory text

OSHA Proposed Rule
  • OSHA is looking at 3-year implementation schedule
    from date of final rule
  • OSHA would remove the floor of covering
    substances based on several cited references, as
    well as eliminate the one-study criteria
  • GHS Building block approach allows competent
    authorities to choose from regulatory options in
    terms of which hazard classes and categories are
  • OSHA has proposed to adopt the same BB as the EU
    EXCEPT it will not address environmental
    hazards (outside jurisdiction) and it proposes to
    add one more category of the flammable liquid
    class than EU did.
  • OSHA must also adjust substance-specific health
    standards that include labeling provisions
    inconsistent with GHS
  • OSHA claims that the proposal is economically and
    technically feasible some commenters disagreed!

Sample Comments - Union
  • AFL-CIO strongly support proposal but wanted
    OSHA to expand exposure limits listed on SDSs to
    include ACGIH TLVs and NIOSH RELs, because OSHA
    PELs are outdated
  • Union also wants substance-specific standards to
    be included in SDSs (Sec. 15) to alert workers
    that there is a comprehensive standard on that
  • Union supports adding a definition of
    unclassified hazards to make sure that emergent
    hazards can be included within the scope of
    HazCom and to address combustible dust hazards.

Sample Comment - Business
  • US Chamber of Commerce has had several meeting
    with OIRA opposing inclusion of unclassified
    hazards in the rule
  • It has also challenged the purported cost savings
    as well as the economic impact analysis prepared
    by OSHA
  • Urged switching the compliance deadlines
    (currently 2 years to train, 3 years to prepare
    new SDSs) so training can be done after SDSs are
  • Another group with significant concerns is the
    American Chemistry Council, which also met with

Sample Comments ASSE
  • ASSE endorsed the rule, but was disappointed
    that control banding was ignored in the
    development of the rule
  • Urged OSHA to incorporate elements of control
    banding into HazCom to avoid need to revisit this
  • Challenged cost estimates for training time
  • Suggested ACGIH TLVs should continue to be listed
    as well as NIOSH RELs, and suggested additional
    references to be considered by end users (AIHA
    also supports retention of TLVs and RELs)
  • Advocated a quicker effective date for training
    but not for phsae in for the SDS and labeling
    requirements, and recommended significant
    compliance assistance be made available from OSHA

Whats the Impact?
  • Rule will impact nearly 5 million workplaces, and
    40 million workers
  • OSHA claims costs range from 38-47 per covered
    entity for one-hour of training
  • This did not add costs for developing new labels,
    SDSs etc.
  • According to OSHA
  • Annualized savings for employers of between 585
    mil and 798 mil
  • Most of this through increased productivity for
    HS managers and logistics personnel
  • Savings attributed to uniform SDSs and labels
    accounts for between 16 mil and 32.2 mil

HazCom GHS Comparison
  • GHS scope is consistent with the HazCom
    exemptions and labeling exceptions.
  • HazCom includes laboratories, sealed containers
    and distributors while, as a framework for
    systems, GHS does not include these specific
  • GHS addresses testing in the scope section, while
    HazCom addresses testing under hazard
  • Neither GHS and HazCom require testing for health
  • Physical hazards in the HazCom are not linked to
    specific test methods (as is the case in the GHS)
    and testing for physical hazards is not required.

HazCom GHS Comparison
  • HazCom is performance -- oriented GHS is a
    specification oriented. OSHA may choose to
    incorporate only selected building blocks from
  • HazCom may not implement all GHS hazard classes,
    e.g., hazardous for the environment.
  • HazCom may not regulate all hazard categories,
    e.g., acute toxicity.
  • Many hazard classes will require some type of
    change to the HazCom standards if OSHA/MSHA wish
    to achieve global consistency.
  • Substantive GHS implementation will require
  • Changes to required label elements
  • Modification of required MSDS format
  • Criteria changes.

HazCom GHS Comparison
  • A significant difference between HazCom and GHS
    is the evaluation of mixtures.
  • GHS criteria for mixtures varies by hazard class.
  • HazCom allows test data on mixtures to be used
    for all hazard classes.
  • GHS allows test data on carcinogens, mutagens
    reproductive toxins on a case-by-case basis.
  • GHS expectation of physical test data for
    mixtures is another difference.
  • HazCom "floor" of hazardous chemicals is a
    difference and one which is likely helpful to
    small businesses.
  • OSHA suggests that guidance on how IARC, NTP and
    OSHA carcinogens fit with the GHS cancer
    classification scheme could be useful in the

Sector-Specific Implementation
  • For transport, application of GHS will be similar
    to application of current transport requirements.
  • US DOT has already adopted.
  • Containers of dangerous goods will be marked with
    pictograms that address acute toxicity, physical
    hazards, and environmental hazards.
  • Workers in the transport sector will be trained.
  • In the workplace, it is expected that all GHS
    elements will be adopted by OSHA, including
    labels that have the harmonized information, and
    safety data sheets.
  • This must be supplemented by employee training to
    ensure effective communication
  • Training constitutes the majority of OSHAs
    estimated costs for the rule
  • For the consumer sector, it is expected that
    labels will be the primary focus of GHS
    application. These labels will include the core
    elements of the GHS, subject to some
    sector-specific considerations in certain
  • CPSC has already adopted GHS.

Safety Data Sheet Impact
  • The performance orientation of HazComs MSDS will
    need to be changed.
  • GHS requires a 16 section MSDS format with
    specified sequence and minimum required contents.
  • There is discretion in the GHS for determining
    when an MSDS is required the hazard
    pictogram/symbol can be graphically reproduced on
    the MSDS or the name of the symbol may be
    provided instead.
  • The level of hazardous components can be given as
    ranges or concentrations - the values for
    component disclosure in mixtures vary by end
    point. Therefore, some changes will be needed for
    component disclosure.

Safety Data Sheets
  • Guidance on Preparation of Safety Data Sheet
  • ILO Recommendation 177 on Safety in the Use of
    Chemicals at Work
  • ISO Standard 11014
  • European Union SDS Directive 91/155/EEC
  • ANSI Standard Z400.1

Hazard Determination
  • GHS and HCS hazard determination/classification
    are self-classification processes
  • Classification is more involved in the GHS
    because GHS uses weight of evidence in hazard
    determination (positive and negative results are
    considered, although a strong single positive
    study may be determinative)
  • HazCom uses a one positive study threshold,
    while GHS provides for the one positive study
    issue within the individual endpoints.
  • In vitro studies are treated differently and
    substances not bioavailable or inextricably bound
    are addressed.
  • Professional/expert judgment is included. Human
    experience is taken into account.
  • GHS addresses the import concept of previously
    classified substances.

Health Hazard Considerations
  • GHS has several health hazard endpoints, e.g.,
    mutagenicity and target organ systemic toxicity,
    that do not exactly correspond to the HazCom
  • Major difference between HazCom and the GHS is
    untested mixtures.
  • OSHA has a single 1 cut-off value for all health
    hazards, except carcinogens at 0.1. These
    cut-off values require labels, MSDSs, and
    disclosure of hazardous components.
  • In the GHS, cut-off values for mixtures vary by
  • GHS cut-off values for labeling, MSDSs and
    disclosure can be different.
  • GHS acute toxicity and irritant hazard
    determinations for mixtures have more steps.

Acute Toxicity
  • Five GHS categories have been included in the GHS
    Acute Toxicity scheme from which the appropriate
    elements relevant to means of transport,
    consumer, worker and environment protection can
    be selected.
  • HazCom has 2 Acute Toxicity hazard categories
    whose cut-off values do not exactly correspond to
    the GHS cut-offs.
  • The untested mixture hazard determination is
    different in HazCom and GHS. The GHS Acute
    Toxicity hazard determination for mixtures is
  • Acute Toxicity is a common data set in GHS.

Acute Toxicity
Classification of Carcinogens
  • OSHA HazCom
  • A chemical is considered to be a carcinogen if
  • It has been evaluated by the International Agency
    for Research on Cancer (IARC), and found to be a
    carcinogen or potential carcinogenor
  • It is listed as a carcinogen or potential
    carcinogen in the Annual Report on Carcinogens
    published by the National Toxicology Program
    (NTP) (latest edition) or
  • It is regulated by OSHA as a carcinogen.
  • GHS
  • Carcinogen means a chemical substance or a
    mixture of chemical substances which induce
    cancer or increase its incidence.
  • Substances and mixtures of this hazard class are
    assigned to one of two hazard categories.

GHS Carcinogen Classes
  • GHS Category 1 Known or Presumed Human
  • Category 1A - Known Human Carcinogen
  • Based on human evidence
  • Category 1B Presumed Human Carcinogen
  • Strength of evidence with additional
  • Evidence of animal carcinogenicity (presumed
    human carcinogen).
  • On a case by case basis, limited evidence of
    carcinogenicity in humans together with limited
    evidence of carcinogenicity in animals.Including
    mixtures containing gt 0.1 of such a substance.
  • GHS Category 2 Suspected human carcinogen
  • Evidence from human and/or animal studies,
  • Strength of evidence together with additional
    considerations. Including mixtures containing
    more than gt0.1 or gt1.0 of such a substance.

Physical Hazards
  • In GHS, physical hazards are defined by criteria
    that specifies a test method.
  • For several physical hazard endpoints, the HazCom
    criteria is a definition.
  • GHS has multiple subcategories within an
    endpoint, leading to specific signal words,
    hazard phrases and pictograms.
  • For substances previously classified under
    HazCom, existing data should be accepted when the
    substances are reclassified under GHS.
  • HazCom has only one hazard category for
    Explosives, while GHS has 6 hazard categories.

GHS Labeling Requirements
  • Information Required on GHS Label
  • Signal Words
  • Hazard Statements
  • Precautionary Statements and Pictograms
  • Product Identifier
  • Supplier Identification
  • Multiple Hazards and precedence of hazard
  • Arrangements for presenting the GHS label
  • Special Labelling Arrangements

Comparison of Labeling Requirements
  • HazCom label requirements are totally performance
    -- oriented.
  • The GHS labeling requirements are specified
    signal words, hazard statements, and pictograms.
  • The use of pictograms is a significant change for
    US labeling.
  • If HazCom retains NTP/OSHA/IARC carcinogen info,
    guidance on labeling is needed to conform with
  • USA liability concerns are a label consideration.

Sample Pictograms

Sample Flammability Pictograms
  • Liquids Solids
  • Gases

GHS Sample Label HAZARDS (Liquid) flammable
liquid, flash point 120F  oral LD50 275
  • Danger!
  • Toxic if swallowedFlammable liquid and vapor
  • Contains XYZ
  • Do not taste or swallow.  Get medical
    attention.  Do not take internally.  Wash
    thoroughly after handling.  Keep away from heat,
    sparks and flame.  Keep container closed.  Use
    only with adequate ventilation. FIRST AIDIf
    swallowed, induce vomiting immediately, as
    directed by medical personnel. Never give
    anything by mouth to an unconscious person.See
    Material Safety Data Sheet for further details
    regarding safe use of this product.Company
    name, Address, Phone number

GHS Sample Label Suspected Carcinogen
  • My Product
  • Warning!Cause Skin And Eye IrritationSuspected
    of causing cancer by inhalationContains XYZDo
    not breathe vapors or mist. Use only with
    adequate ventilation. Avoid contact with eyes,
    skin and clothing. Wash thoroughly after
    handlingFIRST AIDEYES Immediately flush eyes
    with plenty of water for at least 15 minutes. Get
    medical attention.SKIN In case of contact,
    immediately flush skin with plenty of water.
    Remove contaminated clothing and shoes. Wash
    clothing before reuse. Get medical attention if
    irritation develops and persists.Company name,
    Address, Phone number HAZARDS (Liquid)
    moderate skin and eye irritant, possible cancer
    hazard by inhalation

Global Harmonization System
  • GHS hazard classification criteria were adopted
    by consensus for physical hazards and key health
    and environmental classes.
  • Standardized label elements (symbols, signal
    words, hazard statements) were developed along
    with standard format for SDS.
  • GHS also addresses product identifiers,
    confidential business information, and precedence
    of hazards.

Global Harmonization - Training
  • Training users of hazard information is integral
    part of hazard communication.
  • Systems should identify appropriate education and
    training for GHS target audiences who must
    interpret label and/or SDS information and take
    action in response to chemical hazards.
  • Training should address workers, emergency
    responders, and those involved with preparation
    of labels, SDS and HazCom strategies as part of
    risk management systems.
  • Systems should also educate consumers in
    interpreting label information on products they

Global Harmonization Summary
  • GHS is a VOLUNTARY system it does NOT impose
    binding treaty obligations on countries, but
    where countries adopt GHS into national
    regulatory requirements, it will be part of
    mandatory standards.
  • Implementation objective was January 2008 many
    countries (but not US) met this deadline.
  • Congress has considered legislation in prior
    sessions that would force OSHA to adopt a rule,
    but those lost momentum when the rulemaking

GHS Summary
  • Level of protection offered to workers,
    consumers, general public and environment should
    not be reduced by GHS
  • Involvement of concerned organizations of
    employers, workers, consumers and other relevant
    groups is essential
  • Validated data already generated for
    classification of chemicals under existing
    systems should be accepted when reclassifying the
    chemicals under GHS
  • The new harmonized system may require adaptation
    of existing methods for testing.

  • Overall benefits of globally harmonized system
  • Promotes safer transportation, handling and use
    of chemicals
  • Improves understanding of hazards
  • Increases compliance and reduces costs for
    companies involved in international activities
  • Helps protect workers, consumers and potential
    exposed populations around the globe.
  • Bottom Line A new OSHA HazCom standard is
    inevitable . . . Plan ahead!

  • Contact Adele L. Abrams, Esq., CMSP
  • at 301-595-3520 or write to
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