Global Harmonization System: Impact On OSHA

1
Global Harmonization SystemImpact On OSHAs
Hazard Communication Standard

• Adele L. Abrams, Esq., CMSP
• Law Office of Adele L. Abrams P.C.
• www.safety-law.com
• 301-595-3520

2
Overview

• OSHA is at final rule stage to release revision
  to 29 CFR 1910.1200 (Hazard Communication
  Standard)
• 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
  employees.
• 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.)

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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.

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Global Harmonization Project

• Organization for Economic Cooperation and
  Development (OECD) coordinated the development of
  environmental and health hazard classification
  criteria.
• 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.

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Global Harmonization SystemBased on Existing
Frameworks

• 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

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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
  public.
• 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.

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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
  audience.
• 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.

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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
  programs
• 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

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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
  consistent
• 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
  1910.1200)

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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
  training
• 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
  itself

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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
  adopted
• 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!

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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
  chemical
• 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.

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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
  available.
• Another group with significant concerns is the
  American Chemistry Council, which also met with
  OIRA

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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
  later
• 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

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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

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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
  issues.
• GHS addresses testing in the scope section, while
  HazCom addresses testing under hazard
  determination.
• Neither GHS and HazCom require testing for health
  hazards.
• 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.

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HazCom GHS Comparison

• HazCom is performance -- oriented GHS is a
  specification oriented. OSHA may choose to
  incorporate only selected building blocks from
  GHS.
• 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.

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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
  future.

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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
  systems.
• CPSC has already adopted GHS.

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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.

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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

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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.

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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
  system.
• 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
  endpoint.
• GHS cut-off values for labeling, MSDSs and
  disclosure can be different.
• GHS acute toxicity and irritant hazard
  determinations for mixtures have more steps.

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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
  involved.
• Acute Toxicity is a common data set in GHS.

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Acute Toxicity
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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.

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GHS Carcinogen Classes

• GHS Category 1 Known or Presumed Human
  Carcinogen
• Category 1A - Known Human Carcinogen
• Based on human evidence
• Category 1B Presumed Human Carcinogen
• Strength of evidence with additional
  considerations
• 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.

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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.

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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
  information
• Arrangements for presenting the GHS label
  elements
• Special Labelling Arrangements

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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
  GHS.
• USA liability concerns are a label consideration.

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Sample Pictograms

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Sample Flammability Pictograms

• Liquids Solids
• Gases

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GHS Sample Label HAZARDS (Liquid) flammable
liquid, flash point 120F  oral LD50 275
mg/kg

• 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

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GHS Sample Label Suspected Carcinogen
(inhalation)

• 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

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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.

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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
  use.

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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
  proceeded.

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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.

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Conclusion

• 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!

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QUESTIONS ?

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