 OSHA’s Final Rule Aligning the Hazard Communication System with the
Globally Harmonized System of Classification and Labeling of Chemicals
Regulation Week’s audio conference:
“OSHA’s Final Rule Aligning the Hazard Communication
System with the Globally Harmonized System of
Classification and Labeling of Chemicals”
*Presented by:
HOUSTON CHEM SAFE INC.
A WDBE ▪ SINCE 1992
H OUSTON C HEM S AFE . COM 11430 S LASH P INE P LACE T HE W OODLANDS TX 77380
M ARY S CAGGS • P RESIDENT M ARY @H OUSTON C HEM S AFE . COM
O FFICE 281-296.9599 E FAX 877.480.2179 D IRECT 713.443.9992
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
1
*Presented by:
HOUSTON CHEM SAFE INC.
A WDBE ▪ SINCE 1992
H OUSTON C HEM S AFE . COM 11430 S LASH P INE P LACE T HE W OODLANDS TX 77380
M ARY S CAGGS • P RESIDENT M ARY @H OUSTON C HEM S AFE . COM
O FFICE 281-296.9599 E FAX 877.480.2179 D IRECT 713.443.9992
 Following material obtained after attending an
audio conference sponsored by Regulation
Week.
 *Permission to share this info obtained from
Christopher Bryant of Bergeson & Campbell, P.C.
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
2
*Presented by:
HOUSTON CHEM SAFE INC.
A WDBE ▪ SINCE 1992
H OUSTON C HEM S AFE . COM 11430 S LASH P INE P LACE T HE W OODLANDS TX 77380
M ARY S CAGGS • P RESIDENT M ARY @H OUSTON C HEM S AFE . COM
O FFICE 281-296.9599 E FAX 877.480.2179 D IRECT 713.443.9992

Following material obtained after attending a webinar sponsored by REGWEEK.

*Permission to share this info obtained from Christopher Bryant of Bergeson & Campbell,
P.C.
 Are you ready for OSHA HazCom 2012 & GHS? Houston
Chem Safe Inc can help.
 Our regulatory compliance partners include chemical
management software providers, SDS Sheets authoring
& management.
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3
OSHA’s Final Rule Aligning the Hazard Communication
System with the Globally Harmonized System of
Classification and Labeling of Chemicals
CHRISTOPHER R. BRYANT and LESLIE S. MACDOUGALL
Bergeson & Campbell, P.C.
Washington, D.C.
www.lawbc.com
REGULATION WEEK AUDIO CONFERENCES
www.regulationweek.com
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, PC. All Rights Reserved.
Topics Covered Today
 Overview, Background, and Scope of the Final Rule
 Revised Hazard Categories
 Labels
 Safety Data Sheets
 Training and Related Information
 Trade Secrets
 Comparison to International Standards
 Questions and Wrap Up
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
5
Overview
 On March 26, 2012, OSHA released its long awaited final
rule revising the HCS by aligning it with the United
Nations GHS (77 Fed. Reg. 17574)
 The rule took effect on May 25, 2012
 Implementation will be phased, with full implementation
by 2016
 During the transition period, chemical manufacturers,
importers, distributors, and employers may comply with
either 29 C.F.R. Part 1910.1200 (the final standard), the
current standard, or both
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
6
Overview (cont’d)
 The rule makes four major changes to the HCS:
 Hazard classification: Chemical manufacturers and
importers are required to determine the hazards of the chemicals
they produce or import
 Labels: Chemical manufacturers and importers must provide a
label that includes a signal word, pictogram, hazard statement,
and precautionary statement for each hazard class and category
 Safety Data Sheets (SDS): The new format requires 16
specific sections, ensuring consistency in presentation of
important protection information
 Information and training: To facilitate understanding of the
new system, the new standard requires that workers be trained
by December 1, 2013, on the new label elements and SDS
format, in addition to the current training requirements
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
7
Overview (cont’d)
Effective Completion Date
Requirement(s)
Who
Train employees on the new label
December 1, 2013
Employers
elements and SDS format
June 1, 2015
Comply with all modified provisions of
this final rule, except:
Chemical manufacturers, importers,
December 1, 2015
Distributors may ship products labeled distributors, and employers
by manufacturers under the old system
until December 1, 2015
Update alternative workplace labeling
and hazard communication program as
June 1, 2016
necessary, and provide additional
Employers
employee training for newly identified
physical or health hazards
Comply with either 29 C.F.R. Part
All chemical manufacturers, importers,
Transition Period
1910.1200 (this final standard), or the
distributors, and employers
current standard, or both
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
8
Why Align with GHS?
 Complying with myriad, multi-jurisdictional regulations
on chemical hazard communication can be a burden for
manufacturers, importers, transporters, and distributors
 This burden is magnified by the need to develop multiple
sets of labels and SDSs for each product in international
trade
 OSHA first recognized the problems associated with
differing national and international requirements when
it issued the original HCS in 1983, when OSHA also
noted the benefits of global harmonization and
committed to reviewing its rules to ensure consistency
with global standards
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
9
Why Align with GHS? (cont’d)
 GHS was adopted by the UN Committee of Experts on the
Transport of Dangerous Goods and the Globally
Harmonized System of Classification and Labeling of
Chemicals in December 2002
 In 2003 GHS was endorsed by the Economic and Social
Council of the United Nations. Countries were encouraged
to implement the GHS as soon as possible, and have fully
operational systems by 2008
 This goal was adopted by countries in the Intergovernmental Forum on Chemical Safety, and was endorsed by
the World Summit on Sustainable Development. The U.S.
participated in these groups, and agreed to work toward
achieving these goals
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
10
Why Align with GHS? (cont’d)
 The scope of the rule is broad -- it covers over 43 million
workers who produce or handle hazardous chemicals in
more than five million workplaces across the country
 OSHA estimates that the revised HCS will prevent over
500 workplace injuries and illnesses and 43 fatalities
annually
 Other benefits according to OSHA
 Improving the quality and consistency of hazard information in
the workplace, making it safer for workers to do their jobs, and
easier for employers to stay competitive;
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
11
Why Align with GHS? (cont’d)
 Enhancing worker comprehension of hazards, especially for low
and limited-literacy workers, reducing confusion in the
workplace, facilitating safety training, and resulting in safer
handling and use of chemicals;
 Providing workers quicker and more efficient access to
information on the SDSs;
 Cost savings to American businesses of more than $475 million
in productivity improvements, fewer SDS and label updates and
simpler new hazard communication training; and
 Reducing trade barriers by harmonizing with systems around the
world
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
12
Hazard Categories -- Revisions
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
13
Topics to Be Covered
 Overview -- Revisions/Principles
 Basis for Classification
 Methodology for Classification of Substances and
Mixtures (Products)
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
14
Overview -- Revisions/Principles
 Creates a building-block approach
 Modifications to hazard classifications
 Only those provisions that allow for alignment with GHS
 Underlying framework unchanged
 Enhances level of protection and accuracy
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
15
Overview -- Revisions/Principles
(cont’d)
 Maintain consistency with GHS except where
determined contrary
 Several areas
 Revisions necessary to OSHA-specific standards to
maintain consistency
 I.e., substance-specific standards; flammable liquids; laboratory
standard…
 Manufacturers are still responsible for determining the
hazards of substances they produce
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
16
Overview -- Revisions/Principles
(cont’d)
 Classification should be based on ALL available
information
 Can and should determine if the manufacturer accurately
classifies the substance/mixture
 Can modify classification provided by manufacturer provided
that it can be supported that the SDS misstates or omits required
information
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
17
Overview -- Revisions/Principles
(cont’d)
 Mixtures
 Tiered Approach
• SDS should be provided on mixture (as a whole);
• Bridging principles to extrapolate from other data, i.e., dilution
principle;
• Hazard estimate based on known information of compositional
ingredients
– Limit restrictions may apply for classification (cut-offs/concentration
limits)
– Additivity approach
 Tiered Approach -- Exceptions
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
18
Overview -- Revisions/Principles
(cont’d)
 Germ cell mutagenicity, carcinogenicity, and reproductive
toxicity
 Consider the cut-off levels as the primary tier and allowing the
classification to be modified on a case-by-case basis based on
available test data for the mixture as a whole
 Sensitivity of available test methods to detect these types of
effects at small concentrations in the mixture as a whole
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
19
Overview -- Revisions/Principles
(cont’d)
 As with substance SDS -- information in the substance SDS can
be relied upon unless it is known that the SDS misstates or omits
required information
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
20
Hazard Categories -- Revisions
 Modifications to the following hazard classification
categories
 Physical
 Health
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
21
Hazard Categories -- Changed
Definitions
 Physical hazard definitions are located in a new
Appendix B (formerly paragraph (c));
 Flashpoint (crucial for flammable liquids, fuels, and oils)
(methods included in Appendix B), hazard warning, and
material safety data sheets (MSDS) definitions deleted;
and
 Definitions revised or proposed to be GHS-consistent
 Skin corrosive definition modified
• Skin corrosion is the production of irreversible damage to the skin;
namely, visible necrosis through the epidermis and into the dermis,
following the application of a test substance for up to four hours
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
22
Hazard Categories -- Changed
Definitions (cont’d)
• Corrosive reactions are typified by ulcers, bleeding, bloody scabs,
and, by the end of observation at 14 days, by discoloration due to
blanching of the skin, complete areas of alopecia, and scars.
Histopathology should be considered to evaluate questionable
lesions
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
23
Hazard Classes
 Each hazard “class,” i.e., physical, health, is sub-divided
into a “hazard category”
 Hazard categories are:
 Based on degree of severity;
 Several categories per class
• Cat 1 – 4/5/6 depending upon the hazard class
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
24
Hazard Classes (cont’d)
 Increase in hazard category number indicates a decrease in
severity
• Cat 1 is highest level of severity
 Hazard category number is inconsistent with HMIS number
rating
• Cat 4 is highest level of severity
• HMIS anticipated to modify its rating system (eventually)
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
25
Basis for Classification
 Substances
 Classification based upon full range of available information
• Scientific literature
• Study reports
• Other reliable evidence
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
26
Hazard Class and Hazard
Category
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
27
Hazard Class and Hazard
Category (cont’d)
Hazard Class
Hazard Category
Acute Toxicity
1
2
3
4
Skin Corrosion/Irritation
1A
1B
1C
2
Serious Eye Damage/ Eye
Irritation
1
2A
2B
Respiratory or Skin
Sensitization
1
Germ Cell Mutagenicity
1A
1B
2
Carcinogenicity
1A
1B
2
Reproductive Toxicity
1A
1B
2
STOT –
Single Exposure
1
2
STOT –
Repeated Exposure
1
2
Aspiration
1
Simple Asphyxiants
Single Category
Lactation
3
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
28
Criteria for Classification
 Substances
 Result of specific test (dose-effect relationship)
 Example: Irreversible Eye Effects: Category 1
A substance is classified as Serious Eye Damage Category 1
(irreversible effects on the eye) when it produces:
(a)At least in one tested animal, effects on the cornea, iris or
conjunctiva that are not expected to reverse or have not fully reversed
within an observation period of normally 21 days; and/or
(b)At least in 2 of 3 tested animals, a positive response of:
(i)Corneal opacity ≥3; and/or
(ii)Iritis >1.5;
Calculated as the mean scores following grading at 24, 48 and 72 hours
after installation of the substance.
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
29
Criteria for Classification (cont’d)
 Mixtures
 Classification based upon information on the mixture when
available, or
 When data are not available on the mixture but on the
ingredients and similar mixtures, extrapolation or bridging of
data to classify the mixture is allowed, or
• I.e., if there is a mixture that is comprised of 1% of an acutely toxic
material, regardless of severity of that effect, and 99% water, the
current HCS would require the mixture be defined as acutely toxic,
however, under the new HCS, the classification would be unlikely
due to dilution effect
• Where an ingredient with unknown acute toxicity is used in a
mixture at a concentration >1% and the mixture is not classified
based on testing of the mixture as a whole, a statement that X% of
the mixture consists of ingredient(s) of unknown acute toxicity is
required
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
30
Criteria for Classification (cont’d)
 Classification based upon the classification of some
constituent substances based on cut-offs (concentration
limits) specific to the hazard or additivity
 Additivity approach
Sum of ingredients
classified as:
Skin Category 1
Skin Category 2
(10 x Skin Category 1) +
Skin Category 2
Skin corrosive Category Skin Irritant Category 2
1
>5%
≥1% but <5%
≥10%
≥10%
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
31
Criteria for Classification (cont’d)
 Mixtures
Ingredient:
Concentration:
Mixture classified as:
Skin
Acid with pH ≤2
Base with pH ≥11.5
Other corrosive
(category 1)
ingredients for which
additivity does not
apply
≥1%
≥1%
≥1%
Category 1.
Category 1.
Category 1.
Other irritant
(category 2)
ingredients for which
additivity does not
apply, including acids
and bases
≥1%
Category 2.
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
32
Health -- Hazard Class and Hazard
Category
 Carcinogenicity -- Only one positive study necessary
 Clarification offered by OSHA -- where the weight of evidence for the
carcinogenicity of a substance does not meet the above criteria, any
positive study conducted in accordance with established scientific
principles, and which reports statistically significant findings
regarding the carcinogenic potential of the substance, must be noted on
the SDS
 OSHA is allowing classifiers to use determinations of International
Agency for Research on Cancer (IARC)/National Toxicology
Program (NTP) for classification instead of performing their own
hazard evaluation
 Included in Appendix F
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
33
Environmental
 Not OSHA’s mandate
 No environmental categories defined by OSHA HCS
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
34
Hazards Not Otherwise Classified
(HNOC)
 Minimum information for an SDS includes “other hazards
which do not result in classification (e.g., “dust explosion
hazard”) or are not covered by the GHS” in Section 2, Hazards
Identification
 OSHA is specifically attempting to address hazards that are
not currently addressed in the 3rd revision of the Purple Book
 I.e., simple asphyxiants and combustible dust for which OSHA
standards exist
 HNOCs are not required to be presented on labels but are
required to be presented in the SDS and during training
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
35
Hazard Communication Labeling
under the Revised HCS
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
36
Topics Covered
 GHS Implementation
 Obligations
 Label content -- Transported containers
 Label content -- Workplace containers
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
37
Effective Dates for Labeling and
Documentation
 May 25, 2012 (60 days following publication) -- Effective
date
 May 25, 2012 – June 1, 2015 -- Transitional period
 June 1, 2015 -- Compliance with all modified provisions
of the final rule
 December 1, 2015 -- Distributors must only ship GHS
labeled containers
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
38
Effective Dates for Labeling and
Documentation (cont’d)
 June 1, 2016 -- Employers must update workplace
labeling and employee training within six months of new
hazards becoming known
 Labels must be updated within six months of new
information available to preparer
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
39
Label Requirements for Shipped
Containers
 Beginning June 1, 2015, all shipped containers must be
labeled with the required information, as displayed on
this slide
 This is the standard information for GHS across most countries
that have implemented GHS
 Containers must also meet the safety standards set out in the
final rule
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
40
Label Requirements for Shipped
Containers (cont’d)
 Labels for hazardous substances
 Product identifier
• A product identifier can be a chemical name, trade name, or other
designation that is unique to the substance or product. This
designation must be the same across all hazard communication
documents and other sources of information
 Signal word
 Hazard statement(s)
 Pictogram(s)
 Precautionary statement(s)
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
41
Label Requirements for Shipped
Containers (cont’d)
 Name, address, and telephone number of the chemical
manufacturer, importer, or other responsible party
 In English, prominently displayed, includes all
associated hazard categories
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
42
Label Requirements for Shipped
Containers (cont’d)
 All hazard communication elements must be easily
legible
 No required label size
 No required pictogram size
 Must be easily legible
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
43
Label Requirements for Shipped
Containers (cont’d)
 Articles -- Exempt from labeling
 No intentional release of substances
 Hazardous Substances and Products -- Each container
must be labeled
 Hazardous Materials Transportation Act (49 U.S.C. 1801 et seq.)
 Solid materials
 Solid metal/wood/plastic or whole grains
 Not subject to article exemption
 Label included in initial shipment only
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
44
Workplace Labels
 Do not remove original labels from containers, unless
immediately re-labeled
 Signs, placards, process sheets, batch tickets, operating
procedures, or other such written materials can be used
in conjunction with written materials instead of affixed
labels
 Written materials must be readily accessible to
employees in their work area, throughout each work shift
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
45
Workplace Labels (cont’d)
 Employer must ensure that each container is labeled (or
tagged or marked) in the workplace
(i)
(ii)
(iii)
(iv)
(v)
(vi)
Product identifier;
Signal word;
Hazard statement(s);
Pictogram(s);
Precautionary statement(s); and,
Name, address, and telephone
number of the chemical
manufacturer, importer or other
responsible party


Product identifier, Words,
Pictures, Symbols or combination
thereof which provides at least
general hazard information;
In conjunction with other
information available to employees
provides specific hazard
information regarding the physical
and health hazards of the
hazardous chemical.
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
46
Workplace Labels (cont’d)
Product 123
DANGER
Heating may cause a fire or explosion.
Keep away from heat/sparks/open flames/hot surfaces. – No smoking.
Keep/Store away from clothing/oxidising materials/combustible
materials.
Keep only in original container.
Wear protective gloves/eye protection/face protection.
24 Chemhotline
(555) 123-1234
Chemchain
123 Sunset boulevard, L.A.
California, 123-1234
(555) 321-4321
Store at temperatures not exceeding 12 °C/53.6 °F. Keep cool.
Protect from sunlight.
Store away from other materials.
Dispose of contents/container to licensed hazardous waste treatment
agent.
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
47
Workplace Labels (cont’d)
Product 123
SDS
Containing full H-statements,
P-statements and supplier
contact information.
DANGER
Heating may cause a fire or explosion.
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
48
Safety Data Sheet
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
49
SDS
 Overview
 Implementation Dates
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
50
SDS Overview
 Amended HCS modifies the SDS requirements from
proposed rule
 HCS mandates 16 section format
 SDS outline is located in Appendix D of the HCS
 OSHA will not enforce Sections 12 - 15
 Disposal, Transport, Regulatory information
 These sections require information that is outside the scope of
OSHA’s enforcement authority
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
51
SDS Overview (cont’d)
 All data should be completed as specified in the format
criteria
 Headings order must be followed
 Sub-headings should be completed
 Appendix D specifies that in the event that no information is
available then no available information shall be stated
 American Conference of Governmental Industrial
Hygienists (ACGIH) Threshold Limit Values (TLV) are
required to be provided
 Carcinogenicity classifications assigned by IARC and
NTP must be provided
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
52
SDS Overview (cont’d)
 When transitioning to new provisions, U.S. chemical
manufacturers, importers, and downstream users can
rely on the pre-existing SDS except when:
 It is known, or in the exercise of reasonable diligence should
know, that the SDS misstates or omits required information
• E.g., varied hazard information available in the public domain
 SDS must be updated within three months of when new
hazard information becomes known
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
53
Dates of Implementation
 No later than June 1, 2015 -- SDS modifications must
be in place
 Optional beginning May 25, 2012
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
54
TRAINING, INFORMATION, AND
TRADE SECRETS
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
55
Training -- Background
 Employee training is one of the three information
communication components in the HCS (with labels and
SDSs)
 One of the major changes to the HSC is the requirements
related to training
 OSHA states that one of the benefits of the new HCS is
that it will: “Enhance worker comprehension of hazards,
especially for low and limited-literacy workers, reduce
confusion in the workplace, facilitate safety training, and
result in safer handling and use of chemicals”
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
56
Training -- Implementation
Effective Completion Date
Requirement(s)
Who
December 1, 2013
Train employees on the new label
Employers
elements and SDS format
June 1, 2016
Provide additional employee
training for newly identified
physical or health hazards
Employers
 OSHA chose this deadline for training because it believes
that employees will begin seeing the new style labels
considerably earlier than the compliance date for
labeling
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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57
Training -- What Remains the
Same
 Training is already a component of the HCS
 Definitions of “employer” and “employee” are unchanged
from former HCS to current HCS
 Because GHS does not have any training requirements,
OSHA’s modification to HCS is only what is necessary to
ensure appropriate compliance with the revised
standard, and does not introduce any new approaches or
requirements
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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58
Training -- What Changed
 The revised training provisions at 29 C.F.R. §
1900.1200(h):
 Conforms new hazard definitions into training requirements
 Requires that training ensures employees are familiar with the
new label, SDS formats, and presentation of information
 Clarifies that the labels on shipped containers and workplace
labels must be explained
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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59
Training -- What Needs to Be
Communicated
 GHS does not include harmonized training requirements
 Training will support and enhance the effectiveness of
the new label and SDS requirements
 Signal words
 Pictograms
 Hazard statements
 Precautionary statements
 Standardized headings and a consistent order of information
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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60
Training -- What Needs to Be
Communicated (cont’d)
 Note that there is a transition period: Employers may
wish to explain to employees why labels and SDS may
not be the same for the next few years
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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61
Training -- Resources
 United Nations Institute for Training and Research
UNITAR training materials:
http://www2.unitar.org/cwm/publications/ghs.aspx
 OSHA guidance and compliance assistance materials:
http://www.osha.gov/dsg/hazcom/index.html
 GHS Annex 6 (Comprehensibility testing methodology):
http://www.unece.org/fileadmin/DAM/trans/danger/p
ubli/ghs/ghs_rev04/English/10e_annex6.pdf
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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62
Trade Secrets -- Background
 “Trade secret” means any confidential formula, pattern,
process, device, information or compilation of
information that is used in an employer’s business, and
that gives the employer an opportunity to obtain an
advantage over competitors who do not know or use it
 The protection of trade secrets involves balancing the
safety and health of workers, consumers, and the public
in general, as well as the protection of the environment,
with the protection of confidential business information
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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63
Trade Secrets -- What Remains
the Same
 Existing and revised HCS includes provisions to:
 Define what can be considered trade secret information
 Delineate the conditions under which this information must be
disclosed to ensure the safety and health of exposed employees
 Many elements of GHS regarding trade secrets were
already incorporated in HCS
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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64
Trade Secrets -- What Changes
 There is one substantive change to the trade secret
provisions: allowing manufacturers to claim the
percentage composition of mixtures on the SDS as
confidential
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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65
COMPARISON TO OTHER
INTERNATIONAL STANDARDS
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66
Topics Discussed
 Introduction to Global GHS
 Key Differences in Hazard Categories
 Communication Differences
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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67
Global GHS
 1st edition of GHS adopted 2002
 Revised 2005 (1st revision), 2007 (2nd revision), 2008 (3rd
revision), and 2010 (4th revision)
 Adopted by individual countries
 Building-block approach
 Often based upon previous classification and labeling system
 UN Transport regulations
 IATA, ADR, IMDG, ADN
 Standardised for global transport
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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68
Implementation Dates
Indonesia
(Transport)
January 1,
2005
Korea
(New
substances)
July 1, 2008
Australia
(Transport)
2007
Japan
(All sectors)
December 1,
2006
Canada
(Transport)
February
20, 2008
China
(All sectors)
February 1,
2009
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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69
Implementation Dates (cont’d)
Mexico
(All sectors,
Voluntary)
June 30,
2011
Indonesia
(All sectors)
March 23,
2010
European
Union
(All
substances)
December 1,
2010
Australia
(All sectors)
January 1,
2012
Korea
(All
substances)
June 30,
2011
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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70
Implementation Dates (cont’d)
European Union
(mixtures on the
market before
December 1,
2010)
December 1, 2012
OSHA HCS
(Training
deadline)
December 1, 2013
Korea
(All mixtures)
June 30, 2013
European Union
(All mixtures)
June 1, 2015
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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71
Differences in Communication
 Basic Differences
 Language
 Emergency contact information
 Company contact details
 Label size and position
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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72
Key Differences in Hazard
Classification
 Pre-existing classification thresholds
 Building-block approach
 Specific concerns -- allowances made for specific
industry sectors
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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73
Key Differences in Hazard
Classification (cont’d)
Flammable Liquids
Category
1
2
3
4
OSHA HCS
Flash point <23 °C (73.4 °F)
and initial boiling point ≤35 °C
(95 °F)
Flash point <23 °C (73.4 °F)
and initial boiling point >35 °C
(95 °F)
Flash point ≥23 °C (73.4 °F)
and ≤60 °C (140 °F)
EU CLP
Flash point <23 °C (73.4 °F) and
initial boiling point ≤35 °C (95 °F)
Flash point <23 °C (73.4 °F) and
initial boiling point >35 °C (95 °F)
Flash point ≥23 °C (73.4 °F) and
≤60 °C (140 °F)
For the purpose of this Regulation
gas oils, diesel and light heating oils
having a flash point between ≥55 °C
and ≤75 °C may be regarded as
Category 3.
Flash point ≥60 °C (140 °F) and
≤93 °C (199.4 °F)
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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74
Key Differences in Hazard
Classification (cont’d)
Sensitisation
Category
1A
1B
OSHA HCS1
Substances showing a high
frequency of occurrence in
humans and/or a high
potency in animals can be
presumed to have the
potential to produce
significant sensitization in
humans. Severity of reaction
may also be considered.
Substances showing a low to
moderate frequency of
occurrence in humans and/or
a low to moderate potency in
animals can be presumed to
have the potential to produce
sensitization in humans.
Severity of reaction may also
be considered.
1Where
Category
1
EU CLP
(i) if there is evidence in
humans that the substance
can lead to sensitization by
skin contact in a substantial
number of persons, or
(ii) if there are positive results
from an appropriate animal
test.
data are not sufficient for sub-categorization, skin sensitizers shall be classified in Category 1.
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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75
Key Differences in Hazard
Classification (cont’d)
Classification of Mixtures
Hazard Class
OSHA GHS
Acute Toxicity
-
Skin Corrosion/Irritation
Serious Eye Damage/Eye
irritation
Respiratory/Skin Sensitisation
Germ cell Mutagenicity: Cat 1
Germ cell Mutagenicity: Cat 2
Carcinogenicity
Specific Target Organ Systemic
Toxicity (Single Exposure)
Target Organ Systemic Toxicity
(Repeated Exposure)
Specific Target Organ Systemic
Toxicity Category 3
-
Generic Threshold Value/Concentration Limit
EU CLP
CHINA
GB 13690-2009
CAT 1-3 0.1%
CAT 4
1%
1%
1%
≥1.0%
≥0.1%
≥0.1%
≥1.0%
≥0.1%
≥1.0%
-
≥1.0%
≥1.0%
≥1.0%
≥1.0%
≥1.0%
≥1.0%
-
≥1.0%
≥20%
Not adopted
Not adopted
-
≥1.0%
≥1.0%
-= No generic threshold.
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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76
Labeling Differences
 Labeling of small and difficult shaped containers
 OSHA HCS
• No omissions from information to be communicated
• Other methods of providing all information to exposed workers are
available
 EU CLP
 Specific exemptions -- Specific circumstances and criteria
 Fold-out labels, tie-on labels, labeling of outer packaging
 Omission of specific labeling elements
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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77
Confidentiality Differences
 OSHA HCS
 Only hazardous components listed (with percent concentration)
 “Trade secret” exemption available
 EU CLP
 Only hazardous components listed (with percent concentration)
 Confidentiality exemptions available for masking component
names
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
78
Confidentiality Differences
(cont’d)
 China
 Confidentiality can be applied for
 Use of generic names is acceptable without application
 Use of concentration range is acceptable without application
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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79
Liability Differences
 Variation between required labeling
 Variation between classification criteria/categories
 Problems with re-labeling/re-packaging
 Additional or supplementary hazard communication
information reduces the liability
From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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80
THANK YOU
BERGESON & CAMPBELL, P.C.
The Acta Group
2200 Pennsylvania Avenue, N.W.
Suite 100W
Washington, D.C. 20037
[email protected]
[email protected]
www.lawbc.com
www.actagroup.com
Contact HCS Inc. for more information:
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