© 2012 bergeson & campbell, p.c., all rights reserved * presented by: 1 h ouston c hem s afe i...

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved *Presented by: 1 HO HOUSTONCHEMSAFE.COM 11430 SLASH PINE PLAC MARY SCAGGS • PRESIDENT OFFICE 281-296.9599 EFAX 877.480.217 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” From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Page 1: © 2012 Bergeson & Campbell, P.C., All Rights Reserved * Presented by: 1 H OUSTON C HEM S AFE I NC. A WDBE ▪ S INCE 1992 H OUSTON C HEM S AFE. COM 11430

© 2012 Bergeson & Campbell, P.C., All Rights Reserved

*Presented by:

1

HOUSTON CHEM SAFE INC.A WDBE ▪ SINCE 1992

HOUSTONCHEMSAFE.COM 11430 SLASH PINE PLACE THE WOODLANDS TX 77380

MARY SCAGGS • PRESIDENT [email protected]

OFFICE 281-296.9599 EFAX 877.480.2179 DIRECT 713.443.9992

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”

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

Page 2: © 2012 Bergeson & Campbell, P.C., All Rights Reserved * Presented by: 1 H OUSTON C HEM S AFE I NC. A WDBE ▪ S INCE 1992 H OUSTON C HEM S AFE. COM 11430

© 2012 Bergeson & Campbell, P.C., All Rights Reserved

*Presented by:

2

HOUSTON CHEM SAFE INC.A WDBE ▪ SINCE 1992

HOUSTONCHEMSAFE.COM 11430 SLASH PINE PLACE THE WOODLANDS TX 77380

MARY SCAGGS • PRESIDENT [email protected]

OFFICE 281-296.9599 EFAX 877.480.2179 DIRECT 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.

Page 3: © 2012 Bergeson & Campbell, P.C., All Rights Reserved * Presented by: 1 H OUSTON C HEM S AFE I NC. A WDBE ▪ S INCE 1992 H OUSTON C HEM S AFE. COM 11430

© 2012 Bergeson & Campbell, P.C., All Rights Reserved

*Presented by:

3

HOUSTON CHEM SAFE INC.A WDBE ▪ SINCE 1992

HOUSTONCHEMSAFE.COM 11430 SLASH PINE PLACE THE WOODLANDS TX 77380

MARY SCAGGS • PRESIDENT [email protected]

OFFICE 281-296.9599 EFAX 877.480.2179 DIRECT 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.

Free demos & transition plan analysis services.

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

Page 4: © 2012 Bergeson & Campbell, P.C., All Rights Reserved * Presented by: 1 H OUSTON C HEM S AFE I NC. A WDBE ▪ S INCE 1992 H OUSTON C HEM S AFE. COM 11430

© 2012 Bergeson & Campbell, P.C., All Rights Reserved

© 2012 Bergeson & Campbell, PC. All Rights Reserved.

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. MACDOUGALLBergeson & Campbell, P.C.

Washington, D.C.www.lawbc.com

REGULATION WEEK AUDIO CONFERENCESwww.regulationweek.com

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

Page 5: © 2012 Bergeson & Campbell, P.C., All Rights Reserved * Presented by: 1 H OUSTON C HEM S AFE I NC. A WDBE ▪ S INCE 1992 H OUSTON C HEM S AFE. COM 11430

© 2012 Bergeson & Campbell, P.C., 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

5From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

Page 6: © 2012 Bergeson & Campbell, P.C., All Rights Reserved * Presented by: 1 H OUSTON C HEM S AFE I NC. A WDBE ▪ S INCE 1992 H OUSTON C HEM S AFE. COM 11430

© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

6From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

7From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Overview (cont’d)Effective Completion Date Requirement(s) Who

December 1, 2013Train employees on the new label

elements and SDS formatEmployers

June 1, 2015

 

December 1, 2015

Comply with all modified

provisions of this final rule,

except:

 

Distributors may ship products

labeled by manufacturers under

the old system until December 1,

2015

Chemical manufacturers,

importers, distributors, and

employers

June 1, 2016

Update alternative workplace

labeling and hazard

communication program as

necessary, and provide additional

employee training for newly

identified physical or health

hazards

Employers

Transition Period

Comply with either 29 C.F.R. Part

1910.1200 (this final standard), or

the current standard, or both

All chemical manufacturers,

importers, distributors, and

employers8

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

9From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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 Intergovern-mental 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

10From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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;

11From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

12From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Hazard Categories -- Revisions

13From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Topics to Be Covered Overview -- Revisions/Principles Basis for Classification Methodology for Classification of Substances and

Mixtures (Products)

14From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

15From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

16From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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 

17From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

18From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

19From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

20From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Hazard Categories -- Revisions Modifications to the following hazard

classification categories Physical Health

21From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

22From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

23From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

24From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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)

25From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Basis for Classification Substances

Classification based upon full range of available information

• Scientific literature• Study reports• Other reliable evidence

26From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Hazard Class and Hazard Category

27From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Hazard Class and Hazard Category (cont’d)

28

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 Lactation

STOT –Single Exposure 1 2 3

STOT – Repeated Exposure 1 2

Aspiration 1

Simple Asphyxiants Single Category

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Criteria for Classification Substances

Result of specific test (dose-effect relationship)

Example: Irreversible Eye Effects: Category 1

29

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.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

30From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

31

Sum of ingredients classified as:

Skin corrosive Category 1

Skin Irritant Category 2

Skin Category 1 >5% ≥1% but <5%Skin Category 2   ≥10%(10 x Skin Category 1) + Skin Category 2

  ≥10%

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Criteria for Classification (cont’d) Mixtures

32

Ingredient: Concentration: Mixture classified as: Skin

Acid with pH ≤2 ≥1% Category 1.

Base with pH ≥11.5 ≥1% Category 1.

Other corrosive (category 1) ingredients for which additivity does not apply

≥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.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

33From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Environmental Not OSHA’s mandate No environmental categories defined by OSHA

HCS

34From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

35From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Hazard Communication Labeling

under the Revised HCS

36From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

Topics Covered GHS Implementation Obligations Label content -- Transported containers Label content -- Workplace containers

37From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

38From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

39From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

40From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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)

41From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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© 2012 Bergeson & Campbell, P.C., All Rights Reserved

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

42From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

43From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

44From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

45From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Workplace Labels (cont’d) Employer must ensure that each container is

labeled (or tagged or marked) in the workplace

46

(i) Product identifier;(ii) Signal word;(iii) Hazard statement(s);(iv) Pictogram(s);(v) Precautionary statement(s);

and,(vi) 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.

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Workplace Labels (cont’d)

47

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. 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.

24 Chemhotline (555) 123-1234 Chemchain 123 Sunset boulevard, L.A. California, 123-1234 (555) 321-4321

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Workplace Labels (cont’d)

48

Product 123

DANGER

Heating may cause a fire or explosion.

SDSContaining full H-statements,

P-statements and supplier contact information.

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Safety Data Sheet

49From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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SDS Overview Implementation Dates

50From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

51From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

52From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

53From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Dates of Implementation No later than June 1, 2015 -- SDS modifications

must be in place Optional beginning May 25, 2012

54From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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TRAINING, INFORMATION, AND TRADE SECRETS

55From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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”

56From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Training -- Implementation

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

57

Effective Completion Date Requirement(s) Who

December 1, 2013Train employees on the new label elements and SDS format

Employers

June 1, 2016Provide additional employee training for newly identified physical or health hazards

Employers

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

58From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

59From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

60From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

61From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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/publi/ghs/ghs_rev04/English/10e_annex6.pdf

62From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

63From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

64From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

65From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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COMPARISON TO OTHER INTERNATIONAL STANDARDS

66From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Topics Discussed Introduction to Global GHS Key Differences in Hazard Categories Communication Differences

67From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

68From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Implementation Dates

69

Indonesia (Transport) January 1, 2005

Japan (All

sectors) December

1, 2006

Australia (Transport

) 2007

Canada (Transport) February 20, 2008

Korea (New

substances) July 1,

2008

China (All

sectors) February 1, 2009

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Implementation Dates (cont’d)

70

Indonesia (All

sectors) March 23,

2010

European Union

(All substances

) December

1, 2010

Mexico (All

sectors, Voluntary) June 30,

2011

Korea (All

substances) June 30,

2011

Australia (All

sectors) January 1,

2012

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Implementation Dates (cont’d)

71

European Union

(mixtures on the market

before December 1,

2010) December 1,

2012

Korea (All mixtures) June 30, 2013

OSHA HCS (Training deadline)

December 1, 2013

European Union

(All mixtures) June 1, 2015

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Differences in Communication Basic Differences

Language Emergency contact information Company contact details Label size and position

72From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Key Differences in Hazard Classification Pre-existing classification thresholds Building-block approach Specific concerns -- allowances made for specific

industry sectors

73From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Key Differences in Hazard Classification (cont’d)

Category OSHA HCS EU CLP1 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)

2 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)

3 Flash point ≥23 °C (73.4 °F) and ≤60 °C (140 °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.

4 Flash point ≥60 °C (140 °F) and ≤93 °C (199.4 °F)

74

Flammable Liquids

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Key Differences in Hazard Classification (cont’d)

75

Category OSHA HCS1 Category

EU CLP

1A 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.

1 (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.

1B 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 data are not sufficient for sub-categorization, skin sensitizers shall be classified in Category 1.

Sensitisation

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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Key Differences in Hazard Classification (cont’d)

76

-= No generic threshold.

Hazard Class Generic Threshold Value/Concentration LimitOSHA GHS EU CLP CHINA

GB 13690-2009Acute Toxicity - CAT 1-3 0.1%

CAT 4 1%≥1.0%

Skin Corrosion/Irritation - 1% ≥1.0%Serious Eye Damage/Eye irritation

- 1% ≥1.0%

Respiratory/Skin Sensitisation

≥0.1% - ≥1.0%

Germ cell Mutagenicity: Cat 1

≥0.1% - ≥1.0%

Germ cell Mutagenicity: Cat 2

≥1.0% - ≥1.0%

Carcinogenicity ≥0.1% - ≥1.0%Specific Target Organ Systemic Toxicity (Single Exposure)

≥1.0% - ≥1.0%

Target Organ Systemic Toxicity (Repeated Exposure)

≥1.0% - ≥1.0%

Specific Target Organ Systemic Toxicity Category 3

≥20% Not adopted Not adopted

Classification of Mixtures

From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

77From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

78From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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

79From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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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 

80From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

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THANK YOUBERGESON & CAMPBELL, P.C.

The Acta Group2200 Pennsylvania Avenue, N.W.

Suite 100WWashington, D.C. 20037

[email protected]@lawbc.com

www.lawbc.comwww.actagroup.com

81From Houston Chem Safe Inc. – Regulatory Compliance Specialists.

HOUSTON CHEM SAFE INC.A WDBE ▪ SINCE 1992

HOUSTONCHEMSAFE.COM 11430 SLASH PINE PLACE THE WOODLANDS TX 77380

MARY SCAGGS • PRESIDENT [email protected]

OFFICE 281-296.9599 EFAX 877.480.2179 DIRECT 713.443.9992REGULATORY COMPLIANCE SOLUTIONS INCLUDING AUTHORING, ELECTRONIC MSDS (SDS) MANAGEMENT

CONTACT FOR FREE SOFTWARE DEMO AND TO DISCUSS TRANSITION PLAN DESIGN SERVICES

Contact HCS Inc. for more information: