© 2012 bergeson & campbell, p.c., all rights reserved * presented by: 1 h ouston c hem s afe i...
TRANSCRIPT
© 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.
© 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.
© 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.
© 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.
© 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.
© 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.
© 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.
© 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.
© 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.
© 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.
© 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.
© 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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
Hazard Categories -- Revisions
13From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 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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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.
© 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.
© 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.
© 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.
© 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.
© 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.
© 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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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.
© 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.
© 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.
© 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.
© 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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Hazard Class and Hazard Category
27From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
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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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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.
© 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.
© 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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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.
© 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.
© 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.
© 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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
Hazard Communication Labeling
under the Revised HCS
36From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 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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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.
© 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.
© 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.
© 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.
© 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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
Differences in Communication Basic Differences
Language Emergency contact information Company contact details Label size and position
72From Houston Chem Safe Inc. – Regulatory Compliance Specialists.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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.
© 2012 Bergeson & Campbell, P.C., All Rights Reserved
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
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