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Avoiding HCS Citations: OSHA Issues Useful “How To” Guidance
Webinar April 2, 2015, 1:00 p.m. - 2:00 p.m. (EDT)
Karin F. Baron Acta®
Elizabeth Tanner 3E
Lynn L. Bergeson B&C®
© 2015 Bergeson & Campbell, P.C. All Rights Reserved.
Speakers
Karin F. Baron, MSPH, Regulatory Consultant, The Acta Group (Acta®)
Primary areas of practice include hazard and risk assessment and communication, industrial hygiene, and EHS and GHS programs
Elizabeth Tanner, Product Manager, 3E
Seasoned Hazard Communicator, a registered Safety Data Sheet and Label Author, and a member of the SCHC Board of Directors
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®)
Counsels on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters pertinent to products of conventional, biotechnology, biobased chemicals, nanotechnologies, and other emerging technologies
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© 2015 Bergeson & Campbell, P.C. All Rights Reserved. © 2015 Bergeson & Campbell, P.C. All Rights Reserved.
Lynn L. Bergeson
Karin F. Baron, MSPH.
Bergeson & Campbell P.C.
Washington, D.C.
www.lawbc.com
Elizabeth Tanner
3E Company
Carlsbad, CA
www.3ecompany.com
Avoiding HCS Citations: OSHA
Issues Useful “How To” Guidance
Bergeson & Campbell, P.C.
The Acta Group
April 2, 2015
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© 2015 Bergeson & Campbell, P.C. All Rights Reserved.
What Is GHS?
Globally Harmonised System for Classification and Labelling of Chemicals (GHS)
1992 mandate from United Nations (UN) Conference on Environment and Development
UN developed standardized system, which was first adopted in 2002 and published in 2003
Establishes “harmonized” criteria for classification with associated communications tools, including requirements for labeling and Safety Data Sheets (SDS)
Organized by parts, chapters, and annexes
Currently in 5th revised version (Rev. 5)
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GHS Building Blocks
UN model is based on “building blocks” approach
Each building block consists of a hazard and specified criteria
Hazard determination, not risk
Risk or the likelihood of harm occurring involves exposure in conjunction with potential hazards
Hazard X Exposure = Risk
Currently, Rev. 5 consists of 16 physical chemical hazards, 10 health hazards, and 2 environmental hazards
Understanding the complexities and decision logics for each part/chapter is critical
Ten annexes are available in Rev. 5; each provides additional guidance and interpretative assistance
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GHS Building Blocks (cont’d)
Hazard classification concept in three steps
Identification of relevant data
Review of data
A decision on if classification applies and to what
extent
Classification criteria
Tiered or hierarchy approach should be considered
Test results should be considered before bridging
principles
Bridging principles before estimation
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GHS Building Blocks (cont’d)
Classification criteria
Consideration should be made
Animal welfare (alternative methods)
Evidence from humans (epidemiological and
occupational information)
Weight of evidence (alpha 2u-globulin nephropathy and
carcinogenesis)
Expert judgement
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U.S. GHS Implementation
Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS) adopted May 25, 2012 (29 C.F.R. § 1910.1200)
Criteria-based adoption based on UN GHS Rev. 3
Not all building blocks were adopted
Additional elements were considered
Transitional period for compliance was established to give industry time to comply
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OSHA HCS 2012
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OSHA HCS 2012 (cont’d) Overview
Scope has not changed, covers chemicals in the workplace
Material Safety Data Sheet (MSDS) = SDS
Changes to health and physical hazard criteria (Appendices A and B)
Changes to the label (Appendix C)
Additional elements (Combustible dust)
Changes to the SDS (Appendix D)
Additional considerations (Hazards Not Otherwise Classified (HNOC))
Not covered
Environmental hazards; not OSHA mandate
Transportation; not OSHA mandate
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OSHA HCS 2012 (cont’d)
The major changes to the HCS:
Hazard classification: Criteria are completely revised with new approaches to mixtures and new hazard categories
1994 Appendix A: definitions and criteria for seven health hazard criteria in Hazard Communication 1994 (HazCom 1994) standard (i.e., toxic oral > 50 mg/kg - < 500 mg/kg)
HCS 2012 Appendix A: 10 hazard chapters with definitions that contain roughly 34 criteria throughout (i.e., acute toxicity, oral 4 categories ≤5 mg/kg - ≤ 2000 mg/kg)
HazCom 1994: definitions contained 10 physical hazards (i.e., combustible liquid, flashpoint >100°F (37.8°C) - < 200°F (93.3°C))
HCS 2012 Appendix B: 16 physical hazard chapters that contain approximately 42 criteria throughout. (i.e., flammable liquids, 4 categories flash points < 23°C - ≤ 93°C)
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OSHA HCS 2012 (cont’d) The major changes to the HCS:
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https://www.osha.gov/dsg/hazcom/side-by-side.html
https://www.osha.gov/dsg/hazcom/index.html
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OSHA Enforcement Guidance
Issued February 9, 2015 -- “The Enforcement Guidance for the Hazard Communication Standard’s (HCS) June 1, 2015 Effective Date”
Describes “the Agency’s enforcement position on the HCS June 1, 2015 effective date for manufacturers and importers, including product formulators, that have exercised reasonable diligence and good faith to classify their chemical mixtures according HCS 2012…”
Details process and documentation elements for demonstration of “reasonable diligence” and “good faith efforts”
https://www.osha.gov/dep/enforcement/hazcom_enforcement-memo.html
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OSHA Enforcement Guidance (cont’d)
Documentation of demonstrated efforts
includes:
Details on what efforts were employed to obtain data
to determine classification
Written accounts of continual communication with
upstream supplier to obtain information when publicly
available sources resulted in no data to determine
classification
Written accounts of continual communication with
downstream users who are potentially impacted
Developing an action plan for addressing changes to
the SDS and labels
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OSHA Enforcement Guidance (cont’d)
Points to consider with documenting efforts
employed for the classification of mixtures
HCS 2012 provides processes for classification of mixtures based on GHS concepts
29 C.F.R. § 1910.1200 Appendix A
Reliance on supplier information is one method
Critical to demonstrate no other source of data is available for classification of mixtures as indicated in 29 C.F.R. § 1910.1200(d)(2)
Enforcement could be an issue if a manufacturer is aware of or can with “reasonable diligence” demonstrate knowledge that additional data or misstated data are being supplied
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OSHA Enforcement Guidance (cont’d)
Process of documenting written accounts of continual communications with upstream and downstream supply chain
Recommend any documentation include methods for communication
Recommend any documentation include dates of each attempt and name of individual contacted
Developing an action plan
HCS 2012 states requirements for updating SDS (3 months) and label (6 months) when new information is available in 29 C.F.R. § 1910.1200(f)(11) and 29 C.F.R. § 1910.1200(g)(5)
Consider how changes to ingredients are addressed
Consider how these changes are communicated throughout the supply chain
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How do I show due diligence?
• Document communication with supplier requesting GHS SDS or additional data to be used to create your own GHS classification
• Professional judgment
• Experience with the product
• Review all publicly available data on the components known to be in the purchased product
• Utilizing data on previously supplied SDS
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Professional judgment
• Can you use bridging principles to gain knowledge on the components/compound
• Can the structure be broken down into monomeric form
– Is there information at that level
• Are there generic groupings
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Experience with the product
• What do you know about the product from experience
• How is it used in your final product
• What do your coworkers have to say
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Publicly available data 29 C.F.R.§1910.1200(d)(2)
– Other country GHS classifications
– Regulatory lists
– IARC/NTP
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How can you use a Supplier SDS that is not GHS compliant to determine a GHS classification on your product?
Utilizing data on previously supplied SDS
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Start by taking it section by section to see what useful information you can extract.
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What is the vendor classification?
Where did this come from?
How can we use it to make GHS classification?
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What can we learn about the composition?
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Have other countries classified 68391-01-5 Benzalkonium chloride
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68391-01-5 (cont’d)
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68391-01-5 (cont’d)
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68391-01-5 (cont’d)
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68391-01-5 (cont’d)
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Physical and chemical properties
Do these data alone substantiate the classification of the mixture?
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Flammability criteria
Table from SCHC-OSHA alliance information sheet on flammable liquids https://schc.memberclicks.net/assets/docs/ghs_info_sheets/schc_ghs_fs2_flammable_liquid.pdf
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GHS criteria for Flammable
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How can you use DG data
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HMIS/NFPA
Health 4. Life-threatening, major or permanent damage may result from single or repeated overexposures (e.g., hydrogen cyanide). 3. Major injury likely unless prompt action is taken and medical treatment is given. 2. Temporary or minor injury may occur. 1. Irritation or minor reversible injury possible. 0. No significant risk to health.
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Toxicity information on the mixture level
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GHS acute toxicity criteria
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Use of Section 10
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What can we get from product sheets
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Key Legal Issues
Timely Compliance
June 1, 2015, compliance deadline for new labeling and SDS is fast approaching
Even diligent health and safety professionals may find themselves behind the curve due to unresolved questions or lack of scientific/technical information
If OSHA comes calling after the deadline and compliance is incomplete:
Document all compliance-related activities
In the early post-deadline period, tangible evidence of efforts and progress may buy more time from OSHA
Redouble efforts before the deadline to address logjams that impede compliance
Assure ongoing compliance with the HazCom 1994 standards while moving to comply with HCS 2012 standards
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Key Legal Issues (cont’d)
Trade Secret Protection
New approach to trade secrets creates potentially significant pitfalls for global chemical sales that may be overlooked until too late
HazCom 1994: To protect trade secrets, MSDS could specify concentration ranges of proprietary components in a mixture
HCS 2012: Trade secret protection may be claimed only for exact percentages of components specified on the new SDS
Under both 1994 and 2012 standards, Chemical Abstracts Service (CAS) information need not be provided
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Key Legal Issues (cont’d)
Foreign Jurisdictions Issues
May require different responses due to other legislative demands; foreign jurisdictions may require disclosure of trade secret information on SDS beyond what is called for in the U.S.
Result -- a ticking time-bomb
Non-disclosure could impede chemical sales in non-U.S. markets
Disclosure to enable non-U.S. sales may undercut the producer’s confidentiality claim for OSHA purposes on grounds that information was not sufficiently protected elsewhere and therefore not “supported” under 29 C.F.R. § 1910.1200(i)(1)(i)
One possible solution for North American sales is to devote the lead-time and cost to obtain trade secret protection under Canadian law; European nations may be more complicated
Be familiar with 29 C.F.R. § 1910.1200(i) and Appendix E
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Key Legal Issues (cont’d)
“New Hazards”
The revised format of 2012 SDS requires substantial changes in how mixtures are assessed, how their components are evaluated, and how hazard information is presented
New health effects/exposure/risk assessment data are becoming available, and chemical suppliers and users risk liability for failure to integrate new information
Acknowledge that there are limits on how far one reasonably can rely on an SDS from a supplier that ignores publicly available relevant data
Replacement of 1994 MSDS “0.1% - 1% approach” to characterizing hazards from mixtures by a more complex tiered approach to endpoints places a greater burden of effort and care on SDS preparers and users
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Key Legal Issues (cont’d)
With endpoints for acute toxicity requiring a proportional approach, endpoints for irritation and aspiration requiring a summation approach, and endpoints such as carcinogenicity, reproductive toxicity, or mutagenicity subject to a threshold approach, the task is more difficult and missteps are possible
“Do your homework” -- be familiar with the standard and the relevant OSHA Appendices, e.g., Appendix A to 29 C.F.R. § 1910.1200 -- Health Hazard Criteria (Mandatory)
Satisfy the requirements of OSHA’s Enforcement Guidance
Manage Recordkeeping -- remember 30-year retention requirement
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Enforcement Statistics
Between December 1, 2013, and February 2, 2015, OSHA issued 7,311 total HCS violations citing:
29 C.F.R. § 1910.1200(h) training
(h)(1) -- information and training program
(h)(3)(iv) -- training on shipped labels, workplace labeling, and SDS
29 C.F.R. § 1910.1200(e) written program
29 C.F.R. § 1910.1200(g) (M)SDS
(g)(8) -- maintain MSDS/SDS and have readily accessible during work shift
(g)(1) -- manufacturer/importer obtain or develop SDS; employer have a SDS for each chemical
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Enforcement Statistics (cont’d)
29 C.F.R. § 1910.1200(f) labeling
(f)(5)(i) and (ii) -- container labeling
The manufacturer or importer may not partially
implement a HCS 2012-compliant label or
SDS for product (i.e., not including all the
required precautionary statements on the
revised label or all the required information on
the SDS)
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Q&A
Karin F. Baron, MSPH
Regulatory Consultant, Acta
Elizabeth Tanner
Product Manager, 3E
Lynn L. Bergeson
Managing Partner, B&C
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Thank You
Lynn L. Bergeson Karin F. Baron, MSPH
Bergeson & Campbell, P.C. The Acta Group
2200 Pennsylvania Avenue, N.W. Suite 100W
Washington, DC 20037 www.lawbc.com
www.actagroup.com
Elizabeth Tanner
3E Company 3207 Grey Hawk Court
Suite 200 Carlsbad, CA 92010
www.3ecompany.com
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