Avoiding HCS Citations: OSHA Issues Useful “How To” Guidance · 2019. 12. 12. · (i.e.,...

© 2015 Bergeson & Campbell, P.C. All Rights Reserved.

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®


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

2

© 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

3


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)

4

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=6IiLoWCOIUMj5M&tbnid=NkK40tF7o_39FM:&ved=0CAUQjRw&url=http://www.labeline.com/store_uk/ecom-catshow/multi_modal_regulations.html&ei=YTr2U8TJHpaBygSL5YG4Cw&bvm=bv.73373277,d.aWw&psig=AFQjCNEEqxgYjmUPbE8EqWqLe-38ZzlUfw&ust=1408732101923640


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

5


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

6


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

7


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

8

https://www.google.com/imgres?imgurl&imgrefurl=http://www.usflag.org/the.50.star.flag.html&h=0&w=0&tbnid=65ldohmlyNlmRM&zoom=1&tbnh=126&tbnw=224&docid=UB4nxc4ZymdypM&tbm=isch&ei=z4E1VKaGK4r48QWpj4LQDA&ved=0CAQQsCUoAA


OSHA HCS 2012

9


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

10


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)

11


OSHA HCS 2012 (cont’d) The major changes to the HCS:

12

https://www.osha.gov/dsg/hazcom/side-by-side.html

https://www.osha.gov/dsg/hazcom/index.html






https://www.osha.gov/dsg/hazcom/index.html


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

13





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

14



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

15



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

16

©2015, 3E Company, All Rights Reserved

17

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


18

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


19

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


20

Publicly available data 29 C.F.R.§1910.1200(d)(2)

– Other country GHS classifications

– Regulatory lists

– IARC/NTP


21

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


22

Start by taking it section by section to see what useful information you can extract.


23

What is the vendor classification?

Where did this come from?

How can we use it to make GHS classification?


24

What can we learn about the composition?


25

Have other countries classified 68391-01-5 Benzalkonium chloride


26

68391-01-5 (cont’d)


27

68391-01-5 (cont’d)


28

68391-01-5 (cont’d)


29

68391-01-5 (cont’d)


30

Physical and chemical properties

Do these data alone substantiate the classification of the mixture?


31

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


32

GHS criteria for Flammable


33

How can you use DG data


34

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.

http://en.wikipedia.org/wiki/Hydrogen_cyanide


35

Toxicity information on the mixture level


36

GHS acute toxicity criteria


37

Use of Section 10


38

What can we get from product sheets


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

39


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

40



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

41



“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

42



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

43


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

44


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)

45


Q&A

Karin F. Baron, MSPH

Regulatory Consultant, Acta

Elizabeth Tanner

Product Manager, 3E

Lynn L. Bergeson

Managing Partner, B&C

46


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

47

http://www.lawbc.com/

http://www.actagroup.com/

http://www.3ecompany.com/

Avoiding HCS Citations: OSHA Issues Useful “How To” Guidance · 2019. 12. 12. · (i.e.,...

Documents

Transcript of Avoiding HCS Citations: OSHA Issues Useful “How To” Guidance · 2019. 12. 12. · (i.e.,...