SNAPSHOT OF CHANGES

HCS 2012 and Ultraviolet/Electron Beam

Technology

February 25, 2015

Martha E. Marrapese, Partner

Keller and Heckman LLP

1001 G Street NW

Suite 500 West

Washington, DC 20001

+1 202.434.4123

marrapese@khlaw.com

www.khlaw.com

Washington, DC ● Brussels ● San Francisco ● Shanghai

A Preliminary Word



This presentation provides information about the law.

Legal information is not the same as legal advice, which involves the application of law to an individual’s specific circumstances. The interpretation and application of the law to an individual’s specific circumstance depend on many factors. This presentation is not intended to provide legal advice.

The information provided in this presentation is drawn entirely from public information. The views expressed in this presentation are the author’s alone.

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│ K ELLER AND H ECKMAN LLP Copyright © 2015

SNAPSHOT OF CHANGES

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Snapshot of HCS 2012 Changes - Elements

Old HCS

Purpose

Scope and application

Definitions

Hazard determination

Written hazard communication program

Labels and other forms of warning

Material safety data sheets

Employee information and training

Trade secrets

Effective dates

 HCS 2012

Purpose (rev)

Scope and application (rev)

Definitions (rev)

Hazard classification (rev)

Written hazard communication program (rev)

Labels and other forms of warning (rev)

Safety data sheets (rev)

Employee information and training (rev)

Trade secrets (rev)

Effective dates (rev)

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Snapshot of HCS 2012 Changes

Old HCS

A. Health hazard definitions (M)

B. Hazard determination (M)

C. Reserved

D. Definition of

Trade Secret (M)

E. Guidelines for

Employer

Compliance (A)



Old E re-issued as a guidance document

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HCS 2012

A. Health Hazard Criteria

(M)

B. Physical Hazard Criteria

(M)

C. Allocation of Label

Elements (M)

D. Safety Data Sheets (M)

E. Definition of "Trade

Secret" (M)

F. Guidance for Hazard

Classification re:

Carcinogenicity (NM)

Copyright © 2015

Snapshot of HCS 2012 Changes

Old HCS

Mixture cut-offs

Health

1.0%

Carcinogens:

0.1%

– hazards:



HCS 2012

Hazard Class Label

Respiratory / skin sensitization

>

0.1%

SDS

>

0.1%

Germ cell mutagenicity (Cat. 1)

>

0.1%

>

0.1%

Germ cell mutagenicity (Cat. 2)

>

1.0%

>

1.0%

Carcinogenicity

Reproductive toxicity

STOT (single exposure)

STOT (repeated exposure)

STOT (Cat. 3)

>

0.1%

>

0.1%

>

0.1%

>

0.1%

>

1.0%

>

1.0%

>

1.0%

>

1.0%

> 20% > 20%

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Snapshot of HCS 2012 Changes – Inner label

Old HCS

Label elements

 Identity of the hazardous chemical(s)

 Appropriate hazard warnings

 Name and address of the chemical manufacturer, importer or other responsible party

Label Phrasing/Language

 Developed by the manufacturer, importer or other responsible party

 ANSI standard commonly used, other industry guidance.

HCS 2012



Label elements



Product identifier



Signal word



Hazard statement(s)



Pictogram(s)



Precautionary statement(s)



Name, address, and telephone number of the chemical manufacturer, importer or other responsible party

Label Phrasing/Language



Mandatory language from GHS is provided in

Appendix C, Allocation of

Label Elements

Label border



Must be red, no empty red blocks

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Workplace Labels



Old HCS

Label, tag or mark with:



Identity of the hazardous chemical(s)



Appropriate hazard warnings or words, pictures, symbols or a combination thereof which provide at least general information regarding the hazards

HCS 2012

Label, tag or mark with :

Option A: Elements required for shipped containers

– Product identifier

– Signal word

– Hazard statement(s)

– Pictogram(s)

– Precautionary statement(s)

Option B

– Product identifier, and

– Words, pictures, symbols, or a combination thereof which provide at least general information regarding the hazards

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Material Safety Data Sheets (MSDS) v. SDS

Old HCS

No required format



HCS 2012

16 section format required

Performance-based description of minimum required information

Appendix D specifies information required under each heading

Sections 12-15 will not be enforced



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SDS Elements

 Section 1, Identification

 Section 2, Hazard(s) identification

 Section 3, Composition -information on ingredients

 Section 4, First-aid measures

 Section 5, Fire-fighting measures

 Section 6, Accidental release measures

 Section 7, Handling and storage

 Section 8, Exposure controls/personal protection

 Section 9, Physical and chemical properties;

 Section 10, Stability and reactivity;

 Section 11, Toxicological information.

 Section 12, Ecological information;

 Section 13, Disposal considerations;

 Section 14, Transport information; and

 Section 15, Regulatory information.

 Section 16, Other information, including date of preparation or last revision

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Reliance on Supplier SDS

Old HCS

Chemical manufacturers, importers and users may rely on the information provided on current MSDS of the individual ingredients



HCS 2012

Chemical manufacturers, importers and users may rely on the information provided on SDS for the individual ingredients, except –

Formulators of physical mixtures could prepare an

MSDS by attaching individual ingredient

MSDS to cover sheet (no

“intermediate” exception?)

Where the manufacturer, importer or user knows, or in the exercise of reasonable diligence should know, that the SDS misstates or omits required information

Need to provide SDS for mixture as a whole based on bridging principles; cover sheet approach not permitted

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Trade Secrets

P rocess remains unchanged

For asserting trade secret



For responding to requests for trade secret information based on medical need

Revised labeling requirement: changed from listing chemical identity to product identifier, which facilitates “missing” protection

Concentration of substance in mixture is a potential trade secret

Single number % concentration – yes

Numerical range % concentration – no (there is no guidance as to what range would be permissible, but presumably couldn’t misrepresent actual nature of hazard).

Existing protection against disclosure of “other specific identification of a hazardous chemical” would logically include a unique set of

PELs and/or PEL and TLV combination where the properties and effects of the chemical are disclosed.

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Training

• Additional training: whenever a new person or a new physical or health hazard is introduced, not just a new chemical.

• For example, a new solvent with similar hazards to existing chemicals = no new training is required.

• Technically, under the HCS, the employer need only make employees aware of the hazards to which they will be exposed and how to identify them.

• If PPE is required, then a hazard assessment and training would be specific to the hazardous chemicals requiring

PPE.

– The data sheet for each hazardous chemical must be readily available, and the product must be properly labeled.

• If a newly introduced chemical presents a new hazard not covered in prior training, the employer must provide new training to exposed employees.

• In the real world, periodic refresher training is generally necessary.

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SCOPE, EXEMPTIONS, DEADLINES

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Scope of Coverage

 Manufacturers and Importers:

• Assess inherent hazards (generally not risk) and classify chemical; create SDS (generally inherent hazards) & labels (consider risk)

 All Employers : Communicate info to their employees and contractor employers about hazardous chemicals they may be exposed to in normal operations or foreseeable emergencies

 Distributors : Transmit required info to downstream employers

• Also responsible for proper label

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Exemptions

 Complete Exemption from HCS

• Food, drugs or cosmetics for employee consumption/use

• Food sold, used or prepared in retail store or restaurant

(scope of “used” is unclear)

• OTC drugs and cosmetics packaged for retail sale

• Drugs in tablet or pill form

• Consumer product when “consumer” exposure

– Greater exposure from foreseeable emergency (leak)?

• Hazardous waste regulated by EPA

• Tobacco products

• Wood products not to be further processed (e.g., saw)

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Phasing in HCS 2012

 December 1, 2013 – initial training

• Label and SDS format and pictograms

 June 1, 2015:

• General compliance deadline

• Exception: until 12/1/2015, distributors may ship products that were labeled and shipped by manufacturers under the old system prior to

6/1/2015.

 June 1, 2016 :

• Update alternative workplace labeling and hazard communication programs as necessary, and provide additional employee training for newly identified (due to HCS-2012) physical or health hazards

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Problems with Existing Deadlines

Supply chain of manufacturers

 Same deadline

• Basic chemicals

• Formulated products

 Commercial products

• Additives to enhance processing and use

• Purity varies depending on commercial requirements

• Supply chain depth varies

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Problems with Deadlines

Sources of the problem

• Complex supply chains

• Lengthy supply chains

• Manufacturers of scores or even hundreds or thousands of chemicals o

Coatings/inks with millions of colors

• Distributors that mix generic chemicals from different sources

May easily lead to:

• Almost daily compliance issues and constant need to update information

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IMPLEMENTATION

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Process

 Identify substance or mixture

• Internal knowledge, industry knowledge, public knowledge (the internet?) (info in foreign languages?)

 Assess inherent hazards (generally not risk)

• Internal knowledge, industry knowledge, public knowledge

 Classify chemical

• Appendix A for health hazards

• Appendix B for physical hazards

 Determine appropriate (HCS + tort) label content

• Appendix C

 Determine appropriate (HCS + tort) SDS content

• Appendix D

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Health Hazard Classification

 Substance v. Mixture

• Substance

– Weight of evidence (WOE) to available data

• Mixture

– WOE to adequate test data on mixture

– WOE to adequate data on ingredients and substantially similar mixture

– Bridging principles

– Threshold cutoff levels for each hazard

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Label Elements

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UV/EB

Supply chain consists of –

 Resin and additive manufacturers

 Formulators

 End Users

Complex formulations –

 E.g., Adhesive

• Resin

• Diluent

• Solvent

• Surfactant

• Preservative

• Photoinitiator (optional)

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Acrylate Chemistry

 In general, UV/EB curing acrylates have low systemic toxicity, but they can cause skin and eye irritation or burns.

 Some individuals may also become sensitized to these chemicals as a result of contact.

 Most acrylate oligomers and monomers have a low vapor pressure, and inhalation of vapors is unlikely to occur at room temperatures. Some of these products may form stable aerosols which can be inhaled and may also cause skin and eye irritation.

 Low molecular weight acrylate monomers represent the most physiologically active materials in this class, due to the high level of acrylate functionality.

 The substantially higher molecular weight and lower net acrylate functionality of acrylate oligomers result in a lower level of physiological activity than the acrylate monomers.

• Skin and eye irritation due to oligomer exposure normally are minimal to mild, and the oligomers exhibitvery low acute toxicity.

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Hazard classification considerations

 Skin sensitization

• 1A or 1B?

– Cut off amounts of 0.1% and 1.0%, respectively, for having to label

– Most SDSs do not classify as HCS 2012 1A or 1B

– Difference is the % of animals and the concentration at which effects are seen.

– Examples - 2-butanone oxime and cobalt compounds versus maleic anhydride

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Skin sensitizer determinations – Animal testing

1A - Assay

Local lymph node assay

Guinea pig maximization test

Buehler assay

Criteria

EC3 value ≤ 2%

≥ 30% responding at ≤ 0.1% intradermal induction dose or

≥ 60% responding at > 0.1% to ≤ 1% intradermal induction dose

≥ 15% responding at ≤ 0.2% topical induction dose or

≥ 60% responding at > 0.2% to ≤ 20% topical induction dose

1B - Assay

Local lymph node assay

Guinea pig maximization test

Buehler assay

Criteria

EC3 value > 2%

≥ 30% to < 60% responding at > 0.1% to ≤ 1% intradermal induction dose or ≥ 30% responding at > 1% intradermal induction dose

≥ 15% to < 60% responding at > 0.2% to ≤ 20% topical induction dose or ≥ 15% responding at > 20% topical induction dose

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Other considerations for UV/EB

 How to address aquatic toxicity?

• Required for EU CLP

• Not required for OSHA compliance

 Presence of photoinitiators, inks, may drive classification of mixtures

 Amount of information on reproductive toxicity of acrylates is limited

 “Family” approach to classifying acrylates in light of TMPTA NTP study?

 Radtech resources may be consulted

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ENFORCEMENT

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Historically. . .



Commonly issued HCS citations were:

• Missing or inadequate written program

• Failure to provide training

• Failure to maintain SDS or chemical inventory or mismatches b/n the two

• Failure to label in-plant containers



Few citations for inadequate MSDS or label



PPE

• Failure to use recommended PPE or failure to keep it readily available

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Enforcement – List of chemicals

 Even with a complete set of SDSs, employers have been cited for:

• An outdated list

• A list that identified a chemical with a different name than the one appearing on the SDS



Ongoing updating requirement

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In the Future . . .

 Increased emphasis on chemical safety

 OSHA will continue to make HCS one of its most frequently cited standards

 Some greater attention to adequacy of classification, SDS and labeling is likely

 OSHA will exercise enforcement discretion for downstream compliance

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Thank you

Martha E. Marrapese

Partner

Keller and Heckman LLP

1001 G Street NW

Suite 500 West

Washington, DC 20001

+1 202.434.4123

marrapese@khlaw.com

www.khlaw.com

Washington, DC ● Brussels ● San Francisco ● Shanghai

SNAPSHOT OF CHANGES

HCS 2012 and Ultraviolet/Electron Beam

Technology