www.khlaw.com washington, dc ● brussels ● san francisco ● shanghai martha e. marrapese,...

www.khlaw.comWashington, DC ● Brussels ● San Francisco ● Shanghai

Martha E. Marrapese, PartnerKeller and Heckman LLP

1001 G Street NWSuite 500 West

Washington, DC 20001+1 202.434.4123

[email protected]

HCS 2012 and Ultraviolet/Electron Beam TechnologyFebruary 25, 2015

│ www.khlaw.com │ KELLER AND HECKMAN LLP2 Copyright © 2015

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.


SNAPSHOT OF CHANGES


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)


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

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)


Snapshot of HCS 2012 Changes

Old HCS Mixture cut-offs –

Health hazards: 1.0% Carcinogens: 0.1%

HCS 2012 Hazard Class

Label

SDS

Respiratory / skin sensitization > 0.1% > 0.1%

Germ cell mutagenicity (Cat. 1) > 0.1% > 0.1%

Germ cell mutagenicity (Cat. 2) > 1.0% > 1.0%

Carcinogenicity > 0.1% > 0.1%

Reproductive toxicity > 0.1% > 0.1%

STOT (single exposure) > 1.0% > 1.0%

STOT (repeated exposure) > 1.0% > 1.0%

STOT (Cat. 3) > 20% > 20%


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


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


Material Safety Data Sheets (MSDS) v. SDS

Old HCS

No required format

Performance-based description of minimum required information

HCS 2012

16 section format required

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


Reliance on Supplier SDS

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

Formulators of physical mixtures could prepare an MSDS by attaching individual ingredient MSDS to cover sheet (no “intermediate” exception?)

HCS 2012 Chemical manufacturers, importers and users may rely on the information provided on SDS for the individual ingredients, except –

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


Trade Secrets

Process 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.


• 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.

Training


SCOPE, EXEMPTIONS, DEADLINES


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

Scope of Coverage


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)

Exemptions


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


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

Problems with Existing 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

Problems with Deadlines


IMPLEMENTATION


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


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

Health Hazard Classification


Label Elements


Supply chain consists of – Resin and additive manufacturers Formulators End Users

Complex formulations – E.g., Adhesive

• Resin• Diluent• Solvent• Surfactant• Preservative• Photoinitiator (optional)

UV/EB


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.


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


Skin sensitizer determinations – Animal testing

1A - Assay Criteria

Local lymph node assay

EC3 value ≤ 2%

Guinea pig maximization test

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

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

1B - Assay Criteria

Local lymph node assay

EC3 value > 2%

Guinea pig maximization test

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

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


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


ENFORCEMENT


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

Historically. . .


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

Enforcement – List of chemicals


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

In the Future . . .

www.khlaw.comWashington, DC ● Brussels ● San Francisco ● Shanghai

Martha E. MarrapesePartner

Keller and Heckman LLP1001 G Street NW

Suite 500 WestWashington, DC 20001

+1 [email protected]

Thank you

www.khlaw.com washington, dc ● brussels ● san francisco ● shanghai martha e. marrapese,...

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