Martha E. Marrapese, Partner - PowerPoint Presentation

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Martha E. Marrapese, PartnerKeller and Heckman LLP1001 G Street NWSuite 500 WestWashington, DC 20001+1 202.434.4123marrapese@khlaw.com

HCS 2012 and Ultraviolet/Electron Beam Technology

February 25, 2015

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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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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

Health hazard definitions (M)

Hazard determination (M)

Reserved

Definition of Trade Secret (M) Guidelines for Employer Compliance (A) Old E re-issued as a guidance document HCS 2012 Health Hazard Criteria (M) Physical Hazard Criteria (M) Allocation of Label Elements (M) Safety Data Sheets (M) Definition of "Trade Secret" (M) Guidance for Hazard Classification re: Carcinogenicity (NM)

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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%

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Snapshot of HCS 2012 Changes – Inner label

Old HCS

Label

elements

Identity

of the hazardous chemical(s)Appropriate hazard warningsName 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 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 ElementsSection 1, IdentificationSection 2, Hazard(s) identificationSection 3, Composition --information

on ingredientsSection 4, First-aid measuresSection 5, Fire-fighting

measures

Section

6, Accidental release

measuresSection 7, Handling and storageSection 8, Exposure controls/personal protectionSection 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; andSection 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 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

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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.

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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

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SCOPE, EXEMPTIONS, DEADLINES

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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 employersAlso responsible for proper labelScope of Coverage

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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” exposureGreater exposure from foreseeable emergency (leak)?Hazardous waste regulated by EPATobacco productsWood products not to be further processed (e.g., saw)Exemptions

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Phasing in HCS 2012 December 1, 2013 – initial trainingLabel and SDS format and pictograms

June 1, 2015: General compliance deadlineException: 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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Supply chain of manufacturers

Same deadline

Basic chemicals

Formulated products

Commercial products

Additives to enhance processing and usePurity varies depending on commercial requirementsSupply chain depth variesProblems with Existing Deadlines

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Sources of the problem

Complex supply chains

Lengthy supply chains

Manufacturers of scores or even hundreds or

thousands of chemicals Coatings/inks with millions of colorsDistributors that mix generic chemicals from different sourcesMay easily lead to:Almost daily compliance issues and constant need to update informationProblems with Deadlines

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IMPLEMENTATION

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Process Identify substance or mixtureInternal knowledge, industry knowledge, public knowledge (the internet?) (info in foreign languages?) Assess inherent hazards (generally not risk) Internal knowledge, industry knowledge, public

knowledgeClassify chemical Appendix A for health hazardsAppendix B for physical hazards

Determine appropriate (HCS + tort) label content

Appendix C

Determine appropriate (HCS + tort) SDS content

Appendix D

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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 mixtureBridging principlesThreshold cutoff levels for each hazard Health Hazard Classification

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Label Elements

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Supply chain consists of –

Resin

and additive manufacturers

Formulators

End Users

Complex formulations –E.g., AdhesiveResinDiluentSolventSurfactantPreservativePhotoinitiator (optional)

UV/EB

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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 considerationsSkin sensitization1A or 1B? Cut off amounts of 0.1% and 1.0%, respectively, for having to labelMost SDSs do not classify as HCS 2012 1A or 1BDifference 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 testing1A - AssayCriteria

Local lymph node assayEC3 value ≤ 2%

Guinea pig maximization test

≥ 30% responding at ≤ 0.1% intradermal induction dose

or

≥ 60% responding at > 0.1% to ≤ 1% intradermal induction doseBuehler assay≥ 15% responding at ≤ 0.2% topical induction dose or≥ 60% responding at > 0.2% to ≤ 20% topical induction dose1B - AssayCriteriaLocal lymph node assayEC3 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 doseBuehler assay≥ 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/EBHow to address aquatic toxicity?Required for EU CLPNot required for OSHA compliancePresence of photoinitiators, inks, may drive classification of mixturesAmount 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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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 labelPPEFailure to use recommended PPE or failure to keep it readily availableHistorically. . .

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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

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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 . . .

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Martha E. MarrapesePartnerKeller and Heckman LLP1001 G Street NWSuite 500 WestWashington, DC 20001+1 202.434.4123

marrapese@khlaw.com

Thank you