ghs: what's new in the americas? -...

GHS: what's new in the Americas?

Webinar, 30 April 2013, 2pm BST

Today’s webinar – aims (1/2)Provide delegates with a round-up of changes to OSHA and implementation;

Provide an overview of activities in Canada, setting out the implications for Canadian industry, next steps and suggestions for pre-implementation preparations;

Consider WHMIS, highlighting anticipated changes;

Today’s webinar – aims (2/2)Provide a regional update, with a specific focus on Latin America.

Look at Argentina's new Labelling and Safety Data Sheet standards aligning with GHS (4th edition) as well as recent Brazil GHS versions.

Detail central American countries adopting GHS and the wider acceptance of GHS.

Q&A session

If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.

http://forum.chemicalwatch.com


Speakers

Deana Holmes, Health Scientist, OSHA Directorate of Standards and Guidance;

Leticia Cuevas, Latin America RegulatoryAnalyst, 3E Company;

Ginette Bouchard, Environmental Affairs Specialist, Bayer Inc.;

Chair: Oliver Curl, Reporter, Chemical Watch

Hazard Communication and the Globally Harmonized

System (GHS)

Deana HolmesOSHA, Directorate of Standards & GuidanceApril 30, 2013

Overview

• Major changes to the Hazard Communication Standard

• Hazard Communication Guidance and Outreach

Development of Final Rule

• ANPR modifying the existing HCS to align it with the GHS was published on September 12, 2006

• NPRM Published in the Federal Register on September 30, 2009 (74 FR 50280-50549)

• Public hearings in 2010• Final rule published in the Federal Register on

March 26, 2012 and became effective on May 25, 2012

MODIFIEDHAZARD COMMUNICATION STANDARD

How Hazard Communication Works

Organization of the Final Rule(a) Purpose(b) Scope and Application(c) Definitions(d) Hazard Classification(e) Written Hazard Communication Program(f) Labels and Other Forms of Warning(g) Safety Data Sheets(h) Employee Information and Training(i) Trade Secrets(j) Effective Dates

Appendices A-F

Appendices• Appendix A, Health Hazard Criteria (Mandatory)

(NEW)• Appendix B, Physical Hazard Criteria (Mandatory)

(NEW)• Appendix C, Allocation of Label Elements

(Mandatory) (NEW)• Appendix D, Safety Data Sheets (Mandatory) (NEW)• Appendix E, Definition of “Trade Secret”

(Mandatory)• Appendix F, Guidance for Hazard Classifications

re: Carcinogenicity (Non-Mandatory) (NEW)

d) Hazard Classification

HazCom 1994• Performance-oriented

– Definitions in paragraph (c), Appendices A and B

– Appendix B—parameters for evaluating data

– “Floor” of chemicals considered hazardous

– “One study” rule– Standardized mixture cut-off

rules

HazCom 2012• Specific and detailed

– Concept of “classification” vs. determination in current rule

– Each hazard class has detailed criteria to apply to data on the chemical

– No floor; based on weight of evidence

– Mixture rules are specific to each hazard class

Hazard Classification

• Manufacturers are still responsible for determining the hazards of the chemicals they produce or import

• Classification (similar to hazard determination) is based on the full range of available information

• The procedures for determining if the manufacturer has properly performed the hazard classification are provided in Appendix A (health) and Appendix B (physical)

11

Hazard Class Hazard Category

Acute Toxicity 1 2 3 4

Skin Corrosion/Irritation 1A 1B 1C 2

Serious Eye Damage/ Eye Irritation 1 2A 2B

Respiratory or Skin Sensitization 1

Germ Cell Mutagenicity 1A 1B 2

Carcinogenicity 1A 1B 2

Reproductive Toxicity 1A 1B 2 Lactation

STOT – Single Exposure 1 2 3

STOT – Repeated Exposure 1 2

Aspiration 1

Simple Asphyxiants Single Category

Health Hazards

Hazard Class Hazard Category Explosives Unstable

Explosives Div 1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div 1.6

Flammable Gases 1 2 Flammable Aerosols 1 2 Oxidizing Gases 1 Gases under Pressure Compressed Gases Liquefied Gases Refrigerated Liquefied Gases Dissolved Gases

1

Flammable Liquids 1 2 3 4 Flammable Solids 1 2 Self-Reactive Chemicals Type A Type B Type C Type D Type E Type F Type G Pyrophoric Liquids 1 Pyrophoric Solid 1

Pyrophoric Gases Single category

Self-heating Chemicals 1 2 Chemicals, which in contact with water, emit flammable gases

1 2 3

Oxidizing Liquids 1 2 3 Oxidizing Solids 1 2 3 Organic Peroxides Type A Type B Type C Type D Type E Type F Type G Corrosive to Metals 1

Combustible Dusts Single Category

Physical Hazards

Hazards not Otherwise Classified

• This definition was added to ensure that hazards currently covered by HazCom continue to be covered

• Information will be required on the safety data sheets in Section 2

• Hazard information on the label, is not mandatory, but can be provided under supplementary information

• Such hazards must also be addressed in worker training

f) Labels and Other Forms of Warning

HazCom 1994• Shipped containers to be

labeled with identity, appropriate hazard warnings, and responsible party

• Performance-oriented, specifics left to discretion of chemical manufacturer or importer

HazCom 2012• Shipped containers to be

labeled with product identifier; signal word; hazard statement(s); pictograms; precautionary statements; and responsible party

• Specifies information by hazard class and category

Approach to Labels

• The final rule—like the GHS—is a specification approach to labels. In Appendix C, OSHA has indicated by hazard class and hazard category the label elements that must be on the label

• Appendix C provides guidance on the application of label elements—once classification of the hazards is completed, Appendix C is to be consulted to determine how to convey the required information

Label Requirements –Shipped Containers

• Product identifier• Signal word• Hazard statement(s)• Pictogram(s)• Precautionary statement(s)• Name, address, and phone number of the

responsible party

Pictograms and Hazards

• OSHA is requiring red borders regardless of the shipment’s destination.

• The red borders increase comprehensibility.

• Blank red diamonds are not permitted on a label.

Red vs. Black Borders

g) Safety Data Sheets

HazCom 1994• Specifies what information is

required, but chemical manufacturer or importer can use whatever format or order of information they want

HazCom 2012• Mandates 16-section SDS

headings, order of information, and what information is to be provided under the headings

• Will not enforce sections 12-15 that require information outside OSHA’s jurisdiction

16-Section Safety Data Sheet1. Identification of the substance

or mixture and of the supplier2. Hazards identification3. Composition/information on

ingredients Substance/Mixture4. First aid measures 5. Firefighting measures6. Accidental release measures7. Handling and storage8. Exposure controls/personal

protection.9. Physical and chemical

properties

10. Stability and reactivity11. Toxicological 12. Ecological information

(non mandatory)13. Disposal considerations

(non mandatory)14. Transport information

(non mandatory)15. Regulatory information

(non mandatory)16. Other information including

information on preparation and revision of the SDS

h) Employee Information and Training

HazCom 1994• Requires employee information

and training before a worker is exposed to the hazardous chemicals in the workplace, and whenever the hazard changes

HazCom 2012• Clarifies that the labels on

shipped containers and workplace labels must be explained, as well as SDS format

• Workers will have to be trained on the new label and SDS formats before all the provisions of the rule are effective

• Employers shall train employees regarding the new label elements and safety data sheet format by December 1, 2013.

• Label elements:– Train employees on the type of information that the employee would

expect to see on the new labels.– How they might use that information –

• Product identifier, Signal word, Hazard statement(s), Pictogram(s), Precautionary statement(s), and Name, address and phone number of the responsible party

• General understanding how the elements interact. – For example, explain the two signal words: Danger means a

more severe hazard within a hazard class. Warning is for the less severe hazard.

• Safety Data Sheet Format

– Train the employees on the standardized 16-section format and the type of information they would find in the various sections.

Employee Information and Training

Effective Completion Date Requirement(s) Who

December 1, 2013 Train employees on the new label elements and SDS format.

Employers

June 1, 2015*

December 1, 2015

Comply with all modified provisions of this final rule, except:Distributors may ship products labeled by manufacturers under the old system until December 1, 2015.

Chemical manufacturers, importers, distributors and employers

June 1, 2016 Update alternative workplace labeling and hazard communication program as necessary, and provide additional employee training for newly identified physical or health hazards.

Employers

Transition Period Comply with either 29 CFR 1910.1200 (this final standard), or the current standard, or both.

All chemical manufacturers, importers, distributors and employers

*This date coincides with the European Union implementation date for classification of mixtures.

j) Effective Dates – HazCom 2012

GUIDANCE & OUTREACH

Updated HazCom Webpage

Guidance & Outreach

OSHA is developing an array of guidance materials• Initial Materials

– Quick cards, fact sheets, OSHA briefs, small entity compliance guides, frequently asked questions

• Technical Materials– Model Training Materials, Safety Data Sheet Preparation

Guidance, Hazard Classification Guidance• Web Applications

– SDS Electronic Form; Acute Toxicity Calculator; Label Elements Application

Updated Webpages

• HazCom 2012 Webpagehttp://www.osha.gov/dsg/hazcom/index.html

• UN GHS Sub-Committee Home Pagehttp://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

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

http://www.unece.org/trans/danger/publi/ghs/gh

Contact information

• Deana [email protected]

mailto:[email protected]

©2013, 3E Company, All Rights Reserved

2013 GHS Developments in Latin America

Leticia CuevasRegulatory Analyst

[email protected]



First North American Country to adopt GHS

Mexico • When? Adopted UN GHS – 3rd edition June 4, 2011• Why? To assist the chemical industry already

burdened with dual labeling and safety data sheet requirements.

Before GHS adoption, NOM-018-STPS-2000 mandatory for chemical industry

After GHS, chemical industry has option of using GHS (voluntary), or using NOM-018-STPS-2000 (still in force)


First North American Country to adopt GHS

Highlights:• Mexico GHS contains 5 Annexes that mirror the UN

Purple Book 3rd Edition (2009)• Annex 1 describes the allocation of labeling elements• Annex 4 fully explains the 16-Section format and

content of the Safety Data Sheet. • It is a voluntary standard, therefore there are no

transitional periods• When using GHS, all communication must be written

in Spanish (as is required by NOM-018-STPS-2000)


Central American Countries soon to adopt GHS

GuatemalaGHS Pending Implementation

Highlights• Under second revision by the Ministry of Environment and

Natural Resources• GHS Regulations – targeted for 2013 for Chemicals and

Transport • Include Classification, Labeling and Safety Data Sheet

requirements• Currently, because there is no current regulation in place,

Guatemala accepts UN Purple Book



El SalvadorGHS Pending Implementation

HighlightsEl Salvador has been working toward:

• Approved tariff codes related to pesticides and ozone-depleting substances.

• On transport of dangerous goods. El Salvador accepts the codes set forth in the framework of the U.N.

• On special substance matter: waste and hazardous waste regulation issued through (Decree No. 41, June 2000). Articles 52 to 69 establish the kinds of identification of dangerous materials and the type of labeling (which correspond to those that are accepted internationally for the transport of dangerous goods of the UN (Orange Book) and the emergency response Guidebook).



HondurasGHS Pending Implementation

HighlightsThe Ministry of the Environment and Natural Resources published: “Environmentally Rational Management of Hazardous Chemicals, which is the draft of the GHS regulation.”

• Classification, Labeling and Safety Data Sheet requirements for hazardous chemicals

• Waiting to be signed by President of Honduras• Like Guatemala, Honduras accepts UN Purple Book


South American GHS Countries

Brazil

ABNT NBR 14725: Chemicals - Information about safety, health and environment (2009)

– Part 1: Terminology– Part 2: Hazard Classification– Part 3: Labeling – Part 4: Safety data sheet for chemicals (SDS)

• With the exception of Part 2, currently in review, the transitional periods have changed since 2009:



Brazil (continued)ABNT NBR 14725 Revisions

• Part 1: Terminology , Chemicals – Information about safety, health and environment- Corrected version: 2010 (in force)

• Part 2: Hazard Classification (ABNT 14725:2009)- Corrected version 2010 (in force)- Under revision (update expected mid-2013)

• Part 3: Labeling (ABNT 14725:2012)- June 14, 2012- Corrected version: Aug. 16, 2012

• Part 4: Safety data sheet for chemicals (SDS) (ABNT 14725:2012)- Aug. 3, 2012



Brazil (continued)ABNT NBR 14725 Transitional Periods

Ø While Part 2: Classification, is still being revised and , according to ABNT, should be ready sometime in 2013, the transitional periods under this regulation:

February 26, 2011 for Substances already expiredJune 1, 2015 for Mixtures

Ø Part 3: Labeling of June 14, 2012transitional period for Substances, has expired.

Ø December 10, 2012 However, for Mixtures, using this standard is optional until:

Ø May 31, 2015, BUT as of Ø June 1, 2015,

chemical products MUST BE LABELED in accordance to ABNT 14725-3:2012



Brazil (continued)ABNT NBR 14725 Transitional Periods

Basis for ABNT 14725-4 was based on Ordinance SIT No. 229 (NR26) of May 24, 2011, issued by the Ministry of Labor and Employment

Ø Part 4: Safety Data Sheet of August 3, 2012

transitional period for Substances, has expired:Ø February 3, 2013

But the transitional period for Mixtures is:June 1, 2015

ABNT-14725-4:2012 is a 16-Section Format based on UN Purple Book 3rd EditionLanguage Requirement: the Safety Data Sheet must be prepared in Brazilian Portuguese



UruguayGHS implemented through Presidential Decree 307/009 of July 3, 2009

– Entry into force originally 120 days after publication in Official Gazette

– Transition period for labeling of chemicals was one year after its publication in Official Gazette.

• Annex 1 - Labels• Annex 2 - Safety Data Sheets (SDS)

– adopt the guidelines of the GHS



Uruguay (Continued)But…

Decree 346/011 of September 28, 2011, published on Oct. 13, 2011:– To extend the transitional period to give companies sufficient time to

comply with the labeling requirements– To require min. labeling information (Annex I)

• Substances (Dec. 31, 2012—expired)• Mixtures (Dec. 31, 2017)

– To require min. information on SDS (Annex II)Safety Data Sheet requirements mirror UN Purple Book - 16 Sections,

etc.– Language Requirement: The SDS must be in Spanish language no

matter where the chemical product was manufactured.


GHS Status of South American Countries

ArgentinaIRAM Standards and GHS Alignment

Safety Data SheetIRAM standard No. 41400/2006 of October 02 is an identical adoption of ISO (1: 1994 11014) chemical safety data sheet with 16 sections. According to IRAM, the standard is being revised for alignment with the GHS 4th

edition. (It was scheduled for late 2012 release, but now it needs to be updated with observations ; therefore, a future release date is unknown.)

LabelingIRAM 41401 on labeling of chemicals is also being revised. When published, it will

also be aligned with GHS 4th Edition and will repeal IRAM 3797, currently in force.At this time, the standard is up for public comments.



EcuadorINEN Standards and GHS

Classification, Labeling and Packaging of Hazardous ChemicalsEcuador’s GHS version was published in the Official Gazette No. 881 on January 29, 2013. Currently, the standard is voluntary, but once Technical Regulation No. 078 is published, which could be in late 2013, INEN 2266:2013 will become mandatory. When this happens, both the standard and the Technical Regulation will be required.The purpose of INEN 2266:2013:

Ø It establishes the requirements that must be met for the transport, storage and handling of hazardous materials.Its Scope:

Ø It applies to activities in production, marketing, transport, storage and handling of hazardous materials.



Ecuador (Continued)INEN Standards and GHS

The Safety Data Sheet (SDS) is found in Annex B, which has 16 Sections and requires the SDS to be written in Spanish.

The standard also specifies that the labeling of containers and packaging must also be in Spanish.

NTE INEN 2266: 2013 combines the UN Purple and Orange Books: Annexes A through D are the Purple Book Component. Annexes F through L belong to the Transport Component (Orange Book).

Labeling • INEN 2288: 2000 This labeling standard for hazardous industrial chemicals is still in force and

it is mandatory. The standard contains label precautions and specifications.



PeruGHS Status

• Peru does not have a regulatory framework for labeling of chemicals and for Safety Data Sheets; however, it is working on ways to implement the GHS within its regulatory framework.

Labeling and Safety Data Sheets

• Peru accepts labeling and Safety Data Sheets created under the UN GHS System – Purple Book


Regional GHS Developments

Mercosur-GHSThere is a current initiative in cooperation with the EC to implement GHS into Mercosur.

Why? Total HarmonizationAccording to some experts, currently there is no total harmonization, at least in Latin American

countries:• In Mexico there are a set of standard rules that implement the GHS regarding the

classification, labeling and chemical safety data sheets. However, they are voluntary.• In Brazil there is a similar situation to the one in Mexico, we have a series of standards

concurring with GHS, but some are believed to be voluntary. • Argentina has a voluntary standard concurrent also with GHS, but its Safety Data Sheet

standard is voluntary. • Ecuador’s GHS standard is quite unusual with two Books in one, and until the Technical

Regulation is published, it is just a voluntary standard.• Uruguay’ decree, which was modified to extend the deadline for implementation of

substances and mixtures, requires the application of the GHS.


GHS Standards—Voluntary or Mandatory?

JapanJapan’s GHS concurring standards have obligated companies to “use best efforts” to comply. However, on 27 March, Japan published a new GHS-based standard, JIS Z 7253, combining two current standards. Under the new standard, the Japanese Ministry of Health, Labor and Welfare obligates companies to comply with the standard at the latest by 31 December 2016, when the transitional period ends and use of the two current standards is no longer allowed. Implementation of the standard, is 1 April 2012.

Russia To determine whether Russia’s GHS standards (GOSTs and GOST R) are voluntary or mandatory:Law on Technical Regulation, N 184-ФЗ (as amended through March 3, 2012) specifies:Ø Art. 2 - GOSTs and GOST R are voluntary

ØArt. 46.1GOSTs and GOST R are mandatory if: 1. related to environment or health, and 2. no specific technical regulation pertaining to the subject is adopted

Because Russia has no technical regulations on this subject matter – classification, labeling and SDS, the GOST and GOST R are to be followed - mandatory)


Global GHS Developments

CroatiaNow , Countries such as Croatia are just concluding the preparationand capacity-building activities for EC CLP and GHS.

Highlights:Croatia is to become the newest member of EU on July 1, 2013.

ü Published on February 15 in the Official Gazette:• Decision on the Proclamation of the Chemicals Act (18/2013).

- establishes the legal framework for implementing in Croatia the REACH, CLP, and Prior Informed Consent (PIC) Regulations (i.e., 1907/2006/EC, 1272/2008/EC, and 689/2008/EC), among others.

ü Approved two amendments on February 6, 2013 to its current laws:• implementing the European Union’s REACH and CLP Regulations,

respectively.



Croatia (continued)ü Published, on February 15, 2013, amendments (that enter into force July 1, 2013

on the day Croatia officially joins the European Union):• To expand the Ministry of Health’s executive powers with regard to the laws,

sanctioning it to issue regulations for REACH’s and CLP’s implementation in Croatia, and

• To authorize other government agencies to act in its stead to do the same. - Most provisions of the act refer directly to EU legislation, applying community

requirements for chemicals classification, SDS compilation, import and export, and marketing and use. - The act preserves some provisions specific to Croatia, including the obligation to

electronically notify the Croatian Institute for Toxicology and Antidoping (CITA; www.hzt.hr) before chemicals are placed on the domestic market.

http://www.hzt.hr



India • has a draft concurrent with GHS, titled, Hazardous Substances Rules,

2011. • Published by Ministry of Environment and Forests on July 8, 2011 on:

Classification, Packaging and LabelingIt covers 685 chemicals and classifies 9 classes of physical hazardsThe Labeling component is Harmonized with the transport of dangerous

goods (UN Orange Book)Ø The Safety Data Sheet (SDS) has 16 sections in a GHS formatØ After publication in the Official Gazette, the regulation will become

effective 360 days after publication.


2013 GHS Developments in Latin America

Thank you.

[email protected]


Ginette Bouchard

Bayer Inc. (Toronto) Canada

April 30, 2013

GHS - A Canadian Industry Perspective

Bayer Inc.

Agenda Implications for industry in Canada

WHMIS: what will change?/what will stay the same?

GHS activities in Canada

How industry can prepare for implementation

Implications for Industry in Canada

GHS affects the following key Canadian sectors:• Health Canada

• Workplace Chemicals (WHMIS)• Pest Control Products• Consumer Chemical Products

• Transport Canada

• Transportation of Dangerous Goods (TDG)

Pharmaceuticals, food additives, cosmetics and pesticide residues in food will be captured where workers may be exposed and in transport.

Bayer Inc.

WHMIS: What Will Change?• New classification criteria

• New hazard classes

• Material Safety Data Sheets (MSDS) will be known as Safety Data Sheets (SDS) - 16 sections, in a specified order (accepted for use now)

• New requirements for labels

• New hazard symbols (pictograms)

Bayer Inc.

WHMIS: What Will Stay the Same?• WHMIS will not be replaced by the GHS

• Roles and responsibilities for suppliers, employers and workers still remain• Suppliers:

• classify hazardous products• prepare labels and SDSs and provide to customers

• Employers:• educate and train employees• ensure the controlled products have WHMIS labels• ensure SDSs on file are current and are accessible

• Workers:• participate in the training provided

Bayer Inc.

GHS Activities in Canada• December 2011 - the prime minister of Canada and the U.S. president

announce the Joint Action Plan for the Canada-U.S. Regulatory Cooperation Council

• Health Canada’s focus has always been to align as much as possible with the U.S., while making sure the level of protection is not reduced

• Legislative and regulatory changes will be required at both the federal and provincial/territorial levels

• Amendments to the Hazardous Products Act (HPA) are expected to be tabled by this Spring (2013)

• Required changes to the Controlled Products Regulations (CPR) are also expected to be ready for publication and consultation around the same time

• Target implementation date is June 1, 2015 – in sync with the U.S.

Bayer Inc.

Preparing for Change• Familiarize yourself with the “Purple Book”

• Stay informed/participate in consultations

• Have ongoing discussions with your IT personnel, health & safety personnel, WHMIS trainers, etc. – to identify and implement the changes that will be required to your existing programs and systems

• Assemble a “change team”

• Look at the possible implementation costs for your organization, and establish a plan/budget

Bayer Inc.

Thank you!Ginette Bouchard – Bayer Inc. (Toronto) Canada

April 30, 2013

Q&A session

If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.



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