DRAFT REGULATIONS FOR HAZARDOUS CHEMICAL AGENTS (2018)

2018.11

E Lourens

• Scope of draft

• New short title

• New definitions

• Comparison of Regulations (1995 / 2018)

• GHS Incorporation

• Annexures 1-3

• Hazardous Chemical Agent

• Number of OELs & BEIs

• Way Forward

CONTENTS

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Chief Directorate Communication | 2011.00.00

SCOPE of draft

To make provision for the inclusion of the Globally Harmonised System for

the Classification and Labelling of hazardous chemicals (GHS or Purple

Book)

To update the Occupational Exposure Limits for chemicals

To update the Biological Exposure Index

Aim of Phase 1 draft

| 2017.11.17

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New title

• 1995 Title- Regulations for Hazardous Chemical Substances

• Proposed- Regulations for Hazardous Chemical Agents

“Agents” includes both single substances and mixtures

New proposed definitions

• “biological monitoring of exposure“

• “CAS number” or “chemical identity”

• “carcinogen” or “carc”

• “chemical agent”

• “consumer product”

• “container”

New proposed definitions

• “GHS classification”

means the GHS hazard classes and hazard categories assigned to a hazardous chemical agent;

• “hazard category”

New proposed definitions (2)

• “hazard class”

• “hazard pictogram”

means a graphical composition, including a symbol plus other graphical elements, such as a boarder, background pattern or colour that is intended to convey specific information, that is assigned in the GHS to a hazard class or hazard category;

New proposed definitions

• “hazard statement”

means a statement assigned in the GHS to a hazard class or hazard category describing the nature of the hazards of a hazardous chemical including, if appropriate, the degree of hazard;

• “Danger” “Warning”

New proposed definitions (2)

• “HCA” or “hazardous chemical agent”

• “importer”

• “in transit”

• “manufacturer”

• “OEL ceiling limit” or “ceiling limit” or “C“

New proposed definitions (3) • “OEL-ML” or “occupational exposure limit-

maximum limit”

means an HCA as listed in Table 2 of Annexure 2;

OLD CL

• “OEL-RL” or “occupational exposure limit-restricted limit”

means an HCA as listed in Table 3 of Annexure 2;

OLD RL

New proposed definitions (3)

• “OEL-Short Term Exposure Limit” or “STEL”

• “prohibited agent”

• “permanent respirator zone”

• “retailer”

• “precautionary statement”

New proposed definitions (4)

• “SDS” or “Safety Data Sheet”

• “sensitizer including: DSEN and RSEN”

• “signal word”

• “skin”

• “supplier”

• “UN IMO International Maritime Dangerous Goods Code”

• “UN Globally Harmonized System” or “GHS”

New proposed definitions (5)

• “UN Number”

• “UN Proper Shipping Name”

• “UN Transport of Dangerous Goods”

Comparison of Regulations (1995 / 2018)

Regulations for Hazardous Chemical Substances (1995)

Draft Regulations for Hazardous Chemical Agents (2018)

2. Scope of application 2. Scope of application

3. Information and training 3. Information, instruction and training

4. Duties of persons who may be exposed to hazardous chemical substances

4. Duties of persons who may be exposed to hazardous chemicals

5. Risk Assessment of exposure 5. Risk Assessment of exposure

6. Air Monitoring 6. Air Monitoring

7. Medical surveillance 7. Medical surveillance

8. Respiratory zone 8. Respiratory zones

9. Records 9. Records

9A Handling of hazardous chemical substances 9A Handling of hazardous chemicals

10. Control of exposure to HCS 10. Control of exposure to HCA

11. Personal protective equipment and facilities 11. Personal protective equipment and facilities

12. Maintenance of control measures 12. Maintenance of control measures

Comparison of Regulations (1995 / 2018)

Regulations for Hazardous Chemical Substances (1995)

Draft Regulations for Hazardous Chemical Agents (2018)

13. Prohibitions 13. Prohibitions

14. Labelling, packaging, transport and storage 14. Classification of HCA

14A. Safety Data Sheet (SDS)

14B. Labelling of HCA

14C. Packaging of an HCA

15. Disposal of Hazardous Chemical substances 15. Disposal of Hazardous Chemical Agents

16. Offences and penalties 16. Offences and penalties

17. Short title 17. Short title

Pause

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14 Classification of HCA

The manufacturer or importer of a chemical agent shall, before it is supplied to a workplace:

a) determine whether the chemical agent is an HCA;

b) ensure that GHS classification is carried out for the HCA; and

review the GHS classification, should a change in composition be made;

14A Safety Data Sheet (SDS) Subject to section 10(3)(b) of the Act, a safety data sheet, for an HCA shall be

prepared by an importer or, manufacturer before manufacture and if not reasonably practicable, immediately after manufacture but before import, provided that the safety data sheet is;

i. GHS compliant;

ii. classified for the HCA, in accordance with Regulation 14;

iii. reviewed at least once every 5 years;

iv. amended whenever necessary to ensure that it contains correct and current information, aligned to its GHS classification required in regulation 14(3), which includes new data regarding the hazard presented by an HCA, that changes its classification in a category or subcategory of a hazard class, or results in its classification in another hazard class;

v. given the most recent applicable date which, may be the date of first issue, review or amendment

14A Safety Data Sheet (SDS)

b) provided by the manufacturer or importer to any person, if the person is

i. likely to be exposed to the HCA;

ii. a medical practitioner who needs the information to treat a person who has been exposed to the HCA;

iii. an emergency service professional who requires the information to fulfil his or her duties as an emergency respondent;

c) provided by the supplier, before first supplying it to a workplace

d) obtained by the employer before the HCA is first supplied to the workplace

e) sub-regulations (1)(a) and (b) do not apply to a manufacturer or importer of a HCA who has not manufactured or imported the HCA in the past 5 years

14A Safety Data Sheet (SDS) 2) The information in the GHS compliant safety data sheet should be presented using the following 16 headings in the order given below, as may be updated from time to time;

• Section 1: identification of the substance/mixture and of the company/undertaking

• Section 2: hazards identification

• Section 3: composition/information on ingredients

• Section 4: first aid measures

• Section 5: firefighting measures

• Section 6: accidental release measure

• 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

• Section14: transport information

• Section 15; regulatory information

• Section16: other information

RHCS 1995 RHCA 2018

Subject to section 10(3) of the Act, every person who manufactures, imports, sells or supplies any hazardous chemical substance for use at work, shall, as far as is reasonably practicable, provide the person receiving such substance, free of charge, with a material safety data sheet in the form of Annexure 1, containing all the information as contemplated in either ISO 1 1014 or ANSIZ400.1.1993 with regard to- a) product and company identification; b) composition/information on ingredients; c) hazards identification; d) first-aid measures; e) fire-fighting measures; f) accidental release measures; g) handling and storage; h) exposure control/personal protection; i) physical and chemical properties; j) stability and reactivity; k) toxicological information; l) ecological information; m) disposal considerations; n) transport information; o) regulatory information; and p) other information: Provided that, where it is not reasonably practicable to provide a material safety data sheet, the manufacturer, importer, seller or supplier shall supply the receiver of any hazardous chemical substance with sufficient information to enable the user to take the necessary measures as regards the protection of health and safety. Every employer who uses any hazardous chemical substance at work, shall be in possession of a copy of Annexure 8 or a copy of sufficient information, as contemplated in subregulation (1). Every employer shall make Annexure 8 or sufficient information, as contemplated in subregulation (1), available at the request of any interested or affected person.

Subject to section 10(3)(b) of the Act, a safety data sheet, for an HCA shall be prepared by an importer or, manufacturer before manufacture and if not reasonably practicable, immediately after manufacture but before import, provided that the safety data sheet is;

i. GHS compliant; ii. classified for the HCA, in accordance with Regulation 14; iii. reviewed at least once every 5 years; iv. amended whenever necessary to ensure that it contains

correct and current information, aligned to its GHS classification required in regulation 14(3), which includes new data regarding the hazard presented by an HCA, that changes its classification in a category or subcategory of a hazard class, or results in its classification in another hazard class;

v. given the most recent applicable date which, may be the date of first issue, review or amendment

2) The information in the GHS compliant safety data sheet should be presented using the following 16 headings in the order given below, as may be updated from time to time; Section 1: identification of the substance/mixture and of the company/undertaking Section 2: hazards identification Section 3: composition/information on ingrédients Section 4: first aid measures Section 5: fire fighting measures Section 6: accidental release measure 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 Section14: transport information Section 15; regulatory information Section16: other information

14B Labelling of HCA

(1) With regard to labelling of a HCA:

(a) a manufacturer or importer of a HCA shall ensure that the HCA is correctly labelled as soon as practicable after manufacturing or importing;

(b) a supplier of a HCA shall not supply a HCA, if it is not correctly labelled;

(c) a retailer of a HCA shall not supply consumer products containing HCA, to be used in a workplace, if they are not correctly labelled;

(d) an employer shall:

– (i) ensure that a HCA used, handled or stored at the workplace is correctly labelled;

– (ii) ensure that a container labelled for a hazardous chemical is used only for the use, handling or storage of that hazardous chemical;

– (iii) so far as is reasonably practicable, ensure that when a HCA is transferred or decanted at the workplace, from its original container into a destination container, the destination container is correctly labelled for that HCA;

(iv) so far as is reasonably practicable, that a hazardous chemical in pipe work is identified by a label, sign or another way on or near the pipe work

14B Labelling of HCA 2) Subject to the provisions of subregulation (1) an HCA is correctly labelled, if the selection and use of label elements is in accordance with the GHS and is packed in a container that has a label:

a) which shall include:

– wording in at least the English language;

• the product identifier and where applicable the UN proper shipping name;

• the chemical identity of all HCA ingredients;

• the name, address, business and telephone number of the manufacturer; or the importer;

• an emergency telephone number, where support is available in at least the English language;

• any signal word, hazard statement, precautionary statement and pictogram consistent with the GHS classification of the HCA, made in accordance with Regulation 14;

b) which may include

• the quantity of the HCA in the package, unless this quantity is specified elsewhere on the package;

• the quantity of each HCA ingredient

• any information about the hazards, first aid and emergency procedures relevant to the HCA, not otherwise included in the hazard statement or precautionary statement:

• first aid measures

• an expiry date

Old Reg 14. Labeling, packaging, transport and storage

14. An employer shall, in order to avoid the spread of contamination of an HCS, take steps, as far as is reasonably practicable, to ensure:

a) that the HCS in storage or distributed are property identified, classified and handled in accordance with SABS 072 and SABS 0228;

b) that a container or a vehicle in which an HCS is transported is clearly identified, classified and packed in accordance with SABS 0228 and SABS 0229; and

c) that any container into which an HCS is decanted, is clearly labelled with regard to the contents thereof.

14C Packaging of an HCA

Packaging for an HCA shall satisfy the relevant requirements of UN Transport of Dangerous Goods for packaging and fastenings, or where applicable the UN IMO International Maritime Dangerous Goods Code, including the following requirements:

1)The manufacturer or importer of an HCA shall ensure that the HCA is correctly packed, as soon as reasonably practicable after manufacturing or importing, where correctly packed means;

• is in sound condition;

• will safely contain the chemical for the time the chemical is likely to be packed;

• is made of material that is compatible with, and will not be adversely affected by, the chemical;

• the packaging and fastenings are strong and solid throughout, to ensure that they will not loosen and will meet the normal stresses and strains of handling; and

• does not usually contain food or beverages and cannot be mistakenly identified as containing food or beverages

14C Packaging of an HCA

(2) An HCA, shall not supply the HCA if it is not correctly packed, as contemplated in subregulation (1);

(3) Where a retailer supplies an HCA into a container that is supplied by the person purchasing the chemical, then the retailer shall ensure that the HCA is correctly packed as contemplated in subregulation(1);

(4) The employer or self-employed person shall only receive, use, handle or store an HCA if it is correctly packed, as contemplated in subregulation (1)

Annexures

ANNEXURE 1

• Table 1: GHS HAZARD CLASSES1 – PHYSICAL HAZARDS

• Table 2: GHS HAZARD CLASSES2 – HEALTH HAZARDS

ANNEXURE 2

• Table 1: PROHIBITED SUBSTANCES

• Table 2: Occupational exposure limits- Maximum limits for hazardous chemical agents

• Table 3: Occupational exposure limits- Restricted limits for hazardous chemical agents

• Table 4: Biological Exposure Indices (BEI) for hazardous chemical agents

ANNEXURE 3

• HAZARDOUS CHEMICAL AGENT GUIDELINES (Paragraphs 1- 75)

Hazardous Chemical Agent

• “HCA” or “hazardous chemical agent” means a GHS aligned chemical agent as provided in Annexure 1;

Hazardous Chemical Agent

Annexure 1

• Table 1: GHS HAZARD CLASSES1 – PHYSICAL HAZARDS

• Table 2: GHS HAZARD CLASSES2 – HEALTH HAZARDS

• Referring to selected GHS building-blocks

Table 1: GHS HAZARD CLASSES1 – PHYSICAL HAZARDS

HAZARD CLASSES CATEGORIES / DIVISIONS / TYPES

Flammable gases Cat 1 Cat 2

Aerosols flammable and non-

flammable Cat 1 Cat 2

Oxidising gases Cat 1

Gases under pressure Cat 1

Compressed gas

Liquefied gas

Refrigerated liquefied gas

Dissolved gas

Flammable liquids Cat 1 Cat 2 Cat 3

Flammable solids Cat 1 Cat 2

Self-reactive agents and mixtures Type A Type B Type C Type D Type E Type F Type G

Pyrophoric liquids Cat 1

Pyrophoric solids Cat 1

Self-heating of agents or mixtures, Cat 1 Cat 2

Agents or mixtures which in contact

with water emit flammable gases Cat 1 Cat 2 Cat 3

Oxidising liquids Cat 1 Cat 2 Cat 3

Oxidising solids Cat 1 Cat 2 Cat 3

Organic peroxides Type A Type B Type C Type D Type E Type F Corrosive to metals Cat 1

Table 2: GHS HAZARD CLASSES2 – HEALTH HAZARDS

HAZARD CLASSES CATEGORIES

Acute toxicity Cat 1 Cat 2 Cat 3 Cat 4

Oral

Dermal

Inhalation

Skin corrosion/irritation Cat 1 Cat 2

Serious eye damage/eye irritation Cat 1 Cat 2

Respiratory or skin sensitisation Cat 1

Germ cell mutagenicity Cat 1 Cat 2

Carcinogenicity Cat 1 Cat 2

Reproductive toxicity Cat 1 Cat 2 Lactation

Specific Target Organ Toxicity - Single exposure Cat 1 Cat 2 Cat 3

Specific Target Organ Toxicity - Repeated exposure Cat 1 Cat 2

Aspiration hazard Cat 1

Source OELs

Limit Health Consideration

Analytical method

Sosio - economic

Regular scientific research

SA ML/RL

X X

NIOS- REL

X X

ACGIH – TLV

X X

UK - WEL X X

OEL & BEI review • Instruction by CI

• OEL’s - Subject to:

• Act “reasonably practicable”, consideration of risk and socio-economic factors

• SEIAS process – consider impact of changes

• Validation of source OEL’s

• Aim for future ease of updates

OEL & BEI review (2) • Guidance values such as ACGIH TLV’s, NIOSH

REL’s do not consider socio-economic factors - not aligned with “reasonably practicable”

• Legal values were reviewed. E.g:

• SA RHCS and DMR

• US – PEL’s

• UK WEL’s

• Australia / New Zealand

• EU Indicative OELV’s (health) or Binding OEL’s BOELV’s (socio-economic)

OEL & BEI review (3)

• OEL’s & BEI’s set at 2 x ACGIH TLV

• Alignment with DMR on selected OEL’s & other industry motivated OEL’s

• No OEL / BEI below the ACGIH TLV / BEI

• No OEL for mixtures

• If no OEL is prescribed – implement reasonably practicable limit

Source OELs

Limit Health Consideration

Analytical method

Sosio - economic

Regular scientific research

SA ML/RL

X X

NIOS- REL

X X

ACGIH – TLV

X X

UK - WEL X X

OELs & BEIs

37

1995

Proposal

Occupational Exposure Limits-

Control Limits - 32

Occupational Exposure Limits- Maximum Limits - 31

Occupational Exposure Limits-

Recommended Limits - 673

Occupational Exposure Limits- Restricted Limits- 455

Biological Exposure Indices (BEI) -29

Biological Exposure Indices (BEI) -43

Public Comment

• Format for comment available

• All comment in writing

• Submitted on but preferably before 14 December 2018

Way Forward STEP 1

• Approval and establichment of a Technical Committee

STEP 2 • Review/ Drafting of regulations

STEP 3 • Obtaining ACOHS (Advisory Council on Occupational Health and Safety) approval

STEP 4 • Ministerial Approval for public comment

STEP5 • Published for 90 day period in the Government Gazette

Step 6 • Consolidate and consider public comment

STEP 7 • Resubmit Draft to ACOHS

STEP 8 • Obtain legal opinion from State Law Advisors

STEP 9 • Draft to undergo language check and editing

STEP 10 • Socio-economic Impact Assessment System (SEIAS)

STEP 11 • Final ACOHS Approval

STEP 12 • Promulgation by the Minister

Thank You…

Chief Directorate OHS | 2017.11.17

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