Republic of of Turkey Republic Turkey Ministry of

Republic of of Turkey Republic Turkey Ministry of and Social Security, Ministry of. Labour and Social Security Directorate General of Occupational Health and Safety Center Özgen TİMUÇİN Chemical Engineer Hygiene Department

OCCUPATIONAL EXPOSURE LIMITS (OELs)

INDUSTRIAL HEALTH MANAGEMENT Working Environment Control Work Control Health Control Safety and Health Education

OCCUPATIONAL SAFETY AND HEALTH MANAGEMENT SYSTEM v Chemical Risk Assessment v Measurement and Evaluation Methods for Harmful Substance Exposure Concentrations

MEASUREMENT and EVALUATION METHODS for HARMFUL SUBSTANCE EXPOSURE CONCENTRATIONS Method for Estimating Exposure Concentration Measurement of exposure concentration A) Working environment measurement (Area monitoring) B) Exposure concentration of each worker (Personal monitoring) C) Biological monitoring

MEASUREMENT and EVALUATION METHODS for HARMFUL SUBSTANCE EXPOSURE CONCENTRATIONS Personal monitoring Area monitoring Biological monitoring

EXPOSURE Exposure is the with chemical • v Exposure is contact the contact with substances, chemical high/low temperatures, vibrations or noise, other substances, high/low noise, temperatures, hazard by persons in the workplace. vibrations or other hazard by persons in the The exposure to chemical substances occurs by workplace. inhalation, skin contact or swallowing, though inhalation is often the route in workplaces. • v. For a given hazard, the greater the exposure, the greater the risk of an adverse effect on health. This is the because of the exposureresponse relationship.

CHEMICAL EXPOSURE LIMIT • Exposure is thelimit contact with maximum chemical Exposure is the substances, high/low concentration that atemperatures, large numbernoise, of vibrations or other hazard without by persons in the workers can tolerate adverse workplace. affects on health, even if repeated for consecutive days. (Tolerance Levels / Threshold Limit Values [TLV] by American • The exposure to chemical substances occurs by Conferenceskinofcontact Governmental Industrial inhalation, or swallowing, though Hygienistsis[ACGIH]) inhalation often the route in workplaces.

CHEMICAL EXPOSURE LIMITS Recommend or mandotary occupational exposure limits (OELs) have been developed in many countries for airborne exposure to gases, vapours and particulates. The most widely used limits, called threshold limit values (TLVs), are those issued in the USA by the American Conference of Governmental Industrial Hygenists (ACGIH)

Occupational Exposure Limits ACGIH: American Conference of Governmental Industrial Hygienists NIOSH: National Institute of Occupational Safety and Health OSHA: Occupational Safety and Health Administration

Occupational Exposure Limit Values: Definitions • Short term exposure limit(TLV-STEL); or maximum concentration of a substance (a) for a continuous 15 -minute exposure period, (b) for maximum of 4 such periods for day, (c) with at least one 60 -minute exposure-free period between two exposure periods, and (d) provided the daily TLV-TWA is met.

Occupational Exposure Limit Values: Protecting Workers Health Definitions Threshold Limit Value (TLV): For gases and vapors, TLV is stated as parts per million (ppm) of surrounding air, and for fumes, mists, and dusts as milligrams per cubic meter (mg / m³) of surrounding air. TLV is classified in three ways: • Time-weighted average (TLV-TWA) exposure limit: The maximum average concentration of a chemical in air for a normal 8 -hour working day and 40 -hour week.

Occupational Exposure Limit Values: Protecting Workers Health Definitions

Occupational Exposure Limit Values: Definitions • Ceiling exposure limit (TLV-C) or maximum exposure concentration that should not be exceeded under any circumstance, while meeting the daily TLV-TWA. • Permissible Exposure Limits (PEL): The difference between TLVs and PELs is the agencies from which they come. • Biological exposure indices (BEIs)

Occupational Exposure Limit Values: Protecting Workers Health (EU) There are three main types of limit values: v Indicative Occupational Exposure Limit Values (IOELVs) v Binding Occupational Exposure Limit Values (BOELVs) v Biological Limit Values (BLVs)

SCOEL: Scientific Committee on Occupational Exposure Limits DG EMPL: DG for Employment

Determination of Occupational Exposure Limit Values (EU procedure) üDG EMPL consults with the Advisory Committee of Safety and Health at Work (ACSH) in developing OELs. üWhen an OEL is proposed by DGEMPL, the legislative procedure starts.

Significance of EU- Indicative Occupational Exposure Limit Values (IOELVs) üCommunity IOELVs are health-based, non-binding values, derived from the most recent scientific data available and taking into account the availability of measurement techniques. They set threshold levels of exposure below which, in general, no detrimental effects are expected for any given substance after short term or daily exposure over a working life time. They are European objectives to assist the employers in determining and assessing risks. üSocio-economic and technical feasibility factors are not taken into account when establishing IOELVs. (Art 3 Council Directive 98/24/EC )

Significance of EU- Indicative Occupational Exposure Limit Values (IOELVs) üFor any chemical agent for which an indicative OEL value is established at EU level, Member States must establish a national exposure limit value, taking into account the Community indicative limit value, determining its nature in accordance with national legislation and practice. (Art 3 (3) Council Directive 98/24/EC)

Significance of EU- Indicative Occupational Exposure Limit Values (IOELVs) The Directives: Council Directive 98/24/EC • Directive 2000/39/EC, establishing a first list of IOELVs • Directive 2006/15/EC, establishing a second list of IOELVs. • Directive 91/322/EEC, which was based on an earlier legal framework (Directive 80/1107/EEC), is still in force. • Directive 89/391/EC

Significance of EU- Binding Occupational Exposure Limit Values (BOELVs) üBOELVs take account of socio-economic and technical feasibility factors as well as the factors considered when establishing IOELVs. Therefore, when setting a BOELV policy considerations are of major importance. (Art 3 (4) Council Directive 98/24/EC) üFor any chemical agent for which a BOELV value is established at EU level, Member States must establish a corresponding national binding OEL value which can be stricter, but cannot exceed the Community limit value. ( Art 3 (5) Council Directive 98/24/EC)

Biological Limit Values (BLVs) & Biological Exposure Indıces (BEIs) Biological limit value or biological tolerance value for occupational exposures is defined as the maximum permissible deviation from the norm of biological parameters induced by these substances in exposed humans. The BLV is established on the basis of currently available scientific data which indicate that these concentrations generally do not affect the health of the employee adversely, even they are attained regularly under workplace conditions.

Biological Limit Values (BLVs) & Biological Exposure Indıces (BEIs) BLV can be defined as concentration or rates of formation or excretion (quantity per unit time). BLVs are conceived as ceiling values for healthy individuals. They are generally established for blood and urine and take into account the effects of the substance and an appropriate safety margin, being based on occupational medical and toxilogical criteria for the prevention of adverse effects on health.

Derivation of Biological Limit Values (BLVs) & Biological Exposure Indıces (BEIs) The derivation of a BLV can be based on various constellations of scientific data which reveal a quantitive relation ship between exposure concentration and body burden and therefore permit the linking of OEL and BLVs.

Criteria for the selection of priority substances When selecting candidate priority substances for setting OELs, the following criteria are taken into account: • Epidemiological evidence including reported cases of illhealth in the workplace • Availability of toxicological data • Severity of effects • Number of persons exposed • Availability of data on exposure • Availability of measurement methods

Exposure limits data of each country Argentina: Maximum permissible concentrations or threshold level values (TLVs) are listed (in Spanish) in Annex III of Decree No. 351/79 introducing regulations under Law Nº 19. 587 concerning occupational safety and health. Australia: Exposure standards are available on the Hazardous Substances Information System (HSIS) database of the Australian Safety and Compensation Council (formerly the Australian National Occupational Health and Safety Commission, NOHSC).

Exposure limits data of each country Austria : Austrian occupational exposure limits are based on international and national sources such as the American Conference of Governmental Industrial Hygienists and the German MAK-Commission. The limits are fixed by the Bundesministerium für Wirtschaft und Arbeit (BMWA, Ministry of the Economy and Labour) and are published in the Austrian Governmental Journal as an ordinance Belgium: Occupational exposure limits (valeurs limites d'exposition professionnelle) are issued by the Ministry of Employment and Work and are listed in Annex 1 of the Arrêté royal du 11 mars 2002 relatif à la protection de la santé et de la sécurité des travailleurs contre les risques liés à des agents chimiques sur le lieu de travail.

Exposure limits data of each country Brazil : Exposure limits in Brazil are given in the Tabela de Limites de Tolerância in Annex 11 of Regulatory Standard NR N-15. They are issued under the authority of Decree Portaria No: 34 of 8 June 1978. Bulgaria : Exposure limits are listed (in Bulgarian) in Decree No: 13 of 30 December 2003 on the protection of workers against the risks ofexposure to chemical agents at work. Canada : Occupational exposure limits in Canada are regulated within each Province. In Alberta, exposure limits are listed in the Chemical Hazards Regulation (Alberta Regulation 393/88).

Exposure limits data of each country Cyprus: Exposure limits for Cyprus are listed (in Greek) in the Safety and Health at Work (Chemical Agents of Regulations 2001. ) Denmark: Exposure limits are listed in Danish in Grænseværdier for stoffer og materialer and in English in Limit Values for Substances and Materials. Estonia : In Estonia, occupational exposure limits are prepared and endorsed by the Ministry of Social Affairs. The limits are set with reference to current European Union and Swedish occupational exposure limits.

Exposure limits data of each country European Union: The legal basis for the preparation of occupational exposure limits and biological limits in the European Union is contained in Directive 98/24/EC on chemical agents and Directive 2004/37/EC on carcinogens and mutagens. Indicative Occupational Exposure Limit Values (IOELVs) are adopted through Commission Directives while Binding Occupational Exposure Limit Values (BOELVs) are adopted through Council and European Parliament Directives. IOELVs listed in Directives 91/322/EEC and 2000/39/EC and BOELVs listed in Directives 98/24/EC, 99/38/EC and 2003/18/EC. On 7 February 2006, the Commission adopted Directive 2006/15/CE establishing a second list of Indicative Occupational Exposure Limit Values (IOELVs) in implementation of Council Directive 98/24/EC and amending Directives 91/322/EEC and 2000/39/EC. This Directive establishes IOELVs for 33 substances following an evaluation by the Scientific Committee on Occupational Exposure Limits (SCOEL) of the latest available scientific data.

Exposure limits data of each country Finland: Concentrations of impurities in workplace air known to be hazardous and corresponding limit values for biological exposure indicators are published by the Finnish Ministry of Social Affairs and Health. France: Exposure limits are listed in Danish in Grænseværdier for stoffer og materialer and in English in Limit Values for Substances and Materials.

Exposure limits data of each country Hungary: Exposure limits are listed in A munkahelyek kémiai biztonságáról szóló 25/2000. (IX. 30. ) EüM-SZCSM rendelet [Ordinance No. 25/2000, of 30 Sept. , concerning the chemical safety of workplaces]. Ireland: Occupational exposure limits are listed by Ireland's National Authority for Occupational Safety and Health in Schedule 1 to the 2002 Code of Practice for the Safety, Health and Welfare at Work (Chemical Agents) Regulations, 2001. Japan : Occupational exposure limits for chemical substances are recommended by the Japan Society for Occupational Health (JSOH). Current values are listed in the Journal of Occupational Health.

Exposure limits data of each country Luxembourg: Exposure limits in Luxembourg are listed in Regulations concerning the protection of the health and safety of workers against the hazards of chemical agents, carcinogens and mutagens in the workplace, July 2002. Netherlands: Occupational exposure limits are listed by Ireland's National Authority for Occupational Safety and Health in Schedule 1 to the 2002 Code of Practice for the Safety, Health and Welfare at Work (Chemical Agents) Regulations, 2001. New Zealand: Exposure limits are available in Workplace Exposure Standards effective from 2002 published by the Occupational Safety and Health Service of the Department of Labour.

Exposure limits data of each country Norway: Administrative standards for contaminants in workplace air (Veiledning om administrative normer forurensning i arbeidsatmosfaere) are available from the Norwegian Labour Inspection Directorate. Slovakia: Exposure limits are listed (in Slovak) in Order No. 45/2002 of 16 Jan. 2002 on health protection while working with chemical agents and in Order No. 46/2002 of 16 Jan. 2002 on health protection while working with carcinogenic and mutagenic agents. South Africa: Occupational Exposure Limits for airborne pollutants in the Republic of South Africa are issued by both the Department of Labour and the Department of Minerals and Energy. Values are listed on the site of the South Africa Institute of Occupational Hygiene.

Exposure limits data of each country Spain: Occupational exposure limits are published by the National Institute for Occupational Safety and Health (Instituto Nacional de Seguridad e Higiene en el Trabajo, INSHT) in Límites de exposición profesional para agentes químicos en España. Sweden: Exposure limits are listed in Swedish in Hygieniska gränsvärden och åtgärder mot luftföroreningar (AFS 2005: 17) and in English in Occupational Exposure Limit Values and Measures Against Air Contaminants (AFS 2005: 17). Switzerland: Swiss occupational exposure limits are published by the Swiss Accident Insurance Institute (SUVA) in SUVA - Valeurs limites d'exposition aux postes de travail, published annually.

Exposure limits data of each country USA: Recommended exposure limits are developed and periodically revised by the National Institute for Occupational Safety and Health (NIOSH). These recommendations are then published and transmitted to the Occupational Safety and Health Administration (OSHA )for use in promulgating legal standards. Permissible exposure limits are published in the U. S. Code of Federal Regulations, Occupational Safety and Health Standards on Toxic and Hazardous Substances, 29 CFR 1910. 1000, Tables Z-1, Z-2, and Z-3. Permissible exposure limits and NIOSH recommended exposure limits are also available in the NIOSH Pocket Guide to Chemical Hazards. Threshold limit values (TLVs) and biological exposure indices (BEIs) are also issued by the American Conference of Governmental Industrial Hygienists (ACGIH). Information on the determination and use of these values and their availability may be found on the ACGIH website.

Exposure limits data of Turkey We have regulations according to standards of EU: Ø Regulation on Health and Safety Requirements Working with Carcinogen and Mutagen Substances was published on 26 th of December, 2003 (90/394/EEC) – (97/42/EEC)– (99/38/EC) Ø Regulation on Health and Safety Requirements Working with Chemical Substances was published on 26 th of December, 2003. Amendment on Official Journal 20 th of March, 200 (98/24/EC ) – (2000/39/EC) Ø Regulation on Protection of Workers from the Risks of Explosive Atmospheres was published on 26 th of December, 2003 (1999/92/EC)

Biological limits data of Turkey Recognising the importance of biological monitoring, we have regulations (Regulation on the Prevention of the Risks Related to Exposure to Biological Agents was published on 10 th of June 2004) according to standards of EU (2000/54/EC) about Biological monitoring. Under these regulations, workers who exposed to following hazards are regulated to undergo specific pre-employment and periodic medical examinations. These hazards are:

Biological limits data of Turkey v v v v Leads and its compounds Mercury and its compounds Arsenic and its compounds Cadmium and its compounds Manganese and its compounds Chromium and its compounds Beryllium and its compounds Phosphor & white phosphor and its compounds (organophosphates) Nitrogen oxide Carbon disulfide Benzene and its derivatives Halogenated hydrocarbons Aniline and its derivatives Hydrogen sulfide Free silica

PARAMETERS THAT HAVE BEEN IMPLEMENTED Parameter Specimen Blood (with heparin) Method AAS Lead Urine Delta Amino Levunilic Acid Urine Uro. Coproporphirin Urine Porphirin – T Reference Limit Values Chromotographic & Spectrophotometric &Colourimetric Chromotographic & spectrophotometric / chromotographic& fluorometric (qualitative) 40 µg/ 100 ml (normal value) 41 -59 µg/ 100 ml (acceptable value) mg/100 ml 0, 60 (negative) 0, 60 -1, 50 (medium level high) mg/100 ml) 1, 50 -3, 00 (high) 3, 00 -6, 00 (more higher) Coproporfirin 35 -150 µg/24 hour Uroproporfirin 15 -50 µg/24 hour 50 -200 µg/ 24 hour (for men) 35 -180 µg/ 24 hour (for women) > 59 µg/ 100 ml (pathologic value) > 6, 00 mg/100 ml critical level

PARAMETERS THAT HAVE BEEN IMPLEMENTED Parameter Protoporphirin (IX )(Erythrocyte) Specimen Method Blood (with EDTA and heparin) Reference Limit Values 0, 60 µg/ 100 ml (normal value) Urine Qualitative (-) Urine (8 hour, 24 hour) <20 mg/lt (normal value) 20 -40 mg/ lt (acceptable value) 5, 3 µg / g. Hb Porphoobilinogen TCA (tetrachloroethylen e) (SGOT, SGPT, GGT, EK G) Colourometricquantative & spectrophotometri c Hippuric acid Urine (24 hour) Colourometricquantative 200 -1600 mg/24 hour 41 -100 mg/lt (affected value) 100 -200 mg/lt (intoxication) > 200 mg/lt (high degree of intoxication, hazar dous)

PARAMETERS THAT HAVE BEEN IMPLEMENTED Parameter Specimen Urine Phenol Benzole Methemoglobin (nitro derivatives of alifatic hydrocarbons) Carboxyhemoglob in (CO) Method Spectrophotometri c &Colourometricquantative Blood Reference Limit Values > 20 mg/lt (normal value) 5 gama /dl (critical maximum value) Blood (with EDTA and heparine) Spectophotometri c < 20 mg/lt (pathologic value) 25 mg / lt (critical maximum value)

OEL VALUES EXAMPLE (GERMANY)

OEL

OEL DATABASE

Identification and Classification of Chemicals: Procedures of the Chemical Substances Threshold Limit Value Committee (ACGIH) The American Conference of Governmental Industrial Hygienists (ACGIH) is a professional organization whose members are primarily industrial hygienists working for local, state, or federal government agencies. The Chemical Substances Threshold Limit Value Committee of ACGIH produces guidelines for practicing industrial hygienists, which are published annually as Threshold Limit Values (TLVs).

Procedures of the Chemical Substances Threshold Limit Value Committee (ACGIH) v Epidemiologic studies having detailed exposure data; v Toxicologic studies in whole-body bioassays in mammals; v Epidemiologic studies of a descriptive nature; v Case histories from clinical records; v Short-term bioassays for genotoxicity; v Toxicologic studies of non-mammalian species; v Chemical structure analogy.

Calculation of OEL The approach used to set OELs was based on the "no-observed-effect-level/safety factor"(NOEL/SF)approach. 1. In this approach, all of the pertinent animal studies are reviewed and the highest dose that did not cause an effect in the most sensitive health endpoint (the NOEL) is identified.

Calculation of OEL 2. Once a NOEL has been identified, a set of uncertainty (or safety) factors are applied to this value to accommodate for limitations in the data and to try to assure that workers are protected. (The number and magnitude of these safety factors depend on the quality of the data. ) ***If a NOEL is not available, then a LOEL can be used. The LOEL, or lowest-observed effect-level, is the lowest dose that causes an effect in the most sensitive health endpoint.

Calculation of OEL = [(NOEL) x (human body weight)]/[(safety factor)n x (human breathing rate)] NOEL is typically in units of milligram of chemical administered/kilogram of animal body weight/day; Human body weight typically is assumed to be 70 kilograms for an adult male; Safety factors for accomodating limitations in the data, Breathing rate in workers typically is assumed to be 10 m 3/8 -hour workday.

Example of OEL Calculation Ø Example of using this approach for the synthetic estrogen, ethinyl estradiol: The NOEL in humans has been estimated to be around 3. 5 μ g/day. (Because it is reported in these units, there is no need to multiply by the human body weight). If one assumes a safety factor of 10 for the human variability in response and a breathing rate 10 m 3/8 -hour workday, then the OEL is estimated to be 0. 035 μ g/m 3.

Final Goal of the OHS Services: To improve workers quality of life

THANK YOU… Hediye Özgen TİMUÇİN otimucin@csgb. gov. tr