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The implementation of the noise directives in a Member State Renata Sisto Department of Occupational Hygiene Monte Porzio Catone (Roma), ITALY [email protected] OSH Seminar, Bucharest, October 20-21, 2005 1 SUMMARY • Hearing loss as the first occupational disease in Italy • Early effects on hearing of noise exposure • An evaluation of current law efficacy in risk control • Perspectives and outlooks OSH Seminar, Bucharest, October 20-21, 2005 2 Noise / Hearing Loss Industry, services and agriculture - years 1999÷2004. (data from Italian National Institute of Public Accident Insurance INAIL ) Notification year Hearing impairment in listed occupational fields Hearing impairment in non listed occupational fields N. R. N. 1999 5843 2015 6640 12483 2000 5379 879 6374 11753 2001 4816 549 5943 10759 2002 3641 465 3698 7339 2003 2631 357 3663 6294 2004 2178 209 3725 5903 N: Notified on suspicion R: recognized and refunded R. TOTAL Noise induced Hearing impairment OSH Seminar, Bucharest, October 20-21, 2005 N. R. 3 Noise / Hearing Loss Occupational hearing impairment cases notified on suspicion to INAIL (industry, services, agriculture) Occupational Hearing impairment 14000 12000 10000 8000 6000 4000 2000 0 1999 2000 2001 2002 2003 2004 Notification year OSH Seminar, Bucharest, October 20-21, 2005 4 Noise / Hearing Loss Occupational hearing impairment cases recognized and refunded by INAIL (industry and services) Occupational hearing impairment cases recognized by INAIL 2500 2000 1500 1000 500 0 1999 2000 2001 2002 2003 2004 OSH Seminar, Bucharest, October 20-21, 2005 5 Noise / Hearing loss Noise induced hearing loss is at day the first occupational disease Between 1999 and 2004 the Italian National Institute of Public Accident Insurance (INAIL) recognized and refunded in industry, and services occupational fields about 4470 new cases of occupational noise induced hearing loss. During the years 1999-2004 the percentage incidence of noise induced hearing impairment results to be near 50% of the total number of notified cases of occupational disease OSH Seminar, Bucharest, October 20-21, 2005 6 Noise / Hearing loss Occupational noise-induced hearing impairment is still a major phenomenon, even if its general evolution shows an important and constant decrease, from 12483 cases notified on suspicion in 1999 to 5903 cases notified on suspicion in 2004, and from 2015 cases recognized and refunded in 1999 to 209 cases recognized and refunded in 2004. OSH Seminar, Bucharest, October 20-21, 2005 7 Aging-induced hearing loss 20 years Hearing threshold dB 30 years 50 years 60 years 65 years OSH Seminar, Bucharest, October 20-21, 2005 8 Exposure duration (years) Hearing threshold dB Noise-induced hearing loss OSH Seminar, Bucharest, October 20-21, 2005 9 The ISO 1999 (1990) standard The ISO 1999 standard provides the algorithms to calculate the NIPTS (Noise Induced Permanent Threshold Shift) at different percentiles as a function of frequency, of personal daily exposure level LEX, 8h and of exposure duration, in years. The NIPTS which corresponds to the median of the distribution (50° percentile) can be calculated with the use of the following formula: N0,50 = [u + v log(q/q0)](Lex, 8h – L0)2 where u, v and L0 are functions of frequency and q is the duration in years of the exposure OSH Seminar, Bucharest, October 20-21, 2005 10 The ISO 1999 (1990) standard NIPTS relative to fiftieth percentile at 4000 Hz Permanent Threshold Shift (dB) 45 NIPTS Lexp 80 NIPTS Lexp 87 NIPTS Lexp 95,7 NIPTS Lexp 100 40 35 30 25 20 15 10 5 0 0 5 10 15 20 Exposure time (years) 25 OSH Seminar, Bucharest, October 20-21, 2005 30 35 11 The ISO 1999: 1990 standard It is the standard currently used to estimate the dose-effect relation also by the Italian National Institute of Public Accident Insurance (INAIL) The ISO standard gives the predicted hearing threshold H’, expressed in decibel, as function of the age and of the noise exposure: H’ = H + N – (HN/120) where: H is the predicted hearing threshold, in decibel, as function of the age (HTLA); N is the noise induced permanent threshold shift (NIPTS) The H and N values are given in different percentile ranges OSH Seminar, Bucharest, October 20-21, 2005 12 Cochlear gain and feedback • The outer hair cells (OHCs) are the heart of an active feedback mechanism that permits to obtain high sensitivity to low amplitude signals and a good frequency discrimination capability. • The amplification gain associated with this system can be estimated of order 40 dB. • Noise induced damage initially affects OHCs, with a reduction of this gain resulting in a corresponding increase of the hearing threshold. OSH Seminar, Bucharest, October 20-21, 2005 13 Outer hair cells (OHCs) schematics TM IHC=mechanoelectrical transduction OHC=electromechanical transduction BM OSH Seminar, Bucharest, October 20-21, 2005 14 Noise exposure and early hearing impairment • Experimental data show that even in the cases in which there has not been observed yet a hearing threshold increase corresponding to the clinical definition of hearing impairment (threshold higher than 20 dB at one or more audiometric frequency), the hearing threshold undergoes a statistically significant increase in the populations of subjects exposed to noise. • In the next figure a comparison is shown between the average hearing threshold of non exposed (normal) and exposed subjects. Even if for the exposed population there is not yet any clinically defined hearing loss (for the MHL class, 10dB<HT≤20dB), the degradation of the threshold (with the characteristic frequency dependence of noise induced hearing loss) is already visible with respect to the non exposed subjects of the same age. OSH Seminar, Bucharest, October 20-21, 2005 15 Comparison of average audiometric thresholds between a population of young (mean age=30 years) exposed (MHL, HL) and non exposed subjects (Normal) 0 Normal non exposed MHL Hearing Loss (dB HTL) -5 HL -10 exposed -15 exposed -20 -25 -30 0 2000 4000 f (Hz) 6000 8000 OSH Seminar, Bucharest, October 20-21, 2005 10000 16 A new diagnostic technique based on otoacoustic emissions can be used to detect the early effects of noise exposure Comparison of TEOAE SNR between a population of young (mean age=30 years) exposed (MHL, HL) and non exposed subjects TEOAE SNR in third of octave bands 20 HL MHL TEOAE SNR (dB) 15 exposed not exposed 10 exposed 5 0 -5 0 1000 2000 3000 4000 5000 6000 f (Hz) OSH Seminar, Bucharest, October 20-21, 2005 17 Noise / State of the Art Actual evaluation and control of risk from occupational noise exposure The risk evaluation reports in some productive fields are either absent or unsatisfactory from a qualitative point of view. The technical reports often lack fundamental information The level of performance of the law against noise implementations is not sufficient. In particular, the implementations relative to the technical, organizational and procedural participations are disregarded. OSH Seminar, Bucharest, October 20-21, 2005 18 Noise / State of the Art Actual evaluation and control of risk from occupational noise exposure There is no territorial uniformity in the risk evaluation reports and also in the regional regulations Official statistical studies are absent relative to occupational noise exposure in Italy. A national data base is absent containing the personal daily exposure level in the different occupational fields. OSH Seminar, Bucharest, October 20-21, 2005 19 Noise / State of the Art Actual evaluation and control of risk from occupational noise exposure According to the data communicated to Italian National Institute for Prevention and Safety at Working Places (ISPESL), the workers officially exposed to personal noise levels above 90dB(A) are 41000, and the workers exposed to levels in the range 80dB(A) < LEX, 8h < 90dB(A) are about 12000. These data are evidently underestimated, if one thinks that there are in Italy more than three millions of companies OSH Seminar, Bucharest, October 20-21, 2005 20 Noise / Risk evaluation The risk evaluation reports in some particular occupational field are totally absent or they are insufficient from a qualitative point of view. Transports: in many public or private transport companies a noise risk evaluation is still absent due to an incorrect interpretation of the Italian law. Schools: the noise risk evaluation is totally absent although occurrence of hearing impairment pathologies is growing among the teachers. OSH Seminar, Bucharest, October 20-21, 2005 21 Noise / Risk evaluation in schools ISPESL is promoting a national project research about noise risk at school. High noise levels were found, especially in maternal and elementary schools. The high levels of noise cause hearing impairment and insurgence of laryngopathologies in teaching staff and they cause learning difficulties and loss of attention in pupils. The high levels of noise are principally due to the architectural characteristic of scholastic buildings. For example: -the insufficient insulation of the classrooms cause high levels of disturbances produced by external sources -reverberating effects from the walls produce sound distortion and loss of speech intelligibility OSH Seminar, Bucharest, October 20-21, 2005 22 Noise / Risk evaluation in schools Maternal school Teachers (a.m. turn) LEX,8h= 85.3 ± 1.8 dB(A) (dosimetric methodology) LEX,8h= 84.3 ± 2.9 dB(A) (phonometric methodology) Lpeak= 123.5 dB Maternal school Teachers (p.m. turn) LEX,8h= 85.8 ± 1.4 dB(A) (dosimetric methodology) LEX,8h= 84.3 ± 2.3 dB(A) (phonometric methodology) Lpeak= 123.5 dB Non teaching staff LEX,8h= 80.9 ± 1.4 dB(A) (phonometric methodology) Lpeak= 110.7 dB Nataletti P., Pieroni A. in Acustica and Scholastic Environments. Venezia, 5 maggio, 2005 OSH Seminar, Bucharest, October 20-21, 2005 23 Noise / Technical reports The technical reports are often incomplete and not exhaustive. Hearing protectors: it is very rare to find in the reports the effective degree of protection given by the personal protective equipments calculated in agreement with the standard EN 458 (2001) OSH Seminar, Bucharest, October 20-21, 2005 24 Hearing protectors Attenuation is a statistical variable characterized at each octave frequency band by a mean value and by a standard deviation APV ( f ) m( f ) s( f ) This statistical aspect is often neglected in technical reports so leading to an underestimate of the actual noise exposure. OSH Seminar, Bucharest, October 20-21, 2005 25 density(%) Probability densità di probabilità Gaussian probability distribution 10 8 6 m-s 4 m+s 34% 34% 2 0 15 20 25 30 35 40 45 attenuazione Attenuation (dB) Population in the interval between m-s and m+s OSH Seminar, Bucharest, October 20-21, 2005 26 Probability density densità di probabilità (%) Gaussian probability distribution 10 8 6 m-s 4 84% 2 0 15 20 25 30 35 40 45 attenuazione(dB) Attenuation (dB) The mean attenuation m(f) minus 1 standard deviation, (m-s), is the minimum attenuation for 84 % of the population of exposed subjects OSH Seminar, Bucharest, October 20-21, 2005 27 m - s The choice = 1 is currently done without considering that 16% of workers have an attenuation lower than the assumed minimum value. The attenuation data reported by manufacturers are referred to the minimum attenuation for the 84% of the population. The italian regulations do not sufficiently stress this statistical aspect. Neglecting the statistical nature of the attenuation given by hearing protectors could produce mistakes in the risk evaluation. OSH Seminar, Bucharest, October 20-21, 2005 28 Hearing protectors / Real attenuation The attenuation data reported by manufacturers are referred to the maximum attenuation evaluated in standardized conditions. In working places the conditions are very different 1) 2) 3) 4) 5) 6) 7) 8) workers are not formed to the use of hearing protectors the wearing conditions are not optimized the size is often not optimized there are anthropometric differences in the external ear the hearing protectors have to be worn for a long time there are uncontrolled movements (mandibular, etc.) the wearing conditions are affected by physical activity discomfort The attenuation of hearing protectors in working places are lower than those declared by manufacturer OSH Seminar, Bucharest, October 20-21, 2005 29 Hearing protectors / Real attenuation Work di ambiente enviroment(min) lavoro (min) Work di ambiente enviroment(max) lavoro (max) Declared by produttore attenuazione (dB) 0 10 20 manufacturer 30 40 50 60 125 250 500 1000 2000 4000 8000 (Hz) frequenza Frequency (Hz) Muffle Mean attenuations and their standard deviations declared by manufacturer compared to those measured in a real work environment OSH Seminar, Bucharest, October 20-21, 2005 30 Hearing protectors / Formation effect attenuazione (dB) 0 No instructions nessuna istruzione With ainstructions istruzioni corredo Practical demonstration dimostrazion e pratica Declared by manufacturer produttore 10 20 30 40 50 60 125 250 500 1000 2000 4000 8000 frequenza (Hz) 0 10 nessuna No instructions istruzione 20 istruzioni Witha corredo demonstration 30 Practical dimostrazione pratica Declared produttore by manufacturer 40 50 attenuazione (dB) attenuazione (dB) 0 10 instructions 20 30 40 50 60 60 125 250 500 4000 8000 1000 2000 OSH Seminar, Bucharest, October 20-21, 2005 frequenza (Hz) 125 250 31500 1000 2 frequenza (H Risk evaluation in call centers Call centers: This is a case in which the methodology given by the current law to perform risk assessment is totally inadequate. The incorrect risk evaluation standard methodology (phonometric measurements with a microphone at 10 cm from the ear) causes an underestimate of exposure levels, and consequently, an insufficient level of protection. The solution is a new methodology based on an artificial manikin and/or a miniaturized microphone inserted into the ear canal. The first methodology is being standardized in Italy. OSH Seminar, Bucharest, October 20-21, 2005 32 Methodology and instrumentation for the inside and outside evaluation of noise Manikin method (ISO/DIS 11904-2 (2000). “Acoustics Determination of sound immissions from sound sources placed close to the ears - Part 2: Technique using a manikin (manikin-technique)” ) 1. Noise is measured at tympanic height with the manikin microphones; 2. A correction is performed using the transfer function (provided by the manufacturer, by the ISO 11904-2 or experimental) 3. Elaboration of the recorded spectrum provides an estimate of the noise outside the ear that would produce inside it the measured noise OSH Seminar, Bucharest, October 20-21, 2005 33 Manikin used for the measurements Manikin: B&K 4128 Right Ear: B&K 4158 Left Ear: B&K 4159 Outer Ear: B&K DZ 9752 OSH Seminar, Bucharest, October 20-21, 2005 34 Frequency response provided by Bruel & Kjaer for the manikin 4128 C, valid in conditions of diffuse field and free field 18 B&K campoFree liberofield 16 B&K campoDiffused diffuso field 14 (dB) (dB) Gain Guadagno 12 10 8 6 4 2 0 20 40 80 160 315 630 1.25k 2.5k 5k 10k 20k Frequenza(Hz) (Hz) Frequency OSH Seminar, Bucharest, October 20-21, 2005 35 Equivalent sound levels outside the operator ear, estimated using the frequency response provided by B&K for diffuse field. Amplification volume Sound level (dB(A)) Mean dev. Call center Standard min max Level I 71.8 1.9 69.7 73.5 Level II 77.8 1.7 75.9 80.7 Level III 81.8 1.7 79.9 84.1 Level I 77.3 1.3 75.9 78.5 Level II 80.3 2.3 76.7 83.0 Level III 84.2 1.7 82.4 87.0 Data from Peretti et al., 2002 OSH Seminar, Bucharest, October 20-21, 2005 36 The noise directive 2003/10/CE News The new directive applies to all occupational fields. This is a clear improvement with respect to the old one. It introduces new action and limit value based on LEX,8h and/or to Lpeak limit value: 87 dB(A) LEX,8h and/or 140 dB(C) Lpeak upper action value: 85 dB(A) LEX,8h and/or 137 dB(C) Lpeak lower action value: 80 dB(A) LEX,8h and/or 135 dB(C) Lpeak Decrease by 5 dB in the main requirements (formation, DPI, …) OSH Seminar, Bucharest, October 20-21, 2005 37 The noise directive 2003/10/CE Critical points The limit value of 87 dB(A) proposed by the new noise directive includes the hearing protectors. In other words, the attenuation given by hearing protectors has to be taken into account when assessing if the limit is being adhered to. Consequently, the limit value is not well defined. The real protection given by personal protective equipments is dependent on several variables such as real environmental conditions, wearing procedures and workers formation. The average attenuation given by hearing protectors is about 20 dB: so the limit value is adhered to also if the environmental levels rise to 110 dB(A) So the serious risk exists that the employees will continue to be exposed to high environmental noise level. The employee protection could result to be based less on technical and procedural measures to reduce noise emission and exposure, and more on checking the behaviour of employees. OSH Seminar, Bucharest, October 20-21, 2005 38 The noise directive 2003/10/CE Critical points Another critical point is related to the fact that in the new noise directive there are no technical enclosures providing methodologic and metrologic instructions for the measure of noise exposure and of hearing function in exposed workers. The lack of technical enclosures requires detailed national guidelines to help the operators in the field of occupational prevention and safety. In Italy, ISPESL has promoted the development of such guidelines, also providing widespread diffusion of this information, which is freely available online on the web page: http://www.ispesl.it/linee_guida/fattore_di_rischio/rumore_eng. htm OSH Seminar, Bucharest, October 20-21, 2005 39 Italian national guidelines on noise National guidelines for evaluation of risk from noise exposure in working places OSH Seminar, Bucharest, October 20-21, 2005 40 Conclusions and outlooks The aim of the new directive was to introduce more protective standards for the noise exposure, by shifting the requested countermeasures to the immediately lower threshold level, and by setting at 87 dB a threshold that must not be exceeded in any case. On the other hand, the introduction of DPI attenuation in the evaluation of the effective noise level could lead to confusion and metrological difficulties in practical applications. The challenge that must be faced by national institutions is that of explaining how to apply the new criteria without the risk of lowering the effective level of protection of workers OSH Seminar, Bucharest, October 20-21, 2005 41