Public consultation remarks on the authorisation application for ENTEK use of trichloroethylene. Submission number: EP

Transcription

1 Public consultation remarks on the authorisation application for ENTEK use of trichloroethylene Submission number: EP Communication number: AFA-C /F Responses to remarks 14 th January 2015 A single document has been provided to ENTEK entitled ENETEK we assume this is from a single (unnamed) commenter. Specific comments in that document are addressed in the table below. Although the commenter s comments are not in the form of specific question we have divided them into specific areas and have provided a response on each in the table below. It is noted that a number of the commenter s remarks relate to the non-threshold properties of the substance as a carcinogen and the control of carcinogens in the workplace under different EU wide and member state legislation. Other comments relate to the use of n-hexane as an alternative. The following points are therefore highlighted: ENTEK s application has applied the method (as set out by ECHA) for calculation of excess risk from exposure in its application CSR exposure assessment. ENTEK believes it is also useful and informative to show exposure against the DNEL value for long terms systemic effects (based on the ioel) and this is shown in the assessment in addition to the assessment of excess cancer risk. ENTEK is fully aware of and meets its obligations under current EU regulations and Directives (as transposed into UK law). Through investment in a fugitive emissions reduction programme (as reported in the application) ENTEK has demonstrated substantial reductions in the use and losses of TRI and continues to identify and develop ways to further reduce emissions, losses and exposure. The reason for making this application is because no suitable alternative is available for the ENTEK process and although there may be drop-in alternatives that could provide a similar functionality to TRI the technical, risk and economic barriers to their use are demonstrated to make their use not feasible or would require more than a decade to put in place. Remark Response

2 1 Carcinogenic properties of Trichloroethylene (TRI) are known since a long time. In 1996 the Deutsche Forschungsgemeinschaft classified TRI as a proven carcinogen to humans. This classification has been confirmed and supported with additional data in In 2001, EU legislation (28. ATP to Directive 67/548/EEC) classified TRI as Carc.Cat. 2 (now Carc 1B according to CLP). 2 In 2007 REACH Regulation came into force, and in 2010 TRI was included into the Candidate List with the clear expectance of incorporating TRI into REACH Annex XIV. In 2010, the German AGS (committee on hazardous substances) published the risk-based occupational exposure limit (3.3 mg/m³) associated with a low cancer risk level, deemed as acceptable (work lifetime risk of 4 EE-05). Therefore, for all downstream users of TRI it was obvious since 17 years, that there is a need to substitute this carcinogenic substance. Since at least 7 years (since inclusion into Candidate List) it was clear, that there is an urgent need for substitution or at least for lowering occupational exposure below the risk based limit value of 3.3 mg/m³ (TWA). The classification of TRI is indicated in the application CSR and the assessment presented in the application is based on the substance as a non-threshold carcinogen. The reason for the authorisation application under REACH is exactly because a suitable substitute for TRI is not currently available. The argumentation for this is set out in the analysis of alternatives (AoA) which is part of the application. The applicant s site is in the UK and the UK regulator (the UK HSE) currently has a national OEL of 100 ppm (550 mg/m 3 ). The DNEL derived in the registration CSR and communicated in the supply chain is based on the ioel (as derived by the SCOEL as the safe working limit) at 10 ppm (55 mg/m 3 ). The risk-based occupational exposure limit (3.3 mg/m³) referred to does not legally apply in the UK. The exposure scenario in the application presents the cancer risk calculated form worker and general public exposure and also compares exposure to the DNEL (based on the ioel of 10ppm). The approach to the assessment is described in Section Comments on assessment approach related to toxicological hazard. The reason for taking both approaches is that is it informative to show the non-threshold risk, but the application of the DNEL (ioel) is the obligation that the applicant has today for control of worker exposure to TRI as communicated by its supplier through the esds. The inclusion of TRI onto the candidate list in 2010 did not require industrial

3 users to do anything in terms of not using the substance; rather it indicated the identification of the substance as an SVHC and indicated obligations for article manufacturers under Article 33 of REACH. The need to substitute carcinogens is indicated in the carcinogens directive (Directive 2004/37/EC - carcinogens or mutagens at work) and applies to TRI since it was classified as a Carc 1B in That directive indicates that limit values listed in Annex III should be not be exceeded - TRI is not listed on Annex III, so no specific limit value is listed today. The Directive states that wherever a carcinogen or mutagen is used, the employer shall: limit the quantities of a carcinogen or mutagen at the place of work; keep as low as possible the number of workers exposed; design the work processes so as to minimise the substance release; evacuate carcinogens or mutagens at source, but respect the environment; use appropriate measurement procedures (especially for early detection of abnormal exposures from unforeseeable event or accident); apply suitable working procedures and methods; use individual protection measures if collective protection measures are not enough; provide for hygiene measures (regular cleaning); inform workers; demarcate risk areas and use adequate warning and safety signs (including no smoking ); draw up emergency plans; use sealed and clearly and visibly labelled containers for storage, handling, transportation and waste disposal. 3 In this context, it is neither understandable nor acceptable that in all these years no R&D program was Neither of the statements from the commenter is supported. A comprehensive R&D programme is presented and the applicant is fully

4 conducted to test alternative solvents and/or technologies. The obvious longstanding ignorance of the need to substitute the carcinogen cannot be accepted as a reason or a justification for a prolonged review period. 4 The risk characterisation in the AfA is based on WRONG preconditions. Trichlorethylene (TRI) is a carcinogenic substance without threshold mode of action (see also ECHA RAC/28/2014/07 rec 2). For this substance NO health-based exposure limit value, i.e. no Derived No- Effect Level (DNEL) can be derived, but a risk based exposure limit value may be derived. A risk based exposure limit always hat to be associated with an acceptable cancer risk, typically a work lifetime risk of 4 EE-05. The reference to the acceptable cancer risk of 1 EE-06 per year (equal with 4 EE-05 per work lifetime) is also to be found in Reducing Risks, Protecting People. HSE s decision-making process (published 2001 by HSE). The same risk level (4:100,000 per work lifetime) is deemed acceptable in German regulation. aware of and implements the legislation that applies to TRI. The applicant has presented the argumentation for the lack of suitable alternatives in the AoA. In addition, an on-going and active research programme is focused on solvent and non-solvent alternatives as reported in the AoA. The suggestion of ignorance or lack of research is not founded, as evidenced by the documentation presented in the application. The AfA is NOT based on wrong precondidtions. TRI is assessed as a nonthreshold carcinogen and excess risk values are presented in the CSR. We refer the commenter to Section 9 and 10 of the CSR in which the risk of cancer from exposures to workers and to the general public are assessed by a method for calculating cancer risk as developed by ECHA. We refer to page 1 of the ES in which the approach is described: The risk assessment committee (RAC) of ECHA has determined that TRI is a substance for which no threshold for carcinogenic effects (kidney cancer) can be established and therefore has indicated that application of a doseresponse approach is required. This assessment therefore compared the exposure levels to the excess cancer risk as determined by the dose response curves supplied by ECHA. However, since the DNEL/iOEL approach is that which is communicated in the supply chain (i.e. from ENTEK s TRI supplier via the esds), this approach is applied in addition to that specified by the RAC. Both approaches are set out in this document. The commenter appears to have missed the assessment that clearly calculates the cancer risk on the basis of the method presented by ECHA. It is perhaps misleading of the commenter to suggest that the UK HSE applies this risk level ( 1 EE-06 per year ) in relation to all carcinogenic substances (in particular TRI). The HSE document referred to is a research document that is about the application of policy for the HSE s duties and covers a wide range of activities (not just control of chemicals in the workplace). Within that document the HSE reflects on risk and the tolerability of risk. The document does not specifically refer to tolerable

5 5 As shown in the AoA, there are some reasonable alternatives using NON-carcinogenic substances. Among others, n-hexane is a feasible alternative. n-hexane is neither a proven carcinogen nor a suspected carcinogen. For n-hexane a health-based OEL exists, i.e. a workplace air concentration below of which no adverse health effects occure. Due to current scientific knowledge this OEL is 180 mg n-hexane/m³ as 8-hour-TWA with a short time (15 min.) value 1440 mg/m³ (MAK Deutsche Forschungsgemeinschaft). Even though the DNEL is smaller (75 mg/m³), these limit value is more than 20 times higher than those for TRI. n-hexane shows a vapour pressure not much higher than that of TRI. Therefore the use of n-hexane provides a large margin of flexibility in operating the plant under different levels set for specific carcinogenic substances (in fact the risk level refers to risk of death and not of contracting cancer). The HSE document does however mention how the UK HSE sets specific occupational exposure limits (OELs) based on occupational exposure standard (OES) and a maximum exposure limit (MEL) - that is of course set out in more detail elsewhere (Health and Safety Executive guidance booklets EH40, Occupational exposure limits and EH64, Summary criteria for occupational exposure limits, both published annually). The commenter is reminded that the current OEL in the UK for TRI is 100 ppm (550 mg/m 3 ) - Workplace exposure - limit Long-term exposure limit (8-hr TWA reference period)) and 150 ppm (820 mg/m 3 ) - Short-term exposure limit (15 minute reference period) see EH40/2005 Workplace exposure limits Containing the list of workplace exposure limits for use with the Control of Substances Hazardous to Health Regulations (as amended).hse Books March The commenter appears to have interpreted the HSE report as an enforcement policy rather than an explanatory document that informs policy. The risk level might be set out in German Regulation, but it is not (to our knowledge) set out in UK law on chemicals or adopted at EU level. N-hexane is demonstrated in the applicant s AoA to be not suitable for ENTEK s process on the basis of risk and economic infeasibility, The AoA sets out clearly why n-hexane is not a suitable alterative for TRI for the ENTEK process. Please refer to section 5.2 of the AoA, which concludes: N-hexane is not a technically feasible alternative because the extraction and drying steps are an integral part of the continuous process that ENTEK uses to manufacture battery separators. The potential consequence of a fire or explosion with over ~34,000 litres of hexane being circulated in a closed loop process at the UK plant would be catastrophic. The extraction and drying steps could not be isolated without a complete retrofit of the ENTEK manufacturing process and the plant infrastructure. The large cost to switch to hexane compared to the costs of building additional production lines in the US, means this alternative is also not economically feasible. Even if such

6 conditions, compared with an air concentration restricted to 3.3 mg/m³. a project were completed at great capital expense, the human health risks associated with hexane are substantial and would not justify a change from the current extraction solvent. As mentioned in Section 4 of the AoA, n-hexane is known to be used for the production of PE separators, but there are key technological reasons why ENTEK (and others) has opted for a continuous closed loop process using TRI. Interestingly, the competitor that uses n-hexane in France and one of its US operations, has elected to use TRI at its other three manufacturing locations (Thailand, China, USA) which have been more recently acquired or built. This fact indicates that this competitor views TRI as a better choice for the production of separators as compared to n-hexane. As well as the technological disadvantages of the use of n-hexane there are clear risk indicators for not switching to n-hexane, due to its flammability and its toxicity. N-hexane is currently classified as a reproductive toxin (albeit as a suspected reproductive toxin - Cat 3.) and it is also indicated to have specific target organ toxicity affecting the nervous system (STOT RE 2, H373). Although the substance is not currently an SVHC it is on the CoRAP list. Given the volatility of n-hexane and its low DNEL (long term DNEL for neurotoxicity for workers is 75 mg/m 3 (~21 ppm)) (the SCOEL ioel (1995) is 72 mg/m 3 (20 ppm)) 8 hour TWA), the problems associated with control of this substance are similar to TRI and the impacts to health, whilst not cancer, can cause long-term illness. The conclusion from a hazard and risk management point of view is that there is no advantage in use of n-hexane over TRI, the only advantage is that n-hexane is not designated as a SVHC today, although the indications are that it could well be subject to further restrictions on use in the future. The toxicological profile and the continued regulatory pressure on dangerous substances like n-hexane, mean that the considerable investment

7 6 The use of DNEL values in the ES is contrary to the provisions of REACH (see Annex I.1.0.1). A DNEL of 54.7 mg/m³ for 8 hr shift (36.7 mg/m³ for 12 hr shift) is used in the AfA instead of using a risk-based limit value. An incorrect CSR (e.g. containing DNELs for a nonthreshold substance) produced by the registrant of TRI cannot excuse the downstream user from applying appropriate data and proper RMMs. Furthermore, a downstream user has to communicate in upstream direction any information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him pursuant to REACH Article Being in contradiction to the SEA document (chapter 2.6.2), there is no safe level (in the document designated as DNEL ) for TRI. 8 Exposure Scenario 1: Use as process solvent in semiclosed systems (chapter 9.4): Measurements (personal sampling) conducted outside the enclosures show high exceedances of the limit value. Shift exposure levels up to 49 mg TRI/m³ are reported (meaning a 15-fold exceedance of the exposure limit of to switch from TRI to n-hexane cannot be easily justified It is incorrect to indicate that a risk-based limit value should be applied. An assessment of the excess risk is presented in the AfA as requested by ECHA. The CSR is correct and the use of the cancer risk approach is applied. In Section 10 the excess risk is described for workers and for general public. Tables 24 and 25 show the excess risk for workers as derived from measured data and from modelling, Table 26 shows the excess cancer risk for general public (man via the environment). Please note that the ENTEK s TRI supplier is fully aware of the ECHA position on TRI with regard to assessment (within authorisation applications) as a non-threshold substance. Note also that ECHA has not indicated that the registration dossier for TRI or esds communicated down the supply chain needs to be updated to assess the substance as non-threshold at this time. The CSR assesses TRI as a non-threshold carcinogen using the method requested by ECHA. This comment is not clear. However, as with an earlier comment it seems to suggest that the CSR does not assess the substance as a non-threshold carcinogen. As indicated above the substance is assessed as a non-threshold carcinogen in that the method for assessing cancer risk from exposure as set out by ECHA has been applied. In addition, a comparison with the DNEL is also made as, (as explained in the applicant s dossier) the applicant believes it to be useful to compare the exposure with the exposure limit that is currently applied (ioel). The commenter suggests the application of a limit which is not applicable. The assessment is based on worker monitoring (badged monitor) exposures. The exposure limit referred to by the commenter is not a limit that is

8 3.3 mg/m³). In endangered areas the mean air concentration is 23 mg TRI/m³ (invalid data or incorrect measured values had been excluded). Even in the laboratory, there are up to 16 mg TRI/m³ in the air, pointing to a very poor occupational health standard in this facility. All air concentrations were at least 4-times higher than the exposure limit (3.3 mg/m³). The exposure limit of 3.3 mg/m³ corresponds with an acceptable work lifetime risk of 4:100,000. Even the mean exposure level (23 mg/m³) is 7 times above the exposure limit. Since these measured values are 75th percentile values, 25% of air concentrations are higher than the cited levels and impose an accordingly higher risk on the workers. Referring to a risk based OEL of 3.3 mg/m³, the exposure levels in normal operation are up to 15 times higher than this benchmark. Static monitoring of workplace air outside the enclosure imposed in the UK or currently under REACH. The applicant s assessment uses a method to determine the cancer risk and also compares exposure to the ioel (10 ppm TWA). In the risk characterisation in section 10 of the ES of the application, the highest exposure level for workers is 29.3 mg/m 3 ; this gives a cancer risk of 3.52 x 10-4 i.e. a risk of 3.52 in 10,000 people. The exposure level in the laboratory is 15.6 mg/m 3 giving 1.87 x 10-4 i.e. a risk of just under 2 in 10,000 people. This is not indicative of poor levels of occupational health since levels are well below the ioel (55 mg/m 3 ), no standards are currently set in the UK for the acceptable level of cancer risk (see response to comment number 4 above). There is not an exposure limit set at 3.3 mg/m 3 in the UK or applied across the EU. It is incorrect to suggest that there is an exposure limit (even if there is one set in the German Regulation, it does not necessarily apply in the rest of the EU). Please note that the ECHA method for calculation of risk presents a curve with a break point at 6ppm; this acknowledges that the data that the curve is based on indicates lower levels of cancer risk at or below this concentration (this is of course built into the calculation of cancer risk exposure that is used in the applicant s assessment). The in the BAuA (the German Federal Institute for Occupational Safety and Health) document Exposure-risk relationship for trichloroethylene in BekGS 910 (2008), 6 ppm is described as the Point of departure ; the document states that below this point, there is no relevant cytotoxicity and thus a sublinear curve for the dose-risk relationship. Extrapolated cancer risk at 0.4 % (exposure peaks were not considered) The BAuA assessment for TRI in that document states that Low risk for carcinogenicity supported by negative and nonsignificant epidemiological findings and the risk level following a linear extrapolation; POD [point of departure] supported by an effect level on average of 32 ppm (cytotoxicity). Higher exposure not tolerable (criteria: risk still tolerated in NL; exposure peaks were not

9 shows concentration up to 85 mg TRI/m³ (i.e. 25-fold exceed of the risk based limit), given as 90th percentile values. Therefore, the workers underlying the Exposure Scenario 1 are subjected to a cancer risk up to 25 times higher than the acceptable cancer risk. This is not acceptable. 9 Implementation of more effective LEV and improvement of general ventilation could reduce the worker s exposure to TRI in a considerable extent. These improvements are indispensable, in particular to comply with EU legislation on Safety and Health at Work [see Articles 5 and 6 of CAD (98/24/EC) and Articles 4 and 5 of CMD (2004/37/EC)]. It should be noted that EU Workers Safety Directives (as minimum requirements) demand for minimisation of workers exposure especially to carcinogens. considered). Indeed from 0.6 to 6 ppm the BAuA document reports a reduced risk of tumour formation by two orders of magnitude in case of an exposure which is reduced by one order of magnitude. The commenter has quoted the highest 90 th percentile reading of the static monitoring, please note that the assessment uses the measured data from badge monitoring for the assessment since this is more representative of the worker exposure. Relevant OC and RRM are applied. The methods of control (LEV, general ventilation and enclosure) and prevention measures (PPE, RPE and working procedures) are reported in detail in the assessment. The commenter refers to the Directive 98/24/EC - risks related to chemical agents at work (the so called Chemical Agents Directive - CAD). That directive indicates that for any chemical agent for which an indicative occupational exposure limit [ioel] value is established at Community level, Member States must establish a national occupational exposure limit value, taking into account the Community limit value. Along the same lines, binding occupational exposure limit values and binding biological limit values may be drawn up at Community level taking into account feasibility factors. The commenter should note that the ioel (of 10 ppm) is applied and although the assessment is done in accordance with the risk-based method suggested by ECHA, assessment against the ioel is useful in this context. Article 5 and 6 of the directive refer to methods of control and specific protection and prevention measures, respectively. The methods of control (LEV, general ventilation and enclosure) and prevention measures (PPE, RPE and working procedures) are reported in detail in the assessment. The applicant shows full compliance with the provisions of the Directive, which is enacted in UK law under Control of Substances Hazardous to Health Regulations 2002 (COSHH) and other legislation. The control of the substance under the carcinogens directive (Directive 2004/37/EC - carcinogens or mutagens at work) is referred to in the

10 10 Suggested alternative: If an authorisation should be granted for the use, it is indispensable to include an EFFECTIVE LOCAL EXHAUST VENTILATION of work zones combined with ENHANCED GENERAL VENTILATION into the conditions to be given in the authorisation according to REACH Article 60/8. This conditions should guarantee, together with ongoing air monitoring, a mean TRI concentration not higher than 3.3 mg TRI/m³. Because the risk based exposure limit for TRI is heavily exceeded in the plant, any authorisation should NOT be granted without imposing conditions as described above, including air monitoring, on the applicant. response to question 2 above. A high level of control of TRI is maintained at the ENTEK site and the fugitive emissions control programme has demonstrated considerable reductions in fugitive emissions. We refer the commenter again to the parts of the application that explain and detail the losses of TRI and how the losses are controlled (see section 9 of the CSR). Clearly, the protection of workers from exposure to TRI is of the utmost importance; however this also needs to be balanced against losses of TRI to the environment and the potential for exposure of the general public to TRI from these emissions (which is also assessed in the application).