Risk Reduction Strategy and Analysis of Advantages and Drawbacks for Octabromodiphenyl Ether Final Report Prepared for Department for Environment, Food and Rural Affairs Contract Reference: 16/13/33 RPA June 2002 OCTABROMODIPHENYL ETHER RISK REDUCTION STRATEGY AND ANALYSIS OF ADVANTAGES AND DRAWBACKS FINAL REPORT June 2002 prepared for Department for Environment, Food and Rural Affairs by Risk & Policy Analysts Limited, Farthing Green House, 1 Beccles Road, Loddon, Norfolk, NR14 6LT, UK Tel: +44 1508 528465 Fax: +44 1508 520758 Email: [email protected] Web: www.rpaltd.co.uk RPA REPORT - ASSURED QUALITY Project: Ref/Title J355I/Octa Approach: In accordance with tender specification, RPA proposal and Steering Group input Report Status: Final Report Prepared by: Caspar Corden, Consultant Meg Postle, Director Approved for issue by: Meg Postle, Director Date: 24 June 2002 If printed by RPA, this report will be printed on 100% recycled, chlorine-free paper Risk & Policy Analysts EXECUTIVE SUMMARY 1. Introduction Under Regulation 793/93/EEC, octabromodiphenyl ether is a priority substance for risk assessment and, where necessary, risk management, at the European Union level. The UK and France are jointly responsible for addressing the risks associated with octabromodiphenyl ether (for the environment and human health respectively). Both the human health and environmental risk assessments have identified areas where there is a need for risk reduction. Furthermore, both have identified areas where there is a need for further information and/or testing and, given the uncertainties, where there may be a need for precautionary action to be taken to reduce the risks. The Department for Environment, Food and Rural Affairs (DEFRA) has contracted Risk & Policy Analysts Limited (RPA) to develop the risk reduction strategy for octabromodiphenyl ether. The present report is the Final Report on the study, recommending the risk reduction strategy formulated during the course of the project. 2. The Risks of Concern There are two areas where a definite need for risk reduction measures - conclusion (iii) - has been identified in the draft risk assessments for human health and the environment (subject to any further changes). Firstly, for the environment, there is a risk for secondary poisoning via the earthworm route for the hexabromodiphenyl ether component in the commercial product. This is related primarily to the settling out of dust during the mixing stages of polymer processing and subsequent washing down of floors and equipment to waste water. This leads to the deposition of octabromodiphenyl ether on soil through sewage sludge into which the substance is partitioned. Secondly, in relation to human health, there is a risk relating to systemic, developmental, female fertility and local toxicity, resulting from repeated inhalation and dermal exposure to octabromodiphenyl ether as a dust in the workplace (although local toxicity only relates to inhalation exposure). This risk arises during bag emptying as part of compounding and master batching activities. Whilst worker protection measures are likely to be in place already, it cannot be confirmed that these are universally applied. Additionally, there are several areas where a need for further information and/or testing has been identified, relating to both human health and environmental risks. For these areas, it has been concluded that there is a possible need for precautionary action and that consideration should be given at a policy level to investigating risk management options now in the absence of adequate scientific knowledge. Key concerns for the environment are the suitability of the current risk assessment approach for secondary poisoning and the possible debromination of octabromodiphenyl ether in the environment. - i - Octabromodiphenyl ether - Final Report For human health, there are concerns regarding the presence of octabromodiphenyl ether (and lower congeners in particular) in breast milk and subsequent breast feeding and also for prolonged exposure. This also relates to humans exposed to the substance via the environment, from all life-cycle stages including in-service use and disposal of products. At the first Steering Group meeting in December 2001, it was agreed that consideration should be given in the risk reduction strategy both to measures that will target the areas where there has been identified a definite need for risk reduction and also to measures that would target the possible risks for which there is a need for further information and/or testing. Therefore, the study has considered a number of risk reduction options that could address those areas where there is a definite need for risk reduction (for health and the environment) and also those where the need for risk reduction is less clear. Any decision taken upon the need for implementing measures to address the latter would ultimately be a political one. Thus, the aim herein has been to identify the possible implications of risk reduction measures in order to provide a basis for any such decision. For the environment, where a definite need for risk reduction has been identified1, the concern relates predominantly to emissions at the local level. However, for the areas where there is less certainty about the conclusions, the full range of environmental emissions need to be taken into account. Diffuse sources, particularly during the service life and from ‘waste remaining in the environment’ contribute more than polymer processing to total emissions at the regional and continental level. Risk reduction measures considered for the areas where less certainty exists have, therefore, been wider in scope than for the area where a definite need for risk reduction has been identified. This also applies to the potential measures considered to address the human health concerns. 3 Summary of Markets for Octabromodiphenyl Ether Table 1 summarises data on the quantities and values of octabromodiphenyl ether sold in the EU, the flame-retarded plastics in which it is used and the final electrical and electronic equipment products. The data include total estimated usage of octabromodiphenyl ether, including that imported to the EU within products. 4. Availability of Substitutes for Octabromodiphenyl Ether Table 2 presents information on the suitability of various alternatives to octabromo- diphenyl ether in terms of technical performance, health and environmental risks and cost implications. It should be noted that this table is based upon the available information, which in many cases is significantly less than that for octabromodiphenyl ether. 1 Relating to secondary poisoning via the earthworm-based food chain for the hexabromodiphenyl ether congener released to waste water mainly during use in polymer processing. - ii - Risk & Policy Analysts Table 1: Summary of Estimated Market Data for Octabromodiphenyl Ether Quantity Value (€m) Octabromodiphenyl ether 1,350 tpa a 4.9 ABS containing octabromodiphenyl ether 9,000 tpa 12.5 b E&E products containing ABS with octabromodiphenyl ether 3,000,000 (#) 900 Notes: a Only around 450 tpa imported as the substance itself, with remainder in polymers. b Value of ABS assumed at €1 per kg, with octabromodiphenyl ether at €3.6 per kg and used at a concentration of 15% w/w. # = number of items. Based upon this analysis, there are alternatives to octabromodiphenyl ether available for which existing data do not indicate an equivalent or higher level of risk to health or the environment. This is especially true of reactive type flame retardants that will have significantly lower emissions during the service life of products. However, for all of the potential substitutes identified, the existing data on toxicological and ecotoxicological effects are fewer than for octabromodiphenyl ether. Given that none of these substances have yet undergone a risk assessment as rigorous as those carried out under ESR, it is inevitably not possible to compare the risks on a like-for-like basis (and thus to assure absolutely that substitution would result in an overall reduction in risks to health and the environment). The results of the further testing and assessment that is ongoing for some of the potential substitutes should help to resolve the differences in data availability to a degree. Nonetheless, based on the information presented in Annex 3, it is evident that some of the substances do have data available on some of the key endpoints of concern for octabromodiphenyl ether (e.g. developmental toxicity) and that these indicate lower toxicity. There are also other options for replacing octabromodiphenyl ether, without utilising a substitute flame retardant. These include redesign of the electrical or electronic products or use of polymers with lower rates of combustion. Whilst we have inadequate data to estimate the likely costs of such techniques, it is considered that they are likely to be more expensive than using octabromodiphenyl ether in most cases (at least in the short-term). It would appear that most of the substitution options could result in some adverse cost implications. This is true both of substitutes for octabromodiphenyl ether where used in ABS (except for TBBPA) and also for alternatives that would require substitution of the polymer as well (such as ABS for PC/ABS blends). 5. Identification and Assessment of Possible Risk Reduction Measures A number of potential risk reduction measures were identified during the previous stages of this study. The following options have been